Title 21 Food and Drugs Part 1300 to End

Home , Anol, Ecgonine, Lacing (drugs), Levopropoxyphene, Morpheridine, Quazepam

Revised as of April 1, 2014

Containing a codification of documents of general applicability and future effect

As of April 1, 2014

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 ...... 245

Finding Aids:

Table of CFR Titles and Chapters ...... 317

Alphabetical List of Agencies Appearing in the CFR ...... 337

List of CFR Sections Affected ...... 347

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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, 2014), 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 11:22 May 06, 2014 Jkt 232078 PO 00000 Frm 00005 Fmt 8008 Sfmt 8092 Y:\SGML\232078.XXX 232078 ehiers on DSK2VPTVN1PROD 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. PAST PROVISIONS OF THE CODE Provisions of the Code that are no longer in force and effect as of the revision date stated on the cover of each volume are not carried. Code users may find the text of provisions in effect on any given date in the past by using the appropriate List of CFR Sections Affected (LSA). For the convenience of the reader, a ‘‘List of CFR Sections Affected’’ is published at the end of each CFR volume. For changes to the Code prior to the LSA listings at the end of the volume, consult previous annual editions of the LSA. For changes to the Code prior to 2001, consult the List of CFR Sections Affected compilations, published for 1949- 1963, 1964-1972, 1973-1985, and 1986-2000. ‘‘[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.

VerDate Mar<15>2010 11:22 May 06, 2014 Jkt 232078 PO 00000 Frm 00006 Fmt 8008 Sfmt 8092 Y:\SGML\232078.XXX 232078 ehiers on DSK2VPTVN1PROD with CFR An index to the text of ‘‘Title 3—The President’’ is carried within that volume. 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. The e-CFR is a regularly updated, unofficial editorial compilation of CFR material and Federal Register amendments, produced by the Office of the Federal Register and the Government Printing Office. It is available at www.ecfr.gov.

CHARLES A. BARTH, Director, Office of the Federal Register. April 1, 2014.

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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, 2014.

For this volume, Michele Bugenhagen was Chief Editor. The Code of Federal Regulations publication program is under the direction of the Managing Editor, 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 ...... 54 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 ...... 129 1310 Records and reports of listed chemicals and certain machines ...... 140 1311 Requirements for electronic orders and prescriptions ...... 164 1312 Importation and exportation of controlled substances ...... 185 1313 Importation and exportation of list I and list II chemicals ...... 199 1314 Retail sale of scheduled listed chemical products ... 210 1315 Importation and production quotas for ephedrine, pseudoephedrine, and phenylpropanolamine ...... 218 1316 Administrative functions, practices, and procedures ...... 228 1321 DEA Mailing addresses ...... 241 1322–1399 [Reserved]

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(35) 17a-methyl-3a,17b-dihydroxy-5a-an- (61) testolactone (13-hydroxy-3-oxo- drostane 13,17-secoandrosta-1,4-dien-17-oic (36) 17a-methyl-3b,17b- acid lactone) dihydroxyandrost-4-ene (62) testosterone (17b-hydroxyandrost- (37) 17a-methyl-4-hydroxynandrolone 4-en-3-one) (17a-methyl-4-hydroxy-17b- (63) tetrahydrogestrinone (13b, 17a- hydroxyestr-4-en-3-one) diethyl-17b-hydroxygon-4,9,11-trien- (38) methyldienolone (17a-methyl-17b- 3-one) hydroxyestra-4,9(10)-dien-3-one) (64) trenbolone (17b-hydroxyestr-4,9,11- trien-3-one) (39) methyltrienolone (17a-methyl-17b- (65) Any salt, ester, or ether of a drug hydroxyestra-4,9,11-trien-3-one) or substance described in this para- (40) methyltestosterone (17 -methyl- a graph. Except such term does not 17 -hydroxyandrost-4-en-3-one) b include an anabolic steroid that is (41) mibolerone (7a,17a-dimethyl-17b- expressly intended for administra- hydroxyestr-4-en-3-one) tion through implants to cattle or (42) 17a-methyl-D1-dihydrotestosterone other nonhuman species and that (17b-hydroxy-17a-methyl-5a- has been approved by the Secretary androst-1-en-3-one) (a.k.a. ‘17-a- of Health and Human Services for methyl-1-testosterone‘) such administration. If any person (43) nandrolone (17b-hydroxyestr-4-en-3- prescribes, dispenses, or distributes one) such steroid for human use, the (44) 19-nor-4-androstenediol (3b, 17b- person shall be considered to have dihydroxyestr-4-ene) prescribed, dispensed, or distrib- (45) 19-nor-4-androstenediol (3a, 17b- uted an anabolic steroid within the dihydroxyestr-4-ene) meaning of this paragraph. (46) 19-nor-5-androstenediol (3b, 17b- Automated dispensing system means a dihydroxyestr-5-ene) mechanical system that performs oper- (47) 19-nor-5-androstenediol (3a, 17b- ations or activities, other than dihydroxyestr-5-ene) compounding or administration, rel- (48) 19-nor-4,9(10)-androstadienedione ative to the storage, packaging, count- (estra-4,9(10)-diene-3,17-dione) ing, labeling, and dispensing of medica- (49) 19-nor-4-androstenedione (estr-4-en- tions, and which collects, controls, and 3,17-dione) maintains all transaction information. (50) 19-nor-5-androstenedione (estr-5-en- Basic class means, as to controlled 3,17-dione) substances listed in Schedules I and II: (51) norbolethone (13b, 17a-diethyl-17b- (1) Each of the opiates, including its hydroxygon-4-en-3-one) isomers, esters, ethers, salts, and salts (52) norclostebol (4-chloro-17b- of isomers, esters, and ethers whenever hydroxyestr-4-en-3-one) the existence of such isomers, esters, ethers, and salts is possible within the (53) norethandrolone (17a-ethyl-17b- hydroxyestr-4-en-3-one) specific chemical designation, listed in § 1308.11(b) of this chapter; (54) normethandrolone (17 -methyl-17 - a b (2) Each of the opium derivatives, in- hydroxyestr-4-en-3-one) cluding its salts, isomers, and salts of (55) oxandrolone (17a-methyl-17b-hy- isomers whenever the existence of such droxy-2-oxa-[5a]-androstan-3-one) salts, isomers, and salts of isomers is (56) oxymesterone (17a-methyl-4,17b- possible within the specific chemical dihydroxyandrost-4-en-3-one) designation, listed in § 1308.11(c) of this (57) oxymetholone (17a-methyl-2- chapter; hydroxymethylene-17b-hydroxy- (3) Each of the hallucinogenic sub- [5a]-androstan-3-one) stances, including its salts, isomers, (58) Prostanozol (17b-hydroxy-5a- and salts of isomers whenever the ex- androstano[3,2-c]pyrazole) istence of such salts, isomers, and salts (59) stanozolol (17a-methyl-17b-hy- of isomers is possible within the spe- droxy-[5a]-androst-2-eno[3,2-c]-pyr- cific chemical designation, listed in azole) § 1308.11(d) of this chapter; (60) stenbolone (17b-hydroxy-2-methyl- (4) Each of the following substances, [5a]-androst-1-en-3-one) whether produced directly or indirectly 6

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by extraction from substances of vege- fill pharmacy have a contractual rela- table origin, or independently by tionship providing for such activities means of chemical synthesis, or by a or share a common owner. combination of extraction and chem- Commercial container means any bot- ical synthesis: tle, jar, tube, ampule, or other recep- (i) Opium, including raw opium, tacle in which a substance is held for opium extracts, opium fluid extracts, distribution or dispensing to an ulti- powdered opium, granulated opium, de- mate user, and in addition, any box or odorized opium and tincture of opium; package in which the receptacle is held (ii) Apomorphine; for distribution or dispensing to an ul- (iii) Codeine; timate user. The term commercial con- (iv) Etorphine hydrochloride; tainer does not include any package (v) Ethylmorphine; liner, package insert or other material (vi) Hydrocodone; kept with or within a commercial con- (vii) Hydromorphone; tainer, nor any carton, crate, drum, or (viii) Metopon; other package in which commercial (ix) Morphine; containers are stored or are used for (x) Oxycodone; shipment of controlled substances. (xi) Oxymorphone; Compounder means any person engag- (xii) Thebaine; ing in maintenance or detoxification (xiii) Mixed alkaloids of opium listed treatment who also mixes, prepares, in § 1308.12(b)(2) of this chapter; packages or changes the dosage form of (xiv) Cocaine; and a narcotic drug listed in Schedules II, (xv) Ecgonine; III, IV or V for use in maintenance or (5) Each of the opiates, including its detoxification treatment by another isomers, esters, ethers, salts, and salts narcotic treatment program. of isomers, esters, and ethers whenever Controlled substance has the meaning the existence of such isomers, esters, given in section 802(6) of Title 21, ethers, and salts is possible within the United States Code (U.S.C.). specific chemical designation, listed in Customs territory of the United States § 1308.12(c) of this chapter; and means the several States, the District (6) Methamphetamine, its salts, iso- of Columbia, and Puerto Rico. mers, and salts of its isomers; Detoxification treatment means the (7) Amphetamine, its salts, optical dispensing, for a period of time as spec- isomers, and salts of its optical iso- ified below, of a narcotic drug or nar- mers; cotic drugs in decreasing doses to an (8) Phenmetrazine and its salts; individual to alleviate adverse physio- (9) Methylphenidate; logical or psychological effects inci- (10) Each of the substances having a dent to withdrawal from the contin- depressant effect on the central nerv- uous or sustained use of a narcotic ous system, including its salts, iso- drug and as a method of bringing the mers, and salts of isomers whenever individual to a narcotic drug-free state the existence of such salts, isomers, within such period of time. There are and salts of isomers is possible within two types of detoxification treatment: the specific chemical designation, list- Short-term detoxification treatment ed in § 1308.12(e) of this chapter. and long-term detoxification treat- Central fill pharmacy means a phar- ment. macy which is permitted by the state (1) Short-term detoxification treat- in which it is located to prepare con- ment is for a period not in excess of 30 trolled substances orders for dispensing days. pursuant to a valid prescription trans- (2) Long-term detoxification treat- mitted to it by a registered retail phar- ment is for a period more than 30 days macy and to return the labeled and but not in excess of 180 days. filled prescriptions to the retail phar- Dispenser means an individual practi- macy for delivery to the ultimate user. tioner, institutional practitioner, phar- Such central fill pharmacy shall be macy or pharmacist who dispenses a deemed ‘‘authorized’’ to fill prescrip- controlled substance. tions on behalf of a retail pharmacy Export means, with respect to any ar- only if the retail pharmacy and central ticle, any taking out or removal of

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such article from the jurisdiction of toms territory of the United States, the United States (whether or not such and from the jurisdiction of the United taking out or removal constitutes an States into the customs territory of exportation within the meaning of the the United States (whether or not such customs and related laws of the United bringing in or introduction constitutes States). an importation within the meaning of Exporter includes every person who the tariff laws of the United States). exports, or who acts as an export Importer includes every person who broker for exportation of, controlled imports, or who acts as an import substances listed in any schedule. broker for importation of, controlled Freight forwarding facility means a substances listed in any schedule. separate facility operated by a distrib- Individual practitioner means a physi- uting registrant through which sealed, cian, dentist, veterinarian, or other in- packaged controlled substances in un- dividual licensed, registered, or other- marked shipping containers (i.e., the wise permitted, by the United States or containers do not indicate that the the jurisdiction in which he/she prac- contents include controlled substances) tices, to dispense a controlled sub- are, in the course of delivery to, or re- stance in the course of professional turn from, customers, transferred in practice, but does not include a phar- less than 24 hours. A distributing reg- macist, a pharmacy, or an institutional istrant who operates a freight for- practitioner. warding facility may use the facility to Institutional practitioner means a hos- transfer controlled substances from pital or other person (other than an in- any location the distributing reg- dividual) licensed, registered, or other- istrant operates that is registered with wise permitted, by the United States or the Administration to manufacture, the jurisdiction in which it practices, distribute, or import controlled sub- to dispense a controlled substance in stances, or, with respect to returns, the course of professional practice, but registered to dispense controlled sub- does not include a pharmacy. stances, provided that the notice re- Interested person means any person quired by § 1301.12(b)(4) of Part 1301 of adversely affected or aggrieved by any this chapter has been submitted and rule or proposed rule issuable pursuant approved. For purposes of this defini- to section 201 of the Act (21 U.S.C. 811). tion, a ‘‘distributing registrant’’ is a Inventory means all factory and person who is registered with the Ad- branch stocks in finished form of a ministration as a manufacturer, dis- basic class of controlled substance tributor, and/or importer. manufactured or otherwise acquired by Hearing means: a registrant, whether in bulk, commer- (1) In part 1301 of this chapter, any cial containers, or contained in phar- hearing held for the granting, denial, maceutical preparations in the posses- revocation, or suspension of a registra- sion of the registrant (including stocks tion pursuant to sections 303, 304, and held by the registrant under separate 1008 of the Act (21 U.S.C. 823, 824 and registration as a manufacturer, im- 958). porter, exporter, or distributor). (2) In part 1303 of this chapter, any Isomer means: hearing held regarding the determina- (1) The optical isomer, except as used tion of aggregate production quota or in § 1308.11(d) and § 1308.12(b)(4) of this the issuance, adjustment, suspension, chapter. As used in § 1308.11(d) of this or denial of a procurement quota or an chapter, the term ‘‘isomer’’ means any individual manufacturing quota. optical, positional, or geometric iso- (3) In part 1308 of this chapter, any mer. As used in § 1308.12(b)(4) of this hearing held for the issuance, amend- chapter, the term ‘‘isomer’’ means any ment, or repeal of any rule issuable optical or geometric isomer; pursuant to section 201 of the Act (21 (2) As used in § 1308.11(d) of this chap- U.S.C. 811). ter, the term ‘‘positional isomer’’ Import means, with respect to any ar- means any substance possessing the ticle, any bringing in or introduction same molecular formula and core of such article into either the jurisdic- structure and having the same function of the United States or the cus- tional group(s) and/or substituent(s) as

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those found in the respective Schedule Maintenance treatment means the dis- I hallucinogen, attached at any posi- pensing for a period in excess of twen- tion(s) on the core structure, but in ty-one days, of a narcotic drug or nar- such manner that no new chemical cotic drugs in the treatment of an indi- functionalities are created and no ex- vidual for dependence upon heroin or isting chemical functionalities are de- other morphine-like drug. stroyed relative to the respective Manufacture means the producing, Schedule I hallucinogen. Rearrange- preparation, propagation, ments of alkyl moieties within or be- compounding, or processing of a drug tween functional group(s) or substit- or other substance or the packaging or uent(s), or divisions or combinations of repackaging of such substance, or the alkyl moieties, that do not create new labeling or relabeling of the commer- chemical functionalities or destroy ex- cial container of such substance, but isting chemical functionalities, are al- does not include the activities of a lowed i.e., result in compounds which practitioner who, as an incident to his/ are positional isomers. For purposes of her administration or dispensing such this definition, the ‘‘core structure’’ is substance in the course of his/her pro- the parent molecule that is the com- fessional practice, prepares, common basis for the class; for example, pounds, packages or labels such sub- tryptamine, phenethylamine, or stance. ergoline. Examples of rearrangements Manufacturer means a person who resulting in creation and/or destruction manufactures a drug or other sub- of chemical functionalities (and there- stance, whether under a registration as fore resulting in compounds which are a manufacturer or under authority of not positional isomers) include, but are registration as a researcher or chem- not limited to: Ethoxy to alpha-hy- ical analyst. droxyethyl, hydroxy and methyl to Mid-level practitioner means an indi- methoxy, or the repositioning of a phe- vidual practitioner, other than a physi- nolic or alcoholic hydroxy group to cian, dentist, veterinarian, or podia- create a hydroxyamine. Examples of trist, who is licensed, registered, or rearrangements resulting in com- otherwise permitted by the United pounds which would be positional iso- States or the jurisdiction in which he/ mers include: Tert-butyl to sec-butyl, she practices, to dispense a controlled methoxy and ethyl to isopropoxy, N,N- substance in the course of professional diethyl to N-methyl-N-propyl, or alpha- practice. Examples of mid-level practi- methylamino to N-methylamino. tioners include, but are not limited to, health care providers such as nurse Jurisdiction of the United States means practitioners, nurse midwives, nurse the customs territory of the United anesthetists, clinical nurse specialists States, the Virgin Islands, the Canal and physician assistants who are au- Zone, Guam, American Samoa, and the thorized to dispense controlled sub- Trust Territories of the Pacific Islands. stances by the State in which they Label means any display of written, practice. printed, or graphic matter placed upon Name means the official name, com- the commercial container of any con- mon or usual name, chemical name, or trolled substance by any manufacturer brand name of a substance. of such substance. Narcotic drug means any of the fol- Labeling means all labels and other lowing whether produced directly or in- written, printed, or graphic matter: directly by extraction from substances (1) Upon any controlled substance or of vegetable origin or independently by any of its commercial containers or means of chemical synthesis or by a wrappers, or combination of extraction and chem- (2) Accompanying such controlled ical synthesis: substance. (1) Opium, opiates, derivatives of Long Term Care Facility (LTCF) means opium and opiates, including their iso- a nursing home, retirement care, men- mers, esters, ethers, salts, and salts of tal care or other facility or institution isomers, esters, and ethers whenever which provides extended health care to the existence of such isomers, esters, resident patients. ethers and salts is possible within the

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specific chemical designation. Such Prescription means an order for medi- term does not include the isoquinoline cation which is dispensed to or for an alkaloids of opium. ultimate user but does not include an (2) Poppy straw and concentrate of order for medication which is dispensed poppy straw. for immediate administration to the (3) Coca leaves, except coca leaves ultimate user (e.g., an order to dis- and extracts of coca leaves from which pense a drug to a bed patient for imme- cocaine, ecgonine and derivatives of ec- diate administration in a hospital is gonine or their salts have been re- not a prescription). moved. Proceeding means all actions taken (4) Cocaine, its salts, optical and geo- for the issuance, amendment, or repeal metric isomers, and salts of isomers. of any rule issued pursuant to section (5) Ecgonine, its derivatives, their 201 of the Act (21 U.S.C. 811), com- salts, isomers and salts of isomers. mencing with the publication by the (6) Any compound, mixture, or prepa- Administrator of the proposed rule, ration which contains any quantity of amended rule, or repeal in the FEDERAL any of the substances referred to in REGISTER. paragraphs (1) through (5) of this defi- Purchaser means any registered per- nition. son entitled to obtain and execute Narcotic treatment program means a order forms pursuant to §§ 1305.04 and program engaged in maintenance and/ 1305.06. or detoxification treatment with nar- Readily retrievable means that certain cotic drugs. records are kept by automatic data Net disposal means, for a stated pe- processing systems or other electronic riod, the quantity of a basic class of or mechanized recordkeeping systems controlled substance distributed by the in such a manner that they can be sep- registrant to another person, plus the arated out from all other records in a quantity of that basic class used by the reasonable time and/or records are kept registrant in the production of (or con- on which certain items are asterisked, verted by the registrant into) another basic class of controlled substance or a redlined, or in some other manner vis- noncontrolled substance, plus the ually identifiable apart from other quantity of that basic class otherwise items appearing on the records. disposed of by the registrant, less the Register and registration refer only to quantity of that basic class returned to registration required and permitted by the registrant by any purchaser, and sections 303 or 1007 of the Act (21 U.S.C. less the quantity of that basic class 823 or 957). distributed by the registrant to an- Registrant means any person who is other registered manufacturer of that registered pursuant to either section basic class for purposes other than use 303 or section 1008 of the Act (21 U.S.C. in the production of, or conversion 823 or 958). into, another basic class of controlled Reverse distributor means a registrant substance or a noncontrolled substance who receives controlled substances ac- or in the manufacture of dosage forms quired from another DEA registrant for of that basic class. the purpose of— Person includes any individual, cor- (1) Returning unwanted, unusable, or poration, government or governmental outdated controlled substances to the subdivision or agency, business trust, manufacturer or the manufacturer’s partnership, association, or other legal agent; or entity. (2) Where necessary, processing such Pharmacist means any pharmacist li- substances or arranging for processing censed by a State to dispense controlled substances, and shall include such substances for disposal. any other person (e.g., pharmacist in- tern) authorized by a State to dispense controlled substances under the supervision of a pharmacist licensed by such State.

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Supplier means any registered person the meaning of the customs and related entitled to fill order forms pursuant to laws of the United States). § 1305.06 of this chapter. Chemical exporter is a regulated person who, as the principal party in in- [62 FR 13941, Mar. 24, 1997, as amended at 65 FR 44678, July 19, 2000; 68 FR 37409, June 24, terest in the export transaction, has 2003; 68 FR 41228, July 11, 2003; 70 FR 25465, the power and responsibility for deter- May 13, 2005; 70 FR 74656, Dec. 16, 2005; 71 FR mining and controlling the sending of 60427, Oct. 13, 2006; 72 FR 67852, Dec. 3, 2007; the listed chemical out of the United 74 FR 63609, Dec. 4, 2009; 77 FR 4230, Jan. 27, States. 2012; 77 FR 44461, July 30, 2012] Chemical import means with respect to a listed chemical, any bringing in or § 1300.02 Definitions relating to listed introduction of such listed chemical chemicals. into either the jurisdiction of the (a) Any term not defined in this part United States or into the customs ter- shall have the definition set forth in ritory of the United States (whether or section 102 of the Act (21 U.S.C. 802), not such bringing in or introduction except that certain terms used in part constitutes an importation within the 1316 of this chapter are defined at the meaning of the tariff laws of the beginning of each subpart of that part. United States). (b) As used in parts 1309, 1310, and Chemical importer is a regulated per- 1313 of this chapter, the following son who, as the principal party in in- terms shall have the meaning specified: terest in the import transaction, has Act means the Controlled Substances the power and responsibility for deter- Act, as amended (84 Stat. 1242; 21 U.S.C. mining and controlling the bringing in 801) and/or the Controlled Substances or introduction of the listed chemical Import and Export Act, as amended (84 into the United States. Stat. 1285; 21 U.S.C. 951). Chemical mixture means a combina- Administration means the Drug En- tion of two or more chemical sub- forcement Administration. stances, at least one of which is not a Administrator means the Adminis- listed chemical, except that such term trator of the Drug Enforcement Admin- does not include any combination of a istration. The Administrator has been listed chemical with another chemical delegated authority under the Act by that is present solely as an impurity or the Attorney General (28 CFR 0.100). which has been created to evade the re- At retail, with respect to the sale or quirements of the Act. purchase of a scheduled listed chemical Combination ephedrine product means product, means a sale or purchase for a drug product containing ephedrine or personal use, respectively. its salts, optical isomers, or salts of op- Broker and trader mean any indi- tical isomers, and therapeutically sig- vidual, corporation, corporate division, nificant quantities of another active partnership, association, or other legal medicinal ingredient. entity which assists in arranging an Customs territory of the United States international transaction in a listed means the several States, the District chemical by— of Columbia, and Puerto Rico. (1) Negotiating contracts; Drug product means an active ingre- (2) Serving as an agent or inter- dient in dosage form that has been ap- mediary; or proved or otherwise may be lawfully (3) Fulfilling a formal obligation to marketed under the Federal Food, complete the transaction by bringing Drug, and Cosmetic Act for distribu- together a buyer and seller, a buyer tion in the United States. and transporter, or a seller and trans- Encapsulating machine means any porter, or by receiving any form of manual, semi-automatic, or fully auto- compensation for so doing. matic equipment which may be used to Chemical export means transferring fill shells or capsules with any pow- ownership or control, or the sending or dered, granular, semi-solid, or liquid taking of threshold quantities of listed material. chemicals out of the United States Established business relationship means (whether or not such sending or taking the regulated person has imported or out constitutes an exportation within exported a listed chemical at least

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once within the past six months, or on unimproved real estate (such as a twice within the past twelve months lot or field leased for retail purposes). from or to a foreign manufacturer, dis- Name means the official name, com- tributor, or end user of the chemical mon or usual name, chemical name, or that has an established business with a brand name of a substance. fixed street address. A person or busi- Person includes any individual, cor- ness that functions as a broker or poration, government or governmental intermediary is not a customer for pur- subdivision or agency, business trust, poses of this definition. partnership, association, or other legal Established record as an importer entity. means that the regulated person has Readily retrievable means that certain imported a listed chemical at least records are kept by automatic data once within the past six months, or processing systems or other electronic twice within the past twelve months or mechanized recordkeeping systems from a foreign supplier. in such a manner that they can be sep- Hearing means any hearing held for arated out from all other records in a the granting, denial, revocation, or reasonable time and/or records are kept suspension of a registration pursuant on which certain items are asterisked, to sections 303, 304, and 1008 of the Act redlined, or in some other manner vis- (21 U.S.C. 823, 824 and 958). ually identifiable apart from other items appearing on the records. International transaction means a Register and registration refer only to transaction involving the shipment of registration required and permitted by a listed chemical across an inter- sections 303 or 1007 of the Act (21 U.S.C. national border (other than a United 823 or 957). States border) in which a broker or Registrant means any person who is trader located in the United States registered pursuant to either section participates. 303 or section 1008 of the Act (21 U.S.C. Jurisdiction of the United States means 823 or 958). the customs territory of the United Regular customer means a person with States, the Virgin Islands, the Canal whom the regulated person has an es- Zone, Guam, American Samoa, and the tablished business relationship for a Trust Territories of the Pacific Islands. specified listed chemical or chemicals Listed chemical means any List I that has been reported to the Adminis- chemical or List II chemical. tration subject to the criteria estab- List I chemical means a chemical spe- lished in part 1313 of this chapter. cifically designated by the Adminis- Regular importer means, with respect trator in § 1310.02(a) of this chapter to a listed chemical, a person that has that, in addition to legitimate uses, is an established record as an importer of used in manufacturing a controlled that listed chemical that is reported to substance in violation of the Act and is the Administrator. important to the manufacture of a con- Regulated person means any indi- trolled substance. vidual, corporation, partnership, asso- List II chemical means a chemical, ciation, or other legal entity who man- other than a List I chemical, specifi- ufactures, distributes, imports, or ex- cally designated by the Administrator ports a listed chemical, a tableting main § 1310.02(b) of this chapter that, in chine, or an encapsulating machine, or addition to legitimate uses, is used in who acts as a broker or trader for an manufacturing a controlled substance international transaction involving a in violation of the Act. listed chemical, tableting machine, or Mobile retail vendor means a person or encapsulating machine. entity that makes sales at retail from Regulated seller means a retail dis- a stand that is intended to be tem- tributor (including a pharmacy or a porary or is capable of being moved mobile retail vendor), except that the from one location to another, whether term does not include an employee or the stand is located within or on the agent of the distributor. premises of a fixed facility (such as a Regulated transaction means: kiosk at a shopping center or an air- (1) A distribution, receipt, sale, import) or whether the stand is located portation, or exportation of a listed

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chemical, or an international trans- (v) Any transaction in a scheduled action involving shipment of a listed listed chemical product that is a sale chemical, or if the Administrator es- at retail by a regulated seller or a dis- tablishes a threshold amount for a spe- tributor required to submit reports cific listed chemical, a threshold under § 1310.03(c) of this chapter; or amount as determined by the Adminis- (vi) Any transaction in a chemical trator, which includes a cumulative mixture designated in §§ 1310.12 and threshold amount for multiple trans- 1310.13 of this chapter that the Admin- actions, of a listed chemical, except istrator has exempted from regulation. that such term does not include: (2) A distribution, importation, or ex- (i) A domestic lawful distribution in portation of a tableting machine or en- the usual course of business between capsulating machine except that such agents or employees of a single regu- term does not include a domestic law- lated person; in this context, agents or ful distribution in the usual course of employees means individuals under the business between agents and employees direct management and control of the of a single regulated person; in this regulated person; context, agents or employees means in- (ii) 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 Retail distributor means a grocery of the business of the common or con- store, general merchandise store, drug tract carrier, or to or by a warehouse- store, or other entity or person whose man for storage in the lawful and usual activities as a distributor relating to course of the business of the ware- 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 from compliance with parts 1309, 1310, to-face transactions by direct sales. 1313, and 1315 of this chapter; Also for the purposes of this paragraph, (iii) Any category of transaction or a ‘‘grocery store’’ is an entity within any category of transaction for a spe- Standard Industrial Classification cific listed chemical or chemicals spec- (SIC) code 5411, a ‘‘general merchandise ified by regulation of the Adminis- store’’ is an entity within SIC codes trator as excluded from this definition 5300 through 5399 and 5499, and a ‘‘drug as unnecessary for enforcement of the store’’ is an entity within SIC code Act; 5912. (iv) Any transaction in a listed chem- Scheduled listed chemical product ical that is contained in a drug other means: than a scheduled listed chemical prod- (1) A product that contains ephed- uct that may be marketed or distrib- rine, pseudoephedrine, or phenyl- uted lawfully in the United States propanolamine and may be marketed under the Federal Food, Drug, and Cos- or distributed lawfully in the United metic Act, subject to paragraph (1)(v) States under the Federal Food, Drug, of this definition, unless— and Cosmetic Act as a nonprescription (A) The Administrator has deter- drug. Ephedrine, pseudoephedrine, and mined pursuant to the criteria in phenylpropanolamine include their § 1310.10 of this chapter that the drug or salts, optical isomers, and salts of opti- group of drugs is being diverted to ob- cal isomers. tain the listed chemical for use in the (2) Scheduled listed chemical product illicit production of a controlled sub- does not include any product that is a stance; and controlled substance under part 1308 of (B) The quantity of the listed chem- this chapter. In the absence of such ical contained in the drug included in scheduling by the Attorney General, a the transaction or multiple trans- chemical specified in paragraph (1) of actions equals or exceeds the threshold this definition may not be considered established for that chemical; to be a controlled substance.

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Tableting machine means any manual, (2) Extracting and processing the bio- semi-automatic, or fully automatic metric data from that sample. equipment which may be used for the (3) Storing the extracted information compaction or molding of powdered or in a database. granular solids, or semi-solid material, (4) Comparing the biometric data to produce coherent solid tablets. with data contained in one or more ref- Valid prescription means a prescrip- erence databases. tion that is issued for a legitimate (5) Determining how well the stored medical purpose by an individual prac- data matches the newly captured data titioner licensed by law to administer and indicating whether an identifica- and prescribe the drugs concerned and tion or verification of identity has been acting in the usual course of the prac- achieved. titioner’s professional practice. Cache means to download and store [75 FR 16304, Mar. 31, 2010, as amended at 77 information on a local server or hard FR 4233, Jan. 27, 2012] drive. Certificate policy means a named set § 1300.03 Definitions relating to elec- of rules that sets forth the applica- tronic orders for controlled sub- bility of the specific digital certificate stances and electronic prescriptions for controlled substances. to a particular community or class of application with common security re- For the purposes of this chapter, the quirements. following terms shall have the mean- Certificate revocation list (CRL) means ings specified: a list of revoked, but unexpired certifi- Application service provider means an cates issued by a certification author- entity that sells electronic prescrip- ity. tion or pharmacy applications as a Certification authority (CA) means an hosted service, where the entity con- organization that is responsible for trols access to the application and verifying the identity of applicants, au- maintains the software and records on thorizing and issuing a digital certifi- its servers. cate, maintaining a directory of public Audit trail means a record showing keys, and maintaining a Certificate who has accessed an information tech- Revocation List. nology application and what operations the user performed during a given pe- Certified information systems auditor means an individual who has riod. (CISA) Authentication means verifying the been certified by the Information Sys- identity of the user as a prerequisite to tems Audit and Control Association as allowing access to the information ap- qualified to audit information systems plication. and who performs compliance audits as Authentication protocol means a well a regular ongoing business activity. specified message exchange process Credential means an object or data that verifies possession of a token to structure that authoritatively binds an remotely authenticate a person to an identity (and optionally, additional at- application. tributes) to a token possessed and con- Biometric authentication means au- trolled by a person. thentication based on measurement of Credential service provider (CSP) the individual’s physical features or re- means a trusted entity that issues or peatable actions where those features registers tokens and issues electronic or actions are both distinctive to the credentials to individuals. The CSP individual and measurable. may be an independent third party or Biometric subsystem means the hard- may issue credentials for its own use. ware and software used to capture, CSOS means controlled substance or- store, and compare biometric data. The dering system. biometric subsystem may be part of a Digital certificate means a data record larger application. The biometric sub- that, at a minimum— system is an automated system capable (1) Identifies the certification au- of: thority issuing it; (1) Capturing a biometric sample (2) Names or otherwise identifies the from an end user. certificate holder;

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(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 source of the message and indicates the Federal standard for applications used person’s approval of the information to generate and rely upon digital signa- contained in the message. tures. False match rate means the rate at FIPS 186–3, as incorporated by ref- which an impostor’s biometric is false- erence in § 1311.08 of this chapter, ly accepted as being that of an author- means the National Institute of Stand- ized user. It is one of the statistics ards and Technology publication enti- used to measure biometric performance tled ‘‘Digital Signature Standard when operating in the verification or (DSS),’’ a Federal standard for applica- authentication task. The false match tions used to generate and rely upon rate is similar to the false accept (or digital signatures. acceptance) rate. Hard token means a cryptographic False non-match rate means the rate key stored on a special hardware device at which a genuine user’s biometric is (e.g., a PDA, cell phone, smart card, falsely rejected when the user’s bio- USB drive, one-time password device) metric data fail to match the enrolled rather than on a general purpose com- data for the user. It is one of the statis- puter. tics used to measure biometric per- Identity proofing means the process by formance when operating in the which a credential service provider or verification or authentication task. certification authority validates suffi- The false match rate is similar to the cient information to uniquely identify false reject (or rejection) rate, except a person. that it does not include the rate at Installed electronic prescription applica- which a biometric system fails to action means software that is used to cre- quire a biometric sample from a gen- ate electronic prescriptions and that is uine user. installed on a practitioner’s computers

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and servers, where access and records Password means a secret, typically a are controlled by the practitioner. character string (letters, numbers, and Installed pharmacy application means other symbols), that a person memo- software that is used to process pre- rizes and uses to authenticate his iden- scription information and that is in- tity. stalled on a pharmacy’s computers or PDA means a Personal Digital Assist- servers and is controlled by the phar- ant, a handheld computer used to man- macy. age contacts, appointments, and tasks. Intermediary means any technology Pharmacy application provider means system that receives and transmits an an entity that develops or markets electronic prescription between the software that manages the receipt and practitioner and pharmacy. processing of electronic prescriptions. Key pair means two mathematically Private key means the key of a key related keys having the properties pair that is used to create a digital sig- that: nature. (1) One key can be used to encrypt a Public key means the key of a key message that can only be decrypted pair that is used to verify a digital sig- using the other key; and nature. The public key is made avail- (2) Even knowing one key, it is able to anyone who will receive computationally infeasible to discover digitally signed messages from the the other key. holder of the key pair. NIST means the National Institute of Public Key Infrastructure (PKI) means Standards and Technology. a structure under which a certification NIST SP 800–63–1, as incorporated by authority verifies the identity of appli- reference in § 1311.08 of this chapter, cants; issues, renews, and revokes dig- means the National Institute of Stand- ital certificates; maintains a registry ards and Technology publication enti- of public keys; and maintains an up-to- tled ‘‘Electronic Authentication Guide- date certificate revocation list. line,’’ a Federal standard for electronic Readily retrievable means that certain authentication. records are kept by automatic data NIST SP 800–76–1, as incorporated by processing applications or other elec- reference in § 1311.08 of this chapter, tronic or mechanized recordkeeping means the National Institute of Stand- systems in such a manner that they ards and Technology publication enti- can be separated out from all other tled ‘‘Biometric Data Specification for records in a reasonable time and/or Personal Identity Verification,’’ a Fed- records are kept on which certain eral standard for biometric data speci- items are asterisked, redlined, or in fications for personal identity some other manner visually identifi- verification. able apart from other items appearing Operating point means a point chosen on the records. on a receiver operating characteristic SAS 70 Audit means a third-party (ROC) curve for a specific algorithm at audit of a technology provider that which the biometric system is set to meets the American Institute of Cer- function. It is defined by its cor- tified Public Accountants (AICPA) responding coordinates—a false match Statement of Auditing Standards rate and a false non-match rate. An (SAS) 70 criteria. ROC curve shows graphically the trade- Signing function means any keystroke off between the principal two types of or other action used to indicate that errors (false match rate and false non- the practitioner has authorized for match rate) of a biometric system by transmission and dispensing a con- plotting the performance of a specific trolled substance prescription. The algorithm on a specific set of data. signing function may occur simulta- Paper prescription means a prescrip- neously with or after the completion of tion created on paper or computer gen- the two-factor authentication protocol erated to be printed or transmitted via that meets the requirements of part facsimile that meets the requirements 1311 of this chapter. The signing func- of part 1306 of this chapter including a tion may have different names (e.g., manual signature. approve, sign, transmit), but it serves

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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 WebTrust means a professional serv- same controlled substance as described ice performed by a qualified certified in paragraph (d)(1)); and public accountant to evaluate one or (3) The practitioner, acting in the more aspects of Web sites. usual course of professional practice, [75 FR 16304, Mar. 31, 2010] determines there is a legitimate medical purpose for the issuance of the new § 1300.04 Definitions relating to the prescription. dispensing of controlled substances (e) The term homepage means the by means of the Internet. opening or main page or screen of the (a) Any term not defined in this part Web site of an online pharmacy that is or elsewhere in this chapter shall have viewable on the Internet. the definition set forth in sections 102 (f) The term in-person medical evalua- and 309 of the Act (21 U.S.C. 802, 829). tion means a medical evaluation that is (b) The term covering practitioner conducted with the patient in the phys- means, with respect to a patient, a ical presence of the practitioner, with- practitioner who conducts a medical out regard to whether portions of the evaluation (other than an in-person evaluation are conducted by other medical evaluation) at the request of a health professionals. Nothing in this practitioner who: paragraph shall be construed to imply (1) Has conducted at least one in-per- that one in-person medical evaluation son medical evaluation of the patient demonstrates that a prescription has or an evaluation of the patient through been issued for a legitimate medical the practice of telemedicine, within purpose within the usual course of pro- the previous 24 months; and fessional practice.

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(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; trolled substances to an unregistered (9)(i) Any registered pharmacy whose individual or entity; delivery, distribution, or dispensing of (2) Nonpharmacy practitioners who controlled substances by means of the are registered under section 303(f) of Internet consists solely of filling pre- the Act (21 U.S.C. 823(f)) (§ 1301.13 of scriptions that were electronically pre- this chapter) and whose activities are scribed in a manner authorized by this authorized by that registration; chapter and otherwise in compliance (3) Any hospital or other medical fa- with the Act. cility that is operated by an agency of (ii) A registered pharmacy will be the United States (including the Armed deemed to meet this exception if, in Forces), provided such hospital or view of all of its activities other than other facility is registered under sec- those referred to in paragraph (h)(9)(i) tion 303(f) of the Act (21 U.S.C. 823(f)) of this section, it would fall outside the (§ 1301.13 of this chapter); definition of an online pharmacy; or (4) A health care facility owned or (10)(i) Any registered pharmacy operated by an Indian tribe or tribal whose delivery, distribution, or dis- organization, only to the extent such pensing of controlled substances by facility is carrying out a contract or means of the Internet consists solely of compact under the Indian Self-Deter- the transmission of prescription infor- mination and Education Assistance mation between a pharmacy and an Act; automated dispensing system located (5) Any agent or employee of any hos- in a long term care facility when the pital or facility referred to in para- registration of the automated dis- graph (h)(3) or (h)(4) of this section, pensing system is held by that phar- provided such agent or employee is macy as described in §§ 1301.17 and

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1301.27 and the pharmacy is otherwise State in which the patient is located, complying with this chapter. unless the practitioner: (ii) A registered pharmacy will be (i) Is exempted from such registra- deemed to meet this exception if, in tion in all States under section 302(d) view of all of its activities other than of the Act (21 U.S.C. 822(d)); or those referred to in paragraph (h)(10)(i) (ii) Is an employee or contractor of of this section, it would fall outside the the Department of Veterans Affairs definition of an online pharmacy. who is acting in the scope of such em- (i) Effective January 15, 2010, the ployment or contract, and registered term practice of telemedicine means the under section 303(f) of the Act (21 practice of medicine in accordance U.S.C. 823(f)) in any State or is using with applicable Federal and State laws the registration of a hospital or clinic by a practitioner (other than a phar- operated by the Department of Vet- macist) who is at a location remote erans Affairs registered under section from the patient and is communicating 303(f); with the patient, or health care profes- (3) Indian Health Service or tribal orga- sional who is treating the patient, nization. The practice of telemedicine using a telecommunications system re- is being conducted by a practitioner ferred to in section 1834(m) of the So- who is an employee or contractor of cial Security Act (42 U.S.C. 1395m(m)), the Indian Health Service, or is work- which practice falls within a category ing for an Indian tribe or tribal organi- listed in the following paragraphs (i)(1) zation under its contract or compact through (7): with the Indian Health Service under (1) Treatment in a hospital or clinic. the Indian Self-Determination and The practice of telemedicine is being Education Assistance Act; who is act- conducted while the patient is being ing within the scope of the employ- treated by, and physically located in, a ment, contract, or compact; and who is hospital or clinic registered under sec- designated as an Internet Eligible Con- tion 303(f) of the Act (21 U.S.C. 823(f)) trolled Substances Provider by the Sec- by a practitioner acting in the usual retary of Health and Human Services course of professional practice, who is under section 311(g)(2) of the Act (21 acting in accordance with applicable U.S.C. 831(g)(2)); State law, and who is registered under (4) Public health emergency declared by section 303(f) of the Act (21 U.S.C. the Secretary of Health and Human Serv- 823(f)) in the State in which the patient ices. The practice of telemedicine is is located, unless the practitioner: being conducted during a public health (i) Is exempted from such registra- emergency declared by the Secretary tion in all States under section 302(d) of Health and Human Services under of the Act (21 U.S.C. 822(d); or section 319 of the Public Health Service (ii) Is an employee or contractor of Act (42 U.S.C. 247d), and involves pa- the Department of Veterans Affairs tients located in such areas, and such who is acting in the scope of such em- controlled substances, as the Secretary ployment or contract, and registered of Health and Human Services, with under section 303(f) of the Act (21 the concurrence of the Administrator, U.S.C. 823(f)) in any State or is uti- designates, provided that such designa- lizing the registration of a hospital or tion shall not be subject to the proce- clinic operated by the Department of dures prescribed by the Administrative Veterans Affairs registered under sec- Procedure Act (5 U.S.C. 551–559 and 701– tion 303(f); 706); (2) Treatment in the physical presence (5) Special registration. The practice of of a practitioner. The practice of tele- telemedicine is being conducted by a medicine is being conducted while the practitioner who has obtained from the patient is being treated by, and in the Administrator a special registration physical presence of, a practitioner under section 311(h) of the Act (21 acting in the usual course of profes- U.S.C. 831(h)); sional practice, who is acting in ac- (6) Department of Veterans Affairs med- cordance with applicable State law, ical emergency. The practice of tele- and who is registered under section medicine is being conducted: 303(f) of the Act (21 U.S.C. 823(f)) in the (i) In a medical emergency situation:

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(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 section 303(f) of the Act (21 U.S.C. U.S.C. 1395m(m)), if the practitioner is 823(f)); using an interactive telecommuni- (C) During which the primary care cations system that satisfies the re- practitioner of the patient or a practi- quirements of section 410.78(a)(3) of tioner otherwise practicing telemedi- title 42, Code of Federal Regulations. cine within the meaning of this para- (k) The term refilling prescriptions for graph is unable to provide care or con- controlled substances in Schedule III, IV, sultation; and or V: (D) That requires immediate inter- (1) Means the dispensing of a convention by a health care practitioner trolled substance in Schedule III, IV, or using controlled substances to prevent V in accordance with refill instructions what the practitioner reasonably be- issued by a practitioner as part of a lieves in good faith will be imminent valid prescription that meets the re- and serious clinical consequences, such quirements of subsections (b) and (c) of as further injury or death; and section 309 of the Act (21 U.S.C. 829) (ii) By a practitioner that: and §§ 1306.21 and 1306.22 of this chapter, (A) Is an employee or contractor of as appropriate; and the Veterans Health Administration (2) Does not include the issuance of a acting within the scope of that employ- new prescription to an individual for a ment or contract; controlled substance that individual (B) Is registered under section 303(f) of the Act (21 U.S.C. 823(f)) in any State was previously prescribed. or is utilizing the registration of a hos- (l)(1) The term valid prescription pital or clinic operated by the Depart- means a prescription that is issued for ment of Veterans Affairs registered a legitimate medical purpose in the under section 303(f); and usual course of professional practice (C) Issues a controlled substance pre- by: scription in this emergency context (i) A practitioner who has conducted that is limited to a maximum of a five- at least one in-person medical evalua- day supply which may not be extended tion of the patient; or or refilled; or (ii) A covering practitioner. (7) Other circumstances specified by reg- (2) Nothing in this paragraph (l) shall ulation. The practice of telemedicine is be construed to imply that one in-per- being conducted under any other cir- son medical evaluation demonstrates cumstances that the Administrator that a prescription has been issued for and the Secretary of Health and a legitimate medical purpose within Human Services have jointly, by regu- the usual course of professional prac- lation, determined to be consistent tice. with effective controls against diversion and otherwise consistent with the [74 FR 15619, Apr. 6, 2009] public health and safety. (j) Temporary definition of practice of telemedicine. Prior to January 15, 2010, or as otherwise specified by regulation prior to that date, instead of the defini-

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PART 1301—REGISTRATION OF 1301.33 Application for bulk manufacture of Schedule I and II substances. MANUFACTURERS, DISTRIBUTORS, 1301.34 Application for importation of AND DISPENSERS OF CON- Schedule I and II substances. TROLLED SUBSTANCES 1301.35 Certificate of registration; denial of registration. GENERAL INFORMATION 1301.36 Suspension or revocation of registration; suspension of registration pending Sec. final order; extension of registration 1301.01 Scope of this part 1301. pending final order. 1301.02 Definitions. 1301.37 Order to show cause. 1301.03 Information; special instructions. HEARINGS REGISTRATION 1301.11 Persons required to register; require- 1301.41 Hearings generally. ment of modification of registration au- 1301.42 Purpose of hearing. thorizing activity as an online phar- 1301.43 Request for hearing or appearance; macy. waiver. 1301.12 Separate registrations for separate 1301.44 Burden of proof. locations. 1301.45 Time and place of hearing. 1301.13 Application for registration; time 1301.46 Final order. for application; expiration date; registration for independent activities; applica- MODIFICATION, TRANSFER, AND TERMINATION tion forms, fees, contents and signature; OF REGISTRATION coincident activities. 1301.51 Modification in registration. 1301.14 Filing of application; acceptance for filing; defective applications. 1301.52 Termination of registration; transfer 1301.15 Additional information. of registration; distribution upon dis- 1301.16 Amendments to and withdrawal of continuance of business. applications. SECURITY REQUIREMENTS 1301.17 Special procedures for certain applications. 1301.71 Security requirements generally. 1301.18 Research protocols. 1301.72 Physical security controls for non- 1301.19 Special requirements for online practitioners; narcotic treatment pro- pharmacies. grams and compounders for narcotic treatment programs; storage areas. EXCEPTIONS TO REGISTRATION AND FEES 1301.73 Physical security controls for non- 1301.21 Exception from fees. practitioners; compounders for narcotic 1301.22 Exemption of agents and employees; treatment programs; manufacturing and affiliated practitioners. compounding areas. 1301.23 Exemption of certain military and 1301.74 Other security controls for non- other personnel. practitioners; narcotic treatment pro- 1301.24 Exemption of law enforcement offi- grams and compounders for narcotic cials. treatment programs. 1301.25 Registration regarding ocean ves- 1301.75 Physical security controls for prac- sels, aircraft, and other entities. titioners. 1301.26 Exemptions from import or export 1301.76 Other security controls for practi- requirements for personal medical use. tioners. 1301.27 Separate registration by retail phar- 1301.77 Security controls for freight for- macies for installation and operation of warding facilities. automated dispensing systems at long term care facilities. EMPLOYEE SCREENING—NON-PRACTITIONERS 1301.28 Exemption from separate registration for practitioners dispensing or pre- 1301.90 Employee screening procedures. scribing Schedule III, IV, or V narcotic 1301.91 Employee responsibility to report controlled drugs approved by the Food drug diversion. and Drug Administration specifically for 1301.92 Illicit activities by employees. use in maintenance or detoxification 1301.93 Sources of information for employee treatment. checks.

ACTION ON APPLICATION FOR REGISTRATION: AUTHORITY: 21 U.S.C. 821, 822, 823, 824, 831, REVOCATION OR SUSPENSION OF REGISTRATION 871(b), 875, 877, 886a, 951, 952, 953, 956, 957, 958.

1301.31 Administrative review generally. SOURCE: 36 FR 7778, Apr. 24, 1971, unless 1301.32 Action on applications for research otherwise noted. Redesignated at 38 FR 26609, in Schedule I substances. Sept. 24, 1973.

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GENERAL INFORMATION (b) As provided in sections 303(f) and 401(h) of the Act (21 U.S.C. 823(f) and § 1301.01 Scope of this part 1301. 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 sec- § 1300.04(h) of this chapter) to deliver, tions 301–304 and 1007–1008 of the Act (21 distribute, or dispense a controlled sub- U.S.C. 821–824 and 957–958) are set forth stance by means of the Internet if such generally by those sections and specifi- person is not validly registered with a cally by the sections of this part. 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 or this chapter). The Act further pro- Any term used in this part shall have 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 pharmacy under section 303(f) of the Act (21 [62 FR 13945, Mar. 24, 1997] U.S.C. 823(f)). Accordingly, any pharmacy registered pursuant to § 1301.13 of § 1301.03 Information; special instruc- this part that falls within the definitions. tion of an online pharmacy and pro- Information regarding procedures poses to dispense controlled substances under these rules and instructions by means of the Internet must obtain a supplementing these rules will be fur- modification of its registration author- nished upon request by writing to the izing such activity following the sub- Registration Section, Drug Enforce- mission of an application in accordance ment Administration. See the Table of with § 1301.19 of this part. This require- DEA Mailing Addresses in § 1321.01 of ment does not apply to a registered this chapter for the current mailing ad- pharmacy that does not fall within the dress. definition of an online pharmacy set [75 FR 10676, Mar. 9, 2010] forth in § 1300.04(h). Under the Act, persons other than registered pharmacies REGISTRATION are not eligible to obtain such a modification of registration but remain lia- § 1301.11 Persons required to register; ble under section 401(h) of the Act (21 requirement of modification of reg- U.S.C. 841(h)) if they deliver, dis- istration authorizing activity as an tribute, or dispense a controlled sub- online pharmacy. stance while acting as an online phar- (a) Every person who manufactures, macy without being validly registered distributes, dispenses, imports, or ex- with a modification authorizing such ports any controlled substance or who activity. proposes to engage in the manufacture, distribution, dispensing, importation [74 FR 15621, Apr. 6, 2009] or exportation of any controlled substance shall obtain a registration un- § 1301.12 Separate registrations for separate locations. less exempted by law or pursuant to §§ 1301.22 through 1301.26. Except as pro- (a) A separate registration is re- vided in paragraph (b) of this section, quired for each principal place of busi- only persons actually engaged in such ness or professional practice at one activities are required to obtain a reg- general physical location where con- istration; related or affiliated persons trolled substances are manufactured, who are not engaged in such activities distributed, imported, exported, or dis- are not required to be registered. (For pensed by a person. example, a stockholder or parent cor- (b) The following locations shall be poration of a corporation manufac- deemed not to be places where con- turing controlled substances is not re- trolled substances are manufactured, quired to obtain a registration.) distributed, or dispensed:

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(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 super- ceive written approval from the Spe- vised but which neither contains such cial Agent in Charge of the DEA Office substances (other than substances for in the area in which the freight for- display purposes or lawful distribution warding facility is operated in order to as samples only) nor serves as a discontinue operation of the facility. tribution point for filling sales orders; [62 FR 13945, Mar. 24, 1997, as amended at 65 and FR 44678, July 19, 2000; 65 FR 45829, July 25, (3) An office used by a practitioner 2000; 71 FR 69480, Dec. 1, 2006] (who is registered at another location in the same State or jurisdiction of the § 1301.13 Application for registration; United States) where controlled sub- time for application; expiration stances are prescribed but neither ad- date; registration for independent ministered nor otherwise dispensed as activities; application forms, fees, a regular part of the professional prac- contents and signature; coincident tice of the practitioner at such office, activities. and where no supplies of controlled (a) Any person who is required to be substances are maintained. registered and who is not so registered (4) A freight forwarding facility, as may apply for registration at any time. defined in § 1300.01 of this part, provided No person required to be registered that the distributing registrant oper- shall engage in any activity for which ating the facility has submitted writ- registration is required until the appli- ten notice of intent to operate the fa- cation for registration is granted and a cility by registered mail, return re- Certificate of Registration is issued by ceipt requested (or other suitable the Administrator to such person. means of documented delivery) and (b) Any person who is registered may such notice has been approved. The no- apply to be reregistered not more than tice shall be submitted to the Special 60 days before the expiration date of Agent in Charge of the Administra- his/her registration, except that a bulk tion’s offices in both the area in which manufacturer of Schedule I or II con- the facility is located and each area in trolled substances or an importer of which the distributing registrant main- Schedule I or II controlled substances tains a registered location that will may apply to be reregistered no more transfer controlled substances through than 120 days before the expiration the facility. The notice shall detail the date of their registration. registered locations that will utilize (c) At the time a manufacturer, dis- the facility, the location of the facil- tributor, reverse distributor, re- ity, the hours of operation, the indi- searcher, analytical lab, importer, ex- vidual(s) responsible for the controlled porter or narcotic treatment program substances, the security and record- is first registered, that business activ- keeping procedures that will be em- ity shall be assigned to one of twelve ployed, and whether controlled sub- groups, which shall correspond to the stances returns will be processed months of the year. The expiration through the facility. The notice must date of the registrations of all reg- also detail what state licensing re- istrants within any group will be the quirements apply to the facility and last date of the month designated for the registrant’s actions to comply with that group. In assigning any of these

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business activities to a group, the Ad- deemed to be independent of each ministration may select a group the other. Application for each registration expiration date of which is less than shall be made on the indicated form, one year from the date such business and shall be accompanied by the indi- activity was registered. If the business cated fee. Fee payments shall be made activity is assigned to a group which in the form of a personal, certified, or has an expiration date less than three cashier’s check or money order made months from the date of which the payable to the ‘‘Drug Enforcement Ad- business activity is registered, the reg- ministration’’. The application fees are istration shall not expire until one not refundable. Any person, when reg- year from that expiration date; in all istered to engage in the activities de- other cases, the registration shall ex- scribed in each subparagraph in this pire on the expiration date following paragraph, shall be authorized to en- the date on which the business activity gage in the coincident activities de- is registered. scribed without obtaining a registra- (d) At the time a retail pharmacy, tion to engage in such coincident ac- hospital/clinic, practitioner or teach- tivities, provided that, unless specifi- ing institution is first registered, that cally exempted, he/she complies with business activity shall be assigned to all requirements and duties prescribed one of twelve groups, which shall cor- by law for persons registered to engage respond to the months of the year. The in such coincident activities. Any per- expiration date of the registrations of son who engages in more than one all registrants within any group will be group of independent activities shall the last day of the month designated obtain a separate registration for each for that group. In assigning any of the group of activities, except as provided above business activities to a group, in this paragraph under coincident ac- the Administration may select a group tivities. A single registration to engage the expiration date of which is not less in any group of independent activities than 28 months nor more than 39 listed below may include one or more months from the date such business ac- controlled substances listed in the tivity was registered. After the initial schedules authorized in that group of registration period, the registration independent activities. A person reg- shall expire 36 months from the initial istered to conduct research with con- expiration date. trolled substances listed in Schedule I (e) Any person who is required to be may conduct research with any sub- registered and who is not so registered, stances listed in Schedule I for which shall make application for registration he/she has filed and had approved a re- for one of the following groups of con- search protocol. trolled substances activities, which are (1)

Application Registration Business activity Controlled sub- DEA Application fee period Coincident activities allowed stances forms ($) (years)

(i) Manufacturing Schedules I–V ... New–225 Re- $3,047 1 Schedules I–V: May distribute that sub- newal–225a. stance or class for which registration was issued; may not distribute or dispose of 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 Re- 1,523 1 newal–225a. (iii) Reverse dis- Schedules I–V ... New–225 Re- 1,523 1 tributing. newal–225a.

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Application Registration Business activity Controlled sub- DEA Application fee period Coincident activities allowed stances forms ($) (years)

(iv) Dispensing or Schedules II–V .. New–224 Re- 731 3 May conduct research and instructional instructing (in- newal–224a. activities with those substances for cludes Practi- which registration was granted, ex- tioner, Hospital/ cept that a mid-level practitioner may Clinic, Retail conduct such research only to the Pharmacy, extent expressly authorized under Central fill phar- state statute. A pharmacist may macy, Teaching manufacture an aqueous or oleagi- Institution). nous solution or 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. (v) Research ...... Schedule I ...... New–225 Re- 244 1 A researcher may manufacture or im- newal–225a. 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 Re- 244 1 May conduct chemical analysis with newal–225a. 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. (vii) Narcotic Narcotic Drugs in New–363 Re- 244 1 Treatment Pro- Schedules II–V. newal–363a. gram (including compounder). (viii) Importing ..... Schedules I–V ... New–225 Re- 1,523 1 May distribute that substance or class newal–225a. for which registration was issued; may not distribute any substance or class for which not registered. (ix) Exporting ...... Schedules I–V ... New–225 Re- 1,523 1 newal–225a.

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Application Registration Business activity Controlled sub- DEA Application fee period Coincident activities allowed stances forms ($) (years)

(x) Chemical Schedules I–V ... New–225 Re- 244 1 May manufacture and import controlled Analysis. newal–225a. 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 Registration as an importer or ex- be obtained at any area office of the porter shall not entitle a registrant to Administration or by writing to the import or export any controlled sub- Registration Section, Drug Enforce- stance not specified in such registra- ment Administration. See the Table of tion. DEA Mailing Addresses in § 1321.01 of (h) Each application for registration this chapter for the current mailing ad- to conduct research with any basic dress. class of controlled substance listed in (3) Registrants will receive renewal Schedule II shall include the Adminis- notifications approximately 60 days tration Controlled Substances Code prior to the registration expiration Number, as set forth in part 1308 of this date. DEA Forms 224a, 225a, and 363a chapter, for each such basic class to be may be mailed, as applicable, to reg- manufactured or imported as a coinci- istrants; if any registered person does dent activity of that registration. A not receive such notification within 45 statement listing the quantity of each days before the registration expiration such basic class of controlled substance date, the registrant must promptly to be imported or manufactured during give notice of such fact and may re- the registration period for which appli- quest such forms by writing to the cation is being made shall be included Registration Section, Drug Enforce- with each such application. For pur- ment Administration. poses of this paragraph only, manufac- (f) Each application for registration turing is defined as the production of a to handle any basic class of controlled controlled substance by synthesis, ex- substance listed in Schedule I (except traction or by agricultural/horti- to conduct chemical analysis with such cultural means. classes), and each application for reg- (i) Each application shall include all istration to manufacture a basic class information called for in the form, un- of controlled substance listed in Sched- less the item is not applicable, in ule II shall include the Administration which case this fact shall be indicated. Controlled Substances Code Number, as (j) Each application, attachment, or set forth in part 1308 of this chapter, other document filed as part of an ap- for each basic class to be covered by plication, shall be signed by the appli- such registration. cant, if an individual; by a partner of (g) Each application for registration the applicant, if a partnership; or by an to import or export controlled sub- officer of the applicant, if a corpora- stances shall include the Administra- tion, corporate division, association, tion Controlled Substances Code Num- trust or other entity. An applicant may ber, as set forth in part 1308 of this authorize one or more individuals, who chapter, for each controlled substance would not otherwise be authorized to whose importation or exportation is to do so, to sign applications for the ap- be authorized by such registration. plicant by filing with the Registration

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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 power of attorney shall be valid The Administrator may require an until revoked by the applicant. applicant to submit such documents or 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; 77 FR 15248, Mar. 15, 2012] 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 reg- [62 FR 13948, Mar. 24, 1997] istration fee and any required attachments 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 (a) An application may be amended the current mailing address. or withdrawn without permission of (b) Any person required to obtain the Administrator at any time before more than one registration may submit the date on which the applicant re- all applications in one package. Each ceives an order to show cause pursuant application must be complete and to § 1301.37. An application may be should not refer to any accompanying amended or withdrawn with permission application for required information. of the Administrator at any time (c) Applications submitted for filing where good cause is shown by the ap- are dated upon receipt. If found to be plicant or where the amendment or complete, the application will be ac- withdrawal is in the public interest. cepted for filing. Applications failing (b) After an application has been ac- to comply with the requirements of cepted for filing, the request by the ap- this part will not generally be accepted plicant that it be returned or the fail- for filing. In the case of minor defects ure of the applicant to respond to offi- as to completeness, the Administrator cial correspondence regarding the ap- may accept the application for filing plication, when sent by registered or with a request to the applicant for ad- certified mail, return receipt re- ditional information. A defective appli- quested, shall be deemed to be a with- cation will be returned to the applicant drawal of the application. within 10 days following its receipt with a statement of the reason for not [62 FR 13949, Mar. 24, 1997] accepting the application for filing. A defective application may be corrected § 1301.17 Special procedures for cer- and resubmitted for filing at any time; tain applications. the Administrator shall accept for fil- (a) If, at the time of application for ing any application upon resubmission registration of a new pharmacy, the by the applicant, whether complete or pharmacy has been issued a license not. from the appropriate State licensing (d) Accepting an application for fil- agency, the applicant may include with ing does not preclude any subsequent his/her application an affidavit as to request for additional information pur- the existence of the State license in suant to § 1301.15 and has no bearing on the following form:

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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. by the partner, or other position) of llllll llllllllll (Board of Pharmacy of llllllllll (Corporation, partner- 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 (2) That said company is acquiring the llll by the llllllll (Board of Pharmacy or Licensing Agency) of the State pharmacy business of llllllllll (Name of Seller) doing business of llllll on llllll (Date). 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 This statement is submitted in order U.S.C. 843, the penalties for conviction of to obtain a Drug Enforcement Admin- which include imprisonment for up to 4 istration registration number. years, a fine of not more than $30,000 or both. llllllllllllllllllllllll I understand that if a DEA registration Signature (Person who signs Application for number is issued, the pharmacy may acquire Registration) controlled substances but may not dispense State of lllllllllllllllllll them until a pharmacy permit or license is County of llllllllllllllllll issued by the State board of pharmacy or li- Subscribed to and sworn before me this censing agency. lllllll day of lllllll, 19ll. I understand that if any information is llllllllllllllllllllllll false, the Administration may immediately Notary Public 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 health and safety. I further understand that person to another, if the transferee any false information contained in this affi- owns at least one other pharmacy li- davit may subject me personally to prosecu- censed in the same State as the one the tion under 21 U.S.C. 843, the penalties for ownership of which is being trans- conviction of which include imprisonment ferred, the transferee may apply for for up to 4 years, a fine of not more than registration prior to the date of trans- $30,000 or both. fer. The Administrator may register llllllllllllllllllllllll the applicant and authorize him to ob- Signature (Person who signs Application for tain controlled substances at the time Registration) of transfer. Such registration shall not State of lllllllllllllllllll County of authorize the transferee to dispense llllllllllllllllll Subscribed to and sworn before me this controlled substances until the phar- llllllll day of lllllllll, macy has been issued a valid State li- 19ll. cense. The transferee shall include llllllllllllllllllllllll with his/her application the following Notary Public affidavit: (c) If at the time of application for a Affidavit for Transfer of Pharmacy separate registration at a long term care facility, the retail pharmacy has I, llllllllll, the llllllllll (Title of officer, official, been issued a license, permit, or other partner or other position) of form of authorization from the appro- llllllllll (Corporation, partner- priate State agency to install and oper- ship, or sole proprietor), doing business as ate an automated dispensing system

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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. (i) The affidavit is submitted to ob- (ii) Institutional affiliation. tain a Drug Enforcement Administra- (iii) Qualifications, including a cur- tion registration number; riculum vitae and an appropriate bibli- (ii) If any material information is ography (list of publications). false, the Administrator may com- (2) Research project: mence proceedings to deny the applica- (i) Title of project. tion under section 304 of the Act (21 (ii) Statement of the purpose. U.S.C. 824(a)); (iii) Name of the controlled sub- (iii) Any false or fraudulent material stances or substances involved and the information contained in this affidavit amount of each needed. may subject the person signing this af- (iv) Description of the research to be fidavit and the above-named corpora- conducted, including the number and tion/partnership/business to prosecu- species of research subjects, the dosage tion under section 403 of the Act (21 to be administered, the route and U.S.C. 843); method of administration, and the du- (8) Signature of the person author- ration of the project. ized to sign the Application for Reg- (v) Location where the research will istration for the named retail phar- be conducted. macy; (vi) Statement of the security provi- (9) Notarization of the affidavit. sions for storing the controlled sub- (d) The Administrator shall follow stances (in accordance with § 1301.75) the normal procedures for approving an and for dispensing the controlled sub- application to verify the statements in stances in order to prevent diversion.

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(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 shall indicate that such notice has (c) of this section), he/she shall submit been submitted to the Food and Drug three copies of a supplemental protocol Administration by submitting to the in accordance with paragraph (a) of Administration with his/her DEA Form this section describing the new re- 225 three copies of the following certifi- search and omitting information in the cate: supplemental protocol which has been stated in the original protocol. Supple- I hereby certify that on llllllllll mental protocols shall be processed and (Date), pursuant to 21 U.S.C. 355(i) and 21 CFR 130.3, I, llllllllll (Name and approved or denied in the same manner Address of IND Sponsor) submitted a Notice as original research protocols. of Claimed Investigational Exemption for a [62 FR 13949, Mar. 24, 1997, as amended at 75 New Drug (IND) to the Food and Drug Ad- FR 10676, Mar. 9, 2010] ministration for: llllllllllllllllllllllll § 1301.19 Special requirements for on- (Name of Investigational Drug). line pharmacies. llllllllllllllllllllllll (a) A pharmacy that has been issued (Date) a registration under § 1301.13 may re- llllllllllllllllllllllll quest that the Administrator modify (Signature of Applicant). its registration to authorize the phar- (c) In the event that the registrant macy to dispense controlled substances desires to increase the quantity of a by means of the Internet as an online controlled substance used for an ap- pharmacy. The Administrator may proved research project, he/she shall deny an application for a modification

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of registration if the Administrator de- until the application for such modified termines that the issuance of a modi- registration is granted and an active fication would be inconsistent with the Certificate of Registration indicating public interest. In determining the the modification of the registration public interest, the Administrator will has been issued by the Administrator consider the factors listed in section to such person. 303(f) of the Act (21 U.S.C. 823(f)). (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 § 1301.21 Exemption from fees. State to which it, delivers, distributes, 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 which is operated by an agency of the controlled substances by means of the United States (including the U.S. Internet will be made by an online ap- Army, Navy, Marine Corps., Air Force, plication process as specified in § 1301.13 and Coast Guard), of any State, or any of this part. Subsequent online phar- political subdivision or agency thereof. macy registration renewals will be ac- (2) Any individual practitioner who is complished by an online process. required to obtain an individual reg- (d) A pharmacy that seeks to dis- istration in order to carry out his or continue its modification of registra- her duties as an official of an agency of tion authorizing it to dispense con- the United States (including the U.S. trolled substances by means of the Army, Navy, Marine Corps, Air Force, Internet as an online pharmacy (but and Coast Guard), of any State, or any continue its business activity as a non- political subdivision or agency thereof. online pharmacy) shall so notify the 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 Internet. A pharmacy that has so the registrant is an individual) or offi- changed its registration status back to cer (if the registrant is an agency) cer- that of a non-online pharmacy remains tifies to the status and address of the responsible for submitting reports in registrant and to the authority of the accordance with § 1304.55 of this chapter registrant to acquire, possess, or han- with respect to any controlled sub- dle controlled substances. stances that it dispensed while it was (c) Exemption from payment of a reg- registered with a modification author- istration or reregistration application izing it to operate as an online phar- fee does not relieve the registrant of macy. any other requirements or duties pre- (e) Registrants applying for modified scribed by law. registrations under this section must comply with notification and reporting [62 FR 13950, Mar. 24, 1997] requirements set forth in §§ 1304.40, 1304.45, 1304.50, and 1304.55 of this chap- § 1301.22 Exemption of agents and employees; affiliated practitioners. ter. (f) No person (including a registrant) (a) The requirement of registration is required to obtain a modification of a waived for any agent or employee of a registration under §§ 1301.11(b) and person who is registered to engage in 1301.13 of this part authorizing it to op- any group of independent activities, if erate as an online pharmacy may en- such agent or employee is acting in the gage in any activity for which such usual course of his/her business or em- modification of registration is required ployment.

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(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. minister, or prescribe drugs within the (c) If any official exempted by this jurisdiction; section also engages as a private indi- (4) Such individual practitioner is vidual in any activity or group of ac- acting only within the scope of his/her tivities for which registration is re- employment in the hospital or institu- quired, such official shall obtain a reg- tion; istration for such private activities. (5) The hospital or other institution authorizes the individual practitioner [62 FR 13951, Mar. 24, 1997] to administer, dispense or prescribe under the hospital registration and § 1301.24 Exemption of law enforce- designates a specific internal code ment officials. number for each individual practi- (a) The requirement of registration is tioner so authorized. The code number waived for the following persons in the shall consist of numbers, letters, or a circumstances described in this sec- combination thereof and shall be a suf- tion: fix to the institution’s DEA registra- (1) Any officer or employee of the Ad- tion number, preceded by a hyphen ministration, any officer of the U.S. (e.g., APO123456–10 or APO123456–A12); Customs Service, any officer or em- and ployee of the United States Food and (6) A current list of internal codes Drug Administration, and any other and the corresponding individual prac- Federal officer who is lawfully engaged titioners is kept by the hospital or in the enforcement of any Federal law other institution and is made available relating to controlled substances,

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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 their official duties, are deemed to be (3) Registered under the Act at either officials exempted by this section and of the following locations: within the activity described in section (i) The principal office of the owner 515(d) of the Act (21 U.S.C. 885(d)). For or operator of the vessel, aircraft or purposes of this paragraph, laboratory other entity or activities shall not include field or (ii) At any other location provided other preliminary chemical tests by of- that the name, address, registration ficials exempted by this section. number and expiration date as they ap- (d) In addition to the activities au- pear on his/her Certificate of Registra- thorized under a registration to con- tion (DEA Form 223) for this location duct chemical analysis pursuant to are maintained for inspection at said § 1301.13(e)(1)(ix), laboratories of the principal office in a readily retrievable Administration shall be authorized to manner. manufacture or import controlled sub- (c) A registered medical officer may stances for any lawful purpose, to dis- serve as medical officer for more than tribute or export such substances to one vessel, aircraft, or other entity any person, and to import and export under a single registration, unless he/ such substances in emergencies with- she serves as medical officer for more out regard to the requirements of part than one owner or operator, in which 1312 of this chapter if a report con- case he/she shall either maintain a sep- cerning the importation or exportation arate registration at the location of is made to the Drug Operations Section the principal office of each such owner

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or operator or utilize one or more reg- of the vessel, the port at which the ves- istrations pursuant to paragraph sel is located, signature of the vessel’s (b)(3)(ii) of this section. officer who is ordering the controlled (d) If no medical officer is employed substances and the date of the requisi- by the owner or operator of a vessel, or tion. in the event such medical officer is not (3) The vendor may, after verifying accessible and the acquisition of con- the identification of the vessel’s officer trolled substances is required, the mas- requisitioning the controlled sub- ter or first officer of the vessel, who stances, deliver the control substances shall not be registered under the Act, to that officer. The transaction shall may purchase controlled substances be documented, in triplicate, on a from a registered manufacturer or dis- record of sale in a format similar to tributor, or from an authorized phar- that outlined in paragraph (d)(4) of this macy as described in paragraph (f) of section. The vessel’s requisition shall this section, by following the procedure be attached to copy 1 of the record of outlined below: sale and filed with the controlled sub- (1) The master or first officer of the stances records of the vendor, copy 2 of vessel must personally appear at the the record of sale shall be furnished to vendor’s place of business, present the officer of the vessel and retained proper identification (e.g., Seaman’s aboard the vessel, copy 3 of the record photographic identification card) and a of sale shall be forwarded to the near- written requisition for the controlled est DEA Division Office within 15 days substances. after the end of the month in which the (2) The written requisition must be sale is made. on the vessel’s official stationery or (4) The vendor’s record of sale should purchase order form and must include be similar to, and must include all the the name and address of the vendor, information contained in, the below the name of the controlled substance, listed format. description of the controlled substance (dosage form, strength and number or SALE OF CONTROLLED SUBSTANCES TO VESSELS volume per container) number of containers ordered, the name of the vessel, (Name of registrant) llllllllllll the vessel’s official number and coun- (Address of registrant) lllllllllll try of registry, the owner or operator (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 aircraft, or other entity, and a sum- Name of vessel lllllllllllllll mary accounting for all vessels, air- Vessel’s official number lllllllllll craft, or other entities under his/her Vessel’s country of registry lllllllll Owner or operator of the vessel lllllll supervision for all controlled sub- Name and title of vessel’s officer who pre- stances purchased, dispensed or dis- sented the requisition llll posed of during the year. The medical Signature of vessel’s officer who presented officer shall maintain this report with the requisition llll other records required to be kept under (e) Any medical officer described in the Act and, upon request, deliver a paragraph (b) of this section shall, in copy of the report to the Administra- addition to complying with all require- tion. The medical officer need not be ments and duties prescribed for reg- present when controlled substances are istrants generally, prepare an annual dispensed, if the person who actually report as of the date on which his/her dispensed the controlled substances is registration expires, which shall give responsible to the medical officer to in detail an accounting for each vessel, justify his/her actions.

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(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 § 1301.26 Exemptions from import or the nearest Division Office of the Ad- 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 vention on Psychotropic Substances, and address of the pharmacy or practi- 1971, shall not be deemed to import or tioner who dispensed the substance and export any controlled substances pur- the prescription number. chased and stored in accordance with (c) In addition to (and not in lieu of) that section or applicable article. the foregoing requirements of this sec- (h) The Master of a vessel shall pre- tion, a United States resident may im- pare a report for each calendar year port into the United States no more which shall give in detail an account- than 50 dosage units combined of all ing for all controlled substances pur- such controlled substances in the indi- chased, dispensed, or disposed of during vidual’s possession that were obtained the year. The Master shall file this re- abroad for personal medical use. (For port with the medical officer employed purposes of this section, a United by the owner or operator of his/her ves- States resident is a person whose resi- sel, if any, or, if not, he/she shall main- dence (i.e., place of general abode— tain this report with other records re- meaning one’s principal, actual dwell- quired to be kept under the Act and, ing place in fact, without regard to in- upon request, deliver a copy of the re- tent) is in the United States.) This 50 port to the Administration. dosage unit limitation does not apply (i) Controlled substances acquired to controlled substances lawfully ob- and possessed in accordance with this tained in the United States pursuant to section shall not be distributed to per- a prescription issued by a DEA reg- sons not under the general supervision istrant. of the medical officer employed by the owner or operator of the vessel, air- [69 FR 55347, Sept. 14, 2004]

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§ 1301.27 Separate registration by re- tions specified in paragraph (c) of this tail pharmacies for installation and section. operation of automated dispensing (3) The individual practitioner is in systems at long term care facilities. compliance with either paragraph (d) (a) A retail pharmacy may install or paragraph (e) of this section. and operate automated dispensing sys- (b)(1) The individual practitioner tems, as defined in § 1300.01 of this must submit notification to the Sec- chapter, at long term care facilities, retary of Health and Human Services under the requirements of § 1301.17. No stating the individual practitioner’s in- person other than a registered retail tent to dispense or prescribe narcotic pharmacy may install and operate an drugs under paragraph (a) of this sec- automated dispensing system at a long tion. The notice must contain all of the term care facility. following certifications: (b) Retail pharmacies installing and (i) The individual practitioner is reg- operating automated dispensing sys- istered under § 1301.13 as an individual tems at long term care facilities must practitioner and is a ‘‘qualifying physician’’ as defined in section 303(g)(2)(G) maintain a separate registration at the of the Act (21 U.S.C. 823(g)(2)(G)). location of each long term care facility (ii) The individual practitioner has at which automated dispensing sys- the capacity to refer the patients to tems are located. If more than one reg- whom the individual practitioner will istered retail pharmacy operates auto- provide narcotic drugs or combinations mated dispensing systems at the same of narcotic drugs for appropriate coun- long term care facility, each retail seling and other appropriate ancillary pharmacy must maintain a registra- services. tion at the long term care facility. (iii) The total number of patients to (c) A registered retail pharmacy ap- whom the individual practitioner will plying for a separate registration to provide narcotic drugs or combinations operate an automated dispensing sys- of narcotic drugs under this section tem for the dispensing of controlled will not exceed 30 at any one time un- substances at a long term care facility less, not sooner than 1 year after the is exempt from application fees for any date on which the practitioner sub- such additional registrations. mitted the initial notification to the [70 FR 25465, May 13, 2005] Secretary of Health and Human Serv- ices, the practitioner submits a second § 1301.28 Exemption from separate notification to the Secretary of the registration for practitioners dis- need and intent of the practitioner to pensing or prescribing Schedule III, treat up to 100 patients. A second noti- IV, or V narcotic controlled drugs fication under this subparagraph shall approved by the Food and Drug Ad- contain the certifications required by ministration specifically for use in subparagraphs (i) and (ii) of this para- maintenance or detoxification treatment. graph. The Secretary of Health and Human Services may promulgate regu- (a) An individual practitioner may lations to change the total number of dispense or prescribe Schedule III, IV, patients. or V narcotic controlled drugs or com- (2) If an individual practitioner wish- binations of narcotic controlled drugs es to prescribe or dispense narcotic which have been approved by the Food drugs pursuant to paragraph (e) of this and Drug Administration (FDA) spe- section, the individual practitioner cifically for use in maintenance or de- must provide the Secretary of Health toxification treatment without obtain- and Human Services the following: ing the separate registration required (i) Notification as required under by § 1301.13(e) if all of the following con- paragraph (b)(1) of this section in writ- ditions are met: ing, stating the individual practi- (1) The individual practitioner meets tioner’s name and DEA registration the conditions specified in paragraph number issued under § 1301.13. (b) of this section. (ii) If the individual practitioner is a (2) The narcotic drugs or combina- member of a group practice, the names tion of narcotic drugs meet the condi- of the other individual practitioners in

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the group and the DEA registration number, or will withdraw the identi- numbers issued to the other individual fication number if one has been issued. practitioners under § 1301.13. (3) The individual practitioner must (c) The narcotic drugs or combina- include the identification number on tion of narcotic drugs to be dispensed all records when dispensing and on all or prescribed under this section must prescriptions when prescribing narcotic meet all of the following conditions: drugs under this section. (1) The drugs or combination of drugs (e) An individual practitioner may have been approved for use in ‘‘main- begin to prescribe or dispense narcotic tenance treatment’’ or ‘‘detoxification drugs to a specific individual patient treatment’’ under the Federal Food, under this section before receiving an Drug, and Cosmetic Act or section 351 identification number from the Admin- of the Public Health Service Act. istrator if the following conditions are (2) The drugs or combination of drugs met: have not been the subject of an adverse (1) The individual practitioner has determination by the Secretary of submitted a written notification under Health and Human Services, after con- paragraph (b) of this section in good sultation with the Attorney General, faith to the Secretary of Health and that the use of the drugs or combina- Human Services. tion of drugs requires additional stand- (2) The individual practitioner rea- ards respecting the qualifications of sonably believes that the conditions practitioners or the quantities of the specified in paragraphs (b) and (c) of drugs that may be provided for unsu- this section have been met. pervised use. (3) The individual practitioner rea- (d)(1) After receiving the notification sonably believes that the treatment of submitted under paragraph (b) of this an individual patient would be facili- section, the Secretary of Health and tated if narcotic drugs are prescribed Human Services will forward a copy of or dispensed under this section before the notification to the Administrator. the sooner of: The Secretary of Health and Human (i) Receipt of an identification num- Services will have 45 days from the ber from the Administrator, or date of receipt of the notification to (ii) Expiration of the 45-day period. make a determination of whether the (4) The individual practitioner has individual practitioner involved meets notified both the Secretary of Health all requirements for a waiver under and Human Services and the Adminis- section 303(g)(2)(B) of the Act (21 U.S.C. trator of his or her intent to begin pre- 823(g)(2)(B)). Health and Human Serv- scribing or dispensing the narcotic ices will notify DEA of its determina- drugs before expiration of the 45-day tion regarding the individual practi- period. tioner. If the individual practitioner (5) The Secretary has not notified the has the appropriate registration under registrant that he/she is not qualified § 1301.13, then the Administrator will under paragraph (d) of this section. issue the practitioner an identification number as soon as one of the following (6) The individual practitioner has conditions occurs: the appropriate registration under (i) The Administrator receives a posi- § 1301.13. tive determination from the Secretary (f) If an individual practitioner dis- of Health and Human Services before penses or prescribes Schedule III, IV, or the conclusion of the 45-day review pe- V narcotic drugs approved by the Food riod, or and Drug Administration specifically (ii) The 45-day review period has con- for maintenance or detoxification cluded and no determination by the treatment in violation of any of the Secretary of Health and Human Serv- conditions specified in paragraphs (b), ices has been made. (c) or (e) of this section, the Adminis- (2) If the Secretary denies certifi- trator may revoke the individual prac- cation to an individual practitioner or titioner’s registration in accordance withdraws such certification once it is with § 1301.36. issued, then DEA will not issue the in- [70 FR 36342, June 23, 2005, as amended at 73 dividual practitioner an identification FR 29688, May 22, 2008]

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ACTION ON APPLICATION FOR REGISTRA- the research protocol meritorious, he/ TION: REVOCATION OR SUSPENSION OF she shall notify the Administrator in REGISTRATION writing of such determination. The Ad- ministrator shall issue a certificate of § 1301.31 Administrative review gen- registration within 10 days after re- erally. ceipt of this notice, unless he/she deter- The Administrator may inspect, or mines that the certificate of registra- cause to be inspected, the establish- tion should be denied on a ground spec- ment of an applicant or registrant, pur- ified in section 304(a) of the Act (21 suant to subpart A of part 1316 of this U.S.C. 824(a)). In the case of a supple- chapter. The Administrator shall re- mental protocol, a replacement certifi- view the application for registration cate of registration shall be issued by and other information gathered by the the Administrator. Administrator regarding an applicant (d) If the Secretary determines that in order to determine whether the ap- the protocol is not meritorious and/or plicable standards of section 303 (21 the applicant is not qualified or com- U.S.C. 823) or section 1008 (21 U.S.C. 958) petent, he/she shall notify the Adminis- of the Act have been met by the appli- trator in writing setting forth the rea- cant. sons for such determination. If the Ad- ministrator determines that grounds [62 FR 13953, Mar. 24, 1997] exist for the denial of the application, § 1301.32 Action on applications for re- he/she shall within 10 days issue an search in Schedule I substances. order to show cause pursuant to (a) In the case of an application for § 1301.37 and, if requested by the appli- registration to conduct research with cant, hold a hearing on the application controlled substances listed in Sched- pursuant to § 1301.41. If the grounds for ule I, the Administrator shall process denial of the application include a de- the application and protocol and for- termination by the Secretary, the Sec- ward a copy of each to the Secretary of retary or his duly authorized agent Health and Human Services (Secretary) shall furnish testimony and documents within 7 days after receipt. The Sec- pertaining to his determination at such retary shall determine the qualifica- hearing. tions and competency of the applicant, (e) Supplemental protocols will be as well as the merits of the protocol processed in the same manner as origi- (and shall notify the Administrator of nal research protocols. If the proc- his/her determination) within 21 days essing of an application or research after receipt of the application and protocol is delayed beyond the time complete protocol, except that in the limits imposed by this section, the ap- case of a clinical investigation, the plicant shall be so notified in writing. Secretary shall have 30 days to make [62 FR 13953, Mar. 24, 1997] such determination and notify the Ad- ministrator. The Secretary, in deter- § 1301.33 Application for bulk manu- mining the merits of the protocol, shall facture of Schedule I and II sub- consult with the Administrator as to stances. effective procedures to safeguard ade- (a) In the case of an application for quately against diversion of such con- registration or reregistration to manu- trolled substances from legitimate facture in bulk a basic class of con- medical or scientific use. trolled substance listed in Schedule I (b) An applicant whose protocol is de- or II, the Administrator shall, upon the fective shall be notified by the Sec- filing of such application, publish in retary within 21 days after receipt of the FEDERAL REGISTER a notice naming such protocol from the Administrator the applicant and stating that such ap- (or in the case of a clinical investiga- plicant has applied to be registered as tion within 30 days), and he/she shall be a bulk manufacturer of a basic class of requested to correct the existing de- narcotic or nonnarcotic controlled sub- fects before consideration shall be stance, which class shall be identified. given to his/her submission. A copy of said notice shall be mailed (c) If the Secretary determines the simultaneously to each person reg- applicant qualified and competent and istered as a bulk manufacturer of that

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basic class and to any other applicant person may participate in the hearing therefor. Any such person may, within by filing a notice of appearance in ac- 60 days from the date of publication of cordance with § 1301.43 of this chapter. the notice in the FEDERAL REGISTER, Notice of the hearing shall contain a file with the Administrator written summary of all comments and objec- comments on or objections to the tions filed regarding the application issuance of the proposed registration. 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 952(a)(2)(B)), the Administrator shall, importation and bulk manufacture of upon the filing of such application, such controlled substances to a number publish in the FEDERAL REGISTER a no- of establishments which can produce tice naming the applicant and stating an adequate and uninterrupted supply that such applicant has applied to be of these substances under adequately registered as an importer of a Schedule competitive conditions for legitimate I or II controlled substance, which sub- medical, scientific, research, and instance shall be identified. A copy of dustrial purposes; said notice shall be mailed simulta- (2) Compliance with applicable State neously to each person registered as a and local law; bulk manufacturer of that controlled (3) Promotion of technical advances substance and to any other applicant in the art of manufacturing these sub- therefor. Any such person may, within stances and the development of new 30 days from the date of publication of substances; the notice in the FEDERAL REGISTER, (4) Prior conviction record of appli- file written comments on or objections cant under Federal and State laws re- to the issuance of the proposed reg- lating to the manufacture, distribu- istration, and may, at the same time, tion, or dispensing of such substances; file a written request for a hearing on (5) Past experience in the manufac- the application pursuant to § 1301.43. If ture of controlled substances, and the a hearing is requested, the Adminis- existence in the establishment of effec- trator shall hold a hearing on the ap- tive control against diversion; plication in accordance with § 1301.41. (6) That the applicant will be per- Notice of the hearing shall be published mitted to import only: in the FEDERAL REGISTER, and shall be (i) Such amounts of crude opium, mailed simultaneously to the applicant poppy straw, concentrate of poppy and to all persons to whom notice of straw, and coca leaves as the Adminis- the application was mailed. Any such trator finds to be necessary to provide

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for medical, scientific, or other legiti- ufacturers for shares of the domestic mate purposes; or market including: (ii) Such amounts of any controlled (i) Shifts in market shares and substances listed in Schedule I or II as (ii) Shifts in individual customers the Administrator shall find to be nec- among domestic manufacturers; essary to provide for the medical, sci- (3) The existence of substantial dif- entific, or other legitimate needs of the ferentials between domestic prices and United States during an emergency in the higher of prices generally pre- which domestic supplies of such sub- vailing in foreign markets or the prices stances are found by the Administrator at which the applicant for registration to be inadequate; or (iii) Such amounts of any controlled to import is committed to undertake substance listed in Schedule I or II as to provide such products in the domes- the Administrator shall find to be nec- tic market in conformity with the Act. essary to provide for the medical, sci- In determining the existence of sub- entific, or other legitimate needs of the stantial differentials hereunder, appro- United States in any case in which the priate consideration should be given to Administrator finds that competition any additional costs imposed on domes- among domestic manufacturers of the tic manufacturers by the requirements controlled substance is inadequate and of the Act and such other cost-related will not be rendered adequate by the and other factors as the Administrator registration of additional manufactur- may deem relevant. In no event shall ers under section 303 of the Act (21 an importer’s offering prices in the U.S.C. 823); or United States be considered if they are (iv) Such limited quantities of any lower than those prevailing in the for- controlled substance listed in Schedule eign market or markets from which I or II as the Administrator shall find the importer is obtaining his/her sup- to be necessary for scientific, analyt- ply; ical or research uses; and (4) The existence of competitive re- (7) Such other factors as may be rel- straints imposed upon domestic manu- evant to and consistent with the public facturers by governmental regulations; health and safety. and (c) In determining whether the applicant can and will maintain effective (5) Such other factors as may be rel- controls against diversion within the evant to the determinations required meaning of paragraph (b) of this sec- under this paragraph. tion, the Administrator shall consider (e) In considering the scope of the do- among other factors: mestic market, consideration shall be (1) Compliance with the security re- given to substitute products which are quirements set forth in §§ 1301.71– reasonably interchangeable in terms of 1301.76; and price, quality and use. (2) Employment of security proce- (f) The fact that the number of exist- dures to guard against in-transit losses ing manufacturers is small shall not within and without the jurisdiction of demonstrate, in and of itself, that ade- the United States. quate competition among them does (d) In determining whether competi- not exist. tion among the domestic manufacturers of a controlled substance is ade- [62 FR 13953, Mar. 24, 1997] quate within the meaning of paragraphs (b)(1) and (b)(6)(iii) of this sec- § 1301.35 Certificate of registration; tion, as well as section 1002(a)(2)(B) of denial of registration. the Act (21 U.S.C. 952(a)(2)(B)), the Ad- (a) The Administrator shall issue a ministrator shall consider: Certificate of Registration (DEA Form (1) The extent of price rigidity in the 223) to an applicant if the issuance of light of changes in: registration or reregistration is re- (i) raw materials and other costs and quired under the applicable provisions (ii) conditions of supply and demand; of sections 303 or 1008 of the Act (21 (2) The extent of service and quality U.S.C. 823 and 958). In the event that competition among the domestic man-

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the issuance of registration or rereg- § 1301.36 Suspension or revocation of istration is not required, the Adminis- registration; suspension of registra- trator shall deny the application. Be- tion pending final order; extension fore denying any application, the Ad- of registration pending final order. ministrator shall issue an order to (a) For any registration issued under show cause pursuant to § 1301.37 and, if section 303 of the Act (21 U.S.C. 823), requested by the applicant, shall hold a the Administrator may: hearing on the application pursuant to (1) Suspend the registration pursuant § 1301.41. to section 304(a) of the Act (21 U.S.C. (b) If in response to a show cause 824(a)) for any period of time. order a hearing is requested by an ap- (2) Revoke the registration pursuant to section 304(a) of the Act (21 U.S.C. plicant for registration or reregistra- 824(a)). tion to manufacture in bulk a basic (b) For any registration issued under class of controlled substance listed in section 1008 of the Act (21 U.S.C. 958), Schedule I or II, notice that a hearing the Administrator may: has been requested shall be published (1) Suspend the registration pursuant in the FEDERAL REGISTER and shall be to section 1008(d) of the Act (21 U.S.C. mailed simultaneously to the applicant 958(d)) for any period of time. and to all persons to whom notice of (2) Revoke the registration pursuant the application was mailed. Any person to section 1008(d) of the Act (21 U.S.C. entitled to file comments or objections 958(d)) if he/she determines that such to the issuance of the proposed reg- registration is inconsistent with the istration pursuant to § 1301.33(a) may public interest as defined in section participate in the hearing by filing no- 1008 or with the United States obliga- tice of appearance in accordance with tions under international treaties, con- § 1301.43. Such persons shall have 30 ventions, or protocols in effect on Oc- days to file a notice of appearance after tober 12, 1984. the date of publication of the notice of (c) The Administrator may limit the a request for a hearing in the FEDERAL revocation or suspension of a registra- REGISTER. tion to the particular controlled sub- (c) The Certificate of Registration stance, or substances, with respect to (DEA Form 223) shall contain the which grounds for revocation or suspension exist. name, address, and registration num- (d) Before revoking or suspending ber of the registrant, the activity au- any registration, the Administrator thorized by the registration, the sched- shall issue an order to show cause pur- ules and/or Administration Controlled suant to § 1301.37 and, if requested by Substances Code Number (as set forth the registrant, shall hold a hearing in part 1308 of this chapter) of the con- pursuant to § 1301.41. trolled substances which the registrant (e) The Administrator may suspend is authorized to handle, the amount of any registration simultaneously with fee paid (or exemption), and the expira- or at any time subsequent to the serv- tion date of the registration. The reg- ice upon the registrant of an order to istrant shall maintain the certificate show cause why such registration of registration at the registered loca- should not be revoked or suspended, in tion in a readily retrievable manner any case where he/she finds that there and shall permit inspection of the cer- is an imminent danger to the public tificate by any official, agent or em- health or safety. If the Administrator ployee of the Administration or of any so suspends, he/she shall serve with the Federal, State, or local agency engaged order to show cause pursuant to in enforcement of laws relating to con- § 1301.37 an order of immediate suspen- trolled substances. sion which shall contain a statement of his findings regarding the danger to [62 FR 13954, Mar. 24, 1997] public health or safety. (f) Upon service of the order of the Administrator suspending or revoking registration, the registrant shall immediately deliver his/her Certificate of

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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 the Administration. The suspension or may extend any other existing reg- revocation of a registration, when lim- istration under the circumstances contemplated in this section even though ited to a particular basic class or class- the registrant failed to apply for rereg- es of controlled substances, shall sus- istration at least 45 days before expira- pend or revoke any individual manu- tion of the existing registration, with facturing or procurement quota fixed or without request by the registrant, if for the registrant for such class or the Administrator finds that such ex- classes pursuant to part 1303 of this tension is not inconsistent with the chapter and any import or export per- public health and safety. mits issued to the registrant for such class or classes pursuant to part 1312 of [62 FR 13955, Mar. 24, 1997] this chapter. Also, upon service of the order of the Administrator revoking or § 1301.37 Order to show cause. suspending registration, the registrant (a) If, upon examination of the appli- shall, as instructed by the Adminis- cation for registration from any appli- trator: cant and other information gathered (1) Deliver to the nearest office of the by the Administration regarding the Administration or to authorized agents applicant, the Administrator is unable of the Administration all of the par- to make the determinations required ticular controlled substance or sub- by the applicable provisions of section stances affected by the revocation or 303 and/or section 1008 of the Act (21 suspension which are in his/her posses- U.S.C. 823 and 958) to register the appli- sion; or cant, the Administrator shall serve

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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 [62 FR 13956, Mar. 24, 1997] the Administration regarding any registrant, the Administrator determines § 1301.42 Purpose of hearing. that the registration of such registrant 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, revoca- [62 FR 13956, Mar. 24, 1997] tion, or suspension of registration and a summary of the matters of fact and § 1301.43 Request for hearing or ap- law asserted. pearance; waiver. (d) Upon receipt of an order to show (a) Any person entitled to a hearing cause, the applicant or registrant pursuant to § 1301.32 or §§ 1301.34–1301.36 must, if he/she desires a hearing, file a and desiring a hearing shall, within 30 request for a hearing pursuant to days after the date of receipt of the § 1301.43. If a hearing is requested, the order to show cause (or the date of pub- Administrator shall hold a hearing at lication of notice of the application for the time and place stated in the order, registration in the FEDERAL REGISTER pursuant to § 1301.41. in the case of § 1301.34), file with the (e) When authorized by the Adminis- Administrator a written request for a trator, any agent of the Administra- hearing in the form prescribed in tion may serve the order to show § 1316.47 of this chapter. cause. (b) Any person entitled to participate [62 FR 13955, Mar. 24, 1997] in a hearing pursuant to § 1301.34 or § 1301.35(b) and desiring to do so shall, HEARINGS within 30 days of the date of publication of notice of the request for a hear- § 1301.41 Hearings generally. ing in the FEDERAL REGISTER, file with (a) In any case where the Adminis- the Administrator a written notice of trator shall hold a hearing on any reg- intent to participate in such hearing in istration or application therefor, the the form prescribed in § 1316.48 of this procedures for such hearing shall be chapter. Any person filing a request for governed generally by the adjudication a hearing need not also file a notice of procedures set forth in the Administra- appearance. tive Procedure Act (5 U.S.C. 551–559) (c) Any person entitled to a hearing and specifically by sections 303, 304, or to participate in a hearing pursuant and 1008 of the Act (21 U.S.C. 823–824 to § 1301.32 or §§ 1301.34–1301.36 may, and 958), by §§ 1301.42–1301.46 of this within the period permitted for filing a part, and by the procedures for admin- request for a hearing or a notice of ap- istrative hearings under the Act set pearance, file with the Administrator a forth in §§ 1316.41–1316.67 of this chap- waiver of an opportunity for a hearing ter. or to participate in a hearing, together (b) Any hearing under this part shall with a written statement regarding be independent of, and not in lieu of, such person’s position on the matters

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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 the opportunity for a hearing or to par- ministration shall have the burden of ticipate in the hearing, unless such proving that the requirements for such person shows good cause for such fail- revocation or suspension pursuant to ure. section 304(a) or section 1008(d) of the (e) If all persons entitled to a hearing Act (21 U.S.C. 824(a) or 958(d)) are satis- or to participate in a hearing waive or fied. 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/ her final order pursuant to § 1301.46 The hearing will commence at the without a hearing. place and time designated in the order 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 the Act (21 U.S.C. 823(a)) are satisfied. [62 FR 13956, Mar. 24, 1997] Any other person participating in the hearing pursuant to § 1301.35(b) shall § 1301.46 Final order. have the burden of proving any propo- As soon as practicable after the pre- sitions of fact or law asserted by such siding officer has certified the record person in the hearing. to the Administrator, the Adminis- (b) At any hearing on the granting or trator shall issue his/her order on the denial of an applicant to be registered granting, denial, revocation, or suspen- to conduct a narcotic treatment pro- sion of registration. In the event that gram or as a compounder, the appli- an application for registration to im- cant shall have the burden of proving port or to manufacture in bulk a basic that the requirements for each reg- class of any controlled substance listed istration pursuant to section 303(g) of in Schedule I or II is granted, or any the Act (21 U.S.C. 823(g)) are satisfied. application for registration is denied, (c) At any hearing on the granting or or any registration is revoked or sus- denial of an application to be reg- pended, the order shall include the istered to import or export any con- findings of fact and conclusions of law trolled substance listed in Schedule I upon which the order is based. The or II, the applicant shall have the bur- order shall specify the date on which it den of proving that the requirements shall take effect. The Administrator for such registration pursuant to sec- shall serve one copy of his/her order tions 1008(a) and (d) of the Act (21 upon each party in the hearing. U.S.C. 958 (a) and (d)) are satisfied. Any other person participating in the hear- [62 FR 13956, Mar. 24, 1997]

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MODIFICATION, TRANSFER AND promptly of such fact. In the case of a TERMINATION OF REGISTRATION surrender, termination shall occur upon receipt by any employee of the § 1301.51 Modification in registration. Administration of a duly executed DEA Any registrant may apply to modify form 104 or any signed writing indi- his/her registration to authorize the cating the desire to surrender a reg- handling of additional controlled sub- istration. stances or to change his/her name or (b) No registration or any authority address, by submitting a letter of re- conferred thereby shall be assigned or quest to the Registration Unit, Drug otherwise transferred except upon such Enforcement Administration. See the conditions as the Administration may Table of DEA Mailing Addresses in § 1321.01 of this chapter for the current specifically designate and then only mailing address. The letter shall con- pursuant to written consent. Any pertain the registrant’s name, address, son seeking authority to transfer a reg- and registration number as printed on istration shall submit a written re- the certificate of registration, and the quest, providing full details regarding substances and/or schedules to be added the proposed transfer of registration, to his/her registration or the new name to the Deputy Assistant Administrator, or address and shall be signed in ac- Office of Diversion Control, Drug En- cordance with § 1301.13(j). If the reg- forcement Administration. See the istrant is seeking to handle additional Table of DEA Mailing Addresses in controlled substances listed in Sched- § 1321.01 of this chapter for the current ule I for the purpose of research or in- mailing address. structional activities, he/she shall at- (c) Any registrant desiring to dis- tach three copies of a research protocol continue business activities altogether describing each research project in- or with respect to controlled sub- volving the additional substances, or stances (without transferring such two copies of a statement describing business activities to another person) the nature, extent, and duration of such instructional activities, as appro- shall return for cancellation his/her priate. No fee shall be required to be certificate of registration, and any paid for the modification. The request unexecuted order forms in his/her pos- for modification shall be handled in the session, to the Registration Unit, Drug same manner as an application for reg- Enforcement Administration. See the istration. If the modification in reg- Table of DEA Mailing Addresses in istration is approved, the Adminis- § 1321.01 of this chapter for the current trator shall issue a new certificate of mailing address. Any controlled sub- registration (DEA Form 223) to the reg- stances in his/her possession may be istrant, who shall maintain it with the disposed of in accordance with § 1307.21 old certificate of registration until ex- of this chapter. piration. (d) Any registrant desiring to dis- [75 FR 10676, Mar. 9, 2010] continue business activities altogether or with respect to controlled substance § 1301.52 Termination of registration; (by transferring such business activi- transfer of registration; distribution ties to another person) shall submit in upon discontinuance of business. person or by registered or certified (a) Except as provided in paragraph mail, return receipt requested, to the (b) of this section, the registration of Special Agent in Charge in his/her any person, and any modifications of area, at least 14 days in advance of the that registration, shall terminate, date of the proposed transfer (unless without any further action by the Ad- the Special Agent in Charge waives ministration, if and when such person this time limitation in individual in- dies, ceases legal existence, discon- stances), the following information: tinues business or professional prac- (1) The name, address, registration tice, or surrenders a registration. Any number, and authorized business activ- registrant who ceases legal existence or discontinues business or professional ity of the registrant discontinuing the practice shall notify the Administrator business (registrant-transferor);

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(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 re- (if the latter, the address of the new lo- quired from him, if no further trans- cation should be listed); actions involving controlled substances (4) Whether the registrant-transferor are consummated by him. The initial has a quota to manufacture or procure report of the registrant-transferee any controlled substance listed in shall account for transactions begin- Schedule I or II (if so, the basic class or ning with the day next succeeding the class of the substance should be indi- date of discontinuance or transfer of cated); and business by the transferor-registrant (5) The date on which the transfer of and the substances transferred to him controlled substances will occur. shall be reported as receipts in his/her (e) Unless the registrant-transferor is initial report. informed by the Special Agent in Charge, before the date on which the [62 FR 13957, Mar. 24, 1997, as amended at 74 FR 15623, Apr. 6, 2009; 75 FR 10676, Mar. 9, transfer was stated to occur, that the 2010; 76 FR 61564, Oct. 5, 2011] transfer may not occur, the registrant- transferor may distribute (without SECURITY REQUIREMENTS being registered to distribute) controlled substances in his/her possession § 1301.71 Security requirements gen- to the registrant-transferee in accord- erally. ance with the following: (a) All applicants and registrants (1) On the date of transfer of the con- shall provide effective controls and trolled substances, a complete inven- procedures to guard against theft and tory of all controlled substances being diversion of controlled substances. In transferred shall be taken in accord- order to determine whether a reg- ance with § 1304.11 of this chapter. This istrant has provided effective controls inventory shall serve as the final in- against diversion, the Administrator ventory of the registrant-transferor shall use the security requirements set and the initial inventory of the reg- forth in §§ 1301.72–1301.76 as standards istrant-transferee, and a copy of the infor the physical security controls and ventory shall be included in the records of each person. It shall not be nec- operating procedures necessary to pre- essary to file a copy of the inventory vent diversion. Materials and construc- with the Administration unless re- tion which will provide a structural quested by the Special Agent in equivalent to the physical security Charge. Transfers of any substances controls set forth in §§ 1301.72, 1301.73 listed in Schedule I or II shall require and 1301.75 may be used in lieu of the the use of order forms in accordance materials and construction described with part 1305 of this chapter. in those sections. (2) On the date of transfer of the con- (b) Substantial compliance with the trolled substances, all records required standards set forth in §§ 1301.72–1301.76 to be kept by the registrant-transferor may be deemed sufficient by the Ad- with reference to the controlled sub- ministrator after evaluation of the stances being transferred, under part overall security system and needs of 1304 of this chapter, shall be trans- the applicant or registrant. In evalu- ferred to the registrant-transferee. Re- ating the overall security system of a sponsibility for the accuracy of records registrant or applicant, the Adminis- prior to the date of transfer remains trator may consider any of the fol- with the transferor, but responsibility lowing factors as he may deem relevant for custody and maintenance shall be to the need for strict compliance with upon the transferee. security requirements:

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(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 presence and characteristics of perim- § 1321.01 of this chapter for the current eter fencing, if any; mailing address. (11) The adequacy of supervision over (e) Physical security controls of loca- employees having access to manufac- tions registered under the Harrison turing and storage areas; Narcotic Act or the Narcotics Manufac- (12) The procedures for handling busi- turing Act of 1960 on April 30, 1971, ness guests, visitors, maintenance per- shall be deemed to comply substan- sonnel, and nonemployee service per- tially with the standards set forth in sonnel; §§ 1301.72, 1301.73 and 1301.75. Any new (13) The availability of local police facilities or work or storage areas con- protection or of the registrant’s or ap- structed or utilized for controlled sub- plicant’s security personnel; stances, which facilities or work or (14) The adequacy of the registrant’s storage areas have not been previously or applicant’s system for monitoring approved by the Administration, shall the receipt, manufacture, distribution, not necessarily be deemed to comply and disposition of controlled sub- substantially with the standards set stances in its operations; and forth in §§ 1301.72, 1301.73 and 1301.75, (15) The applicability of the security notwithstanding that such facilities or requirements contained in all Federal, work or storage areas have physical se- State, and local laws and regulations curity controls similar to those pre- governing the management of waste. viously approved by the Administra- (c) When physical security controls tion. become inadequate as a result of a con- [36 FR 18729, Sept. 21, 1971. Redesignated at trolled substance being transferred to a 38 FR 26609, Sept. 24, 1973, and amended at 46 different schedule, or as a result of a FR 28841, May 29, 1981; 47 FR 41735, Sept. 22, noncontrolled substance being listed on 1982; 51 FR 5319, Feb. 13, 1986; 68 FR 41228, any schedule, or as a result of a signifi- July 11, 2003; 75 FR 10677, Mar. 9, 2010]

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§ 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; (i) The walls, floors, and ceilings of (2) A vault as described in paragraph which vault are constructed of at least (a)(2) or (3) of this section equipped 8 inches of reinforced concrete or other with an alarm system as described in substantial masonry, reinforced paragraph (b)(4)(v) of this section; vertically and horizontally with 1⁄2-inch (3) A building used for storage of steel rods tied 6 inches on center, or Schedules III through V controlled sub- the structural equivalent to such rein- stances with perimeter security which forced walls, floors, and ceilings; limits access during working hours and (ii) The door and frame unit of which provides security after working hours vault shall conform to the following and meets the following specifications:

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(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 native, a cage shall be erected which such non-segregated storage does not reaches and is securely attached to the diminish security effectiveness for structural ceiling of the building. A Schedules III through V controlled sub- lighter gauge mesh may be used for the stances. ceilings of large enclosed areas if walls (c) Multiple storage areas. Where sev- are at least 14 feet in height, eral types or classes of controlled sub- (iv) Is equipped with a door con- stances are handled separately by the structed of No. 10 gauge steel fabric on registrant or applicant for different a metal door frame in a metal door purposes (e.g., returned goods, or goods flange, and in all other respects con- in process), the controlled substances

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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 fic control lines or restricted space des- shall be accessible only to an absolute ignation. The employee designated as minimum number of specifically au- responsible for the area may be en- thorized employees. When it is nec- gaged in the particular manufacturing essary for employee maintenance per- operation being conducted: Provided, sonnel, nonemployee maintenance per- That he is able to provide continuous sonnel, business guests, or visitors to surveillance of the area in order that be present in or pass through con- unauthorized persons may not enter or trolled substances storage areas, the leave the area without his knowledge. registrant shall provide for adequate (c) During the production of con- observation of the area by an employee trolled substances, the manufacturing specifically authorized in writing. areas shall be accessible to only those [36 FR 18730, Sept. 21, 1971. Redesignated at employees required for efficient oper- 38 FR 26609, Sept. 24, 1973] ation. When it is necessary for employee maintenance personnel, non- EDITORIAL NOTE: For FEDERAL REGISTER citations affecting § 1301.72, see the List of CFR employee maintenance personnel, busi- Sections Affected, which appears in the ness guests, or visitors to be present in Finding Aids section of the printed volume or pass through manufacturing areas and at www.fdsys.gov. during production of controlled substances, the registrant shall provide for § 1301.73 Physical security controls for adequate observation of the area by an non-practitioners; compounders for employee specifically authorized in narcotic treatment programs; manufacturing and compounding areas. writing. All manufacturing activities (includ- [36 FR 18731, Sept. 21, 1971. Redesignated at ing processing, packaging and labeling) 38 FR 26609, Sept. 24, 1973 and amended at 39 involving controlled substances listed FR 37984, Oct. 25, 1974] in any schedule and all activities of compounders shall be conducted in ac- § 1301.74 Other security controls for non-practitioners; narcotic treat- cordance with the following: ment programs and compounders (a) All in-process substances shall be for narcotic treatment programs. returned to the controlled substances storage area at the termination of the (a) Before distributing a controlled process. If the process is not termi- substance to any person who the reg- nated at the end of a workday (except istrant does not know to be registered where a continuous process or other to possess the controlled substance, the normal manufacturing operation registrant shall make a good faith in- should not be interrupted), the proc- quiry either with the Administration essing area or tanks, vessels, bins or or with the appropriate State con- bulk containers containing such sub- trolled substances registration agency, stances shall be securely locked, with if any, to determine that the person is adequate security for the area or build- registered to possess the controlled ing. If such security requires an alarm, substance. such alarm, upon unauthorized entry, (b) The registrant shall design and shall transmit a signal directly to a operate a system to disclose to the reg- central station protection company, or istrant suspicious orders of controlled local or state police agency which has substances. The registrant shall inform a legal duty to respond, or a 24-hour the Field Division Office of the Admin- control station operated by the registration in his area of suspicious or- istrant. ders when discovered by the registrant. (b) Manufacturing activities with Suspicious orders include orders of un- controlled substances shall be con- usual size, orders deviating substan- ducted in an area or areas of clearly de- tially from a normal pattern, and or- fined limited access which is under sur- ders of unusual frequency.

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(c) The registrant shall notify the and quantity of the specific controlled Field Division Office of the Adminis- substance desired. The request shall be tration in his area, in writing, of any preserved by the registrant with other theft or significant loss of any con- records of distribution of controlled trolled substances within one business substances. In addition, the require- day of discovery of the theft or loss. ments of part 1305 of the chapter shall The supplier is responsible for report- be complied with for any distribution ing all in-transit losses of controlled of a controlled substance listed in substances by the common or contract Schedule II. For purposes of this para- carrier selected pursuant to paragraph graph, the term ‘‘customer’’ includes a (e) of this section, within one business person to whom a complimentary sam- day of discovery of such theft or loss. ple of a substance is given in order to The registrant shall also complete, and encourage the prescribing or recom- submit to the Field Division Office in mending of the substance by the per- his area, DEA Form 106 regarding the son. theft or loss. Thefts and significant (e) When shipping controlled sub- losses must be reported whether or not stances, a registrant is responsible for the controlled substances are subse- selecting common or contract carriers quently recovered or the responsible which provide adequate security to parties are identified and action taken guard against in-transit losses. When against them. When determining storing controlled substances in a pub- whether a loss is significant, a reg- lic warehouse, a registrant is respon- istrant should consider, among others, sible 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 (d) The registrant shall not dis- is authorized to handle the sub- tribute any controlled substance listed stances(s) by contacting the Drug En- in Schedules II through V as a com- forcement Administration. plimentary sample to any potential or (h) The acceptance of delivery of nar- current customer (1) without the prior cotic substances by a narcotic treat- written request of the customer, (2) to ment program shall be made only by a be used only for satisfying the legiti- licensed practitioner employed at the mate medical needs of patients of the facility or other authorized individuals customer, and (3) only in reasonable designated in writing. At the time of quantities. Such request must contain delivery, the licensed practitioner or the name, address, and registration other authorized individual designated number of the customer and the name in writing (excluding persons currently

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or previously dependent on narcotic (b) Controlled substances listed in drugs), shall sign for the narcotics and Schedules II, III, IV, and V shall be place his specific title (if any) on any stored in a securely locked, substan- invoice. Copies of these signed invoices tially constructed cabinet. However, shall be kept by the distributor. pharmacies and institutional practi- (i) Narcotics dispensed or adminis- tioners may disperse such substances tered at a narcotic treatment program throughout the stock of noncontrolled will be dispensed or administered di- substances in such a manner as to ob- rectly to the patient by either (1) the struct the theft or diversion of the con- licensed practitioner, (2) a registered trolled substances. nurse under the direction of the li- (c) This section shall also apply to censed practitioner, (3) a licensed prac- nonpractitioners authorized to conduct tical nurse under the direction of the research or chemical analysis under licensed practitioner, or (4) a phar- another registration. macist under the direction of the li- (d) Carfentanil etorphine hydro- censed practitioner. chloride and diprenorphine shall be (j) Persons enrolled in a narcotic stored in a safe or steel cabinet equiva- treatment program will be required to lent to a U.S. Government Class V se- wait in an area physically separated curity container. from the narcotic storage and dis- [39 FR 3674, Jan. 29, 1974, as amended at 39 pensing area. This requirement will be FR 17838, May 21, 1974; 54 FR 33674, Aug. 16, enforced by the program physician and 1989; 62 FR 13957, Mar. 24, 1997] employees. (k) All narcotic treatment programs § 1301.76 Other security controls for practitioners. must comply with standards established by the Secretary of Health and (a) The registrant shall not employ, Human Services (after consultation as an agent or employee who has access with the Administration) respecting to controlled substances, any person the quantities of narcotic drugs which who has been convicted of a felony of- may be provided to persons enrolled in fense relating to controlled substances a narcotic treatment program for unsu- or who, at any time, had an application pervised use. for registration with the DEA denied, (l) DEA may exercise discretion re- had a DEA registration revoked or has garding the degree of security required surrendered a DEA registration for in narcotic treatment programs based cause. For purposes of this subsection, on such factors as the location of a pro- the term ‘‘for cause’’ means a sur- gram, the number of patients enrolled render in lieu of, or as a consequence in a program and the number of physi- of, any federal or state administrative, cians, staff members and security civil or criminal action resulting from guards. Similarly, such factors will be an investigation of the individual’s taken into consideration when evalu- handling of controlled substances. ating existing security or requiring (b) The registrant shall notify the new security at a narcotic treatment Field Division Office of the Adminis- program. tration in his area, in writing, of the theft or significant loss of any con- [36 FR 7778, Apr. 24, 1971. Redesignated at 38 trolled substances within one business FR 26609, Sept. 24, 1973] day of discovery of such loss or theft. EDITORIAL NOTE: For FEDERAL REGISTER ci- The registrant shall also complete, and tations affecting § 1301.74, see the List of CFR submit to the Field Division Office in Sections Affected, which appears in the his area, DEA Form 106 regarding the Finding Aids section of the printed volume loss or theft. When determining wheth- and at www.fdsys.gov. er a loss is significant, a registrant should consider, among others, the fol- § 1301.75 Physical security controls for lowing factors: practitioners. (1) The actual quantity of controlled (a) Controlled substances listed in substances lost in relation to the type Schedule I shall be stored in a securely of business; locked, substantially constructed cabi- (2) The specific controlled substances net. lost;

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

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Question. Within the past five years, have The employer shall inform all employ- you been convicted of a felony, or within the ees concerning this policy. past two years, of any misdemeanor or are you presently formally charged with com- [40 FR 17143, Apr. 17, 1975] mitting a criminal offense? (Do not include any traffic violations, juvenile offenses or § 1301.92 Illicit activities by employ- military convictions, except by general ees. court-martial.) If the answer is yes, furnish It is the position of DEA that em- details of conviction, offense, location, date ployees who possess, sell, use or divert and sentence. controlled substances will subject Question. In the past three years, have you themselves not only to State or Fed- ever knowingly used any narcotics, amphet- eral prosecution for any illicit activ- amines or barbiturates, other than those pre- ity, but shall also immediately become scribed to you by a physician? If the answer the subject of independent action re- is yes, furnish details. garding their continued employment. Advice. An authorization, in writing, that The employer will assess the serious- allows inquiries to be made of courts and law ness of the employee’s violation, the 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 DEA recommends that inquiries con- employment, but will be considered as part cerning employees’ criminal records be of an overall evaluation of the person’s made as follows: qualifications. The maintaining of fair employment practices, the protection of the Local inquiries. Inquiries should be made by person’s right of privacy, and the assurance name, date and place of birth, and other that the results of such inquiries will be identifying information, to local courts and treated by the employer in confidence will be law enforcement agencies for records of explained to the employee. pending charges and convictions. Local practice may require such inquiries to be made in [40 FR 17143, Apr. 17, 1975] person, rather than by mail, and a copy of an authorization from the employee may be re- § 1301.91 Employee responsibility to quired by certain law enforcement agencies. report drug diversion. DEA inquiries. Inquiries supplying identifying information should also be furnished to Reports of drug diversion by fellow DEA Field Division Offices along with writ- employees is not only a necessary part ten consent from the concerned individual of an overall employee security pro- for a check of DEA files for records of con- gram but also serves the public inter- victions. The Regional check will result in a est at large. It is, therefore, the posi- national check being made by the Field Divi- tion of DEA that an employee who has sion Office. knowledge of drug diversion from his [40 FR 17143, Apr. 17, 1975, as amended at 47 employer by a fellow employee has an FR 41735, Sept. 22, 1982] obligation to report such information to a responsible security official of the PART 1302—LABELING AND PACK- employer. The employer shall treat AGING REQUIREMENTS FOR such information as confidential and CONTROLLED SUBSTANCES shall take all reasonable steps to protect the confidentiality of the informa- Sec. tion and the identity of the employee 1302.01 Scope of part 1302. furnishing information. A failure to re- 1302.02 Definitions. port information of drug diversion will 1302.03 Symbol required; exceptions. 1302.04 Location and size of symbol on label be considered in determining the feasi- and labeling. bility of continuing to allow an em- 1302.05 Effective dates of labeling require- ployee to work in a drug security area. ments.

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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 sub- wrapper. stances. (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 [36 FR 7785, Apr. 24, 1971, as amended at 36 FR 26609, Sept. 24, 1973] FR 18731, Sept. 21, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973] § 1302.02 Definitions. § 1302.04 Location and size of symbol Any term contained in this part shall on label and labeling. have the definition set forth in section The symbol shall be prominently lo- 102 of the Act (21 U.S.C. 802) or part cated on the label or the labeling of the 1300 of this chapter. commercial container and/or the panel [62 FR 13958, Mar. 24, 1997] of the commercial container normally displayed to dispensers of any con- § 1302.03 Symbol required; exceptions. trolled substance. The symbol on labels (a) Each commercial container of a shall be clear and large enough to af- controlled substance (except for a con- ford easy identification of the schedule trolled substance excepted by the Ad- of the controlled substance upon in- ministrator pursuant to § 1308.31 of this spection without removal from the dis- chapter) shall have printed on the label penser’s shelf. The symbol on all other the symbol designating the schedule in labeling shall be clear and large which such controlled substance is list- enough to afford prompt identification ed. Each such commercial container, if of the controlled substance upon in- it otherwise has no label, must bear a spection of the labeling. label complying with the requirement [62 FR 13958, Mar. 24, 1997] of this part. (b) Each manufacturer shall print § 1302.05 Effective dates of labeling re- upon the labeling of each controlled quirements. substance distributed by him the sym- All labels on commercial containers bol designating the schedule in which of, and all labeling of, a controlled sub- such controlled substance is listed. stance which either is transferred to (c) The following symbols shall des- another schedule or is added to any ignate the schedule corresponding schedule shall comply with the require- thereto: ments of § 1302.03, on or before the ef- Schedule fective date established in the final order for the transfer or addition. Schedule I ...... CI or C–I. Schedule II ...... CII or C–II. [62 FR 13958, Mar. 24, 1997] Schedule III ...... CIII or C–III. Schedule IV ...... CIV or C–IV. § 1302.06 Sealing of controlled sub- Schedule V ...... CV or C–V. stances. The word ‘‘schedule’’ need not be used. On each bottle, multiple dose vial, or No distinction need be made between other commercial container of any narcotic and nonnarcotic substances. controlled substance, there shall be se- (d) The symbol is not required on a curely affixed to the stopper, cap, lid, carton or wrapper in which a commer- covering, or wrapper or such container

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a seal to disclose upon inspection any HEARINGS tampering or opening of the container. 1303.31 Hearings generally. 1303.32 Purpose of hearing. [62 FR 13958, Mar. 24, 1997] 1303.33 Waiver or modification of rules. 1303.34 Request for hearing or appearance; § 1302.07 Labeling and packaging re- waiver. quirements for imported and ex- 1303.35 Burden of proof. ported substances. 1303.36 Time and place of hearing. (a) The symbol requirements of 1303.37 Final order. §§ 1302.03–1302.05 apply to every com- AUTHORITY: 21 U.S.C. 821, 826, 871(b). mercial container containing, and to all labeling of, controlled substances GENERAL INFORMATION imported into the jurisdiction of and/or the customs territory of the United § 1303.01 Scope of part 1303. States. Procedures governing the establish- (b) The symbol requirements of ment of production and manufacturing §§ 1302.03–1302.05 do not apply to any quotas on basic classes of controlled commercial containers containing, or substances listed in schedules I and II any labeling of, a controlled substance pursuant to section 306 of the Act (21 intended for export from the jurisdic- U.S.C. 826) are governed generally by tion of the United States. that section and specifically by the (c) The sealing requirements of sections of this part. § 1302.06 apply to every bottle, multiple [36 FR 7786, Apr. 24, 1971. Redesignated at 38 dose vial, or other commercial con- FR 26609, Sept. 24, 1973] tainer of any controlled substance listed in schedule I or II, or any narcotic § 1303.02 Definitions. controlled substance listed in schedule Any term contained in this part shall III or IV, imported into, exported from, have the definition set forth in section or intended for export from, the juris- 102 of the Act (21 U.S.C. 802) or part diction of and/or the customs territory 1300 of this chapter. of the United States. [62 FR 13958, Mar. 24, 1997] [62 FR 13958, Mar. 24, 1997] AGGREGATE PRODUCTION AND PART 1303—QUOTAS PROCUREMENT QUOTAS § 1303.11 Aggregate production quotas. GENERAL INFORMATION (a) The Administrator shall deter- Sec. mine the total quantity of each basic 1303.01 Scope of part 1303. class of controlled substance listed in 1303.02 Definitions. Schedule I or II necessary to be manufactured 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. INDIVIDUAL MANUFACTURING QUOTAS (b) In making his determinations, the Administrator shall consider the fol- 1303.21 Individual manufacturing quotas. lowing factors: 1303.22 Procedure for applying for individual (1) Total net disposal of the class by manufacturing quotas. all manufacturers during the current 1303.23 Procedure for fixing individual manufacturing quotas. and 2 preceding years; 1303.24 Inventory allowance. (2) Trends in the national rate of net 1303.25 Increase in individual manufac- disposal of the class; turing quotas. (3) Total actual (or estimated) inven- 1303.26 Reduction in individual manufac- tories of the class and of all substances turing quotas. manufactured from the class, and 1303.27 Abandonment of quota. trends in inventory accumulation;

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(4) Projected demand for such class as a bulk manufacturer of the basic as indicated by procurement quotas re- class. quested pursuant to § 1303.12; and [36 FR 7786, Apr. 24, 1971, as amended at 37 (5) Other factors affecting medical, FR 15919, Aug. 8, 1972. Redesignated at 38 FR scientific, research, and industrial 26609, Sept. 24, 1973; 77 FR 4235, Jan. 27, 2012] needs in the United States and lawful export requirements, as the Adminis- § 1303.12 Procurement quotas. trator finds relevant, including (a) In order to determine the esti- changes in the currently accepted med- mated needs for, and to insure an ade- ical use in treatment with the class or quate and uninterrupted supply of, the substances which are manufactured basic classes of controlled substances from it, the economic and physical listed in Schedules I and II (except raw availability of raw materials for use in opium being imported by the registrant manufacturing and for inventory pur- pursuant to an import permit) the Ad- poses, yield and stability problems, po- ministrator shall issue procurement tential disruptions to production (in- quotas authorizing persons to procure cluding possible labor strikes), and re- and use quantities of each basic class cent unforeseen emergencies such as of such substances for the purpose of floods and fires. manufacturing such class into dosage 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 not 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 dered by the Administrator shall issue of that form. If the purpose is to manu- and publish in the FEDERAL REGISTER facture another substance, the appli- his final order determining the aggre- cant shall state the official name, com- gate production quota for the basic mon or usual name, chemical name, or class of controlled substances. The brand name of the substance, and, if a order shall include the findings of fact controlled substance listed in any and conclusions of law upon which the schedule, the schedule number and Ad- order is based. The order shall specify ministration Controlled Substances the date on which it shall take effect. Code Number, as set forth in part 1308 A copy of said order shall be mailed si- of this chapter, of the substance. If the multaneously to each person registered purpose is to manufacture another

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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. (c) The Administrator shall, on or be- ment quota has been issued, author- fore July 1 of the year preceding the izing that person to procure and use a calendar year during which the quota quantity of a basic class of controlled shall be effective, issue to each quali- substances listed in Schedules I or II fied applicant a procurement quota au- during the current calendar year, shall, thorizing him to procure and use: at or before the time of giving an order (1) All quantities of such class nec- to another manufacturer requiring the essary to manufacture all quantities of distribution of a quantity of such basic other basic classes of controlled sub- class, certify in writing to such other stances listed in Schedules I and II manufacturer that the quantity of such which the applicant is authorized to basic class ordered does not exceed the manufacture pursuant to § 1303.23; and person’s unused and available procure- (2) Such other quantities of such ment quota of such basic class for the class as the applicant has applied to current calendar year. The written cer- procure and use and are consistent tification shall be executed by the with his past use, his estimated needs, same individual who signed the DEA and the total quantity of such class Form 222 transmitting the order. Man- that will be produced. ufacturers shall not fill an order from (d) Any person to whom a procure- persons required to apply for a procurement quota has been issued may at any ment quota under paragraph (b) of this time request an adjustment in the section unless the order is accompanied quota by applying to the Adminis- by a certification as required under trator with a statement showing the this section. The certification required need for the adjustment. Such applica- by this section shall contain the fol- tion shall be filed with the Drug & lowing: The date of the certification; Chemical Evaluation Section, Drug En- the name and address of the bulk man- forcement Administration. See the ufacturer to whom the certification is Table of DEA Mailing Addresses in directed; a reference to the number of § 1321.01 of this chapter for the current the DEA Form 222 to which the certifi- mailing address. The Administrator cation applies; the name of the person shall increase or decrease the procure- giving the order to which the certifi- ment quota of such person if and to the cation applies; the name of the basic extent that he finds, after considering class specified in the DEA Form 222 to the factors enumerated in paragraph which the certification applies; the ap- (c) of this section and any occurrences propriate schedule within which is list- since the issuance of the procurement ed the basic class specified in the DEA quota, that the need justifies an ad- Form 222 to which the certification ap- justment. plies; a statement that the quantity (e) The following persons need not (expressed in grams) of the basic class obtain a procurement quota: specified in the DEA Form 222 to which

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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 EDITORIAL NOTE: For FEDERAL REGISTER ci- manufacturing and for inventory pur- tations affecting § 1303.12, see the List of CFR poses, yield and stability problems, po- 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 § 1303.13 Adjustments of aggregate floods and fires. production quotas. (c) The Administrator in the event he (a) The Administrator may at any determines to increase or reduce the time increase or reduce the aggregate aggregate production quota for a basic production quota for a basic class of class of controlled substance, shall controlled substance listed in Schedule publish in the FEDERAL REGISTER gen- I or II which he has previously fixed eral notice of an adjustment in the ag- pursuant to § 1303.11. gregate production quota for that class (b) In determining to adjust the ag- determined by him under this section. gregate production quota, the Adminis- A copy of said notice shall be mailed trator shall consider the following fac- simultaneously to each person reg- tors: istered as a bulk manufacturer of the (1) Changes in the demand for that basic class. The Administrator shall class, changes in the national rate of permit any interested person to file net disposal of the class, and changes written comments on or objections to in the rate of net disposal of the class the proposal and shall designate in the by registrants holding individual man- notice the time during which such fil- ufacturing quotas for that class; ings may be made. The Administrator (2) Whether any increased demand for may, but shall not be required to, hold that class, the national and/or indi- a public hearing on one or more issues vidual rates of net disposal of that raised by the comments and objections class are temporary, short term, or filed with him. In the event the Admin- long term; istrator decides to hold such a hearing, (3) Whether any increased demand for he shall publish notice of the hearing that class can be met through existing in the FEDERAL REGISTER, which notice inventories, increased individual man- shall summarize the issues to be heard ufacturing quotas, or increased impor- and shall set the time for the hearing, tation, without increasing the aggre- which shall not be less than 10 days gate production quota, taking into ac- after the date of publication of the no- count production delays and the probability that other individual manufac- tice. After consideration of any com- turing quotas may be suspended pursu- ments or objections, or after a hearing ant to § 1303.24(b); if one is ordered by the Administrator, (4) Whether any decreased demand the Administrator shall issue and pub- for that class will result in excessive lish in the FEDERAL REGISTER his final inventory accumulation by all persons order determining the aggregate pro- registered to handle that class (includ- duction for the basic class of controlled ing manufacturers, distributors, practi- substance. The order shall include the tioners, importers, and exporters), not- findings of fact and conclusions of law withstanding the possibility that indi- upon which the order is based. The vidual manufacturing quotas may be order shall specify the date on which it suspended pursuant to § 1303.24(b) or shall take effect. A copy of said order abandoned pursuant to § 1303.27; shall be mailed simultaneously to each

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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 dress. A separate application must be the current year to his estimated in- made for each basic class desired to be ventory allowance for the next cal- manufactured. The applicant shall endar year, pursuant to § 1303.24, and state: (2) By any other factors which the (a) The name and Administration Administrator deems relevant to the Controlled Substances Code Number, as fixing of the individual manufacturing set forth in part 1308 of this chapter, of quota of the applicant, including the the basic class. trend of (and recent changes in) his and

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the national rates of net disposal, his ufacturer shall be allowed as a part of production cycle and current inventory such quota an amount sufficient to position, the economic and physical maintain an inventory equal to, availability of raw materials for use in (1) For current manufacturers, 50 per- manufacturing and for inventory pur- cent of his average estimated net dis- poses, yield and stability problems, po- posal for the current calendar year and tential disruptions to production (in- the last preceding calendar year; or cluding possible labor strikes), and re- (2) For new manufacturers, 50 percent cent unforeseen emergencies such as of his reasonably estimated net dis- floods and fires. posal for the next calendar year as de- (b) In fixing individual manufac- termined by the Administrator. turing quotas for a basic class of con- (b) During each calendar year each trolled substance listed in Schedule I registered manufacturer shall be al- or II, the Administrator shall allocate lowed to maintain an inventory of a to each applicant who is not currently manufacturing such class a quota equal basic class not exceeding 65 percent of to 100 percent of the reasonably esti- his estimated net disposal of that class mated net disposal of that applicant for that year, as determined at the for the next calendar year, as deter- time his quota for that year was determined by the Administrator, ad- mined. At any time the inventory of a justed— basic class held by a manufacturer ex- (1) By the amount necessary to proceeds 65 percent of his estimated net vide the applicant his estimated inven- disposal, his quota for that class is tory allowance for the next calendar automatically suspended and shall re- year, pursuant to § 1303.24, and main suspended until his inventory is (2) By any other factors which the less than 60 percent of his estimated Administrator deems relevant to the net disposal. The Administrator may, fixing of the individual manufacturing upon application and for good cause quota of the applicant, including the shown, permit a manufacturer whose trend of (and recent changes in) the na- quota is, or is likely to be, suspended tional rate of net disposal, his produc- pursuant to this paragraph to continue tion cycle and current inventory posi- manufacturing and to accumulate an tion, the economic and physical avail- inventory in excess of 65 percent of his ability of raw materials for use in man- estimated net disposal, upon such con- ufacturing and for inventory purposes, ditions and within such limitations as yield and stability problems, potential the Administrator may find necessary disruptions to production (including or desirable. possible labor strikes), and recent un- (c) If, during a calendar year, a reg- foreseen emergencies such as floods istrant has manufactured the entire and fires. quantity of a basic class allocated to (c) The Administrator shall, on or be- him under an individual manufacturing fore March 1 of each year, adjust the quota, and his inventory of that class individual manufacturing quota allo- is less than 40 percent of his estimated cated for that year to each applicant in net disposal of that class for that year, paragraph (a) of this section by the the Administrator may, upon applica- amount necessary to increase or reduce tion pursuant to § 1303.25, increase the the actual inventory of the applicant quota of such registrant sufficiently to to December 31 of the preceding year to allow restoration of the inventory to 50 his estimated inventory allowance for percent of the estimated net disposal the current calendar year, pursuant to for that year. § 1303.24. [36 FR 7786, Apr. 24, 1971, as amended at 36 [36 FR 7786, Apr. 24, 1971, as amended at 37 FR 13386, July 21, 1971. Redesignated at 38 FR FR 15920, Aug. 8, 1972. Redesignated at 38 FR 26609, Sept. 24, 1973] 26609, Sept. 24, 1973] § 1303.25 Increase in individual manu- § 1303.24 Inventory allowance. facturing quotas. (a) For the purpose of determining (a) Any registrant who holds an indi- individual manufacturing quotas pur- vidual manufacturing quota for a basic suant to § 1303.23, each registered man- class of controlled substance listed in

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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 of such registrant’s initial quota appli- [36 FR 7786, Apr. 24, 1971, as amended at 37 cation that may require an increased FR 15920, Aug. 8, 1972. Redesignated at 38 FR manufacturing rate by such registrant 26609, Sept. 24, 1973, as amended at 62 FR 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 consideration the amount, if any, by Any manufacturer assigned an indi- which his determination of the total vidual manufacturing quota for any quantity for the basic class of con- basic class pursuant to § 1303.23 may at trolled substance to be manufactured any time abandon his right to manu- under § 1303.11 exceeds the aggregate of facture all or any part of such quota by all the individual manufacturing filing with the Drug & Chemical Eval- quotas for the basic class of controlled uation Section a written notice of such substance, and the equitable distribu- abandonment, stating the name and tion of such excess among other reg- Administration Controlled Substances istrants. Code Number, as set forth in part 1308 of this chapter, of the substance and [36 FR 7786, Apr. 24, 1971, as amended at 36 FR 13386, July 21, 1971. Redesignated at 38 FR the amount which he has chosen not to 26609, Sept. 24, 1973] manufacture. The Administrator may, in his discretion, allocate such amount § 1303.26 Reduction in individual man- among the other manufacturers in pro- ufacturing quotas. portion to their respective quotas. The Administrator may at any time [36 FR 7786, Apr. 24, 1971, as amended at 36 reduce an individual manufacturing FR 13386, July 21, 1971. Redesignated at 38 FR quota for a basic class of controlled 26609, Sept. 24, 1973, and amended at 46 FR substance listed in Schedule I or II 28841, May 29, 1981; 51 FR 5319, Feb. 13, 1986; which he has previously fixed in order 62 FR 13958, Mar. 24, 1997] to prevent the aggregate of the individual manufacturing quotas and im- HEARINGS port permits outstanding or to be granted from exceeding the aggregate § 1303.31 Hearings generally. production quota which has been estab- (a) In any case where the Adminis- lished for that class pursuant of trator shall hold a hearing regarding § 1303.11, as adjusted pursuant to the determination of an aggregate pro- § 1303.13. If a quota assigned to a new duction quota pursuant to § 1303.11(c), manufacturer pursuant to § 1303.23(b), or regarding the adjustment of an ag- or if a quota assigned to any manufac- gregate production quota pursuant to turer is increased pursuant to § 1303.13(c), the procedures for such § 1303.24(c), or if an import permit hearing shall be governed generally by issued to an importer pursuant to part the rule making procedures set forth in 1312 of this chapter, causes the total the Administrative Procedure Act (5 quantity of a basic class to be manu- U.S.C. 551–559) and specifically by sec- factured and imported during the year tion 306 of the Act (21 U.S.C. 826), by to exceed the aggregate production §§ 1303.32–1303.37, and by the procedures quota which has been established for for administrative hearings under the that class pursuant to § 1303.11, as ad- Act set forth in §§ 1316.41–1316.67 of this justed pursuant to § 1303.13, the Admin- chapter.

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(b) In any case where the Adminis- any rule in this part by notice in ad- trator shall hold a hearing regarding vance of the hearing, if he determines the issuance, adjustment, suspension, that no party in the hearing will be un- or denial of a procurement quota pur- duly prejudiced and the ends of justice suant to § 1303.12, or the issuance, ad- will thereby be served. Such notice of justment, suspension, or denial of an modification or waiver shall be made a individual manufacturing quota pursu- part of the record of the hearing. ant to §§ 1303.21–1303.27, the procedures [36 FR 7786, Apr. 24, 1971. Redesignated at 38 for such hearing shall be governed gen- FR 26609, Sept. 24, 1973] erally by the adjudication procedures set forth in the Administrative Proce- § 1303.34 Request for hearing or ap- dures Act (5 U.S.C. 551–559) and specifi- pearance; waiver. cally by section 306 of the Act (21 (a) Any applicant or registrant who U.S.C. 826), by §§ 1303.32–1303.37, and by desires a hearing on the issuance, ad- the procedures for administrative hear- justment, suspension, or denial of his ings under the Act set forth in procurement and/or individual manu- §§ 1316.41–1316.67 of this chapter. facturing quota shall, within 30 days [36 FR 7786, Apr. 24, 1971, as amended at 37 after the date of receipt of the FR 15920, Aug. 8, 1972. Redesignated at 38 FR issuance, adjustment, suspension, or 26609, Sept. 24, 1973] denial of such quota, file with the Ad- ministrator a written request for a § 1303.32 Purpose of hearing. hearing in the form prescribed in (a) The Administrator may, in his § 1316.47 of this chapter. Any interested sole discretion, hold a hearing for the person who desires a hearing on the de- purpose of receiving factual evidence termination of an aggregate production regarding any one or more issues (to be quota shall, within the time prescribed specified by him) involved in the deter- in § 1303.11(c), file with the Adminis- mination or adjustment of any aggre- trator a written request for a hearing gate production quota. 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, proposed findings of fact and conclu- within the period permitted for filing a sions of law. request for a hearing of notice of ap- [36 FR 7786, Apr. 24, 1971, as amended at 37 pearance, file with the Administrator a FR 15920, Aug. 8, 1972. Redesignated at 38 FR waiver of an opportunity for a hearing 26609, Sept. 24, 1973, as amended at 62 FR or to participate in a hearing, together 13958, Mar. 24, 1997] with a written statement regarding his position on the matters of fact and law § 1303.33 Waiver or modification of involved in such hearing. Such state- rules. ment, if admissible, shall be made a The Administrator or the presiding part of the record and shall be consid- officer (with respect to matters pend- ered in light of the lack of opportunity ing before him) may modify or waive for cross-examination in determining

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the weight to be attached to matters of earlier time, in which case the Admin- fact asserted therein. istrator shall fix a date for such hear- (d) If any person entitled to a hearing ing as early as reasonably possible. or to participate in a hearing pursuant (b) The hearing will commence at the to paragraph (b) of this section, fails to place and time designated in the notice file a request for a hearing or notice of given pursuant to paragraph (a) of this appearance, or if he so files and fails to section or in the notice of hearing pub- appear at the hearing, he shall be lished in the FEDERAL REGISTER pursu- deemed to have waived his opportunity ant to § 1303.11(c) or § 1303.13 (c), but for the hearing or to participate in the thereafter it may be moved to a dif- hearing, unless he shows good cause for ferent place and may be continued such failure. 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 final order pursuant to § 1303.37 without 26609, Sept. 24, 1973] 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, 1972. Redesignated at 38 FR 26609, Sept. 24, siding officer has certified the record 1973] to the Administrator, the Adminis- trator shall issue his order on the de- § 1303.35 Burden of proof. termination or adjustment of the ag- (a) At any hearing regarding the de- gregate production quota or on the termination or adjustment of an aggre- issuance, adjustment, suspension, or gate production quota, each interested denial of the procurement quota or in- person participating in the hearing dividual manufacturing quota, as case shall have the burden of proving any may be. The order shall include the propositions of fact or law asserted by findings of fact and conclusions of law him in the hearing. upon which the order is based. The (b) At any hearing regarding the order shall specify the date on which it issuance, adjustment, suspension, or shall take effect. The Administrator denial of a procurement or individual shall serve one copy of his order upon manufacturing quota, the Administra- each party in the hearing. tion shall have the burden of proving [36 FR 7786, Apr. 24, 1971, as amended at 37 that the requirements of this part for FR 15920, Aug. 8, 1972. Redesignated at 38 FR such issuance, adjustment, suspension, 26609, Sept. 24, 1973] or denial are satisfied. [36 FR 7786, Apr. 24, 1971, as amended at 37 PART 1304—RECORDS AND FR 15920, Aug. 8, 1972. Redesignated at 38 FR REPORTS OF REGISTRANTS 26609, Sept. 24, 1973, as amended at 62 FR 13958, Mar. 24, 1997] GENERAL INFORMATION § 1303.36 Time and place of hearing. Sec. (a) If any applicant or registrant re- 1304.01 Scope of part 1304. quests a hearing on the issuance, ad- 1304.02 Definitions. justment, suspension, or denial of his 1304.03 Persons required to keep records and file reports. procurement and/or individual manu- 1304.04 Maintenance of records and inven- facturing quota pursuant to § 1303.34, tories. the Administrator shall hold such 1304.05 Records of authorized central fill hearing. Notice of the hearing shall be pharmacies and retail pharmacies. given to the applicant or registrant of 1304.06 Records and reports for electronic the time and place at least 30 days prescriptions. prior to the hearing, unless the applicant or registrant waives such notice INVENTORY REQUIREMENTS and requests the hearing be held at an 1304.11 Inventory requirements.

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CONTINUING RECORDS Any registrant who is authorized to 1304.21 General requirements for continuing conduct other activities without being records. registered to conduct those activities, 1304.22 Records for manufacturers, distribu- either pursuant to § 1301.22(b) of this tors, dispensers, researchers, importers, chapter or pursuant to §§ 1307.11–1307.13 and exporters. of this chapter, shall maintain the 1304.23 Records for chemical analysts. records and inventories and shall file 1304.24 Records for maintenance treatment programs and detoxification treatment the reports required by this part for programs. persons registered to conduct such ac- 1304.25 Records for treatment programs tivities. This latter requirement should which compound narcotics for treatment not be construed as requiring stocks of programs and other locations. controlled substances being used in 1304.26 Additional recordkeeping require- various activities under one registra- ments applicable to drug products con- tion to be stored separately, nor that taining gamma-hydroxybutyric acid. separate records are required for each REPORTS activity. The intent of the Administra- tion is to permit the registrant to keep 1304.31 Reports from manufacturers importing narcotic raw material. one set of records which are adapted by 1304.32 Reports of manufacturers importing the registrant to account for controlled coca leaves. substances used in any activity. Also, 1304.33 Reports to ARCOS. the Administration does not wish to require separate stocks of the same sub- ONLINE PHARMACIES stance to be purchased and stored for 1304.40 Notification by online pharmacies. separate activities. Otherwise, there is 1304.45 Internet Web site disclosure require- no advantage gained by permitting sev- ments. eral activities under one registration. 1304.50 Disclosure requirements for Web sites of nonpharmacy practitioners that Thus, when a researcher manufactures dispense controlled substances by means a controlled item, he must keep a of the Internet. record of the quantity manufactured; 1304.55 Reports by online pharmacies. when he distributes a quantity of the AUTHORITY: 21 U.S.C. 821, 827, 831, 871(b), item, he must use and keep invoices or 958(e), 965, unless otherwise noted. order forms to document the transfer; when he imports a substance, he keeps GENERAL INFORMATION as part of his records the documentation required of an importer; and when § 1304.01 Scope of part 1304. substances are used in chemical anal- Inventory and other records and re- ysis, he need not keep a record of this ports required under section 307, sec- because such a record would not be re- tion 311, or section 1008(e) of the Act (21 quired of him under a registration to U.S.C. 827, 831, and 958(e)) shall be in do chemical analysis. All of these accordance with, and contain the infor- records may be maintained in one con- mation required by, those sections and solidated record system. Similarly, the by the sections of this part. researcher may store all of his controlled items in one place, and every [74 FR 15623, Apr. 6, 2009] two years take inventory of all items § 1304.02 Definitions. on hand, regardless of whether the substances were manufactured by him, im- Any term contained in this part shall ported by him, or purchased domesti- have the definition set forth in section cally by him, of whether the sub- 102 of the Act (21 U.S.C. 802) or part stances will be administered to sub- 1300 of this chapter. jects, distributed to other researchers, [62 FR 13958, Mar. 24, 1997] or destroyed during chemical analysis. (b) A registered individual practi- § 1304.03 Persons required to keep tioner is required to keep records, as records and file reports. described in § 1304.04, of controlled sub- (a) Each registrant shall maintain stances in Schedules II, III, IV, and V the records and inventories and shall which are dispensed, other than by pre- file the reports required by this part, scribing or administering in the lawful except as exempted by this section. course of professional practice.

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(c) Except as provided in § 1304.06, a which shall be filed with the applica- registered individual practitioner is tion. not required to keep records of con- (g) A distributing registrant who uti- trolled substances in Schedules II, III, lizes a freight forwarding facility shall IV, and V that are prescribed in the maintain records to reflect transfer of lawful course of professional practice, controlled substances through the fa- unless such substances are prescribed cility. These records must contain the in the course of maintenance or detoxi- date, time of transfer, number of car- fication treatment of an individual. tons, crates, drums or other packages (d) A registered individual practi- in which commercial containers of con- tioner is not required to keep records trolled substances are shipped and au- of controlled substances listed in thorized signatures for each transfer. A Schedules II, III, IV and V which are distributing registrant may, as part of administered in the lawful course of the initial request to operate a freight professional practice unless the practi- forwarding facility, request permission tioner regularly engages in the dis- to store records at a central location. pensing or administering of controlled Approval of the request to maintain substances and charges patients, either central records would be implicit in separately or together with charges for the approval of the request to operate other professional services, for sub- the facility. Otherwise, a request to stances so dispensed or administered. maintain records at a central location Records are required to be kept for must be submitted in accordance with controlled substances administered in § 1304.04 of this part. These records the course of maintenance or detoxi- must be maintained for a period of two fication treatment of an individual. years. (e) Each registered mid-level practi- (h) A person is required to keep the tioner shall maintain in a readily re- records and file the reports specified in trievable manner those documents re- § 1304.06 and part 1311 of this chapter if quired by the state in which he/she they are either of the following: practices which describe the conditions (1) An electronic prescription appli- and extent of his/her authorization to cation provider. dispense controlled substances and (2) An electronic pharmacy applica- shall make such documents available tion provider. for inspection and copying by authorized employees of the Administration. [36 FR 7790, Apr. 24, 1971, as amended at 36 Examples of such documentation in- FR 18731, Sept. 21, 1971; 37 FR 15920, Aug. 8, 1972. Redesignated at 38 FR 26609, Sept. 24, clude protocols, practice guidelines or 1973, and amended at 50 FR 40523, Oct. 4, 1985; practice agreements. 51 FR 5320, Feb. 13, 1986; 51 FR 26154, July 21, (f) Registered persons using any con- 1986; 58 FR 31175, June 1, 1993; 62 FR 13958, trolled substances while conducting Mar. 24, 1997; 65 FR 44679, July 19, 2000; 75 FR preclinical research, in teaching at a 16306, Mar. 31, 2010; 77 FR 4235, Jan. 27, 2012] registered establishment which maintains records with respect to such sub- § 1304.04 Maintenance of records and stances or conducting research in con- inventories. formity with an exemption granted (a) Except as provided in paragraphs under section 505(i) or 512(j) of the Fed- (a)(1) and (a)(2) of this section, every eral Food, Drug, and Cosmetic Act (21 inventory and other records required to U.S.C. 355(i) or 360b(j)) at a registered be kept under this part must be kept establishment which maintains records by the registrant and be available, for in accordance with either of those sec- at least 2 years from the date of such tions, are not required to keep records inventory or records, for inspection if he/she notifies the Administration of and copying by authorized employees the name, address, and registration of the Administration. number of the establishment maintain- (1) Financial and shipping records ing such records. This notification (such as invoices and packing slips but shall be given at the time the person not executed order forms subject to applies for registration or reregistra- §§ 1305.17 and 1305.27 of this chapter) tion and shall be made in the form of may be kept at a central location, an attachment to the application, rather than at the registered location,

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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 term care facilities may keep all (d) ARCOS participants who desire records required by this part for those authorization to report from other additional registered sites at the retail than their registered locations must pharmacy or other approved central lo- obtain a separate central reporting cation. identifier. Request for central report- (b) All registrants that are author- ing identifiers will be submitted to the ized to maintain a central record- ARCOS Unit. See the Table of DEA keeping system under paragraph (a) of Mailing Addresses in § 1321.01 of this this section shall be subject to the fol- chapter for the current mailing ad- lowing conditions: dress. (1) The records to be maintained at (e) All central recordkeeping permits the central record location shall not previously issued by the Administra- include executed order forms and in- tion expired September 30, 1980. ventories, which shall be maintained at (f) Each registered manufacturer, dis- each registered location. tributor, importer, exporter, narcotic (2) If the records are kept on micro- treatment program and compounder film, computer media or in any form for narcotic treatment program shall requiring special equipment to render maintain inventories and records of the records easily readable, the reg- controlled substances as follows: istrant shall provide access to such (1) Inventories and records of con- equipment with the records. If any trolled substances listed in Schedules I code system is used (other than pricing and II shall be maintained separately information), a key to the code shall be from all of the records of the reg- provided to make the records under- istrant; and standable. (2) Inventories and records of con- (3) The registrant agrees to deliver trolled substances listed in Schedules all or any part of such records to the III, IV, and V shall be maintained ei- registered location within two business ther separately from all other records days upon receipt of a written request of the registrant or in such form that

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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 that is readily understandable to an maintain the inventories and records of Administration or other law enforce- controlled substances as follows: ment agent at the registered location. (1) Inventories and records of all con- Electronic copies of prescription trolled substances listed in Schedule I 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. (3) Inventories and records of Sched- [36 FR 7790, Apr. 24, 1971, as amended at 36 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 phar- shall be maintained at the registered macies. 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 in the lower right corner with the let- fill pharmacy authorized to fill pre- ter ‘‘C’’ no less than 1 inch high and scriptions on its behalf. These records filed either in the prescription file for must be made available upon request controlled substances listed in Sched- for inspection by DEA. ules I and II or in the usual consecu- (b) Every central fill pharmacy must tively numbered prescription file for keep a record of all retail pharmacies, noncontrolled substances. However, if a including name, address and DEA num- pharmacy employs a computer applica- ber, for which it is authorized to fill tion for prescriptions that permits prescriptions. The central fill phar- identification by prescription number macy must also verify the registration and retrieval of original documents by for all retail pharmacies for which it is prescriber name, patient’s name, drug authorized to fill prescriptions. These dispensed, and date filled, then the re- records must be made available upon quirement to mark the hard copy pre- request for inspection by DEA. scription with a red ‘‘C’’ is waived. (5) Records of electronic prescrip- [68 FR 37410, June 24, 2003] tions for controlled substances shall be maintained in an application that meets the requirements of part 1311 of

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§ 1304.06 Records and reports for elec- INVENTORY REQUIREMENTS tronic prescriptions. § 1304.11 Inventory requirements. (a) As required by § 1311.120 of this chapter, a practitioner who issues elec- (a) General requirements. Each inven- tronic prescriptions for controlled sub- tory shall contain a complete and accu- stances must use an electronic pre- rate record of all controlled substances scription application that retains the on hand on the date the inventory is following information: taken, and shall be maintained in writ- (1) The digitally signed record of the ten, typewritten, or printed form at information specified in part 1306 of the registered location. An inventory this chapter. taken by use of an oral recording de- (2) The internal audit trail and any vice must be promptly transcribed. auditable event identified by the inter- Controlled substances shall be deemed nal audit as required by § 1311.150 of to be ‘‘on hand’’ if they are in the pos- this chapter. session of or under the control of the (b) An institutional practitioner registrant, including substances re- must retain a record of identity proof- turned by a customer, ordered by a cus- ing and issuance of the two-factor au- tomer but not yet invoiced, stored in a thentication credential, where applica- warehouse on behalf of the registrant, ble, as required by § 1311.110 of this and substances in the possession of em- chapter. ployees of the registrant and intended (c) As required by § 1311.205 of this for distribution as complimentary sam- chapter, a pharmacy that processes ples. A separate inventory shall be electronic prescriptions for controlled made for each registered location and substances must use an application each independent activity registered, that retains the following: except as provided in paragraph (e)(4) (1) All of the information required of this section. In the event controlled under § 1304.22(c) and part 1306 of this substances in the possession or under chapter. the control of the registrant are stored (2) The digitally signed record of the at a location for which he/she is not prescription as received as required by registered, the substances shall be in- § 1311.210 of this chapter. cluded in the inventory of the registered location to which they are sub- (3) The internal audit trail and any ject to control or to which the person auditable event identified by the inter- possessing the substance is responsible. nal audit as required by § 1311.215 of The inventory may be taken either as this chapter. of opening of business or as of the close (d) A registrant and application serv- of business on the inventory date and ice provider must retain a copy of any it shall be indicated on the inventory. security incident report filed with the (b) Initial inventory date. Every person Administration pursuant to §§ 1311.150 required to keep records shall take an and 1311.215 of this chapter. inventory of all stocks of controlled (e) An electronic prescription or substances on hand on the date he/she pharmacy application provider must first engages in the manufacture, dis- retain third party audit or certifi- tribution, or dispensing of controlled cation reports as required by § 1311.300 substances, in accordance with para- of this chapter. graph (e) of this section as applicable. (f) An application provider must re- In the event a person commences busi- tain a copy of any notification to the ness with no controlled substances on Administration regarding an adverse hand, he/she shall record this fact as audit or certification report filed with the initial inventory. the Administration on problems identi- (c) Biennial inventory date. After the fied by the third-party audit or certifi- initial inventory is taken, the reg- cation as required by § 1311.300 of this istrant shall take a new inventory of chapter. all stocks of controlled substances on (g) Unless otherwise specified, hand at least every two years. The bi- records and reports must be retained ennial inventory may be taken on any for two years. date which is within two years of the [75 FR 16306, Mar. 31, 2010] previous biennial inventory date.

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(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 chap- ounce or milliliter) and the number or ter adding a substance to any schedule volume thereof. of controlled substances, which sub- (iii) For each controlled substance in stance was, immediately prior to that finished form the inventory shall in- date, not listed on any such schedule, clude: every registrant required to keep (A) The name of the substance; records who possesses that substance (B) Each finished form of the sub- shall take an inventory of all stocks of stance (e.g., 10-milligram tablet or 10- the substance on hand. Thereafter, milligram concentration per fluid such substance shall be included in ounce or milliliter); each inventory made by the registrant (C) The number of units or volume of pursuant to paragraph (c) of this sec- each finished form in each commercial tion. container (e.g., 100-tablet bottle or 3- (e) Inventories of manufacturers, dis- milliliter vial); and tributors, dispensers, researchers, import- (D) The number of commercial con- ers, exporters and chemical analysts. tainers of each such finished form (e.g. Each person registered or authorized four 100-tablet bottles or six 3-milli- (by § 1301.13 or §§ 1307.11–1307.13 of this liter vials). chapter) to manufacture, distribute, (iv) For each controlled substance dispense, import, export, conduct re- not included in paragraphs (e)(1) (i), (ii) search or chemical analysis with con- or (iii) of this section (e.g., damaged, trolled substances and required to keep defective or impure substances await- records pursuant to § 1304.03 shall ining disposal, substances held for qual- clude in the inventory the information ity control purposes, or substances listed below. maintained for extemporaneous (1) Inventories of manufacturers. Each compoundings) the inventories shall person registered or authorized to man- include: ufacture controlled substances shall in- (A) The name of the substance; clude the following information in the (B) The total quantity of the sub- inventory: stance to the nearest metric unit (i) For each controlled substance in weight or the total number of units of bulk form to be used in (or capable of finished form; and use in) the manufacture of the same or (C) The reason for the substance other controlled or non-controlled sub- being maintained by the registrant and stances in finished form, the inventory whether such substance is capable of shall include: use in the manufacture of any con- (A) The name of the substance and trolled substance in finished form. (B) The total quantity of the sub- (2) Inventories of distributors. Except stance to the nearest metric unit for reverse distributors covered by weight consistent with unit size. paragraph (e)(3) of this section, each (ii) For each controlled substance in person registered or authorized to dis- the process of manufacture on the in- tribute controlled substances shall inventory date, the inventory shall include in the inventory the same infor- clude: mation required of manufacturers pur- (A) The name of the substance; suant to paragraphs (e)(1)(iii) and (iv) (B) The quantity of the substance in of this section. each batch and/or stage of manufac- (3) Inventories of dispensers, research- ture, identified by the batch number or ers, and reverse distributors. Each person other appropriate identifying number; registered or authorized to dispense, and conduct research, or act as a reverse (C) The physical form which the sub- distributor with controlled substances stance is to take upon completion of shall include in the inventory the same the manufacturing process (e.g., granu- information required of manufacturers lations, tablets, capsules, or solutions), pursuant to paragraphs (e)(1)(iii) and identified by the batch number or (iv) of this section. In determining the other appropriate identifying number, number of units of each finished form

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of a controlled substance in a commer- CONTINUING RECORDS cial container which has been opened, the dispenser, researcher, or reverse § 1304.21 General requirements for distributor shall do as follows: continuing records. (i) If the substance is listed in Sched- (a) Every registrant required to keep ule I or II, make an exact count or records pursuant to § 1304.03 shall main- measure of the contents, or tain on a current basis a complete and (ii) If the substance is listed in accurate record of each such substance Schedule III, IV or V, make an esti- manufactured, imported, received, mated count or measure of the con- sold, delivered, exported, or otherwise tents, unless the container holds more disposed of by him/her, except that no than 1,000 tablets or capsules in which registrant shall be required to main- case he/she must make an exact count tain a perpetual inventory. of the contents. (b) Separate records shall be main- (4) Inventories of importers and export- tained by a registrant for each reg- ers. Each person registered or author- istered location except as provided in ized to import or export controlled sub- § 1304.04 (a). In the event controlled stances shall include in the inventory substances are in the possession or the same information required of man- under the control of a registrant at a ufacturers pursuant to paragraphs location for which he is not registered, (e)(1) (iii) and (iv) of this section. Each the substances shall be included in the such person who is also registered as a records of the registered location to manufacturer or as a distributor shall which they are subject to control or to include in his/her inventory as an im- which the person possessing the sub- porter or exporter only those stocks of stance is responsible. controlled substances that are actually (c) Separate records shall be main- separated from his stocks as a manu- tained by a registrant for each inde- facturer or as a distributor (e.g., in pendent activity for which he/she is transit or in storage for shipment). registered, except as provided in (5) Inventories of chemical analysts. § 1304.22(d). Each person registered or authorized to (d) In recording dates of receipt, im- conduct chemical analysis with con- portation, distribution, exportation, or trolled substances shall include in his other transfers, the date on which the inventory the same information re- controlled substances are actually required of manufacturers pursuant to ceived, imported, distributed, exported, paragraphs (e)(1) (iii) and (iv) of this or otherwise transferred shall be used section as to substances which have as the date of receipt or distribution of been manufactured, imported, or re- any documents of transfer (e.g., in- ceived by such person. If less than 1 voices or packing slips). kilogram of any controlled substance (other than a hallucinogenic controlled [36 FR 7792, Apr. 24, 1971, as amended at 36 substance listed in Schedule I), or less FR 13386, July 21, 1971. Redesignated at 38 FR than 20 grams of a hallucinogenic sub- 26609, Sept. 24, 1973, as amended at 62 FR 13960, Mar. 24, 1997] stance listed in Schedule I (other than lysergic acid diethylamide), or less § 1304.22 Records for manufacturers, than 0.5 gram of lysergic acid distributors, dispensers, research- diethylamide, is on hand at the time of ers, importers and exporters. inventory, that substance need not be Each person registered or authorized included in the inventory. Laboratories (by § 1301.13(e) or §§ 1307.11–1307.13 of of the Administration may possess up this chapter) to manufacture, dis- to 150 grams of any hallucinogenic sub- tribute, dispense, import, export or stance in Schedule I without regard to conduct research with controlled sub- a need for an inventory of those substances shall maintain records with the stances. No inventory is required of information listed below. known or suspected controlled sub- (a) Records for manufacturers. Each stances received as evidentiary mate- person registered or authorized to man- rials for analysis. ufacture controlled substances shall [62 FR 13959, Mar. 24, 1997, as amended at 68 maintain records with the following in- FR 41228, July 11, 2003] formation:

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(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 (E) The quantity used in quality con- manufactured from bulk form by the trol; registrant, including the information (F) The quantity lost during manu- required pursuant to paragraph facturing and the causes therefore, if (a)(1)(v) of this section; known; (iv) The number of units of finished (G) The total quantity of the sub- forms and/or commercial containers stance contained in the finished form; acquired from other persons, including (H) The theoretical and actual yields; the date of and number of units and/or and commercial containers in each acquisi- (I) Such other information as is nection to inventory and the name, ad- essary to account for all controlled dress, and registration number of the substances used in the manufacturing person from whom the units were ac- process; quired; (vi) The quantity used to manufac- (v) The number of units of finished ture other controlled and noncon- forms and/or commercial containers trolled substances, including the name imported directly by the person (under of each substance manufactured and a registration or authorization to im- the information required in paragraph port), including the date of, the num- (a)(1)(v) of this section; ber of units and/or commercial con- (vii) The quantity distributed in bulk tainers in, and the import permit or form to other persons, including the declaration number for, each importa- date and quantity of each distribution tion;

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(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 by destruction), including the date and registration as a manufacturer, which manner of distribution or disposal, the quantities (and numbers of units and name, address, and registration num- volumes) are to be recorded pursuant ber of the person to whom distributed, to paragraphs (a)(1)(xiii) or (a)(2)(xiii) and the quantity in finished form dis- of this section. tributed or disposed. (e) Records for reverse distributors. (b) Records for distributors. Except as Each person registered to distribute provided in paragraph (e) of this sec- controlled substances as a reverse dis- tion, each person registered or author- tributor shall maintain records with ized to distribute controlled substances the following information for each con- shall maintain records with the same trolled substance: information required of manufacturers (1) For each controlled substance in pursuant to paragraphs (a)(2)(i), (ii), bulk form the following: (iv), (v), (vii), (viii) and (ix) of this sec- (i) The name of the controlled sub- tion. stance. (c) Records for dispensers and research- (ii) The total quantity of the con- ers. Each person registered or author- trolled substance to the nearest metric ized to dispense or conduct research unit weight consistent with unit size. with controlled substances shall main- (iii) The quantity received from tain records with the same information other persons, including the date and required of manufacturers pursuant to quantity of each receipt and the name, paragraph (a)(2)(i), (ii), (iv), (vii), and address, and registration number of the

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other person from whom the controlled conduct chemical analysis with con- substance was received. trolled substances shall maintain (iv) The quantity returned to the records with the following information original manufacturer of the controlled (to the extent known and reasonably substance or the manufacturer’s agent, ascertainable by him) for each con- including the date of and quantity of trolled substance: each distribution and the name, ad- (1) The name of the substance; dress and registration number of the (2) The form or forms in which the manufacturer or manufacturer’s agent substance is received, imported, or to whom the controlled substance was manufactured by the registrant (e.g., distributed. powder, granulation, tablet, capsule, or (v) The quantity disposed of includ- solution) and the concentration of the ing the date and manner of disposal substance in such form (e.g., C.P., and the signatures of two responsible U.S.P., N.F., 10-milligram tablet or 10- employees of the registrant who wit- milligram concentration per milli- nessed the disposal. liter); (2) For each controlled substance in (3) The total number of the forms re- finished form the following: ceived, imported or manufactured (e.g., (i) The name of the substance. 100 tablets, thirty 1-milliliter vials, or (ii) Each finished form (e.g., 10-milli- 10 grams of powder), including the date gram tablet or 10-milligram concentra- and quantity of each receipt, importation per fluid ounce or milliliter) and tion, or manufacture and the name, ad- the number of units or volume of fin- dress, and registration number, if any, ished form in each commercial con- of the person from whom the substance tainer (e.g., 100-tablet bottle or 3-milli- was received; liter vial). (4) The quantity distributed, ex- (iii) The number of commercial con- ported, or destroyed in any manner by tainers of each such finished form re- the registrant (except quantities used ceived from other persons, including in chemical analysis or other labora- the date of and number of containers in tory work), including the date and each receipt and the name, address, manner of distribution, exportation, or and registration number of the person destruction, and the name, address, from whom the containers were re- and registration number, if any, of ceived. each person to whom the substance was (iv) The number of commercial con- distributed or exported. tainers of each such finished form dis- (b) Records of controlled substances tributed back to the original manufac- used in chemical analysis or other lab- turer of the substance or the manufac- oratory work are not required. turer’s agent, including the date of and (c) Records relating to known or sus- number of containers in each distribu- pected controlled substances received tion and the name, address, and reg- as evidentiary material for analysis are istration number of the manufacturer not required under paragraph (a) of or manufacturer’s agent to whom the this section. containers were distributed. (v) The number of units or volume of [36 FR 7793, Apr. 24, 1971, as amended at 36 finished forms and/or commercial con- FR 13386, July 21, 1971; 36 FR 18732, Sept. 21, tainers disposed of including the date 1971. Redesignated at 38 FR 26609, Sept. 24, 1973, and further redesignated at 62 FR 13961, and manner of disposal, the quantity of Mar. 24, 1997] the substance in finished form disposed, and the signatures of two re- § 1304.24 Records for maintenance sponsible employees of the registrant treatment programs and detoxifica- who witnessed the disposal. tion treatment programs. [62 FR 13960, Mar. 24, 1997, as amended at 68 (a) Each person registered or author- FR 41229, July 11, 2003; 70 FR 293, Jan. 4, 2005] ized (by § 1301.22 of this chapter) to maintain and/or detoxify controlled § 1304.23 Records for chemical ana- substance users in a narcotic treat- lysts. ment program shall maintain records (a) Each person registered or author- with the following information for each ized (by § 1301.22(b) of this chapter) to narcotic controlled substance:

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(1) Name of substance; other person from whom the substance (2) Strength of substance; was received; (3) Dosage form; (4) The quantity imported directly by (4) Date dispensed; the registrant (under a registration as (5) Adequate identification of patient an importer) for use in compounding by (consumer); 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 which are maintained in connection (vi) The quantity lost during with the performance of a narcotic compounding and the causes therefore, treatment program shall be confiden- if known; tial, except that such records may be (vii) The total quantity of the sub- disclosed for purposes and under the stance contained in the finished form; circumstances authorized by part 310 (viii) The theoretical and actual and 42 CFR part 2. yields; and (ix) Such other information as is nec- [39 FR 37985, Oct. 25, 1974. Redesignated and essary to account for all controlled amended at 62 FR 13961, Mar. 24, 1997] substances used in the compounding § 1304.25 Records for treatment pro- process; grams which compound narcotics (6) The quantity used to manufacture for treatment programs and other other controlled and non-controlled locations. substances; including the name of each Each person registered or authorized substance manufactured and the infor- by § 1301.22 of this chapter to compound mation required in paragraph (a)(5) of narcotic drugs for off-site use in a nar- this section; cotic treatment program shall main- (7) The quantity distributed in bulk tain records which include the fol- form to other programs, including the lowing information for each narcotic date and quantity of each distribution drug: and the name, address and registration (a) For each narcotic controlled sub- number of each program to whom a dis- stance in bulk form to be used in, or tribution was made; capable of use in, or being used in, the (8) The quantity exported directly by compounding of the same or other non- the registrant (under a registration as controlled substances in finished form: an exporter), including the date, quan- (1) The name of the substance; tity, and export permit or declaration (2) The quantity compounded in bulk number of each exploration; and form by the registrant, including the (9) The quantity disposed of by de- date, quantity and batch or other iden- struction, including the reason, date tifying number of each batch com- and manner of destruction. All other pounded; destruction of narcotic controlled sub- (3) The quantity received from other stances will comply with § 1307.22. persons, including the date and quan- (b) For each narcotic controlled sub- tity of each receipt and the name, ad- stance in finished form: dress and registration number of the (1) The name of the substance;

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(2) Each finished form (e.g., 10-milli- laration number for each exportation; gram tablet or 10 milligram concentra- and tion per fluid ounce or milliliter) and (9) The number of units of finished the number of units or volume or fin- forms and/or commercial containers ished form in each commercial con- destroyed in any manner by the reg- tainer (e.g., 100-tablet bottle or 3-milli- istrant, including the reason, the date liter vial); and manner of destruction. All other (3) The number of containers of each destruction of narcotic controlled sub- such commercial finished form com- stances will comply with § 1307.22. pounded from bulk form by the reg- [39 FR 37985, Oct. 25, 1974. Redesignated at 62 istrant, including the information re- FR 13961, Mar. 24, 1997] quired pursuant to paragraph (a)(5) of this section; § 1304.26 Additional recordkeeping re- (4) The number of units of finished quirements applicable to drug prod- forms and/or commercial containers re- ucts containing gamma-hydroxy- ceived from other persons, including butyric acid. the date of and number of units and/or In addition to the recordkeeping re- commercial containers in each receipt quirements for dispensers and research- and the name, address and registration ers provided in § 1304.22, practitioners number of the person from whom the dispensing gamma-hydroxybutyric acid units were received; that is manufactured or distributed in (5) The number of units of finished accordance with an application under forms and/or commercial containers section 505 of the Federal Food, Drug, imported directly by the person (under and Cosmetic Act must maintain and a registration or authorization to im- make available for inspection and port), including the date of, the num- copying by the Attorney General, all of ber of units and/or commercial con- the following information for each pre- tainers in, and the import permit or scription: declaration number for, each importa- (a) Name of the prescribing practi- tion; tioner. (6) The number of units and/or com- (b) Prescribing practitioner’s Federal mercial containers compounded by the and State registration numbers, with registrant from units in finished form the expiration dates of these registra- received from others or imported, in- tions. cluding: (c) Verification that the prescribing (i) The date and batch or other iden- practitioner possesses the appropriate tifying number of each compounding; registration to prescribe this con- (ii) The operation performed (e.g., re- trolled substance. packaging or relabeling); (d) Patient’s name and address. (iii) The number of units of finished (e) Patient’s insurance provider, if form used in the compound, the num- available. ber compounded and the number lost [70 FR 293, Jan. 4, 2005] during compounding, with the causes for such losses, if known; and REPORTS (iv) Such other information as is necessary to account for all controlled § 1304.31 Reports from manufacturers substances used in the compounding importing narcotic raw material. process; (a) Every manufacturer which im- (7) The number of containers distrib- ports or manufactures from narcotic uted to other programs, including the raw material (opium, poppy straw, and date, the number of containers in each concentrate of poppy straw) shall sub- distribution, and the name, address and mit information which accounts for the registration number of the program to importation and for all manufacturing whom the containers were distributed; operations performed between importa- (8) The number of commercial con- tion and the production in bulk or fin- tainers exported directly by the reg- ished marketable products, standard- istrant (under a registration as an ex- ized in accordance with the U.S. Phar- porter), including the date, number of macopeia, National Formulary or other containers and export permit or dec- recognized medical standards. Reports

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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; stock record card on which shall be (3) Imports; kept a complete record of all with- (4) Other receipts; drawals therefrom. (5) Quantity put into process; (g) All in-process inventories should (6) Losses on reweighing; be expressed in terms of end-products (7) Other dispositions and and not precursors. Once precursor ma- (8) Ending inventory. terial has been changed or placed into (c) The following information shall process for the manufacture of a speci- be submitted for each narcotic raw ma- fied end-product, it must no longer be terial derivative including morphine, accounted for as precursor stocks codeine, thebaine, oxycodone, available for conversion or use, but hydrocodone, medicinal opium, manu- rather as end-product in-process inven- facturing opium, crude alkaloids and tories. other derivatives (quantities are expressed 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] ufacturing opium and medicinal opium): § 1304.32 Reports of manufacturers importing coca leaves. (1) Beginning inventory; (2) Gains on reweighing; (a) Every manufacturer importing or (3) Quantity extracted from narcotic manufacturing from raw coca leaves raw material; shall submit information accounting (4) Quantity produced/manufactured/ for the importation and for all manu- synthesized; facturing operations performed be- (5) Quantity sold; tween the importation and the manu- (6) Quantity returned to conversion facture of bulk or finished products processes for reworking; standardized in accordance with U.S. (7) Quantity used for conversion; Pharmacopoeia, National Formulary, (8) Quantity placed in process; or other recognized standards. The re- (9) Other dispositions; ports shall be submitted quarterly on (10) Losses on reweighing and company letterhead to the Drug and (11) Ending inventory. Chemical Evaluation Section, Drug En- (d) The following information shall forcement Administration, on or before be submitted for importation of each the 15th day of the month immediately narcotic raw material: following the period for which it is sub- (1) Import permit number; mitted. See the Table of DEA Mailing (2) Date shipment arrived at the Addresses in § 1321.01 of this chapter for United States port of entry; the current mailing address. (3) Actual quantity shipped; (b) The following information shall (4) Assay (percent) of morphine, co- be submitted for raw coca leaf, ecgo- deine and thebaine and nine, ecgonine for conversion or fur- (5) Quantity shipped, expressed as an- ther manufacture, benzoylecgonine, hydrous morphine alkaloid. manufacturing coca extracts (list for

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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; (6) Other receipts; (a) Reports generally. All reports re- (7) Quantity returned to processes for quired by this section shall be filed reworking; with the ARCOS Unit on DEA Form (8) Material used in purification for 333, or on media which contains the sale; data required by DEA Form 333 and (9) Material used for manufacture or which is acceptable to the ARCOS production; Unit. See the Table of DEA Mailing Ad- (10) Losses on reweighing; dresses in § 1321.01 of this chapter for (11) Material used for conversion; the current mailing address. (12) Other dispositions and (b) Frequency of reports. Acquisition/ (13) Ending inventory. Distribution transaction reports shall (c) The following information shall be filed every quarter not later than be submitted for importation of coca the 15th day of the month succeeding leaves: the quarter for which it is submitted; (1) Import permit number; except that a registrant may be given (2) Date the shipment arrived at the permission to file more frequently (but United States port of entry; not more frequently than monthly), de- (3) Actual quantity shipped; pending on the number of transactions (4) Assay (percent) of cocaine alka- being reported each time by that reg- loid and istrant. Inventories shall provide data (5) Total cocaine alkaloid content. on the stocks of each reported con- (d) Upon importation of coca leaves, trolled substance on hand as of the samples will be selected and assays close of business on December 31 of made by the importing manufacturer each year, indicating whether the sub- in accordance with recognized chem- stance is in storage or in process of ical procedures. These assays shall manufacturing. These reports shall be form the basis of accounting for such filed not later than January 15 of the coca leaves, which shall be accounted following year. Manufacturing trans- for in terms of their cocaine alkaloid action reports shall be filed annually content or equivalency or their total for each calendar year not later than anhydrous coca alkaloid content. January 15 of the following year, ex- Where final assay data is not deter- cept that a registrant may be given mined at the time of submission, the permission to file more frequently (but report shall be made on the basis of the not more frequently than quarterly). best data available, subject to adjust- (c) Persons reporting. For controlled ment, and the necessary adjusting en- substances in Schedules I, II, narcotic tries shall be made on the next report. controlled substances in Schedule III, (e) Where factory procedure is such and gamma-hydroxybutyric acid drug that partial withdrawals of medicinal product controlled substances in coca leaves are made from individual Schedule III, each person who is reg- containers, there shall be attached to istered to manufacture in bulk or dos- the container a stock record card on age form, or to package, repackage, which shall be kept a complete record label or relabel, and each person who is of withdrawals therefrom. registered to distribute, including each (f) All in-process inventories should person who is registered to reverse dis- be expressed in terms of end-products tribute, shall report acquisition/dis- and not precursors. Once precursor ma- tribution transactions. In addition to terial has been changed or placed into reporting acquisition/distribution

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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 containing a quantity of a substance hav- who distributes exclusively to (for dis- ing a stimulant effect on the central pensing by) agents, employees, or af- nervous system, which material, com- filiated institutional practitioners of pound, mixture or preparation is listed the registrant may be exempted from in Schedule III or on any narcotic con- filing reports under this section by ap- trolled substance listed in Schedule V), plying to the ARCOS Unit of the Ad- and on gamma-hydroxybutyric acid ministration. 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 following psychotropic controlled sub- [62 FR 13962, Mar. 24, 1997, as amended at 68 FR 41229, July 11, 2003; 70 FR 294, Jan. 4, 2005; stances listed in Schedules III and IV: 75 FR 10678, Mar. 9, 2010] (i) Schedule III (A) Benzphetamine; ONLINE PHARMACIES (B) Cyclobarbital; (C) Methyprylon; and § 1304.40 Notification by online phar- (D) Phendimetrazine. macies. (ii) Schedule IV (a) Thirty days prior to offering a (A) Barbital; controlled substance for sale, delivery, (B) Diethylpropion (Amfepramone); distribution, or dispensing by means of (C) Ethchlorvynol; the Internet, an online pharmacy shall: (D) Ethinamate; (E) Lefetamine (SPA); (1) Notify the Administrator of its in- (F) Mazindol; tent to do so by submitting an applica- (G) Meprobamate; tion for a modified registration in ac- (H) Methylphenobarbital; cordance with §§ 1301.13 and 1301.19 of (I) Phenobarbital; this chapter, with such application (J) Phentermine; and containing the information required by (K) Pipradrol. this section; and (2) Data shall be presented in such a (2) Notify the State boards of phar- manner as to identify the particular macy in any States in which the online form, strength, and trade name, if any, pharmacy offers to sell, deliver, dis- of the product containing the contribute, or dispense controlled sub- trolled substancefor which the report is stances. being made. For this purpose, persons (b) The following information must filing reports shall utilize the National be included in the notification sub- Drug Code Number assigned to the mitted under paragraph (a) of this sec- product under the National Drug Code tion:

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(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 submitted under this section changes (3) Each Internet site address utilized after the online pharmacy submits the by the online pharmacy and a certifi- notification to the Administrator, the cation that the online pharmacy shall online pharmacy shall notify the Ad- notify the Administrator of any change ministrator of the updated information in any such Internet address at least 30 no later than 30 days before the change days in advance. In the event that a becomes effective via the online proc- pharmacy delivers, distributes, or dis- ess. penses controlled substances pursuant (2) If a pharmacy referred to in para- to orders made on, through, or on be- graph (b)(4)(i) of this section ceases to half of, more than one Web site, the deliver, distribute, or dispense con- pharmacy shall provide, for purposes of trolled substances pursuant to orders complying with this paragraph, the made on, through, or on behalf of, each Internet site address of each such site. Web site referred to in paragraph (b)(3) (4) The DEA registration numbers of: of this section, the online pharmacy (i) Every pharmacy that delivers, dis- shall notify the Administrator no later tributes, or dispenses controlled sub- than 30 days after the change becomes stances pursuant to orders made on, effective via the online process. through, or on behalf of, each Web site (3) If a practitioner referred to in referred to in paragraph (b)(3) of this paragraph (b)(4)(ii) of this section section; and ceases to have a contractual relation- (ii) Every practitioner who has a con- ship with the online pharmacy, the on- tractual relationship to provide med- line pharmacy shall notify the Admin- ical evaluations or issue prescriptions istrator no later than 30 days after the for controlled substances, through re- change becomes effective via the online ferrals from the Web site or at the re- process. quest of the owner or operator of the [74 FR 15623, Apr. 6, 2009] Web site, or any employee or agent thereof. § 1304.45 Internet Web site disclosure (c) An online pharmacy that is in op- requirements. eration at the time Public Law 110–425 (a) Each online pharmacy shall dis- becomes effective (April 13, 2009) must play, at all times and in a visible and make the notifications required in this clear manner, on its homepage a state- section on or before May 13, 2009. How- ment that it complies with the require- ever, in accordance with section 401(h) ments of section 311 of the Act (21 of the Act (21 U.S.C. 841(h)), as of April U.S.C. 831) with respect to the delivery 13, 2009, it is unlawful for any online or sale or offer for sale of controlled pharmacy to deliver, distribute, or dis- substances. This statement must in- pense a controlled substance by means clude the name of the pharmacy as it of the Internet unless such online phar- appears on the DEA Certificate of Reg- macy is validly registered with a modi- istration. fication of such registration author- (b) Each online pharmacy shall clear- izing such activity. ly display the following information on

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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 contractual relationship to provide on its homepage and in a manner that medical evaluations or issue prescrip- identifies itself as being responsible for tions for controlled substances, the operation of the Web site. through referrals from the Web site or [74 FR 15623, Apr. 6, 2009] at the request of the owner or operator of the Web site, or any employee or § 1304.55 Reports by online phar- agent thereof. macies. (7) The following statement: ‘‘This (a) Each online pharmacy shall re- online pharmacy is obligated to com- port to the Administrator the total ply fully with the Controlled Sub- quantity of each controlled substance stances Act and DEA regulations. As that the pharmacy has dispensed each part of this obligation, this online calendar month. The report must in- pharmacy has obtained a modified DEA clude the total quantity of such dis- registration authorizing it to operate pensing by any means, regardless of as an online pharmacy. In addition, whether the controlled substances are this online pharmacy will only dis- dispensed by means of the Internet. pense a controlled substance to a per- Thus, such reporting shall include all son who has a valid prescription issued controlled substances dispensed via for a legitimate medical purpose based Internet transactions, mail-order upon a medical relationship with a pre- transactions, face-to-face transactions, scribing practitioner. This includes at or any other means. However, the phar- least one prior in-person medical eval- macy is not required to describe in its uation in accordance with section 309 report to the Administrator such of the Controlled Substances Act (21 means of dispensing. Such reporting is U.S.C. 829) or a medical evaluation via required for every calendar month in

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which the total quantity of controlled PART 1305—ORDERS FOR SCHED- substances dispensed by the pharmacy ULE I AND II CONTROLLED SUB- meets or exceeds one of the following STANCES thresholds: (1) 100 or more prescriptions for con- Subpart A—General Requirements trolled substances filled; or (2) 5,000 or more dosage units dis- Sec. 1305.01 Scope of part 1305. pensed of all controlled substances 1305.02 Definitions. combined. 1305.03 Distributions requiring a Form 222 (b) Each online pharmacy shall re- or digitally signed electronic order. port a negative response if, during a 1305.04 Persons entitled to order Schedule I given calendar month, its total dis- and II controlled substances. 1305.05 Power of attorney. pensing of controlled substances falls 1305.06 Persons entitled to fill orders for below both of the thresholds in para- Schedule I and II controlled substances. graph (a) of this section. 1305.07 Special procedure for filling certain (c) The reporting requirements of orders. this section apply to every pharmacy Subpart B—DEA Form 222 that, at any time during a calendar month, holds a modified registration 1305.11 Procedure for obtaining DEA Forms authorizing it to operate as an online 222. pharmacy, regardless of whether the 1305.12 Procedure for executing DEA Forms 222. online pharmacy dispenses any con- 1305.13 Procedure for filling DEA Forms 222. trolled substances by means of the 1305.14 Procedure for endorsing DEA Forms Internet during the month. 222. (d) Reports will be submitted to DEA 1305.15 Unaccepted and defective DEA electronically via online reporting, Forms 222. 1305.16 Lost and stolen DEA Forms 222. electronic file upload, or other means 1305.17 Preservation of DEA Forms 222. as approved by DEA. 1305.18 Return of unused DEA Forms 222. (e) Reports shall be filed every month 1305.19 Cancellation and voiding of DEA not later than the fifteenth day of the Forms 222. month succeeding the month for which Subpart C—Electronic Orders they are submitted. (f) An online pharmacy filing a report 1305.21 Requirements for electronic orders. under paragraph (a) of this section 1305.22 Procedure for filling electronic or- shall utilize the National Drug Code ders. 1305.23 Endorsing electronic orders. number assigned to the product under 1305.24 Central processing of orders. the National Drug Code System of the 1305.25 Unaccepted and defective electronic Food and Drug Administration, and in- orders. dicate the total number of dosage units 1305.26 Lost electronic orders. dispensed for each such National Drug 1305.27 Preservation of electronic orders. 1305.28 Canceling and voiding electronic or- Code number. ders. (g) Records required to be kept under 1305.29 Reporting to DEA. this section must be kept by the reg- AUTHORITY: 21 U.S.C. 821, 828, 871(b), unless istrant for at least two years from the otherwise noted. date of such records. The information SOURCE: 70 FR 16911, Apr. 1, 2005, unless shall be readily retrievable from the otherwise noted. ordinary business records of the registrant and available for inspection and Subpart A—General Requirements copying by authorized employees of the Administration. § 1305.01 Scope of part 1305. [74 FR 15623, Apr. 6, 2009] Procedures governing the issuance, use, and preservation of orders for Schedule I and II controlled substances are set forth generally by section 308 of the Act (21 U.S.C. 828) and specifically by the sections of this part.

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§ 1305.02 Definitions. to issue orders for Schedule I and II Any term contained in this part shall controlled substances on the reg- have the definition set forth in the Act istrant’s behalf by executing a power of or part 1300 of this chapter. attorney for each such individual, if the power of attorney is retained in the § 1305.03 Distributions requiring a files, with executed Forms 222 where Form 222 or a digitally signed elec- applicable, for the same period as any tronic order. order bearing the signature of the at- Either a DEA Form 222 or its elec- torney. The power of attorney must be tronic equivalent as set forth in sub- available for inspection together with part C of this part and Part 1311 of this other order records. chapter is required for each distribu- (b) A registrant may revoke any tion of a Schedule I or II controlled power of attorney at any time by exe- substance except for the following: cuting a notice of revocation. (a) Distributions to persons exempted (c) The power of attorney and notice from registration under Part 1301 of of revocation must be similar to the this chapter. following format: (b) Exports from the United States Power of Attorney for DEA Forms 222 that conform with the requirements of and Electronic Orders the Act. (c) Deliveries to a registered analyt- llllllllllllllllllllllll ical laboratory or its agent approved (Name of registrant) by DEA. llllllllllllllllllllllll (d) Delivery from a central fill phar- (Address of registrant) macy, as defined in § 1300.01 of this llllllllllllllllllllllll chapter, to a retail pharmacy. (DEA registration number) [70 FR 16911, Apr. 1, 2005, as amended at 77 I, llll (name of person granting FR 4235, Jan. 27, 2012] 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 dle Schedule I or II controlled sub- accordance with 21 U.S.C. 828 and Part stances and persons registered only to 1305 of Title 21 of the Code of Federal import controlled substances are not Regulations. I hereby ratify and con- entitled to obtain Form 222 or issue firm all that said attorney must law- electronic orders for these substances. fully do or cause to be done by virtue (b) An order for Schedule I or II con- hereof. trolled substances may be executed llllllllllllllllllllllll only on behalf of the registrant named (Signature of person granting power) on the order and only if his or her reg- I, llll (name of attorney-in-fact), istration for the substances being pur- hereby affirm that I am the person chased has not expired or been revoked named herein as attorney-in-fact and or suspended. that the signature affixed hereto is my signature. § 1305.05 Power of attorney. (signature of attorney-in-fact) (a) A registrant may authorize one or more individuals, whether or not lo- Witnesses: cated at his or her registered location, 1. llllll

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2. llllll (b) A purchaser who has obtained any Schedule I or II controlled substance Signed and dated on the llll day of llll, (year), at llll . by either a DEA Form 222 or an electronic 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 has been given to the attorney-in-fact (d) A person registered or authorized to conduct chemical analysis or re- llll this same day. search with controlled substances may llllllllllllllllllllllll (Signature of person revoking power) distribute a Schedule I or II controlled Witnesses: substance to another person registered 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, , (year), at . llll 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 § 1305.06 Persons entitled to fill orders off-site narcotic treatment programs for Schedule I and II controlled only. substances. § 1305.07 Special procedure for filling An order for Schedule I and II con- certain orders. trolled substances, whether on a DEA Form 222 or an electronic order, may A supplier of carfentanil, etorphine be filled only by a person registered hydrochloride, or diprenorphine, if he with DEA as a manufacturer or dis- or she determines that the purchaser is tributor of controlled substances listed a veterinarian engaged in zoo and ex- in Schedule I or II pursuant to section otic animal practice, wildlife manage- 303 of the Act (21 U.S.C. 823) or as an ment programs, or research, and is au- importer of such substances pursuant thorized by the Administrator to han- to section 1008 of the Act (21 U.S.C. dle these substances, may fill the order 958), except for the following: in accordance with the procedures set (a) A person registered with DEA to forth in § 1305.17 except that: dispense the substances, or to export (a) A DEA Form 222 or an electronic the substances, if he/she is dis- order for carfentanil, etorphine hydro- continuing business or if his/her reg- chloride, and diprenorphine must con- istration is expiring without rereg- tain only these substances in reason- istration, may dispose of any Schedule able quantities. I or II controlled substances in his/her (b) The substances must be shipped, possession with a DEA Form 222 or an under secure conditions using substan- electronic order in accordance with tial packaging material with no mark- § 1301.52 of this chapter. ings on the outside that would indicate

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the content, only to the purchaser’s mation cannot be altered or changed registered location. by the registrant; any errors must be corrected by the Registration Section Subpart B—DEA Form 222 of the Administration by returning the forms with notification of the error. § 1305.11 Procedure for obtaining DEA Forms 222. § 1305.12 Procedure for executing DEA (a) DEA Forms 222 are issued in mail- Forms 222. ing envelopes containing either seven (a) A purchaser must prepare and or fourteen forms, each form con- execute a DEA Form 222 simulta- taining an original, duplicate, and trip- neously in triplicate by means of licate copy (respectively, Copy 1, Copy interleaved carbon sheets that are part 2, and Copy 3). A limit, which is based of the DEA Form 222. DEA Form 222 on the business activity of the reg- must be prepared by use of a type- istrant, will be imposed on the number writer, pen, or indelible pencil. of DEA Forms 222, which will be fur- (b) Only one item may be entered on nished on any requisition unless addi- each numbered line. An item must con- tional forms are specifically requested sist of one or more commercial or bulk and a reasonable need for such addi- containers of the same finished or bulk tional forms is shown. form and quantity of the same sub- (b) Any person applying for a reg- stance. The number of lines completed istration that would entitle him or her must be noted on that form at the bot- to obtain a DEA Form 222 may requisi- tom of the form, in the space provided. tion the forms by so indicating on the DEA Forms 222 for carfentanil, application form; a DEA Form 222 will etorphine hydrochloride, and be supplied upon the registration of the diprenorphine must contain only these applicant. Any person holding a reg- substances. istration entitling him or her to obtain (c) The name and address of the sup- a DEA Form 222 may requisition the plier from whom the controlled sub- forms for the first time by contacting stances are being ordered must be en- any Division Office or the Registration tered on the form. Only one supplier Section of the Administration. Any may be listed on any form. person already holding a DEA Form 222 (d) Each DEA Form 222 must be may requisition additional forms on signed and dated by a person author- DEA Form 222a, which is mailed to a ized to sign an application for registra- registrant approximately 30 days after tion or a person granted power of at- each shipment of DEA Forms 222 to torney to sign a Form 222 under that registrant, or by contacting any § 1305.05. The name of the purchaser, if Division Office or the Registration Sec- different from the individual signing tion of the Administration. All requisi- the DEA Form 222, must also be in- tion forms (DEA Form 222a) must be serted in the signature space. submitted to the DEA Registration (e) Unexecuted DEA Forms 222 may Section. be kept and may be executed at a loca- (c) Each requisition must show the tion other than the registered location name, address, and registration num- printed on the form, provided that all ber of the registrant and the number of unexecuted forms are delivered books of DEA Forms 222 desired. Each promptly to the registered location requisition must be signed and dated upon an inspection of the location by by the same person who signed the any officer authorized to make inspec- most recent application for registrations, or to enforce, any Federal, State, tion or for reregistration, or by any or local law regarding controlled sub- person authorized to obtain and exe- stances. cute DEA Forms 222 by a power of attorney under § 1305.05. § 1305.13 Procedure for filling DEA (d) DEA Forms 222 will be serially Forms 222. numbered and issued with the name, (a) A purchaser must submit Copy 1 address, and registration number of the and Copy 2 of the DEA Form 222 to the registrant, the authorized activity, and supplier and retain Copy 3 in the pur- schedules of the registrant. This infor- chaser’s files.

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(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 on the DEA Form 222, except as speci- chaser. fied 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 shipments, Copy 2 must be forwarded at the § 1305.15 Unaccepted and defective close of the month during which the DEA Forms 222. 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 fense Supply Center of the Defense Lo- the purchaser with a statement as to gistics Agency for delivery to armed the reason (e.g., illegible or altered). services establishments within the United States may be shipped to loca- (c) A supplier may for any reason tions other than the location printed refuse to accept any order and if a sup- on the DEA Form 222, and in partial plier refuses to accept the order, a shipments at different times not to ex- statement that the order is not accept- ceed six months from the date of the ed is sufficient for purposes of this order, as designated by the procure- paragraph. ment officer when submitting the (d) When a purchaser receives an order. unaccepted order, Copies 1 and 2 of the DEA Form 222 and the statement must § 1305.14 Procedure for endorsing DEA be attached to Copy 3 and retained in Forms 222. the files of the purchaser in accordance (a) A DEA Form 222, made out to any with § 1305.17. A defective DEA Form supplier who cannot fill all or a part of 222 may not be corrected; it must be re- the order within the time limitation placed by a new DEA Form 222 for the set forth in § 1305.13, may be endorsed order to be filled.

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§ 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 DEA Form 222 is subsequently received a purchaser has several registered loca- by the supplier to whom it was ditions, the purchaser must retain Copy 3 rected, the supplier must mark upon of the executed DEA Form 222 and any the face ‘‘Not accepted’’ and return attached statements or other related Copies 1 and 2 to the purchaser, who documents (not including unexecuted must attach it to Copy 3 and the state- DEA Forms 222, which may be kept ment. elsewhere under § 1305.12(e)), at the reg- (b) Whenever any used or unused istered location printed on the DEA DEA Forms 222 are stolen or lost (other Form 222. than in the course of transmission) by (d) The supplier of carfentanil, any purchaser or supplier, the pur- etorphine hydrochloride, and chaser or supplier must immediately diprenorphine must maintain DEA upon discovery of the theft or loss, re- Forms 222 for these substances sepa- port the theft or loss to the Special rately from all other DEA Forms 222 Agent in Charge of the Drug Enforce- and records required to be maintained ment Administration in the Divisional by the registrant. Office responsible for the area in which the registrant is located, stating the § 1305.18 Return of unused DEA Forms serial number of each form stolen or 222. lost. If the registration of any purchaser (c) If the theft or loss includes any terminates (because the purchaser dies, original DEA Forms 222 received from ceases legal existence, discontinues purchasers and the supplier is unable business or professional practice, or to state the serial numbers of the DEA changes the name or address as shown Forms 222, the supplier must report the on the purchaser’s registration) or is date or approximate date of receipt and suspended or revoked under § 1301.36 of the names and addresses of the pur- this chapter for all Schedule I and II chasers. (d) If an entire book of DEA Forms controlled substances for which the 222 is lost or stolen, and the purchaser purchaser is registered, the purchaser is unable to state the serial numbers of must return all unused DEA Forms 222 the DEA Forms 222 in the book, the to the nearest office of the Administra- purchaser must report, in lieu of the tion. numbers of the forms contained in the book, the date or approximate date of § 1305.19 Cancellation and voiding of DEA Forms 222. issuance. (e) If any unused DEA Form 222 re- (a) A purchaser may cancel part or ported stolen or lost is subsequently all of an order on a DEA Form 222 by recovered or found, the Special Agent notifying the supplier in writing of the in Charge of the Drug Enforcement Ad- cancellation. The supplier must indi- ministration in the Divisional Office cate the cancellation on Copies 1 and 2 responsible for the area in which the of the DEA Form 222 by drawing a line

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through the canceled items and print- § 1305.22 Procedure for filling elec- ing ‘‘canceled’’ in the space provided tronic orders. for number of items shipped. (a) A purchaser must submit the (b) A supplier may void part or all of order to a specific supplier. The sup- an order on a DEA Form 222 by noti- plier may initially process the order fying the purchaser in writing of the (e.g., entry of the order into the com- voiding. The supplier must indicate the puter system, billing functions, inven- voiding in the manner prescribed for tory identification, etc.) centrally at cancellation in paragraph (a) of this any location, regardless of the loca- section. tion’s registration with DEA. Fol- lowing centralized processing, the sup- Subpart C—Electronic Orders plier may distribute the order to one or more registered locations maintained § 1305.21 Requirements for electronic by the supplier for filling. The reg- orders. istrant must maintain control of the processing of the order at all times. (a) To be valid, the purchaser must (b) A supplier may fill the order for a sign an electronic order for a Schedule Schedule I or II controlled substance, if I or II controlled substance with a dig- possible and if the supplier desires to ital signature issued to the purchaser, do so and is authorized to do so under or the purchaser’s agent, by DEA as § 1305.06. provided in part 1311 of this chapter. (c) A supplier must do the following (b) The following data fields must be before filling the order: included on an electronic order for (1) Verify the integrity of the signa- Schedule I and II controlled sub- ture and the order by using software stances: that complies with Part 1311 of this (1) A unique number the purchaser chapter to validate the order. assigns to track the order. The number (2) Verify that the digital certificate must be in the following 9-character has not expired. format: the last two digits of the year, (3) Check the validity of the certifi- X, and six characters as selected by the cate holder’s certificate by checking purchaser. the Certificate Revocation List. The (2) The purchaser’s DEA registration supplier may cache the Certificate number. Revocation List until it expires. (3) The name of the supplier. (4) Verify the registrant’s eligibility (4) The complete address of the sup- to order the controlled substances by plier (may be completed by either the checking the certificate extension purchaser or the supplier). data. (5) The supplier’s DEA registration (d) The supplier must retain an elec- number (may be completed by either tronic record of every order, and, the purchaser or the supplier). linked to each order, a record of the number of commercial or bulk con- (6) The date the order is signed. tainers furnished on each item and the (7) The name (including strength date on which the supplier shipped the where appropriate) of the controlled containers to the purchaser. The linked substance product or the National record must also include any data on Drug Code (NDC) number (the NDC the original order that the supplier number may be completed by either completes. Software used to handle the purchaser or the supplier). digitally signed orders must comply (8) The quantity in a single package with part 1311 of this chapter. or container. (e) If an order cannot be filled in its (9) The number of packages or con- entirety, a supplier may fill it in part tainers of each item ordered. and supply the balance by additional (c) An electronic order may include shipments within 60 days following the controlled substances that are not in date of the order. No order is valid schedules I and II and non-controlled more than 60 days after its execution substances. by the purchaser, except as specified in paragraph (h) of this section.

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(f) A supplier must ship the con- (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 the original order and archived. that the order is invalid for any reason. (h) Registered procurement officers (b) If an order cannot be filled for any of the Defense Supply Center of the De- reason under this section, the supplier fense Logistics Agency may order con- must notify the purchaser and provide trolled substances for delivery to a statement as to the reason (e.g., im- armed services establishments within properly prepared or altered). A sup- the United States. These orders may be plier may, for any reason, refuse to ac- shipped to locations other than the cept any order, and if a supplier refuses registered location, and in partial ship- to accept the order, a statement that ments at different times not to exceed the order is not accepted is sufficient six months from the date of the order, for purposes of this paragraph. as designated by the procurement offi- (c) When a purchaser receives an cer when submitting the order. unaccepted electronic order from the supplier, the purchaser must electroni- § 1305.23 Endorsing electronic orders. cally link the statement of nonaccept- A supplier may not endorse an elec- ance to the original order. The original tronic order to another supplier to fill. order and the statement must be retained in accordance with § 1305.27. § 1305.24 Central processing of orders. (d) Neither a purchaser nor a supplier (a) A supplier that has one or more may correct a defective order; the pur- registered locations and maintains a chaser must issue a new order for the central processing computer system in order to be filled. which orders are stored may have one or more of the supplier’s registered lo- § 1305.26 Lost electronic orders. cations fill an electronic order if the (a) If a purchaser determines that an supplier does the following: unfilled electronic order has been lost (1) Assigns each item on the order to before or after receipt, the purchaser a specific registered location for fill- must provide, to the supplier, a signed ing. statement containing the unique (2) Creates a record linked to the cen- tracking number and date of the lost tral file noting both which items a lo- order and stating that the goods cov- cation filled and the location identity. ered by the first order were not re- (3) Ensures that no item is filled by ceived through loss of that order. more than one location. (4) Maintains the original order with (b) If the purchaser executes an order all linked records on the central com- to replace the lost order, the purchaser puter system. must electronically link an electronic (b) A company that has central proc- record of the second order and a copy essing of orders must assign responsi- of the statement with the record of the bility for filling parts of orders only to first order and retain them. registered locations that the company (c) If the supplier to whom the order owns and operates. was directed subsequently receives the first order, the supplier must indicate § 1305.25 Unaccepted and defective that it is ‘‘Not Accepted’’ and return it electronic orders. to the purchaser. The purchaser must (a) No electronic order may be filled link the returned order to the record of if: that order and the statement.

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§ 1305.27 Preservation of electronic or- CONTROLLED SUBSTANCES LISTED IN SCHEDULE ders. II (a) A purchaser must, for each order 1306.11 Requirement of prescription. filled, retain the original signed order 1306.12 Refilling prescriptions; issuance of 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, an electronic order by notifying the IV, and V controlled substances for refill 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] 1306.02 Definitions. 1306.03 Persons entitled to issue prescrip- § 1306.03 Persons entitled to issue pre- tions. scriptions. 1306.04 Purpose of issue of prescription. (a) A prescription for a controlled 1306.05 Manner of issuance of prescriptions. substance may be issued only by an in- 1306.06 Persons entitled to fill prescriptions. dividual practitioner who is: 1306.07 Administering or dispensing of narcotic drugs. (1) Authorized to prescribe controlled 1306.08 Electronic prescriptions. substances by the jurisdiction in which 1306.09 Prescription requirements for online he is licensed to practice his profession pharmacies. and

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(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 number issued by the Administrator substance to be effective must be under § 1301.28(d) of this chapter or a issued for a legitimate medical purpose written notice stating that the practi- by an individual practitioner acting in tioner is acting under the good faith the usual course of his professional exception of § 1301.28(e) of this chapter. practice. The responsibility for the (c) Where a prescription is for proper prescribing and dispensing of gamma-hydroxybutyric acid, the prac- controlled substances is upon the pre- titioner shall note on the face of the scribing practitioner, but a cor- prescription the medical need of the responding responsibility rests with patient for the prescription. the pharmacist who fills the prescrip- (d) A practitioner may sign a paper tion. An order purporting to be a pre- prescription in the same manner as he scription issued not in the usual course would sign a check or legal document of professional treatment or in legiti- (e.g., J.H. Smith or John H. Smith). mate and authorized research is not a Where an oral order is not permitted, prescription within the meaning and paper prescriptions shall be written intent of section 309 of the Act (21 with ink or indelible pencil, type- U.S.C. 829) and the person knowingly writer, or printed on a computer print- filling such a purported prescription, as er and shall be manually signed by the well as the person issuing it, shall be practitioner. A computer-generated subject to the penalties provided for prescription that is printed out or violations of the provisions of law re- faxed by the practitioner must be lating to controlled substances. manually signed. (b) A prescription may not be issued (e) Electronic prescriptions shall be in order for an individual practitioner created and signed using an application to obtain controlled substances for sup- that meets the requirements of part plying the individual practitioner for 1311 of this chapter. the purpose of general dispensing to pa- (f) A prescription may be prepared by tients. the secretary or agent for the signa- (c) A prescription may not be issued ture of a practitioner, but the pre- for ‘‘detoxification treatment’’ or scribing practitioner is responsible in ‘‘maintenance treatment,’’ unless the case the prescription does not conform prescription is for a Schedule III, IV, or in all essential respects to the law and V narcotic drug approved by the Food regulations. A corresponding liability and Drug Administration specifically rests upon the pharmacist, including a for use in maintenance or detoxifica- pharmacist employed by a central fill tion treatment and the practitioner is pharmacy, who fills a prescription not in compliance with requirements in prepared in the form prescribed by § 1301.28 of this chapter. DEA regulations. [36 FR 7799, Apr. 24, 1971. Redesignated at 38 (g) An individual practitioner ex- FR 26609, Sept. 24, 1973, and amended at 39 empted from registration under FR 37986, Oct. 25, 1974; 70 FR 36343, June 23, § 1301.22(c) of this chapter shall include 2005] on all prescriptions issued by him the

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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 after reasonable efforts. [75 FR 16307, Mar. 31, 2010] (d) A practitioner may administer or dispense (including prescribe) any § 1306.06 Persons entitled to fill pre- Schedule III, IV, or V narcotic drug ap- scriptions. proved by the Food and Drug Adminis- A prescription for a controlled sub- tration specifically for use in mainte- stance may only be filled by a phar- nance or detoxification treatment to a macist, acting in the usual course of narcotic dependent person if the practi- his professional practice and either tioner complies with the requirements registered individually or employed in of § 1301.28 of this chapter. a registered pharmacy, a registered central fill pharmacy, or registered in- [39 FR 37986, Oct. 25, 1974, as amended at 70 FR 36344, June 23, 2005] stitutional practitioner. [68 FR 37410, June 24, 2003, as amended at 70 § 1306.08 Electronic prescriptions. FR 36343, June 23, 2005] (a) An individual practitioner may sign and transmit electronic prescrip- § 1306.07 Administering or dispensing tions for controlled substances proof narcotic drugs. vided the practitioner meets all of the (a) A practitioner may administer or following requirements: dispense directly (but not prescribe) a (1) The practitioner must comply narcotic drug listed in any schedule to with all other requirements for issuing a narcotic dependant person for the controlled substance prescriptions in purpose of maintenance or detoxifica- this part; tion treatment if the practitioner (2) The practitioner must use an ap- meets both of the following conditions: plication that meets the requirements (1) The practitioner is separately reg- of part 1311 of this chapter; and istered with DEA as a narcotic treat- (3) The practitioner must comply ment program. with the requirements for practitioners (2) The practitioner is in compliance in part 1311 of this chapter. with DEA regulations regarding treat- (b) A pharmacy may fill an electroni- ment qualifications, security, records, cally transmitted prescription for a

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

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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 ule II narcotic substance for a patient shall have written on its face ‘‘Author- enrolled in a hospice care program cer- ization for Emergency Dispensing,’’ tified and/or paid for by Medicare under and the date of the oral order. The Title XVIII or a hospice program which paper prescription may be delivered to is licensed by the state may be trans- the pharmacist in person or by mail, mitted by the practitioner or the prac- but if delivered by mail it must be titioner’s agent to the dispensing phar- postmarked within the 7-day period. macy by facsimile. The practitioner or Upon receipt, the dispensing phar- the practitioner’s agent will note on macist must attach this paper prescrip- the prescription that the patient is a tion to the oral emergency prescription hospice patient. The facsimile serves as that had earlier been reduced to writ- the original written prescription for ing. For electronic prescriptions, the purposes of this paragraph (g) and it pharmacist must annotate the record shall be maintained in accordance with of the electronic prescription with the § 1304.04(h). original authorization and date of the 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. 24, 1997; 65 FR 45713, July 25, 2000; 68 FR 37410, macist to do so shall void the author- June 24, 2003; 75 FR 16307, Mar. 31, 2010] ity conferred by this paragraph to dispense without a written prescription of § 1306.12 Refilling prescriptions; a prescribing individual practitioner. issuance of multiple prescriptions. (5) Central fill pharmacies shall not (a) The refilling of a prescription for be authorized under this paragraph to a controlled substance listed in Sched- prepare prescriptions for a controlled ule II is prohibited. substance listed in Schedule II upon receiving 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: pounded for the direct administration (i) Each separate prescription is to a patient by parenteral, intra- issued for a legitimate medical purpose venous, intramuscular, subcutaneous by an individual practitioner acting in or intraspinal infusion may be trans- the usual course of professional prac- mitted by the practitioner or the practice; titioner’s agent to the pharmacy by (ii) The individual practitioner pro- facsimile. The facsimile serves as the vides written instructions on each pre- original written prescription for pur- scription (other than the first prescrip- poses of this paragraph (e) and it shall tion, if the prescribing practitioner in- be maintained in accordance with tends for that prescription to be filled § 1304.04(h) of this chapter. immediately) indicating the earliest (f) A prescription prepared in accord- date on which a pharmacy may fill ance with § 1306.05 written for Schedule each prescription;

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(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 when prescribing Schedule II con- the prescription (or on another appro- trolled substances. Rather, individual priate record, uniformly maintained, practitioners must determine on their and readily retrievable) the date of the own, based on sound medical judgment, partial filling, quantity dispensed, re- and in accordance with established maining quantity authorized to be dis- medical standards, whether it is appro- pensed, and the identification of the priate to issue multiple prescriptions dispensing pharmacist. The total quan- and how often to see their patients tity of Schedule II controlled sub- when doing so. stances dispensed in all partial fillings must not exceed the total quantity pre- [72 FR 64929, Nov. 19, 2007] scribed. Schedule II prescriptions for § 1306.13 Partial filling of prescrip- patients in a LTCF or patients with a tions. medical diagnosis documenting a terminal 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 quantity called for in a written or (c) Information pertaining to current emergency oral prescription and he Schedule II prescriptions for patients makes a notation of the quantity sup- in a LTCF or for patients with a med- plied on the face of the written pre- ical diagnosis documenting a terminal scription, written record of the emer- illness may be maintained in a comput- gency oral prescription, or in the elec- erized system if this system has the ca- tronic prescription record. The remain- pability to permit: ing portion of the prescription may be (1) Output (display or printout) of the filled within 72 hours of the first par- original prescription number, date of tial filling; however, if the remaining issue, identification of prescribing indi- portion is not or cannot be filled with- vidual practitioner, identification of in the 72-hour period, the pharmacist patient, address of the LTCF or address shall notify the prescribing individual of the hospital or residence of the pa- practitioner. No further quantity may tient, identification of medication au- be supplied beyond 72 hours without a thorized (to include dosage, form, new prescription. strength and quantity), listing of the (b) A prescription for a Schedule II partial fillings that have been dis- controlled substance written for a pa- pensed under each prescription and the tient in a Long Term Care Facility information required in § 1306.13(b). (LTCF) or for a patient with a medical (2) Immediate (real time) updating of diagnosis documenting a terminal ill- the prescription record each time a ness may be filled in partial quantities partial filling of the prescription is to include individual dosage units. If conducted.

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(3) Retrieval of partially filled Sched- forth the directions for use and cau- ule II prescription information is the tionary statements, if any, contained same as required by § 1306.22(b) (4) and in the prescription or required by law. (5) for Schedule III and IV prescription (d) All written prescriptions and refill information. written records of emergency oral pre- (Authority: 21 U.S.C. 801, et seq.) scriptions shall be kept in accordance with requirements of § 1304.04(h) of this [36 FR 7799, Apr. 24, 1971. Redesignated at 38 chapter. FR 26609, Sept. 24, 1973, and amended at 45 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 in- cautionary statements, if any, con- formation between retail phar- tained in such prescription or required macies and central fill pharmacies for prescriptions of Schedule II con- by law. trolled substances. (b) If the prescription is filled at a central fill pharmacy, the central fill Prescription information may be pro- pharmacy shall affix to the package a vided to an authorized central fill phar- label showing the retail pharmacy macy by a retail pharmacy for dis- name and address and a unique identi- pensing purposes. The following re- fier, (i.e. the central fill pharmacy’s quirements shall also apply: DEA registration number) indicating (a) Prescriptions for controlled sub- that the prescription was filled at the stances listed in Schedule II may be central fill pharmacy, in addition to transmitted electronically from a re- the information required under para- tail pharmacy to a central fill phar- graph (a) of this section. macy including via facsimile. The re- (c) The requirements of paragraph (a) tail pharmacy transmitting the pre- of this section do not apply when a scription information must: controlled substance listed in Schedule (1) Write the words ‘‘CENTRAL II is prescribed for administration to FILL’’ on the face of the original paper an ultimate user who is institutional- prescription and record the name, ad- ized: Provided, That: dress, and DEA registration number of (1) Not more than 7-day supply of the the central fill pharmacy to which the controlled substance listed in Schedule prescription has been transmitted, the II is dispensed at one time; name of the retail pharmacy phar- (2) The controlled substance listed in macist transmitting the prescription, Schedule II is not in the possession of and the date of transmittal. For elec- the ultimate user prior to the adminis- tronic prescriptions the name, address, tration; and DEA registration number of the (3) The institution maintains appro- central fill pharmacy to which the pre- priate safeguards and records regarding scription has been transmitted, the the proper administration, control, dis- name of the retail pharmacy phar- pensing, and storage of the controlled macist transmitting the prescription, substance listed in Schedule II; and and the date of transmittal must be (4) The system employed by the phar- added to the electronic prescription macist in filling a prescription is ade- record. quate to identify the supplier, the (2) Ensure that all information re- product, and the patient, and to set quired to be on a prescription pursuant

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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 (a) No prescription for a controlled FR 16308, Mar. 31, 2010] 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 signed by a practitioner, a facsimile of record. If entered on another docu- a signed paper prescription transmitted ment, such as a medication record, or by the practitioner or the practi- electronic prescription record, the doc- tioner’s agent to the pharmacy, an ument or record must be uniformly electronic prescription that meets the maintained and readily retrievable. requirements of this part and part 1311 (c) The following information must of this chapter, or an oral prescription be retrievable by the prescription num- made by an individual practitioner and ber: promptly reduced to writing by the (1) The name and dosage form of the pharmacist containing all information controlled substance. required in § 1306.05, except for the sig- (2) The date filled or refilled. nature of the practitioner. (3) The quantity dispensed.

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(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 annotates the electronic prescription record tials of the dispensing pharmacist for with the date, quantity of refill, num- each refill and the total number of re- ber of additional refills authorized, and fills dispensed to date for that prescrip- initials the paper prescription or anno- tion order. tates the electronic prescription record (3) Documentation of the fact that showing who received the authoriza- the refill information entered into the tion from the prescribing practitioner computer each time a pharmacist re- who issued the original prescription. fills an original paper, fax, or oral pre- (3) The quantity of each additional scription order for a Schedule III or IV refill authorized is equal to or less than controlled substance is correct must be the quantity authorized for the initial provided by the individual pharmacist filling of the original prescription. who makes use of such an application. (4) The prescribing practitioner must If such an application provides a hard- execute a new and separate prescrip- copy printout of each day’s controlled tion for any additional quantities be- substance prescription order refill yond the five-refill, six-month limita- data, that printout shall be verified, tion. dated, and signed by the individual (f) As an alternative to the proce- pharmacist who refilled such a pre- dures provided by paragraphs (a) scription order. The individual phar- through (e) of this section, a computer macist must verify that the data indi- application may be used for the storage cated are correct and then sign this and retrieval of refill information for document in the same manner as he original paper prescription orders for would sign a check or legal document controlled substances in Schedule III (e.g., J.H. Smith, or John H. Smith). and IV, subject to the following condi- This document shall be maintained in a tions: separate file at that pharmacy for a pe- (1) Any such proposed computerized riod of two years from the dispensing application must provide online re- date. This printout of the day’s con- trieval (via computer monitor or hard- trolled substance prescription order re- copy printout) of original prescription fill data must be provided to each phar- order information for those prescrip- macy using such a computerized appli- tion orders that are currently author- cation within 72 hours of the date on ized for refilling. This shall include, which the refill was dispensed. It must

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

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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) For paper prescriptions and pre- (3) The institution maintains appro- scriptions received orally and reduced priate safeguards and records the prop- to writing by the pharmacist pursuant er administration, control, dispensing, to § 1306.21(a), the pharmacist receiving and storage of the controlled substance the transferred prescription informa- listed in Schedule III, IV, or V; and tion must write the word ‘‘transfer’’ on (4) The system employed by the phar- the face of the transferred prescription macist in filling a prescription is ade- and reduce to writing all information quate to identify the supplier, the required to be on a prescription pursu- product and the patient, and to set ant to § 1306.05 and include: forth the directions for use and cau- (i) Date of issuance of original pre- tionary statements, if any, contained scription. in the prescription or required by law. (ii) Original number of refills author- (d) All prescriptions for controlled ized on original prescription. substances listed in Schedules III, IV, (iii) Date of original dispensing. and V shall be kept in accordance with (iv) Number of valid refills remaining § 1304.04(h) of this chapter. 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 registration number, and prescription § 1306.25 Transfer between pharmacies number from which the prescription in- of prescription information for formation was transferred. Schedules III, IV, and V controlled (vi) Name of pharmacist who trans- substances for refill purposes. ferred the prescription. (a) The transfer of original prescrip- (vii) Pharmacy’s name, address, DEA tion information for a controlled sub- registration number, and prescription stance listed in Schedule III, IV, or V number from which the prescription for the purpose of refill dispensing is was originally filled. permissible between pharmacies on a (4) For electronic prescriptions being one-time basis only. However, phar- transferred electronically, the trans- macies electronically sharing a real- ferring pharmacist must provide the time, online database may transfer up receiving pharmacist with the fol- to the maximum refills permitted by lowing information in addition to the law and the prescriber’s authorization. original electronic prescription data: (b) Transfers are subject to the fol- (i) The date of the original dis- lowing requirements: pensing. (1) The transfer must be commu- (ii) The number of refills remaining nicated directly between two licensed and the date(s) and locations of pre- pharmacists. vious refills. (2) The transferring pharmacist must (iii) The transferring pharmacy’s do the following: name, address, DEA registration num- (i) Write the word ‘‘VOID’’ on the ber, and prescription number for each face of the invalidated prescription; for dispensing.

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(iv) The name of the pharmacist retail to the same purchaser in any transferring the prescription. given 48-hour period; (v) The name, address, DEA registra- (c) The purchaser is at least 18 years tion number, and prescription number of age; from the pharmacy that originally (d) The pharmacist requires every filled the prescription, if different. purchaser of a controlled substance (5) The pharmacist receiving a trans- under this section not known to him to ferred electronic prescription must cre- furnish suitable identification (includ- ate an electronic record for the pre- ing proof of age where appropriate); scription that includes the receiving (e) A bound record book for dis- pharmacist’s name and all of the infor- pensing of controlled substances under mation transferred with the prescrip- this section is maintained by the phar- tion under paragraph (b)(4) of this sec- macist, which book shall contain the tion. name and address of the purchaser, the (c) The original and transferred pre- name and quantity of controlled subscription(s) must be maintained for a stance purchased, the date of each pur- period of two years from the date of chase, and the name or initials of the last refill. pharmacist who dispensed the sub- (d) Pharmacies electronically access- stance to the purchaser (the book shall ing the same prescription record must be maintained in accordance with the satisfy all information requirements of recordkeeping requirement of § 1304.04 a manual mode for prescription trans- of this chapter); and feral. (f) A prescription is not required for (e) The procedure allowing the trans- distribution or dispensing of the sub- fer of prescription information for re- stance pursuant to any other Federal, fill purposes is permissible only if al- State or local law. lowable under existing State or other (g) Central fill pharmacies may not applicable law. dispense controlled substances to a purchaser at retail pursuant to this [75 FR 16309, Mar. 31, 2010] section. § 1306.26 Dispensing without prescrip- [36 FR 7799, Apr. 24, 1971, as amended at 36 tion. FR 18733, Sept. 21, 1971. Redesignated at 38 A controlled substance listed in FR 26609, Sept. 24, 1973, and further redesig- Schedules II, III, IV, or V which is not nated and amended at 62 FR 13966, Mar. 24, 1997; 68 FR 37411, June 24, 2003] a prescription drug as determined under the Federal Food, Drug, and Cos- § 1306.27 Provision of prescription in- metic Act, may be dispensed by a phar- formation between retail pharmacist without a prescription to a pur- macies and central fill pharmacies chaser at retail, provided that: for initial and refill prescriptions of (a) Such dispensing is made only by a Schedule III, IV, or V controlled pharmacist (as defined in part 1300 of substances. this chapter), and not by a nonphar- Prescription information may be pro- macist employee even if under the su- vided to an authorized central fill phar- pervision of a pharmacist (although macy by a retail pharmacy for dis- after the pharmacist has fulfilled his pensing purposes. The following re- professional and legal responsibilities quirements shall also apply: set forth in this section, the actual (a) Prescriptions for controlled sub- cash, credit transaction, or delivery, stances listed in Schedule III, IV or V may be completed by a nonphar- may be transmitted electronically macist); from a retail pharmacy to a central fill (b) Not more than 240 cc. (8 ounces) of pharmacy including via facsimile. The any such controlled substance con- retail pharmacy transmitting the pre- taining opium, nor more than 120 cc. (4 scription information must: ounces) of any other such controlled (1) Write the word ‘‘CENTRAL FILL’’ substance nor more than 48 dosage on the face of the original prescription units of any such controlled substance and record the name, address, and DEA containing opium, nor more than 24 registration number of the central fill dosage units of any other such con- pharmacy to which the prescription trolled substance may be dispensed at has been transmitted and the name of

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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 face of the prescription or in the the Administration. electronic transmission of informa- SPECIAL EXEMPT PERSONS tion); (3) Indicate in the information trans- 1307.31 Native American Church. mitted 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; (4) Maintain the original prescription SOURCE: 36 FR 7801, Apr. 24, 1971, unless otherwise noted. Redesignated at 38 FR 26609, for a period of two years from the date Sept. 24, 1973. the prescription was last refilled; (5) Keep a record of receipt of the GENERAL INFORMATION filled prescription, including the date of receipt, the method of delivery (pri- § 1307.01 Definitions. vate, common or contract carrier) and the name of the retail pharmacy em- Any term contained in this part shall ployee accepting delivery. have the definition set forth in section (b) The central fill pharmacy receiv- 102 of the Act (21 U.S.C. 802) or part ing the transmitted prescription must: 1300 of this chapter. (1) Keep a copy of the prescription (if [62 FR 13966, Mar. 24, 1997] sent via facsimile) or an electronic record of all the information trans- § 1307.02 Application of State law and mitted by the retail pharmacy, includ- other Federal law. ing the name, address, and DEA reg- Nothing in this chapter shall be con- istration number of the retail phar- strued as authorizing or permitting macy transmitting the prescription; any person to do any act which such (2) Keep a record of the date of re- person is not authorized or permitted ceipt of the transmitted prescription, to do under other Federal laws or obli- the name of the licensed pharmacist filling the prescription, and dates of gations under international treaties, filling or refilling of the prescription; conventions or protocols, or under the (3) Keep a record of the date the filled law of the State in which he/she desires prescription was delivered to the retail to do such act nor shall compliance pharmacy and the method of delivery with such parts be construed as compli- (i.e. private, common or contract car- ance with other Federal or State laws rier). unless expressly provided in such other laws. [68 FR 37411, June 24, 2003] [62 FR 13966, Mar. 24, 1997] PART 1307—MISCELLANEOUS § 1307.03 Exceptions to regulations.

GENERAL INFORMATION Any person may apply for an excep- Sec. tion to the application of any provision 1307.01 Definitions. of this chapter by filing a written re- 1307.02 Application of State law and other quest with the Office of Diversion Con- Federal law. trol, Drug Enforcement Administra- 1307.03 Exceptions to regulations. tion, stating the reasons for such ex- SPECIAL EXCEPTIONS FOR MANUFACTURE AND ception. See the Table of DEA Mailing DISTRIBUTION OF CONTROLLED SUBSTANCES Addresses in § 1321.01 of this chapter for the current mailing address. The Ad- 1307.11 Distribution by dispenser to another practitioner or reverse distributor. ministrator may grant an exception in 1307.12 Distribution to supplier or manufac- his discretion, but in no case shall he/ turer. she be required to grant an exception

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to any person which is otherwise re- ing that calendar year, the practitioner quired by law or the regulations cited shall obtain a registration to distribute in this section. controlled substances. [75 FR 10678, Mar. 9, 2010] (c) The distributions that a registered retail pharmacy makes to auto- SPECIAL EXCEPTIONS FOR MANUFACTURE mated dispensing systems at long term AND DISTRIBUTION OF CONTROLLED care facilities for which the retail SUBSTANCES pharmacy also holds registrations do not count toward the 5 percent limit in § 1307.11 Distribution by dispenser to paragraphs (a)(1)(iv) and (b) of this sec- another practitioner or reverse dis- tion. tributor. (a) A practitioner who is registered [68 FR 41229, July 11, 2003, as amended at 70 FR 25466, May 13, 2005] to dispense a controlled substance may distribute (without being registered to § 1307.12 Distribution to supplier or distribute) a quantity of such sub- manufacturer. stance to— (1) Another practitioner for the pur- (a) Any person lawfully in possession pose of general dispensing by the prac- of a controlled substance listed in any titioner to patients, provided that— schedule may distribute (without being (i) The practitioner to whom the con- registered to distribute) that substance trolled substance is to be distributed is to the person from whom he/she ob- registered under the Act to dispense tained it or to the manufacturer of the that controlled substance; substance, or, if designated, to the (ii) The distribution is recorded by manufacturer’s registered agent for ac- the distributing practitioner in accord- cepting returns, provided that a writ- ance with § 1304.22(c) of this chapter ten record is maintained which indi- and by the receiving practitioner in ac- cates the date of the transaction, the cordance with § 1304.22(c) of this chap- name, form and quantity of the sub- ter; stance, the name, address, and reg- (iii) If the substance is listed in istration number, if any, of the person Schedule I or II, an order form is used making the distribution, and the name, as required in part 1305 of this chapter; address, and registration number, if and known, of the supplier or manufac- (iv) The total number of dosage units turer. In the case of returning a con- of all controlled substances distributed trolled substance in Schedule I or II, an by the practitioner pursuant to this order form shall be used in the manner section and § 1301.25 of this chapter dur- prescribed in part 1305 of this chapter ing each calendar year in which the and be maintained as the written practitioner is registered to dispense record of the transaction. Any person does not exceed 5 percent of the total not required to register pursuant to number of dosage units of all con- sections 302(c) or 1007(b)(1) of the Act trolled substances distributed and dis- (21 U.S.C. 822(c) or 957(b)(1)) shall be ex- pensed by the practitioner during the empt from maintaining the records re- same calendar year. quired by this section. (2) A reverse distributor who is reg- (b) Distributions referred to in para- istered to receive such controlled sub- graph (a) may be made through a stances. freight forwarding facility operated by (b) If, during any calendar year in the person to whom the controlled sub- which the practitioner is registered to stance is being returned provided that dispense, the practitioner has reason to prior arrangement has been made for believe that the total number of dosage the return and the person making the units of all controlled substances distribution delivers the controlled which will be distributed by him pursu- substance directly to an agent or em- ant to paragraph (a)(1) of this section ployee of the person to whom the con- and § 1301.25 of this chapter will exceed trolled substance is being returned. 5 percent of this total number of dos- [65 FR 44679, July 19, 2000; 65 FR 45829, July age units of all controlled substances 25, 2000, as amended at 68 FR 41229, July 11, distributed and dispensed by him dur- 2003]

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§ 1307.13 Incidental manufacture of (b) The Special Agent in Charge shall controlled substances. authorize and instruct the applicant to Any registered manufacturer who, in- dispose of the controlled substance in cidentally but necessarily, manufac- one of the following manners: tures a controlled substance as a result (1) By transfer to person registered of the manufacture of a controlled sub- under the Act and authorized to pos- stance or basic class of controlled sub- sess the substance; stance for which he is registered and (2) By delivery to an agent of the Ad- has been issued an individual manufac- ministration or to the nearest office of turing quota pursuant to part 1303 of the Administration; (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 [36 FR 7801, Apr. 24, 1971. Redesignated at 38 to dispose of such substances, in ac- 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 controlled substances. odic reports with the Special Agent in 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 (1) If the person is a registrant, he/ way the disposal of controlled sub- she shall list the controlled substance stances through procedures provided in or substances which he/she desires to laws and regulations adopted by any dispose of on DEA Form 41, and submit State. three copies of that form to the Special Agent in Charge in his/her area; or [36 FR 7801, Apr. 24, 1971, as amended at 37 FR 15922, Aug. 8, 1972. Redesignated at 38 FR (2) If the person is not a registrant, 26609, Sept. 24, 1973, and amended at 47 FR he/she shall submit to the Special 41735, Sept. 22, 1982; 62 FR 13967, Mar. 24, 1997] Agent in Charge a letter stating: (i) The name and address of the per- § 1307.22 Disposal of controlled sub- son; stances by the Administration. (ii) The name and quantity of each Any controlled substance delivered controlled substance to be disposed of; to the Administration under § 1307.21 or (iii) How the applicant obtained the forfeited pursuant to section 511 of the substance, if known; and Act (21 U.S.C. 881) may be delivered to (iv) The name, address, and registra- any department, bureau, or other agen- tion number, if known, of the person cy of the United States or of any State who possessed the controlled sub- upon proper application addressed to stances prior to the applicant, if the Office of Diversion Control, Drug known. Enforcement Administration. See the

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Table of DEA Mailing Addresses in EXCLUDED VETERINARY ANABOLIC STEROID § 1321.01 of this chapter for the current IMPLANT PRODUCTS mailing address. The application shall 1308.25 Exclusion of a veterinary anabolic show the name, address, and official steroid implant product; application. title of the person or agency to whom 1308.26 Excluded veterinary anabolic steroid the controlled drugs are to be deliv- implant products. ered, including the name and quantity of the substances desired and the pur- EXEMPTED PRESCRIPTION PRODUCTS pose for which intended. The delivery 1308.31 Application for exemption of a non- of such controlled drugs shall be or- narcotic prescription product. dered by the Administrator, if, in his 1308.32 Exempted prescription products. opinion, there exists a medical or scientific need therefor. EXEMPT ANABOLIC STEROID PRODUCTS [75 FR 10678, Mar. 9, 2010] 1308.33 Exemption of certain anabolic steroid products; application. SPECIAL EXEMPT PERSONS 1308.34 Exempt anabolic steroid products. EXEMPT CANNABIS PLANT MATERIAL, AND § 1307.31 Native American Church. PRODUCTS MADE THEREFROM, THAT CONTAIN The listing of peyote as a controlled TETRAHYDROCANNABINOLS substance in Schedule I does not apply 1308.35 Exemption of certain cannabis plant to the nondrug use of peyote in bona material, and products made therefrom, fide religious ceremonies of the Native that contain tetrahydrocannabinols. American Church, and members of the Native American Church so using pe- HEARINGS yote are exempt from registration. Any 1308.41 Hearings generally. person who manufactures peyote for or 1308.42 Purpose of hearing. distributes peyote to the Native Amer- 1308.43 Initiation of proceedings for rule- ican Church, however, is required to making. obtain registration annually and to 1308.44 Request for hearing or appearance; comply with all other requirements of waiver. law. 1308.45 Final order. 1308.46 Control required under international PART 1308—SCHEDULES OF treaty. CONTROLLED SUBSTANCES 1308.47 Control of immediate precursors. 1308.49 Emergency scheduling.

GENERAL INFORMATION AUTHORITY: 21 U.S.C. 811, 812, 871(b), unless otherwise noted. Sec. 1308.01 Scope of part 1308. SOURCE: 38 FR 8254, Mar. 30, 1973, unless 1308.02 Definitions. otherwise noted. Redesignated at 38 FR 26609, 1308.03 Administration Controlled Sub- Sept. 24, 1973. stances Code Number. GENERAL INFORMATION SCHEDULES 1308.11 Schedule I. § 1308.01 Scope of part 1308. 1308.12 Schedule II. Schedules of controlled substances 1308.13 Schedule III. established by section 202 of the Act (21 1308.14 Schedule IV. U.S.C. 812), as they are changed, up- 1308.15 Schedule V. dated, and republished from time to

EXCLUDED NONNARCOTIC SUBSTANCES time, are set forth in this part. 1308.21 Application for exclusion of a non- § 1308.02 Definitions. narcotic substance. 1308.22 Excluded substances. Any term contained in this part shall have the definition set forth in section EXEMPT CHEMICAL PREPARATIONS 102 of the Act (21 U.S.C. 802) or part 1308.23 Exemption of certain chemical prep- 1300 of this chapter. arations; application. [62 FR 13967, Mar. 24, 1997] 1308.24 Exemption chemical preparations.

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§ 1308.03 Administration Controlled salts, and salts of isomers, esters and Substances Code Number. ethers, whenever the existence of such (a) Each controlled substance, or isomers, esters, ethers and salts is pos- basic class thereof, has been assigned sible within the specific chemical des- an ‘‘Administration Controlled Sub- ignation (for purposes of paragraph stances Code Number’’ for purposes of (b)(34) only, the term isomer includes identification of the substances or the optical and geometric isomers): class on certain Certificates of Reg- istration issued by the Administration (1) Acetyl-alpha-methylfentanyl pursuant to §§ 1301.35 of this chapter (N-[1-(1-methyl-2-phenethyl)-4- and on certain order forms issued by piperidinyl]-N- the Administration pursuant to 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 propriate code number on the applica- levo-alphacetylmethadol also tion as required in §§ 1303.12(b) and known as levo-alpha- 1303.22(a) of this chapter. Applicants acetylmethadol, levomethadyl for import and export permits must in- acetate, or LAAM) ...... 9603 clude the appropriate code number on (5) Alphameprodine ...... 9604 the application as required in (6) Alphamethadol ...... 9605 §§ 1312.12(a) and 1312.22(a) of this chap- (7) Alpha-methylfentanyl (N-[1- ter. Authorized registrants who desire (alpha-methyl-beta- to import or export a controlled sub- phenyl)ethyl-4-piperidyl] stance for which an import or export propionanilide; 1-(1-methyl-2- permit is not required must include the phenylethyl)-4-(N-propanilido) appropriate Administration Controlled piperidine) ...... 9814 Substances Code Number beneath or (8) Alpha-methylthiofentanyl beside the name of each controlled sub- (N-[1-methyl-2-(2- stance listed on the DEA Form 236 thienyl)ethyl-4-piperidinyl]-N- (Controlled Substance Import/Export phenylpropanamide) ...... 9832 Declaration) which is executed for such (9) Benzethidine ...... 9606 importation or exportation as required (10) Betacetylmethadol ...... 9607 in §§ 1312.18(c) and 1312.27(b) of this (11) Beta-hydroxyfentanyl (N-[1- chapter. (2-hydroxy-2-phenethyl)-4- (b) Except as stated in paragraph (a) piperidinyl]-N- of this section, no applicant or reg- phenylpropanamide) ...... 9830 istrant is required to use the Adminis- (12) Beta-hydroxy-3- tration Controlled Substances Code methylfentanyl (other name: Number for any purpose. N-[1-(2-hydroxy-2-phenethyl)- [38 FR 8254, Mar. 30, 1973. Redesignated at 38 3-methyl-4-piperidinyl]-N- FR 26609, Sept. 24, 1973 and amended at 51 FR phenylpropanamide ...... 9831 15318, Apr. 23, 1986; 62 FR 13968, Mar. 24, 1997] (13) Betameprodine ...... 9608 (14) Betamethadol ...... 9609 SCHEDULES (15) Betaprodine ...... 9611 (16) Clonitazene ...... 9612 § 1308.11 Schedule I. (17) Dextromoramide ...... 9613 (a) Schedule I shall consist of the (18) Diampromide ...... 9615 drugs and other substances, by what- (19) Diethylthiambutene ...... 9616 ever official name, common or usual (20) Difenoxin ...... 9168 name, chemical name, or brand name (21) Dimenoxadol ...... 9617 designated, listed in this section. Each (22) Dimepheptanol ...... 9618 drug or substance has been assigned (23) Dimethylthiambutene ...... 9619 the DEA Controlled Substances Code (24) Dioxaphetyl butyrate ...... 9621 Number set forth opposite it. (25) Dipipanone ...... 9622 (b) Opiates. Unless specifically ex- (26) Ethylmethylthiambutene .... 9623 cepted or unless listed in another (27) Etonitazene ...... 9624 schedule, any of the following opiates, (28) Etoxeridine ...... 9625 including their isomers, esters, ethers, (29) Furethidine ...... 9626

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(30) Hydroxypethidine ...... 9627 (11) Heroin ...... 9200 (31) Ketobemidone ...... 9628 (12) Hydromorphinol ...... 9301 (32) Levomoramide ...... 9629 (13) Methyldesorphine ...... 9302 (33) Levophenacylmorphan ...... 9631 (14) Methyldihydromorphine ...... 9304 (34) 3-Methylfentanyl (N-[3- (15) Morphine methylbromide .... 9305 methyl-1-(2-phenylethyl)-4- (16) Morphine methylsulfonate .. 9306 piperidyl]-N- phenylpropanamide) ...... 9813 (17) Morphine-N-Oxide ...... 9307 (35) 3-methylthiofentanyl (N-[(3- (18) Myrophine ...... 9308 methyl-1-(2-thienyl)ethyl-4- (19) Nicocodeine ...... 9309 piperidinyl]-N- (20) Nicomorphine ...... 9312 phenylpropanamide) ...... 9833 (21) Normorphine ...... 9313 (36) Morpheridine ...... 9632 (22) Pholcodine ...... 9314 (37) MPPP (1-methyl-4-phenyl-4- (23) Thebacon ...... 9315 propionoxypiperidine) ...... 9661 (38) Noracymethadol ...... 9633 (d) Hallucinogenic substances. Unless (39) Norlevorphanol ...... 9634 specifically excepted or unless listed in (40) Normethadone ...... 9635 another schedule, any material, com- (41) Norpipanone ...... 9636 pound, mixture, or preparation, which (42) Para-fluorofentanyl (N-(4- contains any quantity of the following fluorophenyl)-N-[1-(2- hallucinogenic substances, or which phenethyl)-4-piperidinyl] contains any of its salts, isomers, and propanamide ...... 9812 salts of isomers whenever the existence (43) PEPAP (1-(-2-phenethyl)-4- of such salts, isomers, and salts of iso- phenyl-4-acetoxypiperidine ..... 9663 mers is possible within the specific (44) Phenadoxone ...... 9637 chemical designation (for purposes of (45) Phenampromide ...... 9638 this paragraph only, the term ‘‘isomer’’ (46) Phenomorphan ...... 9647 includes the optical, position and geo- (47) Phenoperidine ...... 9641 metric isomers): (48) Piritramide ...... 9642 (49) Proheptazine ...... 9643 (50) Properidine ...... 9644 (1) Alpha-ethyltryptamine ...... 7249 (51) Propiram ...... 9649 Some trade or other names: (52) Racemoramide ...... 9645 etryptamine; Monase; a- (53) Thiofentanyl (N-phenyl-N-[1- ethyl-1H-indole-3- (2-thienyl)ethyl-4-piperidinyl]- ethanamine; 3-(2- propanamide ...... 9835 aminobutyl) indole; a-ET; (54) Tilidine ...... 9750 and AET. (55) Trimeperidine ...... 9646 (2) 4-bromo-2,5-dimethoxy-amphetamine ...... 7391 (c) Opium derivatives. Unless specifically excepted or unless listed in an- Some trade or other names: other schedule, any of the following 4-bromo-2,5-dimethoxy-a- opium derivatives, its salts, isomers, methylphenethylamine; 4- and salts of isomers whenever the ex- bromo-2,5-DMA istence of such salts, isomers, and salts (3) 4-Bromo-2,5- of isomers is possible within the spe- dimethoxyphenethylamine ..... 7392 cific chemical designation: Some trade or other names: 2-(4-bromo-2,5- (1) Acetorphine ...... 9319 dimethoxyphenyl)-1- (2) Acetyldihydrocodeine ...... 9051 aminoethane; alpha- (3) Benzylmorphine ...... 9052 desmethyl DOB; 2C-B, (4) Codeine methylbromide ...... 9070 Nexus. (5) Codeine-N-Oxide ...... 9053 (4) 2,5-dimethoxyamphetamine .. 7396 (6) Cyprenorphine ...... 9054 Some trade or other names: (7) Desomorphine ...... 9055 2,5-dimethoxy-a- (8) Dihydromorphine ...... 9145 methylphenethylamine; (9) Drotebanol ...... 9335 2,5-DMA (10) Etorphine (except hydro- (5) 2,5-dimethoxy-4- chloride salt) ...... 9056 ethylamphet-amine ...... 7399

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Some trade or other names: Some trade and other DOET names: 3-(b- (6) 2,5-dimethoxy-4-(n)- Dimethylaminoethyl)-5- propylthiophenethylamine hydroxyindole; 3-(2- (other name: 2C–T–7) ...... 7348 dimethylaminoethyl)-5- (7) 4-methoxyamphetamine ...... 7411 indolol; N, N- Some trade or other names: dimethylserotonin; 5-hy- 4-methoxy-a- droxy-N,N- methylphenethylamine; dimethyltryptamine; paramethoxyamphetamin- mappine e, PMA (18) Diethyltryptamine ...... 7434 (8) 5-methoxy-3,4- Some trade and other methylenedioxy-amphetamine 7401 names: N,N- (9) 4-methyl-2,5-dimethoxy-am- Diethyltryptamine; DET phetamine ...... 7395 (19) Dimethyltryptamine ...... 7435 Some trade and other Some trade or other names: names: 4-methyl-2,5- DMT dimethoxy-a- (20) 5-methoxy-N,N- methylphenethylamine; diisopropyltryptamine (other ‘‘DOM’’; and ‘‘STP’’ name: 5-MeO-DIPT) ...... 7439 (10) 3,4-methylenedioxy amphet- (21) Ibogaine ...... 7260 amine ...... 7400 Some trade and other (11) 3,4- names: 7-Ethyl- methylenedioxymethampheta- 6,6b,7,8,9,10,12,13- mine (MDMA) ...... 7405 octahydro-2-methoxy-6,9- (12) 3,4-methylenedioxy-N- methano-5H-pyrido [1′, ethylamphetamine (also 2′:1,2] azepino [5,4-b] known as N-ethyl-alpha-meth- indole; Tabernanthe iboga yl-3,4(methylenedioxy)- (22) Lysergic acid diethylamide 7315 phenethylamine, N-ethyl (23) Marihuana ...... 7360 MDA, MDE, MDEA ...... 7404 (24) Mescaline ...... 7381 (13) N-hydroxy-3,4- (25) Parahexyl—7374; some trade methylenedioxyamphetamine or other names: 3-Hexyl-1-hy- (also known as N-hydroxy- droxy-7,8,9,10-tetrahydro-6,6,9- alpha-methyl- trimethyl-6H- 3,4(methylenedioxy)- dibenzo[b,d]pyran; Synhexyl. phenethylamine, and N-hy- (26) Peyote ...... 7415 droxy MDA ...... 7402 Meaning all parts of the (14) 3,4,5-trimethoxy amphet- plant presently classified amine ...... 7390 botanically as Lophophora (15) 5-methoxy-N,N- williamsii Lemaire, whether dimethyltryptamine Some growing or not, the seeds trade or other names: 5- thereof, any extract from methoxy-3-[2- any part of such plant, and (dimethylamino)ethyl]indole; every compound, manufac- 5-MeO-DMT ...... 7431 ture, salts, derivative, (16) Alpha-methyltryptamine mixture, or preparation of (other name: AMT) ...... 7432 such plant, its seeds or ex- (17) Bufotenine ...... 7433 tracts (Interprets 21 USC 812(c), Schedule I(c) (12)) (27) N-ethyl-3-piperidyl benzilate 7482 (28) N-methyl-3-piperidyl benzilate ...... 7484 (29) Psilocybin ...... 7437 (30) Psilocyn ...... 7438 (31) Tetrahydrocannabinols ...... 7370

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Meaning Some other names: TCPy tetrahydrocannabinols (36) 4-methylmethcathinone naturally contained in a (Mephedrone) ...... 1248 plant of the genus Can- (37) 3,4- nabis (cannabis plant), as methylenedioxypyrovalerone well as synthetic equiva- (MDPV) ...... 7535 lents of the substances (38) 2-(2,5-Dimethoxy-4- contained in the cannabis ethylphenyl)ethanamine (2C– plant, or in the resinous E) ...... 7509 extractives of such plant, (39) 2-(2,5-Dimethoxy-4- and/or synthetic sub- methylphenyl)ethanamine stances, derivatives, and (2C–D) ...... 7508 their isomers with similar (40) 2-(4-Chloro-2,5- chemical structure and dimethoxyphenyl)ethanamine pharmacological activity (2C–C) ...... 7519 to those substances con- (41) 2-(4-Iodo-2,5- tained in the plant, such dimethoxyphenyl)ethanamine as the following: (2C–I) ...... 7518 1 cis or trans (42) 2-[4-(Ethylthio)-2,5- tetrahydrocannabinol, and dimethoxyphenyl]ethanamine their optical isomers (2C–T–2) ...... 7385 6 cis or trans (43) 2-[4-(Isopropylthio)-2,5- tetrahydrocannabinol, and dimethoxyphenyl]ethanamine their optical isomers (2C–T–4) ...... 7532 3, 4 cis or trans (44) 2-(2,5- tetrahydrocannabinol, and Dimethoxyphenyl)ethanamine its optical isomers (2C–H) ...... 7517 (Since nomenclature of (45) 2-(2,5-Dimethoxy-4-nitro- these substances is not phenyl)ethanamine (2C–N) ...... 7521 internationally standard- (46) 2-(2,5-Dimethoxy-4-(n)- ized, compounds of these propylphenyl)ethanamine (2C– structures, regardless of P) ...... 7524 numerical designation of (47) 3,4-Methylenedioxy-N- atomic positions covered.) methylcathinone (Methylone) 7540 (32) Ethylamine analog of (e) Depressants. Unless specifically phencyclidine ...... 7455 excepted or unless listed in another Some trade or other names: schedule, any material, compound, N-ethyl-1- mixture, or preparation which contains phenylcyclohexylamine, any quantity of the following sub- (1- stances having a depressant effect on phenylcyclohexy- the central nervous system, including l)ethylamine, N-(1- its salts, isomers, and salts of isomers phenylcyclohexy- whenever the existence of such salts, l)ethylamine, isomers, and salts of isomers is possible cyclohexamine, PCE within the specific chemical designa- (33) Pyrrolidine analog of tion: phencyclidine ...... 7458 Some trade or other names: (1) gamma-hydroxybutyric acid 1-(1-phenylcyclohexyl)- (some other names include pyrrolidine, PCPy, PHP GHB; gamma- (34) Thiophene analog of hydroxybutyrate; 4- phencyclidine ...... 7470 hydroxybutyrate; 4- Some trade or other names: hydroxybutanoic acid; sodium 1-[1-(2-thienyl)- oxybate; sodium oxybutyrate) 2010 cyclohexyl]-piperidine, 2- (2) Mecloqualone ...... 2572 thienylanalog of (3) Methaqualone ...... 2565 phencyclidine, TPCP, TCP (35) 1-[1-(2- (f) Stimulants. Unless specifically ex- thienyl)cyclohexyl]pyrrolidine 7473 cepted or unless listed in another

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schedule, any material, compound, mixture, or preparation which contains (1) 5-(1,1-dimethylheptyl)-2- any quantity of the following sub- [(1R,3S)-3-hydroxycyclohexyl]- stances having a stimulant effect on phenol (CP–47,497) ...... 7297 the central nervous system, including (2) 5-(1,1-dimethyloctyl)-2- its salts, isomers, and salts of isomers: [(1R,3S)-3-hydroxycyclohexyl]- phenol (cannabicyclohexanol (1) Aminorex (Some other or CP–47,497 C8-homolog) ...... 7298 names: aminoxaphen; 2-amino- (3) 1-pentyl-3-(1-naph- 5-phenyl-2-oxazoline; or 4,5- thoyl)indole (JWH–018 and dihydro-5-phenly-2- AM678) ...... 7118 oxazolamine) ...... 1585 (4) 1-butyl-3-(1-naphthoyl)indole (2) N-Benzylpiperazine (some (JWH–073) ...... 7173 other names: BZP, 1- (5) 1-hexyl-3-(1-naphthoyl)indole benzylpiperazine) ...... 7493 (JWH–019) ...... 7019 (6) 1-[2-(4-morpholinyl)ethyl]-3- (3) Cathinone ...... 1235 (1-naphthoyl)indole (JWH–200) 7200 Some trade or other names: (7) 1-pentyl-3-(2- 2-amino-1-phenyl-1- methoxyphenylacetyl)indole propanone, alpha- (JWH–250) ...... 6250 aminopropiophenone, 2- (8) 1-pentyl-3-[1-(4- aminopropiophenone, and methoxynaphthoyl)]indole norephedrone (JWH–081) ...... 7081 (4) Fenethylline ...... 1503 (9) 1-pentyl-3-(4-methyl-1-naph- (5) Methcathinone (Some other thoyl)indole (JWH–122) ...... 7122 names: 2-(methylamino)- (10) 1-pentyl-3-(4-chloro-1-naph- propiophenone; alpha- thoyl)indole (JWH–398) ...... 7398 (methylamino)propiophenone; (11) 1-(5-fluoropentyl)-3-(1-naph- 2-(methylamino)-1- thoyl)indole (AM2201) ...... 7201 phenylpropan-1-one; alpha-N- (12) 1-(5-fluoropentyl)-3-(2- methylaminopropiophenone; iodobenzoyl)indole (AM694) ..... 7694 monomethylpropion; (13) 1-pentyl-3-[(4-methoxy)-ben- ephedrone; N- zoyl]indole (SR–19 and RCS–4) 7104 methylcathinone; (14) 1-cyclohexylethyl-3-(2- methylcathinone; AL–464; AL– methoxyphenylacetyl)indole 422; AL–463 and UR1432), its 7008 (SR–18 and RCS–8) ...... 7008 salts, optical isomers and salts (15) 1-pentyl-3-(2- of optical isomers ...... 1237 chlorophenylacetyl)indole (6) (±)cis-4-methylaminorex (JWH–203) ...... 7203 ± (( )cis-4,5-dihydro-4-methyl-5- (h) Temporary listing of substances sub- phenyl-2-oxazolamine) ...... 1590 ject to emergency scheduling. Any mate- (7) N-ethylamphetamine ...... 1475 rial, compound, mixture or preparation (8) N,N-dimethylamphetamine which contains any quantity of the fol- (also known as N,N-alpha- lowing substances: trimethyl-benzeneethanamine; (1) 3,4-methylenedioxy-N- N,N-alpha- methylcathinone (Other names: trimethylphenethylamine) ..... 1480 methylone)—7540 (g) Cannabimimetic agents. Unless spe- (2) 5-(1,1-Dimethyloctyl)-2-[(1R,3S)-3- cifically exempted or unless listed in hydroxycyclohexyl]-phenol, its optical, another schedule, any material, com- positional, and geometric isomers, salts and salts of isomers—7298 (Other pound, mixture, or preparation which names: cannabicyclohexanol and CP– contains any quantity of the following 47,497 C8 homologue) substances, or which contains their (3) 1-Butyl-3-(1-naphthoyl)indole, its salts, isomers, and salts of isomers optical, positional, and geometric iso- whenever the existence of such salts, mers, salts and salts of isomers—7173 isomers, and salts of isomers is possible (Other names: JWH–073) within the specific chemical designa- (4) 1-[2-(4-Morpholinyl)ethyl]-3-(1- tion: naphthoyl)indole, its optical, positional, and geometric isomers, salts 110

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and salts of isomers—7200 (Other sitional, and geometric isomers, salts names: JWH–200) and salts of isomers—7225 (Other (5) 1-Pentyl-3-(1-naphthoyl)indole, its names: 5-fluoro-PB-22; 5F-PB-22) optical, positional, and geometric iso- (17) N-(1-amino-3-methyl-1-oxobutan- mers, salts and salts of isomers—7118 2-yl)-1-(4-fluorobenzyl)-1H-indazole-3- (Other names: JWH–018 and AM678) carboxamide, its optical, positional, (6) 4-methyl-N-methylcathinone—1248 and geometric isomers, salts and salts (Other names: mephedrone) of isomers—7012 (Other names: AB- (7) 3,4-methylenedioxy-N- FUBINACA) methylcathinone—7540 (Other names: (18) N-(1-amino-3,3-dimethyl-1- methylone) oxobutan-2-yl)-1-pentyl-1H-indazole-3- (8) 3,4-methylenedioxypyrovalerone— carboxamide, its optical, positional, 7535 (Other names: MDPV) and geometric isomers, salts and salts (9) (1-pentyl-1H-indol-3-yl)(2,2,3,3- of isomers—7035 (Other names: ADB- tetramethylcyclopropyl)methanone, PINACA) its optical, positional, and geometric (19) 4-methyl-N-ethylcathinone, its isomers, salts and salts of isomers— optical, positional, and geometric iso- 7144 (Other names: UR–144, 1-pentyl-3- mers, salts and salts of isomers—1249 (2,2,3,3- (Other names: 4-MEC; 2-(ethylamino)-1- tetramethylcyclopropoyl)indole) (4-methylphenyl)propan-1-one) (10) [1-(5-fluoro-pentyl)-1H-indol-3- (20) 4-methyl-alpha- yl](2,2,3,3- pyrrolidinopropiophenone, its optical, tetramethylcyclopropyl)methanone, positional, and geometric isomers, its optical, positional, and geometric salts and salts of isomers—7498 (Other isomers, salts and salts of isomers— names: 4-MePPP; MePPP; 4-methyl-a- 7011 (Other names: 5-fluoro-UR-144, 5-F- pyrrolidinopropiophenone; 1-(4- UR-144, XLR11, 1-(5-fluoro-pentyl)-3- methylphenyl)-2-(pyrrolidin-1-yl)- (2,2,3,3- propan-1-one) tetramethylcyclopropoyl)indole) (21) alpha-pyrrolidinopentiophenone, (11) N-(1-adamantyl)-1-pentyl-1H-in- its optical, positional, and geometric dazole-3-carboxamide, its optical, posi- isomers, salts and salts of isomers— tional, and geometric isomers, salts 7545 (Other names: a-PVP; a- and salts of isomers—7048 (Other pyrrolidinovalerophenone; 1-phenyl-2- names: APINACA, AKB48) (pyrrolidin-1-yl)pentan-1-one) (12) 2-(4-iodo-2,5-dimethoxyphenyl)-N- (22) Butylone, its optical, positional, (2-methoxybenzyl)ethanamine, its opti- and geometric isomers, salts and salts cal, positional, and geometric isomers, of isomers—7541 (Other names: bk- salts and salts of isomers—7538 (Other MBDB; 1-(1,3-benzodioxol-5-yl)-2- names: 25I–NBOMe; 2C–I–NBOMe; 25I; (methylamino)butan-1-one) Cimbi-5) (23) Pentedrone, its optical, posi- (13) 2-(4-chloro-2,5-dimethoxyphenyl)- tional, and geometric isomers, salts N-(2-methoxybenzyl)ethanamine, its and salts of isomers—1246 (Other optical, positional, and geometric iso- names: a-methylaminovalerophenone; mers, salts and salts of isomers—7537 2-(methylamino)-1-phenylpentan-1-one) (Other names: 25C–NBOMe; 2C–C– (24) Pentylone, its optical, positional, NBOMe; 25C; Cimbi-82) and geometric isomers, salts and salts (14) 2-(4-bromo-2,5-dimethoxyphenyl)- of isomers—7542 (Other names: bk- N-(2-methoxybenzyl)ethanamine, its MBDP; 1-(1,3-benzodioxol-5-yl)-2- optical, positional, and geometric iso- (methylamino)pentan-1-one) mers, salts and salts of isomers—7536 (25) 4-fluoro-N-methylcathinone, its (Other names: 25B–NBOMe; 2C–B– optical, positional, and geometric iso- NBOMe; 25B; Cimbi-36) mers, salts and salts of isomers—1238 (15) Quinolin-8-yl 1-pentyl-1H-indole- (Other names: 4-FMC; flephedrone; 1-(4- 3-carboxylate, its optical, positional, fluorophenyl)-2-(methylamino)propan- and geometric isomers, salts and salts 1-one) of isomers—7222 (Other names: PB-22; (26) 3-fluoro-N-methylcathinone, its QUPIC) optical, positional, and geometric iso- (16) Quinolin-8-yl 1-(5-fluoropentyl)- mers, salts and salts of isomers—1233 1H-indole-3-carboxylate, its optical, po- (Other names: 3-FMC; 1-(3-

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fluorophenyl)-2-(methylamino)propan- (xii) Oripavine ...... 9330 1-one) (xiii) Oxycodone ...... 9143 (27) Naphyrone, its optical, posi- (xiv) Oxymorphone ...... 9652 tional, and geometric isomers, salts (xv) Powdered opium ...... 9639 and salts of isomers—1258 (Other (xvi) Raw opium ...... 9600 names: naphthylpyrovalerone; 1- (xvii) Thebaine ...... 9333 (naphthalen-2-yl)-2-(pyrrolidin-1- (xviii) Tincture of opium ...... 9630 yl)pentan-1-one) (28) alpha-pyrrolidinobutiophenone, (2) Any salt, compound, derivative, or its optical, positional, and geometric preparation thereof which is chemi- isomers, salts and salts of isomers— cally equivalent or identical with any 7546 (Other names: a-PBP; 1-phenyl-2- of the substances referred to in para- (pyrrolidin-1-yl)butan-1-one) graph (b) (1) of this section, except that [39 FR 22141, June 20, 1974] these substances shall not include the isoquinoline alkaloids of opium. EDITORIAL NOTE: For FEDERAL REGISTER ci- (3) Opium poppy and poppy straw. tations affecting § 1308.11, see the List of CFR Sections Affected, which appears in the (4) Coca leaves (9040) and any salt, Finding Aids section of the printed volume compound, derivative or preparation of and at www.fdsys.gov. coca leaves (including cocaine (9041) and ecgonine (9180) and their salts, iso- § 1308.12 Schedule II. mers, derivatives and salts of isomers (a) Schedule II shall consist of the and derivatives), and any salt, com- drugs and other substances, by what- pound, derivative, or preparation ever official name, common or usual thereof which is chemically equivalent name, chemical name, or brand name or identical with any of these sub- designated, listed in this section. Each stances, except that the substances drug or substance has been assigned shall not include decocainized coca the Controlled Substances Code Num- leaves or extraction of coca leaves, ber set forth opposite it. which extractions do not contain co- (b) Substances, vegetable origin or caine or ecgonine. chemical synthesis. Unless specifically (5) Concentrate of poppy straw (the excepted or unless listed in another crude extract of poppy straw in either schedule, any of the following sub- liquid, solid or powder form which con- stances whether produced directly or tains the phenanthrene alkaloids of the indirectly by extraction from sub- opium poppy), 9670. stances of vegetable origin, or inde- (c) Opiates. Unless specifically ex- pendently by means of chemical syn- cepted or unless in another schedule thesis, or by a combination of extrac- any of the following opiates, including tion and chemical synthesis: its isomers, esters, ethers, salts and (1) Opium and opiate, and any salt, salts of isomers, esters and ethers compound, derivative, or preparation whenever the existence of such iso- of opium or opiate excluding mers, esters, ethers, and salts is pos- apomorphine, thebaine-derived sible within the specific chemical des- butorphanol, dextrorphan, nalbuphine, ignation, dextrorphan and nalmefene, naloxone, and naltrexone, levopropoxyphene excepted: and their respective salts, but including the following: (1) Alfentanil ...... 9737 (2) Alphaprodine ...... 9010 (i) Codeine ...... 9050 (3) Anileridine ...... 9020 (ii) Dihydroetorphine ...... 9334 (4) Bezitramide ...... 9800 (iii) Ethylmorphine ...... 9190 (5) Bulk dextropropoxyphene (iv) Etorphine hydrochloride ..... 9059 (non-dosage forms) ...... 9273 (v) Granulated opium ...... 9640 (vi) Hydrocodone ...... 9193 (6) Carfentanil ...... 9743 (vii) Hydromorphone ...... 9150 (7) Dihydrocodeine ...... 9120 (viii) Metopon ...... 9260 (8) Diphenoxylate ...... 9170 (ix) Morphine ...... 9300 (9) Fentanyl ...... 9801 (x) Opium extracts ...... 9610 (10) Isomethadone ...... 9226 (xi) Opium fluid ...... 9620 (11) Levo-alphacetylmethadol .... 9648

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[Some other names: levo- its salts, isomers, and salts of isomers alpha-acetylmethadol, whenever the existence of such salts, levomethadyl acetate, isomers, and salts of isomers is possible LAAM] within the specific chemical designa- (12) Levomethorphan ...... 9210 tion: (13) Levorphanol ...... 9220 (14) Metazocine ...... 9240 (1) Amobarbital ...... 2125 (15) Methadone ...... 9250 (2) Glutethimide ...... 2550 (16) Methadone-Intermediate, 4- cyano-2-dimethylamino-4,4-di- (3) Pentobarbital ...... 2270 phenyl butane ...... 9254 (4) Phencyclidine ...... 7471 (17) Moramide-Intermediate, 2- (5) Secobarbital ...... 2315 methyl-3-morpholino-1, 1- (f) Hallucinogenic substances. diphenylpropane-carboxylic acid ...... 9802 (18) Pethidine (meperidine) ...... 9230 (1) Nabilone ...... 7379 (19) Pethidine-Intermediate-A, 4- [Another name for nabilone: ± cyano-1-methyl-4- ( )-trans-3-(1,1- phenylpiperidine ...... 9232 dimethylheptyl)- (20) Pethidine-Intermediate-B, 6,6a,7,8,10,10a-hexahydro-1- ethyl-4-phenylpiperidine-4- hydroxy-6,6-dimethyl-9H- carboxylate ...... 9233 dibenzo[b,d]pyran-9-one] (21) Pethidine-Intermediate-C, 1- (g) Immediate precursors. Unless spe- methyl-4-phenylpiperidine-4- cifically excepted or unless listed in carboxylic acid ...... 9234 another schedule, any material, com- (22) Phenazocine ...... 9715 pound, mixture, or preparation which (23) Piminodine ...... 9730 contains any quantity of the following (24) Racemethorphan ...... 9732 substances: (25) Racemorphan ...... 9733 (1) Immediate precursor to amphet- (26) Remifentanil ...... 9739 (27) Sufentanil ...... 9740 amine and methamphetamine: (28) Tapentadol ...... 9780 (i) Phenylacetone ...... 8501 (d) Stimulants. Unless specifically ex- Some trade or other names: cepted or unless listed in another phenyl-2-propanone; P2P; schedule, any material, compound, benzyl methyl ketone; mixture, or preparation which contains methyl benzyl ketone; any quantity of the following substances having a stimulant effect on (2) Immediate precursors to the central nervous system: phencyclidine (PCP):

(1) Amphetamine, its salts, opti- (i) 1-phenylcyclohexylamine ...... 7460 cal isomers, and salts of its (ii) 1- optical isomers ...... 1100 piperidinocyclohexanecarboni- (2) Methamphetamine, its salts, trile (PCC) ...... 8603 isomers, and salts of its isomers ...... 1105 (3) Immediate precursor to fentanyl: (3) Phenmetrazine and its salts 1631 (4) Methylphenidate ...... 1724 (i) 4-anilino-N-phenethyl-4-pi- (5) Lisdexamfetamine, its salts, peridine (ANPP) ...... 8333 isomers, and salts of its iso- (ii) [Reserved] mers ...... 1205. (e) Depressants. Unless specifically [39 FR 22142, June 20, 1974] excepted or unless listed in another EDITORIAL NOTE: For FEDERAL REGISTER ci- schedule, any material, compound, tations affecting § 1308.12, see the List of CFR mixture, or preparation which contains Sections Affected, which appears in the any quantity of the following sub- Finding Aids section of the printed volume stances having a depressant effect on and at www.fdsys.gov. the central nervous system, including

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§ 1308.13 Schedule III. or any salt thereof and one or more other active me- (a) Schedule III shall consist of the dicinal ingredients which drugs and other substances, by what- are not listed in any ever official name, common or usual schedule. name, chemical name, or brand name (2) Any suppository dosage form designated, listed in this section. Each containing: drug or substance has been assigned (i) Amobarbital ...... 2126 the DEA Controlled Substances Code (ii) Secobarbital ...... 2316 Number set forth opposite it. (iii) Pentobarbital ...... 2271 (b) Stimulants. Unless specifically ex- or any salt of any of these cepted or unless listed in another drugs and approved by the schedule, any material, compound, Food and Drug Adminis- mixture, or preparation which contains tration for marketing only any quantity of the following sub- as a suppository. stances having a stimulant effect on (3) Any substance which con- the central nervous system, including tains any quantity of a deriva- its salts, isomers (whether optical, po- tive of barbituric acid or any sitional, or geometric), and salts of salt thereof ...... 2100 such isomers whenever the existence of (4) Chlorhexadol ...... 2510 such salts, isomers, and salts of iso- (5) Embutramide ...... 2020 mers is possible within the specific (6) Any drug product containing chemical designation: gamma hydroxybutyric acid, including its salts, isomers, (1) Those compounds, mixtures, and salts of isomers, for which or preparations in dosage unit an application is approved form containing any stimu- under section 505 of the Fed- lant substances listed in eral Food, Drug, and Cosmetic schedule II which compounds, Act ...... 2012 mixtures, or preparations were (7) Ketamine, its salts, isomers, listed on August 25, 1971, as ex- and salts of isomers ...... 7285 cepted compounds under [Some other names for § 1308.32, and any other drug of ketamine: (±)-2-(2- the quantitative composition chlorophenyl)-2- shown in that list for those (methylamino)- drugs or which is the same ex- cyclohexanone] cept that it contains a lesser (8) Lysergic acid ...... 7300 quantity of controlled sub- (9) Lysergic acid amide ...... 7310 stances ...... 1405 (10) Methyprylon ...... 2575 (2) Benzphetamine ...... 1228 (11) Perampanel, and its salts, (3) Chlorphentermine ...... 1645 isomers, and salts of isomers .. 2261 (4) Clortermine ...... 1647 (12) Sulfondiethylmethane ...... 2600 (5) Phendimetrazine ...... 1615 (13) Sulfonethylmethane ...... 2605 (c) Depressants. Unless specifically (14) Sulfonmethane ...... 2610 excepted or unless listed in another (15) Tiletamine and zolazepam schedule, any material, compound, or any salt thereof ...... 7295 mixture, or preparation which contains Some trade or other names any quantity of the following sub- for a tiletamine-zolazepam stances having a depressant effect on combination product: the central nervous system: Telazol.. Some trade or other names (1) Any compound, mixture or for tiletamine: preparation containing: 2-(ethylamino)-2-(2- (i) Amobarbital ...... 2126 thienyl)- (ii) Secobarbital ...... 2316 cyclohexanone.. (iii) Pentobarbital ...... 2271

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Some trade or other names (iv) Not more than 300 for zolazepam: milligrams of 4-(2-fluorophenyl)-6,8- dihydrocodeinone dihydro-1,3,8- (hydrocodone) per 100 trimethylpyrazolo-[3,4- milliliters or not more e] [1,4]-diazepin-7(1H)- than 15 milligrams per one, flupyrazapon.. dosage unit, with one or more active nonnar- (d) Nalorphine 9400. cotic ingredients in (e) Narcotic drugs. Unless specifically recognized therapeutic excepted or unless listed in another amounts ...... 9806 schedule: (v) Not more than 1.8 grams of (1) Any material, compound, dihydrocodeine per 100 mixture, or preparation con- milliliters or not more taining any of the following than 90 milligrams per narcotic drugs, or their salts dosage unit, with one calculated as the free anhy- or more active nonnar- drous base or alkaloid, in lim- cotic ingredients in ited quantities as set forth recognized therapeutic below: amounts ...... 9807 (i) Not more than 1.8 (vi) Not more than 300 grams of codeine per milligrams of 100 milliliters or not ethylmorphine per 100 more than 90 milli- milliliters or not more grams per dosage unit, than 15 milligrams per with an equal or great- dosage unit, with one er quantity of an or more active, non- isoquinoline alkaloid narcotic ingredients in of opium ...... 9803 recognized therapeutic (ii) Not more than 1.8 amounts ...... 9808 grams of codeine per (vii) Not more than 500 100 milliliters or not milligrams of opium more than 90 milli- per 100 milliliters or grams per dosage unit, per 100 grams or not with one or more ac- more than 25 milli- tive, nonnarcotic in- grams per dosage unit, gredients in recognized with one or more ac- therapeutic amounts ... 9804 tive, nonnarcotic in- (iii) Not more than 300 gredients in recognized milligrams of therapeutic amounts ... 9809 dihydrocodeinone (viii) Not more than 50 (hydrocodone) per 100 milligrams of mor- milliliters or not more phine per 100 milli- than 15 milligrams per liters or per 100 grams, dosage unit, with a with one or more ac- fourfold or greater tive, nonnarcotic in- quantity of an gredients in recognized isoquinoline alkaloid therapeutic amounts ... 9810 of opium ...... 9805 (2) Any material, compound, mixture, or preparation containing any of the following narcotic drugs or their salts, as set forth below: (i) Buprenorphine ...... 9064 (ii) [Reserved].

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(f) Anabolic Steroids. Unless specifi- any quantity of the following sub- cally excepted or unless listed in an- stances, including its salts, isomers, other schedule, any material, com- and salts of isomers whenever the ex- pound, mixture or preparation con- istence of such salts, isomers, and salts taining any quantity of the following of isomers is possible within the spe- substances, including its salts, esters cific chemical designation: and ethers: (1) Anabolic steroids (see § 1300.01 of (1) Alfaxalone ...... 2731 this chapter)—4000 (2) Alprazolam ...... 2882 (2) [Reserved] (3) Barbital ...... 2145 (g) Hallucinogenic substances. (1) (4) Bromazepam ...... 2748 Dronabinol (synthetic) in sesame oil (5) Camazepam ...... 2749 and encapsulated in a soft gelatin cap- (6) Carisoprodol ...... 8192 sule in a U.S. Food and Drug Adminis- (7) Chloral betaine ...... 2460 tration approved product—7369. (8) Chloral hydrate ...... 2465 (9) Chlordiazepoxide ...... 2744 [Some other names for dronabinol: (6aR- (10) Clobazam ...... 2751 trans)-6a,7,8,10a-tetrahydro-6,6,9-trimethyl-3- (11) Clonazepam ...... 2737 pentyl-6H-dibenzo [b,d]pyran-1-ol] or (-)- (12) Clorazepate ...... 2768 delta-9-(trans)-tetrahydrocannabinol] (13) Clotiazepam ...... 2752 (2) [Reserved] (14) Cloxazolam ...... 2753 [39 FR 22142, June 20, 1974] (15) Delorazepam ...... 2754 (16) Diazepam ...... 2765 EDITORIAL NOTE: For FEDERAL REGISTER ci- (17) Dichloralphenazone ...... 2467 tations affecting § 1308.13, see the List of CFR (18) Estazolam ...... 2756 Sections Affected, which appears in the Finding Aids section of the printed volume (19) Ethchlorvynol ...... 2540 and at www.fdsys.gov. (20) Ethinamate ...... 2545 (21) Ethyl loflazepate ...... 2758 § 1308.14 Schedule IV. (22) Fludiazepam ...... 2759 (a) Schedule IV shall consist of the (23) Flunitrazepam ...... 2763 drugs and other substances, by what- (24) Flurazepam ...... 2767 ever official name, common or usual (25) Fospropofol ...... 2138 name, chemical name, or brand name (26) Halazepam ...... 2762 designated, listed in this section. Each (27) Haloxazolam ...... 2771 drug or substance has been assigned (28) Ketazolam ...... 2772 the DEA Controlled Substances Code (29) Loprazolam ...... 2773 Number set forth opposite it. (30) Lorazepam ...... 2885 (b) Narcotic drugs. Unless specifically (31) Lormetazepam ...... 2774 excepted or unless listed in another (32) Mebutamate ...... 2800 schedule, any material, compound, (33) Medazepam ...... 2836 mixture, or preparation containing any (34) Meprobamate ...... 2820 of the following narcotic drugs, or (35) Methohexital ...... 2264 their salts calculated as the free anhy- (36) Methylphenobarbital drous base or alkaloid, in limited quan- (mephobarbital) ...... 2250 tities as set forth below: (37) Midazolam ...... 2884 (38) Nimetazepam ...... 2837 (39) Nitrazepam ...... 2834 (1) Not more than 1 milligram of (40) Nordiazepam ...... 2838 difenoxin and not less than 25 (41) Oxazepam ...... 2835 micrograms of atropine sul- (42) Oxazolam ...... 2839 fate per dosage unit ...... 9167 (43) Paraldehyde ...... 2585 (2) Dextropropoxyphene (alpha- (44) Petrichloral ...... 2591 (+)-4-dimethylamino-1,2-di- (45) Phenobarbital ...... 2285 phenyl-3-methyl-2- (46) Pinazepam ...... 2883 propionoxybutane) ...... 9278 (47) Prazepam ...... 2764 (c) Depressants. Unless specifically (48) Quazepam ...... 2881 excepted or unless listed in another (49) Temazepam ...... 2925 schedule, any material, compound, (50) Tetrazepam ...... 2886 mixture, or preparation which contains (51) Triazolam ...... 2887

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(52) Zaleplon ...... 2781 (2) Butorphanol (including its (53) Zolpidem ...... 2783 optical isomers) ...... 9720 (54) Zopiclone ...... 2784 [39 FR 22143, June 20, 1974] (d) Fenfluramine. Any material, compound, mixture, or preparation which EDITORIAL NOTE: For FEDERAL REGISTER citations affecting § 1308.14, see the List of CFR contains any quantity of the following Sections Affected, which appears in the substances, including its salts, isomers Finding Aids section of the printed volume (whether optical, position, or geo- and at www.fdsys.gov. metric), and salts of such isomers, whenever the existence of such salts, § 1308.15 Schedule V. isomers, and salts of isomers is pos- (a) Schedule V shall consist of the sible: drugs and other substances, by what- ever official name, common or usual (1) Fenfluramine ...... 1670 name, chemical name, or brand name (e) Lorcaserin. Any material, com- designated, listed in this section. pound, mixture, or preparation which (b) Narcotic drugs. Unless specifically contains any quantity of the following excepted or unless listed in another substances, including its salts, isomers, schedule, any material, compound, and salts of such isomers, whenever the mixture, or preparation containing any existence of such salts, isomers, and of the following narcotic drugs and salts of isomers is possible: their salts, as set forth below: (1) [Reserved] (c) Narcotic drugs containing non-nar- (1) Lorcaserin ...... 1625 cotic active medicinal ingredients. Any (f) Stimulants. Unless specifically ex- compound, mixture, or preparation cepted or unless listed in another containing any of the following nar- schedule, any material, compound, cotic drugs, or their salts calculated as mixture, or preparation which contains the free anhydrous base or alkaloid, in any quantity of the following sub- limited quantities as set forth below, stances having a stimulant effect on which shall include one or more non- the central nervous system, including narcotic active medicinal ingredients its salts, isomers and salts of isomers: in sufficient proportion to confer upon the compound, mixture, or preparation (1) Cathine ((+)- valuable medicinal qualities other than norpseudoephedrine) ...... 1230 those possessed by narcotic drugs (2) Diethylpropion ...... 1610 alone: (3) Fencamfamin ...... 1760 (1) Not more than 200 milligrams of (4) Fenproporex ...... 1575 codeine per 100 milliliters or per 100 (5) Mazindol ...... 1605 grams. (6) Mefenorex ...... 1580 (2) Not more than 100 milligrams of (7)Modafinil ...... 1680 dihydrocodeine per 100 milliliters or (8) Pemoline (including per 100 grams. organometallic complexes and (3) Not more than 100 milligrams of chelates thereof) ...... 1530 ethylmorphine per 100 milliliters or per (9) Phentermine ...... 1640 100 grams. (10) Pipradrol ...... 1750 (4) Not more than 2.5 milligrams of (11) Sibutramine ...... 1675 diphenoxylate and not less than 25 (12) SPA ((-)-1-dimethylamino- micrograms of atropine sulfate per dos- 1,2-diphenylethane) ...... 1635 age unit. (5) Not more than 100 milligrams of (g) Other substances. Unless specifi- opium per 100 milliliters or per 100 cally excepted or unless listed in an- grams. other schedule, any material, com- (6) Not more than 0.5 milligram of pound, mixture or preparation which difenoxin and not less than 25 contains any quantity of the following micrograms of atropine sulfate per dos- substances, including its salts: age unit. (d) Stimulants. Unless specifically ex- (1) Pentazocine ...... 9709 empted or excluded or unless listed in

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another schedule, any material, com- (2) The name of the substance for pound, mixture, or preparation which which exclusion is sought; and contains any quantity of the following (3) The complete quantitative com- substances having a stimulant effect position of the substance. on the central nervous system, includ- (c) Within a reasonable period of ing its salts, isomers and salts of iso- time after the receipt of an application mers: for an exclusion under this section, the Administrator shall notify the appli- (1) Pyrovalerone ...... 1485. cant of his acceptance or nonaccept- (2) [Reserved]. ance of his application, and if not ac- (e) Depressants. Unless specifically cepted, the reason therefore. The Ad- exempted or excluded or unless listed ministrator need not accept an applica- in another schedule, any material, tion for filing if any of the require- compound, mixture, or preparation ments prescribed in paragraph (b) of which contains any quantity of the fol- this section is lacking or is not set lowing substances having a depressant forth as to be readily understood. If the effect on the central nervous system, applicant desires, he may amend the including its salts: application to meet the requirements of paragraph (b) of this section. If the (1) Ezogabine [N-[2-amino-4-(4- application is accepted for filing, the fluorobenzylamino)-phenyl]- Administrator shall issue and publish carbamic acid ethyl ester] ...... 2779 in the FEDERAL REGISTER his order on (2) Lacosamide [(R)-2- acetoamido-N-benzyl-3- the application, which shall include a methoxy-propionamide] ...... 2746 reference to the legal authority under (3) Pregabalin [(S)-3- which the order is issued and the find- (aminomethyl)-5- ings of fact and conclusions of law methylhexanoic acid] ...... 2782 upon which the order is based. This order shall specify the date on which it [39 FR 22143, June 20, 1974, as amended at 43 shall take effect. The Administrator FR 38383, Aug. 28, 1978; 44 FR 40888, July 13, shall permit any interested person to 1979; 47 FR 49841, Nov. 3, 1982; 50 FR 8108, Feb. file written comments on or objections 28, 1985; 52 FR 5952, Feb. 27, 1987; 53 FR 10870, Apr. 4, 1988; 56 FR 61372, Dec. 3, 1991; 67 FR to the order within 60 days of the date 62370, Oct. 7, 2002; 70 FR 43635, July 28, 2005; of publication of his order in the FED- 74 FR 23790, May 21, 2009; 76 FR 77899, Dec. 15, ERAL REGISTER. If any such comments 2011] or objections raise significant issues regarding any finding of fact or conclu- EXCLUDED NONNARCOTIC SUBSTANCES sion of law upon which the order is § 1308.21 Application for exclusion of a based, the Administrator shall imme- nonnarcotic substance. diately suspend the effectiveness of the (a) Any person seeking to have any order until he may reconsider the ap- nonnarcotic drug that may, under the plication in light of the comments and Federal Food, Drug, and Cosmetic Act objections filed. Thereafter, the Ad- (21 U.S.C. 301), be lawfully sold over the ministrator shall reinstate, revoke, or counter without a prescription, ex- amend his original order as he deter- cluded from any schedule, pursuant to mines appropriate. section 201(g)(1) of the Act (21 U.S.C. (d) The Administrator may at any 811(g)(1)), may apply to the Office of time revoke any exclusion granted pur- Diversion Control, Drug Enforcement suant to section 201(g) of the Act (21 Administration. See the Table of DEA U.S.C. 811(g)) by following the proce- Mailing Addresses in § 1321.01 of this dures set forth in paragraph (c) of this chapter for the current mailing ad- section for handling an application for dress. an exclusion which has been accepted (b) An application for an exclusion for filing. under this section shall contain the following information: [38 FR 8254, Mar. 30, 1973, as amended at 70 (1) The name and address of the ap- FR 74657, Dec. 16, 2005; 75 FR 10678, Mar. 9, plicant; 2010]

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§ 1308.22 Excluded substances. be lawfully sold over the counter with- The following nonnarcotic substances out a prescription, are excluded from which may, under the Federal Food, all schedules pursuant to section 201(g) Drug, and Cosmetic Act (21 U.S.C. 301), (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 quantity, proportion, or concentration, that the preparation or mixture does § 1308.23 Exemption of certain chem- not present any potential for abuse. If ical preparations; application. the preparation or mixture contains a (a) The Administrator may, by regu- narcotic controlled substance, the lation, exempt from the application of preparation or mixture must be formu- all or any part of the Act any chemical lated in such a manner that it incor- preparation or mixture containing one porates methods of denaturing or other or more controlled substances listed in means so that the preparation or mix- any schedule, which preparation or ture is not liable to be abused or have mixture is intended for laboratory, in- ill effects, if abused, and so that the dustrial, educational, or special re- narcotic substance cannot in practice search purposes and not for general ad- be removed. ministration to a human being or other (b) Any person seeking to have any animal, if the preparation or mixture preparation or mixture containing a either: controlled substance and one or more (1) Contains no narcotic controlled noncontrolled substances exempted substance and is packaged in such a from the application of all or any part form or concentration that the pack- of the Act, pursuant to paragraph (a) of aged quantity does not present any sig- this section, may apply to the Office of nificant potential for abuse (the type of Diversion Control, Drug Enforcement packaging and the history of abuse of Administration. See the Table of DEA the same or similar preparations may Mailing Addresses in § 1321.01 of this be considered in determining the po- chapter for the current mailing ad- tential for abuse of the preparation or dress. mixture); or (c) An application for an exemption (2) Contains either a narcotic or non- under this section shall contain the fol- narcotic controlled substance and one lowing information: or more adulterating or denaturing (1) The name, address, and registra- agents in such a manner, combination, tion number, if any, of the applicant;

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(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 402(a)(8) of the Act (21 U.S.C. 842(a) (8)) all preparations and mixtures granted or any other law restricting public dis- under the old criteria) and modify the closure of information. scope of exemptions at any time. (d) The Administrator may require [38 FR 8254, Mar. 30, 1973. Redesignated at 38 the applicant to submit such docu- FR 26609, Sept. 24, 1973, and amended at 46 ments or written statements of fact FR 28841, May 29, 1981; 62 FR 13968, Mar. 24, relevant to the application as he deems 1997; 75 FR 10678, Mar. 9, 2010] necessary to determine whether the application should be granted. § 1308.24 Exempt chemical prepara- (e) Within a reasonable period of tions. time after the receipt of an application (a) The chemical preparations and for an exemption under this section, mixtures approved pursuant to § 1308.23 the Administrator shall notify the ap- are exempt from application of sec- plicant of his acceptance or nonaccept- tions 302, 303, 305, 306, 307, 308, 309, 1002, ance of his application, and if not ac- 1003 and 1004 of the Act (21 U.S.C. 822– cepted, the reason therefor. The Ad- 823, 825–829, 952–954) and § 1301.74 of this ministrator need not accept an applica- chapter, to the extent described in tion for filing if any of the require- paragraphs (b) to (h) of this section. ments prescribed in paragraph (c) or re- Substances set forth in paragraph (j) of quested pursuant to paragraph (d) is this section shall be exempt from the

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application of sections 305, 306, 307, 308, paragraph (i) of this section. In lieu of 309, 1002, 1003 and 1004 of the Act (21 records and reports required under part U.S.C. 825–829, 952–954) and §§ 1301.71– 1304 of this chapter regarding exempt 1301.73 and 1301.74 (a), (b), (d), (e) and (f) chemical preparations, the manufac- of this chapter to the extent as herein- turer need only record the name, ad- after may be provided. dress, and registration number, if any, (b) Registration and security: Any of each person to whom the manufac- person who manufactures an exempt turer distributes any exempt chemical chemical preparation or mixture must preparation. Each importer or exporter be registered under the Act and comply of an exempt narcotic chemical prepa- with all relevant security requirements ration must submit a semiannual re- regarding controlled substances being port of the total quantity of each sub- used in the manufacturing process stance imported or exported in each until the preparation or mixture is in calendar half-year within 30 days of the the form described in paragraph (i) of close of the period to the Drug and this section. Any other person who Chemical Evaluation Section, Drug En- handles an exempt chemical prepara- forcement Administration. See the tion after it is in the form described in Table of DEA Mailing Addresses in paragraph (i) of this section is not re- § 1321.01 of this chapter for the current quired to be registered under the Act mailing address. Any other person who to handle that preparation, and the handles an exempt chemical prepara- preparation is not required to be stored tion after it is in the form described in in accordance with security require- paragraph (i) of this section is not re- ments regarding controlled substances. quired to maintain records or file re- (c) Labeling: In lieu of the require- ports. ments set forth in part 1302 of this (e) Quotas, order forms, prescrip- chapter, the label and the labeling of tions, import, export, and trans- an exempt chemical preparation must shipment requirements: Once an ex- be prominently marked with its full empt chemical preparation is in the trade name or other description and form described in paragraph (i) of this the name of the manufacturer or sup- section, the requirements regarding plier as set forth in paragraph (i) of quotas, order forms, prescriptions, im- this section, in such a way that the port permits and declarations, export product can be readily identified as an permit and declarations, and trans- exempt chemical preparation. The shipment and intransit permits and label and labeling must also include in declarations do not apply. These re- a prominent manner the statement quirements do apply, however, to any ‘‘For industrial use only’’ or ‘‘For controlled substances used in manufac- chemical use only’’ or ‘‘For in vitro use turing the exempt chemical prepara- only—not for human or animal use’’ or tion before it is in the form described ‘‘Diagnostic reagent—for professional in paragraph (i) of this section. use only’’ or a comparable statement (f) Criminal penalties: No exemption warning the person reading it that granted pursuant to § 1308.23 affects the human or animal use is not intended. criminal liability for illegal manufac- The symbol designating the schedule of ture, distribution, or possession of con- the controlled substance is not re- trolled substances contained in the ex- quired on either the label or the label- empt chemical preparation. Distribu- ing of the exempt chemical preparation, possession, and use of an exempt tion, nor is it necessary to list all in- chemical preparation are lawful for gredients of the preparation. registrants and nonregistrants only as (d) Records and reports: Any person long as such distribution, possession, who manufactures an exempt chemical or use is intended for laboratory, in- preparation or mixture must keep com- dustrial, or educational purposes and plete and accurate records and file all not for immediate or subsequent ad- reports required under part 1304 of this ministration to a human being or other chapter regarding all controlled sub- animal. stances being used in the manufac- (g) Bulk materials: For materials ex- turing process until the preparation or empted in bulk quantities, the Admin- mixture is in the form described in istrator may prescribe requirements

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other than those set forth in para- Mailing Addresses in § 1321.01 of this graphs (b) through (e) of this section on chapter for the current mailing ad- a case-by-case basis. dress. (h) Changes in chemical preparations: (b) An application for any exclusion Any change in the quantitative or under this section shall be submitted 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; this section, requires a new application (3) The chemical structural formula 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;. (2) EmitR Phenobarbital Enzyme Rea- (8) The name and address of the man- gent B. In one liter quantities each ufacturer of the dosage form if dif- with a 5 ml. retention sample for re- ferent from that of the applicant; and packaging as an exempt chemical prep- (9) Evidence that the product has aration only. been approved by the Secretary of 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 Finding Aids section of the printed volume and at www.fdsys.gov. for an exclusion under this section, the Administrator shall notify the appli- EXCLUDED VETERINARY ANABOLIC cant of his acceptance or nonaccept- STEROID IMPLANT PRODUCTS ance of the application, and if not accepted, the reason therefore. The Ad- § 1308.25 Exclusion of a veterinary an- ministrator need not accept an applica- abolic steroid implant product; ap- tion for filing if any of the require- plication. ments prescribed in paragraph (b) of (a) Any person seeking to have any this section is lacking or is not set anabolic steroid product, which is ex- forth as to be readily understood. The pressly intended for administration applicant may amend the application through implants to cattle or other to meet the requirements of paragraph nonhuman species and which has been (b) of this section. If the application is approved by the Secretary of Health accepted for filing, the Administrator and Human Services for such adminis- shall issue and have published in the tration, identified as being excluded FEDERAL REGISTER his order on the ap- from any schedule, pursuant to section plication, which shall include a ref- 102(41)(B)(i) of the Act (21 U.S.C. erence to the legal authority under 802(41)(B)(i)), may apply to the Office of which the order is issued and the find- Diversion Control, Drug Enforcement ings of fact and conclusions of law Administration. See the Table of DEA upon which the order is based. This

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order shall specify the date on which it in the meaning of section 102(41)(A) of will take effect. The Administrator the Act (21 U.S.C. 802(41)(A)). shall permit any interested person to [56 FR 42936, Aug. 30, 1991, as amended at 57 file written comments on or objections FR 19534, May 7, 1992; 58 FR 15088, Mar. 19, to the order within 60 days of the date 1993; 62 FR 13967, Mar. 24, 1997; 75 FR 10679, of publication in the FEDERAL REG- Mar. 9, 2010] ISTER. If any such comments or objections raise significant issues regarding EXEMPTED PRESCRIPTION PRODUCTS any finding of fact or conclusion of law upon which the order is based, the Ad- § 1308.31 Application for exemption of a nonnarcotic prescription product. ministrator shall immediately suspend the effectiveness of the order until he (a) Any person seeking to have any may reconsider the application in light compound, mixture, or preparation of the comments and objections filed. containing any nonnarcotic controlled Thereafter, the Administrator shall re- substance listed in § 1308.12(e), or in instate, revoke, or amend his original § 1308.13(b) or (c), or in § 1308.14, or in order as he determines appropriate. § 1308.15, exempted from application of (d) The Administrator may at any all or any part of the Act pursuant to time revoke or modify any designation section 201(g)(3)(A), of the Act (21 of excluded status granted pursuant to U.S.C. 811(g)(3)(A)) may apply to the this section by following the proce- Office of Diversion Control, Drug En- dures set forth in paragraph (c) of this forcement Administration. See the section for handling an application for Table of DEA Mailing Addresses in an exclusion which has been accepted § 1321.01 of this chapter for the current mailing address. for filing. (b) An application for an exemption [56 FR 42936, Aug. 30, 1991, as amended at 75 under this section shall contain the fol- FR 10679, Mar. 9, 2010] lowing information: (1) The complete quantitative com- § 1308.26 Excluded veterinary anabolic position of the dosage form. steroid implant products. (2) Description of the unit dosage (a) Products containing an anabolic form together with complete labeling. steroid, that are expressly intended for (3) A summary of the pharmacology administration through implants to of the product including animal inves- cattle or other nonhuman species and tigations and clinical evaluations and which have been approved by the Sec- studies, with emphasis on the psychic retary of Health and Human Services and/or physiological dependence liabil- for such administration are excluded ity (this must be done for each of the from all schedules pursuant to section active ingredients separately and for 102(41)(B)(i) of the Act (21 U.S.C. the combination product). 802(41)(B)(i)). A listing of the excluded (4) Details of synergisms and antag- products may be obtained by submit- onisms among ingredients. ting a written request to the Drug and (5) Deterrent effects of the noncon- Chemical Evaluation Section, Drug En- trolled ingredients. forcement Administration. See the (6) Complete copies of all literature Table of DEA Mailing Addresses in in support of claims. § 1321.01 of this chapter for the current (7) Reported instances of abuse. mailing address. (8) Reported and anticipated adverse (b) In accordance with section effects. 102(41)(B)(ii) of the Act (21 U.S.C. (9) Number of dosage units produced 802(41)(B)(ii)) if any person prescribes, for the past 2 years. dispenses, or distributes a product list- (c) Within a reasonable period of ed in paragraph (a) of this section for time after the receipt of an application human use, such person shall be con- for an exemption under this section, sidered to have prescribed, dispensed, the Administrator shall notify the ap- or distributed an anabolic steroid with- plicant of his acceptance or non-acceptance of the application, and if not

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accepted, the reason therefor. The Ad- § 1308.32 Exempted prescription prod- ministrator need not accept an applica- ucts. tion for filing if any of the require- The compounds, mixtures, or prep- ments prescribed in paragraph (b) of arations that contain a nonnarcotic this section is lacking or is not set controlled substance listed in forth so as to be readily understood. If § 1308.12(e) or in § 1308.13(b) or (c) or in the applicant desires, he may amend § 1308.14 or in § 1308.15 listed in the the application to meet the require- Table of Exempted Prescription Prod- ments of paragraph (b) of this section. ucts have been exempted by the Ad- If accepted for filing, the Adminis- ministrator from the application of trator shall publish in the FEDERAL sections 302 through 305, 307 through REGISTER general notice of this pro- 309, and 1002 through 1004 of the Act (21 posed rulemaking in granting or deny- U.S.C. 822–825, 827–829, and 952–954) and ing the application. Such notice shall §§ 1301.13, 1301.22, and §§ 1301.71 through include a reference to the legal author- 1301.76 of this chapter for administra- ity under which the rule is proposed, a tive purposes only. An exception to the statement of the proposed rule grant- above is that those products containing ing or denying an exemption, and, in butalbital shall not be exempt from the the discretion of the Administrator, a requirement of 21 U.S.C. 952–954 con- summary of the subjects and issues in- cerning importation, exportation, 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 [75 FR 10679, Mar. 9, 2010] order shall specify the date on which it shall take effect, which shall not be EXEMPT ANABOLIC STEROID PRODUCTS less than 30 days from the date of publication in the FEDERAL REGISTER un- § 1308.33 Exemption of certain ana- less the Administrator finds that con- bolic steroid products; application. ditions of public health or safety neces- (a) The Administrator, upon the rec- sitate an earlier effective date, in ommendation of Secretary of Health which event the Administrator shall and Human Services, may, by regula- specify in the order his findings as to tion, exempt from the application of such conditions. all or any part of the Act any com- (d) The Administrator may revoke pound, mixture, or preparation con- any exemption granted pursuant to taining an anabolic steroid as defined section 201(g)(3)(A) of the Act (21 U.S.C. in part 1300 of this chapter, which is in- 811(g)(3)(A)) by following the proce- tended for administration to a human dures set forth in paragraph (c) of this being or animal, if, because of its con- section for handling an application for centration, preparation, formulation, an exemption which has been accepted or delivery system, it has no signifi- for filing. cant potential for abuse. (b) Any person seeking to have any [38 FR 8254, Mar. 30, 1973. Redesignated at 38 compound, mixture, or preparation FR 26609, Sept. 24, 1973, as amended at 44 FR containing an anabolic steroid as de- 18968, Mar. 30, 1979; 52 FR 9803, Mar. 27, 1987; fined in part 1300 of this chapter ex- 75 FR 10679, Mar. 9, 2010] empted from the application of all or

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any part of the Act, pursuant to para- as to whether such product which con- graph (a) of this section, may apply to tains an anabolic steroid should be con- the Office of Diversion Control, Drug sidered for exemption from certain por- Enforcement Administration. See the tions of the Controlled Substances Act. Table of DEA Mailing Addresses in On receipt of the recommendation of § 1321.01 of this chapter for the current the Secretary, the Administrator shall mailing address. make a determination as to whether (c) An application for an exemption the evidence submitted or otherwise under this section shall be submitted available sufficiently establishes that in triplicate and contain the following the product possesses no significant po- information: tential for abuse. The Administrator (1) The name and address of the ap- shall issue and publish in the FEDERAL plicant; REGISTER his order on the application, (2) The name of the product; which shall include a reference to the (3) The chemical structural formula legal authority under which the order or description for any anabolic steroid is issued, and the findings of fact and contained in the product; conclusions of law upon which the (4) The complete description of dos- order is based. This order shall specify age and quantitative composition of the date on which it will take effect. the dosage form; The Administrator shall permit any in- (5) A description of the delivery sys- terested person to file written com- tem, if applicable; ments on or objections to the order (6) The indications and conditions for within 60 days of the date of publica- use in which species, including whether tion of his order in the FEDERAL REG- or not this product is a prescription ISTER. If any such comments or objec- drug; tions raise significant issues regarding (7) Information to facilitate identi- any finding of fact or conclusion of law fication of the dosage form, such as upon which the order is based, the Ad- shape, color, coating, and scoring; ministrator shall immediately suspend (8) The label and labeling of the im- the effectiveness of the order until he mediate container and the commercial may reconsider the application in light containers, if any, of the product; of the comments and objections filed. (9) The units in which the dosage Thereafter, the Administrator shall re- form is ordinarily available; and instate, revoke, or amend his original (10) The facts which the applicant be- order as he determines appropriate. lieves justify: (e) The Administrator may revoke (i) A determination that the product any exemption granted pursuant to has no significant potential for abuse section 1903(a) of Public Law 101–647 by and following the procedures set forth in (ii) a granting of an exemption under paragraph (d) of this section for han- this section. dling an application for an exemption (d) Within a reasonable period of which has been accepted for filing. time after the receipt of the application for an exemption under this sec- [56 FR 42936, Aug. 30, 1991; 57 FR 10815, Mar. tion, the Administrator shall notify 31, 1992, as amended at 62 FR 13968, Mar. 24, the applicant of his acceptance or non- 1997; 70 FR 74657, Dec. 16, 2005; 75 FR 10679, acceptance of the application, and if Mar. 9, 2010] not accepted, the reason therefor. The Administrator need not accept an ap- § 1308.34 Exempt anabolic steroid plication for filing if any of the re- products. quirements prescribed in paragraph (c) The list of compounds, mixtures, or of this section is lacking or is not set preparations that contain an anabolic forth so as to be readily understood. steroid that have been exempted by the The applicant may amend the applica- Administrator from application of section to meet the requirements of para- tions 302 through 309 and 1002 through graph (c) of this section. If accepted for 1004 of the Act (21 U.S.C. 822–829 and filing, the Administrator will request 952–954) and §§ 1301.13, 1301.22, and from the Secretary for Health and 1301.71 through 1301.76 of this chapter Human Services his recommendation, for administrative purposes only may

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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 tetrahydrocannabinols. ration containing THC is exempt from 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, oil, or cake, or the sterilized seed of [66 FR 51544, Oct. 9, 2001] such plant which is incapable of germi- nation] and HEARINGS (2) Not used, or intended for use, for § 1308.41 Hearings generally. human consumption, has been exempted by the Administrator from the ap- In any case where the Administrator plication of the Act and this chapter. shall hold a hearing on the issuance, (b) As used in this section, the fol- amendment, or repeal of rules pursuant lowing terms shall have the meanings to section 201 of the Act, the proce- specified: dures for such hearing and accom- (1) The term processed plant material panying proceedings shall be governed means cannabis plant material that generally by the rulemaking proce- has been subject to industrial proc- dures set forth in the Administrative esses, or mixed with other ingredients, Procedure Act (5 U.S.C. 551–559) and such that it cannot readily be con- specifically by section 201 of the Act (21 verted into any form that can be used U.S.C. 811), by §§ 1308.42–1308.51, and by for human consumption. §§ 1316.41–1316.67 of this chapter. (2) The term animal feed mixture means sterilized cannabis seeds mixed § 1308.42 Purpose of hearing. with other ingredients (not derived If requested by any interested person from the cannabis plant) in a formula- after proceedings are initiated pursu- tion that is designed, marketed, and ant to § 1308.43, the Administrator shall distributed for animal consumption hold a hearing for the purpose of re- (and not for human consumption). ceiving factual evidence and expert (3) The term used for human consump- opinion regarding the issues involved tion means either: in the issuance, amendment or repeal (i) Ingested orally or of a rule issuable pursuant to section

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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 rulemaking. trator within a reasonable period of 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, llllllllll (Date) request from the Secretary a scientific Administrator, Drug Enforcement Adminis- and medical evaluation and the Sec- tration llllll (Mailing Address) retary’s recommendations as to whether such drug or other substance should Dear Sir: The undersigned llllllll hereby petitions the Administrator to ini- be so controlled, transferred, or re- tiate proceedings for the issuance (amend- moved as a controlled substance. The ment 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 (A) The proposed rule in the form proposed other substance not be controlled, the by the petitioner. (If the petitioner seeks the Administrator shall not control that amendment or repeal of an existing rule, the existing rule, together with a reference to drug or other substance. the section in the Code of Federal Regula- (e) If the Administrator determines tions where it appears, should be included.) that the scientific and medical evalua- (B) A statement of the grounds which the tion and recommendations of the Sec- petitioner relies for the issuance (amend- retary and all other relevant data con- ment or repeal) of the rule. (Such grounds stitute substantial evidence of poten- shall include a reasonably concise statement tial for abuse such as to warrant con- of the facts relied upon by the petitioner, in- trol or additional control over the drug cluding a summary of any relevant medical or other substance, or substantial evi- or scientific evidence known to the petitioner.) dence that the drug or other sub- All notices to be sent regarding this peti- stances should be subjected to lesser tion should be addressed to: control or removed entirely from the llllllllll (Name) schedules, he shall initiate proceedings llllllllll (Street Address) for control, transfer, or removal as the llllllllll (City and State) case may be. Respectfully yours, (f) If and when the Administrator de- llllllllll (Signature of petitioner) termines to initiate proceedings, he

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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 redesignated and amended at 62 FR 13968, Mar. 24, [38 FR 8254, Mar. 30, 1973. Redesignated at 38 1997] FR 26609, Sept. 24, 1973, and further redesignated and amended at 62 FR 13968, Mar. 24, § 1308.45 Final order. 1997; 75 FR 10679, Mar. 9, 2010] 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 (b) Any interested person desiring to from the date of publication in the participate in a hearing pursuant to FEDERAL REGISTER unless the Adminis- § 1308.41 shall, within 30 days after the trator finds that conditions of public date of publication of the notice of health or safety necessitate an earlier hearing in the FEDERAL REGISTER, file effective date, in which event the Ad- with the Administrator a written no- ministrator shall specify in the order tice of his intention to participate in his findings as to such conditions. such hearing in the form prescribed in [38 FR 8254, Mar. 30, 1973. Redesignated at 38 § 1316.48 of this chapter. Any person fil- FR 26609, Sept. 24, 1973, and further redesig- ing a request for a hearing need not nated at 62 FR 13968, Mar. 24, 1997] also file a notice of appearance; the request for a hearing shall be deemed to § 1308.46 Control required under inter- be a notice of appearance. national treaty. (c) Any interested person may, with- Pursuant to section 201(d) of the Act in the period permitted for filing a re- (21 U.S.C. 811(d)), where control of a quest for a hearing, file with the Ad- substance is required by U.S. obliga- ministrator a waiver of an opportunity tions under international treaties, con- for a hearing or to participate in a ventions, or protocols in effect on May hearing, together with a written state- 1, 1971, the Administrator shall issue

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and publish in the FEDERAL REGISTER § 1308.49 Emergency scheduling. an order controlling such substance Pursuant to 21 U.S.C. 811(h) and with- under the schedule he deems most ap- out regard to the requirements of 21 propriate to carry out obligations. U.S.C. 811(b) relating to the scientific Issuance of such an order shall be with- and medical evaluation of the Sec- out regard to the findings required by retary of Health and Human Services, subsections 201(a) or 202(b) of the Act the Administrator may place a sub- (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 REGISTER of his intention to issue such necessitate an earlier effective date, in order and the grounds upon which such which event the Administrator shall order is to be issued, and specify in the order his findings as to (b) The date the Administrator has such conditions. transmitted notification to the Sec- [38 FR 8254, Mar. 30, 1973. Redesignated at 38 retary of Health and Human Services FR 26609, Sept. 24, 1973, and further redesig- of his intention to issue such order. An nated at 62 FR 13968, Mar. 24, 1997] order issued under this section shall be vacated upon the conclusion of a subse- § 1308.47 Control of immediate precur- quent rulemaking proceeding initiated sors. under section 201(a) (21 U.S.C. 811(a)) Pursuant to section 201(e) of the Act with respect to such substance or at (21 U.S.C. 811(e)), the Administrator the end of one year from the effective date of the order scheduling the sub- may, without regard to the findings re- stance, except that during the pend- quired by subsection 201(a) or 202 (b) of ency of proceedings under section the Act (21 U.S.C. 811(a) or 812(b)) and 201(a) (21 U.S.C. 811(a)) with respect to without regard to the procedures pre- the substance, the Administrator may scribed by § 1308.41 or subsections 201 extend the temporary scheduling for up (a) and (b) of the Act (21 U.S.C. 811(a) to six months. and (b)), issue and publish in the FED- [51 FR 15318, Apr. 23, 1986. Redesignated and ERAL REGISTER an order controlling an amended at 62 FR 13968, Mar. 24, 1997] immediate precursor. The order shall designate the schedule in which the immediate precursor is to be placed, PART 1309—REGISTRATION OF which shall be the same schedule in MANUFACTURERS, DISTRIBUTORS, which the controlled substance of IMPORTERS AND EXPORTERS OF which it is an immediate precursor is LIST I CHEMICALS placed or any other schedule with a higher numerical designation. An order GENERAL INFORMATION controlling an immediate precursor Sec. shall become effective 30 days from the 1309.01 Scope of part 1309. 1309.02 Definitions. date of publication in the FEDERAL 1309.03 Information; special instructions. REGISTER, unless the Administrator finds that conditions of public health FEES FOR REGISTRATION AND REREGISTRATION or safety necessitate an earlier effec- 1309.11 Fee amounts. tive date, in which event the Adminis- 1309.12 Time and method of payment; re- trator shall specify in the order his fund.

findings as to such conditions. REQUIREMENTS FOR REGISTRATION [38 FR 8254, Mar. 30, 1973. Redesignated at 38 1309.21 Persons required to register. FR 26609, Sept. 24, 1973, and further redesig- 1309.22 Separate registration for inde- nated at 62 FR 13968, Mar. 24, 1997] pendent activities.

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1309.23 Separate registration for separate importers and exporters of List I locations. chemicals pursuant to Sections 102, 302, 1309.24 Waiver of registration requirement 303, 1007 and 1008 of the Act (21 U.S.C. for certain activities. 1309.25 Temporary exemption from registra- 802, 822, 823, 957 and 958) are set forth tion for chemical registration applicants. generally by those sections and specifi- 1309.26 Exemption of law enforcement offi- cally by the sections of this part. cials. § 1309.02 Definitions. APPLICATION FOR REGISTRATION Any term used in this part shall have 1309.31 Time for application for registra- the definition set forth in section 102 of tion; expiration date. the Act (21 U.S.C. 802) or part 1300 of 1309.32 Application forms; contents, signature. this chapter. 1309.33 Filing of application; joint filings. [62 FR 13968, Mar. 24, 1997] 1309.34 Acceptance for filing; defective applications. § 1309.03 Information; special instruc- 1309.35 Additional information. tions. 1309.36 Amendments to and withdrawals of applications. Information regarding procedures under these rules and instructions ACTION ON APPLICATIONS FOR REGISTRATION: supplementing these rules will be fur- REVOCATION OR SUSPENSION OF REGISTRATION nished upon request by writing to the 1309.41 Administrative review generally. Registration Section, Drug Enforce- 1309.42 Certificate of registration; denial of ment Administration. See the Table of registration. DEA Mailing Addresses in § 1321.01 of 1309.43 Suspension or revocation of registration. this chapter for the current mailing ad- 1309.44 Suspension of registration pending dress. final order. [75 FR 10680, Mar. 9, 2010] 1309.45 Extension of registration pending final order. FEES FOR REGISTRATION AND 1309.46 Order to show cause. REREGISTRATION HEARINGS § 1309.11 Fee amounts. 1309.51 Hearings generally. 1309.52 Purpose of hearing. (a) For each application for registra- 1309.53 Request for hearing or appearance; tion or reregistration to manufacture waiver. the applicant shall pay an annual fee of 1309.54 Burden of proof. $3,047. 1309.55 Time and place of hearing. (b) For each application for registra- MODIFICATION, TRANSFER AND TERMINATION tion or reregistration to distribute, im- OF REGISTRATION port, or export a List I chemical, the 1309.61 Modification in registration. applicant shall pay an annual fee of 1309.62 Termination of registration. $1,523. 1309.63 Transfer of registration. [77 FR 15250, Mar. 15, 2012] SECURITY REQUIREMENTS § 1309.12 Time and method of pay- 1309.71 General security requirements. ment; refund. 1309.72 Felony conviction; employer responsibilities. (a) For each application for registra- 1309.73 Employee responsibility to report di- tion or reregistration to manufacture, version. distribute, import, or export, the appli- AUTHORITY: 21 U.S.C. 802, 821, 822, 823, 824, cant shall pay the fee when the appli- 830, 871(b), 875, 877, 886a, 952, 953, 957, 958. cation for registration or reregistra- SOURCE: 60 FR 32454, June 22, 1995, unless tion is submitted for filing. otherwise noted. (b) Payments should be made in the form of a credit card; a personal, cer- GENERAL INFORMATION tified, or cashier’s check; or a money order made payable to ‘‘Drug Enforce- § 1309.01 Scope of part 1309. ment Administration.’’ Payments Procedures governing the registra- made in the form of stamps, foreign tion of manufacturers, distributors, currency, or third party endorsed

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checks will not be accepted. These ap- (2) Every person who distributes or plication fees are not refundable. exports or proposes to distribute or ex- [75 FR 4980, Feb. 1, 2010] port any List I chemical, other than those List I chemicals contained in a REQUIREMENTS FOR REGISTRATION product exempted under paragraph (1)(iv) of the definition of regulated § 1309.21 Persons required to register. transaction in § 1300.02 of this chapter. (a) Unless exempted by law or under (b) Only persons actually engaged in §§ 1309.24 through 1309.26 or §§ 1310.12 the activities are required to obtain a through 1310.13 of this chapter, the fol- registration; related or affiliated per- lowing persons must annually obtain a sons who are not engaged in the activi- registration specific to the List I ties are not required to be registered. chemicals to be handled: (For example, a stockholder or parent (1) Every person who manufactures corporation of a corporation distrib- or imports or proposes to manufacture uting List I chemicals is not required or import a List I chemical or a drug to obtain a registration.) product containing ephedrine, pseudoephedrine, or phenylpropanola- (c) The registration requirements are mine. summarized in the following table:

SUMMARY OF REGISTRATION REQUIREMENTS AND LIMITATIONS

Registration Business Chemicals DEA Forms Application fee period Coincident activities al- activity (years) lowed

Manufacturing ... List I ...... New–510 ...... $3,047 1 May distribute that chemical for which registration was issued; may not distribute any chemical for which not registered. Drug products containing Renewal– 3,047 ephedrine, pseudoephedrine, 510a. phenylpropanolamine. Distributing ...... List I ...... New–510 ...... 1,523 1 Scheduled listed chemical Renewal– 1,523 products. 510a. Importing ...... List I ...... New–510 ...... 1,523 1 May distribute that chemical for which registration was issued; may not distribute any chemical for which not registered. Drug Products containing Renewal– 1,523 ephedrine, pseudoephedrine, 510a. phenylpropanolamine. Exporting ...... List I ...... New–510 ...... 1,523 1 Scheduled listed chemical Renewal– 1,523 products. 510a.

[75 FR 4980, Feb. 1, 2010, as amended at 77 FR (2) Distributing of List I chemicals 4236, Jan. 27, 2012; 77 FR 15250, Mar. 15, 2012] and scheduled listed chemical products. § 1309.22 Separate registration for (3) Importing List I chemicals or independent activities. drug products containing ephedrine, (a) The following groups of activities pseudoephedrine, or phenylpropanola- are deemed to be independent of each mine. other: (4) Exporting List I chemicals and (1) Manufacturing of List I chemicals scheduled listed chemical products. or drug products containing ephedrine, (b) Except as provided in paragraphs pseudoephedrine, or phenylpropanola- (c) and (d) of this section, every person mine. who engages in more than one group of independent activities must obtain a

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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 paragraph (c) A person registered to import any (1)(iv) of the definition of regulated List I chemical shall be authorized to transaction in § 1300.02 of this chapter, distribute that List I chemical after if that person is registered with the importation, but no other chemical Administration to engage in the same that the person is not registered to im- activity 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 paragraph (1)(iv) of the def- istered to manufacture. inition of regulated transaction in § 1300.02 of this chapter, if that person [75 FR 4981, Feb. 1, 2010] is registered with the Administration § 1309.23 Separate registration for sep- to engage in the same activity with a arate locations. controlled substance. (d) The requirement of registration is (a) A separate registration is re- waived for any person who only distrib- quired for each principal place of busi- utes a prescription drug product con- ness at one general physical location taining a List I chemical that is regu- where List I chemicals are manufac- lated pursuant to paragraph (1)(iv) of tured, distributed, imported, or ex- the definition of regulated transaction ported by a person. in § 1300.02 of 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 chemicals were originally delivered; or disposal firm for the purpose of and waste disposal. (2) An office used by agents of a reg- (f) The requirement of registration is istrant where sales of List I chemicals waived for any person whose distribu- are solicited, made, or supervised but tion of red phosphorus or white phos- which neither contains such chemicals phorus is limited solely to residual (other than chemicals for display pur- quantities of chemical returned to the poses) nor serves as a distribution producer, in reusable rail cars and point for filling sales orders. intermodal tank containers which con- [60 FR 32454, June 22, 1995, as amended at 75 form to International Standards Orga- FR 4981, Feb. 1, 2010] nization specifications (with capacities greater than or equal to 2,500 gallons in § 1309.24 Waiver of registration re- a single container). quirement for certain activities. (g) The requirement of registration is (a) The requirement of registration is waived for any person whose activities waived for any agent or employee of a with respect to List I chemicals are person who is registered to engage in limited solely to the distribution of any group of independent activities, if Lugol’s Solution (consisting of 5 per- the agent or employee is acting in the cent iodine and 10 percent potassium usual course of his or her business or iodide in an aqueous solution) in origi- employment. nal manufacturer’s packaging of one (b) The requirement of registration is fluid ounce (30 ml) or less. waived for any person who manufac- (h) The requirement of registration is tures or distributes a scheduled listed waived for any manufacturer of a List

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I chemical, if that chemical is pro- forth in this part 1309 and parts 1310, duced solely for internal consumption and 1313 of this chapter remain in full by the manufacturer and there is no force and effect. subsequent distribution or exportation (b) Each person required by section of the List I chemical. 302 of the Act (21 U.S.C. 822) to obtain (i) If any person exempted under a registration to distribute, import, or paragraph (b), (c), (d), (e), or (f) of this export a pseudoephedrine or phenyl- section also engages in the distribu- propanolamine drug product is tempo- tion, importation, or exportation of a rarily exempted from the registration List I chemical, other than as de- requirement, provided that the person scribed in such paragraph, the person submits a proper application for reg- shall obtain a registration for the ac- istration on or before October 3, 1997. tivities, as required by § 1309.21. The exemption will remain in effect for (j) The Administrator may, upon each person who has made such appli- finding that continuation of the waiver cation until the Administration has ap- would not be in the public interest, proved or denied that application. This suspend or revoke a waiver granted exemption applies only to registration; under paragraph (b), (c), (d), (e), or (f) all other chemical control require- of this section pursuant to the proce- ments set forth in this part 1309 and dures set forth in §§ 1309.43 through parts 1310 and 1313 of this chapter re- 1309.46 and §§ 1309.51 through 1309.55. In main in full force and effect. considering the revocation or suspen- (c) Each person required by sections sion of a person’s waiver granted pur- 302 or 1007 of the Act (21 U.S.C. 822 or suant to paragraph (b) or (c) of this 957) to obtain a registration to manu- section, the Administrator shall also facture or import prescription drug consider whether action to revoke or products containing ephedrine, suspend the person’s controlled sub- pseudoephedrine, or phenylpropanola- stance registration pursuant to section mine is temporarily exempted from the 304 of the Act (21 U.S.C. 824) is war- registration requirement, provided ranted. that the person submits a proper appli- (k) Any person exempted from the cation for registration on or before registration requirement under this March 3, 2010. The exemption will re- section must comply with the security main in effect for each person who has requirements set forth in §§ 1309.71 made such application until the Ad- through 1309.73 and the recordkeeping ministration has approved or denied and reporting requirements set forth the application. This exemption applies under Parts 1310, 1313, 1314, and 1315 of only to registration; all other chemical this chapter. control requirements set forth in this part and parts 1310, 1313, and 1315 of [75 FR 4981, Feb. 1, 2010, as amended at 77 FR 4236, Jan. 25, 2012] this chapter remain in full force and effect. § 1309.25 Temporary exemption from [67 FR 14860, Mar. 28, 2002, as amended at 75 registration for chemical registra- FR 4982, Feb. 1, 2010] tion applicants. (a) Each person required by section § 1309.26 Exemption of law enforce- 302 of the Act (21 U.S.C. 822) to obtain ment officials. a registration to distribute, import, or (a) The requirement of registration is export a combination ephedrine prod- waived for the following persons in the uct is temporarily exempted from the circumstances described in this sec- registration requirement, provided tion: that the person submits a proper appli- (1) Any officer or employee of the Ad- cation for registration on or before ministration, any officer of the U.S. July 12, 1997. The exemption will re- Customs Service, any officer or em- main in effect for each person who has ployee of the United States Food and made such application until the Ad- Drug Administration, any other Fed- ministration has approved or denied eral officer who is lawfully engaged in that application. This exemption ap- the enforcement of any Federal law re- plies only to registration; all other lating to listed chemicals, controlled chemical control requirements set substances, drugs or customs, and is

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duly authorized to possess and dis- § 1309.32 Application forms; contents; tribute List I chemicals in the course signature. of official duties; and (a) Any person who is required to be (2) Any officer or employee of any registered pursuant to § 1309.21 and is State, or any political subdivision or not so registered, shall apply on DEA agency thereof, who is engaged in the Form 510. enforcement of any State or local law (b) Any person who is registered pur- relating to listed chemicals and con- suant to Section 1309.21, shall apply for trolled substances and is duly author- reregistration on DEA Form 510a. ized to possess and distribute List I (c) DEA Form 510 may be obtained at chemicals in the course of his official any divisional office of the Administra- duties. tion or by writing to the Registration (b) Any official exempted by this sec- Section, Drug Enforcement Adminis- tion may, when acting in the course of tration. See the Table of DEA Mailing official duties, possess any List I chem- Addresses in § 1321.01 of this chapter for ical and distribute any such chemical the current mailing address. DEA to any other official who is also ex- Form 510a will be mailed to each List I empted by this section and acting in chemical registrant approximately 60 the course of official duties. days before the expiration date of his or her registration; if any registered APPLICATION FOR REGISTRATION person does not receive such forms within 45 days before the expiration § 1309.31 Time for application for reg- date of the registration, notice must be istration; expiration date. promptly given of such fact and DEA (a) Any person who is required to be Form 510a must be requested by writ- registered and who is not so registered ing to the Registration Section of the may apply for registration at any time. Administration at the foregoing ad- No person required to be registered dress. shall engage in any activity for which (d) Each application for registration registration is required until the appli- shall include the Administration cation for registration is approved and Chemical Code Number, as set forth in a Certificate of Registration is issued § 1310.02 of this chapter, for each List I by the Administrator to such person. chemical to be distributed, imported, (b) Any person who is registered may or exported. apply to be reregistered not more than (e) Registration shall not entitle a 60 days before the expiration date of person to engage in any activity with his registration. any List I chemical not specified in his (c) At the time a person is first reg- or her application. istered, that person shall be assigned (f) Each application shall include all to one of twelve groups, which shall information called for in the form, un- correspond to the months of the year. less the item is not applicable, in The expiration date of the registra- which case this fact shall be indicated. tions of all registrants within any (g) Each application, attachment, or group will be the last day of the month other document filed as part of an ap- designated for that group. In assigning plication, shall be signed by the appli- any of the above persons to a group, cant, if an individual; by a partner of the Administration may select a group the applicant, if a partnership; or by an the expiration date of which is less officer of the applicant, if a corpora- than one year from the date such busi- tion, corporate division, association, ness activity was registered. If the per- trust or other entity. An applicant may son is assigned to a group which has an authorize one or more individuals, who expiration date less than eleven would not otherwise be authorized to months from the date of which the per- do so, to sign applications for the ap- son is registered, the registration shall plicant by filing with the application not expire until one year from that ex- or other document a power of attorney piration date; in all other cases, the for each such individual. The power of registration shall expire on the expira- attorney shall be signed by a person tion date following the date on which who is authorized to sign applications the person is registered. under this paragraph and shall contain

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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 [60 FR 32454, June 22, 1995, as amended at 75 after being requested to do so shall be 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 not refer to any accompanying applica- where good cause is shown by the ap- tion for required information. plicant or where the amendment or 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 ap- § 1309.34 Acceptance for filing; defec- plicant that it be returned or the fail- tive applications. ure of the applicant to respond to official correspondence regarding the ap- (a) Applications submitted for filing are dated upon receipt. If found to be plication, including a request that the complete, the application will be ac- applicant submit the required fee, cepted for filing. Applications failing when sent by registered or certified to comply with the requirements of mail, return receipt requested, shall be this part will not generally be accepted deemed to be a withdrawal of the appli- for filing. In the case of minor defects cation. as to completeness, the Administrator may accept the application for filing ACTION ON APPLICATIONS FOR REGISTRA- with a request to the applicant for ad- TION: REVOCATION OR SUSPENSION OF ditional information. A defective appli- REGISTRATION cation will be returned to the applicant within 10 days of receipt with a state- § 1309.41 Administrative review gen- ment of the reason for not accepting erally. the application for filing. A defective The Administrator may inspect, or application may be corrected and re- cause to be inspected, the establish- submitted for filing at any time. ment of an applicant or registrant, pur- (b) Accepting an application for fil- suant to subpart A of part 1316 of this ing does not preclude any subsequent chapter. The Administrator shall re- request for additional information pur- view the application for registration suant to § 1309.35 and has no bearing on and other information gathered by the whether the application will be grant- Administrator regarding an applicant ed. in order to determine whether the applicable standards of Section 303 of the § 1309.35 Additional information. Act (21 U.S.C. 823) have been met by The Administrator may require an the applicant. applicant to submit such documents or written statements of fact relevant to

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§ 1309.42 Certificate of registration; of the order of the Administrator re- denial of registration. voking or suspending registration, the (a) The Administrator shall issue a registrant shall, as instructed by the Certificate of Registration (DEA Form Administrator: 511) to an applicant if the issuance of (1) Deliver all List I chemicals in his registration or reregistration is re- or her possession that were obtained quired under the applicable provisions under the authority of a registration or of section 303 of the Act (21 U.S.C. 823). an exemption from registration grant- In the event that the issuance of reg- ed by the Administrator by regulation, istration or reregistration is not re- to the nearest office of the Administra- quired, the Administrator shall deny tion or to authorized agents of the Ad- the application. Before denying any ap- ministration; or plication, the Administrator shall issue (2) Place all such List I chemicals in an order to show cause pursuant to his or her possession under seal as de- Section 1309.46 and, if requested by the scribed in section 304(f) of the Act (21 applicant, shall hold a hearing on the U.S.C. 824(f)). application pursuant to § 1309.51. (e) In the event that revocation or (b) The Certificate of Registration suspension is limited to a particular (DEA Form 511) shall contain the chemical or chemicals, the registrant name, address, and registration num- shall be given a new Certificate of Reg- ber of the registrant, the activity au- istration for all substances not affected thorized by the registration, the by such revocation or suspension; no amount of fee paid, and the expiration fee shall be required for the new Cer- date of the registration. The registrant tificate of Registration. The registrant shall maintain the certificate of reg- shall deliver the old Certificate of Reg- istration at the registered location in a istration to the nearest office of the readily retrievable manner and shall Administration. Also, upon service of permit inspection of the certificate by the order of the Administrator revok- any official, agent or employee of the ing or suspending registration with re- Administration or of any Federal, spect to a particular chemical or State, or local agency engaged in en- chemicals, the registrant shall, as in- forcement of laws relating to List I structed by the Administrator: chemicals or controlled substances. (1) Deliver to the nearest office of the Administration or to authorized agents § 1309.43 Suspension or revocation of of the Administration all of the par- registration. ticular chemical or chemicals in his or (a) The Administrator may suspend her possession that were obtained any registration pursuant to section under the authority of a registration or 304(a) of the Act (21 U.S.C. 824(a)) for an exemption from registration grant- any period of time he determines. ed by the Administrator by regulation, (b) The Administrator may revoke which are affected by the revocation or any registration pursuant to section suspension; or 304(a) of the Act (21 U.S.C. 824(a)). (2) Place all of such chemicals under (c) Before revoking or suspending any seal as described in section 304(f) of the registration, the Administrator shall Act (21 U.S.C. 824(f)). issue an order to show cause pursuant [60 FR 32454, June 22, 1995, as amended at 62 to Section 1309.46 and, if requested by FR 5916, Feb. 10, 1997] the registrant, shall hold a hearing pursuant to Section 1309.51. Notwith- § 1309.44 Suspension of registration standing the requirements of this Sec- pending final order. tion, however, the Administrator may (a) The Administrator may suspend suspend any registration pending a any registration simultaneously with final order pursuant to § 1309.44. or at any time subsequent to the serv- (d) Upon service of the order of the ice upon the registrant of an order to Administrator suspending or revoking show cause why such registration registration, the registrant shall im- should not be revoked or suspended, in mediately deliver his or her Certificate any case where he finds that there is of Registration to the nearest office of an imminent danger to the public the Administration. Also, upon service health or safety. If the Administrator

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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 registrant whose registration is sus- pursuant to section 304 of the Act (21 pended under this section may request U.S.C. 824), the Administrator shall a hearing on the revocation or suspen- serve upon the registrant an order to sion of his registration at a time ear- show cause why the registration should lier than specified in the order to show not be revoked or suspended. cause pursuant to Section 1309.46, (c) The order to show cause shall call which request shall be granted by the upon the applicant or registrant to ap- Administrator, who shall fix a date for pear before the Administrator at a such hearing as early as reasonably time and place stated in the order, possible. which shall not be less than 30 days [60 FR 32454, June 22, 1995, as amended at 62 after the date of receipt of the order. FR 5916, Feb. 10, 1997] The order to show cause shall also contain a statement of the legal basis for § 1309.45 Extension of registration such hearing and for the denial, revoca- pending final order. tion, or suspension of registration and In the event that an applicant for re- a summary of the matters of fact and registration (who is doing business law asserted. under a registration previously granted (d) Upon Receipt of an order to show and not revoked or suspended) has ap- cause, the applicant or registrant plied for reregistration at least 45 days must, if he desires a hearing, file a re- before the date on which the existing quest for a hearing pursuant to registration is due to expire, and the § 1309.54. If a hearing is requested, the Administrator has issued no order on Administrator shall hold a hearing at the application on the date on which the time and place stated in the order, the existing registration is due to ex- pursuant to § 1309.51.

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(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. § 1309.51 Hearings generally. (c) If any person entitled to a hearing 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 procedures for such hearing shall be he shall be deemed to have waived his governed generally by the adjudication opportunity for the hearing, unless he procedures set forth in the Administra- shows good cause for such failure. tive Procedure Act (5 U.S.C. 551–559) (d) If any person entitled to a hearing and specifically by sections 303 and 304 waives or is deemed to waive his or her of the Act (21 U.S.C. 823–824), by opportunity for the hearing, the Ad- §§ 1309.52 through 1309.57, and by the ministrator may cancel the hearing, if procedures for administrative hearings scheduled, and issue his final order pur- under the Act set forth in §§ 1316.41 suant to § 1309.57 without a hearing. through 1316.67 of this chapter. (b) Any hearing under this part shall [60 FR 32454, June 22, 1995. Redesignated at 62 FR 13968, Mar. 24, 1997] be independent of, and not in lieu of, criminal prosecutions or other pro- § 1309.54 Burden of proof. ceedings under the Act or any other law of the United States. (a) At any hearing for the denial of a registration, the Administration shall § 1309.52 Purpose of hearing. have the burden of proving that the re- If requested by a person entitled to a quirements for such registration pursu- hearing, the Administrator shall hold a ant to section 303 of the Act (21 U.S.C. hearing for the purpose of receiving 823) are not satisfied. factual evidence regarding the issues (b) At any hearing for the revocation involved in the denial, revocation, or or suspension of a registration, the Ad- suspension of any registration. Exten- ministration shall have the burden of sive argument should not be offered proving that the requirements for such into evidence but rather presented in revocation or suspension pursuant to opening or closing statements of coun- section 304(a) of the Act (21 U.S.C. sel or in memoranda or proposed find- 824(a)) are satisfied. ings of fact and conclusions of law. [60 FR 32454, June 22, 1995. Redesignated at 62 § 1309.53 Request for hearing or ap- FR 13968, Mar. 24, 1997] pearance; waiver. (a) Any person entitled to a hearing § 1309.55 Time and place of hearing. pursuant to §§ 1309.42 and 1309.43 and de- The hearing will commence at the siring a hearing shall, within 30 days place and time designated in the order after the date of receipt of the order to to show cause or notice of hearing pub- show cause, file with the Adminis- lished in the FEDERAL REGISTER (unless trator a written request for a hearing expedited pursuant to Section in the form prescribed in § 1316.47 of 1309.44(c)) but thereafter it may be this chapter. moved to a different place and may be (b) Any person entitled to a hearing continued from day to day or recessed pursuant to §§ 1309.42 and 1309.43 may, to a later day without notice other within the period permitted for filing a than announcement thereof by the pre- request for a hearing, file with the Ad- siding officer at the hearing. ministrator a waiver of an opportunity for a hearing, together with a written [60 FR 32454, June 22, 1995. Redesignated at 62 statement regarding his position on FR 13968, Mar. 24, 1997] the matters of fact and law involved in such hearing. Such statement, if ad-

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MODIFICATION, TRANSFER AND chemicals obtained under the author- TERMINATION OF REGISTRATION ity of that registration. (b) The Special Agent in Charge shall § 1309.61 Modification in registration. authorize and instruct the person to Any registrant may apply to modify dispose of the List I chemical in one of his or her registration to authorize the the following manners: handling of additional List I chemicals (1) By transfer to person registered or to change his or her name or ad- under the Act and authorized to pos- dress, by submitting a letter of request sess the substances; to the Registration Section, Drug En- (2) By delivery to an agent of the Ad- forcement Administration. See the ministration or to the nearest office of Table of DEA Mailing Addresses in the Administration; § 1321.01 of this chapter for the current (3) By such other means as the Spe- mailing address. The letter shall con- cial Agent in Charge may determine to tain the registrant’s name, address, assure that the substance does not be- and registration number as printed on come available to unauthorized per- the certificate of registration, and the sons. List I chemicals to be added to his registration or the new name or address [60 FR 32454, June 22, 1995, as amended at 62 FR 5916, Feb. 10, 1997; 76 FR 61564, Oct. 5, 2011; and shall be signed in accordance with 77 FR 4236, Jan. 27, 2012] § 1309.32(g). No fee shall be required to be paid for the modification. The re- § 1309.63 Transfer of registration. quest for modification shall be handled No registration or any authority con- in the same manner as an application ferred thereby shall be assigned or oth- for registration. If the modification in erwise transferred except upon such registration is approved, the Adminis- conditions as the Administrator may trator shall issue a new certificate of specifically designate and then only registration (DEA Form 511) to the reg- pursuant to his written consent. istrant, who shall maintain it with the old certificate of registration until ex- SECURITY REQUIREMENTS piration. [75 FR 10680, Mar. 9, 2010] § 1309.71 General security requirements. § 1309.62 Termination of registration. (a) All applicants and registrants (a) The registration of any person must provide effective controls and shall terminate, without any further procedures to guard against theft and action by the Administration, if and diversion of List I chemicals. Chemi- when such person dies, ceases legal ex- cals must be stored in containers istence, discontinues business or pro- sealed in such a manner as to indicate fessional practice, or surrenders a reg- any attempts at tampering with the istration. Any registrant who ceases container. Where chemicals cannot be legal existence or discontinues busi- stored in sealed containers, access to ness or professional practice shall the chemicals should be controlled promptly notify the Special Agent in through physical means or through Charge of the Administration in the human or electronic monitoring. area in which the person is located of (b) In evaluating the effectiveness of such fact and seek authority and in- security controls and procedures, the structions to dispose of any List I Administrator shall consider the fol- chemicals obtained under the author- lowing factors: ity of that registration. Any registrant (1) The type, form, and quantity of who ceases legal existence or discon- List I chemicals handled; tinues business or professional practice (2) The location of the premises and or wishes to surrender a registration the relationship such location bears on shall notify the Special Agent in the security needs; Charge of the Administration in the (3) The type of building construction area in which the person is located of comprising the facility and the general such fact and seek authority and in- characteristics of the building or build- structions to dispose of any List I ings;

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(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 report diversion. Mailing Addresses in § 1321.01 of this chapter for the current mailing ad- Reports of listed chemical diversion dress. by fellow employees is not only a necessary part of an overall employee se- [60 FR 32454, June 22, 1995, as amended at 62 curity program but also serves the pub- FR 13968, Mar. 24, 1997; 67 FR 14861, Mar. 28, 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. ministrative, civil or criminal action resulting from an investigation of the PART 1310—RECORDS AND RE- individual’s handling of controlled sub- PORTS OF LISTED CHEMICALS stances or listed chemicals.) The reg- AND CERTAIN MACHINES istrant should be aware of the circumstances regarding the action Sec. against the potential employee and the 1310.01 Definitions.

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1310.02 Substances covered. (6) N-Acetylanthranilic acid, its 1310.03 Persons required to keep records and esters, and its salts ...... 8522 file reports. (7) Norpseudoephedrine, its 1310.04 Maintenance of records. salts, optical isomers, and 1310.05 Reports. 1310.06 Content of records and reports. salts of optical isomers ...... 8317 1310.07 Proof of identity. (8) Phenylacetic acid, its esters, 1310.08 Excluded transactions. and its salts ...... 8791 1310.09 Temporary exemption from registra- (9) Phenylpropanolamine, its tion. salts, optical isomers, and 1310.10 Removal of the exemption of drugs salts of optical isomers ...... 1225 distributed under the Federal Food, Drug (10) Piperidine and its salts ...... 2704 and Cosmetic Act. (11) Pseudoephedrine, its salts, 1310.11 Reinstatement of exemption for drug products distributed under the Food, optical isomers, and salts of Drug and Cosmetic Act. optical isomers ...... 8112 1310.12 Exempt chemical mixtures. (12) 3,4-Methylenedioxyphenyl-2- 1310.13 Exemption of chemical mixtures; ap- propanone ...... 8502 plication. (13) Methylamine and its salts ... 8520 1310.14 Removal of exemption from defini- (14) Ethylamine and its salts ..... 8678 tion of regulated transaction. (15) Propionic anhydride ...... 8328 1310.15 Exempt drug products containing (16) Isosafrole ...... 8704 ephedrine and therapeutically significant (17) Safrole ...... 8323 quantities of another active medicinal (18) Piperonal ...... 8750 ingredient. 1310.21 Sale by Federal departments or (19) N-Methylephedrine, its agencies of chemicals which could be salts, optical isomers, and used to manufacture controlled sub- salts of optical isomers (N- stances. Methylephedrine) ...... 8115 (20) N-Methylpseudoephedrine, AUTHORITY: 21 U.S.C. 802, 827(h), 830, 871(b) 890. its salts, optical isomers, and salts of optical isomers ...... 8119 SOURCE: 54 FR 31665, Aug. 1, 1989, unless (21) Hydriodic Acid ...... 6695 otherwise noted. (22) Benzaldehyde ...... 8256 § 1310.01 Definitions. (23) Nitroethane ...... 6724 (24) Gamma-Butyrolactone Any term used in this part shall have (Other names include: GBL; the definition set forth in section 102 of Dihydro-2 (3H)-furanone; 1,2- the Act (21 U.S.C. 802) or part 1300 of Butanolide; 1,4-Butanolide; 4- this chapter. Hydroxybutanoic acid lactone; [62 FR 13968, Mar. 24, 1997] gamma-hydroxybutyric acid lactone) ...... 2011 § 1310.02 Substances covered. (25) Red phosphorus ...... 6795 The following chemicals have been (26) White phosphorus (Other specifically designated by the Adminis- names: Yellow Phosphorus) .... 6796 trator of the Drug Enforcement Admin- (27) Hypophosphorous acid and istration as the listed chemicals sub- its salts (Including ammonium ject to the provisions of this part and hypophosphite, calcium parts 1309 and 1313 of this chapter. Each hypophosphite, iron chemical has been assigned the DEA hypophosphite, potassium Chemical Code Number set forth oppo- hypophosphite, manganese site it. hypophosphite, magnesium (a) List I chemicals hypophosphite and sodium hypophosphite) ...... 6797 (28) N-phenethyl-4-piperidone (1) Anthranilic acid, its esters, (NPP) ...... 8332 and its salts ...... 8530 (29) Iodine ...... 6699 (2) Benzyl cyanide ...... 8735 (30) Ergocristine and its salts .... 8612 (3) Ephedrine, its salts, optical isomers, and salts of optical (b) List II chemicals: isomers ...... 8113 (4) Ergonovine and its salts ...... 8675 (1) Acetic anhydride ...... 8519 (5) Ergotamine and its salts ...... 8676 (2) Acetone ...... 6532

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(3) Benzyl chloride ...... 8570 listed chemicals as set forth in para- (4) Ethyl ether ...... 6584 graph (c) of this section, he shall issue (5) Potassium permanganate ..... 6579 and publish in the FEDERAL REGISTER a (6) 2-Butanone (or Methyl Ethyl proposal to add or delete a substance as Ketone or MEK) ...... 6714 a listed chemical. The Administrator (7) Toluene ...... 6594 shall permit any interested person to (8) Hydrochloric acid (including file written comments regarding the anhydrous hydrogen chloride) 6545 proposal within 30 days of the date of (9) Sulfuric acid ...... 6552 publication of his order in the FEDERAL (10) Methyl Isobutyl Ketone REGISTER. The Administrator will con- (MIBK) ...... 6715 (11) Sodium Permanganate ...... 6588 sider any comments filed by interested persons and publish a final rule in ac- (c) The Administrator may add or de- cordance with his decision in the mat- lete a substance as a listed chemical by ter. publishing a final rule in the FEDERAL REGISTER following a proposal which [54 FR 31665, Aug. 1, 1989, as amended at 56 shall be published at least 30 days prior FR 48733, Sept. 26, 1991; 57 FR 43615, Sept. 22, to the final rule. 1992; 60 FR 19510, Apr. 19, 1995; 60 FR 32460, (d) Any person may petition the Ad- June 22, 1995; 62 FR 5917, Feb. 10, 1997; 65 FR ministrator to have any substance 21647, Apr. 24, 2000; 65 FR 47316, Aug. 2, 2000; added or deleted from paragraphs (a) or 66 FR 52675, Oct. 17, 2001; 71 FR 60826, Oct. 17, 2006; 72 FR 20046, Apr. 23, 2007; 72 FR 35391, (b) of this section. July 2, 2007; 72 FR 40238, July 24, 2007; 76 FR (e) Any petition under this section 17781, Mar. 31, 2011] shall contain the following information: § 1310.03 Persons required to keep (1) The name and address of the peti- records and file reports. tioner; (2) The name of the chemical to (a) Each regulated person who en- which the petition pertains; gages in a regulated transaction in- (3) The name and address of the man- volving a listed chemical, a tableting ufacturer(s) of the chemical (if known); machine, or an encapsulating machine (4) A complete statement of the facts shall keep a record of the transaction which the petitioner believes justifies as specified by § 1310.04 and file reports the addition or deletion of the sub- as specified by § 1310.05. However, a stance from paragraphs (a) or (b) of non-regulated person who acquires list- this section; ed chemicals for internal consumption (5) The date of the petition. or ‘‘end use’’ and becomes a regulated (f) The Administrator may require person by virtue of infrequent or rare the petitioner to submit such docu- distribution of a listed chemical from ments or written statements of fact inventory, shall not be required to relevant to the petition as he deems maintain receipt records of listed necessary in making a determination. chemicals under this section. (g) Within a reasonable period of (b) Each regulated person who manu- time after the receipt of the petition, factures a List I or List II chemical the Administrator shall notify the petitioner of his decision and the reason shall file reports regarding such manu- therefor. The Administrator need not facture as specified in Section 1310.05. accept a petition if any of the require- (c) Each regulated person who en- ments prescribed in paragraph (e) of gages in a transaction with a nonregu- this section or requested pursuant to lated person or who engages in an ex- paragraph (f) of this section are lack- port transaction that involves ephed- ing or are not clearly set forth as to be rine, pseudoephedrine, phenyl- readily understood. If the petitioner propanolamine, or gamma-hydroxy- desires, he may amend and resubmit butyric acid, including drug products the petition to meet the requirements containing these chemicals, and uses or of paragraphs (e) and (f) of this section. attempts to use the Postal Service or (h) If a petition is granted or the Ad- any private or commercial carrier ministrator, upon his own motion, pro- must file monthly reports of each such poses to add or delete substances as

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transaction as specified in § 1310.05 of area in which the records are required this part. to be kept. [54 FR 31665, Aug. 1, 1989, as amended at 56 (d) The records required to be kept FR 8277, Feb. 28, 1991; 61 FR 14023, Mar. 29, under this section shall be readily re- 1996; 67 FR 14861, Mar. 28, 2002; 68 FR 57804, trievable and available for inspection Oct. 7, 2003; 70 FR 294, Jan. 4, 2005] and copying by authorized employees of the Administration under the provi- § 1310.04 Maintenance of records. sions of 21 U.S.C. 880. (a) Every record required to be kept (e) The regulated person with more subject to § 1310.03 for a List I chem- than one place of business where ical, a tableting machine, or an encap- records are required to be kept shall sulating machine shall be kept by the devise a system to detect any party regulated person for 2 years after the purchasing from several individual lo- date of the transaction. cations of the regulated person thereby (b) Every record required to be kept seeking to avoid the application of the subject to Section 1310.03 for List II cumulative threshold or evading the chemical shall be kept by the regulated requirements of the Act. person for two years after the date of (f) For those listed chemicals for the transaction. which thresholds have been estab- (c) A record under this section shall lished, the quantitative threshold or be kept at the regulated person’s place the cumulative amount for multiple of business where the transaction oc- transactions within a calendar month, curred, except that records may be to be utilized in determining whether a kept at a single, central location of the receipt, sale, importation or expor- regulated person if the regulated per- tation is a regulated transaction is as son has notified the Administration of follows: the intention to do so. Written notifi- (1) List I chemicals: cation must be submitted by registered (i) Except as provided in paragraph or certified mail, return receipt re- (f)(1)(ii) of this section, the following quested, to the Special Agent in Charge thresholds have been established for of the DEA Divisional Office for the 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- paragraph (g) of this section apply only tained in scheduled listed chemical to non-retail distribution, import, and products as defined in § 1300.02 of this export. Sales of these products at retail chapter, the thresholds established in

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are subject to the requirements of part (2) List II Chemicals: 1314 of this chapter. (i) Imports and Exports

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 to recordkeeping and reporting require- applicable to domestic sales of Ace- ments as set forth in this part and no- tone, 2-Butanone (MEK), and Toluene. tification provisions as set forth in (iv) Exports, Transshipments and part 1313 of this chapter. International Transactions to Des- (1) Listed chemicals for which no ignated Countries as Set Forth in thresholds have been established: § 1310.08(b). (i) Ephedrine, its salts, optical iso-

Threshold by Threshold by mers, and salts of optical isomers; Chemical volume weight (ii) Ergocristine and its salts

(A) Hydrochloric acid 50 gallons (iii) Gamma-Butyrolactone (Other (1) Anhydrous ...... 27 kilograms. names include: GBL; Dihydro-2(3H)- Hydrogen chlo- furanone; 1,2-Butanolide; 1,4- ride. Butanolide; 4-Hydroxybutanoic acid (B) Sulfuric acid ...... 50 gallons lactone; gamma-hydroxybutyric acid (v) Export and International Trans- lactone) actions to Designated Countries, and (iv) Hypophosphorous acid and its Importations for Transshipment or salts (including ammonium Transfer to Designated Countries hypophosphite, calcium hypophosphite, iron hypophosphite, potassium Threshold by Threshold by hypophosphite, manganese Chemical volume weight hypophosphite, magnesium (A) Methyl Isobutyl 500 gallons ...... 1523 kilograms. hypophosphite, and sodium Ketone (MIBK). hypophosphite) (B) Reserved. (v) Iodine (g) For listed chemicals for which no (vi) N-phenethyl-4-piperidone (NPP) thresholds have been established, the (vii) Pseudoephedrine, its salts, opti- size of the transaction is not a factor cal isomers, and salts of optical iso- in determining whether the trans- mers action meets the definition of a regu- (viii) Phenylpropanolamine, its salts, lated transaction as set forth in optical isomers, and salts of optical § 1300.02 of this chapter. All such trans- isomers actions, regardless of size, are subject (ix) Red phosphorus

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(x) White phosphorus (Other names: for reporting a loss in-transit is the Yellow Phosphorus) supplier. (2) [Reserved] (4) Any domestic regulated trans- (h) The thresholds and conditions in action in a tableting machine or an en- paragraphs (f) and (g) of this section capsulating machine. will apply to transactions involving (b) Each report submitted pursuant regulated chemical mixtures. For pur- to paragraph (a) of this section shall, poses of determining whether the whenever possible, be made orally to weight or volume of a chemical mix- the DEA Divisional Office for the area ture meets or exceeds the applicable in which the regulated person making quantitative threshold, the following rules apply: the report is located at the earliest (1) For chemical mixtures containing practicable opportunity after the regu- List I chemicals or List II chemicals lated person becomes aware of the cir- other than those in paragraph (h)(2) of cumstances involved and as much in this section, the threshold is deter- advance of the conclusion of the trans- mined by the weight of the listed action as possible. Written reports of chemical in the chemical mixture. transactions listed in paragraphs (a)(1), (2) For the List II chemicals acetone, (a)(3) and (a)(4) of this section will sub- ethyl ether, 2-butanone, toluene, and sequently be filed as set forth in methyl isobutyl ketone, the threshold § 1310.06 within 15 days after the regu- is determined by the weight of the en- lated person becomes aware of the cir- tire chemical mixture. cumstances of the event. A transaction (3) If two or more listed chemicals may not be completed with a person are present in a chemical mixture, and whose description or identifying char- the quantity of any of these chemicals acteristic has previously been fur- equals or exceeds the threshold appli- nished to the regulated person by the cable to that chemical, then the trans- Administration unless the transaction action is regulated. is approved by the Administration. [54 FR 31665, Aug. 1, 1989] (c) Each regulated person who im- EDITORIAL NOTE: For FEDERAL REGISTER ci- ports or exports a tableting machine, tations affecting § 1310.04, see the List of CFR or encapsulation machine, shall file a Sections Affected, which appears in the report (not a 486) of such importation Finding Aids section of the printed volume or exportation with the Import/Export and at www.fdsys.gov. 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 (1) Any regulated transaction involv- implement the purpose of the Act, reg- ing an extraordinary quantity of a list- ulated persons may wish to report to ed chemical, an uncommon method of payment or delivery, or any other cir- the Administration as far in advance as cumstance that the regulated person possible. A copy of the report may be believes may indicate that the listed transmitted directly to the Drug En- chemical will be used in violation of forcement Administration through this part. electronic facsimile media. Any (2) Any proposed regulated trans- tableting machine or encapsulating action with a person whose description machine may be imported or exported or other identifying characteristic the if that machine is needed for medical, Administration has previously fur- commercial, scientific, or other legiti- nished to the regulated person. mate uses. However, an importation or (3) Any unusual or excessive loss or exportation of a tableting machine or disappearance of a listed chemical encapsulating machine may not be under the control of the regulated per- completed with a person whose descrip- son. The regulated person responsible tion or identifying characteristic has

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previously been furnished to the regu- chemical synthesis or by extraction lated person by the Administration un- from other substances. The term bulk less the transaction is approved by the manufacturer does not include persons Administration. whose sole activity consists of the re- (d) Each regulated bulk manufac- packaging or relabeling of listed chem- turer of a listed chemical shall submit ical products or the manufacture of manufacturing, inventory and use data drug dosage form products which con- on an annual basis as set forth in tain a listed chemical. § 1310.06(h). This data shall be sub- (e) Each regulated person required to mitted annually to the Drug and Chem- report pursuant to § 1310.03(c) of this ical Evaluation Section, Drug Enforce- part shall either: ment Administration, on or before the (1) Submit a written report, con- 15th day of March of the year imme- taining the information set forth in diately following the calendar year for § 1310.06(i) of this part, on or before the which submitted. See the Table of DEA 15th day of each month following the Mailing Addresses in § 1321.01 of this month in which the distributions took 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 paragraphs (1)(iv) or (1)(v) of the the Administration, submit the report definition of regulated transaction in in electronic form, either via computer § 1300.02 of this chapter except as set disk or direct electronic data trans- forth in § 1310.06(h)(5). Bulk manufac- mission, in such form as the Adminis- turers that produce a listed chemical tration shall direct. Requests to sub- solely for internal consumption shall mit reports in electronic form should not be required to report for that listed be submitted to the Import/Export chemical. For purposes of these report- Unit, Drug Enforcement Administra- ing requirements, internal consumption. See the Table of DEA Mailing Ad- tion shall consist of any quantity of a dresses in § 1321.01 of this chapter for listed chemical otherwise not available the current mailing address. for further resale or distribution. Inter- (f) Except as provided in paragraph nal consumption shall include (but not (g) of this section, the following dis- be limited to) quantities used for qual- tributions to nonregulated persons, and ity control testing, quantities con- the following export transactions, are sumed in-house or production losses. not subject to the reporting require- Internal consumption does not include ments in § 1310.03(c): the quantities of a listed chemical con- (1) Distributions of sample packages sumed in the production of exempted of drug products when those packages products. If an existing standard indus- contain not more than two solid dosage try report contains the information re- units or the equivalent of two dosage quired in § 1310.06(h) and such informa- units in liquid form, not to exceed 10 tion is separate or readily retrievable milliliters of liquid per package, and from the report, that report may be not more than one package is distrib- submitted in satisfaction of this re- uted to an individual or residential ad- quirement. Each report shall be sub- dress in any 30-day period. mitted to the DEA under company let- (2) Distributions of drug products by terhead and signed by an appropriate, retail distributors that may not in- responsible official. For purposes of clude face-to-face transactions to the this paragraph only, the term regu- extent that such distributions are con- lated bulk manufacturer of a listed sistent with the activities authorized chemical means a person who manufac- for a retail distributor as defined in tures a listed chemical by means of § 1300.02 of this chapter, except that

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this paragraph does not apply to sales (5) The type of identification used by of scheduled listed chemical products the purchaser and any unique number 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 require- subject to a waiver granted under ments of paragraph (a) of this section § 1313.21 of this chapter. with respect to dispensing to patients, 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 [54 FR 31665, Aug. 1, 1989, as amended at 57 reason that the method of payment FR 2461, Jan. 22, 1992; 61 FR 14024, Mar. 29, was uncommon or the loss unusual. If 1996; 61 FR 17958, Apr. 23, 1996; 62 FR 13968, the report is for a loss or disappearance Mar. 24, 1997; 67 FR 14862, Mar. 28, 2002; 67 FR under § 1310.05(a)(4), the circumstances 49569, July 31, 2002; 68 FR 57804, Oct. 7, 2003; of such loss must be provided (in-tran- 71 FR 56024, Sept. 26, 2006; 75 FR 10680, Mar. 9, 2010; 77 FR 4236, Jan. 27, 2012] sit, theft from premises, etc.) (d) A suggested format for the re- § 1310.06 Content of records and reports is provided below: ports. Supplier: (a) Each record required by § 1310.03 Registration Number llllllllllll shall include the following: Name llllllllllllllllllll (1) The name, address, and, if re- Business Address llllllllllllll quired, DEA registration number of City lllllllllllllllllllll each party to the regulated trans- State llllllllllllllllllll Zip lllllllllllllllllllll action. Business Phone lllllllllllllll (2) The date of the regulated trans- Purchaser: action. (3) The name, quantity and form of Registration Number llllllllllll Name llllllllllllllllllll packaging of the listed chemical or a Business Address llllllllllllll description of the tableting machine or City lllllllllllllllllllll encapsulating machine (including State llllllllllllllllllll make, model and serial number). Zip lllllllllllllllllllll (4) The method of transfer (company Business Phone lllllllllllllll truck, picked up by customer, etc.). Identification llllllllllllllll

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Shipping Address (if different than purchaser tined; the name(s) and address(es) of Address): any intermediate consignee(s). Street llllllllllllllllllll (g) Declared exports of machines City lllllllllllllllllllll which are refused, rejected, or other- State llllllllllllllllllll Zip lllllllllllllllllllll wise deemed undeliverable may be re- Date of Shipment llllllllllllll turned to the U.S. exporter of record. A Name of Listed Chemical(s) lllllllll brief written report outlining the cir- Quantity and Form of Packaging llllll cumstances must be sent to the Im- Description of Machine: port/Export Unit, Drug Enforcement Make llllllllllllllllllll Administration, following the return Model llllllllllllllllllll within a reasonable time. See the Serial # lllllllllllllllllll Table of DEA Mailing Addresses in Method of Transfer lllllllllllll § 1321.01 of this chapter for the current If Loss or Disappearance: mailing address. This provision does Date of Loss lllllllllllllllll not apply to shipments that have Type of Loss llllllllllllllll cleared foreign customs, been deliv- Description of Circumstances llllllll (e) Each report of an importation of a ered, and accepted by the foreign con- tableting machine or an encapsulating signee. Returns to third parties in the machine required by § 1310.05(c) shall United States will be regarded as im- include the following information: ports. (1) The name, address, telephone (h) Each annual report required by number, and, where available, the fac- Section 1310.05(d) shall provide the fol- simile number of the regulated person; lowing information for each listed the name, address, telephone number, chemical manufactured: and, where available, the facsimile (1) The name, address and chemical number of the import broker or for- registration number (if any) of the warding agent, if any: manufacturer and person to contact for (2) The description of each machine information. (including make, model, and serial (2) The aggregate quantity of each number) and the number of machines listed chemical that the company man- being received; ufactured during the preceding cal- (3) The proposed import date, and the endar year. first U.S. Customs Port of Entry; and (3) The year-end inventory of each (4) The name, address, telephone listed chemical as of the close of busi- number, and, where available, the fac- ness on the 31st day of December of simile number of the consignor in the each year. (For each listed chemical, if foreign country of exportation. 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 (1) The name, address, telephone shall reflect the quantity of listed number, and, where available, the facsimile number of the regulated person; chemicals, whether in bulk or non-ex- the name, address, telephone number, empt product form, held in storage for and, where available, the facsimile later distribution. Inventory does not number of the export broker, if any: include waste material for destruction, (2) The description of each machine material stored as an in-process inter- (including make, model, and serial mediate or other in-process material. number) and the number of machines (4) The aggregate quantity of each being shipped; listed chemical used for internal con- (3) The proposed export date, the U.S. sumption during the preceding cal- Customs Port of exportation, and the endar year, unless the chemical is pro- foreign Port of Entry; and duced solely for internal consumption. (4) The name, address, telephone (5) The aggregate quantity of each number, and, where available, the fac- listed chemical manufactured which simile number of the consignee in the becomes a component of a product ex- country where the shipment is des- empted from paragraphs (1)(iv) or (1)(v)

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of the definition of regulated trans- party to the regulated person at the action in § 1300.02 of this chapter during time the order is placed. For export the preceding calendar year. transactions, this shall be accom- (6) Data shall identify the specific plished by good faith inquiry through isomer, salt or ester when applicable reasonably available research docu- but quantitative data shall be reported ments or publicly available informa- as anhydrous base or acid in kilogram tion which would indicate the exist- units of measure. ence of the foreign customer. No proof (i) Each monthly report required by of identity is required for foreign sup- § 1310.05(e) of this part shall provide the pliers. following information for each dis- (b) The regulated person must verify tribution: the existence and apparent validity of (1) Supplier name and registration a business entity ordering a listed number. chemical, tableting machine or encap- (2) Purchaser’s name and address. sulating machine. For domestic trans- (3) Name/address shipped to (if dif- actions, this may be accomplished by ferent from purchaser’s name/address). such methods as checking the tele- (4) Name of the chemical and total phone directory, the local credit bu- amount shipped (i.e., Pseudoephedrine, reau, the local Chamber of Commerce 250 grams). or the local Better Business Bureau, or, (5) Date of shipment. if the business entity is a registrant, (6) Product name (if drug product). by verification of the registration. For (7) Dosage form (if drug product) (i.e., export transactions, a good faith in- pill, tablet, liquid). quiry to verify the existence and appar- (8) Dosage strength (if drug product) ent validity of a foreign business entity (i.e., 30mg, 60mg, per dose etc.). may be accomplished by such methods (9) Number of dosage units (if drug as verifying the business telephone product) (100 doses per package). listing through international telephone (10) Package type (if drug product) information, the firm’s listing in inter- (bottle, blister pack, etc.). national or foreign national chemical (11) Number of packages (if drug directories or other commerce direc- product) (10 bottles). tories or trade publications, confirma- (12) Lot number (if drug product). tion through foreign subsidiaries of the (j) Information provided in reports U.S. regulated person, verification required by § 1310.05(e) of this part through the country of destination’s which is exempt from disclosure under embassy Commercial Attache, or offi- section 552(a) of Title 5, by reason of cial documents provided by the pur- section 552(b)(6) of Title 5, will be pro- chaser which confirm the existence and vided the same protections from disclo- apparent validity of the business enti- sure as are provided in section 310(c) of ty. the Act (21 U.S.C. 830(c)) for confiden- (c) When transacting business with a tial business information. new representative of a firm, the regulated person must verify the claimed [54 FR 31665, Aug. 1, 1989, as amended at 57 agency status of the representative. FR 2462, Jan. 22, 1992; 59 FR 51364, Oct. 11, 1994; 60 FR 32461, June 22, 1995; 61 FR 14024, (d) For sales to individuals or cash Mar. 29, 1996; 61 FR 32926, June 26, 1996; 67 FR purchasers, the type of documents and 14862, Mar. 28, 2002; 67 FR 49569, July 31, 2002; other evidence of proof must consist of 75 FR 10681, Mar. 9, 2010; 77 FR 4236, Jan. 27, at least a signature of the purchaser, a 2012] driver’s license and one other form of identification. Any exports to individ- § 1310.07 Proof of identity. uals or exports paid in cash are suspect (a) Each regulated person who en- and should be handled as such. For gages in a regulated transaction must such exports, the regulated person identify the other party to the trans- shall diligently obtain from the pur- action. For domestic transaction, this chaser or independently seek to con- shall be accomplished by having the firm clear documentation which proves other party present documents which the person is properly identified such would verify the identity, or registra- as through foreign identity documents, tion status if a registrant, of the other driver’s license, passport information

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and photograph, etc. Any regulated (10) Paraguay person who fails to adequately prove (11) Peru the identity of the other party to the (12) Suriname transaction may be subject to the spe- (13) Uruguay cific penalties provided for violations (14) Venezuela of law related to regulated trans- (c) Domestic transactions of Methyl actions in listed chemicals. (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 electronic orders and with § 1310.07(e). per transaction. (g) Import transactions of anhydrous [54 FR 31665, Aug. 1, 1989, as amended at 60 hydrogen chloride. FR 32461, June 22, 1995] (h) Domestic distribution of anhy- § 1310.08 Excluded transactions. drous hydrogen chloride weighing 12,000 pounds (net weight) or more in a Pursuant to 21 U.S.C. 802(39)(A)(iii), single container. regulation of the following transactions has been determined to be un- (i) Domestic distribution of anhy- necessary for the enforcement of the drous hydrogen chloride by pipeline. Chemical Diversion and Trafficking (j) Domestic and international return Act and, therefore, they have been ex- shipments of reusable containers from cluded from the definitions of regu- customer to producer containing resid- lated transactions: ual quantities of red phosphorus or (a) Domestic and import transactions white phosphorus in rail cars and inter- of hydrochloric and sulfuric acids but modal tank containers which conform not including anhydrous hydrogen to International Standards Organiza- chloride. tion specifications (with capacities (b) Exports, transshipments, and greater than or equal to 2,500 gallons in international transactions of hydro- a single container). chloric (including anhydrous hydrogen (k) Domestic, import, and export dis- chloride) and sulfuric acids, except for tributions of gamma-butyrolactone exports, transshipments and inter- weighing 4,000 kilograms (net weight) national transactions to the following or more in a single container. countries: (l) Domestic and import transactions (1) Argentina (2) Bolivia in chemical mixtures that contain ace- (3) Brazil tone, ethyl ether, 2-butanone, and/or (4) Chile toluene, unless regulated because of (5) Colombia being formulated with other List I or (6) Ecuador (7) French Guiana (8) Guyana (9) Panama

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List II chemical(s) above the con- has made such application until the centration limit. Administration has approved or denied that application. This exemption ap- [57 FR 43615, Sept. 22, 1992, as amended at 60 FR 19510, Apr. 19, 1995; 60 FR 32461, June 22, plies only to registration; all other 1995; 62 FR 13968, Mar. 24, 1997; 65 FR 47316, chemical control requirements set Aug. 2, 2000; 66 FR 52675, Oct. 17, 2001; 68 FR forth in parts 1309, 1310, and 1313 of this 37414, June 24, 2003; 68 FR 53292, Sept. 10, 2003; chapter remain in full force and effect. 69 FR 74971, Dec. 15, 2004; 72 FR 10928, Mar. 12, (d) Each person required by section 2007; 72 FR 35931, July 2, 2007] 302 of the Act (21 U.S.C. 822) to obtain a registration to distribute, import, or § 1310.09 Temporary exemption from export the List I chemicals red phos- registration. phorus, white phosphorus, and (a) Each person required by section hypophosphorous acid (and its salts), is 302 of the act (21 U.S.C. 822) to obtain a temporarily exempted from the reg- registration to distribute, import, or istration requirement, provided that export a combination ephedrine prod- the person submits a proper applica- uct is temporarily exempted from the tion for registration on or before De- registration requirement, provided cember 17, 2001. The exemption will re- that the person submits a proper appli- main in effect for each person who has cation for registration on or before made such application until the Ad- July 12, 1997. The exemption will re- ministration has approved or denied main in effect for each person who has that application. This exemption ap- made such application until the Ad- plies only to registration; all other ministration has approved or denied chemical control requirements set that application. This exemption ap- forth in parts 1309, 1310, and 1313 of this plies only to registration; all other chapter remain in full force and effect. chemical control requirements set (e) Each person required by section forth in parts 1309, 1310, and 1313 of this 302 of the Act (21 U.S.C. 822) to obtain chapter remain in full force and effect. a registration to distribute, import, or (b) Each person required by section export regulated chemical mixtures 302 of the Act (21 U.S.C. 822) to obtain which contain ephedrine, N- a registration to distribute, import, or methylephedrine, N- export a drug product that contains methylpseudoephedrine, pseudoephedrine or phenylpropanola- norpseudoephedrine, phenylpropanolamine that is regulated pursuant to mine, and/or pseudoephedrine, pursu- paragraph (1)(iv) of the definition of ant to §§ 1310.12 and 1310.13, is tempo- regulated transaction in § 1300.02 of this rarily exempted from the registration chapter is temporarily exempted from requirement, provided that DEA re- the registration requirement, provided ceives a proper application for registra- that the person submits a proper appli- tion or application for exemption on or cation 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 chemical control requirements set forth in parts 1309, 1310, and 1313 of this forth in parts 1309, 1310, and 1313 of this chapter remain in full force and effect. chapter remain in full force and effect. Any person who distributes, imports or (c) Each person required by section exports a chemical mixture whose ap- 302 of the act (21 U.S.C. 822) to obtain a plication for exemption is subsequently registration to distribute, import, or denied by DEA must obtain a registra- export GBL is temporarily exempted tion with DEA. A temporary exemption from the registration requirement, pro- from the registration requirement will vided that the DEA receives a proper also be provided for these persons, pro- application for registration on or be- vided that DEA receives a properly fore July 24, 2000. The exemption will completed application for registration remain in effect for each person who on or before 30 days following the date

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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 tribute, import, or export regulated N- force and effect. Any person who dis- phenethyl-4-piperidone (NPP), includ- tributes, imports, or exports a chem- ing regulated chemical mixtures pursu- ical mixture containing iodine whose ant to § 1310.12, is temporarily exempt- application for exemption is subse- ed from the registration requirement, quently denied by the Administration provided that DEA receives a proper must obtain a registration with the application for registration or applica- Administration. A temporary exemption for exemption for a chemical mix- tion from the registration requirement ture containing NPP pursuant to will also be provided for these persons, § 1310.13 on or before June 22, 2007. The provided that the Administration re- exemption will remain in effect for ceives a properly completed applica- each person who has made such appli- tion for registration on or before 30

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days following the date of official Ad- son who has made such application ministration notification that the ap- until the Administration has approved plication for exemption has not been or denied that application. This exemp- approved. The temporary exemption tion applies only to registration; all for such persons will remain in effect 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, (l)(1) Each person required under sec- 1310, 1313, and 1315 of this chapter re- tions 302 and 1007 of the Act (21 U.S.C. main in full force and effect. Any per- 822, 957) to obtain a registration to son who manufactures, distributes, im- manufacture, distribute, import, or exports, or exports a chemical mixture port regulated ergocristine and its whose application for exemption is sub- salts, including regulated chemical sequently denied by DEA must obtain a mixtures pursuant to § 1310.12, is tem- registration with DEA. A temporary porarily exempted from the registra- exemption from the registration re- tion requirement, provided that DEA quirement will also be provided for receives a properly completed applica- these persons, provided that DEA re- tion for registration or application for ceives a properly completed applica- exemption for a chemical mixture con- tion for registration on or before 30 taining ergocristine and its salts pur- days following the date of official DEA suant to § 1310.13 on or before May 2, notification that the application for 2011. The exemption will remain in ef- exemption has not been approved. The fect for each person who has made such temporary exemption for such persons application until the Administration will remain in effect until DEA takes has approved or denied that applica- final action on their registration appli- tion. This exemption applies only to cation. registration; all other chemical control (k)(1) Each person required by sec- requirements set forth in the Act and tions 302 or 1007 of the Act (21 U.S.C. parts 1309, 1310, 1313, and 1316 of this 822, 957) to obtain a registration to chapter remain in full force and effect. manufacture, distribute, import, or ex- (2) Any person who manufactures, port regulated GBL-containing chem- distributes, imports, or exports a ical mixtures, pursuant to sections chemical mixture containing 1310.12 and 1310.13, is temporarily ex- ergocristine and its salts whose appli- empted from the registration require- cation for exemption is subsequently ment, provided that DEA receives a denied by DEA must obtain a registra- properly completed application for reg- tion with DEA. A temporary exemption istration or application for exemption from the registration requirement will on or before July 29, 2010. The exemp- also be provided for those persons tion will remain in effect for each per- whose applications for exemption are

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denied, provided that DEA receives a § 1310.10 Removal of the exemption of properly completed application for reg- drugs distributed under the Federal istration on or before 30 days following Food, Drug and Cosmetic Act. the date of official DEA notification (a) The Administrator may remove that the application for exemption has from exemption under paragraph (1)(iv) been denied. The temporary exemption of the definition of regulated trans- for such persons will remain in effect action in § 1300.02 of this chapter any until DEA takes final action on their drug or group of drugs that the Admin- registration application. istrator finds is being diverted to ob- (m)(1) Each person required by Sec- tain a listed chemical for use in the il- tions 302 or 1007 of the Act (21 U.S.C. licit production of a controlled sub- 822, 957) to obtain a registration to stance. In removing a drug or group of manufacture, distribute, import, or ex- drugs from the exemption the Adminis- port regulated chemical mixtures trator shall consider: which contain red phosphorus, white (1) The scope, duration, and signifi- phosphorus, hypophosphorous acid (and cance of the diversion; its salts), pursuant to §§ 1310.12 and (2) Whether the drug or group of 1310.13, is temporarily exempted from drugs is formulated in such a way that the registration requirement, provided it cannot be easily used in the illicit that DEA receives a properly com- production of a controlled substance; pleted application for registration or and application for exemption on or before (3) Whether the listed chemical can July 5, 2011. The exemption will remain be readily recovered from the drug or in effect for each person who has made group of drugs. such application until the Administra- (b) Upon determining that a drug or tion has approved or denied that appli- group of drugs should be removed from cation. This exemption applies only to the exemption under paragraph (a) of registration; all other chemical control this section, the Administrator shall requirements set forth in parts 1309, issue and publish in the FEDERAL REG- 1310, and 1313 of this chapter remain in ISTER his proposal to remove the drug full force and effect. or group of drugs from the exemption, (2) Any person who manufactures, which shall include a reference to the distributes, imports, or exports a legal authority under which the pro- chemical mixture which contains red posal is based. The Administrator shall phosphorus, white phosphorus, permit any interested person to file hypophosphorous acid (and its salts) written comments on or objections to whose application for exemption is sub- the proposal. After considering any sequently denied by DEA must obtain a comments or objections filed, the Ad- registration with DEA. A temporary ministrator shall publish in the FED- exemption from the registration re- ERAL REGISTER his final order. quirement will also be provided for (c) The Administrator shall limit the those persons whose applications are removal of a drug or group of drugs denied, provided that DEA receives a from exemption under paragraph (a) of properly completed application for reg- this section to the most identifiable istration on or before 30 days following type of the drug or group of drugs for the date of official DEA notification that the application for exemption has which evidence of diversion exists un- not been approved. The temporary ex- less there is evidence, based on the pat- emption for such persons will remain tern of diversion and other relevant in effect until DEA takes final action factors, that the diversion will not be on their registration application. limited to that particular drug or group of drugs. [62 FR 27693, May 21, 1997, as amended at 62 (d) Any manufacturer seeking rein- FR 53960, Oct. 17, 1997; 65 FR 21647, Apr. 24, statement of a particular drug product 2000; 66 FR 52675, Oct. 17, 2001; 68 FR 23203, that has been removed from an exemp- May 1, 2003; 69 FR 74971, Dec. 15, 2004; 72 FR tion may apply to the Administrator 20046, Apr. 23, 2007; 72 FR 35931, July 2, 2007; 72 FR 40239, July 24, 2007; 72 FR 40744, July 25, for reinstatement of the exemption for 2007; 75 FR 37306, June 29, 2010; 76 FR 17781, that particular drug product on the Mar. 31, 2011; 76 FR 31829, June 2, 2011; 77 FR grounds that the particular drug prod- 4237, Jan. 27, 2012] uct is manufactured and distributed in

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a manner that prevents diversion. In specific drug product is pending resolu- determining whether the exemption tion, provided that the application for should be reinstated the Administrator reinstatement is filed not later than 60 shall consider: days after the publication of the final (1) The package sizes and manner of order removing the exemption; and packaging of the drug product; (2) For a period of 60 days following (2) The manner of distribution and the Administrator’s denial of an appli- advertising of the drug product; cation for reinstatement. (3) Evidence of diversion of the drug (g) An order published by the Admin- product; istrator in the FEDERAL REGISTER, pur- (4) Any actions taken by the manu- suant to paragraph (e) of this section, facturer to prevent diversion of the drug product; and to reinstate an exemption may be (5) Such other factors as are relevant modified or revoked with respect to a to and consistent with the public particular drug product upon a finding health and safety, including the factors that: described in paragraph (a) of this sec- (1) Applying the factors set forth in tion as applied to the drug product. paragraph (a) of this section to the par- (e) Within a reasonable period of ticular drug product, the drug product time after receipt of the application for is being diverted; or reinstatement of the exemption, the (2) There is a significant change in Administrator shall notify the appli- the data that led to the issuance of the cant of his acceptance or non-accept- final rule. ance of his application, and if not accepted, the reason therefor. If the ap- [60 FR 32461, June 22, 1995, as amended at 62 plication is accepted for filing, the Ad- FR 13968, Mar. 24, 1997; 67 FR 14862, Mar. 28, 2002; 75 FR 38922, July 7, 2010; 77 FR 4237, Jan. ministrator shall issue and publish in 27, 2012] the FEDERAL REGISTER his order on the reinstatement of the exemption for the § 1310.11 Reinstatement of exemption particular drug product, which shall infor drug products distributed under clude a reference to the legal authority the Food, Drug and Cosmetic Act. under which the order is based. This 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 the effectiveness of the order until he pursuant to 1310.10 affects the criminal may reconsider the application in light liability for illegal possession or dis- of the comments and objections filed. tribution of listed chemicals contained Thereafter, the Administrator shall rein the exempt drug product. instate, revoke, or amend his original (c) Changes in exempt drug product order as he determines appropriate. compositions: Any change in the quan- (f) Unless the Administrator has evi- titative or qualitative composition, dence that the drug product is being di- trade name or other designation of an verted, as determined by applying the exempt drug product listed in para- factors set forth in paragraph (a) of graph (d) requires a new application for this section, and the Administrator so reinstatement of the exemption. notifies the applicant, transactions involving a specific drug product will not (d) The following drug products, in be considered regulated transactions the form and quantity listed in the ap- during the following periods: plication submitted (indicated as the (1) While a bonafide application for ‘‘date’’) are designated as reinstated reinstatement of exemption under exempt drug products for the purposes paragraph (d) of this section for the set forth in this section:

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EXEMPT DRUG PRODUCTS criminal liability for illegal possession, distribution, exportation, or importa- Supplier Product name Form Date tion of listed chemicals contained in [Reserved] ...... the exempt chemical mixture or the civil liability for unlawful acts related to exempt chemical mixtures, includ- [60 FR 32462, June 22, 1995] ing distribution in violation of 21 U.S.C. 842(a)(11). § 1310.12 Exempt chemical mixtures. (c) Mixtures containing a listed (a) The chemical mixtures meeting chemical in concentrations equal to or the criteria in paragraphs (c) or (d) of less than those specified in the ‘‘Table this section are exempted by the Ad- of Concentration Limits’’ are des- ministrator from application of sec- ignated as exempt chemical mixtures tions 302, 303, 310, 1007, 1008, and 1018 of for the purpose set forth in this sec- the Act (21 U.S.C. 822, 823, 830, 957, 958, tion. The concentration is determined and 971) to the extent described in for liquid-liquid mixtures by using the paragraphs (b) and (c) of this section. volume or weight and for mixtures con- (b) No exemption granted pursuant to taining solids or gases by using the this § 1310.12 or § 1310.13 affects the 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. Ergocristine and its salts .... 8612 Not exempt at any con- Chemical mixtures containing any amount of centration. ergocristine and its salts are not exempt. 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. Hypophosphorous acid and 6797 30% by weight if a solid, The weight is determined by measuring the mass of its salts. weight or volume if a liq- hypophosphorous acid and its salts in the mixture, uid. the concentration limit is calculated by summing the concentrations of all forms of hypophosphorous acid and its salts in the mixture. The Administration does not consider a chemical mixture to mean the combination of a listed chemical and an inert carrier. Therefore, any solution consisting of hypophosphorous acid (and its salts), dispersed in water, alcohol, or another inert carrier, is not considered a chemical mixture and is therefore subject to chemical regulatory controls at all concentrations. 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.

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TABLE OF CONCENTRATION LIMITS—Continued

DEA chemical code Concentration Special conditions number

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. Red Phosphorus ...... 6795 80% by weight. Safrole ...... 8323 20% by Volume...... Concentration in a mixture cannot exceed 20% if taken alone or in any combination with isosafrole. White phosphorus ...... 6796 Not exempt at any con- Chemical mixtures containing any amount of white centration. phosphorus are not exempt due to concentration, unless otherwise exempted. 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.

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TABLE OF CONCENTRATION LIMITS—Continued

DEA chemical code Concentration Special conditions number

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- nonylphenoxypoly (ethyleneoxy) eth- ical mixtures are automatically ex- anol-iodine complex, iodine complex empt from the provisions of the Con- with phosphate ester of alkylaryloxy trolled Substances Act as described in polyethylene glycol, and iodine com- paragraph (a) of this section: plex with ammonium ether sulfate/ (1) Chemical mixtures that are dis- polyoxyethylene sorbitan monolaurate. tributed directly to an incinerator for (4) Iodine products that consist of or- destruction or directly to an author- ganically bound iodine (a non-ionic ized waste recycler or reprocessor complex) (e.g., iopamidol, iohexol, and where such distributions are docu- amiodarone.) mented on United States Environ- (e) The Administrator may, at any mental Protection Agency Form 8700– time, terminate or modify the exemp- 22; persons distributing the mixture to tion for any chemical mixture which the incinerator or recycler must main- has been granted an exemption pursu- tain and make available to agents of ant to the concentration limits as spec- the Administration, upon request, such ified in paragraph (c) of this section or documentation for a period of no less pursuant to the category exemption as than two years. specified in paragraph (d) of this sec- (2) Completely formulated paints and tion. In terminating or modifying an coatings: Completely formulated exemption, the Administrator shall paints and coatings are only those for- issue, and publish in the FEDERAL REG- mulations that contain all of the com- ISTER, notification of the removal of an ponents of the paint or coating for use exemption for a product or group of in the final application without the products for which evidence of diver- need to add any additional substances sion has been found, as well as the date except a thinner if needed in certain on which the termination of exemption cases. A completely formulated paint shall take effect. The Administrator or coating is defined as any clear or shall permit any interested party to pigmented liquid, liquefiable or mastic file written comments on or objections composition designed for application to to the order within 60 days of the date a substrate in a thin layer that is con- of publication of the order in the FED- verted to a clear or opaque solid pro- ERAL REGISTER. If any such comments tective, decorative, or functional ad- or objections raise significant issues herent film after application. Included regarding any finding of fact or conclu- in this category are clear coats, top- sion of law upon which the order is coats, primers, varnishes, sealers, ad- based, the Administrator shall imme- hesives, lacquers, stains, shellacs, inks, diately suspend the effectiveness of the temporary protective coatings and order until he may reconsider the order film-forming agents. in light of comments and objections (3) Iodine products classified as filed. Thereafter, the Administrator iodophors that exist as an iodine com- shall reinstate, terminate, or amend plex to include poloxamer-iodine com- the original order as determined appro- plex, polyvinyl pyrrolidone-iodine com- priate. plex (i.e., povidone-iodine), (f) The Administrator may modify undecoylium chloride iodine, any part of the criteria for exemption

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as specified in paragraphs (c) and (d) of (ii) If a group of mixtures (e.g. formu- this section upon evidence of diversion lations having identical function and or attempted diversion. In doing so, the containing the same listed chem- Administrator shall issue and publish a ical(s)), the information required in Notice of Proposed Rulemaking in the paragraph (c)(3)(i) of this section and a FEDERAL REGISTER. The Administrator brief narrative of their use. shall permit any interested persons to (4) (i) The complete qualitative and file written comments on or objections quantitative composition of the chem- to the proposal. After considering any ical mixture (including all listed and comments or objections filed, the Ad- all non-listed chemicals); or ministrator shall publish in the FED- (ii) If a group of mixtures, the con- ERAL REGISTER a final order. centration range for the listed chemical and a listing of all non-listed [68 FR 23204, May 1, 2003, as amended at 69 FR 74971, Dec. 15, 2004; 71 FR 60826, Oct. 17, chemicals with respective concentra- 2006; 72 FR 20047, Apr. 23, 2007; 72 FR 35931, tion ranges. July 2, 2007; 72 FR 40745, July 25, 2007; 75 FR (5) (i) The chemical and physical 37306, June 29, 2010; 76 FR 17781, Mar. 31, 2011; properties of the mixture and how they 76 FR 31830, June 2, 2011] differ from the properties of the listed chemical or chemicals; and § 1310.13 Exemption of chemical mix- (ii) If a group of mixtures, how the tures; application. group’s properties differ from the prop- (a) The Administrator may, by publi- erties of the listed chemical. cation of a Final Rule in the FEDERAL (6) A statement that the applicant REGISTER, exempt from the application believes justifies an exemption for the of all or any part of the Act a chemical chemical mixture or group of mixtures. mixture consisting of two or more The statement must explain how the chemical components, at least one of chemical mixture(s) meets the exemp- which is not a List I or List II chem- tion criteria set forth in paragraph (a) ical, if: of this section. (1) The mixture is formulated in such (7) A statement that the applicant a way that it cannot be easily used in accepts the right of the Administrator the illicit production of a controlled to terminate exemption from regula- substance; and tion for the chemical mixture(s) grant- (2) The listed chemical or chemicals ed exemption under this section. contained in the chemical mixture can- (8) The identification of any informa- not be readily recovered. tion on the application that is consid- (b) Any manufacturer seeking an ex- ered by the applicant to be a trade se- emption for a chemical mixture, not cret or confidential and entitled to pro- exempt under § 1310.12, from the appli- tection under U.S. laws restricting the cation of all or any part of the Act, public disclosure of such information. may apply to the Office of Diversion (d) The Administrator may require Control, Drug Enforcement Adminis- the applicant to submit such additional tration. See the Table of DEA Mailing documents or written statements of Addresses in § 1321.01 of this chapter for fact relevant to the application that he the current mailing address. deems necessary for determining if the (c) An application for exemption application should be granted. under this section shall contain the fol- (e) Within a reasonable period of lowing information: time after the receipt of an application (1) The name, address, and registra- for an exemption under this section, tion number, if any, of the applicant; the Administrator will notify the ap- (2) The date of the application; plicant in writing of the acceptance or (3) The exact trade name(s) of the ap- rejection of the application for filing. plicant’s chemical mixture and: If the application is not accepted for (i) If the applicant formulates or filing, an explanation will be provided. manufactures the chemical mixture for The Administrator is not required to other entities, the exact trade names of accept an application if any informa- the chemical mixtures and the names tion required pursuant to paragraph (c) of the entities for which the chemical of this section or requested pursuant to mixtures were prepared; and paragraph (d) of this section is lacking

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or not readily understood. The appli- has reconsidered the order in light of cant may, however, amend the applica- comments and objections filed. There- tion to meet the requirements of para- after, the Administrator shall rein- graphs (c) and (d) of this section. If the state, terminate, or amend the original exemption is subsequently granted, the order as determined appropriate. applicant shall again be notified in (g) A manufacturer of an exempted writing and the Administrator shall chemical mixture shall notify DEA in issue, and publish in the FEDERAL REG- writing, of any change in the quan- ISTER, an order on the application. This titative or qualitative composition of a order shall specify the date on which it chemical mixture that has been grant- shall take effect. The Administrator ed an exemption by application. shall permit any interested person to Changes include those greater than the file written comments on or objections range of concentration given in the ap- to the order. If any comments or objec- plication or that remove non-listed tions raise significant issues regarding chemical(s) given in the application as any findings of fact or conclusions of part of the formulation. A new applica- law upon which the order is based, the tion will be required only if reformula- Administrator may suspend the effec- tion results in a new product having a tiveness of the order until he has re- different commercial application or considered the application in light of can no longer be defined as part of a the comments and objections filed. group of exempted chemicals. DEA Thereafter, the Administrator shall re- must be notified of reformulation at instate, terminate, or amend the original order as deemed appropriate. least 30 days in advance of marketing (f) The Administrator may, at any the reformulated mixture. For a time, terminate or modify an exemp- change in name or other designation, tion for any product pursuant to para- code, or any identifier, a written notifi- graph (e) of this section. In termi- cation is required. DEA must be noti- nating or modifying an exemption, the fied of any changes at least 60 days in Administrator shall issue, and publish advance of the effective date for the in the FEDERAL REGISTER, notification change. of the removal of an exempt product or (h) Each manufacturer seeking ex- group of exempt products for which emption must apply for such an exemp- evidence of diversion has been found. tion. A formulation granted exemption This order shall specify the date on by publication in the FEDERAL REG- which the termination of exemption ISTER will not be exempted for all man- shall take effect. The Administrator ufacturers. shall permit any interested party to (i) The following chemical mixtures, file written comments on or objections in the form and quantity listed in the to the order within 60 days of the date application submitted (indicated as the of publication of the order in the FED- ‘‘date’’) are designated as exempt ERAL REGISTER. If any such comments chemical mixtures for the purposes set or objections raise significant issues forth in this section and are exempted regarding any finding of fact or conclu- by the Administrator from application sion of law upon which the order is of Sections 302, 303, 310, 1007, 1008, and based, the Administrator may suspend 1018 of the Act (21 U.S.C. 822, 823, 830, the effectiveness of the order until he 957, 958, and 971):

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.

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EXEMPT CHEMICAL MIXTURES—Continued

Manufacturer Product name 1 Form Date

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. 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 § 1300.02 of this chapter pursuant to the FR 10681, Mar. 9, 2010; 75 FR 53869, Sept. 2, criteria listed in § 1310.10 of this part: 2010; 76 FR 31830, June 2, 2011] (a) Nonprescription drugs containing § 1310.14 Removal of exemption from ephedrine, its salts, optical isomers, definition of regulated transaction. and salts of optical isomers. (b) Nonprescription drugs containing The Administrator finds that the fol- phenylpropanolamine, its salts, optical lowing drugs or groups of drugs are isomers, and salts of optical isomers. being diverted to obtain a listed chemical for use in the illicit production of (c) Nonprescription drugs containing a controlled substance and removes the pseudoephedrine, its salts, optical iso- drugs or groups of drugs from exemp- mers, and salts of optical isomers. tion under paragraph (1)(iv) of the defi- [75 FR 38922, July 7, 2010, as amended at 77 nition of regulated transaction in FR 4237, Jan. 27, 2012]

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§ 1310.16 Exemptions for certain (e) If the application is accepted for scheduled listed chemical products. filing, the Administrator shall issue (a) Upon the application of a manu- and publish in the FEDERAL REGISTER facturer of a scheduled listed chemical an order on the application, which product, the Administrator may by shall include a reference to the legal regulation provide that the product is authority under which the order is exempt from part 1314 of this chapter if based. This order shall specify the date the Administrator determines that the on which it shall take effect. product cannot be used in the illicit (f) The Administrator shall permit manufacture of a controlled substance. any interested person to file written (b) An application for an exemption comments on or objections to the under this section must contain all of order. If any comments or objections the following information: raise significant issues regarding any (1) The name and address of the ap- findings of fact or conclusions of law plicant. upon which the order is based, the Ad- (2) The exact trade name of the ministrator shall immediately suspend scheduled listed chemical product for the effectiveness of the order until he which exemption is sought. may reconsider the application in light (3) The complete quantitative and of the comments and objections filed. qualitative composition of the drug product. Thereafter, the Administrator shall re- (4) A brief statement of the facts that instate, revoke, or amend the original the applicant believes justify the order as deemed appropriate. granting of an exemption under this [71 FR 56024, Sept. 26, 2006] section. (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. (d) Within a reasonable period of would result in the illegal manufacture time after the receipt of a completed of a controlled substance. For purposes application for an exemption under of this requirement, reasonable cause this section, the Administrator shall to believe means that the Administra- notify the applicant of acceptance or tion has knowledge of facts which non-acceptance of the application. If would cause a reasonable person to rea- the application is not accepted, an ex- sonably conclude that a chemical planation will be provided. The Admin- would be diverted to the illegal manu- istrator is not required to accept an ap- facture of a controlled substance. plication if any of the information re- (b) A Federal department or agency quired in paragraph (b) of this section must request certification by submit- or requested under paragraph (c) of this ting a written request to the Adminis- section is lacking or not readily under- trator, Drug Enforcement Administra- stood. The applicant may, however, tion. See the Table of DEA Mailing Ad- amend the application to meet the re- dresses in § 1321.01 of this chapter for quirements of paragraphs (b) and (c) of the current mailing address. A request this section. for certification may be transmitted

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directly to the Office of Diversion Con- and end-user will result in the illegal trol, Drug Enforcement Administra- manufacture of a controlled substance, tion, through electronic facsimile that certification will be effective for media. A request for certification must one year from the date of issuance with be submitted no later than fifteen cal- respect to further sales of the same endar days before the proposed sale is chemical to the same prospective bid- to take place. In order to facilitate the der and end-user, unless the Adminis- sale of chemicals from Federal depart- trator notifies the head of the Federal ments’ or agencies’ stocks, Federal de- department or agency in writing that partments or agencies may wish to the certification is withdrawn. If the submit requests as far in advance of certification is withdrawn, DEA will the fifteen calendar days as possible. also provide written notice to the bid- The written notification of the pro- der and end-user, which will contain a posed sale must include: statement of the legal and factual basis (1) The name and amount of the for this determination. chemical to be sold; (e) If the Administrator determines (2) The name and address of the pro- there is reasonable cause to believe the spective bidder; sale of the specific chemical to a spe- (3) The name and address of the pro- cific bidder and end-user would result spective end-user, in cases where a sale in the illegal manufacture of a con- is being brokered; trolled substance, DEA will provide (4) Point(s) of contact for the pro- written notice to the head of a Federal spective bidder and, where appropriate, department or agency refusing to cer- prospective end-user; and (5) The end use of the chemical. tify the proposed sale under the au- (c) Within fifteen calendar days of re- thority of 21 U.S.C. 890. DEA also will ceipt of a request for certification, the provide, within fifteen calendar days of Administrator will certify in writing to receiving a request for certification the head of the Federal department or from a Federal department or agency, agency that there is, or is not, reason- the same written notice to the prospec- able cause to believe that the sale of tive bidder and end-user, and this no- the specific chemical to the specific tice also will contain a statement of bidder and end-user would result in the the legal and factual basis for the re- illegal manufacture of a controlled fusal of certification. The prospective substance. In making this determina- bidder and end-user may, within thirty tion, the following factors must be con- calendar days of receipt of notification sidered: of the refusal, submit written com- (1) Past experience of the prospective ments or written objections to the Ad- bidder or end-user in the maintenance ministrator’s refusal. At the same of effective controls against diversion time, the prospective bidder and end- of listed chemicals into other than le- user also may provide supporting docu- gitimate medical, scientific, and indus- mentation to contest the Administra- trial channels; tor’s refusal. If such written comments (2) Compliance of the prospective bid- or written objections raise issues re- der or end-user with applicable Fed- garding any finding of fact or conclu- eral, state and local law; sion of law upon which the refusal is (3) Prior conviction record of the pro- based, the Administrator will recon- spective bidder or end-user relating to sider the refusal of the proposed sale in listed chemicals or controlled sub- light of the written comments or writ- stances under Federal or state laws; ten objections filed. Thereafter, within and a reasonable time, the Administrator (4) Such other factors as may be rel- will withdraw or affirm the original re- evant to and consistent with the public fusal of certification as he determines health and safety. appropriate. The Administrator will (d) If the Administrator certifies to provide written reasons for any affir- the head of a Federal department or mation of the original refusal. Such af- agency that there is no reasonable firmation of the original refusal will cause to believe that the sale of a spe- constitute a final decision for purposes cific chemical to a prospective bidder of judicial review under 21 U.S.C. 877.

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(f) If the Administrator determines Subpart B—Obtaining and Using Digital there is reasonable cause to believe Certificates for Electronic Orders that an existing certification should be withdrawn, DEA will provide written 1311.10 Eligibility to obtain a CSOS digital certificate. notice to the head of a Federal depart- 1311.15 Limitations on CSOS digital certifi- ment or agency of such withdrawal cates. under the authority of 21 U.S.C. 890. 1311.20 Coordinators for CSOS digital cer- DEA also will provide, within fifteen tificate holders. calendar days of withdrawal of an ex- 1311.25 Requirements for obtaining a CSOS isting certification, the same written digital certificate. notice to the bidder and end-user, and 1311.30 Requirements for storing and using a this notice also will contain a state- private key for digitally signing orders. 1311.35 Number of CSOS digital certificates ment of the legal and factual basis for needed. the withdrawal. The bidder and end- 1311.40 Renewal of CSOS digital certifi- user may, within thirty calendar days cates. of receipt of notification of the with- 1311.45 Requirements for registrants that drawal of the existing certification, allow powers of attorney to obtain CSOS submit written comments or written digital certificates under their DEA reg- objections to the Administrator’s with- istration. drawal. At the same time, the bidder 1311.50 Requirements for recipients of digitally signed orders. and end-user also may provide sup- 1311.55 Requirements for systems used to porting documentation to contest the process digitally signed orders. Administrator’s withdrawal. If such 1311.60 Recordkeeping. written comments or written objections raise issues regarding any finding Subpart C—Electronic Prescriptions of fact or conclusion of law upon which 1311.100 General. 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. comments or written objections filed. 1311.110 Requirements for obtaining an au- Thereafter, within a reasonable time, thentication credential—Individual prac- the Administrator will withdraw or af- titioners eligible to use an electronic firm the original withdrawal of the ex- prescription application of an institutional 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 bio- mation of the original withdrawal of metrics. the existing certification. Such affir- 1311.120 Electronic prescription application mation of the original withdrawal of requirements. the existing certification will con- 1311.125 Requirements for establishing log- stitute a final decision for purposes of ical access control—Individual practitioner. judicial review under 21 U.S.C. 877. 1311.130 Requirements for establishing log- [68 FR 62737, Nov. 6, 2003, as amended at 75 ical access control—Institutional practi- FR 10681, Mar. 9, 2010] tioner. 1311.135 Requirements for creating a controlled substance prescription. PART 1311—REQUIREMENTS FOR 1311.140 Requirements for signing a con- ELECTRONIC ORDERS AND PRE- trolled substance prescription. SCRIPTIONS 1311.145 Digitally signing the prescription 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.

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1311.300 Application provider require- (b) DEA has identified the following ments—Third-party audits or certifi- means of electronically signing and cations. transmitting order forms as meeting 1311.302 Additional application provider re- all of the standards set forth in para- quirements. 1311.305 Recordkeeping. graph (a) of this section. (1) Digital signatures using Public AUTHORITY: 21 U.S.C. 821, 828, 829, 871(b), Key Infrastructure (PKI) technology. 958(e), 965, unless otherwise noted. (2) [Reserved] SOURCE: 70 FR 16915, Apr. 1, 2005, unless otherwise noted. § 1311.08 Incorporation by reference. (a) These incorporations by reference Subpart A—General were approved by the Director of the Federal Register in accordance with 5 § 1311.01 Scope. U.S.C. 552(a) and 1 CFR part 51. Copies This part sets forth the rules gov- may be inspected at the Drug Enforce- erning the creation, transmission, and ment Administration, 600 Army Navy storage of electronic orders and pre- Drive, Arlington, VA 22202 or at the scriptions. National Archives and Records Admin- istration (NARA). For information on [75 FR 16310, Mar. 31, 2010] the availability of this material at the § 1311.02 Definitions. Drug Enforcement Administration, call (202) 307–1000. For information on the Any term contained in this part shall availability of this material at NARA, have the definition set forth in section call (202) 741–6030 or go to: http:// 102 of the Act (21 U.S.C. 802) or part www.archives.gov/federallregister/ 1300 of this chapter. codeloflfederallregulations/ [75 FR 16310, Mar. 31, 2010] ibrllocations.html. (b) These standards are available § 1311.05 Standards for technologies from the National Institute of Stand- for electronic transmission of or- ards and Technology, Computer Secu- ders. rity Division, Information Technology (a) A registrant or a person with Laboratory, National Institute of power of attorney to sign orders for Standards and Technology, 100 Bureau Schedule I and II controlled substances Drive, Gaithersburg, MD 20899–8930, may use any technology to sign and (301) 975–6478 or TTY (301) 975–8295, electronically transmit orders if the [email protected], and are available at technology provides all of the fol- http://csrc.nist.gov/. The following stand- lowing: ards are incorporated by reference: (1) Authentication: The system must (1) Federal Information Processing enable a recipient to positively verify Standard Publication (FIPS PUB) 140– the signer without direct communica- 2, Change Notices (12–03–2002), Security tion with the signer and subsequently Requirements for Cryptographic Mod- demonstrate to a third party, if needed, ules, May 25, 2001 (FIPS 140–2) includ- that the sender’s identity was properly ing Annexes A through D; incorpora- verified. tion 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.

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(iv) Annex D: Approved Key Estab- thorized to sign a registration applica- lishment Techniques for FIPS PUB 140– tion. 2, Security Requirements for Cryp- (b) A person granted power of attor- tographic Modules, February 23, 2004. ney by a DEA registrant to sign orders (2) Federal Information Processing for one or more schedules of controlled Standard Publication (FIPS PUB) 180– substances. 2, Secure Hash Standard, August 1, 2002, as amended by change notice 1, § 1311.15 Limitations on CSOS digital certificates. February 25, 2004 (FIPS 180–2); incorporation by reference approved for (a) A CSOS digital certificate issued §§ 1311.30(b) and 1311.55(b). by the DEA Certification Authority (3) Federal Information Processing will authorize the certificate holder to Standard Publication (FIPS PUB) 180– sign orders for only those schedules of 3, Secure Hash Standard (SHS), Octo- controlled substances covered by the ber 2008 (FIPS 180–3); incorporation by registration under which the certifi- reference approved for §§ 1311.120(b) and cate is issued. 1311.205(b). (b) When a registrant, in a power of (4) Federal Information Processing attorney letter, limits a certificate ap- Standard Publication (FIPS PUB) 186– plicant to a subset of the registrant’s 2, Digital Signature Standard, January authorized schedules, the registrant is 27, 2000, as amended by Change Notice responsible for ensuring that the cer- 1, October 5, 2001 (FIPS 186–2); incorpo- tificate holder signs orders only for ration by reference approved for that subset of schedules. §§ 1311.30(b) and 1311.55(b). § 1311.20 Coordinators for CSOS dig- (5) Federal Information Processing ital certificate holders. Standard Publication (FIPS PUB) 186– (a) Each registrant, regardless of 3, Digital Signature Standard (DSS), number of digital certificates issued, 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 (b) Once designated, coordinators digital certificate. 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

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Authority provides and submit the fol- certificate holders who will review the lowing: application and submit the completed (1) Two copies of identification, one application and accompanying docu- of which must be a government-issued mentation to the DEA Certification photographic identification. Authority. (2) A copy of each current DEA Cer- (c) When the Certification Authority tificate of Registration (DEA form 223) approves the application, it will send for each registered location for which the applicant a one-time use reference the coordinator will be responsible or, number and access code, via separate if the applicant (or their employer) has channels, and information on how to not been issued a DEA registration, a use them. Using this information, the copy of each application for registra- applicant must then electronically sub- tion of the applicant or the applicant’s mit a request for certification of the employer. public digital signature key. After the (3) The applicant must have the com- request is approved, the Certification pleted application notarized and for- Authority will provide the applicant ward the completed application and ac- with the signed public key certificate. companying documentation to the (d) Once the applicant has generated DEA Certification Authority. the key pair, the Certification Author- (c) Coordinators will communicate ity must prove that the user has pos- with the Certification Authority re- session of the key. For public keys, the garding digital certificate applications, corresponding private key must be renewals and revocations. For appli- used to sign the certificate request. cants applying for a digital certificate Verification of the signature using the from the DEA Certification Authority, public key in the request will serve as and for applicants applying for a power proof of possession of the private key. of attorney digital certificate for a 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 (3) A copy of the power of attorney private key or the password, via a rev- from the registrant, if applicable. ocation request, to the Certification (4) An acknowledgment that the ap- Authority within 24 hours of substan- plicant has read and understands the tiation of the loss, theft, or com- Subscriber Agreement and agrees to promise. Upon receipt and verification the statement of subscriber obligations of a signed revocation request, the Cer- that DEA provides. tification Authority will revoke the (b) The applicant must provide the certificate. The certificate holder must completed application to the reg- apply for a new certificate under the istrant’s coordinator for CSOS digital requirements of § 1311.25.

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§ 1311.35 Number of CSOS digital cer- power of attorney to sign controlled tificates needed. substances orders.

A purchaser of Schedule I and II con- § 1311.50 Requirements for recipients trolled substances must obtain a sepa- of digitally signed orders. rate CSOS certificate for each registered location for which the pur- (a) The recipient of a digitally signed chaser will order these controlled sub- order must do the following before fill- stances. ing the order: (1) Verify the integrity of the signa- § 1311.40 Renewal of CSOS digital cer- ture and the order by having the sys- tificates. tem validate the order. (2) Verify that the certificate hold- (a) A CSOS certificate holder must er’s CSOS digital certificate has not generate a new key pair and obtain a expired by checking the expiration new CSOS digital certificate when the date against the date the order was registrant’s DEA registration expires signed. or whenever the information on which (3) Check the validity of the certifi- the certificate is based changes. This cate holder’s certificate by checking information includes the registered the Certificate Revocation List. name and address, the subscriber’s (4) Check the certificate extension name, and the schedules the registrant data to determine whether the sender is authorized to handle. A CSOS certifi- has the authority to order the con- cate will expire on the date on which trolled substance. the DEA registration on which the cer- (b) A recipient may cache Certificate tificate is based expires. Revocation Lists for use until they ex- (b) The Certification Authority will pire. notify each CSOS certificate holder 45 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 their DEA registration. FIPS 186–2 and FIPS 180–2, as incorporated 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.

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(5) The system must set a 10-minute and invalidate any order with a certifi- inactivity time period after which the cate listed on the Certificate Revoca- certificate holder must reauthenticate tion List. the password to access the private key. (7) The system must check the valid- (6) For software implementations, ity of the certificate and the Certifi- when the signing module is deacti- cation Authority certificate and invali- vated, the system must clear the plain date any order that fails these validity text private key from the system mem- checks. ory to prevent the unauthorized access (8) The system must have a time sys- to, or use of, the private key. tem that is within five minutes of the (7) The system must be able to official National Institute of Standards digitally sign and transmit an order. and Technology time source. (8) The system must have a time sys- (9) The system must check the sub- tem that is within five minutes of the stances ordered against the schedules official National Institute of Standards that the registrant is allowed to order and Technology time source. and invalidate any order that includes (9) The system must archive the substances the registrant is not al- digitally signed orders and any other lowed to order. records required in part 1305 of this (10) The system must ensure that an chapter, including any linked data. invalid finding cannot be bypassed or (10) The system must create an order ignored and the order filled. that includes all data fields listed (11) The system must archive the under § 1305.21(b) of this chapter. order and associate with it the digital (c) A system used to receive, verify, certificate received with the order. and create linked records for orders (12) If a registrant sends reports on signed with a CSOS digital certificate orders to DEA, the system must create must meet the following requirements: a report in the format DEA specifies, (1) The cryptographic module must as provided in § 1305.29 of this chapter. be FIPS 140–2, Level 1 validated, as in- (d) For systems used to process CSOS corporated by reference in § 1311.08. orders, the system developer or vendor (2) The digital signature system and must have an initial independent third- hash function must be compliant with party audit of the system and an addi- FIPS 186–2 and FIPS 180–2, as incor- tional independent third-party audit porated by reference in § 1311.08. whenever the signing or verifying (3) The system must determine that functionality is changed to determine an order has not been altered during whether it correctly performs the func- transmission. The system must invali- tions listed under paragraphs (b) and date any order that has been altered. (c) of this section. The system devel- (4) The system must validate the dig- oper must retain the most recent audit ital signature using the signer’s public results and retain the results of any key. The system must invalidate any other audits of the software completed order in which the digital signature within the previous two years. cannot be validated. (5) The system must validate that § 1311.60 Recordkeeping. the DEA registration number con- (a) A supplier and purchaser must tained in the body of the order cor- maintain records of CSOS electronic responds to the registration number as- orders and any linked records for two sociated with the specific certificate by years. Records may be maintained separately generating the hash value of electronically. Records regarding con- the registration number and certificate trolled substances that are maintained subject distinguished name serial num- electronically must be readily retriev- ber and comparing that hash value to able from all other records. the hash value contained in the certifi- (b) Electronic records must be easily cate extension for the DEA registra- readable or easily rendered into a for- tion number. If the hash values are not mat that a person can read. They must equal the system must invalidate the be made available to the Administra- order. tion upon request. (6) The system must check the Cer- (c) CSOS certificate holders must tificate Revocation List automatically maintain a copy of the subscriber

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agreement that the Certification Au- (2) The prescription is otherwise in thority provides for the life of the cer- conformity with the requirements of tificate. the Act and this chapter. (f) Nothing in this part alters the re- Subpart C—Electronic sponsibilities of the practitioner and Prescriptions pharmacy, specified in part 1306 of this chapter, to ensure the validity of a controlled substance prescription. SOURCE: 75 FR 16310, Mar. 31, 2010, unless otherwise noted. § 1311.102 Practitioner responsibilities. § 1311.100 General. (a) The practitioner must retain sole (a) This subpart addresses the re- possession of the hard token, where ap- quirements that must be met to issue plicable, and must not share the pass- and process Schedule II, III, IV, and V word or other knowledge factor, or bio- controlled substance prescriptions metric information, with any other electronically. person. The practitioner must not (b) A practitioner may issue a pre- allow any other person to use the scription for a Schedule II, III, IV, or V token or enter the knowledge factor or controlled substance electronically if other identification means to sign pre- all of the following conditions are met: scriptions for controlled substances. (1) The practitioner is registered as Failure by the practitioner to secure an individual practitioner or exempt the hard token, knowledge factor, or from the requirement of registration biometric information may provide a under part 1301 of this chapter and is basis for revocation or suspension of authorized under the registration or registration pursuant to section exemption to dispense the controlled 304(a)(4) of the Act (21 U.S.C. 824(a)(4)). substance; (b) The practitioner must notify the (2) The practitioner uses an elec- individuals designated under § 1311.125 tronic prescription application that or § 1311.130 within one business day of meets all of the applicable require- discovery that the hard token has been ments of this subpart; and lost, stolen, or compromised or the authentication 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

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the following accurately and consist- titioner must ensure that the individ- ently: uals designated under § 1311.130 termi- (1) The information required for a nate access for signing controlled sub- prescription under § 1306.05(a) of this stance prescriptions. chapter. (i) An individual practitioner or in- (2) The indication of signing as re- stitutional practitioner that receives a quired by § 1311.120(b)(17) or the digital notification that the electronic pre- signature created by the practitioner’s scription application is not in compli- private key. ance with the requirements of this part (3) The number of refills as required must not use the application to issue by § 1306.22 of this chapter. electronic controlled substance pre- (e) If the third-party auditor or cer- scriptions until it is notified that the tification organization has found that application is again compliant and all an electronic prescription application relevant updates to the application does not accurately and consistently have been installed. record, store, and transmit other infor- (j) The practitioner must notify both mation required for prescriptions under the individuals designated under this chapter, the practitioner must not § 1311.125 or § 1311.130 and the Adminis- create, sign, and transmit electronic tration within one business day of dis- prescriptions for controlled substances covery that one or more prescriptions that are subject to the additional infor- that were issued under a DEA registra- mation requirements. tion held by that practitioner were pre- (f) The practitioner must not use the scriptions the practitioner had not electronic prescription application to signed or were not consistent with the sign and transmit electronic controlled prescriptions he signed. substance prescriptions if any of the (k) The practitioner has the same re- functions of the application required sponsibilities when issuing prescrip- by this subpart have been disabled or appear to be functioning improperly. tions for controlled substances via (g) If an electronic prescription appli- electronic means as when issuing a cation provider notifies an individual paper or oral prescription. Nothing in practitioner that a third-party audit or this subpart relieves a practitioner of certification report indicates that the his responsibility to dispense con- application or the application provider trolled substances only for a legitimate no longer meets the requirements of medical purpose while acting in the this part or notifies him that the appli- usual course of his professional prac- cation provider has identified an issue tice. If an agent enters information at that makes the application non-com- the practitioner’s direction prior to the pliant, the practitioner must do the practitioner reviewing and approving following: the information and signing and au- (1) Immediately cease to issue elec- thorizing the transmission of that in- tronic controlled substance prescrip- formation, the practitioner is respon- tions using the application. sible in case the prescription does not (2) Ensure, for an installed electronic conform in all essential respects to the prescription application at an indi- law and regulations. vidual practitioner’s practice, that the individuals designated under § 1311.125 § 1311.105 Requirements for obtaining an authentication credential—Indi- terminate access for signing controlled vidual practitioners. substance prescriptions. (h) If an electronic prescription ap- (a) An individual practitioner must plication provider notifies an institu- obtain a two-factor authentication cre- tional practitioner that a third-party dential from one of the following: audit or certification report indicates (1) A credential service provider that that the application or the application has been approved by the General Serv- provider no longer meets the require- ices Administration Office of Tech- ments of this part or notifies it that nology Strategy/Division of Identity the application provider has identified Management to conduct identity proof- an issue that makes the application ing that meets the requirements of As- non-compliant, the institutional prac- surance Level 3 or above as specified in

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NIST SP 800–63–1 as incorporated by (3) Either ensure that the individual reference in § 1311.08. practitioner’s DEA registration is cur- (2) For digital certificates, a certifi- rent and in good standing or ensure cation authority that is cross-certified that the institutional practitioner has with the Federal Bridge certification granted the individual practitioner ex- authority and that operates at a Fed- empt from the requirement of registra- eral Bridge Certification Authority tion under § 1301.22 of this chapter basic assurance level or above. privileges to prescribe controlled sub- (b) The practitioner must submit stances using the institutional practi- identity proofing information to the tioner’s DEA registration number. credential service provider or certifi- (4) If the individual practitioner is an cation authority as specified by the employee of a health care facility that credential service provider or certifi- is operated by the Department of Vet- cation authority. erans Affairs, confirm that the indi- (c) The credential service provider or vidual practitioner has been duly ap- certification authority must issue the pointed to practice at that facility by authentication credential using two the Secretary of the Department of channels (e.g., e-mail, mail, or tele- Veterans Affairs pursuant to 38 U.S.C. phone call). If one of the factors used in 7401–7408. the authentication protocol is a bio- (5) If the individual practitioner is metric, or if the practitioner has a working at a health care facility oper- hard token that is being enabled to ated by the Department of Veterans sign controlled substances prescrip- Affairs on a contractual basis pursuant tions, the credential service provider or to 38 U.S.C. 8153 and, in the perform- certification authority must issue two ance of his duties, prescribes controlled pieces of information used to generate substances, confirm that the individual or activate the authentication creden- practitioner meets the criteria for eli- tial using two channels. gibility for appointment under 38 U.S.C. 7401–7408 and is prescribing con- § 1311.110 Requirements for obtaining an authentication credential—Indi- trolled substances under the registra- vidual practitioners eligible to use tion of such facility. an electronic prescription applica- (b) An institutional practitioner that tion of an institutional practitioner. elects to conduct identity proofing (a) For any registrant or person ex- must provide authorization to issue the empted from the requirement of reg- authentication credentials to a sepa- istration under § 1301.22(c) of this chap- rate entity within the institutional ter who is eligible to use the institu- practitioner or to an outside credential tional practitioner’s electronic pre- Service provider or certification au- scription application to sign prescrip- thority that meets the requirements of tions for controlled substances, the en- § 1311.105(a). tity within a DEA-registered institu- (c) When an institutional practi- tional practitioner that grants that in- tioner is conducting identity proofing dividual practitioner privileges at the and submitting information to a cre- institutional practitioner (e.g., a hos- dential service provider or certification pital credentialing office) may conduct authority to authorize the issuance of identity proofing and authorize the authentication credentials, the institu- issuance of the authentication creden- tional practitioner must meet any re- tial. That entity must do the following: quirements that the credential service (1) Ensure that photographic identi- provider or certification authority im- fication issued by the Federal Govern- poses on entities that serve as trusted ment or a State government matches agents. the person presenting the identifica- (d) An institutional practitioner that tion. elects to conduct identity proofing and (2) Ensure that the individual practi- authorize the issuance of the authen- tioner’s State authorization to practice tication credential as provided in para- and, where applicable, State authoriza- graphs (a) through (c) of this section tion to prescribe controlled substances, must do so in a manner consistent with is current and in good standing. the institutional practitioner’s general

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obligation to maintain effective con- rate. Testing to demonstrate perform- trols against diversion. Failure to meet ance must be conducted by the Na- this obligation may result in remedial tional Institute of Standards and Tech- action consistent with § 1301.36 of this nology or another DEA-approved gov- chapter. ernment or nongovernment laboratory. (e) An institutional practitioner that Such testing must comply with the re- elects to conduct identity proofing quirements of paragraph (h) of this sec- must retain a record of the identity- tion. proofing. An institutional practitioner (d) The biometric subsystem must that elects to issue the two-factor au- conform to Personal Identity thentication credential must retain a Verification authentication biometric record of the issuance of the credential. acquisition specifications, pursuant to NIST SP 800–76–1 as incorporated by § 1311.115 Additional requirements for reference in § 1311.08, if they exist for two-factor authentication. the biometric modality of choice. (a) To sign a controlled substance (e) The biometric subsystem must ei- prescription, the electronic prescrip- ther be co-located with a computer or tion application must require the prac- PDA that the practitioner uses to issue titioner to authenticate to the applica- electronic prescriptions for controlled tion using an authentication protocol substances, where the computer or that uses two of the following three PDA is located in a known, controlled factors: location, or be built directly into the (1) Something only the practitioner practitioner’s computer or PDA that knows, such as a password or response he uses to issue electronic prescrip- to a challenge question. tions for controlled substances. (2) Something the practitioner is, bi- (f) The biometric subsystem must ometric data such as a fingerprint or store device ID data at enrollment (i.e., iris scan. biometric registration) with the bio- (3) Something the practitioner has, a metric data and verify the device ID at device (hard token) separate from the the time of authentication to the elec- computer to which the practitioner is tronic prescription application. gaining access. (g) The biometric subsystem must (b) If one factor is a hard token, it protect the biometric data (raw data or must be separate from the computer to templates), match results, and/or non- which it is gaining access and must match results when authentication is meet at least the criteria of FIPS 140– not local. If sent over an open network, 2 Security Level 1, as incorporated by biometric data (raw data or templates), reference in § 1311.08, for cryptographic match results, and/or non-match re- modules or one-time-password devices. sults must be: (c) If one factor is a biometric, the (1) Cryptographically source authen- biometric subsystem must comply with ticated; the requirements of § 1311.116. (2) Combined with a random challenge, a nonce, or a time stamp to pre- § 1311.116 Additional requirements for vent replay; biometrics. (3) Cryptographically protected for (a) If one of the factors used to au- integrity and confidentiality; and thenticate to the electronic prescrip- (4) Sent only to authorized systems. tion application is a biometric as de- (h) Testing of the biometric subscribed in § 1311.115, it must comply system must have the following char- with the following requirements. acteristics: (b) The biometric subsystem must (1) The test is conducted by a labora- operate at a false match rate of 0.001 or tory that does not have an interest in lower. the outcome (positive or negative) of (c) The biometric subsystem must performance of a submission or biomet- use matching software that has dem- ric. onstrated performance at the operating (2) Test data are sequestered. point corresponding with the false (3) Algorithms are provided to the match rate described in paragraph (b) testing laboratory (as opposed to of this section, or a lower false match scores or other information).

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(4) The operating point(s) cor- tional practitioners, a practitioner au- responding with the false match rate thorized to sign controlled substance described in paragraph (b) of this sec- prescriptions must approve logical action, or a lower false match rate, is cess control entries. tested so that there is at least 95% con- (5) The electronic prescription appli- fidence that the false match and non- cation must accept two-factor authen- match rates are equal to or less than tication that meets the requirements the observed value. of § 1311.115 and require its use for sign- (5) Results of the testing are made ing controlled substance prescriptions publicly available. and for approving data that set or change logical access controls related § 1311.120 Electronic prescription ap- to reviewing and signing controlled plication requirements. substance prescriptions. (a) A practitioner may only use an (6) The electronic prescription appli- electronic prescription application cation must be capable of recording all that meets the requirements in para- of the applicable information required graph (b) of this section to issue elec- in part 1306 of this chapter for the con- tronic controlled substance prescrip- trolled substance prescription. tions. (7) If a practitioner has more than (b) The electronic prescription appli- one DEA registration number, the elec- cation must meet the requirements of tronic prescription application must this subpart including the following: require the practitioner or his agent to (1) The electronic prescription appli- select the DEA registration number to cation must do the following: be included on the prescription. (i) Link each registrant, by name, to (8) The electronic prescription appli- at least one DEA registration number. cation must have a time application (ii) Link each practitioner exempt that is within five minutes of the offi- from registration under § 1301.22(c) of cial National Institute of Standards this chapter to the institutional practi- and Technology time source. tioner’s DEA registration number and (9) The electronic prescription appli- the specific internal code number re- cation must present for the practi- quired under § 1301.22(c)(5) of this chap- tioner’s review and approval all of the ter. following data for each controlled sub- (2) The electronic prescription appli- stance prescription: cation must be capable of the setting of (i) The date of issuance. logical access controls to limit permis- (ii) The full name of the patient. sions for the following functions: (iii) The drug name. (i) Indication that a prescription is (iv) The dosage strength and form, ready for signing and signing con- quantity prescribed, and directions for trolled substance prescriptions. use. (ii) Creating, updating, and executing (v) The number of refills authorized, the logical access controls for the func- if applicable, for prescriptions for tions specified in paragraph (b)(2)(i) of Schedule III, IV, and V controlled sub- this section. stances. (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

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application must not permit alteration digitally sign at least the information of the DEA elements after the practi- required by part 1306 of this chapter tioner has indicated that a controlled and electronically archive the digitally substance prescription is ready to be signed record. If the practitioner signs signed without requiring another re- the prescription with his own private view and indication of readiness for key, as provided in § 1311.145, the elec- signing. Any controlled substance pre- tronic prescription application must scription not indicated as ready to be electronically archive a copy of the signed shall not be signed or trans- digitally signed record, but need not mitted. apply the application’s digital signa- (11) While the information required ture to the record. by paragraph (b)(9) of this section and (16) The digital signature the statement required by functionality must meet the following § 1311.140(a)(3) remain displayed, the requirements: electronic prescription application (i) The cryptographic module used to must prompt the prescribing practi- digitally sign the data elements re- tioner to authenticate to the applica- quired by part 1306 of this chapter must tion, using two-factor authentication, be at least FIPS 140–2 Security Level 1 as specified in § 1311.140(a)(4), which validated. FIPS 140–2 is incorporated will constitute the signing of the pre- by reference in § 1311.08. scription by the practitioner for pur- (ii) The digital signature application poses of § 1306.05(a) and (e) of this chap- and hash function must comply with ter. FIPS 186–3 and FIPS 180–3, as incor- (12) The electronic prescription appli- porated by reference in § 1311.08. cation must not permit a practitioner (iii) The electronic prescription ap- other than the prescribing practitioner plication’s private key must be stored whose DEA number (or institutional encrypted on a FIPS 140–2 Security 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

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part 1306 of this chapter after the pre- (26) The electronic prescription appli- scription is digitally signed must can- cation must protect the stored audit cel the prescription. records from unauthorized deletion. (20) The electronic prescription appli- The electronic prescription application cation must not allow transmission of shall prevent modifications to the a prescription that has been printed. audit records. (21) The electronic prescription appli- (27) The electronic prescription application must allow printing of a pre- cation must do the following: scription after transmission only if the (i) Generate a log of all controlled printed prescription is clearly labeled substance prescriptions issued by a as a copy not for dispensing. The elec- practitioner during the previous cal- tronic prescription application may endar month and provide the log to the allow printing of prescription informa- practitioner no later than seven cal- tion if clearly labeled as being for in- endar days after that month. formational purposes. The electronic (ii) Be capable of generating a log of prescription application may transfer all controlled substance prescriptions such prescription information to med- issued by a practitioner for a period ical records. specified by the practitioner upon re- (22) If the transmission of an elec- quest. Prescription information avail- tronic prescription fails, the electronic able from which to generate the log prescription application may print the must span at least the previous two prescription. The prescription must in- years. dicate that it was originally trans- (iii) Archive all logs generated. mitted electronically to, and provide (iv) Ensure that all logs are easily the name of, a specific pharmacy, the readable or easily rendered into a for- date and time of transmission, and mat that a person can read. that the electronic transmission failed. (v) Ensure that all logs are sortable (23) The electronic prescription appli- by patient name, drug name, and date cation must maintain an audit trail of of issuance of the prescription. all actions related to the following: (28) Where the electronic prescription (i) The creation, alteration, indica- application is required by this part to tion of readiness for signing, signing, archive or otherwise maintain records, transmission, or deletion of a con- it must retain such records electroni- trolled substance prescription. cally for two years from the date of the (ii) Any setting or changing of logical record’s creation and comply with all access control permissions related to other requirements of § 1311.305. the issuance of controlled substance prescriptions. § 1311.125 Requirements for estab- (iii) Notification of a failed trans- lishing logical access control—Indi- mission. vidual practitioner. (iv) Auditable events as specified in (a) At each registered location where § 1311.150. one or more individual practitioners (24) The electronic prescription appli- wish to use an electronic prescription cation must record within each audit application meeting the requirements record the following information: of this subpart to issue controlled sub- (i) The date and time of the event. stance prescriptions, the registrant(s) (ii) The type of event. must designate at least two individuals (iii) The identity of the person taking to manage access control to the appli- the action, where applicable. cation. At least one of the designated (iv) The outcome of the event (suc- individuals must be a registrant who is cess or failure). authorized to issue controlled sub- (25) The electronic prescription appli- stance prescriptions and who has ob- cation must conduct internal audits tained a two-factor authentication cre- and generate reports on any of the dential as provided in § 1311.105. events specified in § 1311.150 in a format (b) At least one of the individuals that is readable by the practitioner. designated under paragraph (a) of this Such internal audits may be auto- section must verify that the DEA reg- mated and need not require human istration and State authorization(s) to intervention to be conducted. practice and, where applicable, State

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authorization(s) to dispense controlled (b) After the list is approved, it must substances of each registrant being be sent to a separate entity within the granted permission to sign electronic institutional practitioner that enters prescriptions for controlled substances permissions for logical access controls are current and in good standing. into the application. The institutional (c) After one individual designated practitioner must authorize at least under paragraph (a) of this section en- two individuals or a role filled by at ters data that grants permission for in- least two individuals to enter the log- dividual practitioners to have access to ical access control data. One individual the prescription functions that indi- in the separate entity must authen- cate readiness for signature and sign- ticate to the application and enter the ing or revokes such authorization, a data to grant permissions to individual second individual designated under practitioners to indicate that con- paragraph (a) of this section must use trolled substances prescriptions are his two-factor authentication creden- ready to be signed and to sign con- tial to satisfy the logical access controlled substance prescriptions. A sec- trols. The second individual must be a ond individual must authenticate to DEA registrant. the application to execute the logical (d) A registrant’s permission to indi- access controls. cate that controlled substances pre- (c) The institutional practitioner scriptions are ready to be signed and to must retain a record of the individuals sign controlled substance prescriptions or roles that are authorized to conduct must be revoked whenever any of the identity proofing and logical access following occurs, on the date the occur- control data entry and execution. rence is discovered: (d) Permission to indicate that controlled substances prescriptions are (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 prac- less the registration has been renewed. tice). (3) The institutional practitioner’s or, where applicable, individual practi- § 1311.130 Requirements for estab- tioner’s DEA registration is termi- lishing logical access control—Insti- nated, revoked, or suspended. tutional practitioner. (4) An individual practitioner is no (a) The entity within an institutional longer authorized to use the institu- practitioner that conducts the identity tional practitioner’s electronic pre- proofing under § 1311.110 must develop a scription application (e.g., when the in- list of individual practitioners who are dividual practitioner is no longer asso- permitted to use the institutional prac- ciated with the institutional practi- titioner’s electronic prescription appli- tioner.) cation to indicate that controlled substances prescriptions are ready to be § 1311.135 Requirements for creating a signed and to sign controlled substance controlled substance prescription. prescriptions. The list must be ap- (a) The electronic prescription appli- proved by two individuals. cation may allow the registrant or his

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agent to enter data for a controlled tion by the practitioner for purposes of substance prescription, provided that § 1306.05(a) and (e) of this chapter. only the registrant may sign the pre- (6) Except as provided under scription in accordance with § 1311.145, the practitioner’s completion §§ 1311.120(b)(11) and 1311.140. of the two-factor authentication pro- (b) If a practitioner holds multiple tocol must cause the application to DEA registrations, the practitioner or digitally sign and electronically ar- his agent must select the appropriate chive the information required under registration number for the prescrip- part 1306 of this chapter. tion being issued in accordance with (b) The electronic prescription appli- the requirements of § 1301.12 of this cation must clearly label as the signing chapter. function the function that prompts the (c) If required by State law, a super- practitioner to execute the two-factor visor’s name and DEA number may be authentication protocol using his cre- listed on a prescription, provided the dential. prescription clearly indicates who is (c) Any prescription not signed in the the supervisor and who is the pre- manner required by this section shall scribing practitioner. not be transmitted.

§ 1311.140 Requirements for signing a § 1311.145 Digitally signing the pre- controlled substance prescription. scription with the individual practitioner’s private key. (a) For a practitioner to sign an elec- (a) An individual practitioner who tronic prescription for a controlled has obtained a digital certificate as substance the following must occur: provided in § 1311.105 may digitally sign (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

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prescription with the private key asso- vider and the Administration within ciated with his own digital certificate one business day. obtained as provided under § 1311.105, the electronic prescription application § 1311.170 Transmission requirements. is not required to digitally sign the (a) The electronic prescription appli- prescription using the application’s cation must transmit the electronic private key. prescription as soon as possible after signature by the practitioner. § 1311.150 Additional requirements for (b) The electronic prescription appli- internal application audits. cation may print a prescription that (a) The application provider must es- has been transmitted only if an inter- tablish and implement a list of mediary or the designated pharmacy auditable events. Auditable events notifies a practitioner that an elec- must, at a minimum, include the fol- tronic prescription was not success- lowing: fully delivered to the designated phar- (1) Attempted unauthorized access to macy. If this occurs, the electronic pre- the electronic prescription application, scription application may print the or successful unauthorized access prescription for the practitioner’s man- where the determination of such is fea- ual signature. The printed prescription sible. must include information noting that (2) Attempted unauthorized modifica- the prescription was originally trans- tion or destruction of any information mitted electronically to [name of the or records required by this part, or suc- specific pharmacy] on [date/time] and cessful unauthorized modification or that transmission failed. destruction of any information or (c) The electronic prescription appli- records required by this part where the cation may print copies of the trans- determination of such is feasible. mitted prescription if they are clearly 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

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the pharmacy in its electronic form. At enter information regarding the dis- no time may an intermediary convert pensing of controlled substance pre- an electronic prescription to another scriptions and annotate or alter form (e.g., facsimile) for transmission. records of these prescriptions (to the extent such alterations are permitted § 1311.200 Pharmacy responsibilities. under this chapter). The pharmacy (a) Before initially using a pharmacy must ensure that logical access con- application to process controlled sub- trols in the pharmacy application are stance prescriptions, the pharmacy set so that only such employees are must determine that the third-party granted access to perform these func- auditor or certification organization tions. has found that the pharmacy applica- (f) When a pharmacist fills a pre- tion does the following accurately and scription in a manner that would re- consistently: quire, under part 1306 of this chapter, (1) Import, store, and display the in- the pharmacist to make a notation on formation required for prescriptions the prescription if the prescription under § 1306.05(a) of this chapter. were a paper prescription, the phar- (2) Import, store, and display the in- macist must make the same notation dication of signing as required by electronically when filling an elec- § 1311.120(b)(17). tronic prescription and retain the an- (3) Import, store, and display the notation electronically in the prescrip- number of refills as required by § 1306.22 tion record or in linked files. When a of this chapter. prescription is received electronically, (4) Import, store, and verify the prac- the prescription and all required anno- titioner’s digital signature, as provided tations must be retained electroni- in § 1311.210(c), where applicable. cally. (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 it was originally trans- cates that the application or the appli- mitted electronically to another phar- cation provider no longer meets the re- macy, the pharmacist must check with quirements of this part or notifies it that pharmacy to determine whether that the application provider has iden- the prescription was received and dis- tified an issue that makes the applica- pensed. If the pharmacy that received tion non-compliant, the pharmacy the original electronic prescription had must immediately cease to process not dispensed the prescription, that controlled substance prescriptions pharmacy must mark the electronic using the application. version as void or canceled. If the phar- (d) A pharmacy that receives a notifi- macy that received the original elec- cation that the pharmacy application tronic prescription dispensed the pre- is not in compliance with the require- scription, the pharmacy with the paper ments of this part must not use the ap- version must not dispense the paper plication to process controlled sub- prescription and must mark the pre- stance prescriptions until it is notified scription as void. that the application is again compliant (i) Nothing in this part relieves a and all relevant updates to the applica- pharmacy and pharmacist of the re- tion have been installed. sponsibility to dispense controlled sub- (e) The pharmacy must determine stances only pursuant to a prescription which employees are authorized to issued for a legitimate medical purpose

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by a practitioner acting in the usual stitute of Standards and Technology course of professional practice. time source. (5) The pharmacy application must § 1311.205 Pharmacy application re- verify a practitioner’s digital signature quirements. (if the pharmacy application accepts (a) The pharmacy may only use a prescriptions that were digitally signed pharmacy application that meets the with an individual practitioner’s pri- requirements in paragraph (b) of this vate key and transmitted with the dig- section to process electronic controlled ital signature). substance prescriptions. (6) If the prescription received by the (b) The pharmacy application must pharmacy application has not been meet the following requirements: digitally signed by the practitioner and (1) The pharmacy application must transmitted with the digital signature, be capable of setting logical access the pharmacy application must either: controls to limit access for the fol- (i) Verify that the practitioner signed lowing functions: the prescription by checking the data (i) Annotation, alteration, or dele- field that indicates the prescription tion of prescription information. was signed; or (ii) Setting and changing the logical (ii) Display the field for the phar- access controls. macist’s verification. (2) Logical access controls must be (7) The pharmacy application must set by individual user name or role. read and retain the full DEA number (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 FIPS 186–3 and FIPS 180–3, as incor- (10) The pharmacy application must porated by reference in § 1311.08. provide for the following information (iii) The pharmacy application’s pri- to be added or linked to each electronic vate key must be stored encrypted on a controlled substance prescription FIPS 140–2 Security Level 1 or higher record for each dispensing: validated cryptographic module using (i) Number of units or volume of drug a FIPS-approved encryption algorithm. dispensed. FIPS 140–2 is incorporated by reference (ii) Date dispensed. in § 1311.08. (iii) Name or initials of the person (iv) For software implementations, who dispensed the prescription. when the signing module is deacti- (11) The pharmacy application must vated, the pharmacy application must be capable of retrieving controlled sub- clear the plain text password from the stance prescriptions by practitioner application memory to prevent the un- name, patient name, drug name, and authorized access to, or use of, the pri- date dispensed. vate key. (12) The pharmacy application must (v) The pharmacy application must allow downloading of prescription data have a time application that is within into a database or spreadsheet that is five minutes of the official National In- readable and sortable.

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(13) The pharmacy application must tion must digitally sign the prescrip- maintain an audit trail of all actions tion immediately on receipt. related to the following: (b) If the last intermediary digitally (i) The receipt, annotation, alter- signs the record, it must forward the ation, or deletion of a controlled sub- digitally signed copy to the pharmacy. stance prescription. (c) If a pharmacy receives a digitally (ii) Any setting or changing of logical signed prescription that includes the access control permissions related to individual practitioner’s digital signa- the dispensing of controlled substance ture, the pharmacy application must prescriptions. do the following: (iii) Auditable events as specified in (1) Verify the digital signature as § 1311.215. provided in FIPS 186–3, as incorporated (14) The pharmacy application must by reference in § 1311.08. record within each audit record the fol- (2) Check the validity of the certifi- lowing information: cate holder’s digital certificate by (i) The date and time of the event. checking the certificate revocation (ii) The type of event. list. The pharmacy may cache the CRL (iii) The identity of the person taking until it expires. (3) Archive the digitally signed the action, where applicable. record. The pharmacy record must re- (iv) The outcome of the event (suc- tain an indication that the prescription cess or failure). was verified upon receipt. No addi- (15) The pharmacy application must tional digital signature is required. conduct internal audits and generate 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 (2) The first pharmacy application employee of the application service that receives the electronic prescrip- provider.

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(b) The pharmacy application must the audit requirements of paragraphs analyze the audit trail at least once (b) through (d) of this section, provided every calendar day and generate an in- that the certification that determines cident report that identifies each that the application meets the require- auditable event. ments of this part occurs at each of the (c) The pharmacy must determine following times: whether any identified auditable event (1) Before the application may be represents a security incident that used to create, sign, transmit, or proc- compromised or could have com- ess controlled substance prescriptions. promised the integrity of the prescrip- (2) Whenever a functionality related tion records. Any such incidents must to controlled substance prescription re- be reported to the pharmacy applica- quirements is altered or every two tion service provider, if applicable, and years, whichever occurs first. the Administration within one business (f) The application provider must day. make the audit or certification report available to any practitioner or phar- § 1311.300 Application provider requirements—Third-party audits or macy that uses the application or is certifications. considering use of the application. The electronic prescription or pharmacy (a) Except as provided in paragraph application provider must retain the (e) of this section, the application pro- most recent audit or certification re- vider of an electronic prescription ap- sults and retain the results of any plication or a pharmacy application must have a third-party audit of the other audits or certifications of the ap- 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 con- (2) A Certified Information System trolled substance prescriptions. The ap- Auditor who performs compliance au- plication provider must also notify the dits as a regular ongoing business ac- Administration of the adverse audit or tivity. certification report and provide the re- (c) An audit for installed applications port to the Administration within one must address processing integrity and business day of issuance. determine that the application meets (h) For electronic prescription appli- the requirements of this part. cations, the third-party auditor or cer- (d) An audit for application service tification organization must make the providers must address processing in- following determinations: tegrity and physical security and de- (1) If the information required in termine that the application meets the § 1306.05(a) of this chapter, the indica- requirements of this part. tion that the prescription was signed (e) If a certifying organization whose as required by § 1311.120(b)(17) or the certification process has been approved digital signature created by the practi- by DEA verifies and certifies that an tioner’s private key, if transmitted, electronic prescription or pharmacy and the number of refills as required by application meets the requirements of § 1306.22 of this chapter, cannot be con- this part, certification by that organi- sistently and accurately recorded, zation may be used as an alternative to stored, and transmitted, the third-

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party auditor or certification organiza- soon as feasible, but no later than five tion must indicate that the application business days after discovery, that the does not meet the requirements of this application should not be used to issue part. or process electronic controlled sub- (2) If other information required stance prescriptions. under this chapter cannot be consist- (b) When providing practitioners or ently and accurately recorded, stored, pharmacies with updates to any issue and transmitted, the third-party audi- that makes the application non-com- tor or certification organization must pliant with the requirements of this indicate that the application has failed part, the application provider must in- to meet the requirements for the spe- dicate that the updates must be in- cific information and should not be stalled before the practitioner or phar- used to create, sign, and transmit pre- macy may use the application to issue scriptions that require the additional or process electronic controlled sub- information. stance prescriptions. (i) For pharmacy applications, the third-party auditor or certification or- § 1311.305 Recordkeeping. ganization must make the following (a) If a prescription is created, determinations: signed, transmitted, and received elec- (1) If the information required in tronically, all records related to that § 1306.05(a) of this chapter, the indica- prescription must be retained election that the prescription was signed tronically. as required by § 1311.205(b)(6), and the (b) Records required by this subpart number of refills as required by § 1306.22 must be maintained electronically for 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.

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(g) If a registrant transfers its elec- 1312.45 Burden of proof. tronic prescription files to another reg- 1312.46 Time and place of hearing. istrant, both registrants must ensure 1312.47 Final order. that the records are migrated to the AUTHORITY: 21 U.S.C. 952, 953, 954, 957, 958. new application or are stored in a format that can be retrieved, displayed, SOURCE: 36 FR 7815, Apr. 24, 1971, unless otherwise noted. Redesignated at 38 FR 26609, and printed in a readable format. Sept. 24, 1973. (h) Digitally signed prescription records must be transferred or mi- § 1312.01 Scope of part 1312. grated with the digital signature. Procedures governing the importation, exportation, transshipment and PART 1312—IMPORTATION AND intransit shipment of controlled sub- EXPORTATION OF CONTROLLED stances pursuant to section 1002, 1003, SUBSTANCES and 1004 of the Act (21 U.S.C. 952, 953, and 954) are governed generally by Sec. those sections and specifically by the 1312.01 Scope of part 1312. sections of this part. 1312.02 Definitions.

IMPORTATION OF CONTROLLED SUBSTANCES § 1312.02 Definitions. 1312.11 Requirement of authorization to im- Any term contained in this part shall port. have the definition set forth in section 1312.12 Application for import permit. 102 of the Act (21 U.S.C. 802) or part 1312.13 Issuance of import permit. 1300 of this chapter. 1312.14 Distribution of copies of import permit. [62 FR 13969, Mar. 24, 1997] 1312.15 Shipments in greater or less amount than authorized. IMPORTATION OF CONTROLLED 1312.16 Cancellation of permit; expiration SUBSTANCES date. 1312.17 Special report from importers. § 1312.11 Requirement of authoriza- 1312.18 Contents of import declaration. tion to import. 1312.19 Distribution of import declaration. (a) No person shall import or cause to EXPORTATION OF CONTROLLED SUBSTANCES be imported any controlled substance 1312.21 Requirement of authorization to ex- listed in Schedule I or II or any nar- port. cotic controlled substance listed in 1312.22 Application for export permit. Schedule III, IV or V or any non-nar- 1312.23 Issuance of export permit. cotic controlled substance in Schedule 1312.24 Distribution of copies of export per- III which the Administrator has spe- mit. 1312.25 Expiration date. cifically designated by regulation in 1312.26 Records required of exporter. § 1312.30 of this part or any non-nar- 1312.27 Contents of special controlled sub- cotic controlled substance in Schedule stances invoice. IV or V which is also listed in Schedule 1312.28 Distribution of special controlled I or II of the Convention on Psycho- substances invoice. tropic Substances unless and until such 1312.29 Domestic release prohibited. person is properly registered under the 1312.30 Schedule III, IV, and V non-narcotic controlled substances requiring an im- Act (or exempt from registration) and port and export permit. the Administrator has issued him a permit to do so pursuant to § 1312.13 of TRANSSHIPMENT AND IN-TRANSIT SHIPMENT OF this part. CONTROLLED SUBSTANCES (b) No person shall import or cause to 1312.31 Schedule I: Application for prior be imported any non-narcotic con- written approval. trolled substance listed in Schedule III, 1312.32 Schedules II, III, IV: Advance notice. IV or V, excluding those described in HEARINGS paragraph (a) of this section, unless and until such person is properly reg- 1312.41 Hearings generally. 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.

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(c) When an import permit or dec- should be stated whether shipment will laration is required, a separate permit be made by express, freight, or other- or declaration must be obtained for wise, imports of controlled substances each consignment of controlled sub- in Schedules I or II and narcotic drugs stances to be imported. in Schedules III, IV, or V by mail being [36 FR 7815, Apr. 24, 1971, as amended at 37 prohibited); FR 15923, Aug. 8, 1972. Redesignated at 38 FR (7) The total tentative allotment to 26609, Sept. 24, 1973, and amended at 52 FR the importer of such controlled sub- 17289, May 7, 1987] stance for the current calendar year; (8) The total number of kilograms of § 1312.12 Application for import permit. said allotment for which permits have previously been issued and the total (a) An application for a permit to im- quantity of controlled substance actu- port controlled substances shall be ally imported during the current year made on DEA Form 357. DEA Form 357 to date. may be obtained from, and shall be filed with, the Import/Export Unit, (b) If desired, alternative foreign Drug Enforcement Administration. See ports of exportation within the same the Table of DEA Mailing Addresses in country may be indicated upon the ap- § 1321.01 of this chapter for the current plication (e.g., (1) Calcutta, (2) Bom- mailing address. Each application shall bay). If a formal permit is issued pursu- show the date of execution; the reg- ant to such application, it will bear the istration number of the importer; a de- names of the two ports in the order tailed description of each controlled given in the application and will au- substance to be imported including the thorize shipment from either port. Al- drug name, dosage form, National Drug ternate ports in different countries will Code (NDC) number, the Administra- not be authorized in the same permit. 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 ages or containers, the name and quan- 43218, Dec. 11, 1974; 45 FR 74715, Nov. 12, 1980; tity of the controlled substance con- 51 FR 5319, 5320, Feb. 13, 1986; 52 FR 17289, tained in any finished dosage units, May 7, 1987; 62 FR 13969, Mar. 24, 1997; 75 FR and the net quantity of any controlled 10681, Mar. 9, 2010] substance (expressed in anhydrous acid, base or alkaloid) given in kilo- § 1312.13 Issuance of import permit. grams 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- trator as soon as ascertained by the poppy straw, or coca leaves, in such importer; quantity as the Administrator finds (2) The foreign port of exportation necessary to provide for medical, sci- (i.e., the place where the article will entific, or other legitimate purposes; begin its journey of exportation to the (2) That the substance is necessary to United States); provide for medical and scientific needs (3) The port of entry into the United or other legitimate needs of the United States; States during an emergency where do- (4) The latest date said shipment will mestic supplies of such substance or leave said foreign port; drug are found to be inadequate, or in (5) The stock on hand of the con- any case in which the Administrator trolled substance desired to be im- finds that competition among domestic ported; manufacturers of the controlled sub- (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

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of additional manufacturers under sec- ation by the Administrator in granting tion 303 of the Controlled Substances or denying the application. Act (21 U.S.C. 823); or (e) Each import permit shall be (3) That the domestic supply of any issued in sextuplet and serially num- controlled substance is inadequate for bered, with all six copies bearing the scientific studies, and that the impor- same serial number and being des- tation of that substance for scientific ignated ‘‘original’’ (Copy 1), ‘‘dupli- purposes is only for delivery to offi- cate’’ (Copy 2), etc., respectively. All cials of the United Nations, of the copies of import permits shall bear the United States, or of any State, or to signature of the Director or his dele- any person registered or exempted gate, and facsimiles of signatures shall from registration under sections 1007 not be used. No permit shall be altered and 1008 of the Act (21 U.S.C. 957 and or changed by any person after being 958). signed by the Administrator or his del- (4) That the importation of the con- egate and any change or alteration trolled substance is for ballistics or upon the face of any permit after it other analytical or scientific purposes, shall have been signed by the Adminis- and that the importation of that sub- trator or his delegate shall render it stance is only for delivery to officials void and of no effect. Permits are not of the United Nations, of the United transferable. Each copy of the permit States, or of any State, or to any per- shall have printed or stamped thereon son registered or exempted from reg- the disposition to be made thereof. istration under sections 1007 and 1008 of Each permit shall be dated and shall the Act (21 U.S.C. 957 and 958). certify that the importer named therein 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 appli- (7) Australia. cation should be granted. The failure of (g) At least eighty (80) percent of the the applicant to provide such docu- narcotic raw material imported into ments or statements within a reason- the United States shall have as its able time after being requested to do so original source Turkey and India. Ex- shall be deemed to be a waiver by the cept under conditions of insufficient applicant of an opportunity to present supplies of narcotic raw materials, not such documents or facts for consider- more than twenty (20) percent of the

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narcotic raw material imported into number when compared by the District the United States annually shall have Director, he shall refuse to permit as its source Spain, France, Poland, entry of the merchandise until the Hungary and Australia. facts are communicated to the Admin- istration and further instructions are [36 FR 23624, Dec. 11, 1971, as amended at 37 FR 15923, Aug. 8, 1972. Redesignated at 38 FR received. 26609, Sept. 24, 1973, and amended at 46 FR (d) The triplicate copy (Copy 3) and 41776, Aug. 18, 1981; 52 FR 17289, May 7, 1987; sextuplet copy (Copy 6) shall be re- 73 FR 6851, Feb. 6, 2008] tained by the Administration.

§ 1312.14 Distribution of copies of im- [36 FR 7815, Apr. 24, 1971, as amended at 36 port permit. FR 13387, July 21, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973, and further amended at Copies of the import permit shall be 45 FR 74715, Nov. 12, 1980; 51 FR 5319, Feb. 13, distributed and serve purposes as fol- 1986; 53 FR 48244, Nov. 30, 1988; 62 FR 13969, lows: Mar. 24, 1997] (a) The original and quintuplet copies (Copy 1 and Copy 5) shall be trans- § 1312.15 Shipments in greater or less mitted by the Administration to the amount than authorized. importer, who shall retain the quin- (a) If the shipment made under an tuplet copy (Copy 5) on file as his import permit is greater than the max- 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

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Administration decides to make an ex- said importer under part 1304 of this ception for good cause shown. chapter. [36 FR 7815, Apr. 24, 1971. Redesignated at 38 [36 FR 7815, Apr. 24, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973, and amended at 46 FR 26609, Sept. 24, 1973, as amended at 62 FR FR 28841, May 29, 1981] 13969, Mar. 24, 1997]

§ 1312.16 Cancellation of permit; expi- § 1312.18 Contents of import declara- ration date. tion. (a) Any non-narcotic controlled sub- (a) A permit may be canceled after stance listed in Schedule III, IV, or V, being issued, at the request of the im- not subject to the requirement of an porter, provided no shipment has been import permit pursuant to § 1312.13 (b) made thereunder. In the event that a or (c) of this chapter, may be imported permit is lost, the Administrator may, if that substance is needed for medical, upon the production by the importer of scientific or other legitimate uses in satisfactory proof, by affidavit or oth- the United States, and will be imported erwise, issue a duplicate permit. Noth- pursuant to a controlled substances ing in this part shall affect the right, import declaration. hereby reserved by the Administrator, (b) Any person registered or author- to cancel a permit at any time for ized to import and desiring to import proper cause. any non-narcotic controlled substance (b) An import permit shall not be in Schedules III, IV, or V which is not valid after the date specified therein, subject to the requirement of an im- and in no event shall the date be subse- port permit as described in paragraph quent to 6 months after the date the (a) of this section, must furnish a con- permit is issued. Any unused import trolled substances import declaration permit shall be returned for cancella- on DEA Form 236 to the Import/Export tion by the registrant to the Import/ Unit, Drug Enforcement Administra- 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, following information: Mar. 24, 1997; 75 FR 10682, Mar. 9, 2010] (1) The name, address, and registration number of the importer; and the § 1312.17 Special report from import- name and address and registration ers. number of the import broker, if any; Whenever requested by the Adminis- and trator, importers shall render to him (2) A complete description of the con- not later than 30 days after receipt of trolled substances to be imported, in- the request therefor a statement under cluding drug name, dosage form, Na- oath of the stocks of controlled sub- tional Drug Code (NDC) number, the stances on hand as of the date specified Administration Controlled Substances Code Number as set forth in part 1308 by the Administrator in his request, of this chapter, the number and size of and, if desired by the Administrator, packages or containers, the name and an estimate of the probable require- quantity of the controlled substance ments for legitimate uses of the im- contained in any finished dosage units, porter for any subsequent period that and the net quantity of any controlled may be designated by the Adminis- substance (expressed in anhydrous trator. In lieu of any special statement acid, base, or alkaloid) given in kilo- that may be considered necessary, the grams or parts thereof; and Administrator may accept the figures (3) The proposed import date, the for- given upon the reports subsequent by eign port of exportation to the United

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States, the port of entry, and the (c) Copy 5 shall be retained by the name, address, and registration num- importer on file as his record of au- ber of the recipient in the United thority for the importation. States; and (4) The name and address of the con- [36 FR 7815, Apr. 24, 1971, as amended at 36 signor in the foreign country of expor- FR 13387, July 21, 1971; 37 FR 15923, Aug. 8, 1972. Redesignated at 38 FR 26609, Sept. 24, tation, and any registration or license 1973, and further amended at 45 FR 74715, numbers if the consignor is required to Nov. 12, 1980; 51 FR 5319, Feb. 13, 1986; 53 FR have such numbers either by the coun- 48244, Nov. 30, 1988; 62 FR 13969, Mar. 24, 1997; try of exportation or under U.S. law. 75 FR 10682, Mar. 9, 2010] (d) Notwithstanding the time limitations included in paragraph (b) of this EXPORTATION OF CONTROLLED section, an applicant may obtain a spe- SUBSTANCES cial waiver of these time limitations in emergency or unusual instances, pro- § 1312.21 Requirement of authoriza- vided that a specific confirmation is re- tion to export. ceived from the Administrator or his (a) No person shall in any manner ex- delegate advising the registrant to pro- port or cause to be exported from the ceed pursuant to the special waiver. United States any controlled substance [36 FR 7815, Apr. 24, 1971, as amended at 37 listed in Schedule I or II, or any nar- FR 15923, Aug. 8, 1972. Redesignated at 38 FR cotic substance listed in Schedule III 26609, Sept. 24, 1973, and amended at 45 FR or IV, or any non-narcotic substance in 74715, Nov. 12, 1980; 51 FR 5319, Feb. 13, 1986; Schedule III which the Administrator 52 FR 17290, May 7, 1987; 62 FR 13969, Mar. 24, 1997; 75 FR 10682, Mar. 9, 2010; 77 FR 4237, Jan. has specifically designated by regula- 27, 2012] tion in § 1312.30 of this part or any nonnarcotic substance in Schedule IV or V § 1312.19 Distribution of import dec- which is also listed in Schedule I or II laration. of the Convention on Psychotropic The required five copies of the con- Substances unless and until such per- trolled substances import declaration son is properly registered under the will be distributed as follows: Act (or exempted from registration) (a) Copy 1, Copy 2, and Copy 3 shall and the Administrator has issued a per- be transmitted to the foreign shipper. mit pursuant to § 1312.23 of this part. The foreign shipper will submit Copy 1 (b) No person shall in any manner ex- to the proper governmental authority port or cause to be exported from the in the foreign country, if required as a United States any non-narcotic con- prerequisite to export authorization. trolled substance listed in Schedule III, Copy 1 will then accompany the ship- IV, or V, excluding those described in ment to its destination, and shall be paragraph (a) of this section, or any retained on file by the importer. Copy narcotic controlled substance listed in 2 shall be detached and retained by the Schedule V, unless and until such per- appropriate customs official of the for- son is properly registered under the eign country. Copy 3 shall be removed by the District Director of the U.S. Act (or exempted from registration) Customs Service at the port of entry, and has furnished a special controlled who shall sign and date the certifi- substance export invoice as provided by cation of customs on Copy 3, noting section 1003 of the Act (21 U.S.C. 953(e)) any changes from the entries made by to the Administrator pursuant to the importer, and shall then forward § 1312.28 of this part. that copy to the Drug Operations Sec- (c) A separate authorization request tion of the Administration. is obtained for each consignment of (b) Copy 4 shall be forwarded, within such controlled substances to be ex- the time limit required in § 1312.18, di- ported. rectly to the Import/Export Unit, Drug Enforcement Administration. See the [36 FR 7815, Apr. 24, 1971, as amended at 37 FR 15923, Aug. 8, 1972. Redesignated at 38 FR Table of DEA Mailing Addresses in 26609, Sept. 24, 1973, and amended at 52 FR § 1321.01 of this chapter for the current 17290, May 7, 1987; 77 FR 4237, Jan. 27, 2012] mailing address.

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§ 1312.22 Application for export per- medical or scientific uses within such mit. country, unless the application is sub- (a) An application for a permit to ex- mitted for reexport in accordance with port controlled substances shall be paragraphs (c) and (d) of this section. made on DEA Form 161, and an applica- In the case of exportation of crude co- tion for a permit to reexport controlled caine, the affidavit may state that to substances shall be made on DEA Form the best of affiant’s knowledge and be- 161R. Forms may be obtained from, and lief, the controlled substances will be shall be filed with, the Import/Export processed within the country to which Unit, Drug Enforcement Administra- exported, either for medical or sci- tion. See the Table of DEA Mailing Ad- entific use within that country or for dresses in § 1321.01 of this chapter for reexportation in accordance with the the current mailing address. Each ap- laws of that country to another for plication shall show the exporter’s medical or scientific use within that name, address, and registration num- country. The application shall be ber; a detailed description of each consigned and dated by the exporter and trolled substance desired to be ex- shall contain the address from which ported including the drug name, dosage the substances will be shipped for ex- form, National Drug Code (NDC) num- portation. ber (in accordance with Food and Drug (b) There shall also be submitted Administration regulations), the Ad- with the application any import license ministration Controlled Substance or permit (and a translation thereof if Code Number as set forth in Part 1308 in a foreign language) or a certified of this chapter, the number and size of copy of any such license or permit packages or containers, the name and issued by competent authorities in the quantity of the controlled substance country of destination, or other docu- contained in any finished dosage units, mentary evidence deemed adequate by and the quantity of any controlled sub- the Administrator, showing that the stance (expressed in anhydrous acid, merchandise is consigned to an author- base, or alkaloid) given in kilograms or ized permittee, that it is to be applied parts thereof. The application shall in- exclusively to medical or scientific use clude the name, address, and business within the country of destination, that of the consignee, foreign port of entry, it will not be reexported from such the port of exportation, the approxi- country, and that there is an actual mate date of exportation, the name of need for the controlled substance for the exporting carrier or vessel (if medical or scientific use within such known, or if unknown it should be stat- country. (In the case of exportation of ed whether shipment will be made by bulk coca leaf alkaloid, the submitted express, freight, or otherwise, exports evidence need only show the material of controlled substances by mail being outlined in paragraph (a) of this sec- prohibited), the date and number, if tion 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

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

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(ii) That the controlled substances the current mailing address. The Ad- are to be applied exclusively to medical ministration will evaluate the request or scientific uses within the second after considering all the facts as well country; as the exporter’s registration status (iii) That the controlled substances with the Administration. If the ex- will not be further reexported from the porter provides sufficient documenta- second country, and tion, the Administration will issue an (iv) That there is an actual need for import permit for the return of these the controlled substances for medical drugs, and the exporter can then obtain or scientific uses within the second an export permit from the country of country. original importation. The substance (5) If the applicant proposes that the may be returned to the United States shipment of controlled substances will only after affirmative authorization is be separated into parts after it arrives issued in writing by the Administra- in the first country and then reex- tion. ported to more than one second country, the applicant shall so indicate on (e) In considering whether to grant the DEA Form 161R, providing all the an application for a permit under para- information required in this section for graphs (c) and (d) of this section, the each second country. Administration shall consider whether (6) Within 30 days after the con- the applicant has previously obtained trolled substance is exported from the such a permit and, if so, whether the United States, the person who exported applicant complied fully with the re- the controlled substance shall deliver quirements of this section with respect to the Administration documentation to that previous permit. on the DEA Form 161R initially com- [36 FR 7815, Apr. 24, 1971. Redesignated at 38 pleted for the transaction certifying FR 26609, Sept. 24, 1973, and amended at 52 that such export occurred. This docu- FR 17290, May 7, 1987; 62 FR 13969, Mar. 24, mentation shall be signed by a respon- 1997; 72 FR 72927, Dec. 26, 2007; 75 FR 10682, sible company official and shall include Mar. 9, 2010] all of the following information: (i) Actual quantity shipped; § 1312.23 Issuance of export permit. (ii) Actual date shipped; and (a) The Administrator may authorize (iii) DEA export permit number. exportation of any controlled sub- (7) The controlled substance will be stance listed in Schedule I or II or any reexported from the first country to narcotic controlled substance listed in the second country (or second coun- Schedule III or IV if he finds that such tries) no later than 180 days after the exportation is permitted by sub- controlled substance was exported from sections 1003(a), (b), (c), (d), or (f) of the the United States. Act (21 U.S.C. 953(a), (b), (c), (d), or (f). (8) Shipments that have been ex- (b) The Administrator may require ported from the United States and are refused by the consignee in either the that such non-narcotic controlled sub- first or second country, or are other- stances in Schedule III as shall be des- wise unacceptable or undeliverable, ignated by regulation in § 1312.30 of this may be returned to the registered ex- part be exported only pursuant to the porter in the United States upon au- issuance of an export permit. The Ad- thorization of the Administration. In ministrator may authorize the expor- these circumstances, the exporter in tation of such substances if he finds the United States shall file a written that such exportation is permitted by request for the return of the controlled section 1003(e) of the Act (21 U.S.C. substances to the United States with a 953(e)). brief summary of the facts that war- (c) If a non-narcotic substance listed rant the return, along with a com- in Schedule IV or V is also listed in pleted DEA Form 357, Application for Schedule I or II of the Convention on Import Permit, with the Import/Export Psychotropic Substances, it shall be Unit, Drug Enforcement Administra- exported only pursuant to the issuance tion. See the Table of DEA Mailing Ad- of an export permit. The Administrator dresses in § 1321.01 of this chapter for may authorize the exportation of such

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substances if he finds that such expor- (a) The original, duplicate, and trip- tation is permitted by section 1003(e) of licate copies (Copy 1, Copy 2, and Copy the Act (21 U.S.C. 953(e)). 3) shall be transmitted by the Adminis- (d) The Administrator may require tration to the exporter who will retain an applicant to submit such documents the triplicate copy (Copy 3) as his or written statements of fact relevant record of authority for the exportation. to the application as he deems nec- The exporter shall present to the Dis- essary to determine whether the appli- trict Director of the U.S. Customs cation should be granted. The failure of Service at the port of export and at the the applicant to provide such docu- time of shipment, the original and du- ments or statements within a reason- plicate copies (Copy 1 and Copy 2). able time after being requested to do so After endorsing the port of export on shall be deemed to be a waiver by the the reverse side of the original and du- applicant of an opportunity to present plicate copies (Copy 1 and Copy 2) the such documents or facts for consider- District Director shall forward the en- ation by the Administrator in granting dorsed original copy (Copy 1) with the or denying the application. shipment, and return the endorsed du- (e) Each export permit shall be issued plicate copy (Copy 2) to the Import/Ex- in septuplet and serially numbered, port Unit, Drug Enforcement Adminis- with all seven copies bearing the same tration. See the Table of DEA Mailing serial number and being designated Addresses in § 1321.01 of this chapter for ‘‘original’’ (Copy 1), ‘‘duplicate’’ (Copy the current mailing address. 2), etc., respectively. Each export permit shall be predicated upon an import (b) The quadruplet copy (Copy 4) certificate or other documentary evi- shall be forwarded by the Adminis- dence. Export permits are not transfer- trator to the District Director of the able. U.S. Customs Service at the port of ex- (f) No export permit shall be issued port for comparison with the original for the exportation, or reexportation, copy (Copy 1) and for retention for the of any controlled substance to any customs record. country when the Administration has (c) The quintuplet copy (Copy 5) shall information to show that the estimates be forwarded by the Administration to or assessments submitted with respect the officer in the country of destina- to that country for the current period, tion who issued the import certificate, under the Single Convention on Nar- or other documentary evidence upon cotic Drugs, 1961, or the Convention on which the export permit is founded. Psychotropic Substances, 1971, have (d) The sextuplet and septuplet cop- been, or, considering the quantity pro- ies (Copy 6 and Copy 7) shall be re- posed to be imported, will be exceeded. tained by the Administration. If it shall appear through subsequent advice received from the International [36 FR 7815, Apr. 24, 1971, as amended at 36 Narcotics Control Board of the United FR 13387, July 21, 1971. Redesignated at 38 FR Nations that the estimates or assess- 26609, Sept. 24, 1973, and amended at 45 FR 74715, Nov. 12, 1980; 51 FR 5319, Feb. 13, 1986; ments of the country of destination 53 FR 48244, Nov. 30, 1988; 62 FR 13969, Mar. have been adjusted to permit further 24, 1997; 75 FR 10682, Mar. 9, 2010] importation of the controlled substance, an export permit may then be § 1312.25 Expiration date. issued if otherwise permissible. An export permit shall not be valid [36 FR 23625, Dec. 11, 1971, as amended at 37 after the date specified therein, which FR 15923, Aug. 8, 1972. Redesignated at 38 FR date shall conform to the expiration 26609, Sept. 24, 1973, and amended at 52 FR date specified in the supporting import 17290, May 7, 1987; 72 FR 72929, Dec. 26, 2007] certificate or other documentary evi- § 1312.24 Distribution of copies of ex- dence upon which the export permit is port permit. founded, but in no event shall the date Copies of the export permit shall be be subsequent to 6 months after the distributed and serve purposes as fol- date the permit is issued. Any unused lows: export permit shall be returned by the

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permittee to the Import/Export Unit base, or alkaloid) given in kilograms or for cancellation. parts thereof; and (3) The proposed export date, the port [36 FR 7815, Apr. 24, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973, and amended at 45 of exportation, the foreign port of FR 74715, Nov. 12, 1980; 51 FR 5319, Feb. 13, entry, the carriers and shippers in- 1986; 53 FR 48244, Nov. 30, 1988; 62 FR 13969, volved, method of shipment, the name Mar. 24, 1997; 77 FR 4237, Jan. 27, 2012] of the vessel if applicable, and the name, address, and registration num- § 1312.26 Records required of exporter. ber, if any, of any forwarding agent The exporter shall keep a record of utilized; and any serial numbers that might appear (4) The name and address of the con- on packages of narcotic drugs in quan- signee in the country of destination, tities of one ounce or more in such a and any registration or license number manner as will identify the foreign if the consignee is required to have consignee, along with Copy 3 of the ex- such numbers either by the country of port permit. destination or under United States law. In addition, documentation must be § 1312.27 Contents of special con- provided to show that: trolled substances invoice. (i) The consignee is authorized under (a) A person registered or authorized the laws and regulations of the country to export any non-narcotic controlled of destination to receive the controlled substance listed in Schedule III, IV, or substances, and that V, which is not subject to the require- (ii) The substance is being imported ment of an export permit pursuant to for consumption within the importing § 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 (2) A complete description of the con- DEA Form 236, Controlled Substances trolled substances to be exported in- Import/Export Declaration is com- cluding the drug name, dosage form, pleted, by checking the box marked National Drug Code (NDC) number, the ‘‘other’’ on the certification. The fol- Administration Controlled Substances lowing information will be furnished in Code Number as set forth in part 1308 the remarks section: of this chapter, the number and size of (A) Indicate ‘‘for reexport’’. packages or containers, the name and (B) Indicate if reexport is bulk or fin- quantity of the controlled substance ished dosage units. contained in finished dosage units, and (C) Indicate product name, dosage the net quantity of any controlled sub- strength, commercial package size, and stance (expressed in anhydrous acid, quantity.

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(D) Indicate name of consignee, com- § 1312.28 Distribution of special con- plete address, and expected shipment trolled substances invoice. date, as well as, the name and address The required five copies of the spe- of the ultimate consignee in the coun- cial controlled substances export in- try to where the substances will be re- voice, DEA (or BND) Form 236, will be exported. distributed as follows: (E) A statement that the consignee (a) Copy 1 shall accompany the ship- in the country of ultimate destination ment and remain with the shipment to is authorized under the laws and regu- its destination. lations of the country of ultimate des- (b) Copy 2 shall accompany the ship- tination to receive the controlled sub- ment and will be detached and retained stances. by appropriate customs officials at the (iv) Shipments which have been ex- foreign country of destination. ported from the United States and are (c) Copy 3 shall accompany the ship- refused by the consignee in the country ment and will be detached by the Dis- of destination, or are otherwise unac- trict Director of the U.S. Customs ceptable or undeliverable, may be re- Service at the port of exportation, who turned to the registered exporter in the shall sign and date the certification of United States upon authorization of customs on such Copy 3, noting any the Drug Enforcement Administration. changes from the entries made by the In this circumstance, the exporter in exporter, and shall then promptly for- the United States shall file a written ward Copy 3 to the Import/Export Unit request for reexport, along with a com- of the Administration. pleted DEA Form 236, Import Declara- (d) Copy 4 shall be forwarded, within tion with the Import/Export Unit, Drug the time limit required in § 1312.27 of Enforcement Administration. See the this part, directly to the Import/Export Table of DEA Mailing Addresses in Unit, Drug Enforcement Administra- § 1321.01 of this chapter for the current tion. The documentation required by mailing address. A brief summary of § 1312.27(b)(4) of this part must be at- the facts that warrant the return of the tached to this copy. See the Table of substance to the United States along DEA Mailing Addresses in § 1321.01 of with an authorization from the coun- this chapter for the current mailing ad- try of export will be included with the dress. request. DEA will evaluate the request (e) Copy 5 shall be retained by the ex- after considering all the facts as well porter on file as his record of authority as the exporter’s registration status for the exportation. with DEA. The substance may be re- [36 FR 7815, Apr. 24, 1971, as amended at 36 turned to the United States only after FR 13387, July 21, 1971. Redesignated at 38 FR affirmative authorization is issued in 26609, Sept. 24, 1973, and amended at 45 FR writing by DEA. 74715, Nov. 12, 1980; 51 FR 5319, Feb. 13, 1986; (c) Notwithstanding the time limita- 52 FR 17291, May 7, 1987; 53 FR 48244, Nov. 30, tions included in paragraph (a) of this 1988; 62 FR 13969, Mar. 24, 1997; 75 FR 10683, Mar. 9, 2010; 77 FR 4237, Jan. 27, 2012] section, a registrant may obtain a special waiver of these time limitations in § 1312.29 Domestic release prohibited. emergency or unusual instances; provided that a specific confirmation is re- An exporter or a forwarding agent ceived from the Administrator or his acting for an exporter must either de- delegate advising the registrant to pro- liver the controlled substances to the ceed pursuant to the special waiver. port or border, or deliver the controlled substances to a bonded carrier ap- [36 FR 7815, Apr. 24, 1971, as amended at 37 proved by the consignor for delivery to FR 15923, Aug. 8, 1972. Redesignated at 38 FR the port or border, and may not, under 26609, Sept. 24, 1973, and amended at 45 FR any other circumstances, release a 74715, Nov. 12, 1980; 51 FR 5319, Feb. 13, 1986; shipment of controlled substances to 52 FR 17290, May 7, 1987; 62 FR 13969, Mar. 24, anyone, including the foreign con- 1997; 75 FR 10683, Mar. 9, 2010] signee or his agent, within the United States.

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§ 1312.30 Schedule III, IV, and V non- (8) The identification of the export- narcotic controlled substances re- ing carrier; quiring an import and export per- (9) The name, address and business of mit. the importer, transferor, or The following Schedule III, IV, and V transshipper; non-narcotic controlled substances (10) The registration number, if any, have been specifically designated by of the importer, transferor or the Administrator of the Drug Enforce- transshipper; ment Administration as requiring im- (11) The U.S. port of entry; port and export permits pursuant to (12) The approximate date of entry; sections 1002(b)(2) and 1003(e)(3) of the (13) The name, address and business Act (21 U.S.C. 952(b)(2) and 953(e)(3)): of the consignee at the foreign port of (a) Dronabinol (synthetic) in sesame entry; oil and encapsulated in a soft gelatin (14) The shipping route from the U.S. capsule in a U.S. Food and Drug Ad- port of exportation to the foreign port ministration approved product. of entry; (b) [Reserved] (15) The approximate date of receipt by the consignee at the foreign port of [52 FR 17291, May 7, 1987, as amended at 64 FR 35930, July 2, 1999] entry; and (16) The signature of the importer, TRANSSHIPMENT AND IN-TRANSIT transferor or transshipper, or his agent SHIPMENT OF CONTROLLED SUBSTANCES accompanied by the agent’s title. (c) An application shall be accom- § 1312.31 Schedule I: Application for panied by an export license, permit, or prior written approval. a certified copy of the export license, (a) A controlled substance listed in permit, or other authorization, issued schedule I may be imported into the by a competent authority of the coun- United States for transshipment, or try of origin (or other documentary may be transferred or transshipped evidence deemed adequate by the Ad- within the United States for immediate ministrator). exportation, provided that: (d) An application shall be accom- (1) The controlled substance is nec- panied by an import license or permit essary for scientific, medical, or other or a certified copy of such license or legitimate purposes in the country of permit issued by a competent author- destination, and ity of the country of destination (or (2) A transshipment permit has been other documentary evidence deemed issued by the Administrator. adequate by the Administrator), indi- (b) An application for a trans- cating that the controlled substance: shipment permit must be submitted to (1) Is to be applied exclusively to sci- the Import/Export Unit, Drug Enforce- entific, medical or other legitimate ment Administration, at least 30 days, uses within the country of destination; or in the case of an emergency as soon (2) Will not be exported from such as practicable, prior to the expected country; and date of importation, transfer or trans- (3) Is needed therein because there is shipment. See the Table of DEA Mail- an actual shortage thereof and a de- ing Addresses in § 1321.01 of this chapter mand therefor for scientific, medical or for the current mailing address. Each other legitimate uses within such application shall contain the following: country. (1) The date of execution; (e) Verification by an American con- (2) The identification and description sular officer of the signatures on a for- of the controlled substance; eign import license or permit shall be (3) The net quantity thereof; required, if such license or permit does (4) The number and size of the con- not bear the seal of the authority sign- trolled substance containers; ing them. (5) The name, address, and business (f) The Administrator may require an of the foreign exporter; applicant to submit such documents or (6) The foreign port of exportation; written statements of fact relevant to (7) The approximate date of expor- the application as he deems necessary tation; to determine whether the application

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should be granted. The failure of the HEARINGS applicant to provide such documents or statements within a reasonable time § 1312.41 Hearings generally. after being requested to do so shall be (a) In any case where the Adminis- deemed to be a waiver by the applicant trator shall hold a hearing regarding of an opportunity to present such docu- the denial of an application for an im- ments or facts for consideration by the port, export or transshipment permit, Administrator in granting or denying the procedures for such hearing shall the application. be governed generally by the adjudica- (g) The Administrator shall, within tion procedures set forth in the Admin- 21 days from the date of receipt of the istrative Procedure Act (5 U.S.C. 551– application, either grant or deny the 559) and specifically by sections 1002 application. The applicant shall be ac- and 1003 of the Act (21 U.S.C. 952 and corded an opportunity to amend the 953), by §§ 1312.42–1312.47, and by the application, with the Administrator ei- procedures for administrative hearings ther granting or denying the amended under the Act set forth in §§ 1316.41– application within 7 days of its receipt. 1316.67 of this chapter. If the Administrator does not grant or (b) [Reserved] deny the application within 21 days of its receipt, or in the case of an amend- [36 FR 23625, Dec. 11, 1971, as amended at 37 FR 15923, Aug. 8, 1972. Redesignated at 38 FR ed application, within 7 days of its re- 26609, Sept. 24, 1973] ceipt, the application shall be deemed approved and the applicant may pro- § 1312.42 Purpose of hearing. ceed. (a) If requested by a person applying [36 FR 7815, Apr. 24, 1971, as amended at 37 for an import, export, or transshipment FR 15923, Aug. 8, 1972. Redesignated at 38 FR permit, the Administrator shall hold a 26609, Sept. 24, 1973, and further amended at hearing for the purpose of receiving 45 FR 74715, Nov. 12, 1980; 51 FR 5319, Feb. 13, factual evidence regarding the issues 1986; 53 FR 48244, Nov. 30, 1988; 62 FR 13969, Mar. 24, 1997; 75 FR 10683, Mar. 9, 2010] involved in the issuance or denial of such permit to such person. § 1312.32 Schedules II, III, IV: Advance (b) Extensive argument should not be notice. offered into evidence but rather pre- (a) A controlled substance listed in sented in opening or closing state- Schedules II, III, or IV may be im- ments of counsel or in memoranda or ported into the United States for trans- proposed findings of fact and conclu- shipment, or may be transferred or sions of law. transshipped within the United States [36 FR 23625, Dec. 11, 1971, as amended at 37 for immediate exportation, provided FR 15923, Aug. 8, 1972. Redesignated at 38 FR that written notice is submitted to the 26609, Sept. 24, 1973] Import/Export Unit, Drug Enforcement Administration, at least 15 days prior § 1312.43 Waiver or modification of to the expected date of importation, rules. transfer or transshipment. See the The Administrator of the presiding Table of DEA Mailing Addresses in officer (with respect to matters pend- § 1321.01 of this chapter for the current ing before him) may modify or waive mailing address. any rule in this part by notice in ad- (b) Each advance notice shall contain vance of the hearing, if he determines those items required by § 1312.31 (b) and that no party in the hearing will be un- (c). duly prejudiced and the ends of justice will thereby be served. Such notice of [36 FR 7815, Apr. 24, 1971. Redesignated at 38 modification or waiver shall be made a FR 26609, Sept. 24, 1973, and amended at 45 FR 74715, Nov. 12, 1980; 51 FR 5319, Feb. 13, part of the record of the hearing. 1986; 53 FR 48244, Nov. 30, 1988; 62 FR 13969, [36 FR 23625, Dec. 11, 1971. Redesignated at 38 Mar. 24, 1997; 75 FR 10683, Mar. 9, 2010] FR 26609, Sept. 24, 1973]

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§ 1312.44 Request for hearing or ap- his application, the Administrator pearance; waiver. shall hold such hearing. Notice of the (a) Any applicant entitled to a hear- hearing shall be given to the applicant ing pursuant to § 1312.42 and who de- of the time and place at least 30 days sires a hearing on the denial of his ap- prior to the hearing, unless the appli- plication for an import, export, or cant waives such notice and requests transshipment permit shall, within 30 the hearing be held at an earlier time, days after the date of receipt of the de- in which case the Administrator shall nial of his application, file with the Ad- fix a date for such hearing as early as ministrator a written request for a reasonably possible. hearing in the form prescribed in (b) The hearing will commence at the § 1316.47 of this chapter. place and time designated in the notice (b) Any applicant entitled to a hear- given pursuant to paragraph (a) of this ing pursuant to § 1312.42 may, within section but thereafter it may be moved to a different place and may be contin- the period permitted for filing a re- ued from day to day or recessed to a quest for a hearing, file with the Ad- later day without notice other than an- ministrator a waiver of an opportunity nouncement thereof by the presiding for a hearing, together with a written officer at the hearing. statement regarding his position on the matters of fact and law involved in [37 FR 15924, Aug. 8, 1972. Redesignated at 38 such hearing. Such statement, if ad- FR 26609, Sept. 24, 1973] missible, shall be made a part of the record and shall be considered in light § 1312.47 Final order. of the lack of opportunity for cross-ex- As soon as practicable after the pre- amination in determining the weight siding officer has certified the record to be attached to matters of fact as- to the Administrator, the Adminis- serted therein. trator shall issue his order on the (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- [37 FR 15924, Aug. 8, 1972. Redesignated at 38 trator may cancel the hearing, if 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. Sec. At any hearing on the denial of an 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) IMPORTATION OF LISTED CHEMICALS are not satisfied. 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. 1313.14 Distribution of import declaration. § 1312.46 Time and place of hearing. 1313.15 Waiver of 15-day advance notice for regular importers. (a) If any applicant for an import, ex- 1313.16 Transfers following importation. port, or transshipment permit requests 1313.17 Return declaration or amendment to a hearing on the issuance or denial of Form 486 for imports.

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EXPORTATION OF LISTED CHEMICALS § 1313.05 Requirements for an estab- 1313.21 Requirement of authorization to ex- lished business relationship. port. To document that an importer or ex- 1313.22 Contents of export declaration. porter has an established business rela- 1313.23 Distribution of export declaration. tionship with a customer, the importer 1313.24 Waiver of 15-day advance notice for or exporter must provide the Adminis- chemical exporters. trator with the following information 1313.25 Foreign import restrictions. in accordance with the waiver of 15-day 1313.26 Transfers following exportation. advance notice requirements of § 1313.15 1313.27 Return declaration or amendment to Form 486 for exports. or § 1313.24: (a) The name and street address of TRANSSHIPMENTS, IN-TRANSIT SHIPMENTS AND the chemical importer or exporter and INTERNATIONAL TRANSACTIONS INVOLVING of each regular customer; LISTED CHEMICALS (b) The telephone number, contact 1313.31 Advance notice of importation for person, and where available, the fac- transshipment or transfer. simile number for the chemical im- 1313.32 Requirement of authorization for porter or exporter and for each regular international transactions. customer; 1313.33 Contents of an international trans- (c) The nature of the regular cus- action declaration. tomer’s business (i.e., importer, ex- 1313.34 Distribution of the international porter, distributor, manufacturer, transaction declaration. 1313.35 Return declaration or amendment to etc.), and if known, the use to which Form 486 for international transactions. the listed chemical or chemicals will 1313.41 Suspension of shipments. be applied; 1313.42 Prohibition of shipments from cer- (d) The duration of the business rela- tain foreign sources. tionship; (e) The frequency and number of HEARINGS transactions occurring during the pre- 1313.51 Hearings generally. ceding 12-month period; 1313.52 Purpose of hearing. (f) The amounts and the listed chem- 1313.53 Waiver of modification of rules. ical or chemicals involved in regulated 1313.54 Request for hearing. transactions between the chemical im- 1313.55 Burden of proof. porter or exporter and regular cus- 1313.56 Time and place of hearing. tomer; 1313.57 Final order. (g) The method of delivery (direct AUTHORITY: 21 U.S.C. 802, 830, 871(b), 971. shipment or through a broker or forwarding agent); and SOURCE: 54 FR 31665, Aug. 1, 1989, unless otherwise noted. (h) Other information that the chemical importer or exporter considers rel- § 1313.01 Scope. evant for determining whether a customer is a regular customer. Procedures governing the importation, 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 Administrator with the following infor- [54 FR 31665, Aug. 1, 1989, as amended at 60 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: (a) The name, DEA registration num- Any term used in this part shall have ber (where applicable), street address, the definition set forth in section 102 of telephone number, and, where avail- the Act (21 U.S.C. 802) or part 1300 of able, the facsimile number of the regu- this chapter. lated person and of each foreign sup- [62 FR 13969, Mar. 24, 1997] plier; and

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(b) The frequency and number of (e) For importations where advance transactions occurring during the pre- notification is waived pursuant to ceding 12 month period. paragraph (c)(2) of this section no DEA [72 FR 17407, Apr. 9, 2007] Form 486 is required; however, the regulated person shall submit quarterly IMPORTATION OF LISTED CHEMICALS reports to the Import/Export Unit, Drug Enforcement Administration, no § 1313.12 Requirement of authoriza- later than the 15th day of the month tion to import. following the end of each quarter. See (a) Each regulated person who im- the Table of DEA Mailing Addresses in ports a listed chemical that meets or § 1321.01 of this chapter for the current exceeds the threshold quantities identi- mailing address. The report shall con- fied in § 1310.04(f) or is a listed chemical tain the following information regard- for which no threshold has been estab- ing each individual importation: lished as identified in § 1310.04(g) of this (1) The name of the listed chemical; chapter, shall notify the Administrator (2) The quantity and date imported; of the importation not later than 15 (3) The name and full business ad- days before the transaction is to take dress of the supplier; place. (4) The foreign port of embarkation; (b) A completed DEA Form 486 must be received by the Import/Export Unit, and Drug Enforcement Administration, not (5) The port of entry. later than 15 days prior to the importa- (f) The 15 day advance notification tion. See the Table of DEA Mailing Ad- requirement set forth in paragraph (a) dresses in § 1321.01 of this chapter for has been waived for imports of the fol- the current mailing address. A copy of lowing listed chemicals: the completed DEA Form 486 may be (1) Acetone. 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 requirement for listed chemical im- FR 51367, Oct. 11, 1994; 60 FR 32464, June 22, 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; 77 FR 4237, Jan. 27, 2012] 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. (ii) The importer intends to transfer ed in § 1310.02 of this chapter may be the listed chemicals to a person who is imported if that chemical is necessary a regular customer for the chemical, as for medical, commercial, scientific, or defined in § 1300.02 of this chapter. other legitimate uses within the (2) A specific listed chemical, as set United States. Chemical importations forth in paragraph (f) of this section, into the United States for immediate for which the Administrator deter- transfer/transshipment outside the mines that advance notification is not United States must comply with the necessary for effective chemical diver- procedures set forth in § 1313.31. sion control. (b) Any regulated person who desires (d) For imports where advance notifi- to import a threshold or greater quan- cation is waived pursuant to paragraph tity of a listed chemical shall notify (c)(1) of this section, the DEA Form 486 the Administration through procedures must be received by the Drug Enforce- set forth in § 1313.12 and distribute ment Administration, Import/Export three copies of DEA Form 486 as di- Unit, on or before the date of importa- rected in § 1313.14. tion through use of the mailing address (c) The DEA Form 486 must be exe- listed in § 1313.12(b) or through use of cuted in triplicate and must include electronic facsimile media. the following information:

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(1) The name, address, telephone be retained for four years; declaration number, and, where available, the fac- forms for List II chemical must be re- simile number of the chemical im- tained for two years. porter; the name, address, telephone (b) Copy 2 is the Drug Enforcement number, and, where available, the fac- Administration copy used to fulfill the simile number of the broker or for- notification requirements of Section warding agent (if any); and 6053 of the Chemical Diversion and (2) The name and description of each Trafficking Act of 1988, as specified in listed chemical as it appears on the § 1313.12. label or container, the name of each (c) Copy 3 shall be presented to the chemical as it is designated in 1310.02 U.S. Customs Service along with the of this chapter, the size or weight of customs entry. If the import is a regu- container, the number of containers, lated transaction for which the 15-day the net weight of each listed chemical advance notice requirement has been given in kilograms or parts thereof; waived, the regulated person shall de- and the gross weight of the shipment clare this information to the U.S. Cus- given in kilograms or parts thereof; toms Service Official by checking the and (3) The proposed import date, the for- block on the DEA Form 486 designated eign port of exportation and the first for this purpose. U.S. Customs Port of Entry; and [54 FR 31665, Aug. 1, 1989, as amended at 60 (4) The name, address, telephone FR 32465, June 22, 1995; 77 FR 4237, Jan. 27, number, telex number, and, where 2012] available, the facsimile number of the consigner in the foreign country of ex- § 1313.15 Waiver of 15-day advance no- portation; and tice for regular importers. (5) The name, address, telephone (a) Each regulated person seeking number, and where available, the fac- designation as a ‘‘regular importer’’ simile number of the person or persons shall provide, by certified mail return to whom the importer intends to trans- receipt requested, to the Administra- fer the listed chemical and the quan- tion such information as is required tity to be transferred to each trans- under § 1313.08 documenting their sta- feree. tus as a regular importer. (d) Any regulated person importing (b) Each regulated person making ap- ephedrine, pseudoephedrine, or phenyl- plication under paragraph (a) of this propanolamine must submit, on the section shall be considered a ‘‘regular import declaration, all information importer’’ for purposes of waiving the known to the importer on the chain of 15-day advance notice, 30 days after re- distribution of the chemical from the ceipt of the application by the Admin- manufacturer to the importer. Ephed- istration, as indicated on the return re- rine, pseudoephedrine, or phenyl- ceipt, unless the regulated person is propanolamine include each of the salts, optical isomers, and salts of opti- otherwise notified in writing by the cal isomers of the chemical. Administration. (c) The Administrator, may, at any [54 FR 31665, Aug. 1, 1989, as amended at 60 time, disqualify a regulated person’s FR 32465, June 22, 1995; 72 FR 17407, Apr. 9, status as a regular importer on the 2007; 75 FR 10171, Mar. 5, 2010; 77 FR 4237, Jan. 27, 2012] grounds that the chemical being imported may be diverted to the clandes- § 1313.14 Distribution of import dec- tine manufacture of a controlled sub- laration. stance. The required three copies of the list- (d) Unless the Administration noti- ed chemical import declaration (DEA fies the chemical importer to the con- Form 486) will be distributed as fol- trary, the qualification of a regular im- lows: porter of any one of these three chemi- (a) Copy 1 shall be retained on file by cals, acetone, 2-Butanone (MEK), or the regulated person as the official toluene, qualifies that importer as a record of import. Import declaration regular importer of all three of these forms involving a List I chemical must chemicals.

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(e) All chemical importers shall be (i) May, in accordance with the same required to file a DEA Form 486 as re- procedures as apply under §§ 1313.51 quired by Section 1313.12. through 1313.57, order the suspension of [60 FR 32464, June 22, 1995, as amended at 62 the transfer of the listed chemical by FR 13969, Mar. 24, 1997; 72 FR 17407, Apr. 9, the importer involved, except for a 2007] transfer to a regular customer, on the ground that the chemical may be di- § 1313.16 Transfers following importa- verted to the clandestine manufacture tion. of a controlled substance (without re- (a) In the case of a notice under gard to the form of the chemical that § 1313.12(a) submitted by a regulated may be diverted, including the diver- person, if the transferee identified in sion of a finished drug product to be the notice is not a regular customer, manufactured from bulk chemicals to the importer may not transfer the list- be transferred), subject to the Adminis- ed chemical until after the expiration tration ordering the suspension before of the 15-day period beginning on the the expiration of the 15-day period with date on which the notice is submitted respect to the importation (in any case to the Administration. in which such a period applies); and (b) After a notice under § 1313.12(a) or (ii) May, for purposes of this para- (d) is submitted to the Administration, graph (d), disqualify a regular cus- if circumstances change and the im- tomer on that ground. porter will not be transferring the list- (2) From and after the time when the ed chemical to the transferee identified Administration provides written notice in the notice, or will be transferring a greater quantity of the chemical than of the order under paragraph (d)(1)(i) of specified in the notice, the importer 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 importer, the importer 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 importer transfers a apply if the prospective transferee listed chemical. identified in the update is a regular customer. The preceding sentence ap- [72 FR 17407, Apr. 9, 2007] plies 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 the sentence applies with respect to (a) Within 30 days after a transaction changing circumstances regarding a is completed, the importer must send transferee or quantity identified in the to the Administration a return declara- original notice under § 1313.12(a) or (d). tion containing particulars of the (c) In the case of a transfer of a listed transaction, including the date, quan- chemical that is subject to a 15-day re- tity, chemical, container, name of striction, the transferee involved shall, transferees, and any other information upon the expiration of the 15-day pe- as the Administration may specify. A riod, be considered to qualify as a reg- single return declaration may include ular customer, unless the Administra- the particulars of both the importation tion otherwise notifies the importer in- and distribution. If the importer has volved in writing. not distributed all chemicals imported (d) With respect to a transfer of a by the end of the initial 30-day period, listed chemical with which a notice or the importer must file supplemental update referred to in § 1313.12(a) or (d) return declarations no later than 30 is concerned: days from the date of any further dis- (1) The Administration— tribution, until the distribution or

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other disposition of all chemicals im- vance notification is not necessary for ported under the import notification or effective chemical diversion control. any update are accounted for. (d) For exports where advance notifi- (b) If an importation for which a cation is waived pursuant to paragraph Form 486 has been filed fails to take (c)(1) of this section, the DEA Form 486 place, the importer must file an must be received by the Drug Enforce- amended Form 486 notifying the Ad- ment Administration, Chemical Oper- ministration that the importation did ations Section, on or before the date of not occur. exportation through use of the mailing [72 FR 17408, Apr. 9, 2007] address listed in Section 1313.12(b) or through use of electronic facsimile EXPORTATION OF LISTED CHEMICALS media. (e) For exportations where advance § 1313.21 Requirement of authoriza- notification is waived pursuant to tion to export. paragraph (c)(2) of this section, no DEA (a) No person shall export or cause to Form 486 is required; however, the reg- be exported from the United States any ulated person shall file quarterly re- chemical listed in § 1310.02 of this chap- ports with the Import/Export Unit, ter, which meets or exceeds the thresh- Drug Enforcement Administration, no old quantities identified in § 1310.04(f) later than the 15th day of the month or is a listed chemical for which no following the end of each quarter. See threshold has been established as iden- the Table of DEA Mailing Addresses in tified in § 1310.04(g) of this chapter, § 1321.01 of this chapter for the current until such time as the Administrator mailing address. The report shall con- has been notified. Notification must be tain the following information regard- made not later than 15 days before the ing each individual exportation: transaction is to take place. In order to facilitate the export of listed chemicals (1) The name of the listed chemical; and implement the purpose of the Act, (2) The quantity and date exported; regulated persons may wish to provide (3) The name and full business ad- notification to the Administration as dress of the foreign customer; far in advance of the 15 days as pos- (4) The port of embarkation; and sible. (5) The foreign port of entry. (b) A completed DEA Form 486 must (f) The 15 day advance notification be received by the Import/Export Unit, requirement set forth in paragraph (a) Drug Enforcement Administration, not of this section has been waived for ex- later than 15 days prior to the expor- ports of the following listed chemicals tation. See the Table of DEA Mailing to the following countries: Addresses in § 1321.01 of this chapter for the current mailing address. A copy of Name of Chemical Country the completed DEA Form 486 may be [Reserved] ...... transmitted directly to the Drug En- forcement Administration through (g) No person shall export or cause to electronic facsimile media not later be exported any listed chemical, know- than 15 days prior to the exportation. ing or having reasonable cause to be- (c) The 15-day advance notification lieve the export is in violation of the requirement for listed chemical ex- laws of the country to which the chem- ports may be waived for: ical is exported or the chemical will be (1) Any regulated person who has sat- used to manufacture a controlled sub- isfied the requirements of § 1313.24 for reporting to the Administration an es- stance in violation of the Act or the tablished business relationship, as de- laws of the country to which the chem- fined in § 1300.02 of this chapter, with a ical is exported. The Administration foreign customer. will publish a notice of foreign import (2) A specific listed chemical to a restrictions for listed chemicals of specified country, as set forth in paragraph (f) of this section, for which the Administrator determines that ad-

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which DEA has knowledge as provided tion requirement following the proce- in § 1313.25. dures outlined in § 1313.24. (e) Declared exports of listed chemi- [54 FR 31665, Aug. 1, 1989, as amended at 59 FR 51367, Oct. 11, 1994; 60 FR 32464, June 22, cals which are refused, rejected, or oth- 1995; 62 FR 13969, Mar. 24, 1997; 66 FR 46520, erwise deemed undeliverable may be Sept. 6, 2001; 67 FR 49569, July 31, 2002; 75 FR returned to the U.S. chemical exporter 10683, Mar. 9, 2010; 77 FR 4237, Jan. 27, 2012] of record. A brief written notification (this does not require a DEA Form 486) § 1313.22 Contents of export declara- outlining the circumstances must be tion. sent to the Import/Export Unit, Drug (a) Any List I or List II chemical list- Enforcement Administration, following ed in § 1310.02 of this chapter which the return within a reasonable time. meets or exceeds the quantitative See the Table of DEA Mailing Address- threshold criteria established in es in § 1321.01 of this chapter for the § 1310.04(f) of this chapter may be ex- current mailing address. This provision ported if that chemical is needed for does not apply to shipments that have medical, commercial, scientific, or cleared foreign customs, been deliv- other legitimate uses. ered, and accepted by the foreign con- (b) Any regulated person who desires signee. Returns to third parties in the to export a threshold or greater quan- United States will be regarded as im- tity of a listed chemical shall notify ports. the Administration through procedures [54 FR 31665, Aug. 1, 1989, as amended at 60 outlined in § 1313.21 and distribute FR 32465, June 22, 1995; 67 FR 49569, July 31, three copies of DEA Form 486 as di- 2002; 75 FR 10683, Mar. 9, 2010] rected in § 1313.23. (c) The DEA Form 486 must be exe- § 1313.23 Distribution of export dec- cuted in triplicate and must include all laration. the following information: The required three copies of the list- (1) The name, address, telephone ed chemical export declaration (DEA number, telex number, and, where Form 486) will be distributed as fol- available, the facsimile number of the lows: chemical exporter; the name, address, (a) Copy 1 shall be retained on file by telephone number, telex number, and, the chemical exporters as the official where available, the facsimile number record of export. Export declaration of the export broker, if any; forms involving a List I chemical must (2) The name and description of each be retained for four years; declaration listed chemical as it appears on the forms for list II chemical must be relabel or container, the name of each tained for two years. 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 [54 FR 31665, Aug. 1, 1989, as amended at 60 country where the chemical shipment FR 32465, June 22, 1995; 61 FR 51004, Sept. 30, is destined; the name(s) and address(es) 1996] of any intermediate consignee(s). (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) Each regulated person shall pro- a waiver of the 15-day advance notifica- vide to the Administration the identity

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and information listed in the definition not a regular customer, the regulated of established business relationship in person may not transfer the listed § 1300.02 of this chapter for an estab- chemical until after the expiration of lished business relationship with a for- the 15-day period beginning on the date eign customer not later than August on which the notice is submitted to the 31, 1989. Administration. (b) Not later than October 31, 1989, (b) After a notice under § 1313.21(a) is each regular customer so identified in submitted to the Administration, if notifications made under § 1313.24(a) circumstances change and the exporter shall be a regular customer for pur- will not be transferring the listed poses of waiving the 15-day advance no- chemical to the transferee identified in tice requirement, unless the regulated the notice, or will be transferring a person is otherwise notified in writing greater quantity of the chemical than by the Administration. specified in the notice, the exporter (c) Each foreign customer identified must update the notice to identify the on an initial DEA Form 486 submitted most recent prospective transferee or after the effective date of the imple- the most recent quantity or both (as mentation of part 1313 shall, after the the case may be) and may not transfer expiration of the 15-day period, qualify the listed chemical until after the expi- as a regular customer, unless the Ad- ration of the 15-day period beginning ministration otherwise notifies the on the date on which the update is sub- regulated person in writing. mitted to the Administration, except (d) Unless the Administration noti- that the 15-day restriction does not fies the chemical exporter to the con- apply if the prospective transferee trary, the qualification of a regular identified in the update is a regular customer for any one of these three customer. The preceding sentence ap- chemicals, acetone, 2-Butanone (MEK), plies with respect to changing cir- or toluene, qualifies that customer as a cumstances regarding a transferee or regular customer for all three of these quantity identified in an update to the chemicals. same extent and in the same manner as (e) The Administrator may notify the sentence applies with respect to any chemical exporter that a regular changing circumstances regarding a customer has been disqualified or that transferee or quantity identified in the a new customer for whom a notification has been submitted is not to be ac- original notice under paragraph (a) of corded the status of a regular cus- this section. tomer. In the event of a disqualifica- (c) In the case of a transfer of a listed tion of an established regular cus- chemical that is subject to a 15-day re- tomer, the chemical exporter will be striction, the transferee involved shall, notified in writing of the reasons for upon the expiration of the 15-day pe- such action. riod, be considered to qualify as a regular customer, unless the Administra- [54 FR 31665, Aug. 1, 1989, as amended at 56 tion otherwise notifies the exporter in- FR 55077, Oct. 24, 1991; 62 FR 13969, Mar. 24, volved in writing. 1997; 75 FR 10684, Mar. 9, 2010; 77 FR 4237, Jan. 27, 2012] (d) With respect to a transfer of a listed chemical with which a notice or § 1313.25 Foreign import restrictions. update referred to in § 1313.21(a) is con- Any export from the United States in cerned: violation of the law of the country to (1) The Administration— which the chemical is exported is sub- (i) May, in accordance with the same ject to the penalties of Title 21 United procedures as apply under §§ 1313.51 States Code 960(d). through 1313.57, order the suspension of the transfer of the listed chemical by § 1313.26 Transfers following expor- the exporter involved, except for a tation. transfer to a regular customer, on the (a) In the case of a notice under ground that the chemical may be di- § 1313.21(a) submitted by a regulated verted to the clandestine manufacture person, if the transferee identified in of a controlled substance (without re- the notice, i.e., the foreign importer, is gard to the form of the chemical that

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may be diverted, including the diver- may be transferred or transshipped sion of a finished drug product to be within the United States for immediate manufactured from bulk chemicals to exportation, provided that advance no- be transferred), subject to the Adminis- tice is given to the Administration. tration ordering the suspension before (b) Advance notification must be pro- the expiration of the 15-day period with vided to the Import/Export Unit, Drug respect to the exportation (in any case Enforcement Administration, not later in which such a period applies); and than 15 days prior to the proposed date (ii) May, for purposes of this para- the listed chemical will transship or graph (d), disqualify a regular cus- transfer through the United States. tomer on that ground. See the Table of DEA Mailing Address- (2) From and after the time when the es in § 1321.01 of this chapter for the Administration provides written notice current mailing address. The written of the order under paragraph (d)(1)(i) of notification (not a DEA Form 486) shall this section (including a statement of contain the following information: the legal and factual basis for the (1) The date the notice was executed; order) to the exporter, the exporter (2) The complete name and descrip- may not carry out the transfer. tion of the listed chemical as it ap- (e) For purposes of this section: pears on the label or container. (1) The term transfer, with respect to (3) The name of the listed chemical a listed chemical, includes the sale of as designated by § 1310.02 of this chap- the chemical. ter. (2) The term transferee means a person to whom an exporter transfers a (4) The number of containers and the listed chemical. size or weight of the container for each listed item; [72 FR 17408, Apr. 9, 2007] (5) The net weight of each listed chemical given in kilograms or parts § 1313.27 Return declaration or thereof; amendment to Form 486 for exports. (6) The gross weight of the shipment given in kilograms or parts thereof; (a) Within 30 days after a transaction (7) The name, address, telephone is completed, the exporter must send to number, telex number, business of the the Administration a return declaration containing particulars of the foreign exporter and, where available, transaction, including the date, quan- the facsimile number; tity, chemical, container, name of (8) The foreign port of exportation; transferees, and any other information (9) The approximate date of expor- as the Administration may specify. tation; (b) If an exportation for which a (10) The complete identification of Form 486 has been filed fails to take the exporting carrier; place, the exporter must file an amend- (11) The name, address, business, ed Form 486 notifying the Administra- telephone number, and, where avail- tion that the exportation did not able, the facsimile number of the im- occur. porter, transferor, or transshipper; (12) The U.S. port of entry; [72 FR 17408, Apr. 9, 2007] (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 foreign port of entry; § 1313.31 Advance notice of importa- (15) The shipping route from the U.S. tion for transshipment or transfer. 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

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agent, accompanied by the agent’s will publish a notice of foreign import title. restrictions for listed chemicals of (c) Unless notified to the contrary which DEA has knowledge as provided prior to the expected date of delivery, in Section 1313.25. the importation for transshipment or (d) After a notice under paragraph (a) transfer is considered approved. of this section is submitted to the Ad- (d) No waiver of the 15-day advance ministration, if circumstances change notice will be given for imports of list- and the broker or trader will not be ed chemicals in quantities meeting or transferring the listed chemical to the exceeding threshold quantities for transferee identified in the notice, or transshipment or transfer outside the will be transferring a greater quantity United States. of the chemical than specified in the [54 FR 31665, Aug. 1, 1989, as amended at 67 notice, the broker or trader must up- FR 49569, July 31, 2002; 75 FR 10684, Mar. 9, date the notice to identify the most re- 2010; 77 FR 4237, Jan. 27, 2012] cent prospective transferee or the most recent quantity or both (as the case § 1313.32 Requirement of authoriza- may be). The preceding sentence ap- tion for international transactions. plies with respect to changing cir- (a) A broker or trader shall notify cumstances regarding a transferee or the Administrator prior to an inter- quantity identified in an update to the national transaction involving a listed same extent and in the same manner as chemical which meets or exceeds the the sentence applies with respect to threshold amount identified in Section changing circumstances regarding a 1310.04 of this chapter, in which the transferee or quantity identified in the broker or trader participates. Notifica- original notice under paragraph (a) of tion must be made no later than 15 this section. days before the transaction is to take (e) For purposes of this section: place. In order to facilitate an inter- (1) The term transfer, with respect to national transaction involving listed a listed chemical, includes the sale of chemicals and implement the purpose the chemical. of the Act, regulated persons may wish (2) The term transferee means a per- to provide advance notification to the son to whom an exporter transfers a Administration as far in advance of the listed chemical. 15 days as possible. (b)(1) A completed DEA Form 486 [60 FR 32465, June 22, 1995; 61 FR 17566, Apr. must be received by the Import/Export 22, 1996; 67 FR 49569, July 31, 2002; 72 FR 17408, Unit, Drug Enforcement Administra- Apr. 9, 2007; 75 FR 10684, Mar. 9, 2010; 77 FR tion, not later than 15 days prior to the 4238, Jan. 27, 2012] international transaction. See the § 1313.33 Contents of an international Table of DEA Mailing Addresses in transaction declaration. § 1321.01 of this chapter for the current 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, Import/ criteria established in § 1310.04 of this Export Unit, through electronic fac- chapter may be arranged by a broker simile 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 exe- laws of the country to which the chem- cuted in triplicate and must include all ical is exported. The Administration the following information:

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(1) The name, address, telephone transferees, and any other information number, and, where available, the fac- as the Administration may specify. simile number of the chemical ex- (b) If a transaction for which a Form porter; the name, address, telephone 486 has been filed fails to take place, number, and, where available, the fac- the broker or trader must file an simile number of the chemical im- amended Form 486 notifying the Ad- porter; ministration that the transaction did (2) The name and description of each not occur. listed chemical as it appears on the label or container, the name of each [72 FR 17409, Apr. 9, 2007] listed chemical as it is designated in Section 1310.02 of this chapter, the size § 1313.41 Suspension of shipments. or weight of container, the number of (a) The Administrator may suspend containers, the net weight of each list- any importation or exportation of a ed chemical given in kilograms or chemical listed in § 1310.02 of this chap- parts thereof, and the gross weight of ter based on evidence that the chem- the shipment given in kilograms or ical proposed to be imported or ex- parts thereof; ported may be diverted to the clandes- (3) The proposed export date, the port tine manufacture of a controlled sub- of exportation, and the port of impor- stance. If the Administrator so sus- tation; and pends, he shall provide written notice (4) The name, address, telephone of such suspension to the regulated number, and, where available, the fac- person. Such notice shall contain a simile number of the consignee in the statement of the legal and factual basis country where the chemical shipment is destined; the name(s) and address(es) for the order. of any intermediate consignee(s). (b) Upon service of the order of suspension, the regulated person to whom [60 FR 32465, June 22, 1995, as amended at 77 the order applies under paragraph (a) of FR 4238, Jan. 27, 2012] this section must, if he desires a hear- § 1313.34 Distribution of the inter- ing, file a written request for a hearing national transaction declaration. pursuant to §§ 1313.51–1313.57. The required three copies of the DEA § 1313.42 Prohibition of shipments Form 486 will be distributed as follows: from certain foreign sources. (a) Copies 1 and 3 shall be retained on file by the broker or trader as the offi- (a) If the Administrator determines cial record of the international trans- that a foreign manufacturer or dis- action. Declaration forms involving tributor of ephedrine, pseudoephedrine, List I chemicals shall be retained for or phenylpropanolamine has refused to List II chemicals shall be retained for cooperate with a request by the Admin- four years; declaration forms for two istrator for information known to the years. manufacturer or distributor on the dis- (b) Copy 2 is the Drug Enforcement tribution of the chemical, including Administration copy used to fulfill the sales, the Administrator may issue an notification requirements of Section order prohibiting the importation of 1313.32. the chemical in any case where the manufacturer or distributor is part of [60 FR 32465, June 22, 1995; 60 FR 35264, July 6, 1995] the chain of distribution. (b) Not later than 60 days prior to § 1313.35 Return declaration or issuing the order to prohibit importa- amendment to Form 486 for inter- tion, the Administrator shall publish national transactions. in the FEDERAL REGISTER a notice of (a) Within 30 days after a transaction intent to issue the order. During the 60- is completed, the broker or trader must day period, imports from the foreign send to the Administration a return manufacturer or distributor may not declaration containing particulars of be restricted under this section. the transaction, including the date, quantity, chemical, container, name of [75 FR 10172, Mar. 5, 2010]

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HEARINGS (c) If all persons entitled to a hearing or to participate in a hearing waive or § 1313.51 Hearings generally. are deemed to waive their opportunity In any case where a regulated person for the hearing or to participate in the requests a hearing regarding the sus- hearing, the Administrator may cancel pension of a shipment of a listed chem- the hearing, if scheduled, and issue his ical, the procedures for such hearing final order pursuant to § 1313.57. shall be governed generally by the procedures set forth in the Administrative § 1313.55 Burden of proof. Procedure Act (5 U.S.C. 551–559) and At any hearing regarding the suspen- specifically by section 6053 of the sion of shipments, the Agency shall Chemical Diversion and Trafficking have the burden of proving that the re- Act (Pub. L. 100–690), by 21 CFR 1313.52– quirements of this part for such sus- 1313.57, and by the procedures for ad- pension are satisfied. ministrative hearings under the Con- trolled Substances Act set forth in § 1313.56 Time and place of hearing. §§ 1316.41–1316.67 of this chapter. (a) If any regulated person requests a § 1313.52 Purpose of hearing. hearing on the suspension of ship- If requested by a person entitled to a ments, a hearing will be scheduled no hearing, the Administrator shall cause later than 45 days after the request is a hearing to be held for the purpose of made, unless the regulated person re- receiving factual evidence regarding quests an extension to this date. the issues involved in the suspension of (b) The hearing will commence at the shipments within 45 days of the date of place and time designated in the notice the request, unless the requesting given pursuant to paragraph (a) of this party requests an extension of time. section but thereafter it may be moved to a different place and may be contin- § 1313.53 Waiver of modification of ued from day to day or recessed to a rules. later day without notice other than an- The Administrator or the presiding nouncement thereof by the presiding officer (with respect to matters pend- officer at the hearing. ing before him) may modify or waive any rule in this part by notice in ad- § 1313.57 Final order. vance of the hearing, if he determines As soon as practicable after the pre- that no party in the hearing will be un- siding officer has certified the record duly prejudiced and the ends of justice to the Administrator, the Adminis- will thereby be served. Such notice of trator shall issue his order regarding modification or waiver shall be made a the suspension of shipment. The order part of the record of the hearing. shall include the findings of fact and conclusions of law upon which the § 1313.54 Request for hearing. order is based. The Administrator shall (a) Any person entitled to a hearing serve one copy of his order upon each pursuant to § 1313.52 and desiring a party in the hearing. 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 form prescribed in § 1316.47 of this chap- PRODUCTS ter. (b) If any person entitled to a hearing Subpart A—General or to participate in a hearing pursuant Sec. to § 1313.41 fails to file a request for a 1314.01 Scope. hearing or a notice of appearance, or if 1314.02 Applicability. he so files and fails to appear at the 1314.03 Definitions. hearing, he shall be deemed to have 1314.05 Requirements regarding packaging waived his opportunity for the hearing of nonliquid forms. or to participate in the hearing, unless 1314.10 Effect on state laws. he shows good cause for such failure. 1314.15 Loss reporting.

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Subpart B—Sales by Regulated Sellers fined in § 1300.02 of this chapter. The requirements in subpart C apply to regu- 1314.20 Restrictions on sales quantity. lated persons who ship the products to 1314.25 Requirements for retail transactions. the customer by the U.S. Postal Serv- 1314.30 Recordkeeping for retail trans- ice or by private or common carriers. actions. 1314.35 Training of sales personnel. § 1314.03 Definitions. 1314.40 Self-certification. As used in this part, the term ‘‘mail- 1314.42 Self-certification fee; time and order sale’’ means a retail sale of method of fee payment. 1314.45 Privacy protections. scheduled listed chemical products for 1314.50 Employment measures. personal use where a regulated person uses or attempts to use the U.S. Postal Subpart C—Mail-Order Sales Service or any private or commercial carrier to deliver the product to the 1314.100 Sales limits for mail-order sales. customer. Mail-order sale includes pur- 1314.101 Training of sales personnel. 1314.102 Self-certification. chase orders submitted by phone, mail, 1314.103 Self-certification fee; time and fax, Internet, or any method other method of fee payment. than face-to-face transaction. 1314.105 Verification of identity for mail- order sales. § 1314.05 Requirements regarding 1314.110 Reports for mail-order sales. packaging of nonliquid forms. 1314.115 Distributions not subject to report- A regulated seller or mail order dis- ing requirements. tributor may not sell a scheduled listed Subpart D—Order To Show Cause chemical product in nonliquid form (including gel caps) unless the product is 1314.150 Order to show cause. packaged either in blister packs, with 1314.155 Suspension pending final order. each blister containing no more than AUTHORITY: 21 U.S.C. 802, 830, 842, 871(b), two dosage units or, if blister packs are 875, 877, 886a. technically infeasible, in unit dose SOURCE: 71 FR 56024, Sept. 26, 2006, unless packets or pouches. otherwise noted. § 1314.10 Effect on State laws. Subpart A—General Nothing in this part preempts State law on the same subject matter unless § 1314.01 Scope. there is a positive conflict between this This part specifies the requirements part and a State law so that the two for retail sales of scheduled listed cannot consistently stand together. chemical products to individuals for personal use. § 1314.15 Loss reporting. (a) Each regulated person must re- § 1314.02 Applicability. port to the Special Agent in Charge of (a) This part applies to the following the DEA Divisional Office for the area regulated persons who sell scheduled in which the regulated person making 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.

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(c) Written reports of losses must be cabinet that is located in an area of the filed within 15 days after the regulated facility where customers do have direct person becomes aware of the cir- access. Mobile retail vendors must cumstances of the event. place the product in a locked cabinet. (d) A report submitted under this sec- (c) The regulated seller must deliver tion must include a description of the the product directly into the custody circumstances of the loss (in-transit, of the purchaser. theft from premises, etc.). (e) A suggested format for the report § 1314.30 Recordkeeping for retail is provided below: transactions. (a) Except for purchase by an indi- Regulated Person vidual of a single sales package con- Registration number (if applicable) llll taining not more than 60 milligrams of Name llllllllllllllllllll pseudoephedrine, the regulated seller Business address llllllllllllll must maintain, in accordance with cri- City lllllllllllllllllllll State llllllllllllllllllll teria issued by the Administrator, a Zip lllllllllllllllllllll written or electronic list of each sched- Business phone lllllllllllllll uled listed chemical product sale that Date of loss lllllllllllllllll identifies the products by name, the Type of loss lllllllllllllllll quantity sold, the names and addresses Description of circumstances llllllll of the purchasers, and the dates and times of the sales (referred to as the Subpart B—Sales by Regulated ‘‘logbook’’). Sellers (b) The regulated seller must not sell a scheduled listed chemical product at § 1314.20 Restrictions on sales quan- retail unless the sale is made in accord- tity. ance with the following: (a) Without regard to the number of (1) The purchaser presents an identi- transactions, a regulated seller (includ- fication card that provides a photo- ing a mobile retail vendor) may not in graph and is issued by a State or the a single calendar day sell any pur- Federal Government, or a document chaser more than 3.6 grams of ephed- that, with respect to identification, is rine base, 3.6 grams of pseudoephedrine considered acceptable for purposes of 8 base, or 3.6 grams of phenylpropanola- CFR 274a.2(b)(1)(v)(A) and mine base in scheduled listed chemical 274a.2(b)(1)(v)(B). products. (2) The purchaser signs the logbook (b) A mobile retail vendor may not in as follows: any 30-day period sell an individual (i) For written logbooks, enters in purchaser more than 7.5 grams of the logbook his name, address, and the ephedrine base, 7.5 grams of date and time of the sale. pseudoephedrine base, or 7.5 grams of (ii) For electronic logbooks, provides phenylpropanolamine base in scheduled a signature using one of the following listed chemical products. means: (A) Signing a device presented by the § 1314.25 Requirements for retail seller that captures signatures in an transactions. electronic format. The device must dis- (a) Each regulated seller must ensure play the warning notice in paragraph that sales of a scheduled listed chem- (d) of this section. Any device used ical product at retail are made in ac- must preserve each signature in a man- cordance with this section and § 1314.20. ner that clearly links that signature to (b) The regulated seller must place the other electronically captured log- the product so that customers do not book information relating to the pro- have direct access to the product be- spective purchaser providing that sig- fore the sale is made (in this paragraph nature. referred to as ‘‘behind-the-counter’’ (B) Signing a bound paper book. placement). For purposes of this para- (1) The bound paper book must in- graph, a behind-the-counter placement clude, for such purchaser, either— of a product includes circumstances in (i) A printed sticker affixed to the which the product is stored in a locked bound paper book at the time of sale

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that either displays the name of each the name entered in the logbook cor- product sold, the quantity sold, the responds to the name provided on the name and address of the purchaser, and identification and that the date and the date and time of the sale, or a time entered are correct. unique identifier which can be linked (2) If the seller enters the informa- to that electronic information, or tion, the prospective purchaser must (ii) A unique identifier that can be verify that the information is correct. linked to that information and that is (3) Such information may be cap- written into the book by the seller at tured through electronic means, in- the time of sale. cluding through electronic data cap- (2) The purchaser must sign adjacent ture through bar code reader or similar to the printed sticker or written technology. unique identifier related to that sale. (d) The regulated seller must include The bound paper book must display the in the written or electronic logbook or warning notice in paragraph (d) of this display by the logbook, the following section. notice: (C) Signing a printed document that includes, for the purchaser, the name WARNING: Section 1001 of Title 18, United of each product sold, the quantity sold, States Code, states that whoever, with respect to the logbook, knowingly and will- the name and address of the purchaser, fully falsifies, conceals, or covers up by any and the date and time of the sale. The trick, scheme, or device a material fact, or document must be printed by the seller makes any materially false, fictitious, or at the time of the sale. The document fraudulent statement or representation, or must contain a clearly identified signa- makes or uses any false writing or document ture line for a purchaser to sign. The knowing the same to contain any materially printed document must display the false, fictitious, or fraudulent statement or warning notice in paragraph (d) of this entry, shall be fined not more than $250,000 if an individual or $500,000 if an organization, section. Each signed document must be imprisoned not more than five years, or inserted into a binder or other secure both. means of document storage immediately after the purchaser signs the (e) The regulated seller must main- document. tain each entry in the written or elec- (3) The regulated seller must enter in tronic logbook for not fewer than two the logbook the name of the product years after the date on which the entry and the quantity sold. Examples of is made. methods of recording the quantity sold (f) A record under this section must include the weight of the product per be kept at the regulated seller’s place package and number of packages of of business where the transaction oc- each chemical, the cumulative weight curred, except that records may be of the product for each chemical, or kept at a single, central location of the quantity of product by Universal Prod- regulated seller if the regulated seller uct Code. These examples do not ex- has notified the Administration of the clude other methods of displaying the intention to do so. Written notification quantity sold. Such information may must be submitted by registered or cer- be captured through electronic means, tified mail, return receipt requested, to including through electronic data cap- the Special Agent in Charge of the ture through bar code reader or similar DEA Divisional Office for the area in technology. Such electronic records which the records are required to be must be provided pursuant to para- kept. graph (g) of this section in a human (g) The records required to be kept readable form such that the require- under this section must be readily re- ments of paragraph (a) of this section trievable and available for inspection are satisfied. and copying by authorized employees (c) The logbook maintained by the of the Administration under the provi- seller must include the prospective sions of section 510 of the Act (21 U.S.C. purchaser’s name, address, and the 880). date and time of the sale, as follows: (h) A record developed and main- (1) If the purchaser enters the infor- tained to comply with a State law may mation, the seller must determine that be used to meet the requirements of

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this section if the record includes the (c) The regulated seller must provide information specified in this section. a separate certification for each place of business at which the regulated sell- [76 FR 74698, Dec. 1, 2011] er sells scheduled listed chemical prod- § 1314.35 Training of sales personnel. ucts at retail. Each regulated seller must ensure § 1314.42 Self-certification fee; time that its sales of a scheduled listed and method of fee payment. chemical product at retail are made in (a) A regulated seller must pay a fee accordance with the following: (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 § 1314.30 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. (b) When a regulated seller files the (c) A regulated seller who in good initial self-certification, the Adminis- faith releases information in a logbook tration will assign the regulated seller to Federal, State, or local law enforce- to one of twelve groups. The expiration ment authorities is immune from civil date of the self-certification for all reg- liability for the release unless the re- ulated sellers in any group will be the lease constitutes gross negligence or last day of the month designated for intentional, wanton, or willful mis- that group. In assigning a regulated conduct. seller to a group, the Administration may select a group with an expiration [71 FR 56024, Sept. 26, 2006, as amended at 77 date that is not less than 12 months or FR 4238, Jan. 27, 2012] more than 23 months from the date of the self-certification. After the initial § 1314.50 Employment measures. certification period, the regulated sell- A regulated seller may take reason- er must update the self-certifications able measures to guard against em- annually. ploying individuals who may present a

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risk with respect to the theft and di- gone training provided by the regu- version of scheduled listed chemical lated person to ensure that the individ- products, which may include, notwith- uals understand the requirements that standing State law, asking applicants apply under this part. for employment whether they have (b) The regulated person maintains a been convicted of any crime involving copy of each self-certification and all or related to such products or con- records demonstrating that individuals trolled substances. referred to in paragraph (a) of this section have undergone the training. Subpart C—Mail-Order Sales [76 FR 20523, Apr. 13, 2011] § 1314.100 Sales limits for mail-order sales. § 1314.102 Self-certification. (a) Each regulated person who makes (a) A regulated person who makes a a sale at retail of a scheduled listed sale at retail of a scheduled listed chemical product and is required under chemical product and is required under § 1310.03(c) of this chapter to submit a § 1310.03 of this chapter to submit a re- report of the sales transaction to the port of the sales transaction to the At- Administration may not in a single torney General must submit to the Ad- calendar day sell to any purchaser ministration the self-certification re- more than 3.6 grams of ephedrine base, ferred to in § 1314.101(a) in order to sell 3.6 grams of pseudoephedrine base, or any scheduled listed chemical product. 3.6 grams of phenylpropanolamine base The certification is not effective for in scheduled listed chemical products. purposes of this section unless, in addi- (b) Each regulated person who makes tion to provisions regarding the train- a sale at retail of a scheduled listed ing of individuals referred to in chemical product and is required under § 1314.101(a), the certification includes a § 1310.03(c) of this chapter to submit a statement that the regulated person report of the sales transaction to the understands each of the requirements Administration may not in any 30-day that apply in this part and agrees to period sell to an individual purchaser comply with the requirements. more than 7.5 grams of ephedrine base, (b) When a regulated person files the 7.5 grams of pseudoephedrine base, or initial self-certification, the Adminis- 7.5 grams of phenylpropanolamine base tration will assign the regulated person in scheduled listed chemical products. to one of twelve groups. The expiration date of the self-certification for all reg- § 1314.101 Training of sales personnel. ulated persons in any group will be the Each regulated person who makes a last day of the month designated for sale at retail of a scheduled listed that group. In assigning a regulated chemical product and is required under person to a group, the Administration § 1310.03(c) of this chapter to submit a may select a group with an expiration report of the sales transaction to the date that is not less than 12 months or Administration must ensure that its more than 23 months from the date of sales of a scheduled listed chemical self-certification. After the initial cer- product at retail are made in accord- tification period, the regulated person ance with the following: must update the self-certification an- (a) In the case of individuals who are nually. responsible for preparing and pack- (c) The regulated person who makes a aging scheduled listed chemical prod- sale at retail of a scheduled listed ucts for delivery to purchasers through chemical product and is required under the Postal Service or any private or § 1310.03 of this chapter to submit a re- commercial carrier or who deal either port of the sales transaction to the At- directly or indirectly with purchasers torney General must provide a separate by obtaining payments for the prod- certification for each place of business ucts, the regulated person has sub- at which the regulated person sells mitted to the Administration a self- scheduled listed chemical products at certification that all such individuals retail. have, in accordance with criteria issued by the Administration, under- [76 FR 20523, Apr. 13, 2011]

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§ 1314.103 Self-certification fee; time dresses provided. If the regulated per- and method of fee payment. son cannot verify the identities of both (a) Each regulated person who makes the purchaser and the recipient, the a sale at retail of a scheduled listed person may not ship the scheduled list- chemical product and is required under ed chemical product. § 1310.03 of this chapter to submit a re- § 1314.110 Reports for mail-order sales. port of the sales transaction to the Ad- ministration must pay a fee for each (a) Each regulated person required to self-certification. For each initial ap- report under § 1310.03(c) of this chapter plication to self-certify, and for the re- must either: newal of each existing self-certifi- (1) Submit a written report, con- cation, a regulated seller shall pay a taining the information set forth in fee of $21. paragraph (b) of this section, on or be- (b) The fee for self-certification shall fore the 15th day of each month fol- be waived for any person holding a cur- lowing the month in which the dis- rent, DEA registration in good stand- tributions took place. The report must ing as a pharmacy to dispense con- be submitted under company letter- trolled substances. head, signed by the person authorized (c) A regulated person shall pay the to sign on behalf of the regulated sell- fee at the time of self-certification. er, to the Import/Export Unit, Drug En- (d) Payment shall be made by credit forcement Administration (see the card. Table of DEA Mailing Addresses in (e) The self-certification fee is not re- § 1321.01 of this chapter for the current fundable. mailing address); or (2) Upon request to and approval by [76 FR 20523, Apr. 13, 2011] the Administration, submit the report in electronic form, either via computer § 1314.105 Verification of identity for disk or direct electronic data trans- mail-order sales. mission, in such form as the Adminis- (a) Each regulated person who makes tration shall direct. Requests to sub- a sale at retail of a scheduled listed mit reports in electronic form should chemical product and is required under be submitted to the Import/Export § 1310.03(c) of this chapter to submit a Unit, Drug Enforcement Administra- report of the sales transaction to the tion. See the Table of DEA Mailing Ad- Administration must, prior to shipping dresses in § 1321.01 of this chapter for the product, receive from the purchaser the current mailing address. a copy of an identification card that (b) Each monthly report must pro- provides a photograph and is issued by vide the following information for each a State or the Federal Government, or distribution: a document that, with respect to iden- (1) Supplier name and registration tification, is considered acceptable for number; purposes of 8 CFR 274a.2(b)(1)(v)(A) and (2) Purchaser’s name and address; 274a.2(b)(1)(v)(B). Prior to shipping the (3) Name/address shipped to (if dif- product, the regulated person must de- ferent from purchaser’s name/address); termine that the name and address on (4) Method used to verify the identity the identification correspond to the of the purchaser and, where applicable, name and address provided by the pur- person to whom product is shipped; chaser as part of the sales transaction. (5) Name of the chemical contained If the regulated person cannot verify in the scheduled listed chemical prod- the identities of both the purchaser uct and total quantity shipped (e.g. and the recipient, the person may not pseudoephedrine, 3 grams); ship the scheduled listed chemical (6) Date of shipment; product. (7) Product name; (b) If the product is being shipped to (8) Dosage form (e.g., tablet, liquid); a third party, the regulated person (9) Dosage strength (e.g., 30mg, 60mg, must comply with the requirements of per dose etc.); paragraph (a) to verify that both the (10) Number of dosage units (e.g., 100 purchaser and the person to whom the doses per package); product is being shipped live at the ad- (11) Package type (blister pack, etc.);

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(12) Number of packages; under § 1310.03(c) of this chapter has (13) Lot number. sold a scheduled listed chemical prod- [71 FR 56024, Sept. 26, 2006, as amended at 75 uct in violation of Section 402 of the FR 10684, Mar. 9, 2010] Act (21 U.S.C. 842(a)(12) or (13)), the Ad- ministrator will serve upon the regu- § 1314.115 Distributions not subject to lated seller or distributor an order to reporting requirements. show cause why the regulated seller or (a) The following distributions to distributor should not be prohibited nonregulated persons are not subject to from selling scheduled listed chemical the reporting requirements in § 1314.110: products. (1) Distributions of sample packages (b) The order to show cause shall call when those packages contain not more upon the regulated seller or distributor than two solid dosage units or the to appear before the Administrator at a equivalent of two dosage units in liquid time and place stated in the order, form, not to exceed 10 milliliters of liq- which shall not be less than 30 days uid per package, and not more than one after the date of receipt of the order. package is distributed to an individual The order to show cause shall also con- or residential address in any 30-day pe- tain a statement of the legal basis for riod. such hearing and for the prohibition (2) Distributions by retail distribu- and a summary of the matters of fact tors that may not include face-to-face transactions to the extent that such and law asserted. distributions are consistent with the (c) Upon receipt of an order to show activities authorized for a retail dis- cause, the regulated seller or distributor as specified in the definition tributor must, if he desires a hearing, of retail distributor in § 1300.02 of this file a request for a hearing as specified chapter, except that this paragraph in subpart D of part 1316 of this chap- (a)(2) does not apply to sales of sched- ter. If a hearing is requested, the Ad- uled listed chemical products at retail. ministrator shall hold a hearing at the (3) Distributions to a resident of a time and place stated in the order, as long term care facility or distributions provided in part 1316 of this chapter. to a long term care facility for dis- (d) When authorized by the Adminis- pensing to or for use by a resident of trator, any agent of the Administra- that facility. tion may serve the order to show (4) Distributions in accordance with a cause. valid prescription. (b) The Administrator may revoke § 1314.155 Suspension pending final any or all of the exemptions listed in order. paragraph (a) of this section for an in- (a) The Administrator may suspend dividual regulated person if the Admin- the right to sell scheduled listed chem- istrator finds that drug products distributed by the regulated person are ical products simultaneously with, or being used in violation of the regula- at any time subsequent to, the service tions in this chapter or the Controlled upon the seller or distributor required Substances Act. to file reports under § 1310.03(c) of this chapter of an order to show cause why [[71 FR 56024, Sept. 26, 2006, as amended at 77 the regulated seller or distributor FR 4238, Jan. 27, 2012] should not be prohibited from selling scheduled listed chemical products, in Subpart D—Order to Show Cause any case where he finds that there is § 1314.150 Order To show cause. an imminent danger to the public health or safety. If the Administrator (a) If, upon information gathered by so suspends, he shall serve with the the Administration regarding any reg- order to show cause under § 1314.150 an ulated seller or a distributor required order of immediate suspension that to submit reports under § 1310.03(c) of shall contain a statement of his find- this chapter, the Administrator determines that a regulated seller or dis- ings regarding the danger to public tributor required to submit reports health or safety.

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(b) Upon service of the order of im- 1315.27 Abandonment of quota. mediate suspension, the regulated seller or distributor shall, as instructed by Subpart D—Procurement and Import the Administrator: Quotas (1) Deliver to the nearest office of the 1315.30 Procurement and import quotas. Administration or to authorized agents 1315.32 Obtaining a procurement quota. of the Administration all of the sched- 1315.33 Power of attorney. uled listed chemical products in his or 1315.34 Obtaining an import quota. her possession; or 1315.36 Amending an import quota. (2) Place all of the scheduled listed Subpart E—Hearings chemical products under seal as described in Section 304 of the Act (21 1315.50 Hearings generally. U.S.C. 824(f)). 1315.52 Purpose of hearing. (c) Any suspension shall continue in 1315.54 Waiver or modification of rules. effect until the conclusion of all pro- 1315.56 Request for hearing or appearance; ceedings upon the prohibition, includ- waiver. 1315.58 Burden of proof. ing any judicial review, unless sooner 1315.60 Time and place of hearing. withdrawn by the Administrator or dis- 1315.62 Final order. solved by a court of competent jurisdiction. Any regulated seller or dis- SOURCE: 72 FR 37448, July 10, 2007, unless otherwise noted. tributor whose right to sell scheduled listed chemical products is suspended AUTHORITY: 21 U.S.C. 802, 821, 826, 871(b), under this section may request a hear- 952. ing on the suspension at a time earlier than specified in the order to show Subpart A—General Information cause under § 1314.150, which request shall be granted by the Administrator, § 1315.01 Scope. who shall fix a date for such hearing as This part specifies procedures gov- early as reasonably possible. erning the establishment of an assessment of annual needs, procurement and PART 1315—IMPORTATION AND manufacturing quotas pursuant to sec- PRODUCTION QUOTAS FOR tion 306 of the Act (21 U.S.C. 826), and import quotas pursuant to section 1002 EPHEDRINE, PSEUDOEPHEDRINE, of the Act (21 U.S.C. 952) for ephedrine, AND PHENYLPROPANOLAMINE pseudoephedrine, and phenylpropanolamine. Subpart A—General Information Sec. § 1315.02 Definitions. 1315.01 Scope. (a) Except as specified in paragraphs 1315.02 Definitions. (b) and (c) of this section, any term 1315.03 Personal use exemption. contained in this part shall have the 1315.05 Applicability. definition set forth in section 102 of the Subpart B—Assessment of Annual Needs Act (21 U.S.C. 802) or part 1300 of this chapter. 1315.11 Assessment of annual needs. (b) The term net disposal means, for a 1315.13 Adjustments of assessment of annual stated period, the sum of paragraphs needs. (b)(1) through (b)(3) of this section minus the sum of paragraphs (b)(4) and Subpart C—Individual Manufacturing (b)(5) of this section: Quotas (1) The quantity of ephedrine, 1315.21 Individual manufacturing quotas. pseudoephedrine, or phenylpropanola- 1315.22 Procedure for applying for individual mine distributed by the registrant to manufacturing quotas. another person. 1315.23 Procedure for fixing individual man- (2) The quantity of that chemical ufacturing quotas. used by the registrant in the produc- 1315.24 Inventory allowance. 1315.25 Increase in individual manufac- tion of (or converted by the registrant turing quotas. into) another chemical or product. 1315.26 Reduction in individual manufac- (3) The quantity of that chemical turing quotas. otherwise disposed of by the registrant.

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(4) The quantity of that chemical re- taining ephedrine, pseudoephedrine, turned to the registrant by any pur- and phenylpropanolamine, necessary to chaser. be manufactured and imported during (5) The quantity of that chemical dis- the following calendar year to provide tributed by the registrant to a reg- for the estimated medical, scientific, istered manufacturer of that chemical research, and industrial needs of the for purposes other than use in the pro- United States, for lawful export reduction of, or conversion into, another quirements, and for the establishment chemical or in the manufacture of dos- and maintenance of reserve stocks. age forms of that chemical. (b) In making his determinations, the (c) Ephedrine, pseudoephedrine, and Administrator shall consider the fol- phenylpropanolamine include their lowing factors: salts, optical isomers, and salts of opti- (1) Total net disposal of the chemical cal isomers. by all manufacturers and importers during the current and 2 preceding § 1315.03 Personal use exemption. years; A person need not register as an im- (2) Trends in the national rate of net porter, file an import declaration, and disposal of each chemical; obtain an import quota if both of the (3) Total actual (or estimated) inven- following conditions are met: tories of the chemical and of all sub- (a) The person purchases scheduled stances manufactured from the chem- listed chemical products at retail and ical, and trends in inventory accumula- imports them for personal use, by tion; means of shipping through any private (4) Projected demand for each chem- or commercial carrier or the Postal ical as indicated by procurement and Service. import quotas requested pursuant to (b) In any 30-day period, the person § 1315.32; and imports no more than 7.5 grams of (5) Other factors affecting medical, ephedrine base, 7.5 grams of scientific, research, and industrial pseudoephedrine base, and 7.5 grams of needs in the United States, lawful ex- phenylpropanolamine base in scheduled port requirements, and the establish- listed chemical products. ment and maintenance of reserve stocks, as the Administrator finds rel- § 1315.05 Applicability. evant, including changes in the cur- This part applies to all of the fol- rently accepted medical use in treat- lowing: ment with the chemicals or the sub- (a) Persons registered to manufac- stances which are manufactured from ture (including repackaging or re- them, the economic and physical avail- labeling) or to import ephedrine, ability of raw materials for use in man- pseudoephedrine, or phenylpropanola- ufacturing and for inventory purposes, mine as bulk chemicals. yield and stability problems, potential (b) Persons registered to manufac- disruptions to production (including ture (including repackaging or re- possible labor strikes), and recent un- labeling) or to import prescription and foreseen emergencies such as floods over-the-counter drug products con- and fires. taining ephedrine, pseudoephedrine, or (c) The Administrator shall, on or be- phenylpropanolamine that may be law- fore May 1 of each year, publish in the fully marketed and distributed in the FEDERAL REGISTER, general notice of United States under the Federal Food, an assessment of annual needs for Drug, and Cosmetic Act. ephedrine, pseudoephedrine, and phenylpropanolamine determined by him Subpart B—Assessment of Annual under this section. A notice of the pub- Needs lication shall be mailed simultaneously to each person registered to manufac- § 1315.11 Assessment of annual needs. ture or import the chemical. (a) The Administrator shall deter- (d) The Administrator shall permit mine the total quantity of ephedrine, any interested person to file written pseudoephedrine, and phenylpropanola- comments on or objections to the pro- mine, including drug products con- posed assessment of annual needs and

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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 possible labor strikes), and recent un- § 1315.13 Adjustments of the assess- foreseen emergencies such as floods ment of annual needs. and fires. (a) The Administrator may at any (c) In the event that the Adminis- time increase or reduce the assessment trator determines to increase or reduce of annual needs for ephedrine, the assessment of annual needs for a pseudoephedrine, or phenylpropanola- chemical, the Administrator shall pub- mine that has been previously fixed lish in the FEDERAL REGISTER general pursuant to § 1315.11. notice of an adjustment in the assess- (b) In determining to adjust the as- ment of annual needs for that chemical sessment of annual needs, the Adminis- as determined under this section. A no- trator shall consider the following fac- tice of the publication shall be mailed tors: simultaneously to each person reg- (1) Changes in the demand for that istered as a manufacturer or importer chemical, changes in the national rate of the chemical. of net disposal of the chemical, and (d) The Administrator shall permit changes in the rate of net disposal of any interested person to file written the chemical by registrants holding in- comments on or objections to the pro- dividual manufacturing or import posal and shall designate in the notice quotas for that chemical; the time during which such filings may (2) Whether any increased demand for be made. that chemical, the national and/or (e) The Administrator may, but is changes in individual rates of net dis- not required to, hold a public hearing posal of that chemical are temporary, on one or more issues raised by the short term, or long term; comments and objections filed with (3) Whether any increased demand for him. In the event the Administrator that chemical can be met through ex- decides to hold such a hearing, he shall isting inventories, increased individual publish a notice of the hearing in the manufacturing quotas, or increased im- FEDERAL REGISTER. The notice shall portation, without increasing the as- summarize the issues to be heard and

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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. A notice of the publication shall be (2) The actual or estimated quantity mailed simultaneously to each person manufactured; registered as a manufacturer or im- (3) The actual or estimated net dis- porter of the chemical. posal; (4) The actual or estimated inventory Subpart C—Individual allowance pursuant to § 1315.24; and Manufacturing Quotas (5) The actual or estimated inventory as of December 31. § 1315.21 Individual manufacturing (c) For the chemical in the next cal- quotas. endar year, The Administrator shall, on or before (1) The desired individual manufac- July 1 of each year, fix for and issue to turing quota; and each person registered to manufacture (2) Any additional factors that the in bulk ephedrine, pseudoephedrine, or applicant finds relevant to the fixing of phenylpropanolamine who applies for a the individual manufacturing quota, manufacturing quota an individual including any of the following: manufacturing quota authorizing that (i) The trend of (and recent changes person to manufacture during the next in) the applicant’s and the national calendar year a quantity of that chem- rates of net disposal. ical. Any manufacturing quota fixed (ii) The applicant’s production cycle and issued by the Administrator is sub- and current inventory position. ject to his authority to reduce or limit (iii) The economic and physical avail- it at a later date pursuant to § 1315.26 ability of raw materials for use in man- and to his authority to revoke or sus- ufacturing and for inventory purposes. pend it at any time pursuant to (iv) Yield and stability problems. §§ 1301.36, 1309.43, 1309.44, or 1309.45 of (v) Potential disruptions to produc- this chapter. tion (including possible labor strikes). § 1315.22 Procedure for applying for (vi) Recent unforeseen emergencies individual manufacturing quotas. such as floods and fires. Any person who is registered to man- [72 FR 37448, July 10, 2007, as amended at 73 ufacture ephedrine, pseudoephedrine, FR 73555, Dec. 3, 2008; 75 FR 10684, Mar. 9, or phenylpropanolamine and who de- 2010] sires to manufacture a quantity of the chemical must apply on DEA Form 189 § 1315.23 Procedure for fixing indi- for a manufacturing quota for the vidual manufacturing quotas. quantity of the chemical. Copies of (a) In fixing individual manufac- DEA Form 189 may be obtained from turing quotas for ephedrine, the Office of Diversion Control Web pseudoephedrine, and phenylpropanola- site, and must be filed (on or before mine, the Administrator shall allocate April 1 of the year preceding the cal- to each applicant who is currently endar year for which the manufac- manufacturing the chemical a quota turing quota is being applied) with the equal to 100 percent of the estimated Drug & Chemical Evaluation Section, net disposal of that applicant for the Drug Enforcement Administration. See next calendar year, adjusted—

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(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 next calendar year, as determined by of a chemical held by a manufacturer the Administrator, adjusted— exceeds 65 percent of his estimated net (1) By the amount necessary to pro- disposal, his quota for that chemical is vide the applicant his estimated inven- automatically suspended and shall re- tory allowance for the next calendar main suspended until his inventory is year, pursuant to § 1315.24; and less than 60 percent of his estimated (2) By any other factors which the net disposal. The Administrator may, Administrator deems relevant to the upon application and for good cause fixing of the individual manufacturing shown, permit a manufacturer whose quota of the applicant, including any of quota is, or is likely to be, suspended the following: under this paragraph to continue man- (i) The trend of (and recent changes ufacturing and to accumulate an inven- in) the national rate of net disposal. tory in excess of 65 percent of his esti- (ii) The applicant’s production cycle mated net disposal, upon such condi- and current inventory position. tions and within such limitations as (iii) The economic and physical avail- the Administrator may find necessary ability of raw materials for use in man- or desirable. ufacturing and for inventory purposes. (c) If, during a calendar year, a reg- (iv) Yield and stability problems. istrant has manufactured the entire (v) Potential disruptions to produc- quantity of a chemical allocated to tion (including possible labor strikes). him under an individual manufacturing (vi) Recent unforeseen emergencies quota, and his inventory of that chem- such as floods and fires. ical is less than 40 percent of his esti- (c) On or before March 1 of each year mated net disposal of that chemical for the Administrator shall adjust the in- that year, the Administrator may, dividual manufacturing quota allo- upon application pursuant to § 1315.25, cated for that year to each applicant in increase the quota of such registrant paragraph (a) of this section by the sufficiently to allow restoration of the

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inventory to 50 percent of the esti- portionately reduce the individual mated net disposal for that year. manufacturing quotas and import quotas of all other registrants to keep § 1315.25 Increase in individual manu- the assessment of annual needs within facturing quotas. 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 §§ 1301.36, 1309.43, 1309.44, or 1309.45 of quota to meet the registrant’s esti- this chapter or is abandoned pursuant mated net disposal, inventory, and to § 1315.27. other requirements during the remainder of that calendar year. § 1315.27 Abandonment of quota. (b) The Administrator, in passing Any manufacturer assigned an indi- upon a registrant’s application for an vidual manufacturing quota for a increase in the individual manufac- chemical pursuant to § 1315.23 may at turing quota, shall take into consider- any time abandon his right to manu- ation any occurrences since the filing facture all or any part of the quota by of the registrant’s initial quota appli- filing with the Drug & Chemical Eval- cation that may require an increased uation Section a written notice of the manufacturing rate by the registrant abandonment, stating the name and during the balance of the calendar DEA Chemical Code Number, as set year. In passing upon the application forth in part 1310 of this chapter, of the the Administrator may also take into chemical and the amount which he has consideration the amount, if any, by chosen not to manufacture. The Ad- which his determination of the total ministrator may, in his discretion, al- quantity for the chemical to be manu- locate the amount among the other factured under § 1315.11 exceeds the ag- manufacturers in proportion to their gregate of all the individual manufac- respective quotas. turing quotas for the chemical, and the equitable distribution of such excess Subpart D—Procurement and among other registrants. Import Quotas § 1315.26 Reduction in individual man- § 1315.30 Procurement and import ufacturing quotas. quotas. The Administrator may at any time (a) To determine the estimated needs reduce an individual manufacturing for, and to insure an adequate and un- quota for a chemical that he has pre- interrupted supply of, ephedrine, viously fixed to prevent the aggregate pseudoephedrine, and phenylpropanola- of the individual manufacturing quotas mine the Administrator shall issue pro- and import quotas outstanding or to be curement and import quotas. granted from exceeding the assessment (b) A procurement quota authorizes a of annual needs that has been estab- registered manufacturer to procure and lished for that chemical pursuant to use quantities of each chemical for the § 1315.11, as adjusted pursuant to following purposes: § 1315.13. If a quota assigned to a new (1) Manufacturing the bulk chemical manufacturer pursuant to § 1315.23(b), into dosage forms. or if a quota assigned to any manufac- (2) Manufacturing the bulk chemical turer is increased pursuant to into other substances. § 1315.24(c), or if an import quota issued (3) Repackaging or relabeling the to an importer pursuant to § 1315.34, chemical or dosage forms. causes the total quantity of a chemical (c) An import quota authorizes a reg- to be manufactured and imported dur- istered importer to import quantities ing the year to exceed the assessment of the chemical for the following pur- of annual needs that has been estab- poses: lished for that chemical pursuant to (1) Distribution of the chemical to a § 1315.11, as adjusted pursuant to registered manufacturer that has a § 1315.13, the Administrator may pro- procurement quota for the chemical.

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(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 separately all of the following: trator with a statement showing the (1) Each purpose for which the chem- need for the adjustment. The applica- ical is desired. tion must be filed with the Drug & (2) The quantity desired for each pur- Chemical Evaluation Section, Drug En- pose during the next calendar year. forcement Administration. See the (3) The quantities used and estimated Table of DEA Mailing Addresses in to be used, if any, for that purpose dur- § 1321.01 of this chapter for the current ing the current and preceding 2 cal- mailing address. The Administrator endar years. shall increase or decrease the procure- (c) If the purpose is to manufacture ment quota of the person if and to the the chemical into dosage form, the ap- extent that he finds, after considering plicant must state the official name, the factors enumerated in paragraph (f) common or usual name, chemical of this section and any occurrences name, or brand name of that form. If since the issuance of the procurement the dosage form produced is a con- quota, that the need justifies an ad- trolled substance listed in any sched- justment. ule, the applicant must also state the (h) Any person to whom a procure- schedule number and National Drug ment quota has been issued, author- Code Number, of the substance. izing that person to procure and use a (d) If the purpose is to manufacture quantity of ephedrine, another chemical, the applicant must pseudoephedrine, or phenylpropanola- state the official name, common or mine during the current calendar year, usual name, chemical name, or brand must, at or before the time of placing name of the substance and the DEA an order with another manufacturer or Chemical Code Number, as set forth in importer requiring the distribution of a part 1310 of this chapter. quantity of the chemical, certify in (e) DEA Form 250 must be filed on or writing to the other registrant that the before April 1 of the year preceding the quantity of ephedrine, calendar year for which the procure- pseudoephedrine, or phenylpropanola- ment quota is being applied. Copies of mine ordered does not exceed the per- DEA Form 250 may be obtained from son’s unused and available procure- the Office of Diversion Control Web ment quota of the chemical for the cur- site, and must be filed with the Drug & rent calendar year. The written certifi- Chemical Evaluation Section, Drug En- cation must be executed by a person forcement Administration. See the authorized to sign the registration ap- Table of DEA Mailing Addresses in plication pursuant to § 1301.13 or

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§ 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 (1) The date of the certification. Controlled Substances Act or Controlled (2) The name and address of the reg- Substances Import and Export Act, have istrant to whom the certification is di- made, constituted, and appointed, and by rected. these presents, do make, constitute, and ap- (3) A reference to the purchase order point llllll (name of attorney-in-fact), number to which the certification ap- my true and lawful attorney for me in my 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 order to which the certification ap- in accordance with Part 1315 of Title 21 of plies. the Code of Federal Regulations. I hereby (5) The name of the chemical to ratify and confirm all that said attorney which the certification applies. must lawfully do or cause to be done by vir- (6) A statement that the quantity tue hereof. (expressed in grams) of the chemical to llllllllllllllllllllllll which the certification applies does not (Signature of person granting power) exceed the unused and available pro- I, llllll (name of attorney-in-fact), curement quota of the chemical, issued hereby affirm that I am the person named to the person giving the order, for the herein as attorney-in-fact and that the sig- current calendar year. nature affixed hereto is my signature. (7) The signature of the individual (Signature of attorney-in-fact) authorized to sign a certification as Witnesses: provided in paragraph (h) of this sec- 1. llllll tion. 2. llllll [72 FR 37448, July 10, 2007, as amended at 73 Signed and dated on the ll day of l, FR 73555, Dec. 3, 2008; 75 FR 10684, Mar. 9, (year), at llllll. 2010] Notice of Revocation § 1315.33 Power of attorney. The foregoing power of attorney is hereby (a) A registrant may authorize one or revoked by the undersigned, who is author- more individuals, whether or not lo- ized to sign the current application for registration of the above-named registrant cated at his registered location, to sign under the Controlled Substances Act or the certifications required under § 1315.32(h) Controlled Substances Import and Export on the registrant’s behalf by executing Act. Written notice of this revocation has a power of attorney for each such indi- been given to the attorney-in-fact vidual. The registrant shall retain the llllll this same day. power of attorney in the files, with cer- llllllllllllllllllllllll tifications required by § 1315.32(h), for (Signature of person revoking power) the same period as any certification Witnesses: bearing the signature of the attorney. 1. llllll The power of attorney must be avail- 2. llllll able for inspection together with other Signed and dated on the ll day of l, certification records. (year), at llllll.

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(d) A power of attorney must be exe- (iii) Acquisition—imports. cuted by the person who signed the (c) For each form of the chemical most recent application for DEA reg- (bulk or dosage unit), the applicant istration or reregistration; the person must state the quantity desired for im- to whom the power of attorney is being port during the next calendar year. granted; and two witnesses. (d) DEA Form 488 must be filed on or (e) A power of attorney must be re- before April 1 of the year preceding the voked by the person who signed the calendar year for which the import most recent application for DEA reg- quota is being applied. Copies of DEA istration or reregistration, and two Form 488 may be obtained from the Of- witnesses. fice of Diversion Control Web site, and must be filed with the Drug & Chem- [73 FR 73555, Dec. 3, 2008] ical Evaluation Section. See the Table § 1315.34 Obtaining an import quota. of DEA Mailing Addresses in § 1321.01 of this chapter for the current mailing ad- (a) Any person who is registered to dress. import ephedrine, pseudoephedrine, or (e) The Administrator may at his dis- phenylpropanolamine, or whose re- cretion request additional information quirement of registration is waived from an applicant. pursuant to § 1309.24(c) of this chapter, (f) On or before July 1 of the year and who desires to import during the preceding the calendar year during next calendar year any ephedrine, which the quota shall be effective, the pseudoephedrine, or phenylpropanola- Administrator shall issue to each mine or drug products containing these qualified applicant an import quota au- chemicals, must apply on DEA Form thorizing him to import: 488 for an import quota for the chem- (1) All quantities of the chemical ical. A separate application must be necessary to manufacture products made for each chemical desired to be that registered manufacturers are au- imported. thorized to manufacture pursuant to (b) The applicant must provide the § 1315.23; and following information in the applica- (2) Such other quantities of the tion: chemical that the applicant has ap- (1) The applicant’s name and DEA plied to import and that are consistent registration number. with his past imports, the estimated (2) The name and address of a contact medical, scientific, and industrial person and contact information (tele- needs of the United States, the estab- phone number, fax number, e-mail ad- lishment and maintenance of reserve dress). stocks, and the total quantity of the (3) Name of the chemical and DEA chemical that will be produced. Chemical Code number. (4) Type of product (bulk or finished [72 FR 37448, July 10, 2007, as amended at 75 dosage forms). FR 10684, Mar. 9, 2010] (5) For finished dosage forms, the official name, common or usual name, § 1315.36 Amending an import quota. chemical name, or brand name, NDC (a) An import quota authorizes the number, and the authority to market registered importer to import up to the the drug product under the Federal set quantity of ephedrine, Food, Drug and Cosmetic Act of each pseudoephedrine, or phenylpropanola- form to be imported. mine and distribute the chemical or (6) The amount requested expressed drug products on the DEA Form 488. An in terms of base. importer must apply to change the (7) For the current and preceding two quantity to be imported. calendar years, expressed in terms of (b) Any person to whom an import base: quota has been issued may at any time (i) Distribution/Sales—name, address, request an increase in the quota quan- and registration number (if applicable) tity by applying to the Administrator of each customer and the amount sold. with a statement showing the need for (ii) Inventory as of December 31 (each the adjustment. The application must form—bulk, in-process, finished dosage be filed with the Drug & Chemical form). Evaluation Section, Drug Enforcement

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Administration. See the Table of DEA or individual manufacturing quota, the Mailing Addresses in § 1321.01 of this Administrator shall hold a hearing for chapter for the current mailing ad- the purpose of receiving factual evi- dress. The Administrator may increase dence regarding the issues involved in the import quota of the person if and the issuance, adjustment, suspension, to the extent that he determines that or denial of the quota to the person, the approval is necessary to provide for but the Administrator need not hold a medical, scientific, or other legitimate hearing on suspension of a quota under purposes regarding the chemical. The § 1301.36 or § 1309.43 of this chapter sepa- Administrator shall specify a period of rate from a hearing on the suspension time for which the approval is in effect of registration under that section. or shall provide that the approval is in (c) Extensive argument should not be effect until the Administrator notifies offered into evidence, but rather pre- the applicant in writing that the ap- sented in opening or closing state- proval is terminated. ments of counsel or in memoranda or (c) With respect to the application proposed findings of fact and conclu- under paragraph (b) of this section, the sions of law. Administrator shall approve or deny the application within 60 days of re- § 1315.54 Waiver or modification of ceiving the application. If the Adminis- rules. trator does not approve or deny the ap- The Administrator or the presiding plication within 60 days of receiving it, officer (with respect to matters pend- the application is deemed to be ap- ing before him) may modify or waive proved and the approval remains in ef- any rule in this part by notice in ad- fect until the Administrator notifies vance of the hearing, if he determines the applicant in writing that the ap- that no party in the hearing will be un- proval is terminated. duly prejudiced and the ends of justice will thereby be served. Such notice of [72 FR 37448, July 10, 2007, as amended at 75 FR 10685, Mar. 9, 2010] modification or waiver shall be made a part of the record of the hearing.

Subpart E—Hearings § 1315.56 Request for hearing or appearance; waiver. § 1315.50 Hearings generally. (a) Any applicant or registrant enti- The procedures for the hearing re- tled to a hearing under § 1315.52 and lated to assessment of annual needs or who desires a hearing on the issuance, to the issuance, adjustment, suspen- adjustment, suspension or denial of a sion, or denial of a manufacturing, pro- procurement, import, or individual curement, or import quota are gov- manufacturing quota must, within 30 erned generally by the adjudication days after the date of receipt of the procedures set forth in the Administra- issuance, adjustment, suspension or de- tive Procedure Act (5 U.S.C. 551–559) nial of the application, file with the and specifically by section 1002 of the Administrator a written request for a Act (21 U.S.C. 952), by §§ 1315.52 through hearing in the form prescribed in 1315.62 of this part, and by the proce- § 1316.47 of this chapter. dures for administrative hearings (b) Any interested person who desires under the Act set forth in §§ 1316.41 a hearing on the determination of an through 1316.67 of this chapter. assessment of annual needs must, within the time prescribed in § 1315.11(c), § 1315.52 Purpose of hearing. file with the Administrator a written (a) The Administrator may, in his request for a hearing in the form pre- sole discretion, hold a hearing for the scribed in § 1316.47 of this chapter, in- purpose of receiving factual evidence cluding in the request a statement of regarding any one or more issues (to be the grounds for the hearing. specified by him) involved in the deter- (c) Any interested person who desires mination or adjustment of any assess- to participate in a hearing on the de- ment of national needs. termination or adjustment of an as- (b) If requested by a person applying sessment of annual needs, which hear- for or holding a procurement, import, ing is ordered by the Administrator

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under § 1315.11(c) or § 1315.13(c), may do § 1315.60 Time and place of hearing. so by filing with the Administrator, (a) If any applicant or registrant re- within 30 days of the date of publica- quests a hearing on the issuance, ad- tion of notice of the hearing in the justment, suspension, or denial of his FEDERAL REGISTER, a written notice of procurement, import, or individual his intention to participate in the manufacturing quota under § 1315.54, hearing in the form prescribed in the Administrator shall hold a hearing. § 1316.48 of this chapter. (b) Notice of the hearing shall be (d) Any person entitled to a hearing given to the applicant or registrant of under § 1315.52 or entitled to participate the time and place at least 30 days in a hearing under paragraph (c) of this prior to the hearing, unless the appli- section may, within the period per- cant or registrant waives such notice mitted for filing a request for a hearing and requests the hearing be held at an or notice of appearance, file with the earlier time, in which case the Admin- Administrator a waiver of an oppor- istrator shall fix a date for such hear- tunity for a hearing, together with a ing as early as reasonably possible. written statement regarding his posi- (c) The hearing shall commence at tion on the matters of fact and law in- the place and time designated in the volved in such hearing. The statement, notice given under paragraph (b) of this if admissible, shall be made a part of section or in the notice of hearing pub- the record and shall be considered in lished in the FEDERAL REGISTER pursu- light of the lack of opportunity for ant to § 1315.11(c) or § 1315.13(c), but cross-examination in determining the thereafter it may be moved to a dif- weight to be attached to matters of ferent place and may be continued fact asserted. from day to day or recessed to a later (e) If any person entitled to a hearing day without notice other than an- under § 1315.52 or entitled to participate nouncement by the presiding officer at in a hearing under paragraph (c) of this the hearing. section fails to file a request for a hearing or notice of appearance or if he so § 1315.62 Final order. files and fails to appear at the hearing, he shall be deemed to have waived his As soon as practicable after the pre- opportunity for the hearing unless he siding officer has certified the record shows good cause for such failure. to the Administrator, the Adminis- (f) If all persons entitled to a hearing trator shall issue his order on the de- or to participate in a hearing waive or termination or adjustment of the as- are deemed to waive their opportunity sessment of annual needs or on the for the hearing or to participate in the issuance, adjustment, suspension, or hearing, the Administrator may cancel denial of the procurement, import, or the hearing, if scheduled, and issue his individual manufacturing quota, as the final order under § 1315.62 without a case may be. The order shall include hearing. the findings of fact and conclusions of law upon which the order is based. The § 1315.58 Burden of proof. order shall specify the date on which it shall take effect. The Administrator (a) At any hearing regarding the de- shall serve one copy of his order upon termination or adjustment of an as- each party in the hearing. sessment of annual needs each interested person participating in the hearing shall have the burden of proving PART 1316—ADMINISTRATIVE any propositions of fact or law asserted FUNCTIONS, PRACTICES, AND by him in the hearing. PROCEDURES (b) At any hearing regarding the issuance, adjustment, suspension, or Subpart A—Administrative Inspections denial of a procurement, import, or individual manufacturing quota, the Ad- Sec. 1316.01 Scope of subpart A. ministration shall have the burden of 1316.02 Definitions. proving that the requirements of this 1316.03 Authority to make inspections. part for such issuance, adjustment, 1316.04 Exclusion from inspection. suspension, or denial are satisfied. 1316.05 Entry.

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1316.06 Notice of inspection. 1316.67 Final order. 1316.07 Requirement for administrative in- 1316.68 Copies of petitions for judicial re- spection warrant; exceptions. view. 1316.08 Consent to inspection. SOURCE: 36 FR 7820, Apr. 24, 1971, unless 1316.09 Application for administrative in- otherwise noted. Redesignated at 38 FR 26609, spection warrant. Sept. 24, 1973. 1316.10 Administrative probable cause. 1316.11 Execution of warrants. 1316.12 Refusal to allow inspection with an Subpart A—Administrative administrative warrant. Inspections 1316.13 Frequency of administrative inspections. AUTHORITY: 21 U.S.C. 822(f), 830(a), 871(b), Subpart B—Protection of Researchers and 880, 958(f), 965. Research Subjects § 1316.01 Scope of subpart A. 1316.21 Definitions. Procedures regarding administrative 1316.22 Exemption. inspections and warrants pursuant to 1316.23 Confidentiality of identity of re- sections 302(f), 510, 1008(d), and 1015 of search subjects. the Act (21 U.S.C. 822(f), 880, 958(d), and 1316.24 Exemption from prosecution for researchers. 965) are governed generally by those sections and specifically by the sec- Subpart C—Enforcement Proceedings tions of this subpart. 1316.31 Authority for enforcement pro- § 1316.02 Definitions. ceeding. 1316.32 Notice of proceeding; time and place. As used in this subpart, the following 1316.33 Conduct of proceeding. terms shall have the meanings speci- 1316.34 Records of proceeding. fied: (a) The term Act means the Con- Subpart D—Administrative Hearings trolled Substances Act (84 Stat. 1242; 21 U.S.C. 801) and/or the Controlled Sub- 1316.41 Scope of subpart D. stances Import and Export Act (84 1316.42 Definitions. 1316.43 Information; special instructions. Stat. 1285; 21 U.S.C. 951). 1316.44 Waiver or modification of rules. (b) The term Administration means 1316.45 Filings; address; hours. the Drug Enforcement Administration. 1316.46 Inspection of record. (c) The term controlled premises 1316.47 Request for hearing. means— 1316.48 Notice of appearance. (1) Places where original or other 1316.49 Waiver of hearing. records or documents required under 1316.50 Appearance; representation; author- the Act are kept or required to be kept, ization. 1316.51 Conduct of hearing and parties; ex and parte communications. (2) Places, including factories, ware- 1316.52 Presiding officer. houses, or other establishments and 1316.53 Time and place of hearing. conveyances, where persons registered 1316.54 Prehearing conference. under the Act or exempted from reg- 1316.55 Prehearing ruling. istration under the Act, or regulated 1316.56 Burden of proof. persons may lawfully hold, manufac- 1316.57 Submission of documentary evidence ture, or distribute, dispense, admin- and affidavits and identification of witnesses subsequent to prehearing con- ister, or otherwise dispose of controlled ference. substances or listed chemicals or where 1316.58 Summary of testimony; affidavits. records relating to those activities are 1316.59 Submission and receipt of evidence. maintained. 1316.60 Objections; offer of proof. (d) The term Administrator means the 1316.61 Exceptions to rulings. Administrator of the Administration. 1316.62 Appeal from ruling of presiding offi- The Administrator has been delegated cer. authority under the Act by the Attor- 1316.63 Official transcript; index; correc- ney General (28 CFR 0.100). tions. 1316.64 Proposed findings of fact and conclu- (e) The term inspector means an offi- sions of law. cer or employee of the Administration 1316.65 Report and record. authorized by the Administrator to 1316.66 Exceptions. make inspections under the Act.

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(f) The term register and registration (d) Collecting samples of controlled refer to registration required and per- substances or listed chemicals (in the mitted by sections 303 and 1008 of the event any samples are collected during Act (21 U.S.C. 823 and 958). an inspection, the inspector shall issue (g) Any term not defined in this part a receipt for such samples on DEA shall have the definition set forth in Form 400 to the owner, operator, or section 102 of the Act (21 U.S.C. 802) or agent in charge of the premises); part 1300 of this chapter. (e) Checking of records and informa- [36 FR 7820, Apr. 24, 1971. Redesignated at 38 tion on distribution of controlled sub- FR 26609, Sept. 24, 1973, as amended at 60 FR stances or listed chemicals by the reg- 32465, June 22, 1995; 60 FR 36334, July 14, 1995; istrant or regulated person (i.e., has 62 FR 13969, Mar. 24, 1997] the distribution of controlled substances or listed chemicals increased § 1316.03 Authority to make inspec- markedly within the past year, and if tions. so why); In carrying out his functions under (f) Except as provided in § 1316.04, all the Act, the Administrator, through other things therein (including records, his inspectors, is authorized in accord- files, papers, processes, controls and fa- ance with sections 510 and 1015 of the cilities) appropriate for verification of Act (21 U.S.C. 880 and 965) to enter con- the records, reports, documents re- trolled premises and conduct adminis- ferred to above or otherwise bearing on trative inspections thereof, for the pur- the provisions of the Act and the regu- pose of: lations thereunder. (a) Inspecting, copying, and verifying the correctness of records, reports, or [36 FR 7820, Apr. 24, 1971. Redesignated at 38 other documents required to be kept or FR 26609, Sept. 24, 1973, and amended at 51 made under the Act and regulations FR 5319, Feb. 13, 1986; 55 FR 50827, Dec. 11, promulgated under the Act, including, 1990; 60 FR 32465, June 22, 1995; 77 FR 4238, but not limited to, inventory and other Jan. 27, 2012] records required to be kept pursuant to § 1316.04 Exclusion from inspection. part 1304 of this chapter, order form records required to be kept pursuant to (a) Unless the owner, operator or part 1305 of this chapter, prescription agent in charge of the controlled prem- and distribution records required to be ises so consents in writing, no inspec- kept pursuant to part 1306 of this chap- tion authorized by these regulations ter, records of listed chemicals, shall extend to: tableting machines, and encapsulating (1) Financial data: machines required to be kept pursuant (2) Sales data other than shipping to part 1310 of this chapter, import/ex- data; or port records of listed chemicals re- (3) Pricing data. quired to be kept pursuant to part 1313 (b) [Reserved] of this chapter, shipping records identifying the name of each carrier used and § 1316.05 Entry. the date and quantity of each shipment, and storage records identifying An inspection shall be carried out by the name of each warehouse used and an inspector. Any such inspector, upon the date and quantity of each storage. (a) stating his purpose and (b) pre- (b) Inspecting within reasonable lim- senting to the owner, operator or agent its and to a reasonable manner all per- in charge of the premises to be in- tinent equipment, finished and unfin- spected (1) appropriate credentials, and ished controlled substances, listed (2) written notice of his inspection au- chemicals, and other substances or ma- thority under § 1316.06 of this chapter, terials, containers, and labeling found and (c) receiving informed consent at the controlled premises relating to under § 1316.08 or through the use of ad- this Act; ministrative warrant issued under (c) Making a physical inventory of §§ 1316.09–1316.13, shall have the right to all controlled substances and listed chemicals on-hand at the premises;

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enter such premises and conduct in- consent is obtained from the owner, op- spections at reasonable times and in a erator, or agent in charge of the con- reasonable manner. trolled premises to be inspected. (b) Wherever possible, informed con- [36 FR 7820, Apr. 24, 1971, as amended at 36 FR 13387, July 21, 1971. Redesignated at 38 FR sent shall consist of a written state- 26609, Sept. 24, 1973; 62 FR 13970, Mar. 24, 1997] ment signed by the owner, operator, or agent in charge of the premises to be § 1316.06 Notice of inspection. inspected and witnessed by two per- The notice of inspection (DEA (or sons. The written consent shall contain DNB) Form 82) shall contain: the following information: (a) The name and title of the owner, (1) That he (the owner, operator, or operator, or agent in charge of the con- agent in charge of the premises) has trolled premises; been informed of his constitutional (b) The controlled premises name; right not to have an administrative in- (c) The address of the controlled spection made without an administra- premises to be inspected; tive inspection warrant; (d) The date and time of the inspec- (2) That he has right to refuse to con- tion; sent to such an inspection; (e) A statement that a notice of in- (3) That anything of an incriminating spection is given pursuant to section nature which may be found may be 510 of the Act (21 U.S.C. 880); seized and used against him in a crimi- (f) A reproduction of the pertinent nal prosecution; parts of section 510 of the Act; and (4) That he has been presented with a (g) The signature of the inspector. notice of inspection as set forth in § 1316.06; § 1316.07 Requirement for administra- (5) That the consent is given by him tive inspection warrant; exceptions. is voluntary and without threats of any In all cases where an inspection is kind; and contemplated, an administrative in- (6) That he may withdraw his consent spection warrant is required pursuant at any time during the course of in- to section 510 of the Act (21 U.S.C. 880), spection. except that such warrant shall not be (c) The written consent shall be pro- required for establishments applying duced in duplicate and be distributed for initial registration under the Act, as follows: for the inspection of books and records (1) The original will be retained by pursuant to an administrative sub- the inspector; and poena issued in accordance with sec- (2) The duplicate will be given to the tion 506 of the Act (21 U.S.C. 876) nor person inspected. for entries in administrative inspec- [36 FR 7820, Apr. 24, 1971, as amended at 37 tions (including seizures of property): FR 15924, Aug. 8, 1972. Redesignated at 38 FR (a) With the consent of the owner, op- 26609, Sept. 24, 1973] erator, or agent in charge of the controlled premises as set forth in § 1316.08; § 1316.09 Application for administra- (b) In situations presenting imminent tive inspection warrant. danger to health or safety; (a) An administrative inspection war- (c) In situations involving inspection rant application shall be submitted to of conveyances where there is reason- any judge of the United States or of a able cause to obtain a warrant; State court of record, or any United (d) In any other exceptional or emer- States magistrate and shall contain gency circumstance or time or oppor- the following information: tunity to apply for a warrant is lack- (1) The name and address of the con- ing; or trolled premises to be inspected; (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;

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(3) A statement relating to the na- arrested and the inspection shall com- ture and extent of the administrative mence or continue. inspection, including, where necessary, [36 FR 7820, Apr. 24, 1971. Redesignated at 38 a request to seize specified items and/or FR 26609, Sept. 24, 1973, as amended at 62 FR to collect samples of finished or unfin- 13970, Mar. 24, 1997] ished controlled substances or listed chemicals; § 1316.13 Frequency of administrative (4) A statement that the establish- inspections. ment either: Except where circumstances other- (i) Has not been previously inspected, wise dictate, it is the intent of the Ad- or ministration to inspect all manufactur- (ii) Was last inspected on a particular ers of controlled substances listed in date. Schedules I and II and distributors of (b) The application shall be sub- controlled substances listed in Sched- mitted under oath to an appropriate ule I once each year. Distributors of judge or magistrate. controlled substances listed in Sched- [36 FR 7820, Apr. 24, 1971, as amended at 36 ules II through V and manufacturers of FR 13387, July 21, 1971. Redesignated at 38 FR controlled substances listed in Sched- 26609, Sept. 24, 1973; 60 FR 32466, June 22, 1995] ules III through V shall be inspected as circumstances may require, based in § 1316.10 Administrative probable part on the registrant’s history of com- cause. pliance with the requirements of this If the judge or magistrate is satisfied chapter and maintenance of effective that ‘‘administrative probable cause,’’ controls and procedures to guard as defined in section 510(d)(1) of the Act against the diversion of controlled sub- (21 U.S.C. 880(d)(1)) exists, he shall stances. issue an administrative warrant. Ad- ministrative probable cause shall not [62 FR 13969, Mar. 24, 1997] mean criminal probable cause as defined by Federal statute or case law. Subpart B—Protection of Re- searchers and Research Sub- § 1316.11 Execution of warrants. jects An administrative inspection warrant shall be executed and returned as AUTHORITY: 21 U.S.C. 830, 871(b). required by, and any inventory or seizure made shall comply with the re- § 1316.21 Definitions. quirements of, section 510(d)(3) of the As used in this part, the following Act (21 U.S.C. 880(d)(3)). The inspection shall begin as soon as is practicable terms shall have the meanings speci- after the issuance of the administra- fied: tive inspection warrant and shall be (a) The term investigative personnel completed with reasonable promptness. includes managers, Diversion Inves- The inspection shall be conducted dur- tigators, attorneys, analysts and sup- ing regular business hours and shall be port personnel employed by the Drug completed in a reasonable manner. Enforcement Administration who are involved in the processing, reviewing § 1316.12 Refusal to allow inspection and analyzing of declarations and other with an administrative warrant. relevant documents or data relative to If a registrant or any person subject regulated transactions or are involved to the Act refuses to permit execution in conducting investigations initiated of an administrative warrant or im- pursuant to the receipt of such declara- pedes the inspector in the execution of tions, documents or data. that warrant, he shall be advised that (b) The term law enforcement per- such refusal or action constitutes a sonnel means Special Agents employed violation of section 402(a)(6) of the Act by the Drug Enforcement Administra- (21 U.S.C. 842(a)(6)). If he persists and tion who, in the course of their official the circumstances warrant, he shall be duties, gain knowledge of information

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which is confidential under such sec- (1) A statement as to whether the re- tion. search protocol requires the manufacture, production, import, export, dis- [54 FR 31670, Aug. 1, 1989] tribution, dispensing, administration, § 1316.22 Exemption. or possession of controlled substances, and if so the researcher’s registration (a) Any person who is aggrieved by a number or a statement that an applica- disclosure of information in violation tion for such registration has been sub- of subsection (c)(1) of Section 310 of the mitted to DEA; Controlled Substances Act (21 U.S.C. (2) The location of the research 830) may bring a civil action against project; the violator for appropriate relief. (3) The qualifications of the principal (b) Notwithstanding the provision of investigator; paragraph (a), a civil action may not be (4) A general description of the re- brought under such paragraph against search or a copy of the research pro- investigative or law enforcement per- tocol; sonnel of the Drug Enforcement Ad- (5) The source of funding for the re- ministration. search project; [54 FR 31670, Aug. 1, 1989] (6) A statement as to the risks posed to the research subjects by the re- § 1316.23 Confidentiality of identity of search procedures and what protection research subjects. will be afforded to the research sub- (a) Any person conducting a bona fide jects; research project directly related to the (7) A statement as to the risks posed enforcement of the laws under the ju- to society in general by the research risdiction of the Attorney General con- procedures and what measures will be cerning drugs or other substances taken to protect the interests of soci- which are or may be subject to control ety; under the Controlled Substances Act (8) A specific request to withhold the (84 Stat. 1242; 21 U.S.C. 801) who intends names and/or any other identifying to maintain the confidentiality of the characteristics of the research sub- identity of those persons who are the jects; and subjects of such research may petition (9) Statements establishing that a the Administrator of the Drug Enforce- grant of confidentiality is necessary to ment Administration for a grant of the successful completion of the re- confidentiality: Providing, That: search project. (1) The Attorney General is author- (c) The grant of confidentiality of ized to carry out such research under identity of research subjects shall con- the provisions of Section 502(a) (2–6) of sist of a letter issued by the Adminis- the Controlled Substances Act of 1970 trator, which shall include: (21 U.S.C. 872(a) (2–6)); and the research (1) The researcher’s name and ad- is being conducted with funds provided dress. in whole or part by the Department of (2) The researcher’s registration Justice; or number, if applicable. (2) The research is of a nature that (3) The title and purpose of the re- the Attorney General would be author- search. ized to carry out under the provisions (4) The location of the research of Section 502(a) (2–6) of the Controlled project. Substances Act (21 U.S.C. 872(a) (2–6), (5) An authorization for all persons and is being conducted with funds pro- engaged in the research to withhold vided from sources outside the Depart- the names and identifying characteris- ment of Justice. tics of persons who are the subjects of (b) All petitions for Grants of Con- such research, stating that persons who fidentiality shall be addressed to the obtain this authorization may not be Administrator, Drug Enforcement Ad- compelled in any Federal, State, or ministration (see the Table of DEA local civil, criminal, administrative, Mailing Addresses in § 1321.01 of this legislative, or other proceeding to iden- chapter for the current mailing ad- tify the subjects of such research for dress): which this authorization was obtained.

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(6) The limits of this authorization, if (2) The location of the research any. project; (7) A statement to the effect that the (3) The qualifications of the principal grant of confidentiality of identity of investigator; research subjects shall be perpetual but (4) A general description of the re- shall pertain only to the subjects of the search or a copy of the research pro- research described in the research protocol; tocol, the description of the research (5) The source of funding for the resubmitted to DEA, or as otherwise es- search project; tablished by DEA. (6) A statement as to the risks posed (d) Within 30 days of the date of com- to the research subjects by the re- pletion of the research project, the research procedures and what protection searcher shall so notify the Adminis- will be afforded to the research sub- trator. The Administrator shall issue jects; another letter including the informa- (7) A statement as to the risks posed tion required in paragraph (c) of this to society in general by the research section and stating the starting and procedures and what measures will be finishing dates of the research for taken to protect the interests of soci- which the confidentiality of identity of ety; research subjects was granted; upon re- (8) A specific request for exemption ceipt of this letter, the research shall from prosecution by Federal, State, or return the original letter of exemption. local authorities for offenses related to the possession, distribution, and dis- [42 FR 54946, Oct. 12, 1977. Redesignated at 54 pensing of controlled substances in ac- FR 31670, Aug. 1, 1989, as amended at 62 FR cord with the procedures described in 13970, Mar. 24, 1997; 75 FR 10685, Mar. 9, 2010] the research protocol; (9) A statement establishing that a § 1316.24 Exemption from prosecution grant of exemption from prosecution is for researchers. necessary to the successful completion (a) Upon registration of an individual of the research project. to engage in research in controlled sub- (c) Any researcher or practitioner stances under the Controlled Sub- proposing to engage in research re- stances Act (84 Stat. 1242; 21 U.S.C. questing both exemption from prosecu- 801), the Administrator of the Drug En- tion and confidentiality of identity of forcement Administration, on his own research subjects may submit a single motion or upon request in writing from petition incorporating the information the Secretary or from the researcher or required in §§ 1316.23(b) and 1316.24(b). researching practitioner, may exempt (d) The exemption shall consist of a the registrant when acting within the letter issued by the Administrator, scope of his registration, from prosecu- which shall include: tion under Federal, State, or local laws (1) The researcher’s name and ad- for offenses relating to possession, dis- dress; tribution or dispensing of those con- (2) The researcher’s registration trolled substances within the scope of number for the research project; his exemption. However, this exemp- (3) The location of the research tion does not diminish any require- project; ment of compliance with the Federal (4) A concise statement of the scope Food, Drug and Cosmetic Act (21 U.S.C. of the researcher’s registration; 301). (5) Any limits of the exemption; and (b) All petitions for Grants of Exemp- (6) A statement that the exemption tion from Prosecution for the Re- shall apply to all acts done in the scope searcher shall be addressed to the Ad- of the exemption while the exemption ministrator, Drug Enforcement Admin- is in effect. The exemption shall re- istration, (see the Table of DEA Mail- main in effect until completion of the ing Addresses in § 1321.01 of this chapter research project or until the registra- for the current mailing address) and tion of the researcher is either revoked shall contain the following: or suspended or his renewal of registra- (1) The researcher’s registration tion is denied. However, the protection number if any, for the project; afforded by the grant of exemption

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from prosecution during the research Special Agent in Charge who issued the period shall be perpetual. notice. (e) Within 30 days of the date of com- [36 FR 7820, Apr. 24, 1971. Redesignated at 38 pletion of the research project, the re- FR 26609, Sept. 24, 1973, and amended at 47 searcher shall so notify the Adminis- FR 41735, Sept. 22, 1982] trator. The Administrator shall issue another letter including the informa- § 1316.33 Conduct of proceeding. tion required in paragraph (d) of this Presentation of views at a hearing section and stating the date of which under this subpart shall be private and the period of exemption concluded; informal. The views presented shall be upon receipt of this letter the re- confined to matters relevant to bring- searcher shall return the original let- ing violations into compliance with the ter of exemption. Act or to other contemplated proceedings under the Act. These views [42 FR 54946, Oct. 12, 1977. Redesignated at 54 may be presented orally or in writing FR 31670, Aug. 1, 1989, as amended at 62 FR by the person to whom the notice was 13970, Mar. 24, 1997; 75 FR 10685, Mar. 9, 2010] given, or by his authorized representative. Subpart C—Enforcement Proceedings § 1316.34 Records of proceeding. A formal record, either verbatim or AUTHORITY: 21 U.S.C. 871(b), 883. summarized, of the hearing may be made at the discretion of the Special § 1316.31 Authority for enforcement Agent in Charge. If a verbatim record proceeding. is to be made, the person attending the A hearing may be ordered or granted hearing will be so advised prior to the by any Special Agent in Charge of the start of the hearing. Drug Enforcement Administration, at [37 FR 15924, Aug. 8, 1972. Redesignated at 38 his discretion, to permit any person FR 26609, Sept. 24, 1973, and amended at 47 against whom criminal and/or civil ac- FR 41735, Sept. 22, 1982] tion is contemplated under the Con- trolled Substances Act (84 Stat. 1242; 21 Subpart D—Administrative U.S.C. 801) or the Controlled Sub- Hearings stances Import and Export Act (84 Stat. 1285; 21 U.S.C. 951) an opportunity AUTHORITY: 21 U.S.C. 811, 812, 871(b), 875, to present his views and his proposals 958(d), 965. for bringing his alleged violations into compliance with the law. Such hearing § 1316.41 Scope of subpart D. will also permit him to show cause why Procedures in any administrative prosecution should not be instituted, hearing held under the Act are gov- or to present his views on the con- erned generally by the rule making templated proceeding. and/or adjudication procedures set [36 FR 7820, Apr. 24, 1971. Redesignated at 38 forth in the Administrative Procedure FR 26609, Sept. 24, 1973, and amended at 47 Act (5 U.S.C. 551–559) and specifically FR 41735, Sept. 22, 1982] by the procedures set forth in this subpart, except where more specific regu- § 1316.32 Notice of proceeding; time lations (set forth in §§ 1301.51–1301.57, and place. §§ 1303.31–1303.37, §§ 1308.41–1308.51, Appropriate notice designating the §§ 1311.51–1311.53, §§ 1312.41–1312.47, time and place for the hearing shall be §§ 1313.51–1313.57, or §§ 1315.50–1315.62) apply. given to the person. Upon request, timely and properly made, by the per- [73 FR 73556, Dec. 3, 2008] son to whom notice has been given, the time or place of the hearing, or both, § 1316.42 Definitions. may be changed if the request states As used in this subpart, the following reasonable grounds for such change. terms shall have the meanings speci- Such request shall be addressed to the fied:

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(a) The term Act means the Con- made a part of the record of the hear- trolled Substances Act (84 Stat. 1242; 21 ing. U.S.C. 801) and/or the Controlled Sub- stances Import and Export Act (84 § 1316.45 Filings; address; hours. Stat. 1285; 21 U.S.C. 951). Documents required or permitted to (b) The term Administrator means the be filed in, and correspondence relating Administrator of the Administration. to, hearings governed by the regula- The Administrator has been delegated tions in this chapter shall be filed with authority under the Act by the Attor- the Hearing Clerk, Drug Enforcement ney General (28 CFR 0.100). Administration. See the Table of DEA (c) The term hearing means any hear- Mailing Addresses in § 1321.01 of this ing held pursuant to the Act. chapter for the current mailing ad- (d) The term Hearing Clerk means the dress. This office is open Monday hearing clerk of the Administration. through Friday from 8:30 a.m. to 5 p.m. (e) The term person includes an indi- eastern standard or daylight saving vidual, corporation, government or time, whichever is effective in the Dis- governmental subdivision or agency, trict of Columbia at the time, except business trust, partnership, association on national legal holidays. Documents or other legal entity. shall be dated and deemed filed upon (f) The term presiding officer means receipt by the Hearing Clerk. an administrative law judge qualified [75 FR 10685, Mar. 9, 2010] and appointed as provided in the Ad- ministrative Procedure Act (5 U.S.C. § 1316.46 Inspection of record. 556). (a) The record bearing on any pro- (g) The term proceeding means all ac- ceeding, except for material described tions involving a hearing, commencing in subsection (b) of this section, shall with the publication by the Adminis- be available for inspection and copying trator of the notice of proposed rule- by any person entitled to participate in making or the issuance of an order to such proceeding, during office hours in show cause. the office of the Hearing Clerk, Drug (h) Any term not defined in this part Enforcement Administration. See the shall have the definition set forth in Table of DEA Mailing Addresses in section 102 of the Act (21 U.S.C. 802) or § 1321.01 of this chapter for the current part 1300 of this chapter. mailing address. [36 FR 7820, Apr. 24, 1971, as amended at 38 (b) The following material shall not FR 757, Jan. 4, 1973. Redesignated at 38 FR be available for inspection as part of 26609, Sept. 24, 1973, as amended at 62 FR the record: 13969, Mar. 24, 1997; 77 FR 4238, Jan. 27, 2012] (1) A research protocol filed with an application for registration to conduct § 1316.43 Information; special instruc- research with controlled substances tions. listed in Schedule I, pursuant to Information regarding procedure § 1301.32 (a)(6) of this chapter, if the ap- under these rules and instructions plicant requests that the protocol be supplementing these rules in special kept confidential; instances will be furnished by the (2) An outline of a production or Hearing Clerk upon request. manufacturing process filed with an application for registration to manu- § 1316.44 Waiver or modification of facture a new narcotic controlled sub- rules. stance, pursuant to § 1301.33 of this The Administrator or the presiding chapter, if the applicant requests that officer (with respect to matters pend- the outline be kept confidential; ing before him) may modify or waive (3) Any confidential or trade secret any rule in this subpart by notice in information disclosed in conjunction advance of the hearing, if he deter- with an application for registration, or mines that no party in the hearing will in reports filed while registered, or ac- be unduly prejudiced and the ends of quired in the course of an investiga- justice will thereby be served. Such no- tion, entitled to protection under sub- tice of modification or waiver shall be section 402(a) (8) of the Act (21 U.S.C.

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842(a) (8)) or any other law restricting in the notice of proposed rulemaking, a public disclosure of information; and written notice of appearance in the fol- (4) Any material contained in any in- lowing form (see the Table of DEA vestigatory report, memorandum, or Mailing Addresses in § 1321.01 of this file, or case report compiled by the Ad- chapter for the current mailing administration. dress): llllllllll (Date) [36 FR 7820, Apr. 24, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973, as amended at 62 FR Administrator, Drug Enforcement Adminis- 13970, Mar. 24, 1997; 75 FR 10645, Mar. 9, 2010] tration llllllllll (Mailing Address), Atten- § 1316.47 Request for hearing. tion: Federal Register Representative (a) Any person entitled to a hearing Dear Sir: Please take notice that and desiring a hearing shall, within the llllllll (Name of person) will appear in the matter of: llllllll (Identifica- period permitted for filing, file a re- tion of the proceeding). quest for a hearing in the following (A) (State with particularity the interest form (see the Table of DEA Mailing Ad- of the person in the proceeding.) dresses in § 1321.01 of this chapter for (B) (State with particularity the objections the current mailing address): or issues, if any, concerning which the per- llllllllll(Date) son desires to be heard.) (C) (State briefly the position of the person Administrator, Drug Enforcement Adminis- with regard to the particular objections or tration, Attention: DEA Federal Register issues.) Representative. All notices to be sent pursuant to this ap- Dear Sir: The undersigned llllll pearance should be addressed to: (Name of person) hereby requests a hearing llllllllll (Name) in the matter of: llllllll (Identifica- llllllllll (Street address) tion of the proceeding). llllllllll (City and State) (A) (State with particularity the interest Respectfully yours, of the person in the proceeding.) llllllllll (Signature of person) (B) (State with particularity the objections or issues, if any, concerning which the per- [75 FR 10685, Mar. 9, 2010] son desires to be heard.) (C) (State briefly the position of the person § 1316.49 Waiver of hearing. with regard to the particular objections or Any person entitled to a hearing issues.) may, within the period permitted for All notices to be sent pursuant to the pro- filing a request for hearing or notice of ceeding should be addressed to: appearance, waiver of an opportunity llllllllll (Name) llllllllll (Street address) for a hearing, together with a written llllllllll (City and State) statement regarding his position on Respectfully yours, the matters of fact and law involved in llllllllll (Signature of person) such hearing. Such statement, if admissible, shall be made a part of the (b) The Administrative Law Judge, record and shall be considered in light upon request and showing of good of the lack of opportunity for cross-ex- cause, may grant a reasonable exten- amination in determining the weight sion of the time allowed for response to to be attached to matters of fact as- an Order to Show Cause. serted therein. [36 FR 7820, Apr. 24, 1971, as amended at 36 FR 13387, July 21, 1971. Redesignated at 38 FR § 1316.50 Appearance; representation; 26609, Sept. 24, 1973] authorization.

EDITORIAL NOTE: For FEDERAL REGISTER ci- Any person entitled to appear in a tations affecting § 1316.47, see the List of CFR hearing may appear in person or by a Sections Affected, which appears in the representative in any proceeding or Finding Aids section of the printed volume hearing and may be heard with respect and at www.fdsys.gov. to matters relevant to the issues under consideration. A representative must § 1316.48 Notice of appearance. either be an employee of the person or Any person entitled to a hearing and an attorney at law who is a member of desiring to appear in any hearing, the bar, in good standing, of any State, shall, if he has not filed a request for territory, or the District of Columbia, hearing, file within the time specified and admitted to practice before the

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highest court of that jurisdiction. Any (a) Arrange and change the date, representative may be required by the time, and place of hearings (other than Administrator or the presiding officer the time and place prescribed in to present a notarized power of attor- § 1301.56) and prehearing conferences ney showing his authority to act in and issue notice thereof. such representative capacity and/or an (b) Hold conferences to settle, sim- affidavit or certificate of admission to plify, or determine the issues in a hear- practice. ing, or to consider other matters that may aid in the expeditious disposition [36 FR 7820, Apr. 24, 1971, as amended at 36 of the hearing. FR 13387, July 21, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973] (c) Require parties to state their position in writing with respect to the § 1316.51 Conduct of hearing and par- various issues in the hearing and to ex- ties; ex parte communications. change such statements with all other (a) Hearings shall be conducted in an parties. informal but orderly manner in accord- (d) Sign and issue subpoenas to com- ance with law and the directions of the pel the attendance of witnesses and the presiding officer. production of documents and materials to the extent necessary to conduct ad- (b) Participants in any hearing and ministrative hearings pending before their representatives, whether or not him. members of the bar, shall conduct themselves in accordance with judicial (e) Examine witnesses and direct wit- standards of practice and ethics and nesses to testify. the directions of the presiding officer. (f) Receive, rule on, exclude, or limit Refusal to comply with this section evidence. shall constitute grounds for immediate (g) Rule on procedural items pending exclusion from any hearing. before him. (c) If any official of the Administra- (h) Take any action permitted to the tion is contacted by any individual in presiding officer as authorized by this private or public life concerning any part or by the provisions of the Admin- substantive matter which is the sub- istrative Procedure Act (5 U.S.C. 551– ject of any hearing, at any time after 559). the date on which the proceedings com- [36 FR 7820, Apr. 24, 1971. Redesignated at 38 mence, the official who is contacted FR 26609, Sept. 24, 1973, and amended at 42 shall prepare a memorandum setting FR 57457, Nov. 3, 1977; 62 FR 13970, Mar. 24, forth the substance of the conversation 1997] and shall file this memorandum in the appropriate public docket file. The pre- § 1316.53 Time and place of hearing. siding officer and employees of the Ad- The hearing will commence at the ministration shall comply with the replace and time designated in the notice quirements of 5 U.S.C. 554(d) regarding of hearing published in the FEDERAL ex parte communications and partici- REGISTER but thereafter it may be pation in any hearing. moved to a different place and may be continued from day to day or recessed § 1316.52 Presiding officer. to a later day without notice other A presiding officer, designated by the than announcement thereof by the pre- Administrator, shall preside over all siding officer at the hearing. hearings. The functions of the presiding officer shall commence upon his § 1316.54 Prehearing conference. designation and terminate upon the The presiding officer on his own mo- certification of the record to the Ad- tion, or on the motion of any party for ministrator. The presiding officer shall good cause shown, may direct all par- have the duty to conduct a fair hear- ties to appear at a specified time and ing, to take all necessary action to place for a conference for: avoid delay, and to maintain order. He (a) The simplification of the issues. shall have all powers necessary to (b) The possibility of obtaining stipu- these ends, including (but not limited lations, admission of facts, and docu- to) the power to: ments.

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(c) The possibility of limiting the § 1316.58 Summary of testimony; affi- number of expert witnesses. davits. (d) The identification and, if prac- (a) The presiding officer may direct ticable, the scheduling of all witnesses that summaries of the direct testimony to be called. of witnesses be prepared in writing and (e) The advance submission at the served on all parties in advance of the prehearing conference of all documen- hearing. Witnesses will not be per- tary evidence and affidavits to be mitted to read summaries of their tes- marked for identification. timony into the record and all wit- (f) Such other matters as may aid in nesses shall be available for cross-ex- the expeditious disposition of the hear- amination. Each witness shall, before ing. proceeding to testify, be sworn or make affirmation. § 1316.55 Prehearing ruling. (b) Affidavits submitted at the prehearing conference or pursuant to The presiding officer may have the § 1316.57 with good cause may be exam- prehearing conference reported ver- ined by all parties and opposing affida- batim and shall make a ruling reciting vits may be submitted to the presiding the action taken at the conference, the officer within a period of time fixed by agreements made by the parties, the him. Affidavits admitted into evidence schedule of witnesses, and a statement shall be considered in light of the lack of the issues for hearing. Such ruling of opportunity for cross-examination in shall control the subsequent course of determining the weight to be attached the hearing unless modified by a subse- to statements made therein. quent ruling. [36 FR 7820, Apr. 24, 1971, as amended at 36 § 1316.56 Burden of proof. FR 13387, July 21, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973] At any hearing, the proponent for the issuance, amendment, or repeal of any § 1316.59 Submission and receipt of rule shall have the burden of proof. evidence. (a) The presiding officer shall admit § 1316.57 Submission of documentary only evidence that is competent, rel- evidence and affidavits and identi- evant, material and not unduly repeti- fication of witnesses subsequent to tious. prehearing conference. (b) Opinion testimony shall be admit- All documentary evidence and affida- ted when the presiding officer is satis- vits not submitted and all witnesses fied that the witness is properly quali- not identified at the prehearing con- fied. ference shall be submitted or identified (c) The authenticity of all documents to the presiding officer as soon as pos- submitted in advance shall be deemed sible, with a showing that the offering admitted unless written objection party had good cause for failing to so thereto is filed with the presiding offi- submit or identify at the prehearing cer, except that a party will be per- conference. If the presiding officer de- mitted to challenge such authenticity termines that good cause does exist, at a later time upon a showing of good the documents or affidavits shall be cause for failure to have filed such submitted or witnesses identified to all written objection. parties sufficiently in advance of the (d) Samples, if otherwise admissible offer of such documents or affidavits or into evidence, may be displayed at the witnesses at the hearing to avoid preju- hearing and may be described for purposes of the record, or may be admitted dice or surprise to the other parties. If in evidence as exhibits. the presiding officer determines that (e) Where official notice is taken or good cause does not exist, he may is to be taken of a material fact not ap- refuse to admit as evidence such docu- pearing in the evidence of record, any ments or affidavits or the testimony of party, on timely request, shall be af- such witnesses. forded opportunity to controvert such fact.

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(f) The presiding officer shall file as hearing, except with the consent of the exhibits copies of the following docu- presiding officer and where he certifies ments: on the record or in writing that the al- (1) The order to show cause or notice lowance of an interlocutory appeal is of hearing; clearly necessary to prevent excep- (2) Any notice of waiver or modifica- tional delay, expense, or prejudice to tion of rules made pursuant to § 1316.44 any party or substantial detriment to or otherwise; the public interest. If an appeal is al- (3) Any waiver of hearing (together lowed, any party in the hearing may with any statement filed therewith) file a brief in quintuplicate with the filed pursuant to § 1316.49 or otherwise; Administrator within such period that (4) The prehearing ruling, if any, the presiding officer directs. No oral made pursuant to § 1316.55; argument will be heard unless the Ad- (5) Any other document necessary to ministrator directs otherwise. show the basis for the hearing.

§ 1316.60 Objections; offer of proof. § 1316.63 Official transcript; index; corrections. If any party in the hearing objects to the admission or rejection of any evi- (a) Testimony given at a hearing dence or to other limitation of the shall be reported verbatim. The Admin- scope of any examination or cross-ex- istration will make provision for a amination, he shall state briefly the stenographic record of the testimony grounds for such objection without ex- and for such copies of the transcript tended argument or debate thereon ex- thereof as it requires for its own pur- cept as permitted by the presiding offi- pose. cer. A ruling of the presiding officer on (b) At the close of the hearing, the any such objection shall be a part of presiding officer shall afford the par- the transcript together with such offer ties and witnesses time (not longer of proof as has been made if a proper than 30 days, except in unusual cases) foundation has been laid for its admis- in which to submit written proposed sion. An offer of proof made in connec- corrections of the transcript, pointing tion with an objection taken to any out errors that may have been made in ruling of the presiding officer rejecting transcribing the testimony. The pre- or excluding proffered oral testimony siding officer shall promptly thereafter shall consist of a statement of the sub- order such corrections made as in his stance of the evidence which the party judgment are required to make the contends would be adduced by such tes- transcript conform to the testimony. timony; and, if the excluded evidence consists of evidence in documentary or [36 FR 7820, Apr. 24, 1971, as amended at 36 written form a copy of such evidence FR 13387, July 21, 1971. Redesignated at 38 FR shall be marked for identification and 26609, Sept. 24, 1973, and amended at 50 FR shall accompany the records as the 2046, Jan. 15, 1985] offer of proof. § 1316.64 Proposed findings of fact and § 1316.61 Exceptions to rulings. conclusions of law. Exceptions to rulings of the presiding Any party in the hearing may file in officer are unnecessary. It is sufficient quintuplicate proposed findings of fact that a party, at the time the ruling of and conclusions of law within the time the presiding officer is sought, makes fixed by the presiding officer. Any known the action that he desires the party so filing shall also serve one copy presiding officer to take, or his objec- of his proposed findings and conclusion tion to an action taken, and his upon each other party in the hearing. grounds therefor. The party shall include a statement of supporting reasons for the proposed § 1316.62 Appeal from ruling of pre- findings and conclusions, together with siding officer. evidence of record (including specific Rulings of the presiding officer may and complete citations of the pages of not be appealed to the Administrator the transcript and exhibits) and cita- prior to his consideration of the entire tions of authorities relied upon.

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§ 1316.65 Report and record. of this section for the filing of a response to the exceptions filed by an- (a) As soon as practicable after the time for the parties to file proposed other party if he determines that no findings of fact and conclusions of law party in the hearing will be unduly has expired, the presiding officer shall prejudiced and that the ends of justice prepare a report containing the fol- will be served thereby. Provided how- lowing: ever, that each party shall be entitled (1) His recommended rulings on the to only one filing under this section; proposed findings of fact and conclu- that is, either a set of exceptions or a sions of law; response thereto. (2) His recommended findings of fact [44 FR 55332, Sept. 26, 1979] and conclusions of law, with the reasons therefore; and § 1316.67 Final order. (3) His recommended decision. As soon as practicable after the pre- (b) The presiding officer shall serve a siding officer has certified the record copy of his report upon each party in to the Administrator, the Adminis- the hearing. The report shall be consid- trator shall cause to be published in ered to have been served when it is the FEDERAL REGISTER his final order mailed to such party or its attorney of in the proceeding, which shall set forth record. the final rule and the findings of fact (c) Not less than twenty-five days and conclusions of law upon which the after the date on which he caused cop- rule is based. This order shall specify ies of his report to be served upon the the date on which it shall take effect, parties, the presiding officer shall cer- which date shall not be less than 30 tify to the Administrator the record, days from the date of publication in which shall contain the transcript of the FEDERAL REGISTER unless the Ad- testimony, exhibits, the findings of ministrator finds that the public inter- fact and conclusions of law proposed by est in the matter necessitates an ear- the parties, the presiding officer’s re- lier effective date, in which event the port, and any exceptions thereto which Administrator shall specify in the may have been filed by the parties. order his findings as to the conditions [36 FR 7778, Apr. 24, 1971. Redesignated at 38 which led him to conclude that an ear- FR 26609, Sept. 24, 1973 and amended at 44 FR lier effective date was required. 55332, Sept. 26, 1979] [44 FR 42179, July 19, 1979, as amended at 44 § 1316.66 Exceptions. FR 55332, Sept. 26, 1979] (a) Within twenty days after the date § 1316.68 Copies of petitions for judi- upon which a party is served a copy of cial review. the report of the presiding officer, such party may file with the Hearing Clerk, Copies of petitions for judicial re- Office of the Administrative Law view, filed pursuant to section 507 of Judge, exceptions to the recommended the Act (21 U.S.C. 877) shall be deliv- decision, findings of fact and conclu- ered to and served upon the Adminis- sions of law contained in the report. trator in quintuplicate. The Adminis- The party shall include a statement of trator shall certify the record of the supporting reasons for such exceptions, hearing and shall file the certified together with evidence of record (in- record in the appropriate U.S. Court of cluding specific and complete citations Appeals. of the pages of the transcript and ex- [36 FR 7820, Apr. 24, 1971. Redesignated at 44 hibits) and citations of the authorities FR 42179, July 19, 1979] relied upon. (b) The Hearing Clerk shall cause PART 1321—DEA MAILING such filings to become part of the record of the proceeding. ADDRESSES (c) The Administrative Law Judge may, upon the request of any party to Sec. a proceeding, grant time beyond the 1321.01 DEA mailing addresses. twenty days provided in paragraph (a) AUTHORITY: 21 U.S.C. 871(b).

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SOURCE: 75 FR 10685, Mar. 9, 2010, unless used when sending specified cor- otherwise noted. respondence to the Drug Enforcement Administration. § 1321.01 DEA mailing addresses. The following table provides information regarding mailing addresses to be

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). 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.

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TABLE OF DEA MAILING ADDRESSES—Continued

Code of Federal Regulations Section—Topic DEA Mailing address

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. 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.

PARTS 1322–1399 [RESERVED]

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Part Page 1400 [Reserved] 1401 Public availability of information ...... 247 1402 Mandatory declassification review ...... 250 1403 Uniform administrative requirements for grants and cooperative agreements to State and local governments ...... 251 1404 Governmentwide debarment and suspension (nonprocurement) ...... 284 1405 Governmentwide requirements for drug-free workplace (financial assistance) ...... 307 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) Nonconstruction goods and services to State and local projects. Except as stated in other regu- governments are not required to have a lations or an award document, grantees single audit performed. State and local or subgrantees shall obtain the prior governments should use their own pro- approval of the awarding agency when- cedures to ensure that the contractor ever any of the following changes is an- has complied with laws and regulations ticipated under a nonconstruction affecting the expenditure of Federal 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 for mitted annually. A final report will be Treasury check advance payments will required upon expiration or termi- be submitted on Standard Form 270, nation of grant support. 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 into the covered transaction, we may— lower tier covered transaction with a 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. rrangements to appear and present, the

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information and argument to the sus- (2) Your presentation in opposition pending 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. (1) The agency head; or (b) Voluntarily excluded means the 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 A—Purpose and Subpart E—Violations of This Part 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- § 1405.510(c). However, this part does sistance awards exempt from this not apply directly to procurement con- part? tracts. The portion of the Drug-Free This part does not apply to any Workplace Act of 1988 that applies to award that the Director of National Federal procurement contracts is car- Drug Control Policy determines that ried out through the Federal Acquisi- the application of this part would be tion Regulation in chapter 1 of Title 48 inconsistent with the international ob- of the Code of Federal Regulations (the ligations of the United States or the drug-free workplace coverage currently laws or regulations of a foreign govern- is in 48 CFR part 23, subpart 23.5). ment.

§ 1405.115 Does this part affect the Federal contracts that I receive? It will affect future contract awards indirectly if you are debarred or suspended for a violation of the requirements of this part, as described in

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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 2—199) II Office of Management and Budget Guidance (Parts 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) VII Agency for International Development (Parts 700—799) 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 1800— 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)

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XXX Department of Homeland Security (Parts 3000—3099) 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) XXXIV Department of Education (Parts 3400—3499) 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—199) 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)

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XXXIII Overseas Private Investment Corporation (Parts 4300—4399) XXXIV Securities and Exchange Commission (Parts 4400—4499) XXXV Office of Personnel Management (Parts 4500—4599) XXXVII Federal Election Commission (Parts 4700—4799) 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) LXX Court Services and Offender Supervision Agency for the District of Columbia (Parts 8000—8099) LXXI Consumer Product Safety Commission (Parts 8100—8199) 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 9000—9099) LXXXIII Special Inspector General for Afghanistan Reconstruction (Parts 9300—9399)

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LXXXIV Bureau of Consumer Financial Protection (Parts 9400—9499) LXXXVI National Credit Union Administration (Parts 9600—9699) XCVII Department of Homeland Security Human Resources Manage- ment System (Department of Homeland Security—Office of Personnel Management) (Parts 9700—9799) XCVII Council of the Inspectors General on Integrity and Efficiency (Parts 9800—9899)

Title 6—Domestic Security

I Department of Homeland Security, Office of the Secretary (Parts 1—99) X Privacy and Civil Liberties Oversight Board (Parts 1000—1099)

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)

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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) XXV Office of Advocacy and Outreach, Department of Agriculture (Parts 2500—2599) 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)

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)

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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)

Title 10—Energy

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 1300—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) X Bureau of Consumer Financial Protection (Parts 1000—1099) XI Federal Financial Institutions Examination Council (Parts 1100—1199) XII Federal Housing Finance Agency (Parts 1200—1299) XIII Financial Stability Oversight Council (Parts 1300—1399) XIV Farm Credit System Insurance Corporation (Parts 1400—1499) XV Department of the Treasury (Parts 1500—1599) XVI Office of Financial Research (Parts 1600—1699) 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)

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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)

Title 14—Aeronautics and Space

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—1199) 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)

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

Title 17—Commodity and Securities Exchanges

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)

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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)

Title 22—Foreign Relations

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 Millennium 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)

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II Office of Assistant Secretary for Housing-Federal Housing Com- missioner, Department of Housing and Urban Development (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) 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)

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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)

Title 26—Internal Revenue

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

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)

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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) 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 Safety and Environmental Enforcement, Department of the Interior (Parts 200—299) IV Geological Survey, Department of the Interior (Parts 400—499) V Bureau of Ocean Energy Management, Department of the Inte- rior (Parts 500—599) 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, Department 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)

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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) 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 Improvement, Department of Education (Parts 700—799)[Reserved] SUBTITLE C—REGULATIONS RELATING TO EDUCATION XI National Institute for Literacy (Parts 1100—1199) XII National Council on Disability (Parts 1200—1299)

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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) 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 U.S. Copyright Office, Library of Congress (Parts 200—299) III Copyright Royalty Board, Library of Congress (Parts 300—399) IV Assistant Secretary for Technology Policy, Department of Com- merce (Parts 400—599)

Title 38—Pensions, Bonuses, and Veterans’ Relief

I Department of Veterans Affairs (Parts 0—199) II Armed Forces Retirement Home (Parts 200—299)

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)

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VII Environmental Protection Agency and Department of Defense; Uniform National Discharge Standards for Vessels of the Armed Forces (Parts 1700—1799)

Title 41—Public Contracts and Property Management

SUBTITLE A—FEDERAL PROCUREMENT REGULATIONS SYSTEM [NOTE] 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—599)

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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 I Bureau of Reclamation, Department of the Interior (Parts 400— 999) 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) 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)

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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) 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)

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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) 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 (Parts 5300—5399) [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)

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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) X Surface Transportation Board, Department of Transportation (Parts 1000—1399) XI Research and Innovative Technology Administration, Depart- ment of Transportation (Parts 1400—1499) [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)

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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 Advisory Council on Historic Preservation 36, VIII Advocacy and Outreach, Office of 7, XXV Afghanistan Reconstruction, Special Inspector General for 22, LXXXIII African Development Foundation 22, XV Federal Acquisition Regulation 48, 57 Agency for International Development 2, VII; 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 Advocacy and Outreach, Office of 7, XXV 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

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2009 21 CFR—Continued 74 FR Page 21 CFR 74 FR Chapter II—Continued Page 1306.09 Added; interim ...... 15624 Chapter II 1308.12 (c)(28) added...... 23793 1300 Authority citation re- 1308.14 (c)(23) through (51) redes- vised...... 15619 ignated as (c)(24) through (52); 1300.01 (b)(4)(xiii) through (lx) renew (c)(23) added ...... 51236 designated as (b)(4)(xiv) 1308.15 (e)(1) revised; (e)(2) through (lxi); new (b)(4)(xiii) added...... 23790 added; new (b)(4)(xvii) through 1308.22 Table amended; in- (lxi) further redesignated as terim...... 44283 (b)(4)(xviii) through (lxii); new (b)(4)(xvii) added; new 2010 (b)(4)(xlvii) through (lxii) redesignated as (b)(4)(xlviii) 21 CFR 75 FR through (lxiii); new Page (b)(4)(xlvii) added ...... 63609 Chapter II 1300.04 Added; interim ...... 15619 1300.03 Added; interim; eff. 6–1– 1301 Authority citation re- 10...... 16304 vised...... 15621 1301.03 Revised ...... 10676 1301.11 Revised; interim...... 15621 1301.13 (e)(2) revised ...... 10676 1301.13 (e)(1)(iv) and (3) revised; 1301.14 (a) revised...... 10676 interim...... 15622 1301.18 (c) revised...... 10676 1301.19 Added; interim ...... 15622 1301.51 Revised ...... 10676 1301.52 (a) revised; interim ...... 15623 1301.52 (b) and (c) revised ...... 10676 1304 Authority citation re- 1301.71 (d) revised...... 10677 vised...... 15623 1303.12 (b) and (d) revised...... 10677 1304.01 Revised; interim...... 15623 1303.22 Introductory text re- 1304.40 Undesignated center vised...... 10677 heading and section added; in- 1304.03 (c) revised; (h) added; interim...... 15623 terim; eff. 6–1–10...... 16306 1304.45 Added; interim ...... 15623 1304.04 (d) revised...... 10677 1304.50 Added; interim ...... 15623 (b) introductory text, (1) and (h) 1304.55 Added; interim ...... 15623 revised; interim; eff. 6–1–10 ...... 16306 1306 Authority citation re- 1304.06 Added; interim; eff. 6–1– vised...... 15624 10...... 16306

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21 CFR—Continued 75 FR 21 CFR—Continued 75 FR Page Page Chapter II—Continued Chapter II—Continued 1304.31 (a) revised...... 10677 1310.05 (c), (d), (e)(1) and (2) re- 1304.32 (a) revised...... 10678 vised...... 10680 1304.33 (a) revised...... 10678 1310.06 (d), (g) and (h)(5) re- 1306 Policy statement...... 61613 vised...... 10681 1306.05 Revised; interim; eff. 6–1– 1310.09 (k) added...... 37306 10...... 16307 1310.10 (a) introductory text re- 1306.08 Added; interim; eff. 6–1– vised...... 38922 10...... 16307 1310.12 (c) table amended; (d)(2) 1306.11 (a), (c), (d)(1) and (4) re- revised ...... 37306 vised; interim; eff. 6–1–10 ...... 16307 1310.13 (b) revised...... 10681 1306.13 (a) revised; interim; eff. 6– (i) table revised ...... 53869 1–10...... 16308 1310.14 Added ...... 38922 1306.15 (a)(1) revised; interim; eff. 1310.21 (b) introductory text re- 6–1–10...... 16308 vised...... 10681 1306.21 (a) and (c) revised; in- 1311 Heading revised; interim; eff. terim; eff. 6–1–10...... 16308 6–1–10...... 16310 1306.22 Revised; interim; eff. 6–1– 1311.01 Revised; interim; eff. 6–1– 10...... 16308 10...... 16310 1306.25 Revised; interim; eff. 6–1– 1311.02 Revised; interim; eff. 6–1– 10...... 16309 10...... 16310 1307.03 Revised ...... 10678 1311.08 Revised; interim; eff. 6–1– 1307.22 Revised ...... 10678 10...... 16310 1308 Technical correction ...... 47451 1311.100—1311.305 (Subpart C) 1308.11 (g) revised...... 37301 Added; interim; eff. 6–1–10 ...... 16310 (d)(15) through (34) redesignated 1312.12 (a) revised...... 10681 as (d)(16) through (35); new 1312.16 (b) revised...... 10682 (d)(15) added...... 79300 1312.18 (b) revised...... 10682 1308.12 (g)(3) added ...... 37299 1312.19 (b) revised...... 10682 1308.21 (a) revised...... 10678 1312.22 (a) and (d)(8) revised ...... 10682 1308.22 Regulation at 74 FR 44283 1312.24 (a) revised...... 10682 confirmed...... 13679 1312.27 (a) and (b)(5)(iv) revised...... 10683 1308.23 (b) revised...... 10678 1312.28 (d) revised...... 10683 1308.24 (d) and (i) revised ...... 10678 1312.31 (b) introductory text re- 1308.25 (a) revised...... 10679 1308.26 (a) revised...... 10679 vised...... 10683 1308.31 (a) revised...... 10679 1312.32 (a) revised...... 10683 1308.32 Revised ...... 10679 1313.12 (b) and (e) introductory 1308.33 (b) revised...... 10679 text revised ...... 10683 1308.34 Revised ...... 10679 1313.13 (d) added; eff. 5–4–10...... 10171 1308.43 (b) revised...... 10679 1313.21 (b) and (e) introductory 1309 Authority citation re- text revised ...... 10683 vised ...... 4980 1313.22 (e) revised...... 10683 1309.03 Revised ...... 10680 1313.24 (e) revised...... 10684 1309.11 Revised ...... 4980 1313.31 (b) introductory text re- 1309.12 Revised ...... 4980 vised...... 10684 1309.21 Revised ...... 4980 1313.32 (b)(1) revised...... 10684 1309.22 Revised ...... 4981 1313.42 Added; eff. 5–4–10...... 10172 1309.23 (a) revised ...... 4981 1314.110 (a)(1) and (2) revised...... 10684 1309.24 Revised ...... 4981 1315.22 Introductory text re- 1309.25 (c) added...... 4982 vised...... 10684 1309.32 (c) revised...... 10680 1315.32 (e) and (g) revised ...... 10684 1309.33 (a) revised...... 10680 1315.34 (d) revised...... 10684 1309.61 Revised ...... 10680 1315.36 (b) revised...... 10685 1309.71 (c) revised...... 10680 1316.23 (b) introductory text re- 1310.04 (f)(1)(i) table, (ii) and vised...... 10685 (g)(1)(i) through (vii) revised; 1316.24 (b) introductory text re- (g)(1)(viii) and (ix) added ...... 38922 vised...... 10685

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21 CFR—Continued 75 FR 21 CFR—Continued 77 FR Page Page Chapter II—Continued Chapter II—Continued 1316.45 Revised ...... 10685 1308 Order...... 12201, 64032 1316.46 (a) revised...... 10685 1308.11 (d)(8) revised ...... 4235 1316.47 (a) revised...... 10685 1308.12 (b)(4) revised ...... 4235 1316.48 Revised ...... 10685 1308.13 (b) introductory text re- 1321 Added ...... 10685 vised ...... 4236 1309 Authority citation revised; 2011 eff. 4-16-12 ...... 15250 1309.11 Revised; eff. 4-16-12 ...... 15250 21 CFR 76 FR Page 1309.21 (a)(2) revised ...... 4236 Chapter II (c) revised; eff. 4-16-12 ...... 15250 1300 Policy statement...... 64813 1309.24 (b), (c) and (d) revised...... 4236 1301.52 (a) revised...... 61564 1309.62 (a) amended...... 4236 1304 Policy statement...... 64813 1310.04 (f)(1)(ii) revised; (g) 1306 Policy statement ...... 6481 amended ...... 4236 1308.11 (g)(1) through (5) added ...... 11078 1310.05 (d) amended; (f)(2) re- (g)(6), (7) and (8) added ...... 65374 vised ...... 4236 1308.14 (c)(5) through (52) redesig- 1310.06 (e)(1), (4), (f)(1), (4) and nated as (c)(6) through (53); new (h)(5) revised ...... 4236 (c)(5) added ...... 77358 1310.09 (b) amended ...... 4237 1308.15 (e)(1) and (2) redesignated 1310.10 Heading revised; (a) as (e)(2) and (3); new (e)(1) amended ...... 4237 added...... 77899 1310.14 Introductory text re- 1309.62 (a) revised...... 61564 vised ...... 4237 1310.02 (a)(30) added; eff. 5–2–11 ...... 17781 1312.18 (d) revised ...... 4237 1310.04 (g)(1)(ii) through (ix) re- 1312.21 (c) revised ...... 4237 designated as (g)(1)(iii) 1312.25 Amended...... 4237 through (x); new (g)(1)(ii) 1312.28 (c) revised ...... 4237 added; eff. 5–2–11...... 17781 1313.12 (d) revised ...... 4237 1310.09 (l) added; eff. 5–2–11 ...... 17781 1313.13 (c)(1) revised ...... 4237 (m) added ...... 31829 1313.14 (c) revised ...... 4237 1310.12 Amended; eff. 5–2–11 ...... 17781 1313.21 (c)(1) revised ...... 4237 (a) revised; (c) table amended ...... 31830 1313.24 (a) revised ...... 4237 1310.13 (e) and (i) introductory 1313.31 (b)(5) and (11) revised ...... 4237 text revised ...... 31830 1313.32 (b)(2) revised ...... 4238 1311 Policy statement...... 64813 1313.33 (c)(1) and (4) revised ...... 4238 1314.30 Revised ...... 74698 1314.45 Introductory text re- 1314.101 Added; interim...... 20523 vised ...... 4238 1314.102 Added; interim...... 20523 1314.115 (a)(2) revised...... 4238 1314.103 Added; interim...... 20524 1316.03 (d) revised ...... 4238 1316.42 (g) revised ...... 4238 2012 1316.71—1316.81 (Subpart E) Re- moved ...... 56101 21 CFR 77 FR 1316.90—1316.99 (Subpart F) Re- Page moved ...... 56101 Chapter II 1300.01 (b) revised ...... 4230 2013 (b) amended ...... 44461 1300.02 (b) revised ...... 4233 21 CFR 78 FR 1300.03 Reinstated; CFR correc- Page tion ...... 58767 Chapter II 1301.13 (e)(1) revised; eff. 4-16- 1308.11 (g) redesignated as (h); 12...... 15249 (d)(36) through (46) and new (g) 1303.11 (c) amended...... 4235 added; new (h)(1) revised ...... 665 1304.03 (a) amended ...... 4235 (d)(47) added ...... 21825 1305.03 (d) revised ...... 4235 (h)(9), (10) and (11) added ...... 28738 1306.24 Heading revised...... 4235 (h)(12), (13) and (14) added...... 68719

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21 CFR—Continued 78 FR 2014 Page Chapter II—Continued (Regulations published from January 1, 1308.13 (c)(11) through (14) redes- 2014, through April 1, 2014) ignated as (c)(12) through (15); 21 CFR 79 FR new (c)(11) added ...... 72016 Page 1308.14 (e) and (f) redesignated as Chapter II (f) and (g); new (e) added ...... 26705 1308.11 (h)(15) through (18) added ...... 7582 (h)(19) through (28) added...... 12942 1308.14 (c)(1) through (53) redesignated as (c)(2) through (54); new (c)(1) added ...... 10989 Æ

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