Title 21 Food and Drugs Part 1300 to End

Revised as of April 1, 2011

Containing a codification of documents of general applicability and future effect

As of April 1, 2011

Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register

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Legal Status and Use of Seals and Logos The seal of the National Archives and Records Administration (NARA) authenticates the Code of Federal Regulations (CFR) as the official codification of Federal regulations established under the Federal Register Act. Under the provisions of 44 U.S.C. 1507, the contents of the CFR, a special edition of the Federal Register, shall be judicially noticed. The CFR is prima facie evidence of the original documents published in the Federal Register (44 U.S.C. 1510). It is prohibited to use NARA’s official seal and the stylized Code of Federal Regulations logo on any republication of this material without the express, written permission of the Archivist of the United States or the Archivist’s designee. Any person using NARA’s official seals and logos in a manner inconsistent with the provisions of 36 CFR part 1200 is subject to the penalties specified in 18 U.S.C. 506, 701, and 1017.

Use of ISBN Prefix This is the Official U.S. Government edition of this publication and is herein identified to certify its authenticity. Use of the 0–16 ISBN prefix is for U.S. Government Printing Office Official Edi- tions only. The Superintendent of Documents of the U.S. Govern- ment Printing Office requests that any reprinted edition clearly be labeled as a copy of the authentic work with a new ISBN.

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Page Explanation ...... v

Title 21:

Chapter II—Drug Enforcement Administration, Department of Justice ...... 3

Chapter III—Office of National Drug Control Policy ...... 247

Finding Aids:

Table of CFR Titles and Chapters ...... 319

Alphabetical List of Agencies Appearing in the CFR ...... 339

List of CFR Sections Affected ...... 349

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To cite the regulations in this volume use title, part and section number. Thus, 21 CFR 1300.01 refers to title 21, part 1300, section 01.

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The Code of Federal Regulations is a codification of the general and permanent rules published in the Federal Register by the Executive departments and agencies of the Federal Government. The Code is divided into 50 titles which represent broad areas subject to Federal regulation. Each title is divided into chapters which usually bear the name of the issuing agency. Each chapter is further subdivided into parts covering specific regulatory areas. Each volume of the Code is revised at least once each calendar year and issued on a quarterly basis approximately as follows: Title 1 through Title 16...... as of January 1 Title 17 through Title 27 ...... as of April 1 Title 28 through Title 41 ...... as of July 1 Title 42 through Title 50...... as of October 1 The appropriate revision date is printed on the cover of each volume. LEGAL STATUS The contents of the Federal Register are required to be judicially noticed (44 U.S.C. 1507). The Code of Federal Regulations is prima facie evidence of the text of the original documents (44 U.S.C. 1510). HOW TO USE THE CODE OF FEDERAL REGULATIONS The Code of Federal Regulations is kept up to date by the individual issues of the Federal Register. These two publications must be used together to determine the latest version of any given rule. To determine whether a Code volume has been amended since its revision date (in this case, April 1, 2011), consult the ‘‘List of CFR Sections Affected (LSA),’’ which is issued monthly, and the ‘‘Cumulative List of Parts Affected,’’ which appears in the Reader Aids section of the daily Federal Register. These two lists will identify the Federal Register page number of the latest amendment of any given rule. EFFECTIVE AND EXPIRATION DATES Each volume of the Code contains amendments published in the Federal Reg- ister since the last revision of that volume of the Code. Source citations for the regulations are referred to by volume number and page number of the Federal Register and date of publication. Publication dates and effective dates are usually not the same and care must be exercised by the user in determining the actual effective date. In instances where the effective date is beyond the cut- off date for the Code a note has been inserted to reflect the future effective date. In those instances where a regulation published in the Federal Register states a date certain for expiration, an appropriate note will be inserted following the text. OMB CONTROL NUMBERS The Paperwork Reduction Act of 1980 (Pub. L. 96–511) requires Federal agencies to display an OMB control number with their information collection request.

VerDate Mar<15>2010 07:57 May 04, 2011 Jkt 223073 PO 00000 Frm 00005 Fmt 8008 Sfmt 8092 Y:\SGML\223073.XXX 223073 erowe on DSK5CLS3C1PROD with CFR Many agencies have begun publishing numerous OMB control numbers as amendments to existing regulations in the CFR. These OMB numbers are placed as close as possible to the applicable recordkeeping or reporting requirements. OBSOLETE PROVISIONS Provisions that become obsolete before the revision date stated on the cover of each volume are not carried. Code users may find the text of provisions in effect on a given date in the past by using the appropriate numerical list of sections affected. For the period before April 1, 2001, consult either the List of CFR Sections Affected, 1949–1963, 1964–1972, 1973–1985, or 1986–2000, published in eleven separate volumes. For the period beginning April 1, 2001, a ‘‘List of CFR Sections Affected’’ is published at the end of each CFR volume. ‘‘[RESERVED]’’ TERMINOLOGY The term ‘‘[Reserved]’’ is used as a place holder within the Code of Federal Regulations. An agency may add regulatory information at a ‘‘[Reserved]’’ location at any time. Occasionally ‘‘[Reserved]’’ is used editorially to indicate that a portion of the CFR was left vacant and not accidentally dropped due to a printing or computer error. INCORPORATION BY REFERENCE What is incorporation by reference? Incorporation by reference was established by statute and allows Federal agencies to meet the requirement to publish regulations in the Federal Register by referring to materials already published elsewhere. For an incorporation to be valid, the Director of the Federal Register must approve it. The legal effect of incorporation by reference is that the material is treated as if it were published in full in the Federal Register (5 U.S.C. 552(a)). This material, like any other properly issued regulation, has the force of law. What is a proper incorporation by reference? The Director of the Federal Register will approve an incorporation by reference only when the requirements of 1 CFR part 51 are met. Some of the elements on which approval is based are: (a) The incorporation will substantially reduce the volume of material published in the Federal Register. (b) The matter incorporated is in fact available to the extent necessary to afford fairness and uniformity in the administrative process. (c) The incorporating document is drafted and submitted for publication in accordance with 1 CFR part 51. What if the material incorporated by reference cannot be found? If you have any problem locating or obtaining a copy of material listed as an approved incorporation by reference, please contact the agency that issued the regulation containing that incorporation. If, after contacting the agency, you find the material is not available, please notify the Director of the Federal Register, National Archives and Records Administration, 8601 Adelphi Road, College Park, MD 20740-6001, or call 202-741-6010. CFR INDEXES AND TABULAR GUIDES A subject index to the Code of Federal Regulations is contained in a separate volume, revised annually as of January 1, entitled CFR INDEX AND FINDING AIDS. This volume contains the Parallel Table of Authorities and Rules. A list of CFR titles, chapters, subchapters, and parts and an alphabetical list of agencies publishing in the CFR are also included in this volume. An index to the text of ‘‘Title 3—The President’’ is carried within that volume.

VerDate Mar<15>2010 07:57 May 04, 2011 Jkt 223073 PO 00000 Frm 00006 Fmt 8008 Sfmt 8092 Y:\SGML\223073.XXX 223073 erowe on DSK5CLS3C1PROD with CFR The Federal Register Index is issued monthly in cumulative form. This index is based on a consolidation of the ‘‘Contents’’ entries in the daily Federal Reg- ister. A List of CFR Sections Affected (LSA) is published monthly, keyed to the revision dates of the 50 CFR titles. REPUBLICATION OF MATERIAL There are no restrictions on the republication of material appearing in the Code of Federal Regulations. INQUIRIES For a legal interpretation or explanation of any regulation in this volume, contact the issuing agency. The issuing agency’s name appears at the top of odd-numbered pages. For inquiries concerning CFR reference assistance, call 202–741–6000 or write to the Director, Office of the Federal Register, National Archives and Records Administration, 8601 Adelphi Road, College Park, MD 20740-6001 or e-mail [email protected]. SALES The Government Printing Office (GPO) processes all sales and distribution of the CFR. For payment by credit card, call toll-free, 866-512-1800, or DC area, 202- 512-1800, M-F 8 a.m. to 4 p.m. e.s.t. or fax your order to 202-512-2104, 24 hours a day. For payment by check, write to: US Government Printing Office – New Orders, P.O. Box 979050, St. Louis, MO 63197-9000. ELECTRONIC SERVICES The full text of the Code of Federal Regulations, the LSA (List of CFR Sections Affected), The United States Government Manual, the Federal Register, Public Laws, Public Papers of the Presidents of the United States, Compilation of Presi- dential Documents and the Privacy Act Compilation are available in electronic format via www.ofr.gov. For more information, contact the GPO Customer Con- tact Center, U.S. Government Printing Office. Phone 202-512-1800, or 866-512-1800 (toll-free). E-mail, [email protected]. The Office of the Federal Register also offers a free service on the National Archives and Records Administration’s (NARA) World Wide Web site for public law numbers, Federal Register finding aids, and related information. Connect to NARA’s web site at www.archives.gov/federal-register.

RAYMOND A. MOSLEY, Director, Office of the Federal Register. April 1, 2011.

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Title 21—FOOD AND DRUGS is composed of nine volumes. The parts in these volumes are arranged in the following order: Parts 1–99, 100–169, 170–199, 200–299, 300–499, 500–599, 600–799, 800–1299 and 1300 to end. The first eight volumes, containing parts 1–1299, comprise Chapter I—Food and Drug Administration, Depart- ment of Health and Human Services. The ninth volume, containing part 1300 to end, includes Chapter II—Drug Enforcement Administration, Department of Jus- tice, and Chapter III—Office of National Drug Control Policy. The contents of these volumes represent all current regulations codified under this title of the CFR as of April 1, 2011.

For this volume, Michele Bugenhagen was Chief Editor. The Code of Federal Regulations publication program is under the direction of Michael L. White, assisted by Ann Worley.

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(This book contains part 1300 to End)

Part

CHAPTER II—Drug Enforcement Administration, Depart- ment of Justice ...... 1301

CHAPTER III—Office of National Drug Control Policy ...... 1401

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Part Page 1300 Definitions ...... 5 1301 Registration of manufacturers, distributors, and dispensers of controlled substances ...... 21 1302 Labeling and packaging requirements for controlled substances ...... 55 1303 Quotas ...... 56 1304 Records and reports of registrants ...... 64 1305 Orders for schedule I and II controlled substances 82 1306 Prescriptions ...... 90 1307 Miscellaneous ...... 102 1308 Schedules of controlled substances ...... 105 1309 Registration of manufacturers, distributors, importers and exporters of list I chemicals ...... 125 1310 Records and reports of listed chemicals and certain machines ...... 136 1311 Requirements for electronic orders and prescriptions ...... 159 1312 Importation and exportation of controlled substances ...... 179 1313 Importation and exportation of list I and list II chemicals ...... 194 1314 Retail sale of scheduled listed chemical products ... 205 1315 Importation and production quotas for ephedrine, pseudoephedrine, and phenylpropanolamine 1316 Administrative functions, practices, and procedures ...... 211 1321 DEA Mailing addresses ...... 222

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(xxxi) methandriol (17a-methyl- (lvii) stanozolol (17a-methyl-17b-hy- 3b,17b-dihydroxyandrost-5-ene) droxy-[5a]-androst-2-eno[3,2-c]-pyr- (xxxii) methenolone (1-methyl-17b- azole) hydroxy-5a-androst-1-en-3-one) (lviii) stenbolone (17b-hydroxy-2- (xxxiii) 17a-methyl-3b, 17b-dihydroxy- methyl-[5a]-androst-1-en-3-one) 5a-androstane (lix) testolactone (13-hydroxy-3-oxo- (xxxiv) 17a-methyl-3a,17b-dihydroxy- 13,17-secoandrosta-1,4-dien-17-oic acid 5a-androstane lactone) (xxxv) 17a-methyl-3b,17b- (lx) testosterone (17b- dihydroxyandrost-4-ene hydroxyandrost-4-en-3-one) (lxi) tetrahydrogestrinone (13b, 17a- (xxxvi) 17a-methyl-4- diethyl-17b-hydroxygon-4,9,11-trien-3- hydroxynandrolone (17a-methyl-4-hy- one) droxy-17b-hydroxyestr-4-en-3-one) (lxii) trenbolone (17b-hydroxyestr- (xxxvii) methyldienolone (17 -meth- a 4,9,11-trien-3-one) yl-17 -hydroxyestra-4,9(10)-dien-3-one) b (lxiii) Any salt, ester, or ether of a (xxxviii) methyltrienolone (17a-meth- drug or substance described in this yl-17b-hydroxyestra-4,9-11-trien-3-one) paragraph. Except such term does not (xxxix) methyltestosterone (17a- include an anabolic steroid that is ex- methyl-17b-hydroxyandrost-4-en-3-one) pressly intended for administration (xl) mibolerone (7a,17a-dimethyl-17b- through implants to cattle or other hydroxyestr-4-en-3-one) nonhuman species and that has been (xli) 17a-methyl-D1- approved by the Secretary of Health dihydrotestosterone (17bb-hydroxy-17a- and Human Services for such adminis- methyl-5a-androst-1-en-3-one) (a.k.a. tration. If any person prescribes, dis- ‘17-a-methyl-1-testosterone’) penses, or distributes such steroid for (xlii) nandrolone (17b-hydroxyestr-4- human use, the person shall be consid- en-3-one) ered to have prescribed, dispensed, or (xliii) 19-nor-4-androstenediol (3b, 17b- distributed an anabolic steroid within dihydroxyestr-4-ene) the meaning of this paragraph. (xliv) 19-nor-4-androstenediol (3a, 17b- (5) The term basic class means, as to dihydroxyestr-4-ene) controlled substances listed in Sched- (xlv) 19-nor-5-androstenediol (3b, 17b- ules I and II: dihydroxyestr-5-ene) (i) Each of the opiates, including its (xlvi) 19-nor-5-androstenediol (3a, 17b- isomers, esters, ethers, salts, and salts dihydroxyestr-5-ene) of isomers, esters, and ethers whenever (xlvii) 19-nor-4,9(10)- the existence of such isomers, esters, androstadienedione (estra-4,9(10)-diene- ethers, and salts is possible within the 3,17-dione) specific chemical designation, listed in (xlviii) 19-nor-4-androstenedione § 1308.11(b) of this chapter; (estr-4-en-3,17-dione) (ii) Each of the opium derivatives, including its salts, isomers, and salts of (xlix) 19-nor-5-androstenedione (estr- isomers whenever the existence of such 5-en-3,17-dione salts, isomers, and salts of isomers is (l) norbolethone (13 , 17 -diethyl-17 - b a b possible within the specific chemical hydroxygon-4-en-3-one) designation, listed in § 1308.11(c) of this (li) norclostebol (4-chloro-17b- chapter; hydroxyestr-4-en-3-one) (iii) Each of the hallucinogenic sub- (lii) norethandrolone (17a-ethyl-17b- stances, including its salts, isomers, hydroxyestr-4-en-3-one) and salts of isomers whenever the ex- (liii) normethandrolone (17a-methyl- istence of such salts, isomers, and salts 17b-hydroxyestr-4-en-3-one) of isomers is possible within the spe- (liv) oxandrolone (17a-methyl-17b-hy- cific chemical designation, listed in droxy-2-oxa-[5a]-androstan-3-one) § 1308.11(d) of this chapter; (lv) oxymesterone (17a-methyl-4,17b- (iv) Each of the following substances, dihydroxyandrost-4-en-3-one) whether produced directly or indirectly (lvi) oxymetholone (17a-methyl-2- by extraction from substances of vege- hydroxymethylene-17b-hydroxy-[5a]- table origin, or independently by androstan-3-one) means of chemical synthesis, or by a

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combination of extraction and chem- (7) The term compounder means any ical synthesis: person engaging in maintenance or de- (A) Opium, including raw opium, toxification treatment who also mixes, opium extracts, opium fluid extracts, prepares, packages or changes the dos- powdered opium, granulated opium, de- age form of a narcotic drug listed in odorized opium and tincture of opium; Schedules II, III, IV or V for use in (B) Apomorphine; maintenance or detoxification treat- (C) Codeine; ment by another narcotic treatment (D) Etorphine hydrochloride; program. (E) Ethylmorphine; (8) The term controlled substance has (F) Hydrocodone; the meaning given in section 802(6) of (G) Hydromorphone; Title 21, United States Code (U.S.C.). (H) Metopon; (9) The term customs territory of the (I) Morphine; United States means the several States, the District of Columbia, and (J) Oxycodone; Puerto Rico. (K) Oxymorphone; (10) The term detoxification treatment (L) Thebaine; means the dispensing, for a period of (M) Mixed alkaloids of opium listed time as specified below, of a narcotic in Section 1308.12(b)(2) of this chapter; drug or narcotic drugs in decreasing (N) Cocaine; and doses to an individual to alleviate ad- (O) Ecgonine; verse physiological or psychological ef- (v) Each of the opiates, including its fects incident to withdrawal from the isomers, esters, ethers, salts, and salts continuous or sustained use of a nar- of isomers, esters, and ethers whenever cotic drug and as a method of bringing the existence of such isomers, esters, the individual to a narcotic drug-free ethers, and salts is possible within the state within such period of time. There specific chemical designation, listed in are two types of detoxification treat- § 1308.12(c) of this chapter; and ment: Short-term detoxification treat- (vi) Methamphetamine, its salts, iso- ment and long-term detoxification mers, and salts of its isomers; treatment. (vii) Amphetamine, its salts, optical (i) Short-term detoxification treat- isomers, and salts of its optical iso- ment is for a period not in excess of 30 mers; days. (viii) Phenmetrazine and its salts; (ii) Long-term detoxification treat- (ix) Methylphenidate; ment is for a period more than 30 days (x) Each of the substances having a but not in excess of 180 days. depressant effect on the central nerv- (11) The term dispenser means an in- ous system, including its salts, iso- dividual practitioner, institutional mers, and salts of isomers whenever practitioner, pharmacy or pharmacist the existence of such salts, isomers, who dispenses a controlled substance. and salts of isomers is possible within (12) The term export means, with re- the specific chemical designation, list- spect to any article, any taking out or ed in § 1308.12(e) of this chapter. removal of such article from the juris- (6) The term commercial container diction of the United States (whether means any bottle, jar, tube, ampule, or or not such taking out or removal con- other receptacle in which a substance stitutes an exportation within the is held for distribution or dispensing to meaning of the customs and related an ultimate user, and in addition, any laws of the United States). box or package in which the receptacle (13) The term exporter includes every is held for distribution or dispensing to person who exports, or who acts as an an ultimate user. The term commercial export broker for exportation of, con- container does not include any package trolled substances listed in any sched- liner, package insert or other material ule. kept with or within a commercial con- (14) The term hearing means: tainer, nor any carton, crate, drum, or (i) In part 1301 of this chapter, any other package in which commercial hearing held for the granting, denial, containers are stored or are used for revocation, or suspension of a registra- shipment of controlled substances. tion pursuant to sections 303, 304, and

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1008 of the Act (21 U.S.C. 823, 824 and cial containers, or contained in phar- 958). maceutical preparations in the posses- (ii) In part 1303 of this chapter, any sion of the registrant (including stocks hearing held regarding the determina- held by the registrant under separate tion of aggregate production quota or registration as a manufacturer, im- the issuance, adjustment, suspension, porter, exporter, or distributor). or denial of a procurement quota or an (21) (i) The term isomer means the op- individual manufacturing quota. tical isomer, except as used in (iii) In part 1308 of this chapter, any § 1308.11(d) and § 1308.12(b)(4) of this hearing held for the issuance, amend- chapter. As used in § 1308.11(d) of this ment, or repeal of any rule issuable chapter, the term ‘‘isomer’’ means any pursuant to section 201 of the Act (21 optical, positional, or geometric iso- U.S.C. 811). mer. As used in § 1308.12(b)(4) of this (15) The term import means, with re- chapter, the term ‘‘isomer’’ means any spect to any article, any bringing in or optical or geometric isomer. introduction of such article into either (ii) As used in § 1308.11(d) of this chap- the jurisdiction of the United States or ter, the term ‘‘positional isomer’’ the customs territory of the United means any substance possessing the States, and from the jurisdiction of the same molecular formula and core United States into the customs terri- structure and having the same func- tory of the United States (whether or tional group(s) and/or substituent(s) as not such bringing in or introduction those found in the respective schedule I constitutes an importation within the hallucinogen, attached at any posi- meaning of the tariff laws of the tion(s) on the core structure, but in United States). such manner that no new chemical (16) The term importer includes every functionalities are created and no ex- person who imports, or who acts as an isting chemical functionalities are de- import broker for importation of, con- stroyed relative to the respective trolled substances listed in any sched- schedule I hallucinogen. Rearrange- ule. ments of alkyl moieties within or be- (17) The term individual practitioner tween functional group(s) or substit- means a physician, dentist, veteri- uent(s), or divisions or combinations of narian, or other individual licensed, alkyl moieties, that do not create new registered, or otherwise permitted, by chemical functionalities or destroy ex- the United States or the jurisdiction in isting chemical functionalities, are al- which he/she practices, to dispense a lowed i.e., result in compounds which controlled substance in the course of are positional isomers. For purposes of professional practice, but does not in- this definition, the ‘‘core structure’’ is clude a pharmacist, a pharmacy, or an the parent molecule that is the com- institutional practitioner. mon basis for the class; for example, (18) The term institutional practitioner tryptamine, phenethylamine, or means a hospital or other person (other ergoline. Examples of rearrangements than an individual) licensed, reg- resulting in creation and/or destruction istered, or otherwise permitted, by the of chemical functionalities (and there- United States or the jurisdiction in fore resulting in compounds which are which it practices, to dispense a con- not positional isomers) include, but are trolled substance in the course of pro- not limited to: ethoxy to alpha-hy- fessional practice, but does not include droxyethyl, hydroxy and methyl to a pharmacy. methoxy, or the repositioning of a phe- (19) The term interested person means nolic or alcoholic hydroxy group to any person adversely affected or ag- create a hydroxyamine. Examples of grieved by any rule or proposed rule rearrangements resulting in com- issuable pursuant to section 201 of the pounds which would be positional iso- Act (21 U.S.C. 811). mers include: tert-butyl to sec-butyl, (20) The term inventory means all fac- methoxy and ethyl to isopropoxy, N,N- tory and branch stocks in finished form diethyl to N-methyl-N-propyl, or alpha- of a basic class of controlled substance methylamino to N-methylamino. manufactured or otherwise acquired by (22) The term jurisdiction of the United a registrant, whether in bulk, commer- States means the customs territory of

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the United States, the Virgin Islands, as nurse practitioners, nurse midwives, the Canal Zone, Guam, American nurse anesthetists, clinical nurse spe- Samoa, and the Trust Territories of cialists and physician assistants who the Pacific Islands. are authorized to dispense controlled (23) The term label means any display substances by the state in which they of written, printed, or graphic matter practice. placed upon the commercial container (29) The term name means the official of any controlled substance by any name, common or usual name, chem- manufacturer of such substance. ical name, or brand name of a sub- (24) The term labeling means all la- stance. bels and other written, printed, or (30) The term narcotic drug means any graphic matter: of the following whether produced di- (i) Upon any controlled substance or rectly or indirectly by extraction from any of its commercial containers or substances of vegetable origin or inde- wrappers, or pendently by means of chemical syn- (ii) Accompanying such controlled thesis or by a combination of extrac- substance. tion and chemical synthesis: (25) The term Long Term Care Facility (i) Opium, opiates, derivatives of (LTCF) means a nursing home, retire- opium and opiates, including their iso- ment care, mental care or other facil- mers, esters, ethers, salts, and salts of ity or institution which provides ex- isomers, esters, and ethers whenever tended health care to resident patients. the existence of such isomers, esters, (26) The term maintenance treatment ethers and salts is possible within the means the dispensing for a period in ex- specific chemical designation. Such cess of twenty-one days, of a narcotic term does not include the isoquinoline drug or narcotic drugs in the treat- alkaloids of opium. ment of an individual for dependence (ii) Poppy straw and concentrate of upon heroin or other morphine-like poppy straw. drug. (iii) Coca leaves, except coca leaves (27) The term manufacture means the and extracts of coca leaves from which producing, preparation, propagation, cocaine, ecgonine and derivatives of ec- compounding, or processing of a drug gonine or their salts have been re- or other substance or the packaging or moved. repackaging of such substance, or the (iv) Cocaine, its salts, optical and labeling or relabeling of the commer- geometric isomers, and salts of iso- cial container of such substance, but mers. does not include the activities of a (v) Ecgonine, its derivatives, their practitioner who, as an incident to his/ salts, isomers and salts of isomers. her administration or dispensing such (vi) Any compound, mixture, or prep- substance in the course of his/her pro- aration which contains any quantity of fessional practice, prepares, com- any of the substances referred to in pounds, packages or labels such subparagraphs (b)(31)(i) through (v) of this stance. The term manufacturer means a section. person who manufactures a drug or (31) The term narcotic treatment pro- other substance, whether under a reg- gram means a program engaged in istration as a manufacturer or under maintenance and/or detoxification authority of registration as a re- treatment with narcotic drugs. searcher or chemical analyst. (32) The term net disposal means, for (28) The term mid-level practitioner a stated period, the quantity of a basic means an individual practitioner, other class of controlled substance distrib- than a physician, dentist, veterinarian, uted by the registrant to another per- or podiatrist, who is licensed, reg- son, plus the quantity of that basic istered, or otherwise permitted by the class used by the registrant in the pro- United States or the jurisdiction in duction of (or converted by the reg- which he/she practices, to dispense a istrant into) another basic class of con- controlled substance in the course of trolled substance or a noncontrolled professional practice. Examples of mid- substance, plus the quantity of that level practitioners include, but are not basic class otherwise disposed of by the limited to, health care providers such registrant, less the quantity of that

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basic class returned to the registrant permitted by sections 303 or 1007 of the by any purchaser, and less the quantity Act (21 U.S.C. 823 or 957). of that basic class distributed by the (40) The term registrant means any registrant to another registered manu- person who is registered pursuant to ei- facturer of that basic class for purposes ther section 303 or section 1008 of the other than use in the production of, or Act (21 U.S.C. 823 or 958). conversion into, another basic class of (41) The term reverse distributor means controlled substance or a noncon- a registrant who receives controlled trolled substance or in the manufac- substances acquired from another DEA ture of dosage forms of that basic class. registrant for the purpose of— (33) The term pharmacist means any (i) Returning unwanted, unusable, or pharmacist licensed by a State to dis- outdated controlled substances to the pense controlled substances, and shall manufacturer or the manufacturer’s include any other person (e.g., phar- agent; or macist intern) authorized by a State to (ii) Where necessary, processing such dispense controlled substances under substances or arranging for processing the supervision of a pharmacist li- such substances for disposal. censed by such State. (42) The term supplier means any reg- (34) The term person includes any in- istered person entitled to fill order dividual, corporation, government or forms pursuant to § 1305.08 of this chap- governmental subdivision or agency, ter. business trust, partnership, associa- (43) The term freight forwarding facil- tion, or other legal entity. ity means a separate facility operated by a distributing registrant through (35) The term prescription means an which sealed, packaged controlled sub- order for medication which is dispensed stances in unmarked shipping con- to or for an ultimate user but does not tainers (i.e., the containers do not indi- include an order for medication which cate that the contents include con- is dispensed for immediate administra- trolled substances) are, in the course of tion to the ultimate user. (e.g., an delivery to, or return from, customers, order to dispense a drug to a bed pa- transferred in less than 24 hours. A dis- tient for immediate administration in tributing registrant who operates a a hospital is not a prescription.) freight forwarding facility may use the (36) The term proceeding means all ac- facility to transfer controlled sub- tions taken for the issuance, amend- stances from any location the distrib- ment, or repeal of any rule issued pur- uting registrant operates that is reg- suant to section 201 of the Act (21 istered with the Administration to U.S.C. 811), commencing with the pub- manufacture, distribute, or import con- lication by the Administrator of the trolled substances, or, with respect to proposed rule, amended rule, or repeal returns, registered to dispense con- in the FEDERAL REGISTER. trolled substances, provided that the (37) The term purchaser means any notice required by § 1301.12(b)(4) of Part registered person entitled to obtain 1301 of this chapter has been submitted and execute order forms pursuant to and approved. For purposes of this defi- §§ 1305.04 and 1305.06. nition, a distributing registrant is a (38) The term readily retrievable person who is registered with the Ad- means that certain records are kept by ministration as a manufacturer, dis- automatic data processing systems or tributor, and/or importer. other electronic or mechanized record- (44) The term central fill pharmacy keeping systems in such a manner that means a pharmacy which is permitted they can be separated out from all by the state in which it is located to other records in a reasonable time and/ prepare controlled substances orders or records are kept on which certain for dispensing pursuant to a valid pre- items are asterisked, redlined, or in scription transmitted to it by a reg- some other manner visually identifi- istered retail pharmacy and to return able apart from other items appearing the labeled and filled prescriptions to on the records. the retail pharmacy for delivery to the (39) The terms register and registration ultimate user. Such central fill phar- refer only to registration required and macy shall be deemed ‘‘authorized’’ to

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fill prescriptions on behalf of a retail and transporter, or a seller and trans- pharmacy only if the retail pharmacy porter, or by receiving any form of and central fill pharmacy have a con- compensation for so doing. tractual relationship providing for (5) The term chemical export means such activities or share a common transferring ownership or control, or owner. the sending or taking of threshold (45) The term automated dispensing quantities of listed chemicals out of system means a mechanical system the United States (whether or not such that performs operations or activities, sending or taking out constitutes an other than compounding or administra- exportation within the meaning of the tion, relative to the storage, pack- Customs and related laws of the United aging, counting, labeling, and dis- States). pensing of medications, and which col- (6) The term chemical exporter is a lects, controls, and maintains all regulated person who, as the principal transaction information. party in interest in the export transaction, has the power and responsi- [62 FR 13941, Mar. 24, 1997, as amended at 65 FR 44678, July 19, 2000; 68 FR 37409, June 24, bility for determining and controlling 2003; 68 FR 41228, July 11, 2003; 70 FR 25465, the sending of the listed chemical out May 13, 2005; 70 FR 74656, Dec. 16, 2005; 71 FR of the United States. 60427, Oct. 13, 2006; 72 FR 67852, Dec. 3, 2007; (7) The term chemical import means 74 FR 63609, Dec. 4, 2009] with respect to a listed chemical, any bringing in or introduction of such list- § 1300.02 Definitions relating to listed ed chemical into either the jurisdiction chemicals. of the United States or into the Cus- (a) Any term not defined in this part toms territory of the United States shall have the definition set forth in (whether or not such bringing in or in- section 102 of the Act (21 U.S.C. 802), troduction constitutes an importation except that certain terms used in part within the meaning of the tariff laws of 1316 of this chapter are defined at the the United States). beginning of each subpart of that part. (8) The term chemical importer is a (b) As used in parts 1309, 1310, and regulated person who, as the principal 1313 of this chapter, the following party in interest in the import trans- terms shall have the meaning specified: action, has the power and responsi- (1) The term Act means the Con- bility for determining and controlling trolled Substances Act, as amended (84 the bringing in or introduction of the Stat. 1242; 21 U.S.C. 801) and/or the Con- listed chemical into the United States. trolled Substances Import and Export (9) The term chemical mixture means a Act, as amended (84 Stat. 1285; 21 U.S.C. combination of two or more chemical 951) as amended. substances, at least one of which is not (2) The term Administration means a listed chemical, except that such the Drug Enforcement Administration. term does not include any combination (3) The term Administrator means the of a listed chemical with another Administrator of the Drug Enforce- chemical that is present solely as an ment Administration. The Adminis- impurity or which has been created to trator has been delegated authority evade the requirements of the Act. under the Act by the Attorney General (10) The term customs territory of the (28 CFR 0.100). United States means the several States, (4) The terms broker and trader mean the District of Columbia, and Puerto any individual, corporation, corporate Rico. division, partnership, association, or (11) The term encapsulating machine other legal entity which assists in ar- means any manual, semi-automatic, or ranging an international transaction in fully automatic equipment which may a listed chemical by— be used to fill shells or capsules with (i) Negotiating contracts; any powdered, granular, semi-solid, or (ii) Serving as an agent or inter- liquid material. mediary; or (12) The term established business rela- (iii) Fulfilling a formal obligation to tionship means the regulated person complete the transaction by bringing has imported or exported a listed together a buyer and seller, a buyer chemical at least once within the past

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six months, or twice within the past (22) The term readily retrievable twelve months from or to a foreign means that certain records are kept by manufacturer, distributor, or end user automatic data processing systems or of the chemical that has an established other electronic or mechanized record- business with a fixed street address. A keeping systems in such a manner that person or business that functions as a they can be separated out from all broker or intermediary is not a cus- other records in a reasonable time and/ tomer for purposes of this definition. or records are kept on which certain (13) The term established record as an items are asterisked, redlined, or in importer means that the regulated per- some other manner visually identifi- son has imported a listed chemical at able apart from other items appearing least once within the past six months, on the records. or twice within the past twelve months (23) The terms register and registration from a foreign supplier. refer only to registration required and (14) The term hearing means any permitted by sections 303 or 1007 of the hearing held for the granting, denial, Act (21 U.S.C. 823 or 957). revocation, or suspension of a registra- (24) The term registrant means any tion pursuant to sections 303, 304, and person who is registered pursuant to ei- 1008 of the Act (21 U.S.C. 823, 824 and ther section 303 or section 1008 of the 958). Act (21 U.S.C. 823 or 958). (15) The term international transaction (25) The term regular customer means means a transaction involving the a person with whom the regulated per- shipment of a listed chemical across an son has an established business rela- international border (other than a tionship for a specified listed chemical United States border) in which a or chemicals that has been reported to broker or trader located in the United the Administration subject to the cri- States participates. teria established in part 1313 of this (16) The term jurisdiction of the United chapter. States means the customs territory of (26) The term regular importer means, the United States, the Virgin Islands, with respect to a listed chemical, a the Canal Zone, Guam, American person that has an established record Samoa, and the Trust Territories of as an importer of that listed chemical the Pacific Islands. that is reported to the Administrator. (17) The term listed chemical means (27) The term regulated person means any List I chemical or List II chemical. any individual, corporation, partner- (18) The term List I chemical means a ship, association, or other legal entity chemical specifically designated by the who manufactures, distributes, im- Administrator in § 1310.02(a) of this ports, or exports a listed chemical, a chapter that, in addition to legitimate tableting machine, or an encapsulating uses, is used in manufacturing a con- machine, or who acts as a broker or trolled substance in violation of the trader for an international transaction Act and is important to the manufac- involving a listed chemical, tableting ture of a controlled substance. machine, or encapsulating machine. (19) The term List II chemical means a (28) The term regulated transaction chemical, other than a List I chemical, means: specifically designated by the Adminis- (i) A distribution, receipt, sale, im- trator in § 1310.02(b) of this chapter portation, or exportation of a listed that, in addition to legitimate uses, is chemical, or an international trans- used in manufacturing a controlled action involving shipment of a listed substance in violation of the Act. chemical, or if the Administrator es- (20) The term name means the official tablishes a threshold amount for a spe- name, common or usual name, chem- cific listed chemical, a threshold ical name, or brand name of a sub- amount as determined by the Adminis- stance. trator, which includes a cumulative (21) The term person includes any in- threshold amount for multiple trans- dividual, corporation, government or actions, of a listed chemical, except governmental subdivision or agency, that such term does not include: business trust, partnership, associa- (A) A domestic lawful distribution in tion, or other legal entity. the usual course of business between

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agents or employees of a single regu- such term does not include a domestic lated person; in this context, agents or lawful distribution in the usual course employees means individuals under the of business between agents and employ- direct management and control of the ees of a single regulated person; in this regulated person; context, agents or employees means in- (B) A delivery of a listed chemical to dividuals under the direct management or by a common or contract carrier for and control of the regulated person. carriage in the lawful and usual course (29) The term retail distributor means of the business of the common or con- a grocery store, general merchandise tract carrier, or to or by a warehouse- store, drug store, or other entity or man for storage in the lawful and usual person whose activities as a distributor course of the business of the ware- relating to drug products containing houseman, except that if the carriage pseudoephedrine or phenylpropanola- or storage is in connection with the mine are limited almost exclusively to distribution, importation, or expor- sales for personal use, both in number tation of a listed chemical to a third of sales and volume of sales, either di- person, this paragraph does not relieve rectly to walk-in customers or in face- a distributor, importer, or exporter to-face transactions by direct sales. from compliance with parts 1309, 1310, Also for the purposes of this paragraph, 1313, and 1315 of this chapter; a grocery store is an entity within (C) Any category of transaction or Standard Industrial Classification any category of transaction for a spe- (SIC) code 5411, a general merchandise cific listed chemical or chemicals spec- store is an entity within SIC codes 5300 ified by regulation of the Adminis- through 5399 and 5499, and a drug store trator as excluded from this definition is an entity within SIC code 5912. as unnecessary for enforcement of the (30) The term tableting machine means Act; any manual, semi-automatic, or fully (D) Any transaction in a listed chem- automatic equipment which may be ical that is contained in a drug other used for the compaction or molding of than a scheduled listed chemical prod- powdered or granular solids, or semi- uct that may be marketed or distrib- solid material, to produce coherent uted lawfully in the United States solid tablets. under the Federal Food, Drug, and Cos- (31) The term combination ephedrine metic Act, subject to paragraph product means a drug product con- (b)(28)(i)(E) of this section, unless— taining ephedrine or its salts, optical (1) The Administrator has deter- isomers, or salts of optical isomers, mined pursuant to the criteria in and therapeutically significant quan- § 1310.10 of this chapter that the drug or tities of another active medicinal in- group of drugs is being diverted to ob- gredient. tain the listed chemical for use in the (32) The term drug product means an illicit production of a controlled sub- active ingredient in dosage form that stance; and has been approved or otherwise may be (2) The quantity of the listed chem- lawfully marketed under the Food, ical contained in the drug included in Drug, and Cosmetic Act for distribu- the transaction or multiple trans- tion in the United States. actions equals or exceeds the threshold (33) The term valid prescription means established for that chemical; a prescription that is issued for a le- (E) Any transaction in a scheduled gitimate medical purpose by an indi- listed chemical product that is a sale vidual practitioner licensed by law to at retail by a regulated seller or a dis- administer and prescribe the drugs con- tributor required to submit reports cerned and acting in the usual course under § 1310.03(c) of this chapter; or of the practitioner’s professional prac- (F) Any transaction in a chemical tice. mixture designated in §§ 1310.12 and (34)(i) The term scheduled listed chem- 1310.13 of this chapter that the Admin- ical product means a product that con- istrator has exempted from regulation. tains ephedrine, pseudoephedrine, or (ii) A distribution, importation, or phenylpropanolamine and may be mar- exportation of a tableting machine or keted or distributed lawfully in the encapsulating machine except that United States under the Federal, Food,

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Drug, and Cosmetic Act as a non- the user performed during a given pe- prescription drug. Ephedrine, riod. pseudoephedrine, and phenylpropanola- Authentication means verifying the mine include their salts, optical iso- identity of the user as a prerequisite to mers, and salts of optical isomers. allowing access to the information ap- (ii) Scheduled listed chemical prod- plication. uct does not include any product that Authentication protocol means a well is a controlled substance under part specified message exchange process 1308 of this chapter. In the absence of that verifies possession of a token to such scheduling by the Attorney Gen- remotely authenticate a person to an eral, a chemical specified in paragraph application. (b)(34)(i) of this section may not be Biometric authentication means au- considered to be a controlled sub- thentication based on measurement of stance. the individual’s physical features or re- (35) The term regulated seller means a peatable actions where those features retail distributor (including a phar- or actions are both distinctive to the macy or a mobile retail vendor), except individual and measurable. that the term does not include an em- Biometric subsystem means the hard- ployee or agent of the distributor. ware and software used to capture, (36) The term mobile retail vendor store, and compare biometric data. The means a person or entity that makes biometric subsystem may be part of a sales at retail from a stand that is in- larger application. The biometric sub- tended to be temporary or is capable of system is an automated system capable being moved from one location to an- of: other, whether the stand is located (1) Capturing a biometric sample within or on the premises of a fixed fa- from an end user. cility (such as a kiosk at a shopping (2) Extracting and processing the bio- center or an airport) or whether the metric data from that sample. stand is located on unimproved real es- (3) Storing the extracted information tate (such as a lot or field leased for rein a database. tail purposes). (4) Comparing the biometric data (37) The term at retail, with respect to with data contained in one or more ref- the sale or purchase of a scheduled list- erence databases. ed chemical product, means a sale or (5) Determining how well the stored purchase for personal use, respectively. data matches the newly captured data and indicating whether an identifica- [62 FR 13941, Mar. 24, 1997; 62 FR 15392, Apr. tion or verification of identity has been 1, 1997; 67 FR 14859, Mar. 28, 2002, as amended at 68 FR 23203, May 1, 2003; 68 FR 57803, Oct. achieved. 7, 2003; 71 FR 56023, Sept. 26, 2006; 72 FR 17406, Cache means to download and store Apr. 9, 2007; 72 FR 37448, July 10, 2007] information on a local server or hard drive. § 1300.03 Definitions relating to elec- Certificate policy means a named set tronic orders for controlled sub- of rules that sets forth the applica- stances and electronic prescriptions bility of the specific digital certificate for controlled substances. to a particular community or class of For the purposes of this chapter, the application with common security re- following terms shall have the mean- quirements. ings specified: Certificate revocation list (CRL) means Application service provider means an a list of revoked, but unexpired certifi- entity that sells electronic prescrip- cates issued by a certification author- tion or pharmacy applications as a ity. hosted service, where the entity con- Certification authority (CA) means an trols access to the application and organization that is responsible for maintains the software and records on verifying the identity of applicants, au- its servers. thorizing and issuing a digital certifi- Audit trail means a record showing cate, maintaining a directory of public who has accessed an information tech- keys, and maintaining a Certificate nology application and what operations Revocation List.

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Certified information systems auditor source of the message and indicates the (CISA) means an individual who has person’s approval of the information been certified by the Information Sys- contained in the message. tems Audit and Control Association as False match rate means the rate at qualified to audit information systems which an impostor’s biometric is false- and who performs compliance audits as ly accepted as being that of an author- a regular ongoing business activity. ized user. It is one of the statistics Credential means an object or data used to measure biometric performance structure that authoritatively binds an when operating in the verification or identity (and optionally, additional at- authentication task. The false match tributes) to a token possessed and con- rate is similar to the false accept (or trolled by a person. acceptance) rate. Credential service provider (CSP) False non-match rate means the rate means a trusted entity that issues or at which a genuine user’s biometric is registers tokens and issues electronic falsely rejected when the user’s bio- credentials to individuals. The CSP metric data fail to match the enrolled may be an independent third party or data for the user. It is one of the statis- may issue credentials for its own use. tics used to measure biometric per- CSOS means controlled substance or- formance when operating in the dering system. verification or authentication task. Digital certificate means a data record The false match rate is similar to the that, at a minimum— false reject (or rejection) rate, except (1) Identifies the certification au- that it does not include the rate at thority issuing it; which a biometric system fails to ac- (2) Names or otherwise identifies the quire a biometric sample from a gen- certificate holder; uine user. (3) Contains a public key that cor- FIPS means Federal Information responds to a private key under the Processing Standards. These Federal sole control of the certificate holder; standards, as incorporated by reference (4) Identifies the operational period; in § 1311.08 of this chapter, prescribe and specific performance requirements, (5) Contains a serial number and is practices, formats, communications digitally signed by the certification au- protocols, etc., for hardware, software, thority issuing it. data, etc. Digital signature means a record cre- FIPS 140–2, as incorporated by ref- ated when a file is algorithmically erence in § 1311.08 of this chapter, transformed into a fixed length digest means the National Institute of Stand- that is then encrypted using an asym- ards and Technology publication enti- metric cryptographic private key asso- tled ‘‘Security Requirements for Cryp- ciated with a digital certificate. The tographic Modules,’’ a Federal stand- combination of the encryption and al- ard for security requirements for cryp- gorithm transformation ensure that tographic modules. the signer’s identity and the integrity FIPS 180–2, as incorporated by ref- of the file can be confirmed. erence in § 1311.08 of this chapter, Digitally sign means to affix a digital means the National Institute of Stand- signature to a data file. ards and Technology publication enti- Electronic prescription means a pre- tled ‘‘Secure Hash Standard,’’ a Fed- scription that is generated on an elec- eral secure hash standard. tronic application and transmitted as FIPS 180–3, as incorporated by ref- an electronic data file. erence in § 1311.08 of this chapter, Electronic prescription application pro- means the National Institute of Stand- vider means an entity that develops or ards and Technology publication enti- markets electronic prescription soft- tled ‘‘Secure Hash Standard (SHS),’’ a ware either as a stand-alone applica- Federal secure hash standard. tion or as a module in an electronic FIPS 186–2, as incorporated by ref- health record application. erence in § 1311.08 of this chapter, Electronic signature means a method means the National Institute of Stand- of signing an electronic message that ards and Technology publication enti- identifies a particular person as the tled ‘‘Digital Signature Standard,’’ a

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Federal standard for applications used ards and Technology publication enti- to generate and rely upon digital signa- tled ‘‘Biometric Data Specification for tures. Personal Identity Verification,’’ a Fed- FIPS 186–3, as incorporated by ref- eral standard for biometric data speci- erence in § 1311.08 of this chapter, fications for personal identity means the National Institute of Stand- verification. ards and Technology publication enti- Operating point means a point chosen tled ‘‘Digital Signature Standard on a receiver operating characteristic (DSS),’’ a Federal standard for applica- (ROC) curve for a specific algorithm at tions used to generate and rely upon which the biometric system is set to digital signatures. function. It is defined by its cor- Hard token means a cryptographic responding coordinates—a false match key stored on a special hardware device rate and a false non-match rate. An (e.g., a PDA, cell phone, smart card, ROC curve shows graphically the trade- USB drive, one-time password device) off between the principal two types of rather than on a general purpose com- errors (false match rate and false non- puter. match rate) of a biometric system by Identity proofing means the process by plotting the performance of a specific which a credential service provider or algorithm on a specific set of data. certification authority validates suffi- Paper prescription means a prescrip- cient information to uniquely identify tion created on paper or computer gen- a person. erated to be printed or transmitted via Installed electronic prescription applica- facsimile that meets the requirements tion means software that is used to cre- of part 1306 of this chapter including a ate electronic prescriptions and that is manual signature. installed on a practitioner’s computers Password means a secret, typically a and servers, where access and records character string (letters, numbers, and are controlled by the practitioner. other symbols), that a person memo- Installed pharmacy application means rizes and uses to authenticate his iden- software that is used to process pre- tity. scription information and that is in- PDA means a Personal Digital Assist- stalled on a pharmacy’s computers or ant, a handheld computer used to man- servers and is controlled by the phar- age contacts, appointments, and tasks. macy. Pharmacy application provider means Intermediary means any technology an entity that develops or markets system that receives and transmits an software that manages the receipt and electronic prescription between the processing of electronic prescriptions. practitioner and pharmacy. Private key means the key of a key Key pair means two mathematically pair that is used to create a digital sig- related keys having the properties nature. that: Public key means the key of a key (1) One key can be used to encrypt a pair that is used to verify a digital sig- message that can only be decrypted nature. The public key is made avail- using the other key; and able to anyone who will receive (2) Even knowing one key, it is digitally signed messages from the computationally infeasible to discover holder of the key pair. the other key. Public Key Infrastructure (PKI) means NIST means the National Institute of a structure under which a certification Standards and Technology. authority verifies the identity of appli- NIST SP 800–63–1, as incorporated by cants; issues, renews, and revokes dig- reference in § 1311.08 of this chapter, ital certificates; maintains a registry means the National Institute of Stand- of public keys; and maintains an up-to- ards and Technology publication enti- date certificate revocation list. tled ‘‘Electronic Authentication Guide- Readily retrievable means that certain line,’’ a Federal standard for electronic records are kept by automatic data authentication. processing applications or other elec- NIST SP 800–76–1, as incorporated by tronic or mechanized recordkeeping reference in § 1311.08 of this chapter, systems in such a manner that they means the National Institute of Stand- can be separated out from all other

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records in a reasonable time and/or WebTrust means a professional serv- records are kept on which certain ice performed by a qualified certified items are asterisked, redlined, or in public accountant to evaluate one or some other manner visually identifi- more aspects of Web sites. able apart from other items appearing [75 FR 16304, Mar. 31, 2010] on the records. SAS 70 Audit means a third-party § 1300.04 Definitions relating to the audit of a technology provider that dispensing of controlled substances meets the American Institute of Cer- by means of the Internet. tified Public Accountants (AICPA) (a) Any term not defined in this part Statement of Auditing Standards or elsewhere in this chapter shall have (SAS) 70 criteria. the definition set forth in sections 102 Signing function means any keystroke and 309 of the Act (21 U.S.C. 802, 829). or other action used to indicate that (b) The term covering practitioner the practitioner has authorized for means, with respect to a patient, a transmission and dispensing a con- practitioner who conducts a medical trolled substance prescription. The evaluation (other than an in-person signing function may occur simulta- medical evaluation) at the request of a neously with or after the completion of practitioner who: the two-factor authentication protocol (1) Has conducted at least one in-per- that meets the requirements of part son medical evaluation of the patient 1311 of this chapter. The signing func- or an evaluation of the patient through tion may have different names (e.g., the practice of telemedicine, within approve, sign, transmit), but it serves the previous 24 months; and as the practitioner’s final authoriza- (2) Is temporarily unavailable to con- tion that he intends to issue the pre- duct the evaluation of the patient. scription for a legitimate medical rea- (c) The term deliver, distribute, or dis- son in the normal course of his profes- pense by means of the Internet refers, re- sional practice. spectively, to any delivery, distribu- SysTrust means a professional service tion, or dispensing of a controlled sub- performed by a qualified certified pub- stance that is caused or facilitated by lic accountant to evaluate one or more means of the Internet. aspects of electronic systems. (d) The term filling new prescriptions Third-party audit means an inde- for controlled substances in Schedule III, pendent review and examination of IV, or V means filling a prescription for records and activities to assess the ade- an individual for a controlled sub- quacy of system controls, to ensure stance in Schedule III, IV, or V, if: compliance with established policies (1) The pharmacy dispensing that and operational procedures, and to rec- prescription has previously dispensed ommend necessary changes in controls, to the patient a controlled substance policies, or procedures. other than by means of the Internet Token means something a person pos- and pursuant to the valid prescription sesses and controls (typically a key or of a practitioner that meets the appli- password) used to authenticate the per- cable requirements of subsections (b) son’s identity. and (c) of section 309 of the Act (21 Trusted agent means an entity au- U.S.C. 829) and §§ 1306.21 and 1306.22 of thorized to act as a representative of a this chapter (for purposes of this defi- certification authority or credential nition, such a prescription shall be re- service provider in confirming practi- ferred to as the ‘‘original prescrip- tioner identification during the enroll- tion’’); ment process. (2) The pharmacy contacts the prac- Valid prescription means a prescrip- titioner who issued the original pre- tion that is issued for a legitimate scription at the request of that indi- medical purpose by an individual prac- vidual to determine whether the practitioner licensed by law to administer titioner will authorize the issuance of a and prescribe the drugs concerned and new prescription for that individual for acting in the usual course of the prac- the controlled substance described in titioner’s professional practice. paragraph (d)(1) of this section (i.e., the

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same controlled substance as described trolled substances to an unregistered in paragraph (d)(1)); and individual or entity; (3) The practitioner, acting in the (2) Nonpharmacy practitioners who usual course of professional practice, are registered under section 303(f) of determines there is a legitimate med- the Act (21 U.S.C. 823(f)) (§ 1301.13 of ical purpose for the issuance of the new this chapter) and whose activities are prescription. authorized by that registration; (e) The term homepage means the (3) Any hospital or other medical fa- opening or main page or screen of the cility that is operated by an agency of Web site of an online pharmacy that is the United States (including the Armed viewable on the Internet. Forces), provided such hospital or (f) The term in-person medical evalua- other facility is registered under section means a medical evaluation that is tion 303(f) of the Act (21 U.S.C. 823(f)) conducted with the patient in the phys- (§ 1301.13 of this chapter); ical presence of the practitioner, with- (4) A health care facility owned or out regard to whether portions of the operated by an Indian tribe or tribal evaluation are conducted by other organization, only to the extent such health professionals. Nothing in this facility is carrying out a contract or paragraph shall be construed to imply compact under the Indian Self-Deter- that one in-person medical evaluation mination and Education Assistance Act; demonstrates that a prescription has (5) Any agent or employee of any hos- been issued for a legitimate medical pital or facility referred to in para- purpose within the usual course of pro- graph (h)(3) or (h)(4) of this section, fessional practice. provided such agent or employee is (g) The term Internet means collec- lawfully acting in the usual course of tively the myriad of computer and business or employment, and within telecommunications facilities, includ- the scope of the official duties of such ing equipment and operating software, agent or employee, with such hospital which comprise the interconnected or facility, and, with respect to agents worldwide network of networks that or employees of health care facilities employ the Transmission Control Pro- specified in paragraph (h)(4) of this sec- tocol/Internet Protocol, or any prede- tion, only to the extent such individ- cessor or successor protocol to such uals are furnishing services pursuant protocol, to communicate information to the contracts or compacts described of all kinds by wire or radio. in such paragraph; (h) The term online pharmacy means a (6) Mere advertisements that do not person, entity, or Internet site, wheth- attempt to facilitate an actual trans- er in the United States or abroad, that action involving a controlled sub- knowingly or intentionally delivers, stance; distributes, or dispenses, or offers or (7) A person, entity, or Internet site attempts to deliver, distribute, or dis- that is not in the United States and pense, a controlled substance by means does not facilitate the delivery, dis- of the Internet. The term includes, but tribution, or dispensing of a controlled is not limited to, a pharmacy that has substance by means of the Internet to obtained a modification of its registra- any person in the United States; tion pursuant to §§ 1301.13 and 1301.19 of (8) A pharmacy registered under sec- this chapter that currently authorizes tion 303(f) of the Act (21 U.S.C. 823(f)) it to dispense controlled substances by (§ 1301.13 of this chapter) whose dis- means of the Internet, regardless of pensing of controlled substances via whether the pharmacy is currently dis- the Internet consists solely of: pensing controlled substances by (i) Refilling prescriptions for con- means of the Internet. The term does trolled substances in Schedule III, IV, not include: or V, as defined in paragraph (k) of this (1) Manufacturers or distributors reg- section; or istered under subsection (a), (b), (d), or (ii) Filling new prescriptions for con- (e) of section 303 of the Act (21 U.S.C. trolled substances in Schedule III, IV, 823(a), (b), (d), or (e)) (§ 1301.13 of this or V, as defined in paragraph (d) of this chapter) who do not dispense con- section;

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(9)(i) Any registered pharmacy whose 823(f)) in the State in which the patient delivery, distribution, or dispensing of is located, unless the practitioner: controlled substances by means of the (i) Is exempted from such registra- Internet consists solely of filling pre- tion in all States under section 302(d) scriptions that were electronically pre- of the Act (21 U.S.C. 822(d); or scribed in a manner authorized by this (ii) Is an employee or contractor of chapter and otherwise in compliance the Department of Veterans Affairs with the Act. who is acting in the scope of such em- (ii) A registered pharmacy will be ployment or contract, and registered deemed to meet this exception if, in under section 303(f) of the Act (21 view of all of its activities other than U.S.C. 823(f)) in any State or is uti- those referred to in paragraph (h)(9)(i) lizing the registration of a hospital or of this section, it would fall outside the clinic operated by the Department of definition of an online pharmacy; or Veterans Affairs registered under sec- (10)(i) Any registered pharmacy whose delivery, distribution, or dis- tion 303(f); pensing of controlled substances by (2) Treatment in the physical presence means of the Internet consists solely of of a practitioner. The practice of tele- the transmission of prescription infor- medicine is being conducted while the mation between a pharmacy and an patient is being treated by, and in the automated dispensing system located physical presence of, a practitioner in a long term care facility when the acting in the usual course of profes- registration of the automated dis- sional practice, who is acting in ac- pensing system is held by that phar- cordance with applicable State law, macy as described in §§ 1301.17 and and who is registered under section 1301.27 and the pharmacy is otherwise 303(f) of the Act (21 U.S.C. 823(f)) in the complying with this chapter. State in which the patient is located, (ii) A registered pharmacy will be unless the practitioner: deemed to meet this exception if, in (i) Is exempted from such registra- view of all of its activities other than tion in all States under section 302(d) those referred to in paragraph (h)(10)(i) of the Act (21 U.S.C. 822(d)); or of this section, it would fall outside the (ii) Is an employee or contractor of definition of an online pharmacy. the Department of Veterans Affairs (i) Effective January 15, 2010, the who is acting in the scope of such em- term practice of telemedicine means the ployment or contract, and registered practice of medicine in accordance under section 303(f) of the Act (21 with applicable Federal and State laws U.S.C. 823(f)) in any State or is using by a practitioner (other than a phar- the registration of a hospital or clinic macist) who is at a location remote operated by the Department of Vet- from the patient and is communicating erans Affairs registered under section with the patient, or health care professional who is treating the patient, 303(f); using a telecommunications system re- (3) Indian Health Service or tribal orga- ferred to in section 1834(m) of the So- nization. The practice of telemedicine cial Security Act (42 U.S.C. 1395m(m)), is being conducted by a practitioner which practice falls within a category who is an employee or contractor of listed in the following paragraphs (i)(1) the Indian Health Service, or is work- through (7): ing for an Indian tribe or tribal organi- (1) Treatment in a hospital or clinic. zation under its contract or compact The practice of telemedicine is being with the Indian Health Service under conducted while the patient is being the Indian Self-Determination and treated by, and physically located in, a Education Assistance Act; who is act- hospital or clinic registered under sec- ing within the scope of the employ- tion 303(f) of the Act (21 U.S.C. 823(f)) ment, contract, or compact; and who is by a practitioner acting in the usual designated as an Internet Eligible Con- course of professional practice, who is trolled Substances Provider by the Sec- acting in accordance with applicable retary of Health and Human Services State law, and who is registered under under section 311(g)(2) of the Act (21 section 303(f) of the Act (21 U.S.C. U.S.C. 831(g)(2));

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(4) Public health emergency declared by acting within the scope of that employ- the Secretary of Health and Human Serv- ment or contract; ices. The practice of telemedicine is (B) Is registered under section 303(f) being conducted during a public health of the Act (21 U.S.C. 823(f)) in any State emergency declared by the Secretary or is utilizing the registration of a hos- of Health and Human Services under pital or clinic operated by the Depart- section 319 of the Public Health Service ment of Veterans Affairs registered Act (42 U.S.C. 247d), and involves pa- under section 303(f); and tients located in such areas, and such (C) Issues a controlled substance pre- controlled substances, as the Secretary scription in this emergency context of Health and Human Services, with that is limited to a maximum of a five- the concurrence of the Administrator, day supply which may not be extended designates, provided that such designa- or refilled; or tion shall not be subject to the proce- (7) Other circumstances specified by reg- dures prescribed by the Administrative ulation. The practice of telemedicine is Procedure Act (5 U.S.C. 551–559 and 701– being conducted under any other cir- 706); cumstances that the Administrator (5) Special registration. The practice of and the Secretary of Health and telemedicine is being conducted by a Human Services have jointly, by regu- practitioner who has obtained from the lation, determined to be consistent Administrator a special registration with effective controls against diver- under section 311(h) of the Act (21 sion and otherwise consistent with the U.S.C. 831(h)); public health and safety. (6) Department of Veterans Affairs med- (j) Temporary definition of practice of ical emergency. The practice of tele- telemedicine. Prior to January 15, 2010, medicine is being conducted: or as otherwise specified by regulation (i) In a medical emergency situation: prior to that date, instead of the defini- (A) That prevents the patient from tion in paragraph (i), the term practice being in the physical presence of a of telemedicine means the practice of practitioner registered under section medicine in accordance with applicable 303(f) of the Act (21 U.S.C. 823(f)) who is Federal and State laws by a practi- an employee or contractor of the Vet- tioner (as that term is defined in sec- erans Health Administration acting in tion 102 of the Act (21 U.S.C. 802)) the usual course of business and em- (other than a pharmacist) who is at a ployment and within the scope of the location remote from the patient and is official duties or contract of that em- communicating with the patient, or ployee or contractor; health care professional who is treat- (B) That prevents the patient from ing the patient, using a telecommuni- being physically present at a hospital cations system referred to in section or clinic operated by the Department 1834(m) of the Social Security Act (42 of Veterans Affairs registered under U.S.C. 1395m(m)), if the practitioner is section 303(f) of the Act (21 U.S.C. using an interactive telecommuni- 823(f)); cations system that satisfies the re- (C) During which the primary care quirements of section 410.78(a)(3) of practitioner of the patient or a practi- title 42, Code of Federal Regulations. tioner otherwise practicing telemedi- (k) The term refilling prescriptions for cine within the meaning of this para- controlled substances in Schedule III, IV, graph is unable to provide care or con- or V: sultation; and (1) Means the dispensing of a con- (D) That requires immediate inter- trolled substance in Schedule III, IV, or vention by a health care practitioner V in accordance with refill instructions using controlled substances to prevent issued by a practitioner as part of a what the practitioner reasonably be- valid prescription that meets the relieves in good faith will be imminent quirements of subsections (b) and (c) of and serious clinical consequences, such section 309 of the Act (21 U.S.C. 829) as further injury or death; and and §§ 1306.21 and 1306.22 of this chapter, (ii) By a practitioner that: as appropriate; and (A) Is an employee or contractor of (2) Does not include the issuance of a the Veterans Health Administration new prescription to an individual for a

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controlled substance that individual 1301.25 Registration regarding ocean ves- was previously prescribed. sels, aircraft, and other entities. (l)(1) The term valid prescription 1301.26 Exemptions from import or export means a prescription that is issued for requirements for personal medical use. a legitimate medical purpose in the 1301.27 Separate registration by retail pharmacies for installation and operation of usual course of professional practice automated dispensing systems at long by: term care facilities. (i) A practitioner who has conducted 1301.28 Exemption from separate registra- at least one in-person medical evaluation for practitioners dispensing or pre- tion of the patient; or scribing Schedule III, IV, or V narcotic (ii) A covering practitioner. controlled drugs approved by the Food (2) Nothing in this paragraph (l) shall and Drug Administration specifically for be construed to imply that one in-per- use in maintenance or detoxification son medical evaluation demonstrates treatment. that a prescription has been issued for ACTION ON APPLICATION FOR REGISTRATION: a legitimate medical purpose within REVOCATION OR SUSPENSION OF REGISTRATION the usual course of professional prac- 1301.31 Administrative review generally. tice. 1301.32 Action on applications for research [74 FR 15619, Apr. 6, 2009] in Schedule I substances. 1301.33 Application for bulk manufacture of Schedule I and II substances. PART 1301—REGISTRATION OF 1301.34 Application for importation of MANUFACTURERS, DISTRIBUTORS, Schedule I and II substances. AND DISPENSERS OF CON- 1301.35 Certificate of registration; denial of TROLLED SUBSTANCES registration. 1301.36 Suspension or revocation of registration; suspension of registration pending GENERAL INFORMATION final order; extension of registration Sec. pending final order. 1301.01 Scope of this part 1301. 1301.37 Order to show cause. 1301.02 Definitions. 1301.03 Information; special instructions. HEARINGS 1301.41 Hearings generally. REGISTRATION 1301.42 Purpose of hearing. 1301.11 Persons required to register; require- 1301.43 Request for hearing or appearance; ment of modification of registration au- waiver. thorizing activity as an online phar- 1301.44 Burden of proof. macy. 1301.45 Time and place of hearing. 1301.12 Separate registrations for separate 1301.46 Final order. locations. 1301.13 Application for registration; time MODIFICATION, TRANSFER, AND TERMINATION for application; expiration date; registra- OF REGISTRATION tion for independent activities; application forms, fees, contents and signature; 1301.51 Modification in registration. coincident activities. 1301.52 Termination of registration; transfer 1301.14 Filing of application; acceptance for of registration; distribution upon dis- filing; defective applications. continuance of business. 1301.15 Additional information. SECURITY REQUIREMENTS 1301.16 Amendments to and withdrawal of applications. 1301.71 Security requirements generally. 1301.17 Special procedures for certain appli- 1301.72 Physical security controls for non- cations. practitioners; narcotic treatment pro- 1301.18 Research protocols. grams and compounders for narcotic 1301.19 Special requirements for online treatment programs; storage areas. pharmacies. 1301.73 Physical security controls for non- practitioners; compounders for narcotic EXCEPTIONS TO REGISTRATION AND FEES treatment programs; manufacturing and 1301.21 Exception from fees. compounding areas. 1301.22 Exemption of agents and employees; 1301.74 Other security controls for non- affiliated practitioners. practitioners; narcotic treatment pro- 1301.23 Exemption of certain military and grams and compounders for narcotic other personnel. treatment programs. 1301.24 Exemption of law enforcement offi- 1301.75 Physical security controls for prac- cials. titioners.

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1301.76 Other security controls for practi- ports any controlled substance or who tioners. proposes to engage in the manufacture, 1301.77 Security controls for freight for- distribution, dispensing, importation warding facilities. or exportation of any controlled sub- EMPLOYEE SCREENING—NON-PRACTITIONERS stance shall obtain a registration un- 1301.90 Employee screening procedures. less exempted by law or pursuant to 1301.91 Employee responsibility to report §§ 1301.22 through 1301.26. Except as pro- drug diversion. vided in paragraph (b) of this section, 1301.92 Illicit activities by employees. only persons actually engaged in such 1301.93 Sources of information for employee activities are required to obtain a reg- checks. istration; related or affiliated persons AUTHORITY: 21 U.S.C. 821, 822, 823, 824, 831, who are not engaged in such activities 871(b), 875, 877, 886a, 951, 952, 953, 956, 957, 958. are not required to be registered. (For SOURCE: 36 FR 7778, Apr. 24, 1971, unless example, a stockholder or parent cor- otherwise noted. Redesignated at 38 FR 26609, poration of a corporation manufac- Sept. 24, 1973. turing controlled substances is not required to obtain a registration.) GENERAL INFORMATION (b) As provided in sections 303(f) and § 1301.01 Scope of this part 1301. 401(h) of the Act (21 U.S.C. 823(f) and 841(h)), it is unlawful for any person Procedures governing the registra- who falls within the definition of ‘‘on- tion of manufacturers, distributors, line pharmacy’’ (as set forth in section dispensers, importers, and exporters of 102(52) of the Act (21 U.S.C. 802(52)) and controlled substances pursuant to sections 301–304 and 1007–1008 of the Act (21 § 1300.04(h) of this chapter) to deliver, U.S.C. 821–824 and 957–958) are set forth distribute, or dispense a controlled sub- generally by those sections and specifi- stance by means of the Internet if such cally by the sections of this part. person is not validly registered with a modification of such registration au- [62 FR 13945, Mar. 24, 1997] thorizing such activity (unless such person is exempt from such modified § 1301.02 Definitions. registration requirement under the Act Any term used in this part shall have or this chapter). The Act further pro- the definition set forth in section 102 of vides that the Administrator may only the Act (21 U.S.C. 802) or part 1300 of issue such modification of registration this chapter. to a person who is registered as a phar- [62 FR 13945, Mar. 24, 1997] macy under section 303(f) of the Act (21 U.S.C. 823(f)). Accordingly, any phar- § 1301.03 Information; special instruc- macy registered pursuant to § 1301.13 of tions. this part that falls within the defini- Information regarding procedures tion of an online pharmacy and pro- under these rules and instructions poses to dispense controlled substances supplementing these rules will be fur- by means of the Internet must obtain a nished upon request by writing to the modification of its registration author- Registration Section, Drug Enforce- izing such activity following the sub- ment Administration. See the Table of mission of an application in accordance DEA Mailing Addresses in § 1321.01 of with § 1301.19 of this part. This require- this chapter for the current mailing ad- ment does not apply to a registered dress. pharmacy that does not fall within the definition of an online pharmacy set [75 FR 10676, Mar. 9, 2010] forth in § 1300.04(h). Under the Act, per- REGISTRATION sons other than registered pharmacies are not eligible to obtain such a modi- § 1301.11 Persons required to register; fication of registration but remain lia- requirement of modification of reg- ble under section 401(h) of the Act (21 istration authorizing activity as an U.S.C. 841(h)) if they deliver, dis- online pharmacy. tribute, or dispense a controlled sub- (a) Every person who manufactures, stance while acting as an online phar- distributes, dispenses, imports, or ex- macy without being validly registered

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with a modification authorizing such the facility is located and each area in activity. which the distributing registrant main- [74 FR 15621, Apr. 6, 2009] tains a registered location that will transfer controlled substances through § 1301.12 Separate registrations for the facility. The notice shall detail the separate locations. registered locations that will utilize (a) A separate registration is re- the facility, the location of the facil- quired for each principal place of busi- ity, the hours of operation, the indi- ness or professional practice at one vidual(s) responsible for the controlled general physical location where con- substances, the security and record- trolled substances are manufactured, keeping procedures that will be em- distributed, imported, exported, or dis- ployed, and whether controlled sub- pensed by a person. stances returns will be processed (b) The following locations shall be through the facility. The notice must deemed not to be places where con- also detail what state licensing re- trolled substances are manufactured, quirements apply to the facility and distributed, or dispensed: the registrant’s actions to comply with (1) A warehouse where controlled any such requirements. The Special substances are stored by or on behalf of Agent in Charge of the DEA Office in a registered person, unless such sub- the area where the freight forwarding stances are distributed directly from facility will be operated will provide such warehouse to registered locations written notice of approval or dis- other than the registered location from approval to the person within thirty which the substances were delivered or days after confirmed receipt of the no- to persons not required to register by tice. Registrants that are currently op- virtue of subsection 302(c)(2) or sub- erating freight forwarding facilities section 1007(b)(1)(B) of the Act (21 under a memorandum of understanding U.S.C. 822(c)(2) or 957(b)(1)(B)); with the Administration must provide (2) An office used by agents of a reg- notice as required by this section no istrant where sales of controlled sub- later than September 18, 2000 and re- stances are solicited, made, or supervised but which neither contains such ceive written approval from the Spe- substances (other than substances for cial Agent in Charge of the DEA Office display purposes or lawful distribution in the area in which the freight for- as samples only) nor serves as a dis- warding facility is operated in order to tribution point for filling sales orders; continue operation of the facility. and [62 FR 13945, Mar. 24, 1997, as amended at 65 (3) An office used by a practitioner FR 44678, July 19, 2000; 65 FR 45829, July 25, (who is registered at another location 2000; 71 FR 69480, Dec. 1, 2006] in the same State or jurisdiction of the United States) where controlled sub- § 1301.13 Application for registration; stances are prescribed but neither ad- time for application; expiration ministered nor otherwise dispensed as date; registration for independent a regular part of the professional prac- activities; application forms, fees, contents and signature; coincident tice of the practitioner at such office, activities. and where no supplies of controlled substances are maintained. (a) Any person who is required to be (4) A freight forwarding facility, as registered and who is not so registered defined in § 1300.01 of this part, provided may apply for registration at any time. that the distributing registrant oper- No person required to be registered ating the facility has submitted writ- shall engage in any activity for which ten notice of intent to operate the fa- registration is required until the appli- cility by registered mail, return re- cation for registration is granted and a ceipt requested (or other suitable Certificate of Registration is issued by means of documented delivery) and the Administrator to such person. such notice has been approved. The no- (b) Any person who is registered may tice shall be submitted to the Special apply to be reregistered not more than Agent in Charge of the Administra- 60 days before the expiration date of tion’s offices in both the area in which his/her registration, except that a bulk

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manufacturer of Schedule I or II con- tivity was registered. After the initial trolled substances or an importer of registration period, the registration Schedule I or II controlled substances shall expire 36 months from the initial may apply to be reregistered no more expiration date. than 120 days before the expiration (e) Any person who is required to be date of their registration. registered and who is not so registered, (c) At the time a manufacturer, dis- shall make application for registration tributor, reverse distributor, re- for one of the following groups of con- searcher, analytical lab, importer, ex- trolled substances activities, which are porter or narcotic treatment program deemed to be independent of each is first registered, that business activ- other. Application for each registration ity shall be assigned to one of twelve shall be made on the indicated form, groups, which shall correspond to the and shall be accompanied by the indi- months of the year. The expiration cated fee. Fee payments shall be made date of the registrations of all reg- in the form of a personal, certified, or istrants within any group will be the cashier’s check or money order made last date of the month designated for payable to the ‘‘Drug Enforcement Ad- that group. In assigning any of these ministration’’. The application fees are business activities to a group, the Ad- not refundable. Any person, when reg- ministration may select a group the istered to engage in the activities de- expiration date of which is less than scribed in each subparagraph in this one year from the date such business paragraph, shall be authorized to en- activity was registered. If the business gage in the coincident activities de- activity is assigned to a group which scribed without obtaining a registra- has an expiration date less than three tion to engage in such coincident ac- months from the date of which the tivities, provided that, unless specifi- business activity is registered, the reg- cally exempted, he/she complies with istration shall not expire until one all requirements and duties prescribed year from that expiration date; in all by law for persons registered to engage other cases, the registration shall ex- in such coincident activities. Any per- pire on the expiration date following son who engages in more than one the date on which the business activity group of independent activities shall is registered. obtain a separate registration for each (d) At the time a retail pharmacy, group of activities, except as provided hospital/clinic, practitioner or teach- in this paragraph under coincident ac- ing institution is first registered, that tivities. A single registration to engage business activity shall be assigned to in any group of independent activities one of twelve groups, which shall cor- listed below may include one or more respond to the months of the year. The controlled substances listed in the expiration date of the registrations of schedules authorized in that group of all registrants within any group will be independent activities. A person reg- the last day of the month designated istered to conduct research with con- for that group. In assigning any of the trolled substances listed in Schedule I above business activities to a group, may conduct research with any sub- the Administration may select a group stances listed in Schedule I for which the expiration date of which is not less he/she has filed and had approved a re- than 28 months nor more than 39 search protocol. months from the date such business ac- (1)

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Reg- Applica- istra- Business activity Controlled DEA application tion fee tion pe- Coincident activities allowed substances forms (dollars) riod (years)

(i) Manufacturing Schedules I–V New—225 2,293 1 Schedules I–V: May distribute that Renewal—225a 2,293 substance or class for which registration was issued; may not distribute or dispose any substance or class for which not registered. Schedules II–V: except a person registered to dispose of any controlled substance may conduct chemical analysis and preclinical research (including quality control analysis) with substances listed in those schedules for which authorization as a mfg. was issued. (ii) Distributing Schedules I–V New—225 1,147 1 Renewal—225a 1,147 (iii) Reverse distrib- Schedules I–V New—225 1,147 1 uting Renewal—225a 1,147 (iv) Dispensing or Schedules II–V New—224 551 3 May conduct research and instruc- instructing (in- Renewal—224a 551 tional activities with those sub- cludes Practi- Online Phar- stances for which registration was tioner, Hospital/ macy—224c granted, except that a mid-level Clinic, Retail practitioner may conduct such re- Pharmacy, Online search only to the extent expressly Pharmacy, Cen- authorized under State statute. A tral fill pharmacy, pharmacist may manufacture an Teaching Institu- aqueous or oleaginous solution or tion) solid dosage form containing a narcotic controlled substance in Schedule II–V in a proportion not exceeding 20% of the complete solution, compound or mixture. A retail pharmacy may perform central fill pharmacy activities. An online pharmacy may perform activities of retail pharmacy as well as online pharmacy activities. (v) Research Schedule I New—225 184 1 A researcher may manufacture or im- Renewal—225a 184 port the basic class of substance or substances for which registration was issued, provided that such manufacture or import is set forth in the protocol required in § 1301.18 and to distribute such class to persons registered or authorized to conduct research with such class of substance or registered or authorized to conduct chemical analysis with controlled substances. (vi) Research Schedules II–V New—225 184 1 May conduct chemical analysis with Renewal—225a 184 controlled substances in those schedules for which registration was issued; manufacture such substances if and to the extent that such manufacture is set forth in a statement filed with the application for registration or reregistration and provided that the manufacture is not for the purposes of dosage form development; import such substances for research purposes; distribute such substances to persons registered or authorized to conduct chemical analysis, instructional activities or research with such substances, and to persons exempted from registration pursuant to § 1301.24; and conduct instructional activities with controlled substances.

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Reg- Applica- istra- Business activity Controlled DEA application tion fee tion pe- Coincident activities allowed substances forms (dollars) riod (years)

(vii) Narcotic Treat- Narcotic Drugs in New—363 184 1 ment Program (in- Schedules II–V Renewal—363a 184 cluding compounder) (viii) Importing Schedules I–V New—225 1,147 1 May distribute that substance or class Renewal—225a 1,147 for which registration was issued; may not distribute any substance or class for which not registered. (ix) Exporting Schedules I–V New—225 1,147 1 Renewal—225a 1,147 (x) Chemical Anal- Schedules I–V New—225 184 1 May manufacture and import con- ysis Renewal—225a 184 trolled substances for analytical or instructional activities; may distribute such substances to persons registered or authorized to conduct chemical analysis, instructional activities, or research with such substances and to persons exempted from registration pursuant to § 1301.24; may export such substances to persons in other countries performing chemical analysis or enforcing laws related to controlled substances or drugs in those countries; and may conduct instructional activities with controlled substances.

(2) DEA Forms 224, 225, and 363 may for each basic class to be covered by be obtained at any area office of the such registration. Administration or by writing to the (g) Each application for registration Registration Section, Drug Enforce- to import or export controlled sub- ment Administration. See the Table of stances shall include the Administra- DEA Mailing Addresses in § 1321.01 of tion Controlled Substances Code Num- this chapter for the current mailing ad- ber, as set forth in part 1308 of this dress. chapter, for each controlled substance (3) Registrants will receive renewal whose importation or exportation is to notifications approximately 60 days be authorized by such registration. prior to the registration expiration Registration as an importer or ex- date. DEA Forms 224a, 225a, and 363a porter shall not entitle a registrant to may be mailed, as applicable, to reg- import or export any controlled sub- istrants; if any registered person does stance not specified in such registra- not receive such notification within 45 tion. days before the registration expiration date, the registrant must promptly (h) Each application for registration give notice of such fact and may re- to conduct research with any basic quest such forms by writing to the class of controlled substance listed in Registration Section, Drug Enforce- Schedule II shall include the Adminis- ment Administration. tration Controlled Substances Code (f) Each application for registration Number, as set forth in part 1308 of this to handle any basic class of controlled chapter, for each such basic class to be substance listed in Schedule I (except manufactured or imported as a coinci- to conduct chemical analysis with such dent activity of that registration. A classes), and each application for reg- statement listing the quantity of each istration to manufacture a basic class such basic class of controlled substance of controlled substance listed in Sched- to be imported or manufactured during ule II shall include the Administration the registration period for which appli- Controlled Substances Code Number, as cation is being made shall be included set forth in part 1308 of this chapter,

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with each such application. For pur- to comply with the requirements of poses of this paragraph only, manufac- this part will not generally be accepted turing is defined as the production of a for filing. In the case of minor defects controlled substance by synthesis, ex- as to completeness, the Administrator traction or by agricultural/horti- may accept the application for filing cultural means. with a request to the applicant for ad- (i) Each application shall include all ditional information. A defective appli- information called for in the form, un- cation will be returned to the applicant less the item is not applicable, in within 10 days following its receipt which case this fact shall be indicated. with a statement of the reason for not (j) Each application, attachment, or accepting the application for filing. A other document filed as part of an ap- defective application may be corrected plication, shall be signed by the appli- and resubmitted for filing at any time; cant, if an individual; by a partner of the Administrator shall accept for fil- the applicant, if a partnership; or by an ing any application upon resubmission officer of the applicant, if a corpora- by the applicant, whether complete or tion, corporate division, association, not. trust or other entity. An applicant may authorize one or more individuals, who (d) Accepting an application for fil- would not otherwise be authorized to ing does not preclude any subsequent do so, to sign applications for the ap- request for additional information pur- plicant by filing with the Registration suant to § 1301.15 and has no bearing on Unit of the Administration a power of whether the application will be grant- attorney for each such individual. The ed. power of attorney shall be signed by a [62 FR 13948, Mar. 24, 1997, as amended at 75 person who is authorized to sign appli- FR 10676, Mar. 9, 2010] cations under this paragraph and shall contain the signature of the individual § 1301.15 Additional information. being authorized to sign applications. The Administrator may require an The power of attorney shall be valid applicant to submit such documents or until revoked by the applicant. written statements of fact relevant to [62 FR 13946, Mar. 24, 1997, as amended at 68 the application as he/she deems nec- FR 37409, June 24, 2003; 68 FR 41228, July 11, essary to determine whether the appli- 2003; 68 FR 58598, Oct. 10, 2003; 71 FR 51112, cation should be granted. The failure of Aug. 29, 2006; 74 FR 15622, Apr. 6, 2009; 75 FR 10676, Mar. 9, 2010] the applicant to provide such documents or statements within a reason- § 1301.14 Filing of application; acceptable time after being requested to do so ance for filing; defective applica- shall be deemed to be a waiver by the tions. applicant of an opportunity to present (a) All applications for registration such documents or facts for consider- shall be submitted for filing to the ation by the Administrator in granting Registration Unit, Drug Enforcement or denying the application. Administration. The appropriate registration fee and any required attach- [62 FR 13948, Mar. 24, 1997] ments must accompany the applica- § 1301.16 Amendments to and with- tion. See the Table of DEA Mailing Ad- drawal of applications. dresses in § 1321.01 of this chapter for the current mailing address. (a) An application may be amended (b) Any person required to obtain or withdrawn without permission of more than one registration may submit the Administrator at any time before all applications in one package. Each the date on which the applicant re- application must be complete and ceives an order to show cause pursuant should not refer to any accompanying to § 1301.37. An application may be application for required information. amended or withdrawn with permission (c) Applications submitted for filing of the Administrator at any time are dated upon receipt. If found to be where good cause is shown by the ap- complete, the application will be ac- plicant or where the amendment or cepted for filing. Applications failing withdrawal is in the public interest.

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(b) After an application has been ac- owns at least one other pharmacy li- cepted for filing, the request by the ap- censed in the same State as the one the plicant that it be returned or the fail- ownership of which is being trans- ure of the applicant to respond to offi- ferred, the transferee may apply for cial correspondence regarding the ap- registration prior to the date of trans- plication, when sent by registered or fer. The Administrator may register certified mail, return receipt re- the applicant and authorize him to ob- quested, shall be deemed to be a with- tain controlled substances at the time drawal of the application. of transfer. Such registration shall not [62 FR 13949, Mar. 24, 1997] authorize the transferee to dispense controlled substances until the phar- § 1301.17 Special procedures for cer- macy has been issued a valid State li- tain applications. cense. The transferee shall include (a) If, at the time of application for with his/her application the following registration of a new pharmacy, the affidavit: pharmacy has been issued a license Affidavit for Transfer of Pharmacy from the appropriate State licensing agency, the applicant may include with I, llllllllll, the his/her application an affidavit as to llllllllll (Title of officer, official, the existence of the State license in partner or other position) of the following form: llllllllll (Corporation, partnership, or sole proprietor), doing business as Affidavit for New Pharmacy llllllllll (Store name) hereby certify: I, llllllllll, the (1) That said company was issued a phar- llllllllll (Title of officer, official, macy permit No.llllllby the partner, or other position) of llllllllll (Board of Pharmacy of (Corporation, partner- llllllllll Licensing Agency) of the State of ship, or sole proprietor), doing business as llllll and a DEA Registration Number llllllllll (Store name) at llllllllll for a pharmacy located at llllllllll (Number and Street), llllllllll (Number and Street) llllllllll (City) llllll (State) llllll (City) llllll (State) llllll (Zip code), hereby certify that (Zip Code); and said store was issued a pharmacy permit No. llllll llll by the llllllll (Board of (2) That said company is acquiring the Pharmacy or Licensing Agency) of the State pharmacy business of llllllllll of llllll on llllll (Date). (Name of Seller) doing business This statement is submitted in order to ob- asllllllllllwith DEA Registration tain a Drug Enforcement Administration Number llllll on or about llllll registration number. I understand that if (Date of Transfer) and that said company has any information is false, the Administration applied (or will apply on llllll (Date) may immediately suspend the registration for a pharmacy permit from the board of for this store and commence proceedings to pharmacy (or licensing agency) of the State revoke under 21 U.S.C. 824(a) because of the of llllll to do business as danger to public health and safety. I further llllllllll (Store name) at understand that any false information con- llllllllll (Number and Street) tained in this affidavit may subject me per- llllllllll (City) llllll (State) sonally and the above-named corporation/ llllll (Zip Code). partnership/business to prosecution under 21 U.S.C. 843, the penalties for conviction of This statement is submitted in order which include imprisonment for up to 4 to obtain a Drug Enforcement Admin- years, a fine of not more than $30,000 or both. istration registration number. llllllllllllllllllllllll Signature (Person who signs Application for I understand that if a DEA registration Registration) number is issued, the pharmacy may acquire State of lllllllllllllllllll controlled substances but may not dispense County of llllllllllllllllll them until a pharmacy permit or license is Subscribed to and sworn before me this issued by the State board of pharmacy or li- lllllll day of lllllll, 19ll. censing agency. llllllllllllllllllllllll I understand that if any information is Notary Public false, the Administration may immediately suspend the registration for this store and (b) Whenever the ownership of a commence proceedings to revoke under 21 pharmacy is being transferred from one U.S.C. 824(a) because of the danger to public person to another, if the transferee health and safety. I further understand that

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any false information contained in this affi- (i) The affidavit is submitted to ob- davit may subject me personally to prosecu- tain a Drug Enforcement Administra- tion under 21 U.S.C. 843, the penalties for tion registration number; conviction of which include imprisonment (ii) If any material information is for up to 4 years, a fine of not more than $30,000 or both. false, the Administrator may commence proceedings to deny the applica- llllllllllllllllllllllll tion under section 304 of the Act (21 Signature (Person who signs Application for U.S.C. 824(a)); Registration) (iii) Any false or fraudulent material State of lllllllllllllllllll information contained in this affidavit County of llllllllllllllllll may subject the person signing this af- Subscribed to and sworn before me this llllllll day of lllllllll, fidavit and the above-named corpora- 19ll. tion/partnership/business to prosecu- llllllllllllllllllllllll tion under section 403 of the Act (21 Notary Public U.S.C. 843); (8) Signature of the person author- (c) If at the time of application for a ized to sign the Application for Reg- separate registration at a long term istration for the named retail phar- care facility, the retail pharmacy has macy; been issued a license, permit, or other (9) Notarization of the affidavit. form of authorization from the appro- (d) The Administrator shall follow priate State agency to install and oper- the normal procedures for approving an ate an automated dispensing system application to verify the statements in for the dispensing of controlled sub- the affidavit. If the statements prove stances at the long term care facility, to be false, the Administrator may re- the applicant must include with his/her voke the registration on the basis of application for registration (DEA Form section 304(a)(1) of the Act (21 U.S.C. 224) an affidavit as to the existence of 824(a)(1)) and suspend the registration the State authorization. Exact lan- immediately by pending revocation on guage for this affidavit may be found the basis of section 304(d) of the Act (21 at the DEA Diversion Control Program U.S.C. 824(d)). At the same time, the Web site. The affidavit must include Administrator may seize and place the following information: under seal all controlled substances (1) The name and title of the cor- possessed by the applicant under sec- porate officer or official signing the af- tion 304(f) of the Act (21 U.S.C. 824(f)). fidavit; Intentional misuse of the affidavit pro- (2) The name of the corporation, cedure may subject the applicant to partnership or sole proprietorship oper- prosecution for fraud under section ating the retail pharmacy; 403(a)(4) of the Act (21 U.S.C. 843(a)(4)), (3) The name and complete address and obtaining controlled substances (including city, state, and Zip code) of through registration by fraudulent the retail pharmacy; means may subject the applicant to (4) The name and complete address prosecution under section 403(a)(3) of (including city, state, and Zip code) of the Act (21 U.S.C. 843(a)(3)). The pen- the long term care facility at which alties for conviction of either offense DEA registration is sought; include imprisonment for up to 4 years, (5) Certification that the named re- a fine not exceeding $30,000 or both. tail pharmacy has been authorized by [62 FR 13949, Mar. 24, 1997, as amended at 70 the state Board of Pharmacy or licens- FR 25465, May 13, 2005] ing agency to install and operate an automated dispensing system for the § 1301.18 Research protocols. dispensing of controlled substances at (a) A protocol to conduct research the named long term care facility (in- with controlled substances listed in cluding the license or permit number, Schedule I shall be in the following if applicable); form and contain the following infor- (6) The date on which the authoriza- mation where applicable: tion was issued; (1) Investigator: (7) Statements attesting to the fol- (i) Name, address, and DEA registra- lowing: tion number; if any.

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(ii) Institutional affiliation. shall indicate that such notice has (iii) Qualifications, including a cur- been submitted to the Food and Drug riculum vitae and an appropriate bibli- Administration by submitting to the ography (list of publications). Administration with his/her DEA Form (2) Research project: 225 three copies of the following certifi- (i) Title of project. cate: (ii) Statement of the purpose. I hereby certify that on llllllllll (iii) Name of the controlled sub- (Date), pursuant to 21 U.S.C. 355(i) and 21 stances or substances involved and the CFR 130.3, I, llllllllll (Name and amount of each needed. Address of IND Sponsor) submitted a Notice (iv) Description of the research to be of Claimed Investigational Exemption for a conducted, including the number and New Drug (IND) to the Food and Drug Ad- species of research subjects, the dosage ministration for: to be administered, the route and llllllllllllllllllllllll method of administration, and the du- (Name of Investigational Drug). ration of the project. llllllllllllllllllllllll (v) Location where the research will (Date) be conducted. llllllllllllllllllllllll (vi) Statement of the security provi- (Signature of Applicant). sions for storing the controlled sub- (c) In the event that the registrant stances (in accordance with § 1301.75) desires to increase the quantity of a and for dispensing the controlled sub- controlled substance used for an ap- stances in order to prevent diversion. proved research project, he/she shall (vii) If the investigator desires to submit a request to the Registration manufacture or import any controlled Unit, Drug Enforcement Administra- substance listed in paragraph (a)(2)(iii) tion, by registered mail, return receipt of this section, a statement of the requested. See the Table of DEA Mail- quantity to be manufactured or im- ing Addresses in § 1321.01 of this chapter ported and the sources of the chemicals for the current mailing address. The re- to be used or the substance to be im- quest shall contain the following infor- ported. mation: DEA registration number; (3) Authority: name of the controlled substance or (i) Institutional approval. substances and the quantity of each (ii) Approval of a Human Research authorized in the approved protocol; Committee for human studies. and the additional quantity of each de- (iii) Indication of an approved active sired. Upon return of the receipt, the Notice of Claimed Investigational Ex- registrant shall be authorized to pur- emption for a New Drug (number). chase the additional quantity of the (iv) Indication of an approved funded controlled substance or substances grant (number), if any. specified in the request. The Adminis- (b) In the case of a clinical investiga- tration shall review the letter and for- tion with controlled substances listed ward it to the Food and Drug Adminis- in Schedule I, the applicant shall sub- tration together with the Administra- mit three copies of a Notice of Claimed tion comments. The Food and Drug Ad- Investigational Exemption for a New ministration shall approve or deny the Drug (IND) together with a statement request as an amendment to the proof the security provisions (as protocol and so notify the registrant. Ap- scribed in paragraph (a)(2)(vi) of this proval of the letter by the Food and section for a research protocol) to, and Drug Administration shall authorize have such submission approved by, the the registrant to use the additional Food and Drug Administration as re- quantity of the controlled substance in quired in 21 U.S.C. 355(i) and § 130.3 of the research project. this title. Submission of this Notice (d) In the event the registrant desires and statement to the Food and Drug to conduct research beyond the vari- Administration shall be in lieu of a re- ations provided in the registrant’s ap- search protocol to the Administration proved protocol (excluding any in- as required in paragraph (a) of this sec- crease in the quantity of the controlled tion. The applicant, when applying for substance requested for his/her reregistration with the Administration, search project as outlined in paragraph

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(c) of this section), he/she shall submit Internet. A pharmacy that has so three copies of a supplemental protocol changed its registration status back to in accordance with paragraph (a) of that of a non-online pharmacy remains this section describing the new re- responsible for submitting reports in search and omitting information in the accordance with § 1304.55 of this chapter supplemental protocol which has been with respect to any controlled sub- stated in the original protocol. Supple- stances that it dispensed while it was mental protocols shall be processed and registered with a modification author- approved or denied in the same manner izing it to operate as an online phar- as original research protocols. macy. [62 FR 13949, Mar. 24, 1997, as amended at 75 (e) Registrants applying for modified FR 10676, Mar. 9, 2010] registrations under this section must comply with notification and reporting § 1301.19 Special requirements for on- requirements set forth in §§ 1304.40, line pharmacies. 1304.45, 1304.50, and 1304.55 of this chap- (a) A pharmacy that has been issued ter. a registration under § 1301.13 may re- (f) No person (including a registrant) quest that the Administrator modify required to obtain a modification of a its registration to authorize the phar- registration under §§ 1301.11(b) and macy to dispense controlled substances 1301.13 of this part authorizing it to op- by means of the Internet as an online erate as an online pharmacy may en- pharmacy. The Administrator may gage in any activity for which such deny an application for a modification modification of registration is required of registration if the Administrator determines that the issuance of a modi- until the application for such modified fication would be inconsistent with the registration is granted and an active public interest. In determining the Certificate of Registration indicating public interest, the Administrator will the modification of the registration consider the factors listed in section has been issued by the Administrator 303(f) of the Act (21 U.S.C. 823(f)). to such person. (b) Each online pharmacy shall com- [74 FR 15622, Apr. 6, 2009] ply with the requirements of State law concerning licensure of pharmacies in EXCEPTIONS TO REGISTRATION AND FEES each State from which it, and in each State to which it, delivers, distributes, § 1301.21 Exemption from fees. or dispenses, or offers to deliver, dis- (a) The Administrator shall exempt tribute, or dispense controlled sub- from payment of an application fee for stances by means of the Internet. registration or reregistration: (c) Application for a modified reg- (1) Any hospital or other institution istration authorizing the dispensing of controlled substances by means of the which is operated by an agency of the Internet will be made by an online ap- United States (including the U.S. plication process as specified in § 1301.13 Army, Navy, Marine Corps., Air Force, of this part. Subsequent online phar- and Coast Guard), of any State, or any macy registration renewals will be ac- political subdivision or agency thereof. complished by an online process. (2) Any individual practitioner who is (d) A pharmacy that seeks to dis- required to obtain an individual reg- continue its modification of registra- istration in order to carry out his or tion authorizing it to dispense con- her duties as an official of an agency of trolled substances by means of the the United States (including the U.S. Internet as an online pharmacy (but Army, Navy, Marine Corps, Air Force, continue its business activity as a non- and Coast Guard), of any State, or any online pharmacy) shall so notify the political subdivision or agency thereof. Administrator by requesting to modify (b) In order to claim exemption from its registration to reflect the appro- payment of a registration or rereg- priate business activity. Once the registration application fee, the registrant istration has been so changed, the shall have completed the certification pharmacy may no longer dispense con- on the appropriate application form, trolled substances by means of the wherein the registrant’s superior (if

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the registrant is an individual) or offi- minister, or prescribe drugs within the cer (if the registrant is an agency) cer- jurisdiction; tifies to the status and address of the (4) Such individual practitioner is registrant and to the authority of the acting only within the scope of his/her registrant to acquire, possess, or han- employment in the hospital or institu- dle controlled substances. tion; (c) Exemption from payment of a reg- (5) The hospital or other institution istration or reregistration application authorizes the individual practitioner fee does not relieve the registrant of to administer, dispense or prescribe any other requirements or duties pre- under the hospital registration and scribed by law. designates a specific internal code number for each individual practi- [62 FR 13950, Mar. 24, 1997] tioner so authorized. The code number shall consist of numbers, letters, or a § 1301.22 Exemption of agents and em- combination thereof and shall be a suf- ployees; affiliated practitioners. fix to the institution’s DEA registra- (a) The requirement of registration is tion number, preceded by a hyphen waived for any agent or employee of a (e.g., APO123456–10 or APO123456–A12); person who is registered to engage in and any group of independent activities, if (6) A current list of internal codes such agent or employee is acting in the and the corresponding individual prac- usual course of his/her business or em- titioners is kept by the hospital or ployment. other institution and is made available (b) An individual practitioner who is at all times to other registrants and an agent or employee of another prac- law enforcement agencies upon request titioner (other than a mid-level practi- for the purpose of verifying the author- tioner) registered to dispense con- ity of the prescribing individual practi- trolled substances may, when acting in tioner. the normal course of business or em- [62 FR 13950, Mar. 24, 1997] ployment, administer or dispense (other than by issuance of prescription) § 1301.23 Exemption of certain mili- controlled substances if and to the ex- tary and other personnel. tent that such individual practitioner (a) The requirement of registration is is authorized or permitted to do so by waived for any official of the U.S. the jurisdiction in which he or she Army, Navy, Marine Corps, Air Force, practices, under the registration of the Coast Guard, Public Health Service, or employer or principal practitioner in Bureau of Prisons who is authorized to lieu of being registered him/herself. prescribe, dispense, or administer, but (c) An individual practitioner who is not to procure or purchase, controlled an agent or employee of a hospital or substances in the course of his/her offi- other institution may, when acting in cial duties. Such officials shall follow the normal course of business or em- procedures set forth in part 1306 of this ployment, administer, dispense, or pre- chapter regarding prescriptions, but scribe controlled substances under the shall state the branch of service or registration of the hospital or other in- agency (e.g., ‘‘U.S. Army’’ or ‘‘Public stitution which is registered in lieu of Health Service’’) and the service iden- being registered him/herself, provided tification number of the issuing official that: in lieu of the registration number re- (1) Such dispensing, administering or quired on prescription forms. The serv- prescribing is done in the usual course ice identification number for a Public of his/her professional practice; Health Service employee is his/her So- (2) Such individual practitioner is au- cial Security identification number. thorized or permitted to do so by the (b) The requirement of registration is jurisdiction in which he/she is prac- waived for any official or agency of the ticing; U.S. Army, Navy, Marine Corps, Air (3) The hospital or other institution Force, Coast Guard, or Public Health by whom he/she is employed has Service who or which is authorized to verified that the individual practi- import or export controlled substances tioner is so permitted to dispense, ad- in the course of his/her official duties.

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(c) If any official exempted by this their official duties, are deemed to be section also engages as a private indi- officials exempted by this section and vidual in any activity or group of ac- within the activity described in section tivities for which registration is re- 515(d) of the Act (21 U.S.C. 885(d)). For quired, such official shall obtain a reg- purposes of this paragraph, laboratory istration for such private activities. activities shall not include field or [62 FR 13951, Mar. 24, 1997] other preliminary chemical tests by officials exempted by this section. § 1301.24 Exemption of law enforce- (d) In addition to the activities au- ment officials. thorized under a registration to con- (a) The requirement of registration is duct chemical analysis pursuant to waived for the following persons in the § 1301.13(e)(1)(ix), laboratories of the circumstances described in this sec- Administration shall be authorized to tion: manufacture or import controlled sub- (1) Any officer or employee of the Ad- stances for any lawful purpose, to dis- ministration, any officer of the U.S. tribute or export such substances to Customs Service, any officer or em- any person, and to import and export ployee of the United States Food and such substances in emergencies with- Drug Administration, and any other out regard to the requirements of part Federal officer who is lawfully engaged 1312 of this chapter if a report con- in the enforcement of any Federal law cerning the importation or exportation relating to controlled substances, is made to the Drug Operations Section drugs or customs, and is duly author- of the Administration within 30 days of ized to possess or to import or export such importation or exportation. controlled substances in the course of [62 FR 13951, Mar. 24, 1997] his/her official duties; and (2) Any officer or employee of any § 1301.25 Registration regarding ocean State, or any political subdivision or vessels, aircraft, and other entities. agency thereof, who is engaged in the enforcement of any State or local law (a) If acquired by and dispensed under relating to controlled substances and is the general supervision of a medical of- duly authorized to possess controlled ficer described in paragraph (b) of this substances in the course of his/her offi- section, or the master or first officer of cial duties. the vessel under the circumstances de- (b) Any official exempted by this sec- scribed in paragraph (d) of this section, tion may, when acting in the course of controlled substances may be held for his/her official duties, procure any con- stocking, be maintained in, and dis- trolled substance in the course of an pensed from medicine chests, first aid inspection, in accordance with packets, or dispensaries: § 1316.03(d) of this chapter, or in the (1) On board any vessel engaged in course of any criminal investigation international trade or in trade between involving the person from whom the ports of the United States and any substance was procured, and may pos- merchant vessel belonging to the U.S. sess any controlled substance and dis- Government; tribute any such substance to any (2) On board any aircraft operated by other official who is also exempted by an air carrier under a certificate of per- this section and acting in the course of mit issued pursuant to the Federal his/her official duties. Aviation Act of 1958 (49 U.S.C. 1301); (c) In order to enable law enforce- and ment agency laboratories, including (3) In any other entity of fixed or laboratories of the Administration, to transient location approved by the Ad- obtain and transfer controlled sub- ministrator as appropriate for applica- stances for use as standards in chem- tion of this section (e.g., emergency ical analysis, such laboratories shall kits at field sites of an industrial firm). obtain annually a registration to con- (b) A medical officer shall be: duct chemical analysis. Such labora- (1) Licensed in a state as a physician; tories shall be exempted from payment (2) Employed by the owner or oper- of a fee for registration. Laboratory ator of the vessel, aircraft or other en- personnel, when acting in the scope of tity; and

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(3) Registered under the Act at either (2) The written requisition must be of the following locations: on the vessel’s official stationery or (i) The principal office of the owner purchase order form and must include or operator of the vessel, aircraft or the name and address of the vendor, other entity or the name of the controlled substance, (ii) At any other location provided description of the controlled substance that the name, address, registration (dosage form, strength and number or number and expiration date as they ap- volume per container) number of con- pear on his/her Certificate of Registra- tainers ordered, the name of the vessel, tion (DEA Form 223) for this location the vessel’s official number and coun- are maintained for inspection at said try of registry, the owner or operator principal office in a readily retrievable of the vessel, the port at which the ves- manner. sel is located, signature of the vessel’s (c) A registered medical officer may officer who is ordering the controlled serve as medical officer for more than substances and the date of the requisi- one vessel, aircraft, or other entity tion. under a single registration, unless he/ (3) The vendor may, after verifying she serves as medical officer for more the identification of the vessel’s officer than one owner or operator, in which requisitioning the controlled sub- case he/she shall either maintain a sep- stances, deliver the control substances arate registration at the location of to that officer. The transaction shall the principal office of each such owner be documented, in triplicate, on a or operator or utilize one or more reg- record of sale in a format similar to istrations pursuant to paragraph that outlined in paragraph (d)(4) of this (b)(3)(ii) of this section. section. The vessel’s requisition shall (d) If no medical officer is employed be attached to copy 1 of the record of by the owner or operator of a vessel, or sale and filed with the controlled sub- in the event such medical officer is not stances records of the vendor, copy 2 of accessible and the acquisition of con- the record of sale shall be furnished to trolled substances is required, the mas- the officer of the vessel and retained ter or first officer of the vessel, who aboard the vessel, copy 3 of the record shall not be registered under the Act, of sale shall be forwarded to the near- may purchase controlled substances est DEA Division Office within 15 days from a registered manufacturer or dis- after the end of the month in which the tributor, or from an authorized phar- sale is made. macy as described in paragraph (f) of (4) The vendor’s record of sale should this section, by following the procedure be similar to, and must include all the outlined below: information contained in, the below (1) The master or first officer of the listed format. vessel must personally appear at the vendor’s place of business, present SALE OF CONTROLLED SUBSTANCES TO VESSELS proper identification (e.g., Seaman’s photographic identification card) and a (Name of registrant) llllllllllll written requisition for the controlled (Address of registrant) lllllllllll substances. (DEA registration number) lllllllll

Number of pack- Packages distrib- Line No. ages ordered Size of packages Name of product uted Date distributed

1 ...... 2 ...... 3 ......

FOOTNOTE: Line numbers may be continued according to needs of the vendor.

Number of lines completed lllllllll Name and title of vessel’s officer who pre- Name of vessel lllllllllllllll sented the requisition llll Vessel’s official number lllllllllll Signature of vessel’s officer who presented Vessel’s country of registry lllllllll the requisition llll Owner or operator of the vessel lllllll

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(e) Any medical officer described in vention on Psychotropic Substances, paragraph (b) of this section shall, in 1971, shall not be deemed to import or addition to complying with all require- export any controlled substances pur- ments and duties prescribed for reg- chased and stored in accordance with istrants generally, prepare an annual that section or applicable article. report as of the date on which his/her (h) The Master of a vessel shall pre- registration expires, which shall give pare a report for each calendar year in detail an accounting for each vessel, which shall give in detail an account- aircraft, or other entity, and a sum- ing for all controlled substances pur- mary accounting for all vessels, air- chased, dispensed, or disposed of during craft, or other entities under his/her the year. The Master shall file this re- supervision for all controlled sub- port with the medical officer employed stances purchased, dispensed or dis- by the owner or operator of his/her ves- posed of during the year. The medical sel, if any, or, if not, he/she shall main- officer shall maintain this report with tain this report with other records re- other records required to be kept under quired to be kept under the Act and, the Act and, upon request, deliver a upon request, deliver a copy of the re- copy of the report to the Administra- port to the Administration. tion. The medical officer need not be (i) Controlled substances acquired present when controlled substances are and possessed in accordance with this dispensed, if the person who actually section shall not be distributed to per- dispensed the controlled substances is sons not under the general supervision responsible to the medical officer to of the medical officer employed by the justify his/her actions. owner or operator of the vessel, air- (f) Any registered pharmacy that craft, or other entity, except in accord- wishes to distribute controlled sub- ance with § 1307.21 of this chapter. stances pursuant to this section shall be authorized to do so, provided: [62 FR 13951, Mar. 24, 1997] (1) The registered pharmacy notifies the nearest Division Office of the Ad- § 1301.26 Exemptions from import or export requirements for personal ministration of its intention to so dis- medical use. tribute controlled substances prior to the initiation of such activity. This no- Any individual who has in his/her tification shall be by registered mail possession a controlled substance listed and shall contain the name, address, in schedules II, III, IV, or V, which he/ and registration number of the phar- she has lawfully obtained for his/her macy as well as the date upon which personal medical use, or for adminis- such activity will commence; and tration to an animal accompanying (2) Such activity is authorized by him/her, may enter or depart the state law; and United States with such substance not- (3) The total number of dosage units withstanding sections 1002–1005 of the of all controlled substances distributed Act (21 U.S.C. 952–955), provided the fol- by the pharmacy during any calendar lowing conditions are met: year in which the pharmacy is reg- (a) The controlled substance is in the istered to dispense does not exceed the original container in which it was dis- limitations imposed upon such dispensed to the individual; and tribution by § 1307.11(a)(4) and (b) of (b) The individual makes a declara- this chapter. tion to an appropriate official of the (g) Owners or operators of vessels, Bureau of Customs and Border Protec- aircraft, or other entities described in tion stating: this section shall not be deemed to pos- (1) That the controlled substance is sess or dispense any controlled sub- possessed for his/her personal use, or stance acquired, stored and dispensed for an animal accompanying him/her; in accordance with this section. Addi- and tionally, owners or operators of ves- (2) The trade or chemical name and sels, aircraft, or other entities de- the symbol designating the schedule of scribed in this section or in Article 32 the controlled substance if it appears of the Single Convention on Narcotic on the container label, or, if such name Drugs, 1961, or in Article 14 of the Con- does not appear on the label, the name

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and address of the pharmacy or practi- § 1301.28 Exemption from separate tioner who dispensed the substance and registration for practitioners dis- the prescription number. pensing or prescribing Schedule III, (c) In addition to (and not in lieu of) IV, or V narcotic controlled drugs approved by the Food and Drug Ad- the foregoing requirements of this sec- ministration specifically for use in tion, a United States resident may im- maintenance or detoxification port into the United States no more treatment. than 50 dosage units combined of all (a) An individual practitioner may such controlled substances in the indi- dispense or prescribe Schedule III, IV, vidual’s possession that were obtained or V narcotic controlled drugs or com- abroad for personal medical use. (For binations of narcotic controlled drugs purposes of this section, a United which have been approved by the Food States resident is a person whose resi- and Drug Administration (FDA) spe- dence (i.e., place of general abode— cifically for use in maintenance or de- meaning one’s principal, actual dwell- toxification treatment without obtaining place in fact, without regard to ining the separate registration required tent) is in the United States.) This 50 by § 1301.13(e) if all of the following con- dosage unit limitation does not apply ditions are met: to controlled substances lawfully ob- (1) The individual practitioner meets tained in the United States pursuant to the conditions specified in paragraph a prescription issued by a DEA reg- (b) of this section. istrant. (2) The narcotic drugs or combination of narcotic drugs meet the condi- [69 FR 55347, Sept. 14, 2004] tions specified in paragraph (c) of this section. § 1301.27 Separate registration by re- (3) The individual practitioner is in tail pharmacies for installation and operation of automated dispensing compliance with either paragraph (d) systems at long term care facilities. or paragraph (e) of this section. (b)(1) The individual practitioner (a) A retail pharmacy may install must submit notification to the Sec- and operate automated dispensing sys- retary of Health and Human Services tems, as defined in § 1300.01 of this stating the individual practitioner’s in- chapter, at long term care facilities, tent to dispense or prescribe narcotic under the requirements of § 1301.17. No drugs under paragraph (a) of this sec- person other than a registered retail tion. The notice must contain all of the pharmacy may install and operate an following certifications: automated dispensing system at a long (i) The individual practitioner is reg- term care facility. istered under § 1301.13 as an individual (b) Retail pharmacies installing and practitioner and is a ‘‘qualifying physi- operating automated dispensing sys- cian’’ as defined in section 303(g)(2)(G) tems at long term care facilities must of the Act (21 U.S.C. 823(g)(2)(G)). maintain a separate registration at the (ii) The individual practitioner has location of each long term care facility the capacity to refer the patients to at which automated dispensing sys- whom the individual practitioner will tems are located. If more than one reg- provide narcotic drugs or combinations istered retail pharmacy operates auto- of narcotic drugs for appropriate coun- mated dispensing systems at the same seling and other appropriate ancillary long term care facility, each retail services. pharmacy must maintain a registra- (iii) The total number of patients to tion at the long term care facility. whom the individual practitioner will (c) A registered retail pharmacy ap- provide narcotic drugs or combinations plying for a separate registration to of narcotic drugs under this section operate an automated dispensing sys- will not exceed 30 at any one time un- tem for the dispensing of controlled less, not sooner than 1 year after the substances at a long term care facility date on which the practitioner submitted the initial notification to the is exempt from application fees for any Secretary of Health and Human Serv- such additional registrations. ices, the practitioner submits a second [70 FR 25465, May 13, 2005] notification to the Secretary of the

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need and intent of the practitioner to 823(g)(2)(B)). Health and Human Serv- treat up to 100 patients. A second noti- ices will notify DEA of its determina- fication under this subparagraph shall tion regarding the individual practi- contain the certifications required by tioner. If the individual practitioner subparagraphs (i) and (ii) of this para- has the appropriate registration under graph. The Secretary of Health and § 1301.13, then the Administrator will Human Services may promulgate regu- issue the practitioner an identification lations to change the total number of number as soon as one of the following patients. conditions occurs: (2) If an individual practitioner wish- (i) The Administrator receives a posi- es to prescribe or dispense narcotic tive determination from the Secretary drugs pursuant to paragraph (e) of this of Health and Human Services before section, the individual practitioner the conclusion of the 45-day review pe- must provide the Secretary of Health riod, or and Human Services the following: (ii) The 45-day review period has con- (i) Notification as required under cluded and no determination by the paragraph (b)(1) of this section in writ- Secretary of Health and Human Serv- ing, stating the individual practi- ices has been made. tioner’s name and DEA registration number issued under § 1301.13. (2) If the Secretary denies certifi- (ii) If the individual practitioner is a cation to an individual practitioner or member of a group practice, the names withdraws such certification once it is of the other individual practitioners in issued, then DEA will not issue the in- the group and the DEA registration dividual practitioner an identification numbers issued to the other individual number, or will withdraw the identi- practitioners under § 1301.13. fication number if one has been issued. (c) The narcotic drugs or combina- (3) The individual practitioner must tion of narcotic drugs to be dispensed include the identification number on or prescribed under this section must all records when dispensing and on all meet all of the following conditions: prescriptions when prescribing narcotic (1) The drugs or combination of drugs drugs under this section. have been approved for use in ‘‘main- (e) An individual practitioner may tenance treatment’’ or ‘‘detoxification begin to prescribe or dispense narcotic treatment’’ under the Federal Food, drugs to a specific individual patient Drug, and Cosmetic Act or section 351 under this section before receiving an of the Public Health Service Act. identification number from the Admin- (2) The drugs or combination of drugs istrator if the following conditions are have not been the subject of an adverse met: determination by the Secretary of (1) The individual practitioner has Health and Human Services, after con- submitted a written notification under sultation with the Attorney General, paragraph (b) of this section in good that the use of the drugs or combina- faith to the Secretary of Health and tion of drugs requires additional stand- Human Services. ards respecting the qualifications of (2) The individual practitioner rea- practitioners or the quantities of the sonably believes that the conditions drugs that may be provided for unsu- specified in paragraphs (b) and (c) of pervised use. this section have been met. (d)(1) After receiving the notification submitted under paragraph (b) of this (3) The individual practitioner rea- section, the Secretary of Health and sonably believes that the treatment of Human Services will forward a copy of an individual patient would be facili- the notification to the Administrator. tated if narcotic drugs are prescribed The Secretary of Health and Human or dispensed under this section before Services will have 45 days from the the sooner of: date of receipt of the notification to (i) Receipt of an identification num- make a determination of whether the ber from the Administrator, or individual practitioner involved meets (ii) Expiration of the 45-day period. all requirements for a waiver under (4) The individual practitioner has section 303(g)(2)(B) of the Act (21 U.S.C. notified both the Secretary of Health

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and Human Services and the Adminis- (and shall notify the Administrator of trator of his or her intent to begin pre- his/her determination) within 21 days scribing or dispensing the narcotic after receipt of the application and drugs before expiration of the 45-day complete protocol, except that in the period. case of a clinical investigation, the (5) The Secretary has not notified the Secretary shall have 30 days to make registrant that he/she is not qualified such determination and notify the Ad- under paragraph (d) of this section. ministrator. The Secretary, in deter- (6) The individual practitioner has mining the merits of the protocol, shall the appropriate registration under consult with the Administrator as to § 1301.13. effective procedures to safeguard ade- (f) If an individual practitioner dis- quately against diversion of such con- penses or prescribes Schedule III, IV, or V narcotic drugs approved by the Food trolled substances from legitimate and Drug Administration specifically medical or scientific use. for maintenance or detoxification (b) An applicant whose protocol is de- treatment in violation of any of the fective shall be notified by the Sec- conditions specified in paragraphs (b), retary within 21 days after receipt of (c) or (e) of this section, the Adminis- such protocol from the Administrator trator may revoke the individual prac- (or in the case of a clinical investiga- titioner’s registration in accordance tion within 30 days), and he/she shall be with § 1301.36. requested to correct the existing de- [70 FR 36342, June 23, 2005, as amended at 73 fects before consideration shall be FR 29688, May 22, 2008] given to his/her submission. (c) If the Secretary determines the ACTION ON APPLICATION FOR REGISTRA- applicant qualified and competent and TION: REVOCATION OR SUSPENSION OF the research protocol meritorious, he/ REGISTRATION she shall notify the Administrator in writing of such determination. The Ad- § 1301.31 Administrative review generally. ministrator shall issue a certificate of registration within 10 days after re- The Administrator may inspect, or ceipt of this notice, unless he/she deter- cause to be inspected, the establish- mines that the certificate of registra- ment of an applicant or registrant, pur- tion should be denied on a ground spec- suant to subpart A of part 1316 of this ified in section 304(a) of the Act (21 chapter. The Administrator shall review the application for registration U.S.C. 824(a)). In the case of a supple- and other information gathered by the mental protocol, a replacement certifi- Administrator regarding an applicant cate of registration shall be issued by in order to determine whether the ap- the Administrator. plicable standards of section 303 (21 (d) If the Secretary determines that U.S.C. 823) or section 1008 (21 U.S.C. 958) the protocol is not meritorious and/or of the Act have been met by the appli- the applicant is not qualified or com- cant. petent, he/she shall notify the Adminis- trator in writing setting forth the rea- [62 FR 13953, Mar. 24, 1997] sons for such determination. If the Ad- § 1301.32 Action on applications for re- ministrator determines that grounds search in Schedule I substances. exist for the denial of the application, (a) In the case of an application for he/she shall within 10 days issue an registration to conduct research with order to show cause pursuant to controlled substances listed in Sched- § 1301.37 and, if requested by the appli- ule I, the Administrator shall process cant, hold a hearing on the application the application and protocol and for- pursuant to § 1301.41. If the grounds for ward a copy of each to the Secretary of denial of the application include a de- Health and Human Services (Secretary) termination by the Secretary, the Sec- within 7 days after receipt. The Sec- retary or his duly authorized agent retary shall determine the qualifica- shall furnish testimony and documents tions and competency of the applicant, pertaining to his determination at such as well as the merits of the protocol hearing.

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(e) Supplemental protocols will be 952(a)(2)(B)), the Administrator shall, processed in the same manner as origi- upon the filing of such application, nal research protocols. If the proc- publish in the FEDERAL REGISTER a no- essing of an application or research tice naming the applicant and stating protocol is delayed beyond the time that such applicant has applied to be limits imposed by this section, the ap- registered as an importer of a Schedule plicant shall be so notified in writing. I or II controlled substance, which substance shall be identified. A copy of [62 FR 13953, Mar. 24, 1997] said notice shall be mailed simulta- § 1301.33 Application for bulk manu- neously to each person registered as a facture of Schedule I and II sub- bulk manufacturer of that controlled stances. substance and to any other applicant (a) In the case of an application for therefor. Any such person may, within registration or reregistration to manu- 30 days from the date of publication of facture in bulk a basic class of con- the notice in the FEDERAL REGISTER, trolled substance listed in Schedule I file written comments on or objections or II, the Administrator shall, upon the to the issuance of the proposed reg- filing of such application, publish in istration, and may, at the same time, file a written request for a hearing on the FEDERAL REGISTER a notice naming the applicant and stating that such ap- the application pursuant to § 1301.43. If plicant has applied to be registered as a hearing is requested, the Adminis- a bulk manufacturer of a basic class of trator shall hold a hearing on the ap- narcotic or nonnarcotic controlled sub- plication in accordance with § 1301.41. stance, which class shall be identified. Notice of the hearing shall be published A copy of said notice shall be mailed in the FEDERAL REGISTER, and shall be simultaneously to each person reg- mailed simultaneously to the applicant istered as a bulk manufacturer of that and to all persons to whom notice of basic class and to any other applicant the application was mailed. Any such therefor. Any such person may, within person may participate in the hearing 60 days from the date of publication of by filing a notice of appearance in accordance with § 1301.43 of this chapter. the notice in the FEDERAL REGISTER, file with the Administrator written Notice of the hearing shall contain a comments on or objections to the summary of all comments and objec- issuance of the proposed registration. tions filed regarding the application and shall state the time and place for (b) In order to provide adequate com- the hearing, which shall not be less petition, the Administrator shall not than 30 days after the date of publica- be required to limit the number of tion of such notice in the FEDERAL manufacturers in any basic class to a REGISTER. A hearing pursuant to this number less than that consistent with section may be consolidated with a maintenance of effective controls hearing held pursuant to § 1301.35 or against diversion solely because a § 1301.36 of this part. smaller number is capable of producing (b) The Administrator shall register an adequate and uninterrupted supply. an applicant to import a controlled (c) This section shall not apply to the substance listed in Schedule I or II if manufacture of basic classes of con- he/she determines that such registra- trolled substances listed in Schedules I tion is consistent with the public inter- or II as an incident to research or est and with U.S. obligations under chemical analysis as authorized in international treaties, conventions, or § 1301.13(e)(1). protocols in effect on May 1, 1971. In [62 FR 13953, Mar. 24, 1997] determining the public interest, the following factors shall be considered: § 1301.34 Application for importation (1) Maintenance of effective controls of Schedule I and II substances. against diversion of particular con- (a) In the case of an application for trolled substances and any controlled registration or reregistration to import substance in Schedule I or II com- a controlled substance listed in Sched- pounded therefrom into other than le- ule I or II, under the authority of sec- gitimate medical, scientific research, tion 1002(a)(2)(B) of the Act (21 U.S.C. or industrial channels, by limiting the

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importation and bulk manufacture of (7) Such other factors as may be rel- such controlled substances to a number evant to and consistent with the public of establishments which can produce health and safety. an adequate and uninterrupted supply (c) In determining whether the appli- of these substances under adequately cant can and will maintain effective competitive conditions for legitimate controls against diversion within the medical, scientific, research, and in- meaning of paragraph (b) of this sec- dustrial purposes; tion, the Administrator shall consider (2) Compliance with applicable State among other factors: and local law; (1) Compliance with the security re- (3) Promotion of technical advances quirements set forth in §§ 1301.71– in the art of manufacturing these sub- 1301.76; and stances and the development of new (2) Employment of security proce- substances; dures to guard against in-transit losses (4) Prior conviction record of appli- within and without the jurisdiction of cant under Federal and State laws re- the United States. lating to the manufacture, distribu- (d) In determining whether competition, or dispensing of such substances; tion among the domestic manufactur- (5) Past experience in the manufac- ers of a controlled substance is ade- ture of controlled substances, and the quate within the meaning of para- existence in the establishment of effec- graphs (b)(1) and (b)(6)(iii) of this sec- tive control against diversion; tion, as well as section 1002(a)(2)(B) of (6) That the applicant will be per- the Act (21 U.S.C. 952(a)(2)(B)), the Ad- mitted to import only: ministrator shall consider: (i) Such amounts of crude opium, (1) The extent of price rigidity in the poppy straw, concentrate of poppy light of changes in: straw, and coca leaves as the Adminis- (i) raw materials and other costs and trator finds to be necessary to provide (ii) conditions of supply and demand; for medical, scientific, or other legiti- (2) The extent of service and quality mate purposes; or competition among the domestic man- (ii) Such amounts of any controlled ufacturers for shares of the domestic substances listed in Schedule I or II as market including: the Administrator shall find to be nec- (i) Shifts in market shares and essary to provide for the medical, sci- (ii) Shifts in individual customers entific, or other legitimate needs of the among domestic manufacturers; United States during an emergency in (3) The existence of substantial dif- which domestic supplies of such sub- ferentials between domestic prices and stances are found by the Administrator the higher of prices generally pre- to be inadequate; or vailing in foreign markets or the prices (iii) Such amounts of any controlled at which the applicant for registration substance listed in Schedule I or II as to import is committed to undertake the Administrator shall find to be nec- to provide such products in the domes- essary to provide for the medical, sci- tic market in conformity with the Act. entific, or other legitimate needs of the In determining the existence of sub- United States in any case in which the stantial differentials hereunder, appro- Administrator finds that competition priate consideration should be given to among domestic manufacturers of the any additional costs imposed on domes- controlled substance is inadequate and tic manufacturers by the requirements will not be rendered adequate by the of the Act and such other cost-related registration of additional manufactur- and other factors as the Administrator ers under section 303 of the Act (21 may deem relevant. In no event shall U.S.C. 823); or an importer’s offering prices in the (iv) Such limited quantities of any United States be considered if they are controlled substance listed in Schedule lower than those prevailing in the for- I or II as the Administrator shall find eign market or markets from which to be necessary for scientific, analyt- the importer is obtaining his/her sup- ical or research uses; and ply;

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(4) The existence of competitive re- (c) The Certificate of Registration straints imposed upon domestic manu- (DEA Form 223) shall contain the facturers by governmental regulations; name, address, and registration num- and ber of the registrant, the activity au- (5) Such other factors as may be rel- thorized by the registration, the sched- evant to the determinations required ules and/or Administration Controlled under this paragraph. Substances Code Number (as set forth (e) In considering the scope of the do- in part 1308 of this chapter) of the con- mestic market, consideration shall be trolled substances which the registrant given to substitute products which are is authorized to handle, the amount of reasonably interchangeable in terms of fee paid (or exemption), and the expira- price, quality and use. tion date of the registration. The reg- (f) The fact that the number of exist- istrant shall maintain the certificate ing manufacturers is small shall not of registration at the registered loca- demonstrate, in and of itself, that ade- tion in a readily retrievable manner quate competition among them does and shall permit inspection of the cer- not exist. tificate by any official, agent or employee of the Administration or of any [62 FR 13953, Mar. 24, 1997] Federal, State, or local agency engaged in enforcement of laws relating to con- § 1301.35 Certificate of registration; trolled substances. denial of registration. [62 FR 13954, Mar. 24, 1997] (a) The Administrator shall issue a Certificate of Registration (DEA Form § 1301.36 Suspension or revocation of 223) to an applicant if the issuance of registration; suspension of registra- registration or reregistration is re- tion pending final order; extension quired under the applicable provisions of registration pending final order. of sections 303 or 1008 of the Act (21 (a) For any registration issued under U.S.C. 823 and 958). In the event that section 303 of the Act (21 U.S.C. 823), the issuance of registration or rereg- the Administrator may: istration is not required, the Adminis- (1) Suspend the registration pursuant trator shall deny the application. Be- to section 304(a) of the Act (21 U.S.C. fore denying any application, the Ad- 824(a)) for any period of time. ministrator shall issue an order to (2) Revoke the registration pursuant show cause pursuant to § 1301.37 and, if to section 304(a) of the Act (21 U.S.C. requested by the applicant, shall hold a 824(a)). hearing on the application pursuant to (b) For any registration issued under § 1301.41. section 1008 of the Act (21 U.S.C. 958), (b) If in response to a show cause the Administrator may: order a hearing is requested by an ap- (1) Suspend the registration pursuant plicant for registration or reregistra- to section 1008(d) of the Act (21 U.S.C. tion to manufacture in bulk a basic 958(d)) for any period of time. class of controlled substance listed in (2) Revoke the registration pursuant Schedule I or II, notice that a hearing to section 1008(d) of the Act (21 U.S.C. has been requested shall be published 958(d)) if he/she determines that such in the FEDERAL REGISTER and shall be registration is inconsistent with the mailed simultaneously to the applicant public interest as defined in section and to all persons to whom notice of 1008 or with the United States obliga- the application was mailed. Any person tions under international treaties, con- entitled to file comments or objections ventions, or protocols in effect on Oc- to the issuance of the proposed reg- tober 12, 1984. istration pursuant to § 1301.33(a) may (c) The Administrator may limit the participate in the hearing by filing no- revocation or suspension of a registra- tice of appearance in accordance with tion to the particular controlled sub- § 1301.43. Such persons shall have 30 stance, or substances, with respect to days to file a notice of appearance after which grounds for revocation or sus- the date of publication of the notice of pension exist. a request for a hearing in the FEDERAL (d) Before revoking or suspending REGISTER. any registration, the Administrator

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shall issue an order to show cause pur- the Administration. The suspension or suant to § 1301.37 and, if requested by revocation of a registration, when lim- the registrant, shall hold a hearing ited to a particular basic class or class- pursuant to § 1301.41. es of controlled substances, shall sus- (e) The Administrator may suspend pend or revoke any individual manu- any registration simultaneously with facturing or procurement quota fixed or at any time subsequent to the serv- for the registrant for such class or ice upon the registrant of an order to classes pursuant to part 1303 of this show cause why such registration chapter and any import or export per- should not be revoked or suspended, in mits issued to the registrant for such any case where he/she finds that there class or classes pursuant to part 1312 of is an imminent danger to the public this chapter. Also, upon service of the health or safety. If the Administrator order of the Administrator revoking or so suspends, he/she shall serve with the suspending registration, the registrant order to show cause pursuant to shall, as instructed by the Adminis- § 1301.37 an order of immediate suspen- trator: sion which shall contain a statement of (1) Deliver to the nearest office of the his findings regarding the danger to Administration or to authorized agents public health or safety. of the Administration all of the par- (f) Upon service of the order of the ticular controlled substance or sub- Administrator suspending or revoking stances affected by the revocation or registration, the registrant shall im- suspension which are in his/her posses- mediately deliver his/her Certificate of sion; or Registration, any order forms, and any (2) Place all of such substances under import or export permits in his/her pos- seal as described in sections 304(f) or session to the nearest office of the Ad- 958(d)(6) of the Act (21 U.S.C. 824(f) or ministration. The suspension or rev- 958(d)(6)). ocation of a registration shall suspend (h) Any suspension shall continue in or revoke any individual manufac- effect until the conclusion of all pro- turing or procurement quota fixed for ceedings upon the revocation or sus- the registrant pursuant to part 1303 of pension, including any judicial review this chapter and any import or export thereof, unless sooner withdrawn by permits issued to the registrant pursu- the Administrator or dissolved by a ant to part 1312 of this chapter. Also, court of competent jurisdiction. Any upon service of the order of the Admin- registrant whose registration is sus- istrator revoking or suspending reg- pended under paragraph (e) of this sec- istration, the registrant shall, as in- tion may request a hearing on the rev- structed by the Administrator: ocation or suspension of his/her reg- (1) Deliver all controlled substances istration at a time earlier than speci- in his/her possession to the nearest of- fied in the order to show cause pursu- fice of the Administration or to au- ant to § 1301.37. This request shall be thorized agents of the Administration; granted by the Administrator, who or shall fix a date for such hearing as (2) Place all controlled substances in early as reasonably possible. his/her possession under seal as de- (i) In the event that an applicant for scribed in sections 304(f) or 1008(d)(6) of reregistration (who is doing business the Act (21 U.S.C. 824(f) or 958(d)(6)). under a registration previously granted (g) In the event that revocation or and not revoked or suspended) has ap- suspension is limited to a particular plied for reregistration at least 45 days controlled substance or substances, the before the date on which the existing registrant shall be given a new Certifi- registration is due to expire, and the cate of Registration for all substances Administrator has issued no order on not affected by such revocation or sus- the application on the date on which pension; no fee shall be required to be the existing registration is due to ex- paid for the new Certificate of Reg- pire, the existing registration of the istration. The registrant shall deliver applicant shall automatically be ex- the old Certificate of Registration and, tended and continue in effect until the if appropriate, any order forms in his/ date on which the Administrator so her possession to the nearest office of issues his/her order. The Administrator

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may extend any other existing reg- tion may serve the order to show istration under the circumstances con- cause. templated in this section even though the registrant failed to apply for rereg- [62 FR 13955, Mar. 24, 1997] istration at least 45 days before expira- HEARINGS tion of the existing registration, with or without request by the registrant, if § 1301.41 Hearings generally. the Administrator finds that such extension is not inconsistent with the (a) In any case where the Adminis- public health and safety. trator shall hold a hearing on any registration or application therefor, the [62 FR 13955, Mar. 24, 1997] procedures for such hearing shall be governed generally by the adjudication § 1301.37 Order to show cause. procedures set forth in the Administra- (a) If, upon examination of the appli- tive Procedure Act (5 U.S.C. 551–559) cation for registration from any appli- and specifically by sections 303, 304, cant and other information gathered and 1008 of the Act (21 U.S.C. 823–824 by the Administration regarding the and 958), by §§ 1301.42–1301.46 of this applicant, the Administrator is unable part, and by the procedures for admin- to make the determinations required istrative hearings under the Act set by the applicable provisions of section forth in §§ 1316.41–1316.67 of this chap- 303 and/or section 1008 of the Act (21 ter. U.S.C. 823 and 958) to register the appli- (b) Any hearing under this part shall cant, the Administrator shall serve be independent of, and not in lieu of, upon the applicant an order to show criminal prosecutions or other pro- cause why the registration should not ceedings under the Act or any other be denied. law of the United States. (b) If, upon information gathered by the Administration regarding any reg- [62 FR 13956, Mar. 24, 1997] istrant, the Administrator determines that the registration of such registrant § 1301.42 Purpose of hearing. is subject to suspension or revocation If requested by a person entitled to a pursuant to section 304 or section 1008 hearing, the Administrator shall hold a of the Act (21 U.S.C. 824 and 958), the hearing for the purpose of receiving Administrator shall serve upon the reg- factual evidence regarding the issues istrant an order to show cause why the involved in the denial, revocation, or registration should not be revoked or suspension of any registration, and the suspended. granting of any application for reg- (c) The order to show cause shall call istration to import or to manufacture upon the applicant or registrant to ap- in bulk a basic class of controlled sub- pear before the Administrator at a stance listed in Schedule I or II. Exten- time and place stated in the order, sive argument should not be offered which shall not be less than 30 days into evidence but rather presented in after the date of receipt of the order. opening or closing statements of coun- The order to show cause shall also con- sel or in memoranda or proposed find- tain a statement of the legal basis for ings of fact and conclusions of law. such hearing and for the denial, revocation, or suspension of registration and [62 FR 13956, Mar. 24, 1997] a summary of the matters of fact and law asserted. § 1301.43 Request for hearing or ap- (d) Upon receipt of an order to show pearance; waiver. cause, the applicant or registrant (a) Any person entitled to a hearing must, if he/she desires a hearing, file a pursuant to § 1301.32 or §§ 1301.34–1301.36 request for a hearing pursuant to and desiring a hearing shall, within 30 § 1301.43. If a hearing is requested, the days after the date of receipt of the Administrator shall hold a hearing at order to show cause (or the date of pub- the time and place stated in the order, lication of notice of the application for pursuant to § 1301.41. registration in the FEDERAL REGISTER (e) When authorized by the Adminis- in the case of § 1301.34), file with the trator, any agent of the Administra- Administrator a written request for a

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hearing in the form prescribed in the Act (21 U.S.C. 823(a)) are satisfied. § 1316.47 of this chapter. Any other person participating in the (b) Any person entitled to participate hearing pursuant to § 1301.35(b) shall in a hearing pursuant to § 1301.34 or have the burden of proving any propo- § 1301.35(b) and desiring to do so shall, sitions of fact or law asserted by such within 30 days of the date of publica- person in the hearing. tion of notice of the request for a hear- (b) At any hearing on the granting or ing in the FEDERAL REGISTER, file with denial of an applicant to be registered the Administrator a written notice of to conduct a narcotic treatment pro- intent to participate in such hearing in gram or as a compounder, the appli- the form prescribed in § 1316.48 of this cant shall have the burden of proving chapter. Any person filing a request for that the requirements for each reg- a hearing need not also file a notice of istration pursuant to section 303(g) of appearance. the Act (21 U.S.C. 823(g)) are satisfied. (c) Any person entitled to a hearing (c) At any hearing on the granting or or to participate in a hearing pursuant denial of an application to be reg- to § 1301.32 or §§ 1301.34–1301.36 may, istered to import or export any con- within the period permitted for filing a trolled substance listed in Schedule I request for a hearing or a notice of ap- or II, the applicant shall have the bur- pearance, file with the Administrator a den of proving that the requirements waiver of an opportunity for a hearing for such registration pursuant to sec- or to participate in a hearing, together tions 1008(a) and (d) of the Act (21 with a written statement regarding U.S.C. 958 (a) and (d)) are satisfied. Any such person’s position on the matters other person participating in the hear- of fact and law involved in such hearing pursuant to § 1301.34 shall have the ing. Such statement, if admissible, burden of proving any propositions of shall be made a part of the record and fact or law asserted by him/her in the shall be considered in light of the lack hearings. of opportunity for cross-examination in (d) At any other hearing for the de- determining the weight to be attached nial of a registration, the Administra- to matters of fact asserted therein. tion shall have the burden of proving (d) If any person entitled to a hearing that the requirements for such reg- or to participate in a hearing pursuant istration pursuant to section 303 or sec- to § 1301.32 or §§ 1301.34–1301.36 fails to tion 1008(c) and (d) of the Act (21 U.S.C. file a request for a hearing or a notice 823 or 958(c) and (d)) are not satisfied. of appearance, or if such person so files (e) At any hearing for the revocation and fails to appear at the hearing, such or suspension of a registration, the Ad- person shall be deemed to have waived ministration shall have the burden of the opportunity for a hearing or to par- proving that the requirements for such ticipate in the hearing, unless such revocation or suspension pursuant to person shows good cause for such fail- section 304(a) or section 1008(d) of the ure. Act (21 U.S.C. 824(a) or 958(d)) are satis- (e) If all persons entitled to a hearing fied. or to participate in a hearing waive or are deemed to waive their opportunity [62 FR 13956, Mar. 24, 1997] for the hearing or to participate in the hearing, the Administrator may cancel § 1301.45 Time and place of hearing. the hearing, if scheduled, and issue his/ The hearing will commence at the her final order pursuant to § 1301.46 place and time designated in the order without a hearing. to show cause or notice of hearing pub- [62 FR 13956, Mar. 24, 1997] lished in the FEDERAL REGISTER (unless expedited pursuant to § 1301.36(h)) but § 1301.44 Burden of proof. thereafter it may be moved to a dif- (a) At any hearing on an application ferent place and may be continued to manufacture any controlled sub- from day to day or recessed to a later stance listed in Schedule I or II, the ap- day without notice other than an- plicant shall have the burden of prov- nouncement thereof by the presiding ing that the requirements for such reg- officer at the hearing. istration pursuant to section 303(a) of [62 FR 13956, Mar. 24, 1997]

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§ 1301.46 Final order. istration is approved, the Adminis- trator shall issue a new certificate of As soon as practicable after the pre- registration (DEA Form 223) to the reg- siding officer has certified the record istrant, who shall maintain it with the to the Administrator, the Adminis- old certificate of registration until ex- trator shall issue his/her order on the piration. granting, denial, revocation, or suspension of registration. In the event that [75 FR 10676, Mar. 9, 2010] an application for registration to import or to manufacture in bulk a basic § 1301.52 Termination of registration; transfer of registration; distribution class of any controlled substance listed upon discontinuance of business. in Schedule I or II is granted, or any application for registration is denied, (a) Except as provided in paragraph or any registration is revoked or sus- (b) of this section, the registration of pended, the order shall include the any person, and any modifications of findings of fact and conclusions of law that registration, shall terminate if upon which the order is based. The and when such person dies, ceases legal order shall specify the date on which it existence, or discontinues business or shall take effect. The Administrator professional practice. Any registrant shall serve one copy of his/her order who ceases legal existence or discon- upon each party in the hearing. tinues business or professional practice shall notify the Administrator prompt- [62 FR 13956, Mar. 24, 1997] ly of such fact. (b) No registration or any authority MODIFICATION, TRANSFER AND conferred thereby shall be assigned or TERMINATION OF REGISTRATION otherwise transferred except upon such conditions as the Administration may § 1301.51 Modification in registration. specifically designate and then only Any registrant may apply to modify pursuant to written consent. Any per- his/her registration to authorize the son seeking authority to transfer a reg- handling of additional controlled sub- istration shall submit a written re- stances or to change his/her name or quest, providing full details regarding address, by submitting a letter of re- the proposed transfer of registration, quest to the Registration Unit, Drug to the Deputy Assistant Administrator, Enforcement Administration. See the Office of Diversion Control, Drug En- Table of DEA Mailing Addresses in forcement Administration. See the § 1321.01 of this chapter for the current Table of DEA Mailing Addresses in mailing address. The letter shall con- § 1321.01 of this chapter for the current tain the registrant’s name, address, mailing address. and registration number as printed on (c) Any registrant desiring to dis- the certificate of registration, and the continue business activities altogether substances and/or schedules to be added or with respect to controlled sub- to his/her registration or the new name stances (without transferring such or address and shall be signed in ac- business activities to another person) cordance with § 1301.13(j). If the reg- shall return for cancellation his/her istrant is seeking to handle additional certificate of registration, and any controlled substances listed in Sched- unexecuted order forms in his/her pos- ule I for the purpose of research or in- session, to the Registration Unit, Drug structional activities, he/she shall at- Enforcement Administration. See the tach three copies of a research protocol Table of DEA Mailing Addresses in describing each research project in- § 1321.01 of this chapter for the current volving the additional substances, or mailing address. Any controlled sub- two copies of a statement describing stances in his/her possession may be the nature, extent, and duration of disposed of in accordance with § 1307.21 such instructional activities, as appro- of this chapter. priate. No fee shall be required to be (d) Any registrant desiring to dis- paid for the modification. The request continue business activities altogether for modification shall be handled in the or with respect to controlled substance same manner as an application for reg- (by transferring such business activi- istration. If the modification in reg- ties to another person) shall submit in

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person or by registered or certified (2) On the date of transfer of the con- mail, return receipt requested, to the trolled substances, all records required Special Agent in Charge in his/her to be kept by the registrant-transferor area, at least 14 days in advance of the with reference to the controlled sub- date of the proposed transfer (unless stances being transferred, under part the Special Agent in Charge waives 1304 of this chapter, shall be trans- this time limitation in individual in- ferred to the registrant-transferee. Re- stances), the following information: sponsibility for the accuracy of records (1) The name, address, registration prior to the date of transfer remains number, and authorized business activ- with the transferor, but responsibility ity of the registrant discontinuing the for custody and maintenance shall be business (registrant-transferor); upon the transferee. (2) The name, address, registration (3) In the case of registrants required number, and authorized business activ- to make reports pursuant to part 1304 ity of the person acquiring the business of this chapter, a report marked (registrant-transferee); ‘‘Final’’ will be prepared and submitted (3) Whether the business activities by the registrant-transferor showing will be continued at the location reg- the disposition of all the controlled istered by the person discontinuing substances for which a report is re- business, or moved to another location quired; no additional report will be required from him, if no further trans- (if the latter, the address of the new lo- actions involving controlled substances cation should be listed); are consummated by him. The initial (4) Whether the registrant-transferor report of the registrant-transferee has a quota to manufacture or procure shall account for transactions begin- any controlled substance listed in ning with the day next succeeding the Schedule I or II (if so, the basic class or date of discontinuance or transfer of class of the substance should be indi- business by the transferor-registrant cated); and and the substances transferred to him (5) The date on which the transfer of shall be reported as receipts in his/her controlled substances will occur. initial report. (e) Unless the registrant-transferor is informed by the Special Agent in [62 FR 13957, Mar. 24, 1997, as amended at 74 FR 15623, Apr. 6, 2009; 75 FR 10676, Mar. 9, Charge, before the date on which the 2010] transfer was stated to occur, that the transfer may not occur, the registrant- SECURITY REQUIREMENTS transferor may distribute (without being registered to distribute) con- § 1301.71 Security requirements gen- trolled substances in his/her possession erally. to the registrant-transferee in accord- (a) All applicants and registrants ance with the following: shall provide effective controls and (1) On the date of transfer of the con- procedures to guard against theft and trolled substances, a complete inven- diversion of controlled substances. In tory of all controlled substances being order to determine whether a reg- transferred shall be taken in accord- istrant has provided effective controls ance with § 1304.11 of this chapter. This against diversion, the Administrator inventory shall serve as the final in- shall use the security requirements set ventory of the registrant-transferor forth in §§ 1301.72–1301.76 as standards and the initial inventory of the reg- for the physical security controls and istrant-transferee, and a copy of the in- operating procedures necessary to pre- ventory shall be included in the records vent diversion. Materials and construc- of each person. It shall not be nection which will provide a structural essary to file a copy of the inventory equivalent to the physical security with the Administration unless re- controls set forth in §§ 1301.72, 1301.73 quested by the Special Agent in and 1301.75 may be used in lieu of the Charge. Transfers of any substances materials and construction described listed in Schedule I or II shall require in those sections. the use of order forms in accordance (b) Substantial compliance with the with part 1305 of this chapter. standards set forth in §§ 1301.72–1301.76

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may be deemed sufficient by the Ad- (15) The applicability of the security ministrator after evaluation of the requirements contained in all Federal, overall security system and needs of State, and local laws and regulations the applicant or registrant. In evalu- governing the management of waste. ating the overall security system of a (c) When physical security controls registrant or applicant, the Adminis- become inadequate as a result of a con- trator may consider any of the fol- trolled substance being transferred to a lowing factors as he may deem relevant different schedule, or as a result of a to the need for strict compliance with noncontrolled substance being listed on security requirements: any schedule, or as a result of a signifi- (1) The type of activity conducted cant increase in the quantity of con- (e.g., processing of bulk chemicals, pre- trolled substances in the possession of paring dosage forms, packaging, label- the registrant during normal business ing, cooperative buying, etc.); operations, the physical security con- (2) The type and form of controlled trols shall be expanded and extended substances handled (e.g., bulk liquids accordingly. A registrant may adjust or dosage units, usable powders or non- physical security controls within the usable powders); requirements set forth in §§ 1301.72– (3) The quantity of controlled sub- 1301.76 when the need for such controls stances handled; decreases as a result of a controlled (4) The location of the premises and substance being transferred to a dif- the relationship such location bears on ferent schedule, or a result of a con- security needs; trolled substance being removed from (5) The type of building construction control, or as a result of a significant comprising the facility and the general decrease in the quantity of controlled characteristics of the building or build- substances in the possession of the reg- ings; istrant during normal business oper- (6) The type of vault, safe, and secure ations. enclosures or other storage system (d) Any registrant or applicant desir- (e.g., automatic storage and retrieval ing to determine whether a proposed system) used; security system substantially complies (7) The type of closures on vaults, with, or is the structural equivalent of, safes, and secure enclosures; the requirements set forth in §§ 1301.72– (8) The adequacy of key control sys- 1301.76 may submit any plans, blue- tems and/or combination lock control prints, sketches or other materials re- systems; garding the proposed security system (9) The adequacy of electric detection either to the Special Agent in Charge and alarm systems, if any including in the region in which the system will use of supervised transmittal lines and be used, or to the Regulatory Section, standby power sources; Drug Enforcement Administration. See (10) The extent of unsupervised public the Table of DEA Mailing Addresses in access to the facility, including the § 1321.01 of this chapter for the current presence and characteristics of perim- mailing address. eter fencing, if any; (e) Physical security controls of loca- (11) The adequacy of supervision over tions registered under the Harrison employees having access to manufac- Narcotic Act or the Narcotics Manufac- turing and storage areas; turing Act of 1960 on April 30, 1971, (12) The procedures for handling busi- shall be deemed to comply substan- ness guests, visitors, maintenance per- tially with the standards set forth in sonnel, and nonemployee service per- §§ 1301.72, 1301.73 and 1301.75. Any new sonnel; facilities or work or storage areas con- (13) The availability of local police structed or utilized for controlled sub- protection or of the registrant’s or ap- stances, which facilities or work or plicant’s security personnel; storage areas have not been previously (14) The adequacy of the registrant’s approved by the Administration, shall or applicant’s system for monitoring not necessarily be deemed to comply the receipt, manufacture, distribution, substantially with the standards set and disposition of controlled sub- forth in §§ 1301.72, 1301.73 and 1301.75, stances in its operations; and notwithstanding that such facilities or

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work or storage areas have physical se- (i) The walls, floors, and ceilings of curity controls similar to those pre- which vault are constructed of at least viously approved by the Administra- 8 inches of reinforced concrete or other tion. substantial masonry, reinforced vertically and horizontally with 1⁄2-inch [36 FR 18729, Sept. 21, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973, and amended at 46 steel rods tied 6 inches on center, or FR 28841, May 29, 1981; 47 FR 41735, Sept. 22, the structural equivalent to such rein- 1982; 51 FR 5319, Feb. 13, 1986; 68 FR 41228, forced walls, floors, and ceilings; July 11, 2003; 75 FR 10677, Mar. 9, 2010] (ii) The door and frame unit of which vault shall conform to the following § 1301.72 Physical security controls for specifications or the equivalent: 30 non-practitioners; narcotic treat- man-minutes against surreptitious ment programs and compounders entry, 10 man-minutes against forced for narcotic treatment programs; entry, 20 man-hours against lock ma- storage areas. nipulation, and 20 man-hours against (a) Schedules I and II. Raw material, radiological techniques; bulk materials awaiting further proc- (iii) Which vault, if operations re- essing, and finished products which are quire it to remain open for frequent ac- controlled substances listed in Sched- cess, is equipped with a ‘‘day-gate’’ ule I or II (except GHB that is manu- which is self-closing and self-locking, factured or distributed in accordance or the equivalent, for use during the with an exemption under section 505(i) hours of operation in which the vault of the FFDCA which shall be subject to door is open; the requirements of paragraph (b) of (iv) The walls or perimeter of which this section) shall be stored in one of vault are equipped with an alarm, the following secured areas: which upon unauthorized entry shall (1) Where small quantities permit, a transmit a signal directly to a central safe or steel cabinet; station protection company, or a local (i) Which safe or steel cabinet shall or State police agency which has a have the following specifications or the legal duty to respond, or a 24-hour con- equivalent: 30 man-minutes against trol station operated by the registrant, surreptitious entry, 10 man-minutes or such other protection as the Admin- against forced entry, 20 man-hours istrator may approve, and, if nec- against lock manipulation, and 20 man- essary, holdup buttons at strategic hours against radiological techniques; points of entry to the perimeter area of (ii) Which safe or steel cabinet, if it the vault; weighs less than 750 pounds, is bolted (v) The door of which vault is or cemented to the floor or wall in such equipped with contact switches; and a way that it cannot be readily re- (vi) Which vault has one of the fol- moved; and lowing: Complete electrical lacing of (iii) Which safe or steel cabinet, if the walls, floor and ceilings; sensitive necessary, depending upon the quan- ultrasonic equipment within the vault; tities and type of controlled substances a sensitive sound accumulator system; stored, is equipped with an alarm sys- or such other device designed to detect tem which, upon attempted unauthor- illegal entry as may be approved by the ized entry, shall transmit a signal di- Administration. rectly to a central protection company (b) Schedules III, IV and V. Raw mate- or a local or State police agency which rial, bulk materials awaiting further has a legal duty to respond, or a 24- processing, and finished products which hour control station operated by the are controlled substances listed in registrant, or such other protection as Schedules III, IV, and V, and GHB when the Administrator may approve. it is manufactured or distributed in ac- (2) A vault constructed before, or cordance with an exemption under sec- under construction on, September 1, tion 505(i) of the FFDCA, shall be 1971, which is of substantial construc- stored in the following secure storage tion with a steel door, combination or areas: key lock, and an alarm system; or (1) A safe or steel cabinet as de- (3) A vault constructed after Sep- scribed in paragraph (a)(1) of this sec- tember 1, 1971: tion;

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(2) A vault as described in paragraph native, a cage shall be erected which (a)(2) or (3) of this section equipped reaches and is securely attached to the with an alarm system as described in structural ceiling of the building. A paragraph (b)(4)(v) of this section; lighter gauge mesh may be used for the (3) A building used for storage of ceilings of large enclosed areas if walls Schedules III through V controlled sub- are at least 14 feet in height, stances with perimeter security which (iv) Is equipped with a door con- limits access during working hours and structed of No. 10 gauge steel fabric on provides security after working hours a metal door frame in a metal door and meets the following specifications: flange, and in all other respects con- (i) Has an electronic alarm system as forms to all the requirements of 21 CFR described in paragraph (b)(4)(v) of this 1301.72(b)(3)(ii), and section, (v) Is equipped with an alarm system (ii) Is equipped with self-closing, self- which upon unauthorized entry shall locking doors constructed of substan- transmit a signal directly to a central tial material commensurate with the station protection agency or a local or type of building construction, provided, state police agency, each having a however, a door which is kept closed legal duty to respond, or to a 24-hour and locked at all times when not in use control station operated by the reg- and when in use is kept under direct istrant, or to such other source of pro- observation of a responsible employee tection as the Administrator may ap- or agent of the registrant is permitted prove; in lieu of a self-closing, self-locking (5) An enclosure of masonry or other door. Doors may be sliding or hinged. material, approved in writing by the Regarding hinged doors, where hinges Administrator as providing security are mounted on the outside, such comparable to a cage; hinges shall be sealed, welded or other- (6) A building or enclosure within a wise constructed to inhibit removal. building which has been inspected and Locking devices for such doors shall be approved by DEA or its predecessor either of the multiple-position com- agency, BND, and continues to provide bination or key lock type and: adequate security against the diversion (a) In the case of key locks, shall re- of Schedule III through V controlled quire key control which limits access substances, of which fact written ac- to a limited number of employees, or; knowledgment has been made by the (b) In the case of combination locks, Special Agent in Charge of DEA for the the combination shall be limited to a area in which such building or enclo- minimum number of employees and sure is situated; can be changed upon termination of (7) Such other secure storage areas as employment of an employee having may be approved by the Administrator knowledge of the combination; after considering the factors listed in (4) A cage, located within a building § 1301.71(b); on the premises, meeting the following (8)(i) Schedule III through V con- specifications: trolled substances may be stored with (i) Having walls constructed of not Schedules I and II controlled sub- less than No. 10 gauge steel fabric stances under security measures pro- mounted on steel posts, which posts vided by 21 CFR 1301.72(a); are: (ii) Non-controlled drugs, substances (a) At least one inch in diameter; and other materials may be stored with (b) Set in concrete or installed with Schedule III through V controlled sub- lag bolts that are pinned or brazed; and stances in any of the secure storage (c) Which are placed no more than areas required by 21 CFR 1301.72(b), ten feet apart with horizontal one and provided that permission for such stor- one-half inch reinforcements every age of non-controlled items is obtained sixty inches; in advance, in writing, from the Spe- (ii) Having a mesh construction with cial Agent in Charge of DEA for the openings of not more than two and one- area in which such storage area is situ- half inches across the square, ated. Any such permission tendered (iii) Having a ceiling constructed of must be upon the Special Agent in the same material, or in the alter- Charge’s written determination that

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such non-segregated storage does not shall transmit a signal directly to a diminish security effectiveness for central station protection company, or Schedules III through V controlled sub- local or state police agency which has stances. a legal duty to respond, or a 24-hour (c) Multiple storage areas. Where sev- control station operated by the reg- eral types or classes of controlled sub- istrant. stances are handled separately by the (b) Manufacturing activities with registrant or applicant for different controlled substances shall be con- purposes (e.g., returned goods, or goods ducted in an area or areas of clearly de- in process), the controlled substances fined limited access which is under sur- may be stored separately, provided veillance by an employee or employees that each storage area complies with designated in writing as responsible for the requirements set forth in this sec- the area. ‘‘Limited access’’ may be pro- tion. vided, in the absence of physical divid- (d) Accessibility to storage areas. The ers such as walls or partitions, by traf- controlled substances storage areas shall be accessible only to an absolute fic control lines or restricted space des- minimum number of specifically au- ignation. The employee designated as thorized employees. When it is nec- responsible for the area may be en- essary for employee maintenance per- gaged in the particular manufacturing sonnel, nonemployee maintenance per- operation being conducted: Provided, sonnel, business guests, or visitors to That he is able to provide continuous be present in or pass through con- surveillance of the area in order that trolled substances storage areas, the unauthorized persons may not enter or registrant shall provide for adequate leave the area without his knowledge. observation of the area by an employee (c) During the production of con- specifically authorized in writing. trolled substances, the manufacturing areas shall be accessible to only those [36 FR 18730, Sept. 21, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973] employees required for efficient operation. When it is necessary for em- EDITORIAL NOTE: For FEDERAL REGISTER ci- ployee maintenance personnel, non- tations affecting § 1301.72, see the List of CFR Sections Affected, which appears in the employee maintenance personnel, busi- Finding Aids section of the printed volume ness guests, or visitors to be present in and at www.fdsys.gov. or pass through manufacturing areas during production of controlled sub- § 1301.73 Physical security controls for stances, the registrant shall provide for non-practitioners; compounders for adequate observation of the area by an narcotic treatment programs; manufacturing and compounding areas. employee specifically authorized in writing. All manufacturing activities (including processing, packaging and labeling) [36 FR 18731, Sept. 21, 1971. Redesignated at involving controlled substances listed 38 FR 26609, Sept. 24, 1973 and amended at 39 in any schedule and all activities of FR 37984, Oct. 25, 1974] compounders shall be conducted in accordance with the following: § 1301.74 Other security controls for (a) All in-process substances shall be non-practitioners; narcotic treatment programs and compounders returned to the controlled substances for narcotic treatment programs. storage area at the termination of the process. If the process is not termi- (a) Before distributing a controlled nated at the end of a workday (except substance to any person who the reg- where a continuous process or other istrant does not know to be registered normal manufacturing operation to possess the controlled substance, the should not be interrupted), the proc- registrant shall make a good faith in- essing area or tanks, vessels, bins or quiry either with the Administration bulk containers containing such sub- or with the appropriate State con- stances shall be securely locked, with trolled substances registration agency, adequate security for the area or build- if any, to determine that the person is ing. If such security requires an alarm, registered to possess the controlled such alarm, upon unauthorized entry, substance.

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(b) The registrant shall design and (d) The registrant shall not dis- operate a system to disclose to the reg- tribute any controlled substance listed istrant suspicious orders of controlled in Schedules II through V as a com- substances. The registrant shall inform plimentary sample to any potential or the Field Division Office of the Admin- current customer (1) without the prior istration in his area of suspicious or- written request of the customer, (2) to ders when discovered by the registrant. be used only for satisfying the legiti- Suspicious orders include orders of un- mate medical needs of patients of the usual size, orders deviating substan- customer, and (3) only in reasonable tially from a normal pattern, and or- quantities. Such request must contain ders of unusual frequency. the name, address, and registration (c) The registrant shall notify the number of the customer and the name Field Division Office of the Adminis- and quantity of the specific controlled tration in his area, in writing, of any substance desired. The request shall be theft or significant loss of any con- preserved by the registrant with other trolled substances within one business records of distribution of controlled day of discovery of the theft or loss. substances. In addition, the require- The supplier is responsible for report- ments of part 1305 of the chapter shall ing all in-transit losses of controlled be complied with for any distribution substances by the common or contract of a controlled substance listed in carrier selected pursuant to paragraph Schedule II. For purposes of this para- (e) of this section, within one business graph, the term ‘‘customer’’ includes a day of discovery of such theft or loss. person to whom a complimentary sam- The registrant shall also complete, and ple of a substance is given in order to submit to the Field Division Office in encourage the prescribing or recom- his area, DEA Form 106 regarding the mending of the substance by the per- theft or loss. Thefts and significant son. losses must be reported whether or not (e) When shipping controlled sub- the controlled substances are subse- stances, a registrant is responsible for quently recovered or the responsible selecting common or contract carriers parties are identified and action taken which provide adequate security to against them. When determining guard against in-transit losses. When whether a loss is significant, a reg- storing controlled substances in a pub- istrant should consider, among others, lic warehouse, a registrant is responsible for selecting a warehouseman the following factors: which will provide adequate security to (1) The actual quantity of controlled guard against storage losses; wherever substances lost in relation to the type possible, the registrant shall store con- of business; trolled substances in a public ware- (2) The specific controlled substances house which complies with the require- lost; ments set forth in § 1301.72. In addition, (3) Whether the loss of the controlled the registrant shall employ pre- substances can be associated with ac- cautions (e.g., assuring that shipping cess to those controlled substances by containers do not indicate that con- specific individuals, or whether the loss tents are controlled substances) to can be attributed to unique activities guard against storage or in-transit that may take place involving the con- losses. trolled substances; (f) When distributing controlled sub- (4) A pattern of losses over a specific stances through agents (e.g., time period, whether the losses appear detailmen), a registrant is responsible to be random, and the results of efforts for providing and requiring adequate taken to resolve the losses; and, if security to guard against theft and di- known, version while the substances are being (5) Whether the specific controlled stored or handled by the agent or substances are likely candidates for di- agents. version; (g) Before the initial distribution of (6) Local trends and other indicators carfentanil etorphine hydrochloride of the diversion potential of the miss- and/or diprenorphine to any person, the ing controlled substance. registrant must verify that the person

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is authorized to handle the sub- EDITORIAL NOTE: For FEDERAL REGISTER ci- stances(s) by contacting the Drug En- tations affecting § 1301.74, see the List of CFR forcement Administration. Sections Affected, which appears in the Finding Aids section of the printed volume (h) The acceptance of delivery of nar- and at www.fdsys.gov. cotic substances by a narcotic treatment program shall be made only by a § 1301.75 Physical security controls for licensed practitioner employed at the practitioners. facility or other authorized individuals (a) Controlled substances listed in designated in writing. At the time of Schedule I shall be stored in a securely delivery, the licensed practitioner or locked, substantially constructed cabi- other authorized individual designated net. in writing (excluding persons currently (b) Controlled substances listed in or previously dependent on narcotic Schedules II, III, IV, and V shall be drugs), shall sign for the narcotics and stored in a securely locked, substan- place his specific title (if any) on any tially constructed cabinet. However, invoice. Copies of these signed invoices pharmacies and institutional practi- shall be kept by the distributor. tioners may disperse such substances (i) Narcotics dispensed or adminis- throughout the stock of noncontrolled tered at a narcotic treatment program substances in such a manner as to ob- will be dispensed or administered di- struct the theft or diversion of the con- rectly to the patient by either (1) the trolled substances. licensed practitioner, (2) a registered (c) This section shall also apply to nurse under the direction of the li- nonpractitioners authorized to conduct censed practitioner, (3) a licensed prac- research or chemical analysis under tical nurse under the direction of the another registration. licensed practitioner, or (4) a phar- (d) Carfentanil etorphine hydro- macist under the direction of the li- chloride and diprenorphine shall be censed practitioner. stored in a safe or steel cabinet equiva- (j) Persons enrolled in a narcotic lent to a U.S. Government Class V se- treatment program will be required to curity container. wait in an area physically separated [39 FR 3674, Jan. 29, 1974, as amended at 39 from the narcotic storage and dis- FR 17838, May 21, 1974; 54 FR 33674, Aug. 16, pensing area. This requirement will be 1989; 62 FR 13957, Mar. 24, 1997] enforced by the program physician and employees. § 1301.76 Other security controls for practitioners. (k) All narcotic treatment programs must comply with standards estab- (a) The registrant shall not employ, lished by the Secretary of Health and as an agent or employee who has access Human Services (after consultation to controlled substances, any person with the Administration) respecting who has been convicted of a felony of- the quantities of narcotic drugs which fense relating to controlled substances may be provided to persons enrolled in or who, at any time, had an application a narcotic treatment program for unsu- for registration with the DEA denied, pervised use. had a DEA registration revoked or has surrendered a DEA registration for (l) DEA may exercise discretion re- cause. For purposes of this subsection, garding the degree of security required the term ‘‘for cause’’ means a sur- in narcotic treatment programs based render in lieu of, or as a consequence on such factors as the location of a proof, any federal or state administrative, gram, the number of patients enrolled civil or criminal action resulting from in a program and the number of physi- an investigation of the individual’s cians, staff members and security handling of controlled substances. guards. Similarly, such factors will be (b) The registrant shall notify the taken into consideration when evalu- Field Division Office of the Adminis- ating existing security or requiring tration in his area, in writing, of the new security at a narcotic treatment theft or significant loss of any con- program. trolled substances within one business [36 FR 7778, Apr. 24, 1971. Redesignated at 38 day of discovery of such loss or theft. FR 26609, Sept. 24, 1973] The registrant shall also complete, and

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submit to the Field Division Office in upon discovery of such loss by use of a his area, DEA Form 106 regarding the DEA Form 106. loss or theft. When determining wheth- [36 FR 7778, Apr. 24, 1971, as amended at 36 er a loss is significant, a registrant FR 18731, Sept. 21, 1971; 37 FR 15919, Aug. 8, should consider, among others, the fol- 1972. Redesignated at 38 FR 26609, Sept. 24, lowing factors: 1973; 47 FR 41735, Sept. 22, 1982; 56 FR 36728, (1) The actual quantity of controlled Aug. 1, 1991; 62 FR 13957, Mar. 24, 1997; 68 FR substances lost in relation to the type 37409, June 24, 2003; 70 FR 47097, Aug. 12, 2005] of business; § 1301.77 Security controls for freight (2) The specific controlled substances forwarding facilities. lost; (a) All Schedule II–V controlled sub- (3) Whether the loss of the controlled stances that will be temporarily stored substances can be associated with ac- at the freight forwarding facility must cess to those controlled substances by be either: specific individuals, or whether the loss (1) stored in a segregated area under can be attributed to unique activities constant observation by designated re- that may take place involving the con- sponsible individual(s); or trolled substances; (2) stored in a secured area that (4) A pattern of losses over a specific meets the requirements of Section time period, whether the losses appear 1301.72(b) of this Part. For purposes of to be random, and the results of efforts this requirement, a facility that may taken to resolve the losses; and, if be locked down (i.e., secured against known, physical entry in a manner consistent (5) Whether the specific controlled with requirements of Section substances are likely candidates for di- 1301.72(b)(3)(ii) of this part) and has a version; monitored alarm system or is subject (6) Local trends and other indicators to continuous monitoring by security of the diversion potential of the miss- personnel will be deemed to meet the ing controlled substance. requirements of Section 1301.72(b)(3) of (c) Whenever the registrant distrib- this Part. utes a controlled substance (without (b) Access to controlled substances being registered as a distributor, as must be kept to an absolute minimum permitted in § 1301.13(e)(1) and/or number of specifically authorized indi- §§ 1307.11–1307.12) he/she shall comply viduals. Non-authorized individuals with the requirements imposed on non- may not be present in or pass through practitioners in § 1301.74 (a), (b), and (e). controlled substances storage areas (d) Central fill pharmacies must com- without adequate observation provided ply with § 1301.74(e) when selecting pri- by an individual authorized in writing vate, common or contract carriers to by the registrant. transport filled prescriptions to a re- (c) Controlled substances being trans- tail pharmacy for delivery to the ulti- ferred through a freight forwarding fa- mate user. When central fill phar- cility must be packed in sealed, un- macies contract with private, common marked shipping containers. or contract carriers to transport filled [65 FR 44678, July 19, 2000; 65 FR 45829, July prescriptions to a retail pharmacy, the 25, 2000] central fill pharmacy is responsible for reporting in-transit losses upon dis- EMPLOYEE SCREENING—NON- covery of such loss by use of a DEA PRACTITIONERS Form 106. Retail pharmacies must comply with § 1301.74(e) when selecting pri- § 1301.90 Employee screening proce- vate, common or contract carriers to dures. retrieve filled prescriptions from a cen- It is the position of DEA that the ob- tral fill pharmacy. When retail phar- taining of certain information by non- macies contract with private, common practitioners is vital to fairly assess or contract carriers to retrieve filled the likelihood of an employee commit- prescriptions from a central fill phar- ting a drug security breach. The need macy, the retail pharmacy is respon- to know this information is a matter of sible for reporting in-transit losses business necessity, essential to overall

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controlled substances security. In this tect the confidentiality of the informa- regard, it is believed that conviction of tion and the identity of the employee crimes and unauthorized use of con- furnishing information. A failure to re- trolled substances are activities that port information of drug diversion will are proper subjects for inquiry. It is, be considered in determining the feasi- therefore, assumed that the following bility of continuing to allow an em- questions will become a part of an employee to work in a drug security area. ployer’s comprehensive employee The employer shall inform all employ- screening program: ees concerning this policy. Question. Within the past five years, have you been convicted of a felony, or within the [40 FR 17143, Apr. 17, 1975] past two years, of any misdemeanor or are you presently formally charged with com- § 1301.92 Illicit activities by employ- mitting a criminal offense? (Do not include ees. any traffic violations, juvenile offenses or It is the position of DEA that em- military convictions, except by general court-martial.) If the answer is yes, furnish ployees who possess, sell, use or divert details of conviction, offense, location, date controlled substances will subject and sentence. themselves not only to State or Fed- Question. In the past three years, have you eral prosecution for any illicit activ- ever knowingly used any narcotics, amphet- ity, but shall also immediately become amines or barbiturates, other than those pre- the subject of independent action re- scribed to you by a physician? If the answer garding their continued employment. is yes, furnish details. The employer will assess the serious- Advice. An authorization, in writing, that ness of the employee’s violation, the allows inquiries to be made of courts and law enforcement agencies for possible pending position of responsibility held by the charges or convictions must be executed by a employee, past record of employment, person who is allowed to work in an area etc., in determining whether to sus- where access to controlled substances clear- pend, transfer, terminate or take other ly exists. A person must be advised that any action against the employee. false information or omission of information will jeopardize his or her position with re- [40 FR 17143, Apr. 17, 1975] spect to employment. The application for employment should inform a person that in- § 1301.93 Sources of information for formation furnished or recovered as a result employee checks. of any inquiry will not necessarily preclude employment, but will be considered as part DEA recommends that inquiries con- of an overall evaluation of the person’s cerning employees’ criminal records be qualifications. The maintaining of fair em- made as follows: ployment practices, the protection of the person’s right of privacy, and the assurance Local inquiries. Inquiries should be made by that the results of such inquiries will be name, date and place of birth, and other treated by the employer in confidence will be identifying information, to local courts and explained to the employee. law enforcement agencies for records of [40 FR 17143, Apr. 17, 1975] pending charges and convictions. Local practice may require such inquiries to be made in § 1301.91 Employee responsibility to person, rather than by mail, and a copy of an report drug diversion. authorization from the employee may be re- Reports of drug diversion by fellow quired by certain law enforcement agencies. employees is not only a necessary part DEA inquiries. Inquiries supplying identifying information should also be furnished to of an overall employee security pro- DEA Field Division Offices along with writ- gram but also serves the public inter- ten consent from the concerned individual est at large. It is, therefore, the posi- for a check of DEA files for records of con- tion of DEA that an employee who has victions. The Regional check will result in a knowledge of drug diversion from his national check being made by the Field Divi- employer by a fellow employee has an sion Office. obligation to report such information [40 FR 17143, Apr. 17, 1975, as amended at 47 to a responsible security official of the FR 41735, Sept. 22, 1982] employer. The employer shall treat such information as confidential and shall take all reasonable steps to pro-

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PART 1302—LABELING AND PACK- Schedule AGING REQUIREMENTS FOR Schedule I ...... CI or C–I. CONTROLLED SUBSTANCES Schedule II ...... CII or C–II. Schedule III ...... CIII or C–III. Sec. Schedule IV ...... CIV or C–IV. 1302.01 Scope of part 1302. Schedule V ...... CV or C–V. 1302.02 Definitions. The word ‘‘schedule’’ need not be used. 1302.03 Symbol required; exceptions. 1302.04 Location and size of symbol on label No distinction need be made between and labeling. narcotic and nonnarcotic substances. 1302.05 Effective dates of labeling require- (d) The symbol is not required on a ments. carton or wrapper in which a commer- 1302.06 Sealing of controlled substances. cial container is held if the symbol is 1302.07 Labeling and packaging require- easily legible through such carton or ments for imported and exported substances. wrapper. (e) The symbol is not required on a AUTHORITY: 21 U.S.C. 821, 825, 871(b), 958(e). commercial container too small or oth- SOURCE: 36 FR 7785, Apr. 24, 1971, unless erwise unable to accommodate a label, otherwise noted. Redesignated at 38 FR 26609, if the symbol is printed on the box or Sept. 24, 1973. package from which the commercial container is removed upon dispensing § 1302.01 Scope of part 1302. to an ultimate user. Requirements governing the labeling (f) The symbol is not required on a and packaging of controlled substances commercial container containing, or pursuant to sections 1305 and 1008(d) of on the labeling of, a controlled sub- the Act (21 U.S.C. 825 and 958(d)) are set stance being utilized in clinical re- forth generally by those sections and search involving blind and double blind specifically by the sections of this part. studies. [36 FR 13386, July 21, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973] [36 FR 7785, Apr. 24, 1971, as amended at 36 FR 18731, Sept. 21, 1971. Redesignated at 38 § 1302.02 Definitions. FR 26609, Sept. 24, 1973] Any term contained in this part shall § 1302.04 Location and size of symbol have the definition set forth in section on label and labeling. 102 of the Act (21 U.S.C. 802) or part The symbol shall be prominently lo- 1300 of this chapter. cated on the label or the labeling of the [62 FR 13958, Mar. 24, 1997] commercial container and/or the panel of the commercial container normally § 1302.03 Symbol required; exceptions. displayed to dispensers of any con- (a) Each commercial container of a trolled substance. The symbol on labels controlled substance (except for a con- shall be clear and large enough to af- trolled substance excepted by the Ad- ford easy identification of the schedule ministrator pursuant to § 1308.31 of this of the controlled substance upon in- chapter) shall have printed on the label spection without removal from the dis- the symbol designating the schedule in penser’s shelf. The symbol on all other which such controlled substance is list- labeling shall be clear and large ed. Each such commercial container, if enough to afford prompt identification it otherwise has no label, must bear a of the controlled substance upon in- label complying with the requirement spection of the labeling. of this part. (b) Each manufacturer shall print [62 FR 13958, Mar. 24, 1997] upon the labeling of each controlled substance distributed by him the sym- § 1302.05 Effective dates of labeling re- bol designating the schedule in which quirements. such controlled substance is listed. All labels on commercial containers (c) The following symbols shall des- of, and all labeling of, a controlled sub- ignate the schedule corresponding stance which either is transferred to thereto: another schedule or is added to any

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schedule shall comply with the require- INDIVIDUAL MANUFACTURING QUOTAS ments of § 1302.03, on or before the ef- 1303.21 Individual manufacturing quotas. fective date established in the final 1303.22 Procedure for applying for individual order for the transfer or addition. manufacturing quotas. 1303.23 Procedure for fixing individual man- [62 FR 13958, Mar. 24, 1997] ufacturing quotas. 1303.24 Inventory allowance. § 1302.06 Sealing of controlled sub- 1303.25 Increase in individual manufac- stances. turing quotas. On each bottle, multiple dose vial, or 1303.26 Reduction in individual manufac- other commercial container of any turing quotas. controlled substance, there shall be se- 1303.27 Abandonment of quota. curely affixed to the stopper, cap, lid, HEARINGS covering, or wrapper or such container 1303.31 Hearings generally. a seal to disclose upon inspection any 1303.32 Purpose of hearing. tampering or opening of the container. 1303.33 Waiver or modification of rules. [62 FR 13958, Mar. 24, 1997] 1303.34 Request for hearing or appearance; waiver. § 1302.07 Labeling and packaging re- 1303.35 Burden of proof. quirements for imported and ex- 1303.36 Time and place of hearing. ported substances. 1303.37 Final order. (a) The symbol requirements of AUTHORITY: 21 U.S.C. 821, 826, 871(b). §§ 1302.03–1302.05 apply to every com- GENERAL INFORMATION mercial container containing, and to all labeling of, controlled substances § 1303.01 Scope of part 1303. imported into the jurisdiction of and/or Procedures governing the establish- the customs territory of the United ment of production and manufacturing States. quotas on basic classes of controlled (b) The symbol requirements of substances listed in schedules I and II §§ 1302.03–1302.05 do not apply to any pursuant to section 306 of the Act (21 commercial containers containing, or U.S.C. 826) are governed generally by any labeling of, a controlled substance that section and specifically by the intended for export from the jurisdic- sections of this part. tion of the United States. (c) The sealing requirements of [36 FR 7786, Apr. 24, 1971. Redesignated at 38 § 1302.06 apply to every bottle, multiple FR 26609, Sept. 24, 1973] dose vial, or other commercial container of any controlled substance list- § 1303.02 Definitions. ed in schedule I or II, or any narcotic Any term contained in this part shall controlled substance listed in schedule have the definition set forth in section III or IV, imported into, exported from, 102 of the Act (21 U.S.C. 802) or part or intended for export from, the juris- 1300 of this chapter. diction of and/or the customs territory [62 FR 13958, Mar. 24, 1997] of the United States. [62 FR 13958, Mar. 24, 1997] AGGREGATE PRODUCTION AND PROCUREMENT QUOTAS

PART 1303—QUOTAS § 1303.11 Aggregate production quotas. (a) The Administrator shall deter- GENERAL INFORMATION mine the total quantity of each basic Sec. class of controlled substance listed in 1303.01 Scope of part 1303. Schedule I or II necessary to be manu- 1303.02 Definitions. factured during the following calendar AGGREGATE PRODUCTION AND PROCUREMENT year to provide for the estimated med- QUOTAS ical, scientific, research and industrial 1303.11 Aggregate production quotas. needs of the United States, for lawful 1303.12 Procurement quotas. export requirements, and for the estab- 1303.13 Adjustments of aggregate produc- lishment and maintenance of reserve tion quotas. stocks.

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(b) In making his determinations, the dered by the Administrator, the Ad- Administrator shall consider the fol- ministrator shall issue and publish in lowing factors: the FEDERAL REGISTER his final order (1) Total net disposal of the class by determining the aggregate production all manufacturers during the current quota for the basic class of controlled and 2 preceding years; substance. The order shall include the (2) Trends in the national rate of net findings of fact and conclusions of law disposal of the class; upon which the order is based. The (3) Total actual (or estimated) inven- order shall specify the date on which it tories of the class and of all substances shall take effect. A copy of said order manufactured from the class, and shall be mailed simultaneously to each trends in inventory accumulation; person registered as a bulk manufac- (4) Projected demand for such class turer of the basic class. as indicated by procurement quotas re- [36 FR 7786, Apr. 24, 1971, as amended at 37 quested pursuant to § 1303.12; and FR 15919, Aug. 8, 1972. Redesignated at 38 FR (5) Other factors affecting medical, 26609, Sept. 24, 1973] scientific, research, and industrial needs in the United States and lawful § 1303.12 Procurement quotas. export requirements, as the Adminis- (a) In order to determine the esti- trator finds relevant, including mated needs for, and to insure an ade- changes in the currently accepted med- quate and uninterrupted supply of, ical use in treatment with the class or basic classes of controlled substances the substances which are manufactured listed in Schedules I and II (except raw from it, the economic and physical opium being imported by the registrant availability of raw materials for use in pursuant to an import permit) the Ad- manufacturing and for inventory pur- ministrator shall issue procurement poses, yield and stability problems, po- quotas authorizing persons to procure tential disruptions to production (in- and use quantities of each basic class cluding possible labor strikes), and re- of such substances for the purpose of cent unforeseen emergencies such as manufacturing such class into dosage floods and fires. forms or into other substances. (c) The Administrator shall, on or be- (b) Any person who is registered to fore May 1 of each year, publish in the manufacture controlled substances FEDERAL REGISTER, general notice of listed in any schedule and who desires an aggregate production quota for any to use during the next calendar year basic class determined by him under any basic class of controlled substances this section. A copy of said notice shall listed in Schedule I or II (except raw be mailed simultaneously to each per- opium being imported by the registrant son registered as a bulk manufacturer pursuant to an import permit) for pur- of the basic class. The Administrator poses of manufacturing, shall apply on shall permit any interested person to DEA Form 250 for a procurement quota file written comments on or objections for such basic class. A separate applica- to the proposal and shall designate in tion must be made for each basic class the notice the time during which such desired to be procured or used. The ap- filings may be made. The Adminis- plicant shall state whether he intends trator may, but shall not be required to manufacture the basic class himself to, hold a public hearing on one or or purchase it from another manufac- more issues raised by the comments turer. The applicant shall state sepa- and objections filed with him. In the rately each purpose for which the basic event the Administrator decides to class is desired, the quantity desired hold such a hearing, he shall publish for that purpose during the next cal- notice of the hearing in the FEDERAL endar year, and the quantities used and REGISTER, which notice shall summa- estimated to be used, if any, for that rize the issues to be heard and shall set purpose during the current and pre- the time for the hearing which shall ceding 2 calendar years. If the purpose nnt be less than 30 days after the date is to manufacture the basic class into of publication of the notice. After con- dosage form, the applicant shall state sideration of any comments or objec- the official name, common or usual tions, or after a hearing if one is or- name, chemical name, or brand name

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of that form. If the purpose is to manu- mailing address. The Administrator facture another substance, the appli- shall increase or decrease the procure- cant shall state the official name, com- ment quota of such person if and to the mon or usual name, chemical name, or extent that he finds, after considering brand name of the substance, and, if a the factors enumerated in paragraph controlled substance listed in any (c) of this section and any occurrences schedule, the schedule number and Ad- since the issuance of the procurement ministration Controlled Substances quota, that the need justifies an ad- Code Number, as set forth in part 1308 justment. of this chapter, of the substance. If the (e) The following persons need not purpose is to manufacture another obtain a procurement quota: basic class of controlled substance list- (1) Any person who is registered to ed in Schedule I or II, the applicant manufacture a basic class of controlled shall also state the quantity of the substance listed in Schedule I or II and other basic class which the applicant who uses all of the quantity he manu- has applied to manufacture pursuant to factures in the manufacture of a sub- § 1303.22 and the quantity of the first stance not controlled under the Act; basic class necessary to manufacture a (2) Any person who is registered or specified unit of the second basic class. authorized to conduct chemical anal- DEA Form 250 shall be filed on or be- ysis with controlled substances (for fore April 1 of the year preceding the controlled substances to be used in calendar year for which the procure- such analysis only); and ment quota is being applied. Copies of (3) Any person who is registered to DEA Form 250 may be obtained from, conduct research with a basic class of and shall be filed with, the Drug and controlled substance listed in Schedule Chemical Evaluation Section, Drug En- I or II and who is authorized to manu- forcement Administration. See the facture a quantity of such class pursu- Table of DEA Mailing Addresses in ant to § 1301.13 of this chapter. § 1321.01 of this chapter for the current (f) Any person to whom a procure- mailing address. ment quota has been issued, author- (c) The Administrator shall, on or be- izing that person to procure and use a fore July 1 of the year preceding the quantity of a basic class of controlled calendar year during which the quota substances listed in Schedules I or II shall be effective, issue to each quali- during the current calendar year, shall, fied applicant a procurement quota au- at or before the time of giving an order thorizing him to procure and use: to another manufacturer requiring the (1) All quantities of such class nec- distribution of a quantity of such basic essary to manufacture all quantities of class, certify in writing to such other other basic classes of controlled sub- manufacturer that the quantity of such stances listed in Schedules I and II basic class ordered does not exceed the which the applicant is authorized to person’s unused and available procure- manufacture pursuant to § 1303.23; and ment quota of such basic class for the (2) Such other quantities of such current calendar year. The written cer- class as the applicant has applied to tification shall be executed by the procure and use and are consistent same individual who signed the DEA with his past use, his estimated needs, Form 222 transmitting the order. Man- and the total quantity of such class ufacturers shall not fill an order from that will be produced. persons required to apply for a procure- (d) Any person to whom a procurement quota under paragraph (b) of this ment quota has been issued may at any section unless the order is accompanied time request an adjustment in the by a certification as required under quota by applying to the Adminis- this section. The certification required trator with a statement showing the by this section shall contain the fol- need for the adjustment. Such applica- lowing: The date of the certification; tion shall be filed with the Drug & the name and address of the bulk man- Chemical Evaluation Section, Drug En- ufacturer to whom the certification is forcement Administration. See the directed; a reference to the number of Table of DEA Mailing Addresses in the DEA Form 222 to which the certifi- § 1321.01 of this chapter for the current cation applies; the name of the person

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giving the order to which the certifi- (4) Whether any decreased demand cation applies; the name of the basic for that class will result in excessive class specified in the DEA Form 222 to inventory accumulation by all persons which the certification applies; the ap- registered to handle that class (includ- propriate schedule within which is listing manufacturers, distributors, practi- ed the basic class specified in the DEA tioners, importers, and exporters), not- Form 222 to which the certification ap- withstanding the possibility that indi- plies; a statement that the quantity vidual manufacturing quotas may be (expressed in grams) of the basic class suspended pursuant to § 1303.24(b) or specified in the DEA Form 222 to which abandoned pursuant to § 1303.27; the certification applies does not ex- (5) Other factors affecting medical, ceed the unused and available procure- scientific, research, and industrial ment quota of such basic class, issued needs in the United States and lawful to the person giving the order, for the export requirements, as the Adminis- current calendar year; and the signa- trator finds relevant, including ture of the individual who signed the changes in the currently accepted med- DEA Form 222 to which the certifi- ical use in treatment with the class or cation applies. the substances which are manufactured [36 FR 7786, Apr. 24, 1971. Redesignated at 38 from it, the economic and physical FR 26609, Sept. 24, 1973] availability of raw materials for use in manufacturing and for inventory pur- EDITORIAL NOTE: For FEDERAL REGISTER ci- poses, yield and stability problems, po- tations affecting § 1303.12, see the List of CFR Sections Affected, which appears in the tential disruptions to production (in- Finding Aids section of the printed volume cluding possible labor strikes), and re- and at www.fdsys.gov. cent unforeseen emergencies such as floods and fires. § 1303.13 Adjustments of aggregate (c) The Administrator in the event he production quotas. determines to increase or reduce the (a) The Administrator may at any aggregate production quota for a basic time increase or reduce the aggregate class of controlled substance, shall production quota for a basic class of publish in the FEDERAL REGISTER gen- controlled substance listed in Schedule eral notice of an adjustment in the ag- I or II which he has previously fixed gregate production quota for that class pursuant to § 1303.11. determined by him under this section. (b) In determining to adjust the ag- A copy of said notice shall be mailed gregate production quota, the Adminis- simultaneously to each person reg- trator shall consider the following fac- istered as a bulk manufacturer of the tors: basic class. The Administrator shall (1) Changes in the demand for that permit any interested person to file class, changes in the national rate of written comments on or objections to net disposal of the class, and changes the proposal and shall designate in the in the rate of net disposal of the class notice the time during which such fil- by registrants holding individual man- ings may be made. The Administrator ufacturing quotas for that class; may, but shall not be required to, hold (2) Whether any increased demand for a public hearing on one or more issues that class, the national and/or indi- raised by the comments and objections vidual rates of net disposal of that filed with him. In the event the Admin- class are temporary, short term, or istrator decides to hold such a hearing, long term; he shall publish notice of the hearing (3) Whether any increased demand for in the FEDERAL REGISTER, which notice that class can be met through existing shall summarize the issues to be heard inventories, increased individual man- and shall set the time for the hearing, ufacturing quotas, or increased impor- which shall not be less than 10 days tation, without increasing the aggre- after the date of publication of the no- gate production quota, taking into ac- tice. After consideration of any com- count production delays and the prob- ments or objections, or after a hearing ability that other individual manufac- if one is ordered by the Administrator, turing quotas may be suspended pursu- the Administrator shall issue and pub- ant to § 1303.24(b); lish in the FEDERAL REGISTER his final

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order determining the aggregate pro- dress. A separate application must be duction for the basic class of controlled made for each basic class desired to be substance. The order shall include the manufactured. The applicant shall findings of fact and conclusions of law state: upon which the order is based. The (a) The name and Administration order shall specify the date on which it Controlled Substances Code Number, as shall take effect. A copy of said order set forth in part 1308 of this chapter, of shall be mailed simultaneously to each the basic class. person registered as a bulk manufac- (b) For the basic class in each of the turer of the basic class. current and preceding 2 calendar years, [37 FR 15919, Aug. 8, 1972. Redesignated at 38 (1) The authorized individual manu- FR 26609, Sept. 24, 1973] facturing quota, if any; (2) The actual or estimated quantity INDIVIDUAL MANUFACTURING QUOTAS manufactured; (3) The actual or estimated net dis- § 1303.21 Individual manufacturing posal; quotas. (4) The actual or estimated inventory (a) The Administrator shall, on or be- allowance pursuant to § 1303.24; and fore July 1 of each year, fix for and (5) The actual or estimated inventory issue to each person who is registered as of December 31; to manufacture a basic class of con- (c) For the basic class in the next cal- trolled substance listed in Schedule I endar year, or II, and who applies for a manufac- (1) The desired individual manufacturing quota, an individual manufacturing quota; and turing quota authorizing that person to (2) Any additional factors which the manufacture during the next calendar applicant finds relevant to the fixing of year a quantity of that basic class. Any his individual manufacturing quota, in- manufacturing quota fixed and issued cluding the trend of (and recent by the Administrator shall be subject changes in) his and the national rates to his authority to reduce or limit it at of net disposal, his production cycle a later date pursuant to § 1303.26 and to and current inventory position, the his authority to revoke or suspend it at econolic and physical availability of any time pursuant to §§ 1301.36 of this raw materials for use in manufacturing chapter. and for inventory purposes, yield and (b) No individual manufacturing stability problems, potential disrup- quota shall be required for registrants tions to production (including possible listed in § 1303.12(e). labor strikes) and recent unforeseen [36 FR 7786, Apr. 24, 1971. Redesignated at 38 emergencies such as floods and fires. FR 26609, Sept. 24, 1973, as amended at 62 FR [36 FR 7786, Apr. 24, 1971, as amended at 36 13958, Mar. 24, 1997] FR 13386, July 21, 1971; 37 FR 15920, Aug. 8, 1972. Redesignated at 38 FR 26609, Sept. 24, § 1303.22 Procedure for applying for 1973, and amended at 46 FR 28841, May 29, individual manufacturing quotas. 1981; 51 FR 5319, Feb. 13, 1986; 62 FR 13958, Any person who is registered to man- Mar. 24, 1997; 75 FR 10677, Mar. 9, 2010] ufacture any basic class of controlled substance listed in Schedule I or II and § 1303.23 Procedure for fixing indi- who desires to manufacture a quantity vidual manufacturing quotas. of such class shall apply on DEA Form (a) In fixing individual manufac- 189 for a manufacturing quota for such turing quotas for a basic class of con- quantity of such class. Copies of DEA trolled substance listed in Schedule I Form 189 may be obtained from, and or II, the Administrator shall allocate shall be filed (on or before May 1 of the to each applicant who is currently year preceding the calendar year for manufacturing such class a quota equal which the manufacturing quota is to 100 percent of the estimated net dis- being applied) with, the Drug & Chem- posal of that applicant for the next cal- ical Evaluation Section, Drug Enforce- endar year, adjusted— ment Administration. See the Table of (1) By the amount necessary to in- DEA Mailing Addresses in § 1321.01 of crease or reduce the estimated inven- this chapter for the current mailing ad- tory of the applicant on December 31 of

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the current year to his estimated in- the current calendar year, pursuant to ventory allowance for the next cal- § 1303.24. endar year, pursuant to § 1303.24, and [36 FR 7786, Apr. 24, 1971, as amended at 37 (2) By any other factors which the FR 15920, Aug. 8, 1972. Redesignated at 38 FR Administrator deems relevant to the 26609, Sept. 24, 1973] fixing of the individual manufacturing quota of the applicant, including the § 1303.24 Inventory allowance. trend of (and recent changes in) his and (a) For the purpose of determining the national rates of net disposal, his individual manufacturing quotas pur- production cycle and current inventory suant to § 1303.23, each registered man- position, the economic and physical ufacturer shall be allowed as a part of availability of raw materials for use in such quota an amount sufficient to manufacturing and for inventory pur- maintain an inventory equal to, poses, yield and stability problems, po- (1) For current manufacturers, 50 per- tential disruptions to production (in- cent of his average estimated net dis- cluding possible labor strikes), and re- posal for the current calendar year and cent unforeseen emergencies such as the last preceding calendar year; or floods and fires. (2) For new manufacturers, 50 percent (b) In fixing individual manufac- of his reasonably estimated net dis- turing quotas for a basic class of con- posal for the next calendar year as de- trolled substance listed in Schedule I termined by the Administrator. or II, the Administrator shall allocate (b) During each calendar year each to each applicant who is not currently registered manufacturer shall be al- manufacturing such class a quota equal lowed to maintain an inventory of a to 100 percent of the reasonably esti- basic class not exceeding 65 percent of mated net disposal of that applicant his estimated net disposal of that class for the next calendar year, as deter- for that year, as determined at the mined by the Administrator, ad- time his quota for that year was deter- justed— mined. At any time the inventory of a (1) By the amount necessary to pro- basic class held by a manufacturer ex- vide the applicant his estimated inven- ceeds 65 percent of his estimated net tory allowance for the next calendar disposal, his quota for that class is year, pursuant to § 1303.24, and automatically suspended and shall re- (2) By any other factors which the main suspended until his inventory is Administrator deems relevant to the less than 60 percent of his estimated fixing of the individual manufacturing net disposal. The Administrator may, quota of the applicant, including the upon application and for good cause trend of (and recent changes in) the na- shown, permit a manufacturer whose tional rate of net disposal, his produc- quota is, or is likely to be, suspended tion cycle and current inventory posi- pursuant to this paragraph to continue tion, the economic and physical avail- manufacturing and to accumulate an ability of raw materials for use in man- inventory in excess of 65 percent of his ufacturing and for inventory purposes, estimated net disposal, upon such con- yield and stability problems, potential ditions and within such limitations as disruptions to production (including the Administrator may find necessary possible labor strikes), and recent un- or desirable. foreseen emergencies such as floods (c) If, during a calendar year, a reg- and fires. istrant has manufactured the entire (c) The Administrator shall, on or be- quantity of a basic class allocated to fore March 1 of each year, adjust the him under an individual manufacturing individual manufacturing quota allo- quota, and his inventory of that class cated for that year to each applicant in is less than 40 percent of his estimated paragraph (a) of this section by the net disposal of that class for that year, amount necessary to increase or reduce the Administrator may, upon applica- the actual inventory of the applicant tion pursuant to § 1303.25, increase the to December 31 of the preceding year to quota of such registrant sufficiently to his estimated inventory allowance for allow restoration of the inventory to 50

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percent of the estimated net disposal or if a quota assigned to any manufac- for that year. turer is increased pursuant to § 1303.24(c), or if an import permit [36 FR 7786, Apr. 24, 1971, as amended at 36 FR 13386, July 21, 1971. Redesignated at 38 FR issued to an importer pursuant to part 26609, Sept. 24, 1973] 1312 of this chapter, causes the total quantity of a basic class to be manu- § 1303.25 Increase in individual manufactured and imported during the year facturing quotas. to exceed the aggregate production (a) Any registrant who holds an indi- quota which has been established for vidual manufacturing quota for a basic that class pursuant to § 1303.11, as ad- class of controlled substance listed in justed pursuant to § 1303.13, the Admin- Schedule I or II may file with the Ad- istrator may proportionately reduce ministrator an application on Adminis- the individual manufacturing quotas tration Form 189 for an increase in and import permits of all other reg- such quota in order for him to meet his istrants to keep the aggregate produc- estimated net disposal, inventory and tion quota within the limits originally other requirements during the remain- established, or, alternatively, the Ad- der of such calendar year. ministrator may reduce the individual (b) The Administrator, in passing manufacturing quota of any registrant upon a registrant’s application for an whose quota is suspended pursuant to increase in his individual manufac- § 1303.24(b) or § 1301.36 of this chapter, or turing quota, shall take into consider- is abandoned pursuant to § 1303.27. ation any occurrences since the filing [36 FR 7786, Apr. 24, 1971, as amended at 37 of such registrant’s initial quota appli- FR 15920, Aug. 8, 1972. Redesignated at 38 FR cation that may require an increased 26609, Sept. 24, 1973, as amended at 62 FR manufacturing rate by such registrant 13958, Mar. 24, 1997] during the balance of the calendar year. In passing upon such application § 1303.27 Abandonment of quota. the Administrator may also take into Any manufacturer assigned an indi- consideration the amount, if any, by vidual manufacturing quota for any which his determination of the total basic class pursuant to § 1303.23 may at quantity for the basic class of con- any time abandon his right to manu- trolled substance to be manufactured facture all or any part of such quota by under § 1303.11 exceeds the aggregate of filing with the Drug & Chemical Eval- all the individual manufacturing uation Section a written notice of such quotas for the basic class of controlled abandonment, stating the name and substance, and the equitable distribu- Administration Controlled Substances tion of such excess among other reg- Code Number, as set forth in part 1308 istrants. of this chapter, of the substance and [36 FR 7786, Apr. 24, 1971, as amended at 36 the amount which he has chosen not to FR 13386, July 21, 1971. Redesignated at 38 FR manufacture. The Administrator may, 26609, Sept. 24, 1973] in his discretion, allocate such amount among the other manufacturers in pro- § 1303.26 Reduction in individual man- portion to their respective quotas. ufacturing quotas. The Administrator may at any time [36 FR 7786, Apr. 24, 1971, as amended at 36 FR 13386, July 21, 1971. Redesignated at 38 FR reduce an individual manufacturing 26609, Sept. 24, 1973, and amended at 46 FR quota for a basic class of controlled 28841, May 29, 1981; 51 FR 5319, Feb. 13, 1986; substance listed in Schedule I or II 62 FR 13958, Mar. 24, 1997] which he has previously fixed in order to prevent the aggregate of the indi- HEARINGS vidual manufacturing quotas and import permits outstanding or to be § 1303.31 Hearings generally. granted from exceeding the aggregate (a) In any case where the Adminis- production quota which has been estab- trator shall hold a hearing regarding lished for that class pursuant of the determination of an aggregate pro- § 1303.11, as adjusted pursuant to duction quota pursuant to § 1303.11(c), § 1303.13. If a quota assigned to a new or regarding the adjustment of an ag- manufacturer pursuant to § 1303.23(b), gregate production quota pursuant to

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§ 1303.13(c), the procedures for such proposed findings of fact and conclu- hearing shall be governed generally by sions of law. the rule making procedures set forth in [36 FR 7786, Apr. 24, 1971, as amended at 37 the Administrative Procedure Act (5 FR 15920, Aug. 8, 1972. Redesignated at 38 FR U.S.C. 551–559) and specifically by sec- 26609, Sept. 24, 1973, as amended at 62 FR tion 306 of the Act (21 U.S.C. 826), by 13958, Mar. 24, 1997] §§ 1303.32–1303.37, and by the procedures for administrative hearings under the § 1303.33 Waiver or modification of rules. Act set forth in §§ 1316.41–1316.67 of this chapter. The Administrator or the presiding (b) In any case where the Adminis- officer (with respect to matters pend- trator shall hold a hearing regarding ing before him) may modify or waive the issuance, adjustment, suspension, any rule in this part by notice in advance of the hearing, if he determines or denial of a procurement quota pur- that no party in the hearing will be un- suant to § 1303.12, or the issuance, ad- duly prejudiced and the ends of justice justment, suspension, or denial of an will thereby be served. Such notice of individual manufacturing quota pursu- modification or waiver shall be made a ant to §§ 1303.21–1303.27, the procedures part of the record of the hearing. for such hearing shall be governed generally by the adjudication procedures [36 FR 7786, Apr. 24, 1971. Redesignated at 38 set forth in the Administrative Proce- FR 26609, Sept. 24, 1973] dures Act (5 U.S.C. 551–559) and specifi- § 1303.34 Request for hearing or ap- cally by section 306 of the Act (21 pearance; waiver. U.S.C. 826), by §§ 1303.32–1303.37, and by (a) Any applicant or registrant who the procedures for administrative hear- desires a hearing on the issuance, ad- ings under the Act set forth in justment, suspension, or denial of his §§ 1316.41–1316.67 of this chapter. procurement and/or individual manu- [36 FR 7786, Apr. 24, 1971, as amended at 37 facturing quota shall, within 30 days FR 15920, Aug. 8, 1972. Redesignated at 38 FR after the date of receipt of the 26609, Sept. 24, 1973] issuance, adjustment, suspension, or denial of such quota, file with the Ad- § 1303.32 Purpose of hearing. ministrator a written request for a (a) The Administrator may, in his hearing in the form prescribed in sole discretion, hold a hearing for the § 1316.47 of this chapter. Any interested purpose of receiving factual evidence person who desires a hearing on the de- regarding any one or more issues (to be termination of an aggregate production specified by him) involved in the deter- quota shall, within the time prescribed mination or adjustment of any aggre- in § 1303.11(c), file with the Adminis- gate production quota. trator a written request for a hearing in the form prescribed in § 1316.47 of (b) If requested by a person applying this chapter, including in the request a for or holding a procurement quota or statement of the grounds for a hearing. an individual manufacturing quota, the (b) Any interested person who desires Administrator shall hold a hearing for to participate in a hearing on the de- the purpose of receiving factual evi- termination or adjustment of an aggre- dence regarding the issues involved in gate production quota, which hearing the issuance, adjustment, suspension, is ordered by the Administrator pursu- or denial of such quota to such person, ant to § 1303.11(c) or § 1303.13(c) may do but the Administrator need not hold a so by filing with the Administrator, hearing on the suspension of a quota within 30 days of the date of publica- pursuant to § 1301.36 of this chapter sep- tion of notice of the hearing in the arate from a hearing on the suspension FEDERAL REGISTER, a written notice of of registration pursuant to those sec- his intention to participate in such tions. hearing in the form prescribed in (c) Extensive argument should not be § 1316.48 of this chapter. offered into evidence but rather pre- (c) Any person entitled to a hearing sented in opening or closing state- or to participate in a hearing pursuant ments of counsel or in memoranda or to paragraph (b) of this section, may,

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within the period permitted for filing a § 1303.36 Time and place of hearing. request for a hearing of notice of ap- (a) If any applicant or registrant re- pearance, file with the Administrator a quests a hearing on the issuance, ad- waiver of an opportunity for a hearing justment, suspension, or denial of his or to participate in a hearing, together procurement and/or individual manu- with a written statement regarding his facturing quota pursuant to § 1303.34, position on the matters of fact and law the Administrator shall hold such involved in such hearing. Such state- hearing. Notice of the hearing shall be ment, if admissible, shall be made a given to the applicant or registrant of part of the record and shall be consid- the time and place at least 30 days ered in light of the lack of opportunity prior to the hearing, unless the appli- for cross-examination in determining cant or registrant waives such notice the weight to be attached to matters of and requests the hearing be held at an fact asserted therein. earlier time, in which case the Admin- (d) If any person entitled to a hearing istrator shall fix a date for such hear- or to participate in a hearing pursuant ing as early as reasonably possible. to paragraph (b) of this section, fails to (b) The hearing will commence at the file a request for a hearing or notice of place and time designated in the notice appearance, or if he so files and fails to given pursuant to paragraph (a) of this appear at the hearing, he shall be section or in the notice of hearing pub- deemed to have waived his opportunity lished in the FEDERAL REGISTER pursu- for the hearing or to participate in the ant to § 1303.11(c) or § 1303.13 (c), but hearing, unless he shows good cause for thereafter it may be moved to a dif- such failure. ferent place and may be continued from day to day or recessed to a later (e) If all persons entitled to a hearing day without notice other than an- or to participate in a hearing waive or nouncement thereof by the presiding are deemed to waive their opportunity officer at the hearing. for the hearing or to participate in the hearing, the Administrator may cancel [36 FR 7786, Apr. 24, 1971, as amended at 37 the hearing, if scheduled, and issue his FR 15920, Aug. 8, 1972. Redesignated at 38 FR 26609, Sept. 24, 1973] final order pursuant to § 1303.37 without a hearing. § 1303.37 Final order. [36 FR 7786, Apr. 24, 1971, as amended at 36 As soon as practicable after the pre- FR 18731, Sept. 21, 1971; 37 FR 15920, Aug. 8, siding officer has certified the record 1972. Redesignated at 38 FR 26609, Sept. 24, to the Administrator, the Adminis- 1973] trator shall issue his order on the determination or adjustment of the ag- § 1303.35 Burden of proof. gregate production quota or on the (a) At any hearing regarding the de- issuance, adjustment, suspension, or termination or adjustment of an aggre- denial of the procurement quota or in- gate production quota, each interested dividual manufacturing quota, as case person participating in the hearing may be. The order shall include the shall have the burden of proving any findings of fact and conclusions of law propositions of fact or law asserted by upon which the order is based. The him in the hearing. order shall specify the date on which it (b) At any hearing regarding the shall take effect. The Administrator issuance, adjustment, suspension, or shall serve one copy of his order upon each party in the hearing. denial of a procurement or individual manufacturing quota, the Administra- [36 FR 7786, Apr. 24, 1971, as amended at 37 tion shall have the burden of proving FR 15920, Aug. 8, 1972. Redesignated at 38 FR that the requirements of this part for 26609, Sept. 24, 1973] such issuance, adjustment, suspension, or denial are satisfied. PART 1304—RECORDS AND REPORTS OF REGISTRANTS [36 FR 7786, Apr. 24, 1971, as amended at 37 FR 15920, Aug. 8, 1972. Redesignated at 38 FR GENERAL INFORMATION 26609, Sept. 24, 1973, as amended at 62 FR 13958, Mar. 24, 1997] Sec.

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1304.01 Scope of part 1304. § 1304.02 Definitions. 1304.02 Definitions. 1304.03 Persons required to keep records and Any term contained in this part shall file reports. have the definition set forth in section 1304.04 Maintenance of records and inven- 102 of the Act (21 U.S.C. 802) or part tories. 1300 of this chapter. 1304.05 Records of authorized central fill pharmacies and retail pharmacies. [62 FR 13958, Mar. 24, 1997] 1304.06 Records and reports for electronic prescriptions. § 1304.03 Persons required to keep records and file reports. INVENTORY REQUIREMENTS (a) Each registrant shall maintain 1304.11 Inventory requirements. the records and inventories and shall file the reports required by this part, CONTINUING RECORDS except as exempted by this section. 1304.21 General requirements for continuing Any registrant who is authorized to records. conduct other activities without being 1304.22 Records for manufacturers, distribu- registered to conduct those activities, tors, dispensers, researchers, importers, and exporters. either pursuant to § 1301.22(b) of this 1304.23 Records for chemical analysts. chapter or pursuant to §§ 1307.11–1307.15 1304.24 Records for maintenance treatment of this chapter, shall maintain the programs and detoxification treatment records and inventories and shall file programs. the reports required by this part for 1304.25 Records for treatment programs persons registered to conduct such ac- which compound narcotics for treatment tivities. This latter requirement should programs and other locations. not be construed as requiring stocks of 1304.26 Additional recordkeeping require- controlled substances being used in ments applicable to drug products containing gamma-hydroxybutyric acid. various activities under one registration to be stored separately, nor that REPORTS separate records are required for each 1304.31 Reports from manufacturers import- activity. The intent of the Administra- ing narcotic raw material. tion is to permit the registrant to keep 1304.32 Reports of manufacturers importing one set of records which are adapted by coca leaves. the registrant to account for controlled 1304.33 Reports to ARCOS. substances used in any activity. Also, the Administration does not wish to ONLINE PHARMACIES acquire separate stocks of the same 1304.40 Notification by online pharmacies. substance to be purchased and stored 1304.45 Internet Web site disclosure require- for separate activities. Otherwise, ments. there is no advantage gained by per- 1304.50 Disclosure requirements for Web mitting several activities under one sites of nonpharmacy practitioners that registration. Thus, when a researcher dispense controlled substances by means of the Internet. manufactures a controlled item, he 1304.55 Reports by online pharmacies. must keep a record of the quantity manufactured; when he distributes a AUTHORITY: 21 U.S.C. 821, 827, 831, 871(b), quantity of the item, he must use and 958(e), 965, unless otherwise noted. keep invoices or order forms to document the transfer; when he imports a GENERAL INFORMATION substance, he keeps as part of his § 1304.01 Scope of part 1304. records the documentation required of an importer; and when substances are Inventory and other records and re- used in chemical analysis, he need not ports required under section 307, sec- keep a record of this because such a tion 311, or section 1008(e) of the Act (21 record would not be required of him U.S.C. 827, 831, and 958(e)) shall be in under a registration to do chemical accordance with, and contain the infor- analysis. All of these records may be mation required by, those sections and maintained in one consolidated record by the sections of this part. system. Similarly, the researcher may [74 FR 15623, Apr. 6, 2009] store all of his controlled items in one

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place, and every two years take inven- stances or conducting research in con- tory of all items on hand, regardless of formity with an exemption granted whether the substances were manufac- under section 505(i) or 512(j) of the Fed- tured by him, imported by him, or pur- eral Food, Drug, and Cosmetic Act (21 chased domestically by him, of whether U.S.C. 355(i) or 360b(j)) at a registered the substances will be administered to establishment which maintains records subjects, distributed to other research- in accordance with either of those sec- ers, or destroyed during chemical anal- tions, are not required to keep records ysis. if he/she notifies the Administration of (b) A registered individual practi- the name, address, and registration tioner is required to keep records, as number of the establishment maintain- described in § 1304.04, of controlled sub- ing such records. This notification stances in Schedules II, III, IV, and V shall be given at the time the person which are dispensed, other than by prescribing or administering in the lawful applies for registration or reregistra- course of professional practice. tion and shall be made in the form of (c) Except as provided in § 1304.06, a an attachment to the application, registered individual practitioner is which shall be filed with the applica- not required to keep records of con- tion. trolled substances in Schedules II, III, (g) A distributing registrant who uti- IV, and V that are prescribed in the lizes a freight forwarding facility shall lawful course of professional practice, maintain records to reflect transfer of unless such substances are prescribed controlled substances through the fa- in the course of maintenance or detoxi- cility. These records must contain the fication treatment of an individual. date, time of transfer, number of car- (d) A registered individual practi- tons, crates, drums or other packages tioner is not required to keep records in which commercial containers of con- of controlled substances listed in trolled substances are shipped and au- Schedules II, III, IV and V which are thorized signatures for each transfer. A administered in the lawful course of distributing registrant may, as part of professional practice unless the practi- the initial request to operate a freight tioner regularly engages in the dis- forwarding facility, request permission pensing or administering of controlled to store records at a central location. substances and charges patients, either Approval of the request to maintain separately or together with charges for central records would be implicit in other professional services, for sub- the approval of the request to operate stances so dispensed or administered. the facility. Otherwise, a request to Records are required to be kept for maintain records at a central location controlled substances administered in must be submitted in accordance with the course of maintenance or detoxi- § 1304.04 of this part. These records fication treatment of an individual. must be maintained for a period of two (e) Each registered mid-level practitioner shall maintain in a readily re- years. trievable manner those documents re- (h) A person is required to keep the quired by the state in which he/she records and file the reports specified in practices which describe the conditions § 1304.06 and part 1311 of this chapter if and extent of his/her authorization to they are either of the following: dispense controlled substances and (1) An electronic prescription appli- shall make such documents available cation provider. for inspection and copying by author- (2) An electronic pharmacy applica- ized employees of the Administration. tion provider. Examples of such documentation include protocols, practice guidelines or [36 FR 7790, Apr. 24, 1971, as amended at 36 FR 18731, Sept. 21, 1971; 37 FR 15920, Aug. 8, practice agreements. 1972. Redesignated at 38 FR 26609, Sept. 24, (f) Registered persons using any con- 1973, and amended at 50 FR 40523, Oct. 4, 1985; trolled substances while conducting 51 FR 5320, Feb. 13, 1986; 51 FR 26154, July 21, preclinical research, in teaching at a 1986; 58 FR 31175, June 1, 1993; 62 FR 13958, registered establishment which main- Mar. 24, 1997; 65 FR 44679, July 19, 2000; 75 FR tains records with respect to such sub- 16306, Mar. 31, 2010]

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§ 1304.04 Maintenance of records and include executed order forms and in- inventories. ventories, which shall be maintained at (a) Except as provided in paragraphs each registered location. (a)(1) and (a)(2) of this section, every (2) If the records are kept on micro- inventory and other records required to film, computer media or in any form be kept under this part must be kept requiring special equipment to render by the registrant and be available, for the records easily readable, the reg- at least 2 years from the date of such istrant shall provide access to such inventory or records, for inspection equipment with the records. If any and copying by authorized employees code system is used (other than pricing of the Administration. information), a key to the code shall be (1) Financial and shipping records provided to make the records under- (such as invoices and packing slips but standable. not executed order forms subject to (3) The registrant agrees to deliver §§ 1305.17 and 1305.27 of this chapter) all or any part of such records to the may be kept at a central location, registered location within two business rather than at the registered location, days upon receipt of a written request if the registrant has notified the Ad- from the Administration for such ministration of his intention to keep records, and if the Administration central records. Written notification chooses to do so in lieu of requiring de- must be submitted by registered or cer- livery of such records to the registered tified mail, return receipt requested, in location, to allow authorized employ- triplicate, to the Special Agent in ees of the Administration to inspect Charge of the Administration in the such records at the central location area in which the registrant is located. upon request by such employees with- Unless the registrant is informed by out a warrant of any kind. the Special Agent in Charge that per- (4) In the event that a registrant fails mission to keep central records is de- to comply with these conditions, the nied, the registrant may maintain cen- Special Agent in Charge may cancel tral records commencing 14 days after such central recordkeeping authoriza- receipt of his notification by the Spe- tion, and all other central record- cial Agent in Charge. All notifications keeping authorizations held by the reg- must include the following: istrant without a hearing or other pro- (i) The nature of the records to be cedures. In the event of a cancellation kept centrally. of central recordkeeping authoriza- (ii) The exact location where the tions under this paragraph the reg- records will be kept. istrant shall, within the time specified (iii) The name, address, DEA reg- by the Special Agent in Charge, comply istration number and type of DEA reg- with the requirements of this section istration of the registrant whose that all records be kept at the reg- records are being maintained centrally. istered location. (iv) Whether central records will be (c) Registrants need not notify the maintained in a manual, or computer Special Agent in Charge or obtain cen- readable, form. tral recordkeeping approval in order to (2) A registered retail pharmacy that maintain records on an in-house com- possesses additional registrations for puter system. automated dispensing systems at long (d) ARCOS participants who desire term care facilities may keep all authorization to report from other records required by this part for those than their registered locations must additional registered sites at the retail obtain a separate central reporting pharmacy or other approved central lo- identifier. Request for central report- cation. ing identifiers will be submitted to the (b) All registrants that are author- ARCOS Unit. See the Table of DEA ized to maintain a central record- Mailing Addresses in § 1321.01 of this keeping system under paragraph (a) of chapter for the current mailing ad- this section shall be subject to the fol- dress. lowing conditions: (e) All central recordkeeping permits (1) The records to be maintained at previously issued by the Administra- the central record location shall not tion expired September 30, 1980.

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(f) Each registered manufacturer, dis- controlled substances listed in Sched- tributor, importer, exporter, narcotic ules I and II or in the usual consecu- treatment program and compounder tively numbered prescription file for for narcotic treatment program shall noncontrolled substances. However, if a maintain inventories and records of pharmacy employs a computer applica- controlled substances as follows: tion for prescriptions that permits (1) Inventories and records of con- identification by prescription number trolled substances listed in Schedules I and retrieval of original documents by and II shall be maintained separately prescriber name, patient’s name, drug from all of the records of the reg- dispensed, and date filled, then the re- istrant; and quirement to mark the hard copy pre- (2) Inventories and records of con- scription with a red ‘‘C’’ is waived. trolled substances listed in Schedules (5) Records of electronic prescrip- III, IV, and V shall be maintained ei- tions for controlled substances shall be ther separately from all other records maintained in an application that of the registrant or in such form that meets the requirements of part 1311 of the information required is readily re- this chapter. The computers on which trievable from the ordinary business the records are maintained may be lo- records of the registrant. cated at another location, but the (g) Each registered individual practi- records must be readily retrievable at tioner required to keep records and in- the registered location if requested by stitutional practitioner shall maintain the Administration or other law en- inventories and records of controlled forcement agent. The electronic appli- substances in the manner prescribed in cation must be capable of printing out paragraph (f) of this section. or transferring the records in a format (h) Each registered pharmacy shall maintain the inventories and records of that is readily understandable to an controlled substances as follows: Administration or other law enforce- (1) Inventories and records of all con- ment agent at the registered location. trolled substances listed in Schedule I Electronic copies of prescription and II shall be maintained separately records must be sortable by prescriber from all other records of the pharmacy. name, patient name, drug dispensed, (2) Paper prescriptions for Schedule and date filled. II controlled substances shall be main- (Authority: 21 U.S.C. 821 and 871(b); 28 CFR tained at the registered location in a 0.100) separate prescription file. [36 FR 7790, Apr. 24, 1971, as amended at 36 (3) Inventories and records of Sched- FR 13386, July 21, 1971. Redesignated at 38 FR ules III, IV, and V controlled sub- 26609, Sept. 24, 1973, and amended at 39 FR stances shall be maintained either sep- 37985, Oct. 25, 1974; 45 FR 44266, July 1, 1980; arately from all other records of the 47 FR 41735, Sept. 22, 1982; 51 FR 5320, Feb. 13, pharmacy or in such form that the in- 1986; 62 FR 13959, Mar. 24, 1997; 70 FR 25466, formation required is readily retriev- May 13, 2005; 75 FR 10677, Mar. 9, 2010; 75 FR able from ordinary business records of 16306, Mar. 31, 2010] the pharmacy. (4) Paper prescriptions for Schedules § 1304.05 Records of authorized cen- III, IV, and V controlled substances tral fill pharmacies and retail pharmacies. shall be maintained at the registered location either in a separate prescrip- (a) Every retail pharmacy that uti- tion file for Schedules III, IV, and V lizes the services of a central fill phar- controlled substances only or in such macy must keep a record of all central form that they are readily retrievable fill pharmacies, including name, ad- from the other prescription records of dress and DEA number, that are au- the pharmacy. Prescriptions will be thorized to fill prescriptions on its be- deemed readily retrievable if, at the half. The retail pharmacy must also time they are initially filed, the face of verify the registration for each central the prescription is stamped in red ink fill pharmacy authorized to fill pre- in the lower right corner with the let- scriptions on its behalf. These records ter ‘‘C’’ no less than 1 inch high and must be made available upon request filed either in the prescription file for for inspection by DEA.

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(b) Every central fill pharmacy must (f) An application provider must re- keep a record of all retail pharmacies, tain a copy of any notification to the including name, address and DEA num- Administration regarding an adverse ber, for which it is authorized to fill audit or certification report filed with prescriptions. The central fill phar- the Administration on problems identi- macy must also verify the registration fied by the third-party audit or certifi- for all retail pharmacies for which it is cation as required by § 1311.300 of this authorized to fill prescriptions. These chapter. records must be made available upon (g) Unless otherwise specified, request for inspection by DEA. records and reports must be retained [68 FR 37410, June 24, 2003] for two years. [75 FR 16306, Mar. 31, 2010] § 1304.06 Records and reports for electronic prescriptions. INVENTORY REQUIREMENTS (a) As required by § 1311.120 of this chapter, a practitioner who issues elec- § 1304.11 Inventory requirements. tronic prescriptions for controlled sub- (a) General requirements. Each inven- stances must use an electronic pre- tory shall contain a complete and accu- scription application that retains the rate record of all controlled substances following information: on hand on the date the inventory is (1) The digitally signed record of the taken, and shall be maintained in writ- information specified in part 1306 of ten, typewritten, or printed form at this chapter. the registered location. An inventory (2) The internal audit trail and any taken by use of an oral recording de- auditable event identified by the inter- vice must be promptly transcribed. nal audit as required by § 1311.150 of Controlled substances shall be deemed this chapter. to be ‘‘on hand’’ if they are in the pos- (b) An institutional practitioner session of or under the control of the must retain a record of identity proof- registrant, including substances re- ing and issuance of the two-factor au- turned by a customer, ordered by a cus- thentication credential, where applica- tomer but not yet invoiced, stored in a ble, as required by § 1311.110 of this warehouse on behalf of the registrant, chapter. and substances in the possession of em- (c) As required by § 1311.205 of this ployees of the registrant and intended chapter, a pharmacy that processes for distribution as complimentary sam- electronic prescriptions for controlled ples. A separate inventory shall be substances must use an application made for each registered location and that retains the following: each independent activity registered, (1) All of the information required except as provided in paragraph (e)(4) under § 1304.22(c) and part 1306 of this of this section. In the event controlled chapter. substances in the possession or under (2) The digitally signed record of the the control of the registrant are stored prescription as received as required by at a location for which he/she is not § 1311.210 of this chapter. registered, the substances shall be in- (3) The internal audit trail and any cluded in the inventory of the reg- auditable event identified by the inter- istered location to which they are sub- nal audit as required by § 1311.215 of ject to control or to which the person this chapter. possessing the substance is responsible. (d) A registrant and application serv- The inventory may be taken either as ice provider must retain a copy of any of opening of business or as of the close security incident report filed with the of business on the inventory date and Administration pursuant to §§ 1311.150 it shall be indicated on the inventory. and 1311.215 of this chapter. (b) Initial inventory date. Every person (e) An electronic prescription or required to keep records shall take an pharmacy application provider must inventory of all stocks of controlled retain third party audit or certifi- substances on hand on the date he/she cation reports as required by § 1311.300 first engages in the manufacture, dis- of this chapter. tribution, or dispensing of controlled

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substances, in accordance with para- ventory date, the inventory shall in- graph (e) of this section as applicable. clude: In the event a person commences busi- (A) The name of the substance; ness with no controlled substances on (B) The quantity of the substance in hand, he/she shall record this fact as each batch and/or stage of manufac- the initial inventory. ture, identified by the batch number or (c) Biennial inventory date. After the other appropriate identifying number; initial inventory is taken, the reg- and istrant shall take a new inventory of (C) The physical form which the sub- all stocks of controlled substances on stance is to take upon completion of hand at least every two years. The bi- the manufacturing process (e.g., granu- ennial inventory may be taken on any lations, tablets, capsules, or solutions), date which is within two years of the identified by the batch number or previous biennial inventory date. other appropriate identifying number, (d) Inventory date for newly controlled and if possible the finished form of the substances. On the effective date of a substance (e.g., 10-milligram tablet or rule by the Administrator pursuant to 10-milligram concentration per fluid §§ 1308.45, 1308.46, or 1308.47 of this chapter adding a substance to any schedule ounce or milliliter) and the number or of controlled substances, which sub- volume thereof. stance was, immediately prior to that (iii) For each controlled substance in date, not listed on any such schedule, finished form the inventory shall in- every registrant required to keep clude: records who possesses that substance (A) The name of the substance; shall take an inventory of all stocks of (B) Each finished form of the sub- the substance on hand. Thereafter, stance (e.g., 10-milligram tablet or 10- such substance shall be included in milligram concentration per fluid each inventory made by the registrant ounce or milliliter); pursuant to paragraph (c) of this sec- (C) The number of units or volume of tion. each finished form in each commercial (e) Inventories of manufacturers, dis- container (e.g., 100-tablet bottle or 3- tributors, dispensers, researchers, import- milliliter vial); and ers, exporters and chemical analysts. (D) The number of commercial con- Each person registered or authorized tainers of each such finished form (e.g. (by § 1301.13 or §§ 1307.11–1307.13 of this four 100-tablet bottles or six 3-milli- chapter) to manufacture, distribute, liter vials). dispense, import, export, conduct re- (iv) For each controlled substance search or chemical analysis with con- not included in paragraphs (e)(1) (i), (ii) trolled substances and required to keep or (iii) of this section (e.g., damaged, records pursuant to § 1304.03 shall in- defective or impure substances await- clude in the inventory the information ing disposal, substances held for qual- listed below. ity control purposes, or substances (1) Inventories of manufacturers. Each maintained for extemporaneous person registered or authorized to man- compoundings) the inventories shall ufacture controlled substances shall in- include: clude the following information in the inventory: (A) The name of the substance; (i) For each controlled substance in (B) The total quantity of the sub- bulk form to be used in (or capable of stance to the nearest metric unit use in) the manufacture of the same or weight or the total number of units of other controlled or non-controlled sub- finished form; and stances in finished form, the inventory (C) The reason for the substance shall include: being maintained by the registrant and (A) The name of the substance and whether such substance is capable of (B) The total quantity of the sub- use in the manufacture of any con- stance to the nearest metric unit trolled substance in finished form. weight consistent with unit size. (2) Inventories of distributors. Except (ii) For each controlled substance in for reverse distributors covered by the process of manufacture on the in- paragraph (e)(3) of this section, each

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person registered or authorized to dis- stance listed in Schedule I (other than tribute controlled substances shall in- lysergic acid diethylamide), or less clude in the inventory the same infor- than 0.5 gram of lysergic acid mation required of manufacturers pur- diethylamide, is on hand at the time of suant to paragraphs (e)(1)(iii) and (iv) inventory, that substance need not be of this section. included in the inventory. Laboratories (3) Inventories of dispensers, research- of the Administration may possess up ers, and reverse distributors. Each person to 150 grams of any hallucinogenic sub- registered or authorized to dispense, stance in Schedule I without regard to conduct research, or act as a reverse a need for an inventory of those sub- distributor with controlled substances stances. No inventory is required of shall include in the inventory the same known or suspected controlled sub- information required of manufacturers stances received as evidentiary mate- pursuant to paragraphs (e)(1)(iii) and (iv) of this section. In determining the rials for analysis. number of units of each finished form [62 FR 13959, Mar. 24, 1997, as amended at 68 of a controlled substance in a commer- FR 41228, July 11, 2003] cial container which has been opened, the dispenser, researcher, or reverse CONTINUING RECORDS distributor shall do as follows: (i) If the substance is listed in Sched- § 1304.21 General requirements for ule I or II, make an exact count or continuing records. measure of the contents, or (a) Every registrant required to keep (ii) If the substance is listed in records pursuant to § 1304.03 shall main- Schedule III, IV or V, make an esti- tain on a current basis a complete and mated count or measure of the con- accurate record of each such substance tents, unless the container holds more manufactured, imported, received, than 1,000 tablets or capsules in which sold, delivered, exported, or otherwise case he/she must make an exact count disposed of by him/her, except that no of the contents. registrant shall be required to main- (4) Inventories of importers and export- tain a perpetual inventory. ers. Each person registered or authorized to import or export controlled sub- (b) Separate records shall be main- stances shall include in the inventory tained by a registrant for each reg- the same information required of man- istered location except as provided in ufacturers pursuant to paragraphs § 1304.04 (a). In the event controlled (e)(1) (iii) and (iv) of this section. Each substances are in the possession or such person who is also registered as a under the control of a registrant at a manufacturer or as a distributor shall location for which he is not registered, include in his/her inventory as an im- the substances shall be included in the porter or exporter only those stocks of records of the registered location to controlled substances that are actually which they are subject to control or to separated from his stocks as a manu- which the person possessing the sub- facturer or as a distributor (e.g., in stance is responsible. transit or in storage for shipment). (c) Separate records shall be main- (5) Inventories of chemical analysts. tained by a registrant for each inde- Each person registered or authorized to pendent activity for which he/she is conduct chemical analysis with con- registered, except as provided in trolled substances shall include in his § 1304.22(d). inventory the same information re- (d) In recording dates of receipt, im- quired of manufacturers pursuant to portation, distribution, exportation, or paragraphs (e)(1) (iii) and (iv) of this other transfers, the date on which the section as to substances which have controlled substances are actually re- been manufactured, imported, or received by such person. If less than 1 ceived, imported, distributed, exported, kilogram of any controlled substance or otherwise transferred shall be used (other than a hallucinogenic controlled as the date of receipt or distribution of substance listed in Schedule I), or less than 20 grams of a hallucinogenic sub-

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any documents of transfer (e.g., in- (E) The quantity used in quality con- voices or packing slips). trol; (F) The quantity lost during manu- [36 FR 7792, Apr. 24, 1971, as amended at 36 FR 13386, July 21, 1971. Redesignated at 38 FR facturing and the causes therefore, if 26609, Sept. 24, 1973, as amended at 62 FR known; 13960, Mar. 24, 1997] (G) The total quantity of the substance contained in the finished form; § 1304.22 Records for manufacturers, (H) The theoretical and actual yields; distributors, dispensers, research- and ers, importers and exporters. (I) Such other information as is nec- Each person registered or authorized essary to account for all controlled (by § 1301.13(e) or §§ 1307.11–1307.13 of substances used in the manufacturing this chapter) to manufacture, dis- process; tribute, dispense, import, export or (vi) The quantity used to manufac- conduct research with controlled sub- ture other controlled and noncon- stances shall maintain records with the trolled substances, including the name information listed below. of each substance manufactured and (a) Records for manufacturers. Each the information required in paragraph person registered or authorized to man- (a)(1)(v) of this section; ufacture controlled substances shall (vii) The quantity distributed in bulk maintain records with the following inform to other persons, including the formation: date and quantity of each distribution (1) For each controlled substance in and the name, address, and registration bulk form to be used in, or capable of number of each person to whom a dis- use in, or being used in, the manufac- tribution was made; ture of the same or other controlled or (viii) The quantity exported directly noncontrolled substances in finished by the registrant (under a registration form, as an exporter), including the date, (i) The name of the substance; quantity, and export permit or declara- (ii) The quantity manufactured in tion number of each exportation; bulk form by the registrant, including (ix) The quantity distributed or dis- the date, quantity and batch or other posed of in any other manner by the identifying number of each batch man- registrant (e.g., by distribution of com- ufactured; plimentary samples or by destruction), (iii) The quantity received from including the date and manner of dis- other persons, including the date and tribution or disposal, the name, ad- quantity of each receipt and the name, dress, and registration number of the address, and registration number of the person to whom distributed, and the other person from whom the substance quantity distributed or disposed; and was received; (x) The originals of all written cer- (iv) The quantity imported directly tifications of available procurement by the registrant (under a registration quotas submitted by other persons (as as an importer) for use in manufacture required by § 1303.12(f) of this chapter) by him/her, including the date, quan- relating to each order requiring the tity, and import permit or declaration distribution of a basic class of con- number for each importation; trolled substance listed in Schedule I (v) The quantity used to manufacture or II. the same substance in finished form, (2) For each controlled substance in including: finished form, (A) The date and batch or other iden- (i) The name of the substance; tifying number of each manufacture; (ii) Each finished form (e.g., 10-milli- (B) The quantity used in the manu- gram tablet or 10-milligram concentra- facture; tion per fluid ounce or milliliter) and (C) The finished form (e.g., 10-milli- the number of units or volume of fin- gram tablets or 10-milligram con- ished form in each commercial concentration per fluid ounce or milli- tainer (e.g., 100-tablet bottle or 3-milliliter); liter vial); (D) The number of units of finished (iii) The number of containers of form manufactured; each such commercial finished form

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manufactured from bulk form by the by destruction), including the date and registrant, including the information manner of distribution or disposal, the required pursuant to paragraph name, address, and registration num- (a)(1)(v) of this section; ber of the person to whom distributed, (iv) The number of units of finished and the quantity in finished form dis- forms and/or commercial containers tributed or disposed. acquired from other persons, including (b) Records for distributors. Except as the date of and number of units and/or provided in paragraph (e) of this sec- commercial containers in each acquisition, each person registered or author- tion to inventory and the name, ad- ized to distribute controlled substances dress, and registration number of the shall maintain records with the same person from whom the units were ac- information required of manufacturers quired; pursuant to paragraphs (a)(2)(i), (ii), (v) The number of units of finished (iv), (v), (vii), (viii) and (ix) of this sec- forms and/or commercial containers tion. imported directly by the person (under (c) Records for dispensers and research- a registration or authorization to im- ers. Each person registered or author- port), including the date of, the num- ized to dispense or conduct research ber of units and/or commercial con- with controlled substances shall main- tainers in, and the import permit or tain records with the same information declaration number for, each importa- required of manufacturers pursuant to tion; paragraph (a)(2)(i), (ii), (iv), (vii), and (vi) The number of units and/or com- (ix) of this section. In addition, records mercial containers manufactured by shall be maintained of the number of the registrant from units in finished units or volume of such finished form form received from others or imported, dispensed, including the name and ad- including: dress of the person to whom it was dis- (A) The date and batch or other iden- pensed, the date of dispensing, the tifying number of each manufacture; number of units or volume dispensed, (B) The operation performed (e.g., re- and the written or typewritten name or packaging or relabeling); initials of the individual who dispensed (C) The number of units of finished or administered the substance on be- form used in the manufacture, the half of the dispenser. In addition to the number manufactured and the number requirements of this paragraph, practi- lost during manufacture, with the tioners dispensing gamma-hydroxy- causes for such losses, if known; and butyric acid under a prescription must (D) Such other information as is nec- also comply with § 1304.26. essary to account for all controlled (d) Records for importers and exporters. substances used in the manufacturing Each person registered or authorized to process; import or export controlled substances (vii) The number of commercial con- shall maintain records with the same tainers distributed to other persons, in- information required of manufacturers cluding the date of and number of con- pursuant to paragraphs (a)(2) (i), (iv), tainers in each reduction from inven- (v) and (vii) of this section. In addition, tory, and the name, address, and reg- the quantity disposed of in any other istration number of the person to manner by the registrant (except quan- whom the containers were distributed; tities used in manufacturing by an im- (viii) The number of commercial con- porter under a registration as a manu- tainers exported directly by the reg- facturer), which quantities are to be re- istrant (under a registration as an ex- corded pursuant to paragraphs (a)(1) porter), including the date, number of (iv) and (v) of this section; and the containers and export permit or dec- quantity (or number of units or volume laration number for each exportation; in finished form) exported, including and the date, quantity (or number of units (ix) The number of units of finished or volume), and the export permit or forms and/or commercial containers declaration number for each expor- distributed or disposed of in any other tation, but excluding all quantities manner by the registrant (e.g., by dis- (and number of units and volumes) tribution of complimentary samples or manufactured by an exporter under a

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registration as a manufacturer, which turer of the substance or the manufac- quantities (and numbers of units and turer’s agent, including the date of and volumes) are to be recorded pursuant number of containers in each distribu- to paragraphs (a)(1)(xiii) or (a)(2)(xiii) tion and the name, address, and reg- of this section. istration number of the manufacturer (e) Records for reverse distributors. or manufacturer’s agent to whom the Each person registered to distribute containers were distributed. controlled substances as a reverse dis- (v) The number of units or volume of tributor shall maintain records with finished forms and/or commercial con- the following information for each containers disposed of including the date trolled substance: and manner of disposal, the quantity of (1) For each controlled substance in the substance in finished form dis- bulk form the following: posed, and the signatures of two re- (i) The name of the controlled sub- sponsible employees of the registrant stance. who witnessed the disposal. (ii) The total quantity of the controlled substance to the nearest metric [62 FR 13960, Mar. 24, 1997, as amended at 68 unit weight consistent with unit size. FR 41229, July 11, 2003; 70 FR 293, Jan. 4, 2005] (iii) The quantity received from other persons, including the date and § 1304.23 Records for chemical ana- quantity of each receipt and the name, lysts. address, and registration number of the (a) Each person registered or author- other person from whom the controlled ized (by § 1301.22(b) of this chapter) to substance was received. conduct chemical analysis with con- (iv) The quantity returned to the trolled substances shall maintain original manufacturer of the controlled records with the following information substance or the manufacturer’s agent, (to the extent known and reasonably including the date of and quantity of ascertainable by him) for each con- each distribution and the name, ad- trolled substance: dress and registration number of the (1) The name of the substance; manufacturer or manufacturer’s agent (2) The form or forms in which the to whom the controlled substance was substance is received, imported, or distributed. manufactured by the registrant (e.g., (v) The quantity disposed of includ- powder, granulation, tablet, capsule, or ing the date and manner of disposal solution) and the concentration of the and the signatures of two responsible substance in such form (e.g., C.P., employees of the registrant who wit- U.S.P., N.F., 10-milligram tablet or 10- nessed the disposal. milligram concentration per milli- (2) For each controlled substance in liter); finished form the following: (i) The name of the substance. (3) The total number of the forms re- (ii) Each finished form (e.g., 10-milli- ceived, imported or manufactured (e.g., gram tablet or 10-milligram concentra- 100 tablets, thirty 1-milliliter vials, or tion per fluid ounce or milliliter) and 10 grams of powder), including the date the number of units or volume of fin- and quantity of each receipt, importa- ished form in each commercial con- tion, or manufacture and the name, ad- tainer (e.g., 100-tablet bottle or 3-milli- dress, and registration number, if any, liter vial). of the person from whom the substance (iii) The number of commercial con- was received; tainers of each such finished form re- (4) The quantity distributed, ex- ceived from other persons, including ported, or destroyed in any manner by the date of and number of containers in the registrant (except quantities used each receipt and the name, address, in chemical analysis or other labora- and registration number of the person tory work), including the date and from whom the containers were re- manner of distribution, exportation, or ceived. destruction, and the name, address, (iv) The number of commercial con- and registration number, if any, of tainers of each such finished form dis- each person to whom the substance was tributed back to the original manufac- distributed or exported.

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(b) Records of controlled substances § 1304.25 Records for treatment pro- used in chemical analysis or other lab- grams which compound narcotics oratory work are not required. for treatment programs and other (c) Records relating to known or sus- locations. pected controlled substances received Each person registered or authorized as evidentiary material for analysis are by § 1301.22 of this chapter to compound not required under paragraph (a) of narcotic drugs for off-site use in a nar- this section. cotic treatment program shall maintain records which include the fol- [36 FR 7793, Apr. 24, 1971, as amended at 36 lowing information for each narcotic FR 13386, July 21, 1971; 36 FR 18732, Sept. 21, drug: 1971. Redesignated at 38 FR 26609, Sept. 24, (a) For each narcotic controlled sub- 1973, and further redesignated at 62 FR 13961, stance in bulk form to be used in, or Mar. 24, 1997] capable of use in, or being used in, the § 1304.24 Records for maintenance compounding of the same or other non- treatment programs and detoxifica- controlled substances in finished form: tion treatment programs. (1) The name of the substance; (2) The quantity compounded in bulk (a) Each person registered or author- form by the registrant, including the ized (by § 1301.22 of this chapter) to date, quantity and batch or other iden- maintain and/or detoxify controlled tifying number of each batch com- substance users in a narcotic treat- pounded; ment program shall maintain records (3) The quantity received from other with the following information for each persons, including the date and quan- narcotic controlled substance: tity of each receipt and the name, ad- (1) Name of substance; dress and registration number of the (2) Strength of substance; other person from whom the substance (3) Dosage form; was received; (4) Date dispensed; (4) The quantity imported directly by (5) Adequate identification of patient the registrant (under a registration as (consumer); an importer) for use in compounding by him, including the date, quantity and (6) Amount consumed; import permit or declaration number (7) Amount and dosage form taken of each importation; home by patient; and (5) The quantity used to compound (8) Dispenser’s initials. the same substance in finished form, (b) The records required by paragraph including: (a) of this section will be maintained in (i) The date and batch or other iden- a dispensing log at the narcotic treat- tifying number of each compounding; ment program site and will be main- (ii) The quantity used in the com- tained in compliance with § 1304.22 pound; without reference to § 1304.03. (iii) The finished form (e.g., 10-milli- (c) All sites which compound a bulk gram tablets or 10-milligram con- narcotic solution from bulk narcotic centration per fluid ounce or milliliter; powder to liquid for on-site use must (iv) The number of units of finished keep a separate batch record of the form compounded; compounding. (v) The quantity used in quality con- (d) Records of identity, diagnosis, trol; prognosis, or treatment of any patients (vi) The quantity lost during which are maintained in connection compounding and the causes therefore, with the performance of a narcotic if known; treatment program shall be confiden- (vii) The total quantity of the substance contained in the finished form; tial, except that such records may be (viii) The theoretical and actual disclosed for purposes and under the yields; and circumstances authorized by part 310 (ix) Such other information as is nec- and 42 CFR part 2. essary to account for all controlled [39 FR 37985, Oct. 25, 1974. Redesignated and substances used in the compounding amended at 62 FR 13961, Mar. 24, 1997] process;

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(6) The quantity used to manufacture received from others or imported, in- other controlled and non-controlled cluding: substances; including the name of each (i) The date and batch or other iden- substance manufactured and the infor- tifying number of each compounding; mation required in paragraph (a)(5) of (ii) The operation performed (e.g., re- this section; packaging or relabeling); (7) The quantity distributed in bulk (iii) The number of units of finished form to other programs, including the form used in the compound, the num- date and quantity of each distribution ber compounded and the number lost and the name, address and registration during compounding, with the causes number of each program to whom a dis- for such losses, if known; and tribution was made; (iv) Such other information as is nec- (8) The quantity exported directly by essary to account for all controlled the registrant (under a registration as substances used in the compounding an exporter), including the date, quan- process; tity, and export permit or declaration (7) The number of containers distrib- number of each exploration; and uted to other programs, including the (9) The quantity disposed of by de- date, the number of containers in each struction, including the reason, date distribution, and the name, address and and manner of destruction. All other registration number of the program to destruction of narcotic controlled sub- whom the containers were distributed; stances will comply with § 1307.22. (8) The number of commercial con- (b) For each narcotic controlled sub- tainers exported directly by the reg- stance in finished form: istrant (under a registration as an ex- (1) The name of the substance; porter), including the date, number of (2) Each finished form (e.g., 10-milli- containers and export permit or dec- gram tablet or 10 milligram concentra- laration number for each exportation; tion per fluid ounce or milliliter) and and the number of units or volume or fin- (9) The number of units of finished ished form in each commercial con- forms and/or commercial containers tainer (e.g., 100-tablet bottle or 3-milli- destroyed in any manner by the reg- liter vial); istrant, including the reason, the date (3) The number of containers of each and manner of destruction. All other such commercial finished form com- destruction of narcotic controlled sub- pounded from bulk form by the reg- stances will comply with § 1307.22. istrant, including the information re- [39 FR 37985, Oct. 25, 1974. Redesignated at 62 quired pursuant to paragraph (a)(5) of FR 13961, Mar. 24, 1997] this section; (4) The number of units of finished § 1304.26 Additional recordkeeping re- forms and/or commercial containers requirements applicable to drug prod- ceived from other persons, including ucts containing gamma-hydroxy- the date of and number of units and/or butyric acid. commercial containers in each receipt In addition to the recordkeeping re- and the name, address and registration quirements for dispensers and research- number of the person from whom the ers provided in § 1304.22, practitioners units were received; dispensing gamma-hydroxybutyric acid (5) The number of units of finished that is manufactured or distributed in forms and/or commercial containers accordance with an application under imported directly by the person (under section 505 of the Federal Food, Drug, a registration or authorization to im- and Cosmetic Act must maintain and port), including the date of, the num- make available for inspection and ber of units and/or commercial con- copying by the Attorney General, all of tainers in, and the import permit or the following information for each pre- declaration number for, each importa- scription: tion; (a) Name of the prescribing practi- (6) The number of units and/or com- tioner. mercial containers compounded by the (b) Prescribing practitioner’s Federal registrant from units in finished form and State registration numbers, with

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the expiration dates of these registra- ufacturing opium and medicinal tions. opium): (c) Verification that the prescribing (1) Beginning inventory; practitioner possesses the appropriate (2) Gains on reweighing; registration to prescribe this con- (3) Quantity extracted from narcotic trolled substance. raw material; (d) Patient’s name and address. (4) Quantity produced/manufactured/ (e) Patient’s insurance provider, if synthesized; available. (5) Quantity sold; [70 FR 293, Jan. 4, 2005] (6) Quantity returned to conversion processes for reworking; REPORTS (7) Quantity used for conversion; (8) Quantity placed in process; § 1304.31 Reports from manufacturers (9) Other dispositions; importing narcotic raw material. (10) Losses on reweighing and (a) Every manufacturer which im- (11) Ending inventory. ports or manufactures from narcotic (d) The following information shall raw material (opium, poppy straw, and be submitted for importation of each concentrate of poppy straw) shall sub- narcotic raw material: mit information which accounts for the (1) Import permit number; importation and for all manufacturing (2) Date shipment arrived at the operations performed between importa- United States port of entry; tion and the production in bulk or fin- (3) Actual quantity shipped; ished marketable products, standard- (4) Assay (percent) of morphine, co- ized in accordance with the U.S. Phar- deine and thebaine and macopeia, National Formulary or other (5) Quantity shipped, expressed as an- recognized medical standards. Reports hydrous morphine alkaloid. shall be signed by the authorized offi- (e) Upon importation of crude opium, cial and submitted quarterly on com- samples will be selected and assays pany letterhead to the Drug and Chem- made by the importing manufacturer ical Evaluation Section, Drug Enforce- in the manner and according to the ment Administration, on or before the method specified in the U.S. Pharma- 15th day of the month immediately fol- copoeia. Where final assay data is not lowing the period for which it is sub- determined at the time of rendering re- mitted. See the Table of DEA Mailing port, the report shall be made on the Addresses in § 1321.01 of this chapter for basis of the best data available, subject the current mailing address. to adjustment, and the necessary ad- (b) The following information shall justing entries shall be made on the be submitted for each type of narcotic next report. raw material (quantities are expressed (f) Where factory procedure is such as grams of anhydrous morphine alka- that partial withdrawals of opium are loid): made from individual containers, there (1) Beginning inventory; shall be attached to each container a (2) Gains on reweighing; (3) Imports; stock record card on which shall be (4) Other receipts; kept a complete record of all with- (5) Quantity put into process; drawals therefrom. (6) Losses on reweighing; (g) All in-process inventories should (7) Other dispositions and be expressed in terms of end-products (8) Ending inventory. and not precursors. Once precursor ma- (c) The following information shall terial has been changed or placed into be submitted for each narcotic raw ma- process for the manufacture of a speci- terial derivative including morphine, fied end-product, it must no longer be codeine, thebaine, oxycodone, accounted for as precursor stocks hydrocodone, medicinal opium, manu- available for conversion or use, but facturing opium, crude alkaloids and rather as end-product in-process inven- other derivatives (quantities are ex- tories. pressed as grams of anhydrous base or [62 FR 13961, Mar. 24, 1997, as amended at 75 anhydrous morphine alkaloid for man- FR 10677, Mar. 9, 2010]

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§ 1304.32 Reports of manufacturers im- (d) Upon importation of coca leaves, porting coca leaves. samples will be selected and assays (a) Every manufacturer importing or made by the importing manufacturer manufacturing from raw coca leaves in accordance with recognized chem- shall submit information accounting ical procedures. These assays shall for the importation and for all manu- form the basis of accounting for such facturing operations performed be- coca leaves, which shall be accounted tween the importation and the manu- for in terms of their cocaine alkaloid content or equivalency or their total facture of bulk or finished products anhydrous coca alkaloid content. standardized in accordance with U.S. Where final assay data is not deter- Pharmacopoeia, National Formulary, mined at the time of submission, the or other recognized standards. The re- report shall be made on the basis of the ports shall be submitted quarterly on best data available, subject to adjust- company letterhead to the Drug and ment, and the necessary adjusting en- Chemical Evaluation Section, Drug En- tries shall be made on the next report. forcement Administration, on or before (e) Where factory procedure is such the 15th day of the month immediately that partial withdrawals of medicinal following the period for which it is sub- coca leaves are made from individual mitted. See the Table of DEA Mailing containers, there shall be attached to Addresses in § 1321.01 of this chapter for the container a stock record card on the current mailing address. which shall be kept a complete record (b) The following information shall of withdrawals therefrom. be submitted for raw coca leaf, ecgo- (f) All in-process inventories should nine, ecgonine for conversion or fur- be expressed in terms of end-products ther manufacture, benzoylecgonine, and not precursors. Once precursor ma- manufacturing coca extracts (list for terial has been changed or placed into tinctures and extracts; and others sep- process for the manufacture of a speci- arately), other crude alkaloids and fied end-product, it must no longer be other derivatives (quantities should be accounted for as precursor stocks reported as grams of actual quantity available for conversion or use, but involved and the cocaine alkaloid con- rather as end-product in-process inven- tent or equivalency): tories. (1) Beginning inventory; (2) Imports; [62 FR 13962, Mar. 24, 1997, as amended at 75 FR 10678, Mar. 9, 2010] (3) Gains on reweighing; (4) Quantity purchased; § 1304.33 Reports to ARCOS. (5) Quantity produced; (a) Reports generally. All reports re- (6) Other receipts; quired by this section shall be filed (7) Quantity returned to processes for with the ARCOS Unit on DEA Form reworking; 333, or on media which contains the (8) Material used in purification for data required by DEA Form 333 and sale; which is acceptable to the ARCOS (9) Material used for manufacture or Unit. See the Table of DEA Mailing Ad- production; dresses in § 1321.01 of this chapter for (10) Losses on reweighing; the current mailing address. (11) Material used for conversion; (b) Frequency of reports. Acquisition/ (12) Other dispositions and Distribution transaction reports shall (13) Ending inventory. be filed every quarter not later than (c) The following information shall the 15th day of the month succeeding be submitted for importation of coca the quarter for which it is submitted; leaves: except that a registrant may be given (1) Import permit number; permission to file more frequently (but (2) Date the shipment arrived at the not more frequently than monthly), de- United States port of entry; pending on the number of transactions (3) Actual quantity shipped; being reported each time by that reg- (4) Assay (percent) of cocaine alka- istrant. Inventories shall provide data loid and on the stocks of each reported con- (5) Total cocaine alkaloid content. trolled substance on hand as of the

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close of business on December 31 of (i) Schedule III each year, indicating whether the sub- (A) Benzphetamine; stance is in storage or in process of (B) Cyclobarbital; manufacturing. These reports shall be (C) Methyprylon; and filed not later than January 15 of the (D) Phendimetrazine. following year. Manufacturing trans- (ii) Schedule IV action reports shall be filed annually (A) Barbital; for each calendar year not later than (B) Diethylpropion (Amfepramone); January 15 of the following year, ex- (C) Ethchlorvynol; cept that a registrant may be given (D) Ethinamate; permission to file more frequently (but (E) Lefetamine (SPA); not more frequently than quarterly). (F) Mazindol; (c) Persons reporting. For controlled (G) Meprobamate; substances in Schedules I, II, narcotic (H) Methylphenobarbital; controlled substances in Schedule III, (I) Phenobarbital; and gamma-hydroxybutyric acid drug (J) Phentermine; and product controlled substances in (K) Pipradrol. Schedule III, each person who is reg- (2) Data shall be presented in such a istered to manufacture in bulk or dos- manner as to identify the particular age form, or to package, repackage, form, strength, and trade name, if any, label or relabel, and each person who is of the product containing the con- registered to distribute, including each trolled substancefor which the report is person who is registered to reverse dis- being made. For this purpose, persons tribute, shall report acquisition/dis- filing reports shall utilize the National tribution transactions. In addition to Drug Code Number assigned to the reporting acquisition/distribution product under the National Drug Code transactions, each person who is reg- System of the Food and Drug Adminis- istered to manufacture controlled sub- tration. stances in bulk or dosage form shall re- (e) Transactions reported. Acquisition/ port manufacturing transactions on distribution transaction reports shall controlled substances in Schedules I provide data on each acquisition to in- and II, each narcotic controlled sub- ventory (identifying whether it is, e.g., stance listed in Schedules III, IV, and by purchase or transfer, return from a V, gamma-hydroxybutyric acid drug customer, or supply by the Federal product controlled substances in Government) and each reduction from Schedule III, and on each psychotropic inventory (identifying whether it is, controlled substance listed in Sched- e.g., by sale or transfer, theft, destruc- ules III and IV as identified in para- tion or seizure by Government agen- graph (d) of this section. cies). Manufacturing reports shall pro- (d) Substances covered. (1) Manufac- vide data on material manufactured, turing and acquisition/distribution manufacture from other material, use transaction reports shall include data in manufacturing other material and on each controlled substance listed in use in producing dosage forms. Schedules I and II, on each narcotic (f) Exceptions. A registered institu- controlled substance listed in Schedule tional practitioner who repackages or III (but not on any material, com- relabels exclusively for distribution or pound, mixture or preparation con- who distributes exclusively to (for dis- taining a quantity of a substance hav- pensing by) agents, employees, or af- ing a stimulant effect on the central filiated institutional practitioners of nervous system, which material, com- the registrant may be exempted from pound, mixture or preparation is listed filing reports under this section by ap- in Schedule III or on any narcotic con- plying to the ARCOS Unit of the Ad- trolled substance listed in Schedule V), ministration. and on gamma-hydroxybutyric acid drug products listed in Schedule III. (Approved by the Office of Management and Additionally, reports on manufacturing Budget under control number 1117–0003) transactions shall include the fol- [62 FR 13962, Mar. 24, 1997, as amended at 68 lowing psychotropic controlled sub- FR 41229, July 11, 2003; 70 FR 294, Jan. 4, 2005; stances listed in Schedules III and IV: 75 FR 10678, Mar. 9, 2010]

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ONLINE PHARMACIES referred to in paragraph (b)(3) of this section; and § 1304.40 Notification by online phar- (ii) Every practitioner who has a con- macies. tractual relationship to provide med- (a) Thirty days prior to offering a ical evaluations or issue prescriptions controlled substance for sale, delivery, for controlled substances, through re- distribution, or dispensing by means of ferrals from the Web site or at the re- the Internet, an online pharmacy shall: quest of the owner or operator of the (1) Notify the Administrator of its in- Web site, or any employee or agent tent to do so by submitting an applica- thereof. tion for a modified registration in ac- (c) An online pharmacy that is in op- cordance with §§ 1301.13 and 1301.19 of eration at the time Public Law 110–425 this chapter, with such application becomes effective (April 13, 2009) must containing the information required by make the notifications required in this this section; and section on or before May 13, 2009. How- (2) Notify the State boards of phar- ever, in accordance with section 401(h) macy in any States in which the online of the Act (21 U.S.C. 841(h)), as of April pharmacy offers to sell, deliver, dis- 13, 2009, it is unlawful for any online tribute, or dispense controlled sub- pharmacy to deliver, distribute, or dis- stances. pense a controlled substance by means (b) The following information must of the Internet unless such online phar- be included in the notification sub- macy is validly registered with a modi- mitted under paragraph (a) of this sec- fication of such registration author- tion: izing such activity. (1) The pharmacy’s Internet Phar- (d) On and after the date an online macy Site Disclosure information re- pharmacy makes the notifications required to be posted on the homepage of quired under this section, each online the online pharmacy’s Internet site pharmacy shall display on the home- under section 311(c) of the Act (21 page of its Internet site, a declaration U.S.C. 831(c)) and § 1304.45 of this part. that it has made such notifications to (2) Certification that the information the Administrator in the following disclosed on its Internet site under the form: ‘‘In accordance with the Con- Internet Pharmacy Site Disclosure is trolled Substances Act and the DEA true and accurate. The statement shall regulations, this online pharmacy has be in a form similar to the following: made the notifications to the DEA Ad- ‘‘The above-named pharmacy, a DEA ministrator required by 21 U.S.C. 831 registrant, certifies, under penalty of and 21 CFR 1304.40.’’ perjury, that the information con- (e)(1) Except as provided in para- tained in this statement is true and ac- graphs (e)(2) and (e)(3) of this section, curate.’’ if any of the information required to be (3) Each Internet site address utilized submitted under this section changes by the online pharmacy and a certifi- after the online pharmacy submits the cation that the online pharmacy shall notification to the Administrator, the notify the Administrator of any change online pharmacy shall notify the Ad- in any such Internet address at least 30 ministrator of the updated information days in advance. In the event that a no later than 30 days before the change pharmacy delivers, distributes, or dis- becomes effective via the online proc- penses controlled substances pursuant ess. to orders made on, through, or on be- (2) If a pharmacy referred to in para- half of, more than one Web site, the graph (b)(4)(i) of this section ceases to pharmacy shall provide, for purposes of deliver, distribute, or dispense con- complying with this paragraph, the trolled substances pursuant to orders Internet site address of each such site. made on, through, or on behalf of, each (4) The DEA registration numbers of: Web site referred to in paragraph (b)(3) (i) Every pharmacy that delivers, dis- of this section, the online pharmacy tributes, or dispenses controlled sub- shall notify the Administrator no later stances pursuant to orders made on, than 30 days after the change becomes through, or on behalf of, each Web site effective via the online process.

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(3) If a practitioner referred to in contractual relationship to provide paragraph (b)(4)(ii) of this section medical evaluations or issue prescrip- ceases to have a contractual relation- tions for controlled substances, ship with the online pharmacy, the on- through referrals from the Web site or line pharmacy shall notify the Admin- at the request of the owner or operator istrator no later than 30 days after the of the Web site, or any employee or change becomes effective via the online agent thereof. process. (7) The following statement: ‘‘This [74 FR 15623, Apr. 6, 2009] online pharmacy is obligated to comply fully with the Controlled Sub- § 1304.45 Internet Web site disclosure stances Act and DEA regulations. As requirements. part of this obligation, this online (a) Each online pharmacy shall dis- pharmacy has obtained a modified DEA play, at all times and in a visible and registration authorizing it to operate clear manner, on its homepage a state- as an online pharmacy. In addition, ment that it complies with the require- this online pharmacy will only dis- ments of section 311 of the Act (21 pense a controlled substance to a per- U.S.C. 831) with respect to the delivery son who has a valid prescription issued or sale or offer for sale of controlled for a legitimate medical purpose based substances. This statement must in- upon a medical relationship with a preclude the name of the pharmacy as it scribing practitioner. This includes at appears on the DEA Certificate of Reg- least one prior in-person medical eval- istration. uation in accordance with section 309 (b) Each online pharmacy shall clear- of the Controlled Substances Act (21 ly display the following information on U.S.C. 829) or a medical evaluation via the homepage of each Internet site it telemedicine in accordance with sec- operates, or on a page directly linked tion 102(54) of the Controlled Sub- to the homepage. If the information is stances Act (21 U.S.C. 802(54)).’’ displayed on a page directly linked to [74 FR 15623, Apr. 6, 2009] the homepage, that link on the homepage must be visible and clear. The in- § 1304.50 Disclosure requirements for formation must be displayed for each Web sites of nonpharmacy practi- pharmacy that delivers, distributes, or tioners that dispense controlled dispenses controlled substances pursu- substances by means of the Inter- ant to orders made on, through, or on net. behalf of that Web site. For a Web site to identify itself as (1) The name and address of the phar- being exempt from the definition of an macy as it appears on the pharmacy’s online pharmacy by virtue of section DEA Certificate of Registration. 102(52)(B)(ii) of the Act (21 U.S.C. (2) The pharmacy’s telephone number 802(52)(B)(ii)) and § 1300.04(h)(2) of this and e-mail address. chapter, the Web site shall post in a (3) The name, professional degree, visible and clear manner on its home- and States of licensure of the phar- page, or on a page directly linked macist-in-charge, and a telephone thereto in which the hyperlink is also number at which the pharmacist-in- visible and clear on the homepage, a charge can be contacted. list of the DEA-registered nonphar- (4) A list of the States in which the macy practitioners who are affiliated pharmacy is licensed to dispense con- with the Web site. Any nonpharmacy trolled substances. practitioner affiliated with such a Web (5) A certification that the pharmacy site is responsible for compliance with is registered under part 1301 of this this section. An institutional practi- chapter with a modification of its reg- tioner that otherwise complies with istration authorizing it to deliver, dis- the requirements of the Act and this tribute, or dispense controlled sub- chapter will be deemed to meet the re- stances by means of the Internet. quirements of this section if, in lieu of (6) The name, address, telephone posting the names of each affiliated in- number, professional degree, and dividual practitioner, it posts its name States of licensure with State license (as it appears on its Certificate of Reg- number of any practitioner who has a istration) in a visible and clear manner

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on its homepage and in a manner that shall utilize the National Drug Code identifies itself as being responsible for number assigned to the product under the operation of the Web site. the National Drug Code System of the Food and Drug Administration, and in- [74 FR 15623, Apr. 6, 2009] dicate the total number of dosage units § 1304.55 Reports by online phar- dispensed for each such National Drug macies. Code number. (a) Each online pharmacy shall re- (g) Records required to be kept under port to the Administrator the total this section must be kept by the reg- quantity of each controlled substance istrant for at least two years from the that the pharmacy has dispensed each date of such records. The information calendar month. The report must in- shall be readily retrievable from the clude the total quantity of such dis- ordinary business records of the reg- pensing by any means, regardless of istrant and available for inspection and whether the controlled substances are copying by authorized employees of the dispensed by means of the Internet. Administration. Thus, such reporting shall include all [74 FR 15623, Apr. 6, 2009] controlled substances dispensed via Internet transactions, mail-order PART 1305—ORDERS FOR SCHED- transactions, face-to-face transactions, or any other means. However, the phar- ULE I AND II CONTROLLED SUB- macy is not required to describe in its STANCES report to the Administrator such means of dispensing. Such reporting is Subpart A—General Requirements required for every calendar month in Sec. which the total quantity of controlled 1305.01 Scope of part 1305. substances dispensed by the pharmacy 1305.02 Definitions. meets or exceeds one of the following 1305.03 Distributions requiring a Form 222 thresholds: or digitally signed electronic order. (1) 100 or more prescriptions for con- 1305.04 Persons entitled to order Schedule I and II controlled substances. trolled substances filled; or 1305.05 Power of attorney. (2) 5,000 or more dosage units dis- 1305.06 Persons entitled to fill orders for pensed of all controlled substances Schedule I and II controlled substances. combined. 1305.07 Special procedure for filling certain (b) Each online pharmacy shall re- orders. port a negative response if, during a given calendar month, its total dis- Subpart B—DEA Form 222 pensing of controlled substances falls 1305.11 Procedure for obtaining DEA Forms below both of the thresholds in para- 222. graph (a) of this section. 1305.12 Procedure for executing DEA Forms (c) The reporting requirements of 222. this section apply to every pharmacy 1305.13 Procedure for filling DEA Forms 222. that, at any time during a calendar 1305.14 Procedure for endorsing DEA Forms 222. month, holds a modified registration 1305.15 Unaccepted and defective DEA authorizing it to operate as an online Forms 222. pharmacy, regardless of whether the 1305.16 Lost and stolen DEA Forms 222. online pharmacy dispenses any con- 1305.17 Preservation of DEA Forms 222. trolled substances by means of the 1305.18 Return of unused DEA Forms 222. Internet during the month. 1305.19 Cancellation and voiding of DEA (d) Reports will be submitted to DEA Forms 222. electronically via online reporting, Subpart C—Electronic Orders electronic file upload, or other means as approved by DEA. 1305.21 Requirements for electronic orders. (e) Reports shall be filed every month 1305.22 Procedure for filling electronic or- not later than the fifteenth day of the ders. 1305.23 Endorsing electronic orders. month succeeding the month for which 1305.24 Central processing of orders. they are submitted. 1305.25 Unaccepted and defective electronic (f) An online pharmacy filing a report orders. under paragraph (a) of this section 1305.26 Lost electronic orders.

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1305.27 Preservation of electronic orders. dle Schedule I or II controlled sub- 1305.28 Canceling and voiding electronic or- stances and persons registered only to ders. import controlled substances are not 1305.29 Reporting to DEA. entitled to obtain Form 222 or issue AUTHORITY: 21 U.S.C. 821, 828, 871(b), unless electronic orders for these substances. otherwise noted. (b) An order for Schedule I or II con- SOURCE: 70 FR 16911, Apr. 1, 2005, unless trolled substances may be executed otherwise noted. only on behalf of the registrant named on the order and only if his or her reg- Subpart A—General Requirements istration for the substances being purchased has not expired or been revoked § 1305.01 Scope of part 1305. or suspended. Procedures governing the issuance, § 1305.05 Power of attorney. use, and preservation of orders for Schedule I and II controlled substances (a) A registrant may authorize one or are set forth generally by section 308 of more individuals, whether or not lo- the Act (21 U.S.C. 828) and specifically cated at his or her registered location, by the sections of this part. to issue orders for Schedule I and II controlled substances on the reg- § 1305.02 Definitions. istrant’s behalf by executing a power of attorney for each such individual, if Any term contained in this part shall the power of attorney is retained in the have the definition set forth in the Act files, with executed Forms 222 where or part 1300 of this chapter. applicable, for the same period as any § 1305.03 Distributions requiring a order bearing the signature of the at- Form 222 or a digitally signed elec- torney. The power of attorney must be tronic order. available for inspection together with Either a DEA Form 222 or its elec- other order records. tronic equivalent as set forth in sub- (b) A registrant may revoke any part C of this part and Part 1311 of this power of attorney at any time by exe- chapter is required for each distribu- cuting a notice of revocation. (c) The power of attorney and notice tion of a Schedule I or II controlled of revocation must be similar to the substance except for the following: (a) Distributions to persons exempted following format: from registration under Part 1301 of Power of Attorney for DEA Forms 222 this chapter. and Electronic Orders (b) Exports from the United States that conform with the requirements of llllllllllllllllllllllll the Act. (Name of registrant) (c) Deliveries to a registered analyt- llllllllllllllllllllllll ical laboratory or its agent approved (Address of registrant) by DEA. llllllllllllllllllllllll (d) Delivery from a central fill phar- (DEA registration number) macy, as defined in § 1300.01(b)(44) of I, llll (name of person granting this chapter, to a retail pharmacy. power), the undersigned, who am authorized to sign the current application § 1305.04 Persons entitled to order for registration of the above-named Schedule I and II controlled sub- registrant under the Controlled Sub- stances. stances Act or Controlled Substances (a) Only persons who are registered Import and Export Act, have made, with DEA under section 303 of the Act constituted, and appointed, and by (21 U.S.C. 823) to handle Schedule I or these presents, do make, constitute, II controlled substances, and persons and appoint llll (name of attorney- who are registered with DEA under sec- in-fact), my true and lawful attorney tion 1008 of the Act (21 U.S.C. 958) to for me in my name, place, and stead, to export these substances may obtain execute applications for Forms 222 and and use DEA Form 222 (order forms) or to sign orders for Schedule I and II con- issue electronic orders for these sub- trolled substances, whether these or- stances. Persons not registered to han- ders be on Form 222 or electronic, in

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accordance with 21 U.S.C. 828 and Part with DEA as a manufacturer or dis- 1305 of Title 21 of the Code of Federal tributor of controlled substances listed Regulations. I hereby ratify and con- in Schedule I or II pursuant to section firm all that said attorney must law- 303 of the Act (21 U.S.C. 823) or as an fully do or cause to be done by virtue importer of such substances pursuant hereof. to section 1008 of the Act (21 U.S.C. llllllllllllllllllllllll 958), except for the following: (Signature of person granting power) (a) A person registered with DEA to I, llll (name of attorney-in-fact), dispense the substances, or to export hereby affirm that I am the person the substances, if he/she is dis- named herein as attorney-in-fact and continuing business or if his/her reg- that the signature affixed hereto is my istration is expiring without rereg- signature. istration, may dispose of any Schedule (signature of attorney-in-fact) I or II controlled substances in his/her possession with a DEA Form 222 or an Witnesses: electronic order in accordance with 1. llllll § 1301.52 of this chapter. 2. llllll (b) A purchaser who has obtained any Schedule I or II controlled substance Signed and dated on the llll day of by either a DEA Form 222 or an elec- llll, (year), at llll . tronic order may return the substance Notice of Revocation to the supplier of the substance with either a DEA Form 222 or an electronic The foregoing power of attorney is order from the supplier. hereby revoked by the undersigned, (c) A person registered to dispense who is authorized to sign the current Schedule II substances may distribute application for registration of the the substances to another dispenser above-named registrant under the Con- with either a DEA Form 222 or an elec- trolled Substances Act or the Con- tronic order only in the circumstances trolled Substances Import and Export described in § 1307.11 of this chapter. Act. Written notice of this revocation (d) A person registered or authorized has been given to the attorney-in-fact to conduct chemical analysis or re- llll this same day. search with controlled substances may llllllllllllllllllllllll distribute a Schedule I or II controlled (Signature of person revoking power) substance to another person registered Witnesses: or authorized to conduct chemical 1. llllll analysis, instructional activities, or re- 2. llllll search with the substances with either Signed and dated on the llll day of a DEA Form 222 or an electronic order, llll , (year), at llll . if the distribution is for the purpose of (d) A power of attorney must be exe- furthering the chemical analysis, in- cuted by the person who signed the structional activities, or research. most recent application for DEA reg- (e) A person registered as a istration or reregistration; the person compounder of narcotic substances for to whom the power of attorney is being use at off-site locations in conjunction granted; and two witnesses. with a narcotic treatment program at (e) A power of attorney must be re- the compounding location, who is au- voked by the person who signed the thorized to handle Schedule II nar- most recent application for DEA reg- cotics, is authorized to fill either a istration or reregistration, and two DEA Form 222 or an electronic order witnesses. for distribution of narcotic drugs to off-site narcotic treatment programs § 1305.06 Persons entitled to fill orders only. for Schedule I and II controlled substances. § 1305.07 Special procedure for filling An order for Schedule I and II con- certain orders. trolled substances, whether on a DEA A supplier of carfentanil, etorphine Form 222 or an electronic order, may hydrochloride, or diprenorphine, if he be filled only by a person registered or she determines that the purchaser is

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a veterinarian engaged in zoo and ex- (c) Each requisition must show the otic animal practice, wildlife manage- name, address, and registration num- ment programs, or research, and is au- ber of the registrant and the number of thorized by the Administrator to han- books of DEA Forms 222 desired. Each dle these substances, may fill the order requisition must be signed and dated in accordance with the procedures set by the same person who signed the forth in § 1305.17 except that: most recent application for registra- (a) A DEA Form 222 or an electronic tion or for reregistration, or by any order for carfentanil, etorphine hydro- person authorized to obtain and exe- chloride, and diprenorphine must con- cute DEA Forms 222 by a power of at- tain only these substances in reason- torney under § 1305.05. able quantities. (d) DEA Forms 222 will be serially (b) The substances must be shipped, under secure conditions using substan- numbered and issued with the name, tial packaging material with no mark- address, and registration number of the ings on the outside that would indicate registrant, the authorized activity, and the content, only to the purchaser’s schedules of the registrant. This infor- registered location. mation cannot be altered or changed by the registrant; any errors must be Subpart B—DEA Form 222 corrected by the Registration Section of the Administration by returning the § 1305.11 Procedure for obtaining DEA forms with notification of the error. Forms 222. (a) DEA Forms 222 are issued in mail- § 1305.12 Procedure for executing DEA Forms 222. ing envelopes containing either seven or fourteen forms, each form con- (a) A purchaser must prepare and taining an original, duplicate, and trip- execute a DEA Form 222 simulta- licate copy (respectively, Copy 1, Copy neously in triplicate by means of 2, and Copy 3). A limit, which is based interleaved carbon sheets that are part on the business activity of the reg- of the DEA Form 222. DEA Form 222 istrant, will be imposed on the number must be prepared by use of a type- of DEA Forms 222, which will be fur- writer, pen, or indelible pencil. nished on any requisition unless addi- (b) Only one item may be entered on tional forms are specifically requested each numbered line. An item must con- and a reasonable need for such addi- sist of one or more commercial or bulk tional forms is shown. containers of the same finished or bulk (b) Any person applying for a reg- form and quantity of the same sub- istration that would entitle him or her stance. The number of lines completed to obtain a DEA Form 222 may requisi- must be noted on that form at the bot- tion the forms by so indicating on the tom of the form, in the space provided. application form; a DEA Form 222 will DEA Forms 222 for carfentanil, be supplied upon the registration of the etorphine hydrochloride, and applicant. Any person holding a reg- diprenorphine must contain only these istration entitling him or her to obtain a DEA Form 222 may requisition the substances. forms for the first time by contacting (c) The name and address of the sup- any Division Office or the Registration plier from whom the controlled sub- Section of the Administration. Any stances are being ordered must be en- person already holding a DEA Form 222 tered on the form. Only one supplier may requisition additional forms on may be listed on any form. DEA Form 222a, which is mailed to a (d) Each DEA Form 222 must be registrant approximately 30 days after signed and dated by a person author- each shipment of DEA Forms 222 to ized to sign an application for registra- that registrant, or by contacting any tion or a person granted power of at- Division Office or the Registration Sec- torney to sign a Form 222 under tion of the Administration. All requisi- § 1305.05. The name of the purchaser, if tion forms (DEA Form 222a) must be different from the individual signing submitted to the DEA Registration the DEA Form 222, must also be in- Section. serted in the signature space.

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(e) Unexecuted DEA Forms 222 may fense Supply Center of the Defense Lo- be kept and may be executed at a loca- gistics Agency for delivery to armed tion other than the registered location services establishments within the printed on the form, provided that all United States may be shipped to loca- unexecuted forms are delivered tions other than the location printed promptly to the registered location on the DEA Form 222, and in partial upon an inspection of the location by shipments at different times not to ex- any officer authorized to make inspec- ceed six months from the date of the tions, or to enforce, any Federal, State, order, as designated by the procure- or local law regarding controlled sub- ment officer when submitting the stances. order.

§ 1305.13 Procedure for filling DEA § 1305.14 Procedure for endorsing DEA Forms 222. Forms 222. (a) A purchaser must submit Copy 1 (a) A DEA Form 222, made out to any and Copy 2 of the DEA Form 222 to the supplier who cannot fill all or a part of supplier and retain Copy 3 in the pur- the order within the time limitation chaser’s files. set forth in § 1305.13, may be endorsed (b) A supplier may fill the order, if to another supplier for filling. The en- possible and if the supplier desires to dorsement must be made only by the do so, and must record on Copies 1 and supplier to whom the DEA Form 222 2 the number of commercial or bulk was first made, must state (in the containers furnished on each item and spaces provided on the reverse sides of the date on which the containers are Copies 1 and 2 of the DEA Form 222) the shipped to the purchaser. If an order name and address of the second sup- cannot be filled in its entirety, it may plier, and must be signed by a person be filled in part and the balance sup- authorized to obtain and execute DEA plied by additional shipments within 60 Forms 222 on behalf of the first sup- days following the date of the DEA plier. The first supplier may not fill Form 222. No DEA Form 222 is valid any part of an order on an endorsed more than 60 days after its execution form. The second supplier may fill the by the purchaser, except as specified in order, if possible and if the supplier de- paragraph (f) of this section. sires to do so, in accordance with (c) The controlled substances must be § 1305.13(b), (c), and (d), including ship- shipped only to the purchaser and the ping all substances directly to the pur- location printed by the Administration chaser. on the DEA Form 222, except as specified in paragraph (f) of this section. (b) Distributions made on endorsed (d) The supplier must retain Copy 1 DEA Forms 222 must be reported by the of the DEA Form 222 for his or her files second supplier in the same manner as and forward Copy 2 to the Special all other distributions except that Agent in Charge of the Drug Enforce- where the name of the supplier is re- ment Administration in the area in quested on the reporting form, the sec- which the supplier is located. Copy 2 ond supplier must record the name, ad- must be forwarded at the close of the dress, and registration number of the month during which the order is filled. first supplier. If an order is filled by partial ship- § 1305.15 Unaccepted and defective ments, Copy 2 must be forwarded at the DEA Forms 222. close of the month during which the final shipment is made or the 60-day (a) A DEA Form 222 must not be validity period expires. filled if either of the following apply: (e) The purchaser must record on (1) The order is not complete, legible, Copy 3 of the DEA Form 222 the num- or properly prepared, executed, or en- ber of commercial or bulk containers dorsed. furnished on each item and the dates (2) The order shows any alteration, on which the containers are received erasure, or change of any description. by the purchaser. (b) If a DEA Form 222 cannot be filled (f) DEA Forms 222 submitted by reg- for any reason under this section, the istered procurement officers of the De- supplier must return Copies 1 and 2 to

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the purchaser with a statement as to Forms 222, the supplier must report the the reason (e.g., illegible or altered). date or approximate date of receipt and (c) A supplier may for any reason the names and addresses of the pur- refuse to accept any order and if a sup- chasers. plier refuses to accept the order, a (d) If an entire book of DEA Forms statement that the order is not accept- 222 is lost or stolen, and the purchaser ed is sufficient for purposes of this is unable to state the serial numbers of paragraph. the DEA Forms 222 in the book, the (d) When a purchaser receives an purchaser must report, in lieu of the unaccepted order, Copies 1 and 2 of the numbers of the forms contained in the DEA Form 222 and the statement must book, the date or approximate date of be attached to Copy 3 and retained in issuance. the files of the purchaser in accordance (e) If any unused DEA Form 222 re- with § 1305.17. A defective DEA Form ported stolen or lost is subsequently 222 may not be corrected; it must be re- recovered or found, the Special Agent placed by a new DEA Form 222 for the in Charge of the Drug Enforcement Ad- order to be filled. ministration in the Divisional Office responsible for the area in which the § 1305.16 Lost and stolen DEA Forms registrant is located must immediately 222. be notified. (a) If a purchaser ascertains that an unfilled DEA Form 222 has been lost, § 1305.17 Preservation of DEA Forms he or she must execute another in trip- 222. licate and attach a statement con- (a) The purchaser must retain Copy 3 taining the serial number and date of of each executed DEA Form 222 and all the lost form, and stating that the copies of unaccepted or defective forms goods covered by the first DEA Form with each statement attached. 222 were not received through loss of (b) The supplier must retain Copy 1 that DEA Form 222. Copy 3 of the sec- of each DEA Form 222 that it has filled. ond form and a copy of the statement (c) DEA Forms 222 must be main- must be retained with Copy 3 of the tained separately from all other DEA Form 222 first executed. A copy of records of the registrant. DEA Forms the statement must be attached to 222 are required to be kept available for Copies 1 and 2 of the second DEA Form inspection for a period of two years. If 222 sent to the supplier. If the first a purchaser has several registered loca- DEA Form 222 is subsequently received tions, the purchaser must retain Copy 3 by the supplier to whom it was di- of the executed DEA Form 222 and any rected, the supplier must mark upon attached statements or other related the face ‘‘Not accepted’’ and return documents (not including unexecuted Copies 1 and 2 to the purchaser, who DEA Forms 222, which may be kept must attach it to Copy 3 and the state- elsewhere under § 1305.12(e)), at the reg- ment. istered location printed on the DEA (b) Whenever any used or unused Form 222. DEA Forms 222 are stolen or lost (other (d) The supplier of carfentanil, than in the course of transmission) by etorphine hydrochloride, and any purchaser or supplier, the pur- diprenorphine must maintain DEA chaser or supplier must immediately Forms 222 for these substances sepa- upon discovery of the theft or loss, re- rately from all other DEA Forms 222 port the theft or loss to the Special and records required to be maintained Agent in Charge of the Drug Enforce- by the registrant. ment Administration in the Divisional Office responsible for the area in which § 1305.18 Return of unused DEA Forms the registrant is located, stating the 222. serial number of each form stolen or If the registration of any purchaser lost. terminates (because the purchaser dies, (c) If the theft or loss includes any ceases legal existence, discontinues original DEA Forms 222 received from business or professional practice, or purchasers and the supplier is unable changes the name or address as shown to state the serial numbers of the DEA on the purchaser’s registration) or is

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suspended or revoked under § 1301.36 of substance product or the National this chapter for all Schedule I and II Drug Code (NDC) number (the NDC controlled substances for which the number may be completed by either purchaser is registered, the purchaser the purchaser or the supplier). must return all unused DEA Forms 222 (8) The quantity in a single package to the nearest office of the Administra- or container. tion. (9) The number of packages or containers of each item ordered. § 1305.19 Cancellation and voiding of (c) An electronic order may include DEA Forms 222. controlled substances that are not in (a) A purchaser may cancel part or schedules I and II and non-controlled all of an order on a DEA Form 222 by substances. notifying the supplier in writing of the cancellation. The supplier must indi- § 1305.22 Procedure for filling elec- cate the cancellation on Copies 1 and 2 tronic orders. of the DEA Form 222 by drawing a line (a) A purchaser must submit the through the canceled items and print- order to a specific supplier. The sup- ing ‘‘canceled’’ in the space provided plier may initially process the order for number of items shipped. (e.g., entry of the order into the com- (b) A supplier may void part or all of puter system, billing functions, inven- an order on a DEA Form 222 by noti- tory identification, etc.) centrally at fying the purchaser in writing of the any location, regardless of the loca- voiding. The supplier must indicate the tion’s registration with DEA. Fol- voiding in the manner prescribed for lowing centralized processing, the sup- cancellation in paragraph (a) of this plier may distribute the order to one or section. more registered locations maintained by the supplier for filling. The reg- Subpart C—Electronic Orders istrant must maintain control of the processing of the order at all times. § 1305.21 Requirements for electronic (b) A supplier may fill the order for a orders. Schedule I or II controlled substance, if (a) To be valid, the purchaser must possible and if the supplier desires to sign an electronic order for a Schedule do so and is authorized to do so under I or II controlled substance with a dig- § 1305.06. ital signature issued to the purchaser, (c) A supplier must do the following or the purchaser’s agent, by DEA as before filling the order: provided in part 1311 of this chapter. (1) Verify the integrity of the signa- (b) The following data fields must be ture and the order by using software included on an electronic order for that complies with Part 1311 of this Schedule I and II controlled sub- chapter to validate the order. stances: (2) Verify that the digital certificate (1) A unique number the purchaser has not expired. assigns to track the order. The number (3) Check the validity of the certifi- must be in the following 9-character cate holder’s certificate by checking format: the last two digits of the year, the Certificate Revocation List. The X, and six characters as selected by the supplier may cache the Certificate purchaser. Revocation List until it expires. (2) The purchaser’s DEA registration (4) Verify the registrant’s eligibility number. to order the controlled substances by (3) The name of the supplier. checking the certificate extension (4) The complete address of the sup- data. plier (may be completed by either the (d) The supplier must retain an elec- purchaser or the supplier). tronic record of every order, and, (5) The supplier’s DEA registration linked to each order, a record of the number (may be completed by either number of commercial or bulk con- the purchaser or the supplier). tainers furnished on each item and the (6) The date the order is signed. date on which the supplier shipped the (7) The name (including strength containers to the purchaser. The linked where appropriate) of the controlled record must also include any data on

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the original order that the supplier (4) Maintains the original order with completes. Software used to handle all linked records on the central com- digitally signed orders must comply puter system. with part 1311 of this chapter. (b) A company that has central proc- (e) If an order cannot be filled in its essing of orders must assign responsi- entirety, a supplier may fill it in part bility for filling parts of orders only to and supply the balance by additional registered locations that the company shipments within 60 days following the owns and operates. date of the order. No order is valid § 1305.25 Unaccepted and defective more than 60 days after its execution electronic orders. by the purchaser, except as specified in paragraph (h) of this section. (a) No electronic order may be filled (f) A supplier must ship the con- if: (1) The required data fields have not trolled substances to the registered lo- been completed. cation associated with the digital cer- (2) The order is not signed using a tificate used to sign the order, except digital certificate issued by DEA. as specified in paragraph (h) of this sec- (3) The digital certificate used had tion. expired or had been revoked prior to (g) When a purchaser receives a ship- signature. ment, the purchaser must create a (4) The purchaser’s public key will record of the quantity of each item re- not validate the digital signature. ceived and the date received. The (5) The validation of the order shows record must be electronically linked to that the order is invalid for any reason. the original order and archived. (b) If an order cannot be filled for any (h) Registered procurement officers reason under this section, the supplier of the Defense Supply Center of the De- must notify the purchaser and provide fense Logistics Agency may order con- a statement as to the reason (e.g., im- trolled substances for delivery to properly prepared or altered). A sup- armed services establishments within plier may, for any reason, refuse to ac- the United States. These orders may be cept any order, and if a supplier refuses shipped to locations other than the to accept the order, a statement that registered location, and in partial ship- the order is not accepted is sufficient ments at different times not to exceed for purposes of this paragraph. six months from the date of the order, (c) When a purchaser receives an as designated by the procurement offi- unaccepted electronic order from the cer when submitting the order. supplier, the purchaser must electronically link the statement of nonaccept- § 1305.23 Endorsing electronic orders. ance to the original order. The original A supplier may not endorse an elec- order and the statement must be re- tronic order to another supplier to fill. tained in accordance with § 1305.27. (d) Neither a purchaser nor a supplier § 1305.24 Central processing of orders. may correct a defective order; the purchaser must issue a new order for the (a) A supplier that has one or more order to be filled. registered locations and maintains a central processing computer system in § 1305.26 Lost electronic orders. which orders are stored may have one (a) If a purchaser determines that an or more of the supplier’s registered lo- unfilled electronic order has been lost cations fill an electronic order if the before or after receipt, the purchaser supplier does the following: must provide, to the supplier, a signed (1) Assigns each item on the order to statement containing the unique a specific registered location for fill- tracking number and date of the lost ing. order and stating that the goods cov- (2) Creates a record linked to the cen- ered by the first order were not re- tral file noting both which items a lo- ceived through loss of that order. cation filled and the location identity. (b) If the purchaser executes an order (3) Ensures that no item is filled by to replace the lost order, the purchaser more than one location. must electronically link an electronic

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record of the second order and a copy 1306.02 Definitions. of the statement with the record of the 1306.03 Persons entitled to issue prescrip- first order and retain them. tions. (c) If the supplier to whom the order 1306.04 Purpose of issue of prescription. 1306.05 Manner of issuance of prescriptions. was directed subsequently receives the 1306.06 Persons entitled to fill prescriptions. first order, the supplier must indicate 1306.07 Administering or dispensing of nar- that it is ‘‘Not Accepted’’ and return it cotic drugs. to the purchaser. The purchaser must 1306.08 Electronic prescriptions. link the returned order to the record of 1306.09 Prescription requirements for online that order and the statement. pharmacies. CONTROLLED SUBSTANCES LISTED IN SCHEDULE § 1305.27 Preservation of electronic or- II ders. 1306.11 Requirement of prescription. (a) A purchaser must, for each order 1306.12 Refilling prescriptions; issuance of filled, retain the original signed order multiple prescriptions. and all linked records for that order for 1306.13 Partial filling of prescriptions. two years. The purchaser must also re- 1306.14 Labeling of substances and filling of tain all copies of each unaccepted or prescriptions. defective order and each linked state- 1306.15 Provision of prescription informa- ment. tion between retail pharmacies and cen- (b) A supplier must retain each origi- tral fill pharmacies for prescriptions of nal order filled and the linked records Schedule II controlled substances. for two years. CONTROLLED SUBSTANCES LISTED IN (c) If electronic order records are SCHEDULES III, IV, AND V maintained on a central server, the 1306.21 Requirement of prescription. records must be readily retrievable at 1306.22 Refilling of prescriptions. the registered location. 1306.23 Partial filling of prescriptions. 1306.24 Labeling of substances and filling of § 1305.28 Canceling and voiding elec- prescriptions. tronic orders. 1306.25 Transfer between pharmacies of pre- (a) A supplier may void all or part of scription information for Schedules III, IV, and V controlled substances for refill an electronic order by notifying the purposes. purchaser of the voiding. If the entire 1306.26 Dispensing without prescription. order is voided, the supplier must make 1306.27 Provision of prescription informa- an electronic copy of the order, indi- tion between retail pharmacies and cen- cate on the copy ‘‘Void,’’ and return it tral fill pharmacies for initial and refill to the purchaser. The supplier is not prescriptions of Schedule III, IV, or V required to retain a record of orders controlled substances. that are not filled. AUTHORITY: 21 U.S.C. 821, 829, 831, 871(b), (b) The purchaser must retain an unless otherwise noted. electronic copy of the voided order. SOURCE: 36 FR 7799, Apr. 24, 1971; 36 FR (c) To partially void an order, the 13386, July 21, 1971, unless otherwise noted. supplier must indicate in the linked Redesignated at 38 FR 26609, Sept. 24, 1973. record that nothing was shipped for each item voided. GENERAL INFORMATION

§ 1305.29 Reporting to DEA. § 1306.01 Scope of part 1306. A supplier must, for each electronic Rules governing the issuance, filling order filled, forward either a copy of and filing of prescriptions pursuant to the electronic order or an electronic section 309 of the Act (21 U.S.C. 829) are report of the order in a format that set forth generally in that section and DEA specifies to DEA within two busi- specifically by the sections of this part. ness days. § 1306.02 Definitions. PART 1306—PRESCRIPTIONS Any term contained in this part shall have the definition set forth in section GENERAL INFORMATION 102 of the Act (21 U.S.C. 802) or part 1300 of this chapter. Sec. 1306.01 Scope of part 1306. [62 FR 13964, Mar. 24, 1997]

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§ 1306.03 Persons entitled to issue pre- for use in maintenance or detoxifica- scriptions. tion treatment and the practitioner is (a) A prescription for a controlled in compliance with requirements in substance may be issued only by an in- § 1301.28 of this chapter. dividual practitioner who is: [36 FR 7799, Apr. 24, 1971. Redesignated at 38 (1) Authorized to prescribe controlled FR 26609, Sept. 24, 1973, and amended at 39 substances by the jurisdiction in which FR 37986, Oct. 25, 1974; 70 FR 36343, June 23, he is licensed to practice his profession 2005] and (2) Either registered or exempted § 1306.05 Manner of issuance of pre- from registration pursuant to scriptions. §§ 1301.22(c) and 1301.23 of this chapter. (a) All prescriptions for controlled (b) A prescription issued by an indi- substances shall be dated as of, and vidual practitioner may be commu- signed on, the day when issued and nicated to a pharmacist by an em- shall bear the full name and address of ployee or agent of the individual prac- the patient, the drug name, strength, titioner. dosage form, quantity prescribed, directions for use, and the name, address [36 FR 7799, Apr. 24, 1971, as amended at 36 FR 18732, Sept. 21, 1971. Redesignated at 38 and registration number of the practi- FR 26609, Sept. 24, 1973, as amended at 62 FR tioner. 13966, Mar. 24, 1997] (b) A prescription for a Schedule III, IV, or V narcotic drug approved by § 1306.04 Purpose of issue of prescrip- FDA specifically for ‘‘detoxification tion. treatment’’ or ‘‘maintenance treat- (a) A prescription for a controlled ment’’ must include the identification substance to be effective must be number issued by the Administrator issued for a legitimate medical purpose under § 1301.28(d) of this chapter or a by an individual practitioner acting in written notice stating that the practi- the usual course of his professional tioner is acting under the good faith practice. The responsibility for the exception of § 1301.28(e) of this chapter. proper prescribing and dispensing of (c) Where a prescription is for controlled substances is upon the pre- gamma-hydroxybutyric acid, the prac- scribing practitioner, but a cor- titioner shall note on the face of the responding responsibility rests with prescription the medical need of the the pharmacist who fills the prescrip- patient for the prescription. tion. An order purporting to be a pre- (d) A practitioner may sign a paper scription issued not in the usual course prescription in the same manner as he of professional treatment or in legiti- would sign a check or legal document mate and authorized research is not a (e.g., J.H. Smith or John H. Smith). prescription within the meaning and Where an oral order is not permitted, intent of section 309 of the Act (21 paper prescriptions shall be written U.S.C. 829) and the person knowingly with ink or indelible pencil, type- filling such a purported prescription, as writer, or printed on a computer print- well as the person issuing it, shall be er and shall be manually signed by the subject to the penalties provided for practitioner. A computer-generated violations of the provisions of law re- prescription that is printed out or lating to controlled substances. faxed by the practitioner must be (b) A prescription may not be issued manually signed. in order for an individual practitioner (e) Electronic prescriptions shall be to obtain controlled substances for sup- created and signed using an application plying the individual practitioner for that meets the requirements of part the purpose of general dispensing to pa- 1311 of this chapter. tients. (f) A prescription may be prepared by (c) A prescription may not be issued the secretary or agent for the signa- for ‘‘detoxification treatment’’ or ture of a practitioner, but the pre- ‘‘maintenance treatment,’’ unless the scribing practitioner is responsible in prescription is for a Schedule III, IV, or case the prescription does not conform V narcotic drug approved by the Food in all essential respects to the law and and Drug Administration specifically regulations. A corresponding liability

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rests upon the pharmacist, including a purpose of maintenance or detoxifica- pharmacist employed by a central fill tion treatment if the practitioner pharmacy, who fills a prescription not meets both of the following conditions: prepared in the form prescribed by (1) The practitioner is separately reg- DEA regulations. istered with DEA as a narcotic treat- (g) An individual practitioner ex- ment program. empted from registration under (2) The practitioner is in compliance § 1301.22(c) of this chapter shall include with DEA regulations regarding treat- on all prescriptions issued by him the ment qualifications, security, records, registration number of the hospital or and unsupervised use of the drugs pur- other institution and the special inter- suant to the Act. nal code number assigned to him by (b) Nothing in this section shall pro- the hospital or other institution as hibit a physician who is not specifi- provided in § 1301.22(c) of this chapter, cally registered to conduct a narcotic in lieu of the registration number of treatment program from administering the practitioner required by this sec- (but not prescribing) narcotic drugs to tion. Each paper prescription shall a person for the purpose of relieving have the name of the practitioner acute withdrawal symptoms when nec- stamped, typed, or handprinted on it, essary while arrangements are being as well as the signature of the practi- made for referral for treatment. Not tioner. more than one day’s medication may (h) An official exempted from reg- be administered to the person or for istration under § 1301.23(a) of this chap- the person’s use at one time. Such ter must include on all prescriptions emergency treatment may be carried issued by him his branch of service or out for not more than three days and agency (e.g., ‘‘U.S. Army’’ or ‘‘Public may not be renewed or extended. Health Service’’) and his service identi- (c) This section is not intended to im- fication number, in lieu of the registra- pose any limitations on a physician or tion number of the practitioner re- authorized hospital staff to administer quired by this section. The service or dispense narcotic drugs in a hospital identification number for a Public to maintain or detoxify a person as an Health Service employee is his Social incidental adjunct to medical or sur- Security identification number. Each gical treatment of conditions other paper prescription shall have the name than addiction, or to administer or dis- of the officer stamped, typed, or pense narcotic drugs to persons with handprinted on it, as well as the signa- intractable pain in which no relief or ture of the officer. cure is possible or none has been found [75 FR 16307, Mar. 31, 2010] after reasonable efforts. (d) A practitioner may administer or § 1306.06 Persons entitled to fill pre- dispense (including prescribe) any scriptions. Schedule III, IV, or V narcotic drug ap- A prescription for a controlled sub- proved by the Food and Drug Adminis- stance may only be filled by a phar- tration specifically for use in mainte- macist, acting in the usual course of nance or detoxification treatment to a his professional practice and either narcotic dependent person if the practi- registered individually or employed in tioner complies with the requirements a registered pharmacy, a registered of § 1301.28 of this chapter. central fill pharmacy, or registered in- [39 FR 37986, Oct. 25, 1974, as amended at 70 stitutional practitioner. FR 36344, June 23, 2005] [68 FR 37410, June 24, 2003, as amended at 70 FR 36343, June 23, 2005] § 1306.08 Electronic prescriptions. (a) An individual practitioner may § 1306.07 Administering or dispensing sign and transmit electronic prescrip- of narcotic drugs. tions for controlled substances pro- (a) A practitioner may administer or vided the practitioner meets all of the dispense directly (but not prescribe) a following requirements: narcotic drug listed in any schedule to (1) The practitioner must comply a narcotic dependant person for the with all other requirements for issuing

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controlled substance prescriptions in CONTROLLED SUBSTANCES LISTED IN this part; SCHEDULE II (2) The practitioner must use an application that meets the requirements § 1306.11 Requirement of prescription. of part 1311 of this chapter; and (a) A pharmacist may dispense di- (3) The practitioner must comply rectly a controlled substance listed in with the requirements for practitioners Schedule II that is a prescription drug in part 1311 of this chapter. as determined under section 503 of the (b) A pharmacy may fill an electroni- Federal Food, Drug, and Cosmetic Act cally transmitted prescription for a (21 U.S.C. 353(b)) only pursuant to a controlled substance provided the phar- written prescription signed by the macy complies with all other require- practitioner, except as provided in ments for filling controlled substance paragraph (d) of this section. A paper prescriptions in this part and with the prescription for a Schedule II con- requirements of part 1311 of this chap- trolled substance may be transmitted ter. by the practitioner or the practi- (c) To annotate an electronic pre- tioner’s agent to a pharmacy via fac- scription, a pharmacist must include simile equipment, provided that the all of the information that this part re- original manually signed prescription quires in the prescription record. is presented to the pharmacist for re- (d) If the content of any of the infor- view prior to the actual dispensing of mation required under § 1306.05 for a the controlled substance, except as controlled substance prescription is al- noted in paragraph (e), (f), or (g) of this tered during the transmission, the pre- section. The original prescription shall scription is deemed to be invalid and be maintained in accordance with the pharmacy may not dispense the § 1304.04(h) of this chapter. controlled substance. (b) An individual practitioner may administer or dispense directly a con- [75 FR 16307, Mar. 31, 2010] trolled substance listed in Schedule II § 1306.09 Prescription requirements in the course of his professional prac- for online pharmacies. tice without a prescription, subject to § 1306.07. (a) No controlled substance that is a (c) An institutional practitioner may prescription drug may be delivered, administer or dispense directly (but distributed, or dispensed by means of not prescribe) a controlled substance the Internet without a valid prescrip- listed in Schedule II only pursuant to a tion. written prescription signed by the pre- (b) In accordance with the Act, it is scribing individual practitioner or to unlawful for any person to knowingly an order for medication made by an in- or intentionally fill a prescription for a dividual practitioner that is dispensed controlled substance that was issued in for immediate administration to the a manner that constitutes dispensing ultimate user. by means of the Internet unless such (d) In the case of an emergency situa- person is a pharmacist who is acting in tion, as defined by the Secretary in the usual course of his professional § 290.10 of this title, a pharmacist may practice and is acting on behalf of a dispense a controlled substance listed pharmacy whose registration has been in Schedule II upon receiving oral au- modified under sections 1301.13 and thorization of a prescribing individual 1301.19 of this chapter to authorize it to practitioner, provided that: operate as an online pharmacy. (1) The quantity prescribed and dis- (c) Any online pharmacy that partici- pensed is limited to the amount ade- pates in the transfer between phar- quate to treat the patient during the macies of prescription information emergency period (dispensing beyond must do so in accordance with the re- the emergency period must be pursuant quirements of §§ 1306.15 and 1306.25 of to a paper or electronic prescription this part. signed by the prescribing individual [74 FR 15624, Apr. 6, 2009] practitioner);

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(2) The prescription shall be imme- pounded for the direct administration diately reduced to writing by the phar- to a patient by parenteral, intra- macist and shall contain all informa- venous, intramuscular, subcutaneous tion required in § 1306.05, except for the or intraspinal infusion may be trans- signature of the prescribing individual mitted by the practitioner or the prac- practitioner; titioner’s agent to the pharmacy by (3) If the prescribing individual prac- facsimile. The facsimile serves as the titioner is not known to the phar- original written prescription for pur- macist, he must make a reasonable ef- poses of this paragraph (e) and it shall fort to determine that the oral author- be maintained in accordance with ization came from a registered indi- § 1304.04(h) of this chapter. vidual practitioner, which may include (f) A prescription prepared in accord- a callback to the prescribing individual ance with § 1306.05 written for Schedule practitioner using his phone number as II substance for a resident of a Long listed in the telephone directory and/or Term Care Facility may be trans- other good faith efforts to insure his mitted by the practitioner or the prac- identity; and titioner’s agent to the dispensing phar- (4) Within 7 days after authorizing an macy by facsimile. The facsimile emergency oral prescription, the pre- serves as the original written prescrip- scribing individual practitioner shall tion for purposes of this paragraph (f) cause a written prescription for the and it shall be maintained in accord- emergency quantity prescribed to be ance with § 1304.04(h). delivered to the dispensing pharmacist. (g) A prescription prepared in accord- In addition to conforming to the re- ance with § 1306.05 written for a Sched- quirements of § 1306.05, the prescription shall have written on its face ‘‘Author- ule II narcotic substance for a patient ization for Emergency Dispensing,’’ enrolled in a hospice care program cer- and the date of the oral order. The tified and/or paid for by Medicare under paper prescription may be delivered to Title XVIII or a hospice program which the pharmacist in person or by mail, is licensed by the state may be trans- but if delivered by mail it must be mitted by the practitioner or the prac- postmarked within the 7-day period. titioner’s agent to the dispensing phar- Upon receipt, the dispensing pharmacy by facsimile. The practitioner or macist must attach this paper prescrip- the practitioner’s agent will note on tion to the oral emergency prescription the prescription that the patient is a that had earlier been reduced to writ- hospice patient. The facsimile serves as ing. For electronic prescriptions, the the original written prescription for pharmacist must annotate the record purposes of this paragraph (g) and it of the electronic prescription with the shall be maintained in accordance with original authorization and date of the § 1304.04(h). oral order. The pharmacist must notify [36 FR 7799, Apr. 24, 1971, as amended at 36 the nearest office of the Administra- FR 18733, Sept. 21, 1971. Redesignated at 38 tion if the prescribing individual prac- FR 26609, Sept. 24, 1973 and amended at 53 FR titioner fails to deliver a written pre- 4964, Feb. 19, 1988; 59 FR 26111, May 19, 1994; scription to him; failure of the phar- 59 FR 30832, June 15, 1994; 62 FR 13964, Mar. macist to do so shall void the author- 24, 1997; 65 FR 45713, July 25, 2000; 68 FR 37410, ity conferred by this paragraph to dis- June 24, 2003; 75 FR 16307, Mar. 31, 2010] pense without a written prescription of a prescribing individual practitioner. § 1306.12 Refilling prescriptions; issuance of multiple prescriptions. (5) Central fill pharmacies shall not be authorized under this paragraph to (a) The refilling of a prescription for prepare prescriptions for a controlled a controlled substance listed in Sched- substance listed in Schedule II upon re- ule II is prohibited. ceiving an oral authorization from a (b)(1) An individual practitioner may retail pharmacist or an individual issue multiple prescriptions author- practitioner. izing the patient to receive a total of (e) A prescription prepared in accord- up to a 90-day supply of a Schedule II ance with § 1306.05 written for a Sched- controlled substance provided the fol- ule II narcotic substance to be com- lowing conditions are met:

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(i) Each separate prescription is portion is not or cannot be filled with- issued for a legitimate medical purpose in the 72-hour period, the pharmacist by an individual practitioner acting in shall notify the prescribing individual the usual course of professional prac- practitioner. No further quantity may tice; be supplied beyond 72 hours without a (ii) The individual practitioner pro- new prescription. vides written instructions on each pre- (b) A prescription for a Schedule II scription (other than the first prescrip- controlled substance written for a pation, if the prescribing practitioner in- tient in a Long Term Care Facility tends for that prescription to be filled (LTCF) or for a patient with a medical immediately) indicating the earliest diagnosis documenting a terminal ill- date on which a pharmacy may fill ness may be filled in partial quantities each prescription; to include individual dosage units. If (iii) The individual practitioner con- there is any question whether a patient cludes that providing the patient with may be classified as having a terminal multiple prescriptions in this manner illness, the pharmacist must contact does not create an undue risk of diver- the practitioner prior to partially fill- sion or abuse; ing the prescription. Both the phar- (iv) The issuance of multiple pre- macist and the prescribing practitioner scriptions as described in this section have a corresponding responsibility to is permissible under the applicable assure that the controlled substance is state laws; and for a terminally ill patient. The phar- (v) The individual practitioner com- macist must record on the prescription plies fully with all other applicable re- whether the patient is ‘‘terminally ill’’ quirements under the Act and these or an ‘‘LTCF patient.’’ A prescription regulations as well as any additional that is partially filled and does not requirements under state law. contain the notation ‘‘terminally ill’’ (2) Nothing in this paragraph (b) or ‘‘LTCF patient’’ shall be deemed to shall be construed as mandating or en- have been filled in violation of the Act. couraging individual practitioners to For each partial filling, the dispensing issue multiple prescriptions or to see pharmacist shall record on the back of their patients only once every 90 days the prescription (or on another appro- when prescribing Schedule II con- priate record, uniformly maintained, trolled substances. Rather, individual and readily retrievable) the date of the practitioners must determine on their partial filling, quantity dispensed, re- own, based on sound medical judgment, maining quantity authorized to be dis- and in accordance with established pensed, and the identification of the medical standards, whether it is appro- dispensing pharmacist. The total quan- priate to issue multiple prescriptions tity of Schedule II controlled sub- and how often to see their patients stances dispensed in all partial fillings when doing so. must not exceed the total quantity pre- [72 FR 64929, Nov. 19, 2007] scribed. Schedule II prescriptions for patients in a LTCF or patients with a § 1306.13 Partial filling of prescrip- medical diagnosis documenting a ter- tions. minal illness shall be valid for a period (a) The partial filling of a prescrip- not to exceed 60 days from the issue tion for a controlled substance listed in date unless sooner terminated by the Schedule II is permissible if the phar- discontinuance of medication. macist is unable to supply the full (c) Information pertaining to current quantity called for in a written or Schedule II prescriptions for patients emergency oral prescription and he in a LTCF or for patients with a med- makes a notation of the quantity sup- ical diagnosis documenting a terminal plied on the face of the written pre- illness may be maintained in a comput- scription, written record of the emer- erized system if this system has the ca- gency oral prescription, or in the elec- pability to permit: tronic prescription record. The remain- (1) Output (display or printout) of the ing portion of the prescription may be original prescription number, date of filled within 72 hours of the first par- issue, identification of prescribing indi- tial filling; however, if the remaining vidual practitioner, identification of

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patient, address of the LTCF or address (2) The controlled substance listed in of the hospital or residence of the pa- Schedule II is not in the possession of tient, identification of medication au- the ultimate user prior to the adminis- thorized (to include dosage, form, tration; strength and quantity), listing of the (3) The institution maintains appro- partial fillings that have been dis- priate safeguards and records regarding pensed under each prescription and the the proper administration, control, dis- information required in § 1306.13(b). pensing, and storage of the controlled (2) Immediate (real time) updating of substance listed in Schedule II; and the prescription record each time a (4) The system employed by the phar- partial filling of the prescription is macist in filling a prescription is ade- conducted. quate to identify the supplier, the (3) Retrieval of partially filled Sched- product, and the patient, and to set ule II prescription information is the forth the directions for use and cau- same as required by § 1306.22(b) (4) and tionary statements, if any, contained (5) for Schedule III and IV prescription in the prescription or required by law. refill information. (d) All written prescriptions and written records of emergency oral pre- (Authority: 21 U.S.C. 801, et seq.) scriptions shall be kept in accordance [36 FR 7799, Apr. 24, 1971. Redesignated at 38 with requirements of § 1304.04(h) of this FR 26609, Sept. 24, 1973, and amended at 45 chapter. FR 54330, July 15, 1980; 56 FR 25027, June 3, (e) Where a prescription that has 1991; 62 FR 13965, Mar. 24, 1997; 75 FR 16308, been prepared in accordance with sec- Mar. 31, 2010] tion 1306.12(b) contains instructions from the prescribing practitioner indi- § 1306.14 Labeling of substances and cating that the prescription shall not filling of prescriptions. be filled until a certain date, no phar- (a) The pharmacist filling a written macist may fill the prescription before or emergency oral prescription for a that date. controlled substance listed in Schedule [36 FR 13368, July 21, 1971, as amended at 37 II shall affix to the package a label FR 15921, Aug. 8, 1972. Redesignated at 38 FR showing date of filling, the pharmacy 26609, Sept. 24, 1973, as amended at 62 FR name and address, the serial number of 13965, Mar. 24, 1997; 68 FR 37410, June 24, 2003; the prescription, the name of the pa- 72 FR 64930, Nov. 19, 2007] tient, the name of the prescribing practitioner, and directions for use and § 1306.15 Provision of prescription information between retail phar- cautionary statements, if any, con- macies and central fill pharmacies tained in such prescription or required for prescriptions of Schedule II con- by law. trolled substances. (b) If the prescription is filled at a Prescription information may be pro- central fill pharmacy, the central fill vided to an authorized central fill phar- pharmacy shall affix to the package a macy by a retail pharmacy for dis- label showing the retail pharmacy pensing purposes. The following re- name and address and a unique identi- quirements shall also apply: fier, (i.e. the central fill pharmacy’s (a) Prescriptions for controlled sub- DEA registration number) indicating stances listed in Schedule II may be that the prescription was filled at the transmitted electronically from a re- central fill pharmacy, in addition to tail pharmacy to a central fill phar- the information required under para- macy including via facsimile. The re- graph (a) of this section. tail pharmacy transmitting the pre- (c) The requirements of paragraph (a) scription information must: of this section do not apply when a (1) Write the words ‘‘CENTRAL controlled substance listed in Schedule FILL’’ on the face of the original paper II is prescribed for administration to prescription and record the name, ad- an ultimate user who is institutional- dress, and DEA registration number of ized: Provided, That: the central fill pharmacy to which the (1) Not more than 7-day supply of the prescription has been transmitted, the controlled substance listed in Schedule name of the retail pharmacy phar- II is dispensed at one time; macist transmitting the prescription,

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and the date of transmittal. For elec- signed by a practitioner, a facsimile of tronic prescriptions the name, address, a signed paper prescription transmitted and DEA registration number of the by the practitioner or the practi- central fill pharmacy to which the pre- tioner’s agent to the pharmacy, an scription has been transmitted, the electronic prescription that meets the name of the retail pharmacy phar- requirements of this part and part 1311 macist transmitting the prescription, of this chapter, or an oral prescription and the date of transmittal must be made by an individual practitioner and added to the electronic prescription promptly reduced to writing by the record. pharmacist containing all information (2) Ensure that all information re- required in § 1306.05, except for the sig- quired to be on a prescription pursuant nature of the practitioner. to Section 1306.05 of this part is trans- (b) An individual practitioner may mitted to the central fill pharmacy (ei- administer or dispense directly a con- ther on the face of the prescription or trolled substance listed in Schedule III, in the electronic transmission of infor- IV, or V in the course of his/her profes- mation); sional practice without a prescription, (3) Maintain the original prescription subject to § 1306.07. for a period of two years from the date (c) An institutional practitioner may the prescription was filled; administer or dispense directly (but (4) Keep a record of receipt of the not prescribe) a controlled substance filled prescription, including the date listed in Schedule III, IV, or V only of receipt, the method of delivery (pri- pursuant to a paper prescription signed vate, common or contract carrier) and by an individual practitioner, a fac- the name of the retail pharmacy em- simile of a paper prescription or order ployee accepting delivery. for medication transmitted by the (b) The central fill pharmacy receiv- practitioner or the practitioner’s agent ing the transmitted prescription must: to the institutional practitioner-phar- (1) Keep a copy of the prescription (if macist, an electronic prescription that sent via facsimile) or an electronic meets the requirements of this part record of all the information trans- and part 1311 of this chapter, or an oral mitted by the retail pharmacy, includ- prescription made by an individual ing the name, address, and DEA reg- practitioner and promptly reduced to istration number of the retail phar- writing by the pharmacist (containing macy transmitting the prescription; all information required in § 1306.05 ex- (2) Keep a record of the date of re- cept for the signature of the individual ceipt of the transmitted prescription, practitioner), or pursuant to an order the name of the pharmacist filling the for medication made by an individual prescription, and the date of filling of practitioner that is dispensed for im- the prescription; mediate administration to the ulti- (3) Keep a record of the date the filled mate user, subject to § 1306.07. prescription was delivered to the retail pharmacy and the method of delivery [62 FR 13965, Mar. 24, 1997, as amended at 75 (i.e. private, common or contract car- FR 16308, Mar. 31, 2010] rier). § 1306.22 Refilling of prescriptions. [68 FR 37410, June 24, 2003, as amended at 75 FR 16308, Mar. 31, 2010] (a) No prescription for a controlled substance listed in Schedule III or IV CONTROLLED SUBSTANCES LISTED IN shall be filled or refilled more than six SCHEDULES III, IV, AND V months after the date on which such prescription was issued. No prescrip- § 1306.21 Requirement of prescription. tion for a controlled substance listed in (a) A pharmacist may dispense di- Schedule III or IV authorized to be re- rectly a controlled substance listed in filled may be refilled more than five Schedule III, IV, or V that is a pre- times. scription drug as determined under sec- (b) Each refilling of a prescription tion 503(b) of the Federal Food, Drug, shall be entered on the back of the pre- and Cosmetic Act (21 U.S.C. 353(b)) only scription or on another appropriate pursuant to either a paper prescription document or electronic prescription

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record. If entered on another docu- and retrieval of refill information for ment, such as a medication record, or original paper prescription orders for electronic prescription record, the doc- controlled substances in Schedule III ument or record must be uniformly and IV, subject to the following condi- maintained and readily retrievable. tions: (c) The following information must (1) Any such proposed computerized be retrievable by the prescription num- application must provide online re- ber: trieval (via computer monitor or hard- (1) The name and dosage form of the copy printout) of original prescription controlled substance. order information for those prescrip- (2) The date filled or refilled. tion orders that are currently author- (3) The quantity dispensed. ized for refilling. This shall include, (4) The initials of the dispensing but is not limited to, data such as the pharmacist for each refill. original prescription number; date of (5) The total number of refills for issuance of the original prescription that prescription. order by the practitioner; full name (d) If the pharmacist merely initials and address of the patient; name, ad- and dates the back of the prescription dress, and DEA registration number of or annotates the electronic prescrip- the practitioner; and the name, tion record, it shall be deemed that the strength, dosage form, quantity of the full face amount of the prescription has controlled substance prescribed (and been dispensed. quantity dispensed if different from the (e) The prescribing practitioner may quantity prescribed), and the total authorize additional refills of Schedule number of refills authorized by the pre- III or IV controlled substances on the scribing practitioner. original prescription through an oral (2) Any such proposed computerized refill authorization transmitted to the application must also provide online pharmacist provided the following con- retrieval (via computer monitor or ditions are met: hard-copy printout) of the current re- (1) The total quantity authorized, in- fill history for Schedule III or IV con- cluding the amount of the original pre- trolled substance prescription orders scription, does not exceed five refills (those authorized for refill during the nor extend beyond six months from the past six months). This refill history date of issue of the original prescrip- shall include, but is not limited to, the tion. name of the controlled substance, the (2) The pharmacist obtaining the oral date of refill, the quantity dispensed, authorization records on the reverse of the identification code, or name or ini- the original paper prescription or anno- tials of the dispensing pharmacist for tates the electronic prescription record each refill and the total number of re- with the date, quantity of refill, num- fills dispensed to date for that prescrip- ber of additional refills authorized, and tion order. initials the paper prescription or anno- (3) Documentation of the fact that tates the electronic prescription record the refill information entered into the showing who received the authoriza- computer each time a pharmacist re- tion from the prescribing practitioner fills an original paper, fax, or oral pre- who issued the original prescription. scription order for a Schedule III or IV (3) The quantity of each additional controlled substance is correct must be refill authorized is equal to or less than provided by the individual pharmacist the quantity authorized for the initial who makes use of such an application. filling of the original prescription. If such an application provides a hard- (4) The prescribing practitioner must copy printout of each day’s controlled execute a new and separate prescrip- substance prescription order refill tion for any additional quantities be- data, that printout shall be verified, yond the five-refill, six-month limita- dated, and signed by the individual tion. pharmacist who refilled such a pre- (f) As an alternative to the proce- scription order. The individual phar- dures provided by paragraphs (a) macist must verify that the data indi- through (e) of this section, a computer cated are correct and then sign this application may be used for the storage document in the same manner as he

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would sign a check or legal document (5) In the event that a pharmacy (e.g., J.H. Smith, or John H. Smith). which employs such a computerized ap- This document shall be maintained in a plication experiences system down- separate file at that pharmacy for a pe- time, the pharmacy must have an aux- riod of two years from the dispensing iliary procedure which will be used for date. This printout of the day’s con- documentation of refills of Schedule III trolled substance prescription order re- and IV controlled substance prescrip- fill data must be provided to each phar- tion orders. This auxiliary procedure macy using such a computerized appli- must ensure that refills are authorized cation within 72 hours of the date on by the original prescription order, that which the refill was dispensed. It must the maximum number of refills has not be verified and signed by each phar- been exceeded, and that all of the ap- macist who is involved with such dis- propriate data are retained for online pensing. In lieu of such a printout, the data entry as soon as the computer sys- pharmacy shall maintain a bound log tem is available for use again. book, or separate file, in which each in- (g) When filing refill information for dividual pharmacist involved in such original paper, fax, or oral prescription dispensing shall sign a statement (in orders for Schedule III or IV controlled the manner previously described) each substances, a pharmacy may use only day, attesting to the fact that the refill one of the two applications described in information entered into the computer paragraphs (a) through (e) or (f) of this that day has been reviewed by him and section. is correct as shown. Such a book or file (h) When filing refill information for must be maintained at the pharmacy electronic prescriptions, a pharmacy employing such an application for a pe- must use an application that meets the riod of two years after the date of dis- requirements of part 1311 of this chap- pensing the appropriately authorized ter. refill. (4) Any such computerized applica- [75 FR 16308, Mar. 31, 2010] tion shall have the capability of producing a printout of any refill data § 1306.23 Partial filling of prescrip- that the user pharmacy is responsible tions. for maintaining under the Act and its The partial filling of a prescription implementing regulations. For exam- for a controlled substance listed in ple, this would include a refill-by-refill Schedule III, IV, or V is permissible, audit trail for any specified strength provided that: and dosage form of any controlled sub- (a) Each partial filling is recorded in stance (by either brand or generic the same manner as a refilling, name or both). Such a printout must (b) The total quantity dispensed in include name of the prescribing practi- all partial fillings does not exceed the tioner, name and address of the pa- total quantity prescribed, and tient, quantity dispensed on each refill, (c) No dispensing occurs after 6 date of dispensing for each refill, name months after the date on which the or identification code of the dispensing prescription was issued. pharmacist, and the number of the original prescription order. In any [36 FR 18733, Sept. 21, 1971. Redesignated at computerized application employed by 38 FR 26609, Sept. 24, 1973, and amended at 51 a user pharmacy the central record- FR 5320, Feb. 13, 1986; 62 FR 13965, Mar. 24, keeping location must be capable of 1997] sending the printout to the pharmacy within 48 hours, and if a DEA Special § 1306.24 Labeling of substances and filing of prescriptions. Agent or Diversion Investigator requests a copy of such printout from the (a) The pharmacist filling a prescrip- user pharmacy, it must, if requested to tion for a controlled substance listed in do so by the Agent or Investigator, Schedule III, IV, or V shall affix to the verify the printout transmittal capa- package a label showing the pharmacy bility of its application by documenta- name and address, the serial number tion (e.g., postmark). and date of initial filling, the name of

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the patient, the name of the practi- one-time basis only. However, phar- tioner issuing the prescription, and di- macies electronically sharing a real- rections for use and cautionary state- time, online database may transfer up ments, if any, contained in such pre- to the maximum refills permitted by scription as required by law. law and the prescriber’s authorization. (b) If the prescription is filled at a (b) Transfers are subject to the fol- central fill pharmacy, the central fill lowing requirements: pharmacy shall affix to the package a (1) The transfer must be commu- label showing the retail pharmacy nicated directly between two licensed name and address and a unique identi- pharmacists. fier, (i.e. the central fill pharmacy’s (2) The transferring pharmacist must DEA registration number) indicating do the following: that the prescription was filled at the (i) Write the word ‘‘VOID’’ on the central fill pharmacy, in addition to face of the invalidated prescription; for the information required under para- electronic prescriptions, information graph (a) of this section. that the prescription has been trans- (c) The requirements of paragraph (a) ferred must be added to the prescrip- of this section do not apply when a tion record. controlled substance listed in Schedule (ii) Record on the reverse of the in- III, IV, or V is prescribed for adminis- validated prescription the name, ad- tration to an ultimate user who is in- dress, and DEA registration number of stitutionalized: Provided, That: the pharmacy to which it was trans- (1) Not more than a 34-day supply or ferred and the name of the pharmacist 100 dosage units, whichever is less, of receiving the prescription information; the controlled substance listed in for electronic prescriptions, such infor- Schedule III, IV, or V is dispensed at mation must be added to the prescrip- one time; tion record. (2) The controlled substance listed in (iii) Record the date of the transfer Schedule III, IV, or V is not in the pos- and the name of the pharmacist trans- session of the ultimate user prior to ferring the information. administration; (3) The institution maintains appro- (3) For paper prescriptions and pre- priate safeguards and records the prop- scriptions received orally and reduced er administration, control, dispensing, to writing by the pharmacist pursuant and storage of the controlled substance to § 1306.21(a), the pharmacist receiving listed in Schedule III, IV, or V; and the transferred prescription informa- (4) The system employed by the phar- tion must write the word ‘‘transfer’’ on macist in filling a prescription is ade- the face of the transferred prescription quate to identify the supplier, the and reduce to writing all information product and the patient, and to set required to be on a prescription pursu- forth the directions for use and cau- ant to § 1306.05 and include: tionary statements, if any, contained (i) Date of issuance of original pre- in the prescription or required by law. scription. (d) All prescriptions for controlled (ii) Original number of refills author- substances listed in Schedules III, IV, ized on original prescription. and V shall be kept in accordance with (iii) Date of original dispensing. § 1304.04(h) of this chapter. (iv) Number of valid refills remaining and date(s) and locations of previous [62 FR 13965, Mar. 24, 1997, as amended at 68 refill(s). FR 37411, June 24, 2003] (v) Pharmacy’s name, address, DEA § 1306.25 Transfer between pharmacies registration number, and prescription of prescription information for number from which the prescription in- Schedules III, IV, and V controlled formation was transferred. substances for refill purposes. (vi) Name of pharmacist who trans- (a) The transfer of original prescrip- ferred the prescription. tion information for a controlled sub- (vii) Pharmacy’s name, address, DEA stance listed in Schedule III, IV, or V registration number, and prescription for the purpose of refill dispensing is number from which the prescription permissible between pharmacies on a was originally filled.

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(4) For electronic prescriptions being (a) Such dispensing is made only by a transferred electronically, the trans- pharmacist (as defined in part 1300 of ferring pharmacist must provide the this chapter), and not by a nonphar- receiving pharmacist with the fol- macist employee even if under the su- lowing information in addition to the pervision of a pharmacist (although original electronic prescription data: after the pharmacist has fulfilled his (i) The date of the original dis- professional and legal responsibilities pensing. set forth in this section, the actual (ii) The number of refills remaining cash, credit transaction, or delivery, and the date(s) and locations of pre- may be completed by a nonphar- vious refills. macist); (iii) The transferring pharmacy’s (b) Not more than 240 cc. (8 ounces) of name, address, DEA registration num- any such controlled substance con- ber, and prescription number for each taining opium, nor more than 120 cc. (4 dispensing. ounces) of any other such controlled (iv) The name of the pharmacist substance nor more than 48 dosage transferring the prescription. units of any such controlled substance (v) The name, address, DEA registra- containing opium, nor more than 24 tion number, and prescription number dosage units of any other such con- from the pharmacy that originally trolled substance may be dispensed at filled the prescription, if different. retail to the same purchaser in any (5) The pharmacist receiving a trans- given 48-hour period; ferred electronic prescription must cre- (c) The purchaser is at least 18 years ate an electronic record for the pre- of age; scription that includes the receiving (d) The pharmacist requires every pharmacist’s name and all of the infor- purchaser of a controlled substance mation transferred with the prescrip- under this section not known to him to tion under paragraph (b)(4) of this sec- furnish suitable identification (includ- tion. ing proof of age where appropriate); (c) The original and transferred pre- (e) A bound record book for dis- scription(s) must be maintained for a pensing of controlled substances under period of two years from the date of this section is maintained by the phar- last refill. macist, which book shall contain the (d) Pharmacies electronically access- name and address of the purchaser, the ing the same prescription record must name and quantity of controlled sub- satisfy all information requirements of stance purchased, the date of each pur- a manual mode for prescription trans- chase, and the name or initials of the feral. pharmacist who dispensed the substance to the purchaser (the book shall (e) The procedure allowing the trans- be maintained in accordance with the fer of prescription information for re- recordkeeping requirement of § 1304.04 fill purposes is permissible only if al- of this chapter); and lowable under existing State or other (f) A prescription is not required for applicable law. distribution or dispensing of the sub- [75 FR 16309, Mar. 31, 2010] stance pursuant to any other Federal, State or local law. § 1306.26 Dispensing without prescrip- (g) Central fill pharmacies may not tion. dispense controlled substances to a A controlled substance listed in purchaser at retail pursuant to this Schedules II, III, IV, or V which is not section. a prescription drug as determined [36 FR 7799, Apr. 24, 1971, as amended at 36 under the Federal Food, Drug, and Cos- FR 18733, Sept. 21, 1971. Redesignated at 38 metic Act, may be dispensed by a phar- FR 26609, Sept. 24, 1973, and further macist without a prescription to a pur- redesigated and amended at 62 FR 13966, Mar. chaser at retail, provided that: 24, 1997; 68 FR 37411, June 24, 2003]

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§ 1306.27 Provision of prescription in- filling the prescription, and dates of formation between retail phar- filling or refilling of the prescription; macies and central fill pharmacies (3) Keep a record of the date the filled for initial and refill prescriptions of prescription was delivered to the retail Schedule III, IV, or V controlled pharmacy and the method of delivery substances. (i.e. private, common or contract car- Prescription information may be pro- rier). vided to an authorized central fill pharmacy by a retail pharmacy for dis- [68 FR 37411, June 24, 2003] pensing purposes. The following requirements shall also apply: PART 1307—MISCELLANEOUS (a) Prescriptions for controlled substances listed in Schedule III, IV or V GENERAL INFORMATION may be transmitted electronically Sec. from a retail pharmacy to a central fill 1307.01 Definitions. pharmacy including via facsimile. The 1307.02 Application of State law and other retail pharmacy transmitting the pre- Federal law. scription information must: 1307.03 Exceptions to regulations. (1) Write the word ‘‘CENTRAL FILL’’ SPECIAL EXCEPTIONS FOR MANUFACTURE AND on the face of the original prescription DISTRIBUTION OF CONTROLLED SUBSTANCES and record the name, address, and DEA registration number of the central fill 1307.11 Distribution by dispenser to another practitioner or reverse distributor. pharmacy to which the prescription 1307.12 Distribution to supplier or manufac- has been transmitted and the name of turer. the retail pharmacy pharmacist trans- 1307.13 Incidental manufacture of controlled mitting the prescription, and the date substances. of transmittal; DISPOSAL OF CONTROLLED SUBSTANCES (2) Ensure that all information required to be on a prescription pursuant 1307.21 Procedure for disposing of controlled to § 1306.05 of this part is transmitted substances. to the central fill pharmacy (either on 1307.22 Disposal of controlled substances by the Administration. the face of the prescription or in the electronic transmission of informa- SPECIAL EXEMPT PERSONS tion); 1307.31 Native American Church. (3) Indicate in the information transmitted the number of refills already AUTHORITY: 21 U.S.C. 821, 822(d), 871(b), un- dispensed and the number of refills re- less otherwise noted. maining; SOURCE: 36 FR 7801, Apr. 24, 1971, unless (4) Maintain the original prescription otherwise noted. Redesignated at 38 FR 26609, for a period of two years from the date Sept. 24, 1973. the prescription was last refilled; GENERAL INFORMATION (5) Keep a record of receipt of the filled prescription, including the date § 1307.01 Definitions. of receipt, the method of delivery (private, common or contract carrier) and Any term contained in this part shall the name of the retail pharmacy em- have the definition set forth in section ployee accepting delivery. 102 of the Act (21 U.S.C. 802) or part (b) The central fill pharmacy receiv- 1300 of this chapter. ing the transmitted prescription must: [62 FR 13966, Mar. 24, 1997] (1) Keep a copy of the prescription (if sent via facsimile) or an electronic § 1307.02 Application of State law and record of all the information trans- other Federal law. mitted by the retail pharmacy, includ- Nothing in this chapter shall be con- ing the name, address, and DEA reg- strued as authorizing or permitting istration number of the retail phar- any person to do any act which such macy transmitting the prescription; person is not authorized or permitted (2) Keep a record of the date of re- to do under other Federal laws or obli- ceipt of the transmitted prescription, gations under international treaties, the name of the licensed pharmacist conventions or protocols, or under the

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law of the State in which he/she desires ing each calendar year in which the to do such act nor shall compliance practitioner is registered to dispense with such parts be construed as compli- does not exceed 5 percent of the total ance with other Federal or State laws number of dosage units of all con- unless expressly provided in such other trolled substances distributed and dis- laws. pensed by the practitioner during the same calendar year. [62 FR 13966, Mar. 24, 1997] (2) A reverse distributor who is reg- § 1307.03 Exceptions to regulations. istered to receive such controlled substances. Any person may apply for an excep- (b) If, during any calendar year in tion to the application of any provision which the practitioner is registered to of this chapter by filing a written re- dispense, the practitioner has reason to quest with the Office of Diversion Con- believe that the total number of dosage trol, Drug Enforcement Administra- units of all controlled substances tion, stating the reasons for such ex- which will be distributed by him pursu- ception. See the Table of DEA Mailing ant to paragraph (a)(1) of this section Addresses in § 1321.01 of this chapter for and § 1301.25 of this chapter will exceed the current mailing address. The Ad- 5 percent of this total number of dos- ministrator may grant an exception in age units of all controlled substances his discretion, but in no case shall he/ distributed and dispensed by him dur- she be required to grant an exception ing that calendar year, the practitioner to any person which is otherwise re- shall obtain a registration to distribute quired by law or the regulations cited controlled substances. in this section. (c) The distributions that a reg- [75 FR 10678, Mar. 9, 2010] istered retail pharmacy makes to automated dispensing systems at long term SPECIAL EXCEPTIONS FOR MANUFACTURE care facilities for which the retail AND DISTRIBUTION OF CONTROLLED pharmacy also holds registrations do SUBSTANCES not count toward the 5 percent limit in paragraphs (a)(1)(iv) and (b) of this sec- § 1307.11 Distribution by dispenser to another practitioner or reverse dis- tion. tributor. [68 FR 41229, July 11, 2003, as amended at 70 (a) A practitioner who is registered FR 25466, May 13, 2005] to dispense a controlled substance may distribute (without being registered to § 1307.12 Distribution to supplier or manufacturer. distribute) a quantity of such substance to— (a) Any person lawfully in possession (1) Another practitioner for the pur- of a controlled substance listed in any pose of general dispensing by the prac- schedule may distribute (without being titioner to patients, provided that— registered to distribute) that substance (i) The practitioner to whom the con- to the person from whom he/she ob- trolled substance is to be distributed is tained it or to the manufacturer of the registered under the Act to dispense substance, or, if designated, to the that controlled substance; manufacturer’s registered agent for ac- (ii) The distribution is recorded by cepting returns, provided that a writ- the distributing practitioner in accord- ten record is maintained which indi- ance with § 1304.22(c) of this chapter cates the date of the transaction, the and by the receiving practitioner in ac- name, form and quantity of the sub- cordance with § 1304.22(c) of this chap- stance, the name, address, and reg- ter; istration number, if any, of the person (iii) If the substance is listed in making the distribution, and the name, Schedule I or II, an order form is used address, and registration number, if as required in part 1305 of this chapter; known, of the supplier or manufac- and turer. In the case of returning a con- (iv) The total number of dosage units trolled substance in Schedule I or II, an of all controlled substances distributed order form shall be used in the manner by the practitioner pursuant to this prescribed in part 1305 of this chapter section and § 1301.25 of this chapter dur- and be maintained as the written

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record of the transaction. Any person (1) If the person is a registrant, he/ not required to register pursuant to she shall list the controlled substance sections 302(c) or 1007(b)(1) of the Act or substances which he/she desires to (21 U.S.C. 822(c) or 957(b)(1)) shall be ex- dispose of on DEA Form 41, and submit empt from maintaining the records re- three copies of that form to the Special quired by this section. Agent in Charge in his/her area; or (b) Distributions referred to in para- (2) If the person is not a registrant, graph (a) may be made through a he/she shall submit to the Special freight forwarding facility operated by Agent in Charge a letter stating: the person to whom the controlled sub- (i) The name and address of the per- stance is being returned provided that son; prior arrangement has been made for (ii) The name and quantity of each the return and the person making the controlled substance to be disposed of; distribution delivers the controlled (iii) How the applicant obtained the substance directly to an agent or em- substance, if known; and ployee of the person to whom the con- (iv) The name, address, and registra- trolled substance is being returned. tion number, if known, of the person [65 FR 44679, July 19, 2000; 65 FR 45829, July who possessed the controlled sub- 25, 2000, as amended at 68 FR 41229, July 11, stances prior to the applicant, if 2003] known. (b) The Special Agent in Charge shall § 1307.13 Incidental manufacture of authorize and instruct the applicant to controlled substances. dispose of the controlled substance in Any registered manufacturer who, in- one of the following manners: cidentally but necessarily, manufac- (1) By transfer to person registered tures a controlled substance as a result under the Act and authorized to pos- of the manufacture of a controlled sub- sess the substance; stance or basic class of controlled sub- (2) By delivery to an agent of the Ad- stance for which he is registered and ministration or to the nearest office of has been issued an individual manufac- the Administration; turing quota pursuant to part 1303 of (3) By destruction in the presence of this chapter (if such substance or class an agent of the Administration or is listed in Schedule I or II) shall be ex- other authorized person; or empt from the requirement of registra- (4) By such other means as the Spe- tion pursuant to part 1301 of this chap- cial Agent in Charge may determine to ter and, if such incidentally manufac- assure that the substance does not be- tured substance is listed in Schedule I come available to unauthorized per- or II, shall be exempt from the require- sons. ment of an individual manufacturing (c) In the event that a registrant is quota pursuant to part 1303 of this required regularly to dispose of con- chapter, if such substances are disposed trolled substances, the Special Agent of in accordance with § 1307.21. in Charge may authorize the registrant to dispose of such substances, in ac- [36 FR 7801, Apr. 24, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973, and further redesig- cordance with paragraph (b) of this sec- nated at 62 FR 13967, Mar. 24, 1997] tion, without prior approval of the Ad- ministration in each instance, on the DISPOSAL OF CONTROLLED SUBSTANCES condition that the registrant keep records of such disposals and file peri- § 1307.21 Procedure for disposing of odic reports with the Special Agent in controlled substances. Charge summarizing the disposals (a) Any person in possession of any made by the registrant. In granting controlled substance and desiring or re- such authority, the Special Agent in quired to dispose of such substance Charge may place such conditions as he may request assistance from the Spe- deems proper on the disposal of con- cial Agent in Charge of the Adminis- trolled substances, including the meth- tration in the area in which the person od of disposal and the frequency and is located for authority and instruc- detail of reports. tions to dispose of such substance. The (d) This section shall not be con- request should be made as follows: strued as affecting or altering in any

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way the disposal of controlled sub- 1308.02 Definitions. stances through procedures provided in 1308.03 Administration Controlled Sub- laws and regulations adopted by any stances Code Number. State. SCHEDULES [36 FR 7801, Apr. 24, 1971, as amended at 37 1308.11 Schedule I. FR 15922, Aug. 8, 1972. Redesignated at 38 FR 1308.12 Schedule II. 26609, Sept. 24, 1973, and amended at 47 FR 1308.13 Schedule III. 41735, Sept. 22, 1982; 62 FR 13967, Mar. 24, 1997] 1308.14 Schedule IV. 1308.15 Schedule V. § 1307.22 Disposal of controlled substances by the Administration. EXCLUDED NONNARCOTIC SUBSTANCES Any controlled substance delivered 1308.21 Application for exclusion of a non- to the Administration under § 1307.21 or narcotic substance. forfeited pursuant to section 511 of the 1308.22 Excluded substances. Act (21 U.S.C. 881) may be delivered to any department, bureau, or other agen- EXEMPT CHEMICAL PREPARATIONS cy of the United States or of any State 1308.23 Exemption of certain chemical prep- upon proper application addressed to arations; application. the Office of Diversion Control, Drug 1308.24 Exemption chemical preparations. Enforcement Administration. See the EXCLUDED VETERINARY ANABOLIC STEROID Table of DEA Mailing Addresses in IMPLANT PRODUCTS § 1321.01 of this chapter for the current mailing address. The application shall 1308.25 Exclusion of a veterinary anabolic show the name, address, and official steroid implant product; application. 1308.26 Excluded veterinary anabolic steroid title of the person or agency to whom implant products. the controlled drugs are to be delivered, including the name and quantity EXEMPTED PRESCRIPTION PRODUCTS of the substances desired and the pur- 1308.31 Application for exemption of a non- pose for which intended. The delivery narcotic prescription product. of such controlled drugs shall be or- 1308.32 Exempted prescription products. dered by the Administrator, if, in his opinion, there exists a medical or sci- EXEMPT ANABOLIC STEROID PRODUCTS entific need therefor. 1308.33 Exemption of certain anabolic steroid products; application. [75 FR 10678, Mar. 9, 2010] 1308.34 Exempt anabolic steroid products.

SPECIAL EXEMPT PERSONS EXEMPT CANNABIS PLANT MATERIAL, AND PRODUCTS MADE THEREFROM, THAT CONTAIN § 1307.31 Native American Church. TETRAHYDROCANNABINOLS The listing of peyote as a controlled 1308.35 Exemption of certain cannabis plant substance in Schedule I does not apply material, and products made therefrom, to the nondrug use of peyote in bona that contain tetrahydrocannabinols. fide religious ceremonies of the Native American Church, and members of the HEARINGS Native American Church so using pe- 1308.41 Hearings generally. yote are exempt from registration. Any 1308.42 Purpose of hearing. person who manufactures peyote for or 1308.43 Initiation of proceedings for rule- distributes peyote to the Native Amer- making. ican Church, however, is required to 1308.44 Request for hearing or appearance; obtain registration annually and to waiver. 1308.45 Final order. comply with all other requirements of 1308.46 Control required under international law. treaty. 1308.47 Control of immediate precursors. PART 1308—SCHEDULES OF 1308.49 Emergency scheduling. CONTROLLED SUBSTANCES AUTHORITY: 21 U.S.C. 811, 812, 871(b), unless otherwise noted. GENERAL INFORMATION SOURCE: 38 FR 8254, Mar. 30, 1973, unless Sec. otherwise noted. Redesignated at 38 FR 26609, 1308.01 Scope of part 1308. Sept. 24, 1973.

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GENERAL INFORMATION tration Controlled Substances Code Number for any purpose. § 1308.01 Scope of part 1308. [38 FR 8254, Mar. 30, 1973. Redesignated at 38 Schedules of controlled substances FR 26609, Sept. 24, 1973 and amended at 51 FR established by section 202 of the Act (21 15318, Apr. 23, 1986; 62 FR 13968, Mar. 24, 1997] U.S.C. 812), as they are changed, up- SCHEDULES dated, and republished from time to time, are set forth in this part. § 1308.11 Schedule I. § 1308.02 Definitions. (a) Schedule I shall consist of the drugs and other substances, by what- Any term contained in this part shall ever official name, common or usual have the definition set forth in section name, chemical name, or brand name 102 of the Act (21 U.S.C. 802) or part designated, listed in this section. Each 1300 of this chapter. drug or substance has been assigned [62 FR 13967, Mar. 24, 1997] the DEA Controlled Substances Code Number set forth opposite it. § 1308.03 Administration Controlled (b) Opiates. Unless specifically ex- Substances Code Number. cepted or unless listed in another schedule, any of the following opiates, (a) Each controlled substance, or including their isomers, esters, ethers, basic class thereof, has been assigned salts, and salts of isomers, esters and an ‘‘Administration Controlled Sub- ethers, whenever the existence of such stances Code Number’’ for purposes of isomers, esters, ethers and salts is pos- identification of the substances or sible within the specific chemical des- class on certain Certificates of Reg- ignation (for purposes of paragraph istration issued by the Administration (b)(34) only, the term isomer includes pursuant to §§ 1301.35 of this chapter the optical and geometric isomers): and on certain order forms issued by (1) Acetyl-alpha-methylfentanyl (N-[1-(1-methyl- the Administration pursuant to 2-phenethyl)-4-piperidinyl]-N- phenylacetamide) ...... 9815 § 1305.05(d) of this chapter. Applicants (2) Acetylmethadol ...... 9601 for procurement and/or individual man- (3) Allylprodine ...... 9602 ufacturing quotas must include the ap- (4) Alphacetylmethadol (except levo- alphacetylmethadol also known as levo- propriate code number on the applica- alpha-acetylmethadol, levomethadyl acetate, tion as required in §§ 1303.12(b) and or LAAM) ...... 9603 1303.22(a) of this chapter. Applicants (5) Alphameprodine ...... 9604 (6) Alphamethadol ...... 9605 for import and export permits must in- (7) Alpha-methylfentanyl (N-[1-(alpha-methyl- clude the appropriate code number on beta-phenyl)ethyl-4-piperidyl] propionanilide; 1-(1-methyl-2-phenylethyl)-4-(N-propanilido) the application as required in piperidine) ...... 9814 §§ 1312.12(a) and 1312.22(a) of this chap- (8) Alpha-methylthiofentanyl (N-[1-methyl-2-(2- ter. Authorized registrants who desire thienyl)ethyl-4-piperidinyl]-N- phenylpropanamide) ...... 9832 to import or export a controlled sub- (9) Benzethidine ...... 9606 stance for which an import or export (10) Betacetylmethadol ...... 9607 permit is not required must include the (11) Beta-hydroxyfentanyl (N-[1-(2-hydroxy-2- phenethyl)-4-piperidinyl]-N- appropriate Administration Controlled phenylpropanamide) ...... 9830 Substances Code Number beneath or (12) Beta-hydroxy-3-methylfentanyl (other beside the name of each controlled sub- name: N-[1-(2-hydroxy-2-phenethyl)-3-methyl-4-piperidinyl]-N-phenylpropanamide ...... 9831 stance listed on the DEA Form 236 (13) Betameprodine ...... 9608 (Controlled Substance Import/Export (14) Betamethadol ...... 9609 Declaration) which is executed for such (15) Betaprodine ...... 9611 (16) Clonitazene ...... 9612 importation or exportation as required (17) Dextromoramide ...... 9613 in §§ 1312.18(c) and 1312.27(b) of this (18) Diampromide ...... 9615 chapter. (19) Diethylthiambutene ...... 9616 (20) Difenoxin ...... 9168 (b) Except as stated in paragraph (a) (21) Dimenoxadol ...... 9617 of this section, no applicant or reg- (22) Dimepheptanol ...... 9618 (23) Dimethylthiambutene ...... 9619 istrant is required to use the Adminis- (24) Dioxaphetyl butyrate ...... 9621 (25) Dipipanone ...... 9622 (26) Ethylmethylthiambutene ...... 9623

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(27) Etonitazene ...... 9624 contains any quantity of the following (28) Etoxeridine ...... 9625 hallucinogenic substances, or which (29) Furethidine ...... 9626 (30) Hydroxypethidine ...... 9627 contains any of its salts, isomers, and (31) Ketobemidone ...... 9628 salts of isomers whenever the existence (32) Levomoramide ...... 9629 of such salts, isomers, and salts of iso- (33) Levophenacylmorphan ...... 9631 (34) 3-Methylfentanyl (N-[3-methyl-1-(2- mers is possible within the specific phenylethyl)-4-piperidyl]-N- chemical designation (for purposes of phenylpropanamide) ...... 9813 this paragraph only, the term ‘‘isomer’’ (35) 3-methylthiofentanyl (N-[(3-methyl-1-(2- thienyl)ethyl-4-piperidinyl]-N- includes the optical, position and geo- phenylpropanamide) ...... 9833 metric isomers): (36) Morpheridine ...... 9632 (1) Alpha-ethyltryptamine ...... 7249 (37) MPPP (1-methyl-4-phenyl-4- Some trade or other names: etryptamine; propionoxypiperidine) ...... 9661 Monase; a-ethyl-1H-indole-3- (38) Noracymethadol ...... 9633 ethanamine; 3-(2-aminobutyl) indole; a- (39) Norlevorphanol ...... 9634 ET; and AET. (40) Normethadone ...... 9635 (2) 4-bromo-2,5-dimethoxy-amphetamine ...... 7391 (41) Norpipanone ...... 9636 Some trade or other names: 4-bromo-2,5- (42) Para-fluorofentanyl (N-(4-fluorophenyl)-N- dimethoxy-a-methylphenethylamine; 4- [1-(2-phenethyl)-4-piperidinyl] propanamide .. 9812 bromo-2,5-DMA (43) PEPAP (1-(-2-phenethyl)-4-phenyl-4- (3) 4-Bromo-2,5-dimethoxyphenethylamine ...... 7392 acetoxypiperidine ...... 9663 Some trade or other names: 2-(4-bromo- (44) Phenadoxone ...... 9637 2,5-dimethoxyphenyl)-1-aminoethane; (45) Phenampromide ...... 9638 alpha-desmethyl DOB; 2C-B, Nexus. (46) Phenomorphan ...... 9647 (4) 2,5-dimethoxyamphetamine ...... 7396 (47) Phenoperidine ...... 9641 Some trade or other names: 2,5- (48) Piritramide ...... 9642 dimethoxy-a-methylphenethylamine; 2,5- (49) Proheptazine ...... 9643 DMA (50) Properidine ...... 9644 (5) 2,5-dimethoxy-4-ethylamphet-amine ...... 7399 (51) Propiram ...... 9649 Some trade or other names: DOET (52) Racemoramide ...... 9645 (6) 2,5-dimethoxy-4-(n)- (53) Thiofentanyl (N-phenyl-N-[1-(2- propylthiophenethylamine (other name: 2C– thienyl)ethyl-4-piperidinyl]-propanamide ...... 9835 T–7) ...... 7348 (54) Tilidine ...... 9750 (7) 4-methoxyamphetamine ...... 7411 (55) Trimeperidine ...... 9646 Some trade or other names: 4-methoxy-a- (c) Opium derivatives. Unless specifi- methylphenethylamine; paramethoxyamphetamine, PMA cally excepted or unless listed in an- (8) 5-methoxy-3,4-mdthylenedioxy-amphet- other schedule, any of the following amine ...... 7401 opium derivatives, its salts, isomers, (9) 4-methyl-2,5-dimethoxy-amphetamine ...... 7395 Some trade and other names: 4-methyl- and salts of isomers whenever the ex- 2,5-dimethoxy-a-methylphenethylamine; istence of such salts, isomers, and salts ‘‘DOM’’; and ‘‘STP’’ of isomers is possible within the spe- (10) 3,4-methylenedioxy amphetamine ...... 7400 cific chemical designation: (11) 3,4-methylenedioxymethamphetamine (MDMA) ...... 7405 (1) Acetorphine ...... 9319 (12) 3,4-methylenedioxy-N-ethylamphetamine (2) Acetyldihydrocodeine ...... 9051 (also known as N-ethyl-alpha-methyl- (3) Benzylmorphine ...... 9052 3,4(methylenedioxy)phenethylamine, N-ethyl (4) Codeine methylbromide ...... 9070 MDA, MDE, MDEA ...... 7404 (5) Codeine-N-Oxide ...... 9053 (13) N-hydroxy-3,4- (6) Cyprenorphine ...... 9054 methylenedioxyamphetamine (also known as (7) Desomorphine ...... 9055 N-hydroxy-alpha-methyl- (8) Dihydromorphine ...... 9145 3,4(methylenedioxy)phenethylamine, and N- (9) Drotebanol ...... 9335 hydroxy MDA ...... 7402 (10) Etorphine (except hydrochloride salt) ...... 9056 (14) 3,4,5-trimethoxy amphetamine ...... 7390 (11) Heroin ...... 9200 (15) 5-methoxy-N,N-dimethyltryptamine 7431. (12) Hydromorphinol ...... 9301 Some trade or other names: 5-methoxy-3-[2- (13) Methyldesorphine ...... 9302 (dimethylamino)ethyl]indole; 5-MeO-DMT. (14) Methyldihydromorphine ...... 9304 (16) Alpha-methyltryptamine (other name: (15) Morphine methylbromide ...... 9305 AMT) ...... 7432. (16) Morphine methylsulfonate ...... 9306 (17) Bufotenine ...... 7433 (17) Morphine-N-Oxide ...... 9307 Some trade and other names: 3-(b- (18) Myrophine ...... 9308 Dimethylaminoethyl)-5-hydroxyindole; 3- (19) Nicocodeine ...... 9309 (2-dimethylaminoethyl)-5-indolol; N, N- (20) Nicomorphine ...... 9312 dimethylserotonin; 5-hydroxy-N,N- (21) Normorphine ...... 9313 dimethyltryptamine; mappine (22) Pholcodine ...... 9314 (23) Thebacon ...... 9315 (18) Diethyltryptamine ...... 7434 Some trade and other names: N,N- (d) Hallucinogenic substances. Unless Diethyltryptamine; DET specifically excepted or unless listed in (19) Dimethyltryptamine ...... 7435 Some trade or other names: DMT another schedule, any material, com- (20) 5-methoxy-N,N-diisopropyltryptamine pound, mixture, or preparation, which (other name: 5-MeO-DIPT) ...... 7439. 107

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(21) Ibogaine ...... 7260 the central nervous system, including Some trade and other names: 7-Ethyl- its salts, isomers, and salts of isomers 6,6b,7,8,9,10,12,13-octahydro-2- methoxy-6,9-methano-5H-pyrido [1′, whenever the existence of such salts, 2′:1,2] azepino [5,4-b] indole; isomers, and salts of isomers is possible Tabernanthe iboga within the specific chemical designa- (22) Lysergic acid diethylamide ...... 7315 (23) Marihuana ...... 7360 tion: (24) Mescaline ...... 7381 (1) gamma-hydroxybutyric acid (some other names in- (25) Parahexyl—7374; some trade or other clude GHB; gamma-hydroxybutyrate; 4- names: 3-Hexyl-1-hydroxy-7,8,9,10- hydroxybutyrate; 4-hydroxybutanoic acid; sodium tetrahydro-6,6,9-trimethyl-6H- oxybate; sodium oxybutyrate) ...... 2010 dibenzo[b,d]pyran; Synhexyl. (2) Mecloqualone ...... 2572 (26) Peyote ...... 7415 (3) Methaqualone ...... 2565 Meaning all parts of the plant presently classified botanically as Lophophora (f) Stimulants. Unless specifically ex- williamsii Lemaire, whether growing or cepted or unless listed in another not, the seeds thereof, any extract from schedule, any material, compound, any part of such plant, and every compound, manufacture, salts, derivative, mixture, or preparation which contains mixture, or preparation of such plant, its any quantity of the following sub- seeds or extracts stances having a stimulant effect on (Interprets 21 USC 812(c), Schedule I(c) (12)) the central nervous system, including (27) N-ethyl-3-piperidyl benzilate ...... 7482 its salts, isomers, and salts of isomers: (28) N-methyl-3-piperidyl benzilate ...... 7484 (1) Aminorex (Some other names: aminoxaphen; 2- (29) Psilocybin ...... 7437 amino-5-phenyl-2-oxazoline; or 4,5-dihydro-5- (30) Psilocyn ...... 7438 phenly-2-oxazolamine) ...... 1585 (31) Tetrahydrocannabinols ...... 7370 (2) N-Benzylpiperazine (some other names: BZP, 1- Meaning tetrahydrocannabinols naturally benzylpiperazine) ...... 7493 contained in a plant of the genus Can- (3) Cathinone ...... 1235 nabis (cannabis plant), as well as syn- Some trade or other names: 2-amino-1-phenyl-1- thetic equivalents of the substances propanone, alpha-aminopropiophenone, 2- contained in the cannabis plant, or in aminopropiophenone, and norephedrone the resinous extractives of such plant, (4) Fenethylline ...... 1503 and/or synthetic substances, derivatives, (5) Methcathinone (Some other names: 2- and their isomers with similar chemical (methylamino)-propiophenone; alpha- structure and pharmacological activity to (methylamino)propiophenone; 2-(methylamino)-1- those substances contained in the plant, phenylpropan-1-one; alpha-N- such as the following: methylaminopropiophenone; monomethylpropion; 1 cis or trans tetrahydrocannabinol, and ephedrone; N-methylcathinone; methylcathinone; their optical isomers AL–464; AL–422; AL–463 and UR1432), its salts, 6 cis or trans tetrahydrocannabinol, and optical isomers and salts of optical isomers ...... 1237 their optical isomers (6) (±)cis-4-methylaminorex ((±)cis-4,5-dihydro-4-meth- 3, 4 cis or trans tetrahydrocannabinol, and yl-5-phenyl-2-oxazolamine) ...... 1590 its optical isomers (Since nomenclature of these substances (7) N-ethylamphetamine ...... 1475 is not internationally standardized, com- (8) N,N-dimethylamphetamine (also known as N,N- pounds of these structures, regardless alpha-trimethyl-benzeneethanamine; N,N-alpha- of numerical designation of atomic posi- trimethylphenethylamine) ...... 1480 tions covered.) (g) Temporary listing of substances sub- (32) Ethylamine analog of phencyclidine ...... 7455 Some trade or other names: N-ethyl-1- ject to emergency scheduling. Any mate- phenylcyclohexylamine, (1- rial, compound, mixture or preparation phenylcyclohexyl)ethylamine, N-(1- which contains any quantity of the fol- phenylcyclohexyl)ethylamine, cyclohexamine, PCE lowing substances: (33) Pyrrolidine analog of phencyclidine ...... 7458 (1) 5-(1,1-Dimethylheptyl)-2-[(1R,3S)-3- Some trade or other names: 1-(1- hydroxycyclohexyl]-phenol, its optical, phenylcyclohexyl)-pyrrolidine, PCPy, PHP positional, and geometric isomers, (34) Thiophene analog of phencyclidine ...... 7470 salts and salts of isomers—7297 (Other Some trade or other names: 1-[1-(2- names: CP–47,497) thienyl)-cyclohexyl]-piperidine, 2- (2) 5-(1,1-Dimethyloctyl)-2-[(1R,3S)-3- thienylanalog of phencyclidine, TPCP, TCP hydroxycyclohexyl]-phenol, its optical, (35) 1-[1-(2-thienyl)cyclohexyl]pyrrolidine ...... 7473 positional, and geometric isomers, Some other names: TCPy salts and salts of isomers—7298 (Other (e) Depressants. Unless specifically names: cannabicyclohexanol and CP– excepted or unless listed in another 47,497 C8 homologue) schedule, any material, compound, (3) 1-Butyl-3-(1-naphthoyl)indole, its mixture, or preparation which contains optical, positional, and geometric iso- any quantity of the following sub- mers, salts and salts of isomers—7173 stances having a depressant effect on (Other names: JWH–073) 108

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(4) 1-[2-(4-Morpholinyl)ethyl]-3-(1- (2) Any salt, compound, derivative, or naphthoyl)indole, its optical, posi- preparation thereof which is chemi- tional, and geometric isomers, salts cally equivalent or identical with any and salts of isomers—7200 (Other of the substances referred to in para- names: JWH–200) graph (b) (1) of this section, except that (5) 1-Pentyl-3-(1-naphthoyl)indole, its these substances shall not include the optical, positional, and geometric iso- isoquinoline alkaloids of opium. mers, salts and salts of isomers—7118 (3) Opium poppy and poppy straw. (Other names: JWH–018 and AM678) (4) Coca leaves (9040) and any salt, compound, derivative or preparation of [39 FR 22141, June 20, 1974] coca leaves (including cocaine (9041) EDITORIAL NOTE: For FEDERAL REGISTER ci- and ecgonine (9180) and their salts, iso- tations affecting § 1308.11, see the List of CFR mers, derivatives and salts of isomers Sections Affected, which appears in the and derivatives), and any salt, com- Finding Aids section of the printed volume pound, derivative, or preparation and at www.fdsys.gov. thereof which is chemically equivalent or identical with any of these sub- § 1308.12 Schedule II. stances, except that the substances (a) Schedule II shall consist of the shall not include decocainized coca drugs and other substances, by what- leaves or extraction of coca leaves, ever official name, common or usual whhch extractions do not contain co- name, chemical name, or brand name caine or ecgonine. designated, listed in this section. Each (5) Concentrate of poppy straw (the drug or substance has been assigned crude extract of poppy straw in either the Controlled Substances Code Num- liquid, solid or powder form which con- ber set forth opposite it. tains the phenanthrene alkaloids of the (b) Substances, vegetable origin or opium poppy), 9670. chemical synthesis. Unless specifically (c) Opiates. Unless specifically ex- excepted or unless listed in another cepted or unless in another schedule schedule, any of the following sub- any of the following opiates, including stances whether produced directly or its isomers, esters, ethers, salts and indirectly by extraction from sub- salts of isomers, esters and ethers stances of vegetable origin, or inde- whenever the existence of such iso- pendently by means of chemical syn- mers, esters, ethers, and salts is pos- thesis, or by a combination of extrac- sible within the specific chemical des- tion and chemical synthesis: ignation, dextrorphan and (1) Opium and opiate, and any salt, levopropoxyphene excepted: compound, derivative, or preparation (1) Alfentanil ...... 9737 of opium or opiate excluding (2) Alphaprodine ...... 9010 (3) Anileridine ...... 9020 apomorphine, thebaine-derived (4) Bezitramide ...... 9800 butorphanol, dextrorphan, nalbuphine, (5) Bulk dextropropoxyphene (non-dosage forms) ...... 9273 nalmefene, naloxone, and naltrexone, (6) Carfentanil ...... 9743 (7) Dihydrocodeine ...... 9120 and their respective salts, but includ- (8) Diphenoxylate ...... 9170 ing the following: (9) Fentanyl ...... 9801 (10) Isomethadone ...... 9226 (i) Codeine ...... 9050 (11) Levo-alphacetylmethadol ...... 9648 (ii) Dihydroetorphine ...... 9334 [Some other names: levo-alpha-acetylmethadol, (iii) Ethylmorphine ...... 9190 levomethadyl acetate, LAAM] (iv) Etorphine hydrochloride ...... 9059 (12) Levomethorphan ...... 9210 (v) Granulated opium ...... 9640 (13) Levorphanol ...... 9220 (vi) Hydrocodone ...... 9193 (14) Metazocine ...... 9240 (vii) Hydromorphone ...... 9150 (15) Methadone ...... 9250 (viii) Metopon ...... 9260 (16) Methadone-Intermediate, 4-cyano-2- (ix) Morphine ...... 9300 dimethylamino-4,4-diphenyl butane ...... 9254 (x) Opium extracts ...... 9610 (17) Moramide-Intermediate, 2-methyl-3-morpholino-1, (xi) Opium fluid ...... 9620 1-diphenylpropane-carboxylic acid ...... 9802 (18) Pethidine (meperidine) ...... 9230 (xii) Oripavine ...... 9330 (19) Pethidine-Intermediate-A, 4-cyano-1-methyl-4- (xiii) Oxycodone ...... 9143 phenylpiperidine ...... 9232 (xiv) Oxymorphone ...... 9652 (20) Pethidine-Intermediate-B, ethyl-4- (xv) Powdered opium ...... 9639 phenylpiperidine-4-carboxylate ...... 9233 (xvi) Raw opium ...... 9600 (21) Pethidine-Intermediate-C, 1-methyl-4- (xvii) Thebaine ...... 9333 phenylpiperidine-4-carboxylic acid ...... 9234 (xviii) Tincture of opium ...... 9630 (22) Phenazocine ...... 9715

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(23) Piminodine ...... 9730 (i) 4-anilino-N-phenethyl-4-pi- (24) Racemethorphan ...... 9732 (25) Racemorphan ...... 9733 peridine (ANPP) ...... 8333 (26) Remifentanil ...... 9739 (ii) [Reserved] (27) Sufentanil ...... 9740 (28) Tapentadol ...... 9780 [39 FR 22142, June 20, 1974]

(d) Stimulants. Unless specifically ex- EDITORIAL NOTE: For FEDERAL REGISTER ci- cepted or unless listed in another tations affecting § 1308.12, see the List of CFR schedule, any material, compound, Sections Affected, which appears in the mixture, or preparation which contains Finding Aids section of the printed volume any quantity of the following sub- and at www.fdsys.gov. stances having a stimulant effect on § 1308.13 Schedule III. the central nervous system: (1) Amphetamine, its salts, optical isomers, (a) Schedule III shall consist of the and salts of its optical isomers ...... 1100 drugs and other substances, by what- (2) Methamphetamine, its salts, isomers, and ever official name, common or usual salts of its isomers ...... 1105 name, chemical name, or brand name (3) Phenmetrazine and its salts ...... 1631 (4) Methylphenidate ...... 1724 designated, listed in this section. Each (5) Lisdexamfetamine, its salts, isomers, and drug or substance has been assigned salts of its isomers ...... 1205. the DEA Controlled Substances Code (e) Depressants. Unless specifically Number set forth opposite it. excepted or unless listed in another (b) Stimulants. Unless specifically ex- schedule, any material, compound, cepted or unless listed in another mixture, or preparation which contains schedule, any material, compound, any quantity of the following sub- mixture, or preparation which contains stances having a depressant effect on any quantity of the following sub- the central nervous system, including stances having a stimulant effect on its salts, isomers, and salts of isomers the central nervous sxstem, including whenever the existence of such salts, its salts, isomers (whether optical, po- isomers, and salts of isomers is possible sition, or geometric), and salts of such within the specific chemical designa- isomers whenever the existence of such tion: salts, isomers, and salts of isomers is possible within the specific chemical (1) Amobarbital ...... 2125 (2) Glutethimide ...... 2550 designation: (3) Pentobarbital ...... 2270 (1) Those compounds, mixtures, or preparations in (4) Phencyclidine ...... 7471 dosage unit form containing any stimulant sub- (5) Secobarbital ...... 2315 stances listed in schedule II which compounds, mixtures, or preparations were listed on August 25, (f) Hallucinogenic substances. 1971, as excepted compounds under § 1308.32, and (1) Nabilone ...... 7379 any other drug of the quantitative composition [Another name for nabilone: (±)-trans-3- shown in that list for those drugs or which is the (1,1-dimethylheptyl)-6,6a,7,8,10,10a- same except that it contains a lesser quantity of hexahydro-1-hydroxy-6,6-dimethyl-9H- controlled substances ...... 1405 dibenzo[b,d]pyran-9-one] (2) Benzphetamine ...... 1228 (3) Chlorphentermine ...... 1645 (g) Immediate precursors. Unless spe- (4) Clortermine ...... 1647 cifically excepted or unless listed in (5) Phendimetrazine ...... 1615 another schedule, any material, com- (c) Depressants. Unless specifically pound, mixture, or preparation which excepted or unless listed in another contains any quantity of the following schedule, any material, compound, substances: mixture, or preparation which contains (1) Immediate precursor to amphet- any quantity of the following sub- amine and methamphetamine: stances having a depressant effect on (i) Phenylacetone ...... 8501 the central nervous system: Some trade or other names: phenyl-2-propanone; (1) Any compound, mixture or preparation containing: P2P; benzyl methyl ketone; methyl benzyl ke- (i) Amobarbital ...... 2126 tone; (ii) Secobarbital ...... 2316 (iii) Pentobarbital ...... 2271 (2) Immediate precursors to or any salt thereof and one or more other active phencyclidine (PCP): medicinal ingredients which are not listed in any (i) 1-phenylcyclohexylamine ...... 7460 schedule. (ii) 1-piperidinocyclohexanecarbonitrile (PCC) ...... 8603 (2) Any suppository dosage form containing: (i) Amobarbital ...... 2126 (3) Immediate precursor to fentanyl: (ii) Secobarbital ...... 2316 110

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(iii) Pentobarbital ...... 2271 (vii) Not more than 500 milligrams of opium or any salt of any of these drugs and approved by per 100 milliliters or per 100 grams or not the Food and Drug Administration for marketing more than 25 milligrams per dosage unit, only as a suppository. with one or more active, nonnarcotic ingre- (3) Any substance which contains any quantity of a dients in recognized therapeutic amounts ... 9809 derivative of barbituric acid or any salt thereof ...... 2100 (viii) Not more than 50 milligrams of morphine (4) Chlorhexadol ...... 2510 per 100 milliliters or per 100 grams, with (5) Embutramide ...... 2020 one or more active, nonnarcotic ingredients in recognized therapeutic amounts ...... 9810 (6) Any drug product containing gamma hydroxybutyric (2) Any material, compound, mixture, or preparation acid, including its salts, isomers, and salts of iso- containing any of the following narcotic drugs or mers, for which an application is approved under their salts, as set forth below: section 505 of the Federal Food, Drug, and Cos- (i) Buprenorphine ...... 9064 metic Act ...... 2012 (ii) [Reserved]. (7) Ketamine, its salts, isomers, and salts of isomers .. 7285 [Some other names for ketamine: (±)-2-(2- (f) Anabolic Steroids. Unless specifi- chlorophenyl)-2-(methylamino)-cyclohexanone] cally excepted or unless listed in an- (8) Lysergic acid ...... 7300 other schedule, any material, com- (9) Lysergic acid amide ...... 7310 (10) Methyprylon ...... 2575 pound, mixture or preparation con- (11) Sulfondiethylmethane ...... 2600 taining any quantity of the following (12) Sulfonethylmethane ...... 2605 substances, including its salts, esters (13) Sulfonmethane ...... 2610 and ethers: (14) Tiletamine and zolazepam or any salt thereof ...... 7295 (1) Anabolic steroids (see § 1300.01 of Some trade or other names for a tiletamine- zolazepam combination product: this chapter)—4000 Telazol.. (2) [Reserved] Some trade or other names for tiletamine: 2-(ethylamino)-2-(2-thienyl)-cyclohexanone.. (g) Hallucinogenic substances. (1) Some trade or other names for zolazepam: Dronabinol (synthetic) in sesame oil 4-(2-fluorophenyl)-6,8-dihydro-1,3,8- and encapsulated in a soft gelatin cap- trimethylpyrazolo-[3,4-e] [1,4]-diazepin- sule in a U.S. Food and Drug Adminis- 7(1H)-one, flupyrazapon.. tration approved product—7369. (d) Nalorphine 9400. [Some other names for dronabinol: (6aR- (e) Narcotic drugs. Unless specifically trans)-6a,7,8,10a-tetrahydro-6,6,9-trimethyl-3- excepted or unless listed in another pentyl-6H-dibenzo [b,d]pyran-1-ol] or (-)- schedule: delta-9-(trans)-tetrahydrocannabinol] (1) Any material, compound, mixture, or preparation containing any of the following narcotic drugs, or (2) [Reserved] their salts calculated as the free anhydrous base or [39 FR 22142, June 20, 1974] alkaloid, in limited quantities as set forth below: (i) Not more than 1.8 grams of codeine per EDITORIAL NOTE: For FEDERAL REGISTER ci- 100 milliliters or not more than 90 milli- tations affecting § 1308.13, see the List of CFR grams per dosage unit, with an equal or Sections Affected, which appears in the greater quantity of an isoquinoline alkaloid Finding Aids section of the printed volume of opium ...... 9803 (ii) Not more than 1.8 grams of codeine per and at www.fdsys.gov. 100 milliliters or not more than 90 milligrams per dosage unit, with one or more § 1308.14 Schedule IV. active, nonnarcotic ingredients in recognized therapeutic amounts ...... 9804 (a) Schedule IV shall consist of the (iii) Not more than 300 milligrams of drugs and other substances, by what- dihydrocodeinone (hydrocodone) per 100 ever official name, common or usual milliliters or not more than 15 milligrams name, chemical name, or brand name per dosage unit, with a fourfold or greater quantity of an isoquinoline alkaloid of designated, listed in this section. Each opium ...... 9805 drug or substance has been assigned (iv) Not more than 300 milligrams of the DEA Controlled Substances Code dihydrocodeinone (hydrocodone) per 100 Number set forth opposite it. milliliters or not more than 15 milligrams per dosage unit, with one or more active (b) Narcotic drugs. Unless specifically nonnarcotic ingredients in recognized excepted or unless listed in another therapeutic amounts ...... 9806 schedule, any material, compound, (v) Not more than 1.8 grams of dihydrocodeine per 100 milliliters or not mixture, or preparation containing any more than 90 milligrams per dosage unit, of the following narcotic drugs, or with one or more active nonnarcotic ingre- their salts calculated as the free anhy- dients in recognized therapeutic amounts ... 9807 drous base or alkaloid, in limited quan- (vi) Not more than 300 milligrams of ethylmorphine per 100 milliliters or not tities as set forth below: more than 15 milligrams per dosage unit, (1) Not more than 1 milligram of difenoxin and not less with one or more active, nonnarcotic ingre- than 25 micrograms of atropine sulfate per dosage dients in recognized therapeutic amounts ... 9808 unit ...... 9167 111

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(2) Dextropropoxyphene (alpha-(+)-4-dimethylamino- whenever the existence of such salts, 1,2-diphenyl-3-methyl-2-propionoxybutane) ...... 9278 isomers, and salts of isomers is pos- (c) Depressants. Unless specifically sible: excepted or unless listed in another (1) Fenfluramine ...... 1670 schedule, any material, compound, (e) Stimulants. Unless specifically ex- mixture, or preparation which contains cepted or unless listed in another any quantity of the following sub- schedule, any material, compound, stances, including its salts, isomers, mixture, or preparation which contains and salts of isomers whenever the ex- any quantity of the following sub- istence of such salts, isomers, and salts stances having a stimulant effect on of isomers is possible within the spe- the central nervous system, including cific chemical designation: its salts, isomers and salts of isomers: (1) Alprazolam ...... 2882 (1) Cathine ((+)-norpseudoephedrine) ...... 1230 (2) Barbital ...... 2145 (2) Diethylpropion ...... 1610 (3) Bromazepam ...... 2748 (3) Fencamfamin ...... 1760 (4) Camazepam ...... 2749 (4) Fenproporex ...... 1575 (5) Chloral betaine ...... 2460 (5) Mazindol ...... 1605 (6) Chloral hydrate ...... 2465 (6) Mefenorex ...... 1580 (7) Chlordiazepoxide ...... 2744 (7)Modafinil ...... 1680 (8) Clobazam ...... 2751 (8) Pemoline (including organometallic complexes and (9) Clonazepam ...... 2737 chelates thereof) ...... 1530 (10) Clorazepate ...... 2768 (9) Phentermine ...... 1640 (11) Clotiazepam ...... 2752 (10) Pipradrol ...... 1750 (12) Cloxazolam ...... 2753 (11) Sibutramine ...... 1675 (13) Delorazepam ...... 2754 (12) SPA ((-)-1-dimethylamino- 1,2-diphenylethane) .... 1635 (14) Diazepam ...... 2765 (15) Dichloralphenazone ...... 2467 (f) Other substances. Unless specifi- (16) Estazolam ...... 2756 cally excepted or unless listed in an- (17) Ethchlorvynol ...... 2540 other schedule, any material, com- (18) Ethinamate ...... 2545 (19) Ethyl loflazepate ...... 2758 pound, mixture or preparation which (20) Fludiazepam ...... 2759 contains any quantity of the following (21) Flunitrazepam ...... 2763 substances, including its salts: (22) Flurazepam ...... 2767 (1) Pentazocine ...... 9709 (23) Fospropofol ...... 2138 (2) Butorphanol (including its optical isomers) ...... 9720 (24) Halazepam ...... 2762 (25) Haloxazolam ...... 2771 (26) Ketazolam ...... 2772 [39 FR 22143, June 20, 1974] (27) Loprazolam ...... 2773 EDITORIAL NOTE: For FEDERAL REGISTER ci- (28) Lorazepam ...... 2885 tations affecting § 1308.14, see the List of CFR (29) Lormetazepam ...... 2774 Sections Affected, which appears in the (30) Mebutamate ...... 2800 (31) Medazepam ...... 2836 Finding Aids section of the printed volume (32) Meprobamate ...... 2820 and at www.fdsys.gov. (33) Methohexital ...... 2264 (34) Methylphenobarbital (mephobarbital) ...... 2250 § 1308.15 Schedule V. (35) Midazolam ...... 2884 (36) Nimetazepam ...... 2837 (a) Schedule V shall consist of the (37) Nitrazepam ...... 2834 drugs and other substances, by what- (38) Nordiazepam ...... 2838 ever official name, common or usual (39) Oxazepam ...... 2835 (40) Oxazolam ...... 2839 name, chemical name, or brand name (41) Paraldehyde ...... 2585 designated, listed in this section. (42) Petrichloral ...... 2591 (b) Narcotic drugs. Unless specifically (43) Phenobarbital ...... 2285 excepted or unless listed in another (44) Pinazepam ...... 2883 (45) Prazepam ...... 2764 schedule, any material, compound, (46) Quazepam ...... 2881 mixture, or preparation containing any (47) Temazepam ...... 2925 of the following narcotic drugs and (48) Tetrazepam ...... 2886 (49) Triazolam ...... 2887 their salts, as set forth below: (50) Zaleplon ...... 2781 (1) [Reserved] (51) Zolpidem ...... 2783 (c) Narcotic drugs containing non-nar- (52) Zopiclone ...... 2784 cotic active medicinal ingredients. Any (d) Fenfluramine. Any material, com- compound, mixture, or preparation pound, mixture, or preparation which containing any of the following nar- contains any quantity of the following cotic drugs, or their salts calculated as substances, including its salts, isomers the free anhydrous base or alkaloid, in (whether optical, position, or geo- limited quantities as set forth below, metric), and salts of such isomers, which shall include one or more non- 112

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narcotic active medicinal ingredients EXCLUDED NONNARCOTIC SUBSTANCES in sufficient proportion to confer upon the compound, mixture, or preparation § 1308.21 Application for exclusion of a valuable medicinal qualities other than nonnarcotic substance. those possessed by narcotic drugs (a) Any person seeking to have any alone: nonnarcotic drug that may, under the (1) Not more than 200 milligrams of Federal Food, Drug, and Cosmetic Act codeine per 100 milliliters or per 100 (21 U.S.C. 301), be lawfully sold over the grams. counter without a prescription, excluded from any schedule, pursuant to (2) Not more than 100 milligrams of section 201(g)(1) of the Act (21 U.S.C. dihydrocodeine per 100 milliliters or 811(g)(1)), may apply to the Office of per 100 grams. Diversion Control, Drug Enforcement (3) Not more than 100 milligrams of Administration. See the Table of DEA ethylmorphine per 100 milliliters or per Mailing Addresses in § 1321.01 of this 100 grams. chapter for the current mailing ad- (4) Not more than 2.5 milligrams of dress. diphenoxylate and not less than 25 (b) An application for an exclusion micrograms of atropine sulfate per dos- under this section shall contain the fol- age unit. lowing information: (5) Not more than 100 milligrams of (1) The name and address of the ap- opium per 100 milliliters or per 100 plicant; grams. (2) The name of the substance for (6) Not more than 0.5 milligram of which exclusion is sought; and difenoxin and not less than 25 (3) The complete quantitative com- micrograms of atropine sulfate per dos- position of the substance. age unit. (c) Within a reasonable period of time after the receipt of an application (d) Stimulants. Unless specifically ex- for an exclusion under this section, the empted or excluded or unless listed in Administrator shall notify the appli- another schedule, any material, com- cant of his acceptance or nonaccept- pound, mixture, or preparation which ance of his application, and if not ac- contains any quantity of the following cepted, the reason therefore. The Ad- substances having a stimulant effect ministrator need not accept an applica- on the central nervous system, includ- tion for filing if any of the require- ing its salts, isomers and salts of iso- ments prescribed in paragraph (b) of mers: this section is lacking or is not set (1) Pyrovalerone ...... 1485. forth as to be readily understood. If the (2) [Reserved] applicant desires, he may amend the (e) Depressants. Unless specifically application to meet the requirements of paragraph (b) of this section. If the exempted or excluded or unless listed application is accepted for filing, the in another schedule, any material, Administrator shall issue and publish compound, mixture, or preparation in the FEDERAL REGISTER his order on which contains any quantity of the fol- the application, which shall include a lowing substances having a depressant reference to the legal authority under effect on the central nervous system, which the order is issued and the find- including its salts: ings of fact and conclusions of law (1) Lacosamide [(R)-2-acetoamido-N- upon which the order is based. This benzyl-3-methoxy-propionamide]—2746 order shall specify the date on which it (2) Pregabalin [(S)-3-(aminomethyl)- shall take effect. The Administrator 5-methylhexanoic acid]—2782 shall permit any interested person to file written comments on or objections [39 FR 22143, June 20, 1974, as amended at 43 FR 38383, Aug. 28, 1978; 44 FR 40888, July 13, to the order within 60 days of the date 1979; 47 FR 49841, Nov. 3, 1982; 50 FR 8108, Feb. of publication of his order in the FED- 28, 1985; 52 FR 5952, Feb. 27, 1987; 53 FR 10870, ERAL REGISTER. If any such comments Apr. 4, 1988; 56 FR 61372, Dec. 3, 1991; 67 FR or objections raise significant issues 62370, Oct. 7, 2002; 70 FR 43635, July 28, 2005; regarding any finding of fact or conclu- 74 FR 23790, May 21, 2009] sion of law upon which the order is

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based, the Administrator shall imme- an exclusion which has been accepted diately suspend the effectiveness of the for filing. order until he may reconsider the ap- [38 FR 8254, Mar. 30, 1973, as amended at 70 plication in light of the comments and FR 74657, Dec. 16, 2005; 75 FR 10678, Mar. 9, objections filed. Thereafter, the Ad- 2010] ministrator shall reinstate, revoke, or amend his original order as he deter- § 1308.22 Excluded substances. mines appropriate. The following nonnarcotic substances (d) The Administrator may at any which may, under the Federal Food, time revoke any exclusion granted pur- Drug, and Cosmetic Act (21 U.S.C. 301), suant to section 201(g) of the Act (21 be lawfully sold over the counter with- U.S.C. 811(g)) by following the proce- out a prescription, are excluded from dures set forth in paragraph (c) of this all schedules pursuant to section 201(g) section for handling an application for (1) of the Act (21 U.S.C. 811(g) (1)):

EXCLUDED NONNARCOTIC PRODUCTS

(mg or mg/ Company Trade name NDC code Form Controlled substance ml)

Bioline Laboratories ...... Theophed ...... 00719–1945 TB Phenobarbital ...... 8.00 Classic Pharmaceuticals Nasal Decongestant In- IN Levmetamfetamine (l-Des- 50.00 LLC. haler/Vapor Inhaler. oxyephedrine). Goldline Laboratories ...... Guiaphed Elixir ...... 00182–1377 EL Phenobarbital ...... 4.00 Goldline Laboratories ...... Tedrigen Tablets ...... 00182–0134 TB Phenobarbital ...... 8.00 Hawthorne Products Inc .... Choate’s Leg Freeze ...... LQ Chloral hydrate ...... 246.67 Parke-Davis & Co ...... Tedral ...... 00071–0230 TB Phenobarbital ...... 8.00 Parke-Davis & Co ...... Tedral Elixir ...... 00071–0242 EX Phenobarbital ...... 40.00 Parke-Davis & Co ...... Tedral S.A...... 00071–0231 TB Phenobarbital ...... 8.00 Parke-Davis & Co ...... Tedral Suspension ...... 00071–0237 SU Phenobarbital ...... 80.00 Parmed Pharmacy ...... Asma-Ese ...... 00349–2018 TB Phenobarbital ...... 8.10 Rondex Labs ...... Azma-Aids ...... 00367–3153 TB Phenobarbital ...... 8.00 Smith Kline Consumer ...... Benzedrex ...... 49692–0928 IN Propylhexedrine ...... 250.00 Sterling Drug, Inc ...... Bronkolixir ...... 00057–1004 EL Phenobarbital ...... 0.80 Sterling Drug, Inc ...... Bronkotabs ...... 00057–1005 TB Phenobarbital ...... 8.00 Vicks Chemical Co ...... Vicks Inhaler ...... 23900–0010 IN I-Desoxyephedrine ...... 113.00 White Hall Labs ...... Primatene (P-tablets) ...... 00573–2940 TB Phenobarbital ...... 8.00

[38 FR 8255, Mar. 30, 1973. Redesignated at 38 FR 26609, Sept. 24, 1973, and amended at 41 FR 16553, Apr. 20, 1976; 41 FR 53477, Dec. 7, 1976; 46 FR 51603, Oct. 21, 1981; 47 FR 45867, Oct. 14, 1982; 54 FR 2100, Jan. 19, 1989; 55 FR 12162, Mar. 30, 1990; 62 FR 13968, Mar. 24, 1997; 74 FR 44283, Aug. 28, 2009]

EXEMPT CHEMICAL PREPARATIONS nificant potential for abuse (the type of packaging and the history of abuse of § 1308.23 Exemption of certain chem- the same or similar preparations may ical preparations; application. be considered in determining the po- (a) The Administrator may, by regu- tential for abuse of the preparation or lation, exempt from the application of mixture); or all or any part of the Act any chemical (2) Contains either a narcotic or non- preparation or mixture containing one narcotic controlled substance and one or more controlled substances listed in or more adulterating or denaturing any schedule, which preparation or agents in such a manner, combination, mixture is intended for laboratory, in- quantity, proportion, or concentration, dustrial, educational, or special re- that the preparation or mixture does search purposes and not for general ad- not present any potential for abuse. If ministration to a human being or other the preparation or mixture contains a animal, if the preparation or mixture narcotic controlled substance, the either: preparation or mixture must be formu- (1) Contains no narcotic controlled lated in such a manner that it incor- substance and is packaged in such a porates methods of denaturing or other form or concentration that the pack- means so that the preparation or mix- aged quantity does not present any sig- ture is not liable to be abused or have

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ill effects, if abused, and so that the 402(a)(8) of the Act (21 U.S.C. 842(a) (8)) narcotic substance cannot in practice or any other law restricting public dis- be removed. closure of information. (b) Any person seeking to have any (d) The Administrator may require preparation or mixture containing a the applicant to submit such docu- controlled substance and one or more ments or written statements of fact noncontrolled substances exempted relevant to the application as he deems from the application of all or any part necessary to determine whether the ap- of the Act, pursuant to paragraph (a) of plication should be granted. this section, may apply to the Office of (e) Within a reasonable period of Diversion Control, Drug Enforcement time after the receipt of an application Administration. See the Table of DEA for an exemption under this section, Mailing Addresses in § 1321.01 of this the Administrator shall notify the ap- chapter for the current mailing ad- plicant of his acceptance or nonaccept- dress. ance of his application, and if not ac- (c) An application for an exemption cepted, the reason therefor. The Ad- under this section shall contain the fol- ministrator need not accept an applica- lowing information: tion for filing if any of the require- (1) The name, address, and registra- ments prescribed in paragraph (c) or re- tion number, if any, of the applicant; quested pursuant to paragraph (d) is (2) The name, address, and registra- lacking or is not set forth as to be tion number, if any, of the manufac- readily understood. If the applicant de- turer or importer of the preparation or sires, he may amend the application to mixture, if not the applicant; meet the requirements of paragraphs (3) The exact trade name or other (c) and (d) of this section. If the appli- designation of the preparation or mix- cation is accepted for filing, the Ad- ture; ministrator shall issue and publish in (4) The complete qualitative and the FEDERAL REGISTER his order on the quantitative composition of the prepa- application, which shall include a ref- ration or mixture (including all active erence to the legal authority under and inactive ingredients and all con- which the order is based. This order trolled and noncontrolled substances); shall specify the date on which it shall (5) The form of the immediate con- take effect. The Administrator shall tainer in which the preparation or mix- permit any interested person to file ture will be distributed with sufficient written comments on or objections to descriptive detail to identify the prepa- the order within 60 days of the date of ration or mixture (e.g., bottle, packet, publication of his order in the FEDERAL vial, soft plastic pillow, agar gel plate, REGISTER. If any such comments or ob- etc.); jections raise significant issues regard- (6) The dimensions or capacity of the ing any finding of fact or conclusion of immediate container of the prepara- law upon which the order is based, the tion or mixture; Administrator shall immediately sus- (7) The label and labeling, as defined pend the effectiveness of the order in part 1300 of this chapter, of the im- until he may reconsider the application mediate container and the commercial in light of the comments and objec- containers, if any, of the preparation tions filed. Thereafter, the Adminis- or mixture; trator shall reinstate, revoke, or (8) A brief statement of the facts amend his original order as he deter- which the applicant believes justify the mines appropriate. granting of an exemption under this (f) The Administrator may at any paragraph, including information on time revoke or modify any exemption the use to which the preparation or granted pursuant to this section by fol- mixture will be put; lowing the procedures set forth in para- (9) The date of the application; and graph (e) of this section for handling an (10) Which of the information sub- application for an exemption which has mitted on the application, if any, is been accepted for filing. The Adminis- deemed by the applicant to be a trade trator may also modify or revoke the secret or otherwise confidential and en- criteria by which exemptions are titled to protection under subsection granted (and thereby modify or revoke

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all preparations and mixtures granted only—not for human or animal use’’ or under the old criteria) and modify the ‘‘Diagnostic reagent—for professional scope of exemptions at any time. use only’’ or a comparable statement [38 FR 8254, Mar. 30, 1973. Redesignated at 38 warning the person reading it that FR 26609, Sept. 24, 1973, and amended at 46 human or animal use is not intended. FR 28841, May 29, 1981; 62 FR 13968, Mar. 24, The symbol designating the schedule of 1997; 75 FR 10678, Mar. 9, 2010] the controlled substance is not required on either the label or the label- § 1308.24 Exempt chemical prepara- ing of the exempt chemical preparations. tion, nor is it necessary to list all in- (a) The chemical preparations and gredients of the preparation. mixtures approved pursuant to § 1308.23 (d) Records and reports: Any person are exempt from application of sec- who manufactures an exempt chemical tions 302, 303, 305, 306, 307, 308, 309, 1002, preparation or mixture must keep com- 1003 and 1004 of the Act (21 U.S.C. 822– plete and accurate records and file all 823, 825–829, 952–954) and § 1301.74 of this reports required under part 1304 of this chapter, to the extent described in paragraphs (b) to (h) of this section. chapter regarding all controlled sub- Substances set forth in paragraph (j) of stances being used in the manufac- this section shall be exempt from the turing process until the preparation or application of sections 305, 306, 307, 308, mixture is in the form described in 309, 1002, 1003 and 1004 of the Act (21 paragraph (i) of this section. In lieu of U.S.C. 825–829, 952–954) and §§ 1301.71– records and reports required under part 1301.73 and 1301.74 (a), (b), (d), (e) and (f) 1304 of this chapter regarding exempt of this chapter to the extent as herein- chemical preparations, the manufac- after may be provided. turer need only record the name, ad- (b) Registration and security: Any dress, and registration number, if any, person who manufactures an exempt of each person to whom the manufac- chemical preparation or mixture must turer distributes any exempt chemical be registered under the Act and comply preparation. Each importer or exporter with all relevant security requirements of an exempt narcotic chemical prepa- regarding controlled substances being ration must submit a semiannual re- used in the manufacturing process port of the total quantity of each sub- until the preparation or mixture is in stance imported or exported in each the form described in paragraph (i) of calendar half-year within 30 days of the this section. Any other person who close of the period to the Drug and handles an exempt chemical prepara- Chemical Evaluation Section, Drug En- tion after it is in the form described in forcement Administration. See the paragraph (i) of this section is not re- Table of DEA Mailing Addresses in quired to be registered under the Act § 1321.01 of this chapter for the current to handle that preparation, and the mailing address. Any other person who preparation is not required to be stored handles an exempt chemical prepara- in accordance with security require- tion after it is in the form described in ments regarding controlled substances. paragraph (i) of this section is not re- (c) Labeling: In lieu of the require- quired to maintain records or file re- ments set forth in part 1302 of this ports. chapter, the label and the labeling of an exempt chemical preparation must (e) Quotas, order forms, prescrip- be prominently marked with its full tions, import, export, and trans- trade name or other description and shipment requirements: Once an ex- the name of the manufacturer or sup- empt chemical preparation is in the plier as set forth in paragraph (i) of form described in paragraph (i) of this this section, in such a way that the section, the requirements regarding product can be readily identified as an quotas, order forms, prescriptions, im- exempt chemical preparation. The port permits and declarations, export label and labeling must also include in permit and declarations, and trans- a prominent manner the statement shipment and intransit permits and ‘‘For industrial use only’’ or ‘‘For declarations do not apply. These re- chemical use only’’ or ‘‘For in vitro use quirements do apply, however, to any

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controlled substances used in manufac- Finding Aids section of the printed volume turing the exempt chemical prepara- and at www.fdsys.gov. tion before it is in the form described in paragraph (i) of this section. EXCLUDED VETERINARY ANABOLIC (f) Criminal penalties: No exemption STEROID IMPLANT PRODUCTS granted pursuant to § 1308.23 affects the § 1308.25 Exclusion of a veterinary an- criminal liability for illegal manufac- abolic steroid implant product; ap- ture, distribution, or possession of con- plication. trolled substances contained in the ex- (a) Any person seeking to have any empt chemical preparation. Distribu- anabolic steroid product, which is ex- tion, possession, and use of an exempt pressly intended for administration chemical preparation are lawful for through implants to cattle or other registrants and nonregistrants only as nonhuman species and which has been long as such distribution, possession, approved by the Secretary of Health or use is intended for laboratory, in- and Human Services for such adminis- dustrial, or educational purposes and tration, identified as being excluded not for immediate or subsequent ad- from any schedule, pursuant to section ministration to a human being or other 102(41)(B)(i) of the Act (21 U.S.C. animal. 802(41)(B)(i)), may apply to the Office of (g) Bulk materials: For materials ex- Diversion Control, Drug Enforcement empted in bulk quantities, the Admin- Administration. See the Table of DEA istrator may prescribe requirements Mailing Addresses in § 1321.01 of this other than those set forth in para- chapter for the current mailing ad- graphs (b) through (e) of this section on dress. a case-by-case basis. (b) An application for any exclusion (h) Changes in chemical preparations: under this section shall be submitted Any change in the quantitative or qualitative composition of the prepara- in triplicate and contain the following tion or mixture after the date of appli- information: cation, or change in the trade name or (1) The name and address of the ap- other designation of the preparation or plicant; mixture, set forth in paragraph (i) of (2) The name of the product; (3) The chemical structural formula this section, requires a new application for exemption. or description for any anabolic steroid (i) A listing of exempt chemical prep- contained in the product; arations may be obtained by submit- (4) A complete description of dosage ting a written request to the Drug and and quantitative composition of the Chemical Evaluation Section, Drug En- dosage form;. forcement Administration. See the (5) The conditions of use including Table of DEA Mailing Addresses in whether or not Federal law restricts § 1321.01 of this chapter for the current this product to use by or on the order mailing address. of a licensed veterinarian; (j) The following substances are des- (6) A description of the delivery sys- ignated as exempt chemical prepara- tem in which the dosage form will be tions for the purposes set forth in this distributed with sufficient detail to section. identify the product (e.g. 20 cartridge (1) Chloral. When packaged in a brown plastic belt); sealed, oxygen-free environment, under (7) The label and labeling of the im- nitrogen pressure, safeguarded against mediate container and the commercial exposure to the air. containers, if any, of the product;. (8) The name and address of the man- (2) EmitR Phenobarbital Enzyme Rea- ufacturer of the dosage form if dif- gent B. In one liter quantities each with a 5 ml. retention sample for re- ferent from that of the applicant; and (9) Evidence that the product has packaging as an exempt chemical prep- been approved by the Secretary of aration only. Health and Human Services for admin- [38 FR 8255, Mar. 30, 1973] istration through implant to cattle or EDITORIAL NOTE: For FEDERAL REGISTER ci- other nonhuman species. tations affecting § 1308.24, see the List of CFR (c) Within a reasonable period of Sections Affected, which appears in the time after the receipt of an application

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for an exclusion under this section, the 102(41)(B)(i) of the Act (21 U.S.C. Administrator shall notify the appli- 802(41)(B)(i)). A listing of the excluded cant of his acceptance or nonaccept- products may be obtained by submit- ance of the application, and if not acting a written request to the Drug and cepted, the reason therefore. The Ad- Chemical Evaluation Section, Drug En- ministrator need not accept an applica- forcement Administration. See the tion for filing if any of the require- Table of DEA Mailing Addresses in ments prescribed in paragraph (b) of § 1321.01 of this chapter for the current this section is lacking or is not set mailing address. forth as to be readily understood. The (b) In accordance with section applicant may amend the application 102(41)(B)(ii) of the Act (21 U.S.C. to meet the requirements of paragraph 802(41)(B)(ii)) if any person prescribes, (b) of this section. If the application is dispenses, or distributes a product list- accepted for filing, the Administrator ed in paragraph (a) of this section for shall issue and have published in the human use, such person shall be con- FEDERAL REGISTER his order on the ap- sidered to have prescribed, dispensed, plication, which shall include a ref- or distributed an anabolic steroid with- erence to the legal authority under in the meaning of section 102(41)(A) of which the order is issued and the find- the Act (21 U.S.C. 802(41)(A)). ings of fact and conclusions of law upon which the order is based. This [56 FR 42936, Aug. 30, 1991, as amended at 57 order shall specify the date on which it FR 19534, May 7, 1992; 58 FR 15088, Mar. 19, 1993; 62 FR 13967, Mar. 24, 1997; 75 FR 10679, will take effect. The Administrator Mar. 9, 2010] shall permit any interested person to file written comments on or objections EXEMPTED PRESCRIPTION PRODUCTS to the order within 60 days of the date of publication in the FEDERAL REG- § 1308.31 Application for exemption of ISTER. If any such comments or objec- a nonnarcotic prescription product. tions raise significant issues regarding (a) Any person seeking to have any any finding of fact or conclusion of law compound, mixture, or preparation upon which the order is based, the Ad- containing any nonnarcotic controlled ministrator shall immediately suspend substance listed in § 1308.12(e), or in the effectiveness of the order until he § 1308.13(b) or (c), or in § 1308.14, or in may reconsider the application in light § 1308.15, exempted from application of of the comments and objections filed. all or any part of the Act pursuant to Thereafter, the Administrator shall re- section 201(g)(3)(A), of the Act (21 instate, revoke, or amend his original U.S.C. 811(g)(3)(A)) may apply to the order as he determines appropriate. Office of Diversion Control, Drug En- (d) The Administrator may at any forcement Administration. See the time revoke or modify any designation Table of DEA Mailing Addresses in of excluded status granted pursuant to § 1321.01 of this chapter for the current this section by following the proce- mailing address. dures set forth in paragraph (c) of this (b) An application for an exemption section for handling an application for under this section shall contain the fol- an exclusion which has been accepted lowing information: for filing. (1) The complete quantitative com- [56 FR 42936, Aug. 30, 1991, as amended at 75 position of the dosage form. FR 10679, Mar. 9, 2010] (2) Description of the unit dosage form together with complete labeling. § 1308.26 Excluded veterinary anabolic (3) A summary of the pharmacology steroid implant products. of the product including animal inves- (a) Products containing an anabolic tigations and clinical evaluations and steroid, that are expressly intended for studies, with emphasis on the psychic administration through implants to and/or physiological dependence liabil- cattle or other nonhuman species and ity (this must be done for each of the which have been approved by the Sec- active ingredients separately and for retary of Health and Human Services the combination product). for such administration are excluded (4) Details of synergisms and antag- from all schedules pursuant to section onisms among ingredients.

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(5) Deterrent effects of the noncon- (d) The Administrator may revoke trolled ingredients. any exemption granted pursuant to (6) Complete copies of all literature section 201(g)(3)(A) of the Act (21 U.S.C. in support of claims. 811(g)(3)(A)) by following the proce- (7) Reported instances of abuse. dures set forth in paragraph (c) of this (8) Reported and anticipated adverse section for handling an application for effects. an exemption which has been accepted (9) Number of dosage units produced for filing. for the past 2 years. (c) Within a reasonable period of [38 FR 8254, Mar. 30, 1973. Redesignated at 38 time after the receipt of an application FR 26609, Sept. 24, 1973, as amended at 44 FR for an exemption under this section, 18968, Mar. 30, 1979; 52 FR 9803, Mar. 27, 1987; 75 FR 10679, Mar. 9, 2010] the Administrator shall notify the applicant of his acceptance or non-ac- § 1308.32 Exempted prescription prod- ceptance of the application, and if not ucts. accepted, the reason therefor. The Ad- ministrator need not accept an applica- The compounds, mixtures, or prep- tion for filing if any of the require- arations that contain a nonnarcotic ments prescribed in paragraph (b) of controlled substance listed in this section is lacking or is not set § 1308.12(e) or in § 1308.13(b) or (c) or in forth so as to be readily understood. If § 1308.14 or in § 1308.15 listed in the the applicant desires, he may amend Table of Exempted Prescription Prod- the application to meet the require- ucts have been exempted by the Ad- ments of paragraph (b) of this section. ministrator from the application of If accepted for filing, the Adminis- sections 302 through 305, 307 through trator shall publish in the FEDERAL 309, and 1002 through 1004 of the Act (21 REGISTER general notice of this pro- U.S.C. 822–825, 827–829, and 952–954) and posed rulemaking in granting or deny- §§ 1301.13, 1301.22, and §§ 1301.71 through ing the application. Such notice shall 1301.76 of this chapter for administra- include a reference to the legal author- tive purposes only. An exception to the ity under which the rule is proposed, a above is that those products containing statement of the proposed rule grant- butalbital shall not be exempt from the ing or denying an exemption, and, in requirement of 21 U.S.C. 952–954 con- the discretion of the Administrator, a cerning importation, exportation, summary of the subjects and issues in- transshipment and in-transit shipment volved. The Administrator shall permit of controlled substances. Any deviation any interested person to file written from the quantitative composition of comments on or objections to the pro- any of the listed drugs shall require a posal and shall designate in the notice petition of exemption in order for the of proposed rule making the time dur- product to be exempted. A listing of ing which such filings may be made. the Exempted Prescription Products After consideration of the application may be obtained by submitting a writ- and any comments on or objections to ten request to the Drug and Chemical his proposed rulemaking, the Adminis- Evaluation Section, Drug Enforcement trator shall issue and publish in the Administration. See the Table of DEA FEDERAL REGISTER his final order on Mailing Addresses in § 1321.01 of this the application, which shall set forth chapter for the current mailing ad- the findings of fact and conclusions of dress. law upon which the order is based. This order shall specify the date on which it [75 FR 10679, Mar. 9, 2010] shall take effect, which shall not be less than 30 days from the date of pub- EXEMPT ANABOLIC STEROID PRODUCTS lication in the FEDERAL REGISTER unless the Administrator finds that con- § 1308.33 Exemption of certain ana- ditions of public health or safety neces- bolic steroid products; application. sitate an earlier effective date, in (a) The Administrator, upon the rec- which event the Administrator shall ommendation of Secretary of Health specify in the order his findings as to and Human Services, may, by regula- such conditions. tion, exempt from the application of

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all or any part of the Act any com- the applicant of his acceptance or non- pound, mixture, or preparation con- acceptance of the application, and if taining an anabolic steroid as defined not accepted, the reason therefor. The in part 1300 of this chapter, which is in- Administrator need not accept an ap- tended for administration to a human plication for filing if any of the re- being or animal, if, because of its con- quirements prescribed in paragraph (c) centration, preparation, formulation, of this section is lacking or is not set or delivery system, it has no signifi- forth so as to be readily understood. cant potential for abuse. The applicant may amend the applica- (b) Any person seeking to have any tion to meet the requirements of para- compound, mixture, or preparation containing an anabolic steroid as de- graph (c) of this section. If accepted for fined in part 1300 of this chapter ex- filing, the Administrator will request empted from the application of all or from the Secretary for Health and any part of the Act, pursuant to para- Human Services his recommendation, graph (a) of this section, may apply to as to whether such product which con- the Office of Diversion Control, Drug tains an anabolic steroid should be con- Enforcement Administration. See the sidered for exemption from certain por- Table of DEA Mailing Addresses in tions of the Controlled Substances Act. § 1321.01 of this chapter for the current On receipt of the recommendation of mailing address. the Secretary, the Administrator shall (c) An application for an exemption make a determination as to whether under this section shall be submitted the evidence submitted or otherwise in triplicate and contain the following available sufficiently establishes that information: the product possesses no significant po- (1) The name and address of the ap- tential for abuse. The Administrator plicant; shall issue and publish in the FEDERAL (2) The name of the product; REGISTER his order on the application, (3) The chemical structural formula which shall include a reference to the or description for any anabolic steroid legal authority under which the order contained in the product; (4) The complete description of dos- is issued, and the findings of fact and age and quantitative composition of conclusions of law upon which the the dosage form; order is based. This order shall specify (5) A description of the delivery sys- the date on which it will take effect. tem, if applicable; The Administrator shall permit any in- (6) The indications and conditions for terested person to file written com- use in which species, including whether ments on or objections to the order or not this product is a prescription within 60 days of the date of publica- drug; tion of his order in the FEDERAL REG- (7) Information to facilitate identi- ISTER. If any such comments or objec- fication of the dosage form, such as tions raise significant issues regarding shape, color, coating, and scoring; any finding of fact or conclusion of law (8) The label and labeling of the im- upon which the order is based, the Ad- mediate container and the commercial ministrator shall immediately suspend containers, if any, of the product; the effectiveness of the order until he (9) The units in which the dosage may reconsider the application in light form is ordinarily available; and of the comments and objections filed. (10) The facts which the applicant be- Thereafter, the Administrator shall relieves justify: (i) A determination that the product instate, revoke, or amend his original has no significant potential for abuse order as he determines appropriate. and (e) The Administrator may revoke (ii) a granting of an exemption under any exemption granted pursuant to this section. section 1903(a) of Public Law 101–647 by (d) Within a reasonable period of following the procedures set forth in time after the receipt of the application for an exemption under this section, the Administrator shall notify

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paragraph (d) of this section for han- (b) As used in this section, the fol- dling an application for an exemption lowing terms shall have the meanings which has been accepted for filing. specified: (1) The term processed plant material [56 FR 42936, Aug. 30, 1991; 57 FR 10815, Mar. means cannabis plant material that 31, 1992, as amended at 62 FR 13968, Mar. 24, 1997; 70 FR 74657, Dec. 16, 2005; 75 FR 10679, has been subject to industrial proc- Mar. 9, 2010] esses, or mixed with other ingredients, such that it cannot readily be con- § 1308.34 Exempt anabolic steroid verted into any form that can be used products. for human consumption. (2) The term animal feed mixture The list of compounds, mixtures, or means sterilized cannabis seeds mixed preparations that contain an anabolic with other ingredients (not derived steroid that have been exempted by the from the cannabis plant) in a formula- Administrator from application of section that is designed, marketed, and tions 302 through 309 and 1002 through distributed for animal consumption 1004 of the Act (21 U.S.C. 822–829 and (and not for human consumption). 952–954) and §§ 1301.13, 1301.22, and (3) The term used for human consump- 1301.71 through 1301.76 of this chapter tion means either: for administrative purposes only may (i) Ingested orally or be obtained by submitting a written re- (ii) Applied by any means such that quest to the Drug and Chemical Eval- THC enters the human body. uation Section, Drug Enforcement Ad- (4) The term intended for use for ministration. See the Table of DEA human consumption means any of the Mailing Addresses in § 1321.01 of this following: chapter for the current mailing ad- (i) Designed by the manufacturer for dress. human consumption; [75 FR 10679, Mar. 9, 2010] (ii) Marketed for human consumption; or EXEMPT CANNABIS PLANT MATERIAL, (iii) Distributed, exported, or im- AND PRODUCTS MADE THEREFROM, ported, with the intent that it be used THAT CONTAIN for human consumption. TETRAHYDROCANNABINOLS (c) In any proceeding arising under the Act or this chapter, the burden of § 1308.35 Exemption of certain can- going forward with the evidence that a nabis plant material, and products material, compound, mixture, or prepa- made therefrom, that contain ration containing THC is exempt from tetrahydrocannabinols. control pursuant to this section shall (a) Any processed plant material or be upon the person claiming such ex- animal feed mixture containing any emption, as set forth in section amount of tetrahydrocannabinols 515(a)(1) of the Act (21 U.S.C. 885(a)(1)). (THC) that is both: In order to meet this burden with re- (1) Made from any portion of a plant spect to a product or plant material of the genus Cannabis excluded from that has not been expressly exempted the definition of marijuana under the from control by the Administrator pur- Act [i.e., the mature stalks of such suant to § 1308.23, the person claiming plant, fiber produced from such stalks, the exemption must present rigorous oil or cake made from the seeds of such scientific evidence, including well-doc- plant, any other compound, manufac- umented scientific studies by experts ture, salt, derivative, mixture, or prep- trained and qualified to evaluate the aration of such mature stalks (except effects of drugs on humans. the resin extracted therefrom), fiber, [66 FR 51544, Oct. 9, 2001] oil, or cake, or the sterilized seed of such plant which is incapable of germi- HEARINGS nation] and (2) Not used, or intended for use, for § 1308.41 Hearings generally. human consumption, has been exempt- In any case where the Administrator ed by the Administrator from the ap- shall hold a hearing on the issuance, plication of the Act and this chapter. amendment, or repeal of rules pursuant

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to section 201 of the Act, the proce- (A) The proposed rule in the form proposed dures for such hearing and accom- by the petitioner. (If the petitioner seeks the panying proceedings shall be governed amendment or repeal of an existing rule, the generally by the rulemaking proce- existing rule, together with a reference to the section in the Code of Federal Regula- dures set forth in the Administrative tions where it appears, should be included.) Procedure Act (5 U.S.C. 551–559) and (B) A statement of the grounds which the specifically by section 201 of the Act (21 petitioner relies for the issuance (amend- U.S.C. 811), by §§ 1308.42–1308.51, and by ment or repeal) of the rule. (Such grounds §§ 1316.41–1316.67 of this chapter. shall include a reasonably concise statement of the facts relied upon by the petitioner, in- § 1308.42 Purpose of hearing. cluding a summary of any relevant medical or scientific evidence known to the peti- If requested by any interested person tioner.) after proceedings are initiated pursu- All notices to be sent regarding this peti- ant to § 1308.43, the Administrator shall tion should be addressed to: hold a hearing for the purpose of re- llllllllll (Name) ceiving factual evidence and expert llllllllll (Street Address) opinion regarding the issues involved llllllllll (City and State) Respectfully yours, in the issuance, amendment or repeal llllllllll (Signature of petitioner) of a rule issuable pursuant to section 201(a) of the Act (21 U.S.C. 811(a)). Ex- (c) Within a reasonable period of tensive argument should not be offered time after the receipt of a petition, the into evidence but rather presented in Administrator shall notify the peti- opening or closing statements of coun- tioner of his acceptance or nonaccept- sel or in memoranda or proposed find- ance of the petition, and if not accept- ings of fact and conclusions of law. Ad- ed, the reason therefor. The Adminis- ditional information relating to hear- trator need not accept a petition for ings to include waivers or modification filing if any of the requirements pre- of rules, request for hearing, burden of scribed in paragraph (b) of this section proof, time and place, and final order is lacking or is not set forth so as to be are set forth in part 1316 of this chap- readily understood. If the petitioner ter. desires, he may amend the petition to meet the requirements of paragraph (b) [62 FR 13968, Mar. 24, 1997] of this section. If accepted for filing, a petition may be denied by the Adminis- § 1308.43 Initiation of proceedings for trator within a reasonable period of rulemaking. time thereafter if he finds the grounds (a) Any interested person may sub- upon which the petitioner relies are mit a petition to initiate proceedings not sufficient to justify the initiation for the issuance, amendment, or repeal of proceedings. of any rule or regulation issuable pur- (d) The Administrator shall, before suant to the provisions of section 201 of initiating proceedings for the issuance, the Act. amendment, or repeal of any rule ei- (b) Petitions shall be submitted in ther to control a drug or other sub- quintuplicate to the Administrator. stance, or to transfer a drug or other See the Table of DEA Mailing Address- substance from one schedule to an- es in § 1321.01 of this chapter for the other, or to remove a drug or other current mailing address. Petitions substance entirely from the schedules, shall be in the following form: and after gathering the necessary data, request from the Secretary a scientific llllllllll (Date) and medical evaluation and the Sec- Administrator, Drug Enforcement Adminis- retary’s recommendations as to wheth- tration llllll (Mailing Address) er such drug or other substance should Dear Sir: The undersigned llllllll be so controlled, transferred, or re- hereby petitions the Administrator to ini- moved as a controlled substance. The tiate proceedings for the issuance (amendment or repeal) of a rule or regulation pursu- recommendations of the Secretary to ant to section 201 of the Controlled Sub- the Administrator shall be binding on stances Act. the Administrator as to such scientific Attached hereto and constituting a part of and medical matters, and if the Sec- this petition are the following: retary recommends that a drug or

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other substance not be controlled, the (b) Any interested person desiring to Administrator shall not control that participate in a hearing pursuant to drug or other substance. § 1308.41 shall, within 30 days after the (e) If the Administrator determines date of publication of the notice of that the scientific and medical evalua- hearing in the FEDERAL REGISTER, file tion and recommendations of the Sec- with the Administrator a written no- retary and all other relevant data con- tice of his intention to participate in stitute substantial evidence of poten- such hearing in the form prescribed in tial for abuse such as to warrant con- § 1316.48 of this chapter. Any person fil- trol or additional control over the drug ing a request for a hearing need not or other substance, or substantial evi- also file a notice of appearance; the re- dence that the drug or other sub- quest for a hearing shall be deemed to stances should be subjected to lesser be a notice of appearance. control or removed entirely from the (c) Any interested person may, with- schedules, he shall initiate proceedings in the period permitted for filing a re- for control, transfer, or removal as the quest for a hearing, file with the Ad- case may be. ministrator a waiver of an opportunity (f) If and when the Administrator de- for a hearing or to participate in a termines to initiate proceedings, he hearing, together with a written state- shall publish in the FEDERAL REGISTER ment regarding his position on the general notice of any proposed rule matters of fact and law involved in making to issue, amend, or repeal any such hearing. Such statement, if ad- rule pursuant to section 201 of the Act. missible, shall be made a part of the Such published notice shall include a record and shall be considered in light statement of the time, place, and na- of the lack of opportunity for cross-ex- ture of any hearings on the proposal in amination in determining the weight the event a hearing is requested pursu- to be attached to matters of fact as- ant to § 1308.44. Such hearings may not serted therein. be commenced until after the expira- (d) If any interested person fails to tion of at least 30 days from the date file a request for a hearing; or if he so the general notice is published in the files and fails to appear at the hearing, FEDERAL REGISTER. Such published no- he shall be deemed to have waived his tice shall also include a reference to opportunity for the hearing or to par- the legal authority under which the ticipate in the hearing, unless he shows rule is proposed, a statement of the good cause for such failure. proposed rule, and, in the discretion of (e) If all interested persons waive or the Administrator, a summary of the are deemed to waive their opportunity subjects and issues involved. for the hearing or to participate in the (g) The Administrator may permit hearing, the Administrator may cancel any interested persons to file written the hearing, if scheduled, and issue his comments on or objections to the pro- final order pursuant to § 1308.45 without posal and shall designate in the notice a hearing. of proposed rule making the time dur- [38 FR 8254, Mar. 30, 1973. Redesignated at 38 ing which such filings may be made. FR 26609, Sept. 24, 1973, and further redesig- [38 FR 8254, Mar. 30, 1973. Redesignated at 38 nated and amended at 62 FR 13968, Mar. 24, FR 26609, Sept. 24, 1973, and further redesig- 1997] nated and amended at 62 FR 13968, Mar. 24, 1997; 75 FR 10679, Mar. 9, 2010] § 1308.45 Final order. As soon as practicable after the pre- § 1308.44 Request for hearing or ap- siding officer has certified the record pearance; waiver. to the Administrator, the Adminis- (a) Any interested person desiring a trator shall cause to be published in hearing on a proposed rulemaking, the FEDERAL REGISTER his order in the shall, within 30 days after the date of proceeding, which shall set forth the publication of notice of the proposed final rule and the findings of fact and rulemaking in the FEDERAL REGISTER, conclusions of law upon which the rule file with the Administrator a written is based. This order shall specify the request for a hearing in the form pre- date on which it shall take effect, scribed in § 1316.47 of this chapter. which shall not be less than 30 days

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from the date of publication in the which the controlled substance of FEDERAL REGISTER unless the Adminis- which it is an immediate precursor is trator finds that conditions of public placed or any other schedule with a health or safety necessitate an earlier higher numerical designation. An order effective date, in which event the Ad- controlling an immediate precursor ministrator shall specify in the order shall become effective 30 days from the his findings as to such conditions. date of publication in the FEDERAL [38 FR 8254, Mar. 30, 1973. Redesignated at 38 REGISTER, unless the Administrator FR 26609, Sept. 24, 1973, and further redesig- finds that conditions of public health nated at 62 FR 13968, Mar. 24, 1997] or safety necessitate an earlier effective date, in which event the Adminis- § 1308.46 Control required under international treaty. trator shall specify in the order his findings as to such conditions. Pursuant to section 201(d) of the Act (21 U.S.C. 811(d) ), where control of a [38 FR 8254, Mar. 30, 1973. Redesignated at 38 substance is required by U.S. obliga- FR 26609, Sept. 24, 1973, and further redesig- tions under international treaties, con- nated at 62 FR 13968, Mar. 24, 1997] ventions, or protocols in effect on May 1, 1971, the Administrator shall issue § 1308.49 Emergency scheduling. and publish in the FEDERAL REGISTER Pursuant to 21 U.S.C. 811(h) and with- an order controlling such substance out regard to the requirements of 21 under the schedule he deems most ap- U.S.C. 811(b) relating to the scientific propriate to carry out obligations. and medical evaluation of the Sec- Issuance of such an order shall be with- retary of Health and Human Services, out regard to the findings required by the Administrator may place a sub- subsections 201(a) or 202(b) of the Act (21 U.S.C. 811(a) or 812(b)) and without stance into Schedule I on a temporary regard to the procedures prescribed by basis, if he determines that such action § 1308.41 or subsections 201 (a) and (b) of is necessary to avoid an imminent haz- the Act (21 U.S.C. 811 (a) and (b)). An ard to the public safety. An order order controlling a substance shall be- issued under this section may not be come effective 30 days from the date of effective before the expiration of 30 publication in the FEDERAL REGISTER, days from: unless the Administrator finds that (a) The date of publication by the Ad- conditions of public health or safety ministrator of a notice in the FEDERAL necessitate an earlier effective date, in REGISTER of his intention to issue such which event the Administrator shall order and the grounds upon which such specify in the order his findings as to order is to be issued, and such conditions. (b) The date the Administrator has [38 FR 8254, Mar. 30, 1973. Redesignated at 38 transmitted notification to the Sec- FR 26609, Sept. 24, 1973, and further redesig- retary of Health and Human Services nated at 62 FR 13968, Mar. 24, 1997] of his intention to issue such order. An order issued under this section shall be § 1308.47 Control of immediate precursors. vacated upon the conclusion of a subsequent rulemaking proceeding initiated Pursuant to section 201(e) of the Act under section 201(a) (21 U.S.C. 811(a)) (21 U.S.C. 811(e)), the Administrator with respect to such substance or at may, without regard to the findings re- the end of one year from the effective quired by subsection 201(a) or 202 (b) of the Act (21 U.S.C. 811(a) or 812(b)) and date of the order scheduling the sub- without regard to the procedures pre- stance, except that during the pend- scribed by § 1308.41 or subsections 201 ency of proceedings under section (a) and (b) of the Act (21 U.S.C. 811(a) 201(a) (21 U.S.C. 811(a)) with respect to and (b)), issue and publish in the FED- the substance, the Administrator may ERAL REGISTER an order controlling an extend the temporary scheduling for up immediate precursor. The order shall to six months. designate the schedule in which the im- [51 FR 15318, Apr. 23, 1986. Redesignated and mediate precursor is to be placed, amended at 62 FR 13968, Mar. 24, 1997] which shall be the same schedule in

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PART 1309—REGISTRATION OF MODIFICATION, TRANSFER AND TERMINATION MANUFACTURERS, DISTRIBUTORS, OF REGISTRATION IMPORTERS AND EXPORTERS OF 1309.61 Modification in registration. LIST I CHEMICALS 1309.62 Termination of registration. 1309.63 Transfer of registration.

GENERAL INFORMATION SECURITY REQUIREMENTS Sec. 1309.71 General security requirements. 1309.01 Scope of part 1309. 1309.72 Felony conviction; employer respon- 1309.02 Definitions. sibilities. 1309.03 Information; special instructions. 1309.73 Employee responsibility to report diversion. FEES FOR REGISTRATION AND REREGISTRATION AUTHORITY: 21 U.S.C. 802, 821, 822, 823, 824, 1309.11 Fee amounts. 830, 871(b), 875, 877, 886a, 952, 958. 1309.12 Time and method of payment; refund. SOURCE: 60 FR 32454, June 22, 1995, unless otherwise noted. REQUIREMENTS FOR REGISTRATION GENERAL INFORMATION 1309.21 Persons required to register. 1309.22 Separate registration for independent activities. § 1309.01 Scope of part 1309. 1309.23 Separate registration for separate Procedures governing the registra- locations. tion of manufacturers, distributors, 1309.24 Waiver of registration requirement importers and exporters of List I for certain activities. chemicals pursuant to Sections 102, 302, 1309.25 Temporary exemption from registra- 303, 1007 and 1008 of the Act (21 U.S.C. tion for chemical registration applicants. 802, 822, 823, 957 and 958) are set forth 1309.26 Exemption of law enforcement officials. generally by those sections and specifically by the sections of this part. APPLICATION FOR REGISTRATION § 1309.02 Definitions. 1309.31 Time for application for registration; expiration date. Any term used in this part shall have 1309.32 Application forms; contents, signa- the definition set forth in section 102 of ture. the Act (21 U.S.C. 802) or part 1300 of 1309.33 Filing of application; joint filings. this chapter. 1309.34 Acceptance for filing; defective applications. [62 FR 13968, Mar. 24, 1997] 1309.35 Additional information. 1309.36 Amendments to and withdrawals of § 1309.03 Information; special instruc- applications. tions. Information regarding procedures ACTION ON APPLICATIONS FOR REGISTRATION: REVOCATION OR SUSPENSION OF REGISTRATION under these rules and instructions supplementing these rules will be fur- 1309.41 Administrative review generally. nished upon request by writing to the 1309.42 Certificate of registration; denial of Registration Section, Drug Enforce- registration. ment Administration. See the Table of 1309.43 Suspension or revocation of registration. DEA Mailing Addresses in § 1321.01 of 1309.44 Suspension of registration pending this chapter for the current mailing ad- final order. dress. 1309.45 Extension of registration pending [75 FR 10680, Mar. 9, 2010] final order. 1309.46 Order to show cause. FEES FOR REGISTRATION AND HEARINGS REREGISTRATION 1309.51 Hearings generally. § 1309.11 Fee amounts. 1309.52 Purpose of hearing. 1309.53 Request for hearing or appearance; (a) For each application for registra- waiver. tion or reregistration to manufacture 1309.54 Burden of proof. the applicant shall pay an annual fee of 1309.55 Time and place of hearing. $2,293.

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(b) For each application for registra- through 1310.13 of this chapter, the fol- tion or reregistration to distribute, im- lowing persons must annually obtain a port, or export a List I chemical, the registration specific to the List I applicant shall pay an annual fee of chemicals to be handled: $1,147. (1) Every person who manufactures [75 FR 4980, Feb. 1, 2010] or imports or proposes to manufacture or import a List I chemical or a drug § 1309.12 Time and method of pay- product containing ephedrine, ment; refund. pseudoephedrine, or phenylpropanola- (a) For each application for registra- mine. tion or reregistration to manufacture, (2) Every person who distributes or distribute, import, or export, the appli- exports or proposes to distribute or ex- cant shall pay the fee when the appli- port any List I chemical, other than cation for registration or reregistra- those List I chemicals contained in a tion is submitted for filing. product exempted under (b) Payments should be made in the § 1300.02(b)(28)(i)(D) of this chapter. form of a credit card; a personal, certified, or cashier’s check; or a money (b) Only persons actually engaged in order made payable to ‘‘Drug Enforce- the activities are required to obtain a ment Administration.’’ Payments registration; related or affiliated per- made in the form of stamps, foreign sons who are not engaged in the activi- currency, or third party endorsed ties are not required to be registered. checks will not be accepted. These ap- (For example, a stockholder or parent plication fees are not refundable. corporation of a corporation distributing List I chemicals is not required [75 FR 4980, Feb. 1, 2010] to obtain a registration.) REQUIREMENTS FOR REGISTRATION (c) The registration requirements are summarized in the following table: § 1309.21 Persons required to register. (a) Unless exempted by law or under §§ 1309.24 through 1309.26 or §§ 1310.12

SUMMARY OF REGISTRATION REQUIREMENTS AND LIMITATIONS

Registration Business activity Chemicals DEA forms Application fee period Coincident activities (years) allowed

Manufacturing ...... List I, Drug prod- New—510 ...... $2,293 1 May distribute that ucts containing Renewal—510a ...... 2,293 chemical for ephedrine, which registration pseudoephedrin- was issued; may e, phenyl- not distribute any propanolamine. chemical for which not registered. Distributing ...... List I, Scheduled New—510 ...... 1,147 1 listed chemical Renewal—510a ...... 1,147 products. Importing ...... List I, Drug Prod- New—510 ...... 1,147 1 May distribute that ucts containing Renewal—510a ...... 1,147 chemical for ephedrine, which registration pseudoephedrin- was issued; may e, phenyl- not distribute any propanolamine. chemical for which not registered. Exporting ...... List I, Scheduled New—510 ...... 1,147 1 listed chemical Renewal—510a ...... 1,147 products.

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[75 FR 4980, Feb. 1, 2010] chemicals were originally delivered; and § 1309.22 Separate registration for (2) An office used by agents of a reg- independent activities. istrant where sales of List I chemicals (a) The following groups of activities are solicited, made, or supervised but are deemed to be independent of each which neither contains such chemicals other: (other than chemicals for display pur- (1) Manufacturing of List I chemicals poses) nor serves as a distribution or drug products containing ephedrine, point for filling sales orders. pseudoephedrine, or phenylpropanolamine. [60 FR 32454, June 22, 1995, as amended at 75 FR 4981, Feb. 1, 2010] (2) Distributing of List I chemicals and scheduled listed chemical prod- § 1309.24 Waiver of registration re- ucts. quirement for certain activities. (3) Importing List I chemicals or (a) The requirement of registration is drug products containing ephedrine, waived for any agent or employee of a pseudoephedrine, or phenylpropanola- person who is registered to engage in mine. any group of independent activities, if (4) Exporting List I chemicals and the agent or employee is acting in the scheduled listed chemical products. usual course of his or her business or (b) Except as provided in paragraphs employment. (c) and (d) of this section, every person (b) The requirement of registration is who engages in more than one group of waived for any person who manufac- independent activities must obtain a tures or distributes a scheduled listed separate registration for each group of chemical product or other product con- activities, unless otherwise exempted taining a List I chemical that is de- by the Act or §§ 1309.24 through 1309.26. scribed and included in the definition (c) A person registered to import any of ‘‘regulated transaction’’ in List I chemical shall be authorized to § 1300.02(b)(28)(i)(D) of this chapter, if distribute that List I chemical after that person is registered with the Ad- importation, but no other chemical ministration to engage in the same ac- that the person is not registered to im- tivity with a controlled substance. port. (c) The requirement of registration is (d) A person registered to manufac- waived for any person who imports or ture any List I chemical shall be au- exports a scheduled listed chemical thorized to distribute that List I chem- product or other product containing a ical after manufacture, but no other List I chemical that is described and chemical that the person is not reg- included in the definition of ‘‘regulated istered to manufacture. transaction’’ in § 1300.02(b)(28)(i)(D) of [75 FR 4981, Feb. 1, 2010] this chapter, if that person is registered with the Administration to en- § 1309.23 Separate registration for sep- gage in the same activity with a con- arate locations. trolled substance. (a) A separate registration is re- (d) The requirement of registration is quired for each principal place of busi- waived for any person who only distrib- ness at one general physical location utes a prescription drug product con- where List I chemicals are manufac- taining a List I chemical that is regu- tured, distributed, imported, or ex- lated pursuant to § 1300.02(b)(28)(i)(D) of ported by a person. this chapter. (b) The following locations shall be (e) The requirement of registration is deemed to be places not subject to the waived for any person whose activities registration requirement: with respect to List I chemicals are (1) A warehouse where List I chemi- limited to the distribution of red phos- cals are stored by or on behalf of a reg- phorus, white phosphorus, or istered person, unless such chemicals hypophosphorous acid (and its salts) to are distributed directly from such another location operated by the same warehouse to locations other than the firm solely for internal end-use, or an registered location from which the EPA or State licensed waste treatment

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or disposal firm for the purpose of and reporting requirements set forth waste disposal. under Parts 1310, 1313, 1314, and 1315 of (f) The requirement of registration is this chapter. waived for any person whose distribu- [75 FR 4981, Feb. 1, 2010] tion of red phosphorus or white phosphorus is limited solely to residual § 1309.25 Temporary exemption from quantities of chemical returned to the registration for chemical registra- producer, in reusable rail cars and tion applicants. intermodal tank containers which con- (a) Each person required by section form to International Standards Orga- 302 of the Act (21 U.S.C. 822) to obtain nization specifications (with capacities a registration to distribute, import, or greater than or equal to 2,500 gallons in export a combination ephedrine prod- a single container). uct is temporarily exempted from the (g) The requirement of registration is registration requirement, provided waived for any person whose activities that the person submits a proper appli- with respect to List I chemicals are cation for registration on or before limited solely to the distribution of July 12, 1997. The exemption will re- Lugol’s Solution (consisting of 5 per- main in effect for each person who has cent iodine and 10 percent potassium made such application until the Ad- iodide in an aqueous solution) in origi- ministration has approved or denied nal manufacturer’s packaging of one that application. This exemption ap- fluid ounce (30 ml) or less. plies only to registration; all other (h) The requirement of registration is chemical control requirements set waived for any manufacturer of a List forth in this part 1309 and parts 1310, I chemical, if that chemical is pro- and 1313 of this chapter remain in full duced solely for internal consumption force and effect. by the manufacturer and there is no (b) Each person required by section subsequent distribution or exportation 302 of the Act (21 U.S.C. 822) to obtain of the List I chemical. a registration to distribute, import, or (i) If any person exempted under export a pseudoephedrine or phenyl- paragraph (b), (c), (d), (e), or (f) of this propanolamine drug product is tempo- section also engages in the distribu- rarily exempted from the registration tion, importation, or exportation of a requirement, provided that the person List I chemical, other than as de- submits a proper application for reg- scribed in such paragraph, the person istration on or before October 3, 1997. shall obtain a registration for the ac- The exemption will remain in effect for tivities, as required by § 1309.21. each person who has made such appli- (j) The Administrator may, upon cation until the Administration has ap- finding that continuation of the waiver proved or denied that application. This would not be in the public interest, exemption applies only to registration; suspend or revoke a waiver granted all other chemical control require- under paragraph (b), (c), (d), (e), or (f) ments set forth in this part 1309 and of this section pursuant to the proce- parts 1310 and 1313 of this chapter re- dures set forth in §§ 1309.43 through main in full force and effect. 1309.46 and §§ 1309.51 through 1309.55. In (c) Each person required by sections considering the revocation or suspen- 302 or 1007 of the Act (21 U.S.C. 822 or sion of a person’s waiver granted pur- 957) to obtain a registration to manu- suant to paragraph (b) or (c) of this facture or import prescription drug section, the Administrator shall also products containing ephedrine, consider whether action to revoke or pseudoephedrine, or phenylpropanola- suspend the person’s controlled sub- mine is temporarily exempted from the stance registration pursuant to section registration requirement, provided 304 of the Act (21 U.S.C. 824) is war- that the person submits a proper appli- ranted. cation for registration on or before (k) Any person exempted from the March 3, 2010. The exemption will reregistration requirement under this main in effect for each person who has section must comply with the security made such application until the Ad- requirements set forth in §§ 1309.71 ministration has approved or denied through 1309.73 and the recordkeeping the application. This exemption applies

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only to registration; all other chemical 60 days before the expiration date of control requirements set forth in this his registration. part and parts 1310, 1313, and 1315 of (c) At the time a person is first reg- this chapter remain in full force and ef- istered, that person shall be assigned fect. to one of twelve groups, which shall correspond to the months of the year. [67 FR 14860, Mar. 28, 2002, as amended at 75 The expiration date of the registra- FR 4982, Feb. 1, 2010] tions of all registrants within any § 1309.26 Exemption of law enforce- group will be the last day of the month ment officials. designated for that group. In assigning any of the above persons to a group, (a) The requirement of registration is the Administration may select a group waived for the following persons in the the expiration date of which is less circumstances described in this sec- than one year from the date such busi- tion: ness activity was registered. If the per- (1) Any officer or employee of the Ad- son is assigned to a group which has an ministration, any officer of the U.S. expiration date less than eleven Customs Service, any officer or em- months from the date of which the per- ployee of the United States Food and son is registered, the registration shall Drug Administration, any other Fed- not expire until one year from that ex- eral officer who is lawfully engaged in piration date; in all other cases, the the enforcement of any Federal law reregistration shall expire on the expira- lating to listed chemicals, controlled tion date following the date on which substances, drugs or customs, and is the person is registered. duly authorized to possess and distribute List I chemicals in the course § 1309.32 Application forms; contents; of official duties; and signature. (2) Any officer or employee of any (a) Any person who is required to be State, or any political subdivision or registered pursuant to § 1309.21 and is agency thereof, who is engaged in the not so registered, shall apply on DEA enforcement of any State or local law Form 510. relating to listed chemicals and con- (b) Any person who is registered pur- trolled substances and is duly author- suant to Section 1309.21, shall apply for ized to possess and distribute List I reregistration on DEA Form 510a. chemicals in the course of his official (c) DEA Form 510 may be obtained at duties. any divisional office of the Administra- (b) Any official exempted by this section or by writing to the Registration tion may, when acting in the course of Section, Drug Enforcement Adminis- official duties, possess any List I chem- tration. See the Table of DEA Mailing ical and distribute any such chemical Addresses in § 1321.01 of this chapter for to any other official who is also ex- the current mailing address. DEA empted by this section and acting in Form 510a will be mailed to each List I the course of official duties. chemical registrant approximately 60 days before the expiration date of his APPLICATION FOR REGISTRATION or her registration; if any registered person does not receive such forms § 1309.31 Time for application for reg- within 45 days before the expiration istration; expiration date. date of the registration, notice must be (a) Any person who is required to be promptly given of such fact and DEA registered and who is not so registered Form 510a must be requested by writ- may apply for registration at any time. ing to the Registration Section of the No person required to be registered Administration at the foregoing ad- shall engage in any activity for which dress. registration is required until the appli- (d) Each application for registration cation for registration is approved and shall include the Administration a Certificate of Registration is issued Chemical Code Number, as set forth in by the Administrator to such person. § 1310.02 of this chapter, for each List I (b) Any person who is registered may chemical to be distributed, imported, apply to be reregistered not more than or exported.

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(e) Registration shall not entitle a to comply with the requirements of person to engage in any activity with this part will not generally be accepted any List I chemical not specified in his for filing. In the case of minor defects or her application. as to completeness, the Administrator (f) Each application shall include all may accept the application for filing information called for in the form, un- with a request to the applicant for ad- less the item is not applicable, in ditional information. A defective appli- which case this fact shall be indicated. cation will be returned to the applicant (g) Each application, attachment, or within 10 days of receipt with a state- other document filed as part of an ap- ment of the reason for not accepting plication, shall be signed by the appli- the application for filing. A defective cant, if an individual; by a partner of application may be corrected and re- the applicant, if a partnership; or by an submitted for filing at any time. officer of the applicant, if a corpora- (b) Accepting an application for fil- tion, corporate division, association, ing does not preclude any subsequent trust or other entity. An applicant may request for additional information pur- authorize one or more individuals, who suant to § 1309.35 and has no bearing on would not otherwise be authorized to whether the application will be grant- do so, to sign applications for the ap- ed. plicant by filing with the application or other document a power of attorney § 1309.35 Additional information. for each such individual. The power of attorney shall be signed by a person The Administrator may require an who is authorized to sign applications applicant to submit such documents or under this paragraph and shall contain written statements of fact relevant to the signature of the individual being the application as he deems necessary authorized to sign the application or to determine whether the application other document. The power of attorney should be granted. The failure of the shall be valid until revoked by the ap- applicant to provide such documents or plicant. statements within a reasonable time after being requested to do so shall be [60 FR 32454, June 22, 1995, as amended at 75 FR 10680, Mar. 9, 2010] deemed to be a waiver by the applicant of an opportunity to present such docu- § 1309.33 Filing of application; joint fil- ments or facts for consideration by the ings. Administrator in granting or denying (a) All applications for registration the application. shall be submitted for filing to the Registration Section, Drug Enforce- § 1309.36 Amendments to and with- ment Administration. See the Table of drawals of applications. DEA Mailing Addresses in § 1321.01 of (a) An application may be amended this chapter for the current mailing ad- or withdrawn without permission of dress. The appropriate registration fee the Administration at any time before and any required attachments must ac- the date on which the applicant re- company the application. ceives an order to show cause pursuant (b) Any person required to obtain to § 1309.46. An application may be more than one registration may submit amended or withdrawn with permission all applications in one package. Each of the Administrator at any time application must be complete and must where good cause is shown by the ap- not refer to any accompanying applica- plicant or where the amendment or tion for required information. withdrawal is in the public interest. [60 FR 32454, June 22, 1995, as amended at 75 (b) After an application has been ac- FR 10680, Mar. 9, 2010] cepted for filing, the request by the applicant that it be returned or the fail- § 1309.34 Acceptance for filing; defec- ure of the applicant to respond to offi- tive applications. cial correspondence regarding the ap- (a) Applications submitted for filing plication, including a request that the are dated upon receipt. If found to be applicant submit the required fee, complete, the application will be ac- when sent by registered or certified cepted for filing. Applications failing mail, return receipt requested, shall be

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deemed to be a withdrawal of the appli- § 1309.43 Suspension or revocation of cation. registration. (a) The Administrator may suspend ACTION ON APPLICATIONS FOR REGISTRA- any registration pursuant to section TION: REVOCATION OR SUSPENSION OF 304(a) of the Act (21 U.S.C. 824(a)) for REGISTRATION any period of time he determines. (b) The Administrator may revoke § 1309.41 Administrative review gen- any registration pursuant to section erally. 304(a) of the Act (21 U.S.C. 824(a)). The Administrator may inspect, or (c) Before revoking or suspending any cause to be inspected, the establish- registration, the Administrator shall ment of an applicant or registrant, pur- issue an order to show cause pursuant suant to subpart A of part 1316 of this to Section 1309.46 and, if requested by chapter. The Administrator shall re- the registrant, shall hold a hearing view the application for registration pursuant to Section 1309.51. Notwith- and other information gathered by the standing the requirements of this Sec- Administrator regarding an applicant tion, however, the Administrator may suspend any registration pending a in order to determine whether the ap- final order pursuant to § 1309.44. plicable standards of Section 303 of the (d) Upon service of the order of the Act (21 U.S.C. 823) have been met by Administrator suspending or revoking the applicant. registration, the registrant shall immediately deliver his or her Certificate § 1309.42 Certificate of registration; of Registration to the nearest office of denial of registration. the Administration. Also, upon service (a) The Administrator shall issue a of the order of the Administrator re- Certificate of Registration (DEA Form voking or suspending registration, the 511) to an applicant if the issuance of registrant shall, as instructed by the registration or reregistration is re- Administrator: quired under the applicable provisions (1) Deliver all List I chemicals in his of section 303 of the Act (21 U.S.C. 823). or her possession that were obtained In the event that the issuance of reg- under the authority of a registration or istration or reregistration is not re- an exemption from registration grant- quired, the Administrator shall deny ed by the Administrator by regulation, the application. Before denying any ap- to the nearest office of the Administra- plication, the Administrator shall issue tion or to authorized agents of the Ad- an order to show cause pursuant to ministration; or Section 1309.46 and, if requested by the (2) Place all such List I chemicals in his or her possession under seal as de- applicant, shall hold a hearing on the scribed in section 304(f) of the Act (21 application pursuant to § 1309.51. U.S.C. 824(f)). (b) The Certificate of Registration (e) In the event that revocation or (DEA Form 511) shall contain the suspension is limited to a particular name, address, and registration num- chemical or chemicals, the registrant ber of the registrant, the activity au- shall be given a new Certificate of Reg- thorized by the registration, the istration for all substances not affected amount of fee paid, and the expiration by such revocation or suspension; no date of the registration. The registrant fee shall be required for the new Cer- shall maintain the certificate of reg- tificate of Registration. The registrant istration at the registered location in a shall deliver the old Certificate of Reg- readily retrievable manner and shall istration to the nearest office of the permit inspection of the certificate by Administration. Also, upon service of any official, agent or employee of the the order of the Administrator revok- Administration or of any Federal, ing or suspending registration with re- State, or local agency engaged in en- spect to a particular chemical or forcement of laws relating to List I chemicals, the registrant shall, as in- chemicals or controlled substances. structed by the Administrator: (1) Deliver to the nearest office of the Administration or to authorized agents

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of the Administration all of the par- registrant whose registration is sus- ticular chemical or chemicals in his or pended under this section may request her possession that were obtained a hearing on the revocation or suspen- under the authority of a registration or sion of his registration at a time ear- an exemption from registration grant- lier than specified in the order to show ed by the Administrator by regulation, cause pursuant to Section 1309.46, which are affected by the revocation or which request shall be granted by the suspension; or Administrator, who shall fix a date for (2) Place all of such chemicals under such hearing as early as reasonably seal as described in section 304(f) of the possible. Act (21 U.S.C. 824(f)). [60 FR 32454, June 22, 1995, as amended at 62 [60 FR 32454, June 22, 1995, as amended at 62 FR 5916, Feb. 10, 1997] FR 5916, Feb. 10, 1997] § 1309.45 Extension of registration § 1309.44 Suspension of registration pending final order. pending final order. In the event that an applicant for re- (a) The Administrator may suspend registration (who is doing business any registration simultaneously with under a registration previously granted or at any time subsequent to the serv- and not revoked or suspended) has ap- ice upon the registrant of an order to plied for reregistration at least 45 days show cause why such registration before the date on which the existing should not be revoked or suspended, in registration is due to expire, and the any case where he finds that there is Administrator has issued no order on an imminent danger to the public the application on the date on which health or safety. If the Administrator the existing registration is due to ex- so suspends, he shall serve with the pire, the existing registration of the order to show cause pursuant to applicant shall automatically be ex- § 1309.46 an order of immediate suspen- tended and continue in effect until the sion that shall contain a statement of date on which the Administrator so his findings regarding the danger to issues his order. The Administrator public health or safety. may extend any other existing reg- (b) Upon service of the order of im- istration under the circumstances con- mediate suspension, the registrant templated in this section even though shall promptly return his Certificate of the registrant failed to apply for rereg- Registration to the nearest office of istration at least 45 days before expira- the Administration. Also, upon service tion of the existing registration, with of the order of immediate suspension, or without request by the registrant, if the registrant shall, as instructed by the Administrator finds that such ex- the Administrator: tension is not inconsistent with the (1) Deliver to the nearest office of the public health and safety. Administration or to authorized agents of the Administration all of the par- § 1309.46 Order to show cause. ticular chemical or chemicals in his or (a) If, upon examination of the appli- her possession that were obtained cation for registration from any appli- under the authority of a registration or cant and other information gathered an exemption from registration grant- by the Administration regarding the ed by the Administrator by regulation, applicant, the Administrator is unable which are affected by the revocation or to make the determinations required suspension; or by the applicable provisions of section (2) Place all of such chemicals under 303 of the Act (21 U.S.C. 823) to register seal as described in section 304(f) of the the applicant, the Administrator shall Act (21 U.S.C. 824(f)). serve upon the applicant an order to (c) Any suspension shall continue in show cause why the application for reg- effect until the conclusion of all pro- istration should not be denied. ceedings upon the revocation or sus- (b) If, upon information gathered by pension, including any judicial review the Administration regarding any reg- thereof, unless sooner withdrawn by istrant, the Administrator determines the Administrator or dissolved by a that the registration of such registrant court of competent jurisdiction. Any is subject to suspension or revocation

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pursuant to section 304 of the Act (21 sive argument should not be offered U.S.C. 824), the Administrator shall into evidence but rather presented in serve upon the registrant an order to opening or closing statements of coun- show cause why the registration should sel or in memoranda or proposed find- not be revoked or suspended. ings of fact and conclusions of law. (c) The order to show cause shall call upon the applicant or registrant to ap- § 1309.53 Request for hearing or appear before the Administrator at a pearance; waiver. time and place stated in the order, (a) Any person entitled to a hearing which shall not be less than 30 days pursuant to §§ 1309.42 and 1309.43 and de- after the date of receipt of the order. siring a hearing shall, within 30 days The order to show cause shall also con- after the date of receipt of the order to tain a statement of the legal basis for show cause, file with the Adminis- such hearing and for the denial, revoca- trator a written request for a hearing tion, or suspension of registration and in the form prescribed in § 1316.47 of a summary of the matters of fact and this chapter. law asserted. (b) Any person entitled to a hearing (d) Upon Receipt of an order to show pursuant to §§ 1309.42 and 1309.43 may, cause, the applicant or registrant within the period permitted for filing a must, if he desires a hearing, file a re- request for a hearing, file with the Ad- quest for a hearing pursuant to ministrator a waiver of an opportunity § 1309.54. If a hearing is requested, the for a hearing, together with a written Administrator shall hold a hearing at statement regarding his position on the time and place stated in the order, the matters of fact and law involved in pursuant to § 1309.51. such hearing. Such statement, if ad- (e) When authorized by the Adminis- missible, shall be made a part of the trator, any agent of the Administra- record and shall be considered in light tion may serve the order to show of the lack of opportunity for cross-ex- cause. amination in determining the weight to be attached to matters of fact as- HEARINGS serted therein. (c) If any person entitled to a hearing § 1309.51 Hearings generally. pursuant to §§ 1309.42 and 1309.43 fails to (a) In any case where the Adminis- file a request for a hearing, or if he so trator shall hold a hearing on any reg- files and fails to appear at the hearing, istration or application therefore, the he shall be deemed to have waived his procedures for such hearing shall be opportunity for the hearing, unless he governed generally by the adjudication shows good cause for such failure. procedures set forth in the Administra- (d) If any person entitled to a hearing tive Procedure Act (5 U.S.C. 551–559) waives or is deemed to waive his or her and specifically by sections 303 and 304 opportunity for the hearing, the Ad- of the Act (21 U.S.C. 823–824), by ministrator may cancel the hearing, if §§ 1309.52 through 1309.57, and by the scheduled, and issue his final order pur- procedures for administrative hearings suant to § 1309.57 without a hearing. under the Act set forth in §§ 1316.41 [60 FR 32454, June 22, 1995. Redesignated at 62 through 1316.67 of this chapter. FR 13968, Mar. 24, 1997] (b) Any hearing under this part shall be independent of, and not in lieu of, § 1309.54 Burden of proof. criminal prosecutions or other pro- (a) At any hearing for the denial of a ceedings under the Act or any other registration, the Administration shall law of the United States. have the burden of proving that the requirements for such registration pursu- § 1309.52 Purpose of hearing. ant to section 303 of the Act (21 U.S.C. If requested by a person entitled to a 823) are not satisfied. hearing, the Administrator shall hold a (b) At any hearing for the revocation hearing for the purpose of receiving or suspension of a registration, the Ad- factual evidence regarding the issues ministration shall have the burden of involved in the denial, revocation, or proving that the requirements for such suspension of any registration. Exten- revocation or suspension pursuant to

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section 304(a) of the Act (21 U.S.C. practice. Any registrant who cases 824(a)) are satisfied. legal existence or discontinues business or professional practice shall [60 FR 32454, June 22, 1995. Redesignated at 62 FR 13968, Mar. 24, 1997] promptly notify the Special Agent in Charge of the Administration in the § 1309.55 Time and place of hearing. area in which the person is located of The hearing will commence at the such fact and seek authority and in- place and time designated in the order structions to dispose of any List I to show cause or notice of hearing pub- chemicals obtained under the authority of that registration. lished in the FEDERAL REGISTER (unless expedited pursuant to Section (b) The Special Agent in Charge shall 1309.44(c)) but thereafter it may be authorize and instruct the person to moved to a different place and may be dispose of the List I chemical in one of continued from day to day or recessed the following manners: to a later day without notice other (1) By transfer to person registered than announcement thereof by the pre- under the Act and authorized to pos- siding officer at the hearing. sess the substances; (2) By delivery to an agent of the Ad- [60 FR 32454, June 22, 1995. Redesignated at 62 ministration or to the nearest office of FR 13968, Mar. 24, 1997] the Administration; MODIFICATION, TRANSFER AND (3) By such other means as the Spe- TERMINATION OF REGISTRATION cial Agent in Charge may determine to assure that the substance does not be- § 1309.61 Modification in registration. come available to unauthorized per- Any registrant may apply to modify sons. his or her registration to authorize the [60 FR 32454, June 22, 1995, as amended at 62 handling of additional List I chemicals FR 5916, Feb. 10, 1997] or to change his or her name or address, by submitting a letter of request § 1309.63 Transfer of registration. to the Registration Section, Drug En- No registration or any authority con- forcement Administration. See the ferred thereby shall be assigned or oth- Table of DEA Mailing Addresses in erwise transferred except upon such § 1321.01 of this chapter for the current conditions as the Administrator may mailing address. The letter shall con- specifically designate and then only tain the registrant’s name, address, pursuant to his written consent. and registration number as printed on the certificate of registration, and the SECURITY REQUIREMENTS List I chemicals to be added to his registration or the new name or address § 1309.71 General security require- and shall be signed in accordance with ments. § 1309.32(g). No fee shall be required to (a) All applicants and registrants be paid for the modification. The re- must provide effective controls and quest for modification shall be handled procedures to guard against theft and in the same manner as an application diversion of List I chemicals. Chemi- for registration. If the modification in cals must be stored in containers registration is approved, the Adminis- sealed in such a manner as to indicate trator shall issue a new certificate of any attempts at tampering with the registration (DEA Form 511) to the reg- container. Where chemicals cannot be istrant, who shall maintain it with the stored in sealed containers, access to old certificate of registration until ex- the chemicals should be controlled piration. through physical means or through [75 FR 10680, Mar. 9, 2010] human or electronic monitoring. (b) In evaluating the effectiveness of § 1309.62 Termination of registration. security controls and procedures, the (a) The registration of any person Administrator shall consider the fol- shall terminate if and when such per- lowing factors: son dies, ceases legal existence, or dis- (1) The type, form, and quantity of continues business or professional List I chemicals handled;

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(2) The location of the premises and ministrative, civil or criminal action the relationship such location bears on resulting from an investigation of the the security needs; individual’s handling of controlled sub- (3) The type of building construction stances or listed chemicals.) The reg- comprising the facility and the general istrant should be aware of the cir- characteristics of the building or build- cumstances regarding the action ings; against the potential employee and the (4) The availability of electronic de- rehabilitative efforts following the ac- tection and alarm systems; tion. The registrant shall assess the (5) the extent of unsupervised public risks involved in employing such per- access to the facility; sons, including the potential for action (6) The adequacy of supervision over against the registrant pursuant to employees having access to List I § 1309.43, If such person is found to have chemicals; diverted listed chemicals, and, in the (7) The procedures for handling busi- event of employment, shall institute ness guests, visitors, maintenance per- procedures to limit the potential for sonnel, and nonemployee service per- diversion of List I chemicals. sonnel in areas where List I chemicals (b) It is the position of DEA that em- are processed or stored; ployees who possess, sell, use or divert (8) The adequacy of the registrant’s listed chemicals or controlled sub- or applicant’s systems for monitoring stances will subject themselves not the receipt, distribution, and disposi- only to State or Federal prosecution tion of List I chemicals in its oper- for any illicit activity, but shall also ations. immediately become the subject of (c) Any registrant or applicant desir- independent action regarding their ing to determine whether a proposed continued employment. The employer system of security controls and proce- will assess the seriousness of the em- dures is adequate may submit mate- ployee’s violation, the position of re- rials and plans regarding the proposed sponsibility held by the employee, past security controls and procedures either record of employment, etc., in deter- to the Special Agent in Charge in the mining whether to suspend, transfer, region in which the security controls terminate or take other action against and procedures will be used, or to the the employee. Regulatory Section, Drug Enforcement Administration. See the Table of DEA § 1309.73 Employee responsibility to Mailing Addresses in § 1321.01 of this report diversion. chapter for the current mailing ad- Reports of listed chemical diversion dress. by fellow employees is not only a nec- [60 FR 32454, June 22, 1995, as amended at 62 essary part of an overall employee se- FR 13968, Mar. 24, 1997; 67 FR 14861, Mar. 28, curity program but also serves the pub- 2002; 71 FR 56023, Sept. 26, 2006; 75 FR 10680, lic interest at large. It is, therefore, Mar. 9, 2010] the position of DEA that an employee who has knowledge of diversion from § 1309.72 Felony conviction; employer his employer by a fellow employee has responsibilities. an obligation to report such informa- (a) The registrant shall exercise cau- tion to a responsible security official of tion in the consideration of employ- the employer. The employer shall treat ment of persons who will have access such information as confidential and to listed chemicals, who have been con- shall take all reasonable steps to pro- victed of a felony offense relating to tect the confidentiality of the informa- controlled substances or listed chemi- tion and the identity of the employee cals, or who have, at any time, had an furnishing information. A failure to re- application for registration with the port information of chemical diversion DEA denied, had a DEA registration re- will be considered in determining the voked, or surrendered a DEA registra- feasibility of continuing to allow an tion for cause. (For purposes of this employee to work in an area with ac- subsection, the term ‘‘for cause’’ means cess to chemicals. The employer shall a surrender in lieu of, or as a con- inform all employees concerning this sequence of, any Federal or State ad- policy.

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PART 1310—RECORDS AND RE- (3) Ephedrine, its salts, optical isomers, and salts of optical isomers PORTS OF LISTED CHEMICALS ...... 8113 AND CERTAIN MACHINES (4) Ergonovine and its salts ...... 8675 (5) Ergotamine and its salts...... 8676 Sec. (6) N-Acetylanthranilic acid, its 1310.01 Definitions. esters, and its salts...... 8522 1310.02 Substances covered. (7) Norpseudoephedrine, its salts, opti- 1310.03 Persons required to keep records and cal isomers, and salts of optical file reports. isomers ...... 8317 1310.04 Maintenance of records. (8) Phenylacetic acid, its esters, and 1310.05 Reports. its salts...... 8791 1310.06 Content of records and reports. (9) Phenylpropanolamine, its salts, op- 1310.07 Proof of identity. tical isomers, and salts of optical 1310.08 Excluded transactions. isomers ...... 1225 1310.09 Temporary exemption from registra- (10) Piperidine and its salts ...... 2704 tion. (11) Pseudoephedrine, its salts, optical 1310.10 Removal of the exemption of drugs isomers, and salts of optical iso- distributed under the Food, Drug and mers...... 8112 Cosmetic Act. (12) 3,4-Methylenedioxyphenyl-2- 1310.11 Reinstatement of exemption for drug propanone ...... 8502 products distributed under the Food, (13) Methylamine and its salts...... 8520 Drug and Cosmetic Act. (14) Ethylamine and its salts ...... 8678 1310.12 Exempt chemical mixtures. (15) Propionic anhydride...... 8328 1310.13 Exemption of chemical mixtures; ap- (16) Isosafrole...... 8704 plication. 1310.14 Removal of exemption from defini- (17) Safrole...... 8323 tion of regulated transaction. (18) Piperonal...... 8750 1310.15 Exempt drug products containing (19) N-Methylephedrine, its salts, opti- ephedrine and therapeutically significant cal isomers, and salts of optical quantities of another active medicinal isomers (N-Methylephedrine) ...... 8115 ingredient. (20) N-Methylpseudoephedrine, its 1310.21 Sale by Federal departments or salts, optical isomers, and salts of agencies of chemicals which could be optical isomers ...... 8119 used to manufacture controlled sub- (21) Hydriodic Acid ...... 6695 stances. (22) Benzaldehyde...... 8256 (23) Nitroethane ...... 6724 AUTHORITY: 21 U.S.C. 802, 827(h), 830, 871(b) (24) Gamma-Butyrolactone (Other 890. names include: GBL; Dihydro-2 SOURCE: 54 FR 31665, Aug. 1, 1989, unless (3H)-furanone; 1,2-Butanolide; 1,4- otherwise noted. Butanolide; 4-Hydroxybutanoic acid lactone; gamma-hydroxy- § 1310.01 Definitions. butyric acid lactone) ...... 2011 (25) Red phosphorus ...... 6795 Any term used in this part shall have (26) White phosphorus (Other names: the definition set forth in section 102 of Yellow Phosphorus) ...... 6796 the Act (21 U.S.C. 802) or part 1300 of (27) Hypophosphorous acid and its this chapter. salts (Including ammonium hypophosphite, calcium [62 FR 13968, Mar. 24, 1997] hypophosphite, iron hypophosphite, potassium § 1310.02 Substances covered. hypophosphite, manganese The following chemicals have been hypophosphite, magnesium specifically designated by the Adminis- hypophosphite and sodium trator of the Drug Enforcement Admin- hypophosphite) ...... 6797 istration as the listed chemicals sub- (28) N-phenethyl-4-piperidone (NPP)...... 8332 (29) Iodine ...... 6699 ject to the provisions of this part and parts 1309 and 1313 of this chapter. Each (b) List II chemicals: chemical has been assigned the DEA (1) Acetic anhydride...... 8519 Chemical Code Number set forth oppo- (2) Acetone...... 6532 site it. (3) Benzyl chloride ...... 8570 (a) List I chemicals (4) Ethyl ether ...... 6584 (5) Potassium permanganate ...... 6579 (1) Anthranilic acid, its esters, and its (6) 2-Butanone (or Methyl Ethyl Ke- salts ...... 8530 tone or MEK) ...... 6714 (2) Benzyl cyanide...... 8735 (7) Toluene ...... 6594

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(8) Hydrochloric acid (including anhy- proposal within 30 days of the date of drous hydrogen chloride) ...... 6545 publication of his order in the FEDERAL (9) Sulfuric acid ...... 6552 REGISTER. The Administrator will con- (10) Methyl Isobutyl Ketone (MIBK) ...... 6715 sider any comments filed by interested (11) Sodium Permanganate ...... 6588 persons and publish a final rule in accordance with his decision in the mat- (c) The Administrator may add or deter. lete a substance as a listed chemical by publishing a final rule in the FEDERAL [54 FR 31665, Aug. 1, 1989, as amended at 56 REGISTER following a proposal which FR 48733, Sept. 26, 1991; 57 FR 43615, Sept. 22, shall be published at least 30 days prior 1992; 60 FR 19510, Apr. 19, 1995; 60 FR 32460, to the final rule. June 22, 1995; 62 FR 5917, Feb. 10, 1997; 65 FR 21647, Apr. 24, 2000; 65 FR 47316, Aug. 2, 2000; (d) Any person may petition the Ad- 66 FR 52675, Oct. 17, 2001; 71 FR 60826, Oct. 17, ministrator to have any substance 2006; 72 FR 20046, Apr. 23, 2007; 72 FR 35391, added or deleted from paragraphs (a) or July 2, 2007; 72 FR 40238, July 24, 2007] (b) of this section. EFFECTIVE DATE NOTE: At 76 FR 17781, Mar. (e) Any petition under this section 31, 2011, § 1310.02 was amended by adding a shall contain the following informa- new paragraph (a)(30), effective May 2, 2011. tion: For the convenience of the user, the added (1) The name and address of the peti- text is set forth as follows: tioner; (2) The name of the chemical to § 1310.02 Substances covered. which the petition pertains; (3) The name and address of the man- * * * * * ufacturer(s) of the chemical (if known); (a) * * * (4) A complete statement of the facts (30) Ergocristine and its salts 8612 which the petitioner believes justifies the addition or deletion of the substance from paragraphs (a) or (b) of * * * * * this section; § 1310.03 Persons required to keep (5) The date of the petition. records and file reports. (f) The Administrator may require the petitioner to submit such docu- (a) Each regulated person who en- ments or written statements of fact gages in a regulated transaction in- relevant to the petition as he deems volving a listed chemical, a tableting necessary in making a determination. machine, or an encapsulating machine (g) Within a reasonable period of shall keep a record of the transaction time after the receipt of the petition, as specified by § 1310.04 and file reports the Administrator shall notify the pe- as specified by § 1310.05. However, a titioner of his decision and the reason non-regulated person who acquires list- therefor. The Administrator need not ed chemicals for internal consumption accept a petition if any of the require- or ‘‘end use’’ and becomes a regulated ments prescribed in paragraph (e) of person by virtue of infrequent or rare this section or requested pursuant to distribution of a listed chemical from paragraph (f) of this section are lack- inventory, shall not be required to ing or are not clearly set forth as to be maintain receipt records of listed readily understood. If the petitioner chemicals under this section. desires, he may amend and resubmit (b) Each regulated person who manu- the petition to meet the requirements factures a List I or List II chemical of paragraphs (e) and (f) of this section. shall file reports regarding such manu- (h) If a petition is granted or the Ad- facture as specified in Section 1310.05. ministrator, upon his own motion, pro- (c) Each regulated person who en- poses to add or delete substances as gages in a transaction with a nonregu- listed chemicals as set forth in para- lated person or who engages in an ex- graph (c) of this section, he shall issue port transaction that involves ephed- and publish in the FEDERAL REGISTER a rine, pseudoephedrine, phenyl- proposal to add or delete a substance as propanolamine, or gamma-hydroxy- a listed chemical. The Administrator butyric acid, including drug products shall permit any interested person to containing these chemicals, and uses or file written comments regarding the attempts to use the Postal Service or

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any private or commercial carrier of the DEA Divisional Office for the must file monthly reports of each such area in which the records are required transaction as specified in § 1310.05 of to be kept. this part. (d) The records required to be kept [54 FR 31665, Aug. 1, 1989, as amended at 56 under this section shall be readily re- FR 8277, Feb. 28, 1991; 61 FR 14023, Mar. 29, trievable and available for inspection 1996; 67 FR 14861, Mar. 28, 2002; 68 FR 57804, and copying by authorized employees Oct. 7, 2003; 70 FR 294, Jan. 4, 2005] of the Administration under the provisions of 21 U.S.C. 880. § 1310.04 Maintenance of records. (e) The regulated person with more (a) Every record required to be kept than one place of business where subject to § 1310.03 for a List I chem- records are required to be kept shall ical, a tableting machine, or an encap- devise a system to detect any party sulating machine shall be kept by the purchasing from several individual lo- regulated person for 2 years after the cations of the regulated person thereby date of the transaction. seeking to avoid the application of the (b) Every record required to be kept cumulative threshold or evading the subject to Section 1310.03 for List II requirements of the Act. chemical shall be kept by the regulated (f) For those listed chemicals for person for two years after the date of which thresholds have been estab- the transaction. lished, the quantitative threshold or (c) A record under this section shall the cumulative amount for multiple be kept at the regulated person’s place transactions within a calendar month, of business where the transaction oc- to be utilized in determining whether a curred, except that records may be receipt, sale, importation or expor- kept at a single, central location of the tation is a regulated transaction is as regulated person if the regulated per- follows: son has notified the Administration of (1) List I chemicals: the intention to do so. Written notifi- (i) Except as provided in paragraph cation must be submitted by registered (f)(1)(ii) of this section, the following or certified mail, return receipt re- thresholds have been established for quested, to the Special Agent in Charge List I chemicals.

Code Chemical Threshold by base weight

8522 ...... N-Acetylanthranilic acid, its esters, and its salts ...... 40 kilograms. 8530 ...... Anthranilic acid, its esters, and its salts ...... 30 kilograms. 8256 ...... Benzaldehyde ...... 4 kilograms. 8735 ...... Benzyl cyanide ...... 1 kilogram. 8675 ...... Ergonovine and its salts ...... 10 grams. 8676 ...... Ergotamine and its salts ...... 20 grams. 8678 ...... Ethylamine and its salts ...... 1 kilogram. 6695 ...... Hydriodic acid ...... 1.7 kilograms (or 1 liter by volume). 8704 ...... Isosafrole ...... 4 kilograms. 8520 ...... Methylamine and its salts ...... 1 kilogram. 8502 ...... 3,4–Methylenedioxyphenyl-2-propanone ...... 4 kilograms. 8115 ...... N–Methylephedrine, its salts, optical isomers, and salts of optical iso- 1 kilogram. mers. 8119 ...... N–Methylpseudoephedrine, its salts, optical isomers, and salts of opti- 1 kilogram. cal isomers. 6724 ...... Nitroethane ...... 2.5 kilograms. 8317 ...... Norpseudoephedrine, its salts, optical isomers, and salts of optical iso- 2.5 kilograms. mers. 8791 ...... Phenylacetic acid, its esters, and its salts ...... 1 kilogram. 2704 ...... Piperidine and its salts ...... 500 grams. 8750 ...... Piperonal (also called heliotropine) ...... 4 kilograms. 8328 ...... Propionic anhydride ...... 1 gram. 8323 ...... Safrole ...... 4 kilograms.

(ii) For List I chemicals that are con- of this chapter, the thresholds estab- tained in scheduled listed chemical lished in paragraph (g) of this section products as defined in § 1300.02(b)(34)(i) apply only to non-retail distribution,

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import, and export. Sales of these prod- (2) List II Chemicals: ucts at retail are subject to the re- (i) Imports and Exports quirements of part 1314 of this chapter.

Chemical Threshold by volume Threshold by weight

(A) Acetic anhydride ...... 250 gallons ...... 1,023 kilograms. (B) Acetone ...... 500 gallons ...... 1,500 kilograms. (C) Benzyl chloride ...... N/A ...... 4 kilograms. (D) Ethyl ether ...... 500 gallons ...... 1,364 kilograms. (E) Potassium permanganate ...... N/A ...... 500 kilograms. (F) 2-Butanone (MEK) ...... 500 gallons ...... 1,455 kilograms. (G) Toluene ...... 500 gallons ...... 1,591 kilograms. (H) Sodium permanganate ...... N/A ...... 500 kilograms

(ii) Domestic Sales

Chemical Threshold by volume Threshold by weight

(A) Acetic anhydride ...... 250 gallons ...... 1,023 kilograms. (B) Acetone ...... 50 gallons ...... 150 kilograms. (C) Benzyl chloride ...... N/A ...... 1 kilogram. (D) Ethyl ether ...... 50 gallons ...... 135.8 kilograms. (E) Potassium permanganate ...... N/A ...... 55 kilograms. (F) 2-Butanone (MEK) ...... 50 gallons ...... 145 kilograms. (G) Toluene ...... 50 gallons ...... 159 kilograms. (H) Anhydrous Hydrogen chloride ...... N/A ...... 0.0 kilograms. (I) Sodium permanganate ...... N/A ...... 55 kilograms

(iii) The cumulative threshold is not transactions, regardless of size, are applicable to domestic sales of Ace- subject to recordkeeping and reporting tone, 2-Butanone (MEK), and Toluene. requirements as set forth in this part (iv) Exports, Transshipments and and notification provisions as set forth International Transactions to Des- in part 1313 of this chapter. ignated Countries as Set Forth in (1) Listed chemicals for which no § 1310.08(b). thresholds have been established: (i) Ephedrine, its salts, optical iso- Threshold by Threshold by Chemical volume weight mers, and salts of optical isomers; (ii) Gamma-Butyrolactone (Other (A) Hydrochloric acid 50 gallons names include: GBL; Dihydro-2(3H)- (1) Anhydrous ...... 27 kilograms. Hydrogen chlo- furanone; 1,2-Butanolide; 1,4- ride. Butanolide; 4-Hydroxybutanoic acid (B) Sulfuric acid ...... 50 gallons lactone; gamma-hydroxybutyric acid lactone) (v) Export and International Trans- (iii) Hypophosphorous acid and its actions to Designated Countries, and salts (including ammonium Importations for Transshipment or hypophosphite, calcium hypophosphite, Transfer to Designated Countries iron hypophosphite, potassium hypophosphite, manganese Threshold by Threshold by Chemical volume weight hypophosphite, magnesium hypophosphite, and sodium (A) Methyl Isobutyl 500 gallons ...... 1523 kilograms. hypophosphite) Ketone (MIBK). (B) Reserved. (iv) Iodine (v) N-phenethyl-4-piperidone (NPP) (g) For listed chemicals for which no (vi) Pseudoephedrine, its salts, opti- thresholds have been established, the cal isomers, and salts of optical iso- size of the transaction is not a factor mers in determining whether the trans- (vii) Phenylpropanolamine, its salts, action meets the definition of a regu- optical isomers, and salts of optical lated transaction as set forth in isomers § 1300.02(b)(28) of this chapter. All such (viii) Red phosphorus

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(ix) White phosphorus (Other names: (1) Any regulated transaction involv- Yellow Phosphorus) ing an extraordinary quantity of a list- (2) [Reserved] ed chemical, an uncommon method of (h) The thresholds and conditions in payment or delivery, or any other cir- paragraphs (f) and (g) of this section cumstance that the regulated person will apply to transactions involving believes may indicate that the listed regulated chemical mixtures. For pur- chemical will be used in violation of poses of determining whether the this part. weight or volume of a chemical mix- (2) Any proposed regulated trans- ture meets or exceeds the applicable action with a person whose description quantitative threshold, the following or other identifying characteristic the rules apply: Administration has previously fur- (1) For chemical mixtures containing nished to the regulated person. List I chemicals or List II chemicals (3) Any unusual or excessive loss or other than those in paragraph (h)(2) of disappearance of a listed chemical this section, the threshold is deter- under the control of the regulated per- mined by the weight of the listed son. The regulated person responsible chemical in the chemical mixture. for reporting a loss in-transit is the (2) For the List II chemicals acetone, supplier. ethyl ether, 2-butanone, toluene, and (4) Any domestic regulated trans- methyl isobutyl ketone, the threshold action in a tableting machine or an en- is determined by the weight of the encapsulating machine. tire chemical mixture. (b) Each report submitted pursuant (3) If two or more listed chemicals to paragraph (a) of this section shall, are present in a chemical mixture, and whenever possible, be made orally to the quantity of any of these chemicals the DEA Divisional Office for the area equals or exceeds the threshold appli- in which the regulated person making cable to that chemical, then the trans- the report is located at the earliest action is regulated. practicable opportunity after the regu- [54 FR 31665, Aug. 1, 1989] lated person becomes aware of the circumstances involved and as much in EDITORIAL NOTE: For FEDERAL REGISTER citations affecting § 1310.04, see the List of CFR advance of the conclusion of the trans- Sections Affected, which appears in the action as possible. Written reports of Finding Aids section of the printed volume transactions listed in paragraphs (a)(1), and at www.fdsys.gov. (a)(3) and (a)(4) of this section will subsequently be filed as set forth in EFFECTIVE DATE NOTE: At 76 FR 17781, Mar. 31, 2011, § 1310.04 was amended by redesig- § 1310.06 within 15 days after the regu- nating paragraphs (g)(1)(ii) through (g)(1)(ix) lated person becomes aware of the cir- as paragraphs (g)(1)(iii) through (g)(1)(x), and cumstances of the event. A transaction adding a new paragraph (g)(1)(ii), effective may not be completed with a person May 2, 2011. For the convenience of the user, whose description or identifying char- the added text is set forth as follows: acteristic has previously been fur- § 1310.04 Maintenance of records. nished to the regulated person by the Administration unless the transaction is approved by the Administration. * * * * * (c) Each regulated person who im- (g) * * * ports or exports a tableting machine, (1) * * * or encapsulation machine, shall file a (ii) Ergocristine and its salts report (not a 486) of such importation or exportation with the Import/Export * * * * * Unit, Drug Enforcement Administra- tion, on or before the date of importa- § 1310.05 Reports. tion or exportation. See the Table of (a) Each regulated person shall re- DEA Mailing Addresses in § 1321.01 of port to the Special Agent in Charge of this chapter for the current mailing ad- the DEA Divisional Office for the area dress. In order to facilitate the impor- in which the regulated person making tation or exportation of any tableting the report is located, as follows: machine or encapsulating machine and

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implement the purpose of the Act, reg- sumed in the production of exempted ulated persons may wish to report to products. If an existing standard indus- the Administration as far in advance as try report contains the information re- possible. A copy of the report may be quired in § 1310.06(h) and such informa- transmitted directly to the Drug En- tion is separate or readily retrievable forcement Administration through from the report, that report may be electronic facsimile media. Any submitted in satisfaction of this re- tableting machine or encapsulating quirement. Each report shall be sub- machine may be imported or exported mitted to the DEA under company let- if that machine is needed for medical, terhead and signed by an appropriate, commercial, scientific, or other legiti- responsible official. For purposes of mate uses. However, an importation or this paragraph only, the term regu- exportation of a tableting machine or lated bulk manufacturer of a listed encapsulating machine may not be chemical means a person who manufac- completed with a person whose descrip- tures a listed chemical by means of tion or identifying characteristic has chemical synthesis or by extraction previously been furnished to the regu- from other substances. The term bulk lated person by the Administration un- manufacturer does not include persons less the transaction is approved by the whose sole activity consists of the re- Administration. packaging or relabeling of listed chem- (d) Each regulated bulk manufac- ical products or the manufacture of turer of a listed chemical shall submit drug dosage form products which con- manufacturing, inventory and use data tain a listed chemical. on an annual basis as set forth in (e) Each regulated person required to § 1310.06(h). This data shall be sub- report pursuant to § 1310.03(c) of this mitted annually to the Drug and Chem- part shall either: ical Evaluation Section, Drug Enforce- (1) Submit a written report, con- ment Administration, on or before the taining the information set forth in 15th day of March of the year imme- § 1310.06(i) of this part, on or before the diately following the calendar year for 15th day of each month following the which submitted. See the Table of DEA month in which the distributions took Mailing Addresses in § 1321.01 of this chapter for the current mailing ad- place. The report shall be submitted dress. A business entity which manu- under company letterhead, signed by factures a listed chemical may elect to the person authorized to sign the reg- report separately by individual loca- istration application forms on behalf of tion or report as an aggregate amount the registrant, to the Import/Export for the entire business entity provided Unit, Drug Enforcement Administra- that they inform the DEA of which tion (see the Table of DEA Mailing Ad- method they will use. This reporting dresses in § 1321.01 of this chapter for requirement does not apply to drug or the current mailing address); or other products which are exempted (2) Upon request to and approval by under §§ 1300.02(b)(28)(i)(D) or the Administration, submit the report 1300.02(b)(28)(i)(E) except as set forth in in electronic form, either via computer § 1310.06(h)(5). Bulk manufacturers that disk or direct electronic data trans- produce a listed chemical solely for in- mission, in such form as the Adminis- ternal consumption shall not be re- tration shall direct. Requests to sub- quired to report for that listed chem- mit reports in electronic form should ical. For purposes of these reporting re- be submitted to the Import/Export quirements, internal consumption shall Unit, Drug Enforcement Administra- consist of any quantity of a listed tion. See the Table of DEA Mailing Ad- chemical otherwise not available for dresses in § 1321.01 of this chapter for further resale or distribution. Internal the current mailing address. consumption shall include (but not be (f) Except as provided in paragraph limited to) quantities used for quality (g) of this section, the following dis- control testing, quantities consumed tributions to nonregulated persons, and in-house or production losses. Internal the following export transactions, are consumption does not include the not subject to the reporting require- quantities of a listed chemical con- ments in § 1310.03(c):

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(1) Distributions of sample packages § 1310.06 Content of records and re- of drug products when those packages ports. contain not more than two solid dosage (a) Each record required by § 1310.03 units or the equivalent of two dosage shall include the following: units in liquid form, not to exceed 10 (1) The name, address, and, if re- milliliters of liquid per package, and quired, DEA registration number of not more than one package is distrib- each party to the regulated trans- uted to an individual or residential ad- action. dress in any 30-day period. (2) The date of the regulated trans- (2) Distributions of drug products by action. retail distributors that may not in- (3) The name, quantity and form of clude face-to-face transactions to the packaging of the listed chemical or a extent that such distributions are con- description of the tableting machine or encapsulating machine (including sistent with the activities authorized make, model and serial number). for a retail distributor as specified in (4) The method of transfer (company § 1300.02(b)(29) of this chapter, except truck, picked up by customer, etc.). that this paragraph does not apply to (5) The type of identification used by sales of scheduled listed chemical prod- the purchaser and any unique number ucts at retail. on that identification. (3) Distributions of drug products to (b) For purposes of this section, nor- a resident of a long term care facility mal business records shall be consid- or distributions of drug products to a ered adequate if they contain the infor- long term care facility for dispensing mation listed in paragraph (a) of this to or for use by a resident of that facil- section and are readily retrievable ity. from other business records of the reg- (4) Distributions of drug products in ulated person. For prescription drug accordance with a valid prescription. products, prescription and hospital (5) Exports which have been reported records kept in the normal course of to the Administrator under §§ 1313.31 medical treatment shall be considered and 1313.32 of this chapter or which are adequate for satisfying the requirements of paragraph (a) of this section subject to a waiver granted under with respect to dispensing to patients, § 1313.21 of this chapter. and records required to be maintained (g) The Administrator may revoke pursuant to the Federal Food and Drug any or all of the exemptions listed in Administration regulations relating to paragraph (f) of this section for an indi- the distribution of prescription drugs, vidual regulated person if the Adminis- as set forth in 21 CFR part 205, shall be trator finds that drug products distrib- considered adequate for satisfying the uted by the regulated person are being requirements of paragraph (a) of this used in violation of the regulations in section with respect to distributions. this chapter or the Controlled Sub- (c) Each report required by Section stances Act. The Administrator will 1310.05(a) shall include the information notify the regulated person of the rev- as specified by Section 1310.06(a) and, ocation, as provided in § 1313.41(a) of where obtainable, the registration this chapter. The revocation will be ef- number of the other party, if such fective upon receipt of the notice by party is registered. A report submitted the person. The regulated person has pursuant to § 1310.05(a)(1) or (a)(4) must the right to an expedited hearing re- also include a description of the cir- garding the revocation, as provided in cumstances leading the regulated per- § 1313.56(a) of this chapter. son to make the report, such as the reason that the method of payment [54 FR 31665, Aug. 1, 1989, as amended at 57 was uncommon or the loss unusual. If FR 2461, Jan. 22, 1992; 61 FR 14024, Mar. 29, the report is for a loss or disappearance 1996; 61 FR 17958, Apr. 23, 1996; 62 FR 13968, under § 1310.05(a)(4), the circumstances Mar. 24, 1997; 67 FR 14862, Mar. 28, 2002; 67 FR of such loss must be provided (in-tran- 49569, July 31, 2002; 68 FR 57804, Oct. 7, 2003; sit, theft from premises, etc.) 71 FR 56024, Sept. 26, 2006; 75 FR 10680, Mar. (d) A suggested format for the re- 9, 2010] ports is provided below:

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Supplier: (1) The name, address, telephone Registration Number llllllllllll number, telex number, and, where Name llllllllllllllllllll available, the facsimile number of the Business Address llllllllllllll regulated person; the name, address, City lllllllllllllllllllll telephone number, telex number, and, State llllllllllllllllllll Zip lllllllllllllllllllll where available, the facsimile number Business Phone lllllllllllllll of the export broker, if any; Purchaser: (2) The description of each machine Registration Number llllllllllll (including make, model, and serial Name llllllllllllllllllll number) and the number of machines Business Address llllllllllllll being shipped; City lllllllllllllllllllll (3) The proposed export date, the U.S. State llllllllllllllllllll Customs Port of exportation, and the Zip lllllllllllllllllllll foreign Port of Entry; and Business Phone lllllllllllllll (4) The name, address, telephone, Identification llllllllllllllll telex, and, where available, the fac- Shipping Address (if different than purchaser Address): simile number of the consignee in the country where the shipment is des- Street llllllllllllllllllll City lllllllllllllllllllll tined; the name(s) and address(es) of State llllllllllllllllllll any intermediate consignee(s). Zip lllllllllllllllllllll (g) Declared exports of machines Date of Shipment llllllllllllll which are refused, rejected, or other- Name of Listed Chemical(s) lllllllll wise deemed undeliverable may be re- Quantity and Form of Packaging llllll turned to the U.S. exporter of record. A Description of Machine: brief written report outlining the cir- Make llllllllllllllllllll cumstances must be sent to the Im- Model llllllllllllllllllll port/Export Unit, Drug Enforcement Serial # lllllllllllllllllll Administration, following the return Method of Transfer lllllllllllll within a reasonable time. See the If Loss or Disappearance: Table of DEA Mailing Addresses in Date of Loss lllllllllllllllll § 1321.01 of this chapter for the current Type of Loss llllllllllllllll Description of Circumstances llllllll mailing address. This provision does (e) Each report of an importation of a not apply to shipments that have tableting machine or an encapsulating cleared foreign customs, been deliv- machine required by § 1310.05(c) shall ered, and accepted by the foreign con- include the following information: signee. Returns to third parties in the (1) The name, address, telephone United States will be regarded as im- number, telex number, and, where ports. available, the facsimile number of the (h) Each annual report required by regulated person; the name, address, Section 1310.05(d) shall provide the fol- telephone number, telex number, and, lowing information for each listed where available, the facsimile number chemical manufactured: of the import broker or forwarding (1) The name, address and chemical agent, if any: registration number (if any) of the (2) The description of each machine manufacturer and person to contact for (including make, model, and serial information. number) and the number of machines (2) The aggregate quantity of each being received; listed chemical that the company man- (3) The proposed import date, and the ufactured during the preceding cal- first U.S. Customs Port of Entry; and endar year. (4) The name, address, telephone (3) The year-end inventory of each number, telex number, and, where listed chemical as of the close of busi- available, the facsimile number of the ness on the 31st day of December of consignor in the foreign country of ex- each year. (For each listed chemical, if portation. the prior period’s ending inventory has (f) Each report of an exportation of a not previously been reported to DEA, tableting machine or an encapsulating this report should also detail the begin- machine required by § 1310.05(c) shall ning inventory for the period.) For pur- include the following information: poses of this requirement, inventory

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shall reflect the quantity of listed the Act (21 U.S.C. 830(c)) for confiden- chemicals, whether in bulk or non-ex- tial business information. empt product form, held in storage for [54 FR 31665, Aug. 1, 1989, as amended at 57 later distribution. Inventory does not FR 2462, Jan. 22, 1992; 59 FR 51364, Oct. 11, include waste material for destruction, 1994; 60 FR 32461, June 22, 1995; 61 FR 14024, material stored as an in-process inter- Mar. 29, 1996; 61 FR 32926, June 26, 1996; 67 FR mediate or other in-process material. 14862, Mar. 28, 2002; 67 FR 49569, July 31, 2002; (4) The aggregate quantity of each 75 FR 10681, Mar. 9, 2010] listed chemical used for internal consumption during the preceding cal- § 1310.07 Proof of identity. endar year, unless the chemical is pro- (a) Each regulated person who en- duced solely for internal consumption. gages in a regulated transaction must (5) The aggregate quantity of each identify the other party to the trans- listed chemical manufactured which action. For domestic transaction, this becomes a component of a product ex- shall be accomplished by having the empted from §§ 1300.02(b)(28)(i)(D) or other party present documents which 1300.02(b)(28)(i)(E) during the preceding would verify the identity, or registra- calendar year. tion status if a registrant, of the other (6) Data shall identify the specific party to the regulated person at the time the order is placed. For export isomer, salt or ester when applicable transactions, this shall be accom- but quantitative data shall be reported plished by good faith inquiry through as anhydrous base or acid in kilogram reasonably available research docu- units of measure. ments or publicly available informa- (i) Each monthly report required by tion which would indicate the exist- § 1310.05(e) of this part shall provide the ence of the foreign customer. No proof following information for each dis- of identity is required for foreign sup- tribution: pliers. (1) Supplier name and registration (b) The regulated person must verify number. the existence and apparent validity of (2) Purchaser’s name and address. a business entity ordering a listed (3) Name/address shipped to (if dif- chemical, tableting machine or encap- ferent from purchaser’s name/address). sulating machine. For domestic trans- (4) Name of the chemical and total actions, this may be accomplished by amount shipped (i.e., Pseudoephedrine, such methods as checking the tele- 250 grams). phone directory, the local credit bu- (5) Date of shipment. reau, the local Chamber of Commerce (6) Product name (if drug product). or the local Better Business Bureau, or, (7) Dosage form (if drug product) (i.e., if the business entity is a registrant, pill, tablet, liquid). by verification of the registration. For export transactions, a good faith in- (8) Dosage strength (if drug product) quiry to verify the existence and appar- (i.e., 30mg, 60mg, per dose etc.). ent validity of a foreign business entity (9) Number of dosage units (if drug may be accomplished by such methods product) (100 doses per package). as verifying the business telephone (10) Package type (if drug product) listing through international telephone (bottle, blister pack, etc.). information, the firm’s listing in inter- (11) Number of packages (if drug national or foreign national chemical product) (10 bottles). directories or other commerce direc- (12) Lot number (if drug product). tories or trade publications, confirma- (j) Information provided in reports tion through foreign subsidiaries of the required by § 1310.05(e) of this part U.S. regulated person, verification which is exempt from disclosure under through the country of destination’s section 552(a) of Title 5, by reason of embassy Commercial Attache, or offi- section 552(b)(6) of Title 5, will be pro- cial documents provided by the pur- vided the same protections from disclo- chaser which confirm the existence and sure as are provided in section 310(c) of apparent validity of the business entity.

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(c) When transacting business with a (a) Domestic and import transactions new representative of a firm, the regu- of hydrochloric and sulfuric acids but lated person must verify the claimed not including anhydrous hydrogen agency status of the representative. chloride. (d) For sales to individuals or cash (b) Exports, transshipments, and purchasers, the type of documents and international transactions of hydro- other evidence of proof must consist of chloric (including anhydrous hydrogen at least a signature of the purchaser, a chloride) and sulfuric acids, except for driver’s license and one other form of exports, transshipments and inter- identification. Any exports to individ- national transactions to the following uals or exports paid in cash are suspect countries: and should be handled as such. For (1) Argentina such exports, the regulated person (2) Bolivia shall diligently obtain from the pur- (3) Brazil chaser or independently seek to con- (4) Chile firm clear documentation which proves (5) Colombia the person is properly identified such (6) Ecuador as through foreign identity documents, (7) French Guiana driver’s license, passport information (8) Guyana and photograph, etc. Any regulated (9) Panama person who fails to adequately prove (10) Paraguay the identity of the other party to the (11) Peru transaction may be subject to the spe- (12) Suriname cific penalties provided for violations (13) Uruguay of law related to regulated trans- (14) Venezuela actions in listed chemicals. (c) Domestic transactions of Methyl (e) For a new customer who is not an Isobutyl Ketone (MIBK). individual or cash customer, the regu- (d) Import transactions of Methyl lated person shall establish the iden- Isobutyl Ketone (MIBK) destined for tity of the authorized purchasing agent the United States. or agents and have on file that person’s (e) Export transactions, inter- signature, electronic password, or national transactions, and import other identification. Once the author- transactions for transshipment or ized purchasing agent has been estab- transfer of Methyl Isobutyl Ketone lished, the agent list may be updated (MIBK) destined for Canada or any annually rather than on each order. country outside of the Western Hemi- The regulated person must ensure that sphere. shipments are not made unless the (f) Domestic and international trans- order is placed by an authorized agent actions of Lugol’s Solution (consisting of record. of 5 percent iodine and 10 percent po- (f) With respect to electronic orders, tassium iodide in an aqueous solution) the identity of the purchaser shall con- in original manufacturer’s packaging sist of a computer password, identifica- of one-fluid-ounce (30 milliliters) or tion number or some other means of less, and no greater than one package identification consistent with elec- per transaction. tronic orders and with § 1310.07(e). (g) Import transactions of anhydrous hydrogen chloride. [54 FR 31665, Aug. 1, 1989, as amended at 60 (h) Domestic distribution of anhy- FR 32461, June 22, 1995] drous hydrogen chloride weighing 12,000 pounds (net weight) or more in a § 1310.08 Excluded transactions. single container. Pursuant to 21 U.S.C. 802(39)(A)(iii), (i) Domestic distribution of anhy- regulation of the following trans- drous hydrogen chloride by pipeline. actions has been determined to be un- (j) Domestic and international return necessary for the enforcement of the shipments of reusable containers from Chemical Diversion and Trafficking customer to producer containing resid- Act and, therefore, they have been ex- ual quantities of red phosphorus or cluded from the definitions of regu- white phosphorus in rail cars and inter- lated transactions: modal tank containers which conform

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to International Standards Organiza- chemical control requirements set tion specifications (with capacities forth in parts 1309, 1310, and 1313 of this greater than or equal to 2,500 gallons in chapter remain in full force and effect. a single container). (c) Each person required by section (k) Domestic, import, and export dis- 302 of the act (21 U.S.C. 822) to obtain a tributions of gamma-butyrolactone registration to distribute, import, or weighing 4,000 kilograms (net weight) export GBL is temporarily exempted or more in a single container. from the registration requirement, pro- (l) Domestic and import transactions vided that the DEA receives a proper in chemical mixtures that contain ace- application for registration on or be- tone, ethyl ether, 2-butanone, and/or fore July 24, 2000. The exemption will toluene, unless regulated because of remain in effect for each person who being formulated with other List I or has made such application until the List II chemical(s) above the con- Administration has approved or denied centration limit. that application. This exemption applies only to registration; all other [57 FR 43615, Sept. 22, 1992, as amended at 60 chemical control requirements set FR 19510, Apr. 19, 1995; 60 FR 32461, June 22, 1995; 62 FR 13968, Mar. 24, 1997; 65 FR 47316, forth in parts 1309, 1310, and 1313 of this Aug. 2, 2000; 66 FR 52675, Oct. 17, 2001; 68 FR chapter remain in full force and effect. 37414, June 24, 2003; 68 FR 53292, Sept. 10, 2003; (d) Each person required by section 69 FR 74971, Dec. 15, 2004; 72 FR 10928, Mar. 12, 302 of the Act (21 U.S.C. 822) to obtain 2007; 72 FR 35931, July 2, 2007] a registration to distribute, import, or export the List I chemicals red phos- § 1310.09 Temporary exemption from phorus, white phosphorus, and registration. hypophosphorous acid (and its salts), is (a) Each person required by section temporarily exempted from the reg- 302 of the act (21 U.S.C. 822) to obtain a istration requirement, provided that registration to distribute, import, or the person submits a proper applica- export a combination ephedrine prod- tion for registration on or before De- uct is temporarily exempted from the cember 17, 2001. The exemption will reregistration requirement, provided main in effect for each person who has that the person submits a proper appli- made such application until the Ad- cation for registration on or before ministration has approved or denied July 12, 1997. The exemption will re- that application. This exemption ap- main in effect for each person who has plies only to registration; all other made such application until the Ad- chemical control requirements set ministration has approved or denied forth in parts 1309, 1310, and 1313 of this that application. This exemption ap- chapter remain in full force and effect. plies only to registration; all other (e) Each person required by section chemical control requirements set 302 of the Act (21 U.S.C. 822) to obtain forth in parts 1309, 1310, and 1313 of this a registration to distribute, import, or chapter remain in full force and effect. export regulated chemical mixtures (b) Each person required by section which contain ephedrine, N- 302 of the act (21 U.S.C. 822) to obtain a methylephedrine, N- registration to distribute, import, or methylpseudoephedrine, export a drug product that contains norpseudoephedrine, phenylpropanola- pseudoephedrine or phenylpropanolamine, and/or pseudoephedrine, pursu- mine that is regulated pursuant to ant to §§ 1310.12 and 1310.13, is tempo- § 1300.02(b)(28)(1)(D) of this chapter is rarily exempted from the registration temporarily exempted from the reg- requirement, provided that DEA re- istration requirement, provided that ceives a proper application for registra- the person submits a proper application or application for exemption on or tion for registration on or before De- before June 30, 2003. The exemption cember 3, 1997. The exemption will re- will remain in effect for each person main in effect for each person who has who has made such application until made such application until the Ad- the Administration has approved or de- ministration has approved or denied nied that application. This exemption that application. This exemption ap- applies only to registration; all other plies only to registration; all other chemical control requirements set

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forth in parts 1309, 1310, and 1313 of this tribute, import, or export regulated N- chapter remain in full force and effect. phenethyl-4-piperidone (NPP), includ- Any person who distributes, imports or ing regulated chemical mixtures pursu- exports a chemical mixture whose ap- ant to § 1310.12, is temporarily exempt- plication for exemption is subsequently ed from the registration requirement, denied by DEA must obtain a registra- provided that DEA receives a proper tion with DEA. A temporary exemption application for registration or applica- from the registration requirement will tion for exemption for a chemical mix- also be provided for these persons, pro- ture containing NPP pursuant to vided that DEA receives a properly § 1310.13 on or before June 22, 2007. The completed application for registration exemption will remain in effect for on or before 30 days following the date each person who has made such appli- of official DEA notification that the cation until the Administration has ap- application for exemption has not been proved or denied that application. This approved. The temporary exemption exemption applies only to registration; for such persons will remain in effect all other chemical control require- until DEA takes final action on their ments set forth in the Act and parts registration application. 1309, 1310, 1313, and 1316 of this chapter (f) Except for chemical mixtures con- remain in full force and effect. Any taining the listed chemicals in para- person who manufactures, distributes, graph (e) of this section, each person imports or exports a chemical mixture required by section 302 of the Act (21 containing N-phenethyl-4-piperidone U.S.C. 822) to obtain a registration to (NPP) whose application for exemption distribute, import, or export regulated is subsequently denied by DEA must chemical mixtures, pursuant to obtain a registration with DEA. A tem- §§ 1310.12 and 1310.13, is temporarily ex- porary exemption from the registration empted from the registration require- requirement will also be provided for ment, provided that DEA receives a those persons whose application for ex- proper application for registration or emption are denied, provided that DEA application for exemption on or before receives a properly completed applica- February 14, 2005. The exemption will tion for registration on or before 30 remain in effect for each person who days following the date of official DEA has made such application until the notification that the application for Administration has approved or denied exemption has been denied. The tem- that application. This exemption ap- porary exemption for such persons will plies only to registration; all other remain in effect until DEA takes final chemical control requirements set action on their registration applica- forth in parts 1309, 1310, and 1313 of this tion. chapter remain in full force and effect. (i) Each person required by section (g) Any person who distributes, im- 302 of the Act (21 U.S.C. 822) to obtain ports, or exports a chemical mixture a registration to manufacture, dis- whose application for exemption is sub- tribute, import, or export regulated io- sequently denied by DEA must obtain a dine, including regulated iodine chem- registration with DEA. A temporary ical mixtures pursuant to §§ 1310.12 and exemption from the registration re- 1310.13, is temporarily exempted from quirement will also be provided for the registration requirement, provided these persons, provided that DEA re- that the Administration receives a ceives a properly completed applica- proper application for registration or tion for registration on or before 30 application for exemption for a chem- days following the date of official DEA ical mixture containing iodine on or notification that the application for before August 31, 2007. The exemption exemption has not been approved. The will remain in effect for each person temporary exemption for such persons who has made such application until will remain in effect until DEA takes the Administration has approved or de- final action on their registration appli- nied that application. This exemption cation. applies only to registration; all other (h) Each person required under 21 chemical control requirements set U.S.C. 822 and 21 U.S.C. 957 to obtain a forth in the Act and parts 1309, 1310, registration to manufacture, dis- and 1313 of this chapter remain in full

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force and effect. Any person who dis- (k)(1) Each person required by sec- tributes, imports, or exports a chem- tions 302 or 1007 of the Act (21 U.S.C. ical mixture containing iodine whose 822, 957) to obtain a registration to application for exemption is subse- manufacture, distribute, import, or ex- quently denied by the Administration port regulated GBL-containing chem- must obtain a registration with the ical mixtures, pursuant to sections Administration. A temporary exemp- 1310.12 and 1310.13, is temporarily ex- tion from the registration requirement empted from the registration require- will also be provided for these persons, ment, provided that DEA receives a provided that the Administration re- properly completed application for reg- ceives a properly completed applica- istration or application for exemption tion for registration on or before 30 on or before July 29, 2010. The exemp- days following the date of official Ad- tion will remain in effect for each per- ministration notification that the ap- son who has made such application plication for exemption has not been until the Administration has approved approved. The temporary exemption or denied that application. This exemp- for such persons will remain in effect tion applies only to registration; all other chemical control requirements until the Administration takes final set forth in parts 1309, 1310, and 1313 of action on their registration applica- this chapter remain in full force and ef- tion. fect. (j) Each person required by section (2) Any person who manufactures, 302 of the Act (21 U.S.C. 822) to obtain distributes, imports or exports a GBL- a registration to manufacture, dis- containing chemical mixture whose ap- tribute, import, or export regulated plication for exemption is subsequently chemical mixtures which contain denied by DEA must obtain a registra- ephedrine, and/or pseudoephedrine, pur- tion with DEA. A temporary exemption suant to Sections 1310.12 and 1310.13, is from the registration requirement will temporarily exempted from the reg- also be provided for those persons istration requirement, provided that whose applications for exemption are DEA receives a properly completed ap- denied, provided that DEA receives a plication for registration or applica- properly completed application for reg- tion for exemption on or before August istration on or before 30 days following 24, 2007. The exemption will remain in the date of official DEA notification effect for each person who has made that the application for exemption has such application until the Administra- been denied. The temporary exemption tion has approved or denied that appli- for such persons will remain in effect cation. This exemption applies only to until DEA takes final action on their registration; all other chemical control registration application. requirements set forth in parts 1309, [62 FR 27693, May 21, 1997, as amended at 62 1310, 1313, and 1315 of this chapter re- FR 53960, Oct. 17, 1997; 65 FR 21647, Apr. 24, main in full force and effect. Any per- 2000; 66 FR 52675, Oct. 17, 2001; 68 FR 23203, son who manufactures, distributes, im- May 1, 2003; 69 FR 74971, Dec. 15, 2004; 72 FR ports, or exports a chemical mixture 20046, Apr. 23, 2007; 72 FR 35931, July 2, 2007; whose application for exemption is sub- 72 FR 40239, July 24, 2007; 72 FR 40744, July 25, sequently denied by DEA must obtain a 2007; 75 FR 37306, June 29, 2010] registration with DEA. A temporary EFFECTIVE DATE NOTE: At 76 FR 17781, Mar. exemption from the registration re- 31, 2011, § 1310.09 was amended by adding a quirement will also be provided for new paragraph (l), effective May 2, 2011. For these persons, provided that DEA re- the convenience of the user, the added text is ceives a properly completed applica- set forth as follows: tion for registration on or before 30 § 1310.09 Temporary exemption from reg- days following the date of official DEA istration. notification that the application for exemption has not been approved. The * * * * * temporary exemption for such persons (l)(1) Each person required under sections will remain in effect until DEA takes 302 and 1007 of the Act (21 U.S.C. 822, 957) to final action on their registration appli- obtain a registration to manufacture, dis- cation. tribute, import, or export regulated

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ergocristine and its salts, including regu- or group of drugs from the exemption, lated chemical mixtures pursuant to § 1310.12, which shall include a reference to the is temporarily exempted from the registra- legal authority under which the pro- tion requirement, provided that DEA receives a properly completed application for posal is based. The Administrator shall registration or application for exemption for permit any interested person to file a chemical mixture containing ergocristine written comments on or objections to and its salts pursuant to § 1310.13 on or before the proposal. After considering any May 2, 2011. The exemption will remain in ef- comments or objections filed, the Ad- fect for each person who has made such ap- ministrator shall publish in the FED- plication until the Administration has ap- ERAL REGISTER his final order. proved or denied that application. This exemption applies only to registration; all (c) The Administrator shall limit the other chemical control requirements set removal of a drug or group of drugs forth in the Act and parts 1309, 1310, 1313, and from exemption under paragraph (a) of 1316 of this chapter remain in full force and this section to the most identifiable effect. type of the drug or group of drugs for (2) Any person who manufactures, distrib- which evidence of diversion exists un- utes, imports, or exports a chemical mixture less there is evidence, based on the pat- containing ergocristine and its salts whose application for exemption is subsequently tern of diversion and other relevant denied by DEA must obtain a registration factors, that the diversion will not be with DEA. A temporary exemption from the limited to that particular drug or registration requirement will also be pro- group of drugs. vided for those persons whose applications (d) Any manufacturer seeking rein- for exemption are denied, provided that DEA statement of a particular drug product receives a properly completed application for registration on or before 30 days following that has been removed from an exemp- the date of official DEA notification that the tion may apply to the Administrator application for exemption has been denied. for reinstatement of the exemption for The temporary exemption for such persons that particular drug product on the will remain in effect until DEA takes final grounds that the particular drug prod- action on their registration application. uct is manufactured and distributed in a manner that prevents diversion. In § 1310.10 Removal of the exemption of determining whether the exemption drugs distributed under the Food, Drug and Cosmetic Act. should be reinstated the Administrator shall consider: (a) The Administrator may remove (1) The package sizes and manner of from exemption under packaging of the drug product; § 1300.02(b)(28)(i)(D) of this chapter any drug or group of drugs that the Admin- (2) The manner of distribution and istrator finds is being diverted to ob- advertising of the drug product; tain a listed chemical for use in the il- (3) Evidence of diversion of the drug licit production of a controlled sub- product; stance. In removing a drug or group of (4) Any actions taken by the manu- drugs from the exemption the Adminis- facturer to prevent diversion of the trator shall consider: drug product; and (1) The scope, duration, and signifi- (5) Such other factors as are relevant cance of the diversion; to and consistent with the public (2) Whether the drug or group of health and safety, including the factors drugs is formulated in such a way that described in paragraph (a) of this sec- it cannot be easily used in the illicit tion as applied to the drug product. production of a controlled substance; (e) Within a reasonable period of and time after receipt of the application for (3) Whether the listed chemical can reinstatement of the exemption, the be readily recovered from the drug or Administrator shall notify the appli- group of drugs. cant of his acceptance or non-accept- (b) Upon determining that a drug or ance of his application, and if not ac- group of drugs should be removed from cepted, the reason therefor. If the ap- the exemption under paragraph (a) of plication is accepted for filing, the Ad- this section, the Administrator shall ministrator shall issue and publish in issue and publish in the FEDERAL REG- the FEDERAL REGISTER his order on the ISTER his proposal to remove the drug reinstatement of the exemption for the

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particular drug product, which shall in- § 1310.11 Reinstatement of exemption clude a reference to the legal authority for drug products distributed under under which the order is based. This the Food, Drug and Cosmetic Act. order shall specify the date on which it (a) The Administrator has reinstated shall take effect. The Administrator the exemption for the drug products shall permit any interested person to listed in paragraph (e) of this section file written comments on or objections from application of sections 302, 303, to the order. If any such comments 310, 1007, and 1008 of the Act (21 U.S.C. raise significant issues regarding any 822–823, 830, and 957–958), to the extent finding of fact or conclusion of law described in paragraphs (b), (c), and (d) upon which the order is based, the Ad- of this section. ministrator shall immediately suspend (b) No reinstated exemption granted pursuant to 1310.10 affects the criminal the effectiveness of the order until he liability for illegal possession or dis- may reconsider the application in light tribution of listed chemicals contained of the comments and objections filed. in the exempt drug product. Thereafter, the Administrator shall re- (c) Changes in exempt drug product instate, revoke, or amend his original compositions: Any change in the quan- order as he determines appropriate. titative or qualitative composition, (f) Unless the Administrator has evi- trade name or other designation of an dence that the drug product is being di- exempt drug product listed in para- verted, as determined by applying the graph (d) requires a new application for factors set forth in paragraph (a) of reinstatement of the exemption. this section, and the Administrator so (d) The following drug products, in notifies the applicant, transactions in- the form and quantity listed in the ap- volving a specific drug product will not plication submitted (indicated as the be considered regulated transactions ‘‘date’’) are designated as reinstated during the following periods: exempt drug products for the purposes (1) While a bonafide application for set forth in this section: reinstatement of exemption under EXEMPT DRUG PRODUCTS paragraph (d) of this section for the specific drug product is pending resolu- Supplier Product name Form Date tion, provided that the application for [Reserved] ...... reinstatement is filed not later than 60 days after the publication of the final [60 FR 32462, June 22, 1995] order removing the exemption; and (2) For a period of 60 days following § 1310.12 Exempt chemical mixtures. the Administrator’s denial of an appli- (a) The chemical mixtures meeting cation for reinstatement. the criteria in paragraphs (c) or (d) of (g) An order published by the Admin- this section are exempted by the Ad- istrator in the FEDERAL REGISTER, pur- ministrator from application of sec- suant to paragraph (e) of this section, tions 302, 303, 310, 1007, and 1008 of the to reinstate an exemption may be Act (21 U.S.C. 822, 823, 830, 957 and 958) modified or revoked with respect to a to the extent described in paragraphs particular drug product upon a finding (b) and (c) of this section. that: (b) No exemption granted pursuant to (1) Applying the factors set forth in this § 1310.12 or § 1310.13 affects the paragraph (a) of this section to the par- criminal liability for illegal possession, ticular drug product, the drug product distribution, exportation, or importa- is being diverted; or tion of listed chemicals contained in the exempt chemical mixture or the (2) There is a significant change in civil liability for unlawful acts related the data that led to the issuance of the to exempt chemical mixtures, includ- final rule. ing distribution in violation of 21 [60 FR 32461, June 22, 1995, as amended at 62 U.S.C. 842(a)(11). FR 13968, Mar. 24, 1997; 67 FR 14862, Mar. 28, (c) Mixtures containing a listed 2002; 75 FR 38922, July 7, 2010] chemical in concentrations equal to or less than those specified in the ‘‘Table

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of Concentration Limits’’ are des- for liquid-liquid mixtures by using the ignated as exempt chemical mixtures volume or weight and for mixtures con- for the purpose set forth in this sec- taining solids or gases by using the tion. The concentration is determined unit of weight.

TABLE OF CONCENTRATION LIMITS

DEA chemical code Concentration Special conditions number

List I Chemicals

N-Acetylanthranilic acid, its 8522 20% by Weight...... Concentration based on any combination of N- salts and esters. acetylanthranilic acid and its salts and esters. Anthranilic acid, and its 8530 50% by Weight ...... Concentration is based on any combination of anthra- salts and esters. nilic acid and its salts and esters. Benzaldehyde ...... 8256 50% by Weight or Volume. Benzyl cyanide ...... 8570 20% by Weight or Volume. Ephedrine, its salts, optical 8113 Not exempt at any con- Chemical mixtures containing any amount of ephed- isomers, and salts of op- centration. rine and/or pseudoephedrine, and their salts, optical tical isomers. isomers and salts of optical isomers are not exempt due to concentration, unless otherwise exempted. Ergonovine and its salts .... 8675 Not exempt at any con- Chemical mixtures containing any amount of ergo- centration. novine, including its salts, are not exempt. Ergotamine and its salts .... 8676 Not exempt at any con- Chemical mixtures containing amount of any ergot- centration. amine, including its salts, are not exempt. Ethylamine and its salts ..... 8678 20% by Weight or Volume Ethylamine or its salts in an inert carrier solvent is not considered a mixture. Concentration is based on ethylamine in the mixture and not the combination of ethylamine and carrier solvent, if any. Gamma-Butyrolactone ...... 2011 70% by weight or volume. Hydriodic acid ...... 6695 20% by Weight or Volume. Iodine ...... 6699 2.2 ...... Calculated as weight/volume (w/v). Isosafrole ...... 8704 20% by Weight or Volume Concentration in a mixture cannot exceed 20% if taken alone or in any combination with safrole. Methylamine and its salts .. 8520 20% by Weight ...... Methylamine or its salts in an inert carrier solvent is not considered a mixture. Weight is based on methylamine in the mixture and not the combined weight of carrier solvent, if any. 3,4-Methylenedioxyphenyl- 8502 20% by Weight. 2-propanone. N-Methylephedrine, its 8115 0.1% by Weight ...... Concentration based on any combination of salts N- salts, optical isomers, methylephedrine, N-methylpseudoephedrine and and salts of optical iso- their salts, optical isomers and salts of optical isomers. mers. N-Methylpseudoephedrine, 8119 0.1% by Weight...... Concentration based on any combination of N- its salts, optical isomers, methylpseudoephedrine, N-methylephedrine, and and salts of optical iso- their salts, optical isomers and salts of optical isomers. mers. Nitroethane ...... 6724 20% by Weight or Volume. Norpseudoephedrine, its 8317 0.6% by Weight...... Concentration based on any combination of salts, optical isomers, norpseudoephedrine, phenylpropanolamine and and salts of optical iso- their salts, optical isomers and salts of optical isomers. mers. N-phenethyl-4-piperidone 8332 Not exempt at any con- Chemical mixtures containing any amount of NPP are (NPP). centration. not exempt. Phenylacetic acid, and its 8791 40% by Weight...... Concentration is based on any combination of salts and esters. phenylacetic acid and its salts and esters. . Phenylpropanolamine, its 1225 0.6% by Weight ...... Concentration based on any combination of phenyl- salts, optical isomers, propanolamine, norpseudoephedrine and their salts, and salts of optical iso- optical isomers and salts of optical isomers. mers. Piperidine, and its salts ...... 2704 20% by Weight or Volume Concentration based on any combination of piperidine and its salts. Concentration based on weight if a solid, weight or volume if a liquid. Piperonal ...... 8750 20% by Weight or Volume. Propionic anhydride ...... 8328 20% by Weight or Volume. Pseudoephedrine, its salts, 8112 Not exempt at any con- Chemical mixtures containing any amount of ephed- optical isomers, and salts centration. rine and/or pseudoephedrine, and their salts, optical of optical isomers. isomers and salts of optical isomers are not exempt due to concentration, unless otherwise exempted.

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TABLE OF CONCENTRATION LIMITS—Continued

DEA chemical code Concentration Special conditions number

Safrole ...... 8323 20% by Volume...... Concentration in a mixture cannot exceed 20% if taken alone or in any combination with isosafrole.

List II Chemicals

Acetic Anhydride ...... 8519 20% by Weight or Volume. Acetone ...... 6532 35% by Weight or Volume Exports only; Limit applies to acetone or any combination of acetone, ethyl ether, 2-butanone, methyl isobutyl ketone, and toluene if present in the mixture by summing the concentrations for each chemical. Benzyl chloride ...... 8568 20% by Weight or Volume. 2-butanone ...... 6714 35% by Weight or Volume Exports only; Limit applies to 2-butanone or any combination of acetone, ethyl ether, 2-butanone, methyl isobutyl ketone, and toluene if present in the mixture by summing the concentrations for each chemical. Ethyl ether ...... 6584 35% by Weight or Volume Exports only; Limit applies to ethyl ether or any combination of acetone, ethyl ether, 2-butanone, methyl isobutyl ketone, and toluene if present in the mixture by summing the concentrations for each chemical. Hydrochloric acid ...... 6545 20% by Weight or Volume Hydrogen chloride in an inert carrier solvent, such as aqueous or alcoholic solutions, is not considered a mixture. Weight is based on hydrogen chloride in the mixture and not the combined weight of the carrier solvent, if any. Methyl isobutyl ketone ...... 6715 35% by Weight or Volume Exports only pursuant to § 1310.08; Limit applies to methyl isobutyl ketone or any combination of acetone, ethyl ether, 2-butanone, methyl isobutyl ketone, and toluene if present in the mixture by summing the concentrations for each chemical. Potassium permanganate .. 6579 15% by Weight. Sodium Permanganate ...... 6588 15% by Weight. Sulfuric acid ...... 6552 20% by Weight or Volume Sulfuric acid in an inert carrier solvent, such as aqueous or alcoholic solutions, is not considered a mixture. Weight is based on sulfuric acid in the mixture and not the combined weight of the carrier solvent, if any. Toluene ...... 594 35% by Weight or Volume Exports only; Limit applies to toluene or any combination of acetone, ethyl ether, 2-butanone, methyl isobutyl ketone, and toluene if present in the mixture by summing the concentrations for each chemical.

(d) The following categories of chem- (2) Completely formulated paints and ical mixtures are automatically ex- coatings: Completely formulated empt from the provisions of the Con- paints and coatings are only those for- trolled Substances Act as described in mulations that contain all of the com- paragraph (a) of this section: ponents of the paint or coating for use (1) Chemical mixtures that are dis- in the final application without the tributed directly to an incinerator for need to add any additional substances destruction or directly to an author- except a thinner if needed in certain ized waste recycler or reprocessor cases. A completely formulated paint where such distributions are docu- or coating is defined as any clear or mented on United States Environ- pigmented liquid, liquefiable or mastic mental Protection Agency Form 8700– composition designed for application to 22; persons distributing the mixture to a substrate in a thin layer that is con- the incinerator or recycler must main- verted to a clear or opaque solid pro- tain and make available to agents of tective, decorative, or functional ad- the Administration, upon request, such herent film after application. Included documentation for a period of no less in this category are clear coats, top- than two years.

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coats, primers, varnishes, sealers, ad- or objections raise significant issues hesives, lacquers, stains, shellacs, inks, regarding any finding of fact or conclu- temporary protective coatings and sion of law upon which the order is film-forming agents. based, the Administrator shall imme- (3) Iodine products classified as diately suspend the effectiveness of the iodophors that exist as an iodine com- order until he may reconsider the order plex to include poloxamer-iodine com- in light of comments and objections plex, polyvinyl pyrrolidone-iodine com- filed. Thereafter, the Administrator plex (i.e., povidone-iodine), shall reinstate, terminate, or amend undecoylium chloride iodine, the original order as determined appro- nonylphenoxypoly (ethyleneoxy) eth- priate. anol-iodine complex, iodine complex (f) The Administrator may modify with phosphate ester of alkylaryloxy any part of the criteria for exemption polyethylene glycol, and iodine com- as specified in paragraphs (c) and (d) of plex with ammonium ether sulfate/ this section upon evidence of diversion polyoxyethylene sorbitan monolaurate. or attempted diversion. In doing so, the (4) Iodine products that consist of or- Administrator shall issue and publish a ganically bound iodine (a non-ionic Notice of Proposed Rulemaking in the complex) (e.g., iopamidol, iohexol, and FEDERAL REGISTER. The Administrator amiodarone.) shall permit any interested persons to (e) The Administrator may, at any file written comments on or objections time, terminate or modify the exemp- to the proposal. After considering any tion for any chemical mixture which comments or objections filed, the Ad- has been granted an exemption pursu- ministrator shall publish in the FED- ant to the concentration limits as spec- ERAL REGISTER a final order. ified in paragraph (c) of this section or pursuant to the category exemption as [68 FR 23204, May 1, 2003, as amended at 69 FR 74971, Dec. 15, 2004; 71 FR 60826, Oct. 17, specified in paragraph (d) of this sec- 2006; 72 FR 20047, Apr. 23, 2007; 72 FR 35931, tion. In terminating or modifying an July 2, 2007; 72 FR 40745, July 25, 2007; 75 FR exemption, the Administrator shall 37306, June 29, 2010] issue, and publish in the FEDERAL REG- EFFECTIVE DATE NOTE: At 76 FR 17781, Mar. ISTER, notification of the removal of an 31, 2011, § 1310.12 was amended by adding in exemption for a product or group of alphabetical order an entry ‘‘Ergocristine products for which evidence of diver- and its salts’’ in the table ‘‘Table of Con- sion has been found, as well as the date centration Limits’’, effective May 2, 2011. on which the termination of exemption For the convenience of the user, the added shall take effect. The Administrator text is set forth as follows: shall permit any interested party to § 1310.12 Exempt chemical mixtures. file written comments on or objections to the order within 60 days of the date of publication of the order in the FED- * * * * * ERAL REGISTER. If any such comments (c) * * *

TABLE OF CONCENTRATION LIMITS

DEA chemical code No. Concentration Special conditions

List I Chemicals

******* Ergocristine and its salts .. 8612 Not exempt at any con- Chemical mixtures containing any amount of centration. ergocristine and its salts are not exempt.

*******

* * * * * § 1310.13 Exemption of chemical mixtures; application. (a) The Administrator may, by publication of a Final Rule in the FEDERAL

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REGISTER, exempt from the application (6) A statement that the applicant of all or any part of the Act a chemical believes justifies an exemption for the mixture consisting of two or more chemical mixture or group of mixtures. chemical components, at least one of The statement must explain how the which is not a List I or List II chem- chemical mixture(s) meets the exemp- ical, if: tion criteria set forth in paragraph (a) (1) The mixture is formulated in such of this section. a way that it cannot be easily used in (7) A statement that the applicant the illicit production of a controlled accepts the right of the Administrator substance; and to terminate exemption from regula- (2) The listed chemical or chemicals tion for the chemical mixture(s) grant- contained in the chemical mixture can- ed exemption under this section. not be readily recovered. (8) The identification of any informa- (b) Any manufacturer seeking an ex- tion on the application that is consid- emption for a chemical mixture, not ered by the applicant to be a trade se- exempt under § 1310.12, from the appli- cret or confidential and entitled to pro- cation of all or any part of the Act, tection under U.S. laws restricting the may apply to the Office of Diversion public disclosure of such information. Control, Drug Enforcement Adminis- (d) The Administrator may require tration. See the Table of DEA Mailing the applicant to submit such additional Addresses in § 1321.01 of this chapter for documents or written statements of the current mailing address. fact relevant to the application that he (c) An application for exemption deems necessary for determining if the under this section shall contain the fol- application should be granted. lowing information: (e) Within 30 days after the receipt of (1) The name, address, and registra- an application for an exemption under tion number, if any, of the applicant; this section, the Administrator will notify the applicant of acceptance or re- (2) The date of the application; jection of the application. If the appli- (3) The exact trade name(s) of the ap- cation is not accepted, an explanation plicant’s chemical mixture and: will be provided. The Administrator is (i) If the applicant formulates or not required to accept an application if manufactures the chemical mixture for any information required pursuant to other entities, the exact trade names of paragraph (c) of this section or re- the chemical mixtures and the names quested pursuant to paragraph (d) of of the entities for which the chemical this section is lacking or not readily mixtures were prepared; and understood. The applicant may, how- (ii) If a group of mixtures (e.g. formu- ever, amend the application to meet lations having identical function and the requirements of paragraphs (c) and containing the same listed chem- (d) of this section. If the exemption is ical(s)), the information required in granted, the applicant shall be notified paragraph (c)(3)(i) of this section and a in writing and the Administrator shall brief narrative of their use. issue, and publish in the FEDERAL REG- (4) (i) The complete qualitative and ISTER, an order on the application. This quantitative composition of the chem- order shall specify the date on which it ical mixture (including all listed and shall take effect. The Administrator all non-listed chemicals); or shall permit any interested person to (ii) If a group of mixtures, the con- file written comments on or objections centration range for the listed chem- to the order. If any comments or objec- ical and a listing of all non-listed tions raise significant issues regarding chemicals with respective concentra- any findings of fact or conclusions of tion ranges. law upon which the order is based, the (5) (i) The chemical and physical Administrator may suspend the effec- properties of the mixture and how they tiveness of the order until he has re- differ from the properties of the listed considered the application in light of chemical or chemicals; and the comments and objections filed. (ii) If a group of mixtures, how the Thereafter, the Administrator shall re- group’s properties differ from the prop- instate, terminate, or amend the origi- erties of the listed chemical. nal order as deemed appropriate.

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(f) The Administrator may, at any range of concentration given in the ap- time, terminate or modify an exemp- plication or that remove non-listed tion for any product pursuant to para- chemical(s) given in the application as graph (e) of this section. In termi- part of the formulation. A new applica- nating or modifying an exemption, the tion will be required only if reformula- Administrator shall issue, and publish tion results in a new product having a in the FEDERAL REGISTER, notification different commercial application or of the removal of an exempt product or can no longer be defined as part of a group of exempt products for which group of exempted chemicals. DEA evidence of diversion has been found. must be notified of reformulation at This order shall specify the date on least 30 days in advance of marketing which the termination of exemption the reformulated mixture. For a shall take effect. The Administrator change in name or other designation, shall permit any interested party to code, or any identifier, a written notifi- file written comments on or objections cation is required. DEA must be noti- to the order within 60 days of the date fied of any changes at least 60 days in of publication of the order in the FED- advance of the effective date for the ERAL REGISTER. If any such comments change. or objections raise significant issues regarding any finding of fact or conclu- (h) Each manufacturer seeking ex- sion of law upon which the order is emption must apply for such an exemp- based, the Administrator may suspend tion. A formulation granted exemption the effectiveness of the order until he by publication in the FEDERAL REG- has reconsidered the order in light of ISTER will not be exempted for all man- comments and objections filed. There- ufacturers. after, the Administrator shall rein- (i) The following chemical mixtures, state, terminate, or amend the original in the form and quantity listed in the order as determined appropriate. application submitted (indicated as the (g) A manufacturer of an exempted ‘‘date’’ ) are designated as exempt chemical mixture shall notify DEA in chemical mixtures for the purposes set writing, of any change in the quan- forth in this section and are exempted titative or qualitative composition of a by the Administrator from application chemical mixture that has been grant- of sections 302, 303, 310, 1007, and 1008 of ed an exemption by application. the Act (21 U.S.C. 822, 823, 830, 957 and Changes include those greater than the 958):

EXEMPT CHEMICAL MIXTURES

Manufacturer Product name 1 Form Date

Cerilliant Corporation ... 1R,2S(-)-Ephedrine hydrochloride 1.0 mg/ml as free base in one of: Liquid ...... 8/2/2007 1,2-dimethoxyethane, acetonitrile, acetonitrile: water (≥ 50% acetonitrile), dimethylformamide, ethylene glycol, isopropanol, methanol, methanol/water (50:50), methanol/dimethyl sulfoxide (80:20), methylene chloride, or tetrahydrofuran.

Cerilliant Corporation ... 1S,2R(+)-Ephedrine-D3 hydrochloride 0.1 mg/ml as free base in one Liquid ...... 8/2/2007 of: 1,2-dimethoxyethane, acetonitrile, acetonitrile: water (≥ 50% acetonitrile), dimethylformamide, ethylene glycol, isopropanol, methanol, methanol/water (50:50), methanol/dimethyl sulfoxide (80:20), methylene chloride, or tetrahydrofuran.

Cerilliant Corporation ... 1S,2R(+)-Ephedrine-D3 hydrochloride 1.0 mg/ml as free base in one Liquid ...... 8/2/2007 of: 1,2-dimethoxyethane, acetonitrile, acetonitrile: water (≥ 50% acetonitrile), dimethylformamide, ethylene glycol, isopropanol, methanol, methanol/water (50:50), methanol/dimethyl sulfoxide (80:20), methylene chloride, or tetrahydrofuran. Cerilliant Corporation ... 1S,2R(+)-Ephedrine hydrochloride 1.0 mg/ml as free base in one of: Liquid ...... 8/2/2007 1,2-dimethoxyethane, acetonitrile, acetonitrile: water (≥ 50% acetonitrile), dimethylformamide, ethylene glycol, isopropanol, methanol, methanol/water (50:50), methanol/dimethyl sulfoxide (80:20), methylene chloride, or tetrahydrofuran.

Cerilliant Corporation ... Pseudoephedrine-D3 hydrochloride 0.1 mg/ml as free base in one of: Liquid ...... 8/2/2007 1,2-dimethoxyethane, acetonitrile, acetonitrile: water (≥ 50% acetonitrile), dimethylformamide, ethylene glycol, isopropanol, methanol, methanol/water (50:50), methanol/dimethyl sulfoxide (80:20), methylene chloride, or tetrahydrofuran.

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EXEMPT CHEMICAL MIXTURES—Continued

Manufacturer Product name 1 Form Date

Cerilliant Corporation ... R,R(-)-Pseudoephedrine 1.0 mg/ml as free base in one of: 1,2- Liquid ...... 8/2/2007 dimethoxyethane, acetonitrile, acetonitrile: water (≥ 50% acetonitrile), dimethylformamide, ethylene glycol, isopropanol, methanol, methanol/water (50:50), methanol/dimethyl sulfoxide (80:20) methylene chloride, or tetrahydrofuran. Cerilliant Corporation ... S,S(+)-Pseudoephedrine 1.0 mg/ml as free base in one of: 1,2- Liquid ...... 8/2/2007 dimethoxyethane, acetonitrile, acetonitrile: water (≥ 50% acetonitrile), dimethylformamide, ethylene glycol, isopropanol, methanol, methanol/water (50:50), methanol/dimethyl sulfoxide (80:20), methylene chloride, or tetrahydrofuran. E.I. DuPont deNemours RC–5156 ...... Liquid ...... 4/22/2005 & Co. E.I. DuPont deNemours VH–6037 ...... Liquid ...... 4/22/2005 & Co. Hawthorne Products, Sole Pack Hoof Dressing ...... Paste ...... 8/14/2007 Inc. Hawthorne Products, Sole Pack Hoof Packing ...... Paste ...... 8/14/2007 Inc. Quality Assurance 10 to 1000 nanograms per milliliter of ephedrine in blood, serum, or Liquid ...... 9/26/2007 Service Corporation. urine. Quality Assurance 10 to 1000 nanograms per milliliter of pseudoephedrine in blood, Liquid ...... 9/26/2007 Service Corporation. serum, or urine. Quality Assurance 10 to 1000 nanograms per milliliter of phenylpropanolamine in blood, Liquid ...... 9/26/2007 Service Corporation. serum, or urine. Reichhold, Inc ...... Beckosol® 12021–00 AA–200, IA–441, P531–T ...... Liquid ...... 5/05/2005 Reichhold, Inc ...... Urotuf® L06–30S, F78–50T ...... Liquid ...... 5/05/2005 Reichhold, Inc ...... Beckosol AA–220 ...... Liquid ...... 6/14/2005 Waterbury Companies, Waterbury 332500 ...... Liquid ...... 4/11/2005 Inc. Waterbury Companies, Waterbury 332762 ...... Liquid ...... 4/11/2005 Inc. Waterbury Companies, Waterbury 332400 ...... Liquid ...... 4/11/2005 Inc. Waterbury Companies, Waterbury 346201 ...... Liquid ...... 4/11/2005 Inc. 1 Designate product line if a group.

[68 FR 23204, May 1, 2003, as amended at 75 § 1310.16 Exemptions for certain FR 10681, Mar. 9, 2010; 75 FR 53869, Sept. 2, scheduled listed chemical products. 2010] (a) Upon the application of a manu- § 1310.14 Removal of exemption from facturer of a scheduled listed chemical definition of regulated transaction. product, the Administrator may by The Administrator finds that the fol- regulation provide that the product is lowing drugs or groups of drugs are exempt from part 1314 of this chapter if being diverted to obtain a listed chem- the Administrator determines that the ical for use in the illicit production of product cannot be used in the illicit a controlled substance and removes the manufacture of a controlled substance. drugs or groups of drugs from exemp- (b) An application for an exemption tion under § 1300.02(b)(28)(i)(D) of this under this section must contain all of chapter pursuant to the criteria listed the following information: in § 1310.10 of this part: (1) The name and address of the ap- (a) Nonprescription drugs containing plicant. ephedrine, its salts, optical isomers, (2) The exact trade name of the and salts of optical isomers. scheduled listed chemical product for which exemption is sought. (b) Nonprescription drugs containing (3) The complete quantitative and phenylpropanolamine, its salts, optical qualitative composition of the drug isomers, and salts of optical isomers. product. (c) Nonprescription drugs containing (4) A brief statement of the facts that pseudoephedrine, its salts, optical iso- the applicant believes justify the mers, and salts of optical isomers. granting of an exemption under this [75 FR 38922, July 7, 2010] section.

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(5) Certification by the applicant § 1310.21 Sale by Federal departments that the product may be lawfully mar- or agencies of chemicals which keted or distributed under the Federal, could be used to manufacture con- Food, Drug, and Cosmetic Act. trolled substances. (6) The identification of any informa- (a) A Federal department or agency tion on the application that is consid- may not sell from the stocks of the de- ered by the applicant to be a trade se- partment or agency any chemical cret or confidential and entitled to pro- which, as determined by the Adminis- tection under U.S. laws restricting the trator of the Drug Enforcement Admin- public disclosure of such information istration, could be used in the manu- by government employees. facture of a controlled substance, un- (c) The Administrator may require less the Administrator certifies in the applicant to submit additional doc- writing to the head of the department uments or written statements of fact or agency that there is no reasonable relevant to the application that he cause to believe that the sale of the deems necessary for determining if the specific chemical to a specific person application should be granted. would result in the illegal manufacture (d) Within a reasonable period of of a controlled substance. For purposes time after the receipt of a completed of this requirement, reasonable cause application for an exemption under to believe means that the Administra- this section, the Administrator shall tion has knowledge of facts which notify the applicant of acceptance or would cause a reasonable person to rea- non-acceptance of the application. If sonably conclude that a chemical the application is not accepted, an ex- would be diverted to the illegal manu- planation will be provided. The Admin- facture of a controlled substance. istrator is not required to accept an ap- (b) A Federal department or agency plication if any of the information re- must request certification by submit- quired in paragraph (b) of this section ting a written request to the Adminis- or requested under paragraph (c) of this trator, Drug Enforcement Administra- section is lacking or not readily under- tion. See the Table of DEA Mailing Ad- stood. The applicant may, however, dresses in § 1321.01 of this chapter for amend the application to meet the re- the current mailing address. A request quirements of paragraphs (b) and (c) of for certification may be transmitted this section. directly to the Office of Diversion Con- trol, Drug Enforcement Administra- (e) If the application is accepted for tion, through electronic facsimile filing, the Administrator shall issue media. A request for certification must and publish in the FEDERAL REGISTER be submitted no later than fifteen cal- an order on the application, which endar days before the proposed sale is shall include a reference to the legal to take place. In order to facilitate the authority under which the order is sale of chemicals from Federal depart- based. This order shall specify the date ments’ or agencies’ stocks, Federal de- on which it shall take effect. partments or agencies may wish to (f) The Administrator shall permit submit requests as far in advance of any interested person to file written the fifteen calendar days as possible. comments on or objections to the The written notification of the pro- order. If any comments or objections posed sale must include: raise significant issues regarding any (1) The name and amount of the findings of fact or conclusions of law chemical to be sold; upon which the order is based, the Ad- (2) The name and address of the pro- ministrator shall immediately suspend spective bidder; the effectiveness of the order until he (3) The name and address of the pro- may reconsider the application in light spective end-user, in cases where a sale of the comments and objections filed. is being brokered; Thereafter, the Administrator shall re- (4) Point(s) of contact for the pro- instate, revoke, or amend the original spective bidder and, where appropriate, order as deemed appropriate. prospective end-user; and [71 FR 56024, Sept. 26, 2006] (5) The end use of the chemical.

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(c) Within fifteen calendar days of re- provide, within fifteen calendar days of ceipt of a request for certification, the receiving a request for certification Administrator will certify in writing to from a Federal department or agency, the head of the Federal department or the same written notice to the prospec- agency that there is, or is not, reason- tive bidder and end-user, and this no- able cause to believe that the sale of tice also will contain a statement of the specific chemical to the specific the legal and factual basis for the re- bidder and end-user would result in the fusal of certification. The prospective illegal manufacture of a controlled bidder and end-user may, within thirty substance. In making this determina- calendar days of receipt of notification tion, the following factors must be con- of the refusal, submit written com- sidered: ments or written objections to the Ad- (1) Past experience of the prospective ministrator’s refusal. At the same bidder or end-user in the maintenance time, the prospective bidder and end- of effective controls against diversion user also may provide supporting docu- of listed chemicals into other than le- mentation to contest the Administra- gitimate medical, scientific, and indus- tor’s refusal. If such written comments trial channels; or written objections raise issues re- (2) Compliance of the prospective bid- garding any finding of fact or conclu- der or end-user with applicable Fed- sion of law upon which the refusal is eral, state and local law; based, the Administrator will recon- (3) Prior conviction record of the pro- sider the refusal of the proposed sale in spective bidder or end-user relating to light of the written comments or writ- listed chemicals or controlled sub- ten objections filed. Thereafter, within stances under Federal or state laws; a reasonable time, the Administrator and will withdraw or affirm the original re- (4) Such other factors as may be rel- fusal of certification as he determines evant to and consistent with the public appropriate. The Administrator will health and safety. provide written reasons for any affir- (d) If the Administrator certifies to mation of the original refusal. Such af- the head of a Federal department or firmation of the original refusal will agency that there is no reasonable constitute a final decision for purposes cause to believe that the sale of a spe- of judicial review under 21 U.S.C. 877. cific chemical to a prospective bidder (f) If the Administrator determines and end-user will result in the illegal there is reasonable cause to believe manufacture of a controlled substance, that an existing certification should be that certification will be effective for withdrawn, DEA will provide written one year from the date of issuance with notice to the head of a Federal depart- respect to further sales of the same ment or agency of such withdrawal chemical to the same prospective bid- under the authority of 21 U.S.C. 890. der and end-user, unless the Adminis- DEA also will provide, within fifteen trator notifies the head of the Federal calendar days of withdrawal of an ex- department or agency in writing that isting certification, the same written the certification is withdrawn. If the notice to the bidder and end-user, and certification is withdrawn, DEA will this notice also will contain a state- also provide written notice to the bid- ment of the legal and factual basis for der and end-user, which will contain a the withdrawal. The bidder and end- statement of the legal and factual basis user may, within thirty calendar days for this determination. of receipt of notification of the with- (e) If the Administrator determines drawal of the existing certification, there is reasonable cause to believe the submit written comments or written sale of the specific chemical to a spe- objections to the Administrator’s with- cific bidder and end-user would result drawal. At the same time, the bidder in the illegal manufacture of a con- and end-user also may provide sup- trolled substance, DEA will provide porting documentation to contest the written notice to the head of a Federal Administrator’s withdrawal. If such department or agency refusing to cer- written comments or written objec- tify the proposed sale under the au- tions raise issues regarding any finding thority of 21 U.S.C. 890. DEA also will of fact or conclusion of law upon which

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the withdrawal of the existing certifi- 1311.102 Practitioner responsibilities. cation is based, the Administrator will 1311.105 Requirements for obtaining an au- reconsider the withdrawal of the exist- thentication credential—Individual prac- ing certification in light of the written titioners. 1311.110 Requirements for obtaining an au- comments or written objections filed. thentication credential—Individual prac- Thereafter, within a reasonable time, titioners eligible to use an electronic the Administrator will withdraw or af- prescription application of an institu- firm the original withdrawal of the ex- tional practitioner. isting certification as he determines 1311.115 Additional requirements for two- appropriate. The Administrator will factor authentication. provide written reasons for any affir- 1311.116 Additional requirements for biometrics. mation of the original withdrawal of 1311.120 Electronic prescription application the existing certification. Such affir- requirements. mation of the original withdrawal of 1311.125 Requirements for establishing log- the existing certification will con- ical access control—Individual practi- stitute a final decision for purposes of tioner. judicial review under 21 U.S.C. 877. 1311.130 Requirements for establishing logical access control—Institutional practi- [68 FR 62737, Nov. 6, 2003, as amended at 75 tioner. FR 10681, Mar. 9, 2010] 1311.135 Requirements for creating a controlled substance prescription. PART 1311—REQUIREMENTS FOR 1311.140 Requirements for signing a controlled substance prescription. ELECTRONIC ORDERS AND PRE- 1311.145 Digitally signing the prescription SCRIPTIONS with the individual practitioner’s private key. Subpart A—General 1311.150 Additional requirements for internal application audits. Sec. 1311.170 Transmission requirements. 1311.01 Scope. 1311.200 Pharmacy responsibilities. 1311.02 Definitions. 1311.205 Pharmacy application require- 1311.05 Standards for technologies for elec- ments. tronic transmission of orders. 1311.210 Archiving the initial record. 1311.08 Incorporation by reference. 1311.215 Internal audit trail. 1311.300 Application provider require- Subpart B—Obtaining and Using Digital ments—Third-party audits or certifi- Certificates for Electronic Orders cations. 1311.302 Additional application provider re- 1311.10 Eligibility to obtain a CSOS digital quirements. certificate. 1311.305 Recordkeeping. 1311.15 Limitations on CSOS digital certificates. AUTHORITY: 21 U.S.C. 821, 828, 829, 871(b), 1311.20 Coordinators for CSOS digital cer- 958(e), 965, unless otherwise noted. tificate holders. SOURCE: 70 FR 16915, Apr. 1, 2005, unless 1311.25 Requirements for obtaining a CSOS otherwise noted. digital certificate. 1311.30 Requirements for storing and using a private key for digitally signing orders. Subpart A—General 1311.35 Number of CSOS digital certificates needed. § 1311.01 Scope. 1311.40 Renewal of CSOS digital certifi- This part sets forth the rules gov- cates. erning the creation, transmission, and 1311.45 Requirements for registrants that storage of electronic orders and pre- allow powers of attorney to obtain CSOS digital certificates under their DEA reg- scriptions. istration. [75 FR 16310, Mar. 31, 2010] 1311.50 Requirements for recipients of digitally signed orders. § 1311.02 Definitions. 1311.55 Requirements for systems used to process digitally signed orders. Any term contained in this part shall 1311.60 Recordkeeping. have the definition set forth in section 102 of the Act (21 U.S.C. 802) or part Subpart C—Electronic Prescriptions 1300 of this chapter. 1311.100 General. [75 FR 16310, Mar. 31, 2010]

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§ 1311.05 Standards for technologies (b) These standards are available for electronic transmission of or- from the National Institute of Stand- ders. ards and Technology, Computer Secu- (a) A registrant or a person with rity Division, Information Technology power of attorney to sign orders for Laboratory, National Institute of Schedule I and II controlled substances Standards and Technology, 100 Bureau may use any technology to sign and Drive, Gaithersburg, MD 20899–8930, electronically transmit orders if the (301) 975–6478 or TTY (301) 975–8295, technology provides all of the fol- [email protected], and are available at lowing: http://csrc.nist.gov/. The following stand- (1) Authentication: The system must ards are incorporated by reference: enable a recipient to positively verify (1) Federal Information Processing the signer without direct communica- Standard Publication (FIPS PUB) 140– tion with the signer and subsequently 2, Change Notices (12–03–2002), Security demonstrate to a third party, if needed, Requirements for Cryptographic Mod- that the sender’s identity was properly ules, May 25, 2001 (FIPS 140–2) includ- verified. ing Annexes A through D; incorporation by reference approved for (2) Nonrepudiation: The system must §§ 1311.30(b), 1311.55(b), 1311.115(b), ensure that strong and substantial evi- 1311.120(b), 1311.205(b). dence is available to the recipient of (i) Annex A: Approved Security Func- the sender’s identity, sufficient to pre- tions for FIPS PUB 140–2, Security Re- vent the sender from successfully deny- quirements for Cryptographic Modules, ing having sent the data. This criterion September 23, 2004. includes the ability of a third party to (ii) Annex B: Approved Protection verify the origin of the document. Profiles for FIPS PUB 140–2, Security (3) Message integrity: The system Requirements for Cryptographic Mod- must ensure that the recipient, or a ules, November 4, 2004. third party, can determine whether the (iii) Annex C: Approved Random contents of the document have been al- Number Generators for FIPS PUB 140– tered during transmission or after re- 2, Security Requirements for Cryp- ceipt. tographic Modules, January 31, 2005. (b) DEA has identified the following (iv) Annex D: Approved Key Estab- means of electronically signing and lishment Techniques for FIPS PUB 140– transmitting order forms as meeting 2, Security Requirements for Cryp- all of the standards set forth in para- tographic Modules, February 23, 2004. graph (a) of this section. (2) Federal Information Processing (1) Digital signatures using Public Standard Publication (FIPS PUB) 180– Key Infrastructure (PKI) technology. 2, Secure Hash Standard, August 1, (2) [Reserved] 2002, as amended by change notice 1, February 25, 2004 (FIPS 180–2); incorpo- § 1311.08 Incorporation by reference. ration by reference approved for (a) These incorporations by reference §§ 1311.30(b) and 1311.55(b). were approved by the Director of the (3) Federal Information Processing Federal Register in accordance with 5 Standard Publication (FIPS PUB) 180– U.S.C. 552(a) and 1 CFR part 51. Copies 3, Secure Hash Standard (SHS), Octo- may be inspected at the Drug Enforce- ber 2008 (FIPS 180–3); incorporation by ment Administration, 600 Army Navy reference approved for §§ 1311.120(b) and Drive, Arlington, VA 22202 or at the 1311.205(b). National Archives and Records Admin- (4) Federal Information Processing istration (NARA). For information on Standard Publication (FIPS PUB) 186– the availability of this material at the 2, Digital Signature Standard, January Drug Enforcement Administration, call 27, 2000, as amended by Change Notice (202) 307–1000. For information on the 1, October 5, 2001 (FIPS 186–2); incorpo- availability of this material at NARA, ration by reference approved for call (202) 741–6030 or go to: http:// §§ 1311.30(b) and 1311.55(b). www.archives.gov/federallregister/ (5) Federal Information Processing codeloflfederallregulations/ Standard Publication (FIPS PUB) 186– ibrllocations.html. 3, Digital Signature Standard (DSS),

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June 2009 (FIPS 186–3); incorporation must designate one or more responsible by reference approved for §§ 1311.120(b), persons to serve as that registrant’s 1311.205(b), and 1311.210(c). CSOS coordinator regarding issues per- (6) Draft NIST Special Publication taining to issuance of, revocation of, 800–63–1, Electronic Authentication and changes to digital certificates Guideline, December 8, 2008 (NIST SP issued under that registrant’s DEA reg- 800–63–1); Burr, W. et al.; incorporation istration. While the coordinator will be by reference approved for § 1311.105(a). the main point of contact between one (7) NIST Special Publication 800–76–1, or more DEA registered locations and Biometric Data Specification for Per- the CSOS Certification Authority, all sonal Identity Verification, January digital certificate activities are the re- 2007 (NIST SP 800–76–1); Wilson, C. et sponsibility of the registrant with al.; incorporation by reference ap- whom the digital certificate is associ- proved for § 1311.116(d). ated. Even when an individual reg- [75 FR 16310, Mar. 31, 2010] istrant, i.e., an individual practitioner, is applying for a digital certificate to order controlled substances a CSOS Co- Subpart B—Obtaining and Using ordinator must be designated; though Digital Certificates for Elec- in such a case, the individual practi- tronic Orders tioner may also serve as the coordinator. § 1311.10 Eligibility to obtain a CSOS digital certificate. (b) Once designated, coordinators must identify themselves, on a one- The following persons are eligible to time basis, to the Certification Author- obtain a CSOS digital certificate from ity. If a designated coordinator the DEA Certification Authority to changes, the Certification Authority sign electronic orders for controlled must be notified of the change and the substances. new responsibilities assumed by each of (a) The person who signed the most the registrant’s coordinators, if appli- recent DEA registration application or cable. Coordinators must complete the renewal application and a person au- application that the DEA Certification thorized to sign a registration applica- Authority provides and submit the fol- tion. lowing: (b) A person granted power of attor- (1) Two copies of identification, one ney by a DEA registrant to sign orders for one or more schedules of controlled of which must be a government-issued substances. photographic identification. (2) A copy of each current DEA Cer- § 1311.15 Limitations on CSOS digital tificate of Registration (DEA form 223) certificates. for each registered location for which (a) A CSOS digital certificate issued the coordinator will be responsible or, by the DEA Certification Authority if the applicant (or their employer) has will authorize the certificate holder to not been issued a DEA registration, a sign orders for only those schedules of copy of each application for registra- controlled substances covered by the tion of the applicant or the applicant’s registration under which the certifi- employer. cate is issued. (3) The applicant must have the com- (b) When a registrant, in a power of pleted application notarized and for- attorney letter, limits a certificate ap- ward the completed application and ac- plicant to a subset of the registrant’s companying documentation to the authorized schedules, the registrant is DEA Certification Authority. responsible for ensuring that the cer- (c) Coordinators will communicate tificate holder signs orders only for with the Certification Authority re- that subset of schedules. garding digital certificate applications, renewals and revocations. For appli- § 1311.20 Coordinators for CSOS dig- cants applying for a digital certificate ital certificate holders. from the DEA Certification Authority, (a) Each registrant, regardless of and for applicants applying for a power number of digital certificates issued, of attorney digital certificate for a

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DEA registrant, the registrant’s Coor- § 1311.30 Requirements for storing and dinator must verify the applicant’s using a private key for digitally identity, review the application pack- signing orders. age, and submit the completed package (a) Only the certificate holder may to the Certification Authority. access or use his or her digital certificate and private key. § 1311.25 Requirements for obtaining a (b) The certificate holder must pro- CSOS digital certificate. vide FIPS-approved secure storage for (a) To obtain a certificate to use for the private key, as discussed by FIPS signing electronic orders for controlled 140–2, 180–2, 186–2, and accompanying substances, a registrant or person with change notices and annexes, as incor- power of attorney for a registrant must porated by reference in § 1311.08. complete the application that the DEA (c) A certificate holder must ensure Certification Authority provides and that no one else uses the private key. submit the following: While the private key is activated, the (1) Two copies of identification, one certificate holder must prevent unau- of which must be a government-issued thorized use of that private key. photographic identification. (d) A certificate holder must not (2) A current listing of DEA registra- make back-up copies of the private tions for which the individual has au- key. thority to sign controlled substances (e) The certificate holder must report orders. the loss, theft, or compromise of the private key or the password, via a rev- (3) A copy of the power of attorney ocation request, to the Certification from the registrant, if applicable. Authority within 24 hours of substan- (4) An acknowledgment that the ap- tiation of the loss, theft, or com- plicant has read and understands the promise. Upon receipt and verification Subscriber Agreement and agrees to of a signed revocation request, the Cer- the statement of subscriber obligations tification Authority will revoke the that DEA provides. certificate. The certificate holder must (b) The applicant must provide the apply for a new certificate under the completed application to the reg- requirements of § 1311.25. istrant’s coordinator for CSOS digital certificate holders who will review the § 1311.35 Number of CSOS digital cer- application and submit the completed tificates needed. application and accompanying docu- A purchaser of Schedule I and II con- mentation to the DEA Certification trolled substances must obtain a sepa- Authority. rate CSOS certificate for each reg- (c) When the Certification Authority istered location for which the pur- approves the application, it will send chaser will order these controlled sub- the applicant a one-time use reference stances. number and access code, via separate channels, and information on how to § 1311.40 Renewal of CSOS digital cer- use them. Using this information, the tificates. applicant must then electronically sub- (a) A CSOS certificate holder must mit a request for certification of the generate a new key pair and obtain a public digital signature key. After the new CSOS digital certificate when the request is approved, the Certification registrant’s DEA registration expires Authority will provide the applicant or whenever the information on which with the signed public key certificate. the certificate is based changes. This (d) Once the applicant has generated information includes the registered the key pair, the Certification Author- name and address, the subscriber’s ity must prove that the user has pos- name, and the schedules the registrant session of the key. For public keys, the is authorized to handle. A CSOS certifi- corresponding private key must be cate will expire on the date on which used to sign the certificate request. the DEA registration on which the cer- Verification of the signature using the tificate is based expires. public key in the request will serve as (b) The Certification Authority will proof of possession of the private key. notify each CSOS certificate holder 45

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days in advance of the expiration of the § 1311.55 Requirements for systems certificate holder’s CSOS digital cer- used to process digitally signed or- tificate. ders. (c) If a CSOS certificate holder ap- (a) A CSOS certificate holder and re- plies for a renewal before the certifi- cipient of an electronic order may use cate expires, the certificate holder may any system to write, track, or main- renew electronically twice. For every tain orders provided that the system third renewal, the CSOS certificate has been enabled to process digitally holder must submit a new application signed documents and that it meets the and documentation, as provided in requirements of paragraph (b) or (c) of § 1311.25. this section. (d) If a CSOS certificate expires be- (b) A system used to digitally sign fore the holder applies for a renewal, Schedule I or II orders must meet the the certificate holder must submit a following requirements: new application and documentation, as (1) The cryptographic module must provided in § 1311.25. be FIPS 140–2, Level 1 validated, as incorporated by reference in § 1311.08. § 1311.45 Requirements for registrants (2) The digital signature system and that allow powers of attorney to ob- hash function must be compliant with tain CSOS digital certificates under FIPS 186–2 and FIPS 180–2, as incor- their DEA registration. porated by reference in § 1311.08. (a) A registrant that grants power of (3) The private key must be stored on attorney must report to the DEA Cer- a FIPS 140–2 Level 1 validated cryp- tification Authority within 6 hours of tographic module using a FIPS-ap- either of the following (advance notice proved encryption algorithm, as incor- may be provided, where applicable): porated by reference in § 1311.08. (1) The person with power of attorney (4) The system must use either a user has left the employ of the institution. identification and password combina- (2) The person with power of attorney tion or biometric authentication to ac- has had his or her privileges revoked. cess the private key. Activation data (b) A registrant must maintain a must not be displayed as they are en- record that lists each person granted tered. power of attorney to sign controlled (5) The system must set a 10-minute substances orders. inactivity time period after which the certificate holder must reauthenticate § 1311.50 Requirements for recipients the password to access the private key. of digitally signed orders. (6) For software implementations, when the signing module is deacti- (a) The recipient of a digitally signed vated, the system must clear the plain order must do the following before fill- text private key from the system mem- ing the order: ory to prevent the unauthorized access (1) Verify the integrity of the signa- to, or use of, the private key. ture and the order by having the sys- (7) The system must be able to tem validate the order. digitally sign and transmit an order. (2) Verify that the certificate hold- (8) The system must have a time sys- er’s CSOS digital certificate has not tem that is within five minutes of the expired by checking the expiration official National Institute of Standards date against the date the order was and Technology time source. signed. (9) The system must archive the (3) Check the validity of the certifi- digitally signed orders and any other cate holder’s certificate by checking records required in part 1305 of this the Certificate Revocation List. chapter, including any linked data. (4) Check the certificate extension (10) The system must create an order data to determine whether the sender that includes all data fields listed has the authority to order the con- under § 1305.21(b) of this chapter. trolled substance. (c) A system used to receive, verify, (b) A recipient may cache Certificate and create linked records for orders Revocation Lists for use until they ex- signed with a CSOS digital certificate pire. must meet the following requirements:

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(1) The cryptographic module must a report in the format DEA specifies, be FIPS 140–2, Level 1 validated, as in- as provided in § 1305.29 of this chapter. corporated by reference in § 1311.08. (d) For systems used to process CSOS (2) The digital signature system and orders, the system developer or vendor hash function must be compliant with must have an initial independent third- FIPS 186–2 and FIPS 180–2, as incor- party audit of the system and an addi- porated by reference in § 1311.08. tional independent third-party audit (3) The system must determine that whenever the signing or verifying an order has not been altered during functionality is changed to determine transmission. The system must invali- whether it correctly performs the func- date any order that has been altered. tions listed under paragraphs (b) and (4) The system must validate the dig- (c) of this section. The system devel- ital signature using the signer’s public oper must retain the most recent audit key. The system must invalidate any results and retain the results of any order in which the digital signature other audits of the software completed cannot be validated. within the previous two years. (5) The system must validate that § 1311.60 Recordkeeping. the DEA registration number contained in the body of the order cor- (a) A supplier and purchaser must responds to the registration number as- maintain records of CSOS electronic sociated with the specific certificate by orders and any linked records for two separately generating the hash value of years. Records may be maintained the registration number and certificate electronically. Records regarding con- subject distinguished name serial num- trolled substances that are maintained ber and comparing that hash value to electronically must be readily retriev- the hash value contained in the certifi- able from all other records. cate extension for the DEA registra- (b) Electronic records must be easily tion number. If the hash values are not readable or easily rendered into a for- equal the system must invalidate the mat that a person can read. They must order. be made available to the Administra- (6) The system must check the Cer- tion upon request. tificate Revocation List automatically (c) CSOS certificate holders must and invalidate any order with a certifi- maintain a copy of the subscriber cate listed on the Certificate Revoca- agreement that the Certification Au- tion List. thority provides for the life of the cer- (7) The system must check the valid- tificate. ity of the certificate and the Certifi- cation Authority certificate and invali- Subpart C—Electronic date any order that fails these validity Prescriptions checks.

(8) The system must have a time sys- SOURCE: 75 FR 16310, Mar. 31, 2010, unless tem that is within five minutes of the otherwise noted. official National Institute of Standards and Technology time source. § 1311.100 General. (9) The system must check the sub- (a) This subpart addresses the re- stances ordered against the schedules quirements that must be met to issue that the registrant is allowed to order and process Schedule II, III, IV, and V and invalidate any order that includes controlled substance prescriptions substances the registrant is not al- electronically. lowed to order. (b) A practitioner may issue a pre- (10) The system must ensure that an scription for a Schedule II, III, IV, or V invalid finding cannot be bypassed or controlled substance electronically if ignored and the order filled. all of the following conditions are met: (11) The system must archive the (1) The practitioner is registered as order and associate with it the digital an individual practitioner or exempt certificate received with the order. from the requirement of registration (12) If a registrant sends reports on under part 1301 of this chapter and is orders to DEA, the system must create authorized under the registration or

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exemption to dispense the controlled (b) The practitioner must notify the substance; individuals designated under § 1311.125 (2) The practitioner uses an elec- or § 1311.130 within one business day of tronic prescription application that discovery that the hard token has been meets all of the applicable require- lost, stolen, or compromised or the au- ments of this subpart; and thentication protocol has been other- (3) The prescription is otherwise in wise compromised. A practitioner who conformity with the requirements of fails to comply with this provision may the Act and this chapter. be held responsible for any controlled (c) An electronic prescription for a substance prescriptions written using Schedule II, III, IV, or V controlled his two-factor authentication creden- substance created using an electronic tial. prescription application that does not (c) If the practitioner is notified by meet the requirements of this subpart an intermediary or pharmacy that an is not a valid prescription, as that term electronic prescription was not suc- is defined in § 1300.03 of this chapter. cessfully delivered, as provided in (d) A controlled substance prescrip- § 1311.170, he must ensure that any tion created using an electronic pre- paper or oral prescription (where per- scription application that meets the re- mitted) issued as a replacement of the quirements of this subpart is not a original electronic prescription indi- valid prescription if any of the func- cates that the prescription was origi- tions required under this subpart were nally transmitted electronically to a disabled when the prescription was in- particular pharmacy and that the dicated as ready for signature and transmission failed. signed. (d) Before initially using an elec- (e) A registered pharmacy may proc- tronic prescription application to sign ess electronic prescriptions for con- and transmit controlled substance pre- trolled substances only if all of the fol- scriptions, the practitioner must deter- lowing conditions are met: mine that the third-party auditor or (1) The pharmacy uses a pharmacy certification organization has found application that meets all of the appli- that the electronic prescription applicable requirements of this subpart; and cation records, stores, and transmits (2) The prescription is otherwise in the following accurately and consist- conformity with the requirements of ently: the Act and this chapter. (1) The information required for a (f) Nothing in this part alters the re- prescription under § 1306.05(a) of this sponsibilities of the practitioner and chapter. pharmacy, specified in part 1306 of this (2) The indication of signing as re- chapter, to ensure the validity of a quired by § 1311.120(b)(17) or the digital controlled substance prescription. signature created by the practitioner’s private key. § 1311.102 Practitioner responsibil- (3) The number of refills as required ities. by § 1306.22 of this chapter. (a) The practitioner must retain sole (e) If the third-party auditor or cer- possession of the hard token, where ap- tification organization has found that plicable, and must not share the pass- an electronic prescription application word or other knowledge factor, or bio- does not accurately and consistently metric information, with any other record, store, and transmit other infor- person. The practitioner must not mation required for prescriptions under allow any other person to use the this chapter, the practitioner must not token or enter the knowledge factor or create, sign, and transmit electronic other identification means to sign pre- prescriptions for controlled substances scriptions for controlled substances. that are subject to the additional infor- Failure by the practitioner to secure mation requirements. the hard token, knowledge factor, or (f) The practitioner must not use the biometric information may provide a electronic prescription application to basis for revocation or suspension of sign and transmit electronic controlled registration pursuant to section substance prescriptions if any of the 304(a)(4) of the Act (21 U.S.C. 824(a)(4)). functions of the application required

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by this subpart have been disabled or tions for controlled substances via appear to be functioning improperly. electronic means as when issuing a (g) If an electronic prescription appli- paper or oral prescription. Nothing in cation provider notifies an individual this subpart relieves a practitioner of practitioner that a third-party audit or his responsibility to dispense con- certification report indicates that the trolled substances only for a legitimate application or the application provider medical purpose while acting in the no longer meets the requirements of usual course of his professional prac- this part or notifies him that the appli- tice. If an agent enters information at cation provider has identified an issue the practitioner’s direction prior to the that makes the application non-com- practitioner reviewing and approving pliant, the practitioner must do the the information and signing and au- following: thorizing the transmission of that in- (1) Immediately cease to issue elec- formation, the practitioner is respon- tronic controlled substance prescrip- sible in case the prescription does not tions using the application. conform in all essential respects to the (2) Ensure, for an installed electronic law and regulations. prescription application at an individual practitioner’s practice, that the § 1311.105 Requirements for obtaining individuals designated under § 1311.125 an authentication credential—Indi- terminate access for signing controlled vidual practitioners. substance prescriptions. (a) An individual practitioner must (h) If an electronic prescription ap- obtain a two-factor authentication cre- plication provider notifies an institu- dential from one of the following: tional practitioner that a third-party (1) A credential service provider that audit or certification report indicates has been approved by the General Serv- that the application or the application ices Administration Office of Tech- provider no longer meets the require- nology Strategy/Division of Identity ments of this part or notifies it that Management to conduct identity proof- the application provider has identified ing that meets the requirements of As- an issue that makes the application surance Level 3 or above as specified in non-compliant, the institutional prac- NIST SP 800–63–1 as incorporated by titioner must ensure that the individ- reference in § 1311.08. uals designated under § 1311.130 termi- (2) For digital certificates, a certifi- nate access for signing controlled sub- cation authority that is cross-certified stance prescriptions. with the Federal Bridge certification (i) An individual practitioner or in- authority and that operates at a Fed- stitutional practitioner that receives a eral Bridge Certification Authority notification that the electronic pre- basic assurance level or above. scription application is not in compli- (b) The practitioner must submit ance with the requirements of this part identity proofing information to the must not use the application to issue credential service provider or certifi- electronic controlled substance pre- cation authority as specified by the scriptions until it is notified that the credential service provider or certifi- application is again compliant and all cation authority. relevant updates to the application (c) The credential service provider or have been installed. certification authority must issue the (j) The practitioner must notify both authentication credential using two the individuals designated under channels (e.g., e-mail, mail, or tele- § 1311.125 or § 1311.130 and the Adminis- phone call). If one of the factors used in tration within one business day of dis- the authentication protocol is a bio- covery that one or more prescriptions metric, or if the practitioner has a that were issued under a DEA registra- hard token that is being enabled to tion held by that practitioner were pre- sign controlled substances prescrip- scriptions the practitioner had not tions, the credential service provider or signed or were not consistent with the certification authority must issue two prescriptions he signed. pieces of information used to generate (k) The practitioner has the same re- or activate the authentication creden- sponsibilities when issuing prescrip- tial using two channels.

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§ 1311.110 Requirements for obtaining trolled substances under the registra- an authentication credential—Indi- tion of such facility. vidual practitioners eligible to use (b) An institutional practitioner that an electronic prescription applica- elects to conduct identity proofing tion of an institutional practitioner. must provide authorization to issue the (a) For any registrant or person ex- authentication credentials to a sepa- empted from the requirement of reg- rate entity within the institutional istration under § 1301.22(c) of this chap- practitioner or to an outside credential ter who is eligible to use the institu- Service provider or certification au- tional practitioner’s electronic pre- thority that meets the requirements of scription application to sign prescrip- § 1311.105(a). tions for controlled substances, the en- (c) When an institutional practi- tity within a DEA-registered institu- tioner is conducting identity proofing tional practitioner that grants that in- and submitting information to a cre- dividual practitioner privileges at the dential service provider or certification institutional practitioner (e.g., a hos- authority to authorize the issuance of pital credentialing office) may conduct authentication credentials, the institu- identity proofing and authorize the tional practitioner must meet any re- issuance of the authentication creden- quirements that the credential service tial. That entity must do the following: provider or certification authority im- (1) Ensure that photographic identi- poses on entities that serve as trusted fication issued by the Federal Govern- agents. ment or a State government matches (d) An institutional practitioner that the person presenting the identifica- elects to conduct identity proofing and tion. authorize the issuance of the authen- (2) Ensure that the individual practi- tication credential as provided in para- tioner’s State authorization to practice graphs (a) through (c) of this section and, where applicable, State authoriza- must do so in a manner consistent with tion to prescribe controlled substances, the institutional practitioner’s general is current and in good standing. obligation to maintain effective con- (3) Either ensure that the individual trols against diversion. Failure to meet practitioner’s DEA registration is cur- this obligation may result in remedial rent and in good standing or ensure action consistent with § 1301.36 of this that the institutional practitioner has chapter. granted the individual practitioner ex- (e) An institutional practitioner that empt from the requirement of registra- elects to conduct identity proofing tion under § 1301.22 of this chapter must retain a record of the identity- privileges to prescribe controlled sub- proofing. An institutional practitioner stances using the institutional practi- that elects to issue the two-factor au- tioner’s DEA registration number. thentication credential must retain a (4) If the individual practitioner is an record of the issuance of the credential. employee of a health care facility that is operated by the Department of Vet- § 1311.115 Additional requirements for erans Affairs, confirm that the indi- two-factor authentication. vidual practitioner has been duly ap- (a) To sign a controlled substance pointed to practice at that facility by prescription, the electronic prescrip- the Secretary of the Department of tion application must require the prac- Veterans Affairs pursuant to 38 U.S.C. titioner to authenticate to the applica- 7401–7408. tion using an authentication protocol (5) If the individual practitioner is that uses two of the following three working at a health care facility oper- factors: ated by the Department of Veterans (1) Something only the practitioner Affairs on a contractual basis pursuant knows, such as a password or response to 38 U.S.C. 8153 and, in the perform- to a challenge question. ance of his duties, prescribes controlled (2) Something the practitioner is, bi- substances, confirm that the individual ometric data such as a fingerprint or practitioner meets the criteria for eli- iris scan. gibility for appointment under 38 (3) Something the practitioner has, a U.S.C. 7401–7408 and is prescribing con- device (hard token) separate from the

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computer to which the practitioner is the time of authentication to the elec- gaining access. tronic prescription application. (b) If one factor is a hard token, it (g) The biometric subsystem must must be separate from the computer to protect the biometric data (raw data or which it is gaining access and must templates), match results, and/or non- meet at least the criteria of FIPS 140– match results when authentication is 2 Security Level 1, as incorporated by not local. If sent over an open network, reference in § 1311.08, for cryptographic biometric data (raw data or templates), modules or one-time-password devices. match results, and/or non-match re- (c) If one factor is a biometric, the sults must be: biometric subsystem must comply with (1) Cryptographically source authen- the requirements of § 1311.116. ticated; (2) Combined with a random chal- § 1311.116 Additional requirements for lenge, a nonce, or a time stamp to pre- biometrics. vent replay; (a) If one of the factors used to au- (3) Cryptographically protected for thenticate to the electronic prescrip- integrity and confidentiality; and tion application is a biometric as de- (4) Sent only to authorized systems. scribed in § 1311.115, it must comply (h) Testing of the biometric sub- with the following requirements. system must have the following char- (b) The biometric subsystem must acteristics: operate at a false match rate of 0.001 or (1) The test is conducted by a labora- lower. tory that does not have an interest in (c) The biometric subsystem must the outcome (positive or negative) of use matching software that has dem- performance of a submission or biomet- onstrated performance at the operating ric. point corresponding with the false (2) Test data are sequestered. match rate described in paragraph (b) (3) Algorithms are provided to the of this section, or a lower false match testing laboratory (as opposed to rate. Testing to demonstrate perform- scores or other information). ance must be conducted by the Na- (4) The operating point(s) cor- tional Institute of Standards and Tech- responding with the false match rate nology or another DEA-approved gov- described in paragraph (b) of this sec- ernment or nongovernment laboratory. tion, or a lower false match rate, is Such testing must comply with the re- tested so that there is at least 95% con- quirements of paragraph (h) of this sec- fidence that the false match and non- tion. match rates are equal to or less than (d) The biometric subsystem must the observed value. conform to Personal Identity (5) Results of the testing are made Verification authentication biometric publicly available. acquisition specifications, pursuant to NIST SP 800–76–1 as incorporated by § 1311.120 Electronic prescription ap- reference in § 1311.08, if they exist for plication requirements. the biometric modality of choice. (a) A practitioner may only use an (e) The biometric subsystem must ei- electronic prescription application ther be co-located with a computer or that meets the requirements in para- PDA that the practitioner uses to issue graph (b) of this section to issue elec- electronic prescriptions for controlled tronic controlled substance prescrip- substances, where the computer or tions. PDA is located in a known, controlled (b) The electronic prescription appli- location, or be built directly into the cation must meet the requirements of practitioner’s computer or PDA that this subpart including the following: he uses to issue electronic prescrip- (1) The electronic prescription appli- tions for controlled substances. cation must do the following: (f) The biometric subsystem must (i) Link each registrant, by name, to store device ID data at enrollment (i.e., at least one DEA registration number. biometric registration) with the bio- (ii) Link each practitioner exempt metric data and verify the device ID at from registration under § 1301.22(c) of

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this chapter to the institutional practi- cial National Institute of Standards tioner’s DEA registration number and and Technology time source. the specific internal code number re- (9) The electronic prescription appli- quired under § 1301.22(c)(5) of this chap- cation must present for the practi- ter. tioner’s review and approval all of the (2) The electronic prescription appli- following data for each controlled sub- cation must be capable of the setting of stance prescription: logical access controls to limit permis- (i) The date of issuance. sions for the following functions: (ii) The full name of the patient. (i) Indication that a prescription is (iii) The drug name. ready for signing and signing con- (iv) The dosage strength and form, trolled substance prescriptions. quantity prescribed, and directions for (ii) Creating, updating, and executing use. the logical access controls for the func- (v) The number of refills authorized, tions specified in paragraph (b)(2)(i) of if applicable, for prescriptions for this section. Schedule III, IV, and V controlled substances. (3) Logical access controls must be (vi) For prescriptions written in ac- set by individual user name or role. If cordance with the requirements of the application sets logical access con- § 1306.12(b) of this chapter, the earliest trol by role, it must not allow an indi- date on which a pharmacy may fill vidual to be assigned the role of reg- each prescription. istrant unless that individual is linked (vii) The name, address, and DEA to at least one DEA registration num- registration number of the prescribing ber as provided in paragraph (b)(1) of practitioner. this section. (viii) The statement required under (4) The application must require that § 1311.140(a)(3). the setting and changing of logical ac- (10) The electronic prescription appli- cess controls specified under paragraph cation must require the prescribing (b)(2) of this section involve the ac- practitioner to indicate that each con- tions of two individuals as specified in trolled substance prescription is ready §§ 1311.125 or 1311.130. Except for institu- for signing. The electronic prescription tional practitioners, a practitioner au- application must not permit alteration thorized to sign controlled substance of the DEA elements after the practi- prescriptions must approve logical ac- tioner has indicated that a controlled cess control entries. substance prescription is ready to be (5) The electronic prescription appli- signed without requiring another re- cation must accept two-factor authen- view and indication of readiness for tication that meets the requirements signing. Any controlled substance pre- of § 1311.115 and require its use for sign- scription not indicated as ready to be ing controlled substance prescriptions signed shall not be signed or trans- and for approving data that set or mitted. change logical access controls related (11) While the information required to reviewing and signing controlled by paragraph (b)(9) of this section and substance prescriptions. the statement required by (6) The electronic prescription appli- § 1311.140(a)(3) remain displayed, the cation must be capable of recording all electronic prescription application of the applicable information required must prompt the prescribing practi- in part 1306 of this chapter for the con- tioner to authenticate to the applica- trolled substance prescription. tion, using two-factor authentication, (7) If a practitioner has more than as specified in § 1311.140(a)(4), which one DEA registration number, the elec- will constitute the signing of the pre- tronic prescription application must scription by the practitioner for pur- require the practitioner or his agent to poses of § 1306.05(a) and (e) of this chap- select the DEA registration number to ter. be included on the prescription. (12) The electronic prescription appli- (8) The electronic prescription application must not permit a practitioner cation must have a time application other than the prescribing practitioner that is within five minutes of the offi- whose DEA number (or institutional

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practitioner DEA number and exten- Level 1 or higher validated cryp- sion data for the individual practi- tographic module using a FIPS-ap- tioner) is listed on the prescription as proved encryption algorithm. FIPS 140– the prescribing practitioner and who 2 is incorporated by reference in has indicated that the prescription is § 1311.08. ready to be signed to sign the prescrip- (iv) For software implementations, tion. when the signing module is deacti- (13) Where a practitioner seeks to vated, the application must clear the prescribe more than one controlled plain text password from the applica- substance at one time for a particular tion memory to prevent the unauthor- patient, the electronic prescription ap- ized access to, or use of, the private plication may allow the practitioner to key. sign multiple prescriptions for a single (17) Unless the digital signature cre- patient at one time using a single invo- ated by an individual practitioner’s cation of the two-factor authentication private key is being transmitted to the protocol provided the following has oc- pharmacy with the prescription, the curred: The practitioner has individ- electronic prescription application ually indicated that each controlled must include in the data file trans- substance prescription is ready to be mitted an indication that the prescrip- signed while the information required tion was signed by the prescribing by paragraph (b)(9) of this section for practitioner. each such prescription is displayed (18) The electronic prescription appli- along with the statement required by cation must not transmit a controlled § 1311.140(a)(3). substance prescription unless the sign- (14) The electronic prescription appli- ing function described in § 1311.140(a)(4) cation must time and date stamp the has been used. prescription when the signing function (19) The electronic prescription appli- is used. cation must not allow alteration of any (15) When the practitioner uses his of the information required by part two-factor authentication credential as 1306 of this chapter after the prescrip- specified in § 1311.140(a)(4), the election has been digitally signed. Any al- tronic prescription application must teration of the information required by digitally sign at least the information part 1306 of this chapter after the pre- required by part 1306 of this chapter scription is digitally signed must can- and electronically archive the digitally cel the prescription. signed record. If the practitioner signs (20) The electronic prescription appli- the prescription with his own private cation must not allow transmission of key, as provided in § 1311.145, the elec- a prescription that has been printed. tronic prescription application must (21) The electronic prescription appli- electronically archive a copy of the cation must allow printing of a pre- digitally signed record, but need not scription after transmission only if the apply the application’s digital signa- printed prescription is clearly labeled ture to the record. as a copy not for dispensing. The elec- (16) The digital signature tronic prescription application may functionality must meet the following allow printing of prescription informa- requirements: tion if clearly labeled as being for in- (i) The cryptographic module used to formational purposes. The electronic digitally sign the data elements re- prescription application may transfer quired by part 1306 of this chapter must such prescription information to med- be at least FIPS 140–2 Security Level 1 ical records. validated. FIPS 140–2 is incorporated (22) If the transmission of an elec- by reference in § 1311.08. tronic prescription fails, the electronic (ii) The digital signature application prescription application may print the and hash function must comply with prescription. The prescription must in- FIPS 186–3 and FIPS 180–3, as incor- dicate that it was originally trans- porated by reference in § 1311.08. mitted electronically to, and provide (iii) The electronic prescription ap- the name of, a specific pharmacy, the plication’s private key must be stored date and time of transmission, and encrypted on a FIPS 140–2 Security that the electronic transmission failed.

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(23) The electronic prescription appli- (v) Ensure that all logs are sortable cation must maintain an audit trail of by patient name, drug name, and date all actions related to the following: of issuance of the prescription. (i) The creation, alteration, indica- (28) Where the electronic prescription tion of readiness for signing, signing, application is required by this part to transmission, or deletion of a con- archive or otherwise maintain records, trolled substance prescription. it must retain such records electroni- (ii) Any setting or changing of logical cally for two years from the date of the access control permissions related to record’s creation and comply with all the issuance of controlled substance other requirements of § 1311.305. prescriptions. (iii) Notification of a failed trans- § 1311.125 Requirements for estab- mission. lishing logical access control—Indi- (iv) Auditable events as specified in vidual practitioner. § 1311.150. (a) At each registered location where (24) The electronic prescription appli- one or more individual practitioners cation must record within each audit wish to use an electronic prescription record the following information: application meeting the requirements (i) The date and time of the event. of this subpart to issue controlled sub- (ii) The type of event. stance prescriptions, the registrant(s) (iii) The identity of the person taking must designate at least two individuals the action, where applicable. to manage access control to the appli- (iv) The outcome of the event (suc- cation. At least one of the designated cess or failure). individuals must be a registrant who is (25) The electronic prescription appli- authorized to issue controlled sub- cation must conduct internal audits stance prescriptions and who has ob- and generate reports on any of the tained a two-factor authentication cre- events specified in § 1311.150 in a format dential as provided in § 1311.105. that is readable by the practitioner. (b) At least one of the individuals Such internal audits may be auto- designated under paragraph (a) of this mated and need not require human section must verify that the DEA reg- intervention to be conducted. istration and State authorization(s) to (26) The electronic prescription appli- practice and, where applicable, State cation must protect the stored audit authorization(s) to dispense controlled records from unauthorized deletion. substances of each registrant being The electronic prescription application granted permission to sign electronic shall prevent modifications to the prescriptions for controlled substances audit records. are current and in good standing. (27) The electronic prescription appli- (c) After one individual designated cation must do the following: under paragraph (a) of this section en- (i) Generate a log of all controlled ters data that grants permission for in- substance prescriptions issued by a dividual practitioners to have access to practitioner during the previous cal- the prescription functions that indi- endar month and provide the log to the cate readiness for signature and sign- practitioner no later than seven cal- ing or revokes such authorization, a endar days after that month. second individual designated under (ii) Be capable of generating a log of paragraph (a) of this section must use all controlled substance prescriptions his two-factor authentication creden- issued by a practitioner for a period tial to satisfy the logical access con- specified by the practitioner upon re- trols. The second individual must be a quest. Prescription information avail- DEA registrant. able from which to generate the log (d) A registrant’s permission to indi- must span at least the previous two cate that controlled substances pre- years. scriptions are ready to be signed and to (iii) Archive all logs generated. sign controlled substance prescriptions (iv) Ensure that all logs are easily must be revoked whenever any of the readable or easily rendered into a for- following occurs, on the date the occur- mat that a person can read. rence is discovered:

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(1) A hard token or any other authen- ready to be signed and to sign con- tication factor required by the two-fac- trolled substance prescriptions must be tor authentication protocol is lost, sto- revoked whenever any of the following len, or compromised. Such access must occurs, on the date the occurrence is be terminated immediately upon re- discovered: ceiving notification from the indi- (1) An individual practitioner’s hard vidual practitioner. token or any other authentication fac- (2) The individual practitioner’s DEA tor required by the practitioner’s two- registration expires, unless the reg- factor authentication protocol is lost, istration has been renewed. stolen, or compromised. Such access (3) The individual practitioner’s DEA must be terminated immediately upon registration is terminated, revoked, or receiving notification from the indi- suspended. vidual practitioner. (4) The individual practitioner is no (2) The institutional practitioner’s longer authorized to use the electronic or, where applicable, individual practi- prescription application (e.g., when the tioner’s DEA registration expires, un- individual practitioner leaves the practice). less the registration has been renewed. (3) The institutional practitioner’s § 1311.130 Requirements for estab- or, where applicable, individual practi- lishing logical access control—Insti- tioner’s DEA registration is termi- tutional practitioner. nated, revoked, or suspended. (a) The entity within an institutional (4) An individual practitioner is no practitioner that conducts the identity longer authorized to use the institu- proofing under § 1311.110 must develop a tional practitioner’s electronic pre- list of individual practitioners who are scription application (e.g., when the in- permitted to use the institutional prac- dividual practitioner is no longer asso- titioner’s electronic prescription appli- ciated with the institutional practi- cation to indicate that controlled sub- tioner.) stances prescriptions are ready to be signed and to sign controlled substance § 1311.135 Requirements for creating a prescriptions. The list must be ap- controlled substance prescription. proved by two individuals. (a) The electronic prescription appli- (b) After the list is approved, it must cation may allow the registrant or his be sent to a separate entity within the agent to enter data for a controlled institutional practitioner that enters substance prescription, provided that permissions for logical access controls only the registrant may sign the pre- into the application. The institutional scription in accordance with practitioner must authorize at least §§ 1311.120(b)(11) and 1311.140. two individuals or a role filled by at (b) If a practitioner holds multiple least two individuals to enter the log- DEA registrations, the practitioner or ical access control data. One individual his agent must select the appropriate in the separate entity must authen- registration number for the prescrip- ticate to the application and enter the tion being issued in accordance with data to grant permissions to individual the requirements of § 1301.12 of this practitioners to indicate that controlled substances prescriptions are chapter. ready to be signed and to sign con- (c) If required by State law, a super- trolled substance prescriptions. A sec- visor’s name and DEA number may be ond individual must authenticate to listed on a prescription, provided the the application to execute the logical prescription clearly indicates who is access controls. the supervisor and who is the pre- (c) The institutional practitioner scribing practitioner. must retain a record of the individuals or roles that are authorized to conduct § 1311.140 Requirements for signing a identity proofing and logical access controlled substance prescription. control data entry and execution. (a) For a practitioner to sign an elec- (d) Permission to indicate that con- tronic prescription for a controlled trolled substances prescriptions are substance the following must occur:

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(1) The practitioner must access a a controlled substance prescription list of one or more controlled sub- using the private key associated with stance prescriptions for a single pa- his digital certificate. tient. The list must display the infor- (b) The electronic prescription appli- mation required by § 1311.120(b)(9). cation must require the individual (2) The practitioner must indicate practitioner to complete a two-factor the prescriptions that are ready to be authentication protocol as specified in signed. § 1311.140(a)(4) to use his private key. (3) While the prescription informa- (c) The electronic prescription appli- tion required in § 1311.120(b)(9) is dis- cation must digitally sign at least all played, the following statement or its information required under part 1306 of substantial equivalent is displayed: this chapter. ‘‘By completing the two-factor authen- (d) The electronic prescription appli- tication protocol at this time, you are cation must electronically archive the legally signing the prescription(s) and digitally signed record. authorizing the transmission of the (e) A prescription that is digitally above information to the pharmacy for signed with a practitioner’s private dispensing. The two-factor authentica- key may be transmitted to a pharmacy tion protocol may only be completed without the digital signature. by the practitioner whose name and (f) If the electronic prescription is DEA registration number appear transmitted without the digital signa- above.’’ ture, the electronic prescription appli- (4) While the prescription informa- cation must check the certificate rev- tion required in § 1311.120(b)(9) and the ocation list of the certification author- statement required by paragraph (a)(3) ity that issued the practitioner’s dig- of this section remain displayed, the ital certificate. If the digital certifi- practitioner must be prompted to com- cate is not valid, the electronic pre- plete the two-factor authentication scription application must not trans- protocol. mit the prescription. The certificate (5) The completion by the practi- revocation list may be cached until the tioner of the two-factor authentication certification authority issues a new protocol in the manner provided in certificate revocation list. paragraph (a)(4) of this section will (g) When the individual practitioner constitute the signing of the prescrip- digitally signs a controlled substance tion by the practitioner for purposes of prescription with the private key asso- § 1306.05(a) and (e) of this chapter. ciated with his own digital certificate (6) Except as provided under obtained as provided under § 1311.105, § 1311.145, the practitioner’s completion the electronic prescription application of the two-factor authentication pro- is not required to digitally sign the tocol must cause the application to prescription using the application’s digitally sign and electronically ar- private key. chive the information required under part 1306 of this chapter. § 1311.150 Additional requirements for (b) The electronic prescription appli- internal application audits. cation must clearly label as the signing (a) The application provider must es- function the function that prompts the tablish and implement a list of practitioner to execute the two-factor auditable events. Auditable events authentication protocol using his cre- must, at a minimum, include the fol- dential. lowing: (c) Any prescription not signed in the (1) Attempted unauthorized access to manner required by this section shall the electronic prescription application, not be transmitted. or successful unauthorized access where the determination of such is fea- § 1311.145 Digitally signing the pre- sible. scription with the individual practi- (2) Attempted unauthorized modifica- tioner’s private key. tion or destruction of any information (a) An individual practitioner who or records required by this part, or suc- has obtained a digital certificate as cessful unauthorized modification or provided in § 1311.105 may digitally sign destruction of any information or

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records required by this part where the mitted prescription if they are clearly determination of such is feasible. labeled: ‘‘Copy only—not valid for dis- (3) Interference with application op- pensing.’’ Data on the prescription may erations of the prescription applica- be electronically transferred to med- tion. ical records, and a list of prescriptions (4) Any setting of or change to log- written may be printed for patients if ical access controls related to the the list indicates that it is for informa- issuance of controlled substance pre- tional purposes only and not for dis- scriptions. pensing. (5) Attempted or successful inter- (d) The electronic prescription appli- ference with audit trail functions. cation must not allow the transmission (6) For application service providers, of an electronic prescription if an attempted or successful creation, original prescription was printed prior modification, or destruction of con- to attempted transmission. trolled substance prescriptions or log- (e) The contents of the prescription ical access controls related to con- required by part 1306 of this chapter trolled substance prescriptions by any must not be altered during trans- agent or employee of the application mission between the practitioner and service provider. pharmacy. Any change to the content (b) The electronic prescription appli- during transmission, including trunca- cation must analyze the audit trail at tion or removal of data, will render the least once every calendar day and gen- electronic prescription invalid. The erate an incident report that identifies electronic prescription data may be each auditable event. converted from one software version to (c) Any person designated to set log- another between the electronic pre- ical access controls under §§ 1311.125 or scription application and the pharmacy 1311.130 must determine whether any application; conversion includes alter- identified auditable event represents a ing the structure of fields or machine security incident that compromised or language so that the receiving phar- could have compromised the integrity macy application can read the pre- of the prescription records. Any such scription and import the data. incidents must be reported to the elec- (f) An electronic prescription must be tronic prescription application pro- transmitted from the practitioner to vider and the Administration within the pharmacy in its electronic form. At one business day. no time may an intermediary convert an electronic prescription to another § 1311.170 Transmission requirements. form (e.g., facsimile) for transmission. (a) The electronic prescription application must transmit the electronic § 1311.200 Pharmacy responsibilities. prescription as soon as possible after (a) Before initially using a pharmacy signature by the practitioner. application to process controlled sub- (b) The electronic prescription appli- stance prescriptions, the pharmacy cation may print a prescription that must determine that the third-party has been transmitted only if an inter- auditor or certification organization mediary or the designated pharmacy has found that the pharmacy applica- notifies a practitioner that an election does the following accurately and tronic prescription was not success- consistently: fully delivered to the designated phar- (1) Import, store, and display the in- macy. If this occurs, the electronic pre- formation required for prescriptions scription application may print the under § 1306.05(a) of this chapter. prescription for the practitioner’s man- (2) Import, store, and display the in- ual signature. The printed prescription dication of signing as required by must include information noting that § 1311.120(b)(17). the prescription was originally trans- (3) Import, store, and display the mitted electronically to [name of the number of refills as required by § 1306.22 specific pharmacy] on [date/time] and of this chapter. that transmission failed. (4) Import, store, and verify the prac- (c) The electronic prescription appli- titioner’s digital signature, as provided cation may print copies of the trans- in § 1311.210(c), where applicable.

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(b) If the third-party auditor or cer- (g) When a pharmacist receives a tification organization has found that paper or oral prescription that indi- a pharmacy application does not accu- cates that it was originally trans- rately and consistently import, store, mitted electronically to the pharmacy, and display other information required the pharmacist must check its records for prescriptions under this chapter, to ensure that the electronic version the pharmacy must not process elec- was not received and the prescription tronic prescriptions for controlled sub- dispensed. If both prescriptions were stances that are subject to the addi- received, the pharmacist must mark tional information requirements. one as void. (c) If a pharmacy application pro- (h) When a pharmacist receives a vider notifies a pharmacy that a third- paper or oral prescription that indi- party audit or certification report indicates that the application or the appli- cates that it was originally trans- cation provider no longer meets the re- mitted electronically to another phar- quirements of this part or notifies it macy, the pharmacist must check with that the application provider has iden- that pharmacy to determine whether tified an issue that makes the applica- the prescription was received and dis- tion non-compliant, the pharmacy pensed. If the pharmacy that received must immediately cease to process the original electronic prescription had controlled substance prescriptions not dispensed the prescription, that using the application. pharmacy must mark the electronic (d) A pharmacy that receives a notifi- version as void or canceled. If the phar- cation that the pharmacy application macy that received the original elec- is not in compliance with the require- tronic prescription dispensed the pre- ments of this part must not use the ap- scription, the pharmacy with the paper plication to process controlled sub- version must not dispense the paper stance prescriptions until it is notified prescription and must mark the pre- that the application is again compliant scription as void. and all relevant updates to the applica- (i) Nothing in this part relieves a tion have been installed. pharmacy and pharmacist of the re- (e) The pharmacy must determine sponsibility to dispense controlled sub- which employees are authorized to stances only pursuant to a prescription enter information regarding the dis- issued for a legitimate medical purpose pensing of controlled substance pre- by a practitioner acting in the usual scriptions and annotate or alter records of these prescriptions (to the course of professional practice. extent such alterations are permitted § 1311.205 Pharmacy application re- under this chapter). The pharmacy quirements. must ensure that logical access controls in the pharmacy application are (a) The pharmacy may only use a set so that only such employees are pharmacy application that meets the granted access to perform these func- requirements in paragraph (b) of this tions. section to process electronic controlled (f) When a pharmacist fills a pre- substance prescriptions. scription in a manner that would re- (b) The pharmacy application must quire, under part 1306 of this chapter, meet the following requirements: the pharmacist to make a notation on (1) The pharmacy application must the prescription if the prescription be capable of setting logical access were a paper prescription, the phar- controls to limit access for the fol- macist must make the same notation lowing functions: electronically when filling an elec- (i) Annotation, alteration, or dele- tronic prescription and retain the an- tion of prescription information. notation electronically in the prescription record or in linked files. When a (ii) Setting and changing the logical prescription is received electronically, access controls. the prescription and all required anno- (2) Logical access controls must be tations must be retained electroni- set by individual user name or role. cally.

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(3) The pharmacy application must including the specific internal code digitally sign and archive a prescrip- number assigned to individual practi- tion on receipt or be capable of receiv- tioners authorized to prescribe con- ing and archiving a digitally signed trolled substances by the hospital or record. other institution as provided in (4) For pharmacy applications that § 1301.22(c) of this chapter. digitally sign prescription records upon (8) The pharmacy application must receipt, the digital signature read and store, and be capable of dis- functionality must meet the following playing, all information required by requirements: part 1306 of this chapter. (i) The cryptographic module used to (9) The pharmacy application must digitally sign the data elements re- read and store in full the information quired by part 1306 of this chapter must required under § 1306.05(a) of this chap- be at least FIPS 140–2 Security Level 1 ter. The pharmacy application must ei- validated. FIPS 140–2 is incorporated ther verify that such information is by reference in § 1311.08. present or must display the informa- (ii) The digital signature application tion for the pharmacist’s verification. and hash function must comply with (10) The pharmacy application must FIPS 186–3 and FIPS 180–3, as incor- provide for the following information porated by reference in § 1311.08. to be added or linked to each electronic (iii) The pharmacy application’s pri- controlled substance prescription vate key must be stored encrypted on a record for each dispensing: FIPS 140–2 Security Level 1 or higher (i) Number of units or volume of drug validated cryptographic module using dispensed. a FIPS-approved encryption algorithm. (ii) Date dispensed. FIPS 140–2 is incorporated by reference (iii) Name or initials of the person in § 1311.08. who dispensed the prescription. (iv) For software implementations, (11) The pharmacy application must when the signing module is deacti- be capable of retrieving controlled sub- vated, the pharmacy application must stance prescriptions by practitioner clear the plain text password from the name, patient name, drug name, and application memory to prevent the un- date dispensed. authorized access to, or use of, the pri- (12) The pharmacy application must vate key. allow downloading of prescription data (v) The pharmacy application must into a database or spreadsheet that is have a time application that is within readable and sortable. five minutes of the official National In- (13) The pharmacy application must stitute of Standards and Technology maintain an audit trail of all actions time source. related to the following: (5) The pharmacy application must (i) The receipt, annotation, alter- verify a practitioner’s digital signature ation, or deletion of a controlled sub- (if the pharmacy application accepts stance prescription. prescriptions that were digitally signed (ii) Any setting or changing of logical with an individual practitioner’s pri- access control permissions related to vate key and transmitted with the dig- the dispensing of controlled substance ital signature). prescriptions. (6) If the prescription received by the (iii) Auditable events as specified in pharmacy application has not been § 1311.215. digitally signed by the practitioner and (14) The pharmacy application must transmitted with the digital signature, record within each audit record the fol- the pharmacy application must either: lowing information: (i) Verify that the practitioner signed (i) The date and time of the event. the prescription by checking the data (ii) The type of event. field that indicates the prescription (iii) The identity of the person taking was signed; or the action, where applicable. (ii) Display the field for the phar- (iv) The outcome of the event (suc- macist’s verification. cess or failure). (7) The pharmacy application must (15) The pharmacy application must read and retain the full DEA number conduct internal audits and generate

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reports on any of the events specified § 1311.215 Internal audit trail. in § 1311.215 in a format that is readable (a) The pharmacy application pro- by the pharmacist. Such an internal vider must establish and implement a audit may be automated and need not list of auditable events. The auditable require human intervention to be con- events must, at a minimum, include ducted. the following: (16) The pharmacy application must (1) Attempted unauthorized access to protect the stored audit records from the pharmacy application, or success- unauthorized deletion. The pharmacy ful unauthorized access to the phar- application shall prevent modifications macy application where the determina- to the audit records. tion of such is feasible. (17) The pharmacy application must (2) Attempted or successful unau- back up the controlled substance pre- thorized modification or destruction of scription records daily. any information or records required by (18) The pharmacy application must this part, or successful unauthorized retain all archived records electroni- modification or destruction of any in- cally for at least two years from the formation or records required by this date of their receipt or creation and part where the determination of such is comply with all other requirements of feasible. § 1311.305. (3) Interference with application operations of the pharmacy application. § 1311.210 Archiving the initial record. (4) Any setting of or change to log- (a) Except as provided in paragraph ical access controls related to the dis- (c) of this section, a copy of each elec- pensing of controlled substance pre- tronic controlled substance prescrip- scriptions. tion record that a pharmacy receives (5) Attempted or successful inter- must be digitally signed by one of the ference with audit trail functions. following: (6) For application service providers, (1) The last intermediary transmit- attempted or successful annotation, al- ting the record to the pharmacy must teration, or destruction of controlled digitally sign the prescription imme- substance prescriptions or logical ac- diately prior to transmission to the cess controls related to controlled sub- pharmacy. stance prescriptions by any agent or employee of the application service (2) The first pharmacy application provider. that receives the electronic prescrip- (b) The pharmacy application must tion must digitally sign the prescrip- analyze the audit trail at least once tion immediately on receipt. every calendar day and generate an in- (b) If the last intermediary digitally cident report that identifies each signs the record, it must forward the auditable event. digitally signed copy to the pharmacy. (c) The pharmacy must determine (c) If a pharmacy receives a digitally whether any identified auditable event signed prescription that includes the represents a security incident that individual practitioner’s digital signa- compromised or could have com- ture, the pharmacy application must promised the integrity of the prescrip- do the following: tion records. Any such incidents must (1) Verify the digital signature as be reported to the pharmacy applica- provided in FIPS 186–3, as incorporated tion service provider, if applicable, and by reference in § 1311.08. the Administration within one business (2) Check the validity of the certifi- day. cate holder’s digital certificate by checking the certificate revocation § 1311.300 Application provider re- list. The pharmacy may cache the CRL quirements—Third-party audits or until it expires. certifications. (3) Archive the digitally signed (a) Except as provided in paragraph record. The pharmacy record must re- (e) of this section, the application pro- tain an indication that the prescription vider of an electronic prescription ap- was verified upon receipt. No addi- plication or a pharmacy application tional digital signature is required. must have a third-party audit of the

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application that determines that the plication completed within the pre- application meets the requirements of vious two years. this part at each of the following (g) Except as provided in paragraphs times: (h) and (i) of this section, if the third- (1) Before the application may be party auditor or certification organiza- used to create, sign, transmit, or proc- tion finds that the application does not ess controlled substance prescriptions. meet one or more of the requirements (2) Whenever a functionality related of this part, the application must not to controlled substance prescription re- be used to create, sign, transmit, or quirements is altered or every two process electronic controlled substance years, whichever occurs first. prescriptions. The application provider (b) The third-party audit must be must notify registrants within five conducted by one of the following: business days of the issuance of the (1) A person qualified to conduct a audit or certification report that they SysTrust, WebTrust, or SAS 70 audit. should not use the application for controlled substance prescriptions. The ap- (2) A Certified Information System plication provider must also notify the Auditor who performs compliance au- Administration of the adverse audit or dits as a regular ongoing business ac- certification report and provide the re- tivity. port to the Administration within one (c) An audit for installed applications business day of issuance. must address processing integrity and (h) For electronic prescription appli- determine that the application meets cations, the third-party auditor or cer- the requirements of this part. tification organization must make the (d) An audit for application service following determinations: providers must address processing in- (1) If the information required in tegrity and physical security and de- § 1306.05(a) of this chapter, the indica- termine that the application meets the tion that the prescription was signed requirements of this part. as required by § 1311.120(b)(17) or the (e) If a certifying organization whose digital signature created by the practi- certification process has been approved tioner’s private key, if transmitted, by DEA verifies and certifies that an and the number of refills as required by electronic prescription or pharmacy § 1306.22 of this chapter, cannot be con- application meets the requirements of sistently and accurately recorded, this part, certification by that organi- stored, and transmitted, the third- zation may be used as an alternative to party auditor or certification organiza- the audit requirements of paragraphs tion must indicate that the application (b) through (d) of this section, provided does not meet the requirements of this that the certification that determines part. that the application meets the require- (2) If other information required ments of this part occurs at each of the under this chapter cannot be consist- following times: ently and accurately recorded, stored, (1) Before the application may be and transmitted, the third-party audi- used to create, sign, transmit, or proc- tor or certification organization must ess controlled substance prescriptions. indicate that the application has failed (2) Whenever a functionality related to meet the requirements for the spe- to controlled substance prescription re- cific information and should not be quirements is altered or every two used to create, sign, and transmit pre- years, whichever occurs first. scriptions that require the additional (f) The application provider must information. make the audit or certification report (i) For pharmacy applications, the available to any practitioner or phar- third-party auditor or certification or- macy that uses the application or is ganization must make the following considering use of the application. The determinations: electronic prescription or pharmacy (1) If the information required in application provider must retain the § 1306.05(a) of this chapter, the indica- most recent audit or certification re- tion that the prescription was signed sults and retain the results of any as required by § 1311.205(b)(6), and the other audits or certifications of the ap- number of refills as required by § 1306.22

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of this chapter, cannot be consistently two years from the date of their cre- and accurately imported, stored, and ation or receipt. This record retention displayed, the third-party auditor or requirement shall not pre-empt any certification organization must indi- longer period of retention which may cate that the application does not meet be required now or in the future, by the requirements of this part. any other Federal or State law or regu- (2) If the pharmacy application ac- lation, applicable to practitioners, cepts prescriptions with the practi- pharmacists, or pharmacies. tioner’s digital signature, the third- (c) Records regarding controlled sub- party auditor or certification organiza- stances prescriptions must be readily tion must indicate that the application retrievable from all other records. does not meet the requirements of this Electronic records must be easily read- part if the application does not consist- able or easily rendered into a format ently and accurately import, store, and that a person can read. verify the digital signature. (d) Records required by this part (3) If other information required must be made available to the Admin- under this chapter cannot be consist- istration upon request. ently and accurately imported, stored, (e) If an application service provider and displayed, the third-party auditor ceases to provide an electronic pre- or certification organization must indi- scription application or an electronic cate that the application has failed to pharmacy application or if a registrant meet the requirements for the specific ceases to use an application service information and should not be used to provider, the application service pro- process electronic prescriptions that vider must transfer any records subject require the additional information. to this part to the registrant in a format that the registrant’s applications § 1311.302 Additional application pro- are capable of retrieving, displaying, vider requirements. and printing in a readable format. (a) If an application provider identi- (f) If a registrant changes application fies or is made aware of any issue with providers, the registrant must ensure its application that make the applica- that any records subject to this part tion non-compliant with the require- are migrated to the new application or ments of this part, the application pro- are stored in a format that can be re- vider must notify practitioners or trieved, displayed, and printed in a pharmacies that use the application as readable format. soon as feasible, but no later than five (g) If a registrant transfers its elec- business days after discovery, that the tronic prescription files to another reg- application should not be used to issue istrant, both registrants must ensure or process electronic controlled sub- that the records are migrated to the stance prescriptions. new application or are stored in a for- (b) When providing practitioners or mat that can be retrieved, displayed, pharmacies with updates to any issue and printed in a readable format. that makes the application non-com- (h) Digitally signed prescription pliant with the requirements of this records must be transferred or mi- part, the application provider must in- grated with the digital signature. dicate that the updates must be installed before the practitioner or phar- PART 1312—IMPORTATION AND macy may use the application to issue or process electronic controlled sub- EXPORTATION OF CONTROLLED stance prescriptions. SUBSTANCES

§ 1311.305 Recordkeeping. Sec. 1312.01 Scope of part 1312. (a) If a prescription is created, 1312.02 Definitions. signed, transmitted, and received electronically, all records related to that IMPORTATION OF CONTROLLED SUBSTANCES prescription must be retained elec- 1312.11 Requirement of authorization to im- tronically. port. (b) Records required by this subpart 1312.12 Application for import permit. must be maintained electronically for 1312.13 Issuance of import permit.

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1312.14 Distribution of copies of import per- 102 of the Act (21 U.S.C. 802) or part mit. 1300 of this chapter. 1312.15 Shipments in greater or less amount than authorized. [62 FR 13969, Mar. 24, 1997] 1312.16 Cancellation of permit; expiration date. IMPORTATION OF CONTROLLED 1312.17 Special report from importers. SUBSTANCES 1312.18 Contents of import declaration. 1312.19 Distribution of import declaration. § 1312.11 Requirement of authorization to import. EXPORTATION OF CONTROLLED SUBSTANCES (a) No person shall import or cause to 1312.21 Requirement of authorization to ex- be imported any controlled substance port. listed in Schedule I or II or any nar- 1312.22 Application for export permit. cotic controlled substance listed in 1312.23 Issuance of export permit. 1312.24 Distribution of copies of export per- Schedule III, IV or V or any non-nar- mit. cotic controlled substance in Schedule 1312.25 Expiration date. III which the Administrator has spe- 1312.26 Records required of exporter. cifically designated by regulation in 1312.27 Contents of special controlled sub- § 1312.30 of this part or any non-nar- stances invoice. cotic controlled substance in Schedule 1312.28 Distribution of special controlled IV or V which is also listed in Schedule substances invoice. I or II of the Convention on Psycho- 1312.29 Domestic release prohibited. tropic Substances unless and until such 1312.30 Schedule III, IV, and V non-narcotic person is properly registered under the controlled substances requiring an import and export permit. Act (or exempt from registration) and the Administrator has issued him a TRANSSHIPMENT AND IN-TRANSIT SHIPMENT OF permit to do so pursuant to § 1312.13 of CONTROLLED SUBSTANCES this part. 1312.31 Schedule I: Application for prior (b) No person shall import or cause to written approval. be imported any non-narcotic con- 1312.32 Schedules II, III, IV: Advance notice. trolled substance listed in Schedule III, IV or V, excluding those described in HEARINGS paragraph (a) of this section, unless 1312.41 Hearings generally. and until such person is properly reg- 1312.42 Purpose of hearing. istered under the Act (or exempt from 1312.43 Waiver or modification of rules. registration) and has filed an import 1312.44 Request for hearing or appearance; declaration to do so with the Adminis- waiver. trator, pursuant to § 1312.18 of this part. 1312.45 Burden of proof. (c) When an import permit or dec- 1312.46 Time and place of hearing. 1312.47 Final order. laration is required, a separate permit or declaration must be obtained for AUTHORITY: 21 U.S.C. 952, 953, 954, 957, 958. each consignment of controlled sub- SOURCE: 36 FR 7815, Apr. 24, 1971, unless stances to be imported. otherwise noted. Redesignated at 38 FR 26609, [36 FR 7815, Apr. 24, 1971, as amended at 37 Sept. 24, 1973. FR 15923, Aug. 8, 1972. Redesignated at 38 FR 26609, Sept. 24, 1973, and amended at 52 FR § 1312.01 Scope of part 1312. 17289, May 7, 1987] Procedures governing the importation, exportation, transshipment and § 1312.12 Application for import per- intransit shipment of controlled submit. stances pursuant to section 1002, 1003, (a) An application for a permit to im- and 1004 of the Act (21 U.S.C. 952, 953, port controlled substances shall be and 954) are governed generally by made on DEA Form 357. DEA Form 357 those sections and specifically by the may be obtained from, and shall be sections of this part. filed with, the Import/Export Unit, Drug Enforcement Administration. See § 1312.02 Definitions. the Table of DEA Mailing Addresses in Any term contained in this part shall § 1321.01 of this chapter for the current have the definition set forth in section mailing address. Each application shall

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show the date of execution; the reg- names of the two ports in the order istration number of the importer; a de- given in the application and will au- tailed description of each controlled thorize shipment from either port. Al- substance to be imported including the ternate ports in different countries will drug name, dosage form, National Drug not be authorized in the same permit. Code (NDC) number, the Administra- tion Controlled Substance Code Num- [36 FR 7815, Apr. 24, 1971, as amended at 36 ber as set forth in part 1308 of this FR 13387, July 21, 1971. Redesignated at 38 FR chapter, the number and size of pack- 26609, Sept. 24, 1973, and amended at 39 FR 43218, Dec. 11, 1974; 45 FR 74715, Nov. 12, 1980; ages or containers, the name and quan- 51 FR 5319 and 5320, Feb. 13, 1986; 52 FR 17289, tity of the controlled substance con- May 7, 1987; 62 FR 13969, Mar. 24, 1997; 75 FR tained in any finished dosage units, 10681, Mar. 9, 2010] and the net quantity of any controlled substance (expressed in anhydrous § 1312.13 Issuance of import permit. acid, base or alkaloid) given in kilograms or parts thereof. The application (a) The Administrator may authorize shall also include the following: importation of any controlled sub- (1) The name, address, and business stance listed in Schedule I or II or any of the consignor, if known at the time narcotic drug listed in Schedule III, IV, application is submitted, but if un- or V if he finds: known at that time, the fact should be (1) That the substance is crude indicated and the name and address opium, poppy straw, concentrate of afterwards furnished to the Adminis- poppy straw, or coca leaves, in such trator as soon as ascertained by the quantity as the Administrator finds importer; necessary to provide for medical, sci- (2) The foreign port of exportation entific, or other legitimate purposes; (i.e., the place where the article will (2) That the substance is necessary to begin its journey of exportation to the provide for medical and scientific needs United States); or other legitimate needs of the United (3) The port of entry into the United States during an emergency where do- States; mestic supplies of such substance or (4) The latest date said shipment will drug are found to be inadequate, or in leave said foreign port; any case in which the Administrator (5) The stock on hand of the con- finds that competition among domestic trolled substance desired to be im- manufacturers of the controlled sub- ported; (6) The name of the importing carrier stance is inadequate and will not be or vessel (if known, or if unknown it rendered adequate by the registration should be stated whether shipment will of additional manufacturers under sec- be made by express, freight, or other- tion 303 of the Controlled Substances wise, imports of controlled substances Act (21 U.S.C. 823); or in Schedules I or II and narcotic drugs (3) That the domestic supply of any in Schedules III, IV, or V by mail being controlled substance is inadequate for prohibited); scientific studies, and that the impor- (7) The total tentative allotment to tation of that substance for scientific the importer of such controlled sub- purposes is only for delivery to offi- stance for the current calendar year; cials of the United Nations, of the (8) The total number of kilograms of United States, or of any State, or to said allotment for which permits have any person registered or exempted previously been issued and the total from registration under sections 1007 quantity of controlled substance actu- and 1008 of the Act (21 U.S.C. 957 and ally imported during the current year 958). to date. (4) That the importation of the con- (b) If desired, alternative foreign trolled substance is for ballistics or ports of exportation within the same other analytical or scientific purposes, country may be indicated upon the ap- and that the importation of that sub- plication (e.g., (1) Calcutta, (2) Bom- stance is only for delivery to officials bay). If a formal permit is issued pursuant to such application, it will bear the of the United Nations, of the United

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States, or of any State, or to any per- the disposition to be made thereof. son registered or exempted from reg- Each permit shall be dated and shall istration under sections 1007 and 1008 of certify that the importer named there- the Act (21 U.S.C. 957 and 958). in is thereby permitted as a registrant (b) The Administrator may require under the Act, to import, through the that such non-narcotic controlled sub- port named, one shipment of not to ex- stances in Schedule III as he shall des- ceed the specified quantity of the ignate by regulation in § 1312.30 of this named controlled substances, shipment part be imported only pursuant to the to be made before a specified date. Not issuance of an import permit. The Ad- more than one shipment shall be made ministrator may authorize the impor- on a single import permit. The permit tation of such substances if he finds shall state that the Administrator is that the substance is being imported satisfied that the consignment pro- for medical, scientific or other legiti- posed to be imported is required for le- mate uses. gitimate purposes. (c) If a non-narcotic substance listed (f) Notwithstanding paragraphs (a)(1) in Schedule IV or V is also listed in and (a)(2) of this section, the Adminis- Schedule I or II of the Convention on trator shall permit, pursuant to sec- Psychotropic Substances, 1971, it shall tion 1002(a)(1) or 1002(a)(2)(A) of the Act be imported only pursuant to the (21 U.S.C. 952(a)(1) or (a)(2)(A)), the im- issuance of an import permit. The Ad- portation of approved narcotic raw ma- ministrator may authorize the impor- terial (opium, poppy straw and con- tation of such substances if it is found centrate of poppy straw) having as its that the substance is being imported source: for medical, scientific or other legiti- (1) Turkey, mate uses. (2) India, (d) The Administrator may require (3) Spain, an applicant to submit such documents (4) France, or written statements of fact relevant (5) Poland, to the application as he deems nec- (6) Hungary, and essary to determine whether the application should be granted. The failure of (7) Australia. the applicant to provide such docu- (g) At least eighty (80) percent of the ments or statements within a reason- narcotic raw material imported into able time after being requested to do so the United States shall have as its shall be deemed to be a waiver by the original source Turkey and India. Ex- applicant of an opportunity to present cept under conditions of insufficient such documents or facts for consider- supplies of narcotic raw materials, not ation by the Administrator in granting more than twenty (20) percent of the or denying the application. narcotic raw material imported into (e) Each import permit shall be the United States annually shall have issued in sextuplet and serially num- as its source Spain, France, Poland, bered, with all six copies bearing the Hungary and Australia. same serial number and being des- [36 FR 23624, Dec. 11, 1971, as amended at 37 ignated ‘‘original’’ (Copy 1), ‘‘dupli- FR 15923, Aug. 8, 1972. Redesignated at 38 FR cate’’ (Copy 2), etc., respectively. All 26609, Sept. 24, 1973, and amended at 46 FR copies of import permits shall bear the 41776, Aug. 18, 1981; 52 FR 17289, May 7, 1987; signature of the Director or his dele- 73 FR 6851, Feb. 6, 2008] gate, and facsimiles of signatures shall not be used. No permit shall be altered § 1312.14 Distribution of copies of im- or changed by any person after being port permit. signed by the Administrator or his del- Copies of the import permit shall be egate and any change or alteration distributed and serve purposes as fol- upon the face of any permit after it lows: shall have been signed by the Adminis- (a) The original and quintuplet copies trator or his delegate shall render it (Copy 1 and Copy 5) shall be trans- void and of no effect. Permits are not mitted by the Administration to the transferable. Each copy of the permit importer, who shall retain the quin- shall have printed or stamped thereon tuplet copy (Copy 5) on file as his

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record of authority for the importa- imum amount authorized to be im- tion, and shall transmit the original ported under the permit, as determined copy (Copy 1) to the foreign exporter. at the weighing by the District Direc- The foreign exporter will submit the tor of the U.S. Customs Service, such original copy (Copy 1) to the proper difference shall be seized subject to for- governmental authority in the export- feiture, pending an explanation; except ing country, if required, as a pre- that shipments of substances exceeding requisite to the issuance of an export the maximum authorized amount by authorization. This copy of the permit less than 1 percent may be released to will accompany the shipment. Upon ar- the importer upon the filing by him of rival of the imported merchandise, the an amended import permit. If the sub- District Director of the U.S. Customs stance is included in Schedule I, it will Service at the port of entry will, after be summarily forfeited to the Govern- appraising the merchandise, forward ment. the original copy (Copy 1) to the Drug (b) If the shipment made under the Operations Section with a report on permit is less than the maximum the reverse side of such copy, showing amount authorized to be imported the name of the port of importation, under the permit as determined at the date prepared, name and net quantity weighing by the District Director of of each substance, and report of anal- the U.S. Customs Service, such dif- ysis of the merchandise entered. ference, when ascertained by the Ad- (b) The duplicate copy (Copy 2) shall ministration, shall be recredited to the be forwarded by the Administration to tentative allotment against which the the proper governmental authorities of quantity covered by the permit was the exporting country. charged, and the balance of any such (c) The quadruplet copy (Copy 4) tentative allotment with any such re- shall be forwarded by the Administra- credits will remain available to the im- tion to the District Director of the U.S. porter to whom made (unless pre- Customs Service at the U.S. port of viously revoked in whole or in part), entry, which shall be the customs port for importations pursuant to any per- of destination in the case of shipments mit or permits as are requested and transported under immediate transpor- issued during the remainder of the cal- tation entries, in order that the Dis- endar year to which the allotment is trict Director may compare it with the applicable. No permit shall be issued original copy (Copy 1) and the bill of for importation of a quantity of con- lading upon arrival of the merchandise. trolled substances as a charge against If a discrepancy is noted between cor- the tentative allotment for a given cal- responding items upon different copies endar year, after the close of such cal- of a permit bearing the same serial endar year, unless the Director of the number when compared by the District Administration decides to make an ex- Director, he shall refuse to permit ception for good cause shown. entry of the merchandise until the [36 FR 7815, Apr. 24, 1971. Redesignated at 38 facts are communicated to the Admin- FR 26609, Sept. 24, 1973, and amended at 46 istration and further instructions are FR 28841, May 29, 1981] received. (d) The triplicate copy (Copy 3) and § 1312.16 Cancellation of permit; expi- sextuplet copy (Copy 6) shall be re- ration date. tained by the Administration. (a) A permit may be canceled after being issued, at the request of the im- [36 FR 7815, Apr. 24, 1971, as amended at 36 porter, provided no shipment has been FR 13387, July 21, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973, and further amended at made thereunder. In the event that a 45 FR 74715, Nov. 12, 1980; 51 FR 5319, Feb. 13, permit is lost, the Administrator may, 1986; 53 FR 48244, Nov. 30, 1988; 62 FR 13969, upon the production by the importer of Mar. 24, 1997] satisfactory proof, by affidavit or otherwise, issue a duplicate permit. Noth- § 1312.15 Shipments in greater or less ing in this part shall affect the right, amount than authorized. hereby reserved by the Administrator, (a) If the shipment made under an to cancel a permit at any time for import permit is greater than the max- proper cause.

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(b) An import permit shall not be subject to the requirement of an im- valid after the date specified therein, port permit as described in paragraph and in no event shall the date be subse- (a) of this section, must furnish a con- quent to 6 months after the date the trolled substances import declaration permit is issued. Any unused import on DEA Form 236 to the Import/Export permit shall be returned for cancella- Unit, Drug Enforcement Administra- tion by the registrant to the Import/ tion, not later than 15 calendar days Export Unit, Drug Enforcement Ad- prior to the proposed date of importa- ministration. See the Table of DEA tion and distribute four copies of same Mailing Addresses in § 1321.01 of this as hereinafter directed in § 1312.19. See chapter for the current mailing ad- the Table of DEA Mailing Addresses in dress. § 1321.01 of this chapter for the current [36 FR 7815, Apr. 24, 1971. Redesignated at 38 mailing address. FR 26609, Sept. 24, 1973, and amended at 45 (c) DEA Form 236 must be executed FR 74715, Nov. 12, 1980; 51 FR 5319, Feb. 13, in quintuplicate and will include the 1986; 53 FR 48244, Nov. 30, 1988; 62 FR 13969, Mar. 24, 1997; 75 FR 10682, Mar. 9, 2010] following information: (1) The name, address, and registra- § 1312.17 Special report from import- tion number of the importer; and the ers. name and address and registration Whenever requested by the Adminis- number of the import broker, if any; trator, importers shall render to him and not later than 30 days after receipt of (2) A complete description of the con- the request therefor a statement under trolled substances to be imported, in- oath of the stocks of controlled sub- cluding drug name, dosage form, Na- stances on hand as of the date specified tional Drug Code (NDC) number, the by the Administrator in his request, Administration Controlled Substances and, if desired by the Administrator, Code Number as set forth in part 1308 an estimate of the probable require- of this chapter, the number and size of ments for legitimate uses of the im- packages or containers, the name and porter for any subsequent period that quantity of the controlled substance may be designated by the Adminis- contained in any finished dosage units, trator. In lieu of any special statement and the net quantity of any controlled that may be considered necessary, the substance (expressed in anhydrous Administrator may accept the figures acid, base, or alkaloid) given in kilo- given upon the reports subsequent by said importer under part 1304 of this grams or parts thereof; and chapter. (3) The proposed import date, the foreign port of exportation to the United [36 FR 7815, Apr. 24, 1971. Redesignated at 38 States, the port of entry, and the FR 26609, Sept. 24, 1973, as amended at 62 FR name, address, and registration num- 13969, Mar. 24, 1997] ber of the recipient in the United § 1312.18 Contents of import declara- States; and tion. (4) The name and address of the con- (a) Any non-narcotic controlled sub- signor in the foreign country of expor- stance listed in Schedule III, IV, or V, tation, and any registration or license not subject to the requirement of an numbers if the consignor is required to import permit pursuant to § 1312.13 (b) have such numbers either by the coun- or (c) of this chapter, may be imported try of exportation or under U.S. law. if that substance is needed for medical, (d) Notwithstanding the time limita- scientific or other legitimate uses in tions included in paragraph (a) of this the United States, and will be imported section, an applicant may obtain a spe- pursuant to a controlled substances cial waiver of these time limitations in import declaration. emergency or unusual instances, pro- (b) Any person registered or author- vided that a specific confirmation is re- ized to import and desiring to import ceived from the Administrator or his any non-narcotic controlled substance in Schedules III, IV, or V which is not

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delegate advising the registrant to pro- listed in Schedule I or II, or any nar- ceed pursuant to the special waiver. cotic substance listed in Schedule III [36 FR 7815, Apr. 24, 1971, as amended at 37 or IV, or any non-narcotic substance in FR 15923, Aug. 8, 1972. Redesignated at 38 FR Schedule III which the Administrator 26609, Sept. 24, 1973, and amended at 45 FR has specifically designated by regula- 74715, Nov. 12, 1980; 51 FR 5319, Feb. 13, 1986; tion in § 1312.30 of this part or any non- 52 FR 17290, May 7, 1987; 62 FR 13969, Mar. 24, narcotic substance in Schedule IV or V 1997; 75 FR 10682, Mar. 9, 2010] which is also listed in Schedule I or II of the Convention on Psychotropic § 1312.19 Distribution of import declaration. Substances unless and until such person is properly registered under the The required five copies of the con- Act (or exempted from registration) trolled substances import declaration and the Administrator has issued a per- will be distributed as follows: mit pursuant to § 1312.23 of this part. (a) Copy 1, Copy 2, and Copy 3 shall (b) No person shall in any manner ex- be transmitted to the foreign shipper. The foreign shipper will submit Copy 1 port or cause to be exported from the to the proper governmental authority United States any non-narcotic con- in the foreign country, if required as a trolled substance listed in Schedule III, prerequisite to export authorization. IV, or V, excluding those described in Copy 1 will then accompany the ship- paragraph (a) of this section, or any ment to its destination, and shall be narcotic controlled substance listed in retained on file by the importer. Copy Schedule V, unless and until such per- 2 shall be detached and retained by the son is properly registered under the appropriate customs official of the for- Act (or exempted from registration) eign country. Copy 3 shall be removed and has furnished a special controlled by the District Director of the U.S. substance export invoice as provided by Customs Service at the port of entry, section 1003 of the Act (21 U.S.C. 953(e)) who shall sign and date the certifi- to the Administrator pursuant to cation of customs on Copy 3, noting § 1312.28 of this part. any changes from the entries made by (c) A separate authorization repuest the importer, and shall then forward is obtained for each consignment of that copy to the Drug Operations Sec- such controlled substances to be ex- tion of the Administration. ported. (b) Copy 4 shall be forwarded, within [36 FR 7815, Apr. 24, 1971, as amended at 37 the time limit required in § 1312.18, di- FR 15923, Aug. 8, 1972. Redesignated at 38 FR rectly to the Import/Export Unit, Drug 26609, Sept. 24, 1973, and amended at 52 FR Enforcement Administration. See the 17290, May 7, 1987] Table of DEA Mailing Addresses in § 1321.01 of this chapter for the current § 1312.22 Application for export per- mailing address. mit. (c) Copy 5 shall be retained by the (a) An application for a permit to ex- importer on file as his record of au- port controlled substances shall be thority for the importation. made on DEA Form 161, and an applica- [36 FR 7815, Apr. 24, 1971, as amended at 36 tion for a permit to reexport controlled FR 13387, July 21, 1971; 37 FR 15923, Aug. 8, substances shall be made on DEA Form 1972. Redesignated at 38 FR 26609, Sept. 24, 161R. Forms may be obtained from, and 1973, and further amended at 45 FR 74715, shall be filed with, the Import/Export Nov. 12, 1980; 51 FR 5319, Feb. 13, 1986; 53 FR 48244, Nov. 30, 1988; 62 FR 13969, Mar. 24, 1997; Unit, Drug Enforcement Administra- 75 FR 10682, Mar. 9, 2010] tion. See the Table of DEA Mailing Ad- dresses in § 1321.01 of this chapter for EXPORTATION OF CONTROLLED the current mailing address. Each ap- SUBSTANCES plication shall show the exporter’s name, address, and registration num- § 1312.21 Requirement of authoriza- ber; a detailed description of each con- tion to export. trolled substance desired to be ex- (a) No person shall in any manner exported including the drug name, dosage port or cause to be exported from the form, National Drug Code (NDC) num- United States any controlled substance ber (in accordance with Food and Drug

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Administration regulations), the Ad- (b) There shall also be submitted ministration Controlled Substance with the application any import license Code Number as set forth in Part 1308 or permit (and a translation thereof if of this chapter, the number and size of in a foreign language) or a certified packages or containers, the name and copy of any such license or permit quantity of the controlled substance issued by competent authorities in the contained in any finished dosage units, country of destination, or other docu- and the quantity of any controlled sub- mentary evidence deemed adequate by stance (expressed in anhydrous acid, the Administrator, showing that the base, or alkaloid) given in kilograms or merchandise is consigned to an author- parts thereof. The application shall in- ized permittee, that it is to be applied clude the name, address, and business exclusively to medical or scientific use of the consignee, foreign port of entry, within the country of destination, that the port of exportation, the approxi- it will not be reexported from such mate date of exportation, the name of country, and that there is an actual the exporting carrier or vessel (if need for the controlled substance for known, or if unknown it should be stat- medical or scientific use within such ed whether shipment will be made by country. (In the case of exportation of express, freight, or otherwise, exports bulk coca leaf alkaloid, the submitted of controlled substances by mail being evidence need only show the material prohibited), the date and number, if outlined in paragraph (a) of this section for such exportations.) any, of the supporting foreign import (c) Notwithstanding paragraphs (a) license or permit accompanying the ap- and (b) of this section, the Administra- plication, and the authority by whom tion may authorize any controlled sub- such foreign license or permit was stance listed in Schedule I or II, or any issued. The application shall also con- narcotic drug listed in Schedule III or tain an affidavit that the packages are IV, to be exported from the United labeled in conformance with obliga- States to a country for subsequent ex- tions of the United States under inter- port from that country to another national treaties, conventions, or pro- country, if each of the following condi- tocols in effect on May 1, 1971. The affi- tions is met, in accordance with davit shall further state that to the § 1003(f) of the Act (21 U.S.C. 953(f)): best of affiant’s knowledge and belief, (1) Both the country to which the the controlled substances therein are controlled substance is exported from to be applied exclusively to medical or the United States (referred to in this scientific uses within the country to section as the ‘‘first country’’) and the which exported, will not be reexported country to which the controlled sub- therefrom and that there is an actual stance is exported from the first coun- need for the controlled substance for try (referred to in this section as the medical or scientific uses within such ‘‘second country’’) are parties to the country, unless the application is sub- Single Convention on Narcotic Drugs, mitted for reexport in accordance with 1961, and the Convention on Psycho- paragraphs (c) and (d) of this section. tropic Substances, 1971; In the case of exportation of crude co- (2) The first country and the second caine, the affidavit may state that to country have each instituted and main- the best of affiant’s knowledge and be- tain, in conformity with such Conven- lief, the controlled substances will be tions, a system of controls of imports processed within the country to which of controlled substances which the Ad- exported, either for medical or sci- ministration deems adequate; entific use within that country or for (3) With respect to the first country, reexportation in accordance with the the controlled substance is consigned laws of that country to another for to a holder of such permits or licenses medical or scientific use within that as may be required under the laws of country. The application shall be such country, and a permit or license signed and dated by the exporter and to import the controlled substance has shall contain the address from which been issued by the country; the substances will be shipped for ex- (4) With respect to the second coun- portation. try, substantial evidence is furnished

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to the Administration by the applicant (2) Finished dosage units, if reex- for the export permit that— ported, must be in a commercial pack- (i) The controlled substance is to be age, properly sealed and labeled for le- consigned to a holder of such permits gitimate medical use in the second or licenses as may be required under country. the laws of such country, and a permit (3) Any proposed reexportation must or license to import the controlled sub- be made known to the Administration stance is to be issued by the country; at the time the initial DEA Form 161R and is submitted. In addition, the following (ii) The controlled substance is to be information must also be provided applied exclusively to medical, sci- where indicated on the form: entific, or other legitimate uses within (i) Whether the drug or preparation the country; will be reexported in bulk or finished (5) The controlled substance will not dosage units; be exported from the second country; (ii) The product name, dosage (6) The person who exported the con- strength, commercial package size, and trolled substance from the United quantity; States has complied with paragraph (d) (iii) The name of consignee, complete of this section and a permit to export address, and expected shipment date, the controlled substance from the as well as the name and address of the United States has been issued by the ultimate consignee in the second coun- Administration; and try. (7) Within 30 days after the con- (4) The application (DEA Form 161R) trolled substance is exported from the must also contain an affidavit that the first country to the second country, consignee in the second country is au- the person who exported the controlled thorized under the laws and regula- substance from the United States must tions of the second country to receive deliver to the Administration docu- the controlled substances. The affi- mentation certifying that such export davit must also contain the following from the first country has occurred. If statement, in addition to the state- the permit issued by the Administra- ments required under paragraph (a) of tion authorized the reexport of a con- this section: trolled substance from the first coun- (i) That the packages are labeled in try to more than one second country, conformance with the obligations of notification of each individual reexport the United States under the Single shall be provided. This documentation Convention on Narcotic Drugs, 1961, shall be submitted on company letter- the Convention on Psychotropic Sub- head, signed by a responsible company stances, 1971, and any amendments to official, and shall include all of the fol- such treaties; lowing information: (ii) That the controlled substances (i) Name of second country; are to be applied exclusively to medical (ii) Actual quantity shipped; or scientific uses within the second (iii) Actual date shipped; and country; (iv) DEA export permit number for (iii) That the controlled substances the original export. will not be further reexported from the (d) Where a person is seeking to ex- second country, and port a controlled substance for reex- (iv) That there is an actual need for port in accordance with paragraph (c) the controlled substances for medical of this section, the following require- or scientific uses within the second ments shall apply in addition to (and country. not in lieu of) the requirements of (5) If the applicant proposes that the paragraphs (a) and (b) of this section: shipment of controlled substances will (1) Bulk substances will not be reex- be separated into parts after it arrives ported in the same form as exported in the first country and then reex- from the United States, i.e., the mate- ported to more than one second coun- rial must undergo further manufac- try, the applicant shall so indicate on turing process. This further manufac- the DEA Form 161R, providing all the tured material may only be reexported information required in this section for to a second country. each second country.

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(6) Within 30 days after the con- such a permit and, if so, whether the trolled substance is exported from the applicant complied fully with the re- United States, the person who exported quirements of this section with respect the controlled substance shall deliver to that previous permit. to the Administration documentation [36 FR 7815, Apr. 24, 1971. Redesignated at 38 on the DEA Form 161R initially com- FR 26609, Sept. 24, 1973, and amended at 52 pleted for the transaction certifying FR 17290, May 7, 1987; 62 FR 13969, Mar. 24, that such export occurred. This docu- 1997; 72 FR 72927, Dec. 26, 2007; 75 FR 10682, mentation shall be signed by a respon- Mar. 9, 2010] sible company official and shall include all of the following information: § 1312.23 Issuance of export permit. (i) Actual quantity shipped; (a) The Administrator may authorize (ii) Actual date shipped; and exportation of any controlled sub- (iii) DEA export permit number. stance listed in Schedule I or II or any (7) The controlled substance will be narcotic controlled substance listed in reexported from the first country to Schedule III or IV if he finds that such the second country (or second coun- exportation is permitted by sub- tries) no later than 180 days after the sections 1003(a), (b), (c), (d), or (f) of the controlled substance was exported from Act (21 U.S.C. 953(a), (b), (c), (d), or (f). the United States. (b) The Administrator may require (8) Shipments that have been ex- that such non-narcotic controlled sub- ported from the United States and are stances in Schedule III as shall be des- refused by the consignee in either the ignated by regulation in § 1312.30 of this first or second country, or are other- part be exported only pursuant to the wise unacceptable or undeliverable, issuance of an export permit. The Ad- may be returned to the registered ex- ministrator may authorize the expor- porter in the United States upon au- tation of such substances if he finds thorization of the Administration. In that such exportation is permitted by these circumstances, the exporter in section 1003(e) of the Act (21 U.S.C. the United States shall file a written 953(e)). request for the return of the controlled (c) If a non-narcotic substance listed substances to the United States with a in Schedule IV or V is also listed in brief summary of the facts that war- Schedule I or II of the Convention on rant the return, along with a com- Psychotropic Substances, it shall be pleted DEA Form 357, Application for exported only pursuant to the issuance Import Permit, with the Import/Export of an export permit. The Administrator Unit, Drug Enforcement Administra- may authorize the exportation of such tion. See the Table of DEA Mailing Ad- substances if he finds that such expor- dresses in § 1321.01 of this chapter for tation is permitted by section 1003(e) of the current mailing address. The Ad- the Act (21 U.S.C. 953(e)). ministration will evaluate the request (d) The Administrator may require after considering all the facts as well an applicant to submit such documents as the exporter’s registration status or written statements of fact relevant with the Administration. If the ex- to the application as he deems nec- porter provides sufficient documenta- essary to determine whether the appli- tion, the Administration will issue an cation should be granted. The failure of import permit for the return of these the applicant to provide such docu- drugs, and the exporter can then obtain ments or statements within a reason- an export permit from the country of able time after being requested to do so original importation. The substance shall be deemed to be a waiver by the may be returned to the United States applicant of an opportunity to present only after affirmative authorization is such documents or facts for consider- issued in writing by the Administra- ation by the Administrator in granting tion. or denying the application. (e) In considering whether to grant (e) Each export permit shall be issued an application for a permit under para- in septuplet and serially numbered, graphs (c) and (d) of this section, the with all seven copies bearing the same Administration shall consider whether serial number and being designated the applicant has previously obtained ‘‘original’’ (Copy 1), ‘‘duplicate’’ (Copy

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2), etc., respectively. Each export per- (b) The quadruplet copy (Copy 4) mit shall be predicated upon an import shall be forwarded by the Adminis- certificate or other documentary evi- trator to the District Director of the dence. Export permits are not transfer- U.S. Customs Service at the port of ex- able. port for comparison with the original (f) No export permit shall be issued copy (Copy 1) and for retention for the for the exportation, or reexportation, customs record. of any controlled substance to any (c) The quintuplet copy (Copy 5) shall country when the Administration has be forwarded by the Administration to information to show that the estimates the officer in the country of destina- or assessments submitted with respect tion who issued the import certificate, to that country for the current period, or other documentary evidence upon under the Single Convention on Nar- which the export permit is founded. cotic Drugs, 1961, or the Convention on (d) The sextuplet and septuplet cop- Psychotropic Substances, 1971, have ies (Copy 6 and Copy 7) shall be re- been, or, considering the quantity pro- tained by the Administration. posed to be imported, will be exceeded. [36 FR 7815, Apr. 24, 1971, as amended at 36 If it shall appear through subsequent FR 13387, July 21, 1971. Redesignated at 38 FR advice received from the International 26609, Sept. 24, 1973, and amended at 45 FR Narcotics Control Board of the United 74715, Nov. 12, 1980; 51 FR 5319, Feb. 13, 1986; Nations that the estimates or assess- 53 FR 48244, Nov. 30, 1988; 62 FR 13969, Mar. ments of the country of destination 24, 1997; 75 FR 10682, Mar. 9, 2010] have been adjusted to permit further importation of the controlled sub- § 1312.25 Expiration date. stance, an export permit may then be An export permit shall not be valid issued if otherwise permissible. after the date specified therein, which date shall conform to the expiration [36 FR 23625, Dec. 11, 1971, as amended at 37 FR 15923, Aug. 8, 1972. Redesignated at 38 FR date specified in the supporting import 26609, Sept. 24, 1973, and amended at 52 FR certificate or other documentary evi- 17290, May 7, 1987; 72 FR 72929, Dec. 26, 2007] dence upon which the export permit is founded, but in no event shall the date § 1312.24 Distribution of copies of ex- be subsequent to 6 months after the port permit. date the permit is issued. Any unused Copies of the export permit shall be export permit shall be returned by the distributed and serve purposes as fol- permittee to the Drug Operations Sec- lows: tion for cancellation. (a) The original, duplicate, and trip- [36 FR 7815, Apr. 24, 1971. Redesignated at 38 licate copies (Copy 1, Copy 2, and Copy FR 26609, Sept. 24, 1973, and amended at 45 3) shall be transmitted by the Adminis- FR 74715, Nov. 12, 1980; 51 FR 5319, Feb. 13, tration to the exporter who will retain 1986; 53 FR 48244, Nov. 30, 1988; 62 FR 13969, the triplicate copy (Copy 3) as his Mar. 24, 1997] record of authority for the exportation. § 1312.26 Records required of exporter. The exporter shall present to the Dis- trict Director of the U.S. Customs The exporter shall keep a record of Service at the port of export and at the any serial numbers that might appear time of shipment, the original and du- on packages of narcotic drugs in quan- plicate copies (Copy 1 and Copy 2). tities of one ounce or more in such a After endorsing the port of export on manner as will identify the foreign the reverse side of the original and du- consignee, along with Copy 3 of the ex- plicate copies (Copy 1 and Copy 2) the port permit. District Director shall forward the endorsed original copy (Copy 1) with the § 1312.27 Contents of special con- shipment, and return the endorsed du- trolled substances invoice. plicate copy (Copy 2) to the Import/Ex- (a) A person registered or authorized port Unit, Drug Enforcement Adminis- to export any non-narcotic controlled tration. See the Table of DEA Mailing substance listed in Schedule III, IV, or Addresses in § 1321.01 of this chapter for V, which is not subject to the require- the current mailing address. ment of an export permit pursuant to

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§ 1312.23 (b) or (c), or any person reg- country to satisfy medical, scientific istered or authorized to export any or other legitimate purposes, and that controlled substance in Schedule V, (5) The reexport of non-narcotic con- must furnish a special controlled sub- trolled substances in Schedules III and stances export invoice on DEA Form IV, and controlled substances in Sched- 236 to the Import/Export Unit, Drug ule V is not permitted under the au- Enforcement Administration, not less thority of 21 U.S.C. 953(e), except as than 15 calendar days prior to the pro- provided below: posed date of exportation, and dis- (i) Bulk substances will not be reex- tribute four copies of same as herein- ported in the same form as exported after directed in § 1312.28 of this part. from the United States, i.e, the mate- See the Table of DEA Mailing Address- rial must undergo further manufac- es in § 1321.01 of this chapter for the turing process. This further manufac- current mailing address. tured material may only be reexported (b) This invoice must be executed by to a country of ultimate consumption. the exporter in quintuplicate and in- (ii) Finished dosage units, if reex- clude the following information. ported, will be in a commercial pack- (1) The name, address, and registra- age, properly sealed and labeled for le- tion number, if any, of the exporter; gitimate medical use in the country of and the name, address and registration destination. number of the exporter broker, if any; (iii) Any reexportation be made and known to DEA at the time the initial DEA Form 236, Controlled Substances (2) A complete description of the con- Import/Export Declaration is com- trolled substances to be exported in- pleted, by checking the box marked cluding the drug name, dosage form, ‘‘other’’ on the certification. The fol- National Drug Code (NDC) number, the lowing information will be furnished in Administration Controlled Substances the remarks section: Code Number as set forth in part 1308 (A) Indicate ‘‘for reexport’’. of this chapter, the number and size of (B) Indicate if reexport is bulk or fin- packages or containers, the name and ished dosage units. quantity of the controlled substance (C) Indicate product name, dosage contained in finished dosage units, and strength, commercial package size, and the net quantity of any controlled sub- quantity. stance (expressed in anhydrous acid, (D) Indicate name of consignee, com- base, or alkaloid) given in kilograms or plete address, and expected shipment parts thereof; and date, as well as, the name and address (3) The proposed export date, the port of the ultimate consignee in the coun- of exportation, the foreign port of try to where the substances will be re- entry, the carriers and shippers in- exported. volved, method of shipment, the name (E) A statement that the consignee of the vessel if applicable, and the in the country of ultimate destination name, address, and registration num- is authorized under the laws and regu- ber, if any, of any forwarding agent lations of the country of ultimate des- utilized; and tination to receive the controlled sub- (4) The name and address of the con- stances. signee in the country of destination, (iv) Shipments which have been ex- and any registration or license number ported from the United States and are if the consignee is required to have refused by the consignee in the country such numbers either by the country of of destination, or are otherwise unac- destination or under United States law. ceptable or undeliverable, may be re- In addition, documentation must be turned to the registered exporter in the provided to show that: United States upon authorization of (i) The consignee is authorized under the Drug Enforcement Administration. the laws and regulations of the country In this circumstance, the exporter in of destination to receive the controlled the United States shall file a written substances, and that request for reexport, along with a com- (ii) The substance is being imported pleted DEA Form 236, Import Declara- for consumption within the importing tion with the Import/Export Unit, Drug

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Enforcement Administration. See the § 1312.27(b)(4) of this part must be at- Table of DEA Mailing Addresses in tached to this copy. See the Table of § 1321.01 of this chapter for the current DEA Mailing Addresses in § 1321.01 of mailing address. A brief summary of this chapter for the current mailing ad- the facts that warrant the return of the dress. substance to the United States along (e) Copy 5 shall be retained by the ex- with an authorization from the coun- porter on file as his record of authority try of export will be included with the for the exportation. request. DEA will evaluate the request [36 FR 7815, Apr. 24, 1971, as amended at 36 after considering all the facts as well FR 13387, July 21, 1971. Redesignated at 38 FR as the exporter’s registration status 26609, Sept. 24, 1973, and amended at 45 FR with DEA. The substance may be re- 74715, Nov. 12, 1980; 51 FR 5319, Feb. 13, 1986; turned to the United States only after 52 FR 17291, May 7, 1987; 53 FR 48244, Nov. 30, affirmative authorization is issued in 1988; 62 FR 13969, Mar. 24, 1997; 75 FR 10683, writing by DEA. Mar. 9, 2010] (c) Notwithstanding the time limitations included in paragraph (a) of this § 1312.29 Domestic release prohibited. section, a registrant may obtain a spe- An exporter or a forwarding agent cial waiver of these time limitations in acting for an exporter must either de- emergency or unusual instances; pro- liver the controlled substances to the vided that a specific confirmation is report or border, or deliver the controlled ceived from the Administrator or his substances to a bonded carrier ap- delegate advising the registrant to pro- proved by the consignor for delivery to ceed pursuant to the special waiver. the port or border, and may not, under any other circumstances, release a [36 FR 7815, Apr. 24, 1971, as amended at 37 FR 15923, Aug. 8, 1972. Redesignated at 38 FR shipment of controlled substances to 26609, Sept. 24, 1973, and amended at 45 FR anyone, including the foreign con- 74715, Nov. 12, 1980; 51 FR 5319, Feb. 13, 1986; signee or his agent, within the United 52 FR 17290, May 7, 1987; 62 FR 13969, Mar. 24, States. 1997; 75 FR 10683, Mar. 9, 2010] § 1312.30 Schedule III, IV, and V non- § 1312.28 Distribution of special con- narcotic controlled substances re- trolled substances invoice. quiring an import and export permit. The required five copies of the special controlled substances export in- The following Schedule III, IV, and V voice, DEA (or BND) Form 236, will be non-narcotic controlled substances distributed as follows: have been specifically designated by (a) Copy 1 shall accompany the ship- the Administrator of the Drug Enforce- ment and remain with the shipment to ment Administration as requiring im- its destination. port and export permits pursuant to (b) Copy 2 shall accompany the ship- sections 1002(b)(2) and 1003(e)(3) of the ment and will be detached and retained Act (21 U.S.C. 952(b)(2) and 953(e)(3)): by appropriate customs officials at the (a) Dronabinol (synthetic) in sesame foreign country of destination. oil and encapsulated in a soft gelatin (c) Copy 3 shall accompany the ship- capsule in a U.S. Food and Drug Ad- ment and will be detached by the Dis- ministration approved product. trict Director of the U.S. Customs (b) [Reserved] Service at the port of exportation, who [52 FR 17291, May 7, 1987, as amended at 64 shall sign and date the certification of FR 35930, July 2, 1999] customs on such Copy 3, noting any changes from the entries made by the TRANSSHIPMENT AND IN-TRANSIT exporter, and shall then promptly for- SHIPMENT OF CONTROLLED SUBSTANCES ward Copy 3 to the Drug Control Sec- tion of the Administration. § 1312.31 Schedule I: Application for (d) Copy 4 shall be forwarded, within prior written approval. the time limit required in § 1312.27 of (a) A controlled substance listed in this part, directly to the Import/Export schedule I may be imported into the Unit, Drug Enforcement Administra- United States for transshipment, or tion. The documentation required by may be transferred or transshipped

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within the United States for immediate evidence deemed adequate by the Ad- exportation, provided that: ministrator). (1) The controlled substance is nec- (d) An application shall be accom- essary for scientific, medical, or other panied by an import license or permit legitimate purposes in the country of or a certified copy of such license or destination, and permit issued by a competent author- (2) A transshipment permit has been ity of the country of destination (or issued by the Administrator. other documentary evidence deemed (b) An application for a trans- adequate by the Administrator), indi- shipment permit must be submitted to cating that the controlled substance: the Import/Export Unit, Drug Enforce- (1) Is to be applied exclusively to sci- ment Administration, at least 30 days, entific, medical or other legitimate or in the case of an emergency as soon as practicable, prior to the expected uses within the country of destination; date of importation, transfer or trans- (2) Will not be exported from such shipment. See the Table of DEA Mail- country; and ing Addresses in § 1321.01 of this chapter (3) Is needed therein because there is for the current mailing address. Each an actual shortage thereof and a de- application shall contain the following: mand therefor for scientific, medical or (1) The date of execution; other legitimate uses within such (2) The identification and description country. of the controlled substance; (e) Verification by an American con- (3) The net quantity thereof; sular officer of the signatures on a for- (4) The number and size of the con- eign import license or permit shall be trolled substance containers; required, if such license or permit does (5) The name, address, and business not bear the seal of the authority sign- of the foreign exporter; ing them. (6) The foreign port of exportation; (f) The Administrator may require an (7) The approximate date of expor- applicant to submit such documents or tation; written statements of fact relevant to (8) The identification of the export- the application as he deems necessary ing carrier; to determine whether the application (9) The name, address and business of should be granted. The failure of the the importer, transferor, or applicant to provide such documents or transshipper; statements within a reasonable time (10) The registration number, if any, after being requested to do so shall be of the importer, transferor or transshipper; deemed to be a waiver by the applicant (11) The U.S. port of entry; of an opportunity to present such docu- (12) The approximate date of entry; ments or facts for consideration by the (13) The name, address and business Administrator in granting or denying of the consignee at the foreign port of the application. entry; (g) The Administrator shall, within (14) The shipping route from the U.S. 21 days from the date of receipt of the port of exportation to the foreign port application, either grant or deny the of entry; application. The applicant shall be ac- (15) The approximate date of receipt corded an opportunity to amend the by the consignee at the foreign port of application, with the Administrator ei- entry; and ther granting or denying the amended (16) The signature of the importer, application within 7 days of its receipt. transferor or transshipper, or his agent If the Administrator does not grant or accompanied by the agent’s title. deny the application within 21 days of (c) An application shall be accom- its receipt, or in the case of an amend- panied by an export license, permit, or ed application, within 7 days of its re- a certified copy of the export license, ceipt, the application shall be deemed permit, or other authorization, issued by a competent authority of the country of origin (or other documentary

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approved and the applicant may pro- permit, the Administrator shall hold a ceed. hearing for the purpose of receiving [36 FR 7815, Apr. 24, 1971, as amended at 37 factual evidence regarding the issues FR 15923, Aug. 8, 1972. Redesignated at 38 FR involved in the issuance or denial of 26609, Sept. 24, 1973, and further amended at such permit to such person. 45 FR 74715, Nov. 12, 1980; 51 FR 5319, Feb. 13, (b) Extensive argument should not be 1986; 53 FR 48244, Nov. 30, 1988; 62 FR 13969, offered into evidence but rather pre- Mar. 24, 1997; 75 FR 10683, Mar. 9, 2010] sented in opening or closing statements of counsel or in memoranda or § 1312.32 Schedules II, III, IV: Advance notice. proposed findings of fact and conclusions of law. (a) A controlled substance listed in Schedules II, III, or IV may be im- [36 FR 23625, Dec. 11, 1971, as amended at 37 ported into the United States for trans- FR 15923, Aug. 8, 1972. Redesignated at 38 FR shipment, or may be transferred or 26609, Sept. 24, 1973] transshipped within the United States for immediate exportation, provided § 1312.43 Waiver or modification of that written notice is submitted to the rules. Import/Export Unit, Drug Enforcement The Administrator of the presiding Administration, at least 15 days prior officer (with respect to matters pend- to the expected date of importation, ing before him) may modify or waive transfer or transshipment. See the any rule in this part by notice in ad- Table of DEA Mailing Addresses in vance of the hearing, if he determines § 1321.01 of this chapter for the current that no party in the hearing will be un- mailing address. duly prejudiced and the ends of justice (b) Each advance notice shall contain will thereby be served. Such notice of those items required by § 1312.31 (b) and modification or waiver shall be made a (c). part of the record of the hearing. [36 FR 7815, Apr. 24, 1971. Redesignated at 38 [36 FR 23625, Dec. 11, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973, and amended at 45 FR 26609, Sept. 24, 1973] FR 74715, Nov. 12, 1980; 51 FR 5319, Feb. 13, 1986; 53 FR 48244, Nov. 30, 1988; 62 FR 13969, § 1312.44 Request for hearing or ap- Mar. 24, 1997; 75 FR 10683, Mar. 9, 2010] pearance; waiver. HEARINGS (a) Any applicant entitled to a hearing pursuant to § 1312.42 and who de- § 1312.41 Hearings generally. sires a hearing on the denial of his ap- (a) In any case where the Adminis- plication for an import, export, or trator shall hold a hearing regarding transshipment permit shall, within 30 the denial of an application for an im- days after the date of receipt of the de- port, export or transshipment permit, nial of his application, file with the Ad- the procedures for such hearing shall ministrator a written request for a be governed generally by the adjudica- hearing in the form prescribed in tion procedures set forth in the Admin- § 1316.47 of this chapter. istrative Procedure Act (5 U.S.C. 551– (b) Any applicant entitled to a hear- 559) and specifically by sections 1002 ing pursuant to § 1312.42 may, within and 1003 of the Act (21 U.S.C. 952 and the period permitted for filing a re- 953), by §§ 1312.42–1312.47, and by the quest for a hearing, file with the Ad- procedures for administrative hearings ministrator a waiver of an opportunity under the Act set forth in §§ 1316.41– for a hearing, together with a written 1316.67 of this chapter. statement regarding his position on (b) [Reserved] the matters of fact and law involved in [36 FR 23625, Dec. 11, 1971, as amended at 37 such hearing. Such statement, if ad- FR 15923, Aug. 8, 1972. Redesignated at 38 FR missible, shall be made a part of the 26609, Sept. 24, 1973] record and shall be considered in light of the lack of opportunity for cross-ex- § 1312.42 Purpose of hearing. amination in determining the weight (a) If requested by a person applying to be attached to matters of fact as- for an import, export, or transshipment serted therein.

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(c) If any applicant entitled to a issuance or denial of the application hearing pursuant to § 1312.42 fails to ap- for and import, export, or trans- pear at the hearing, he shall be deemed shipment permit. The order shall in- to have waived his opportunity for the clude the findings of fact and conclu- hearing unless he shows good cause for sions of law upon which the order is such failure. based. The Administrator shall serve (d) If the applicant waives or is one copy of his order upon the appli- deemed to have waived this oppor- cant. tunity for the hearing, the Adminis- trator may cancel the hearing, if [37 FR 15924, Aug. 8, 1972. Redesignated at 38 FR 26609, Sept. 24, 1973] scheduled, and issue his final order pursuant to § 1312.47 without a hearing. PART 1313—IMPORTATION AND [37 FR 15923, Aug. 8, 1972. Redesignated at 38 EXPORTATION OF LIST I AND LIST FR 26609, Sept. 24, 1973] II CHEMICALS § 1312.45 Burden of proof. At any hearing on the denial of an Sec. 1313.01 Scope. application for an import, export, or 1313.02 Definitions. transshipment permit, the Adminis- 1313.05 Requirements for an established trator shall have the burden of proving business relationship. that the requirements for such permit 1313.08 Requirements for establishing a pursuant to sections 1002, 1003, and 1004 record as an importer. of the Act (21 U.S.C. 952, 953, and 954) are not satisfied. IMPORTATION OF LISTED CHEMICALS 1313.12 Requirement of authorization to im- [37 FR 15924, Aug. 8, 1972. Redesignated at 38 port. FR 26609, Sept. 24, 1973] 1313.13 Contents of import declaration. § 1312.46 Time and place of hearing. 1313.14 Distribution of import declaration. 1313.15 Waiver of 15-day advance notice for (a) If any applicant for an import, ex- regular importers. port, or transshipment permit requests 1313.16 Transfers following importation. a hearing on the issuance or denial of 1313.17 Return declaration or amendment to his application, the Administrator Form 486 for imports. shall hold such hearing. Notice of the EXPORTATION OF LISTED CHEMICALS hearing shall be given to the applicant of the time and place at least 30 days 1313.21 Requirement of authorization to ex- prior to the hearing, unless the appli- port. 1313.22 Contents of export declaration. cant waives such notice and requests 1313.23 Distribution of export declaration. the hearing be held at an earlier time, 1313.24 Waiver of 15-day advance notice for in which case the Administrator shall chemical exporters. fix a date for such hearing as early as 1313.25 Foreign import restrictions. reasonably possible. 1313.26 Transfers following exportation. (b) The hearing will commence at the 1313.27 Return declaration or amendment to place and time designated in the notice Form 486 for exports. given pursuant to paragraph (a) of this TRANSSHIPMENTS, IN-TRANSIT SHIPMENTS AND section but thereafter it may be moved INTERNATIONAL TRANSACTIONS INVOLVING to a different place and may be contin- LISTED CHEMICALS ued from day to day or recessed to a later day without notice other than an- 1313.31 Advance notice of importation for transshipment or transfer. nouncement thereof by the presiding 1313.32 Requirement of authorization for officer at the hearing. international transactions. [37 FR 15924, Aug. 8, 1972. Redesignated at 38 1313.33 Contents of an international trans- FR 26609, Sept. 24, 1973] action declaration. 1313.34 Distribution of the international § 1312.47 Final order. transaction declaration. 1313.35 Return declaration or amendment to As soon as practicable after the pre- Form 486 for international transactions. siding officer has certified the record 1313.41 Suspension of shipments. to the Administrator, the Adminis- 1313.42 Prohibition of shipments from cer- trator shall issue his order on the tain foreign sources.

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HEARINGS (e) The frequency and number of 1313.51 Hearings generally. transactions occurring during the pre- 1313.52 Purpose of hearing. ceding 12-month period; 1313.53 Waiver of modification of rules. (f) The amounts and the listed chem- 1313.54 Request for hearing. ical or chemicals involved in regulated 1313.55 Burden of proof. transactions between the chemical im- 1313.56 Time and place of hearing. porter or exporter and regular cus- 1313.57 Final order. tomer; (g) The method of delivery (direct AUTHORITY: 21 U.S.C. 802, 830, 871(b), 971. shipment or through a broker or for- SOURCE: 54 FR 31665, Aug. 1, 1989, unless warding agent); and otherwise noted. (h) Other information that the chemical importer or exporter considers rel- § 1313.01 Scope. evant for determining whether a cus- Procedures governing the importa- tomer is a regular customer. tion, exportation, transshipment and [72 FR 17407, Apr. 9, 2007] in-transit shipment of listed chemicals pursuant to section 1018 of the Act (21 § 1313.08 Requirements for estab- U.S.C. 971) are governed generally by lishing a record as an importer. that section and specifically by the To establish a record as an importer, sections of this part. the regulated person must provide the [54 FR 31665, Aug. 1, 1989, as amended at 60 Administrator with the following infor- FR 32465, June 22, 1995] mation in accordance with the waiver of the 15-day advance notice require- § 1313.02 Definitions. ments of § 1313.15: Any term used in this part shall have (a) The name, DEA registration num- the definition set forth in section 102 of ber (where applicable), street address, the Act (21 U.S.C. 802) or part 1300 of telephone number, and, where avail- this chapter. able, the facsimile number of the regulated person and of each foreign sup- [62 FR 13969, Mar. 24, 1997] plier; and (b) The frequency and number of § 1313.05 Requirements for an estab- transactions occurring during the pre- lished business relationship. ceding 12 month period. To document that an importer or ex- [72 FR 17407, Apr. 9, 2007] porter has an established business relationship with a customer, the importer IMPORTATION OF LISTED CHEMICALS or exporter must provide the Adminis- trator with the following information § 1313.12 Requirement of authoriza- in accordance with the waiver of 15-day tion to import. advance notice requirements of § 1313.15 (a) Each regulated person who im- or § 1313.24: ports a listed chemical that meets or (a) The name and street address of exceeds the threshold quantities identi- the chemical importer or exporter and fied in § 1310.04(f) or is a listed chemical of each regular customer; for which no threshold has been estab- (b) The telephone number, contact lished as identified in § 1310.04(g) of this person, and where available, the fac- chapter, shall notify the Administrator simile number for the chemical im- of the importation not later than 15 porter or exporter and for each regular days before the transaction is to take customer; place. (c) The nature of the regular cus- (b) A completed DEA Form 486 must tomer’s business (i.e., importer, ex- be received by the Import/Export Unit, porter, distributor, manufacturer, Drug Enforcement Administration, not etc.), and if known, the use to which later than 15 days prior to the importa- the listed chemical or chemicals will tion. See the Table of DEA Mailing Ad- be applied; dresses in § 1321.01 of this chapter for (d) The duration of the business rela- the current mailing address. A copy of tionship; the completed DEA Form 486 may be

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transmitted directly to the Drug En- (2) 2-Butanone (or Methyl Ethyl Ke- forcement Administration through tone or MEK). electronic facsimile media not later (3) Toluene. than 15 days prior to the importation. (c) The 15-day advance notification [54 FR 31665, Aug. 1, 1989, as amended at 59 FR 51367, Oct. 11, 1994; 60 FR 32464, June 22, requirement for listed chemical im- 1995; 66 FR 46520, Sept. 6, 2001; 67 FR 49569, ports may be waived for the following: July 31, 2002; 72 FR 17407, Apr. 9, 2007; 75 FR (1) Any importation that meets both 10683, Mar. 9, 2010] of the following requirements: (i) The regulated person has satisfied § 1313.13 Contents of import declara- the requirements for reporting to the tion. Administration as a regular importer (a) Any List I or List II chemical list- of the listed chemicals. ed in § 1310.02 of this chapter may be (ii) The importer intends to transfer imported if that chemical is necessary the listed chemicals to a person who is for medical, commercial, scientific, or a regular customer for the chemical, as other legitimate uses within the defined in § 1300.02 of this chapter. United States. Chemical importations (2) A specific listed chemical, as set into the United States for immediate forth in paragraph (f) of this section, transfer/transshipment outside the for which the Administrator deter- United States must comply with the mines that advance notification is not procedures set forth in § 1313.31. necessary for effective chemical diver- (b) Any regulated person who desires sion control. to import a threshold or greater quan- (d) For imports where advance notifi- tity of a listed chemical shall notify cation is waived pursuant to paragraph the Administration through procedures (c)(1) of this section, the DEA Form 486 set forth in § 1313.12 and distribute must be received by the Drug Enforce- three copies of DEA Form 486 as di- ment Administration, Chemical Oper- ations Section, on or before the date of rected in § 1313.14. importation through use of the mailing (c) The DEA Form 486 must be exe- address listed in § 1313.12(b) or through cuted in triplicate and must include use of electronic facsimile media. the following information: (e) For importations where advance (1) The name, address, telephone notification is waived pursuant to number, telex number, and, where paragraph (c)(2) of this section no DEA available, the facsimile number of the Form 486 is required; however, the reg- chemical importer; the name, address, ulated person shall submit quarterly telephone, telex, and where available, reports to the Import/Export Unit, the facsimile number of the broker or Drug Enforcement Administration, no forwarding agent (if any); and later than the 15th day of the month (2) The name and description of each following the end of each quarter. See listed chemical as it appears on the the Table of DEA Mailing Addresses in label or container, the name of each § 1321.01 of this chapter for the current chemical as it is designated in 1310.02 mailing address. The report shall con- of this chapter, the size or weight of tain the following information regard- container, the number of containers, ing each individual importation: the net weight of each listed chemical (1) The name of the listed chemical; given in kilograms or parts thereof; (2) The quantity and date imported; and the gross weight of the shipment (3) The name and full business ad- given in kilograms or parts thereof; dress of the supplier; and (4) The foreign port of embarkation; (3) The proposed import date, the for- and eign port of exportation and the first (5) The port of entry. U.S. Customs Port of Entry; and (f) The 15 day advance notification (4) The name, address, telephone requirement set forth in paragraph (a) number, telex number, and, where has been waived for imports of the fol- available, the facsimile number of the lowing listed chemicals: consigner in the foreign country of ex- (1) Acetone. portation; and

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(5) The name, address, telephone receipt requested, to the Administra- number, and where available, the faction such information as is required simile number of the person or persons under § 1313.08 documenting their sta- to whom the importer intends to trans- tus as a regular importer. fer the listed chemical and the quan- (b) Each regulated person making ap- tity to be transferred to each trans- plication under paragraph (a) of this feree. section shall be considered a ‘‘regular (d) Any regulated person importing importer’’ for purposes of waiving the ephedrine, pseudoephedrine, or phenyl- 15-day advance notice, 30 days after re- propanolamine must submit, on the ceipt of the application by the Admin- import declaration, all information istration, as indicated on the return re- known to the importer on the chain of ceipt, unless the regulated person is distribution of the chemical from the otherwise notified in writing by the manufacturer to the importer. Ephed- Administration. rine, pseudoephedrine, or phenyl- (c) The Administrator, may, at any propanolamine include each of the time, disqualify a regulated person’s salts, optical isomers, and salts of opti- status as a regular importer on the cal isomers of the chemical. grounds that the chemical being im- [54 FR 31665, Aug. 1, 1989, as amended at 60 ported may be diverted to the clandes- FR 32465, June 22, 1995; 72 FR 17407, Apr. 9, tine manufacture of a controlled sub- 2007; 75 FR 10171, Mar. 5, 2010] stance. (d) Unless the Administration noti- § 1313.14 Distribution of import dec- fies the chemical importer to the con- laration. trary, the qualification of a regular im- The required three copies of the list- porter of any one of these three chemi- ed chemical import declaration (DEA cals, acetone, 2-Butanone (MEK), or Form 486) will be distributed as fol- toluene, qualifies that importer as a lows: regular importer of all three of these (a) Copy 1 shall be retained on file by chemicals. the regulated person as the official (e) All chemical importers shall be record of import. Import declaration required to file a DEA Form 486 as re- forms involving a List I chemical must quired by Section 1313.12. be retained for four years; declaration [60 FR 32464, June 22, 1995, as amended at 62 forms for List II chemical must be re- FR 13969, Mar. 24, 1997; 72 FR 17407, Apr. 9, tained for two years. 2007] (b) Copy 2 is the Drug Enforcement Administration copy used to fulfill the § 1313.16 Transfers following importa- notification requirements of Section tion. 6053 of the Chemical Diversion and (a) In the case of a notice under Trafficking Act of 1988, as specified in § 1313.12(a) submitted by a regulated § 1313.12. person, if the transferee identified in (c) Copy 3 shall be presented to the the notice is not a regular customer, U.S. Customs Sevice along with the the importer may not transfer the list- customs entry. If the import is a regu- ed chemical until after the expiration lated transaction for which the 15-day of the 15-day period beginning on the advance notice requirement has been date on which the notice is submitted waived, the regulated person shall de- to the Administration. clare this information to the U.S. Cus- (b) After a notice under § 1313.12(a) or toms Service Official by checking the (d) is submitted to the Administration, block on the DEA Form 486 designated if circumstances change and the im- for this purpose. porter will not be transferring the list- [54 FR 31665, Aug. 1, 1989, as amended at 60 ed chemical to the transferee identified FR 32465, June 22, 1995] in the notice, or will be transferring a greater quantity of the chemical than § 1313.15 Waiver of 15-day advance no- specified in the notice, the importer tice for regular importers. must update the notice to identify the (a) Each regulated person seeking most recent prospective transferee or designation as a ‘‘regular importer’’ the most recent quantity or both (as shall provide, by certified mail return the case may be) and may not transfer

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the listed chemical until after the expi- (1) The term transfer, with respect to ration of the 15-day period beginning a listed chemical, includes the sale of on the date on which the update is sub- the chemical. mitted to the Administration, except (2) The term transferee means a per- that the 15-day restriction does not son to whom an importer transfers a apply if the prospective transferee listed chemical. identified in the update is a regular [72 FR 17407, Apr. 9, 2007] customer. The preceding sentence applies with respect to changing cir- § 1313.17 Return declaration or cumstances regarding a transferee or amendment to Form 486 for im- quantity identified in an update to the ports. same extent and in the same manner as (a) Within 30 days after a transaction the sentence applies with respect to is completed, the importer must send changing circumstances regarding a to the Administration a return declara- transferee or quantity identified in the tion containing particulars of the original notice under § 1313.12(a) or (d). transaction, including the date, quan- (c) In the case of a transfer of a listed tity, chemical, container, name of chemical that is subject to a 15-day re- transferees, and any other information striction, the transferee involved shall, as the Administration may specify. A upon the expiration of the 15-day pe- single return declaration may include riod, be considered to qualify as a reg- the particulars of both the importation ular customer, unless the Administra- and distribution. If the importer has tion otherwise notifies the importer in- not distributed all chemicals imported volved in writing. by the end of the initial 30-day period, (d) With respect to a transfer of a the importer must file supplemental listed chemical with which a notice or return declarations no later than 30 update referred to in § 1313.12(a) or (d) days from the date of any further distribution, until the distribution or is concerned: other disposition of all chemicals im- (1) The Administration— ported under the import notification or (i) May, in accordance with the same any update are accounted for. procedures as apply under §§ 1313.51 (b) If an importation for which a through 1313.57, order the suspension of Form 486 has been filed fails to take the transfer of the listed chemical by place, the importer must file an the importer involved, except for a amended Form 486 notifying the Ad- transfer to a regular customer, on the ministration that the importation did ground that the chemical may be di- not occur. verted to the clandestine manufacture of a controlled substance (without re- [72 FR 17408, Apr. 9, 2007] gard to the form of the chemical that EXPORTATION OF LISTED CHEMICALS may be diverted, including the diversion of a finished drug product to be § 1313.21 Requirement of authoriza- manufactured from bulk chemicals to tion to export. be transferred), subject to the Adminis- (a) No person shall export or cause to tration ordering the suspension before be exported from the United States any the expiration of the 15-day period with chemical listed in § 1310.02 of this chap- respect to the importation (in any case ter, which meets or exceeds the thresh- in which such a period applies); and old quantities identified in § 1310.04(f) (ii) May, for purposes of this para- or is a listed chemical for which no graph (d), disqualify a regular cus- threshold has been established as iden- tomer on that ground. tified in § 1310.04(g) of this chapter, (2) From and after the time when the until such time as the Administrator Administration provides written notice has been notified. Notification must be of the order under paragraph (d)(1)(i) of made not later than 15 days before the this section (including a statement of transaction is to take place. In order to the legal and factual basis for the facilitate the export of listed chemicals order) to the importer, the importer and implement the purpose of the Act, may not carry out the transfer. regulated persons may wish to provide (e) For purposes of this section: notification to the Administration as

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far in advance of the 15 days as pos- (f) The 15 day advance notification sible. requirement set forth in paragraph (a) (b) A completed DEA Form 486 must of this section has been waived for ex- be received by the Import/Export Unit, ports of the following listed chemicals Drug Enforcement Administration, not to the following countries: later than 15 days prior to the exportation. See the Table of DEA Mailing Name of Chemical Country Addresses in § 1321.01 of this chapter for [Reserved] ...... the current mailing address. A copy of the completed DEA Form 486 may be (g) No person shall export or cause to transmitted directly to the Drug En- be exported any listed chemical, know- forcement Administration through ing or having reasonable cause to be- electronic facsimile media not later lieve the export is in violation of the than 15 days prior to the exportation. laws of the country to which the chem- (c) The 15-day advance notification ical is exported or the chemical will be requirement for listed chemical ex- used to manufacture a controlled sub- ports may be waived for: stance in violation of the Act or the (1) Any regulated person who has sat- laws of the country to which the chem- isfied the requirements of Section ical is exported. The Administration 1313.24 for reporting to the Administra- will publish a notice of foreign import tion an established business relation- restrictions for listed chemicals of ship with a foreign customer as defined which DEA has knowledge as provided in § 1300.02(b)(12). in § 1313.25. (2) A specific listed chemical to a [54 FR 31665, Aug. 1, 1989, as amended at 59 specified country, as set forth in para- FR 51367, Oct. 11, 1994; 60 FR 32464, June 22, graph (f) of this section, for which the 1995; 62 FR 13969, Mar. 24, 1997; 66 FR 46520, Administrator determines that ad- Sept. 6, 2001; 67 FR 49569, July 31, 2002; 75 FR vance notification is not necessary for 10683, Mar. 9, 2010] effective chemical diversion control. (d) For exports where advance notifi- § 1313.22 Contents of export declara- cation is waived pursuant to paragraph tion. (c)(1) of this section, the DEA Form 486 (a) Any List I or List II chemical list- must be received by the Drug Enforce- ed in § 1310.02 of this chapter which ment Administration, Chemical Oper- meets or exceeds the quantitative ations Section, on or before the date of threshold criteria established in exportation through use of the mailing § 1310.04(f) of this chapter may be ex- address listed in Section 1313.12(b) or ported if that chemical is needed for through use of electronic facsimile medical, commercial, scientific, or media. other legitimate uses. (e) For exportations where advance (b) Any regulated person who desires notification is waived pursuant to to export a threshold or greater quan- paragraph (c)(2) of this section, no DEA tity of a listed chemical shall notify Form 486 is required; however, the reg- the Administration through procedures ulated person shall file quarterly re- outlined in § 1313.21 and distribute ports with the Import/Export Unit, three copies of DEA Form 486 as di- Drug Enforcement Administration, no rected in § 1313.23. later than the 15th day of the month (c) The DEA Form 486 must be exe- following the end of each quarter. See cuted in triplicate and must include all the Table of DEA Mailing Addresses in the following information: § 1321.01 of this chapter for the current (1) The name, address, telephone mailing address. The report shall con- number, telex number, and, where tain the following information regard- available, the facsimile number of the ing each individual exportation: chemical exporter; the name, address, (1) The name of the listed chemical; telephone number, telex number, and, (2) The quantity and date exported; where available, the facsimile number (3) The name and full business ad- of the export broker, if any; dress of the foreign customer; (2) The name and description of each (4) The port of embarkation; and listed chemical as it appears on the (5) The foreign port of entry. label or container, the name of each

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listed chemical as it is designated in (b) Copy 2 is the Drug Enforcement § 1310.02 of this chapter, the size or Administration copy used to fulfill the weight of container, the number of con- notification requirements of Section tainers, the net weight of each listed 6053 of the Chemical Diversion and chemical given in kilograms or parts Trafficking Act of 1988, as specified in thereof, and the gross weight of the § 1313.21 shipment given in kilograms or parts (c) Copy 3 shall be presented to the thereof; U.S. Customs Service at the port of (3) The proposed export date, the U.S. exit for each export of a listed chem- Customs port of exportation, and the ical or chemicals on or before the day foreign port of entry; and of exportation, and when possible, (4) The name, address, telephone, along with the Shippers Export Dec- telex, and where available, the fac- laration. simile number of the consignee in the country where the chemical shipment [54 FR 31665, Aug. 1, 1989, as amended at 60 is destined; the name(s) and address(es) FR 32465, June 22, 1995; 61 FR 51004, Sept. 30, of any intermediate consignee(s). 1996] (d) Notwithstanding the time limita- § 1313.24 Waiver of 15-day advance no- tions included in paragraph (b) of this tice for chemical exporters. section, a regulated person may receive a waiver of the 15-day advance notifica- (a) Each regulated person shall pro- tion requirement following the proce- vide to the Administration the identity dures outlined in § 1313.24. and information listed in § 1300.02(b)(12) (e) Declared exports of listed chemi- for an established business relationship cals which are refused, rejected, or oth- with a foreign customer not later than erwise deemed undeliverable may be August 31, 1989. returned to the U.S. chemical exporter (b) Not later than October 31, 1989, of record. A brief written notification each regular customer so identified in (this does not require a DEA Form 486) notifications made under § 1313.24(a) outlining the circumstances must be shall be a regular customer for pur- sent to the Import/Export Unit, Drug poses of waiving the 15-day advance no- Enforcement Administration, following tice requirement, unless the regulated the return within a reasonable time. person is otherwise notified in writing See the Table of DEA Mailing Address- by the Administration. es in § 1321.01 of this chapter for the (c) Each foreign customer identified current mailing address. This provision on an initial DEA Form 486 submitted does not apply to shipments that have after the effective date of the imple- cleared foreign customs, been deliv- mentation of part 1313 shall, after the ered, and accepted by the foreign con- expiration of the 15-day period, qualify signee. Returns to third parties in the as a regular customer, unless the Ad- United States will be regarded as im- ministration otherwise notifies the ports. regulated person in writing. [54 FR 31665, Aug. 1, 1989, as amended at 60 (d) Unless the Administration noti- FR 32465, June 22, 1995; 67 FR 49569, July 31, fies the chemical exporter to the con- 2002; 75 FR 10683, Mar. 9, 2010] trary, the qualification of a regular customer for any one of these three § 1313.23 Distribution of export dec- chemicals, acetone, 2-Butanone (MEK), laration. or toluene, qualifies that customer as a The required three copies of the list- regular customer for all three of these ed chemical export declaration (DEA chemicals. Form 486) will be distributed as fol- (e) The Administrator may notify lows: any chemical exporter that a regular (a) Copy 1 shall be retained on file by customer has been disqualified or that the chemical exporters as the official a new customer for whom a notifica- record of export. Export declaration tion has been submitted is not to be ac- forms involving a List I chemical must corded the status of a regular cus- be retained for four years; declaration tomer. In the event of a disqualifica- forms for list II chemical must be re- tion of an established regular cus- tained for two years. tomer, the chemical exporter will be

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notified in writing of the reasons for ular customer, unless the Administra- such action. tion otherwise notifies the exporter involved in writing. [54 FR 31665, Aug. 1, 1989, as amended at 56 FR 55077, Oct. 24, 1991; 62 FR 13969, Mar. 24, (d) With respect to a transfer of a 1997; 75 FR 10684, Mar. 9, 2010] listed chemical with which a notice or update referred to in § 1313.21(a) is con- § 1313.25 Foreign import restrictions. cerned: Any export from the United States in (1) The Administration— violation of the law of the country to (i) May, in accordance with the same which the chemical is exported is sub- procedures as apply under §§ 1313.51 ject to the penalties of Title 21 United through 1313.57, order the suspension of States Code 960(d). the transfer of the listed chemical by the exporter involved, except for a § 1313.26 Transfers following expor- transfer to a regular customer, on the tation. ground that the chemical may be di- (a) In the case of a notice under verted to the clandestine manufacture § 1313.21(a) submitted by a regulated of a controlled substance (without re- person, if the transferee identified in gard to the form of the chemical that the notice, i.e., the foreign importer, is may be diverted, including the diver- not a regular customer, the regulated sion of a finished drug product to be person may not transfer the listed manufactured from bulk chemicals to chemical until after the expiration of be transferred), subject to the Adminis- the 15-day period beginning on the date tration ordering the suspension before on which the notice is submitted to the the expiration of the 15-day period with Administration. respect to the exportation (in any case (b) After a notice under § 1313.21(a) is in which such a period applies); and submitted to the Administration, if (ii) May, for purposes of this para- circumstances change and the exporter graph (d), disqualify a regular cus- will not be transferring the listed tomer on that ground. chemical to the transferee identified in (2) From and after the time when the the notice, or will be transferring a Administration provides written notice greater quantity of the chemical than of the order under paragraph (d)(1)(i) of specified in the notice, the exporter this section (including a statement of must update the notice to identify the the legal and factual basis for the most recent prospective transferee or order) to the exporter, the exporter the most recent quantity or both (as may not carry out the transfer. the case may be) and may not transfer (e) For purposes of this section: the listed chemical until after the expi- (1) The term transfer, with respect to ration of the 15-day period beginning a listed chemical, includes the sale of on the date on which the update is sub- the chemical. mitted to the Administration, except (2) The term transferee means a per- that the 15-day restriction does not son to whom an exporter transfers a apply if the prospective transferee listed chemical. identified in the update is a regular customer. The preceding sentence ap- [72 FR 17408, Apr. 9, 2007] plies with respect to changing circumstances regarding a transferee or § 1313.27 Return declaration or quantity identified in an update to the amendment to Form 486 for ex- same extent and in the same manner as ports. the sentence applies with respect to (a) Within 30 days after a transaction changing circumstances regarding a is completed, the exporter must send to transferee or quantity identified in the the Administration a return declara- original notice under paragraph (a) of tion containing particulars of the this section. transaction, including the date, quan- (c) In the case of a transfer of a listed tity, chemical, container, name of chemical that is subject to a 15-day re- transferees, and any other information striction, the transferee involved shall, as the Administration may specify. upon the expiration of the 15-day pe- (b) If an exportation for which a riod, be considered to qualify as a reg- Form 486 has been filed fails to take

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place, the exporter must file an amend- (11) The name, address, business, ed Form 486 notifying the Administra- telephone number, telex number, and, tion that the exportation did not where available, the facsimile number occur. of the importer, transferor, or transshipper; [72 FR 17408, Apr. 9, 2007] (12) The U.S. port of entry; (13) The approximate date of entry; TRANSSHIPMENTS, IN-TRANSIT SHIP- (14) The name, address, telephone MENTS AND INTERNATIONAL TRANS- number, telex number, business of the ACTIONS INVOLVING LISTED CHEMI- consignee and, where available, fac- CALS simile number of the consignee at the § 1313.31 Advance notice of importa- foreign port of entry; tion for transshipment or transfer. (15) The shipping route from the U.S. port of exportation to the foreign port (a) A quantity of a chemical listed in of entry at final destination; § 1310.02 of this chapter that meets or (16) The approximate date of receipt exceeds the threshold reporting re- by the consignee at the foreign port of quirements found in § 1310.04(f) of this entry; and chapter may be imported into the (17) The signature of the importer, United States for transshipment, or transferor or transshipper, or his may be transferred or transshipped agent, accompanied by the agent’s within the United States for immediate title. exportation, provided that advance no- (c) Unless notified to the contrary tice is given to the Administration. prior to the expected date of delivery, (b) Advance notification must be pro- the importation for transshipment or vided to the Import/Export Unit, Drug transfer is considered approved. Enforcement Administration, not later (d) No waiver of the 15-day advance than 15 days prior to the proposed date notice will be given for imports of list- the listed chemical will transship or ed chemicals in quantities meeting or transfer through the United States. exceeding threshold quantities for See the Table of DEA Mailing Address- transshipment or transfer outside the es in § 1321.01 of this chapter for the United States. current mailing address. The written notification (not a DEA Form 486) shall [54 FR 31665, Aug. 1, 1989, as amended at 67 contain the following information: FR 49569, July 31, 2002; 75 FR 10684, Mar. 9, 2010] (1) The date the notice was executed; (2) The complete name and descrip- § 1313.32 Requirement of authorization of the listed chemical as it ap- tion for international transactions. pears on the label or container. (a) A broker or trader shall notify (3) The name of the listed chemical the Administrator prior to an inter- as designated by § 1310.02 of this chap- national transaction involving a listed ter. chemical which meets or exceeds the (4) The number of containers and the threshold amount identified in Section size or weight of the container for each 1310.04 of this chapter, in which the listed item; broker or trader participates. Notifica- (5) The new weight of each listed tion must be made no later than 15 chemical given in kilograms or parts days before the transaction is to take thereof; place. In order to facilitate an inter- (6) The gross weight of the shipment national transaction involving listed given in kilograms or parts thereof; chemicals and implement the purpose (7) The name, address, telephone of the Act, regulated persons may wish number, telex number, business of the to provide advance notification to the foreign exporter and, where available, Administration as far in advance of the the facsimile number; 15 days as possible. (8) The foreign port of exportation; (b)(1) A completed DEA Form 486 (9) The approximate date of expor- must be received by the Import/Export tation; Unit, Drug Enforcement Administra- (10) The complete identification of tion, not later than 15 days prior to the the exporting carrier; international transaction. See the

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Table of DEA Mailing Addresses in § 1313.33 Contents of an international § 1321.01 of this chapter for the current transaction declaration. mailing address. (a) An international transaction in- (2) A copy of the DEA Form 486 may volving a chemical listed in § 1310.02 of be transmitted directly to the Drug this chapter which meets the threshold Enforcement Administration, Chemical criteria established in § 1310.04 of this Operations Section, through electronic chapter may be arranged by a broker facsimile media not later than 15 days or trader if the chemical is needed for prior to the exportation. medical, commercial, scientific, or (c) No person shall serve as a broker other legitimate uses. or trader for an international trans- (b) Any broker or trader who desires action involving a listed chemical to arrange an international trans- knowing or having reasonable cause to action involving a listed chemical believe that the transaction is in viola- which meets the criteria set forth in tion of the laws of the country to Section 1310.04 shall notify the Admin- which the chemical is exported or the istration through the procedures out- chemical will be used to manufacture a lined in Section 1313.32(b). controlled substance in violation of the (c) The DEA Form 486 must be executed in triplicate and must include all laws of the country to which the chem- the following information: ical is exported. The Administration (1) The name, address, telephone will publish a notice of foreign import number, telex number, and, where restrictions for listed chemicals of available, the facsimile number of the which DEA has knowledge as provided chemical exporter; the name, address, in Section 1313.25. telephone number, telex number, and, (d) After a notice under paragraph (a) where available, the facsimile number of this section is submitted to the Ad- of the chemical importer; ministration, if circumstances change (2) The name and description of each and the broker or trader will not be listed chemical as it appears on the transferring the listed chemical to the label or container, the name of each transferee identified in the notice, or listed chemical as it is designated in will be transferring a greater quantity Section 1310.02 of this chapter, the size of the chemical than specified in the or weight of container, the number of notice, the broker or trader must up- containers, the net weight of each list- date the notice to identify the most re- ed chemical given in kilograms or cent prospective transferee or the most parts thereof, and the gross weight of recent quantity or both (as the case the shipment given in kilograms or may be). The preceding sentence ap- parts thereof; plies with respect to changing cir- (3) The proposed export date, the port cumstances regarding a transferee or of exportation, and the port of impor- quantity identified in an update to the tation; and same extent and in the same manner as (4) The name, address, telephone, telex, and where available, the fac- the sentence applies with respect to simile number, of the consignee in the changing circumstances regarding a country where the chemical shipment transferee or quantity identified in the is destined; the name(s) and address(es) original notice under paragraph (a) of of any intermediate consignee(s). this section. (e) For purposes of this section: [60 FR 32465, June 22, 1995] (1) The term transfer, with respect to § 1313.34 Distribution of the inter- a listed chemical, includes the sale of national transaction declaration. the chemical. The required three copies of the DEA (2) The term transferee means a per- Form 486 will be distributed as follows: son to whom an exporter transfers a (a) Copies 1 and 3 shall be retained on listed chemical. file by the broker or trader as the offi- [60 FR 32465, June 22, 1995; 61 FR 17566, Apr. cial record of the international trans- 22, 1996; 67 FR 49569, July 31, 2002; 72 FR 17408, action. Declaration forms involving Apr. 9, 2007; 75 FR 10684, Mar. 9, 2010] List I chemicals shall be retained for

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List II chemicals shall be retained for manufacturer or distributor on the dis- four years; declaration forms for two tribution of the chemical, including years. sales, the Administrator may issue an (b) Copy 2 is the Drug Enforcement order prohibiting the importation of Administration copy used to fulfill the the chemical in any case where the notification requirements of Section manufacturer or distributor is part of 1313.32. the chain of distribution. [60 FR 32465, June 22, 1995; 60 FR 35264, July (b) Not later than 60 days prior to 6, 1995] issuing the order to prohibit importation, the Administrator shall publish § 1313.35 Return declaration or in the FEDERAL REGISTER a notice of amendment to Form 486 for inter- intent to issue the order. During the 60- national transactions. day period, imports from the foreign (a) Within 30 days after a transaction manufacturer or distributor may not is completed, the broker or trader must be restricted under this section. send to the Administration a return declaration containing particulars of [75 FR 10172, Mar. 5, 2010] the transaction, including the date, HEARINGS quantity, chemical, container, name of transferees, and any other information § 1313.51 Hearings generally. as the Administration may specify. (b) If a transaction for which a Form In any case where a regulated person 486 has been filed fails to take place, requests a hearing regarding the sus- the broker or trader must file an pension of a shipment of a listed chem- amended Form 486 notifying the Ad- ical, the procedures for such hearing ministration that the transaction did shall be governed generally by the pro- not occur. cedures set forth in the Administrative Procedure Act (5 U.S.C. 551–559) and [72 FR 17409, Apr. 9, 2007] specifically by section 6053 of the § 1313.41 Suspension of shipments. Chemical Diversion and Trafficking Act (Pub. L. 100–690), by 21 CFR 1313.52– (a) The Administrator may suspend 1313.57, and by the procedures for ad- any importation or exportation of a ministrative hearings under the Con- chemical listed in § 1310.02 of this chap- trolled Substances Act set forth in ter based on evidence that the chem- §§ 1316.41–1316.67 of this chapter. ical proposed to be imported or exported may be diverted to the clandes- § 1313.52 Purpose of hearing. tine manufacture of a controlled substance. If the Administrator so sus- If requested by a person entitled to a pends, he shall provide written notice hearing, the Administrator shall cause of such suspension to the regulated a hearing to be held for the purpose of person. Such notice shall contain a receiving factual evidence regarding statement of the legal and factual basis the issues involved in the suspension of for the order. shipments within 45 days of the date of (b) Upon service of the order of sus- the request, unless the requesting pension, the regulated person to whom party requests an extension of time. the order applies under paragraph (a) of this section must, if he desires a hear- § 1313.53 Waiver of modification of rules. ing, file a written request for a hearing pursuant to §§ 1313.51–1313.57. The Administrator or the presiding officer (with respect to matters pend- § 1313.42 Prohibition of shipments ing before him) may modify or waive from certain foreign sources. any rule in this part by notice in ad- (a) If the Administrator determines vance of the hearing, if he determines that a foreign manufacturer or dis- that no party in the hearing will be un- tributor of ephedrine, pseudoephedrine, duly prejudiced and the ends of justice or phenylpropanolamine has refused to will thereby be served. Such notice of cooperate with a request by the Admin- modification or waiver shall be made a istrator for information known to the part of the record of the hearing.

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§ 1313.54 Request for hearing. order is based. The Administrator shall serve one copy of his order upon each (a) Any person entitled to a hearing party in the hearing. pursuant to § 1313.52 and desiring a hearing shall, within 30 days after receipt of the notice to suspend the ship- PART 1314—RETAIL SALE OF ment, file with the Administrator a SCHEDULED LISTED CHEMICAL written request for a hearing in the PRODUCTS form prescribed in § 1316.47 of this chapter. Subpart A—General (b) If any person entitled to a hearing or to participate in a hearing pursuant Sec. 1314.01 Scope. to § 1313.41 fails to file a request for a 1314.02 Applicability. hearing or a notice of appearance, or if 1314.03 Definitions. he so files and fails to appear at the 1314.05 Requirements regarding packaging hearing, he shall be deemed to have of nonliquid forms. waived his opportunity for the hearing 1314.10 Effect on state laws. or to participate in the hearing, unless 1314.15 Loss reporting. he shows good cause for such failure. (c) If all persons entitled to a hearing Subpart B—Sales by Regulated Sellers or to participate in a hearing waive or 1314.20 Restrictions on sales quantity. are deemed to waive their opportunity 1314.25 Requirements for retail trans- for the hearing or to participate in the actions. hearing, the Administrator may cancel 1314.30 Recordkeeping for retail trans- the hearing, if scheduled, and issue his actions. final order pursuant to § 1313.57. 1314.35 Training of sales personnel. 1314.40 Self-certification. § 1313.55 Burden of proof. 1314.42 Self-certification fee; time and method of fee payment. At any hearing regarding the suspen- 1314.45 Privacy protections. sion of shipments, the Agency shall 1314.50 Employment measures. have the burden of proving that the requirements of this part for such sus- Subpart C—Mail-Order Sales pension are satisfied. 1314.100 Sales limits for mail-order sales. § 1313.56 Time and place of hearing. 1314.105 Verification of identity for mail- order sales. (a) If any regulated person requests a 1314.110 Reports for mail-order sales. hearing on the suspension of ship- 1314.115 Distributions not subject to report- ments, a hearing will be scheduled no ing requirements. later than 45 days after the request is made, unless the regulated person re- Subpart D—Order To Show Cause quests an extension to this date. 1314.150 Order to show cause. (b) The hearing will commence at the 1314.155 Suspension pending final order. place and time designated in the notice given pursuant to paragraph (a) of this AUTHORITY: 21 U.S.C. 802, 830, 842, 871(b), 875, 877, 886a. section but thereafter it may be moved to a different place and may be contin- SOURCE: 71 FR 56024, Sept. 26, 2006, unless ued from day to day or recessed to a otherwise noted. later day without notice other than announcement thereof by the presiding Subpart A—General officer at the hearing. § 1314.01 Scope. § 1313.57 Final order. This part specifies the requirements As soon as practicable after the pre- for retail sales of scheduled listed siding officer has certified the record chemical products to individuals for to the Administrator, the Adminis- personal use. trator shall issue his order regarding the suspension of shipment. The order § 1314.02 Applicability. shall include the findings of fact and (a) This part applies to the following conclusions of law upon which the regulated persons who sell scheduled

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listed chemical products for personal the report is located, any unusual or use: excessive loss or disappearance of a (1) Regulated sellers of scheduled scheduled listed chemical product listed chemical products sold at retail under the control of the regulated per- for personal use through face-to-face son. The regulated person responsible sales at stores or mobile retail vendors. for reporting a loss in-transit is the (2) Regulated persons who engage in supplier. a transaction with a non-regulated per- (b) Each report submitted under son and who ship the products to the paragraph (a) of this section must, non-regulated person by the U.S. Post- whenever possible, be made orally to al Service or by private or common the DEA Divisional Office for the area carriers. in which the regulated person making (b) The requirements in subpart A the report is located at the earliest apply to all regulated persons subject practicable opportunity after the regu- to this part. The requirements in sub- lated person becomes aware of the cir- part B apply to regulated sellers as de- cumstances involved. fined in § 1300.02 of this chapter. The re- (c) Written reports of losses must be quirements in subpart C apply to regu- filed within 15 days after the regulated lated persons who ship the products to person becomes aware of the cir- the customer by the U.S. Postal Serv- cumstances of the event. ice or by private or common carriers. (d) A report submitted under this section must include a description of the § 1314.03 Definitions. circumstances of the loss (in-transit, As used in this part, the term ‘‘mail- theft from premises, etc.). order sale’’ means a retail sale of (e) A suggested format for the report scheduled listed chemical products for is provided below: personal use where a regulated person uses or attempts to use the U.S. Postal Regulated Person Service or any private or commercial Registration number (if applicable) llll carrier to deliver the product to the Name llllllllllllllllllll customer. Mail-order sale includes pur- Business address llllllllllllll chase orders submitted by phone, mail, City lllllllllllllllllllll State llllllllllllllllllll fax, Internet, or any method other Zip lllllllllllllllllllll than face-to-face transaction. Business phone lllllllllllllll Date of loss lllllllllllllllll § 1314.05 Requirements regarding Type of loss lllllllllllllllll packaging of nonliquid forms. Description of circumstances llllllll A regulated seller or mail order distributor may not sell a scheduled listed Subpart B—Sales by Regulated chemical product in nonliquid form (in- Sellers cluding gel caps) unless the product is packaged either in blister packs, with § 1314.20 Restrictions on sales quan- each blister containing no more than tity. two dosage units or, if blister packs are (a) Without regard to the number of technically infeasible, in unit dose transactions, a regulated seller (includ- packets or pouches. ing a mobile retail vendor) may not in a single calendar day sell any pur- § 1314.10 Effect on State laws. chaser more than 3.6 grams of ephed- Nothing in this part preempts State rine base, 3.6 grams of pseudoephedrine law on the same subject matter unless base, or 3.6 grams of phenylpropanola- there is a positive conflict between this mine base in scheduled listed chemical part and a State law so that the two products. cannot consistently stand together. (b) A mobile retail vendor may not in any 30-day period sell an individual § 1314.15 Loss reporting. purchaser more than 7.5 grams of (a) Each regulated person must re- ephedrine base, 7.5 grams of port to the Special Agent in Charge of pseudoephedrine base, or 7.5 grams of the DEA Divisional Office for the area phenylpropanolamine base in scheduled in which the regulated person making listed chemical products.

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§ 1314.25 Requirements for retail electronic signature system to capture transactions. the signature and may have the com- (a) Each regulated seller must ensure puter automatically enter the date and that sales of a scheduled listed chem- time of the sale. The regulated seller ical product at retail are made in ac- may ask the purchaser for their name cordance with this section and § 1314.20. and address and enter information if it (b) The regulated seller must place is not feasible for the purchaser to the product so that customers do not enter the information electronically. have direct access to the product be- (d) The regulated seller must deter- fore the sale is made (in this paragraph mine that the name entered in the log- referred to as ‘‘behind-the-counter’’ book corresponds to the name provided placement). For purposes of this para- on identification presented and that graph, a behind-the-counter placement the date and time entered are correct. of a product includes circumstances in (e) The regulated seller must enter in which the product is stored in a locked the logbook the name of the product cabinet that is located in an area of the and the quantity sold. Examples of facility where customers do have direct methods of recording the quantity sold access. Mobile retail vendors must include the weight of the product per place the product in a locked cabinet. package and number of packages of (c) The regulated seller must deliver each chemical, the cumulative weight the product directly into the custody of the product for each chemical, or of the purchaser. quantity of product by Universal Prod- uct Code. These examples do not ex- § 1314.30 Recordkeeping for retail clude other methods of displaying the transactions. quantity sold. For electronic records, (a)(1) Except for purchase by an indi- the regulated seller may use a point-of- vidual of a single sales package con- sale and bar code reader. Such elec- taining not more than 60 milligrams of tronic records must be provided pursuant to paragraph (i) of this section in a pseudoephedrine, the regulated seller human readable form such that the re- must maintain, in accordance with cri- quirements of paragraph (a)(1) of this teria issued by the Administrator, a section are satisfied. written or electronic list of each sched- (f) The regulated seller must include uled listed chemical product sale that in the logbook or display by the log- identifies the products by name, the book, the following notice: quantity sold, the names and addresses of the purchasers, and the dates and WARNING: Section 1001 of Title 18, United times of the sales (referred to as the States Code, states that whoever, with re- ‘‘logbook’’). The logbook may be main- spect to the logbook, knowingly and will- tained on paper or in electronic form. fully falsifies, conceals, or covers up by any trick, scheme, or device a material fact, or (2) Effective November 27, 2006, if a makes any materially false, fictitious, or logbook is maintained on paper, it fraudulent statement or representation, or must be created and maintained in a makes or uses any false writing or document bound record book. knowing the same to contain any materially (b) The regulated seller must not sell false, fictitious, or fraudulent statement or a scheduled listed chemical product at entry, shall be fined not more than $250,000 if retail unless the purchaser does the fol- an individual or $500,000 if an organization, lowing: imprisoned not more than five years, or (1) Presents an identification card both. that provides a photograph and is (g) The regulated seller must main- issued by a State or the Federal Gov- tain each entry in the logbook for not ernment, or a document that, with re- fewer than 2 years after the date on spect to identification, is considered which the entry is made. acceptable for purposes of 8 CFR (h) A record under this section must 274a.2(b)(1)(v)(A) and 274a.2(b)(1)(v)(B). be kept at the regulated seller’s place (2) Signs the logbook and enters in of business where the transaction oc- the logbook his or her name, address, curred, except that records may be and the date and time of the sale. kept at a single, central location of the (c) For records created electroni- regulated seller if the regulated seller cally, the regulated seller may use an has notified the Administration of the

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intention to do so. Written notification (b) When a regulated seller files the must be submitted by registered or cer- initial self-certification, the Adminis- tified mail, return receipt requested, to tration will assign the regulated seller the Special Agent in Charge of the to one of twelve groups. The expiration DEA Divisional Office for the area in date of the self-certification for all reg- which the records are required to be ulated sellers in any group will be the kept. last day of the month designated for (i) The records required to be kept that group. In assigning a regulated under this section must be readily re- seller to a group, the Administration trievable and available for inspection may select a group with an expiration and copying by authorized employees date that is not less than 12 months or of the Administration under the provi- more than 23 months from the date of sions of 21 U.S.C. 880. the self-certification. After the initial (j) A record developed and main- certification period, the regulated sell- tained to comply with a State law may er must update the self-certifications be used to meet the requirements of annually. this section if the record includes the (c) The regulated seller must provide a separate certification for each place information specified in this section. of business at which the regulated sell- § 1314.35 Training of sales personnel. er sells scheduled listed chemical products at retail. Each regulated seller must ensure that its sales of a scheduled listed § 1314.42 Self-certification fee; time chemical product at retail are made in and method of fee payment. accordance with the following: (a) A regulated seller must pay a fee (a) In the case of individuals who are for each self-certification. For each ini- responsible for delivering the products tial application to self-certify, and for into the custody of purchasers or who the renewal of each existing self-cer- deal directly with purchasers by ob- tification, a regulated seller shall pay taining payments for the products, the a fee of $21. regulated seller has submitted to the (b) The fee for self-certification shall Administration a self-certification be waived for any person holding a cur- that all such individuals have, in ac- rent, DEA registration in good stand- cordance with criteria issued by the ing as a pharmacy to dispense con- Administration, undergone training trolled substances. provided by the regulated seller to en- (c) A regulated seller shall pay the sure that the individuals understand fee at the time of self-certification. the requirements that apply under this (d) Payment shall be made by credit part. card. (b) The regulated seller maintains a (e) The self-certification fee is not re- copy of each self-certification and all fundable. records demonstrating that individuals [73 FR 79323, Dec. 29, 2008] referred to in paragraph (a) of this section have undergone the training. § 1314.45 Privacy protections. To protect the privacy of individuals § 1314.40 Self-certification. who purchase scheduled listed chem- (a) A regulated seller must submit to ical products, the disclosure of infor- the Administration the self-certifi- mation in logbooks under § 1314.15 is re- cation referred to in § 1314.35(a) in order stricted as follows: to sell any scheduled listed chemical (a) The information shall be disclosed product. The certification is not effec- as appropriate to the Administration tive for purposes of this section unless, and to State and local law enforcement in addition to provisions regarding the agencies. training of individuals referred to in (b) The information in the logbooks § 1314.35(a), the certification includes a shall not be accessed, used, or shared statement that the regulated seller un- for any purpose other than to ensure derstands each of the requirements compliance with this title or to facili- that apply under this part and agrees tate a product recall to protect public to comply with the requirements. health and safety.

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(c) A regulated seller who in good provides a photograph and is issued by faith releases information in a logbook a State or the Federal Government, or to Federal, State, or local law enforce- a document that, with respect to iden- ment authorities is immune from civil tification, is considered acceptable for liability for the release unless the re- purposes of 8 CFR 274a.2(b)(1)(v)(A) and lease constitutes gross negligence or 274a.2(b)(1)(v)(B). Prior to shipping the intentional, wanton, or willful mis- product, the regulated person must de- conduct. termine that the name and address on the identification correspond to the § 1314.50 Employment measures. name and address provided by the pur- A regulated seller may take reason- chaser as part of the sales transaction. able measures to guard against em- If the regulated person cannot verify ploying individuals who may present a the identities of both the purchaser risk with respect to the theft and di- and the recipient, the person may not version of scheduled listed chemical ship the scheduled listed chemical products, which may include, notwith- product. standing State law, asking applicants (b) If the product is being shipped to for employment whether they have a third party, the regulated person been convicted of any crime involving must comply with the requirements of or related to such products or con- paragraph (a) to verify that both the trolled substances. purchaser and the person to whom the product is being shipped live at the ad- Subpart C—Mail-Order Sales dresses provided. If the regulated person cannot verify the identities of both § 1314.100 Sales limits for mail-order the purchaser and the recipient, the sales. person may not ship the scheduled list- (a) Each regulated person who makes ed chemical product. a sale at retail of a scheduled listed chemical product and is required under § 1314.110 Reports for mail-order sales. § 1310.03(c) of this chapter to submit a report of the sales transaction to the (a) Each regulated person required to Administration may not in a single report under § 1310.03(c) of this chapter calendar day sell to any purchaser must either: more than 3.6 grams of ephedrine base, (1) Submit a written report, con- 3.6 grams of pseudoephedrine base, or taining the information set forth in 3.6 grams of phenylpropanolamine base paragraph (b) of this section, on or be- in scheduled listed chemical products. fore the 15th day of each month fol- (b) Each regulated person who makes lowing the month in which the dis- a sale at retail of a scheduled listed tributions took place. The report must chemical product and is required under be submitted under company letter- § 1310.03(c) of this chapter to submit a head, signed by the person authorized report of the sales transaction to the to sign on behalf of the regulated sell- Administration may not in any 30-day er, to the Import/Export Unit, Drug En- period sell to an individual purchaser forcement Administration (see the more than 7.5 grams of ephedrine base, Table of DEA Mailing Addresses in 7.5 grams of pseudoephedrine base, or § 1321.01 of this chapter for the current 7.5 grams of phenylpropanolamine base mailing address); or in scheduled listed chemical products. (2) Upon request to and approval by the Administration, submit the report § 1314.105 Verification of identity for in electronic form, either via computer mail-order sales. disk or direct electronic data trans- (a) Each regulated person who makes mission, in such form as the Adminis- a sale at retail of a scheduled listed tration shall direct. Requests to sub- chemical product and is required under mit reports in electronic form should § 1310.03(c) of this chapter to submit a be submitted to the Import/Export report of the sales transaction to the Unit, Drug Enforcement Administra- Administration must, prior to shipping tion. See the Table of DEA Mailing Ad- the product, receive from the purchaser dresses in § 1321.01 of this chapter for a copy of an identification card that the current mailing address.

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(b) Each monthly report must pro- (b) The Administrator may revoke vide the following information for each any or all of the exemptions listed in distribution: paragraph (a) of this section for an in- (1) Supplier name and registration dividual regulated person if the Admin- number; istrator finds that drug products dis- (2) Purchaser’s name and address; tributed by the regulated person are (3) Name/address shipped to (if dif- being used in violation of the regula- ferent from purchaser’s name/address); tions in this chapter or the Controlled (4) Method used to verify the identity Substances Act. of the purchaser and, where applicable, person to whom product is shipped; (5) Name of the chemical contained Subpart D—Order to Show Cause in the scheduled listed chemical product and total quantity shipped (e.g. § 1314.150 Order To show cause. pseudoephedrine, 3 grams); (a) If, upon information gathered by (6) Date of shipment; the Administration regarding any reg- (7) Product name; ulated seller or a distributor required (8) Dosage form (e.g., tablet, liquid); to submit reports under § 1310.03(c) of (9) Dosage strength (e.g., 30mg, 60mg, this chapter, the Administrator deter- per dose etc.); mines that a regulated seller or dis- (10) Number of dosage units (e.g., 100 tributor required to submit reports doses per package); under § 1310.03(c) of this chapter has (11) Package type (blister pack, etc.); sold a scheduled listed chemical prod- (12) Number of packages; (13) Lot number. uct in violation of Section 402 of the Act (21 U.S.C. 842(a)(12) or (13)), the Ad- [71 FR 56024, Sept. 26, 2006, as amemded at 75 ministrator will serve upon the regu- FR 10684, Mar. 9, 2010] lated seller or distributor an order to § 1314.115 Distributions not subject to show cause why the regulated seller or reporting requirements. distributor should not be prohibited (a) The following distributions to from selling scheduled listed chemical nonregulated persons are not subject to products. the reporting requirements in § 1314.110: (b) The order to show cause shall call (1) Distributions of sample packages upon the regulated seller or distributor when those packages contain not more to appear before the Administrator at a than two solid dosage units or the time and place stated in the order, equivalent of two dosage units in liquid which shall not be less than 30 days form, not to exceed 10 milliliters of liq- after the date of receipt of the order. uid per package, and not more than one The order to show cause shall also con- package is distributed to an individual tain a statement of the legal basis for or residential address in any 30-day pe- such hearing and for the prohibition riod. and a summary of the matters of fact (2) Distributions by retail distribu- and law asserted. tors that may not include face-to-face (c) Upon receipt of an order to show transactions to the extent that such cause, the regulated seller or dis- distributions are consistent with the tributor must, if he desires a hearing, activities authorized for a retail dis- file a request for a hearing as specified tributor as specified in § 1300.02(b)(29) of in subpart D of part 1316 of this chap- this chapter, except that this para- ter. If a hearing is requested, the Ad- graph (a)(2) does not apply to sales of ministrator shall hold a hearing at the scheduled listed chemical products at retail. time and place stated in the order, as (3) Distributions to a resident of a provided in part 1316 of this chapter. long term care facility or distributions (d) When authorized by the Adminis- to a long term care facility for dis- trator, any agent of the Administra- pensing to or for use by a resident of tion may serve the order to show that facility. cause. (4) Distributions in accordance with a valid prescription.

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§ 1314.155 Suspension pending final PART 1315—IMPORTATION AND order. PRODUCTION QUOTAS FOR (a) The Administrator may suspend EPHEDRINE, PSEUDOEPHEDRINE, the right to sell scheduled listed chem- AND PHENYLPROPANOLAMINE ical products simultaneously with, or at any time subsequent to, the service Subpart A—General Information upon the seller or distributor required Sec. to file reports under § 1310.03(c) of this 1315.01 Scope. chapter of an order to show cause why 1315.02 Definitions. the regulated seller or distributor 1315.03 Personal use exemption. should not be prohibited from selling 1315.05 Applicability. scheduled listed chemical products, in Subpart B—Assessment of Annual Needs any case where he finds that there is an imminent danger to the public 1315.11 Assessment of annual needs. health or safety. If the Administrator 1315.13 Adjustments of assessment of annual so suspends, he shall serve with the needs. order to show cause under § 1314.150 an Subpart C—Individual Manufacturing order of immediate suspension that Quotas shall contain a statement of his findings regarding the danger to public 1315.21 Individual manufacturing quotas. health or safety. 1315.22 Procedure for applying for individual manufacturing quotas. (b) Upon service of the order of im- 1315.23 Procedure for fixing individual man- mediate suspension, the regulated sell- ufacturing quotas. er or distributor shall, as instructed by 1315.24 Inventory allowance. the Administrator: 1315.25 Increase in individual manufac- (1) Deliver to the nearest office of the turing quotas. 1315.26 Reduction in individual manufac- Administration or to authorized agents turing quotas. of the Administration all of the sched- 1315.27 Abandonment of quota. uled listed chemical products in his or her possession; or Subpart D—Procurement and Import (2) Place all of the scheduled listed Quotas chemical products under seal as de- 1315.30 Procurement and import quotas. scribed in Section 304 of the Act (21 1315.32 Obtaining a procurement quota. U.S.C. 824(f)). 1315.33 Power of attorney. (c) Any suspension shall continue in 1315.34 Obtaining an import quota. effect until the conclusion of all pro- 1315.36 Amending an import quota. ceedings upon the prohibition, includ- Subpart E—Hearings ing any judicial review, unless sooner withdrawn by the Administrator or dis- 1315.50 Hearings generally. solved by a court of competent juris- 1315.52 Purpose of hearing. 1315.54 Waiver or modification of rules. diction. Any regulated seller or dis- 1315.56 Request for hearing or appearance; tributor whose right to sell scheduled waiver. listed chemical products is suspended 1315.58 Burden of proof. under this section may request a hear- 1315.60 Time and place of hearing. ing on the suspension at a time earlier 1315.62 Final order. than specified in the order to show SOURCE: 72 FR 37448, July 10, 2007, unless cause under § 1314.150, which request otherwise noted. shall be granted by the Administrator, AUTHORITY: 21 U.S.C. 802, 821, 826, 871(b), who shall fix a date for such hearing as 952. early as reasonably possible. Subpart A—General Information § 1315.01 Scope. This part specifies procedures governing the establishment of an assessment of annual needs, procurement and

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manufacturing quotas pursuant to sec- phenylpropanolamine base in scheduled tion 306 of the Act (21 U.S.C. 826), and listed chemical products. import quotas pursuant to section 1002 of the Act (21 U.S.C. 952) for ephedrine, § 1315.05 Applicability. pseudoephedrine, and phenylpropanola- This part applies to all of the fol- mine. lowing: (a) Persons registered to manufac- § 1315.02 Definitions. ture (including repackaging or re- (a) Except as specified in paragraphs labeling) or to import ephedrine, (b) and (c) of this section, any term pseudoephedrine, or phenylpropanola- contained in this part shall have the mine as bulk chemicals. definition set forth in section 102 of the (b) Persons registered to manufac- Act (21 U.S.C. 802) or part 1300 of this ture (including repackaging or re- chapter. labeling) or to import prescription and (b) The term net disposal means, for a over-the-counter drug products con- stated period, the sum of paragraphs taining ephedrine, pseudoephedrine, or (b)(1) through (b)(3) of this section phenylpropanolamine that may be law- minus the sum of paragraphs (b)(4) and fully marketed and distributed in the (b)(5) of this section: United States under the Federal Food, (1) The quantity of ephedrine, Drug, and Cosmetic Act. pseudoephedrine, or phenylpropanolamine distributed by the registrant to another person. Subpart B—Assessment of Annual (2) The quantity of that chemical Needs used by the registrant in the produc- § 1315.11 Assessment of annual needs. tion of (or converted by the registrant into) another chemical or product. (a) The Administrator shall deter- (3) The quantity of that chemical mine the total quantity of ephedrine, otherwise disposed of by the registrant. pseudoephedrine, and phenylpropanola- (4) The quantity of that chemical re- mine, including drug products con- turned to the registrant by any pur- taining ephedrine, pseudoephedrine, chaser. and phenylpropanolamine, necessary to (5) The quantity of that chemical dis- be manufactured and imported during tributed by the registrant to a reg- the following calendar year to provide istered manufacturer of that chemical for the estimated medical, scientific, for purposes other than use in the pro- research, and industrial needs of the duction of, or conversion into, another United States, for lawful export re- chemical or in the manufacture of dos- quirements, and for the establishment age forms of that chemical. and maintenance of reserve stocks. (c) Ephedrine, pseudoephedrine, and (b) In making his determinations, the phenylpropanolamine include their Administrator shall consider the fol- salts, optical isomers, and salts of opti- lowing factors: cal isomers. (1) Total net disposal of the chemical by all manufacturers and importers § 1315.03 Personal use exemption. during the current and 2 preceding A person need not register as an im- years; porter, file an import declaration, and (2) Trends in the national rate of net obtain an import quota if both of the disposal of each chemical; following conditions are met: (3) Total actual (or estimated) inven- (a) The person purchases scheduled tories of the chemical and of all sub- listed chemical products at retail and stances manufactured from the chem- imports them for personal use, by ical, and trends in inventory accumula- means of shipping through any private tion; or commercial carrier or the Postal (4) Projected demand for each chem- Service. ical as indicated by procurement and (b) In any 30-day period, the person import quotas requested pursuant to imports no more than 7.5 grams of § 1315.32; and ephedrine base, 7.5 grams of (5) Other factors affecting medical, pseudoephedrine base, and 7.5 grams of scientific, research, and industrial

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needs in the United States, lawful ex- § 1315.13 Adjustments of the assess- port requirements, and the establishment of annual needs. ment and maintenance of reserve (a) The Administrator may at any stocks, as the Administrator finds rel- time increase or reduce the assessment evant, including changes in the cur- of annual needs for ephedrine, rently accepted medical use in treat- pseudoephedrine, or phenylpropanola- ment with the chemicals or the sub- mine that has been previously fixed stances which are manufactured from pursuant to § 1315.11. them, the economic and physical availability of raw materials for use in man- (b) In determining to adjust the as- ufacturing and for inventory purposes, sessment of annual needs, the Adminis- yield and stability problems, potential trator shall consider the following fac- disruptions to production (including tors: possible labor strikes), and recent un- (1) Changes in the demand for that foreseen emergencies such as floods chemical, changes in the national rate and fires. of net disposal of the chemical, and (c) The Administrator shall, on or be- changes in the rate of net disposal of fore May 1 of each year, publish in the the chemical by registrants holding in- FEDERAL REGISTER, general notice of dividual manufacturing or import an assessment of annual needs for quotas for that chemical; ephedrine, pseudoephedrine, and phen- (2) Whether any increased demand for ylpropanolamine determined by him that chemical, the national and/or under this section. A notice of the pub- changes in individual rates of net dis- lication shall be mailed simultaneously posal of that chemical are temporary, to each person registered to manufac- short term, or long term; ture or import the chemical. (3) Whether any increased demand for (d) The Administrator shall permit that chemical can be met through ex- any interested person to file written isting inventories, increased individual comments on or objections to the pro- manufacturing quotas, or increased imposed assessment of annual needs and portation, without increasing the as- shall designate in the notice the time sessment of annual needs, taking into during which the filings may be made. account production delays and the (e) The Administrator may, but is probability that other individual man- not required to, hold a public hearing ufacturing quotas may be suspended on one or more issues raised by the pursuant to § 1315.24(b); comments and objections filed with (4) Whether any decreased demand him. In the event the Administrator for that chemical will result in exces- decides to hold such a hearing, he shall sive inventory accumulation by all per- publish a notice of the hearing in the sons registered to handle that chemical FEDERAL REGISTER. The notice shall (including manufacturers, distributors, summarize the issues to be heard and importers, and exporters), notwith- set the time for the hearing, which standing the possibility that individual shall not be less than 30 days after the manufacturing quotas may be sus- date of publication of the notice. pended pursuant to § 1315.24(b) or aban- (f) After consideration of any com- doned pursuant to § 1315.27; ments or objections, or after a hearing (5) Other factors affecting medical, if one is ordered by the Administrator, scientific, research, industrial, and im- the Administrator shall issue and pub- portation needs in the United States, lish in the FEDERAL REGISTER the final lawful export requirements, and re- order determining the assessment of serve stocks, as the Administrator annual needs for the chemicals. The finds relevant, including changes in the order shall include the findings of fact currently accepted medical use in and conclusions of law upon which the treatment with the chemical or the order is based. The order shall specify substances that are manufactured from the date on which it shall take effect. it, the economic and physical avail- A notice of the publication shall be ability of raw materials for use in man- mailed simultaneously to each person ufacturing and for inventory purposes, registered as a manufacturer or im- yield and stability problems, potential porter of the chemical. disruptions to production (including

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possible labor strikes), and recent un- manufacturing quota an individual foreseen emergencies such as floods manufacturing quota authorizing that and fires. person to manufacture during the next (c) In the event that the Adminis- calendar year a quantity of that chem- trator determines to increase or reduce ical. Any manufacturing quota fixed the assessment of annual needs for a and issued by the Administrator is sub- chemical, the Administrator shall pub- ject to his authority to reduce or limit lish in the FEDERAL REGISTER general it at a later date pursuant to § 1315.26 notice of an adjustment in the assess- and to his authority to revoke or sus- ment of annual needs for that chemical pend it at any time pursuant to as determined under this section. A no- §§ 1301.36, 1309.43, 1309.44, or 1309.45 of tice of the publication shall be mailed this chapter. simultaneously to each person registered as a manufacturer or importer § 1315.22 Procedure for applying for of the chemical. individual manufacturing quotas. (d) The Administrator shall permit Any person who is registered to man- any interested person to file written ufacture ephedrine, pseudoephedrine, comments on or objections to the pro- or phenylpropanolamine and who de- posal and shall designate in the notice sires to manufacture a quantity of the the time during which such filings may chemical must apply on DEA Form 189 be made. for a manufacturing quota for the (e) The Administrator may, but is quantity of the chemical. Copies of not required to, hold a public hearing DEA Form 189 may be obtained from on one or more issues raised by the the Office of Diversion Control Web comments and objections filed with site, and must be filed (on or before him. In the event the Administrator April 1 of the year preceding the cal- decides to hold such a hearing, he shall endar year for which the manufac- publish a notice of the hearing in the turing quota is being applied) with the FEDERAL REGISTER. The notice shall Drug & Chemical Evaluation Section, summarize the issues to be heard and Drug Enforcement Administration. See set the time for the hearing, which the Table of DEA Mailing Addresses in shall not be less than 10 days after the § 1321.01 of this chapter for the current date of publication of the notice. mailing address. A separate application (f) After consideration of any com- must be made for each chemical de- ments or objections, or after a hearing sired to be manufactured. The appli- if one is ordered by the Administrator, cant must state the following: the Administrator shall issue and pub- (a) The name and DEA Chemical lish in the FEDERAL REGISTER the final Code Number, as set forth in part 1310 order determining the assessment of of this chapter, of the chemical. annual needs for the chemical. The (b) For the chemical in each of the order shall include the findings of fact current and preceding 2 calendar years, and conclusions of law upon which the (1) The authorized individual manu- order is based. The order shall specify facturing quota, if any; the date on which it shall take effect. (2) The actual or estimated quantity A notice of the publication shall be manufactured; mailed simultaneously to each person (3) The actual or estimated net dis- registered as a manufacturer or im- posal; porter of the chemical. (4) The actual or estimated inventory allowance pursuant to § 1315.24; and Subpart C—Individual (5) The actual or estimated inventory Manufacturing Quotas as of December 31. (c) For the chemical in the next cal- § 1315.21 Individual manufacturing endar year, quotas. (1) The desired individual manufac- The Administrator shall, on or before turing quota; and July 1 of each year, fix for and issue to (2) Any additional factors that the each person registered to manufacture applicant finds relevant to the fixing of in bulk ephedrine, pseudoephedrine, or the individual manufacturing quota, phenylpropanolamine who applies for a including any of the following:

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(i) The trend of (and recent changes next calendar year, as determined by in) the applicant’s and the national the Administrator, adjusted— rates of net disposal. (1) By the amount necessary to pro- (ii) The applicant’s production cycle vide the applicant his estimated inven- and current inventory position. tory allowance for the next calendar (iii) The economic and physical avail- year, pursuant to § 1315.24; and ability of raw materials for use in man- (2) By any other factors which the ufacturing and for inventory purposes. Administrator deems relevant to the (iv) Yield and stability problems. fixing of the individual manufacturing (v) Potential disruptions to produc- quota of the applicant, including any of tion (including possible labor strikes). the following: (vi) Recent unforeseen emergencies (i) The trend of (and recent changes such as floods and fires. in) the national rate of net disposal. [72 FR 37448, July 10, 2007, as amended at 73 (ii) The applicant’s production cycle FR 73555, Dec. 3, 2008; 75 FR 10684, Mar. 9, and current inventory position. 2010] (iii) The economic and physical availability of raw materials for use in man- § 1315.23 Procedure for fixing indi- ufacturing and for inventory purposes. vidual manufacturing quotas. (iv) Yield and stability problems. (a) In fixing individual manufac- (v) Potential disruptions to produc- turing quotas for ephedrine, tion (including possible labor strikes). pseudoephedrine, and phenylpropanola- (vi) Recent unforeseen emergencies mine, the Administrator shall allocate such as floods and fires. to each applicant who is currently (c) On or before March 1 of each year manufacturing the chemical a quota the Administrator shall adjust the in- equal to 100 percent of the estimated dividual manufacturing quota allo- net disposal of that applicant for the cated for that year to each applicant in next calendar year, adjusted— paragraph (a) of this section by the (1) By the amount necessary to in- amount necessary to increase or reduce crease or reduce the estimated inven- the actual inventory of the applicant tory of the applicant on December 31 of to December 31 of the preceding year to the current year to his estimated in- his estimated inventory allowance for ventory allowance for the next cal- the current calendar year, pursuant to endar year, pursuant to § 1315.24, and § 1315.24. (2) By any other factors which the Administrator deems relevant to the § 1315.24 Inventory allowance. fixing of the individual manufacturing (a) For the purpose of determining quota of the applicant, including: individual manufacturing quotas pur- (i) The trend of (and recent changes suant to § 1315.23, each registered man- in) the applicant’s and the national ufacturer shall be allowed as a part of rates of net disposal, the quota an amount sufficient to (ii) The applicant’s production cycle maintain an inventory equal to either and current inventory position, of the following: (iii) The economic and physical avail- (1) For current manufacturers, 50 per- ability of raw materials for use in man- cent of his average estimated net dis- ufacturing and for inventory purposes, posal for the current calendar year and (iv) Yield and stability problems, the last preceding calendar year; or (v) Potential disruptions to produc- (2) For new manufacturers, 50 percent tion (including possible labor strikes), of his reasonably estimated net dis- and posal for the next calendar year as de- (vi) Recent unforeseen emergencies termined by the Administrator. such as floods and fires. (b) During each calendar year each (b) In fixing individual manufac- registered manufacturer shall be al- turing quotas for a chemical, the Ad- lowed to maintain an inventory of a ministrator shall allocate to each ap- chemical not exceeding 65 percent of plicant who is not currently manufac- his estimated net disposal of that turing the chemical a quota equal to chemical for that year, as determined 100 percent of the reasonably estimated at the time his quota for that year was net disposal of that applicant for the determined. At any time the inventory

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of a chemical held by a manufacturer equitable distribution of such excess exceeds 65 percent of his estimated net among other registrants. disposal, his quota for that chemical is automatically suspended and shall re- § 1315.26 Reduction in individual man- main suspended until his inventory is ufacturing quotas. less than 60 percent of his estimated The Administrator may at any time net disposal. The Administrator may, reduce an individual manufacturing upon application and for good cause quota for a chemical that he has pre- shown, permit a manufacturer whose viously fixed to prevent the aggregate quota is, or is likely to be, suspended of the individual manufacturing quotas under this paragraph to continue man- and import quotas outstanding or to be ufacturing and to accumulate an inven- granted from exceeding the assessment tory in excess of 65 percent of his esti- of annual needs that has been estab- mated net disposal, upon such condi- lished for that chemical pursuant to tions and within such limitations as § 1315.11, as adjusted pursuant to the Administrator may find necessary § 1315.13. If a quota assigned to a new or desirable. manufacturer pursuant to § 1315.23(b), (c) If, during a calendar year, a reg- or if a quota assigned to any manufac- istrant has manufactured the entire turer is increased pursuant to quantity of a chemical allocated to § 1315.24(c), or if an import quota issued him under an individual manufacturing to an importer pursuant to § 1315.34, quota, and his inventory of that chem- causes the total quantity of a chemical ical is less than 40 percent of his esti- to be manufactured and imported dur- mated net disposal of that chemical for ing the year to exceed the assessment that year, the Administrator may, of annual needs that has been estab- upon application pursuant to § 1315.25, lished for that chemical pursuant to increase the quota of such registrant § 1315.11, as adjusted pursuant to sufficiently to allow restoration of the § 1315.13, the Administrator may pro- inventory to 50 percent of the esti- portionately reduce the individual mated net disposal for that year. manufacturing quotas and import § 1315.25 Increase in individual manu- quotas of all other registrants to keep facturing quotas. the assessment of annual needs within the limits originally established, or, al- (a) Any registrant who holds an indi- ternatively, the Administrator may re- vidual manufacturing quota for a duce the individual manufacturing chemical may file with the Adminis- quota of any registrant whose quota is trator an application on DEA Form 189 suspended pursuant to § 1315.24(b) or for an increase in the registrant’s quota to meet the registrant’s esti- §§ 1301.36, 1309.43, 1309.44, or 1309.45 of mated net disposal, inventory, and this chapter or is abandoned pursuant other requirements during the remain- to § 1315.27. der of that calendar year. § 1315.27 Abandonment of quota. (b) The Administrator, in passing upon a registrant’s application for an Any manufacturer assigned an indi- increase in the individual manufac- vidual manufacturing quota for a turing quota, shall take into consider- chemical pursuant to § 1315.23 may at ation any occurrences since the filing any time abandon his right to manu- of the registrant’s initial quota appli- facture all or any part of the quota by cation that may require an increased filing with the Drug & Chemical Eval- manufacturing rate by the registrant uation Section a written notice of the during the balance of the calendar abandonment, stating the name and year. In passing upon the application DEA Chemical Code Number, as set the Administrator may also take into forth in part 1310 of this chapter, of the consideration the amount, if any, by chemical and the amount which he has which his determination of the total chosen not to manufacture. The Ad- quantity for the chemical to be manu- ministrator may, in his discretion, al- factured under § 1315.11 exceeds the ag- locate the amount among the other gregate of all the individual manufac- manufacturers in proportion to their turing quotas for the chemical, and the respective quotas.

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Subpart D—Procurement and ing the current and preceding 2 cal- Import Quotas endar years. (c) If the purpose is to manufacture § 1315.30 Procurement and import the chemical into dosage form, the ap- quotas. plicant must state the official name, (a) To determine the estimated needs common or usual name, chemical for, and to insure an adequate and un- name, or brand name of that form. If interrupted supply of, ephedrine, the dosage form produced is a con- pseudoephedrine, and phenylpropanola- trolled substance listed in any sched- mine the Administrator shall issue pro- ule, the applicant must also state the curement and import quotas. schedule number and National Drug Code Number, of the substance. (b) A procurement quota authorizes a (d) If the purpose is to manufacture registered manufacturer to procure and another chemical, the applicant must use quantities of each chemical for the state the official name, common or following purposes: usual name, chemical name, or brand (1) Manufacturing the bulk chemical name of the substance and the DEA into dosage forms. Chemical Code Number, as set forth in (2) Manufacturing the bulk chemical part 1310 of this chapter. into other substances. (e) DEA Form 250 must be filed on or (3) Repackaging or relabeling the before April 1 of the year preceding the chemical or dosage forms. calendar year for which the procure- (c) An import quota authorizes a reg- ment quota is being applied. Copies of istered importer to import quantities DEA Form 250 may be obtained from of the chemical for the following pur- the Office of Diversion Control Web poses: site, and must be filed with the Drug & (1) Distribution of the chemical to a Chemical Evaluation Section, Drug En- registered manufacturer that has a forcement Administration. See the procurement quota for the chemical. Table of DEA Mailing Addresses in (2) Other distribution of the chemical § 1321.01 of this chapter for the current consistent with the legitimate medical mailing address. and scientific needs of the United (f) The Administrator shall, on or be- States. fore July 1 of the year preceding the calendar year during which the quota § 1315.32 Obtaining a procurement shall be effective, issue to each quali- quota. fied applicant a procurement quota au- (a) Any person who is registered to thorizing him to procure and use: manufacture ephedrine, (1) All quantities of the chemical pseudoephedrine, or phenylpropanola- necessary to manufacture products mine, or whose requirement of reg- that the applicant is authorized to istration is waived pursuant to § 1309.24 manufacture pursuant to § 1315.23; and of this chapter, and who desires to use (2) Such other quantities of the during the next calendar year any chemical as the applicant has applied ephedrine, pseudoephedrine, or phenyl- to procure and use and are consistent propanolamine for purposes of manu- with his past use, his estimated needs, facturing (including repackaging or re- and the total quantity of the chemical labeling), must apply on DEA Form 250 that will be produced. for a procurement quota for the chem- (g) Any person to whom a procure- ical. A separate application must be ment quota has been issued may at any made for each chemical desired to be time request an adjustment in the procured or used. quota by applying to the Adminis- (b) The applicant must state sepa- trator with a statement showing the rately all of the following: need for the adjustment. The applica- (1) Each purpose for which the chem- tion must be filed with the Drug & ical is desired. Chemical Evaluation Section, Drug En- (2) The quantity desired for each pur- forcement Administration. See the pose during the next calendar year. Table of DEA Mailing Addresses in (3) The quantities used and estimated § 1321.01 of this chapter for the current to be used, if any, for that purpose dur- mailing address. The Administrator

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shall increase or decrease the procure- which the certification applies does not ment quota of the person if and to the exceed the unused and available pro- extent that he finds, after considering curement quota of the chemical, issued the factors enumerated in paragraph (f) to the person giving the order, for the of this section and any occurrences current calendar year. since the issuance of the procurement (7) The signature of the individual quota, that the need justifies an ad- authorized to sign a certification as justment. provided in paragraph (h) of this sec- (h) Any person to whom a procure- tion. ment quota has been issued, author- [72 FR 37448, July 10, 2007, as amended at 73 izing that person to procure and use a FR 73555, Dec. 3, 2008; 75 FR 10684, Mar. 9, quantity of ephedrine, 2010] pseudoephedrine, or phenylpropanolamine during the current calendar year, § 1315.33 Power of attorney. must, at or before the time of placing (a) A registrant may authorize one or an order with another manufacturer or more individuals, whether or not lo- importer requiring the distribution of a cated at his registered location, to sign quantity of the chemical, certify in certifications required under § 1315.32(h) writing to the other registrant that the on the registrant’s behalf by executing quantity of ephedrine, a power of attorney for each such indi- pseudoephedrine, or phenylpropanola- vidual. The registrant shall retain the mine ordered does not exceed the per- power of attorney in the files, with cer- son’s unused and available procure- tifications required by § 1315.32(h), for ment quota of the chemical for the cur- the same period as any certification rent calendar year. The written certifi- bearing the signature of the attorney. cation must be executed by a person The power of attorney must be avail- authorized to sign the registration ap- able for inspection together with other plication pursuant to § 1301.13 or certification records. § 1309.32(g) of this chapter or by a per- (b) A registrant may revoke any son granted power of attorney under power of attorney at any time by exe- § 1315.33 to sign the certifications. A cuting a notice of revocation. copy of such certification must be re- (c) The power of attorney and notice tained by the person procuring the of revocation must be similar to the quantity of ephedrine, following format: pseudoephedrine, or phenylpropanola- Power of Attorney for certifications mine for two years from the date of the of quota for procurement of ephedrine, certification. Registrants must not fill pseudoephedrine, and phenylpropanola- an order from persons required to apply mine for a procurement quota under para- llllll (Name of registrant) graph (b) of this section unless the llllll (Address of registrant) order is accompanied by a certification llllll (DEA registration number) as required under this section. I, llllll (name of person granting (i) The certification required by para- power), the undersigned, who am authorized graph (h) of this section must contain to sign the current application for registra- all of the following: tion of the above-named registrant under the Controlled Substances Act or Controlled (1) The date of the certification. Substances Import and Export Act, have (2) The name and address of the reg- made, constituted, and appointed, and by istrant to whom the certification is di- these presents, do make, constitute, and ap- rected. point llllll (name of attorney-in-fact), (3) A reference to the purchase order my true and lawful attorney for me in my number to which the certification ap- name, place, and stead, to sign certifications plies. of quota for procurement of ephedrine, (4) The name of the person giving the pseudoephedrine, and phenylpropanolamine in accordance with Part 1315 of Title 21 of order to which the certification ap- the Code of Federal Regulations. I hereby plies. ratify and confirm all that said attorney (5) The name of the chemical to must lawfully do or cause to be done by vir- which the certification applies. tue hereof. (6) A statement that the quantity llllllllllllllllllllllll (expressed in grams) of the chemical to (Signature of person granting power)

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I, llllll (name of attorney-in-fact), (1) The applicant’s name and DEA hereby affirm that I am the person named registration number. herein as attorney-in-fact and that the sig- (2) The name and address of a contact nature affixed hereto is my signature. person and contact information (tele- (Signature of attorney-in-fact) phone number, fax number, e-mail ad- Witnesses: dress). 1. llllll (3) Name of the chemical and DEA 2. llllll Chemical Code number. Signed and dated on the ll day of l, (4) Type of product (bulk or finished (year), at llllll. dosage forms). Notice of Revocation (5) For finished dosage forms, the official name, common or usual name, The foregoing power of attorney is hereby revoked by the undersigned, who is author- chemical name, or brand name, NDC ized to sign the current application for reg- number, and the authority to market istration of the above-named registrant the drug product under the Federal under the Controlled Substances Act or the Food, Drug and Cosmetic Act of each Controlled Substances Import and Export form to be imported. Act. Written notice of this revocation has (6) The amount requested expressed been given to the attorney-in-fact in terms of base. llllll this same day. llllllllllllllllllllllll (7) For the current and preceding two calendar years, expressed in terms of (Signature of person revoking power) base: Witnesses: (i) Distribution/Sales—name, address, 1. llllll and registration number (if applicable) 2. llllll of each customer and the amount sold. Signed and dated on the ll day of l, (year), at llllll. (ii) Inventory as of December 31 (each form—bulk, in-process, finished dosage (d) A power of attorney must be exe- form). cuted by the person who signed the (iii) Acquisition—imports. most recent application for DEA reg- (c) For each form of the chemical istration or reregistration; the person (bulk or dosage unit), the applicant to whom the power of attorney is being must state the quantity desired for im- granted; and two witnesses. port during the next calendar year. (e) A power of attorney must be re- (d) DEA Form 488 must be filed on or voked by the person who signed the before April 1 of the year preceding the most recent application for DEA reg- calendar year for which the import istration or reregistration, and two quota is being applied. Copies of DEA witnesses. Form 488 may be obtained from the Of- [73 FR 73555, Dec. 3, 2008] fice of Diversion Control Web site, and must be filed with the Drug & Chem- § 1315.34 Obtaining an import quota. ical Evaluation Section. See the Table (a) Any person who is registered to of DEA Mailing Addresses in § 1321.01 of import ephedrine, pseudoephedrine, or this chapter for the current mailing ad- phenylpropanolamine, or whose re- dress. quirement of registration is waived (e) The Administrator may at his dis- pursuant to § 1309.24(c) of this chapter, cretion request additional information and who desires to import during the from an applicant. next calendar year any ephedrine, (f) On or before July 1 of the year pseudoephedrine, or phenylpropanola- preceding the calendar year during mine or drug products containing these which the quota shall be effective, the chemicals, must apply on DEA Form Administrator shall issue to each 488 for an import quota for the chem- qualified applicant an import quota au- ical. A separate application must be thorizing him to import: made for each chemical desired to be (1) All quantities of the chemical imported. necessary to manufacture products (b) The applicant must provide the that registered manufacturers are au- following information in the applica- thorized to manufacture pursuant to tion: § 1315.23; and

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(2) Such other quantities of the Subpart E—Hearings chemical that the applicant has applied to import and that are consistent § 1315.50 Hearings generally. with his past imports, the estimated The procedures for the hearing re- medical, scientific, and industrial lated to assessment of annual needs or needs of the United States, the estab- to the issuance, adjustment, suspen- lishment and maintenance of reserve sion, or denial of a manufacturing, pro- stocks, and the total quantity of the curement, or import quota are gov- chemical that will be produced. erned generally by the adjudication [72 FR 37448, July 10, 2007, as amended at 75 procedures set forth in the Administra- FR 10684, Mar. 9, 2010] tive Procedure Act (5 U.S.C. 551–559) and specifically by section 1002 of the § 1315.36 Amending an import quota. Act (21 U.S.C. 952), by §§ 1315.52 through (a) An import quota authorizes the 1315.62 of this part, and by the proce- registered importer to import up to the dures for administrative hearings set quantity of ephedrine, under the Act set forth in §§ 1316.41 pseudoephedrine, or phenylpropanola- through 1316.67 of this chapter. mine and distribute the chemical or drug products on the DEA Form 488. An § 1315.52 Purpose of hearing. importer must apply to change the (a) The Administrator may, in his quantity to be imported. sole discretion, hold a hearing for the (b) Any person to whom an import purpose of receiving factual evidence quota has been issued may at any time regarding any one or more issues (to be request an increase in the quota quan- specified by him) involved in the deter- tity by applying to the Administrator mination or adjustment of any assess- with a statement showing the need for ment of national needs. the adjustment. The application must (b) If requested by a person applying be filed with the Drug & Chemical for or holding a procurement, import, Evaluation Section, Drug Enforcement or individual manufacturing quota, the Administration. See the Table of DEA Administrator shall hold a hearing for Mailing Addresses in § 1321.01 of this the purpose of receiving factual evi- chapter for the current mailing ad- dence regarding the issues involved in dress. The Administrator may increase the issuance, adjustment, suspension, the import quota of the person if and or denial of the quota to the person, to the extent that he determines that but the Administrator need not hold a the approval is necessary to provide for hearing on suspension of a quota under medical, scientific, or other legitimate § 1301.36 or § 1309.43 of this chapter sepa- purposes regarding the chemical. The rate from a hearing on the suspension Administrator shall specify a period of of registration under that section. time for which the approval is in effect (c) Extensive argument should not be or shall provide that the approval is in offered into evidence, but rather pre- effect until the Administrator notifies sented in opening or closing state- the applicant in writing that the ap- ments of counsel or in memoranda or proval is terminated. proposed findings of fact and conclu- (c) With respect to the application sions of law. under paragraph (b) of this section, the Administrator shall approve or deny § 1315.54 Waiver or modification of the application within 60 days of re- rules. ceiving the application. If the Adminis- The Administrator or the presiding trator does not approve or deny the ap- officer (with respect to matters pend- plication within 60 days of receiving it, ing before him) may modify or waive the application is deemed to be ap- any rule in this part by notice in ad- proved and the approval remains in ef- vance of the hearing, if he determines fect until the Administrator notifies that no party in the hearing will be un- the applicant in writing that the ap- duly prejudiced and the ends of justice proval is terminated. will thereby be served. Such notice of [72 FR 37448, July 10, 2007, as amended at 75 modification or waiver shall be made a FR 10685, Mar. 9, 2010] part of the record of the hearing.

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§ 1315.56 Request for hearing or ap- he shall be deemed to have waived his pearance; waiver. opportunity for the hearing unless he (a) Any applicant or registrant enti- shows good cause for such failure. tled to a hearing under § 1315.52 and (f) If all persons entitled to a hearing who desires a hearing on the issuance, or to participate in a hearing waive or adjustment, suspension or denial of a are deemed to waive their opportunity procurement, import, or individual for the hearing or to participate in the manufacturing quota must, within 30 hearing, the Administrator may cancel days after the date of receipt of the the hearing, if scheduled, and issue his issuance, adjustment, suspension or de- final order under § 1315.62 without a nial of the application, file with the hearing. Administrator a written request for a hearing in the form prescribed in § 1315.58 Burden of proof. § 1316.47 of this chapter. (a) At any hearing regarding the de- (b) Any interested person who desires termination or adjustment of an as- a hearing on the determination of an sessment of annual needs each inter- assessment of annual needs must, within the time prescribed in § 1315.11(c), ested person participating in the hear- file with the Administrator a written ing shall have the burden of proving request for a hearing in the form pre- any propositions of fact or law asserted scribed in § 1316.47 of this chapter, in- by him in the hearing. cluding in the request a statement of (b) At any hearing regarding the the grounds for the hearing. issuance, adjustment, suspension, or (c) Any interested person who desires denial of a procurement, import, or in- to participate in a hearing on the de- dividual manufacturing quota, the Ad- termination or adjustment of an as- ministration shall have the burden of sessment of annual needs, which hear- proving that the requirements of this ing is ordered by the Administrator part for such issuance, adjustment, under § 1315.11(c) or § 1315.13(c), may do suspension, or denial are satisfied. so by filing with the Administrator, within 30 days of the date of publica- § 1315.60 Time and place of hearing. tion of notice of the hearing in the (a) If any applicant or registrant re- FEDERAL REGISTER, a written notice of quests a hearing on the issuance, ad- his intention to participate in the justment, suspension, or denial of his hearing in the form prescribed in procurement, import, or individual § 1316.48 of this chapter. manufacturing quota under § 1315.54, (d) Any person entitled to a hearing the Administrator shall hold a hearing. under § 1315.52 or entitled to participate (b) Notice of the hearing shall be in a hearing under paragraph (c) of this given to the applicant or registrant of section may, within the period per- the time and place at least 30 days mitted for filing a request for a hearing prior to the hearing, unless the appli- or notice of appearance, file with the cant or registrant waives such notice Administrator a waiver of an opportunity for a hearing, together with a and requests the hearing be held at an written statement regarding his posi- earlier time, in which case the Admin- tion on the matters of fact and law in- istrator shall fix a date for such hear- volved in such hearing. The statement, ing as early as reasonably possible. if admissible, shall be made a part of (c) The hearing shall commence at the record and shall be considered in the place and time designated in the light of the lack of opportunity for notice given under paragraph (b) of this cross-examination in determining the section or in the notice of hearing pub- weight to be attached to matters of lished in the FEDERAL REGISTER pursu- fact asserted. ant to § 1315.11(c) or § 1315.13(c), but (e) If any person entitled to a hearing thereafter it may be moved to a dif- under § 1315.52 or entitled to participate ferent place and may be continued in a hearing under paragraph (c) of this from day to day or recessed to a later section fails to file a request for a hear- day without notice other than an- ing or notice of appearance or if he so nouncement by the presiding officer at files and fails to appear at the hearing, the hearing.

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§ 1315.62 Final order. 1316.42 Definitions. 1316.43 Information; special instructions. As soon as practicable after the pre- 1316.44 Waiver or modification of rules. siding officer has certified the record 1316.45 Filings; address; hours. to the Administrator, the Adminis- 1316.46 Inspection of record. trator shall issue his order on the de- 1316.47 Request for hearing. termination or adjustment of the as- 1316.48 Notice of appearance. sessment of annual needs or on the 1316.49 Waiver of hearing. issuance, adjustment, suspension, or 1316.50 Appearance; representation; author- denial of the procurement, import, or ization. individual manufacturing quota, as the 1316.51 Conduct of hearing and parties; ex case may be. The order shall include parte communications. 1316.52 Presiding officer. the findings of fact and conclusions of 1316.53 Time and place of hearing. law upon which the order is based. The 1316.54 Prehearing conference. order shall specify the date on which it 1316.55 Prehearing ruling. shall take effect. The Administrator 1316.56 Burden of proof. shall serve one copy of his order upon 1316.57 Submission of documentary evidence each party in the hearing. and affidavits and identification of witnesses subsequent to prehearing conference. PART 1316—ADMINISTRATIVE 1316.58 Summary of testimony; affidavits. FUNCTIONS, PRACTICES, AND 1316.59 Submission and receipt of evidence. PROCEDURES 1316.60 Objections; offer of proof. 1316.61 Exceptions to rulings. Subpart A—Administrative Inspections 1316.62 Appeal from ruling of presiding officer. Sec. 1316.63 Official transcript; index; correc- 1316.01 Scope of subpart A. tions. 1316.02 Definitions. 1316.64 Proposed findings of fact and conclu- 1316.03 Authority to make inspections. sions of law. 1316.04 Exclusion from inspection. 1316.65 Report and record. 1316.05 Entry. 1316.66 Exceptions. 1316.06 Notice of inspection. 1316.07 Requirement for administrative in- 1316.67 Final order. spection warrant; exceptions. 1316.68 Copies of petitions for judicial re- 1316.08 Consent to inspection. view. 1316.09 Application for administrative inspection warrant. Subpart E—Seizure, Forfeiture, and 1316.10 Administrative probable cause. Disposition of Property 1316.11 Execution of warrants. 1316.12 Refusal to allow inspection with an 1316.71 Definitions. administrative warrant. 1316.72 Officers who will make seizures. 1316.13 Frequency of administrative inspec- 1316.73 Custody and other duties. tions. 1316.74 Appraisement. 1316.75 Advertisement. Subpart B—Protection of Researchers and 1316.76 Requirements as to claim and bond. Research Subjects 1316.77 Administrative forfeiture. 1316.78 Judicial forfeiture. 1316.21 Definitions. 1316.79 Petitions for remission or mitiga- 1316.22 Exemption. tion of forfeiture. 1316.23 Confidentiality of identity of re- 1316.80 Time for filing petitions. search subjects. 1316.81 Handling of petitions. 1316.24 Exemption from prosecution for researchers. Subpart F—Expedited Forfeiture Subpart C—Enforcement Proceedings Proceedings for Certain Property 1316.90 Purpose and scope. 1316.31 Authority for enforcement proceeding. 1316.91 Definitions. 1316.32 Notice of proceeding; time and place. 1316.92 Petition for expedited release in an 1316.33 Conduct of proceeding. administrative forfeiture action. 1316.34 Records of proceeding. 1316.93 Ruling on petition for expedited release in an administrative forfeiture ac- Subpart D—Administrative Hearings tion. 1316.94 Posting of substitute res in an ad- 1316.41 Scope of subpart D. ministrative forfeiture action.

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1316.95 Petition for expedited release of a (d) The term Administrator means the conveyance in a judicial forfeiture ac- Administrator of the Administration. tion. The Administrator has been delegated 1316.96 Ruling on a petition for expedited release of a conveyance in a judicial for- authority under the Act by the Attor- feiture action. ney General (28 CFR 0.100). 1316.97 Initiating judicial forfeiture pro- (e) The term inspector means an offi- ceeding against a conveyance within 60 cer or employee of the Administration days of the filing of a claim and cost authorized by the Administrator to bond. 1316.98 Substitute res bond in a judicial for- make inspections under the Act. feiture action against a conveyance. (f) The term register and registration 1316.99 Notice provisions. refer to registration required and per- SOURCE: 36 FR 7820, Apr. 24, 1971, unless mitted by sections 303 and 1008 of the otherwise noted. Redesignated at 38 FR 26609, Act (21 U.S.C. 823 and 958). Sept. 24, 1973. (g) Any term not defined in this part shall have the definition set forth in Subpart A—Administrative section 102 of the Act (21 U.S.C. 802) or Inspections part 1300 of this chapter. [36 FR 7820, Apr. 24, 1971. Redesignated at 38 AUTHORITY: 21 U.S.C. 822(f), 830(a), 871(b), FR 26609, Sept. 24, 1973, as amended at 60 FR 880, 958(f), 965. 32465, June 22, 1995; 60 FR 36334, July 14, 1995; 62 FR 13969, Mar. 24, 1997] § 1316.01 Scope of subpart A. Procedures regarding administrative § 1316.03 Authority to make inspec- inspections and warrants pursuant to tions. sections 302(f), 510, 1008(d), and 1015 of In carrying out his functions under the Act (21 U.S.C. 822(f), 880, 958(d), and the Act, the Administrator, through 965) are governed generally by those his inspectors, is authorized in accord- sections and specifically by the sec- ance with sections 510 and 1015 of the tions of this subpart. Act (21 U.S.C. 880 and 965) to enter con- § 1316.02 Definitions. trolled premises and conduct adminis- As used in this subpart, the following trative inspections thereof, for the pur- terms shall have the meanings speci- pose of: fied: (a) Inspecting, copying, and verifying (a) The term Act means the Con- the correctness of records, reports, or trolled Substances Act (84 Stat. 1242; 21 other documents required to be kept or U.S.C. 801) and/or the Controlled Sub- made under the Act and regulations stances Import and Export Act (84 promulgated under the Act, including, Stat. 1285; 21 U.S.C. 951). but not limited to, inventory and other (b) The term Administration means records required to be kept pursuant to the Drug Enforcement Administration. part 1304 of this chapter, order form (c) The term controlled premises records required to be kept pursuant to means— part 1305 of this chapter, prescription (1) Places where original or other and distribution records required to be records or documents required under kept pursuant to part 1306 of this chap- the Act are kept or required to be kept, ter, records of listed chemicals, and tableting machines, and encapsulating (2) Places, including factories, ware- machines required to be kept pursuant houses, or other establishments and to part 1310 of this chapter, import/ex- conveyances, where persons registered port records of listed chemicals re- under the Act or exempted from registration under the Act, or regulated quired to be kept pursuant to part 1313 persons may lawfully hold, manufac- of this chapter, shipping records identi- ture, or distribute, dispense, admin- fying the name of each carrier used and ister, or otherwise dispose of controlled the date and quantity of each ship- substances or listed chemicals or where ment, and storage records identifying records relating to those activities are the name of each warehouse used and maintained. the date and quantity of each storage.

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(b) Inspecting within reasonable lim- thority under § 1316.06 of this chapter, its and to a reasonable manner all per- and (c) receiving informed consent tinent equipment, finished and unfin- under § 1316.08 or through the use of ad- ished controlled substances, listed ministrative warrant issued under chemicals, and other substances or ma- §§ 1316.09–1316.13, shall have the right to terials, containers, and labeling found enter such premises and conduct in- at the controlled premises relating to spections at reasonable times and in a this Act; reasonable manner. (c) Making a physical inventory of all controlled substances and listed [36 FR 7820, Apr. 24, 1971, as amended at 36 chemicals on-hand at the premises; FR 13387, July 21, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973; 62 FR 13970, Mar. 24, 1997] (d) Collecting samples of controlled substances or listed chemicals (in the § 1316.06 Notice of inspection. event any samples are collected during an inspection, the inspector shall issue The notice of inspection (DEA (or a receipt for such samples on DEA DNB) Form 82) shall contain: Form 84 to the owner, operator, or (a) The name and title of the owner, agent in charge of the premises); operator, or agent in charge of the con- (e) Checking of records and informa- trolled premises; tion on distribution of controlled sub- (b) The controlled premises name; stances or listed chemicals by the reg- (c) The address of the controlled istrant or regulated person (i.e., has premises to be inspected; the distribution of controlled sub- (d) The date and time of the inspec- stances or listed chemicals increased tion; markedly within the past year, and if (e) A statement that a notice of in- so why); spection is given pursuant to section (f) Except as provided in § 1316.04, all 510 of the Act (21 U.S.C. 880); other things therein (including records, (f) A reproduction of the pertinent files, papers, processes, controls and fa- parts of section 510 of the Act; and cilities) appropriate for verification of (g) The signature of the inspector. the records, reports, documents referred to above or otherwise bearing on § 1316.07 Requirement for administra- the provisions of the Act and the regu- tive inspection warrant; exceptions. lations thereunder. In all cases where an inspection is [36 FR 7820, Apr. 24, 1971. Redesignated at 38 contemplated, an administrative in- FR 26609, Sept. 24, 1973, and amended at 51 spection warrant is required pursuant FR 5319, Feb. 13, 1986; 55 FR 50827, Dec. 11, 1990; 60 FR 32465, June 22, 1995] to section 510 of the Act (21 U.S.C. 880), except that such warrant shall not be § 1316.04 Exclusion from inspection. required for establishments applying (a) Unless the owner, operator or for initial registration under the Act, agent in charge of the controlled prem- for the inspection of books and records ises so consents in writing, no inspec- pursuant to an administrative sub- tion authorized by these regulations poena issued in accordance with sec- shall extend to: tion 506 of the Act (21 U.S.C. 876) nor (1) Financial data: for entries in administrative inspec- (2) Sales data other than shipping tions (including seizures of property): data; or (a) With the consent of the owner, op- (3) Pricing data. erator, or agent in charge of the con- (b) [Reserved] trolled premises as set forth in § 1316.08; (b) In situations presenting imminent § 1316.05 Entry. danger to health or safety; An inspection shall be carried out by (c) In situations involving inspection an inspector. Any such inspector, upon of conveyances where there is reason- (a) stating his purpose and (b) pre- able cause to obtain a warrant; senting to the owner, operator or agent (d) In any other exceptional or emer- in charge of the premises to be in- gency circumstance or time or oppor- spected (1) appropriate credentials, and tunity to apply for a warrant is lack- (2) written notice of his inspection au- ing; or

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(e) In any other situations where a (2) A statement of statutory author- warrant is not constitutionally re- ity for the administrative inspection quired. warrant, and that the fact that the particular inspection in question is de- § 1316.08 Consent to inspection. signed to insure compliance with the (a) An administrative inspection war- Act and the regulations promulgated rant shall not be required if informed thereunder; consent is obtained from the owner, op- (3) A statement relating to the na- erator, or agent in charge of the con- ture and extent of the administrative trolled premises to be inspected. inspection, including, where necessary, (b) Wherever possible, informed con- a request to seize specified items and/or sent shall consist of a written state- to collect samples of finished or unfin- ment signed by the owner, operator, or ished controlled substances or listed agent in charge of the premises to be chemicals; inspected and witnessed by two per- (4) A statement that the establish- sons. The written consent shall contain ment either: the following information: (i) Has not been previously inspected, (1) That he (the owner, operator, or or agent in charge of the premises) has (ii) Was last inspected on a particular been informed of his constitutional date. right not to have an administrative in- (b) The application shall be sub- spection made without an administra- mitted under oath to an appropriate tive inspection warrant; judge or magistrate. (2) That he has right to refuse to con- [36 FR 7820, Apr. 24, 1971, as amended at 36 sent to such an inspection; FR 13387, July 21, 1971. Redesignated at 38 FR (3) That anything of an incriminating 26609, Sept. 24, 1973; 60 FR 32466, June 22, 1995] nature which may be found may be seized and used against him in a crimi- § 1316.10 Administrative probable nal prosecution; cause. (4) That he has been presented with a If the judge or magistrate is satisfied notice of inspection as set forth in that ‘‘administrative probable cause,’’ § 1316.06; as defined in section 510(d)(1) of the Act (5) That the consent is given by him (21 U.S.C. 880(d)(1)) exists, he shall is voluntary and without threats of any issue an administrative warrant. Ad- kind; and ministrative probable cause shall not (6) That he may withdraw his consent mean criminal probable cause as de- at any time during the course of in- fined by Federal statute or case law. spection. (c) The written consent shall be pro- § 1316.11 Execution of warrants. duced in duplicate and be distributed An administrative inspection war- as follows: rant shall be executed and returned as (1) The original will be retained by required by, and any inventory or sei- the inspector; and zure made shall comply with the re- (2) The duplicate will be given to the quirements of, section 510(d)(3) of the person inspected. Act (21 U.S.C. 880(d)(3)). The inspection [36 FR 7820, Apr. 24, 1971, as amended at 37 shall begin as soon as is practicable FR 15924, Aug. 8, 1972. Redesignated at 38 FR after the issuance of the administra- 26609, Sept. 24, 1973] tive inspection warrant and shall be completed with reasonable promptness. § 1316.09 Application for administra- The inspection shall be conducted dur- tive inspection warrant. ing regular business hours and shall be (a) An administrative inspection war- completed in a reasonable manner. rant application shall be submitted to any judge of the United States or of a § 1316.12 Refusal to allow inspection State court of record, or any United with an administrative warrant. States magistrate and shall contain If a registrant or any person subject the following information: to the Act refuses to permit execution (1) The name and address of the con- of an administrative warrant or im- trolled premises to be inspected; pedes the inspector in the execution of

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that warrant, he shall be advised that tion who, in the course of their official such refusal or action constitutes a duties, gain knowledge of information violation of section 402(a)(6) of the Act which is confidential under such sec- (21 U.S.C. 842(a)(6)). If he persists and tion. the circumstances warrant, he shall be [54 FR 31670, Aug. 1, 1989] arrested and the inspection shall commence or continue. § 1316.22 Exemption. [36 FR 7820, Apr. 24, 1971. Redesignated at 38 (a) Any person who is aggrieved by a FR 26609, Sept. 24, 1973, as amended at 62 FR disclosure of information in violation 13970, Mar. 24, 1997] of subsection (c)(1) of Section 310 of the § 1316.13 Frequency of administrative Controlled Substances Act (21 U.S.C. inspections. 830) may bring a civil action against the violator for appropriate relief. Except where circumstances other- (b) Notwithstanding the provision of wise dictate, it is the intent of the Ad- paragraph (a), a civil action may not be ministration to inspect all manufactur- brought under such paragraph against ers of controlled substances listed in investigative or law enforcement per- Schedules I and II and distributors of controlled substances listed in Sched- sonnel of the Drug Enforcement Ad- ule I once each year. Distributors of ministration. controlled substances listed in Sched- [54 FR 31670, Aug. 1, 1989] ules II through V and manufacturers of controlled substances listed in Sched- § 1316.23 Confidentiality of identity of ules III through V shall be inspected as research subjects. circumstances may require, based in (a) Any person conducting a bona fide part on the registrant’s history of com- research project directly related to the pliance with the requirements of this enforcement of the laws under the ju- chapter and maintenance of effective risdiction of the Attorney General con- controls and procedures to guard cerning drugs or other substances against the diversion of controlled sub- which are or may be subject to control stances. under the Controlled Substances Act [62 FR 13969, Mar. 24, 1997] (84 Stat. 1242; 21 U.S.C. 801) who intends to maintain the confidentiality of the identity of those persons who are the Subpart B—Protection of Re- subjects of such research may petition searchers and Research Sub- the Administrator of the Drug Enforce- jects ment Administration for a grant of confidentiality: Providing, That: AUTHORITY: 21 U.S.C. 830, 871(b). (1) The Attorney General is authorized to carry out such research under § 1316.21 Definitions. the provisions of Section 502(a) (2–6) of As used in this part, the following the Controlled Substances Act of 1970 terms shall have the meanings speci- (21 U.S.C. 872(a) (2–6)); and the research fied: is being conducted with funds provided (a) The term investigative personnel in whole or part by the Department of includes managers, Diversion Inves- Justice; or tigators, attorneys, analysts and sup- (2) The research is of a nature that port personnel employed by the Drug the Attorney General would be author- Enforcement Administration who are ized to carry out under the provisions involved in the processing, reviewing of Section 502(a) (2–6) of the Controlled and analyzing of declarations and other Substances Act (21 U.S.C. 872(a) (2–6), relevant documents or data relative to and is being conducted with funds pro- regulated transactions or are involved vided from sources outside the Depart- in conducting investigations initiated ment of Justice. pursuant to the receipt of such declara- (b) All petitions for Grants of Con- tions, documents or data. fidentiality shall be addressed to the (b) The term law enforcement per- Administrator, Drug Enforcement Ad- sonnel means Special Agents employed ministration (see the Table of DEA by the Drug Enforcement Administra- Mailing Addresses in § 1321.01 of this

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chapter for the current mailing ad- tify the subjects of such research for dress): which this authorization was obtained. (1) A statement as to whether the re- (6) The limits of this authorization, if search protocol requires the manufac- any. ture, production, import, export, dis- (7) A statement to the effect that the tribution, dispensing, administration, grant of confidentiality of identity of or possession of controlled substances, research subjects shall be perpetual but and if so the researcher’s registration shall pertain only to the subjects of the number or a statement that an applica- research described in the research pro- tion for such registration has been sub- tocol, the description of the research mitted to DEA; submitted to DEA, or as otherwise es- (2) The location of the research tablished by DEA. project; (d) Within 30 days of the date of com- (3) The qualifications of the principal pletion of the research project, the re- investigator; searcher shall so notify the Adminis- (4) A general description of the re- trator. The Administrator shall issue search or a copy of the research pro- another letter including the informa- tocol; tion required in paragraph (c) of this (5) The source of funding for the re- section and stating the starting and search project; finishing dates of the research for (6) A statement as to the risks posed which the confidentiality of identity of to the research subjects by the re- research subjects was granted; upon research procedures and what protection ceipt of this letter, the research shall will be afforded to the research sub- return the original letter of exemption. jects; (7) A statement as to the risks posed [42 FR 54946, Oct. 12, 1977. Redesignated at 54 to society in general by the research FR 31670, Aug. 1, 1989, as amended at 62 FR procedures and what measures will be 13970, Mar. 24, 1997; 75 FR 10685, Mar. 9, 2010] taken to protect the interests of society; § 1316.24 Exemption from prosecution for researchers. (8) A specific request to withhold the names and/or any other identifying (a) Upon registration of an individual characteristics of the research sub- to engage in research in controlled subjects; and stances under the Controlled Sub- (9) Statements establishing that a stances Act (84 Stat. 1242; 21 U.S.C. grant of confidentiality is necessary to 801), the Administrator of the Drug En- the successful completion of the re- forcement Administration, on his own search project. motion or upon request in writing from (c) The grant of confidentiality of the Secretary or from the researcher or identity of research subjects shall con- researching practitioner, may exempt sist of a letter issued by the Adminis- the registrant when acting within the trator, which shall include: scope of his registration, from prosecu- (1) The researcher’s name and ad- tion under Federal, State, or local laws dress. for offenses relating to possession, dis- (2) The researcher’s registration tribution or dispensing of those con- number, if applicable. trolled substances within the scope of (3) The title and purpose of the re- his exemption. However, this exemp- search. tion does not diminish any require- (4) The location of the research ment of compliance with the Federal project. Food, Drug and Cosmetic Act (21 U.S.C. (5) An authorization for all persons 301). engaged in the research to withhold (b) All petitions for Grants of Exemp- the names and identifying characteris- tion from Prosecution for the Re- tics of persons who are the subjects of searcher shall be addressed to the Ad- such research, stating that persons who ministrator, Drug Enforcement Admin- obtain this authorization may not be istration, (see the Table of DEA Mail- compelled in any Federal, State, or ing Addresses in § 1321.01 of this chapter local civil, criminal, administrative, for the current mailing address) and legislative, or other proceeding to iden- shall contain the following:

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(1) The researcher’s registration tion is denied. However, the protection number if any, for the project; afforded by the grant of exemption (2) The location of the research from prosecution during the research project; period shall be perpetual. (3) The qualifications of the principal (e) Within 30 days of the date of com- investigator; pletion of the research project, the re- (4) A general description of the researcher shall so notify the Adminis- search or a copy of the research pro- trator. The Administrator shall issue tocol; another letter including the informa- (5) The source of funding for the re- tion required in paragraph (d) of this search project; section and stating the date of which (6) A statement as to the risks posed the period of exemption concluded; to the research subjects by the re- upon receipt of this letter the research procedures and what protection searcher shall return the original let- will be afforded to the research sub- ter of exemption. jects; [42 FR 54946, Oct. 12, 1977. Redesignated at 54 (7) A statement as to the risks posed FR 31670, Aug. 1, 1989, as amended at 62 FR to society in general by the research 13970, Mar. 24, 1997; 75 FR 10685, Mar. 9, 2010] procedures and what measures will be taken to protect the interests of soci- Subpart C—Enforcement ety; (8) A specific request for exemption Proceedings from prosecution by Federal, State, or local authorities for offenses related to AUTHORITY: 21 U.S.C. 871(b), 883. the possession, distribution, and dispensing of controlled substances in ac- § 1316.31 Authority for enforcement proceeding. cord with the procedures described in the research protocol; A hearing may be ordered or granted (9) A statement establishing that a by any Special Agent in Charge of the grant of exemption from prosecution is Drug Enforcement Administration, at necessary to the successful completion his discretion, to permit any person of the research project. against whom criminal and/or civil ac- (c) Any researcher or practitioner tion is contemplated under the Con- proposing to engage in research re- trolled Substances Act (84 Stat. 1242; 21 questing both exemption from prosecu- U.S.C. 801) or the Controlled Sub- tion and confidentiality of identity of stances Import and Export Act (84 research subjects may submit a single Stat. 1285; 21 U.S.C. 951) an opportunity petition incorporating the information to present his views and his proposals required in §§ 1316.23(b) and 1316.24(b). for bringing his alleged violations into (d) The exemption shall consist of a compliance with the law. Such hearing letter issued by the Administrator, will also permit him to show cause why which shall include: prosecution should not be instituted, (1) The researcher’s name and ad- or to present his views on the con- dress; templated proceeding. (2) The researcher’s registration [36 FR 7820, Apr. 24, 1971. Redesignated at 38 number for the research project; FR 26609, Sept. 24, 1973, and amended at 47 (3) The location of the research FR 41735, Sept. 22, 1982] project; (4) A concise statement of the scope § 1316.32 Notice of proceeding; time of the researcher’s registration; and place. (5) Any limits of the exemption; and Appropriate notice designating the (6) A statement that the exemption time and place for the hearing shall be shall apply to all acts done in the scope given to the person. Upon request, of the exemption while the exemption timely and properly made, by the per- is in effect. The exemption shall re- son to whom notice has been given, the main in effect until completion of the time or place of the hearing, or both, research project or until the registra- may be changed if the request states tion of the researcher is either revoked reasonable grounds for such change. or suspended or his renewal of registra- Such request shall be addressed to the

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Special Agent in Charge who issued the (a) The term Act means the Con- notice. trolled Substances Act (84 Stat. 1242; 21 U.S.C. 801) and/or the Controlled Sub- [36 FR 7820, Apr. 24, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973, and amended at 47 stances Import and Export Act (84 FR 41735, Sept. 22, 1982] Stat. 1285; 21 U.S.C. 951). (b) The term Administrator means the § 1316.33 Conduct of proceeding. Administrator of the Administration. Presentation of views at a hearing The Administrator has been delegated under this subpart shall be private and authority under the Act by the Attor- informal. The views presented shall be ney General (28 CFR 0.100). confined to matters relevant to bring- (c) The term hearing means any hearing violations into compliance with the ing held pursuant to the Act. Act or to other contemplated pro- (d) The term Hearing Clerk means the ceedings under the Act. These views hearing clerk of the Administration. may be presented orally or in writing (e) The term person includes an indi- by the person to whom the notice was vidual, corporation, government or given, or by his authorized representa- governmental subdivision or agency, tive. business trust, partnership, association or other legal entity. § 1316.34 Records of proceeding. (f) The term presiding officer means A formal record, either verbatim or an administrative law judge qualified summarized, of the hearing may be and appointed as provided in the Ad- made at the discretion of the Special ministrative Procedure Act (5 U.S.C. Agent in Charge. If a verbatim record 556). is to be made, the person attending the (g) The term proceeding means all ac- hearing will be so advised prior to the tions involving a hearing, colmencing start of the hearing. with the publication by the Adminis- trator of the notice of proposed rule [37 FR 15924, Aug. 8, 1972. Redesignated at 38 making or the issuance of an order to FR 26609, Sept. 24, 1973, and amended at 47 FR 41735, Sept. 22, 1982] show cause. (h) Any term not defined in this part shall have the definition set forth in Subpart D—Administrative section 102 of the Act (21 U.S.C. 802) or Hearings part 1300 of this chapter.

AUTHORITY: 21 U.S.C. 811, 812, 871(b), 875, [36 FR 7820, Apr. 24, 1971, as amended at 38 958(d), 965. FR 757, Jan. 4, 1973. Redesignated at 38 FR 26609, Sept. 24, 1973, as amended at 62 FR § 1316.41 Scope of subpart D. 13969, Mar. 24, 1997] Procedures in any administrative § 1316.43 Information; special instruc- hearing held under the Act are gov- tions. erned generally by the rule making Information regarding procedure and/or adjudication procedures set under these rules and instructions forth in the Administrative Procedure supplementing these rules in special Act (5 U.S.C. 551–559) and specifically instances will be furnished by the by the procedures set forth in this sub- Hearing Clerk upon request. part, except where more specific regulations (set forth in §§ 1301.51–1301.57, § 1316.44 Waiver or modification of §§ 1303.31–1303.37, §§ 1308.41–1308.51, rules. §§ 1311.51–1311.53, §§ 1312.41–1312.47, §§ 1313.51–1313.57, or §§ 1315.50–1315.62) The Administrator or the presiding apply. officer (with respect to matters pending before him) may modify or waive [73 FR 73556, Dec. 3, 2008] any rule in this subpart by notice in advance of the hearing, if he deter- § 1316.42 Definitions. mines that no party in the hearing will As used in this subpart, the following be unduly prejudiced and the ends of terms shall have the meanings speci- justice will thereby be served. Such no- fied: tice of modification or waiver shall be

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made a part of the record of the hear- 842(a) (8)) or any other law restricting ing. public disclosure of information; and (4) Any material contained in any in- § 1316.45 Filings; address; hours. vestigatory report, memorandum, or Documents required or permitted to file, or case report compiled by the Ad- be filed in, and correspondence relating ministration. to, hearings governed by the regula- [36 FR 7820, Apr. 24, 1971. Redesignated at 38 tions in this chapter shall be filed with FR 26609, Sept. 24, 1973, as amended at 62 FR the Hearing Clerk, Drug Enforcement 13970, Mar. 24, 1997; 75 FR 10645, Mar. 9, 2010] Administration. See the Table of DEA Mailing Addresses in § 1321.01 of this § 1316.47 Request for hearing. chapter for the current mailing ad- (a) Any person entitled to a hearing dress. This office is open Monday and desiring a hearing shall, within the through Friday from 8:30 a.m. to 5 p.m. period permitted for filing, file a re- eastern standard or daylight saving quest for a hearing in the following time, whichever is effective in the Dis- form (see the Table of DEA Mailing Ad- trict of Columbia at the time, except dresses in § 1321.01 of this chapter for on national legal holidays. Documents the current mailing address): shall be dated and deemed filed upon llllllllll(Date) receipt by the Hearing Clerk. Administrator, Drug Enforcement Adminis- tration, Attention: DEA Federal Register [75 FR 10685, Mar. 9, 2010] Representative. § 1316.46 Inspection of record. Dear Sir: The undersigned llllll (Name of person) hereby requests a hearing (a) The record bearing on any pro- in the matter of: llllllll (Identifica- ceeding, except for material described tion of the proceeding). in subsection (b) of this section, shall (A) (State with particularity the interest be available for inspection and copying of the person in the proceeding.) by any person entitled to participate in (B) (State with particularity the objections such proceeding, during office hours in or issues, if any, concerning which the person desires to be heard.) the office of the Hearing Clerk, Drug (C) (State briefly the position of the person Enforcement Administration. See the with regard to the particular objections or Table of DEA Mailing Addresses in issues.) § 1321.01 of this chapter for the current All notices to be sent pursuant to the pro- mailing address. ceeding should be addressed to: (b) The following material shall not llllllllll (Name) be available for inspection as part of llllllllll (Street address) (City and State) the record: llllllllll (1) A research protocol filed with an Respectfully yours, llllllllll (Signature of person) application for registration to conduct research with controlled substances (b) The Administrative Law Judge, listed in Schedule I, pursuant to upon request and showing of good § 1301.32 (a)(6) of this chapter, if the ap- cause, may grant a reasonable exten- plicant requests that the protocol be sion of the time allowed for response to kept confidential; an Order to Show Cause. (2) An outline of a production or [36 FR 7820, Apr. 24, 1971, as amended at 36 manufacturing process filed with an FR 13387, July 21, 1971. Redesignated at 38 FR application for registration to manu- 26609, Sept. 24, 1973] facture a new narcotic controlled sub- EDITORIAL NOTE: For FEDERAL REGISTER ci- stance, pursuant to § 1301.33 of this tations affecting § 1316.47, see the List of CFR chapter, if the applicant requests that Sections Affected, which appears in the the outline be kept confidential; Finding Aids section of the printed volume (3) Any confidential or trade secret and at www.fdsys.gov. information disclosed in conjunction with an application for registration, or § 1316.48 Notice of appearance. in reports filed while registered, or ac- Any person entitled to a hearing and quired in the course of an investiga- desiring to appear in any hearing, tion, entitled to protection under sub- shall, if he has not filed a request for section 402(a) (8) of the Act (21 U.S.C. hearing, file within the time specified

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in the notice of proposed rulemaking, a highest court of that jurisdiction. Any written notice of appearance in the fol- representative may be required by the lowing form (see the Table of DEA Administrator or the presiding officer Mailing Addresses in § 1321.01 of this to present a notarized power of attor- chapter for the current mailing ad- ney showing his authority to act in dress): such representative capacity and/or an llllllllll (Date) affidavit or certificate of admission to Administrator, Drug Enforcement Adminis- practice. tration [36 FR 7820, Apr. 24, 1971, as amended at 36 llllllllll (Mailing Address), Atten- tion: Federal Register Representative FR 13387, July 21, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973] Dear Sir: Please take notice that llllllll (Name of person) will appear § 1316.51 Conduct of hearing and par- in the matter of: llllllll (Identifica- ties; ex parte communications. tion of the proceeding). (A) (State with particularity the interest (a) Hearings shall be conducted in an of the person in the proceeding.) informal but orderly manner in accord- (B) (State with particularity the objections ance with law and the directions of the or issues, if any, concerning which the per- presiding officer. son desires to be heard.) (C) (State briefly the position of the person (b) Participants in any hearing and with regard to the particular objections or their representatives, whether or not issues.) members of the bar, shall conduct All notices to be sent pursuant to this ap- themselves in accordance with judicial pearance should be addressed to: standards of practice and ethics and llllllllll (Name) the directions of the presiding officer. llllllllll (Street address) llllllllll (City and State) Refusal to comply with this section Respectfully yours, shall constitute grounds for immediate llllllllll (Signature of person) exclusion from any hearing. (c) If any official of the Administra- [75 FR 10685, Mar. 9, 2010] tion is contacted by any individual in § 1316.49 Waiver of hearing. private or public life concerning any substantive matter which is the sub- Any person entitled to a hearing ject of any hearing, at any time after may, within the period permitted for the date on which the proceedings com- filing a request for hearing or notice of mence, the official who is contacted appearance, waiver of an opportunity shall prepare a memorandum setting for a hearing, together with a written forth the substance of the conversation statement regarding his position on and shall file this memorandum in the the matters of fact and law involved in appropriate public docket file. The pre- such hearing. Such statement, if admissible, shall be made a part of the siding officer and employees of the Ad- record and shall be considered in light ministration shall comply with the re- of the lack of opportunity for cross-ex- quirements of 5 U.S.C. 554(d) regarding amination in determining the weight ex parte communications and partici- to be attached to matters of fact as- pation in any hearing. serted therein. § 1316.52 Presiding officer. § 1316.50 Appearance; representation; A presiding officer, designated by the authorization. Administrator, shall preside over all Any person entitled to appear in a hearings. The functions of the prehearing may appear in person or by a siding officer shall commence upon his representative in any proceeding or designation and terminate upon the hearing and may be heard with respect certification of the record to the Ad- to matters relevant to the issues under ministrator. The presiding officer shall consideration. A representative must have the duty to conduct a fair hear- either be an employee of the person or ing, to take all necessary action to an attorney at law who is a member of avoid delay, and to maintain order. He the bar, in good standing, of any State, shall have all powers necessary to territory, or the District of Columbia, these ends, including (but not limited and admitted to practice before the to) the power to:

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(a) Arrange and change the date, (c) The possibility of limiting the time, and place of hearings (other than number of expert witnesses. the time and place prescribed in (d) The identification and, if prac- § 1301.56) and prehearing conferences ticable, the scheduling of all witnesses and issue notice thereof. to be called. (b) Hold conferences to settle, sim- (e) The advance submission at the plify, or determine the issues in a hear- prehearing conference of all documen- ing, or to consider other matters that tary evidence and affidavits to be may aid in the expeditious disposition marked for identification. of the hearing. (f) Such other matters as may aid in (c) Require parties to state their po- the expeditious disposition of the hear- sition in writing with respect to the ing. various issues in the hearing and to exchange such statements with all other § 1316.55 Prehearing ruling. parties. (d) Sign and issue subpoenas to com- The presiding officer may have the pel the attendance of witnesses and the prehearing conference reported ver- production of documents and materials batim and shall make a ruling reciting to the extent necessary to conduct ad- the action taken at the conference, the ministrative hearings pending before agreements made by the parties, the him. schedule of witnesses, and a statement (e) Examine witnesses and direct wit- of the issues for hearing. Such ruling nesses to testify. shall control the subsequent course of (f) Receive, rule on, exclude, or limit the hearing unless modified by a subse- evidence. quent ruling. (g) Rule on procedural items pending before him. § 1316.56 Burden of proof. (h) Take any action permitted to the At any hearing, the proponent for the presiding officer as authorized by this issuance, amendment, or repeal of any part or by the provisions of the Admin- rule shall have the burden of proof. istrative Procedure Act (5 U.S.C. 551– 559). § 1316.57 Submission of documentary [36 FR 7820, Apr. 24, 1971. Redesignated at 38 evidence and affidavits and identi- FR 26609, Sept. 24, 1973, and amended at 42 fication of witnesses subsequent to FR 57457, Nov. 3, 1977; 62 FR 13970, Mar. 24, prehearing conference. 1997] All documentary evidence and affidavits not submitted and all witnesses § 1316.53 Time and place of hearing. not identified at the prehearing con- The hearing will commence at the ference shall be submitted or identified place and time designated in the notice to the presiding officer as soon as pos- of hearing published in the FEDERAL sible, with a showing that the offering REGISTER but thereafter it may be party had good cause for failing to so moved to a different place and may be submit or identify at the prehearing continued from day to day or recessed conference. If the presiding officer de- to a later day without notice other termines that good cause does exist, than announcement thereof by the pre- the documents or affidavits shall be siding officer at the hearing. submitted or witnesses identified to all § 1316.54 Prehearing conference. parties sufficiently in advance of the offer of such documents or affidavits or The presiding officer on his own mo- witnesses at the hearing to avoid preju- tion, or on the motion of any party for dice or surprise to the other parties. If good cause shown, may direct all parties to appear at a specified time and the presiding officer determines that place for a conference for: good cause does not exist, he may (a) The simplification of the issues. refuse to admit as evidence such docu- (b) The possibility of obtaining stipu- ments or affidavits or the testimony of lations, admission of facts, and docu- such witnesses. ments.

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§ 1316.58 Summary of testimony; affi- (f) The presiding officer shall file as davits. exhibits copies of the following docu- (a) The presiding officer may direct ments: that summaries of the direct testimony (1) The order to show cause or notice of witnesses be prepared in writing and of hearing; served on all parties in advance of the (2) Any notice of waiver or modifica- hearing. Witnesses will not be per- tion of rules made pursuant to § 1316.44 mitted to read summaries of their tes- or otherwise; (3) Any waiver of hearing (together timony into the record and all wit- with any statement filed therewith) nesses shall be available for cross-ex- filed pursuant to § 1316.49 or otherwise; amination. Each witness shall, before (4) The prehearing ruling, if any, proceeding to testify, be sworn or make made pursuant to § 1316.55; affirmation. (5) Any other document necessary to (b) Affidavits submitted at the pre- show the basis for the hearing. hearing conference or pursuant to § 1316.57 with good cause may be exam- § 1316.60 Objections; offer of proof. ined by all parties and opposing affida- If any party in the hearing objects to vits may be submitted to the presiding the admission or rejection of any evi- officer within a period of time fixed by dence or to other limitation of the him. Affidavits admitted into evidence scope of any examination or cross-ex- shall be considered in light of the lack amination, he shall state briefly the of opportunity for cross-examination in grounds for such objection without ex- determining the weight to be attached tended argument or debate thereon ex- to statements made therein. cept as permitted by the presiding offi- [36 FR 7820, Apr. 24, 1971, as amended at 36 cer. A ruling of the presiding officer on FR 13387, July 21, 1971. Redesignated at 38 FR any such objection shall be a part of 26609, Sept. 24, 1973] the transcript together with such offer of proof as has been made if a proper § 1316.59 Submission and receipt of foundation has been laid for its admis- evidence. sion. An offer of proof made in connec- (a) The presiding officer shall admit tion with an objection taken to any only evidence that is competent, rel- ruling of the presiding officer rejecting evant, material and not unduly repeti- or excluding proffered oral testimony tious. shall consist of a statement of the sub- (b) Opinion testimony shall be admit- stance of the evidence which the party ted when the presiding officer is satis- contends would be adduced by such tes- fied that the witness is properly quali- timony; and, if the excluded evidence fied. consists of evidence in documentary or (c) The authenticity of all documents written form a copy of such evidence submitted in advance shall be deemed shall be marked for identification and admitted unless written objection shall accompany the records as the thereto is filed with the presiding offi- offer of proof. cer, except that a party will be permitted to challenge such authenticity § 1316.61 Exceptions to rulings. at a later time upon a showing of good Exceptions to rulings of the presiding cause for failure to have filed such officer are unnecessary. It is sufficient written objection. that a party, at the time the ruling of (d) Samples, if otherwise admissible the presiding officer is sought, makes into evidence, may be displayed at the known the action that he desires the hearing and may be described for pur- presiding officer to take, or his objec- poses of the record, or may be admitted tion to an action taken, and his in evidence as exhibits. grounds therefor. (e) Where official notice is taken or is to be taken of a material fact not ap- § 1316.62 Appeal from ruling of pre- pearing in the evidence of record, any siding officer. party, on timely request, shall be af- Rulings of the presiding officer may forded opportunity to controvert such not be appealed to the Administrator fact. prior to his consideration of the entire

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hearing, except with the consent of the § 1316.65 Report and record. presiding officer and where he certifies (a) As soon as practicable after the on the record or in writing that the al- time for the parties to file proposed lowance of an interlocutory appeal is findings of fact and conclusions of law clearly necessary to prevent excep- has expired, the presiding officer shall tional delay, expense, or prejudice to prepare a report containing the fol- any party or substantial detriment to lowing: the public interest. If an appeal is al- (1) His recommended rulings on the lowed, any party in the hearing may proposed findings of fact and conclu- file a brief in quintuplicate with the sions of law; Administrator within such period that (2) His recommended findings of fact the presiding officer directs. No oral and conclusions of law, with the rea- argument will be heard unless the Ad- sons therefore; and ministrator directs otherwise. (3) His recommended decision. (b) The presiding officer shall serve a § 1316.63 Official transcript; index; copy of his report upon each party in corrections. the hearing. The report shall be consid- (a) Testimony given at a hearing ered to have been served when it is shall be reported verbatim. The Admin- mailed to such party or its attorney of istration will make provision for a record. stenographic record of the testimony (c) Not less than twenty-five days and for such copies of the transcript after the date on which he caused cop- thereof as it requires for its own pur- ies of his report to be served upon the pose. parties, the presiding officer shall cer- (b) At the close of the hearing, the tify to the Administrator the record, presiding officer shall afford the par- which shall contain the transcript of ties and witnesses time (not longer testimony, exhibits, the findings of fact and conclusions of law proposed by than 30 days, except in unusual cases) the parties, the presiding officer’s rein which to submit written proposed port, and any exceptions thereto which corrections of the transcript, pointing may have been filed by the parties. out errors that may have been made in transcribing the testimony. The pre- [36 FR 7778, Apr. 24, 1971. Redesignated at 38 siding officer shall promptly thereafter FR 26609, Sept. 24, 1973 and amended at 44 FR order such corrections made as in his 55332, Sept. 26, 1979] judgment are required to make the § 1316.66 Exceptions. transcript conform to the testimony. (a) Within twenty days after the date [36 FR 7820, Apr. 24, 1971, as amended at 36 upon which a party is served a copy of FR 13387, July 21, 1971. Redesignated at 38 FR the report of the presiding officer, such 26609, Sept. 24, 1973, and amended at 50 FR party may file with the Hearing Clerk, 2046, Jan. 15, 1985] Office of the Administrative Law Judge, exceptions to the recommended § 1316.64 Proposed findings of fact and conclusions of law. decision, findings of fact and conclusions of law contained in the report. Any party in the hearing may file in The party shall include a statement of quintuplicate proposed findings of fact supporting reasons for such exceptions, and conclusions of law within the time together with evidence of record (in- fixed by the presiding officer. Any cluding specific and complete citations party so filing shall also serve one copy of the pages of the transcript and ex- of his proposed findings and conclusion hibits) and citations of the authorities upon each other party in the hearing. relied upon. The party shall include a statement of (b) The Hearing Clerk shall cause supporting reasons for the proposed such filings to become part of the findings and conclusions, together with record of the proceeding. evidence of record (including specific (c) The Administrative Law Judge and complete citations of the pages of may, upon the request of any party to the transcript and exhibits) and cita- a proceeding, grant time beyond the tions of authorities relied upon. twenty days provided in paragraph (a)

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of this section for the filing of a re- § 1316.71 Definitions. sponse to the exceptions filed by an- As used in this subpart, the following other party if he determines that no terms shall have the meanings speci- party in the hearing will be unduly fied: prejudiced and that the ends of justice (a) The term Act means the Con- will be served thereby. Provided how- trolled Substances Act (84 Stat. 1242; 21 ever, that each party shall be entitled U.S.C. 801) and/or the Controlled Sub- to only one filing under this section; stances Import and Export Act (84 that is, either a set of exceptions or a Stat. 1285; 21 U.S.C. 951). response thereto. (b) The term custodian means the of- [44 FR 55332, Sept. 26, 1979] ficer required under § 1316.72 to take custody of particular property which § 1316.67 Final order. has been seized pursuant to the Act. As soon as practicable after the pre- (c) The term property means a con- siding officer has certified the record trolled substance, raw material, prod- to the Administrator, the Adminis- uct, container, equipment, money or trator shall cause to be published in other asset, vessel, vehicle, or aircraft the FEDERAL REGISTER his final order within the scope of the Act. in the proceeding, which shall set forth (d) The terms seizing officer, officer the final rule and the findings of fact seizing, etc., mean any officer, author- and conclusions of law upon which the ized and designated by § 1316.72 to carry rule is based. This order shall specify out the provisions of the Act, who ini- the date on which it shall take effect, tially seizes property or adopts a sei- which date shall not be less than 30 zure initially made by any other officer days from the date of publication in or by a private person. the FEDERAL REGISTER unless the Ad- (e) The term Special Agents-in-Charge ministrator finds that the public inter- means Drug Enforcement Administra- est in the matter necessitates an ear- tion Special Agents-in-Charge or Resi- lier effective date, in which event the dent Agents in Charge and Federal Bu- Administrator shall specify in the reau of Investigation Special Agents- order his findings as to the conditions in-Charge. which led him to conclude that an ear- (f) Any term not defined in this sec- lier effective date was required. tion shall have the definition set forth in section 102 of the Act (21 U.S.C. 802) [44 FR 42179, July 19, 1979, as amended at 44 or part 1300 of this chapter. FR 55332, Sept. 26, 1979] [36 FR 7820, Apr. 24, 1971. Redesignated at 38 § 1316.68 Copies of petitions for judi- FR 26609, Sept. 24, 1973, and amended at 45 cial review. FR 20096, Mar. 27, 1980; 47 FR 43370, Oct. 1, 1982; 49 FR 28701, July 16, 1984; 62 FR 13969, Copies of petitions for judicial re- Mar. 24, 1997] view, filed pursuant to section 507 of the Act (21 U.S.C. 877) shall be deliv- § 1316.72 Officers who will make sei- ered to and served upon the Adminis- zures. trator in quintuplicate. The Adminis- For the purpose of carrying out the trator shall certify the record of the provisions of the Act, all special agents hearing and shall file the certified of the Drug Enforcement Administra- record in the appropriate U.S. Court of tion and the Federal Bureau of Inves- Appeals. tigation are authorized and designated [36 FR 7820, Apr. 24, 1971. Redesignated at 44 to seize such property as may be sub- FR 42179, July 19, 1979] ject to seizure. [47 FR 43370, Oct. 1, 1982] Subpart E—Seizure, Forfeiture, and Disposition of Property § 1316.73 Custody and other duties. An officer seizing property under the AUTHORITY: 21 U.S.C 871(b), 881, 965, 19 Act shall store the property in a loca- U.S.C. 1606, 1607, 1608, 1610, 1613, 1618, 28 tion designated by the custodian, gen- U.S.C. 509, 510. erally in the judicial district of seizure.

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The Special Agents-in-Charge are des- notice, file with the custodian or DEA ignated as custodians to receive and Asset Forfeiture Section a claim to the maintain in storage all property seized property and a bond with satisfactory pursuant to the Act, are authorized to sureties in the sum of $5,000 or ten per- dispose of any property pursuant to the cent of the value of the claimed prop- Act and any other applicable statutes erty whichever is lower, but not less or regulations relative to disposal, and than $250. to perform such other duties regarding such seized property as are appro- (Authority: Sec. 607, 46 Stat. 754, as amended priate, including the impound release (19 U.S.C. 1607); Pub. L. 98–473, Pub. L. 98–573) of property pursuant to 28 CFR 0.101(c). [36 FR 7820, Apr. 24, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973 and amended at 44 FR [47 FR 43370, Oct. 1, 1982] 56324, Oct. 1, 1979; 49 FR 1178, Jan. 10, 1984; 49 § 1316.74 Appraisement. FR 50643, Dec. 31, 1984; 52 FR 24446, July 1, 1987; 56 FR 8686, Mar. 1, 1991] The custodian shall appraise the property to determine the domestic § 1316.76 Requirements as to claim and value at the time and place of seizure. bond. The domestic value shall be considered (a) The bond shall be rendered to the the price at which such or similar prop- United States, with sureties to be ap- erty is freely offered for sale. If there is proved by the custodian or DEA Asset no market for the property at the place of seizure, the domestic value shall be Forfeiture Section, conditioned that in considered the value in the principal the case of condemnation of the prop- market nearest the place of seizure. erty the obligor shall pay all costs and expenses of the proceedings to obtain (Authority: Sec. 606, 46 Stat. 754 (19 U.S.C. such condemnation. When the claim 1606)) and bond are received by the custodian [36 FR 7820, Apr. 24, 1971. Redesignated at 38 or DEA Asset Forfeiture Section, he FR 26609, Sept. 24, 1973, and amended at 52 shall, after finding the documents in FR 41418, Oct. 28, 1987] proper form and the sureties satisfac- § 1316.75 Advertisement. tory, transmit the documents, together with a description of the property and (a) If the appraised value does not ex- a complete statement of the facts and ceed the monetary amount set forth in circumstances surrounding the seizure, title 19, United States Code, Section to the United States Attorney for the 1607; the seized merchandise is any judicial district in which the pro- monetary instrument within the meaning of section 5312(a)(3) of title 31 of the ceeding for forfeiture is brought. If the United States Code; or if a conveyance documents are not in satisfactory con- used to import, export or otherwise dition when first received, a reasonable transport or store any controlled sub- time for correction may be allowed. If stance is involved, the custodian or correction is not made within a reason- DEA Asset Forfeiture Section shall able time the documents may be treat- cause a notice of the seizure and of the ed as nugatory, and the case shall pro- intention to forfeit and sell or other- ceed as though they had not been ten- wise dispose of the property to be pub- dered. lished once a week for at least 3 succes- (b) The filing of the claim and the sive weeks in a newspaper of general posting of the bond does not entitle the circulation in the judicial district in claimant to possession of the property, which the processing for forfeiture is however, it does stop the administra- brought. tive forfeiture proceedings. The bond (b) The notice shall: (1) Describe the posted to cover corts may be in cash, property seized and show the motor certified check, or satisfactory sure- and serial numbers, if any; (2) state the ties. The costs and expenses secured by time, cause, and place of seizure; and the bond are such as are incurred after (3) state that any person desiring to the filing of the bond including storage claim the property may, within 20 days from the date of first publication of the

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cost, safeguarding, court fees, mar- § 1316.78 Judicial forfeiture. shal’s costs, etc. If the appraised value is greater than (Authority: Sec. 608, 46 Stat. 755 (19 U.S.C. the jurisdictional limits in § 1316.75(a) 1608); Pub. L. 98–473, Pub. L. 98–573) or a claim and satisfactory bond have been received for property the jurisdic- [36 FR 7820, Apr. 24, 1971. Redesignated at 38 tional limits in § 1316.76, the custodian FR 26609, Sept. 24, 1973 and amended at 49 FR or DEA Asset Forfeiture Section shall 1178, Jan. 10, 1984; 49 FR 50643, Dec. 31, 1984; 56 FR 8686, Mar. 1, 1991] transmit a description of the property and a complete statement of the facts § 1316.77 Administrative forfeiture. and circumstances surrounding the seizure to the U.S. Attorney for the judi- (a) For property seized by officers of cial district in which the proceeding the Drug Enforcement Administration, for forfeiture is sought for the purpose if the appraised value does not exceed of instituting condemnation pro- the jurisdictional limits in § 1316.75(a), ceedings. The U.S. Attorney shall also and a claim and bond are not filed be furnished the newspaper advertise- within the 20 days hereinbefore men- ments required by § 1316.75. The For- tioned, the DEA Special Agent-in- feiture Counsel of DEA shall make ap- Charge or DEA Asset Forfeiture Sec- plications to the U.S. District Courts tion shall declare the property for- to place property in official DEA use. feited. The DEA Special Agent-in- (Authority: Sec. 610, 46 Stat. 755 (19 U.S.C. Charge or DEA Asset Forfeiture Sec- 1610); Pub. L. 98–473, Pub. L. 98–573) tion shall prepare the Declaration of [36 FR 7820, Apr. 24, 1971. Redesignated at 38 Forfeiture and forward it to the Ad- FR 26609, Sept. 24, 1973 and amended at 44 FR ministrator of the Administration as 56324, Oct. 1, 1979; 49 FR 1178, Jan. 10, 1984; 49 notification of the action he has taken. FR 32174, Aug. 13, 1984; 49 FR 50643, Dec. 31, Thereafter, the property shall be re- 1984; 56 FR 8686, Mar. 1, 1991] tained in the district of the DEA Spe- cial Agent-in-Charge or DEA Asset § 1316.79 Petitions for remission or mitigation of forfeiture. Forfeiture Section or delivered elsewhere for official use, or otherwise dis- (a) Any person interested in any posed of, in accordance with official in- property which has been seized, or for- structions received by the DEA Special feited either administratively or by court proceedings, may file a petition Agent-in-Charge or DEA Asset For- for remission or mitigation of the forfeiture Section. feiture. Such petition shall be filed in (b) For property seized by officers of triplicate with the DEA Asset For- the Federal Bureau of Investigation, if feiture Section or Special Agent-in- the appraised value does not exceed the Charge of the DEA or FBI, depending jurisdictional limits in § 1316.75(a), and upon which agency seized the property, a claim and bond are not filed within for the judicial district in which the the 20 days hereinbefore mentioned, proceeding for forfeiture is brought. It the FBI Property Management Officer shall be addressed to the Director of shall declare the property forfeited. the FBI or the Administrator of the The FBI Property Management Officer DEA, depending upon which agency shall prepare the Declaration of For- seized the property, if the property is feiture. Thereafter, the property shall subject to administrative forfeiture be retained in the field office or deliv- pursuant to § 1316.77, and addressed to ered elsewhere for official use, or oth- the Attorney General if the property is erwise disposed of, in accordance with subject to judicial forfeiture pursuant the official instructions of the FBI to § 1316.78. The petition must be exe- Property Management Officer. cuted and sworn to by the person alleg- ing interest in the property. (Authority: 28 U.S.C. 509 and 510; 21 U.S.C. (b) The petition shall include the fol- 871 and 881(d); Pub. L. 98–473, Pub. L. 98–573) lowing: (1) A complete description of [48 FR 35087, Aug. 3, 1983, as amended at 49 the property, including motor and se- FR 1178, Jan. 10, 1984; 49 FR 50643, Dec. 31, rial numbers, if any, and the date and 1984; 56 FR 8686, Mar. 1, 1991; 62 FR 13970, place of seizure; (2) the petitioner’s in- Mar. 24, 1997] terest in the property, which shall be

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supported by bills of sale, contracts, vestigation shall be forwarded to the mortgages, or other satisfactory docu- Director of the FBI or to the Adminis- mentary evidence; and, (3) the facts trator of the DEA, depending upon and circumstances, to be established by which agency seized the property. If satisfactory proof, relied upon by the the petition involves a case which has petitioner to justify remission or miti- been referred to the U.S. Attorney for gation. the institution of court proceedings, (c) Where the petition is for restora- the custodian or DEA Asset Forfeiture tion of the proceeds of sale, or for value System shall transmit the petition to of the property placed in official use, it the U.S. Attorney for the judicial dis- must be supported by satisfactory trict in which the proceeding for for- proof that the petitioner did not know feiture is brought. He shall notify the of the seizure prior to the declaration petitioner of this action. of condemnation of forfeiture and was in such circumstances as prevented (Authority: 28 U.S.C. 509 and 510; 21 U.S.C. him from knowing of the same. 871 and 881(d); Pub. L. 98–473, Pub. L. 98–573) [48 FR 35088, Aug. 3, 1983, as amended at 49 (Authority: Secs. 613, 618, 46 Stat. 756, 757, as FR 1178, Jan. 10, 1984; 49 FR 50643, Dec. 31, amended (19 U.S.C. 1613, 1618; 28 U.S.C. 509 1984; 56 FR 8686, Mar. 1, 1991; 62 FR 13970, and 510; 21 U.S.C. 871 and 881(d)); Pub. L. 98– Mar. 24, 1997] 473, Pub. L. 98–573) [36 FR 7820, Apr. 24, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973, and amended at 48 Subpart F—Expedited Forfeiture FR 35088, Aug. 3, 1983; 49 FR 1178, Jan. 10, Proceedings for Certain Property 1984; 49 FR 50643, Dec. 31, 1984; 56 FR 8686, Mar. 1, 1991] AUTHORITY: 21 U.S.C. 822, 871, 872, 880, 881, 881–1, 883, 958, 965; 19 U.S.C. 1606, 1607, 1608, § 1316.80 Time for filing petitions. 1610, 1613, 1618; 28 U.S.C. 509, 510; Pub. L. No. (a) In order to be considered as sea- 100–690, sec. 6079, 6080. sonably filed, a petition for remission SOURCE: 54 FR 37610, Sept. 11, 1989, unless or mitigation of forfeiture should be otherwise noted. filed within 30 days of the receipt of the notice of seizure. If a petition for § 1316.90 Purpose and scope. remission or mitigation of forfeiture (a) The following definitions, regula- has not been received within 30 days of tions, and criteria are designed to es- the notice of seizure, the property will tablish and implement procedures re- either be placed in official service or quired by sections 6079 and 6080 of the sold as soon as it is forfeited. Once Anti-Drug Abuse Act of 1988, Public property is placed in official use, or is Law No. 100–690 (102 Stat. 4181). They sold, a petition for remission or mitiga- are intended to supplement existing tion of forfeiture can no longer be ac- law and procedures relative to the for- cepted. feiture of property under the identified (b) A petition for restoration of pro- statutory authority. The provisions of ceeds of sale, or for the value of prop- these regulations do not affect the ex- erty placed in official use, must be isting legal and equitable rights and filed within 90 days of the sale of the remedies of those with an interest in property, or within 90 days of the date property seized for forfeiture, nor do the property is placed in official use. these provisions relieve interested par- (Authority: Secs. 613, 618, 46 Stat. 756, 757, as ties from their existing obligations and amended (19 U.S.C. 1613, 1618); Pub. L. 98–473, responsibilities in pursuing their inter- Pub. L. 98–573) ests through such courses of action. [36 FR 7820, Apr. 24, 1971. Redesignated at 38 These regulations are intended to re- FR 26609, Sept. 24, 1973, and amended at 49 flect the intent of Congress to mini- FR 50643, Dec. 31, 1984] mize the adverse impact on those entitled to legal or equitable relief occa- § 1316.81 Handling of petitions. sioned by the prolonged detention of Upon receipt of a petition, the custo- property subject to forfeiture due to dian or DEA Asset Forfeiture System violations of law involving personal use shall request an appropriate investiga- quantities of controlled substances, tion. The petition and the report of in- and conveyances seized for drug-related

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offenses. The definition of personal use or an activity that can reasonably be quantities of a controlled substance as expected to result in the catching, tak- contained herein is intended to distin- ing, or harvesting of fish; guish between those quantities small (2) Commercially prepares fish or fish in amount which are generally consid- products other than by gutting, decapi- ered to be possessed for personal con- tating, gilling, skinning, shucking, sumption and not for further distribu- icing, freezing, or brine chilling; or tion, and those larger quantities gen- (3) Commercially supplies, stores, re- erally considered to be subject to fur- frigerates, or transports fish, fish prod- ther distribution. ucts, or materials directly related to (b) In this regard, for violations in- fishing or the preparation of fish to or volving the possession of personal use from a fishing, fish processing, or fish quantities of a controlled substance, tender vessel or fish processing facil- section 6079(b)(2) requires either that ity. administrative forfeiture be completed (c) The term Controlled Substance has within 21 days of the seizure of the the meaning given in section 802 of property, or alternatively, that proce- title 21, United States Code (U.S.C.). dures are established that provide a (d) The term Drug-Related Offense means by which an individual entitled means any proscribed offense which in- to relief may initiate an expedited ad- volves the possession, distribution, ministrative review of the legal and factual basis of the seizure for for- manufacture, cultivation, sale, trans- feiture. Should an individual request fer, or the attempt or conspiracy to relief pursuant to these regulations possess, distribute, manufacture, cul- and be entitled to the return of the tivate, sell or transfer any substance seized property, such property shall be the possession of which is prohibited by returned immediately following that Title 21, U.S.C. determination, and the administrative (e) The term Immediately means with- forfeiture process shall cease. Should in 20 days of the filing of a petition for the individual not be entitled to the re- expedited release by an owner. turn of the seized property, however, (f) The term Interested Party means the administrative forfeiture of that one who was in legal possession of the property shall proceed. The owner may, property at the time of seizure and is in any event, obtain release of property entitled to legal possession at the time pending the administrative forfeiture of the granting of the petition for expe- by submitting to the agency making dited release. This includes a the determination, property sufficient lienholder (to the extent of his interest to preserve the government’s vested in- in the property) whose claim is in writ- terest for purposes of the administra- ing (except for a maritime lien which tive forfeiture. need not be in writing), unless the col- (c) Section 6080 requires a similar ex- lateral is in the posession of the se- pedited review by the Attorney General cured party. The agreement securing or his representative in those instances such lien must create or provide for a where a conveyance is being forfeited security interest in the collateral, de- in a civil judicial proceeding following scribe the collateral, and be signed by its seizure for a drug-related offense. the debtor. (g) The term Legal and Factual Basis § 1316.91 Definitions. of the Seizure means a statement of the As used in this subpart, the following applicable law under which the prop- terms shall have the meanings speci- erty is seized, and a statement of the fied: circumstances of the seizure suffi- (a) The term Appraised Value means ciently precise to enable an owner or the estimated domestic price at the other interested party to identify the time of seizure at which such or simi- date, place, and use or acquisition lar property is freely offered for sale. which makes the property subject to (b) The term Commercial Fishing In- forfeiture. dustry Vessel means a vessel that: (h) The term Normal and Customary (1) Commercially engages in the Manner means that inquiry suggested catching, taking, or harvesting of fish by particular facts and circumstances

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which would customarily be under- Federal, State or local law that indi- taken by a reasonably prudent indicates an intent to distribute a con- vidual in a like or similar situation. trolled substance; Actual knowledge of such facts and cir- (iv) The controlled substance is re- cumstances is unnecessary, and im- lated to large amounts of cash or any plied, imputed, or constructive knowl- amount of prerecorded government edge is sufficient. An established norm, funds; standard, or custom is persuasive but (v) The controlled substance is pos- not conclusive or controlling in deter- sessed under circumstances that indi- mining whether an owner acted in a cate such a controlled substance is a normal and customary manner to as- sample intended for distribution in an- certain how property would be used by ticipation of a transaction involving another legally in possession of the large quantities, or is part of a larger property. The failure to act in a nor- delivery; or mal and customary manner as defined (vi) Statements by the possessor, or herein will result in the denial of a pe- otherwise attributable to the pos- tition for expedited release of the prop- sessor, including statements of con- erty and is intended to have the desir- spirators, that indicate possession with able effect of inducing owners of the intent to distribute. property to exercise greater care in (2) Possession of a controlled sub- transferring possession of their prop- stance shall be presumed to be for per- erty. sonal use when there are no indicia of (i) The term Owner means one having illicit drug trafficking or distribution a legal and possessory interest in the such as, but not limited to, the factors property seized for forfeiture. Even listed above and the amounts do not though one may hold primary and di- exceed the following quantities: rect title to the property seized, such (i) One gram of a mixture of sub- person may not have sufficient actual stance containing a detectable amount beneficial interest in the property to of heroin; support a petition as owner if the facts (ii) One gram of a mixture or sub- indicate that another person had do- stance containing a detectable amount minion and control over the property. of— (j) The term Personal Use Quantities (A) Coca leaves, except coba leaves means possession of controlled sub- and extracts of coca leaves frol which stances in circumstances where there cocaine, ecgonine, and derivations of is no other evidence of an intent to dis- ecgonine or their salts have been re- tribute, of to facilitate the manufac- moved; turing, compounding, processing, delivering, importing or exporting of any (B) Cocaine, its salts, optical and controlled substance. Evidence of per- geometric isomers, and salts of iso- sonal use quantities shall not include mers; sweepings or other evidence of posses- (C) Ecgonine, its derivatives, their sion of quantities of a controlled sub- salts, isomers, and salts of isomers; or stance for other than personal use. (D) Any compound, mixture or prepa- (1) Such other evidence shall include: ration which contains any quantity of (i) Evidence, such as drug scales, any of the substances referred to in drug distribution paraphernalia, drug paragraphs (j)(2)(ii)(A) through records, drug packaging material, (j)(2)(ii)(C) of this section; method of drug packaging, drug ‘‘cut- (iii) 1⁄10th gram of a mixture or sub- ting’’ agents and other equipment, that stance described in paragraph (j)(2)(ii) indicates an intent to process, package of this section which contains cocaine or distribute a controlled substance; base; (ii) Information from reliable sources (iv) 1⁄10th gram of a mixture or sub- indicating possession of a controlled stance containing a detectable amount substance with intent to distribute; of phencyclidine (PCP); (iii) The arrest and/or conviction (v) 500 micrograms of a mixture or record of the person or persons in ac- substance containing a detectable tual or constructive possession of the amount of lysergic acid diethylamide controlled substance for offenses under (LSD);

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(vi) One ounce of a mixture of sub- the port designated in the summons. stance containing a detectable amount The seizing agency shall be authorized of marihuana; to effect administrative forfeiture as if (vii) One gram of methamphetamine, the vessel had been physically seized. its salts, isomers, and salts of its iso- Upon answering the summons to ap- mers, or one gram of a mixture or sub- pear on or prior to the last reporting stance containing a detectable amount date specified in the summons, the of methamphetamine, its salts, iso- owner of the vessel may file a petition mers, or salts of its isomers. for expedited release pursuant to para- (3) The possession of a narcotic, a de- graph (a) of this section and the provi- pressant, a stimulant, a hallucinogen sions of paragraph (a) of this section or cannabis-controlled substance will and other provishons in this subpart be considered in excess of personal use pertaining to a petition for expedited quantities if the dosage unit amount release shall apply as if the vessel had possessed provides the same or greater been physically seized. equivalent efficacy as described in (c) The owner filing the petition for paragraph (j)(2) of this section. expedited release shall establish the (k) The term Property means property following: subject to forfeiture under title 21, (1) The owner has a valid, good faith U.S.C., sections 881(a) (4), (6), and (7); interest in the seized property as owner title 19, U.S.C., section 1595a, and; title or otherwise; 49, U.S.C. App., section 782. (2) The owner reasonably attempted (l) The term Seizing Agency means the to ascertain the use of the property in Federal agency which has seized the a normal and customary manner; and property or adopted the seizure of an- (3) The owner did not know or con- other agency, and has the responsi- sent to the illegal use of the property, bility for administratively forfeiting or in the event that the owner knew or the property; should have known of the illegal use, (m) The term Statutory Rights or De- the owner did what reasonably could be fenses to the Forfeiture means all legal expected to prevent the violation. and equitable rights and remedies (d) In addition to those factors listed available to a claimant of property in paragraph (c) of this section, if an seized for forfeiture. owner can demonstrate that the owner (n) The term Sworn to as used in has other statutory rights or defenses §§ 1316.92(e) and 1316.95(c) refers to the that would cause the owner to prevail oath as provided by Title 28, U.S.C., on the issue of forfeiture, such factors section 1746. shall also be considered in ruling on the petition for expedited release. § 1316.92 Petition for expedited release (e) A petition for expedited release in an administrative forfeiture ac- must be filed in a timely manner to be tion. considered by the seizing agency. In (a) Where property is seized for ad- order to be filed in a timely manner, ministrative forfeiture involving con- the petition must be received by the trolled substances in personal use appropriate seizing agency within 20 quantities the owner may petition the days from the date of the first publica- seizing agency for expedited release of tion of the notice of seizure. The peti- the property. tion must be executed and sworn to by (b) Where property described in para- the owner and both the envelope and graph (a) of this section is a commer- the request must be clearly marked cial fishing industry vessel proceeding ‘‘PETITION FOR EXPEDITED RE- to or from a fishing area or inter- LEASE.’’ Such petition shall be filed in mediate port of call or actually en- triplicate with the Special Agent in gaged in fishing operations, which Charge of the Drug Enforcement Ad- would be subject to seizure for adminis- ministration (DEA) or Federal Bureau trative forfeiture for a violation of law of Investigation (FBI) field office in the involving controlled substances in per- judicial district in which the property sonal use quantities, a summons to ap- was seized, depending upon which agen- pear shall be issued in lieu of a phys- cy seized the property. The petition ical seizure. The vessel shall report to shall be addressed to the Director of

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the FBI or to the Administrator of the § 1316.94 Posting of substitute res in DEA, depending upon which agency an administrative forfeiture action. seized the property. (a) Where property is seized for ad- (f) The petition shall include the fol- ministrative forfeiture involving con- lowing: trolled substances in personal use (1) A complete description of the quantities, the owner may obtain re- property, including identification num- lease of the property by posting a sub- bers, if any, and the date and place of stitute res with the seizing agency. The seizure; property will be released to the owner (2) The petitioner’s interest in the upon the payment of an amount equal property, which shall be supported by to the appraised value of the property title documentation, bills of sale, con- if it is not evidence of a violation of tracts, mortgages, or other satisfac- law or has design or other characteris- tory documentary evidence; and tics that particularly suit it for use in (3) A statement of the facts and cir- illegal activities. This payment must cumstances, to be established by satis- be in the form of a traveler’s check, a money order, a cashier’s check or an ir- factory proof, relied upon by the peti- revocable letter of credit made payable tioner to justify expedited release of to the seizing agency. A bond in the the seized property. form of a cashier’s check will be considered as paid once the check has been § 1316.93 Ruling on petition for expedited release in an administrative accepted for payment by the financial forfeiture action. institution which issued the check. (b) If a substitute res is posted and (a) Upon receipt of a petition for ex- the property is administratively for- pedited release filed pursuant to feited, the seizing agency will forfeit § 1316.92(a), the seizing agency shall de- the substitute res in lieu of the prop- termine first whether a final adminis- erty. trative determination of the case, without regard to the provisions of this § 1316.95 Petition for expedited release subpart, can be made within 21 days of of a conveyance in a judicial for- the seizure. If such a final administra- feiture action. tive determination is made within 21 (a) Where a conveyance has been days, no further action need be taken seized and is being forfeited in a judi- under this subpart. cial proceeding for a drug-related of- (b) If no such final administrative defense, the owner may petition the termination is made within 21 days of United States Attorney for an expe- the seizure, the following procedure dited release of the conveyance. shall apply. The seizing agency shall, (b) The owner filing the petition for within 20 days after the receipt of the expedited release shall establish the petition for expedited release, deter- following: (1) The owner has a valid, good faith mine whether the petition filed by the interest in the seized conveyance as owner has established the factors listed owner or otherwise; in § 1316.92(c) and: (2) The owner has statutory rights or (1) If the seizing agency determines defenses that would show to a substan- that those factors have been estab- tial probability that the owner would lished, it shall terminate the adminis- prevail on the issue of forfeiture; trative proceedings and return the (3) The owner reasonably attempted property to the owner (or in the case of to ascertain the use of the conveyance a commercial fishing industry vessel in a normal and customary manner; for which a summons has been issued and shall dismiss the summons), except (4) The owner did not know or con- where it is evidence of a violation of sent to the illegal use of the convey- law; or ance; or in the event that the owner (2) If the seizing agency determines knew or should have known of the ille- that those factors have not been estab- gal use, the owner did what reasonably lished, the agency shall proceed with could be expected to prevent the viola- the administrative forfeiture. tion.

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(c) A petition for expedited release (c) Upon a favorable ruling on the pe- must be filed in a timely manner in tition for expedited release, the United order to be considered by the United States Attorney shall, where nec- States Attorney. To be considered as essary, move to terminate the judicial filed in a timely manner, the petition proceedings against the conveyance must be received by the appropriate and immediately direct the return of United States Attorney within 20 days the conveyance except where it is evi- from the date of the first publication of dence of a violation of law. the notice of the action and arrest of (d) If, within 20 days, the United the property, or within 30 days after States Attorney denies the petition for filing of the claim, whichever occurs expedited release, the government later. The petition must be executed shall retain possession of the convey- and sworn to by the owner, and both ance until the owner provides a sub- the envelope and the request must be stitute res bond pursuant to § 1316.98 or clearly marked ‘‘PETITION FOR EX- the forfeiture is finalized. PEDITED RELEASE.’’ Such petition shall be filed in triplicate and ad- § 1316.97 Initiating judicial forfeiture dressed to and filed with the United proceeding against a conveyance States Attorney prosecuting the con- within 60 days of the filing of a veyance for forfeiture with a copy to claim and cost bond. the seizing agency. (a) The United States Attorney shall (d) The petition shall include the fol- file a complaint for forfeiture of the lowing: conveyance within 60 days of the filing (1) A complete description of the con- of the claim and cost bond. veyance, including the identification (b) Upon the failure of the United number, and the date and place of sei- States Attorney to file a complaint for zure; forfeiture of a conveyance within 60 (2) The petitioner’s interest in the days unless the court extends the 60- conveyance, which shall be supported day period following a showing of good by bills of sale, contracts, mortgages, cause, or unless the owner and the or other satisfactory documentary evi- United States Attorney agree to such dence; and, an extension, the court shall order the (3) The facts and circumstances, to be return of the conveyance and the reestablished by satisfactory proof, relied turn of any bond. upon by the petitioner to justify expedited release of the seized conveyance. § 1316.98 Substitute res bond in a judicial forfeiture action against a con- § 1316.96 Ruling on a petition for expe- veyance. dited release of a conveyance in a (a) Where a conveyance is being for- judicial forfeiture action. feited in a judicial proceeding for a (a) Upon receipt of a petition for ex- drug-related offense, the owner may pedited release filed pursuant to obtain release of the property by filing § 1316.95, the United States Attorney a substitute res bond with the seizing shall rule on the petition within 20 agency. The conveyance will be re- days of receipt. A petition shall be leased to the owner upon the payment deemed filed on the date it is received of a bond in the amount of the ap- by the United States Attorney. praised value of the conveyance if it is (b) If the United States Attorney not evidence of a violation of law or does not rule on the petition for expe- has design or other characteristics that dited release within 20 days after the particularly suit it for use in illegal ac- date on which it is filed, the convey- tivities. This bond must be in the form ance shall be returned to the owner or of a traveler’s check, a money order, a interested party pending further for- cashier’s check or an irrevocable letter feiture proceedings, except where it is of credit made payable to the Depart- evidence of a violation of law. Release ment of Justice or to the United States of conveyance under provisions of this Customs Service depending on which paragraph shall not affect the for- agency seized the conveyance. A bond feiture action with respect to that con- in the form of a cashier’s check will be veyance. considered as paid once the check has

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been accepted for payment by the fi- (b) Standard notice provision. The nancial institution which issued the standard notice to the owner as re- check. quired by title 19, U.S.C., section 1607 (b) If a substitute res bond is filed and applicable regulations, shall be and the conveyance is judicially for- made at the earliest practicable oppor- feited, the court will forfeit the bond in tunity after determining ownership of lieu of the property. the seized property or conveyance and shall include the legal and factual § 1316.99 Notice provisions. basis of the seizure. (a) Special notice provision. At the time of seizure of property defined in PART 1321—DEA MAILING § 1316.91 for violations involving the ADDRESSES possession of personal use quantities of a controlled substance and convey- Sec. ances seized pursuant to § 1316.95, writ- 1321.01 DEA mailing addresses. ten notice must be provided to the pos- AUTHORITY: 21 U.S.C. 871(b). sessor of the property regarding appli- SOURCE: 75 FR 10685, Mar. 9, 2010, unless cable statutes and Federal regulations otherwise noted. including the procedures established for the filing of a petition for expedited § 1321.01 DEA mailing addresses. release and for the posting of a sub- The following table provides informa- stitute res bond as set forth in sections tion regarding mailing addresses to be 6079 and 6080 of the Anti-Drug Abuse used when sending specified cor- Act of 1988 and implementing regula- respondence to the Drug Enforcement tions. Administration.

TABLE OF DEA MAILING ADDRESSES

Code of Federal Regulations Section—Topic DEA Mailing address

DEA Administrator

1308.43(b)—Petition to initiate proceedings for rulemaking ...... Drug Enforcement Administration, Attn: 316.23(b)—Petition for grant of confidentiality for research subjects. Administrator, 8701 Morrissette Drive, 1316.24(b)—Petition for exemption from prosecution for researchers. Springfield, VA 22152. 1316.48—Notice of appearance.

DEA Office of Diversion Control

1301.52(c)—Controlled substances registration return for cancellation ...... Drug Enforcement Administration, Attn: 1307.03—Exception request filing. Office of Diversion Control/OD, 8701 1307.22—Disposal of controlled substances by the Administration delivery applica- Morrissette Drive, Springfield, VA tion. 22152. 1308.21(a)—Exclusion of nonnarcotic substance. 1308.23(b)—Exemption for chemical preparations. 1308.25(a)—Exclusion of veterinary anabolic steroid implant product application. 1308.31(a)—Exemption of a nonnarcotic prescription product application. 1308.33(b)—Exemption of certain anabolic steroid products application. 1310.13(b)—Exemption for chemical preparations. 1310.21(b)—Sale by Federal departments or agencies of chemicals which could be used to manufacture controlled substances certification request.

DEA Regulatory Section

1301.71(d)—Security system compliance review for controlled substances ...... Drug Enforcement Administration, Attn: 1309.71(c)—Security system compliance review for List I chemicals. Regulatory Section/ODG, 8701 Morrissette Drive, Springfield, VA 22152

DEA Import/Export Unit

1310.05(c)—Importer/exporter of tableting or encapsulation machines reporting ...... Drug Enforcement Administration, Attn: 1310.05(e)(1)—Reporting by persons required to keep records and file reports re- Import/Export Unit/ODGI, 8701 garding List I chemicals. Morrissette Drive, Springfield, VA 22152. 1310.05(e)(2)—Request to submit List I chemicals reports in electronic form. 1310.06(g)—Report of declared exports of machines refused, rejected, or returned. 1312.12(a)—Application for import permit (DEA Form 357).

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TABLE OF DEA MAILING ADDRESSES—Continued

Code of Federal Regulations Section—Topic DEA Mailing address

1312.16(b)—Return unused import permits. 1312.18(b)—Import declaration (DEA Form 236) submission. 1312.19(b)—DEA Form 236 copy 4 filing. 1312.22(a)—Application for export permit (DEA Form 161). 1312.22(d)(8)—Request for return of unacceptable or undeliverable exported controlled substances. 1312.24(a)—DEA Form 161 copy 2 filing. 1312.27(a)—Special controlled substances export invoice (DEA Form 236) filing. 1312.27(b)(5)(iv)—Request for reexport. 1312.28(d)—Distribution of special controlled substances invoice (DEA Form 236) copy 4. 1312.31(b)—Controlled substances transshipment permit application. 1312.32(a)—Advanced notice of importation for transshipment or transfer of controlled substances. 1313.12(b)—Authorization to import listed chemicals (DEA Form 486). 1313.12(e)—Quarterly reports of listed chemicals importation. 1313.21(b)—Authorization to export listed chemicals (DEA Form 486). 1313.21(e)—Quarterly reports of listed chemicals exportation. 1313.22(e)—Written notice of declared exports of listed chemicals refused, rejected or undeliverable. 1313.31(b)—Advanced notice of importation for transshipment or transfer of listed chemicals. 1313.32(b)(1)—International transaction authorization (DEA Form 486). 1314.110(a)(1)—Reports for mail-order sales. 1314.110(a)(2)—Request to submit mail-order sales reports in electronic form.

DEA Drug & Chemical Evaluation Section

1303.12(b)—Application for controlled substances procurement quota (DEA Form Drug Enforcement Administration, Attn: 250) filing and request. Drug & Chemical Evaluation Section/ 1303.12(d)—Controlled substances quota adjustment request. ODE, 8701 Morrissette Drive, Spring- field, VA 22152. 1303.22—Application for individual manufacturing quota (DEA Form 189) filing and request for schedule I or II controlled substances. 1304.31(a)—Manufacturers importing narcotic raw material report submission. 1304.32(a)—Manufacturers importing coca leaves report submission. 1308.24(d)—Exempt narcotic chemical preparations importer/exporter reporting. 1308.24(i)—Exempted chemical preparations listing. 1308.26(a)—Excluded veterinary anabolic steroid implant products listing. 1308.32—Exempted prescription products listing. 1308.34—Exempted anabolic steroid products listing. 1310.05(d)—Bulk manufacturer of listed chemicals reporting. 1315.22—Application for individual manufacturing quota for ephedrine, pseudoephedrine, phenylpropanolamine (DEA Form 189) filing and request. 1315.32(e)—Application for procurement quota for ephedrine, pseudoephedrine, phenylpropanolamine (DEA Form 250) filing and request. 1315.32(g)—Procurement quota adjustment request for ephedrine, pseudoephedrine, phenylpropanolamine. 1315.34(d)—Application for import quota for ephedrine, pseudoephedrine, phenylpropanolamine (DEA Form 488) request and filing. 1315.36(b)—Request import quota increase for ephedrine, pseudoephedrine, or phenylpropanolamine.

DEA ARCOS Unit

1304.04(d)—ARCOS separate central reporting identifier request ...... Drug Enforcement Administration, Attn: 1304.33(a)—Reports to ARCOS. ARCOS Unit/ODPT, P.O. Box 2520, Springfield, VA 22152–2520, OR Drug Enforcement Administration, Attn: ARCOS Unit, 8701 Morrissette Drive, Springfield, VA 22152.

DEA Registration Section

1301.03—Procedures information request (controlled substances registration) ...... Drug Enforcement Administration, Attn: 1301.13(e)(2)—Request DEA Forms 224, 225, and 363. Registration Section/ODR P.O. Box 1301.14(a)—Controlled substances registration application submission. 2639, Springfield, VA 22152–2639. 1301.18(c)—Research project controlled substance increase request. 1301.51—Controlled substances registration modification request. 1301.52(b)—Controlled substances registration transfer request. 1309.03—List I chemicals registration procedures information request. 1309.32(c)—Request DEA Form 510.

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TABLE OF DEA MAILING ADDRESSES—Continued

Code of Federal Regulations Section—Topic DEA Mailing address

1309.33(a)—List I chemicals registration application submission. 1309.61—List I chemicals registration modification request.

DEA Hearing Clerk

1316.45—Hearings documentation filing ...... Drug Enforcement Administration, Attn: 1316.46(a)—Inspection of record. Hearing Clerk/LJ, 8701 Morrissette Drive, Springfield, VA 22152.

DEA Federal Register Representative

1316.47(a)—Request for hearing ...... Drug Enforcement Administration, Attn: Federal Register Representative/ODL, 8701 Morrissette Drive, Springfield, VA 22152.

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Part Page 1400 [Reserved] 1401 Public availability of information ...... 249 1402 Mandatory declassification review ...... 252 1403 Uniform administrative requirements for grants and cooperative agreements to State and local governments ...... 253 1404 Governmentwide debarment and suspension (nonprocurement) ...... 286 1405 Governmentwide requirements for drug-free workplace (financial assistance) ...... 309 1406–1499 [Reserved]

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(f) Noncommercial scientific institution § 1401.5 How to request records. means an institution that is not oper- (a) Each request must reasonably de- ated on a commercial basis as that scribe the record(s) sought including term is defined in this section, and the type of document, specific event or that is operated solely for the purpose action, originator of the record, date or of conducting scientific research not time period, subject matter, location, intended to promote any particular and all other pertinent data. product or industry. (b) Requests must be received by (g) Records and any other terms used ONDCP through the mail or by elec- in this part in reference to information tronic facsimile transmission. Mailed includes any information that would be requests must be addressed to Execu- an agency record subject to the re- tive Office of the President, Office of quirements of this part when main- National Drug Control Policy, Office of tained in any format, including elec- Legal Counsel, Washington, DC 20503. tronic format. The applicable fax number is (202) 395– (h) Representative of the news media 5543. means any person actively gathering (c) The words ‘‘FOIA REQUEST’’ or news for an entity that is organized ‘‘REQUEST FOR RECORDS’’ must be and operated to publish or broadcast clearly marked on the cover-letter, let- news to the public. News is information ter and envelope. The time limitations about current events or information imposed by § 1401.7 will not begin until that would be of interest to the public. the Office of the General Counsel iden- Examples of the news media include tifies a letter or fax as a FOIA request. television or radio stations that broad- § 1401.6 Expedited process. cast to the public at large and pub- lishers of news periodicals that make (a) Requests and appeals will be given their products available to the general expedited treatment whenever ONDCP public for purchase or subscription. determines either: Freelance journalists may be regarded (1) The lack of expedited treatment as working for the news media where could reasonably be expected to pose they demonstrate a reasonable basis an imminent threat to the life or phys- for expecting publication through that ical safety of an individual; or organization, even though not actually (2) An urgency to inform the public employed by it. about an actual or alleged federal gov- (i) Request means a letter or other ernment activity occurs and the re- written communication seeking quest is made by a person primarily engaged in disseminating information. records or information under FOIA. (b) A request for expedited processing (j) Review means the process of exam- may be made at the time of the initial ining documents that are located dur- request for records or at a later time. ing a search to determine if any por- (c) A requester who seeks expedited tion should lawfully be withheld. It is processing must submit a statement, the processing of determining certified to be true and correct to the disclosability. best of that person’s knowledge and be- (k) Search means to review, manually lief, explaining in detail the basis for or by automated means, agency records requesting expedited processing. A re- for the purpose of locating those quester within the category in para- records responsive to a request. graph (a)(2) of this section also must establish a particular urgency to in- § 1401.4 Access to information. form the public about the government The Office of National Drug Control activity involved in the request, be- Policy makes available information yond the public’s right to know about pertaining to matters issued, adopted, government activity generally. The or promulgated by ONDCP, that are formality of certification may be within the scope of 5 U.S.C. 552(a)(2). A waived as a matter of administrative public reading area and the ONDCP discretion. FOIA Handbook are located at http:// (d) Within ten days of receipt of a re- www.whitehousedrugpolicy.gov/about/ quest for expedited processing, ONDCP about.html. will decide whether to grant it and will

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notify the requester of the decision. If (d) ONDCP may aggregate requests a request for expedited treatment is by a requester or a group of requestors granted, the request will be given pri- where multiple requests reasonably ap- ority and will be processed as soon as pear to be a single request. practicable. If a request for expedited processing is denied, any appeal of that § 1401.9 Appeals. decision will be acted on expeditiously. An appeal to the ONDCP must explain in writing the legal and factual § 1401.7 Prompt response. basis for the appeal. It must be re- The General Counsel, or designee, ceived by mail at the address specified will determine within 20 days (except- in § 1401.5 within 30 days of receipt of a ing Saturdays, Sundays and legal pub- denial. The Director or designee will lic holidays) after the receipt of a FOIA decide the appeal within 20 days (ex- request whether it is appropriate to cepting Saturdays, Sundays, and legal grant the request and will provide writ- public holidays). If the Director or des- ten notification to the person making ignee deny an appeal in whole or in the request. If the request is denied, the written notification will include part, the written determination will the names of the individuals who par- contain the reason for the denial, the ticipated in the determination, the rea- names of the individuals who partici- sons for the denial, and that an appeal pated in the determination, and the may be lodged within the Office of Na- provisions for judicial review. tional Drug Control Policy. § 1401.10 Fees to be charged—general. § 1401.8 Extension of time. ONDCP will recoup the full allowable (a) In unusual circumstances, the Of- costs it incurs in response to a FOIA fice of General Counsel may extend the request. time limit prescribed in § 1401.7 or (a) Manual search for records. ONDCP § 1401.9 by written notice to the FOIA will charge 116% of the salary of the in- requester. The notice will state the dividual(s) making a search. reasons for the extension and the date (b) Computerized search for records. a determination is expected. The ex- ONDCP will charge 116% of the salary tension period may be divided among of the programmer/operator and the the initial request and an appeal but apportionable time of the central proc- will not exceed a total of 10 working essing unit directly attributed to the days (excepting Saturdays, Sundays, or search. legal public holidays). (c) Review of records. ONDCP will (b) The phrase ‘‘unusual cir- charge 116% of the salary of the indi- cumstances’’ means: vidual(s) conducting a review. Records (1) The requested records are located or portions of records withheld under in establishments that are separated an exemption subsequently determined from the office processing the request; not to apply may be reviewed to deter- (2) A voluminous amount of separate mine the applicability of exemptions and distinct records are demanded in a not considered. The cost for a subse- single request; or quent review is assessable. (3) Another agency or two or more (d) Duplication of records. Request for components in the same agency have substantial interest in the determina- copies prepared by computer will cost tion of the request. 116% of the apportionable operator (c) Where unusual circumstance time and the cost of the tape or disk. exist, ONDCP may provide an oppor- Other methods of duplication will cost tunity for amendment of the initial re- 116% of the salary of the individual quest so that the request may be time- copying the data plus 15 cents per copy ly processed. Refusal by the person to of 81⁄2×11 inch original. reasonably modify the request or ar- (e) Other charges. ONDCP will recover range an alternative time frame shall the costs of providing other services be considered as a factor for purposes such as certifying records or sending of 5 U.S.C. 552 (a)(6)(C). records by special methods.

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§ 1401.11 Fees to be charged—miscella- commercial use. A request that sup- neous provisions. ports the news dissemination function (a) Remittance shall be mailed to the of the requester shall not be considered Office of Legal Counsel, ONDCP, Wash- a commercial use. ington DC 20503, and made payable to (4) All other requesters. ONDCP will re- the order of the Treasury of the United cover the full direct cost of the search States on a postal money order or per- and the reproduction of records, ex- sonal check or bank draft drawn on a cluding the first 100 pages of reproduc- bank in the United States. tion and the first two hours of search (b) ONDCP may require advance pay- time. Requests for records concerning ment where the estimated fee exceeds the requester will be treated under the $250, or a requester previously failed to fee provisions of the Privacy Act of pay within 30 days of the billing date. 1974, 5 U.S.C. 552a, which permits fees (c) ONDCP may assess interest only for reproduction. charges beginning the 31st day of billing. Interest will be at the rate pre- § 1401.13 Waiver or reduction of fees. scribed in section 3717 of title 31 of the United States Code and will accrue Fees chargeable in connection with a from the date of the billing. request may be waived or reduced (d) ONDCP may assess search charges where ONDCP determines that disclo- where records are not located or where sure is in the public interest because it records are exempt from disclosure. is likely to contribute significantly to (e) ONDCP may aggregate individual public understanding of the operations requests and charge accordingly for re- or activities of the Government and is quests seeking portions of a document not primarily in the commercial inter- or documents. est of the requester. § 1401.12 Fees to be charged—categories of requesters. PART 1402—MANDATORY (a) There are four categories of FOIA DECLASSIFICATION REVIEW requesters: commercial use requesters; educational and non-commercial sci- Sec. entific institutions; representatives of 1402.1 Purpose. the news media; and all other request- 1402.2 Responsibility. ers. 1402.3 Information in the custody of (b) The specific levels of fees for each ONDCP. of these categories are: 1402.4 Information classified by another (1) Commercial use requesters. ONDCP agency. will recover the full direct cost of pro- 1402.5 Appeal procedure. 1402.6 Fees. viding search, review and duplication 1402.7 Suggestions and complaints. services. Commercial use requesters will not receive free search-time or free AUTHORITY: Section 3.4, E.O. 12356 (3 CFR, reproduction of documents. 1982 Comp., p. 166), and Information Security (2) Educational and non-commercial sci- Oversight Office Directive No. 1 (32 CFR entific institution requesters. ONDCP will 2001.32). charge the cost of reproduction, ex- SOURCE: 57 FR 55089, Nov. 24, 1992, unless cluding charges for the first 100 pages. otherwise noted. Requesters must demonstrate the request is authorized by and under the § 1402.1 Purpose. auspices of a qualifying institution and Other government agencies, U.S. citi- that the records are sought for schol- zens or permanent resident aliens may arly or scientific research not a com- request that classified information in mercial use. files of the Office of National Drug (3) Requesters who are representatives of the news media. ONDCP will charge Control Policy (ONDCP) be reviewed the cost of reproduction, excluding for possible declassification and re- charges for the first 100 pages. Request- lease. This part prescribes the proce- ers must meet the criteria in § 1401.3(h), dures for such review and subsequent and the request must not be made for a release or denial.

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§ 1402.2 Responsibility. ONDCP, who will take action as nec- All requests for the mandatory de- essary to determine whether any part classification review of classified infor- of the information may be declassified. mation in ONDCP files should be ad- If so, the Director shall notify the re- dressed to the Security Officer, Office quester of this determination and shall of National Drug Control Policy, Exec- make any information available that is utive Office of the President, Wash- declassified and is otherwise releas- ington, DC 20500, who will acknowledge able. If continued classification is re- receipt of the request. When a request quired, the requester shall be notified does not reasonably describe the infor- by the Director of ONDCP of the rea- mation sought, the requester shall be sons therefore. notified that unless additional information is provided, or the scope of the § 1402.6 Fees. request is narrowed, no further action There will normally be no fees will be taken. charged for the mandatory review of classified material for declassification § 1402.3 Information in the custody of under this part. ONDCP. Information contained in ONDCP § 1402.7 Suggestions and complaints. files and under the exclusive declas- Suggestions and complaints regard- sification jurisdiction of ONDCP will ing the information security program be reviewed by the Director of the Of- of ONDCP should be submitted, in writ- fice of Planning, Budget, and Adminis- ing, to the Security Officer, Office of tration of ONDCP and/or the office of National Drug Control Policy, Wash- primary interest to determine whether, ington, DC 20500. under the declassification provisions of section 3.1 of Executive Order 12356 (3 CFR, 1982 Comp., p. 166), the requested PART 1403—UNIFORM ADMINIS- information may be declassified. If the TRATIVE REQUIREMENTS FOR information may not be released, in GRANTS AND COOPERATIVE whole or in part, the requester shall be AGREEMENTS TO STATE AND given a brief statement as to the rea- LOCAL GOVERNMENTS sons for denial, a notice of the right to appeal the determination to the Direc- Subpart A—General tor of ONDCP, and a notice that such an appeal must be filed within 60 days Sec. in order to be considered. 1403.1 Purpose and scope of this part. 1403.2 Scope of subpart. § 1402.4 Information classified by an- 1403.3 Definitions. other agency. 1403.4 Applicability. When a request is received for infor- 1403.5 Effect on other issuances. mation that was classified by another 1403.6 Additions and exceptions. agency, the Director of the Office of Subpart B—Pre-Award Requirements Planning, Budget, and Administration of ONDCP will forward the request and 1403.10 Forms for applying for grants. a copy of the document(s) along with 1403.11 State plans. any other related materials, to the ap- 1403.12 Special grant or subgrant conditions propriate agency for review and deter- for ‘‘high-risk’’ grantees. mination as to release. Recommenda- tions as to release or denial may be Subpart C—Post-Award Requirements made if appropriate. The requester will FINANCIAL ADMINISTRATION be notified of the referral, unless the receiving agency objects on the 1403.20 Standards for financial management systems. grounds that its association with the 1403.21 Payment. information requires protection. 1403.22 Allowable costs. 1403.23 Period of availability of funds. § 1402.5 Appeal procedure. 1403.24 Matching or cost sharing. Appeals reviewed as a result of a de- 1403.25 Program income. nial will be routed to the Director of 1403.26 Non-Federal audit.

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CHANGES, PROPERTY, AND SUBAWARDS (2) Services performed by employees, 1403.30 Changes. contractors, subgrantees, subcontrac- 1403.31 Real property. tors, and other payees; and 1403.32 Equipment. (3) Other amounts becoming owed 1403.33 Supplies. under programs for which no current 1403.34 Copyrights. services or performance is required, 1403.35 Subawards to debarred and sus- such as annuities, insurance claims, pended parties. 1403.36 Procurement. and other benefit payments. 1403.37 Subgrants. Accrued income means the sum of: (1) Earnings during a given period REPORTS, RECORDS, RETENTION, AND from services performed by the grantee ENFORCEMENT and goods and other tangible property 1403.40 Monitoring and reporting program delivered to purchasers, and performance. (2) Amounts becoming owed to the 1403.41 Financial reporting. grantee for which no current services 1403.42 Retention and access requirements for records. or performance is required by the 1403.43 Enforcement. grantee. 1403.44 Termination for convenience. Acquisition cost of an item of purchased equipment means the net in- Subpart D—After-The-Grant Requirements voice unit price of the property includ- 1403.50 Closeout. ing the cost of modifications, attach- 1403.51 Later disallowances and adjustments, accessories, or auxiliary appa- ments. ratus necessary to make the property 1403.52 Collection of amounts due. usable for the purpose for which it was acquired. Other charges such as the Subpart E—Entitlement [Reserved] cost of installation, transportation, taxes, duty or protective in-transit in- APPENDIX A TO PART 1403—OMB CIRCULAR A– surance, shall be included or excluded 128, ‘‘AUDITS OF STATE AND LOCAL GOV- from the unit acquisition cost in ac- ERNMENTS’’ cordance with the grantee’s regular ac- AUTHORITY: 5 U.S.C. 301. counting practices. SOURCE: 57 FR 55092, Nov. 24, 1992, unless Administrative requirements mean otherwise noted. those matters common to grants in general, such as financial management, Subpart A—General kinds and frequency of reports, and retention of records. These are distin- § 1403.1 Purpose and scope of this guished from ‘‘programmatic’’ require- part. ments, which concern matters that can This part establishes uniform admin- be treated only on a program-by-pro- istrative rules for Federal grants and gram or grant-by-grant basis, such as cooperative agreements and subawards kinds of activities that can be sup- to State, local and Indian tribal gov- ported by grants under a particular ernments. program. Awarding agency means: § 1403.2 Scope of subpart. (1) With respect to a grant, the Fed- This subpart contains general rules eral agency, and pertaining to this part and procedures (2) With respect to a subgrant, the for control of exceptions from this party that awarded the subgrant. part. Cash contributions means the grantee’s cash outlay, including the outlay § 1403.3 Definitions. of money contributed to the grantee or As used in this part: subgrantee by other public agencies Accrued expenditures mean the and institutions, and private organiza- charges incurred by the grantee during tions and individuals. When authorized a given period requiring the provision by Federal legislation, Federal funds of funds for: received from other assistance agree- (1) Goods and other tangible property ments may be considered as grantee or received; subgrantee cash contributions.

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Contract means (except as used in the direct appropriations. Also, the term definitions for ‘‘grant’’ and ‘‘subgrant’’ does not include assistance, such as a in this section and except where quali- fellowship or other lump sum award, fied by ‘‘Federal’’) a procurement con- which the grantee is not required to ac- tract under a grant or subgrant, and count for. means a procurement subcontract Grantee means the government to under a contract. which a grant is awarded and which is Cost sharing or matching means the accountable for the use of the funds value of the third party in-kind con- provided. The grantee is the entire tributions and the portion of the costs legal entity even if only a particular of a federally assisted project or pro- component of the entity is designated gram not borne by the Federal Govern- in the grant award document. ment. Local government means a county, Cost-type contract means a contract or municipality, city, town, township, subcontract under a grant in which the local public authority (including any contractor or subcontractor is paid on public and Indian housing agency the basis of the costs it incurs, with or under the United States Housing Act of without a fee. 1937) school district, special district, Equipment means tangible, non- intrastate district, council of govern- expendable, personal property having a ments (whether or not incorporated as useful life of more than one year and a nonprofit corporation under state an acquisition cost of $5,000 or more law), any other regional or interstate per unit. A grantee may use its own government entity, or any agency or definition of equipment provided that instrumentality of a local government. such definition would at least include Obligations means the amounts of or- all equipment defined above. ders placed, contracts and subgrants Expenditure report means: awarded, goods and services received, (1) For nonconstruction grants, the and similar transactions during a given SF–269 ‘‘Financial Status Report’’ (or period that will require payment by other equivalent report); the grantee during the same or a future (2) For construction grants, the SF– period. 271 ‘‘Outlay Report and Request for Re- OMB means the United States Office imbursement’’ (or other equivalent re- of Management and Budget. port). Outlays (expenditures) means charges Federally recognized Indian tribal gov- made to the project or program. They ernment means the governing body or a may be reported on a cash or accrual governmental agency of any Indian basis. For reports prepared on a cash tribe, band, nation, or other organized basis, outlays are the sum of actual group or community (including any cash disbursement for direct charges Native village as defined in section 3 of for goods and service, the amount of in- the Alaska Native Claims Settlement direct expense incurred, the value of Act, 85 Stat. 688) certified by the Sec- in-kind contributions applied, and the retary of the Interior as eligible for the amount of cash advances and payments special programs and services provided made to contractors and subgrantees. by him through the Bureau of Indian For reports prepared on an accrued ex- Affairs. penditure basis, outlays are the sum of Government means a State or local actual cash disbursements, the amount government or a federally recognized of indirect expense incurred, the value Indian tribal government. of in-kind contributions applied, and Grant means an award of financial as- the new increase (or decrease) in the sistance, including cooperative agree- amounts owed by the grantee for goods ments, in the form of money, or prop- and other property received, for serv- erty in lieu of money, by the Federal ices performed by employees, contrac- Government to an eligible grantee. The tors, subgrantees, subcontractors, and term does not include technical assist- other payees, and other amounts be- ance which provides services instead of coming owed under programs for which money, or other assistance in the form no current services or performance are of revenue sharing, loans, loan guaran- required, such as annuities, insurance tees, interest subsidies, insurance, or claims, and other benefit payments.

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Percentage of completion method refers subgrantee or a decision to terminate to a system under which payments are the grant, or made for construction work according (2) In action taken by a suspending to the percentage of completion of the official in accordance with agency reg- work, rather than to the grantee’s cost ulations implementing E.O. 12549 to incurred. immediately exclude a person from Prior approval means documentation participating in grant transactions for evidencing consent prior to incurring a period, pending completion of an in- specific cost. vestigation and such legal or debar- Real property means land, including ment proceedings as may ensue. land improvements, structures and ap- Termination means permanent with- purtenances thereto, excluding mov- drawal of the authority to obligate pre- able machinery and equipment. viously-awarded grant funds before Share, when referring to the awarding that authority would otherwise expire. agency’s portion of real property, It also means the voluntary relinquish- equipment or supplies, means the same ment of that authority by the grantee percentage as the awarding agency’s or subgrantee. ‘‘Termination’’ does not portion of the acquiring party’s total include: costs under the grant to which the ac- (1) Withdrawal of funds awarded on quisition costs under the grant to the basis of the grantee’s underesti- which the acquisition cost of the prop- mate of the unobligated balance in a erty was charged. Only costs are to be prior period; counted—not the value of third-party (2) Withdrawal of the unobligated in-kind contributions. balance as of the expiration of a grant; State means any of the several States (3) Refusal to extend a grant or of the United States, the District of award additional funds, to make a com- Columbia, the Commonwealth of Puer- peting or noncompeting continuation, to Rico, any territory or possession of renewal, extension, or supplemental the United States, or any agency or in- award; or strumentality of a State exclusive of local governments. The term does not (4) Voiding of a grant upon deter- include any public and Indian housing mination that the award was obtained agency under United States Housing fraudulently, or was otherwise illegal Act of 1937. or invalid from inception. Subgrant means an award of financial Terms of a grant or subgrant mean all assistance in the form of money, or requirements of the grant or subgrant, property in lieu of money, made under whether in statute, regulations, or the a grant by a grantee to an eligible sub- award document. grantee. The term includes financial Third party in-kind contributions mean assistance when provided by contrac- property or services which benefit a tual legal agreement, but does not in- federally assisted project or program clude procurement purchases, nor does and which are contributed by non-Fed- it include any form of assistance which eral third parties without charge to the is excluded from the definition of grantee, or a cost-type contractor ‘‘grant’’ in this part. under the grant agreement. Subgrantee means the government or Unliquidated obligations for reports other legal entity to which a subgrant prepared on a cash basis mean the is awarded and which is accountable to amount of obligations incurred by the the grantee for the use of the funds grantee that has not been paid. For re- provided. ports prepared on an accrued expendi- Supplies means all tangible personal ture basis, they represent the amount property other than ‘‘equipment’’ as of obligations incurred by the grantee defined in this part. for which an outlay has not been re- Suspension means depending on the corded. context, either Unobligated balance means the por- (1) Temporary withdrawal of the au- tion of the funds authorized by the thority to obligate grant funds pending Federal agency that has not been obli- corrective action by the grantee or gated by the grantee and is determined

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by deducting the cumulative obliga- (4) Entitlement grants under the fol- tions from the cumulative funds au- lowing programs of The National thorized. School Lunch Act: (i) School Lunch (section 4 of the § 1403.4 Applicability. Act), (a) General. Subparts A–D of this part (ii) Commodity Assistance (section 6 apply to all grants and subgrants to of the Act), governments, except where incon- (iii) Special Meal Assistance (section sistent with Federal statutes or with 11 of the Act), regulations authorized in accordance (iv) Summer Food Service for Chil- with the exception provision of § 1403.6, dren (section 13 of the Act), and or: (v) Child Care Food Program (section (1) Grants and subgrants to State and 17 of the Act); local institutions of higher education (5) Entitlement grants under the fol- or State and local hospitals; lowing programs of The Child Nutri- (2) The block grants authorized by tion Act of 1966: the Omnibus Budget Reconciliation (i) Special Milk (section 3 of the Act), Act of 1981 (Community Services; Pre- and ventive Health and Health Services; Al- (ii) School Breakfast (section 4 of the cohol, Drug Abuse, and Mental Health Act); Services; Maternal and Child Health (6) Entitlement grants for State Ad- Services; Social Services; Low-Income ministrative expenses under The Food Home Energy Assistance; States’ Pro- Stamp Act of 1977 (section 16 of the gram of Community Development Act); Block Grants for Small Cities; and Ele- (7) A grant for an experimental, pilot, mentary and Secondary Education or demonstration project that is also other than programs administered by supported by a grant listed in para- the Secretary of Education under title graph (a)(3) of this section; V, subtitle D, chapter 2, section 583— (8) Grant funds awarded under sub- the Secretary’s discretionary grant section 412(e) of the Immigration and program) and titles I–III of the Job Nationality Act (8 U.S.C. 1522(e)) and Training Partnership Act of 1982 and subsection 501(a) of the Refugee Edu- under the Public Health Services Act cation Assistance Act of 1980 (Pub. L. (Section 1921), Alcohol and Drug Abuse 96–422, 94 Stat. 1809), for cash assist- Treatment and Rehabilitation Block ance, medical assistance, and supple- Grant and part C of title V, Mental mental security income benefits to ref- Health Service for the Homeless Block ugees and entrants and the administra- Grant); tive costs of providing the assistance (3) Entitlement grants to carry out and benefits; the following programs of the Social (9) Grants to local education agencies Security Act: under 20 U.S.C. 236 through 241–1(a), (i) Aid to Needy Families with De- and 242 through 244 (portions of the Im- pendent Children (title IV–A of the pact Aid program), except for 20 U.S.C. Act, not including the Work Incentive 238(d)(2)(c) and 240(f) (Entitlement In- Program (WIN) authorized by section crease for Handicapped Children); and 402(a)19(G); HHS grants for WIN are (10) Payments under the Veterans subject to this part); Administration’s State Home Per Diem (ii) Child Support Enforcement and Program (38 U.S.C. 641(a)). Establishment of Paternity (title IV–D (b) Entitlement programs. Entitlement of the Act); programs enumerated above in (iii) Foster Care and Adoption Assist- § 1403.4(a) (3) through (8) are subject to ance (title IV–E of the Act); subpart E. (iv) Aid to the Aged, Blind, and Dis- abled (titles I, X, XIV, and XVI–AABD § 1403.5 Effect on other issuances. of the Act); and All other grants administration pro- (v) Medical Assistance (Medicaid) visions of codified program regula- (title XIX of the Act) not including the tions, program manuals, handbooks State Medicaid Fraud Control program and other nonregulatory materials authorized by section 1903(a)(6)(B); which are inconsistent with this part

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are superseded, except to the extent work under a grant. Other supple- they are required by statute, or au- mentary instructions may be issued thorized in accordance with the excep- only with the approval of OMB to the tion provision in § 1403.6. extent required under the Paperwork Reduction Act of 1980. For any stand- § 1403.6 Additions and exceptions. ard form, except the SF–424 facesheet, (a) For classes of grants and grantees Federal agencies may shade out or in- subject to this part, Federal agencies struct the applicant to disregard any may not impose additional administra- line item that is not needed. tive requirements except in codified (4) When a grantee applies for addi- regulations published in the FEDERAL tional funding (such as a continuation REGISTER. or supplemental award) or amends a (b) Exceptions for classes of grants or previously submitted application, only grantees may be authorized only by the affected pages need be submitted. OMB. Previously submitted pages with infor- (c) Exceptions on a case-by-case basis mation that is still current need not be and for subgrantees may be authorized resubmitted. by the affected Federal agencies. § 1403.11 State plans. Subpart B—Pre-Award (a) Scope. The statutes for some pro- Requirements grams require States to submit plans before receiving grants. Under regula- § 1403.10 Forms for applying for tions implementing Executive Order grants. 12372, ‘‘Intergovernmental Review of (a) Scope. (1) This section prescribes Federal Programs,’’ States are allowed forms and instructions to be used by to simplify, consolidate and substitute governmental organizations (except plans. This section contains additional hospitals and institutions of higher provisions for plans that are subject to education operated by a government) regulations implementing the Execu- in applying for grants. This section is tive Order. not applicable, however, to formula (b) Requirements. A State need meet grant programs which do not require only Federal administrative or pro- applicants to apply for funds on a grammatic requirements for a plan project basis. that are in statutes or codified regula- (2) This section applies only to appli- tions. cations to Federal agencies for grants, (c) Assurances. In each plan the and is not required to be applied by States will include an assurance that grantees in dealing with applicants for the State shall comply with all appli- subgrants. However, grantees are en- cable Federal statutes and regulations couraged to avoid more detailed or bur- in effect with respect to the periods for densome application requirements for which it receives grant funding. For subgrants. this assurance and other assurances re- (b) Authorized forms and instructions quired in the plan, the State may: for governmental organizations. (1) In ap- (1) Cite by number the statutory or plying for grants, applicants shall only regulatory provisions requiring the as- use standard application forms or those surances and affirm that it gives the prescribed by the granting agency with assurances required by those provi- the approval of OMB under the Paper- sions, work Reduction Act of 1980. (2) Repeat the assurance language in (2) Applicants are not required to the statutes or regulations, or submit more than the original and two (3) Develop its own language to the copies of preapplications or applica- extent permitted by law. tions. (d) Amendments. A State will amend a (3) Applicants must follow all appli- plan whenever necessary to reflect: (1) cable instructions that bear OMB New or revised Federal statutes or reg- clearance numbers. Federal agencies ulations or (2) a material change in any may specify and describe the programs, State law, organization, policy, or functions, or activities that will be State agency operation. The State will used to plan, budget, and evaluate the obtain approval for the amendment and

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its effective date but need submit for Subpart C—Post-Award approval only the amended portions of Requirements the plan. FINANCIAL ADMINISTRATION § 1403.12 Special grant or subgrant conditions for ‘‘high-risk’’ grantees. § 1403.20 Standards for financial man- (a) A grantee or subgrantee may be agement systems. considered ‘‘high risk’’ if an awarding (a) A State must expend and account agency determines that a grantee or for grant funds in accordance with subgrantee: State laws and procedures for expend- (1) Has a history of unsatisfactory ing and accounting for its own funds. performance, or Fiscal control and accounting proce- (2) Is not financially stable, or dures of the State, as well as its sub- (3) Has a management system which grantees and cost-type contractors, does not meet the management stand- must be sufficient to— ards set forth in this part, or (1) Permit preparation of reports re- (4) Has not conformed to terms and quired by this part and the statutes au- conditions of previous awards, or thorizing the grant, and (5) Is otherwise not responsible; and (2) Permit the tracing of funds to a if the awarding agency determines that level of expenditures adequate to es- an award will be made, special condi- tablish that such funds have not been tions and/or restrictions shall cor- used in violation of the restrictions respond to the high risk condition and and prohibitions of applicable statutes. shall be included in the award. (b) The financial management sys- (b) Special conditions or restrictions tems of other grantees and subgrantees may include: must meet the following standards: (1) Payment on a reimbursement (1) Financial reporting. Accurate, cur- basis; rent, and complete disclosure of the fi- (2) Withholding authority to proceed nancial results of financially assisted to the next phase until receipt of evi- activities must be made in accordance dence of acceptable performance within with the financial reporting require- a given funding period; ments of the grant or subgrant. (3) Requiring additional, more de- (2) Accounting records. Grantees and tailed financial reports; subgrantees must maintain records (4) Additional project monitoring; which adequately identify the source (5) Requiring the grantee or sub- and application of funds provided for fi- grantee to obtain technical or manage- nancially-assisted activities. These ment assistance; or records must contain information per- (6) Establishing additional prior ap- taining to grant or subgrant awards provals; and authorizations, obligations, unobli- (c) If an awarding agency decides to gated balances, assets, liabilities, out- impose such conditions, the awarding lays or expenditures, and income. official will notify the grantee or sub- (3) Internal control. Effective control grantee as early as possible, in writing, and accountability must be maintained of: for all grant and subgrant cash, real (1) The nature of the special condi- and personal property, and other as- tions/restrictions; sets. Grantees and subgrantees must (2) The reason(s) for imposing them; adequately safeguard all such property (3) The corrective actions which must and must assure that it is used solely be taken before they will be removed for authorized purposes. and the time allowed for completing (4) Budget control. Actual expendi- the corrective actions; and tures or outlays must be compared (4) The method of requesting recon- with budgeted amounts for each grant sideration of the conditions/restric- or subgrant. Financial information tions imposed.

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must be related to performance or pro- (b) Basic standard. Methods and productivity data, including the develop- cedures for payment shall minimize ment of unit cost information when- the time elapsing between the transfer ever appropriate or specifically re- of funds and disbursement by the quired in the grant or subgrant agree- grantee or subgrantee, in accordance ment. If unit cost data are required, es- with Treasury regulations at 31 CFR timates based on available documenta- part 205. tion will be accepted whenever pos- (c) Advances. Grantees and sub- sible. grantees shall be paid in advance, pro- (5) Allowable cost. Applicable OMB vided they maintain or demonstrate cost principles, agency program regula- the willingness and ability to maintain tions, and the terms of grant and procedures to minimize the time elaps- subgrant agreements will be followed ing between the transfer of the funds in determining the reasonableness, al- and their disbursement by the grantee lowability, and allocability of costs. or subgrantee. (6) Source documentation. Accounting (d) Reimbursement. Reimbursement records must be supported by such shall be the preferred method when the source documentation as canceled requirements in paragraph (c) of this checks, paid bills, payrolls, time and section are not met. Grantees and sub- attendance records, contract and grantees may also be paid by reim- subgrant award documents, etc. bursement for any construction grant. Except as otherwise specified in regula- (7) Cash management. Procedures for tion, Federal agencies shall not use the minimizing the time elapsing between percentage of completion method to the transfer of funds from the U.S. pay construction grants. The grantee Treasury and disbursement by grantees or subgrantee may use that method to and subgrantees must be followed pay its construction contractor, and if whenever advance payment procedures it does, the awarding agency’s pay- are used. Grantees must establish rea- ments to the grantee or subgrantee sonable procedures to ensure the re- will be based on the grantee’s or sub- ceipt of reports on subgrantees’ cash grantee’s actual rate of disbursement. balances and cash disbursements in (e) Working capital advances. If a sufficient time to enable them to pre- grantee cannot meet the criteria for pare complete and accurate cash trans- advance payments described in para- actions reports to the awarding agen- graph (c) of this section, and the Fed- cy. When advances are made by letter- eral agency has determined that reim- of-credit or electronic transfer of funds bursement is not feasible the grantee methods, the grantee must make lacks sufficient working capital, the drawdowns as close as possible to the awarding agency may provide cash or a time of making disbursements. Grant- working capital advance basis. Under ees must monitor cash drawdowns by this procedure the awarding agency their subgrantees to assure that they shall advance cash to the grantee to conform substantially to the same cover its estimated disbursement needs standards of timing and amount as for an initial period generally geared apply to advances to the grantees. to the grantee’s disbursing cycle. (c) An awarding agency may review Thereafter, the awarding agency shall the adequacy of the financial manage- reimburse the grantee for its actual ment system of any applicant for fi- cash disbursements. The working cap- nancial assistance as part of a ital advance method of payment shall preaward review or at any time subse- not be used by grantees or subgrantees quent to award. if the reason for using such method is the unwillingness or inability of the § 1403.21 Payment. grantee to provide timely advances to (a) Scope. This section prescribes the the subgrantee to meet the sub- basic standard and the methods under grantee’s actual cash disbursements. which a Federal agency will make pay- (f) Effect of program income, refunds, ments to grantees, and grantees will and audit recoveries on payment. (1) make payments to subgrantees and Grantees and subgrantees shall dis- contractors. burse repayments to and interest

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earned on a revolving fund before re- subgrantees shall promptly, but at questing additional cash payments for least quarterly, remit interest earned the same activity. on advances to the Federal agency. The (2) Except as provided in paragraph grantee or subgrantee may keep inter- (f)(1) of this section, grantees and sub- est amounts up to $100 per year for ad- grantees shall disburse program in- ministrative expenses. come, rebates, refunds, contract settle- ments, audit recoveries and interest § 1403.22 Allowable costs. earned on such funds before requesting (a) Limitation on use of funds. Grant additional cash payments. funds may be used only for: (g) Withholding payments. (1) Unless otherwise required by Federal statute, (1) The allowable costs of the grant- awarding agencies shall not withhold ees, subgrantees and cost-type contrac- payments for proper charges incurred tors, including allowable costs in the by grantees or subgrantees unless— form of payments to fixed-price con- (i) The grantee or subgrantee has tractors; and failed to comply with grant award con- (2) Reasonable fees or profit to cost- ditions or type contractors but not any fee or (ii) The grantee or subgrantee is in- profit (or other increment above allow- debted to the United States. able costs) to the grantee or sub- (2) Cash withheld for failure to com- grantee. ply with grant award condition, but (b) Applicable cost principles. For each without suspension of the grant, shall kind of organization, there is a set of be released to the grantee upon subse- Federal principles for determining al- quent compliance. When a grant is sus- lowable costs. Allowable costs will be pended, payment adjustments will be determined in accordance with the cost made in accordance with § 1403.43(c). principles applicable to the organiza- (3) A Federal agency shall not make tion incurring the costs. The following payment to grantees for amounts that chart lists the kinds of organizations are withheld by grantees or sub- and the applicable cost principles. grantees from payment to contractors to assure satisfactory completion of For the costs of a— Use the principles in— work. Payments shall be made by the State, local or Indian tribal OMB Circular A–87. Federal agency when the grantees or government. subgrantees actually disburse the with- Private nonprofit organization OMB Circular A–122. held funds to the contractors or to es- other than (1) institution of crow accounts established to assure higher education, (2) hospital, or (3) organization satisfactory completion of work. named in OMB Circular A– (h) Cash depositories. (1) Consistent 122 as not subject to that with the national goal of expanding the circular. opportunities for minority business en- Educational institutions ...... OMB Circular A–21. For-profit organizations other 48 CFR part 31. Contract terprises, grantees and subgrantees are than a hospital and an or- Cost Principles and Proce- encouraged to use minority banks (a ganization named in OMB dures, or uniform cost ac- bank which is owned at least 50 percent Circular A–122 as not sub- counting standards that by minority group members). A list of ject to that circular. comply with cost principles acceptable to the Federal minority owned banks can be obtained agency. from the Minority Business Develop- ment Agency, Department of Com- § 1403.23 Period of availability of merce, Washington, DC 20230. funds. (2) A grantee or subgrantee shall maintain a separate bank account only (a) General. Where a funding period is when required by Federal-State agree- specified, a grantee may charge to the ment. award only costs resulting from obliga- (i) Interest earned on advances. Except tions of the funding period unless car- for interest earned on advances of ryover of unobligated balances is per- funds exempt under the Intergovern- mitted, in which case the carryover mental Cooperation Act (31 U.S.C. 6501 balances may be charged for costs re- et seq.) and the Indian Self-Determina- sulting from obligations of the subse- tion Act (23 U.S.C. 450), grantees and quent funding period.

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(b) Liquidation of obligations. A grant- wards satisfying a cost sharing or ee must liquidate all obligations in- matching requirement unless they are curred under the award not later than expressly permitted in the terms of the 90 days after the end of the funding pe- assistant agreement. (This use of gen- riod (or as specified in a program regu- eral program income is described in lation) to coincide with the submission § 1403.25(g).) of the annual Financial Status Report (5) Services or property financed by in- (SF–269). The Federal agency may ex- come earned by contractors. Contractors tend this deadline at the request of the under a grant may earn income from grantee. the activities carried out under the contract in addition to the amounts § 1403.24 Matching or cost sharing. earned from the party awarding the (a) Basic rule: Costs and contributions contract. No costs of services or prop- acceptable. With the qualifications and erty supported by this income may exceptions listed in paragraph (b) of count toward satisfying cost sharing or this section, a matching or cost shar- matching requirement unless other ing requirement may be satisfied by ei- provisions of the grant agreement ex- ther or both of the following: pressly permit this kind of income to (1) Allowable costs incurred by the be used to meet the requirement. grantee, subgrantee or a cost-type con- (6) Records. Costs and third party in- tractor under the assistance agree- kind contributions counting towards ment. This includes allowable costs satisfying a cost sharing or matching borne by non-Federal grants or by oth- requirement must be verifiable from ers cash donations from non-Federal the records of grantees and subgrantee third parties. or cost-type contractors. These records (2) The value of third party in-kind must show how the value placed on contributions applicable to the period third party in-kind contributions was to which the cost sharing or matching derived. To the extent feasible, volun- requirements applies. teer services will be supported by the (b) —(1) Qualifications and exceptions same methods that the organization Costs borne by other Federal grant agree- uses to support the allocability of reg- ments. Except as provided by Federal ular personnel costs. statute, a cost sharing or matching requirement may not be met by costs (7) Special standards for third party in- borne by another Federal grant. This kind contributions. (i) Third party in- prohibition does not apply to income kind contributions count towards sat- earned by a grantee or subgrantee from isfying a cost sharing or matching re- a contract awarded under another Fed- quirement only where, if the party re- eral grant. ceiving the contributions were to pay (2) General revenue sharing. For the for them, the payments would be allow- purpose of this section, general revenue able costs. sharing funds distributed under 31 (ii) Some third party in-kind con- U.S.C. 6702 are not considered Federal tributions are goods and services that, grant funds. if the grantee, subgrantee, or con- (3) Cost or contributions counted to- tractor receiving the contribution had wards other Federal cost-sharing require- to pay for them, the payments would ments. Neither costs nor the values of have been an indirect costs. Costs shar- third party in-kind contributions may ing or matching credit for such con- count towards satisfying a cost sharing tributions shall be given only if the or matching requirement of a grant grantee, subgrantee, or contractor has agreement if they have been or will be established, along with its regular indi- counted towards satisfying a cost shar- rect cost rate, a special rate for allo- ing or matching requirement of an- cating to individual projects or pro- other Federal grant agreement, a Fed- grams the value of the contributions. eral procurement contract, or any (iii) A third party in-kind contribu- other award of Federal funds. tion to a fixed-price contract may (4) Costs financed by program income. count towards satisfying a cost sharing Costs financed by program income, as or matching requirement only if it re- defined in § 1403.25, shall not count to- sults in:

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(A) An increase in the services or (1) Awards for capital expenditures. If property provided under the contract the purpose of the grant or subgrant is (without additional cost to the grantee to assist the grantee or subgrantee in or subgrantee) or the acquisition of property, the market (B) A cost savings to the grantee or value of that property at the time of subgrantee. donation may be counted as cost shar- (iv) The values placed on third party ing or matching. in-kind contributions for cost sharing (2) Other awards. If assisting in the or matching purposes will conform to acquisition of property is not the pur- the rules in the succeeding sections of pose of the grant or subgrant, para- this part. If a third party in-kind con- graphs (e)(2) (i) and (ii) of this section tribution is a type not treated in those apply: sections, the value placed upon it shall (i) If approval is obtained from the be fair and reasonable. awarding agency, the market value at (c) Valuation of donated services—(1) the time of donation of the donated Volunteer services. Unpaid services pro- equipment or buildings and the fair vided to a grantee or subgrantee by in- rental rate of the donated land may be dividuals will be valued at rates con- counted as cost sharing or matching. sistent with those ordinarily paid for In the case of a subgrant, the terms of similar work in the grantee’s or sub- the grant agreement may require that grantee’s organization. If the grantee the approval be obtained from the Fed- or subgrantee does not have employees eral agency as well as the grantee. In performing similar work, the rates will all cases, the approval may be given be consistent with those ordinarily only if a purchase of the equipment or paid by other employers for similar rental of the land would be approved as work in the same labor market. In ei- an allowable direct cost. If any part of ther case, a reasonable amount for the donated property was acquired fringe benefits may be included in the with Federal funds, only the non-fed- valuation. eral share of the property may be (2) Employees of other organizations. counted as cost-sharing or matching. When an employer other than a grant- (ii) If approval is not obtained under ee, subgrantee, or cost-type contractor paragraph (e)(2)(i) of this section, no furnishes free of charge the services of amount may be counted for donated an employee in the employee’s normal land, and only depreciation or use al- line of work, the services will be valued lowances may be counted for donated at the employee’s regular rate of pay equipment and buildings. The deprecia- exclusive of the employee’s fringe ben- tion or use allowances for this property efits and overhead costs. If the services are not treated as third party in-kind are in a different line of work, para- contributions. Instead, they are treat- graph (c)(1) of this section applies. ed as costs incurred by the grantee or (d) Valuation of third party donated subgrantee. They are computed and al- supplies and loaned equipment or space. located (usually as indirect costs) in (1) If a third party donates supplies, accordance with the cost principles the contribution will be valued at the specified in § 1403.22, in the same way as market value of the supplies at the depreciation or use allowances for pur- time of donation. chased equipment and buildings. The (2) If a third party donates the use of amount of depreciation or use allow- equipment or space in a building but ances for donated equipment and build- retains title, the contribution will be ings is based on the property’s market valued at the fair rental rate of the value at the time it was donated. equipment or space. (f) Valuation of grantee or subgrantee (e) Valuation of third party donated donates real property for construction/ac- equipment, buildings, and land. If a third quisition. If a grantee or subgrantee do- party donates equipment, buildings, or nates real property for a construction land, and title passes to a grantee or or facilities acquisition project, the subgrantee, the treatment of the do- current market value of that property nated property will depend upon the may be counted as cost sharing or purpose of the grant or subgrant, as matching. If any part of the donated follows: property was acquired with Federal

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funds, only the non-federal share of the (e) Royalties. Income from royalties property may be counted as cost shar- and license fees for copyrighted mate- ing or matching. rial, patents, and inventions developed (g) Appraisal of real property. In some by a grantee or subgrantee is program cases under paragraphs (d), (e) and (f) income only if the revenues are specifi- of this section, it will be necessary to cally identified in the grant agreement establish the market value of land or a or Federal agency regulations as pro- building or the fair rental rate of land gram income. (See § 1403.34.) or of space in a building. In these cases, (f) Property. Proceeds from the sale of the Federal agency may require the real property or equipment will be han- market value or fair rental value be set dled in accordance with the require- by an independent appraiser, and that ments of § 1403.31 and § 1403.32. the value or rate be certified by the (g) Use of program income. Program grantee. This requirement will also be income shall be deducted from outlays imposed by the grantee on subgrantees. which may be both Federal and non- Federal as described below, unless the § 1403.25 Program income. Federal agency regulations or the grant agreement specify another alter- (a) General. Grantees are encouraged native (or a combination of the alter- to earn income to defray program natives). In specifying alternatives, the costs. Program income includes income Federal agency may distinguish be- from fees for services performed, from tween income earned by the grantee the use of rental of real or personal and income earned by subgrantees and property acquired with grant funds, between the sources, kinds, or amounts from the sale of commodities or items of income. When Federal agencies au- fabricated under a grant agreement, thorize the alternatives in paragraphs and from payments of principal and in- (g) (2) and (3) of this section, program terest on loans made with grant funds. income in excess of any limits stipu- Except as otherwise provided in regula- lated shall also be deducted from out- tions of the Federal agency, program lays. income does not include interest on (1) Deduction. Ordinarily program in- grant funds, rebates, credits, discounts, come shall be deducted from total al- refunds, etc., and interest earned on lowable costs to determine the net al- any of them. lowable costs. Program income shall be (b) Definition of program income. Pro- used for current costs unless the Fed- gram income means gross income re- eral agency authorizes otherwise. Pro- ceived by the grantee or subgrantee di- gram income which the grantee did not rectly generated by a grant supported anticipate at the time of the award activity, or earned only as a result of shall be used to reduce the Federal the grant agreement during the grant agency and grantee contributions rath- period. ‘‘During the grant period’’ is er than to increase the funds com- the time between the effective date of mitted to the project. the award and the ending date of the (2) Addition. When authorized, pro- award reflected in the final financial gram income may be added to the report. funds committed to the grant agree- (c) Cost of generating program income. ment by the Federal agency and the If authorized by Federal regulations or grantee. The program income shall be the grant agreement, costs incident to used for the purposes and under the the generation of program income may conditions of the grant agreement. be deducted from gross income to de- (3) Cost sharing or matching. When au- termine program income. thorized, program income may be used (d) Governmental revenues. Taxes, spe- to meet the cost sharing or matching cial assessments levies, fines, and other requirement of the grant agreement. such revenues raised by a grantee or The amount of the Federal grant award subgrantee are not program income un- remains the same. less the revenues are specifically iden- (h) Income after the award period. tified in the grant agreement or Fed- There are no Federal requirements gov- eral agency regulations as program in- erning the disposition of program income. come earned after the end of the award

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period (i.e., until the ending date of the after receipt of the audit report in in- final financial report, see paragraph (a) stance of noncompliance with Federal of this section), unless the terms of the laws and regulations; agreement or the Federal agency regu- (4) Consider whether subgrantee au- lations provide otherwise. dits necessitate adjustment of the grantee’s own records; and § 1403.26 Non-Federal audit. (5) Require each subgrantee to permit (a) Basic rule. Grantees and sub- independent auditors to have access to grantees are responsible for obtaining the records and financial statements. audits in accordance with the Single (c) Auditor selection. In arranging for Audit Act Amendments of 1996 (31 audit services, § 1403.36 shall be fol- U.S.C. 7501–7507) and revised OMB Cir- lowed. cular A–133, ‘‘Audits of States, Local Governments, and Non-Profit Organi- [57 FR 55092, Nov. 24, 1992, as amended at 62 zations.’’ The audits shall be made by FR 45939, 45941, Aug. 29, 1997] an independent auditor in accordance CHANGES, PROPERTY, AND SUBAWARDS with generally accepted government auditing standards covering financial § 1403.30 Changes. audits. (b) Subgrantees. State or local govern- (a) General. Grantees and subgrantees ments, as those terms are defined for are permitted to rebudget within the purposes of the Single Audit Act approved direct cost budget to meet Amendments of 1996, that provide Fed- unanticipated requirements and may eral awards to a subgrantee, which ex- make limited program changes to the pends $300,000 or more (or other approved project. However, unless amount as specified by OMB) in Fed- waived by the awarding agency, certain eral awards in a fiscal year, shall: types of post-award changes in budgets (1) Determine whether State or local and projects shall require the prior subgrantees have met the audit re- written approval of the awarding agen- quirements of the Act and whether sub- cy. grantees covered by OMB Circular A– (b) Relation to cost principles. The ap- 110, ‘‘Uniform Administrative Require- plicable cost principles (see § 1403.22) ments for Grants and Agreements with contain requirements for prior ap- Institutions of Higher Education, Hos- proval of certain types of costs. Except pitals, and Other Non-Profit Organiza- where waived, those requirements tions,’’ have met the audit require- apply to all grants and subgrants even ments of the Act. Commercial contrac- if paragraphs (c) through (f) of this sec- tors (private for-profit and private and tion do not. governmental organizations) providing (c) Budget changes—(1) Nonconstruc- goods and services to State and local tion projects. Except as stated in other governments are not required to have a regulations or an award document, single audit performed. State and local grantees or subgrantees shall obtain governments should use their own pro- the prior approval of the awarding cedures to ensure that the contractor agency whenever any of the following has complied with laws and regulations changes is anticipated under a non- affecting the expenditure of Federal construction award: funds; (i) Any revision which would result (2) Determine whether the sub- in the need for additional funding. grantee spent Federal assistance funds (ii) Unless waived by the awarding provided in accordance with applicable agency, cumulative transfers among di- laws and regulations. This may be ac- rect cost categories, or, if applicable, complished by reviewing an audit of among separately budgeted programs, the subgrantee made in accordance projects, functions, or activities which with the Act, Circular A–110, or exceed or are expected to exceed ten through other means (e.g., program re- percent of the current total approved views) if the subgrantee has not had budget, whenever the awarding agen- such an audit; cy’s share exceeds $100,000. (3) Ensure that appropriate correc- (iii) Transfer of funds allotted for tive action is taken within six months training allowances (i.e., from direct

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payments to trainees to other expense (2) A request for a prior approval categories). under the applicable Federal cost prin- (2) Construction projects. Grantees and ciples (see § 1403.22) may be made by subgrantees shall obtain prior written letter. approval for any budget revision which (3) A request by a subgrantee for would result in the need for additional prior approval will be addressed in funds. writing to the grantee. The grantee (3) Combined construction and non- will promptly review such request and construction projects. When a grant or shall approve or disapprove the request subgrant provides funding for both con- in writing. A grantee will not approve struction and nonconstruction activi- any budget or project revision which is ties, the grantee or subgrantee must inconsistent with the purpose or terms obtain prior written approval from the and conditions of the Federal grant to awarding agency before making any the grantee. If the revision requested fund or budget transfer from non- by the subgrantee would result in a construction to construction or vice change to the grantee’s approved versa. project which requires Federal prior approval, the grantee will obtain the (d) Programmatic changes. Grantees or Federal agency’s approval before ap- subgrantees must obtain the prior approving the subgrantee’s request. proval of the awarding agency whenever any of the following actions is an- § 1403.31 Real property. ticipated: (a) Title. Subject to the obligations (1) Any revision of the scope or objec- and conditions set forth in this section, tives of the project (regardless of title to real property acquired under a whether there is an associated budget grant or subgrant will vest upon acqui- revision requiring prior approval). sition in the grantee or subgrantee re- (2) Need to extend the period of avail- spectively. ability of funds. (b) Use. Except as otherwise provided (3) Changes in key persons in cases by Federal statutes, real property will where specified in an application or a be used for the originally authorized grant award. In research projects, a purposes as long as needed for those change in the project director or prin- purposes, and the grantee or sub- cipal investigator shall always require grantee shall not dispose of or encum- approval unless waived by the award- ber its title or other interests. ing agency. (c) Disposition. When real property is (4) Under nonconstruction projects, no longer needed for the originally au- contracting out, subgranting (if authorized purpose, the grantee or sub- thorized by law) or otherwise obtaining grantee will request disposition in- the services of a third party to perform structions from the awarding agency. activities which are central to the pur- The instructions will provide for one of poses of the award. This approval re- the following alternatives: quirement is in addition to the ap- (1) Retention of title. Retain title after proval requirements of § 1403.36 but compensating the awarding agency. does not apply to the procurement of The amount paid to the awarding agen- equipment, supplies, and general sup- cy will be computed by applying the port services. awarding agency’s percentage of par- (e) Additional prior approval require- ticipation in the cost of the original ments. The awarding agency may not purchase to the fair market value of require prior approval for any budget the property. However, in those situa- revision which is not described in para- tions were a grantee or subgrantee is graph (c) of this section. disposing of real property acquired (f) Requesting prior approval. (1) A re- with grant funds and acquiring replace- quest for prior approval of any budget ment real property under the same pro- revision will be in the same budget for- gram, the net proceeds from the dis- mat the grantee used in its application position may be used as an offset to the and shall be accompanied by a nar- cost of the replacement property. rative justification for the proposed re- (2) Sale of property. Sell the property vision. and compensate the awarding agency.

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The amount due to the awarding agen- erence for other use shall be given to cy will be calculated by applying the other programs or projects supported awarding agency’s percentage of par- by the awarding agency. User fees ticipation in the cost of the original should be considered if appropriate. purchase to the proceeds of the sale (3) Notwithstanding the encourage- after deduction of any actual and rea- ment in § 1403.25(a) to earn program in- sonable selling and fixing-up expenses. come, the grantee or subgrantee must If the grant is still active, the net pro- not use equipment acquired with grant ceeds from sale may be offset against funds to provide services for a fee to the original cost of the property. When compete unfairly with private compa- a grantee or subgrantee is directed to nies that provide equivalent services, sell property, sales procedures shall be unless specifically permitted or con- followed that provide for competition templated by Federal statute. to the extent practicable and result in (4) When acquiring replacement the highest possible return. equipment, the grantee or subgrantee (3) Transfer of title. Transfer title to may use the equipment to be replaced the awarding agency or to a third- as a trade-in or sell the property and party designated/approved by the use the proceeds to offset the cost of awarding agency. The grantee or sub- the replacement property, subject to grantee shall be paid an amount cal- the approval of the awarding agency. culated by applying the grantee or sub- (d) Management requirements. Proce- grantee’s percentage of participation dures for managing equipment (includ- in the purchase of the real property to ing replacement equipment), whether the current fair market value of the acquired in whole or in part with grant property. funds, until disposition takes place will, as a minimum, meet the following § 1403.32 Equipment. requirements: (a) Title. Subject to the obligations (1) Property records must be main- and conditions set forth in this section, tained that include a description of the title to equipment acquired under a property, a serial number or other grant or subgrant will vest upon acqui- identification number, the source of sition in the grantee or subgrantee re- property, who holds title, the acquisi- spectively. tion date, and cost of the property, per- (b) States. A State will use, manage, centage of Federal participation in the and dispose of equipment acquired cost of the property, the location, use under a grant by the State in accord- and condition of the property, and any ance with State laws and procedures. ultimate disposition data including the Other grantees and subgrantees will date of disposal and sale price of the follow paragraphs (c) through (e) of property. this section. (2) A physical inventory of the prop- (c) Use. (1) Equipment shall be used erty must be taken and the results rec- by the grantee or subgrantee in the onciled with the property records at program or project for which it was ac- least once every two years. quired as long as needed, whether or (3) A control system must be devel- not the project or program continues oped to ensure adequate safeguards to to be supported by Federal funds. When prevent loss, damage, or theft of the no longer needed for the original pro- property. Any loss, damage, or theft gram or project, the equipment may be shall be investigated. used in other activities currently or (4) Adequate maintenance procedures previously supported by a Federal must be developed to keep the property agency. in good condition. (2) The grantee or subgrantee shall (5) If the grantee or subgrantee is au- also make equipment available for use thorized or required to sell the prop- on other projects or programs cur- erty, proper sales procedures must be rently or previously supported by the established to ensure the highest pos- Federal Government, providing such sible return. use will not interfere with the work on (e) Disposition. When original or re- the projects or program for which it placement equipment acquired under a was originally acquired. First pref- grant or subgrant is no longer needed

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for the original project or program or amount calculated by applying the per- for other activities currently or pre- centage of participation in the pur- viously supported by a Federal agency, chase to the current fair market value disposition of the equipment will be of the property. made as follows: (1) Items of equipment with a current § 1403.33 Supplies. per-unit fair market value of less than (a) Title. Title to supplies acquired $5,000 may be retained, sold or other- under a grant or subgrant will vest, wise disposed of with no further obliga- upon acquisition, in the grantee or sub- tion to the awarding agency. grantee respectively. (2) Items of equipment with a current (b) Disposition. If there is a residual per unit fair market value in excess of inventory of unused supplies exceeding $5,000 may be retained or sold and the $5,000 in total aggregate fair market awarding agency shall have a right to value upon termination or completion an amount calculated by multiplying of the award, and if the supplies are the current market value or proceeds not needed for any other federally from sale by the awarding agency’s sponsored programs or projects, the share of the equipment. grantee or subgrantee shall com- (3) In cases where a grantee or sub- pensate the awarding agency for its grantee fails to take appropriate dis- share. position actions, the awarding agency may direct the grantee or subgrantee § 1403.34 Copyrights. to take excess and disposition actions. The Federal awarding agency re- (f) Federal equipment. In the event a serves a royalty-free, nonexclusive, and grantee or subgrantee is provided fed- irrevocable license to reproduce, pub- erally-owned equipment: lish or otherwise use, and to authorize (1) Title will remain vested in the others to use, for Federal Government Federal Government. purposes: (2) Grantees or subgrantees will man- (a) The copyright in any work devel- age the equipment in accordance with oped under a grant, subgrant, or con- Federal agency rules and procedures, tract under a grant or subgrant; and and submit an annual inventory list- (b) Any rights of copyright to which ing. a grantee, subgrantee or a contractor (3) When the equipment is no longer purchases ownership with grant sup- needed, the grantee or subgrantee will port. request disposition instructions from the Federal agency. § 1403.35 Subawards to debarred and (g) Right to transfer title. The Federal suspended parties. awarding agency may reserve the right Grantees and subgrantees must not to transfer title to the Federal Govern- make any award or permit any award ment or a third party named by the (subgrant or contract) at any tier to awarding agency when such a third any party which is debarred or sus- party is otherwise eligible under exist- pended or is otherwise excluded from or ing statutes. Such transfers shall be ineligible for participation in Federal subject to the following standards: assistance programs under Executive (1) The property shall be identified in Order 12549, ‘‘Debarment and Suspen- the grant or otherwise made known to sion.’’ the grantee in writing. (2) The Federal awarding agency § 1403.36 Procurement. shall issue disposition instruction (a) States. When procuring property within 120 calendar days after the end and services under a grant, a State will of the Federal support of the project follow the same policies and procedures for which it was acquired. If the federal it uses for procurements from its non- awarding agency fails to issue disposi- Federal funds. The State will ensure tion instructions within the 120 cal- that every purchase order or other con- endar-day period the grantee shall fol- tract includes any clauses required by low § 1403.32(e). Federal statutes and executive orders (3) When title to equipment is trans- and their implementing regulations. ferred, the grantee shall be paid an Other grantees and subgrantees will

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follow paragraphs (b) through (i) of this posed procurements to avoid purchase section. of unnecessary or duplicative items. (b) Procurement standards. (1) Grant- Consideration should be given to con- ees and subgrantees will use their own solidating or breaking out procure- procurement procedures which reflect ments to obtain a more economical applicable State and local laws and purchase. Where appropriate, an anal- regulations, provided that the procure- ysis will be made of lease versus pur- ments conform to applicable Federal chase alternatives, and any other ap- law and the standards identified in this propriate analysis to determine the section. most economical approach. (2) Grantees and subgrantees will (5) To foster greater economy and ef- maintain a contract administration ficiency, grantees and subgrantees are system which ensures that contractors encouraged to enter into State and perform in accordance with the terms, local intergovernmental agreements conditions, and specifications of their for procurement or use of common contracts or purchase orders. goods and services. (3) Grantees and subgrantees will (6) Grantees and subgrantees are en- maintain a written code of standards of couraged to use Federal excess and sur- conduct governing the performance of plus property in lieu of purchasing new their employees engaged in the award equipment and property whenever such and administration of contracts. No use is feasible and reduces project employee, officer or agent of the grant- costs. ee or subgrantee shall participate in se- (7) Grantees and subgrantees are en- lection, or in the award or administra- couraged to use value engineering tion of a contract supported by Federal clauses in contracts for construction funds if a conflict of interest, real or projects of sufficient size to offer rea- apparent, would be involved. Such a sonable opportunities for cost reduc- conflict would arise when: tions. Value engineering is a system- (i) The employee, officer or agent, atic and creative analysis of each con- (ii) Any member of his immediate tract item or task to ensure that its es- family, sential function is provided at the (iii) His or her partner, or overall lower cost. (iv) An organization which employs, (8) Grantees and subgrantees will or is about to employ, any of the make awards only to responsible con- above, has a financial or other interest tractors possessing the ability to per- in the firm selected for award. The form successfully under the terms and grantee’s or subgrantee’s officers, em- conditions of a proposed procurement. ployees or agents will neither solicit Consideration will be given to such nor accept gratuities, favors or any- matters as contractor integrity, com- thing of monetary value from contrac- pliance with public policy, record of tors, potential contractors, or parties past performance, and financial and to subagreements. Grantee and sub- technical resources. grantees may set minimum rules where (9) Grantees and subgrantees will the financial interest is not substantial maintain records sufficient to detail or the gift is an unsolicited item of the significant history of a procure- nominal intrinsic value. To the extent ment. These records will include, but permitted by State or local law or reg- are not necessarily limited to the fol- ulations, such standards or conduct lowing: rationale for the method of will provide for penalties, sanctions, or procurement, selection of contract other disciplinary actions for viola- type, contractor selection or rejection, tions of such standards by the grant- and the basis for the contract price. ee’s and subgrantee’s officers, employ- (10) Grantees and subgrantees will ees, or agents, or by contractors or use time and material type contracts their agents. The awarding agency may only— in regulation provide additional prohi- (i) After a determination that no bitions relative to real, apparent, or other contract is suitable, and potential conflicts of interest. (ii) If the contract includes a ceiling (4) Grantee and subgrantee proce- price that the contractor exceeds at its dures will provide for a review of pro- own risk.

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(11) Grantees and subgrantees alone (v) Organizational conflicts of inter- will be responsible, in accordance with est, good administrative practice and sound (vi) Specifying only a ‘‘brand name’’ business judgment, for the settlement product instead of allowing ‘‘an equal’’ of all contractual and administrative product to be offered and describing issues arising out of procurements. the performance of other relevant re- These issues include, but are not lim- quirements of the procurement, and ited to source evaluation, protests, dis- (vii) Any arbitrary action in the pro- putes, and claims. These standards do curement process. not relieve the grantee or subgrantee (2) Grantees and subgrantees will of any contractual responsibilities conduct procurements in a manner under its contracts. Federal agencies that prohibits the use of statutorily or will not substitute their judgment for administratively imposed in-State or that of the grantee or subgrantee un- local geographical preferences in the less the matter is primarily a Federal evaluation of bids or proposals, except concern. Violations of law will be rein those cases where applicable Federal ferred to the local, State, or Federal statutes expressly mandate or encour- authority having proper jurisdiction. age geographic preference. Nothing in (12) Grantees and subgrantees will this section preempts State licensing have protest procedures to handle and laws. When contracting for architec- resolve disputes relating to their pro- tural and engineering (A/E) services, curements and shall in all instances geographic location may be a selection disclose information regarding the pro- criteria provided its application leaves test to the awarding agency. A an appropriate number of qualified protestor must exhaust all administra- firms, given the nature and size of the tive remedies with the grantee and sub- project, to compete for the contract. grantee before pursuing a protest with (3) Grantees will have written selec- the Federal agency. Reviews of pro- tion procedures for procurement trans- tests by the Federal agency will be lim- actions. These procedures will ensure ited to: that all solicitations: (i) Incorporate a clear and accurate (i) Violations of Federal law or regu- description of the technical require- lations and the standards of this sec- ments for the material, product, or tion (violations of State or local law service to be procured. Such descrip- will be under the jurisdiction of State tion shall not, in competitive procure- or local authorities) and ments, contain features which unduly (ii) Violations of the grantee’s or sub- restrict competition. The description grantee’s protest procedures for failure may include a statement of the quali- to review a complaint or protest. Pro- tative nature of the material, product tests received by the Federal agency or service to be procured, and when other than those specified above will be necessary, shall set forth those min- referred to the grantee or subgrantee. imum essential characteristics and (c) Competition. (1) All procurement standards to which it must conform if transactions will be conducted in a it is to satisfy its intended use. De- manner providing full and open com- tailed product specifications should be petition consistent with the standards avoided if at all possible. When it is of § 1403.36. Some of the situations con- impractical or uneconomical to make a sidered to be restrictive of competition clear and accurate description of the include but are not limited to: technical requirements, a ‘‘brand name (i) Placing unreasonable require- or equal’’ description may be used as a ments on firms in order for them to means to define the performance or qualify to do business, other salient requirements of a pro- (ii) Requiring unnecessary experience curement. The specific features of the and excessive bonding, named brand which must be met by (iii) Noncompetitive pricing practices offerors shall be clearly stated; and between firms or between affiliated (ii) Identify all requirements which companies, the offerors must fulfill and all other (iv) Noncompetitive awards to con- factors to be used in evaluating bids or sultants that are on retainer contracts, proposals.

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(4) Grantees and subgrantees will en- items or services in order for the bidder sure that all prequalified lists of per- to properly respond; sons, firms, or products which are used (C) All bids will be publicly opened at in acquiring goods and services are cur- the time and place prescribed in the in- rent and include enough qualified vitation for bids; sources to ensure maximum open and (D) A firm fixed-price contract award free competition. Also, grantees and will be made in writing to the lowest subgrantees will not preclude potential responsive and responsible bidder. bidders from qualifying during the so- Where specified in bidding documents, licitation period. factors such as discounts, transpor- (d) Methods of procurement to be fol- tation cost, and life cycle costs shall be lowed. (1) Procurement by small pur- considered in determining which bid is chase procedures. Small purchase proce- lowest. Payment discounts will only be dures are those relatively simple and used to determine the low bid when informal procurement methods for se- prior experience indicates that such curing services, supplies, or other prop- discounts are usually taken advantage erty that do not cost more than the of; and simplified acquisition threshold fixed (E) Any or all bids may be rejected if at 41 U.S.C. 403(11) (currently set at there is a sound documented reason. $100,000). If small purchase procedures (3) Procurement by competitive pro- are used, price or rate quotations shall posals. The technique of competitive be obtained from an adequate number proposals is normally conducted with of qualified sources. more than one source submitting an (2) Procurement by sealed bids (for- offer, and either a fixed-price or cost- mal advertising). Bids are publicly so- reimbursement type contract is award- licited and a firm-fixed-price contract ed. It is generally used when conditions (lump sum or unit price) is awarded to are not appropriate for the use of the responsible bidder whose bid, con- sealed bids. If this method is used, the forming with all the material terms following requirements apply: and conditions of the invitation for (i) Requests for proposals will be pub- bids, is the lowest in price. The sealed licized and identify all evaluation fac- bid method is the preferred method for tors and their relative importance. Any procuring construction, if the condi- response to publicized requests for pro- tions in § 1403.36(d)(2)(i) apply. posals shall be honored to the maximum extent practical; (i) In order for sealed bidding to be (ii) Proposals will be solicited from feasible, the following conditions an adequate number of qualified should be present: sources; (A) A complete, adequate, and real- (iii) Grantees and subgrantees will istic specification or purchase descrip- have a method for conducting tech- tion is available; nical evaluations of the proposals re- (B) Two or more responsible bidders ceived and for selecting awardees; are willing and able to compete effec- (iv) Awards will be made to the re- tively and for the business; and sponsible firm whose proposal is most (C) The procurement lends itself to a advantageous to the program, with firm fixed price contract and the selec- price and other factors considered; and tion of the successful bidder can be (v) Grantees and subgrantees may made principally on the basis of price. use competitive proposal procedures (ii) If sealed bids are used, the fol- for qualifications-based procurement of lowing requirements apply: architectural/engineering (A/E) profes- (A) The invitation for bids will be sional services whereby competitors’ publicly advertised and bids shall be qualifications are evaluated and the solicited from an adequate number of most qualified competitor is selected, known suppliers, providing them suffi- subject to negotiation of fair and rea- cient time prior to the date set for sonable compensation. The method, opening the bids; where price is not used as a selection (B) The invitation for bids, which factor, can only be used in procure- will include any specifications and per- ment of A/E professional services. It tinent attachments, shall define the cannot be used to purchase other types

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of services though A/E firms are a po- (iv) Establishing delivery schedules, tential source to perform the proposed where the requirement permits, which effort. encourage participation by small and (4) Procurement by noncompetitive minority business, and women’s busi- proposals is procurement through solic- ness enterprises; itation of a proposal from only one (v) Using the services and assistance source, or after solicitation of a num- of the Small Business Administration, ber of sources, competition is deter- and the Minority Business Develop- mined inadequate. ment Agency of the Department of (i) Procurement by noncompetitive Commerce; and proposals may be used only when the (vi) Requiring the prime contractor, award of a contract is infeasible under if subcontracts are to be let, to take small purchase procedures, sealed bids the affirmative steps listed in para- or competitive proposals and one of the graphs (e)(2) (i) through (v) of this sec- following circumstances applies: tion. (A) The item is available only from a (f) Contract cost and price. (1) Grant- single source; ees and subgrantees must perform a (B) The public exigency or emergency cost or price analysis in connection for the requirement will not permit a with every procurement action includ- delay resulting from competitive solic- ing contract modifications. The meth- itation; od and degree of analysis is dependent (C) The awarding agency authorizes on the facts surrounding the particular noncompetitive proposals; or procurement situation, but as a starting point, grantees must make inde- (D) After solicitation of a number of pendent estimates before receiving bids sources, competition is determined in- or proposals. A cost analysis must be adequate. performed when the offeror is required (ii) Cost analysis, i.e., verifying the to submit the elements of his esti- proposed cost data, the projections of mated cost, e.g., under professional, the data, and the evaluation of the spe- consulting, and architectural engineer- cific elements of costs and profits, is ing services contracts. A cost analysis required. will be necessary when adequate price (iii) Grantees and subgrantees may competition is lacking, and for sole be required to submit the proposed pro- source procurements, including con- curement to the awarding agency for tract modifications or change orders, pre-award review in accordance with unless price reasonableness can be es- paragraph (g) of this section. tablished on the basis of a catalog or (e) Contracting with small and minority market price of a commercial product firms, women’s business enterprise and sold in substantial quantities to the labor surplus area firms. (1) The grantee general public or based on prices set by and subgrantee will take all necessary law or regulation. A price analysis will affirmative steps to assure that minor- be used in all other instances to deter- ity firms, women’s business enter- mine the reasonableness of the pro- prises, and labor surplus area firms are posed contract price. used when possible. (2) Grantees and subgrantees will ne- (2) Affirmative steps shall include: gotiate profit as a separate element of (i) Placing qualified small and minor- the price for each contract in which ity businesses and women’s business there is no price competition and in all enterprises on solicitation lists; cases where cost analysis is performed. (ii) Assuring that small and minority To establish a fair and reasonable prof- businesses, and women’s business en- it, consideration will be given to the terprises are solicited whenever they complexity of the work to be per- are potential sources; formed, the risk borne by the con- (iii) Dividing total requirements, tractor, the contractor’s investment, when economically feasible, into small- the amount of subcontracting, the er tasks or quantities to permit max- quality of its record of past perform- imum participation by small and mi- ance, and industry profit rates in the nority business, and women’s business surrounding geographical area for enterprises; similar work.

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(3) Costs or prices based on estimated creases the contract amount by more costs for contracts under grants will be than the simplified acquisition thresh- allowable only to the extent that costs old. incurred or cost estimates included in (3) A grantee or subgrantee will be negotiated prices are consistent with exempt from the pre-award review in Federal cost principles (see § 1403.22). paragraph (g)(2) of this section if the Grantees may reference their own cost awarding agency determines that its principles that comply with the appli- procurement systems comply with the cable Federal cost principles. standards of this section. (4) The cost plus a percentage of cost (i) A grantee or subgrantee may re- and percentage of constructing cost quest that its procurement system be methods of contracting shall not be reviewed by the awarding agency to de- used. termine whether its system meets (g) Awarding agency review. (1) Grant- these standards in order for its system ees and subgrantees must make avail- to be certified. Generally, these re- able, upon request of the awarding views shall occur where there is a con- agency, technical specifications on pro- tinuous high-dollar funding, and third- posed procurements where the award- party contracts are awarded on a reg- ing agency believes such review is ular basis. needed to ensure that the item and/or (ii) A grantee or subgrantee may self- service specified is the one being pro- certify its procurement system. Such posed for purchase. This review gen- self-certification shall not limit the erally will take place prior to the time awarding agency’s right to survey the the specification is incorporated into a system. Under a self-certification pro- solicitation document. However, if the cedure, awarding agencies may wish to grantee or subgrantee desires to have rely on written assurances from the the review accomplished after a solici- grantee or subgrantee that it is com- tation has been developed, the award- plying with these standards. A grantee ing agency may still review the speci- or subgrantee will cite specific proce- fications, with such review usually lim- dures, regulations, standards, etc., as ited to the technical aspects of the pro- being in compliance with these require- posed purchase. ments and have its system available (2) Grantees and subgrantees must on for review. request make available for awarding (h) Bonding requirements. For con- agency pre-award review procurement struction or facility improvement con- documents, such as requests for pro- tracts or subcontracts exceeding the posals or invitations for bids, inde- simplified acquisition threshold, the pendent cost estimates, etc. when: awarding agency may accept the bond- (i) A grantee’s or subgrantee’s pro- ing policy and requirements of the curement procedures or operation fails grantee or subgrantee provided the to comply with the procurement stand- awarding agency has made a deter- ards in this section; or mination that the awarding agency’s (ii) The procurement is expected to interest is adequately protected. If exceed the simplified acquisition such a determination has not been threshold and is to be awarded without made, the minimum requirements shall competition or only one bid or offer is be as follows: received in response to a solicitation; (1) A bid guarantee from each bidder or equivalent to five percent of the bid price. (iii) The procurement, which is ex- The ‘‘bid guarantee’’ shall consist of a pected to exceed the simplified acquisi- firm commitment such as a bid bond, tion threshold, specifies a ‘‘brand certified check, or other negotiable in- name’’ product; or strument accompanying a bid as assur- (iv) The proposed award is more than ance that the bidder will, upon accept- the simplified acquisition threshold ance of his bid, execute such contrac- and is to be awarded to other than the tual documents as may be required apparent low bidder under a sealed bid within the time specified. procurement; or (2) A performance bond on the part of (v) A proposed contract modification the contractor for 100 percent of the con- changes the scope of a contract or in- tract price. A ‘‘performance bond’’ is

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one executed in connection with a con- (6) Compliance with Sections 103 and tract to secure fulfillment of all the 107 of the Contract Work Hours and contractor’s obligations under such Safety Standards Act (40 U.S.C. 327–330) contract. as supplemented by Department of (3) A payment bond on the part of the Labor regulations (29 CFR Part 5). contractor for 100 percent of the contract (Construction contracts awarded by price. A ‘‘payment bond’’ is one exe- grantees and subgrantees in excess of cuted in connection with a contract to $2000, and in excess of $2500 for other assure payment as required by law of contracts which involve the employ- all persons supplying labor and mate- ment of mechanics or laborers) rial in the execution of the work pro- (7) Notice of awarding agency re- vided for in the contract. quirements and regulations pertaining (i) Contract provisions. A grantee’s to reporting. (8) Notice of awarding agency re- and subgrantee’s contracts must con- quirements and regulations pertaining tain provisions in paragraph (i) of this to patent rights with respect to any section. Federal agencies are permitted discovery or invention which arises or to require changes, remedies, changed is developed in the course of or under conditions, access and records reten- such contract. tion, suspension of work, and other (9) Awarding agency requirements clauses approved by the Office of Fed- and regulations pertaining to copy- eral Procurement Policy. rights and rights in data. (1) Administrative, contractual, or (10) Access by the grantee, the sub- legal remedies in instances where con- grantee, the Federal grantor agency, tractors violate or breach contract the Comptroller General of the United terms, and provide for such sanctions States, or any of their duly authorized and penalties as may be appropriate. representatives to any books, docu- (Contracts more than the simplified ac- ments, papers, and records of the con- quisition threshold) tractor which are directly pertinent to (2) Termination for cause and for that specific contract for the purpose convenience by the grantee or sub- of making audit, examination, ex- grantee including the manner by which cerpts, and transcriptions. it will be effected and the basis for set- (11) Retention of all required records tlement. (All contracts in excess of for three years after grantees or sub- $10,000) grantees make final payments and all (3) Compliance with Executive Order other pending matters are closed. 11246 of September 24, 1965, entitled (12) Compliance with all applicable ‘‘Equal Employment Opportunity,’’ as standards, orders, or requirements amended by Executive Order 11375 of issued under section 306 of the Clean October 13, 1967, and as supplemented Air Act (42 U.S.C. 1857(h)), section 508 in Department of Labor regulations (41 of the Clean Water Act (33 U.S.C. 1368), CFR chapter 60). (All construction con- Executive Order 11738, and Environ- tracts awarded in excess of $10,000 by mental Protection Agency regulations grantees and their contractors or sub- (40 CFR part 15). (Contracts, subgrantees) contracts, and subgrants of amounts in (4) Compliance with the Copeland excess of $100,000). ‘‘Anti-Kickback’’ Act (18 U.S.C. 874) as (13) Mandatory standards and policies supplemented in Department of Labor relating to energy efficiency which are regulations (29 CFR Part 3). (All con- contained in the state energy conserva- tracts and subgrants for construction tion plan issued in compliance with the or repair) Energy Policy and Conservation Act (5) Compliance with the Davis-Bacon (Pub. L. 94–163, 89 Stat. 871). Act (40 U.S.C. 276a to 276a–7) as supple- [57 FR 55092, Nov. 24, 1992, as amended at 60 mented by Department of Labor regu- FR 19639, 19642, Apr. 19, 1995] lations (29 CFR Part 5). (Construction contracts in excess of $2000 awarded by § 1403.37 Subgrants. grantees and subgrantees when re- (a) States. States shall follow state quired by Federal grant program legis- law and procedures when awarding and lation) administering subgrants (whether on a

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cost reimbursement or fixed amount must monitor grant and subgrant sup- basis) of financial assistance to local ported activities to assure compliance and Indian tribal governments. States with applicable Federal requirements shall: and that performance goals are being (1) Ensure that every subgrant in- achieved. Grantee monitoring must cludes any clauses required by Federal cover each program, function or activ- statute and executive orders and their ity. implementing regulations; (b) Nonconstruction performance re- (2) Ensure that subgrantees are ports. The Federal agency may, if it de- aware of requirements imposed upon them by Federal statute and regula- cides that performance information tion; available from subsequent applications (3) Ensure that a provision for com- contains sufficient information to pliance with § 1403.42 is placed in every meet its programmatic needs, require cost reimbursement subgrant; and the grantee to submit a performance (4) Conform any advances of grant report only upon expiration or termi- funds to subgrantees substantially to nation of grant support. Unless waived the same standards of timing and by the Federal agency this report will amount that apply to cash advances by be due on the same date as the final Fi- Federal agencies. nancial Status Report. (b) All other grantees. All other grant- (1) Grantees shall submit annual per- ees shall follow the provisions of this formance reports unless the awarding part which are applicable to awarding agency requires quarterly or semi-an- agencies when awarding and admin- nual reports. However, performance re- istering subgrants (whether on a cost ports will not be required more fre- reimbursement or fixed amount basis) quently than quarterly. Annual reports of financial assistance to local and In- shall be due 90 days after the grant dian tribal governments. Grantees shall: year, quarterly or semi-annual reports (1) Ensure that every subgrant in- shall be due 30 days after the reporting cludes a provision for compliance with period. The final performance report this part; will be due 90 days after the expiration (2) Ensure that every subgrant in- or termination of grant support. If a cludes any clauses required by Federal justified request is submitted by a statute and executive orders and their grantee, the Federal agency may ex- implementing regulations; and tend the due date for any performance (3) Ensure that subgrantees are report. Additionally, requirements for aware of requirements imposed upon unnecessary performance reports may them by Federal statutes and regula- be waived by the Federal agency. tions. (2) Performance reports will contain, (c) Exceptions. By their own terms, for each grant, brief information on the certain provisions of this part do not following: apply to the award and administration (i) A comparison of actual accom- of subgrants: (1) Section 1403.10; plishments to the objectives estab- (2) Section 1403.11; lished for the period. Where the output (3) The letter-of-credit procedures of the project can be quantified, a com- specified in Treasury Regulations at 31 putation of the cost per unit of output CFR part 205, cited in § 1403.21; and may be required if that information (4) Section 1403.50. will be useful. (ii) The reasons for slippage if estab- REPORTS, RECORDS, RETENTION, AND lished objectives were not met. ENFORCEMENT (iii) Additional pertinent information § 1403.40 Monitoring and reporting including, when appropriate, analysis program performance. and explanation of cost overruns or (a) Monitoring by grantees. Grantees high unit costs. are responsible for managing the day- (3) Grantees will not be required to to-day operations of grant and submit more than the original and two subgrant supported activities. Grantees copies of performance reports.

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(4) Grantees will adhere to the stand- (i) Submitting financial reports to ards in this section in prescribing per- Federal agencies, or formance reporting requirements for (ii) Requesting advances or reim- subgrantees. bursements when letters of credit are (c) Construction performance reports. not used. For the most part, on-site technical in- (2) Grantees need not apply the forms spections and certified percentage-of- prescribed in this section in dealing completion data are relied on heavily with their subgrantees. However, by Federal agencies to monitor grantees shall not impose more burden- progress under construction grants and some requirements on subgrantees. subgrants. The Federal agency will re- (3) Grantees shall follow all applica- quire additional formal performance ble standard and supplemental Federal reports only when considered nec- agency instructions approved by OMB essary, and never more frequently than to the extent required under the Paper- quarterly. work Reduction Act of 1980 for use in (d) Significant developments. Events connection with forms specified in may occur between the scheduled per- paragraphs (b) through (e) of this sec- formance reporting dates which have tion. Federal agencies may issue sub- significant impact upon the grant or stantive supplementary instructions subgrant supported activity. In such only with the approval of OMB. Federal cases, the grantee must inform the agencies may shade out or instruct the Federal agency as soon as the following grantee to disregard any line item that types of conditions become known: the Federal agency finds unnecessary (1) Problems, delays, or adverse con- for its decision making purposes. ditions which will materially impair the ability to meet the objective of the (4) Grantees will not be required to award. This disclosure must include a submit more than the original and two statement of the action taken, or con- copies of forms required under this templated, and any assistance needed part. to resolve the situation. (5) Federal agencies may provide (2) Favorable developments which en- computer outputs to grantees to expe- able meeting time schedules and objec- dite or contribute to the accuracy of tives sooner or at less cost than antici- reporting. Federal agencies may accept pated or producing more beneficial re- the required information from grantees sults than originally planned. in machine usable format or computer (e) Federal agencies may make site printouts instead of prescribed forms. visits as warranted by program needs. (6) Federal agencies may waive any (f) Waivers, extensions. (1) Federal report required by this section if not agencies may waive any performance needed. report required by this part if not need- (7) Federal agencies may extend the ed. due date of any financial report upon (2) The grantee may waive any per- receiving a justified request from a formance report from a subgrantee grantee. when not needed. The grantee may ex- (b) Financial Status Report—(1) Form. tend the due date for any performance Grantees will use Standard Form 269 or report from a subgrantee if the grantee 269A, Financial Status Report, to re- will still be able to meet its perform- port the status of funds for all non- ance reporting obligations to the Fed- construction grants and for construc- eral agency. tion grants when required in accordance with paragraph § 1403.41(e)(2)(iii) § 1403.41 Financial reporting. of this section. (a) General. (1) Except as provided in (2) Accounting basis. Each grantee will paragraphs (a) (2) and (5) of this sec- report program outlays and program tion, grantees will use only the forms income on a cash or accrual basis as specified in paragraphs (a) through (e) prescribed by the awarding agency. If of this section, and such supple- the Federal agency requires accrual in- mentary or other forms as may from formation and the grantee’s accounting time to time be authorized by OMB, records are not normally kept on the for: accrual basis, the grantee shall not be

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required to convert its accounting sys- working days following the end of each tem but shall develop such accrual in- quarter. However, where an advance ei- formation through an analysis of the ther by letter of credit or electronic documentation on hand. transfer of funds is authorized at an (3) Frequency. The Federal agency annualized rate of one million dollars may prescribe the frequency of the re- or more, the Federal agency may report for each project or program. How- quire the report to be submitted within ever, the report will not be required 15 working days following the end of more frequently than quarterly. If the each month. Federal agency does not specify the (d) Request for advance or reimburse- frequency of the report, it will be sub- ment—(1) Advance payments. Requests mitted annually. A final report will be for Treasury check advance payments required upon expiration or termi- will be submitted on Standard Form nation of grant support. 270, Request for Advance or Reimburse- (4) Due date. When reports are re- ment. (This form will not be used for quired on a quarterly or semiannual drawdowns under a letter of credit, basis, they will be due 30 days after the electronic funds transfer or when reporting period. When required on an Treasury check advance payments are annual basis, they will be due 90 days made to the grantee automatically on after the grant year. Final reports will a predetermined basis.) be due 90 days after the expiration or (2) Reimbursements. Requests for reim- termination of grant support. bursement under nonconstruction (c) Federal Cash Transactions Report— grants will also be submitted on Stand- (1) Form. (i) For grants paid by letter of ard Form 270. (For reimbursement re- credit, Treasury check advances or quests under construction grants, see electronic transfer of funds, the grant- paragraph (e)(1) of this section.) ee will submit the Standard Form 272, (3) The frequency for submitting pay- Federal Cash Transactions Report, and ment requests is treated in when necessary, its continuation sheet, § 1403.41(b)(3). Standard Form 272a, unless the terms of the award exempt the grantee from (e) Outlay report and request for reim- this requirement. bursement for construction programs—(1) (ii) These reports will be used by the Grants that support construction activi- Federal agency to monitor cash ad- ties paid by reimbursement method. (i) vanced to grantees and to obtain dis- Requests for reimbursement under con- bursement or outlay information for struction grants will be submitted on each grant from grantees. The format Standard Form 271, Outlay Report and of the report may be adapted as appro- Request for Reimbursement for Con- priate when reporting is to be accom- struction Programs. Federal agencies plished with the assistance of auto- may, however, prescribe the Request matic data processing equipment pro- for Advance or Reimbursement form, vided that the information to be sub- specified in § 1403.41(d), instead of this mitted is not changed in substance. form. (2) Forecasts of Federal cash require- (ii) The frequency for submitting re- ments. Forecasts of Federal cash reimbursement requests is treated in quirements may be required in the § 1403.41(b)(3). ‘‘Remarks’’ section of the report. (2) Grants that support construction ac- (3) Cash in hands of subgrantees. When tivities paid by letter of credit, electronic considered necessary and feasible by funds transfer or Treasury check ad- the Federal agency, grantees may be vance. (i) When a construction grant is required to report the amount of cash paid by letter of credit, electronic advances in excess of three days’ needs funds transfer or Treasury check ad- in the hands of their subgrantees or vances, the grantee will report its out- contractors and to provide short nar- lays to the Federal agency using rative explanations of actions taken by Standard Form 271, Outlay Report and the grantee to reduce the excess bal- Request for Reimbursement for Con- ances. struction Programs. The Federal agen- (4) Frequency and due date. Grantees cy will provide any necessary special must submit the report no later than 15 instruction. However, frequency and

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due date shall be governed by long-term retention value. When the § 1403.41(b) (3) and (4). records are transferred to or main- (ii) When a construction grant is paid tained by the Federal agency, the 3- by Treasury check advances based on year retention requirement is not ap- periodic requests from the grantee, the plicable to the grantee or subgrantees. advances will be requested on the form (c) Starting date of retention period—(1) specified in § 1403.41(d). General. When grant support is contin- (iii) The Federal agency may sub- ued or renewed at annual or other institute the Financial Status Report tervals, the retention period for the specified in § 1403.41(b) for the Outlay records of each funding period starts on Report and Request for Reimbursement the day the grantee or subgrantee sub- for Construction Programs. mits to the awarding agency its single (3) Accounting basis. The accounting or last expenditure report for that pe- basis for the Outlay Report and Re- riod. However, if grant support is con- quest for Reimbursement for Construc- tinued or renewed quarterly, the retention Programs shall be governed by tion period for each year’s records § 1403.41(b)(2). starts on the day the grantee submits its expenditure report for the last quar- § 1403.42 Retention and access re- ter of the Federal fiscal year. In all quirements for records. other cases, the retention period starts (a) Applicability. (1) This section ap- on the day the grantee submits its plies to all financial and programmatic final expenditure report. If an expendi- records, supporting documents, statis- ture report has been waived, the reten- tical records, and other records of tion period starts on the day the report grantees or subgrantees which are: would have been due. (i) Required to be maintained by the (2) Real property and equipment terms of this Part, program regula- records. The retention period for real tions or the grant agreement, or property and equipment records starts (ii) Otherwise reasonably considered from the date of the disposition or re- as pertinent to program regulations or placement or transfer at the direction the grant agreement. of the awarding agency. (2) This section does not apply to (3) Records for income transactions records maintained by contractors or after grant or subgrant support. In some subcontractors. For a requirement to cases grantees must report income place a provision concerning records in after the period of grant support. certain kinds of contracts, see Where there is such a requirement, the § 1403.36(i)(10). retention period for the records per- (b) Length of retention period. (1) Ex- taining to the earning of the income cept as otherwise provided, records starts from the end of the grantee’s fis- must be retained for three years from cal year in which the income is earned. the starting date specified in paragraph (4) Indirect cost rate proposals, cost al- (c) of this section. locations plans, etc. This paragraph ap- (2) If any litigation, claim, negotia- plies to the following types of docu- tion, audit or other action involving ments, and their supporting records: the records has been started before the indirect cost rate computations or pro- expiration of the 3-year period, the posals, cost allocation plans, and any records must be retained until comple- similar accounting computations of tion of the action and resolution of all the rate at which a particular group of issues which arise from it, or until the costs is chargeable (such as computer end of the regular 3-year period, which- usage chargeback rates or composite ever is later. fringe benefit rates). (3) To avoid duplicate recordkeeping, (i) If submitted for negotiation. If the awarding agencies may make special proposal, plan, or other computation is arrangements with grantees and sub- required to be submitted to the Federal grantees to retain any records which Government (or to the grantee) to form are continuously needed for joint use. the basis for negotiation of the rate, The awarding agency will request then the 3-year retention period for its transfer of records to its custody when supporting records starts from the date it determines that the records possess of such submission.

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(ii) If not submitted for negotiation. If (3) Wholly or partly suspend or ter- the proposal, plan, or other computa- minate the current award for the tion is not required to be submitted to grantee’s or subgrantee’s program, the Federal Government (or to the (4) Withhold further awards for the grantee) for negotiation purposes, then program, or the 3-year retention period for the pro- (5) Take other remedies that may be posal plan, or computation and its sup- legally available. porting records starts from end of the (b) Hearings, appeals. In taking an en- fiscal year (or other accounting period) forcement action, the awarding agency covered by the proposal, plan, or other will provide the grantee or subgrantee computation. an opportunity for such hearing, ap- (d) Substitution of microfilm. Copies peal, or other administrative pro- made by microfilming, photocopying, ceeding to which the grantee or sub- or similar methods may be substituted grantee is entitled under any statute for the original records. or regulation applicable to the action (e) Access to records—(1) Records of involved. grantees and subgrantees. The awarding (c) Effects of suspension and termi- agency and the Comptroller General of nation. Costs of grantee or subgrantee the United States, or any of their au- resulting from obligations incurred by thorized representatives, shall have the the grantee or subgrantee during a sus- right of access to any pertinent books, pension or after termination of an documents, papers, or other records of award are not allowable unless the grantees and subgrantees which are awarding agency expressly authorizes pertinent to the grant, in order to them in the notice of suspension or ter- make audits, examinations, excerpts, mination or subsequently. Other grant- and transcripts. ee or subgrantee costs during suspen- (2) Expiration of right of access. The sion or after termination which are rights of access in this section must necessary and not reasonably avoidable not be limited to the required reten- are allowable if: tion period but shall last as long as the (1) The costs result from obligations records are retained. which were properly incurred by the (f) Restrictions on public access. The grantee or subgrantee before the effec- Federal Freedom of Information Act (5 tive date of suspension or termination, U.S.C. 552) does not apply to records. are not in anticipation of it, and, in the Unless required by Federal, State, or case of a termination, are local law, grantees and subgrantees are noncancellable, and, not required to permit public access to their records. (2) The costs would be allowable if the award were not suspended or ex- § 1403.43 Enforcement. pired normally at the end of the funding period in which the termination (a) Remedies for noncompliance. If a takes effect. grantee or subgrantee materially fails to comply with any term of an award, (d) Relationship to Debarment and Sus- whether stated in a Federal statute or pension. The enforcement remedies regulation, an assurance, in a State identified in this section, including plan or application, a notice of award, suspension and termination, do not or elsewhere, the awarding agency may preclude grantee or subgrantee from take one or more of the following ac- being subject to ‘‘Debarment and Sus- tions, as appropriate in the cir- pension’’ under E.O. 12549 (see § 1403.35). cumstances: § 1403.44 Termination for convenience. (1) Temporarily withhold cash payments pending correction of the defi- Except as provided in § 1403.43 awards ciency by the grantee or subgrantee or may be terminated in whole or in part more severe enforcement action by the only as follows: awarding agency, (a) By the awarding agency with the (2) Disallow (that is, deny both use of consent of the grantee or subgrantee in funds and matching credit for) all or which case the two parties shall agree part of the cost of the activity or ac- upon the termination conditions, in- tion not in compliance, cluding the effective date and in the

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case of partial termination, the portion (d) Cash adjustments. (1) The Federal to be terminated, or agency will make prompt payment to (b) By the grantee or subgrantee the grantee for allowable reimbursable upon written notification to the award- costs. ing agency, setting forth the reasons (2) The grantee must immediately re- for such termination, the effective fund to the Federal agency any balance date, and in the case of partial termi- of unobligated (unencumbered) cash nation, the portion to be terminated. advanced that is not authorized to be However, if, in the case of a partial ter- retained for use on other grants. mination, the awarding agency determines that the remaining portion of § 1403.51 Later disallowances and ad- the award will not accomplish the pur- justments. poses for which the award was made, The closeout of a grant does not af- the awarding agency may terminate fect: the award in its entirety under either (a) The Federal agency’s right to dis- § 1403.43 or paragraph (a) of this sec- allow costs and recover funds on the tion. basis of a later audit or other review; (b) The grantee’s obligation to return Subpart D—After-The-Grant any funds due as a result of later re- Requirements funds, corrections, or other transactions; § 1403.50 Closeout. (c) Records retention as required in § 1403.42; (a) General. The Federal agency will (d) Property management require- close out the award when it determines ments in § 1403.31 and § 1403.32; and that all applicable administrative ac- (e) Audit requirements in § 1403.26. tions and all required work of the grant has been completed. § 1403.52 Collection of amounts due. (b) Reports. Within 90 days after the expiration or termination of the grant, (a) Any funds paid to a grantee in ex- the grantee must submit all financial, cess of the amount to which the grant- performance, and other reports re- ee is finally determined to be entitled quired as a condition of the grant. under the terms of the award con- Upon request by the grantee, Federal stitute a debt to the Federal Govern- agencies may extend this time frame. ment. If not paid within a reasonable These may include but are not limited period after demand, the Federal agen- to: cy may reduce the debt by: (1) Final performance or progress re- (1) Making an administrative offset port. against other requests for reimburse- (2) Financial Status Report (SF 269) ment, or Outlay Report and Request for Re- (2) Withholding advance payments imbursement for Construction Pro- otherwise due to the grantee, or grams (SF–271) (as applicable). (3) Other action permitted by law. (3) Final request for payment (SF– (b) Except where otherwise provided 270) (if applicable). by statutes or regulations, the Federal (4) Invention disclosure (if applica- agency will charge interest on an over- ble). due debt in accordance with the Fed- (5) Federally-owned property report: eral Claims Collection Standards (4 In accordance with § 1403.32(f), a grant- CFR ch. II). The date from which inter- ee must submit an inventory of all fed- est is computed is not extended by liti- erally owned property (as distinct from gation or the filing of any form of ap- property acquired with grant funds) for peal. which it is accountable and request disposition instructions from the Federal Subpart E—Entitlement [Reserved] agency of property no longer needed. (c) Cost adjustment. The Federal agen- APPENDIX A TO PART 1403—OMB CIR- cy will, within 90 days after receipt of CULAR A–128, ‘‘AUDITS OF STATE AND reports in paragraph (b) of this section, LOCAL GOVERNMENTS’’ make upward or downward adjust- Circular No. A–128 ments to the allowable costs. April 12, 1985.

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To the Heads of Executive Departments and b. Federal financial assistance means assist- Establishments ance provided by a Federal agency in the Subject: Audits of State and Local Govern- form of grants, contracts, cooperative agreements. ments, loans, loan guarantees, property, in- 1. Purpose. This Circular is issued pursuant terest subsidies, insurance, or direct appro- to the Single Audit Act of 1984, Pub. L. 98– priations, but does not include direct Federal 502. It establishes audit requirements for cash assistance to individuals. It includes State and local governments that receive awards received directly from Federal agen- Federal aid, and defines Federal responsibil- cies, or indirectly through other units of ities for implementing and monitoring those requirements. States and local governments. 2. Supersession. The Circular supersedes c. Federal agency has the same meaning as Attachment P, ‘‘Audit Requirements,’’ of the term ‘‘agency’’ in section 551(1) of Title Circular A–102, ‘‘Uniform requirements for 5, United States Code. grants to State and local governments.’’ d. Generally accepted accounting principles 3. Background. The Single Audit Act builds has the meaning specified in the generally upon earlier efforts to improve audits of Fed- accepted government auditing standards. eral aid programs. The Act requires State or e. Generally accepted government auditing local governments that receive $100,000 or standards means the Standards For Audit of more a year in Federal funds to have an Government Organizations, Programs, Ac- audit made for that year. Section 7505 of the tivities, and Functions, developed by the Act requires the Director of the Office of Comptroller General, dated February 27, Management and Budget to prescribe poli- 1981. cies, procedures and guidelines to implement the Act. It specifies that the Director shall f. Independent auditor means: designate ‘‘cognizant’’ Federal agencies, de- (1) A State or local government auditor termine criteria for making appropriate who meets the independence standards speci- charges to federal programs for the cost of fied in generally accepted government audit- audits, and provide procedures to assure that ing standards; or small firms or firms owned and controlled by (2) A public accountant who meets such disadvantaged individuals have the oppor- independence standards. tunity to participate in contracts for single g. Internal controls means the plan of orga- audits. nization and methods and procedures adopt- 4. Policy. The Single Audit Act requires ed by management to ensure that: the following: (1) Resource use is consistent with laws, a. State or local governments that receive regulations, and policies; $100,000 or more a year in Federal financial (2) Resources are safeguarded against assistance shall have an audit made in ac- waste, loss, and misuse; and cordance with this Circular. b. State or local governments that receive (3) Reliable data are obtained, maintained, between $25,000 and $100,000 a year shall have and fairly disclosed in reports. an audit made in accordance with this Cir- h. Indian tribe means any Indian tribe, cular, or in accordance with Federal laws band, nations, or other organized group or and regulations governing the programs they community, including any Alaskan Native participate in. village or regional or village corporations (as c. State or local governments that receive defined in, or established under, the Alaskan less than $25,000 a year shall be exempt from Native Claims Settlement Act) that is recog- compliance with the Act and other Federal nized by the United States as eligible for the audit requirements. These State and local special programs and services provided by governments shall be governed by audit re- the United States to Indians because of their quirements prescribed by State or local law status as Indians. or regulation. i. Local government means any unit of local d. Nothing in this paragraph exempts State government within a State, including a or local governments from maintaining county, a borough, municipality, city, town, records of Federal financial assistance or township, parish, local public authority, spe- from providing access to such records to Fed- cial district, school district, intrastate dis- eral agencies, as provided for in Federal law trict, council of government, and any other or in Circular A–102, ‘‘Uniform requirements instrumentality of local government. for grants to state or local governments.’’ 5. Definitions. For the purposes of this Cir- j. Major Federal Assistance Program, as de- cular the following definitions from the Sin- fined by Pub. L. 98–502, is described in the gle Audit Act apply: Attachment to this Circular. a. Cognizant agency means the Federal k. Public accountants means those individ- agency assigned by the Office of Manage- uals who meet the qualification standards ment and Budget to carry out the respon- included in generally accepted government sibilities described in paragraph 11 of this auditing standards for personnel performing Circular. government audits.

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l. State means any State of the United tional or statutory requirement for less fre- States, the District of Columbia, the Com- quent audits. For those governments, the monwealth of Puerto Rico, the Virgin Is- cognizant agency shall permit biennial au- lands, Guam, American Samoa, the Com- dits, covering both years, if the government monwealth of the Northern Mariana Islands, so requests. It shall also honor requests for and the Trust Territory of the Pacific Is- biennial audits by governments that have an lands, any instrumentality thereof, and any administrative policy calling for audits less multi-State, regional, or interstate entity frequent than annual, but only for fiscal that has governmental functions and any In- years beginning before January 1, 1987. dian tribe. 8. Internal control and compliance reviews. m. Subrecipient means any person or gov- The Single Audit Act requires that the inde- ernment department, agency, or establish- pendent auditor determine and report on ment that receives Federal financial assist- whether the organization has internal con- ance to carry out a program through a State trol systems to provide reasonable assurance or local government, but does not include an that it is managing Federal assistance pro- individual that is a beneficiary of such a programs in compliance with applicable laws gram. A subrecipient may also be a direct re- and regulations. cipient of Federal financial assistance. a. Internal control review. In order to pro- 6. Scope of audit. The Single Act provides vide this assurance the auditor must make a that: study and evaluation of internal control sys- a. The audit shall be made by an inde- tems used in administering Federal assist- pendent auditor in accordance with gen- ance programs. The study and evaluation erally accepted government auditing stand- must be made whether or not the auditor in- ards covering financial and compliance au- tends to place reliance on such systems. As dits. part of this review, the auditor shall: b. The audit shall cover the entire oper- (1) Test whether these internal control sys- ations of a State or local government or, at the option of that government, it may cover tems are functioning in accordance with pre- departments, agencies or establishments scribed procedures. that received, expended, or otherwise admin- (2) Examine the recipient’s system for istered Federal financial assistance during monitoring subrecipients and obtaining and the year. However, if a State or local govern- acting on subrecipient audit reports. ment receives $25,000 or more in General b. Compliance review. The law also re- Revenue Sharing Funds in a fiscal year, it quires the auditor to determine whether the shall have an audit of its entire operations. organization has complied with laws and reg- A series of audits of individual departments, ulations that may have a material effect on agencies, and establishments for the same each major Federal assistance program. fiscal year may be considered a single audit. (1) In order to determine which major pro- c. Public hospitals and public colleges and grams are to be tested for compliance, State universities may be excluded from State and and local governments shall identify in their local audits and the requirements of this Cir- accounts all Federal funds received and ex- cular. However, if such entities are excluded, pended and the programs under which they audits of these entities shall be made in ac- were received. This shall include funds re- cordance with statutory requirements and ceived directly from Federal agencies and the provisions of Circular A–110, ‘‘Uniform through other State and local governments. requirements for grants to universities, hos- (2) The review must include the selection pitals, and other nonprofit organizations.’’ and testing of a representative number of d. The auditor shall determine whether: charges from each major Federal assistance (1) The financial statements of the govern- program. The selection and testing of trans- ment, department, agency or establishment actions shall be based on the auditor’s pro- present fairly its financial position and the fessional judgment considering such factors results of its financial operations in accord- as the amount of expenditures for the pro- ance with generally accepted accounting gram and the individual awards; the newness principles; of the program or changes in its conditions; (2) The organization has internal account- prior experience with the program, particu- ing and other control systems to provide rea- larly as revealed in audits and other evalua- sonable assurance that it is managing Fed- tions (e.g., inspections program reviews); the eral financial assistance programs in compli- extent to which the program is carried out ance with applicable laws and regulations; through subrecipients; the extent to which and the program contracts for goods or services; (3) The organization has complied with the level to which the program is already laws and regulations that may have material subject to program reviews or other forms of effect on its financial statements and on independent oversight; the adequacy of the each major Federal assistance program. controls for ensuring compliance; the excep- 7. Frequency of audit. Audits shall be made tion of adherence or lack of adherence to the annually unless the State or local govern- applicable laws and regulations; and the po- ment has, by January 1, 1987, a constitu- tential impact of adverse findings.

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(a) In making the test of transactions, the d. Consider whether subrecipient audits ne- auditor shall determine whether: cessitate adjustment of the recipient’s own —The amounts reported as expenditures records; and were for allowable services, and e. Require each subrecipient to permit —The records show that those who received independent auditors to have access to the services or benefits were eligible to receive records and financial statements as nec- them. essary to comply with this Circular. (b) In addition to transaction testing, the 10. Relation to other audit requirements. auditor shall determine whether: The Single Audit Act provides that an audit —Matching requirements, levels of effort and made in accordance with this Circular shall earmarking limitations were met, be in lieu of any financial or financial com- —Federal financial reports and claims for pliance audit required under individual Fed- advances and reimbursements contain in- eral assistance programs. To the extent that formation that is supported by the books a single audit provides Federal agencies with and records from which the basic financial information and assurances they need to statements have been prepared, and carry out their overall responsibilities, they —Amounts claimed or used for matching shall rely upon and use such information. were determined in accordance with OMB However, a Federal agency shall make any Circular A–87, ‘‘Cost principles for State additional audits which are necessary to and local governments,’’ and Attachment carry out its responsibilities under Federal F of Circular A–102, ‘‘Uniform require- law and regulation. Any additional Federal ments for grants to State and local govern- audit effort shall be planned and carried out ments.’’ in such a way as to avoid duplication. (c) The principal compliance requirements a. The provisions of this Circular do not of the largest Federal aid programs may be limit the authority of Federal agencies to ascertained by referring to the Compliance make, or contract for audits and evaluations Supplement for Single Audits of State and of Federal financial assistance programs, nor Local Governments, issued by OMB and do they limit the authority of any Federal available from the Government Printing Of- agency Inspector General or other Federal fice. For those programs not covered in the audit official. Compliance Supplement, the auditor may as- b. The provisions of this Circular do not certain compliance requirements by re- authorize any State or local government or searching the statutes, regulations, and subrecipient thereof to constrain Federal agreements governing individual programs. agencies, in any manner, from carrying out (3) Transactions related to other Federal additional audits. assistance programs that are selected in connection with examinations of financial state- c. A Federal agency that makes or con- ments and evaluations of internal controls tracts for audits in addition to the audits shall be tested for compliance with Federal made by recipients pursuant to this Circular laws and regulations that apply to such shall, consistent with other applicable laws transactions. and regulations, arrange for funding the cost 9. Subrecipients. State or local govern- of such additional audits. Such additional ments that receive Federal financial assist- audits include economy and efficiency au- ance and provide $25,000 or more of it in a fis- dits, program results audits, and program cal year to a subrecipient shall: evaluations. a. Determine whether State or local sub- 11. Cognizant agency responsibilities. The recipients have met the audit requirements Single Audit Act provides for cognizant Fed- of this Circular and whether subrecipients eral agencies to oversee the implementation covered by Circular A–110, ‘‘Uniform require- of this Circular. ments for grants to universities, hospitals, a. The Office of Management and Budget and other nonprofit organizations,’’ have will assign cognizant agencies for States and met that requirement; their subdivisions and larger local govern- b. Determine whether the subrecipient ments and their subdivisions. Other Federal spent Federal assistance funds provided in agencies may participate with an assigned accordance with applicable laws and regula- cognizant agency, in order to fulfill the cog- tions. This may be accomplished by review- nizance responsibilities. Smaller governing an audit of the subrecipient made in ac- ments not assigned a cognizant agency will cordance with this Circular, Circular A–110, be under the general oversight of the Federal or through other means (e.g., program re- agency that provides them the most funds views) if the subrecipient has not yet had whether directly or indirectly. such an audit; b. A cognizant agency shall have the fol- c. Ensure that appropriate corrective ac- lowing responsibilities: tion is taken within six months after receipt (1) Ensure that audits are made and re- of the audit report in instances of non- ports are received in a timely manner and in compliance with Federal laws and regula- accordance with the requirements of this tions; Circular.

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(2) Provide technical advice and liaison to grants that have not been assigned a catalog State and local governments and inde- number shall be identified under the caption pendent auditors. ‘‘other Federal assistance.’’ (3) Obtain or make quality control reviews (2) The auditor’s report on the study and of selected audits made by non-Federal audit evaluation of internal control systems must organizations, and provide the results, when identify the organization’s significant inter- appropriate, to other interested organiza- nal accounting controls, and those controls tions. designed to provide reasonable assurance (4) Promptly inform other affected Federal that Federal programs are being managed in agencies and appropriate Federal law en- compliance with laws and regulations. It forcement officials of any reported illegal must also identify the controls that were acts or irregularities. They should also in- evaluated, the controls that were not evalu- form State or local law enforcement and ated, and the material weaknesses identified prosecuting authorities, if not advised by the as a result of the evaluation. recipient, of any violation of law within (3) The auditor’s report on compliance con- their jurisdiction. taining: (5) Advise the recipient of audits that have —A statement of positive assurance with re- been found not to have met the requirements spect to those items tested for compliance, set forth in this Circular. In such instances, including compliance with law and regula- the recipient will be expected to work with tions pertaining to financial reports and the auditor to take corrective action. If cor- claims for advances and reimbursements; rective action is not taken, the cognizant —Negative assurance on those items not agency shall notify the recipient and Federal tested; awarding agencies of the facts and make rec- —A summary of all instances of noncompli- ommendations for followup action. Major in- ance; and adequacies or repetitive substandard per- —An identification of total amounts ques- formance of independent auditors shall be re- tioned, if any, for each Federal assistance ferred to appropriate professional bodies for award, as a result of noncompliance. disciplinary action. b. The three parts of the audit report may (6) Coordinate, to the extent practicable, be bound into a single report, or presented at audits made by or for Federal agencies that the same time as separate documents. are in addition to the audits made pursuant c. All fraud abuse, or illegal acts or indica- to this Circular; so that the additional au- tions of such acts, including all questioned dits build upon such audits. costs found as the result of these acts that (7) Oversee the resolution of audit findings auditors become aware of, should normally that affect the programs of more than one be covered in a separate written report sub- agency. mitted in accordance with paragraph 13f. 12. Illegal acts or irregularities. If the d. In addition to the audit report, the re- auditor becomes aware of illegal acts or cipient shall provide comments on the find- other irregularities, prompt notice shall be ings and recommendations in the report, in- given to recipient management officials cluding a plan for corrective action taken or above the level of involvement. (See also planned and comments on the status of cor- paragraph 13(a)(3) below for the auditor’s re- rective action taken on prior findings. If cor- porting responsibilities.) The recipient, in rective action is not necessary, a statement turn, shall promptly notify the cognizant describing the reason it is not should accom- agency of the illegal acts or irregularities pany the audit report. and of proposed and actual actions, if any. Il- e. The reports shall be made available by legal acts and irregularities include such the State or local government for public in- matters as conflicts of interest, falsification spection within 30 days after the completion of records or reports, and misappropriations of the audit. of funds or other assets. f. In accordance with generally accepted 13. Audit reports. Audit reports must be government audit standards, reports shall be prepared at the completion of the audit. Re- submitted by the auditor to the organization ports serve many needs of State and local audited and to those requiring or arranging governments as well as meeting the require- for the audit. In addition, the recipient shall ments of the Single Audit Act. submit copies of the reports to each Federal a. The audit report shall state that the department or agency that provided Federal audit was made in accordance with the pro- assistance funds to the recipient. Subrecipi- visions of this Circular. The report shall be ents shall submit copies to recipients that made up of at least: provided them Federal assistance funds. The (1) The auditor’s report on financial state- reports shall be sent within 30 days after the ments and on a schedule of Federal assist- completion of the audit, but no later than ance; the financial statements; and a sched- one year after the end of the audit period un- ule of Federal assistance, showing the total less a longer period is agreed to with the cog- expenditures for each Federal assistance pro- nizant agency. gram as identified in the Catalog of Federal g. Recipients of more than $100,000 in Fed- Domestic Assistance. Federal programs or eral funds shall submit one copy of the audit

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report within 30 days after issuance to a cen- 18. Auditor Selection. In arranging for tral clearinghouse to be designated by the audit services State and local governments Office of Management and Budget. The clear- shall follow the procurement standards pre- inghouse will keep completed audits on file scribed by Attachment O of Circular A–102, and follow up with State and local govern- ‘‘Uniform requirements for grants to State ments that have not submitted required and local governments.’’ The standards pro- audit reports. vide that while recipients are encouraged to h. Recipients shall keep audit reports on enter into intergovernmental agreements for file for three years from their issuance. audit and other services, analysis should be 14. Audit Resolution. As provided in para- made to determine whether it would be more graph 11, the cognizant agency shall be re- economical to purchase the services from sponsible for monitoring the resolution of private firms. In instances where use of such audit findings that affect the programs of intergovernmental agreements are required more than one Federal agency. Resolution of by State statutes (e.g., audit services) these findings that relate to the programs of a sin- statutes will take precedence. gle Federal agency will be the responsibility 19. Small and Minority Audit Firms. Small of the recipient and that agency. Alternate audit firms and audit firms owned and con- arrangements may be made on a case-by- trolled by socially and economically dis- case basis by agreement among the agencies advantaged individuals shall have the max- concerned. imum practicable opportunity to participate Resolution shall be made within six in contracts awarded to fulfill the require- months after receipt of the report by the ments of this Circular. Recipients of Federal Federal departments and agencies. Correc- assistance shall take the following steps to tive action should proceed as rapidly as pos- further this goal: sible. a. Assure that small audit firms and audit 15. Audit workpapers and reports. firms owned and controlled by socially and Workpapers and reports shall be retained for economically disadvantaged individuals are a minimum of three years from the date of used to the fullest extent practicable. the audit report, unless the auditor is noti- b. Make information on forthcoming op- fied in writing by the cognizant agency to portunities available and arrange time extend the retention period. Audit frames for the audit so as to encourage and workpapers shall be made available upon re- facilitate participation by small audit firms quest to the cognizant agency or its designee and audit firms owned and controlled by so- or the General Accounting Office, at the cially and economically disadvantaged indi- completion of the audit. viduals. 16. Audit Costs. The cost of audits made in c. Consider in the contract process whether accordance with the provisions of this Cir- firms competing for larger audits intend to cular are allowable charges to Federal as- subcontract with small audit firms and audit sistance programs. firms owned and controlled by socially and a. The charges may be considered a direct economically disadvantaged individuals. cost or an allocated indirect cost, deter- d. Encourage contracting with small audit mined in accordance with the provision of firms or audit firms owned and controlled by Circular A–87, ‘‘Cost principles for State and socially and economically disadvantaged in- local governments.’’ dividuals which have traditionally audited b. Generally, the percentage of costs government programs and, in such cases charged to Federal assistance programs for a where this is not possible, assure that these single audit shall not exceed the percentage firms are given consideration for audit sub- that Federal funds expended represent of contracting opportunities. total funds expended by the recipient during e. Encourage contracting with consortiums the fiscal year. The percentage may be ex- of small audit firms as described in para- ceeded, however, if appropriate documenta- graph (a) above when a contract is too large tion demonstrates higher actual cost. for an individual small audit firm or audit 17. Sanctions. The Single Audit Act pro- firm owned and controlled by socially and vides that no cost may be charged to Federal economically disadvantaged individuals. assistance programs for audits required by f. Use the services and assistance, as appro- the Act that are not made in accordance priate, of such organizations as the Small with this Circular. In cases of continued in- Business Administration in the solicitation ability or unwillingness to have a proper and utilization of small audit firms or audit audit, Federal agencies must consider other firms owned and controlled by socially and appropriate sanctions including: economically disadvantaged individuals. —Withhodling a percentage of assistance 20. Reporting. Each Federal agency will repayments until the audit is completed sat- port to the Director of OMB on or before isfactorily, March 1, 1987, and annually thereafter on the —Withholding or disallowing overhead costs, effectiveness of State and local governments and in carrying out the provisions of this Cir- —Suspending the Federal assistance agree- cular. The report must identify each State or ment until the audit is made. local government or Indian tribe that, in the

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opinion of the agency, is failing to comply Subpart A—General with Circular. 21. Regulations. Each Federal agency shall 1404.100 What does this part do? include the provisions of this Circular in its 1404.105 Does this part apply to me? regulations implementing the Single Audit 1404.110 What is the purpose of the non- Act. procurement debarment and suspension 22. Effective date. This Circular is effective system? upon publication and shall apply to fiscal 1404.115 How does an exclusion restrict a years of State and local governments that person’s involvement in covered trans- begin after December 31, 1984. Earlier imple- actions? mentation is encouraged. However, until it is 1404.120 May we grant an exception to let an implemented, the audit provisions of Attach- excluded person participate in a covered ment P to Circular A–102 shall continue to be transaction? observed. 1404.125 Does an exclusion under the non- 23. Inquiries. All questions or inquiries procurement system affect a person’s eli- should be addressed to Financial Manage- gibility for Federal procurement con- ment Division, Office of Management and tracts? Budget, telephone number (202) 395–3993. 1404.130 Does exclusion under the Federal 24. Sunset review date. This Circular shall procurement system affect a person’s eli- have an independent policy review to ascer- gibility to participate in nonprocure- tain its effectiveness three years from the ment transactions? date of issuance. 1404.135 May the Office of National Drug David A. Stockman, Control Policy exclude a person who is Director. not currently participating in a nonprocurement transaction? CIRCULAR A–128 ATTACHMENT 1404.140 How do I know if a person is excluded? DEFINITION OF MAJOR PROGRAM AS PROVIDED 1404.145 Does this part address persons who IN PUB. L. 98–502 are disqualified, as well as those who are ‘‘Major Federal Assistance Program,’’ for excluded from nonprocurement trans- State and local governments having Federal actions? assistance expenditures between $100,000 and $100,000,000. means any program for which Subpart B—Covered Transactions Federal expenditures during the applicable year exceed the larger of $300,000, or 3 per- 1404.200 What is a covered transaction? cent of such total expenditures. 1404.205 Why is it important to know if a Where total expenditures of Federal assist- particular transaction is a covered trans- ance exceed $100,000,000, the following cri- action? teria apply: 1404.210 Which nonprocurement transactions are covered transactions? Total expenditures of Federal financial Major Federal as- 1404.215 Which nonprocurement trans- assistance for all programs sistance program means any program actions are not covered transactions? More than But less than that exceeds 1404.220 Are any procurement contracts included as covered transactions? $100 million 1 billion $3 million 1404.225 How do I know if a transaction in 1 billion 2 billion 4 million which I may participate is a covered 2 billion 3 billion 7 million 3 billion 4 billion 10 million transaction? 4 billion 5 billion 13 million 5 billion 6 billion 16 million Subpart C—Responsibilities of Participants 6 billion 7 billion 19 million Regarding Transactions Over 7 billion 20 million DOING BUSINESS WITH OTHER PERSONS [57 FR 55092, Nov. 24, 1992; 58 FR 26185, Apr. 1404.300 What must I do before I enter into 30, 1993] a covered transaction with another person at the next lower tier? PART 1404—GOVERNMENTWIDE 1404.305 May I enter into a covered transaction with an excluded or disqualified DEBARMENT AND SUSPENSION person? (NONPROCUREMENT) 1404.310 What must I do if a Federal agency excludes a person with whom I am al- Sec. ready doing business in a covered trans- 1404.25 How is this part organized? action? 1404.50 How is this part written? 1404.315 May I use the services of an ex- 1404.75 Do terms in this part have special cluded person as a principal under a cov- meanings? ered transaction?

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1404.320 Must I verify that principals of my 1404.440 What method do I use to commu- covered transactions are eligible to par- nicate those requirements to partici- ticipate? pants? 1404.325 What happens if I do business with 1404.445 What action may I take if a pri- an excluded person in a covered trans- mary tier participant knowingly does action? business with an excluded or disqualified 1404.330 What requirements must I pass person? down to persons at lower tiers with 1404.450 What action may I take if a pri- whom I intend to do business? mary tier participant fails to disclose the information required under § 1404.335? DISCLOSING INFORMATION—PRIMARY TIER 1404.455 What may I do if a lower tier par- PARTICIPANTS ticipant fails to disclose the information required under § 1404.355 to the next high- 1404.335 What information must I provide er tier? before entering into a covered transaction with the Office of National Drug Subpart E—Excluded Parties List System Control Policy? 1404.340 If I disclose unfavorable informa- 1404.500 What is the purpose of the Excluded tion required under § 1404.335, will I be Parties List System (EPLS)? prevented from participating in the 1404.505 Who uses the EPLS? transaction? 1404.510 Who maintains the EPLS? 1404.345 What happens if I fail to disclose 1404.515 What specific information is in the the information required under § 1404.335? EPLS? 1404.350 What must I do if I learn of the in- 1404.520 Who places the information into formation required under § 1404.335 after the EPLS? entering into a covered transaction with 1404.525 Whom do I ask if I have questions the Office of National Drug Control Pol- about a person in the EPLS? icy? 1404.530 Where can I find the EPLS?

DISCLOSING INFORMATION—LOWER TIER Subpart F—General Principles Relating to PARTICIPANTS Suspension and Debarment Actions 1404.355 What information must I provide to 1404.600 How do suspension and debarment a higher tier participant before entering actions start? into a covered transaction with that par- 1404.605 How does suspension differ from de- ticipant? barment? 1404.360 What happens if I fail to disclose 1404.610 What procedures does the Office of the information required under § 1404.355? National Drug Control Policy use in sus- 1404.365 What must I do if I learn of infor- pension and debarment actions? mation required under § 1404.355 after en- 1404.615 How does the Office of National tering into a covered transaction with a Drug Control Policy notify a person of a higher tier participant? suspension and debarment action? 1404.620 Do Federal agencies coordinate sus- Subpart D—Responsibilities of Office of Na- pension and debarment actions? tional Drug Control Policy Officials Re- 1404.625 What is the scope of a suspension or garding Transactions debarment action? 1404.630 May the Office of National Drug 1404.400 May I enter into a transaction with Control Policy impute the conduct of one an excluded or disqualified person? person to another? 1404.405 May I enter into a covered trans- 1404.635 May the Office of National Drug action with a participant if a principal of Control Policy settle a debarment or sus- the transaction is excluded? pension action? 1404.410 May I approve a participant’s use of 1404.640 May a settlement include a vol- the services of an excluded person? untary exclusion? 1404.415 What must I do if a Federal agency 1404.645 Do other Federal agencies know if excludes the participant or a principal the Office of National Drug Control Pol- after I enter into a covered transaction? icy agrees to a voluntary exclusion? 1404.420 May I approve a transaction with an excluded or disqualified person at a Subpart G—Suspension lower tier? 1404.700 When may the suspending official 1404.425 When do I check to see if a person issue a suspension? is excluded or disqualified? 1404.705 What does the suspending official 1404.430 How do I check to see if a person is consider in issuing a suspension? excluded or disqualified? 1404.710 When does a suspension take effect? 1404.435 What must I require of a primary 1404.715 What notice does the suspending of- tier participant? ficial give me if I am suspended?

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1404.720 How may I contest a suspension? 1404.885 May the debarring official extend a 1404.725 How much time do I have to contest debarment? a suspension? 1404.730 What information must I provide to Subpart I—Definitions the suspending official if I contest a suspension? 1404.900 Adequate evidence. 1404.735 Under what conditions do I get an 1404.905 Affiliate. additional opportunity to challenge the 1404.910 Agency. facts on which the suspension is based? 1404.915 Agent or representative. 1404.740 Are suspension proceedings formal? 1404.920 Civil judgment. 1404.745 How is fact-finding conducted? 1404.925 Conviction. 1404.750 What does the suspending official consider in deciding whether to continue 1404.930 Debarment. or terminate my suspension? 1404.935 Debarring official. 1404.755 When will I know whether the sus- 1404.940 Disqualified. pension is continued or terminated? 1404.945 Excluded or exclusion. 1404.760 How long may my suspension last? 1404.950 Excluded Parties List System. 1404.955 Indictment. Subpart H—Debarment 1404.960 Ineligible or ineligibility. 1404.965 Legal proceedings. 1404.800 What are the causes for debarment? 1404.970 Nonprocurement transaction. 1404.805 What notice does the debarring official give me if I am proposed for debar- 1404.975 Notice. ment? 1404.980 Participant. 1404.810 When does a debarment take effect? 1404.985 Person. 1404.815 How may I contest a proposed de- 1404.990 Preponderance of the evidence. barment? 1404.995 Principal. 1404.820 How much time do I have to contest 1404.1000 Respondent. a proposed debarment? 1404.1005 State. 1404.825 What information must I provide to 1404.1010 Suspending official. the debarring official if I contest a pro- 1404.1015 Suspension. posed debarment? 1404.1020 Voluntary exclusion or voluntarily 1404.830 Under what conditions do I get an excluded. additional opportunity to challenge the facts on which the proposed debarment is Subpart J [Reserved] based? 1404.835 Are debarment proceedings formal? APPENDIX TO PART 1404—COVERED TRANS- 1404.840 How is fact-finding conducted? ACTIONS 1404.845 What does the debarring official consider in deciding whether to debar AUTHORITY: E.O. 12549 3 CFR 1986 Comp., p. me? 189; E.O. 12689 3 CFR 1989 Comp., p. 235; sec. 1404.850 What is the standard of proof in a 2455, Pub. L. 103–355, 108 Stat. 3327 (31 U.S.C. debarment action? 6101 note); 21 U.S.C. 1701. 1404.855 Who has the burden of proof in a debarment action? SOURCE: 68 FR 66544, 66580, 66581, Nov. 26, 1404.860 What factors may influence the de- 2003, unless otherwise noted. barring official’s decision? 1404.865 How long may my debarment last? § 1404.25 How is this part organized? 1404.870 When do I know if the debarring of- (a) This part is subdivided into ten ficial debars me? 1404.875 May I ask the debarring official to subparts. Each subpart contains infor- reconsider a decision to debar me? mation related to a broad topic or spe- 1404.880 What factors may influence the de- cific audience with special responsibil- barring official during reconsideration? ities, as shown in the following table:

In subpart . . . You will find provisions related to . . .

A ...... general information about this rule. B ...... the types of Office of National Drug Control Policy transactions that are covered by the Government- wide nonprocurement suspension and debarment system. C ...... the responsibilities of persons who participate in covered transactions. D ...... the responsibilities of Office of National Drug Control Policy officials who are authorized to enter into covered transactions. E ...... the responsibilities of Federal agencies for the Excluded Parties List System (Disseminated by the General Services Administration). F ...... the general principles governing suspension, debarment, voluntary exclusion and settlement. G ...... suspension actions. H ...... debarment actions. I ...... definitions of terms used in this part.

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In subpart . . . You will find provisions related to . . .

J ...... [Reserved]

(b) The following table shows which Disqualifications frequently are not subparts may be of special interest to subject to the discretion of an agency you, depending on who you are: official, may have a different scope than exclusions, or have special condi- If you are . . . See subpart(s) . . . tions that apply to the disqualifica- (1) a participant or principal in a non- A, B, C, and I. tion; and procurement transaction. (c) Ineligibility or ineligible, which gen- (2) a respondent in a suspension action A, B, F, G and I. (3) a respondent in a debarment action A, B, F, H and I. erally refers to a person who is either (4) a suspending official ...... A, B, D, E, F, G excluded or disqualified. and I. (5) a debarring official ...... A, B, D, E, F, H and I. Subpart A—General (6) a (n) Office of National Drug Control A, B, D, E and I. Policy official authorized to enter into a covered transaction. § 1404.100 What does this part do? (7) Reserved ...... J. This part adopts a governmentwide system of debarment and suspension § 1404.50 How is this part written? for Office of National Drug Control (a) This part uses a ‘‘plain language’’ Policy nonprocurement activities. It format to make it easier for the gen- also provides for reciprocal exclusion eral public and business community to of persons who have been excluded use. The section headings and text, under the Federal Acquisition Regula- often in the form of questions and an- tion, and provides for the consolidated swers, must be read together. listing of all persons who are excluded, (b) Pronouns used within this part, or disqualified by statute, executive such as ‘‘I’’ and ‘‘you,’’ change from order, or other legal authority. This subpart to subpart depending on the part satisfies the requirements in sec- audience being addressed. The pronoun tion 3 of Executive Order 12549, ‘‘De- ‘‘we’’ always is the Office of National barment and Suspension’’ (3 CFR 1986 Drug Control Policy. Comp., p. 189), Executive Order 12689, (c) The ‘‘Covered Transactions’’ dia- ‘‘Debarment and Suspension’’ (3 CFR gram in the appendix to this part 1989 Comp., p. 235) and 31 U.S.C. 6101 shows the levels or ‘‘tiers’’ at which note (Section 2455, Public Law 103–355, the Office of National Drug Control 108 Stat. 3327). Policy enforces an exclusion under this part. § 1404.105 Does this part apply to me? § 1404.75 Do terms in this part have Portions of this part (see table at special meanings? § 1404.25(b)) apply to you if you are a(n)— This part uses terms throughout the text that have special meaning. Those (a) Person who has been, is, or may terms are defined in Subpart I of this reasonably be expected to be, a partici- part. For example, three important pant or principal in a covered trans- terms are— action; (a) Exclusion or excluded, which refers (b) Respondent (a person against only to discretionary actions taken by whom the Office of National Drug Con- a suspending or debarring official trol Policy has initiated a debarment under this part or the Federal Acquisi- or suspension action); tion Regulation (48 CFR part 9, subpart (c) Office of National Drug Control 9.4); Policy debarring or suspending official; (b) Disqualification or disqualified, or which refers to prohibitions under spe- (d) Office of National Drug Control cific statutes, executive orders (other Policy official who is authorized to than Executive Order 12549 and Execu- enter into covered transactions with tive Order 12689), or other authorities. non-Federal parties.

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§ 1404.110 What is the purpose of the § 1404.125 Does an exclusion under the nonprocurement debarment and nonprocurement system affect a suspension system? person’s eligibility for Federal procurement contracts? (a) To protect the public interest, the Federal Government ensures the integ- If any Federal agency excludes a per- rity of Federal programs by conducting son under its nonprocurement common rule on or after August 25, 1995, the ex- business only with responsible persons. cluded person is also ineligible to par- (b) A Federal agency uses the non- ticipate in Federal procurement trans- procurement debarment and suspension actions under the FAR. Therefore, an system to exclude from Federal pro- exclusion under this part has recip- grams persons who are not presently rocal effect in Federal procurement responsible. transactions. (c) An exclusion is a serious action that a Federal agency may take only § 1404.130 Does exclusion under the to protect the public interest. A Fed- Federal procurement system affect eral agency may not exclude a person a person’s eligibility to participate or commodity for the purposes of pun- in nonprocurement transactions? ishment. If any Federal agency excludes a person under the FAR on or after August § 1404.115 How does an exclusion re- 25, 1995, the excluded person is also in- strict a person’s involvement in cov- eligible to participate in nonprocure- ered transactions? ment covered transactions under this With the exceptions stated in part. Therefore, an exclusion under the §§ 1404.120, 1404.315, and 1404.420, a per- FAR has reciprocal effect in Federal son who is excluded by the Office of Na- nonprocurement transactions. tional Drug Control Policy or any § 1404.135 May the Office of National other Federal agency may not: Drug Control Policy exclude a per- (a) Be a participant in a(n) Office of son who is not currently partici- National Drug Control Policy trans- pating in a nonprocurement transaction that is a covered transaction action? under subpart B of this part; Given a cause that justifies an exclu- (b) Be a participant in a transaction sion under this part, we may exclude of any other Federal agency that is a any person who has been involved, is covered transaction under that agen- currently involved, or may reasonably cy’s regulation for debarment and sus- be expected to be involved in a covered pension; or transaction. (c) Act as a principal of a person participating in one of those covered § 1404.140 How do I know if a person is excluded? transactions. Check the Excluded Parties List System § 1404.120 May we grant an exception (EPLS) to determine whether a person to let an excluded person partici- is excluded. The General Services Ad- pate in a covered transaction? ministration (GSA) maintains the (a) The Director of National Drug EPLS and makes it available, as de- Control Policy may grant an exception tailed in subpart E of this part. When a permitting an excluded person to par- Federal agency takes an action to exclude a person under the nonprocure- ticipate in a particular covered trans- ment or procurement debarment and action. If the Director of National Drug suspension system, the agency enters Control Policy grants an exception, the the information about the excluded exception must be in writing and state person into the EPLS. the reason(s) for deviating from the governmentwide policy in Executive § 1404.145 Does this part address per- Order 12549. sons who are disqualified, as well (b) An exception granted by one as those who are excluded from agency for an excluded person does not nonprocurement transactions? extend to the covered transactions of Except if provided for in Subpart J of another agency. this part, this part—

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(a) Addresses disqualified persons have the responsibilities laid out in only to— subpart D of this part. (1) Provide for their inclusion in the (c) As an excluded person, you may EPLS; and not be a participant or principal in the (2) State responsibilities of Federal transaction unless— agencies and participants to check for (1) The person who entered into the disqualified persons before entering transaction with you allows you to into covered transactions. continue your involvement in a trans- (b) Does not specify the— action that predates your exclusion, as (1) Office of National Drug Control permitted under § 1404.310 or § 1404.415; Policy transactions for which a dis- or qualified person is ineligible. Those (2) A(n) Office of National Drug Con- transactions vary on a case-by-case trol Policy official obtains an excep- basis, because they depend on the lan- tion from the Director of National guage of the specific statute, Executive Drug Control Policy to allow you to be order, or regulation that caused the involved in the transaction, as per- disqualification; mitted under § 1404.120. (2) Entities to which the disqualification applies; or § 1404.210 Which nonprocurement (3) Process that the agency uses to transactions are covered trans- disqualify a person. Unlike exclusion, actions? disqualification is frequently not a dis- All nonprocurement transactions, as cretionary action that a Federal agen- defined in § 1404.970, are covered trans- cy takes. actions unless listed in § 1404.215. (See appendix to this part.) Subpart B—Covered Transactions § 1404.215 Which nonprocurement § 1404.200 What is a covered trans- transactions are not covered transaction? actions? A covered transaction is a non- The following types of nonprocure- procurement or procurement trans- ment transactions are not covered action that is subject to the prohibi- transactions: tions of this part. It may be a trans- (a) A direct award to— action at— (1) A foreign government or foreign (a) The primary tier, between a Fed- governmental entity; eral agency and a person (see appendix (2) A public international organiza- to this part); or tion; (b) A lower tier, between a partici- (3) An entity owned (in whole or in pant in a covered transaction and an- part) or controlled by a foreign govern- other person. ment; or (4) Any other entity consisting whol- § 1404.205 Why is it important if a par- ly or partially of one or more foreign ticular transaction is a covered governments or foreign governmental transaction? entities. The importance of a covered trans- (b) A benefit to an individual as a action depends upon who you are. personal entitlement without regard to (a) As a participant in the trans- the individual’s present responsibility action, you have the responsibilities (but benefits received in an individual’s laid out in Subpart C of this part. business capacity are not excepted). Those include responsibilities to the For example, if a person receives social person or Federal agency at the next security benefits under the Supple- higher tier from whom you received mental Security Income provisions of the transaction, if any. They also in- the Social Security Act, 42 U.S.C. 1301 clude responsibilities if you subse- et seq., those benefits are not covered quently enter into other covered trans- transactions and, therefore, are not af- actions with persons at the next lower fected if the person is excluded. tier. (c) Federal employment. (b) As a Federal official who enters (d) A transaction that the Office of into a primary tier transaction, you National Drug Control Policy needs to

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respond to a national or agency-recog- you that you must comply with appli- nized emergency or disaster. cable portions of this part. (e) A permit, license, certificate, or similar instrument issued as a means Subpart C—Responsibilities of Par- to regulate public health, safety, or the ticipants Regarding Trans- environment, unless the Office of Na- actions tional Drug Control Policy specifically designates it to be a covered trans- DOING BUSINESS WITH OTHER PERSONS action. (f) An incidental benefit that results § 1404.300 What must I do before I from ordinary governmental oper- enter into a covered transaction ations. with another person at the next (g) Any other transaction if the ap- lower tier? plication of an exclusion to the trans- When you enter into a covered transaction is prohibited by law. action with another person at the next lower tier, you must verify that the § 1404.220 Are any procurement con- person with whom you intend to do tracts included as covered trans- business is not excluded or disqualified. actions? You do this by: (a) Covered transactions under this (a) Checking the EPLS; or part— (b) Collecting a certification from (1) Do not include any procurement that person if allowed by this rule; or contracts awarded directly by a Fed- (c) Adding a clause or condition to eral agency; but the covered transaction with that per- (2) Do include some procurement con- son. tracts awarded by non-Federal participants in nonprocurement covered § 1404.305 May I enter into a covered transactions (see appendix to this transaction with an excluded or dis- part). qualified person? (b) Specifically, a contract for goods (a) You as a participant may not or services is a covered transaction if enter into a covered transaction with any of the following applies: an excluded person, unless the Office of (1) The contract is awarded by a par- National Drug Control Policy grants ticipant in a nonprocurement trans- an exception under § 1404.120. action that is covered under § 1404.210, (b) You may not enter into any trans- and the amount of the contract is ex- action with a person who is disqualified pected to equal or exceed $25,000. from that transaction, unless you have (2) The contract requires the consent obtained an exception under the dis- of a(n) Office of National Drug Control qualifying statute, Executive order, or Policy official. In that case, the con- regulation. tract, regardless of the amount, always is a covered transaction, and it does § 1404.310 What must I do if a Federal not matter who awarded it. For exam- agency excludes a person with ple, it could be a subcontract awarded whom I am already doing business in a covered transaction? by a contractor at a tier below a nonprocurement transaction, as shown in (a) You as a participant may con- the appendix to this part. tinue covered transactions with an ex- (3) The contract is for federally-re- cluded person if the transactions were quired audit services. in existence when the agency excluded the person. However, you are not re- § 1404.225 How do I know if a trans- quired to continue the transactions, action in which I may participate is and you may consider termination. a covered transaction? You should make a decision about As a participant in a transaction, whether to terminate and the type of you will know that it is a covered termination action, if any, only after a transaction because the agency regula- thorough review to ensure that the actions governing the transaction, the tion is proper and appropriate. appropriate agency official, or partici- (b) You may not renew or extend cov- pant at the next higher tier who enters ered transactions (other than no-cost into the transaction with you, will tell time extensions) with any excluded

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person, unless the Office of National od(s), unless § 1404.440 requires you to Drug Control Policy grants an excep- use specific methods. tion under § 1404.120. (b) Pass the requirement to comply with this subpart to each person with § 1404.315 May I use the services of an whom the participant enters into a excluded person as a principal under a covered transaction? covered transaction at the next lower tier. (a) You as a participant may continue to use the services of an excluded DISCLOSING INFORMATION—PRIMARY person as a principal under a covered TIER PARTICIPANTS transaction if you were using the services of that person in the transaction § 1404.335 What information must I before the person was excluded. How- provide before entering into a cov- ever, you are not required to continue ered transaction with the Office of using that person’s services as a prin- National Drug Control Policy? cipal. You should make a decision Before you enter into a covered about whether to discontinue that per- transaction at the primary tier, you as son’s services only after a thorough re- the participant must notify the Office view to ensure that the action is proper of National Drug Control Policy office and appropriate. that is entering into the transaction (b) You may not begin to use the with you, if you know that you or any services of an excluded person as a of the principals for that covered trans- principal under a covered transaction unless the Office of National Drug Con- action: trol Policy grants an exception under (a) Are presently excluded or dis- § 1404.120. qualified; (b) Have been convicted within the § 1404.320 Must I verify that principals preceding three years of any of the of- of my covered transactions are eli- fenses listed in § 1404.800(a) or had a gible to participate? civil judgment rendered against you for Yes, you as a participant are respon- one of those offenses within that time sible for determining whether any of period; your principals of your covered trans- (c) Are presently indicted for or oth- actions is excluded or disqualified from erwise criminally or civilly charged by participating in the transaction. You a governmental entity (Federal, State may decide the method and frequency or local) with commission of any of the by which you do so. You may, but you offenses listed in § 1404.800(a); or are not required to, check the EPLS. (d) Have had one or more public § 1404.325 What happens if I do busi- transactions (Federal, State, or local) ness with an excluded person in a terminated within the preceding three covered transaction? years for cause or default. If as a participant you knowingly do § 1404.340 If I disclose unfavorable in- business with an excluded person, we formation required under may disallow costs, annul or terminate § 1404.335, will I be prevented from the transaction, issue a stop work participating in the transaction? order, debar or suspend you, or take other remedies as appropriate. As a primary tier participant, your disclosure of unfavorable information § 1404.330 What requirements must I about yourself or a principal under pass down to persons at lower tiers § 1404.335 will not necessarily cause us with whom I intend to do business? to deny your participation in the cov- Before entering into a covered trans- ered transaction. We will consider the action with a participant at the next information when we determine wheth- lower tier, you must require that par- er to enter into the covered trans- ticipant to— action. We also will consider any addi- (a) Comply with this subpart as a tional information or explanation that condition of participation in the trans- you elect to submit with the disclosed action. You may do so using any meth- information.

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§ 1404.345 What happens if I fail to dis- § 1404.365 What must I do if I learn of close information required under information required under § 1404.335? § 1404.355 after entering into a covered transaction with a higher tier If we later determine that you failed participant? to disclose information under § 1404.335 that you knew at the time you entered At any time after you enter into a lower tier covered transaction with a into the covered transaction, we may— person at a higher tier, you must pro- (a) Terminate the transaction for vide immediate written notice to that material failure to comply with the person if you learn either that— terms and conditions of the trans- (a) You failed to disclose information action; or earlier, as required by § 1404.355; or (b) Pursue any other available rem- (b) Due to changed circumstances, edies, including suspension and debar- you or any of the principals for the ment. transaction now meet any of the criteria in § 1404.355. § 1404.350 What must I do if I learn of information required under § 1404.335 after entering into a cov- Subpart D—Responsibilities of Of- ered transaction with the Office of fice of National Drug Control National Drug Control Policy? Policy Officials Regarding At any time after you enter into a Transactions covered transaction, you must give immediate written notice to the Office of § 1404.400 May I enter into a trans- National Drug Control Policy office action with an excluded or disqualified person? with which you entered into the transaction if you learn either that— (a) You as an agency official may not (a) You failed to disclose information enter into a covered transaction with earlier, as required by § 1404.335; or an excluded person unless you obtain an exception under § 1404.120. (b) Due to changed circumstances, you or any of the principals for the (b) You may not enter into any transaction with a person who is disqualified transaction now meet any of the cri- from that transaction, unless you ob- teria in § 1404.335. tain a waiver or exception under the statute, Executive order, or regulation DISCLOSING INFORMATION—LOWER TIER that is the basis for the person’s dis- PARTICIPANTS qualification. § 1404.355 What information must I provide to a higher tier participant § 1404.405 May I enter into a covered before entering into a covered transaction with a participant if a transaction with that participant? principal of the transaction is excluded? Before you enter into a covered As an agency official, you may not transaction with a person at the next enter into a covered transaction with a higher tier, you as a lower tier partici- participant if you know that a prin- pant must notify that person if you cipal of the transaction is excluded, un- know that you or any of the principals less you obtain an exception under are presently excluded or disqualified. § 1404.120.

§ 1404.360 What happens if I fail to dis- § 1404.410 May I approve a partici- close the information required pant’s use of the services of an ex- under § 1404.355? cluded person? If we later determine that you failed After entering into a covered trans- to tell the person at the higher tier action with a participant, you as an that you were excluded or disqualified agency official may not approve a par- at the time you entered into the cov- ticipant’s use of an excluded person as ered transaction with that person, we a principal under that transaction, un- may pursue any available remedies, in- less you obtain an exception under cluding suspension and debarment. § 1404.120.

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§ 1404.415 What must I do if a Federal § 1404.430 How do I check to see if a agency excludes the participant or person is excluded or disqualified? a principal after I enter into a cov- You check to see if a person is ex- ered transaction? cluded or disqualified in two ways: (a) You as an agency official may (a) You as an agency official must continue covered transactions with an check the EPLS when you take any ac- excluded person, or under which an ex- tion listed in § 1404.425. cluded person is a principal, if the (b) You must review information that transactions were in existence when a participant gives you, as required by the person was excluded. You are not § 1404.335, about its status or the status required to continue the transactions, of the principals of a transaction. however, and you may consider termi- § 1404.435 What must I require of a nation. You should make a decision primary tier participant? about whether to terminate and the You as an agency official must re- type of termination action, if any, only quire each participant in a primary after a thorough review to ensure that tier covered transaction to— the action is proper. (a) Comply with subpart C of this (b) You may not renew or extend cov- part as a condition of participation in ered transactions (other than no-cost the transaction; and time extensions) with any excluded (b) Communicate the requirement to person, or under which an excluded per- comply with Subpart C of this part to son is a principal, unless you obtain an persons at the next lower tier with exception under § 1404.120. whom the primary tier participant enters into covered transactions. § 1404.420 May I approve a transaction with an excluded or disqualified § 1404.440 What method do I use to person at a lower tier? communicate those requirements to participants? If a transaction at a lower tier is subject to your approval, you as an agency You must obtain certifications from official may not approve— participants that they will comply with subpart C of this part and that (a) A covered transaction with a per- they will obtain similar certifications son who is currently excluded, unless from lower-tier participants. you obtain an exception under § 1404.120; or [68 FR 66581, Nov. 26, 2003] (b) A transaction with a person who § 1404.445 What action may I take if a is disqualified from that transaction, primary tier participant knowingly unless you obtain a waiver or exception does business with an excluded or under the statute, Executive order, or disqualified person? regulation that is the basis for the per- If a participant knowingly does busi- son’s disqualification. ness with an excluded or disqualified person, you as an agency official may § 1404.425 When do I check to see if a refer the matter for suspension and de- person is excluded or disqualified? barment consideration. You may also As an agency official, you must disallow costs, annul or terminate the check to see if a person is excluded or transaction, issue a stop work order, or disqualified before you— take any other appropriate remedy. (a) Enter into a primary tier covered transaction; § 1404.450 What action may I take if a primary tier participant fails to dis- (b) Approve a principal in a primary close the information required tier covered transaction; under § 1404.335? (c) Approve a lower tier participant if If you as an agency official deter- agency approval of the lower tier par- mine that a participant failed to dis- ticipant is required; or close information, as required by (d) Approve a principal in connection § 1404.335, at the time it entered into a with a lower tier transaction if agency covered transaction with you, you approval of the principal is required. may—

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(a) Terminate the transaction for the information about the excluded material failure to comply with the person into the EPLS. terms and conditions of the transaction; or § 1404.515 What specific information is (b) Pursue any other available rem- in the EPLS? edies, including suspension and debar- (a) At a minimum, the EPLS indi- ment. cates— (1) The full name (where available) § 1404.455 What may I do if a lower and address of each excluded or dis- tier participant fails to disclose the qualified person, in alphabetical order, information required under with cross references if more than one § 1404.355 to the next higher tier? name is involved in a single action; If you as an agency official deter- (2) The type of action; mine that a lower tier participant (3) The cause for the action; failed to disclose information, as re- (4) The scope of the action; quired by § 1404.355, at the time it en- (5) Any termination date for the ac- tered into a covered transaction with a tion; participant at the next higher tier, you (6) The agency and name and tele- may pursue any remedies available to phone number of the agency point of you, including the initiation of a sus- contact for the action; and pension or debarment action. (7) The Dun and Bradstreet Number (DUNS), or other similar code approved Subpart E—Excluded Parties List by the GSA, of the excluded or dis- System qualified person, if available. (b)(1) The database for the EPLS in- § 1404.500 What is the purpose of the cludes a field for the Taxpayer Identi- Excluded Parties List System fication Number (TIN) (the social secu- (EPLS)? rity number (SSN) for an individual) of The EPLS is a widely available an excluded or disqualified person. source of the most current information (2) Agencies disclose the SSN of an about persons who are excluded or dis- individual to verify the identity of an qualified from covered transactions. individual, only if permitted under the Privacy Act of 1974 and, if appropriate, § 1404.505 Who uses the EPLS? the Computer Matching and Privacy (a) Federal agency officials use the Protection Act of 1988, as codified in 5 EPLS to determine whether to enter U.S.C. 552(a). into a transaction with a person, as required under § 1404.430. § 1404.520 Who places the information (b) Participants also may, but are into the EPLS? not required to, use the EPLS to deter- Federal officials who take actions to mine if— exclude persons under this part or offi- (1) Principals of their transactions cials who are responsible for identi- are excluded or disqualified, as re- fying disqualified persons must enter quired under § 1404.320; or the following information about those (2) Persons with whom they are en- persons into the EPLS: tering into covered transactions at the (a) Information required by next lower tier are excluded or dis- § 1404.515(a); qualified. (b) The Taxpayer Identification Num- (c) The EPLS is available to the gen- ber (TIN) of the excluded or disquali- eral public. fied person, including the social security number (SSN) for an individual, if § 1404.510 Who maintains the EPLS? the number is available and may be In accordance with the OMB guide- disclosed under law; lines, the General Services Administra- (c) Information about an excluded or tion (GSA) maintains the EPLS. When disqualified person, generally within a Federal agency takes an action to ex- five working days, after— clude a person under the nonprocure- (1) Taking an exclusion action; ment or procurement debarment and (2) Modifying or rescinding an exclu- suspension system, the agency enters sion action;

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(3) Finding that a person is disquali- scription from the Superintendent of fied; or Documents, U.S. Government Printing (4) Finding that there has been a Office, Washington, DC 20402, or by change in the status of a person who is calling the Government Printing Office listed as disqualified. Inquiry and Order Desk at (202) 783– 3238. § 1404.525 Whom do I ask if I have questions about a person in the Subpart F—General Principles Re- EPLS? lating to Suspension and De- If you have questions about a person barment Actions in the EPLS, ask the point of contact for the Federal agency that placed the § 1404.600 How do suspension and de- person’s name into the EPLS. You may barment actions start? find the agency point of contact from When we receive information from the EPLS. any source concerning a cause for suspension or debarment, we will prompt- § 1404.530 Where can I find the EPLS? ly report and investigate it. We refer (a) You may access the EPLS through the question of whether to suspend or the Internet, currently at http:// debar you to our suspending or debar- epls.arnet.gov. ring official for consideration, if appro- (b) As of November 26, 2003, you may priate. also subscribe to a printed version. However, we anticipate discontinuing § 1404.605 How does suspension differ the printed version. Until it is discon- from debarment? tinued, you may obtain the printed Suspension differs from debarment in version by purchasing a yearly sub- that—

A suspending official . . . A debarring official . . .

(a) Imposes suspension as a temporary status of ineligibility for Imposes debarment for a specified period as a final determina- procurement and nonprocurement transactions, pending tion that a person is not presently responsible. completion of an investigation or legal proceedings. (b) Must— ...... Must conclude, based on a preponderance of the evidence, (1) Have adequate evidence that there may be a cause for de- that the person has engaged in conduct that warrants debar- barment of a person; and. ment. (2) Conclude that immediate action is necessary to protect the Federal interest. (c) Usually imposes the suspension first, and then promptly no- Imposes debarment after giving the respondent notice of the tifies the suspended person, giving the person an opportunity action and an opportunity to contest the proposed debar- to contest the suspension and have it lifted. ment.

§ 1404.610 What procedures does the § 1404.615 How does the Office of Na- Office of National Drug Control Pol- tional Drug Control Policy notify a icy use in suspension and debar- person of a suspension or debarment actions? ment action? In deciding whether to suspend or (a) The suspending or debarring offi- debar you, we handle the actions as in- cial sends a written notice to the last formally as practicable, consistent known street address, facsimile num- with principles of fundamental fair- ber, or e-mail address of— ness. (1) You or your identified counsel; or (a) For suspension actions, we use (2) Your agent for service of process, the procedures in this subpart and sub- or any of your partners, officers, direc- part G of this part. tors, owners, or joint venturers. (b) For debarment actions, we use the (b) The notice is effective if sent to procedures in this subpart and subpart any of these persons. H of this part.

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§ 1404.620 Do Federal agencies coordi- (b) Conduct imputed from an organiza- nate suspension and debarment action to an individual, or between individ- tions? uals. We may impute the fraudulent, Yes, when more than one Federal criminal, or other improper conduct of agency has an interest in a suspension any organization to an individual, or or debarment, the agencies may con- from one individual to another indi- sider designating one agency as the vidual, if the individual to whom the lead agency for making the decision. improper conduct is imputed either Agencies are encouraged to establish participated in, had knowledge of, or methods and procedures for coordi- reason to know of the improper con- nating their suspension and debarment duct. actions. (c) Conduct imputed from one organization to another organization. We may § 1404.625 What is the scope of a suspension or debarment? impute the fraudulent, criminal, or other improper conduct of one organi- If you are suspended or debarred, the zation to another organization when suspension or debarment is effective as follows: the improper conduct occurred in con- (a) Your suspension or debarment nection with a partnership, joint ven- constitutes suspension or debarment of ture, joint application, association or all of your divisions and other organi- similar arrangement, or when the orga- zational elements from all covered nization to whom the improper conduct transactions, unless the suspension or is imputed has the power to direct, debarment decision is limited— manage, control or influence the ac- (1) By its terms to one or more spe- tivities of the organization responsible cifically identified individuals, divi- for the improper conduct. Acceptance sions, or other organizational ele- of the benefits derived from the con- ments; or duct is evidence of knowledge, approval (2) To specific types of transactions. or acquiescence. (b) Any affiliate of a participant may be included in a suspension or debar- § 1404.635 May the Office of National ment action if the suspending or debar- Drug Control Policy settle a debarring official— ment or suspension action? (1) Officially names the affiliate in Yes, we may settle a debarment or the notice; and suspension action at any time if it is in (2) Gives the affiliate an opportunity the best interest of the Federal Gov- to contest the action. ernment. § 1404.630 May the Office of National Drug Control Policy impute con- § 1404.640 May a settlement include a duct of one person to another? voluntary exclusion? For purposes of actions taken under Yes, if we enter into a settlement this rule, we may impute conduct as with you in which you agree to be ex- follows: cluded, it is called a voluntary exclu- (a) Conduct imputed from an individual sion and has governmentwide effect. to an organization. We may impute the fraudulent, criminal, or other improper § 1404.645 Do other Federal agencies conduct of any officer, director, share- know if the Office of National Drug holder, partner, employee, or other in- Control Policy agrees to a vol- dividual associated with an organiza- untary exclusion? tion, to that organization when the im- (a) Yes, we enter information regard- proper conduct occurred in connection ing a voluntary exclusion into the with the individual’s performance of EPLS. duties for or on behalf of that organiza- (b) Also, any agency or person may tion, or with the organization’s knowl- contact us to find out the details of a edge, approval or acquiescence. The or- voluntary exclusion. ganization’s acceptance of the benefits derived from the conduct is evidence of knowledge, approval or acquiescence.

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Subpart G—Suspension § 1404.715 What notice does the suspending official give me if I am sus- § 1404.700 When may the suspending pended? official issue a suspension? After deciding to suspend you, the Suspension is a serious action. Using suspending official promptly sends you the procedures of this subpart and sub- a Notice of Suspension advising you— part F of this part, the suspending offi- (a) That you have been suspended; cial may impose suspension only when (b) That your suspension is based that official determines that— on— (a) There exists an indictment for, or (1) An indictment; other adequate evidence to suspect, an (2) A conviction; offense listed under § 1404.800(a), or (3) Other adequate evidence that you (b) There exists adequate evidence to have committed irregularities which suspect any other cause for debarment seriously reflect on the propriety of listed under § 1404.800(b) through (d); further Federal Government dealings and with you; or (c) Immediate action is necessary to (4) Conduct of another person that protect the public interest. has been imputed to you, or your affiliation with a suspended or debarred per- § 1404.705 What does the suspending son; official consider in issuing a sus- (c) Of any other irregularities in pension? terms sufficient to put you on notice (a) In determining the adequacy of without disclosing the Federal Govern- the evidence to support the suspension, ment’s evidence; the suspending official considers how (d) Of the cause(s) upon which we re- much information is available, how lied under § 1404.700 for imposing sus- credible it is given the circumstances, pension; whether or not important allegations (e) That your suspension is for a tem- are corroborated, and what inferences porary period pending the completion can reasonably be drawn as a result. of an investigation or resulting legal or During this assessment, the suspending debarment proceedings; official may examine the basic docu- (f) Of the applicable provisions of this ments, including grants, cooperative subpart, Subpart F of this part, and agreements, loan authorizations, con- any other Office of National Drug Con- tracts, and other relevant documents. trol Policy procedures governing sus- (b) An indictment, conviction, civil pension decision making; and judgment, or other official findings by (g) Of the governmentwide effect of Federal, State, or local bodies that de- your suspension from procurement and termine factual and/or legal matters, nonprocurement programs and activi- constitutes adequate evidence for pur- ties. poses of suspension actions. (c) In deciding whether immediate § 1404.720 How may I contest a suspen- action is needed to protect the public sion? interest, the suspending official has If you as a respondent wish to con- wide discretion. For example, the sus- test a suspension, you or your rep- pending official may infer the neces- resentative must provide the sus- sity for immediate action to protect pending official with information in the public interest either from the na- opposition to the suspension. You may ture of the circumstances giving rise to do this orally or in writing, but any in- a cause for suspension or from poten- formation provided orally that you tial business relationships or involve- consider important must also be sub- ment with a program of the Federal mitted in writing for the official Government. record.

§ 1404.710 When does a suspension § 1404.725 How much time do I have to take effect? contest a suspension? A suspension is effective when the (a) As a respondent you or your rep- suspending official signs the decision resentative must either send, or make to suspend. arrangements to appear and present,

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the information and argument to the (2) Your presentation in opposition suspending official within 30 days after contains only general denials to infor- you receive the Notice of Suspension. mation contained in the Notice of Sus- (b) We consider the notice to be re- pension; ceived by you— (3) The issues raised in your presen- (1) When delivered, if we mail the notation in opposition to the suspension tice to the last known street address, are not factual in nature, or are not or five days after we send it if the let- material to the suspending official’s ter is undeliverable; initial decision to suspend, or the offi- (2) When sent, if we send the notice cial’s decision whether to continue the by facsimile or five days after we send suspension; or it if the facsimile is undeliverable; or (4) On the basis of advice from the (3) When delivered, if we send the no- Department of Justice, an office of the tice by e-mail or five days after we United States Attorney, a State attor- send it if the e-mail is undeliverable. ney general’s office, or a State or local prosecutor’s office, that substantial in- § 1404.730 What information must I terests of the government in pending or provide to the suspending official if I contest a suspension? contemplated legal proceedings based on the same facts as the suspension (a) In addition to any information would be prejudiced by conducting and argument in opposition, as a re- fact-finding. spondent your submission to the sus- (b) You will have an opportunity to pending official must identify— challenge the facts if the suspending (1) Specific facts that contradict the official determines that— statements contained in the Notice of (1) The conditions in paragraph (a) of Suspension. A general denial is insuffi- this section do not exist; and cient to raise a genuine dispute over (2) Your presentation in opposition facts material to the suspension; raises a genuine dispute over facts ma- (2) All existing, proposed, or prior ex- terial to the suspension. clusions under regulations imple- (c) If you have an opportunity to menting E.O. 12549 and all similar ac- challenge disputed material facts tions taken by Federal, state, or local under this section, the suspending offi- agencies, including administrative cial or designee must conduct addi- agreements that affect only those agencies; tional proceedings to resolve those (3) All criminal and civil proceedings facts. not included in the Notice of Suspen- § 1404.740 Are suspension proceedings sion that grew out of facts relevant to formal? the cause(s) stated in the notice; and (4) All of your affiliates. (a) Suspension proceedings are con- (b) If you fail to disclose this infor- ducted in a fair and informal manner. mation, or provide false information, The suspending official may use flexi- the Office of National Drug Control ble procedures to allow you to present Policy may seek further criminal, civil matters in opposition. In so doing, the or administrative action against you, suspending official is not required to as appropriate. follow formal rules of evidence or procedure in creating an official record § 1404.735 Under what conditions do I upon which the official will base a final get an additional opportunity to suspension decision. challenge the facts on which the (b) You as a respondent or your rep- suspension is based? resentative must submit any documen- (a) You as a respondent will not have tary evidence you want the suspending an additional opportunity to challenge official to consider. the facts if the suspending official determines that— § 1404.745 How is fact-finding con- (1) Your suspension is based upon an ducted? indictment, conviction, civil judgment, (a) If fact-finding is conducted— or other finding by a Federal, State, or (1) You may present witnesses and local body for which an opportunity to other evidence, and confront any wit- contest the facts was provided; ness presented; and

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(2) The fact-finder must prepare writ- tional 6 months if an office of a U.S. ten findings of fact for the record. Assistant Attorney General, U.S. At- (b) A transcribed record of fact-find- torney, or other responsible pros- ing proceedings must be made, unless ecuting official requests an extension you as a respondent and the Office of in writing. In no event may a suspen- National Drug Control Policy agree to sion exceed 18 months without initi- waive it in advance. If you want a copy ating proceedings under paragraph (a) of the transcribed record, you may pur- of this section. chase it. (c) The suspending official must notify the appropriate officials under § 1404.750 What does the suspending paragraph (b) of this section of an im- official consider in deciding wheth- pending termination of a suspension at er to continue or terminate my suspension? least 30 days before the 12 month period expires to allow the officials an (a) The suspending official bases the opportunity to request an extension. decision on all information contained in the official record. The record includes— Subpart H—Debarment (1) All information in support of the § 1404.800 What are the causes for de- suspending official’s initial decision to barment? suspend you; (2) Any further information and argu- We may debar a person for— ment presented in support of, or oppo- (a) Conviction of or civil judgment sition to, the suspension; and for— (3) Any transcribed record of fact- (1) Commission of fraud or a criminal finding proceedings. offense in connection with obtaining, (b) The suspending official may refer attempting to obtain, or performing a disputed material facts to another offi- public or private agreement or trans- cial for findings of fact. The suspending action; official may reject any resulting find- (2) Violation of Federal or State anti- ings, in whole or in part, only after trust statutes, including those pro- specifically determining them to be ar- scribing price fixing between competi- bitrary, capricious, or clearly erro- tors, allocation of customers between neous. competitors, and bid rigging; (3) Commission of embezzlement, § 1404.755 When will I know whether theft, forgery, bribery, falsification or the suspension is continued or ter- destruction of records, making false minated? statements, tax evasion, receiving sto- The suspending official must make a len property, making false claims, or written decision whether to continue, obstruction of justice; or modify, or terminate your suspension (4) Commission of any other offense within 45 days of closing the official indicating a lack of business integrity record. The official record closes upon or business honesty that seriously and the suspending official’s receipt of final directly affects your present responsi- submissions, information and findings bility; of fact, if any. The suspending official (b) Violation of the terms of a public may extend that period for good cause. agreement or transaction so serious as to affect the integrity of an agency § 1404.760 How long may my suspen- program, such as— sion last? (1) A willful failure to perform in ac- (a) If legal or debarment proceedings cordance with the terms of one or more are initiated at the time of, or during public agreements or transactions; your suspension, the suspension may (2) A history of failure to perform or continue until the conclusion of those of unsatisfactory performance of one or proceedings. However, if proceedings more public agreements or trans- are not initiated, a suspension may not actions; or exceed 12 months. (3) A willful violation of a statutory (b) The suspending official may ex- or regulatory provision or requirement tend the 12 month limit under para- applicable to a public agreement or graph (a) of this section for an addi- transaction;

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(c) Any of the following causes: (e) Of the governmentwide effect of a (1) A nonprocurement debarment by debarment from procurement and non- any Federal agency taken before Octo- procurement programs and activities. ber 1, 1988, or a procurement debarment by any Federal agency taken pursuant § 1404.810 When does a debarment to 48 CFR part 9, subpart 9.4, before Au- take effect? gust 25, 1995; A debarment is not effective until (2) Knowingly doing business with an the debarring official issues a decision. ineligible person, except as permitted The debarring official does not issue a under § 1404.120; decision until the respondent has had (3) Failure to pay a single substantial an opportunity to contest the proposed debt, or a number of outstanding debts debarment. (including disallowed costs and over- § 1404.815 How may I contest a pro- payments, but not including sums owed posed debarment? the Federal Government under the In- ternal Revenue Code) owed to any Fed- If you as a respondent wish to con- eral agency or instrumentality, protest a proposed debarment, you or your vided the debt is uncontested by the representative must provide the debar- debtor or, if contested, provided that ring official with information in oppo- the debtor’s legal and administrative sition to the proposed debarment. You remedies have been exhausted; may do this orally or in writing, but any information provided orally that (4) Violation of a material provision you consider important must also be of a voluntary exclusion agreement en- submitted in writing for the official tered into under § 1404.640 or of any set- record. tlement of a debarment or suspension action; or § 1404.820 How much time do I have to (5) Violation of the provisions of the contest a proposed debarment? Drug-Free Workplace Act of 1988 (41 (a) As a respondent you or your rep- U.S.C. 701); or resentative must either send, or make (d) Any other cause of so serious or arrangements to appear and present, compelling a nature that it affects the information and argument to the your present responsibility. debarring official within 30 days after you receive the Notice of Proposed De- § 1404.805 What notice does the debar- barment. ring official give me if I am proposed for debarment? (b) We consider the Notice of Pro- posed Debarment to be received by After consideration of the causes in you— § 1404.800 of this subpart, if the debar- (1) When delivered, if we mail the no- ring official proposes to debar you, the tice to the last known street address, official sends you a Notice of Proposed or five days after we send it if the let- Debarment, pursuant to § 1404.615, ad- ter is undeliverable; vising you— (2) When sent, if we send the notice (a) That the debarring official is con- by facsimile or five days after we send sidering debarring you; it if the facsimile is undeliverable; or (b) Of the reasons for proposing to (3) When delivered, if we send the no- debar you in terms sufficient to put tice by e-mail or five days after we you on notice of the conduct or trans- send it if the e-mail is undeliverable. actions upon which the proposed debarment is based; § 1404.825 What information must I (c) Of the cause(s) under § 1404.800 provide to the debarring official if I upon which the debarring official relied contest a proposed debarment? for proposing your debarment; (a) In addition to any information (d) Of the applicable provisions of and argument in opposition, as a re- this subpart, Subpart F of this part, spondent your submission to the debar- and any other Office of National Drug ring official must identify— Control Policy procedures governing (1) Specific facts that contradict the debarment; and statements contained in the Notice of

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Proposed Debarment. Include any in- § 1404.835 Are debarment proceedings formation about any of the factors list- formal? ed in § 1404.860. A general denial is in- (a) Debarment proceedings are con- sufficient to raise a genuine dispute ducted in a fair and informal manner. over facts material to the debarment; The debarring official may use flexible (2) All existing, proposed, or prior ex- procedures to allow you as a respond- clusions under regulations imple- ent to present matters in opposition. In menting E.O. 12549 and all similar ac- so doing, the debarring official is not tions taken by Federal, State, or local required to follow formal rules of evi- agencies, including administrative dence or procedure in creating an offi- agreements that affect only those cial record upon which the official will agencies; base the decision whether to debar. (3) All criminal and civil proceedings (b) You or your representative must not included in the Notice of Proposed submit any documentary evidence you Debarment that grew out of facts rel- want the debarring official to consider. evant to the cause(s) stated in the notice; and § 1404.840 How is fact-finding con- (4) All of your affiliates. ducted? (b) If you fail to disclose this infor- (a) If fact-finding is conducted— mation, or provide false information, (1) You may present witnesses and the Office of National Drug Control other evidence, and confront any wit- Policy may seek further criminal, civil ness presented; and or administrative action against you, (2) The fact-finder must prepare writ- as appropriate. ten findings of fact for the record. (b) A transcribed record of fact-find- § 1404.830 Under what conditions do I ing proceedings must be made, unless get an additional opportunity to you as a respondent and the Office of challenge the facts on which a pro- National Drug Control Policy agree to posed debarment is based? waive it in advance. If you want a copy (a) You as a respondent will not have of the transcribed record, you may pur- an additional opportunity to challenge chase it. the facts if the debarring official determines that— § 1404.845 What does the debarring official consider in deciding whether (1) Your debarment is based upon a to debar me? conviction or civil judgment; (a) The debarring official may debar (2) Your presentation in opposition you for any of the causes in § 1404.800. contains only general denials to infor- However, the official need not debar mation contained in the Notice of Pro- you even if a cause for debarment ex- posed Debarment; or ists. The official may consider the seri- (3) The issues raised in your presen- ousness of your acts or omissions and tation in opposition to the proposed de- the mitigating or aggravating factors barment are not factual in nature, or set forth at § 1404.860. are not material to the debarring offi- (b) The debarring official bases the cial’s decision whether to debar. decision on all information contained (b) You will have an additional op- in the official record. The record in- portunity to challenge the facts if the cludes— debarring official determines that— (1) All information in support of the (1) The conditions in paragraph (a) of debarring official’s proposed debar- this section do not exist; and ment; (2) Your presentation in opposition (2) Any further information and argu- raises a genuine dispute over facts ma- ment presented in support of, or in op- terial to the proposed debarment. position to, the proposed debarment; (c) If you have an opportunity to and challenge disputed material facts (3) Any transcribed record of fact- under this section, the debarring offi- finding proceedings. cial or designee must conduct addi- (c) The debarring official may refer tional proceedings to resolve those disputed material facts to another offi- facts. cial for findings of fact. The debarring

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official may reject any resultant find- (d) Whether you are or have been ex- ings, in whole or in part, only after cluded or disqualified by an agency of specifically determining them to be ar- the Federal Government or have not bitrary, capricious, or clearly erro- been allowed to participate in State or neous. local contracts or assistance agreements on a basis of conduct similar to § 1404.850 What is the standard of one or more of the causes for debar- proof in a debarment action? ment specified in this part. (a) In any debarment action, we must (e) Whether you have entered into an establish the cause for debarment by a administrative agreement with a Fed- preponderance of the evidence. eral agency or a State or local govern- (b) If the proposed debarment is ment that is not governmentwide but based upon a conviction or civil judg- is based on conduct similar to one or ment, the standard of proof is met. more of the causes for debarment specified in this part. § 1404.855 Who has the burden of proof (f) Whether and to what extent you in a debarment action? planned, initiated, or carried out the wrongdoing. (a) We have the burden to prove that (g) Whether you have accepted re- a cause for debarment exists. sponsibility for the wrongdoing and (b) Once a cause for debarment is es- recognize the seriousness of the mis- tablished, you as a respondent have the conduct that led to the cause for debar- burden of demonstrating to the satis- ment. faction of the debarring official that (h) Whether you have paid or agreed you are presently responsible and that to pay all criminal, civil and adminis- debarment is not necessary. trative liabilities for the improper activity, including any investigative or § 1404.860 What factors may influence the debarring official’s decision? administrative costs incurred by the government, and have made or agreed This section lists the mitigating and to make full restitution. aggravating factors that the debarring (i) Whether you have cooperated fully official may consider in determining with the government agencies during whether to debar you and the length of the investigation and any court or ad- your debarment period. The debarring ministrative action. In determining the official may consider other factors if extent of cooperation, the debarring of- appropriate in light of the cir- ficial may consider when the coopera- cumstances of a particular case. The tion began and whether you disclosed existence or nonexistence of any fac- all pertinent information known to tor, such as one of those set forth in you. this section, is not necessarily deter- (j) Whether the wrongdoing was per- minative of your present responsi- vasive within your organization. bility. In making a debarment deci- (k) The kind of positions held by the sion, the debarring official may con- individuals involved in the wrongdoing. sider the following factors: (l) Whether your organization took (a) The actual or potential harm or appropriate corrective action or reme- impact that results or may result from dial measures, such as establishing eth- the wrongdoing. ics training and implementing pro- (b) The frequency of incidents and/or grams to prevent recurrence. duration of the wrongdoing. (m) Whether your principals toler- (c) Whether there is a pattern or ated the offense. prior history of wrongdoing. For exam- (n) Whether you brought the activity ple, if you have been found by another cited as a basis for the debarment to Federal agency or a State agency to the attention of the appropriate gov- have engaged in wrongdoing similar to ernment agency in a timely manner. that found in the debarment action, (o) Whether you have fully inves- the existence of this fact may be used tigated the circumstances surrounding by the debarring official in deter- the cause for debarment and, if so, mining that you have a pattern or made the result of the investigation prior history of wrongdoing. available to the debarring official.

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(p) Whether you had effective stand- (iii) States the period of your debar- ards of conduct and internal control ment, including the effective dates; systems in place at the time the ques- and tioned conduct occurred. (iv) Advises you that your debarment (q) Whether you have taken appro- is effective for covered transactions priate disciplinary action against the and contracts that are subject to the individuals responsible for the activity Federal Acquisition Regulation (48 which constitutes the cause for debar- CFR chapter 1), throughout the execu- ment. tive branch of the Federal Government (r) Whether you have had adequate unless an agency head or an authorized time to eliminate the circumstances designee grants an exception. within your organization that led to the cause for the debarment. § 1404.875 May I ask the debarring of- (s) Other factors that are appropriate ficial to reconsider a decision to to the circumstances of a particular debar me? case. Yes, as a debarred person you may ask the debarring official to reconsider § 1404.865 How long may my debar- the debarment decision or to reduce ment last? the time period or scope of the debar- (a) If the debarring official decides to ment. However, you must put your re- debar you, your period of debarment quest in writing and support it with will be based on the seriousness of the documentation. cause(s) upon which your debarment is based. Generally, debarment should not § 1404.880 What factors may influence exceed three years. However, if cir- the debarring official during recon- cumstances warrant, the debarring of- sideration? ficial may impose a longer period of de- The debarring official may reduce or barment. terminate your debarment based on— (b) In determining the period of de- (a) Newly discovered material evi- barment, the debarring official may dence; consider the factors in § 1404.860. If a (b) A reversal of the conviction or suspension has preceded your debar- civil judgment upon which your debarment, the debarring official must con- ment was based; sider the time you were suspended. (c) A bona fide change in ownership (c) If the debarment is for a violation or management; of the provisions of the Drug-Free Workplace Act of 1988, your period of (d) Elimination of other causes for debarment may not exceed five years. which the debarment was imposed; or (e) Other reasons the debarring offi- § 1404.870 When do I know if the de- cial finds appropriate. barring official debars me? (a) The debarring official must make § 1404.885 May the debarring official extend a debarment? a written decision whether to debar within 45 days of closing the official (a) Yes, the debarring official may record. The official record closes upon extend a debarment for an additional the debarring official’s receipt of final period, if that official determines that submissions, information and findings an extension is necessary to protect of fact, if any. The debarring official the public interest. may extend that period for good cause. (b) However, the debarring official (b) The debarring official sends you may not extend a debarment solely on written notice, pursuant to § 1404.615 the basis of the facts and cir- that the official decided, either— cumstances upon which the initial de- (1) Not to debar you; or barment action was based. (2) To debar you. In this event, the (c) If the debarring official decides notice: that a debarment for an additional pe- (i) Refers to the Notice of Proposed riod is necessary, the debarring official Debarment; must follow the applicable procedures (ii) Specifies the reasons for your de- in this subpart, and subpart F of this barment; part, to extend the debarment.

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Subpart I—Definitions § 1404.925 Conviction. Conviction means— § 1404.900 Adequate evidence. (a) A judgment or any other deter- Adequate evidence means information mination of guilt of a criminal offense sufficient to support the reasonable be- by any court of competent jurisdiction, lief that a particular act or omission whether entered upon a verdict or plea, has occurred. including a plea of nolo contendere; or (b) Any other resolution that is the § 1404.905 Affiliate. functional equivalent of a judgment, Persons are affiliates of each other if, including probation before judgment directly or indirectly, either one con- and deferred prosecution. A disposition trols or has the power to control the without the participation of the court other or a third person controls or has is the functional equivalent of a judg- the power to control both. The ways we ment only if it includes an admission use to determine control include, but of guilt. are not limited to— § 1404.930 Debarment. (a) Interlocking management or ownership; Debarment means an action taken by (b) Identity of interests among fam- a debarring official under subpart H of ily members; this part to exclude a person from par- (c) Shared facilities and equipment; ticipating in covered transactions and transactions covered under the Federal (d) Common use of employees; or Acquisition Regulation (48 CFR chap- (e) A business entity which has been ter 1). A person so excluded is debarred. organized following the exclusion of a person which has the same or similar § 1404.935 Debarring official. management, ownership, or principal (a) Debarring official means an agency employees as the excluded person. official who is authorized to impose de- § 1404.910 Agency. barment. A debarring official is either— Agency means any United States ex- (1) The agency head; or ecutive department, military depart- (2) An official designated by the ment, defense agency, or any other agency head. agency of the executive branch. Other (b) [Reserved] agencies of the Federal government are not considered ‘‘agencies’’ for the pur- § 1404.940 Disqualified. poses of this part unless they issue reg- Disqualified means that a person is ulations adopting the governmentwide prohibited from participating in speci- Debarment and Suspension system fied Federal procurement or non- under Executive orders 12549 and 12689. procurement transactions as required under a statute, Executive order (other § 1404.915 Agent or representative. than Executive Orders 12549 and 12689) Agent or representative means any per- or other authority. Examples of dis- son who acts on behalf of, or who is au- qualifications include persons prohib- thorized to commit, a participant in a ited under— covered transaction. (a) The Davis-Bacon Act (40 U.S.C. 276(a)); § 1404.920 Civil judgment. (b) The equal employment oppor- Civil judgment means the disposition tunity acts and Executive orders; or of a civil action by any court of com- (c) The Clean Air Act (42 U.S.C. 7606), petent jurisdiction, whether by verdict, Clean Water Act (33 U.S.C. 1368) and decision, settlement, stipulation, other Executive Order 11738 (3 CFR, 1973 disposition which creates a civil liabil- Comp., p. 799). ity for the complained of wrongful acts, or a final determination of liabil- § 1404.945 Excluded or exclusion. ity under the Program Fraud Civil Excluded or exclusion means— Remedies Act of 1988 (31 U.S.C. 3801– (a) That a person or commodity is 3812). prohibited from being a participant in

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covered transactions, whether the per- (9) Insurances. son has been suspended; debarred; pro- (10) Payments for specified uses. posed for debarment under 48 CFR part (11) Donation agreements. 9, subpart 9.4; voluntarily excluded; or (b) A nonprocurement transaction at (b) The act of excluding a person. any tier does not require the transfer of Federal funds. § 1404.950 Excluded Parties List Sys- tem § 1404.975 Notice. Excluded Parties List System (EPLS) Notice means a written communica- means the list maintained and dissemi- tion served in person, sent by certified nated by the General Services Adminis- mail or its equivalent, or sent elec- tration (GSA) containing the names tronically by e-mail or facsimile. (See and other information about persons § 1404. 615.) who are ineligible. The EPLS system includes the printed version entitled, § 1404.980 Participant. ‘‘List of Parties Excluded or Disquali- Participant means any person who fied from Federal Procurement and submits a proposal for or who enters Nonprocurement Programs,’’ so long as into a covered transaction, including published. an agent or representative of a participant. § 1404.955 Indictment. Indictment means an indictment for a § 1404.985 Person. criminal offense. A presentment, infor- Person means any individual, cor- mation, or other filing by a competent poration, partnership, association, unit authority charging a criminal offense of government, or legal entity, however shall be given the same effect as an in- organized. dictment. § 1404.990 Preponderance of the evi- § 1404.960 Ineligible or ineligibility. dence. Ineligible or ineligibility means that a Preponderance of the evidence means person or commodity is prohibited proof by information that, compared from covered transactions because of with information opposing it, leads to an exclusion or disqualification. the conclusion that the fact at issue is more probably true than not. § 1404.965 Legal proceedings. Legal proceedings means any criminal § 1404.995 Principal. proceeding or any civil judicial pro- Principal means— ceeding, including a proceeding under (a) An officer, director, owner, part- the Program Fraud Civil Remedies Act ner, principal investigator, or other (31 U.S.C. 3801–3812), to which the Fed- person within a participant with man- eral Government or a State or local agement or supervisory responsibilities government or quasi-governmental au- related to a covered transaction; or thority is a party. The term also in- (b) A consultant or other person, cludes appeals from those proceedings. whether or not employed by the participant or paid with Federal funds, who— § 1404.970 Nonprocurement trans- (1) Is in a position to handle Federal action. funds; (a) Nonprocurement transaction means (2) Is in a position to influence or any transaction, regardless of type (ex- control the use of those funds; or, cept procurement contracts), includ- (3) Occupies a technical or profes- ing, but not limited to the following: sional position capable of substantially (1) Grants. influencing the development or out- (2) Cooperative agreements. come of an activity required to perform (3) Scholarships. the covered transaction. (4) Fellowships. (5) Contracts of assistance. § 1404.1000 Respondent. (6) Loans. Respondent means a person against (7) Loan guarantees. whom an agency has initiated a debar- (8) Subsidies. ment or suspension action.

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§ 1404.1005 State. § 1404.1015 Suspension. (a) State means— Suspension is an action taken by a (1) Any of the states of the United suspending official under subpart G of States; this part that immediately prohibits a (2) The District of Columbia; person from participating in covered (3) The Commonwealth of Puerto transactions and transactions covered under the Federal Acquisition Regula- Rico; tion (48 CFR chapter 1) for a temporary (4) Any territory or possession of the period, pending completion of an agen- United States; or cy investigation and any judicial or ad- (5) Any agency or instrumentality of ministrative proceedings that may a state. ensue. A person so excluded is sus- (b) For purposes of this part, State pended. does not include institutions of higher education, hospitals, or units of local § 1404.1020 Voluntary exclusion or vol- government. untarily excluded. (a) Voluntary exclusion means a per- § 1404.1010 Suspending official. son’s agreement to be excluded under (a) Suspending official means an agen- the terms of a settlement between the cy official who is authorized to impose person and one or more agencies. Vol- suspension. The suspending official is untary exclusion must have govern- either: mentwide effect. (b) Voluntarily excluded means the (1) The agency head; or status of a person who has agreed to a (2) An official designated by the voluntary exclusion. agency head. (b) [Reserved] Subpart J [Reserved]

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APPENDIX TO PART 1404—COVERED TRANSACTIONS

PART 1405—GOVERNMENTWIDE 1405.205 What must I include in my drug- free workplace statement? REQUIREMENTS FOR DRUG-FREE 1405.210 To whom must I distribute my WORKPLACE (FINANCIAL ASSIST- drug-free workplace statement? ANCE) 1405.215 What must I include in my drug- free awareness program? Subpart A—Purpose and Coverage 1405.220 By when must I publish my drug- free workplace statement and establish Sec. my drug-free awareness program? 1405.100 What does this part do? 1405.225 What actions must I take con- 1405.105 Does this part apply to me? cerning employees who are convicted of 1405.110 Are any of my Federal assistance drug violations in the workplace? awards exempt from this part? 1405.230 How and when must I identify 1405.115 Does this part affect the Federal workplaces? contracts that I receive? Subpart C—Requirements for Recipients Subpart B—Requirements for Recipients Who Are Individuals Other Than Individuals 1405.300 What must I do to comply with this 1405.200 What must I do to comply with this part if I am an individual recipient? part?

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1405.301 [Reserved] 1405.660 Recipient. 1405.665 State. Subpart D—Responsibilities of Office of Na- 1405.670 Suspension. tional Drug Control Policy Awarding AUTHORITY: 21 U.S.C. 1701; 41 U.S.C. 701, et Officials seq.

1405.400 What are my responsibilities as an SOURCE: 68 FR 66557, 66581, 66582, Nov. 26, Office of National Drug Control Policy 2003, unless otherwise noted. awarding official?

Subpart E—Violations of This Part and Subpart A—Purpose and Consequences Coverage 1405.500 How are violations of this part de- § 1405.100 What does this part do? termined for recipients other than indi- This part carries out the portion of viduals? the Drug-Free Workplace Act of 1988 1405.505 How are violations of this part determined for recipients who are individ- (41 U.S.C. 701 et seq., as amended) that uals? applies to grants. It also applies the 1405.510 What actions will the Federal Gov- provisions of the Act to cooperative ernment take against a recipient deter- agreements and other financial assist- mined to have violated this part? ance awards, as a matter of Federal 1405.515 Are there exceptions to those ac- Government policy. tions? § 1405.105 Does this part apply to me? Subpart F—Definitions (a) Portions of this part apply to you 1405.605 Award. if you are either— 1405.610 Controlled substance. (1) A recipient of an assistance award 1405.615 Conviction. from the Office of National Drug Con- 1405.620 Cooperative agreement. trol Policy; or 1405.625 Criminal drug statute. (2) A(n) Office of National Drug Con- 1405.630 Debarment. 1405.635 Drug-free workplace. trol Policy awarding official. (See defi- 1405.640 Employee. nitions of award and recipient in 1405.645 Federal agency or agency. §§ 1405.605 and 1405.660, respectively.) 1405.650 Grant. (b) The following table shows the 1405.655 Individual. subparts that apply to you:

If you are . . . see subparts . . .

(1) A recipient who is not an individual ...... A, B and E. (2) A recipient who is an individual ...... A, C and E. (3) A(n) Office of National Drug Control Policy awarding official A, D and E.

§ 1405.110 Are any of my Federal as- pended for a violation of the require- sistance awards exempt from this ments of this part, as described in part? § 1405.510(c). However, this part does This part does not apply to any not apply directly to procurement con- award that the Director of National tracts. The portion of the Drug-Free Drug Control Policy determines that Workplace Act of 1988 that applies to the application of this part would be Federal procurement contracts is car- inconsistent with the international ob- ried out through the Federal Acquisi- ligations of the United States or the tion Regulation in chapter 1 of Title 48 laws or regulations of a foreign govern- of the Code of Federal Regulations (the ment. drug-free workplace coverage currently is in 48 CFR part 23, subpart 23.5). § 1405.115 Does this part affect the Federal contracts that I receive? It will affect future contract awards indirectly if you are debarred or sus-

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Subpart B—Requirements for (1) Will abide by the terms of the Recipients Other Than Individuals statement; and (2) Must notify you in writing if he or § 1405.200 What must I do to comply she is convicted for a violation of a with this part? criminal drug statute occurring in the There are two general requirements workplace and must do so no more if you are a recipient other than an in- than five calendar days after the con- dividual. viction. (a) First, you must make a good faith effort, on a continuing basis, to main- § 1405.210 To whom must I distribute my drug-free workplace statement? tain a drug-free workplace. You must agree to do so as a condition for receiv- You must require that a copy of the ing any award covered by this part. statement described in § 1405.205 be The specific measures that you must given to each employee who will be en- take in this regard are described in gaged in the performance of any Fed- more detail in subsequent sections of eral award. this subpart. Briefly, those measures are to— § 1405.215 What must I include in my (1) Publish a drug-free workplace drug-free awareness program? statement and establish a drug-free You must establish an ongoing drug- awareness program for your employees free awareness program to inform em- (see §§ 1405.205 through 1405.220); and ployees about— (2) Take actions concerning employ- (a) The dangers of drug abuse in the ees who are convicted of violating drug workplace; statutes in the workplace (see (b) Your policy of maintaining a § 1405.225). drug-free workplace; (b) Second, you must identify all (c) Any available drug counseling, re- known workplaces under your Federal habilitation, and employee assistance awards (see § 1405.230). programs; and (d) The penalties that you may im- § 1405.205 What must I include in my pose upon them for drug abuse viola- drug-free workplace statement? tions occurring in the workplace. You must publish a statement that— (a) Tells your employees that the un- § 1405.220 By when must I publish my lawful manufacture, distribution, dis- drug-free workplace statement and pensing, possession, or use of a con- establish my drug-free awareness trolled substance is prohibited in your program? workplace; If you are a new recipient that does (b) Specifies the actions that you will not already have a policy statement as take against employees for violating described in § 1405.205 and an ongoing that prohibition; and awareness program as described in (c) Lets each employee know that, as § 1405.215, you must publish the state- a condition of employment under any ment and establish the program by the award, he or she: time given in the following table:

If . . . then you . . .

(a) The performance period of the award is less than 30 days must have the policy statement and program in place as soon as possible, but before the date on which performance is expected to be completed. (b) The performance period of the award is 30 days or more ... must have the policy statement and program in place within 30 days after award. (c) You believe there are extraordinary circumstances that will may ask the Office of National Drug Control Policy awarding require more than 30 days for you to publish the policy state- official to give you more time to do so. The amount of addi- ment and establish the awareness program. tional time, if any, to be given is at the discretion of the awarding official.

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§ 1405.225 What actions must I take for inspection upon request by Office of concerning employees who are con- National Drug Control Policy officials victed of drug violations in the or their designated representatives. workplace? (b) Your workplace identification for There are two actions you must take an award must include the actual ad- if an employee is convicted of a drug dress of buildings (or parts of build- violation in the workplace: ings) or other sites where work under (a) First, you must notify Federal the award takes place. Categorical de- agencies if an employee who is engaged scriptions may be used (e.g., all vehi- in the performance of an award informs cles of a mass transit authority or you about a conviction, as required by State highway department while in op- § 1405.205(c)(2), or you otherwise learn eration, State employees in each local of the conviction. Your notification to unemployment office, performers in the Federal agencies must— concert halls or radio studios). (1) Be in writing; (c) If you identified workplaces to (2) Include the employee’s position the Office of National Drug Control title; Policy awarding official at the time of (3) Include the identification num- application or award, as described in ber(s) of each affected award; paragraph (a)(1) of this section, and (4) Be sent within ten calendar days any workplace that you identified after you learn of the conviction; and changes during the performance of the (5) Be sent to every Federal agency on whose award the convicted em- award, you must inform the Office of ployee was working. It must be sent to National Drug Control Policy awarding every awarding official or his or her of- official. ficial designee, unless the Federal agency has specified a central point for Subpart C—Requirements for the receipt of the notices. Recipients Who Are Individuals (b) Second, within 30 calendar days of learning about an employee’s convic- § 1405.300 What must I do to comply tion, you must either— with this part if I am an individual (1) Take appropriate personnel action recipient? against the employee, up to and includ- As a condition of receiving a(n) Of- ing termination, consistent with the fice of National Drug Control Policy requirements of the Rehabilitation Act award, if you are an individual recipi- of 1973 (29 U.S.C. 794), as amended; or ent, you must agree that— (2) Require the employee to partici- (a) You will not engage in the unlaw- pate satisfactorily in a drug abuse as- ful manufacture, distribution, dis- sistance or rehabilitation program ap- pensing, possession, or use of a con- proved for these purposes by a Federal, trolled substance in conducting any ac- State or local health, law enforcement, tivity related to the award; and or other appropriate agency. (b) If you are convicted of a criminal § 1405.230 How and when must I iden- drug offense resulting from a violation tify workplaces? occurring during the conduct of any (a) You must identify all known award activity, you will report the con- workplaces under each Office of Na- viction: tional Drug Control Policy award. A (1) In writing. failure to do so is a violation of your (2) Within 10 calendar days of the drug-free workplace requirements. You conviction. may identify the workplaces— (3) To the Office of National Drug (1) To the Office of National Drug Control Policy awarding official or Control Policy official that is making other designee for each award that you the award, either at the time of appli- currently have, unless § 1405.301 or the cation or upon award; or award document designates a central (2) In documents that you keep on point for the receipt of the notices. file in your offices during the perform- When notice is made to a central point, ance of the award, in which case you it must include the identification num- must make the information available ber(s) of each affected award.

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§ 1405.301 [Reserved] § 1405.510 What actions will the Fed- eral Government take against a recipient determined to have violated Subpart D—Responsibilities of Of- this part? fice of National Drug Control If a recipient is determined to have Policy Awarding Officials violated this part, as described in § 1405.500 or § 1405.505, the Office of Na- § 1405.400 What are my responsibilities as a(n) Office of National Drug Con- tional Drug Control Policy may take trol Policy awarding official? one or more of the following actions— (a) Suspension of payments under the As a(n) Office of National Drug Con- award; trol Policy awarding official, you must (b) Suspension or termination of the obtain each recipient’s agreement, as a award; and condition of the award, to comply with (c) Suspension or debarment of the the requirements in— recipient under 21 CFR Part 1404, for a (a) Subpart B of this part, if the re- period not to exceed five years. cipient is not an individual; or (b) Subpart C of this part, if the re- § 1405.515 Are there any exceptions to cipient is an individual. those actions? The Director of National Drug Con- Subpart E—Violations of this Part trol Policy may waive with respect to a particular award, in writing, a sus- and Consequences pension of payments under an award, § 1405.500 How are violations of this suspension or termination of an award, part determined for recipients or suspension or debarment of a recipi- other than individuals? ent if the Director of National Drug Control Policy determines that such a A recipient other than an individual waiver would be in the public interest. is in violation of the requirements of This exception authority cannot be del- this part if the Director of National egated to any other official. Drug Control Policy determines, in writing, that— Subpart F—Definitions (a) The recipient has violated the requirements of subpart B of this part; or § 1405.605 Award. (b) The number of convictions of the Award means an award of financial recipient’s employees for violating assistance by the Office of National criminal drug statutes in the work- Drug Control Policy or other Federal place is large enough to indicate that agency directly to a recipient. the recipient has failed to make a good (a) The term award includes: faith effort to provide a drug-free (1) A Federal grant or cooperative workplace. agreement, in the form of money or property in lieu of money. § 1405.505 How are violations of this (2) A block grant or a grant in an en- part determined for recipients who titlement program, whether or not the are individuals? grant is exempted from coverage under An individual recipient is in viola- the Governmentwide rule 21 CFR Part tion of the requirements of this part if 1403 that implements OMB Circular A– the Director of National Drug Control 102 (for availability, see 5 CFR 1310.3) Policy determines, in writing, that— and specifies uniform administrative (a) The recipient has violated the re- requirements. quirements of subpart C of this part; or (b) The term award does not include: (b) The recipient is convicted of a (1) Technical assistance that provides criminal drug offense resulting from a services instead of money. violation occurring during the conduct (2) Loans. of any award activity. (3) Loan guarantees. (4) Interest subsidies. (5) Insurance. (6) Direct appropriations.

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(7) Veterans’ benefits to individuals tive Order 12549 and Executive Order (i.e., any benefit to veterans, their fam- 12689. ilies, or survivors by virtue of the service of a veteran in the Armed Forces of § 1405.635 Drug-free workplace. the United States). Drug-free workplace means a site for the performance of work done in con- § 1405.610 Controlled substance. nection with a specific award at which Controlled substance means a con- employees of the recipient are prohib- trolled substance in schedules I ited from engaging in the unlawful through V of the Controlled Substances manufacture, distribution, dispensing, Act (21 U.S.C. 812), and as further de- possession, or use of a controlled sub- fined by regulation at 21 CFR 1308.11 stance. through 1308.15. § 1405.640 Employee. § 1405.615 Conviction. (a) Employee means the employee of a Conviction means a finding of guilt recipient directly engaged in the per- (including a plea of nolo contendere) or formance of work under the award, in- imposition of sentence, or both, by any cluding— judicial body charged with the respon- (1) All direct charge employees; sibility to determine violations of the (2) All indirect charge employees, un- Federal or State criminal drug stat- less their impact or involvement in the utes. performance of work under the award is insignificant to the performance of § 1405.620 Cooperative agreement. the award; and Cooperative agreement means an award (3) Temporary personnel and consult- of financial assistance that, consistent ants who are directly engaged in the with 31 U.S.C. 6305, is used to enter into performance of work under the award the same kind of relationship as a and who are on the recipient’s payroll. grant (see definition of grant in (b) This definition does not include § 1405.650), except that substantial in- workers not on the payroll of the re- volvement is expected between the cipient (e.g., volunteers, even if used to Federal agency and the recipient when meet a matching requirement; consult- carrying out the activity contemplated ants or independent contractors not on by the award. The term does not in- the payroll; or employees of subrecipi- clude cooperative research and devel- ents or subcontractors in covered opment agreements as defined in 15 workplaces). U.S.C. 3710a. § 1405.645 Federal agency or agency. § 1405.625 Criminal drug statute. Federal agency or agency means any Criminal drug statute means a Federal United States executive department, or non-Federal criminal statute involv- military department, government cor- ing the manufacture, distribution, dis- poration, government controlled cor- pensing, use, or possession of any con- poration, any other establishment in trolled substance. the executive branch (including the Ex- ecutive Office of the President), or any § 1405.630 Debarment. independent regulatory agency. Debarment means an action taken by a Federal agency to prohibit a recipi- § 1405.650 Grant. ent from participating in Federal Gov- Grant means an award of financial as- ernment procurement contracts and sistance that, consistent with 31 U.S.C. covered nonprocurement transactions. 6304, is used to enter into a relation- A recipient so prohibited is debarred, ship— in accordance with the Federal Acqui- (a) The principal purpose of which is sition Regulation for procurement con- to transfer a thing of value to the re- tracts (48 CFR part 9, subpart 9.4) and cipient to carry out a public purpose of the common rule, Government-wide support or stimulation authorized by a Debarment and Suspension (Non- law of the United States, rather than procurement), that implements Execu- to acquire property or services for the

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Federal Government’s direct benefit or § 1405.670 Suspension. use; and Suspension means an action taken by (b) In which substantial involvement is not expected between the Federal a Federal agency that immediately agency and the recipient when carrying prohibits a recipient from partici- out the activity contemplated by the pating in Federal Government procure- award. ment contracts and covered nonprocurement transactions for a tem- § 1405.655 Individual. porary period, pending completion of Individual means a natural person. an investigation and any judicial or administrative proceedings that may § 1405.660 Recipient. ensue. A recipient so prohibited is sus- Recipient means any individual, cor- pended, in accordance with the Federal poration, partnership, association, unit Acquisition Regulation for procure- of government (except a Federal agen- ment contracts (48 CFR part 9, subpart cy) or legal entity, however organized, 9.4) and the common rule, Government- that receives an award directly from a wide Debarment and Suspension (Non- Federal agency. procurement), that implements Execu- tive Order 12549 and Executive Order § 1405.665 State. 12689. Suspension of a recipient is a dis- State means any of the States of the tinct and separate action from suspen- United States, the District of Colum- sion of an award or suspension of pay- bia, the Commonwealth of Puerto Rico, ments under an award. or any territory or possession of the United States. PARTS 1406–1499 [RESERVED]

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A list of CFR titles, subtitles, chapters, subchapters and parts and an alphabetical list of agencies publishing in the CFR are included in the CFR Index and Finding Aids volume to the Code of Federal Regulations which is published separately and revised annually. Table of CFR Titles and Chapters Alphabetical List of Agencies Appearing in the CFR List of CFR Sections Affected

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Title 1—General Provisions

I Administrative Committee of the Federal Register (Parts 1—49) II Office of the Federal Register (Parts 50—299) III Administrative Conference of the United States (Parts 300—399) IV Miscellaneous Agencies (Parts 400—500)

Title 2—Grants and Agreements

SUBTITLE A—OFFICE OF MANAGEMENT AND BUDGET GUIDANCE FOR GRANTS AND AGREEMENTS I Office of Management and Budget Governmentwide Guidance for Grants and Agreements (Parts 100—199) II Office of Management and Budget Circulars and Guidance (200— 299) SUBTITLE B—FEDERAL AGENCY REGULATIONS FOR GRANTS AND AGREEMENTS III Department of Health and Human Services (Parts 300— 399) IV Department of Agriculture (Parts 400—499) VI Department of State (Parts 600—699) VIII Department of Veterans Affairs (Parts 800—899) IX Department of Energy (Parts 900—999) XI Department of Defense (Parts 1100—1199) XII Department of Transportation (Parts 1200—1299) XIII Department of Commerce (Parts 1300—1399) XIV Department of the Interior (Parts 1400—1499) XV Environmental Protection Agency (Parts 1500—1599) XVIII National Aeronautics and Space Administration (Parts 1880— 1899) XX United States Nuclear Regulatory Commission (Parts 2000—2099) XXII Corporation for National and Community Service (Parts 2200— 2299) XXIII Social Security Administration (Parts 2300—2399) XXIV Housing and Urban Development (Parts 2400—2499) XXV National Science Foundation (Parts 2500—2599) XXVI National Archives and Records Administration (Parts 2600—2699) XXVII Small Business Administration (Parts 2700—2799) XXVIII Department of Justice (Parts 2800—2899) XXX Department of Homeland Security (Parts 3000—3099)

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XXXI Institute of Museum and Library Services (Parts 3100—3199) XXXII National Endowment for the Arts (Parts 3200—3299) XXXIII National Endowment for the Humanities (Parts 3300—3399) XXXV Export-Import Bank of the United States (Parts 3500—3599) XXXVII Peace Corps (Parts 3700—3799) LVIII Election Assistance Commission (Parts 5800—5899)

Title 3—The President

I Executive Office of the President (Parts 100—199)

Title 4—Accounts

I Government Accountability Office (Parts 1—99) II Recovery Accountability and Transparency Board (Parts 200— 299)

Title 5—Administrative Personnel

I Office of Personnel Management (Parts 1—1199) II Merit Systems Protection Board (Parts 1200—1299) III Office of Management and Budget (Parts 1300—1399) V The International Organizations Employees Loyalty Board (Parts 1500—1599) VI Federal Retirement Thrift Investment Board (Parts 1600—1699) VIII Office of Special Counsel (Parts 1800—1899) IX Appalachian Regional Commission (Parts 1900—1999) XI Armed Forces Retirement Home (Parts 2100—2199) XIV Federal Labor Relations Authority, General Counsel of the Fed- eral Labor Relations Authority and Federal Service Impasses Panel (Parts 2400—2499) XV Office of Administration, Executive Office of the President (Parts 2500—2599) XVI Office of Government Ethics (Parts 2600—2699) XXI Department of the Treasury (Parts 3100—3199) XXII Federal Deposit Insurance Corporation (Parts 3200—3299) XXIII Department of Energy (Parts 3300—3399) XXIV Federal Energy Regulatory Commission (Parts 3400—3499) XXV Department of the Interior (Parts 3500—3599) XXVI Department of Defense (Parts 3600— 3699) XXVIII Department of Justice (Parts 3800—3899) XXIX Federal Communications Commission (Parts 3900—3999) XXX Farm Credit System Insurance Corporation (Parts 4000—4099) XXXI Farm Credit Administration (Parts 4100—4199) XXXIII Overseas Private Investment Corporation (Parts 4300—4399) XXXIV Securities and Exchange Commission (Parts 4400—4499)

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XXXV Office of Personnel Management (Parts 4500—4599) XL Interstate Commerce Commission (Parts 5000—5099) XLI Commodity Futures Trading Commission (Parts 5100—5199) XLII Department of Labor (Parts 5200—5299) XLIII National Science Foundation (Parts 5300—5399) XLV Department of Health and Human Services (Parts 5500—5599) XLVI Postal Rate Commission (Parts 5600—5699) XLVII Federal Trade Commission (Parts 5700—5799) XLVIII Nuclear Regulatory Commission (Parts 5800—5899) XLIX Federal Labor Relations Authority (Parts 5900—5999) L Department of Transportation (Parts 6000—6099) LII Export-Import Bank of the United States (Parts 6200—6299) LIII Department of Education (Parts 6300—6399) LIV Environmental Protection Agency (Parts 6400—6499) LV National Endowment for the Arts (Parts 6500—6599) LVI National Endowment for the Humanities (Parts 6600—6699) LVII General Services Administration (Parts 6700—6799) LVIII Board of Governors of the Federal Reserve System (Parts 6800— 6899) LIX National Aeronautics and Space Administration (Parts 6900— 6999) LX United States Postal Service (Parts 7000—7099) LXI National Labor Relations Board (Parts 7100—7199) LXII Equal Employment Opportunity Commission (Parts 7200—7299) LXIII Inter-American Foundation (Parts 7300—7399) LXIV Merit Systems Protection Board (Parts 7400—7499) LXV Department of Housing and Urban Development (Parts 7500— 7599) LXVI National Archives and Records Administration (Parts 7600—7699) LXVII Institute of Museum and Library Services (Parts 7700—7799) LXVIII Commission on Civil Rights (Parts 7800—7899) LXIX Tennessee Valley Authority (Parts 7900—7999) LXXI Consumer Product Safety Commission (Parts 8100—8199) LXXII Special Inspector General for Iraq Reconstruction (Parts 8200— 8299) LXXIII Department of Agriculture (Parts 8300—8399) LXXIV Federal Mine Safety and Health Review Commission (Parts 8400—8499) LXXVI Federal Retirement Thrift Investment Board (Parts 8600—8699) LXXVII Office of Management and Budget (Parts 8700—8799) LXXX Federal Housing Finance Agency (Parts 8700—8799) LXXXII Special Inspector General for Iraq Reconstruction (Parts 9200— 9299) XCVII Department of Homeland Security Human Resources Manage- ment System (Department of Homeland Security—Office of Personnel Management) (Parts 9700—9799)

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XCIX Department of Defense Human Resources Management and Labor Relations Systems (Department of Defense—Office of Personnel Management) (Parts 9900—9999)

Title 6—Domestic Security

I Department of Homeland Security, Office of the Secretary (Parts 0—99)

Title 7—Agriculture

SUBTITLE A—OFFICE OF THE SECRETARY OF AGRICULTURE (PARTS 0—26) SUBTITLE B—REGULATIONS OF THE DEPARTMENT OF AGRICULTURE I Agricultural Marketing Service (Standards, Inspections, Mar- keting Practices), Department of Agriculture (Parts 27—209) II Food and Nutrition Service, Department of Agriculture (Parts 210—299) III Animal and Plant Health Inspection Service, Department of Ag- riculture (Parts 300—399) IV Federal Crop Insurance Corporation, Department of Agriculture (Parts 400—499) V Agricultural Research Service, Department of Agriculture (Parts 500—599) VI Natural Resources Conservation Service, Department of Agri- culture (Parts 600—699) VII Farm Service Agency, Department of Agriculture (Parts 700— 799) VIII Grain Inspection, Packers and Stockyards Administration (Fed- eral Grain Inspection Service), Department of Agriculture (Parts 800—899) IX Agricultural Marketing Service (Marketing Agreements and Or- ders; Fruits, Vegetables, Nuts), Department of Agriculture (Parts 900—999) X Agricultural Marketing Service (Marketing Agreements and Or- ders; Milk), Department of Agriculture (Parts 1000—1199) XI Agricultural Marketing Service (Marketing Agreements and Or- ders; Miscellaneous Commodities), Department of Agriculture (Parts 1200—1299) XIV Commodity Credit Corporation, Department of Agriculture (Parts 1400—1499) XV Foreign Agricultural Service, Department of Agriculture (Parts 1500—1599) XVI Rural Telephone Bank, Department of Agriculture (Parts 1600— 1699) XVII Rural Utilities Service, Department of Agriculture (Parts 1700— 1799) XVIII Rural Housing Service, Rural Business-Cooperative Service, Rural Utilities Service, and Farm Service Agency, Depart- ment of Agriculture (Parts 1800—2099) XX Local Television Loan Guarantee Board (Parts 2200—2299)

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XXVI Office of Inspector General, Department of Agriculture (Parts 2600—2699) XXVII Office of Information Resources Management, Department of Agriculture (Parts 2700—2799) XXVIII Office of Operations, Department of Agriculture (Parts 2800— 2899) XXIX Office of Energy Policy and New Uses, Department of Agri- culture (Parts 2900—2999) XXX Office of the Chief Financial Officer, Department of Agriculture (Parts 3000—3099) XXXI Office of Environmental Quality, Department of Agriculture (Parts 3100—3199) XXXII Office of Procurement and Property Management, Department of Agriculture (Parts 3200—3299) XXXIII Office of Transportation, Department of Agriculture (Parts 3300—3399) XXXIV National Institute of Food and Agriculture (Parts 3400—3499) XXXV Rural Housing Service, Department of Agriculture (Parts 3500— 3599) XXXVI National Agricultural Statistics Service, Department of Agri- culture (Parts 3600—3699) XXXVII Economic Research Service, Department of Agriculture (Parts 3700—3799) XXXVIII World Agricultural Outlook Board, Department of Agriculture (Parts 3800—3899) XLI [Reserved] XLII Rural Business-Cooperative Service and Rural Utilities Service, Department of Agriculture (Parts 4200—4299) L Rural Business-Cooperative Service, Rurual Housing Service, and Rural Utilities Service, Department of Agriculture (Parts 5000—5099)

Title 8—Aliens and Nationality

I Department of Homeland Security (Immigration and Naturaliza- tion) (Parts 1—499) V Executive Office for Immigration Review, Department of Justice (Parts 1000—1399)

Title 9—Animals and Animal Products

I Animal and Plant Health Inspection Service, Department of Ag- riculture (Parts 1—199) II Grain Inspection, Packers and Stockyards Administration (Packers and Stockyards Programs), Department of Agri- culture (Parts 200—299) III Food Safety and Inspection Service, Department of Agriculture (Parts 300—599)

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I Nuclear Regulatory Commission (Parts 0—199) II Department of Energy (Parts 200—699) III Department of Energy (Parts 700—999) X Department of Energy (General Provisions) (Parts 1000—1099) XIII Nuclear Waste Technical Review Board (Parts 1303—1399) XVII Defense Nuclear Facilities Safety Board (Parts 1700—1799) XVIII Northeast Interstate Low-Level Radioactive Waste Commission (Parts 1800—1899)

Title 11—Federal Elections

I Federal Election Commission (Parts 1—9099) II Election Assistance Commission (Parts 9400—9499)

Title 12—Banks and Banking

I Comptroller of the Currency, Department of the Treasury (Parts 1—199) II Federal Reserve System (Parts 200—299) III Federal Deposit Insurance Corporation (Parts 300—399) IV Export-Import Bank of the United States (Parts 400—499) V Office of Thrift Supervision, Department of the Treasury (Parts 500—599) VI Farm Credit Administration (Parts 600—699) VII National Credit Union Administration (Parts 700—799) VIII Federal Financing Bank (Parts 800—899) IX Federal Housing Finance Board (Parts 900—999) XI Federal Financial Institutions Examination Council (Parts 1100—1199) XII Federal Housing Finance Agency (Parts 1200—1299) XIV Farm Credit System Insurance Corporation (Parts 1400—1499) XV Department of the Treasury (Parts 1500—1599) XVII Office of Federal Housing Enterprise Oversight, Department of Housing and Urban Development (Parts 1700—1799) XVIII Community Development Financial Institutions Fund, Depart- ment of the Treasury (Parts 1800—1899)

Title 13—Business Credit and Assistance

I Small Business Administration (Parts 1—199) III Economic Development Administration, Department of Com- merce (Parts 300—399) IV Emergency Steel Guarantee Loan Board (Parts 400—499) V Emergency Oil and Gas Guaranteed Loan Board (Parts 500—599)

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I Federal Aviation Administration, Department of Transportation (Parts 1—199) II Office of the Secretary, Department of Transportation (Aviation Proceedings) (Parts 200—399) III Commercial Space Transportation, Federal Aviation Adminis- tration, Department of Transportation (Parts 400—499) V National Aeronautics and Space Administration (Parts 1200— 1299) VI Air Transportation System Stabilization (Parts 1300—1399)

Title 15—Commerce and Foreign Trade

SUBTITLE A—OFFICE OF THE SECRETARY OF COMMERCE (PARTS 0— 29) SUBTITLE B—REGULATIONS RELATING TO COMMERCE AND FOREIGN TRADE I Bureau of the Census, Department of Commerce (Parts 30—199) II National Institute of Standards and Technology, Department of Commerce (Parts 200—299) III International Trade Administration, Department of Commerce (Parts 300—399) IV Foreign-Trade Zones Board, Department of Commerce (Parts 400—499) VII Bureau of Industry and Security, Department of Commerce (Parts 700—799) VIII Bureau of Economic Analysis, Department of Commerce (Parts 800—899) IX National Oceanic and Atmospheric Administration, Department of Commerce (Parts 900—999) XI Technology Administration, Department of Commerce (Parts 1100—1199) XIII East-West Foreign Trade Board (Parts 1300—1399) XIV Minority Business Development Agency (Parts 1400—1499) SUBTITLE C—REGULATIONS RELATING TO FOREIGN TRADE AGREE- MENTS XX Office of the United States Trade Representative (Parts 2000— 2099) SUBTITLE D—REGULATIONS RELATING TO TELECOMMUNICATIONS AND INFORMATION XXIII National Telecommunications and Information Administration, Department of Commerce (Parts 2300—2399)

Title 16—Commercial Practices

I Federal Trade Commission (Parts 0—999) II Consumer Product Safety Commission (Parts 1000—1799)

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I Commodity Futures Trading Commission (Parts 1—199) II Securities and Exchange Commission (Parts 200—399) IV Department of the Treasury (Parts 400—499)

Title 18—Conservation of Power and Water Resources

I Federal Energy Regulatory Commission, Department of Energy (Parts 1—399) III Delaware River Basin Commission (Parts 400—499) VI Water Resources Council (Parts 700—799) VIII Susquehanna River Basin Commission (Parts 800—899) XIII Tennessee Valley Authority (Parts 1300—1399)

Title 19—Customs Duties

I U.S. Customs and Border Protection, Department of Homeland Security; Department of the Treasury (Parts 0—199) II United States International Trade Commission (Parts 200—299) III International Trade Administration, Department of Commerce (Parts 300—399) IV U.S. Immigration and Customs Enforcement, Department of Homeland Security (Parts 400—599)

Title 20—Employees’ Benefits

I Office of Workers’ Compensation Programs, Department of Labor (Parts 1—199) II Railroad Retirement Board (Parts 200—399) III Social Security Administration (Parts 400—499) IV Employees Compensation Appeals Board, Department of Labor (Parts 500—599) V Employment and Training Administration, Department of Labor (Parts 600—699) VI Office of Workers’ Compensation Programs, Department of Labor (Parts 700—799) VII Benefits Review Board, Department of Labor (Parts 800—899) VIII Joint Board for the Enrollment of Actuaries (Parts 900—999) IX Office of the Assistant Secretary for Veterans’ Employment and Training Service, Department of Labor (Parts 1000—1099)

Title 21—Food and Drugs

I Food and Drug Administration, Department of Health and Human Services (Parts 1—1299) II Drug Enforcement Administration, Department of Justice (Parts 1300—1399) III Office of National Drug Control Policy (Parts 1400—1499)

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I Department of State (Parts 1—199) II Agency for International Development (Parts 200—299) III Peace Corps (Parts 300—399) IV International Joint Commission, United States and Canada (Parts 400—499) V Broadcasting Board of Governors (Parts 500—599) VII Overseas Private Investment Corporation (Parts 700—799) IX Foreign Service Grievance Board (Parts 900—999) X Inter-American Foundation (Parts 1000—1099) XI International Boundary and Water Commission, United States and Mexico, United States Section (Parts 1100—1199) XII United States International Development Cooperation Agency (Parts 1200—1299) XIII Millenium Challenge Corporation (Parts 1300—1399) XIV Foreign Service Labor Relations Board; Federal Labor Relations Authority; General Counsel of the Federal Labor Relations Authority; and the Foreign Service Impasse Disputes Panel (Parts 1400—1499) XV African Development Foundation (Parts 1500—1599) XVI Japan-United States Friendship Commission (Parts 1600—1699) XVII United States Institute of Peace (Parts 1700—1799)

Title 23—Highways

I Federal Highway Administration, Department of Transportation (Parts 1—999) II National Highway Traffic Safety Administration and Federal Highway Administration, Department of Transportation (Parts 1200—1299) III National Highway Traffic Safety Administration, Department of Transportation (Parts 1300—1399)

Title 24—Housing and Urban Development

SUBTITLE A—OFFICE OF THE SECRETARY, DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT (PARTS 0—99) SUBTITLE B—REGULATIONS RELATING TO HOUSING AND URBAN DE- VELOPMENT I Office of Assistant Secretary for Equal Opportunity, Department of Housing and Urban Development (Parts 100—199) II Office of Assistant Secretary for Housing-Federal HousingCommissioner, Department of Housing and Urban De- velopment (Parts 200—299) III Government National Mortgage Association, Department of Housing and Urban Development (Parts 300—399) IV Office of Housing and Office of Multifamily Housing Assistance Restructuring, Department of Housing and Urban Develop- ment (Parts 400—499)

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V Office of Assistant Secretary for Community Planning and De- velopment, Department of Housing and Urban Development (Parts 500—599) VI Office of Assistant Secretary for Community Planning and De- velopment, Department of Housing and Urban Development (Parts 600—699) [Reserved] VII Office of the Secretary, Department of Housing and Urban Devel- opment (Housing Assistance Programs and Public and Indian Housing Programs) (Parts 700—799) VIII Office of the Assistant Secretary for Housing—Federal Housing Commissioner, Department of Housing and Urban Develop- ment (Section 8 Housing Assistance Programs, Section 202 Di- rect Loan Program, Section 202 Supportive Housing for the El- derly Program and Section 811 Supportive Housing for Persons With Disabilities Program) (Parts 800—899) IX Office of Assistant Secretary for Public and Indian Housing, De- partment of Housing and Urban Development (Parts 900—1699) X Office of Assistant Secretary for Housing—Federal Housing Commissioner, Department of Housing and Urban Develop- ment (Interstate Land Sales Registration Program) (Parts 1700—1799) XII Office of Inspector General, Department of Housing and Urban Development (Parts 2000—2099) XV Emergency Mortgage Insurance and Loan Programs, Depart- ment of Housing and Urban Development (Parts 2700—2799) XX Office of Assistant Secretary for Housing—Federal Housing Commissioner, Department of Housing and Urban Develop- ment (Parts 3200—3899) XXIV Board of Directors of the HOPE for Homeowners Program (Parts 4000—4099) XXV Neighborhood Reinvestment Corporation (Parts 4100—4199)

Title 25—Indians

I Bureau of Indian Affairs, Department of the Interior (Parts 1— 299) II Indian Arts and Crafts Board, Department of the Interior (Parts 300—399) III National Indian Gaming Commission, Department of the Inte- rior (Parts 500—599) IV Office of Navajo and Hopi Indian Relocation (Parts 700—799) V Bureau of Indian Affairs, Department of the Interior, and Indian Health Service, Department of Health and Human Services (Part 900) VI Office of the Assistant Secretary-Indian Affairs, Department of the Interior (Parts 1000—1199) VII Office of the Special Trustee for American Indians, Department of the Interior (Parts 1200—1299)

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I Internal Revenue Service, Department of the Treasury (Parts 1— 899)

Title 27—Alcohol, Tobacco Products and Firearms

I Alcohol and Tobacco Tax and Trade Bureau, Department of the Treasury (Parts 1—399) II Bureau of Alcohol, Tobacco, Firearms, and Explosives, Depart- ment of Justice (Parts 400—699)

Title 28—Judicial Administration

I Department of Justice (Parts 0—299) III Federal Prison Industries, Inc., Department of Justice (Parts 300—399) V Bureau of Prisons, Department of Justice (Parts 500—599) VI Offices of Independent Counsel, Department of Justice (Parts 600—699) VII Office of Independent Counsel (Parts 700—799) VIII Court Services and Offender Supervision Agency for the District of Columbia (Parts 800—899) IX National Crime Prevention and Privacy Compact Council (Parts 900—999) XI Department of Justice and Department of State (Parts 1100— 1199)

Title 29—Labor

SUBTITLE A—OFFICE OF THE SECRETARY OF LABOR (PARTS 0—99) SUBTITLE B—REGULATIONS RELATING TO LABOR I National Labor Relations Board (Parts 100—199) II Office of Labor-Management Standards, Department of Labor (Parts 200—299) III National Railroad Adjustment Board (Parts 300—399) IV Office of Labor-Management Standards, Department of Labor (Parts 400—499) V Wage and Hour Division, Department of Labor (Parts 500—899) IX Construction Industry Collective Bargaining Commission (Parts 900—999) X National Mediation Board (Parts 1200—1299) XII Federal Mediation and Conciliation Service (Parts 1400—1499) XIV Equal Employment Opportunity Commission (Parts 1600—1699) XVII Occupational Safety and Health Administration, Department of Labor (Parts 1900—1999) XX Occupational Safety and Health Review Commission (Parts 2200—2499) XXV Employee Benefits Security Administration, Department of Labor (Parts 2500—2599)

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XXVII Federal Mine Safety and Health Review Commission (Parts 2700—2799) XL Pension Benefit Guaranty Corporation (Parts 4000—4999)

Title 30—Mineral Resources

I Mine Safety and Health Administration, Department of Labor (Parts 1—199) II Bureau of Ocean Energy Management, Regulation, and Enforce- ment, Department of the Interior (Parts 200—299) IV Geological Survey, Department of the Interior (Parts 400—499) VII Office of Surface Mining Reclamation and Enforcement, Depart- ment of the Interior (Parts 700—999) XII Office of Natural Resources Revenue, Department of the Interior (Parts 1200—1299)

Title 31—Money and Finance: Treasury

SUBTITLE A—OFFICE OF THE SECRETARY OF THE TREASURY (PARTS 0—50) SUBTITLE B—REGULATIONS RELATING TO MONEY AND FINANCE I Monetary Offices, Department of the Treasury (Parts 51—199) II Fiscal Service, Department of the Treasury (Parts 200—399) IV Secret Service, Department of the Treasury (Parts 400—499) V Office of Foreign Assets Control, Department of the Treasury (Parts 500—599) VI Bureau of Engraving and Printing, Department of the Treasury (Parts 600—699) VII Federal Law Enforcement Training Center, Department of the Treasury (Parts 700—799) VIII Office of International Investment, Department of the Treasury (Parts 800—899) IX Federal Claims Collection Standards (Department of the Treas- ury—Department of Justice) (Parts 900—999) X Financial Crimes Enforcement Network, Departmnent of the Treasury (Parts 1000—1099)

Title 32—National Defense

SUBTITLE A—DEPARTMENT OF DEFENSE I Office of the Secretary of Defense (Parts 1—399) V Department of the Army (Parts 400—699) VI Department of the Navy (Parts 700—799) VII Department of the Air Force (Parts 800—1099) SUBTITLE B—OTHER REGULATIONS RELATING TO NATIONAL DE- FENSE XII Defense Logistics Agency (Parts 1200—1299) XVI Selective Service System (Parts 1600—1699)

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XVII Office of the Director of National Intelligence (Parts 1700—1799) XVIII National Counterintelligence Center (Parts 1800—1899) XIX Central Intelligence Agency (Parts 1900—1999) XX Information Security Oversight Office, National Archives and Records Administration (Parts 2000—2099) XXI National Security Council (Parts 2100—2199) XXIV Office of Science and Technology Policy (Parts 2400—2499) XXVII Office for Micronesian Status Negotiations (Parts 2700—2799) XXVIII Office of the Vice President of the United States (Parts 2800— 2899)

Title 33—Navigation and Navigable Waters

I Coast Guard, Department of Homeland Security (Parts 1—199) II Corps of Engineers, Department of the Army (Parts 200—399) IV Saint Lawrence Seaway Development Corporation, Department of Transportation (Parts 400—499)

Title 34—Education

SUBTITLE A—OFFICE OF THE SECRETARY, DEPARTMENT OF EDU- CATION (PARTS 1—99) SUBTITLE B—REGULATIONS OF THE OFFICES OF THE DEPARTMENT OF EDUCATION I Office for Civil Rights, Department of Education (Parts 100—199) II Office of Elementary and Secondary Education, Department of Education (Parts 200—299) III Office of Special Education and Rehabilitative Services, Depart- ment of Education (Parts 300—399) IV Office of Vocational and Adult Education, Department of Edu- cation (Parts 400—499) V Office of Bilingual Education and Minority Languages Affairs, Department of Education (Parts 500—599) VI Office of Postsecondary Education, Department of Education (Parts 600—699) VII Office of Educational Research and Improvmeent, Department of Education [Reserved] XI National Institute for Literacy (Parts 1100—1199) SUBTITLE C—REGULATIONS RELATING TO EDUCATION XII National Council on Disability (Parts 1200—1299)

Title 35 [Reserved]

Title 36—Parks, Forests, and Public Property

I National Park Service, Department of the Interior (Parts 1—199) II Forest Service, Department of Agriculture (Parts 200—299) III Corps of Engineers, Department of the Army (Parts 300—399)

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IV American Battle Monuments Commission (Parts 400—499) V Smithsonian Institution (Parts 500—599) VI [Reserved] VII Library of Congress (Parts 700—799) VIII Advisory Council on Historic Preservation (Parts 800—899) IX Pennsylvania Avenue Development Corporation (Parts 900—999) X Presidio Trust (Parts 1000—1099) XI Architectural and Transportation Barriers Compliance Board (Parts 1100—1199) XII National Archives and Records Administration (Parts 1200—1299) XV Oklahoma City National Memorial Trust (Parts 1500—1599) XVI Morris K. Udall Scholarship and Excellence in National Environ- mental Policy Foundation (Parts 1600—1699)

Title 37—Patents, Trademarks, and Copyrights

I United States Patent and Trademark Office, Department of Commerce (Parts 1—199) II Copyright Office, Library of Congress (Parts 200—299) III Copyright Royalty Board, Library of Congress (Parts 301—399) IV Assistant Secretary for Technology Policy, Department of Com- merce (Parts 400—499) V Under Secretary for Technology, Department of Commerce (Parts 500—599)

Title 38—Pensions, Bonuses, and Veterans’ Relief

I Department of Veterans Affairs (Parts 0—99) II Armed Forces Retirement Home

Title 39—Postal Service

I United States Postal Service (Parts 1—999) III Postal Regulatory Commission (Parts 3000—3099)

Title 40—Protection of Environment

I Environmental Protection Agency (Parts 1—1099) IV Environmental Protection Agency and Department of Justice (Parts 1400—1499) V Council on Environmental Quality (Parts 1500—1599) VI Chemical Safety and Hazard Investigation Board (Parts 1600— 1699) VII Environmental Protection Agency and Department of Defense; Uniform National Discharge Standards for Vessels of the Armed Forces (Parts 1700—1799)

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SUBTITLE B—OTHER PROVISIONS RELATING TO PUBLIC CONTRACTS 50 Public Contracts, Department of Labor (Parts 50–1—50–999) 51 Committee for Purchase From People Who Are Blind or Severely Disabled (Parts 51–1—51–99) 60 Office of Federal Contract Compliance Programs, Equal Employ- ment Opportunity, Department of Labor (Parts 60–1—60–999) 61 Office of the Assistant Secretary for Veterans’ Employment and Training Service, Department of Labor (Parts 61–1—61–999) 62—100 [Reserved] SUBTITLE C—FEDERAL PROPERTY MANAGEMENT REGULATIONS SYSTEM 101 Federal Property Management Regulations (Parts 101–1—101–99) 102 Federal Management Regulation (Parts 102–1—102–299) 103—104 [Reserved] 105 General Services Administration (Parts 105–1—105–999) 109 Department of Energy Property Management Regulations (Parts 109–1—109–99) 114 Department of the Interior (Parts 114–1—114–99) 115 Environmental Protection Agency (Parts 115–1—115–99) 128 Department of Justice (Parts 128–1—128–99) 129—200 [Reserved] SUBTITLE D—OTHER PROVISIONS RELATING TO PROPERTY MANAGE- MENT [RESERVED] SUBTITLE E—FEDERAL INFORMATION RESOURCES MANAGEMENT REGULATIONS SYSTEM [RESERVED] SUBTITLE F—FEDERAL TRAVEL REGULATION SYSTEM 300 General (Parts 300–1—300–99) 301 Temporary Duty (TDY) Travel Allowances (Parts 301–1—301–99) 302 Relocation Allowances (Parts 302–1—302–99) 303 Payment of Expenses Connected with the Death of Certain Em- ployees (Part 303–1—303–99) 304 Payment of Travel Expenses from a Non-Federal Source (Parts 304–1—304–99)

Title 42—Public Health

I Public Health Service, Department of Health and Human Serv- ices (Parts 1—199) IV Centers for Medicare & Medicaid Services, Department of Health and Human Services (Parts 400—499) V Office of Inspector General-Health Care, Department of Health and Human Services (Parts 1000—1999)

Title 43—Public Lands: Interior

SUBTITLE A—OFFICE OF THE SECRETARY OF THE INTERIOR (PARTS 1—199) SUBTITLE B—REGULATIONS RELATING TO PUBLIC LANDS

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I Bureau of Reclamation, Department of the Interior (Parts 200— 499) II Bureau of Land Management, Department of the Interior (Parts 1000—9999) III Utah Reclamation Mitigation and Conservation Commission (Parts 10000—10099)

Title 44—Emergency Management and Assistance

I Federal Emergency Management Agency, Department of Home- land Security (Parts 0—399) IV Department of Commerce and Department of Transportation (Parts 400—499)

Title 45—Public Welfare

SUBTITLE A—DEPARTMENT OF HEALTH AND HUMAN SERVICES (PARTS 1—199) SUBTITLE B—REGULATIONS RELATING TO PUBLIC WELFARE II Office of Family Assistance (Assistance Programs), Administra- tion for Children and Families, Department of Health and Human Services (Parts 200—299) III Office of Child Support Enforcement (Child Support Enforce- ment Program), Administration for Children and Families, Department of Health and Human Services (Parts 300—399) IV Office of Refugee Resettlement, Administration for Children and Families, Department of Health and Human Services (Parts 400—499) V Foreign Claims Settlement Commission of the United States, Department of Justice (Parts 500—599) VI National Science Foundation (Parts 600—699) VII Commission on Civil Rights (Parts 700—799) VIII Office of Personnel Management (Parts 800—899) [Reserved] X Office of Community Services, Administration for Children and Families, Department of Health and Human Services (Parts 1000—1099) XI National Foundation on the Arts and the Humanities (Parts 1100—1199) XII Corporation for National and Community Service (Parts 1200— 1299) XIII Office of Human Development Services, Department of Health and Human Services (Parts 1300—1399) XVI Legal Services Corporation (Parts 1600—1699) XVII National Commission on Libraries and Information Science (Parts 1700—1799) XVIII Harry S. Truman Scholarship Foundation (Parts 1800—1899) XXI Commission on Fine Arts (Parts 2100—2199) XXIII Arctic Research Commission (Part 2301) XXIV James Madison Memorial Fellowship Foundation (Parts 2400— 2499)

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XXV Corporation for National and Community Service (Parts 2500— 2599)

Title 46—Shipping

I Coast Guard, Department of Homeland Security (Parts 1—199) II Maritime Administration, Department of Transportation (Parts 200—399) III Coast Guard (Great Lakes Pilotage), Department of Homeland Security (Parts 400—499) IV Federal Maritime Commission (Parts 500—599)

Title 47—Telecommunication

I Federal Communications Commission (Parts 0—199) II Office of Science and Technology Policy and National Security Council (Parts 200—299) III National Telecommunications and Information Administration, Department of Commerce (Parts 300—399) IV National Telecommunications and Information Administration, Department of Commerce, and National Highway Traffic Safe- ty Administration, Department of Transportation (Parts 400— 499)

Title 48—Federal Acquisition Regulations System

1 Federal Acquisition Regulation (Parts 1—99) 2 Defense Acquisition Regulations System, Department of Defense (Parts 200—299) 3 Health and Human Services (Parts 300—399) 4 Department of Agriculture (Parts 400—499) 5 General Services Administration (Parts 500—599) 6 Department of State (Parts 600—699) 7 Agency for International Development (Parts 700—799) 8 Department of Veterans Affairs (Parts 800—899) 9 Department of Energy (Parts 900—999) 10 Department of the Treasury (Parts 1000—1099) 12 Department of Transportation (Parts 1200—1299) 13 Department of Commerce (Parts 1300—1399) 14 Department of the Interior (Parts 1400—1499) 15 Environmental Protection Agency (Parts 1500—1599) 16 Office of Personnel Management, Federal Employees Health Benefits Acquisition Regulation (Parts 1600—1699) 17 Office of Personnel Management (Parts 1700—1799) 18 National Aeronautics and Space Administration (Parts 1800— 1899) 19 Broadcasting Board of Governors (Parts 1900—1999) 20 Nuclear Regulatory Commission (Parts 2000—2099)

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21 Office of Personnel Management, Federal Employees Group Life Insurance Federal Acquisition Regulation (Parts 2100—2199) 23 Social Security Administration (Parts 2300—2399) 24 Department of Housing and Urban Development (Parts 2400— 2499) 25 National Science Foundation (Parts 2500—2599) 28 Department of Justice (Parts 2800—2899) 29 Department of Labor (Parts 2900—2999) 30 Department of Homeland Security, Homeland Security Acquisi- tion Regulation (HSAR) (Parts 3000—3099) 34 Department of Education Acquisition Regulation (Parts 3400— 3499) 51 Department of the Army Acquisition Regulations (Parts 5100— 5199) 52 Department of the Navy Acquisition Regulations (Parts 5200— 5299) 53 Department of the Air Force Federal Acquisition Regulation Supplement [Reserved] 54 Defense Logistics Agency, Department of Defense (Parts 5400— 5499) 57 African Development Foundation (Parts 5700—5799) 61 Civilian Board of Contract Appeals, General Services Adminis- tration (Parts 6100—6199) 63 Department of Transportation Board of Contract Appeals (Parts 6300—6399) 99 Cost Accounting Standards Board, Office of Federal Procure- ment Policy, Office of Management and Budget (Parts 9900— 9999)

Title 49—Transportation

SUBTITLE A—OFFICE OF THE SECRETARY OF TRANSPORTATION (PARTS 1—99) SUBTITLE B—OTHER REGULATIONS RELATING TO TRANSPORTATION I Pipeline and Hazardous Materials Safety Administration, De- partment of Transportation (Parts 100—199) II Federal Railroad Administration, Department of Transportation (Parts 200—299) III Federal Motor Carrier Safety Administration, Department of Transportation (Parts 300—399) IV Coast Guard, Department of Homeland Security (Parts 400—499) V National Highway Traffic Safety Administration, Department of Transportation (Parts 500—599) VI Federal Transit Administration, Department of Transportation (Parts 600—699) VII National Railroad Passenger Corporation (AMTRAK) (Parts 700—799) VIII National Transportation Safety Board (Parts 800—999)

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X Surface Transportation Board, Department of Transportation (Parts 1000—1399) XI Research and Innovative Technology Administration, Depart- ment of Transportation [Reserved] XII Transportation Security Administration, Department of Home- land Security (Parts 1500—1699)

Title 50—Wildlife and Fisheries

I United States Fish and Wildlife Service, Department of the Inte- rior (Parts 1—199) II National Marine Fisheries Service, National Oceanic and Atmos- pheric Administration, Department of Commerce (Parts 200— 299) III International Fishing and Related Activities (Parts 300—399) IV Joint Regulations (United States Fish and Wildlife Service, De- partment of the Interior and National Marine Fisheries Serv- ice, National Oceanic and Atmospheric Administration, De- partment of Commerce); Endangered Species Committee Reg- ulations (Parts 400—499) V Marine Mammal Commission (Parts 500—599) VI Fishery Conservation and Management, National Oceanic and Atmospheric Administration, Department of Commerce (Parts 600—699)

CFR Index and Finding Aids

Subject/Agency Index List of Agency Prepared Indexes Parallel Tables of Statutory Authorities and Rules List of CFR Titles, Chapters, Subchapters, and Parts Alphabetical List of Agencies Appearing in the CFR

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CFR Title, Subtitle or Agency Chapter Administrative Committee of the Federal Register 1, I Administrative Conference of the United States 1, III Advanced Research Projects Agency 32, I Advisory Council on Historic Preservation 36, VIII African Development Foundation 22, XV Federal Acquisition Regulation 48, 57 Agency for International Development 22, II Federal Acquisition Regulation 48, 7 Agricultural Marketing Service 7, I, IX, X, XI Agricultural Research Service 7, V Agriculture Department 2, IV; 5, LXXIII Agricultural Marketing Service 7, I, IX, X, XI Agricultural Research Service 7, V Animal and Plant Health Inspection Service 7, III; 9, I Chief Financial Officer, Office of 7, XXX Commodity Credit Corporation 7, XIV Economic Research Service 7, XXXVII Energy Policy and New Uses, Office of 2, IX; 7, XXIX Environmental Quality, Office of 7, XXXI Farm Service Agency 7, VII, XVIII Federal Acquisition Regulation 48, 4 Federal Crop Insurance Corporation 7, IV Food and Nutrition Service 7, II Food Safety and Inspection Service 9, III Foreign Agricultural Service 7, XV Forest Service 36, II Grain Inspection, Packers and Stockyards Administration 7, VIII; 9, II Information Resources Management, Office of 7, XXVII Inspector General, Office of 7, XXVI National Agricultural Library 7, XLI National Agricultural Statistics Service 7, XXXVI National Institute of Food and Agriculture. 7, XXXIV Natural Resources Conservation Service 7, VI Operations, Office of 7, XXVIII Procurement and Property Management, Office of 7, XXXII Rural Business-Cooperative Service 7, XVIII, XLII, L Rural Development Administration 7, XLII Rural Housing Service 7, XVIII, XXXV, L Rural Telephone Bank 7, XVI Rural Utilities Service 7, XVII, XVIII, XLII, L Secretary of Agriculture, Office of 7, Subtitle A Transportation, Office of 7, XXXIII World Agricultural Outlook Board 7, XXXVIII Air Force Department 32, VII Federal Acquisition Regulation Supplement 48, 53 Air Transportation Stabilization Board 14, VI Alcohol and Tobacco Tax and Trade Bureau 27, I Alcohol, Tobacco, Firearms, and Explosives, Bureau of 27, II AMTRAK 49, VII American Battle Monuments Commission 36, IV American Indians, Office of the Special Trustee 25, VII Animal and Plant Health Inspection Service 7, III; 9, I Appalachian Regional Commission 5, IX

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2001 21 CFR—Continued 67 FR Page 21 CFR 66 FR Chapter II—Continued Page Policy statement ...... 42479 Chapter II 1308.11 (g)(3) and (4) added ...... 59162 1306 Policy statement...... 56607 (g)(5) added ...... 59165 1306.11 Regulation at 65 FR 45713 1308.13 (e) revised...... 62370 confirmed ...... 2214 1308.15 (b) revised...... 62370 1308 Policy statement...... 51530 1309.21 Revised ...... 14860 1308.14 (c)(15) through (49) redes- 1309.22 (b) revised02 ...... 14860 ignated as (c)(16) through (50); 1309.24 Revised ...... 14860 new (c)(15) added ...... 42944 1309.25 Revised ...... 14860 1308.35 Undesignated center 1309.27 Removed ...... 14861 heading and section added...... 51544 1309.28 Removed ...... 14861 1309.29 Revised ...... 52674 1309.29 Removed ...... 14861 1310.02 Regulation at 65 FR 47316 1309.71 (a)(2) revised ...... 14861 confirmed...... 42944 1310.03 (c) added...... 14861 (a)(25), (26) and (27) added ...... 52675 1310.04 (g) removed; (f)(1) re- 1310.04 Regulation at 65 FR 47316 vised...... 14861 confirmed...... 42944 1310.05 (e) added...... 14862 (g)(1)(ii), (iii) and (iv) added ...... 52675 (c) amended...... 49569 Corrected...... 54061 1310.06 (i) and (j) added...... 14862 1310.08 Regulation at 65 FR 47316 (g) amended ...... 49569 confirmed...... 42944 1310.10 (d) introductory text re- (j) added ...... 52675 vised...... 14862 1310.09 (d) added ...... 52675 1313.12 (b) and (e) introductory 1313.12 (b) and (f) revised ...... 46520 text amended...... 49569 1313.21 (b) and (e) introductory 1313.21 (b) and (e) introductory text revised ...... 46520 text amended...... 49569 1313.22 (e) amended ...... 49569 2002 1313.31 (b) introductory text amended...... 49569 21 CFR 67 FR 1313.32 (b)(1) amended ...... 49569 Page Chapter II 1300.02 (b)(28)(i)(D) revised; 2003 (b)(31) and (32) added; eff. 4–29– 21 CFR 68 FR 02...... 14859 Page 1301 Policy statement...... 51988 Chapter II 1308 Grace period extension...... 7073 1300.01 (b)(43) added ...... 37409

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21 CFR—Continued 68 FR 21 CFR—Continued 68 FR Page Page Chapter II—Continued Chapter II—Continued (b)(41), (42) and (43) redesignated (h) added ...... 23203 as (b)(42), (43) and (44); new (g)(1)(v) added ...... 53292 (b)(41) added; interim ...... 41228 (c)(1) and (2), (d)(2), (e)(1) and (2), 1300.02 (b)(28)(i)(E) revised ...... 23203 (f)(1)(ii) and (2) revised...... 57804 (b)(28)(i)(D)(2) revised; (b)(33) and 1310.05 (f) and (g) added...... 57804 (34) added ...... 57803 1310.08 (j) revised ...... 37414 1301.13 (e)(1)(iii) revised ...... 37409 (k) added ...... 53292 (c) revised; (e)(1)(iii) through (ix) 1310.09 (e) added ...... 23203 redesignated as (e)(1)(iv) through (x); new (e)(1)(iii) 1310.12 Added ...... 23204 added; interim ...... 41228 1310.13 Added ...... 23204 (e)(1) revised ...... 58598 1310.21 Added ...... 62737 1301.71 (b)(13) and (14) revised; Chapter III (b)(15) added; interim ...... 41228 1404 Revised ...... 66544, 66580 1301.72 (b)(7) revised; interim ...... 41228 1404.440 Added ...... 66581 1301.76 (d) added ...... 37409 1405 Added ...... 66557, 66581 1304.05 Added ...... 37410 1405.510 (c) amended...... 66582 1304.11 (e)(2) and (3) introductory 1405.605 (a)(2) amended...... 66582 text revised; interim...... 41228 1304.22 (b) revised; (e) added; interim...... 41229 2004 1304.33 (c) revised; interim ...... 41229 21 CFR 69 FR 1305.03 Revised ...... 37410 Page 1305.08 (b) revised; interim ...... 41229 Chapter II 1306.05 (a) revised...... 37410 1300 Policy statement...... 2062, 7348 1306.06 Revised ...... 37410 Technical correction ...... 3198 1306.11 (d)(5) added ...... 37410 1301 Technical correction ...... 34568 1306.14 (b) and (c) redesignated as Authority citation revised ...... 55347 (c) and (d); new (b) added...... 37410 1301.26 Revised ...... 55347 1306.15 Added ...... 37410 1308.11 (g)(3), (4) and (5) removed; 1306.24 (b) and (c) redesignated as (d)(6) through (31), (f)(2) (c) and (d); new (b) added...... 37411 through (7), (g)(6) and (7) redes- 1306.26 (g) added ...... 37411 ignated as (d)(7) through (32), 1306.27 Added ...... 37411 (f)(3) through (8), (g)(3) and (4); 1307.11 Revised; interim...... 41229 new (d)(6) and (f)(2) added ...... 12796 1307.12 Heading and (a) revised; Regulation at 68 FR 16430 con- interim...... 41229 firmed...... 17034 1308 Regulation at 68 FR 1964 suspended...... 35293 (d)(15) through (32) redesignated Policy statement ...... 53289 as (d)(16) through (33); new Suspension withdrawn ...... 53677 (d)(15) added; new (d)(19) 1308.11 (d)(27) revised; eff. date 4- through (33) redesignated as 21-03 ...... 14119 (d)(20) through (34); new (d)(19) (g)(6) and (7) added...... 16430 added; (g)(3) and (4) removed 1308.35 Regulation at 66 FR 51544 ...... 58053 eff. 4-21-03 ...... 14126 1309 Policy statement ...... 2062 1309.24 (g) revised...... 37414 Technical correction ...... 3198 (e) revised ...... 57803 1310 Policy statement ...... 2062 1310 Authority citation amend- Technical correction ...... 3198 ed ...... 62737 1310.04 (h) revised; (i) and (j) 1310.03 (c) revised...... 57804 added...... 74970 1310.04 (f)(1)(i)(C) removed; 1310.08 (l) added...... 74971 (f)(1)(i)(D) through (W) redesig- 1310.09 (f) and (g) added...... 74971 nated as new (f)(1)(i)(C) 1310.12 (c) revised; (d)(2) and (3) through (V); (f)(1)(ii) introduc- added...... 74971 tory text revised; (g) added...... 11472 1313 Policy statement ...... 7348

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21 CFR—Continued 72 FR 21 CFR—Continued 72 FR Page Page Chapter II—Continued Chapter II—Continued 1309.24 (h) through (k) redesig- Regulation at 72 FR 17408 stayed nated as (i) through (l); new (h) through 6–7–07; interim ...... 28602 added...... 35930 1313.27 Added; interim ...... 17408 1310 Technical correction ...... 41820 Regulation at 72 FR 17408 stayed 1310.02 (a)(28) added; (b)(11) re- through 6–7–07; interim ...... 28602 moved; (b)(12) redesignated as 1313.32 (d) and (e) added; in- new (b)(11) ...... 35931 terim...... 17408 (a)(29) correctly added...... 40238 Regulation at 72 FR 17408 stayed 1310.04 (g)(1)(vi) added; in- through 6–7–07; interim ...... 28602 terim...... 20046 1313.35 Added; interim ...... 17409 (f)(2)(ii)(H) removed; (f)(2)(ii)(I) redesignated as new Regulation at 72 FR 17409 stayed (f)(2)(ii)(H); (g)(1)(vi) added ...... 35931 through 6–7–07; interim ...... 28602 (f)(2)(ii)(I) and (J) correctly re- 1315 Added; interim ...... 37448 designated as (f)(2)(ii)(H) and new (I); (g)(1)(vii) correctly 2008 added ...... 40238 1310.08 (f) revised ...... 35931 21 CFR 73 FR Page (l) revised...... 10928 1310.09 (h) added; interim ...... 20046 Chapter II (h) added ...... 35931 1301.28 (b)(1)(iii) revised; (b)(1)(iv) (i) correctly added...... 40239 removed ...... 29688 (j) added; interim ...... 40744 1308.34 Regulation at 71 FR 51997 1310.12 (c) table amended; in- confirmed; eff. 4–16–08 ...... 14179 terim...... 20047 1310.02 Regulation at 72 FR 20046 (c) table amended; (d)(4) and (5) confirmed...... 43357 added ...... 35931 1310.04 Regulation at 72 FR 20046 (c) table amended; (d)(1) re- confirmed...... 43357 moved; (d)(2) through (5) redes- 1310.09 Regulation at 72 FR 40744 ignated as (d)(1) through (4); in- confirmed...... 39614 terim ...... 40745 Regulation at 72 FR 20046 con- 1312.22 (a) revised; (c), (d) and (e) firmed...... 43357 added...... 72927 1310.12 Regulation at 72 FR 40745 1312.23 (a) and (f) revised ...... 72929 confirmed...... 39614 1313 Heading revised; interim ...... 17407 Regulation at 72 FR 20047 con- 1313.05 Added; interim ...... 17407 firmed...... 43357 1313.08 Added; interim ...... 17407 1312.13 (f) and (g) revised ...... 6851 1313.12 (c) revised; interim ...... 17407 1314 Authority citation re- Regulation at 72 FR 17407 stayed vised...... 79323 in part through 6–7–07; interim ...... 28602 1314.42 Added ...... 79323 1313.13 (c)(4) revised; (c)(5) added; 1315.22 Introductory text re- interim...... 17407 vised...... 73555 Regulation at 72 FR 17407 stayed 1315.32 (h) revised...... 73555 in part through 6–7–07; interim 1315.33 Added ...... 73555 ...... 28602 1316.41 Revised ...... 73556 1313.15 (a) revised; interim ...... 17407 1313.16 Added; interim ...... 17407 2009 Regulation at 72 FR 17407 stayed through 6–7–07; interim ...... 28602 21 CFR 74 FR 1313.17 Added; interim ...... 17408 Page Regulation at 72 FR 17408 stayed Chapter II through 6–7–07; interim ...... 28602 1300 Authority citation re- 1313.26 Added; interim ...... 17408 vised...... 15619

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21 CFR—Continued 74 FR 21 CFR—Continued 75 FR Page Page Chapter II—Continued Chapter II—Continued 1300.01 (b)(4)(xiii) through (lx) re- 1304.03 (c) revised; (h) added; in- designated as (b)(4)(xiv) terim; eff. 6–1–10...... 16306 through (lxi); new (b)(4)(xiii) 1304.04 (d) revised...... 10677 added; new (b)(4)(xvii) through (b) introductory text, (1) and (h) (lxi) further redesignated as revised; interim; eff. 6–1–10 ...... 16306 (b)(4)(xviii) through (lxii); new 1304.06 Added; interim; eff. 6–1– (b)(4)(xvii) added; new 10...... 16306 (b)(4)(xlvii) through (lxii) re- 1304.31 (a) revised...... 10677 designated as (b)(4)(xlviii) 1304.32 (a) revised...... 10678 through (lxiii); new 1304.33 (a) revised...... 10678 (b)(4)(xlvii) added ...... 63609 1306 Policy statement...... 61613 1300.04 Added; interim ...... 15619 1306.05 Revised; interim; eff. 6–1– 1301 Authority citation re- 10...... 16307 vised...... 15621 1306.08 Added; interim; eff. 6–1– 1301.11 Revised; interim...... 15621 10...... 16307 1301.13 (e)(1)(iv) and (3) revised; 1306.11 (a), (c), (d)(1) and (4) re- interim...... 15622 vised; interim; eff. 6–1–10 ...... 16307 1301.19 Added; interim ...... 15622 1306.13 (a) revised; interim; eff. 6– 1301.52 (a) revised; interim ...... 15623 1–10...... 16308 1304 Authority citation re- 1306.15 (a)(1) revised; interim; eff. vised...... 15623 6–1–10...... 16308 1304.01 Revised; interim...... 15623 1306.21 (a) and (c) revised; in- 1304.40 Undesignated center terim; eff. 6–1–10...... 16308 heading and section added; in- 1306.22 Revised; interim; eff. 6–1– terim...... 15623 10...... 16308 1304.45 Added; interim ...... 15623 1306.25 Revised; interim; eff. 6–1– 1304.50 Added; interim ...... 15623 10...... 16309 1304.55 Added; interim ...... 15623 1307.03 Revised ...... 10678 1306 Authority citation re- 1307.22 Revised ...... 10678 vised...... 15624 1308 Technical correction ...... 47451 1306.09 Added; interim ...... 15624 1308.11 (g) revised...... 37301 1308.12 (c)(28) added...... 23793 (d)(15) through (34) redesignated 1308.14 (c)(23) through (51) redes- as (d)(16) through (35); new ignated as (c)(24) through (52); (d)(15) added...... 79300 new (c)(23) added ...... 51236 1308.12 (g)(3) added ...... 37299 1308.15 (e)(1) revised; (e)(2) 1308.21 (a) revised...... 10678 added...... 23790 1308.22 Regulation at 74 FR 44283 1308.22 Table amended; in- confirmed...... 13679 terim...... 44283 1308.23 (b) revised...... 10678 1308.24 (d) and (i) revised ...... 10678 2010 1308.25 (a) revised...... 10679 21 CFR 75 FR 1308.26 (a) revised...... 10679 Page 1308.31 (a) revised...... 10679 Chapter II 1308.32 Revised ...... 10679 1300.03 Added; interim; eff. 6–1– 1308.33 (b) revised...... 10679 10...... 16304 1308.34 Revised ...... 10679 1301.03 Revised ...... 10676 1308.43 (b) revised...... 10679 1301.13 (e)(2) revised ...... 10676 1309 Authority citation re- 1301.14 (a) revised...... 10676 vised ...... 4980 1301.18 (c) revised...... 10676 1309.03 Revised ...... 10680 1301.51 Revised ...... 10676 1309.11 Revised ...... 4980 1301.52 (b) and (c) revised ...... 10676 1309.12 Revised ...... 4980 1301.71 (d) revised...... 10677 1309.21 Revised ...... 4980 1303.12 (b) and (d) revised...... 10677 1309.22 Revised ...... 4981 1303.22 Introductory text re- 1309.23 (a) revised ...... 4981 vised...... 10677 1309.24 Revised ...... 4981

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21 CFR—Continued 75 FR 21 CFR—Continued 75 FR Page Page Chapter II—Continued Chapter II—Continued 1309.25 (c) added...... 4982 1313.12 (b) and (e) introductory 1309.32 (c) revised...... 10680 text revised ...... 10683 1309.33 (a) revised...... 10680 1313.13 (d) added; eff. 5–4–10...... 10171 1309.61 Revised ...... 10680 1313.21 (b) and (e) introductory 1309.71 (c) revised...... 10680 text revised ...... 10683 1310.04 (f)(1)(i) table, (ii) and 1313.22 (e) revised...... 10683 (g)(1)(i) through (vii) revised; 1313.24 (e) revised...... 10684 (g)(1)(viii) and (ix) added ...... 38922 1313.31 (b) introductory text re- 1310.05 (c), (d), (e)(1) and (2) revised...... 10684 vised...... 10680 1313.32 (b)(1) revised...... 10684 1310.06 (d), (g) and (h)(5) re- 1313.42 Added; eff. 5–4–10...... 10172 vised...... 10681 1314.110 (a)(1) and (2) revised...... 10684 1310.09 (k) added...... 37306 1315.22 Introductory text re- 1310.10 (a) introductory text revised...... 10684 vised...... 38922 1315.32 (e) and (g) revised ...... 10684 1310.12 (c) table amended; (d)(2) 1315.34 (d) revised...... 10684 revised ...... 37306 1315.36 (b) revised...... 10685 1310.13 (b) revised...... 10681 1316.23 (b) introductory text re- (i) table revised ...... 53869 vised...... 10685 1310.14 Added ...... 38922 1316.24 (b) introductory text re- 1310.21 (b) introductory text revised...... 10685 vised...... 10681 1316.45 Revised ...... 10685 1311 Heading revised; interim; eff. 1316.46 (a) revised...... 10685 6–1–10...... 16310 1316.47 (a) revised...... 10685 1311.01 Revised; interim; eff. 6–1– 1316.48 Revised ...... 10685 10...... 16310 1321 Added ...... 10685 1311.02 Revised; interim; eff. 6–1– 10...... 16310 1311.08 Revised; interim; eff. 6–1– 2011 10...... 16310 (Regulations published from January 1, 1311.100—1311.305 (Subpart C) 2011, through April 1, 2011) Added; interim; eff. 6–1–10 ...... 16310 1312.12 (a) revised...... 10681 21 CFR 76 FR 1312.16 (b) revised...... 10682 Page 1312.18 (b) revised...... 10682 Chapter II 1312.19 (b) revised...... 10682 1308.11 (g)(1) through (5) added ...... 11078 1312.22 (a) and (d)(8) revised ...... 10682 1310.02 (a)(30) added; eff. 5–2–11 ...... 17781 1312.24 (a) revised...... 10682 1310.04 (g)(1)(ii) through (ix) re- 1312.27 (a) and (b)(5)(iv) revised...... 10683 designated as (g)(1)(iii) 1312.28 (d) revised...... 10683 through (x); new (g)(1)(ii) 1312.31 (b) introductory text re- added; eff. 5–2–11...... 17781 vised...... 10683 1310.09 (l) added; eff. 5–2–11 ...... 17781 1312.32 (a) revised...... 10683 1310.12 Amended; eff. 5–2–11 ...... 17781 Æ

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