Title 21 Food and Drugs Part 1300 to End

Revised as of April 1, 2019

Containing a codification of documents of general applicability and future effect

As of April 1, 2019

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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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 Publishing Office Official Edi- tions only. The Superintendent of Documents of the U.S. Govern- ment Publishing 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 ...... 279

Finding Aids:

Table of CFR Titles and Chapters ...... 289

Alphabetical List of Agencies Appearing in the CFR ...... 309

List of CFR Sections Affected ...... 319

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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 sub- divided 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, 2019), 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 Sep<11>2014 08:20 Aug 16, 2019 Jkt 247078 PO 00000 Frm 00005 Fmt 8008 Sfmt 8092 Y:\SGML\247078.XXX 247078 pparker on DSK3GDR082PROD 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 Sep<11>2014 08:20 Aug 16, 2019 Jkt 247078 PO 00000 Frm 00006 Fmt 8008 Sfmt 8092 Y:\SGML\247078.XXX 247078 pparker on DSK3GDR082PROD 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 Publishing 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 Publishing 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.govinfo.gov. For more information, contact the GPO Customer Contact Center, U.S. Government Publishing 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 Publishing Office. It is available at www.ecfr.gov.

OLIVER A. POTTS, Director, Office of the Federal Register April 1, 2019.

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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, 2019.

For this volume, Michele Bugenhagen was Chief Editor. The Code of Federal Regulations publication program is under the direction of John Hyrum Martinez, assisted by Stephen J. Frattini.

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(This book contains part 1300 to end)

Part

CHAPTER II—Drug Enforcement Administration, Depart- ment of Justice ...... 1300

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 ...... 23 1302 Labeling and packaging requirements for controlled substances ...... 58 1303 Quotas ...... 60 1304 Records and reports of registrants ...... 69 1305 Orders for schedule I and II controlled substances 89 1306 Prescriptions ...... 97 1307 Miscellaneous ...... 109 1308 Schedules of controlled substances ...... 111 1309 Registration of manufacturers, distributors, importers and exporters of list I chemicals ...... 138 1310 Records and reports of listed chemicals and certain machines; importation and exportation of certain machines ...... 149 1311 Requirements for electronic orders and prescriptions ...... 176 1312 Importation and exportation of controlled substances ...... 197 1313 Importation and exportation of list I and list II chemicals ...... 221 1314 Retail sale of scheduled listed chemical products ... 234 1315 Importation and production quotas for ephedrine, pseudoephedrine, and phenylpropanolamine ...... 241 1316 Administrative functions, practices, and procedures ...... 252 1317 Disposal ...... 265 1321 DEA Mailing addresses ...... 274 1322–1399 [Reserved]

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(34) 17a-methyl-3b,17b-dihydroxy-5a-an- (61) testolactone (13-hydroxy-3-oxo- drostane 13,17-secoandrosta-1,4-dien-17-oic (35) 17a-methyl-3a,17b-dihydroxy-5a-an- acid lactone) drostane (62) testosterone (17b-hydroxyandrost- (36) 17a-methyl-3b,17b- 4-en-3-one) dihydroxyandrost-4-ene (63) tetrahydrogestrinone (13b, 17a- (37) 17a-methyl-4-hydroxynandrolone diethyl-17b-hydroxygon-4,9,11-trien- (17a-methyl-4-hydroxy-17b- 3-one) hydroxyestr-4-en-3-one) (64) trenbolone (17b-hydroxyestr-4,9,11- (38) methyldienolone (17a-methyl-17b- trien-3-one) hydroxyestra-4,9(10)-dien-3-one) (65) Any salt, ester, or ether of a drug (39) methyltrienolone (17a-methyl-17b- or substance described in this para- hydroxyestra-4,9,11-trien-3-one) graph. Except such term does not (40) methyltestosterone (17a-methyl- include an anabolic steroid that is 17b-hydroxyandrost-4-en-3-one) expressly intended for administra- (41) mibolerone (7a,17a-dimethyl-17b- tion through implants to cattle or hydroxyestr-4-en-3-one) other nonhuman species and that (42) 17a-methyl-D1-dihydrotestosterone has been approved by the Secretary (17b-hydroxy-17a-methyl-5a- of Health and Human Services for androst-1-en-3-one) (a.k.a. ‘17-a- such administration. If any person methyl-1-testosterone‘) prescribes, dispenses, or distributes (43) nandrolone (17b-hydroxyestr-4-en-3- such steroid for human use, the one) person shall be considered to have (44) 19-nor-4-androstenediol (3b, 17b- prescribed, dispensed, or distrib- dihydroxyestr-4-ene) uted an anabolic steroid within the (45) 19-nor-4-androstenediol (3a, 17b- meaning of this paragraph. dihydroxyestr-4-ene) Automated dispensing system means a (46) 19-nor-5-androstenediol (3b, 17b- mechanical system that performs oper- dihydroxyestr-5-ene) ations or activities, other than (47) 19-nor-5-androstenediol (3a, 17b- compounding or administration, rel- dihydroxyestr-5-ene) ative to the storage, packaging, count- (48) 19-nor-4,9(10)-androstadienedione ing, labeling, and dispensing of medica- (estra-4,9(10)-diene-3,17-dione) tions, and which collects, controls, and (49) 19-nor-4-androstenedione (estr-4-en- maintains all transaction information. 3,17-dione) Basic class means, as to controlled (50) 19-nor-5-androstenedione (estr-5-en- substances listed in Schedules I and II: 3,17-dione) (1) Each of the opiates, including its (51) norbolethone (13b, 17a-diethyl-17b- isomers, esters, ethers, salts, and salts hydroxygon-4-en-3-one) of isomers, esters, and ethers whenever (52) norclostebol (4-chloro-17b- the existence of such isomers, esters, hydroxyestr-4-en-3-one) ethers, and salts is possible within the (53) norethandrolone (17a-ethyl-17b- specific chemical designation, listed in hydroxyestr-4-en-3-one) § 1308.11(b) of this chapter; (54) normethandrolone (17a-methyl-17b- (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- Collection means to receive a con- ical synthesis: trolled substance for the purpose of de- (i) Opium, including raw opium, struction from an ultimate user, a per- opium extracts, opium fluid extracts, son lawfully entitled to dispose of an powdered opium, granulated opium, de- ultimate user decedent’s property, or a odorized opium and tincture of opium; long-term care facility on behalf of an (ii) Apomorphine; ultimate user who resides or has re- (iii) Codeine; sided at that facility. The term col- (iv) Etorphine hydrochloride; lector means a registered manufacturer, (v) Ethylmorphine; distributor, reverse distributor, nar- (vi) Hydrocodone; cotic treatment program, hospital/clin- (vii) Hydromorphone; ic with an on-site pharmacy, or retail (viii) Metopon; pharmacy that is authorized under this (ix) Morphine; chapter to so receive a controlled sub- (x) Oxycodone; stance for the purpose of destruction. (xi) Oxymorphone; Commercial container means any bot- (xii) Thebaine; tle, jar, tube, ampule, or other recep- (xiii) Mixed alkaloids of opium listed tacle in which a substance is held for in § 1308.12(b)(2) of this chapter; distribution or dispensing to an ulti- (xiv) Cocaine; and mate user, and in addition, any box or (xv) Ecgonine; package in which the receptacle is held (5) Each of the opiates, including its for distribution or dispensing to an ul- isomers, esters, ethers, salts, and salts timate user. The term commercial con- of isomers, esters, and ethers whenever tainer does not include any package the existence of such isomers, esters, liner, package insert or other material ethers, and salts is possible within the kept with or within a commercial con- specific chemical designation, listed in tainer, nor any carton, crate, drum, or § 1308.12(c) of this chapter; and other package in which commercial (6) Methamphetamine, its salts, isomers, and salts of its isomers; containers are stored or are used for (7) Amphetamine, its salts, optical shipment of controlled substances. isomers, and salts of its optical iso- Competent national authority, for pur- mers; poses of importation and exportation of (8) Phenmetrazine and its salts; controlled substances and listed chemi- (9) Methylphenidate; cals, means an entity lawfully entitled (10) Each of the substances having a to authorize the import and export of depressant effect on the central nerv- controlled substances, and to regulate ous system, including its salts, iso- or enforce national controls over listed mers, and salts of isomers whenever chemicals, and included as such in the the existence of such salts, isomers, directory of ‘‘Competent National Au- and salts of isomers is possible within thorities Under the International Drug the specific chemical designation, list- Control Treaties’’ published by the ed in § 1308.12(e) of this chapter. United Nations Office on Drugs and Central fill pharmacy means a phar- Crime. For purposes of exports of nar- macy which is permitted by the state cotic drugs, the term also includes in which it is located to prepare con- freely associated states authorized to trolled substances orders for dispensing receive such exports pursuant to 48 pursuant to a valid prescription trans- U.S.C. 1972. mitted to it by a registered retail phar- Compounder means any person engag- macy and to return the labeled and ing in maintenance or detoxification filled prescriptions to the retail phar- treatment who also mixes, prepares, macy for delivery to the ultimate user. packages or changes the dosage form of Such central fill pharmacy shall be a narcotic drug listed in Schedules II, deemed ‘‘authorized’’ to fill prescrip- III, IV or V for use in maintenance or tions on behalf of a retail pharmacy detoxification treatment by another only if the retail pharmacy and central narcotic treatment program.

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Controlled substance has the meaning contents include controlled substances) given in section 802(6) of Title 21, are, in the course of delivery to, or re- United States Code (U.S.C.). turn from, customers, transferred in Customs officer means either an Offi- less than 24 hours. A distributing reg- cer of the Customs as defined in 19 istrant who operates a freight for- U.S.C. 1401(i) (that is, of the U.S. Cus- warding facility may use the facility to toms and Border Protection), or any transfer controlled substances from individual duly authorized to accept any location the distributing reg- entries of merchandise, to collect du- istrant operates that is registered with ties, and to enforce the customs laws of the Administration to manufacture, any commonwealth, territory, or pos- distribute, or import controlled sub- session of the United States. stances, or, with respect to returns, Customs territory of the United States registered to dispense controlled sub- means the several States, the District stances, provided that the notice re- of Columbia, and Puerto Rico. quired by § 1301.12(b)(4) of Part 1301 of Detoxification treatment means the this chapter has been submitted and dispensing, for a period of time as spec- approved. For purposes of this defini- ified below, of a narcotic drug or nar- tion, a distributing registrant is a per- cotic drugs in decreasing doses to an son who is registered with the Admin- individual to alleviate adverse physio- istration as a manufacturer, dis- logical or psychological effects inci- tributor (excluding reverse dis- dent to withdrawal from the contin- tributor), and/or importer. uous or sustained use of a narcotic Hearing means: drug and as a method of bringing the (1) In part 1301 of this chapter, any individual to a narcotic drug-free state hearing held for the granting, denial, within such period of time. There are revocation, or suspension of a registra- two types of detoxification treatment: tion pursuant to sections 303, 304, and Short-term detoxification treatment 1008 of the Act (21 U.S.C. 823, 824 and and long-term detoxification treat- 958). ment. (2) In part 1303 of this chapter, any (1) Short-term detoxification treat- hearing held regarding the determina- ment is for a period not in excess of 30 tion of aggregate production quota or days. the issuance, adjustment, suspension, (2) Long-term detoxification treat- or denial of a procurement quota or an ment is for a period more than 30 days individual manufacturing quota. but not in excess of 180 days. (3) In part 1308 of this chapter, any Dispenser means an individual practi- hearing held for the issuance, amend- tioner, institutional practitioner, phar- ment, or repeal of any rule issuable macy or pharmacist who dispenses a pursuant to section 201 of the Act (21 controlled substance. U.S.C. 811). Export means, with respect to any ar- Import means, with respect to any article, any taking out or removal of ticle, any bringing in or introduction such article from the United States of such article into the customs terri- (whether or not such taking out or re- tory of the United States from any moval constitutes an exportation with- place outside thereof (but within the in the meaning of the customs laws, ex- United States), or into the United port control laws enforced by other States from any place outside thereof agencies, or related laws of the United (whether or not such bringing in or in- States). troduction constitutes an importation Exporter includes every person who within the meaning of the tariff laws of exports, or who acts as an export the United States). broker for exportation of, controlled Importer includes every person who substances listed in any schedule. imports, or who acts as an import Freight forwarding facility means a broker for importation of, controlled separate facility operated by a distrib- substances listed in any schedule. uting registrant through which sealed, Individual practitioner means a physi- packaged controlled substances in un- cian, dentist, veterinarian, or other in- marked shipping containers (i.e., the dividual licensed, registered, or other- containers do not indicate that the wise permitted, by the United States or

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the jurisdiction in which he/she prac- are positional isomers. For purposes of tices, to dispense a controlled sub- this definition, the ‘‘core structure’’ is stance in the course of professional the parent molecule that is the com- practice, but does not include a phar- mon basis for the class; for example, macist, a pharmacy, or an institutional tryptamine, phenethylamine, or practitioner. ergoline. Examples of rearrangements Institutional practitioner means a hos- resulting in creation and/or destruction pital or other person (other than an in- of chemical functionalities (and there- dividual) licensed, registered, or other- fore resulting in compounds which are wise permitted, by the United States or not positional isomers) include, but are the jurisdiction in which it practices, not limited to: Ethoxy to alpha-hy- to dispense a controlled substance in droxyethyl, hydroxy and methyl to the course of professional practice, but methoxy, or the repositioning of a phe- does not include a pharmacy. nolic or alcoholic hydroxy group to Interested person means any person create a hydroxyamine. Examples of adversely affected or aggrieved by any rearrangements resulting in com- rule or proposed rule issuable pursuant pounds which would be positional iso- to section 201 of the Act (21 U.S.C. 811). mers include: Tert-butyl to sec-butyl, Inventory means all factory and methoxy and ethyl to isopropoxy, N,N- branch stocks in finished form of a diethyl to N-methyl-N-propyl, or alpha- basic class of controlled substance methylamino to N-methylamino. manufactured or otherwise acquired by Label means any display of written, a registrant, whether in bulk, commer- printed, or graphic matter placed upon cial containers, or contained in phar- the commercial container of any con- maceutical preparations in the posses- trolled substance by any manufacturer sion of the registrant (including stocks of such substance. held by the registrant under separate Labeling means all labels and other registration as a manufacturer, im- written, printed, or graphic matter: porter, exporter, or distributor). (1) Upon any controlled substance or Isomer means: (1) The optical isomer, except as used any of its commercial containers or in § 1308.11(d) and § 1308.12(b)(4) of this wrappers, or chapter. As used in § 1308.11(d) of this (2) Accompanying such controlled chapter, the term ‘‘isomer’’ means any substance. optical, positional, or geometric iso- Long Term Care Facility (LTCF) means mer. As used in § 1308.12(b)(4) of this a nursing home, retirement care, men- chapter, the term ‘‘isomer’’ means any tal care or other facility or institution optical or geometric isomer; which provides extended health care to (2) As used in § 1308.11(d) of this chap- resident patients. ter, the term ‘‘positional isomer’’ Maintenance treatment means the dis- means any substance possessing the pensing for a period in excess of twen- same molecular formula and core ty-one days, of a narcotic drug or nar- structure and having the same func- cotic drugs in the treatment of an indi- tional group(s) and/or substituent(s) as vidual for dependence upon heroin or those found in the respective Schedule other morphine-like drug. I hallucinogen, attached at any posi- Manufacture means the producing, tion(s) on the core structure, but in preparation, propagation, such manner that no new chemical compounding, or processing of a drug functionalities are created and no ex- or other substance or the packaging or isting chemical functionalities are de- repackaging of such substance, or the stroyed relative to the respective labeling or relabeling of the commer- Schedule I hallucinogen. Rearrange- cial container of such substance, but ments of alkyl moieties within or be- does not include the activities of a tween functional group(s) or substit- practitioner who, as an incident to his/ uent(s), or divisions or combinations of her administration or dispensing such alkyl moieties, that do not create new substance in the course of his/her pro- chemical functionalities or destroy ex- fessional practice, prepares, com- isting chemical functionalities, are al- pounds, packages or labels such sub- lowed i.e., result in compounds which stance.

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Manufacturer means a person who Narcotic treatment program means a manufactures a drug or other sub- program engaged in maintenance and/ stance, whether under a registration as or detoxification treatment with nar- a manufacturer or under authority of cotic drugs. registration as a researcher or chem- Net disposal means, for a stated pe- ical analyst. riod, the quantity of a basic class of Mid-level practitioner means an indi- controlled substance distributed by the vidual practitioner, other than a physi- registrant to another person, plus the cian, dentist, veterinarian, or podia- quantity of that basic class used by the trist, who is licensed, registered, or registrant in the production of (or con- otherwise permitted by the United verted by the registrant into) another States or the jurisdiction in which he/ basic class of controlled substance or a she practices, to dispense a controlled noncontrolled substance, plus the substance in the course of professional quantity of that basic class otherwise practice. Examples of mid-level practi- disposed of by the registrant, less the tioners include, but are not limited to, quantity of that basic class returned to health care providers such as nurse the registrant by any purchaser, and practitioners, nurse midwives, nurse less the quantity of that basic class anesthetists, clinical nurse specialists distributed by the registrant to an- and physician assistants who are au- other registered manufacturer of that thorized to dispense controlled sub- basic class for purposes other than use stances by the State in which they in the production of, or conversion practice. into, another basic class of controlled Name means the official name, com- substance or a noncontrolled substance mon or usual name, chemical name, or or in the manufacture of dosage forms brand name of a substance. of that basic class. Narcotic drug means any of the fol- Person includes any individual, cor- lowing whether produced directly or in- poration, government or governmental directly by extraction from substances subdivision or agency, business trust, of vegetable origin or independently by partnership, association, or other legal means of chemical synthesis or by a entity. combination of extraction and chem- Pharmacist means any pharmacist li- ical synthesis: censed by a State to dispense con- (1) Opium, opiates, derivatives of trolled substances, and shall include opium and opiates, including their iso- any other person (e.g., pharmacist in- mers, esters, ethers, salts, and salts of tern) authorized by a State to dispense isomers, esters, and ethers whenever controlled substances under the super- the existence of such isomers, esters, vision of a pharmacist licensed by such ethers and salts is possible within the State. specific chemical designation. Such Port of entry means, unless distin- term does not include the isoquinoline guished as being a foreign port of alkaloids of opium. entry, any place at which a customs of- (2) Poppy straw and concentrate of ficer is duly authorized to accept en- poppy straw. tries of merchandise, to collect duties, (3) Coca leaves, except coca leaves and to enforce the various provisions of and extracts of coca leaves from which the customs laws of the United States cocaine, ecgonine and derivatives of ec- (whether or not such place is a port of gonine or their salts have been re- entry as defined in title 19 of the moved. United States Code or its associated (4) Cocaine, its salts, optical and geo- implementing regulations). Examples metric isomers, and salts of isomers. of ports of entry include, but are not (5) Ecgonine, its derivatives, their limited to, places designated as ports salts, isomers and salts of isomers. of entry or customs stations in title 19 (6) Any compound, mixture, or prepa- of the Code of Federal Regulations or by ration which contains any quantity of the governing customs authority of any of the substances referred to in that area. When shipments are trans- paragraphs (1) through (5) of this defi- ported under U.S. Customs and Border nition. Protection’s immediate transportation

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procedures, the port of entry shall be Registrant means any person who is the port of final destination. registered pursuant to either section Port of export means, unless distin- 303 or section 1008 of the Act (21 U.S.C. guished as being a foreign port of ex- 823 or 958). port, any place under the control of a Return information means supple- customs officer where goods are loaded mental information required to be re- on an aircraft, vessel or other convey- ported to the Administration following ance for export outside of the United an import or export transaction con- States. For goods loaded aboard an air- taining the particulars of the trans- craft or vessel in the United States, action and any other information as that stops at several ports before de- the Administration may specify. parting the United States, the port of Reverse distribute means to acquire export is the first port where the goods controlled substances from another were actually loaded. For goods off- registrant or law enforcement for the loaded from the original conveyance to purpose of: another conveyance (even if the air- (1) Return to the registered manufac- craft or vessel belongs to the same car- turer or another registrant authorized rier) at any port subsequent to the port by the manufacturer to accept returns where the first on-loading occurred in on the manufacturer’s behalf; or the United States, the port where the (2) Destruction. goods were loaded onto the last con- Reverse distributor is a person reg- veyance before departing the United istered with the Administration as a States is the port of export. reverse distributor. Prescription means an order for medi- Supplier means any registered person cation which is dispensed to or for an entitled to fill order forms pursuant to ultimate user but does not include an § 1305.06 of this chapter. order for medication which is dispensed United States, when used in a geo- for immediate administration to the graphic sense, means all places and ultimate user (e.g., an order to dis- waters, continental or insular, subject pense a drug to a bed patient for imme- to the jurisdiction of the United diate administration in a hospital is States, which, in addition to the cus- not a prescription). toms territory of the United States, in- Proceeding means all actions taken clude but are not limited to the U.S. for the issuance, amendment, or repeal Virgin Islands, Guam, American of any rule issued pursuant to section Samoa, and the Northern Mariana Is- 201 of the Act (21 U.S.C. 811), com- lands. mencing with the publication by the Administrator of the proposed rule, [62 FR 13941, Mar. 24, 1997, as amended at 65 FR 44678, July 19, 2000; 68 FR 37409, June 24, amended rule, or repeal in the FEDERAL 2003; 68 FR 41228, July 11, 2003; 70 FR 25465, REGISTER. May 13, 2005; 70 FR 74656, Dec. 16, 2005; 71 FR Purchaser means any registered per- 60427, Oct. 13, 2006; 72 FR 67852, Dec. 3, 2007; son entitled to obtain and execute 74 FR 63609, Dec. 4, 2009; 77 FR 4230, Jan. 27, order forms pursuant to §§ 1305.04 and 2012; 77 FR 44461, July 30, 2012; 79 FR 53559, 1305.06. Sept. 9, 2014; 81 FR 97018, Dec. 30, 2016] Readily retrievable means that certain records are kept by automatic data § 1300.02 Definitions relating to listed processing systems or other electronic chemicals. or mechanized recordkeeping systems (a) Any term not defined in this part in such a manner that they can be sep- shall have the definition set forth in arated out from all other records in a section 102 of the Act (21 U.S.C. 802), reasonable time and/or records are kept except that certain terms used in part on which certain items are asterisked, 1316 of this chapter are defined at the redlined, or in some other manner vis- beginning of each subpart of that part. ually identifiable apart from other (b) As used in parts 1309, 1310, and items appearing on the records. 1313 of this chapter, the following Register and registration refer only to terms shall have the meaning specified: registration required and permitted by Act means the Controlled Substances sections 303 or 1007 of the Act (21 U.S.C. Act, as amended (84 Stat. 1242; 21 U.S.C. 823 or 957). 801) and/or the Controlled Substances

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Import and Export Act, as amended (84 Combination ephedrine product means Stat. 1285; 21 U.S.C. 951). a drug product containing ephedrine or Administration means the Drug En- its salts, optical isomers, or salts of op- forcement Administration. tical isomers, and therapeutically sig- Administrator means the Adminis- nificant quantities of another active trator of the Drug Enforcement Admin- medicinal ingredient. istration. The Administrator has been Competent national authority, for pur- delegated authority under the Act by poses of importation and exportation of the Attorney General (28 CFR 0.100). controlled substances and listed chemi- At retail, with respect to the sale or cals, means an entity lawfully entitled purchase of a scheduled listed chemical to authorize the import and export of product, means a sale or purchase for controlled substances, and to regulate personal use, respectively. or enforce national controls over listed Broker and trader mean any indi- chemicals, and included as such in the vidual, corporation, corporate division, directory of ‘‘Competent National Au- partnership, association, or other legal thorities Under the International Drug entity which assists in arranging an Control Treaties’’ published by the international transaction in a listed United Nations Office on Drugs and chemical by— Crime. (1) Negotiating contracts; Customs officer means either an Offi- (2) Serving as an agent or inter- cer of the Customs as defined in 19 mediary; or U.S.C. 1401(i) (that is, of the U.S. Cus- (3) Fulfilling a formal obligation to toms and Border Protection), or any complete the transaction by bringing individual duly authorized to accept together a buyer and seller, a buyer entries of merchandise, to collect du- and transporter, or a seller and trans- ties, and to enforce the customs laws of porter, or by receiving any form of any commonwealth, territory, or pos- compensation for so doing. session of the United States. Chemical export means transferring Customs territory of the United States ownership or control, or the sending or means the several States, the District taking of threshold quantities of listed of Columbia, and Puerto Rico. chemicals out of the United States Drug product means an active ingre- (whether or not such sending or taking dient in dosage form that has been ap- out constitutes an exportation within proved or otherwise may be lawfully the meaning of the customs and related marketed under the Federal Food, laws of the United States). Drug, and Cosmetic Act for distribu- Chemical exporter is a regulated per- tion in the United States. son who, as the principal party in in- Encapsulating machine means any terest in the export transaction, has manual, semi-automatic, or fully auto- the power and responsibility for deter- matic equipment which may be used to mining and controlling the sending of fill shells or capsules with any pow- the listed chemical out of the United dered, granular, semi-solid, or liquid States. material. Chemical importer is a regulated per- Established business relationship means son who, as the principal party in in- the regulated person has imported or terest in the import transaction, has exported a listed chemical at least the power and responsibility for deter- once within the past six months, or mining and controlling the bringing in twice within the past twelve months or introduction of the listed chemical from or to a foreign manufacturer, dis- into the United States. tributor, or end user of the chemical Chemical mixture means a combina- that has an established business with a tion of two or more chemical sub- fixed street address. A person or busi- stances, at least one of which is not a ness that functions as a broker or listed chemical, except that such term intermediary is not a customer for pur- does not include any combination of a poses of this definition. listed chemical with another chemical Established record as an importer that is present solely as an impurity or means that the regulated person has which has been created to evade the re- imported a listed chemical at least quirements of the Act. once within the past six months, or

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twice within the past twelve months port) or whether the stand is located from a foreign supplier. on unimproved real estate (such as a Export means, with respect to any ar- lot or field leased for retail purposes). ticle, any taking out or removal of Name means the official name, com- such article from the United States mon or usual name, chemical name, or (whether or not such taking out or re- brand name of a substance. moval constitutes an exportation with- Person includes any individual, cor- in the meaning of the customs laws, ex- poration, government or governmental port control laws enforced by other subdivision or agency, business trust, agencies, or related laws of the United partnership, association, or other legal States). entity. Hearing means any hearing held for Port of entry, unless distinguished as the granting, denial, revocation, or being a foreign port of entry, means suspension of a registration pursuant any place at which a customs officer is to sections 303, 304, and 1008 of the Act duly authorized to accept entries of (21 U.S.C. 823, 824 and 958). merchandise, to collect duties, and to Import means, with respect to any ar- enforce the various provisions of the ticle, any bringing in or introduction customs laws of the United States of such article into the customs terri- (whether or not such place is a port of tory of the United States from any entry as defined in title 19 of the place outside thereof (but within the United States Code or its associated United States), or into the United implementing regulations). Examples States from any place outside thereof of ports of entry include, but are not (whether or not such bringing in or in- limited to, places designated as ports troduction constitutes an importation of entry or customs stations in title 19 within the meaning of the tariff laws of of the Code of Federal Regulations or by the United States). the governing customs authority of International transaction means a that area. When shipments are trans- transaction involving the shipment of ported under U.S. Customs and Border a listed chemical across an inter- Protection immediate transportation national border (other than a United procedures, the port of entry shall be States border) in which a broker or the port of final destination. trader located in the United States Port of export means, unless distin- participates. guished as being a foreign port of ex- Listed chemical means any List I port, any place under the control of a chemical or List II chemical. customs officer where goods are loaded List I chemical means a chemical spe- on an aircraft, vessel or other convey- cifically designated by the Adminis- ance for export outside of the United trator in § 1310.02(a) of this chapter States. For goods loaded aboard an air- that, in addition to legitimate uses, is craft or vessel in the United States used in manufacturing a controlled that stops at several ports before de- substance in violation of the Act and is parting the United States, the port of important to the manufacture of a con- export is the first port where the goods trolled substance. were loaded. For goods off-loaded from List II chemical means a chemical, the original conveyance to another other than a List I chemical, specifi- conveyance (even if the aircraft or ves- cally designated by the Administrator sel belongs to the same carrier) at any in § 1310.02(b) of this chapter that, in port subsequent to the port where the addition to legitimate uses, is used in first on-loading occurred in the United manufacturing a controlled substance States, the port where the goods were in violation of the Act. loaded onto the last conveyance before Mobile retail vendor means a person or departing the United States is the port entity that makes sales at retail from of export. For reporting purposes, in a stand that is intended to be tem- the case of an otherwise lawful export porary or is capable of being moved occurring by mail, the port of export is from one location to another, whether the place of mailing. the stand is located within or on the Readily retrievable means that certain premises of a fixed facility (such as a records are kept by automatic data kiosk at a shopping center or an air- processing systems or other electronic

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or mechanized recordkeeping systems lated person; in this context, agents or in such a manner that they can be sep- employees means individuals under the arated out from all other records in a direct management and control of the reasonable time and/or records are kept regulated person; on which certain items are asterisked, (ii) A delivery of a listed chemical to redlined, or in some other manner vis- or by a common or contract carrier for ually identifiable apart from other carriage in the lawful and usual course items appearing on the records. of the business of the common or con- Register and registration refer only to tract carrier, or to or by a warehouse- registration required and permitted by man for storage in the lawful and usual sections 303 or 1007 of the Act (21 U.S.C. course of the business of the ware- 823 or 957). houseman, except that if the carriage Registrant means any person who is or storage is in connection with the registered pursuant to either section distribution, importation, or expor- 303 or section 1008 of the Act (21 U.S.C. tation of a listed chemical to a third 823 or 958). person, this paragraph does not relieve Regular customer means a person with a distributor, importer, or exporter whom the regulated person has an es- from compliance with parts 1309, 1310, tablished business relationship for a 1313, and 1315 of this chapter; specified listed chemical or chemicals (iii) Any category of transaction or that has been reported to the Adminis- any category of transaction for a spe- tration subject to the criteria estab- cific listed chemical or chemicals spec- lished in part 1313 of this chapter. ified by regulation of the Adminis- Regular importer means, with respect trator as excluded from this definition to a listed chemical, a person that has as unnecessary for enforcement of the an established record as an importer of Act; that listed chemical that is reported to (iv) Any transaction in a listed chem- the Administrator. ical that is contained in a drug other Regulated person means any indi- than a scheduled listed chemical prod- vidual, corporation, partnership, association, or other legal entity who man- uct that may be marketed or distrib- ufactures, distributes, imports, or ex- uted lawfully in the United States ports a listed chemical, a tableting ma- under the Federal Food, Drug, and Cos- chine, or an encapsulating machine, or metic Act, subject to paragraph (1)(v) who acts as a broker or trader for an of this definition, unless— international transaction involving a (A) The Administrator has deter- listed chemical, tableting machine, or mined pursuant to the criteria in encapsulating machine. § 1310.10 of this chapter that the drug or Regulated seller means a retail dis- group of drugs is being diverted to ob- tributor (including a pharmacy or a tain the listed chemical for use in the mobile retail vendor), except that the illicit production of a controlled sub- term does not include an employee or stance; and agent of the distributor. (B) The quantity of the listed chem- Regulated transaction means: ical contained in the drug included in (1) A distribution, receipt, sale, im- the transaction or multiple transportation, or exportation of a listed actions equals or exceeds the threshold chemical, or an international trans- established for that chemical; action involving shipment of a listed (v) Any transaction in a scheduled chemical, or if the Administrator es- listed chemical product that is a sale tablishes a threshold amount for a spe- at retail by a regulated seller or a dis- cific listed chemical, a threshold tributor required to submit reports amount as determined by the Adminis- under § 1310.03(c) of this chapter; or trator, which includes a cumulative (vi) Any transaction in a chemical threshold amount for multiple trans- mixture designated in §§ 1310.12 and actions, of a listed chemical, except 1310.13 of this chapter that the Admin- that such term does not include: istrator has exempted from regulation. (i) A domestic lawful distribution in (2) A distribution, importation, or ex- the usual course of business between portation of a tableting machine or en- agents or employees of a single regu- capsulating machine except that such

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term does not include a domestic law- United States, when used in a geo- ful distribution in the usual course of graphic sense, means all places and business between agents and employees waters, continental or insular, subject of a single regulated person; in this to the jurisdiction of the United context, agents or employees means in- States, which, in addition to the cus- dividuals under the direct management toms territory of the United States, in- and control of the regulated person. clude but are not limited to the U.S. Retail distributor means a grocery Virgin Islands, Guam, American store, general merchandise store, drug Samoa, and the Northern Mariana Is- store, or other entity or person whose lands. activities as a distributor relating to Valid prescription means a prescrip- drug products containing tion that is issued for a legitimate pseudoephedrine or phenylpropanola- medical purpose by an individual prac- mine are limited almost exclusively to titioner licensed by law to administer sales for personal use, both in number and prescribe the drugs concerned and of sales and volume of sales, either di- acting in the usual course of the prac- rectly to walk-in customers or in face- titioner’s professional practice. to-face transactions by direct sales. [75 FR 16304, Mar. 31, 2010, as amended at 77 Also for the purposes of this paragraph, FR 4233, Jan. 27, 2012; 81 FR 97019, Dec. 30, a ‘‘grocery store’’ is an entity within 2016] Standard Industrial Classification (SIC) code 5411, a ‘‘general merchandise § 1300.03 Definitions relating to elec- store’’ is an entity within SIC codes tronic orders for controlled sub- 5300 through 5399 and 5499, and a ‘‘drug stances and electronic prescriptions store’’ is an entity within SIC code for controlled substances. 5912. For the purposes of this chapter, the Return information means supple- following terms shall have the mean- mental information required to be re- ings specified: ported to the Administration following Application service provider means an an import or export transaction con- entity that sells electronic prescrip- taining the particulars of the trans- tion or pharmacy applications as a action and any other information as hosted service, where the entity con- the Administration may specify. trols access to the application and Scheduled listed chemical product maintains the software and records on means: its servers. (1) A product that contains ephed- Audit trail means a record showing rine, pseudoephedrine, or phenyl- who has accessed an information tech- propanolamine and may be marketed nology application and what operations or distributed lawfully in the United the user performed during a given pe- States under the Federal Food, Drug, riod. and Cosmetic Act as a nonprescription Authentication means verifying the drug. Ephedrine, pseudoephedrine, and identity of the user as a prerequisite to phenylpropanolamine include their allowing access to the information ap- salts, optical isomers, and salts of opti- plication. cal isomers. Authentication protocol means a well (2) Scheduled listed chemical product specified message exchange process does not include any product that is a that verifies possession of a token to controlled substance under part 1308 of remotely authenticate a person to an this chapter. In the absence of such application. scheduling by the Attorney General, a Biometric authentication means au- chemical specified in paragraph (1) of thentication based on measurement of this definition may not be considered the individual’s physical features or re- to be a controlled substance. peatable actions where those features Tableting machine means any manual, or actions are both distinctive to the semi-automatic, or fully automatic individual and measurable. equipment which may be used for the Biometric subsystem means the hard- compaction or molding of powdered or ware and software used to capture, granular solids, or semi-solid material, store, and compare biometric data. The to produce coherent solid tablets. biometric subsystem may be part of a

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larger application. The biometric sub- (1) Identifies the certification au- system is an automated system capable thority issuing it; of: (2) Names or otherwise identifies the (1) Capturing a biometric sample certificate holder; from an end user. (3) Contains a public key that cor- (2) Extracting and processing the bio- responds to a private key under the metric data from that sample. sole control of the certificate holder; (3) Storing the extracted information (4) Identifies the operational period; in a database. and (4) Comparing the biometric data (5) Contains a serial number and is with data contained in one or more ref- digitally signed by the certification au- erence databases. thority issuing it. (5) Determining how well the stored Digital signature means a record cre- data matches the newly captured data ated when a file is algorithmically and indicating whether an identifica- transformed into a fixed length digest tion or verification of identity has been that is then encrypted using an asym- achieved. metric cryptographic private key asso- Cache means to download and store ciated with a digital certificate. The information on a local server or hard combination of the encryption and al- drive. gorithm transformation ensure that Certificate policy means a named set the signer’s identity and the integrity of rules that sets forth the applica- of the file can be confirmed. bility of the specific digital certificate Digitally sign means to affix a digital to a particular community or class of signature to a data file. application with common security re- Electronic prescription means a pre- quirements. scription that is generated on an elec- Certificate revocation list (CRL) means tronic application and transmitted as a list of revoked, but unexpired certifi- an electronic data file. cates issued by a certification author- Electronic prescription application pro- ity. vider means an entity that develops or Certification authority (CA) means an markets electronic prescription soft- organization that is responsible for ware either as a stand-alone applica- verifying the identity of applicants, au- tion or as a module in an electronic thorizing and issuing a digital certifi- health record application. cate, maintaining a directory of public Electronic signature means a method keys, and maintaining a Certificate of signing an electronic message that Revocation List. identifies a particular person as the Certified information systems auditor source of the message and indicates the (CISA) means an individual who has person’s approval of the information been certified by the Information Sys- contained in the message. tems Audit and Control Association as False match rate means the rate at qualified to audit information systems which an impostor’s biometric is false- and who performs compliance audits as ly accepted as being that of an author- a regular ongoing business activity. ized user. It is one of the statistics Credential means an object or data used to measure biometric performance structure that authoritatively binds an when operating in the verification or identity (and optionally, additional at- authentication task. The false match tributes) to a token possessed and con- rate is similar to the false accept (or trolled by a person. acceptance) rate. Credential service provider (CSP) False non-match rate means the rate means a trusted entity that issues or at which a genuine user’s biometric is registers tokens and issues electronic falsely rejected when the user’s bio- credentials to individuals. The CSP metric data fail to match the enrolled may be an independent third party or data for the user. It is one of the statis- may issue credentials for its own use. tics used to measure biometric per- CSOS means controlled substance or- formance when operating in the dering system. verification or authentication task. Digital certificate means a data record The false match rate is similar to the that, at a minimum— false reject (or rejection) rate, except

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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 FIPS means Federal Information and servers, where access and records Processing Standards. These Federal are controlled by the practitioner. standards, as incorporated by reference Installed pharmacy application means in § 1311.08 of this chapter, prescribe software that is used to process pre- specific performance requirements, scription information and that is in- practices, formats, communications stalled on a pharmacy’s computers or protocols, etc., for hardware, software, servers and is controlled by the phar- data, etc. macy. FIPS 140–2, as incorporated by ref- Intermediary means any technology erence in § 1311.08 of this chapter, system that receives and transmits an means the National Institute of Stand- electronic prescription between the ards and Technology publication enti- practitioner and pharmacy. tled ‘‘Security Requirements for Cryp- Key pair means two mathematically tographic Modules,’’ a Federal stand- related keys having the properties ard for security requirements for cryp- that: tographic modules. (1) One key can be used to encrypt a FIPS 180–2, as incorporated by ref- message that can only be decrypted erence in § 1311.08 of this chapter, using the other key; and means the National Institute of Stand- (2) Even knowing one key, it is ards and Technology publication enti- computationally infeasible to discover tled ‘‘Secure Hash Standard,’’ a Fed- the other key. eral secure hash standard. NIST means the National Institute of FIPS 180–3, as incorporated by ref- Standards and Technology. erence in § 1311.08 of this chapter, NIST SP 800–63–1, as incorporated by means the National Institute of Stand- reference in § 1311.08 of this chapter, ards and Technology publication enti- means the National Institute of Stand- tled ‘‘Secure Hash Standard (SHS),’’ a ards and Technology publication enti- Federal secure hash standard. tled ‘‘Electronic Authentication Guide- FIPS 186–2, as incorporated by ref- line,’’ a Federal standard for electronic erence in § 1311.08 of this chapter, authentication. means the National Institute of Stand- NIST SP 800–76–1, as incorporated by ards and Technology publication enti- reference in § 1311.08 of this chapter, tled ‘‘Digital Signature Standard,’’ a means the National Institute of Stand- Federal standard for applications used ards and Technology publication enti- to generate and rely upon digital signa- tled ‘‘Biometric Data Specification for tures. Personal Identity Verification,’’ a Fed- FIPS 186–3, as incorporated by ref- eral standard for biometric data speci- erence in § 1311.08 of this chapter, fications for personal identity means the National Institute of Stand- verification. ards and Technology publication enti- Operating point means a point chosen tled ‘‘Digital Signature Standard on a receiver operating characteristic (DSS),’’ a Federal standard for applica- (ROC) curve for a specific algorithm at tions used to generate and rely upon which the biometric system is set to digital signatures. function. It is defined by its cor- Hard token means a cryptographic responding coordinates—a false match key stored on a special hardware device rate and a false non-match rate. An (e.g., a PDA, cell phone, smart card, ROC curve shows graphically the trade- USB drive, one-time password device) off between the principal two types of rather than on a general purpose com- errors (false match rate and false non- puter. match rate) of a biometric system by Identity proofing means the process by plotting the performance of a specific which a credential service provider or algorithm on a specific set of data. certification authority validates suffi- Paper prescription means a prescrip- cient information to uniquely identify tion created on paper or computer gen- a person. erated to be printed or transmitted via

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facsimile that meets the requirements tion may have different names (e.g., of part 1306 of this chapter including a approve, sign, transmit), but it serves manual signature. as the practitioner’s final authoriza- Password means a secret, typically a tion that he intends to issue the pre- character string (letters, numbers, and scription for a legitimate medical rea- other symbols), that a person memo- son in the normal course of his profes- rizes and uses to authenticate his iden- sional practice. tity. SysTrust means a professional service PDA means a Personal Digital Assist- performed by a qualified certified pub- ant, a handheld computer used to man- lic accountant to evaluate one or more age contacts, appointments, and tasks. aspects of electronic systems. Pharmacy application provider means Third-party audit means an inde- an entity that develops or markets pendent review and examination of software that manages the receipt and records and activities to assess the ade- processing of electronic prescriptions. quacy of system controls, to ensure Private key means the key of a key compliance with established policies pair that is used to create a digital sig- and operational procedures, and to rec- nature. ommend necessary changes in controls, Public key means the key of a key policies, or procedures. pair that is used to verify a digital sig- Token means something a person pos- nature. The public key is made avail- sesses and controls (typically a key or able to anyone who will receive password) used to authenticate the per- digitally signed messages from the son’s identity. holder of the key pair. Trusted agent means an entity au- Public Key Infrastructure (PKI) means thorized to act as a representative of a a structure under which a certification certification authority or credential authority verifies the identity of appli- service provider in confirming practi- cants; issues, renews, and revokes dig- tioner identification during the enroll- ital certificates; maintains a registry ment process. of public keys; and maintains an up-to- Valid prescription means a prescrip- date certificate revocation list. tion that is issued for a legitimate Readily retrievable means that certain medical purpose by an individual prac- records are kept by automatic data titioner licensed by law to administer processing applications or other elec- and prescribe the drugs concerned and tronic or mechanized recordkeeping acting in the usual course of the prac- systems in such a manner that they titioner’s professional practice. can be separated out from all other WebTrust means a professional serv- records in a reasonable time and/or ice performed by a qualified certified records are kept on which certain public accountant to evaluate one or items are asterisked, redlined, or in more aspects of Web sites. some other manner visually identifiable apart from other items appearing [75 FR 16304, Mar. 31, 2010] on the records. SAS 70 Audit means a third-party § 1300.04 Definitions relating to the audit of a technology provider that dispensing of controlled substances by means of the Internet. meets the American Institute of Cer- tified Public Accountants (AICPA) (a) Any term not defined in this part Statement of Auditing Standards or elsewhere in this chapter shall have (SAS) 70 criteria. the definition set forth in sections 102 Signing function means any keystroke and 309 of the Act (21 U.S.C. 802, 829). or other action used to indicate that (b) The term covering practitioner the practitioner has authorized for means, with respect to a patient, a transmission and dispensing a con- practitioner who conducts a medical trolled substance prescription. The evaluation (other than an in-person signing function may occur simulta- medical evaluation) at the request of a neously with or after the completion of practitioner who: the two-factor authentication protocol (1) Has conducted at least one in-per- that meets the requirements of part son medical evaluation of the patient 1311 of this chapter. The signing func- or an evaluation of the patient through

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the practice of telemedicine, within purpose within the usual course of pro- the previous 24 months; and fessional practice. (2) Is temporarily unavailable to con- (g) The term Internet means collec- duct the evaluation of the patient. tively the myriad of computer and (c) The term deliver, distribute, or dis- telecommunications facilities, includ- pense by means of the Internet refers, re- ing equipment and operating software, spectively, to any delivery, distribu- which comprise the interconnected tion, or dispensing of a controlled sub- worldwide network of networks that stance that is caused or facilitated by employ the Transmission Control Pro- means of the Internet. tocol/Internet Protocol, or any prede- (d) The term filling new prescriptions cessor or successor protocol to such for controlled substances in Schedule III, protocol, to communicate information IV, or V means filling a prescription for of all kinds by wire or radio. an individual for a controlled sub- (h) The term online pharmacy means a stance in Schedule III, IV, or V, if: person, entity, or Internet site, wheth- (1) The pharmacy dispensing that er in the United States or abroad, that prescription has previously dispensed knowingly or intentionally delivers, to the patient a controlled substance distributes, or dispenses, or offers or other than by means of the Internet attempts to deliver, distribute, or dis- and pursuant to the valid prescription pense, a controlled substance by means of a practitioner that meets the appli- of the Internet. The term includes, but cable requirements of subsections (b) is not limited to, a pharmacy that has and (c) of section 309 of the Act (21 obtained a modification of its registra- U.S.C. 829) and §§ 1306.21 and 1306.22 of tion pursuant to §§ 1301.13 and 1301.19 of this chapter (for purposes of this defi- this chapter that currently authorizes nition, such a prescription shall be re- it to dispense controlled substances by ferred to as the ‘‘original prescrip- means of the Internet, regardless of tion’’); whether the pharmacy is currently dis- (2) The pharmacy contacts the prac- pensing controlled substances by titioner who issued the original pre- means of the Internet. The term does scription at the request of that indi- not include: vidual to determine whether the prac- (1) Manufacturers or distributors reg- titioner will authorize the issuance of a istered under subsection (a), (b), (d), or new prescription for that individual for (e) of section 303 of the Act (21 U.S.C. the controlled substance described in paragraph (d)(1) of this section (i.e., the 823(a), (b), (d), or (e)) (§ 1301.13 of this same controlled substance as described chapter) who do not dispense con- in paragraph (d)(1)); and trolled substances to an unregistered (3) The practitioner, acting in the individual or entity; usual course of professional practice, (2) Nonpharmacy practitioners who determines there is a legitimate med- are registered under section 303(f) of ical purpose for the issuance of the new the Act (21 U.S.C. 823(f)) (§ 1301.13 of prescription. this chapter) and whose activities are (e) The term homepage means the authorized by that registration; opening or main page or screen of the (3) Any hospital or other medical fa- Web site of an online pharmacy that is cility that is operated by an agency of viewable on the Internet. the United States (including the Armed (f) The term in-person medical evalua- Forces), provided such hospital or tion means a medical evaluation that is other facility is registered under sec- conducted with the patient in the phys- tion 303(f) of the Act (21 U.S.C. 823(f)) ical presence of the practitioner, with- (§ 1301.13 of this chapter); out regard to whether portions of the (4) A health care facility owned or evaluation are conducted by other operated by an Indian tribe or tribal health professionals. Nothing in this organization, only to the extent such paragraph shall be construed to imply facility is carrying out a contract or that one in-person medical evaluation compact under the Indian Self-Deter- demonstrates that a prescription has mination and Education Assistance been issued for a legitimate medical Act;

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(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 lawfully acting in the usual course of 1301.27 and the pharmacy is otherwise business or employment, and within complying with this chapter. the scope of the official duties of such (ii) A registered pharmacy will be agent or employee, with such hospital deemed to meet this exception if, in or facility, and, with respect to agents view of all of its activities other than or employees of health care facilities those referred to in paragraph (h)(10)(i) specified in paragraph (h)(4) of this sec- of this section, it would fall outside the tion, only to the extent such individ- definition of an online pharmacy. uals are furnishing services pursuant (i) Effective January 15, 2010, the to the contracts or compacts described term practice of telemedicine means the in such paragraph; practice of medicine in accordance (6) Mere advertisements that do not with applicable Federal and State laws attempt to facilitate an actual trans- by a practitioner (other than a phar- action involving a controlled sub- macist) who is at a location remote stance; from the patient and is communicating (7) A person, entity, or Internet site with the patient, or health care profes- that is not in the United States and sional who is treating the patient, does not facilitate the delivery, dis- using a telecommunications system re- tribution, or dispensing of a controlled ferred to in section 1834(m) of the So- substance by means of the Internet to cial Security Act (42 U.S.C. 1395m(m)), any person in the United States; which practice falls within a category (8) A pharmacy registered under sec- listed in the following paragraphs (i)(1) tion 303(f) of the Act (21 U.S.C. 823(f)) through (7): (§ 1301.13 of this chapter) whose dis- (1) Treatment in a hospital or clinic. pensing of controlled substances via The practice of telemedicine is being the Internet consists solely of: (i) Refilling prescriptions for con- conducted while the patient is being trolled substances in Schedule III, IV, treated by, and physically located in, a or V, as defined in paragraph (k) of this hospital or clinic registered under sec- section; or tion 303(f) of the Act (21 U.S.C. 823(f)) (ii) Filling new prescriptions for con- by a practitioner acting in the usual trolled substances in Schedule III, IV, course of professional practice, who is or V, as defined in paragraph (d) of this acting in accordance with applicable section; State law, and who is registered under (9)(i) Any registered pharmacy whose section 303(f) of the Act (21 U.S.C. delivery, distribution, or dispensing of 823(f)) in the State in which the patient controlled substances by means of the is located, unless the practitioner: Internet consists solely of filling pre- (i) Is exempted from such registra- scriptions that were electronically pre- tion in all States under section 302(d) scribed in a manner authorized by this of the Act (21 U.S.C. 822(d); or chapter and otherwise in compliance (ii) Is an employee or contractor of with the Act. the Department of Veterans Affairs (ii) A registered pharmacy will be who is acting in the scope of such em- deemed to meet this exception if, in ployment or contract, and registered view of all of its activities other than under section 303(f) of the Act (21 those referred to in paragraph (h)(9)(i) U.S.C. 823(f)) in any State or is uti- of this section, it would fall outside the lizing the registration of a hospital or definition of an online pharmacy; or clinic operated by the Department of (10)(i) Any registered pharmacy Veterans Affairs registered under sec- whose delivery, distribution, or dis- tion 303(f); pensing of controlled substances by (2) Treatment in the physical presence means of the Internet consists solely of of a practitioner. The practice of tele- the transmission of prescription infor- medicine is being conducted while the mation between a pharmacy and an patient is being treated by, and in the automated dispensing system located physical presence of, a practitioner

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acting in the usual course of profes- under section 311(h) of the Act (21 sional practice, who is acting in ac- U.S.C. 831(h)); cordance with applicable State law, (6) Department of Veterans Affairs med- and who is registered under section ical emergency. The practice of tele- 303(f) of the Act (21 U.S.C. 823(f)) in the medicine is being conducted: State in which the patient is located, (i) In a medical emergency situation: unless the practitioner: (A) That prevents the patient from (i) Is exempted from such registra- being in the physical presence of a tion in all States under section 302(d) practitioner registered under section of the Act (21 U.S.C. 822(d)); or 303(f) of the Act (21 U.S.C. 823(f)) who is (ii) Is an employee or contractor of an employee or contractor of the Vet- the Department of Veterans Affairs erans Health Administration acting in who is acting in the scope of such em- the usual course of business and employment or contract, and registered ployment and within the scope of the under section 303(f) of the Act (21 official duties or contract of that em- U.S.C. 823(f)) in any State or is using ployee or contractor; the registration of a hospital or clinic (B) That prevents the patient from operated by the Department of Vet- being physically present at a hospital erans Affairs registered under section or clinic operated by the Department 303(f); of Veterans Affairs registered under (3) Indian Health Service or tribal orga- section 303(f) of the Act (21 U.S.C. nization. The practice of telemedicine 823(f)); is being conducted by a practitioner (C) During which the primary care who is an employee or contractor of practitioner of the patient or a practi- the Indian Health Service, or is work- tioner otherwise practicing telemedi- ing for an Indian tribe or tribal organi- cine within the meaning of this para- zation under its contract or compact graph is unable to provide care or con- with the Indian Health Service under sultation; and the Indian Self-Determination and (D) That requires immediate inter- Education Assistance Act; who is act- vention by a health care practitioner ing within the scope of the employ- using controlled substances to prevent ment, contract, or compact; and who is what the practitioner reasonably be- designated as an Internet Eligible Con- lieves in good faith will be imminent trolled Substances Provider by the Sec- and serious clinical consequences, such retary of Health and Human Services as further injury or death; and under section 311(g)(2) of the Act (21 (ii) By a practitioner that: U.S.C. 831(g)(2)); (A) Is an employee or contractor of (4) Public health emergency declared by the Veterans Health Administration the Secretary of Health and Human Serv- acting within the scope of that employ- ices. The practice of telemedicine is ment or contract; being conducted during a public health (B) Is registered under section 303(f) emergency declared by the Secretary of the Act (21 U.S.C. 823(f)) in any State of Health and Human Services under or is utilizing the registration of a hos- section 319 of the Public Health Service pital or clinic operated by the Depart- Act (42 U.S.C. 247d), and involves pa- ment of Veterans Affairs registered tients located in such areas, and such under section 303(f); and controlled substances, as the Secretary (C) Issues a controlled substance pre- of Health and Human Services, with scription in this emergency context the concurrence of the Administrator, that is limited to a maximum of a five- designates, provided that such designa- day supply which may not be extended tion shall not be subject to the proce- or refilled; or dures prescribed by the Administrative (7) Other circumstances specified by reg- Procedure Act (5 U.S.C. 551–559 and 701– ulation. The practice of telemedicine is 706); being conducted under any other cir- (5) Special registration. The practice of cumstances that the Administrator telemedicine is being conducted by a and the Secretary of Health and practitioner who has obtained from the Human Services have jointly, by regu- Administrator a special registration lation, determined to be consistent

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with effective controls against diver- § 1300.05 Definitions relating to the sion and otherwise consistent with the disposal of controlled substances. public health and safety. (a) Any term not defined in this part (j) Temporary definition of practice of or elsewhere in this chapter shall have telemedicine. Prior to January 15, 2010, the definition set forth in section 102 of or as otherwise specified by regulation the Act (21 U.S.C. 802). prior to that date, instead of the defini- (b) As used in part 1317 of this chap- tion in paragraph (i), the term practice ter, the following terms shall have the of telemedicine means the practice of meanings specified: medicine in accordance with applicable Employee means an employee as de- Federal and State laws by a practi- fined under the general common law of tioner (as that term is defined in sec- agency. Some of the factors relevant to tion 102 of the Act (21 U.S.C. 802)) the determination of employee status (other than a pharmacist) who is at a include: The hiring party’s right to location remote from the patient and is control the manner and means by communicating with the patient, or which the product is accomplished; the health care professional who is treat- skill required; the source of the instru- ing the patient, using a telecommuni- mentalities and tools; the location of cations system referred to in section the work; the duration of the relation- 1834(m) of the Social Security Act (42 ship between the parties; whether the U.S.C. 1395m(m)), if the practitioner is hiring party has the right to assign ad- using an interactive telecommuni- ditional projects to the hired party; the cations system that satisfies the re- extent of the hired party’s discretion quirements of section 410.78(a)(3) of over when and how long to work; the title 42, Code of Federal Regulations. method of payment; the hired party’s (k) The term refilling prescriptions for role in hiring and paying assistants; controlled substances in Schedule III, IV, whether the work is part of the regular or V: business of the hiring party; whether (1) Means the dispensing of a con- the hiring party is in business; the pro- trolled substance in Schedule III, IV, or vision of employee benefits; and the V in accordance with refill instructions tax treatment of the hired party. Other issued by a practitioner as part of a applicable factors may be considered valid prescription that meets the re- and no one factor is dispositive. The quirements of subsections (b) and (c) of following criteria will determine section 309 of the Act (21 U.S.C. 829) whether a person is an employee of a and §§ 1306.21 and 1306.22 of this chapter, registrant for the purpose of disposal: as appropriate; and The person is directly paid by the reg- (2) Does not include the issuance of a istrant; subject to direct oversight by new prescription to an individual for a the registrant; required, as a condition controlled substance that individual of employment, to follow the reg- was previously prescribed. istrant’s procedures and guidelines per- (l)(1) The term valid prescription taining to the handling of controlled means a prescription that is issued for substances; subject to receive a per- a legitimate medical purpose in the formance rating or performance eval- usual course of professional practice uation on a regular/routine basis from by: the registrant; subject to disciplinary (i) A practitioner who has conducted action by the registrant; and required at least one in-person medical evalua- to render services at the registrant’s tion of the patient; or registered location. (ii) A covering practitioner. Law enforcement officer means a per- (2) Nothing in this paragraph (l) shall son who is described in paragraph (1), be construed to imply that one in-per- (2) or (3) of this definition: (1) Meets all of the following criteria: son medical evaluation demonstrates (i) Employee of either a law enforce- that a prescription has been issued for ment agency, or law enforcement com- a legitimate medical purpose within ponent of a Federal agency; the usual course of professional prac- (ii) Is under the direction and control tice. of a Federal, State, tribal, or local gov- [74 FR 15619, Apr. 6, 2009] ernment;

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(iii) Acting in the course of his/her PART 1301—REGISTRATION OF official duty; and MANUFACTURERS, DISTRIBUTORS, (iv) Duly sworn and given the author- AND DISPENSERS OF CON- ity by a Federal, State, tribal, or local TROLLED SUBSTANCES government to carry firearms, execute and serve warrants, make arrests with- GENERAL INFORMATION out warrant, and make seizures of Sec. property; 1301.01 Scope of this part 1301. (2) Is a Veterans Health Administra- 1301.02 Definitions. tion (VHA) police officer authorized by 1301.03 Information; special instructions. the Department of Veterans Affairs to REGISTRATION participate in collection activities conducted by the VHA; or 1301.11 Persons required to register; require- (3) Is a Department of Defense (DOD) ment of modification of registration authorizing activity as an online phar- police officer authorized by the DOD to macy. participate in collection activities con- 1301.12 Separate registrations for separate ducted by the DOD. locations. Non-retrievable means, for the purpose 1301.13 Application for registration; time of destruction, the condition or state for application; expiration date; registration for independent activities; applica- to which a controlled substance shall tion forms, fees, contents and signature; be rendered following a process that coincident activities. permanently alters that controlled 1301.14 Filing of application; acceptance for substance’s physical or chemical condi- filing; defective applications. tion or state through irreversible 1301.15 Additional information. 1301.16 Amendments to and withdrawal of means and thereby renders the con- applications. trolled substance unavailable and un- 1301.17 Special procedures for certain appli- usable for all practical purposes. The cations. process to achieve a non-retrievable 1301.18 Research protocols. condition or state may be unique to a 1301.19 Special requirements for online substance’s chemical or physical prop- pharmacies. erties. A controlled substance is con- EXCEPTIONS TO REGISTRATION AND FEES sidered ‘‘non-retrievable’’ when it can- 1301.21 Exception from fees. not be transformed to a physical or 1301.22 Exemption of agents and employees; chemical condition or state as a con- affiliated practitioners. trolled substance or controlled sub- 1301.23 Exemption of certain military and stance analogue. The purpose of de- other personnel. struction is to render the controlled 1301.24 Exemption of law enforcement officials. substance(s) to a non-retrievable state 1301.25 Registration regarding ocean ves- and thus prevent diversion of any such sels, aircraft, and other entities. substance to illicit purposes. 1301.26 Exemptions from import or export On-site means located on or at the requirements for personal medical use. physical premises of the registrant’s 1301.27 Separate registration by retail pharmacies for installation and operation of registered location. A controlled sub- automated dispensing systems at long stance is destroyed on-site when de- term care facilities. struction occurs on the physical prem- 1301.28 Exemption from separate registra- ises of the destroying registrant’s reg- tion for practitioners dispensing or pre- istered location. A hospital/clinic has scribing Schedule III, IV, or V narcotic an on-site pharmacy when it has a phar- controlled drugs approved by the Food and Drug Administration specifically for macy located on the physical premises use in maintenance or detoxification of the registrant’s registered location. treatment. 1301.29 [Reserved] [79 FR 53560, Sept. 9, 2014] ACTION ON APPLICATION FOR REGISTRATION: REVOCATION OR SUSPENSION OF REGISTRATION 1301.31 Administrative review generally. 1301.32 Action on applications for research in Schedule I substances.

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1301.33 Application for bulk manufacture of GENERAL INFORMATION Schedule I and II substances. 1301.34 Application for importation of § 1301.01 Scope of this part 1301. Schedule I and II substances. Procedures governing the registra- 1301.35 Certificate of registration; denial of registration. tion of manufacturers, distributors, 1301.36 Suspension or revocation of registra- dispensers, importers, and exporters of tion; suspension of registration pending controlled substances pursuant to sec- final order; extension of registration tions 301–304 and 1007–1008 of the Act (21 pending final order. U.S.C. 821–824 and 957–958) are set forth 1301.37 Order to show cause. generally by those sections and specifically by the sections of this part. HEARINGS [62 FR 13945, Mar. 24, 1997] 1301.41 Hearings generally. 1301.42 Purpose of hearing. § 1301.02 Definitions. 1301.43 Request for hearing or appearance; waiver. Any term used in this part shall have 1301.44 Burden of proof. the definition set forth in section 102 of 1301.45 Time and place of hearing. the Act (21 U.S.C. 802) or part 1300 of 1301.46 Final order. this chapter. [62 FR 13945, Mar. 24, 1997] MODIFICATION, TRANSFER, AND TERMINATION OF REGISTRATION § 1301.03 Information; special instruc- 1301.51 Modification in registration. tions. 1301.52 Termination of registration; transfer Information regarding procedures of registration; distribution upon dis- under these rules and instructions continuance of business. supplementing these rules will be fur- SECURITY REQUIREMENTS nished upon request by writing to the Registration Section, Drug Enforce- 1301.71 Security requirements generally. ment Administration. See the Table of 1301.72 Physical security controls for non- practitioners; narcotic treatment pro- DEA Mailing Addresses in § 1321.01 of grams and compounders for narcotic this chapter for the current mailing ad- treatment programs; storage areas. dress. 1301.73 Physical security controls for non- [75 FR 10676, Mar. 9, 2010] practitioners; compounders for narcotic treatment programs; manufacturing and REGISTRATION compounding areas. 1301.74 Other security controls for non- § 1301.11 Persons required to register; practitioners; narcotic treatment pro- requirement of modification of reg- grams and compounders for narcotic istration authorizing activity as an treatment programs. online pharmacy. 1301.75 Physical security controls for practitioners. (a) Every person who manufactures, 1301.76 Other security controls for practi- distributes, dispenses, imports, or ex- tioners. ports any controlled substance or who 1301.77 Security controls for freight for- proposes to engage in the manufacture, warding facilities. distribution, dispensing, importation or exportation of any controlled sub- EMPLOYEE SCREENING—NON-PRACTITIONERS stance shall obtain a registration un- 1301.90 Employee screening procedures. less exempted by law or pursuant to 1301.91 Employee responsibility to report §§ 1301.22 through 1301.26. Except as pro- drug diversion. vided in paragraph (b) of this section, 1301.92 Illicit activities by employees. only persons actually engaged in such 1301.93 Sources of information for employee activities are required to obtain a reg- checks. istration; related or affiliated persons AUTHORITY: 21 U.S.C. 821, 822, 823, 824, 831, who are not engaged in such activities 871(b), 875, 877, 886a, 951, 952, 956, 957, 958, 965 are not required to be registered. (For unless otherwise noted. example, a stockholder or parent cor- SOURCE: 36 FR 7778, Apr. 24, 1971, unless poration of a corporation manufac- otherwise noted. Redesignated at 38 FR 26609, turing controlled substances is not re- Sept. 24, 1973. quired to obtain a registration.)

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(b) As provided in sections 303(f) and (1) A warehouse where controlled 401(h) of the Act (21 U.S.C. 823(f) and substances are stored by or on behalf of 841(h)), it is unlawful for any person a registered person, unless such sub- who falls within the definition of ‘‘on- stances are distributed directly from line pharmacy’’ (as set forth in section such warehouse to registered locations 102(52) of the Act (21 U.S.C. 802(52)) and other than the registered location from § 1300.04(h) of this chapter) to deliver, which the substances were delivered or distribute, or dispense a controlled sub- to persons not required to register by stance by means of the Internet if such virtue of subsection 302(c)(2) or sub- person is not validly registered with a section 1007(b)(1)(B) of the Act (21 modification of such registration au- U.S.C. 822(c)(2) or 957(b)(1)(B)); thorizing such activity (unless such (2) An office used by agents of a reg- person is exempt from such modified istrant where sales of controlled sub- registration requirement under the Act stances are solicited, made, or super- or this chapter). The Act further pro- vised but which neither contains such vides that the Administrator may only substances (other than substances for issue such modification of registration display purposes or lawful distribution to a person who is registered as a phar- as samples only) nor serves as a dis- macy under section 303(f) of the Act (21 tribution point for filling sales orders; U.S.C. 823(f)). Accordingly, any phar- and macy registered pursuant to § 1301.13 of (3) An office used by a practitioner this part that falls within the defini- (who is registered at another location tion of an online pharmacy and pro- in the same State in which he or she poses to dispense controlled substances practices) where controlled substances by means of the Internet must obtain a are prescribed but neither adminis- modification of its registration author- tered nor otherwise dispensed as a reg- izing such activity following the sub- ular part of the professional practice of mission of an application in accordance the practitioner at such office, and with § 1301.19 of this part. This require- where no supplies of controlled sub- ment does not apply to a registered stances are maintained. pharmacy that does not fall within the (4) A freight forwarding facility, as definition of an online pharmacy set defined in § 1300.01 of this part, provided forth in § 1300.04(h). Under the Act, per- that the distributing registrant oper- sons other than registered pharmacies ating the facility has submitted writ- are not eligible to obtain such a modi- ten notice of intent to operate the fa- fication of registration but remain lia- cility by registered mail, return re- ble under section 401(h) of the Act (21 ceipt requested (or other suitable U.S.C. 841(h)) if they deliver, dis- means of documented delivery) and tribute, or dispense a controlled sub- such notice has been approved. The no- stance while acting as an online phar- tice shall be submitted to the Special macy without being validly registered Agent in Charge of the Administra- with a modification authorizing such tion’s offices in both the area in which activity. the facility is located and each area in which the distributing registrant main- [74 FR 15621, Apr. 6, 2009] tains a registered location that will transfer controlled substances through § 1301.12 Separate registrations for the facility. The notice shall detail the separate locations. registered locations that will utilize (a) A separate registration is re- the facility, the location of the facil- quired for each principal place of busi- ity, the hours of operation, the indi- ness or professional practice at one vidual(s) responsible for the controlled general physical location where con- substances, the security and record- trolled substances are manufactured, keeping procedures that will be em- distributed, imported, exported, or dis- ployed, and whether controlled sub- pensed by a person. stances returns will be processed (b) The following locations shall be through the facility. The notice must deemed not to be places where con- also detail what state licensing re- trolled substances are manufactured, quirements apply to the facility and distributed, or dispensed: the registrant’s actions to comply with

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any such requirements. The Special business activities to a group, the Ad- Agent in Charge of the DEA Office in ministration may select a group the the area where the freight forwarding expiration date of which is less than facility will be operated will provide one year from the date such business written notice of approval or dis- activity was registered. If the business approval to the person within thirty activity is assigned to a group which days after confirmed receipt of the no- has an expiration date less than three tice. Registrants that are currently op- months from the date of which the erating freight forwarding facilities business activity is registered, the reg- under a memorandum of understanding istration shall not expire until one with the Administration must provide year from that expiration date; in all notice as required by this section no other cases, the registration shall ex- later than September 18, 2000 and re- pire on the expiration date following ceive written approval from the Spe- the date on which the business activity cial Agent in Charge of the DEA Office is registered. in the area in which the freight for- (d) At the time a retail pharmacy, warding facility is operated in order to hospital/clinic, practitioner or teach- continue operation of the facility. ing institution is first registered, that [62 FR 13945, Mar. 24, 1997, as amended at 65 business activity shall be assigned to FR 44678, July 19, 2000; 65 FR 45829, July 25, one of twelve groups, which shall cor- 2000; 71 FR 69480, Dec. 1, 2006; 81 FR 97019, respond to the months of the year. The Dec. 30, 2016] expiration date of the registrations of all registrants within any group will be § 1301.13 Application for registration; the last day of the month designated time for application; expiration date; registration for independent for that group. In assigning any of the activities; application forms, fees, above business activities to a group, contents and signature; coincident the Administration may select a group activities. the expiration date of which is not less (a) Any person who is required to be than 28 months nor more than 39 registered and who is not so registered months from the date such business ac- may apply for registration at any time. tivity was registered. After the initial No person required to be registered registration period, the registration shall engage in any activity for which shall expire 36 months from the initial registration is required until the appli- expiration date. cation for registration is granted and a (e) Any person who is required to be Certificate of Registration is issued by registered and who is not so registered, the Administrator to such person. shall make application for registration (b) Any person who is registered may for one of the following groups of con- apply to be reregistered not more than trolled substances activities, which are 60 days before the expiration date of deemed to be independent of each his/her registration, except that a bulk other. Application for each registration manufacturer of Schedule I or II con- shall be made on the indicated form, trolled substances or an importer of and shall be accompanied by the indi- Schedule I or II controlled substances cated fee. Fee payments shall be made may apply to be reregistered no more in the form of a personal, certified, or than 120 days before the expiration cashier’s check or money order made date of their registration. payable to the ‘‘Drug Enforcement Ad- (c) At the time a manufacturer, dis- ministration’’. The application fees are tributor, reverse distributor, re- not refundable. Any person, when reg- searcher, analytical lab, importer, ex- istered to engage in the activities de- porter or narcotic treatment program scribed in each subparagraph in this is first registered, that business activ- paragraph, shall be authorized to en- ity shall be assigned to one of twelve gage in the coincident activities de- groups, which shall correspond to the scribed without obtaining a registra- months of the year. The expiration tion to engage in such coincident ac- date of the registrations of all reg- tivities, provided that, unless specifi- istrants within any group will be the cally exempted, he/she complies with last date of the month designated for all requirements and duties prescribed that group. In assigning any of these by law for persons registered to engage

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in such coincident activities. Any per- schedules authorized in that group of son who engages in more than one independent activities. A person reg- group of independent activities shall istered to conduct research with con- obtain a separate registration for each trolled substances listed in Schedule I group of activities, except as provided may conduct research with any sub- in this paragraph under coincident ac- stances listed in Schedule I for which tivities. A single registration to engage he/she has filed and had approved a rein any group of independent activities search protocol. listed below may include one or more (1) controlled substances listed in the

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 any substance or class for which not registered. Schedules II–V: May conduct chemical analysis and preclinical research (including quality control analysis) with substances listed in those schedules for which authorization as a mfr. was issued. (ii) Distributing .... Schedules I–V ... New—225 Re- 1,523 1 May acquire Schedules II–V controlled newal—225a. substances from collectors for the purposes of destruction. (iii) Reverse dis- Schedules I–V ... New–225 Re- 1,523 1 tributing. newal–225a. (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.

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

(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. (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 give notice of such fact and may re- be obtained at any area office of the quest such forms by writing to the Administration or by writing to the Registration Section, Drug Enforce- Registration Section, Drug Enforce- ment Administration. ment Administration. See the Table of (f) Each application for registration DEA Mailing Addresses in § 1321.01 of to handle any basic class of controlled this chapter for the current mailing ad- substance listed in Schedule I (except dress. to conduct chemical analysis with such (3) Registrants will receive renewal classes), and each application for reg- notifications approximately 60 days istration to manufacture a basic class prior to the registration expiration of controlled substance listed in Sched- date. DEA Forms 224a, 225a, and 363a ule II shall include the Administration may be mailed, as applicable, to reg- Controlled Substances Code Number, as istrants; if any registered person does set forth in part 1308 of this chapter, not receive such notification within 45 for each basic class to be covered by days before the registration expiration such registration. date, the registrant must promptly

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(g) Each application for registration The power of attorney shall be valid to import or export controlled sub- until revoked by the applicant. stances shall include the Administra- [62 FR 13946, Mar. 24, 1997, as amended at 68 tion Controlled Substances Code Num- FR 37409, June 24, 2003; 68 FR 41228, July 11, ber, as set forth in part 1308 of this 2003; 68 FR 58598, Oct. 10, 2003; 71 FR 51112, chapter, for each controlled substance Aug. 29, 2006; 74 FR 15622, Apr. 6, 2009; 75 FR whose importation or exportation is to 10676, Mar. 9, 2010; 77 FR 15248, Mar. 15, 2012; be authorized by such registration. 79 FR 53560, Sept. 9, 2014] Registration as an importer or exporter shall not entitle a registrant to § 1301.14 Filing of application; accept- import or export any controlled sub- ance for filing; defective applications. stance not specified in such registration. (a) All applications for registration (h) Each application for registration shall be submitted for filing to the to conduct research with any basic Registration Unit, Drug Enforcement class of controlled substance listed in Administration. The appropriate reg- Schedule II shall include the Adminis- istration fee and any required attach- tration Controlled Substances Code ments must accompany the applica- Number, as set forth in part 1308 of this tion. See the Table of DEA Mailing Ad- chapter, for each such basic class to be dresses in § 1321.01 of this chapter for manufactured or imported as a coinci- the current mailing address. dent activity of that registration. A (b) Any person required to obtain statement listing the quantity of each more than one registration may submit such basic class of controlled substance all applications in one package. Each to be imported or manufactured during application must be complete and the registration period for which appli- should not refer to any accompanying cation is being made shall be included application for required information. with each such application. For pur- (c) Applications submitted for filing poses of this paragraph only, manufac- are dated upon receipt. If found to be turing is defined as the production of a complete, the application will be ac- controlled substance by synthesis, excepted for filing. Applications failing traction or by agricultural/horti- to comply with the requirements of cultural means. this part will not generally be accepted (i) Each application shall include all for filing. In the case of minor defects information called for in the form, un- as to completeness, the Administrator less the item is not applicable, in may accept the application for filing which case this fact shall be indicated. with a request to the applicant for ad- (j) Each application, attachment, or ditional information. A defective appli- other document filed as part of an ap- cation will be returned to the applicant plication, shall be signed by the appli- within 10 days following its receipt cant, if an individual; by a partner of with a statement of the reason for not the applicant, if a partnership; or by an accepting the application for filing. A officer of the applicant, if a corpora- defective application may be corrected tion, corporate division, association, and resubmitted for filing at any time; trust or other entity. An applicant may the Administrator shall accept for fil- authorize one or more individuals, who ing any application upon resubmission would not otherwise be authorized to by the applicant, whether complete or do so, to sign applications for the ap- not. plicant by filing with the Registration (d) Accepting an application for fil- Unit of the Administration a power of ing does not preclude any subsequent attorney for each such individual. The request for additional information pur- power of attorney shall be signed by a suant to § 1301.15 and has no bearing on person who is authorized to sign appli- whether the application will be grant- cations under this paragraph and shall ed. contain the signature of the individual [62 FR 13948, Mar. 24, 1997, as amended at 75 being authorized to sign applications. FR 10676, Mar. 9, 2010]

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§ 1301.15 Additional information. llllllllll (Number and Street), llllllllll (City) llllll (State) The Administrator may require an llllll (Zip code), hereby certify that applicant to submit such documents or said store was issued a pharmacy permit No. written statements of fact relevant to llll by the llllllll (Board of the application as he/she deems nec- Pharmacy or Licensing Agency) of the State essary to determine whether the appli- of llllll on llllll (Date). cation should be granted. The failure of This statement is submitted in order to ob- the applicant to provide such docu- tain a Drug Enforcement Administration registration number. I understand that if ments or statements within a reason- any information is false, the Administration able time after being requested to do so may immediately suspend the registration shall be deemed to be a waiver by the for this store and commence proceedings to applicant of an opportunity to present revoke under 21 U.S.C. 824(a) because of the such documents or facts for consider- danger to public health and safety. I further ation by the Administrator in granting understand that any false information con- or denying the application. tained in this affidavit may subject me personally and the above-named corporation/ [62 FR 13948, Mar. 24, 1997] partnership/business to prosecution under 21 U.S.C. 843, the penalties for conviction of § 1301.16 Amendments to and with- which include imprisonment for up to 4 drawal of applications. years, a fine of not more than $30,000 or both. llllllllllllllllllllllll (a) An application may be amended Signature (Person who signs Application for or withdrawn without permission of Registration) the Administrator at any time before State of lllllllllllllllllll the date on which the applicant re- County of llllllllllllllllll ceives an order to show cause pursuant Subscribed to and sworn before me this to § 1301.37. An application may be lllllll day of lllllll, 19ll. amended or withdrawn with permission llllllllllllllllllllllll of the Administrator at any time Notary Public where good cause is shown by the ap- (b) Whenever the ownership of a plicant or where the amendment or pharmacy is being transferred from one withdrawal is in the public interest. person to another, if the transferee (b) After an application has been ac- owns at least one other pharmacy li- cepted for filing, the request by the ap- censed in the same State as the one the plicant that it be returned or the fail- ownership of which is being trans- ure of the applicant to respond to offi- ferred, the transferee may apply for cial correspondence regarding the ap- registration prior to the date of trans- plication, when sent by registered or fer. The Administrator may register certified mail, return receipt re- the applicant and authorize him to ob- quested, shall be deemed to be a with- tain controlled substances at the time drawal of the application. of transfer. Such registration shall not [62 FR 13949, Mar. 24, 1997] authorize the transferee to dispense controlled substances until the phar- § 1301.17 Special procedures for cer- macy has been issued a valid State li- tain applications. cense. The transferee shall include (a) If, at the time of application for with his/her application the following registration of a new pharmacy, the affidavit: pharmacy has been issued a license Affidavit for Transfer of Pharmacy from the appropriate State licensing agency, the applicant may include with I, llllllllll, the llllllllll (Title of officer, official, his/her application an affidavit as to partner or other position) of the existence of the State license in llllllllll (Corporation, partner- the following form: ship, or sole proprietor), doing business as llllllllll (Store name) hereby cer- Affidavit for New Pharmacy tify: I, llllllllll, the (1) That said company was issued a phar- llllllllll (Title of officer, official, macy permit No.llllllby the partner, or other position) of llllllllll (Board of Pharmacy of 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

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llllllllll (Number and Street) Web site. The affidavit must include llllll (City) llllll (State) the following information: llllll (Zip Code); and (1) The name and title of the cor- (2) That said company is acquiring the pharmacy business of llllllllll porate officer or official signing the af- (Name of Seller) doing business fidavit; asllllllllllwith DEA Registration (2) The name of the corporation, Number llllll on or about llllll partnership or sole proprietorship oper- (Date of Transfer) and that said company has ating the retail pharmacy; applied (or will apply on llllll (Date) (3) The name and complete address for a pharmacy permit from the board of (including city, state, and Zip code) of pharmacy (or licensing agency) of the State the retail pharmacy; of llllll to do business as llllllllll (Store name) at (4) The name and complete address llllllllll (Number and Street) (including city, state, and Zip code) of llllllllll (City) llllll (State) the long term care facility at which llllll (Zip Code). DEA registration is sought; This statement is submitted in order (5) Certification that the named re- to obtain a Drug Enforcement Admin- tail pharmacy has been authorized by istration registration number. the state Board of Pharmacy or licensing agency to install and operate an I understand that if a DEA registration automated dispensing system for the number is issued, the pharmacy may acquire dispensing of controlled substances at controlled substances but may not dispense them until a pharmacy permit or license is the named long term care facility (in- issued by the State board of pharmacy or li- cluding the license or permit number, censing agency. if applicable); I understand that if any information is (6) The date on which the authoriza- false, the Administration may immediately tion was issued; suspend the registration for this store and (7) Statements attesting to the fol- commence proceedings to revoke under 21 lowing: U.S.C. 824(a) because of the danger to public health and safety. I further understand that (i) The affidavit is submitted to ob- any false information contained in this affi- tain a Drug Enforcement Administra- davit may subject me personally to prosecution registration number; tion under 21 U.S.C. 843, the penalties for (ii) If any material information is conviction of which include imprisonment false, the Administrator may com- for up to 4 years, a fine of not more than mence proceedings to deny the applica- $30,000 or both. tion under section 304 of the Act (21 llllllllllllllllllllllll U.S.C. 824(a)); Signature (Person who signs Application for (iii) Any false or fraudulent material Registration) State of lllllllllllllllllll information contained in this affidavit County of llllllllllllllllll may subject the person signing this af- Subscribed to and sworn before me this fidavit and the above-named corpora- llllllll day of lllllllll, tion/partnership/business to prosecu- 19ll. tion under section 403 of the Act (21 llllllllllllllllllllllll U.S.C. 843); Notary Public (8) Signature of the person author- (c) If at the time of application for a ized to sign the Application for Reg- separate registration at a long term istration for the named retail phar- care facility, the retail pharmacy has macy; been issued a license, permit, or other (9) Notarization of the affidavit. form of authorization from the appro- (d) The Administrator shall follow priate State agency to install and oper- the normal procedures for approving an ate an automated dispensing system application to verify the statements in for the dispensing of controlled sub- the affidavit. If the statements prove stances at the long term care facility, to be false, the Administrator may re- the applicant must include with his/her voke the registration on the basis of application for registration (DEA Form section 304(a)(1) of the Act (21 U.S.C. 224) an affidavit as to the existence of 824(a)(1)) and suspend the registration the State authorization. Exact lan- immediately by pending revocation on guage for this affidavit may be found the basis of section 304(d) of the Act (21 at the DEA Diversion Control Program U.S.C. 824(d)). At the same time, the

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Administrator may seize and place (3) Authority: under seal all controlled substances (i) Institutional approval. possessed by the applicant under sec- (ii) Approval of a Human Research tion 304(f) of the Act (21 U.S.C. 824(f)). Committee for human studies. Intentional misuse of the affidavit pro- (iii) Indication of an approved active cedure may subject the applicant to Notice of Claimed Investigational Ex- prosecution for fraud under section emption for a New Drug (number). 403(a)(4) of the Act (21 U.S.C. 843(a)(4)), (iv) Indication of an approved funded and obtaining controlled substances grant (number), if any. through registration by fraudulent (b) In the case of a clinical investiga- means may subject the applicant to tion with controlled substances listed prosecution under section 403(a)(3) of in Schedule I, the applicant shall sub- the Act (21 U.S.C. 843(a)(3)). The pen- mit three copies of a Notice of Claimed alties for conviction of either offense Investigational Exemption for a New include imprisonment for up to 4 years, Drug (IND) together with a statement a fine not exceeding $30,000 or both. of the security provisions (as pro- scribed in paragraph (a)(2)(vi) of this [62 FR 13949, Mar. 24, 1997, as amended at 70 FR 25465, May 13, 2005] section for a research protocol) to, and have such submission approved by, the § 1301.18 Research protocols. Food and Drug Administration as re- (a) A protocol to conduct research quired in 21 U.S.C. 355(i) and § 130.3 of with controlled substances listed in this title. Submission of this Notice Schedule I shall be in the following and statement to the Food and Drug form and contain the following infor- Administration shall be in lieu of a re- mation where applicable: search protocol to the Administration (1) Investigator: as required in paragraph (a) of this sec- (i) Name, address, and DEA registration. The applicant, when applying for tion number; if any. registration with the Administration, (ii) Institutional affiliation. shall indicate that such notice has (iii) Qualifications, including a cur- been submitted to the Food and Drug riculum vitae and an appropriate bibli- Administration by submitting to the ography (list of publications). Administration with his/her DEA Form (2) Research project: 225 three copies of the following certifi- (i) Title of project. cate: (ii) Statement of the purpose. I hereby certify that on llllllllll (iii) Name of the controlled sub- (Date), pursuant to 21 U.S.C. 355(i) and 21 stances or substances involved and the CFR 130.3, I, llllllllll (Name and amount of each needed. Address of IND Sponsor) submitted a Notice (iv) Description of the research to be of Claimed Investigational Exemption for a conducted, including the number and New Drug (IND) to the Food and Drug Ad- species of research subjects, the dosage ministration for: to be administered, the route and llllllllllllllllllllllll method of administration, and the du- (Name of Investigational Drug). ration of the project. llllllllllllllllllllllll (v) Location where the research will (Date) be conducted. llllllllllllllllllllllll (vi) Statement of the security provi- (Signature of Applicant). sions for storing the controlled sub- (c) In the event that the registrant stances (in accordance with § 1301.75) desires to increase the quantity of a and for dispensing the controlled sub- controlled substance used for an ap- stances in order to prevent diversion. proved research project, he/she shall (vii) If the investigator desires to submit a request to the Registration manufacture or import any controlled Unit, Drug Enforcement Administra- substance listed in paragraph (a)(2)(iii) tion, by registered mail, return receipt of this section, a statement of the requested. See the Table of DEA Mail- quantity to be manufactured or im- ing Addresses in § 1321.01 of this chapter ported and the sources of the chemicals for the current mailing address. The re- to be used or the substance to be im- quest shall contain the following infor- ported. mation: DEA registration number;

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name of the controlled substance or (b) Each online pharmacy shall com- substances and the quantity of each ply with the requirements of State law authorized in the approved protocol; concerning licensure of pharmacies in and the additional quantity of each de- each State from which it, and in each sired. Upon return of the receipt, the State to which it, delivers, distributes, registrant shall be authorized to pur- or dispenses, or offers to deliver, dis- chase the additional quantity of the tribute, or dispense controlled sub- controlled substance or substances stances by means of the Internet. specified in the request. The Adminis- (c) Application for a modified reg- tration shall review the letter and for- istration authorizing the dispensing of ward it to the Food and Drug Adminis- controlled substances by means of the tration together with the Administra- Internet will be made by an online ap- tion comments. The Food and Drug Ad- plication process as specified in § 1301.13 ministration shall approve or deny the of this part. Subsequent online phar- request as an amendment to the pro- macy registration renewals will be ac- tocol and so notify the registrant. Ap- complished by an online process. proval of the letter by the Food and (d) A pharmacy that seeks to dis- Drug Administration shall authorize continue its modification of registra- the registrant to use the additional tion authorizing it to dispense controlled substances by means of the quantity of the controlled substance in Internet as an online pharmacy (but the research project. continue its business activity as a non- (d) In the event the registrant desires online pharmacy) shall so notify the to conduct research beyond the vari- Administrator by requesting to modify ations provided in the registrant’s ap- its registration to reflect the appro- proved protocol (excluding any in- priate business activity. Once the reg- crease in the quantity of the controlled istration has been so changed, the substance requested for his/her re- pharmacy may no longer dispense con- search project as outlined in paragraph trolled substances by means of the (c) of this section), he/she shall submit Internet. A pharmacy that has so three copies of a supplemental protocol changed its registration status back to in accordance with paragraph (a) of that of a non-online pharmacy remains this section describing the new re- responsible for submitting reports in search and omitting information in the accordance with § 1304.55 of this chapter supplemental protocol which has been with respect to any controlled sub- stated in the original protocol. Supple- stances that it dispensed while it was mental protocols shall be processed and registered with a modification author- approved or denied in the same manner izing it to operate as an online phar- as original research protocols. macy. [62 FR 13949, Mar. 24, 1997, as amended at 75 (e) Registrants applying for modified FR 10676, Mar. 9, 2010] registrations under this section must comply with notification and reporting § 1301.19 Special requirements for on- requirements set forth in §§ 1304.40, line pharmacies. 1304.45, 1304.50, and 1304.55 of this chap- (a) A pharmacy that has been issued ter. a registration under § 1301.13 may re- (f) No person (including a registrant) quest that the Administrator modify required to obtain a modification of a its registration to authorize the phar- registration under §§ 1301.11(b) and macy to dispense controlled substances 1301.13 of this part authorizing it to op- by means of the Internet as an online erate as an online pharmacy may en- pharmacy. The Administrator may gage in any activity for which such deny an application for a modification modification of registration is required of registration if the Administrator 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)). [74 FR 15622, Apr. 6, 2009]

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EXCEPTIONS TO REGISTRATION AND FEES the jurisdiction in which he or she practices, under the registration of the § 1301.21 Exemption from fees. employer or principal practitioner in (a) The Administrator shall exempt lieu of being registered him/herself. from payment of an application fee for (c) An individual practitioner who is registration or reregistration: an agent or employee of a hospital or (1) Any hospital or other institution other institution may, when acting in which is operated by an agency of the the normal course of business or em- United States (including the U.S. ployment, administer, dispense, or pre- Army, Navy, Marine Corps., Air Force, scribe controlled substances under the and Coast Guard), of any State, or any registration of the hospital or other in- political subdivision or agency thereof. stitution which is registered in lieu of (2) Any individual practitioner who is being registered him/herself, provided required to obtain an individual reg- that: istration in order to carry out his or (1) Such dispensing, administering or her duties as an official of an agency of prescribing is done in the usual course the United States (including the U.S. of his/her professional practice; Army, Navy, Marine Corps, Air Force, (2) Such individual practitioner is au- and Coast Guard), of any State, or any thorized or permitted to do so by the political subdivision or agency thereof. jurisdiction in which he/she is prac- (b) In order to claim exemption from ticing; payment of a registration or rereg- (3) The hospital or other institution istration application fee, the registrant by whom he/she is employed has shall have completed the certification verified that the individual practi- on the appropriate application form, tioner is so permitted to dispense, ad- wherein the registrant’s superior (if minister, or prescribe drugs within the the registrant is an individual) or offi- jurisdiction; cer (if the registrant is an agency) cer- (4) Such individual practitioner is tifies to the status and address of the acting only within the scope of his/her registrant and to the authority of the employment in the hospital or institu- registrant to acquire, possess, or han- tion; dle controlled substances. (5) The hospital or other institution (c) Exemption from payment of a reg- authorizes the individual practitioner istration or reregistration application to administer, dispense or prescribe fee does not relieve the registrant of under the hospital registration and any other requirements or duties pre- designates a specific internal code scribed by law. number for each individual practitioner so authorized. The code number [62 FR 13950, Mar. 24, 1997] shall consist of numbers, letters, or a § 1301.22 Exemption of agents and em- combination thereof and shall be a suf- ployees; affiliated practitioners. fix to the institution’s DEA registra- (a) The requirement of registration is tion number, preceded by a hyphen waived for any agent or employee of a (e.g., APO123456–10 or APO123456–A12); person who is registered to engage in and any group of independent activities, if (6) A current list of internal codes such agent or employee is acting in the and the corresponding individual prac- usual course of his/her business or em- titioners is kept by the hospital or ployment. other institution and is made available (b) An individual practitioner who is at all times to other registrants and an agent or employee of another prac- law enforcement agencies upon request titioner (other than a mid-level practi- for the purpose of verifying the author- tioner) registered to dispense con- ity of the prescribing individual practi- trolled substances may, when acting in tioner. the normal course of business or em- [62 FR 13950, Mar. 24, 1997] ployment, administer or dispense (other than by issuance of prescription) § 1301.23 Exemption of certain mili- controlled substances if and to the ex- tary and other personnel. tent that such individual practitioner (a) The requirement of registration is is authorized or permitted to do so by waived for any official of the U.S.

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Army, Navy, Marine Corps, Air Force, (b) Any official exempted by this sec- Coast Guard, Public Health Service, or tion may, when acting in the course of Bureau of Prisons who is authorized to his/her official duties, procure any con- prescribe, dispense, or administer, but trolled substance in the course of an not to procure or purchase, controlled inspection, in accordance with substances in the course of his/her offi- § 1316.03(d) of this chapter, or in the cial duties. Such officials shall follow course of any criminal investigation procedures set forth in part 1306 of this involving the person from whom the chapter regarding prescriptions, but substance was procured, and may pos- shall state the branch of service or sess any controlled substance and dis- agency (e.g., ‘‘U.S. Army’’ or ‘‘Public tribute any such substance to any Health Service’’) and the service iden- other official who is also exempted by tification number of the issuing official this section and acting in the course of in lieu of the registration number re- his/her official duties. quired on prescription forms. The serv- (c) In order to enable law enforce- ice identification number for a Public ment agency laboratories, including Health Service employee is his/her So- laboratories of the Administration, to cial Security identification number. obtain and transfer controlled sub- (b) The requirement of registration is stances for use as standards in chem- waived for any official or agency of the ical analysis, such laboratories shall U.S. Army, Navy, Marine Corps, Air obtain annually a registration to con- Force, Coast Guard, or Public Health duct chemical analysis. Such labora- Service who or which is authorized to tories shall be exempted from payment import or export controlled substances of a fee for registration. Laboratory in the course of his/her official duties. personnel, when acting in the scope of (c) If any official exempted by this their official duties, are deemed to be section also engages as a private indi- officials exempted by this section and vidual in any activity or group of ac- within the activity described in section tivities for which registration is re- 515(d) of the Act (21 U.S.C. 885(d)). For quired, such official shall obtain a reg- purposes of this paragraph, laboratory istration for such private activities. activities shall not include field or [62 FR 13951, Mar. 24, 1997] other preliminary chemical tests by officials exempted by this section. § 1301.24 Exemption of law enforce- (d) In addition to the activities au- ment officials. thorized under a registration to con- (a) The requirement of registration is duct chemical analysis pursuant to waived for the following persons in the § 1301.13(e)(1)(ix), laboratories of the circumstances described in this sec- Administration shall be authorized to tion: manufacture or import controlled substances for any lawful purpose, to dis- (1) Any officer or employee of the Ad- tribute or export such substances to ministration, any customs officer, any any person, and to import and export officer or employee of the U.S. Food such substances in emergencies with- and Drug Administration, and any out regard to the requirements of part other Federal or Insular officer who is 1312 of this chapter if a report con- lawfully engaged in the enforcement of cerning the importation or exportation any Federal law relating to controlled is made to the Drug Operations Section substances, drugs, or customs, and is of the Administration within 30 days of duly authorized to possess or to import such importation or exportation. or export controlled substances in the course of his/her official duties; and [62 FR 13951, Mar. 24, 1997, as amended at 81 (2) Any officer or employee of any FR 97019, Dec. 30, 2016] State, or any political subdivision or agency thereof, who is engaged in the § 1301.25 Registration regarding ocean enforcement of any State or local law vessels, aircraft, and other entities. relating to controlled substances and is (a) If acquired by and dispensed under duly authorized to possess controlled the general supervision of a medical of- substances in the course of his/her offi- ficer described in paragraph (b) of this cial duties. section, or the master or first officer of

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the vessel under the circumstances de- from a registered manufacturer or dis- scribed in paragraph (d) of this section, tributor, or from an authorized phar- controlled substances may be held for macy as described in paragraph (f) of stocking, be maintained in, and dis- this section, by following the procedure pensed from medicine chests, first aid outlined below: packets, or dispensaries: (1) The master or first officer of the (1) On board any vessel engaged in vessel must personally appear at the international trade or in trade between vendor’s place of business, present ports of the United States and any proper identification (e.g., Seaman’s merchant vessel belonging to the U.S. photographic identification card) and a Government; written requisition for the controlled (2) On board any aircraft operated by substances. an air carrier under a certificate of per- (2) The written requisition must be mit issued pursuant to the Federal on the vessel’s official stationery or Aviation Act of 1958 (49 U.S.C. 1301); and purchase order form and must include (3) In any other entity of fixed or the name and address of the vendor, transient location approved by the Ad- the name of the controlled substance, ministrator as appropriate for applica- description of the controlled substance tion of this section (e.g., emergency (dosage form, strength and number or kits at field sites of an industrial firm). volume per container) number of con- (b) A medical officer shall be: tainers ordered, the name of the vessel, (1) Licensed in a state as a physician; the vessel’s official number and coun- (2) Employed by the owner or oper- try of registry, the owner or operator ator of the vessel, aircraft or other en- of the vessel, the port at which the ves- tity; and sel is located, signature of the vessel’s (3) Registered under the Act at either officer who is ordering the controlled of the following locations: substances and the date of the requisi- (i) The principal office of the owner tion. or operator of the vessel, aircraft or (3) The vendor may, after verifying other entity or the identification of the vessel’s officer (ii) At any other location provided requisitioning the controlled sub- that the name, address, registration stances, deliver the control substances number and expiration date as they ap- to that officer. The transaction shall pear on his/her Certificate of Registra- be documented, in triplicate, on a tion (DEA Form 223) for this location record of sale in a format similar to are maintained for inspection at said that outlined in paragraph (d)(4) of this principal office in a readily retrievable section. The vessel’s requisition shall manner. be attached to copy 1 of the record of (c) A registered medical officer may sale and filed with the controlled sub- serve as medical officer for more than stances records of the vendor, copy 2 of one vessel, aircraft, or other entity the record of sale shall be furnished to under a single registration, unless he/ the officer of the vessel and retained she serves as medical officer for more aboard the vessel, copy 3 of the record than one owner or operator, in which of sale shall be forwarded to the near- case he/she shall either maintain a sep- est DEA Division Office within 15 days arate registration at the location of after the end of the month in which the the principal office of each such owner sale is made. or operator or utilize one or more registrations pursuant to paragraph (4) The vendor’s record of sale should (b)(3)(ii) of this section. be similar to, and must include all the (d) If no medical officer is employed information contained in, the below by the owner or operator of a vessel, or listed format. in the event such medical officer is not SALE OF CONTROLLED SUBSTANCES TO accessible and the acquisition of con- VESSELS trolled substances is required, the master or first officer of the vessel, who (Name of registrant) llllllllllll shall not be registered under the Act, (Address of registrant) lllllllllll may purchase controlled substances (DEA registration number) lllllllll

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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 year in which the pharmacy is reg- Name of vessel lllllllllllllll istered to dispense does not exceed the Vessel’s official number lllllllllll limitations imposed upon such dis- Vessel’s country of registry lllllllll Owner or operator of the vessel lllllll tribution by § 1307.11(a)(4) and (b) of this chapter. Name and title of vessel’s officer who presented the requisition llll (g) Owners or operators of vessels, Signature of vessel’s officer who presented aircraft, or other entities described in the requisition llll this section shall not be deemed to possess or dispense any controlled sub- (e) Any medical officer described in stance acquired, stored and dispensed paragraph (b) of this section shall, in in accordance with this section. Addi- addition to complying with all require- tionally, owners or operators of ves- ments and duties prescribed for reg- sels, aircraft, or other entities de- istrants generally, prepare an annual scribed in this section or in Article 32 report as of the date on which his/her of the Single Convention on Narcotic registration expires, which shall give in detail an accounting for each vessel, Drugs, 1961, or in Article 14 of the Con- aircraft, or other entity, and a sum- vention on Psychotropic Substances, mary accounting for all vessels, air- 1971, shall not be deemed to import or craft, or other entities under his/her export any controlled substances pur- supervision for all controlled sub- chased and stored in accordance with stances purchased, dispensed or dis- that section or applicable article. posed of during the year. The medical (h) The Master of a vessel shall pre- officer shall maintain this report with pare a report for each calendar year other records required to be kept under which shall give in detail an account- the Act and, upon request, deliver a ing for all controlled substances pur- copy of the report to the Administra- chased, dispensed, or disposed of during tion. The medical officer need not be the year. The Master shall file this represent when controlled substances are port with the medical officer employed dispensed, if the person who actually by the owner or operator of his/her ves- dispensed the controlled substances is sel, if any, or, if not, he/she shall main- responsible to the medical officer to tain this report with other records re- justify his/her actions. quired to be kept under the Act and, (f) Any registered pharmacy that upon request, deliver a copy of the re- wishes to distribute controlled sub- port to the Administration. stances pursuant to this section shall (i) Controlled substances acquired be authorized to do so, provided: and possessed in accordance with this (1) The registered pharmacy notifies section shall be distributed only to per- the nearest Division Office of the Ad- sons under the general supervision of ministration of its intention to so dis- the medical officer employed by the tribute controlled substances prior to owner or operator of the vessel, air- the initiation of such activity. This no- craft, or other entity, except in accord- tification shall be by registered mail ance with part 1317 of this chapter. and shall contain the name, address, [62 FR 13951, Mar. 24, 1997, as amended at 79 and registration number of the phar- FR 53561, Sept. 9, 2014] macy as well as the date upon which such activity will commence; and § 1301.26 Exemptions from import or (2) Such activity is authorized by export requirements for personal state law; and medical use. (3) The total number of dosage units Any individual who has in his/her of all controlled substances distributed possession a controlled substance listed by the pharmacy during any calendar in schedules II, III, IV, or V, which he/

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she has lawfully obtained for his/her automated dispensing system at a long personal medical use, or for adminis- term care facility. tration to an animal accompanying (b) Retail pharmacies installing and him/her, may enter or depart the operating automated dispensing sys- United States with such substance not- tems at long term care facilities must withstanding sections 1002–1005 of the maintain a separate registration at the Act (21 U.S.C. 952–955), provided the fol- location of each long term care facility lowing conditions are met: at which automated dispensing sys- (a) The controlled substance is in the tems are located. If more than one reg- original container in which it was dis- istered retail pharmacy operates auto- pensed to the individual; and mated dispensing systems at the same (b) The individual makes a declara- long term care facility, each retail tion to an appropriate customs officer pharmacy must maintain a registra- stating: tion at the long term care facility. (1) That the controlled substance is possessed for his/her personal use, or (c) A registered retail pharmacy ap- for an animal accompanying him/her; plying for a separate registration to and operate an automated dispensing sys- (2) The trade or chemical name and tem for the dispensing of controlled the symbol designating the schedule of substances at a long term care facility the controlled substance if it appears is exempt from application fees for any on the container label, or, if such name such additional registrations. does not appear on the label, the name [70 FR 25465, May 13, 2005] and address of the pharmacy or practitioner who dispensed the substance and § 1301.28 Exemption from separate the prescription number. registration for practitioners dis- (c) In addition to (and not in lieu of) pensing or prescribing Schedule III, the foregoing requirements of this sec- IV, or V narcotic controlled drugs tion, a United States resident may im- approved by the Food and Drug Ad- port into the United States no more ministration specifically for use in than 50 dosage units combined of all maintenance or detoxification such controlled substances in the indi- treatment. vidual’s possession that were obtained (a) An individual practitioner may abroad for personal medical use. (For dispense or prescribe Schedule III, IV, purposes of this section, a United or V narcotic controlled drugs or com- States resident is a person whose resi- binations of narcotic controlled drugs dence (i.e., place of general abode— which have been approved by the Food meaning one’s principal, actual dwell- and Drug Administration (FDA) spe- ing place in fact, without regard to in- cifically for use in maintenance or de- tent) is in the United States.) This 50 toxification treatment without obtain- dosage unit limitation does not apply ing the separate registration required to controlled substances lawfully ob- by § 1301.13(e) if all of the following contained in the United States pursuant to ditions are met: a prescription issued by a DEA registrant. (1) The individual practitioner meets the conditions specified in paragraph [69 FR 55347, Sept. 14, 2004, as amended at 81 (b) of this section. FR 97019, Dec. 30, 2016] (2) The narcotic drugs or combina- § 1301.27 Separate registration by re- tion of narcotic drugs meet the condi- tail pharmacies for installation and tions specified in paragraph (c) of this operation of automated dispensing section. systems at long term care facilities. (3) The individual practitioner is in (a) A retail pharmacy may install compliance with either paragraph (d) and operate automated dispensing sys- or paragraph (e) of this section. tems, as defined in § 1300.01 of this (b)(1) The individual practitioner chapter, at long term care facilities, must submit notification to the Sec- under the requirements of § 1301.17. No retary of Health and Human Services person other than a registered retail stating the individual practitioner’s in- pharmacy may install and operate an tent to dispense or prescribe narcotic

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drugs under paragraph (a) of this sec- (2) If an individual practitioner wish- tion. The notice must contain all of the es to prescribe or dispense narcotic following certifications: drugs pursuant to paragraph (e) of this (i) The individual practitioner is reg- section, the individual practitioner istered under § 1301.13 as an individual must provide the Secretary of Health practitioner and is a ‘‘qualifying physi- and Human Services the following: cian’’ as defined in section (i) Notification as required under 303(g)(2)(G)(ii) of the Act (21 U.S.C. paragraph (b)(1) of this section in writ- 823(g)(2)(G)(ii)), or during the period being, stating the individual practi- ginning on July 22, 2016 and ending on tioner’s name and DEA registration October 1, 2021, a ‘‘qualifying other number issued under § 1301.13. practitioner’’ as defined in section (ii) If the individual practitioner is a 303(g)(2)(G)(iv) of Act (21 U.S.C. member of a group practice, the names 823(g)(2)(G)(iv)). The Secretary of of the other individual practitioners in Health and Human Services may, by the group and the DEA registration regulation, revise the requirements for numbers issued to the other individual being a qualifying other practitioner. practitioners under § 1301.13. (ii) With respect to patients to whom (c) The narcotic drugs or combina- the practitioner will provide such tion of narcotic drugs to be dispensed drugs or combinations of drugs, the in- or prescribed under this section must dividual practitioner has the capacity meet all of the following conditions: to provide directly, by referral, or in (1) The drugs or combination of drugs such other manner as determined by have been approved for use in ‘‘main- the Secretary of Health and Human tenance treatment’’ or ‘‘detoxification Services: treatment’’ under the Federal Food, (A) All drugs approved by the Food Drug, and Cosmetic Act or section 351 and Drug Administration for the treat- of the Public Health Service Act. ment of opioid use disorder, including (2) The drugs or combination of drugs for maintenance, detoxification, over- have not been the subject of an adverse dose reversal, and relapse prevention; determination by the Secretary of and Health and Human Services, after con- (B) Appropriate counseling and other sultation with the Attorney General, appropriate ancillary services. that the use of the drugs or combina- (iii)(A) The total number of patients tion of drugs requires additional stand- to whom the individual practitioner ards respecting the qualifications of will provide narcotic drugs or combina- practitioners or the quantities of the tions of narcotic drugs under this sec- drugs that may be provided for unsu- tion at any one time will not exceed pervised use. the applicable number. Except as pro- (d)(1) After receiving the notification vided in paragraphs (b)(1)(iii)(B) and submitted under paragraph (b) of this (C) of this section, the applicable num- section, the Secretary of Health and ber is 30. Human Services will forward a copy of (B) The applicable number is 100 if, the notification to the Administrator. not sooner than 1 year after the date The Secretary of Health and Human on which the practitioner submitted Services will have 45 days from the the initial notification, the practi- date of receipt of the notification to tioner submits a second notification to make a determination of whether the the Secretary of Health and Human individual practitioner involved meets Services of the need and intent of the all requirements for a waiver under practitioner to treat up to 100 patients. section 303(g)(2)(B) of the Act (21 U.S.C. (C) The applicable number is 275 for a 823(g)(2)(B)). Health and Human Serv- practitioner who has been approved by ices will notify DEA of its determina- the Secretary of Health and Human tion regarding the individual practi- Services under 42 CFR part 8 to treat tioner. If the individual practitioner up to 275 patients at any one time, and has the appropriate registration under provided further that the practitioner § 1301.13, then the Administrator will has renewed such approval to the ex- issue the practitioner an identification tent such renewal is required under number as soon as one of the following this part of the HHS regulations. conditions occurs:

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(i) The Administrator receives a posi- (f) If an individual practitioner dis- tive determination from the Secretary penses or prescribes Schedule III, IV, or of Health and Human Services before V narcotic drugs approved by the Food the conclusion of the 45-day review pe- and Drug Administration specifically riod, or for maintenance or detoxification (ii) The 45-day review period has con- treatment in violation of any of the cluded and no determination by the conditions specified in paragraphs (b), Secretary of Health and Human Serv- (c) or (e) of this section, the Adminis- ices has been made. trator may revoke the individual prac- (2) If the Secretary denies certifi- titioner’s registration in accordance cation to an individual practitioner or with § 1301.36. withdraws such certification once it is 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; 83 FR 3074, Jan. 23, number, or will withdraw the identi- 2018] fication number if one has been issued. (3) The individual practitioner must § 1301.29 [Reserved] include the identification number on ACTION ON APPLICATION FOR REGISTRA- all records when dispensing and on all TION: REVOCATION OR SUSPENSION OF prescriptions when prescribing narcotic REGISTRATION drugs under this section. (e) An individual practitioner may § 1301.31 Administrative review gen- begin to prescribe or dispense narcotic erally. drugs to a specific individual patient under this section before receiving an The Administrator may inspect, or identification number from the Admin- cause to be inspected, the establish- istrator if the following conditions are ment of an applicant or registrant, pur- met: suant to subpart A of part 1316 of this (1) The individual practitioner has chapter. The Administrator shall resubmitted a written notification under view the application for registration paragraph (b) of this section in good and other information gathered by the faith to the Secretary of Health and Administrator regarding an applicant Human Services. in order to determine whether the ap- (2) The individual practitioner rea- plicable standards of section 303 (21 sonably believes that the conditions U.S.C. 823) or section 1008 (21 U.S.C. 958) specified in paragraphs (b) and (c) of of the Act have been met by the appli- this section have been met. cant. (3) The individual practitioner rea- [62 FR 13953, Mar. 24, 1997] sonably believes that the treatment of an individual patient would be facili- § 1301.32 Action on applications for re- tated if narcotic drugs are prescribed search in Schedule I substances. or dispensed under this section before the sooner of: (a) In the case of an application for (i) Receipt of an identification num- registration to conduct research with ber from the Administrator, or controlled substances listed in Sched- (ii) Expiration of the 45-day period. ule I, the Administrator shall process (4) The individual practitioner has the application and protocol and for- notified both the Secretary of Health ward a copy of each to the Secretary of and Human Services and the Adminis- Health and Human Services (Secretary) trator of his or her intent to begin pre- within 7 days after receipt. The Sec- scribing or dispensing the narcotic retary shall determine the qualifica- drugs before expiration of the 45-day tions and competency of the applicant, period. as well as the merits of the protocol (5) The Secretary has not notified the (and shall notify the Administrator of registrant that he/she is not qualified his/her determination) within 21 days under paragraph (d) of this section. after receipt of the application and (6) The individual practitioner has complete protocol, except that in the the appropriate registration under case of a clinical investigation, the § 1301.13. Secretary shall have 30 days to make

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such determination and notify the Ad- § 1301.33 Application for bulk manu- ministrator. The Secretary, in deter- facture of Schedule I and II sub- mining the merits of the protocol, shall stances. consult with the Administrator as to (a) In the case of an application for effective procedures to safeguard ade- registration or reregistration to manu- quately against diversion of such con- facture in bulk a basic class of controlled substances from legitimate trolled substance listed in Schedule I medical or scientific use. or II, the Administrator shall, upon the (b) An applicant whose protocol is de- filing of such application, publish in fective shall be notified by the Sec- the FEDERAL REGISTER a notice naming retary within 21 days after receipt of the applicant and stating that such ap- such protocol from the Administrator plicant has applied to be registered as (or in the case of a clinical investiga- a bulk manufacturer of a basic class of tion within 30 days), and he/she shall be narcotic or nonnarcotic controlled sub- requested to correct the existing de- stance, which class shall be identified. fects before consideration shall be A copy of said notice shall be mailed given to his/her submission. simultaneously to each person reg- (c) If the Secretary determines the istered as a bulk manufacturer of that applicant qualified and competent and basic class and to any other applicant the research protocol meritorious, he/ therefor. Any such person may, within she shall notify the Administrator in 60 days from the date of publication of writing of such determination. The Ad- the notice in the FEDERAL REGISTER, ministrator shall issue a certificate of file with the Administrator written registration within 10 days after re- comments on or objections to the ceipt of this notice, unless he/she deter- issuance of the proposed registration. mines that the certificate of registra- (b) In order to provide adequate com- tion should be denied on a ground spec- petition, the Administrator shall not ified in section 304(a) of the Act (21 be required to limit the number of U.S.C. 824(a)). In the case of a supple- manufacturers in any basic class to a mental protocol, a replacement certifi- number less than that consistent with cate of registration shall be issued by maintenance of effective controls the Administrator. against diversion solely because a (d) If the Secretary determines that smaller number is capable of producing the protocol is not meritorious and/or an adequate and uninterrupted supply. the applicant is not qualified or com- (c) This section shall not apply to the petent, he/she shall notify the Adminis- manufacture of basic classes of con- trator in writing setting forth the rea- trolled substances listed in Schedules I sons for such determination. If the Ad- or II as an incident to research or ministrator determines that grounds chemical analysis as authorized in exist for the denial of the application, § 1301.13(e)(1). he/she shall within 10 days issue an order to show cause pursuant to [62 FR 13953, Mar. 24, 1997] § 1301.37 and, if requested by the appli- § 1301.34 Application for importation cant, hold a hearing on the application of Schedule I and II substances. pursuant to § 1301.41. If the grounds for (a) In the case of an application for denial of the application include a de- registration or reregistration to import termination by the Secretary, the Sec- a controlled substance listed in Sched- retary or his duly authorized agent ule I or II, under the authority of sec- shall furnish testimony and documents tion 1002(a)(2)(B) of the Act (21 U.S.C. pertaining to his determination at such 952(a)(2)(B)), the Administrator shall, hearing. upon the filing of such application, (e) Supplemental protocols will be publish in the FEDERAL REGISTER a no- processed in the same manner as origi- tice naming the applicant and stating nal research protocols. If the proc- that such applicant has applied to be essing of an application or research registered as an importer of a Schedule protocol is delayed beyond the time I or II controlled substance, which sub- limits imposed by this section, the ap- stance shall be identified. A copy of plicant shall be so notified in writing. said notice shall be mailed simulta- [62 FR 13953, Mar. 24, 1997] neously to each person registered as a

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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 person may participate in the hearing for medical, scientific, or other legiti- by filing a notice of appearance in ac- mate purposes; or cordance with § 1301.43 of this chapter. (ii) Such amounts of any controlled Notice of the hearing shall contain a substances listed in Schedule I or II as summary of all comments and objec- the Administrator shall find to be nec- tions filed regarding the application essary to provide for the medical, sci- and shall state the time and place for entific, or other legitimate needs of the the hearing, which shall not be less United States during an emergency in than 30 days after the date of publica- which domestic supplies of such sub- tion of such notice in the FEDERAL stances are found by the Administrator REGISTER. A hearing pursuant to this to be inadequate; or section may be consolidated with a (iii) Such amounts of any controlled hearing held pursuant to § 1301.35 or substance listed in Schedule I or II as § 1301.36 of this part. the Administrator shall find to be nec- (b) The Administrator shall register essary to provide for the medical, sci- an applicant to import a controlled entific, or other legitimate needs of the substance listed in Schedule I or II if United States in any case in which the he/she determines that such registra- Administrator finds that competition tion is consistent with the public inter- among domestic manufacturers of the est and with U.S. obligations under controlled substance is inadequate and international treaties, conventions, or will not be rendered adequate by the protocols in effect on May 1, 1971. In registration of additional manufactur- determining the public interest, the ers under section 303 of the Act (21 following factors shall be considered: U.S.C. 823); or (1) Maintenance of effective controls (iv) Such limited quantities of any against diversion of particular con- controlled substance listed in Schedule trolled substances and any controlled I or II as the Administrator shall find substance in Schedule I or II com- to be necessary for scientific, analyt- pounded therefrom into other than le- ical or research uses; and gitimate medical, scientific research, (7) Such other factors as may be rel- or industrial channels, by limiting the evant to and consistent with the public importation and bulk manufacture of health and safety. such controlled substances to a number (c) In determining whether the appli- of establishments which can produce cant can and will maintain effective an adequate and uninterrupted supply controls against diversion within the of these substances under adequately meaning of paragraph (b) of this sec- competitive conditions for legitimate tion, the Administrator shall consider medical, scientific, research, and in- among other factors: dustrial purposes; (1) Compliance with the security re- (2) Compliance with applicable State quirements set forth in §§ 1301.71– and local law; 1301.76; and

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(2) Employment of security proce- quate competition among them does dures to guard against in-transit not exist. losses. [62 FR 13953, Mar. 24, 1997, as amended at 81 (d) In determining whether competi- FR 97019, Dec. 30, 2016] tion among the domestic manufacturers of a controlled substance is ade- § 1301.35 Certificate of registration; quate within the meaning of para- denial of registration. graphs (b)(1) and (b)(6)(iii) of this sec- (a) The Administrator shall issue a tion, as well as section 1002(a)(2)(B) of Certificate of Registration (DEA Form the Act (21 U.S.C. 952(a)(2)(B)), the Ad- 223) to an applicant if the issuance of ministrator shall consider: registration or reregistration is re- (1) The extent of price rigidity in the quired under the applicable provisions light of changes in: of sections 303 or 1008 of the Act (21 (i) raw materials and other costs and U.S.C. 823 and 958). In the event that (ii) conditions of supply and demand; the issuance of registration or rereg- (2) The extent of service and quality istration is not required, the Adminis- competition among the domestic man- trator shall deny the application. Be- ufacturers for shares of the domestic fore denying any application, the Ad- market including: ministrator shall issue an order to (i) Shifts in market shares and show cause pursuant to § 1301.37 and, if (ii) Shifts in individual customers requested by the applicant, shall hold a among domestic manufacturers; hearing on the application pursuant to (3) The existence of substantial dif- § 1301.41. ferentials between domestic prices and (b) If in response to a show cause the higher of prices generally pre- order a hearing is requested by an ap- vailing in foreign markets or the prices plicant for registration or reregistra- at which the applicant for registration tion to manufacture in bulk a basic to import is committed to undertake class of controlled substance listed in to provide such products in the domes- Schedule I or II, notice that a hearing tic market in conformity with the Act. has been requested shall be published In determining the existence of sub- in the FEDERAL REGISTER and shall be stantial differentials hereunder, appro- mailed simultaneously to the applicant priate consideration should be given to and to all persons to whom notice of any additional costs imposed on domes- the application was mailed. Any person tic manufacturers by the requirements entitled to file comments or objections of the Act and such other cost-related to the issuance of the proposed reg- and other factors as the Administrator istration pursuant to § 1301.33(a) may may deem relevant. In no event shall participate in the hearing by filing no- an importer’s offering prices in the tice of appearance in accordance with United States be considered if they are § 1301.43. Such persons shall have 30 lower than those prevailing in the for- days to file a notice of appearance after eign market or markets from which the date of publication of the notice of the importer is obtaining his/her sup- a request for a hearing in the FEDERAL ply; REGISTER. (4) The existence of competitive re- (c) The Certificate of Registration straints imposed upon domestic manu- (DEA Form 223) shall contain the facturers by governmental regulations; name, address, and registration num- and ber of the registrant, the activity au- (5) Such other factors as may be rel- thorized by the registration, the sched- evant to the determinations required ules and/or Administration Controlled under this paragraph. Substances Code Number (as set forth (e) In considering the scope of the do- in part 1308 of this chapter) of the con- mestic market, consideration shall be trolled substances which the registrant given to substitute products which are is authorized to handle, the amount of reasonably interchangeable in terms of fee paid (or exemption), and the expira- price, quality and use. tion date of the registration. The reg- (f) The fact that the number of exist- istrant shall maintain the certificate ing manufacturers is small shall not of registration at the registered loca- demonstrate, in and of itself, that ade- tion in a readily retrievable manner

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and shall permit inspection of the cer- § 1301.37 an order of immediate suspen- tificate by any official, agent or em- sion which shall contain a statement of ployee of the Administration or of any his findings regarding the danger to Federal, State, or local agency engaged public health or safety. in enforcement of laws relating to con- (f) Upon service of the order of the trolled substances. Administrator suspending or revoking [62 FR 13954, Mar. 24, 1997] registration, the registrant shall immediately deliver his/her Certificate of § 1301.36 Suspension or revocation of Registration, any order forms, and any registration; suspension of registra- import or export permits in his/her pos- tion pending final order; extension session to the nearest office of the Ad- of registration pending final order. ministration. The suspension or rev- (a) For any registration issued under ocation of a registration shall suspend section 303 of the Act (21 U.S.C. 823), or revoke any individual manufac- the Administrator may: turing or procurement quota fixed for (1) Suspend the registration pursuant the registrant pursuant to part 1303 of to section 304(a) of the Act (21 U.S.C. this chapter and any import or export 824(a)) for any period of time. permits issued to the registrant pursu- (2) Revoke the registration pursuant ant to part 1312 of this chapter. Also, to section 304(a) of the Act (21 U.S.C. upon service of the order of the Admin- 824(a)). istrator revoking or suspending reg- (b) For any registration issued under istration, the registrant shall, as in- section 1008 of the Act (21 U.S.C. 958), structed by the Administrator: the Administrator may: (1) Deliver all controlled substances (1) Suspend the registration pursuant in his/her possession to the nearest of- to section 1008(d) of the Act (21 U.S.C. fice of the Administration or to au- 958(d)) for any period of time. thorized agents of the Administration; (2) Revoke the registration pursuant or to section 1008(d) of the Act (21 U.S.C. 958(d)) if he/she determines that such (2) Place all controlled substances in registration is inconsistent with the his/her possession under seal as de- public interest as defined in section scribed in sections 304(f) or 1008(d)(6) of 1008 or with the United States obliga- the Act (21 U.S.C. 824(f) or 958(d)(6)). tions under international treaties, con- (g) In the event that revocation or ventions, or protocols in effect on Oc- suspension is limited to a particular tober 12, 1984. controlled substance or substances, the (c) The Administrator may limit the registrant shall be given a new Certifi- revocation or suspension of a registra- cate of Registration for all substances tion to the particular controlled sub- not affected by such revocation or sus- stance, or substances, with respect to pension; no fee shall be required to be which grounds for revocation or sus- paid for the new Certificate of Reg- pension exist. istration. The registrant shall deliver (d) Before revoking or suspending the old Certificate of Registration and, any registration, the Administrator if appropriate, any order forms in his/ shall issue an order to show cause pur- her possession to the nearest office of suant to § 1301.37 and, if requested by the Administration. The suspension or the registrant, shall hold a hearing revocation of a registration, when lim- pursuant to § 1301.41. ited to a particular basic class or class- (e) The Administrator may suspend es of controlled substances, shall sus- any registration simultaneously with pend or revoke any individual manu- or at any time subsequent to the serv- facturing or procurement quota fixed ice upon the registrant of an order to for the registrant for such class or show cause why such registration classes pursuant to part 1303 of this should not be revoked or suspended, in chapter and any import or export per- any case where he/she finds that there mits issued to the registrant for such is an imminent danger to the public class or classes pursuant to part 1312 of health or safety. If the Administrator this chapter. Also, upon service of the so suspends, he/she shall serve with the order of the Administrator revoking or order to show cause pursuant to suspending registration, the registrant

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shall, as instructed by the Adminis- § 1301.37 Order to show cause. trator: (a) If, upon examination of the appli- (1) Deliver to the nearest office of the cation for registration from any appli- Administration or to authorized agents cant and other information gathered of the Administration all of the par- by the Administration regarding the ticular controlled substance or sub- applicant, the Administrator is unable stances affected by the revocation or to make the determinations required suspension which are in his/her posses- by the applicable provisions of section sion; or 303 and/or section 1008 of the Act (21 (2) Place all of such substances under U.S.C. 823 and 958) to register the appli- seal as described in sections 304(f) or cant, the Administrator shall serve 958(d)(6) of the Act (21 U.S.C. 824(f) or upon the applicant an order to show 958(d)(6)). cause why the registration should not (h) Any suspension shall continue in be denied. effect until the conclusion of all pro- (b) If, upon information gathered by ceedings upon the revocation or sus- the Administration regarding any reg- pension, including any judicial review istrant, the Administrator determines thereof, unless sooner withdrawn by that the registration of such registrant the Administrator or dissolved by a is subject to suspension or revocation pursuant to section 304 or section 1008 court of competent jurisdiction. Any of the Act (21 U.S.C. 824 and 958), the registrant whose registration is sus- Administrator shall serve upon the reg- pended under paragraph (e) of this sec- istrant an order to show cause why the tion may request a hearing on the rev- registration should not be revoked or ocation or suspension of his/her reg- suspended. istration at a time earlier than speci- (c) The order to show cause shall call fied in the order to show cause pursu- upon the applicant or registrant to ap- ant to § 1301.37. This request shall be pear before the Administrator at a granted by the Administrator, who time and place stated in the order, shall fix a date for such hearing as which shall not be less than 30 days early as reasonably possible. after the date of receipt of the order. (i) In the event that an applicant for The order to show cause shall also con- reregistration (who is doing business tain a statement of the legal basis for under a registration previously granted such hearing and for the denial, revoca- and not revoked or suspended) has ap- tion, or suspension of registration and plied for reregistration at least 45 days a summary of the matters of fact and before the date on which the existing law asserted. registration is due to expire, and the (d) Upon receipt of an order to show Administrator has issued no order on cause, the applicant or registrant the application on the date on which must, if he/she desires a hearing, file a the existing registration is due to ex- request for a hearing pursuant to pire, the existing registration of the § 1301.43. If a hearing is requested, the applicant shall automatically be ex- Administrator shall hold a hearing at the time and place stated in the order, tended and continue in effect until the pursuant to § 1301.41. date on which the Administrator so (e) When authorized by the Adminis- issues his/her order. The Administrator trator, any agent of the Administra- may extend any other existing reg- tion may serve the order to show istration under the circumstances con- cause. templated in this section even though the registrant failed to apply for rereg- [62 FR 13955, Mar. 24, 1997] istration at least 45 days before expira- HEARINGS tion of the existing registration, with or without request by the registrant, if § 1301.41 Hearings generally. the Administrator finds that such extension is not inconsistent with the (a) In any case where the Adminis- trator shall hold a hearing on any reg- public health and safety. istration or application therefor, the [62 FR 13955, Mar. 24, 1997] procedures for such hearing shall be

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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 criminal prosecutions or other proof fact and law involved in such hear- ceedings under the Act or any other ing. Such statement, if admissible, law of the United States. shall be made a part of the record and [62 FR 13956, Mar. 24, 1997] shall be considered in light of the lack of opportunity for cross-examination in § 1301.42 Purpose of hearing. determining the weight to be attached to matters of fact asserted therein. If requested by a person entitled to a hearing, the Administrator shall hold a (d) If any person entitled to a hearing hearing for the purpose of receiving or to participate in a hearing pursuant factual evidence regarding the issues to § 1301.32 or §§ 1301.34–1301.36 fails to involved in the denial, revocation, or file a request for a hearing or a notice suspension of any registration, and the of appearance, or if such person so files granting of any application for reg- and fails to appear at the hearing, such istration to import or to manufacture person shall be deemed to have waived in bulk a basic class of controlled sub- the opportunity for a hearing or to par- stance listed in Schedule I or II. Exten- ticipate in the hearing, unless such sive argument should not be offered person shows good cause for such fail- into evidence but rather presented in ure. opening or closing statements of coun- (e) If all persons entitled to a hearing sel or in memoranda or proposed find- or to participate in a hearing waive or ings of fact and conclusions of law. are deemed to waive their opportunity for the hearing or to participate in the [62 FR 13956, Mar. 24, 1997] hearing, the Administrator may cancel the hearing, if scheduled, and issue his/ § 1301.43 Request for hearing or ap- her final order pursuant to § 1301.46 pearance; waiver. without a hearing. (a) Any person entitled to a hearing pursuant to § 1301.32 or §§ 1301.34–1301.36 [62 FR 13956, Mar. 24, 1997] and desiring a hearing shall, within 30 days after the date of receipt of the § 1301.44 Burden of proof. order to show cause (or the date of pub- (a) At any hearing on an application lication of notice of the application for to manufacture any controlled sub- registration in the FEDERAL REGISTER stance listed in Schedule I or II, the ap- in the case of § 1301.34), file with the plicant shall have the burden of prov- Administrator a written request for a ing that the requirements for such reg- hearing in the form prescribed in istration pursuant to section 303(a) of § 1316.47 of this chapter. the Act (21 U.S.C. 823(a)) are satisfied. (b) Any person entitled to participate Any other person participating in the in a hearing pursuant to § 1301.34 or hearing pursuant to § 1301.35(b) shall § 1301.35(b) and desiring to do so shall, have the burden of proving any propo- within 30 days of the date of publica- sitions of fact or law asserted by such tion of notice of the request for a hear- person in the hearing. ing in the FEDERAL REGISTER, file with (b) At any hearing on the granting or the Administrator a written notice of denial of an applicant to be registered intent to participate in such hearing in to conduct a narcotic treatment pro- the form prescribed in § 1316.48 of this gram or as a compounder, the appli- chapter. Any person filing a request for cant shall have the burden of proving

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that the requirements for each reg- in Schedule I or II is granted, or any istration pursuant to section 303(g) of application for registration is denied, the Act (21 U.S.C. 823(g)) are satisfied. or any registration is revoked or sus- (c) At any hearing on the granting or pended, the order shall include the denial of an application to be reg- findings of fact and conclusions of law istered to import or export any con- upon which the order is based. The trolled substance listed in Schedule I order shall specify the date on which it or II, the applicant shall have the bur- shall take effect. The Administrator den of proving that the requirements shall serve one copy of his/her order for such registration pursuant to sec- upon each party in the hearing. tions 1008(a) and (d) of the Act (21 [62 FR 13956, Mar. 24, 1997] U.S.C. 958 (a) and (d)) are satisfied. Any other person participating in the hear- MODIFICATION, TRANSFER AND ing pursuant to § 1301.34 shall have the TERMINATION OF REGISTRATION burden of proving any propositions of fact or law asserted by him/her in the § 1301.51 Modification in registration. hearings. (a) Any registrant may apply to mod- (d) At any other hearing for the de- ify his/her registration to authorize the nial of a registration, the Administra- handling of additional controlled sub- tion shall have the burden of proving stances or to change his/her name or that the requirements for such reg- address by submitting a written re- istration pursuant to section 303 or sec- quest to the Registration Unit, Drug tion 1008(c) and (d) of the Act (21 U.S.C. Enforcement Administration. See the 823 or 958(c) and (d)) are not satisfied. Table of DEA Mailing Addresses in (e) At any hearing for the revocation § 1321.01 of this chapter for the current or suspension of a registration, the Ad- mailing address. Additionally, such a ministration shall have the burden of request may be submitted on-line at proving that the requirements for such www.DEAdiversion.usdoj.gov. revocation or suspension pursuant to (1) The request shall contain: section 304(a) or section 1008(d) of the (i) The registrant’s name, address, Act (21 U.S.C. 824(a) or 958(d)) are satis- and registration number as printed on fied. the certificate of registration; [62 FR 13956, Mar. 24, 1997] (ii) The substances and/or schedules to be added to the registration or the § 1301.45 Time and place of hearing. new name or address; and The hearing will commence at the (iii) A signature in accordance with place and time designated in the order § 1301.13(j). (2) If the registrant is seeking to han- to show cause or notice of hearing pub- dle additional controlled substances lished in the FEDERAL REGISTER (unless listed in Schedule I for the purpose of expedited pursuant to § 1301.36(h)) but research or instructional activities, the thereafter it may be moved to a dif- registrant shall attach three copies of ferent place and may be continued a research protocol describing each re- from day to day or recessed to a later search project involving the additional day without notice other than an- substances, or two copies of a state- nouncement thereof by the presiding ment describing the nature, extent, officer at the hearing. and duration of such instructional ac- [62 FR 13956, Mar. 24, 1997] tivities, as appropriate. (b) Any manufacturer, distributor, § 1301.46 Final order. reverse distributor, narcotic treatment As soon as practicable after the pre- program, hospital/clinic with an on-site siding officer has certified the record pharmacy, or retail pharmacy reg- to the Administrator, the Adminis- istered pursuant to this part, may trator shall issue his/her order on the apply to modify its registration to be- granting, denial, revocation, or suspen- come authorized as a collector by sub- sion of registration. In the event that mitting a written request to the Reg- an application for registration to im- istration Unit, Drug Enforcement Ad- port or to manufacture in bulk a basic ministration. See the Table of DEA class of any controlled substance listed Mailing Addresses in § 1321.01 of this

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chapter for the current mailing ad- cating the desire to surrender a reg- dress. Additionally, such request may istration. be submitted on-line at (b) No registration or any authority www.DEAdiversion.usdoj.gov. conferred thereby shall be assigned or (1) The request shall contain: otherwise transferred except upon such (i) The registrant’s name, address, conditions as the Administration may and registration number as printed on specifically designate and then only the certificate of registration; pursuant to written consent. Any per- (ii) The method(s) of collection the son seeking authority to transfer a reg- registrant intends to conduct (collec- istration shall submit a written re- tion receptacle and/or mail-back pro- quest, providing full details regarding gram); and the proposed transfer of registration, (iii) A signature in accordance with to the Deputy Assistant Administrator, § 1301.13(j). Office of Diversion Control, Drug En- (2) If a hospital/clinic with an on-site forcement Administration. See the pharmacy or retail pharmacy is apply- Table of DEA Mailing Addresses in ing for a modification in registration § 1321.01 of this chapter for the current to authorize such registrant to be a mailing address. collector to maintain a collection re- (c) Any registrant desiring to dis- ceptacle at a long-term care facility in continue business activities altogether accordance with § 1317.80 of this chap- or with respect to controlled sub- ter, the request shall also include the stances (without transferring such name and physical location of each business activities to another person) long-term care facility at which the shall return for cancellation his/her hospital/clinic with an on-site phar- certificate of registration, and any macy, or the retail pharmacy, intends unexecuted order forms in his/her pos- to operate a collection receptacle. session, to the Registration Unit, Drug (c) No fee shall be required for modi- Enforcement Administration. See the fication. The request for modification Table of DEA Mailing Addresses in shall be handled in the same manner as § 1321.01 of this chapter for the current an application for registration. If the mailing address. Any controlled sub- modification of registration is ap- stances in his/her possession may be proved, the Administrator shall issue a disposed of in accordance with part 1317 new certificate of registration (DEA of this chapter. Form 223) to the registrant, who shall (d) Any registrant desiring to dis- maintain it with the old certificate of continue business activities altogether registration until expiration. or with respect to controlled substance [79 FR 53561, Sept. 9, 2014] (by transferring such business activities to another person) shall submit in § 1301.52 Termination of registration; person or by registered or certified transfer of registration; distribution mail, return receipt requested, to the upon discontinuance of business. Special Agent in Charge in his/her (a) Except as provided in paragraph area, at least 14 days in advance of the (b) of this section, the registration of date of the proposed transfer (unless any person, and any modifications of the Special Agent in Charge waives that registration, shall terminate, this time limitation in individual in- without any further action by the Ad- stances), the following information: ministration, if and when such person (1) The name, address, registration dies, ceases legal existence, discon- number, and authorized business activ- tinues business or professional prac- ity of the registrant discontinuing the tice, or surrenders a registration. Any business (registrant-transferor); registrant who ceases legal existence (2) The name, address, registration or discontinues business or professional number, and authorized business activ- practice shall notify the Administrator ity of the person acquiring the business promptly of such fact. In the case of a (registrant-transferee); surrender, termination shall occur (3) Whether the business activities upon receipt by any employee of the will be continued at the location reg- Administration of a duly executed DEA istered by the person discontinuing form 104 or any signed writing indi- business, or moved to another location

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(if the latter, the address of the new lo- actions involving controlled substances cation should be listed); are consummated by him. The initial (4) Whether the registrant-transferor report of the registrant-transferee has a quota to manufacture or procure shall account for transactions begin- any controlled substance listed in ning with the day next succeeding the Schedule I or II (if so, the basic class or date of discontinuance or transfer of class of the substance should be indi- business by the transferor-registrant cated); and and the substances transferred to him (5) The date on which the transfer of shall be reported as receipts in his/her controlled substances will occur. initial report. (e) Unless the registrant-transferor is (f) Any registrant that has been au- informed by the Special Agent in thorized as a collector and desires to Charge, before the date on which the discontinue its collection of controlled transfer was stated to occur, that the substances from ultimate users shall transfer may not occur, the registrant- notify the Administration of its intent transferor may distribute (without by submitting a written notification to being registered to distribute) con- the Registration Unit, Drug Enforce- trolled substances in his/her possession ment Administration. See the Table of to the registrant-transferee in accord- DEA Mailing Addresses in § 1321.01 of ance with the following: this chapter for the current mailing ad- (1) On the date of transfer of the con- dress. Additionally, such notice may be trolled substances, a complete inven- submitted on-line at tory of all controlled substances being www.DEAdiversion.usdoj.gov. When transferred shall be taken in accord- ceasing collection activities of an au- ance with § 1304.11 of this chapter. This thorized mail-back program, the reg- inventory shall serve as the final in- istrant shall provide the Administra- ventory of the registrant-transferor tion with the name, registered address, and the initial inventory of the reg- and registration number of the col- istrant-transferee, and a copy of the in- lector that will receive the remaining ventory shall be included in the records mail-back packages in accordance with of each person. It shall not be nec- § 1317.70(e)(3) of this chapter. essary to file a copy of the inventory with the Administration unless re- [62 FR 13957, Mar. 24, 1997, as amended at 74 quested by the Special Agent in FR 15623, Apr. 6, 2009; 75 FR 10676, Mar. 9, Charge. Transfers of any substances 2010; 76 FR 61564, Oct. 5, 2011; 79 FR 53561, listed in Schedule I or II shall require Sept. 9, 2014] the use of order forms in accordance with part 1305 of this chapter. SECURITY REQUIREMENTS (2) On the date of transfer of the con- § 1301.71 Security requirements gen- trolled substances, all records required erally. to be kept by the registrant-transferor with reference to the controlled sub- (a) All applicants and registrants stances being transferred, under part shall provide effective controls and 1304 of this chapter, shall be trans- procedures to guard against theft and ferred to the registrant-transferee. Re- diversion of controlled substances. In sponsibility for the accuracy of records order to determine whether a reg- prior to the date of transfer remains istrant has provided effective controls with the transferor, but responsibility against diversion, the Administrator for custody and maintenance shall be shall use the security requirements set upon the transferee. forth in §§ 1301.72–1301.76 as standards (3) In the case of registrants required for the physical security controls and to make reports pursuant to part 1304 operating procedures necessary to pre- of this chapter, a report marked vent diversion. Materials and construc- ‘‘Final’’ will be prepared and submitted tion which will provide a structural by the registrant-transferor showing equivalent to the physical security the disposition of all the controlled controls set forth in §§ 1301.72, 1301.73 substances for which a report is re- and 1301.75 may be used in lieu of the quired; no additional report will be re- materials and construction described quired from him, if no further trans- in those sections.

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

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forth in §§ 1301.72, 1301.73 and 1301.75, (ii) Which safe or steel cabinet, if it notwithstanding that such facilities or weighs less than 750 pounds, is bolted work or storage areas have physical se- or cemented to the floor or wall in such curity controls similar to those pre- a way that it cannot be readily re- viously approved by the Administra- moved; and tion. (iii) Which safe or steel cabinet, if (f) A collector shall not employ, as an necessary, depending upon the quan- agent or employee who has access to or tities and type of controlled substances influence over controlled substances stored, is equipped with an alarm sys- acquired by collection, any person who tem which, upon attempted unauthor- has been convicted of any felony of- ized entry, shall transmit a signal di- fense relating to controlled substances rectly to a central protection company or who, at any time, had an application or a local or State police agency which for registration with DEA denied, had a has a legal duty to respond, or a 24- DEA registration revoked or sus- hour control station operated by the pended, or has surrendered a DEA reg- registrant, or such other protection as istration for cause. For purposes of this the Administrator may approve. subsection, ‘‘for cause’’ means in lieu (2) A vault constructed before, or of, or as a consequence of, any Federal under construction on, September 1, or State administrative, civil, or crimi- 1971, which is of substantial construc- nal action resulting from an investigation with a steel door, combination or tion of the individual’s handling of con- key lock, and an alarm system; or trolled substances. (3) A vault constructed after Sep- [36 FR 18729, Sept. 21, 1971. Redesignated at tember 1, 1971: 38 FR 26609, Sept. 24, 1973, and amended at 46 (i) The walls, floors, and ceilings of FR 28841, May 29, 1981; 47 FR 41735, Sept. 22, which vault are constructed of at least 1982; 51 FR 5319, Feb. 13, 1986; 68 FR 41228, 8 inches of reinforced concrete or other July 11, 2003; 75 FR 10677, Mar. 9, 2010; 79 FR substantial masonry, reinforced 53561, Sept. 9, 2014] vertically and horizontally with 1⁄2-inch § 1301.72 Physical security controls for steel rods tied 6 inches on center, or non-practitioners; narcotic treat- the structural equivalent to such rein- ment programs and compounders forced walls, floors, and ceilings; for narcotic treatment programs; (ii) The door and frame unit of which storage areas. vault shall conform to the following (a) Schedules I and II. Raw material, specifications or the equivalent: 30 bulk materials awaiting further proc- man-minutes against surreptitious essing, finished products which are entry, 10 man-minutes against forced controlled substances listed in Sched- entry, 20 man-hours against lock ma- ule I or II (except GHB that is manu- nipulation, and 20 man-hours against factured or distributed in accordance radiological techniques; with an exemption under section 505(i) (iii) Which vault, if operations re- of the Federal Food Drug and Cosmetic quire it to remain open for frequent ac- Act which shall be subject to the re- cess, is equipped with a ‘‘day-gate’’ quirements of paragraph (b) of this sec- which is self-closing and self-locking, tion), and sealed mail-back packages or the equivalent, for use during the and inner liners acquired in accordance hours of operation in which the vault with part 1317 of this chapter, shall be door is open; stored in one of the following secured (iv) The walls or perimeter of which areas: vault are equipped with an alarm, (1) Where small quantities permit, a which upon unauthorized entry shall safe or steel cabinet; transmit a signal directly to a central (i) Which safe or steel cabinet shall station protection company, or a local have the following specifications or the or State police agency which has a equivalent: 30 man-minutes against legal duty to respond, or a 24-hour con- surreptitious entry, 10 man-minutes trol station operated by the registrant, against forced entry, 20 man-hours or such other protection as the Admin- against lock manipulation, and 20 man- istrator may approve, and, if nec- hours against radiological techniques; essary, holdup buttons at strategic

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points of entry to the perimeter area of (b) In the case of combination locks, the vault; the combination shall be limited to a (v) The door of which vault is minimum number of employees and equipped with contact switches; and can be changed upon termination of (vi) Which vault has one of the fol- employment of an employee having lowing: Complete electrical lacing of knowledge of the combination; the walls, floor and ceilings; sensitive (4) A cage, located within a building ultrasonic equipment within the vault; on the premises, meeting the following a sensitive sound accumulator system; specifications: or such other device designed to detect (i) Having walls constructed of not illegal entry as may be approved by the less than No. 10 gauge steel fabric Administration. mounted on steel posts, which posts (b) Schedules III, IV and V. Raw mate- are: rial, bulk materials awaiting further (a) At least one inch in diameter; processing, and finished products which (b) Set in concrete or installed with are controlled substances listed in lag bolts that are pinned or brazed; and Schedules III, IV, and V, and GHB when (c) Which are placed no more than it is manufactured or distributed in ac- ten feet apart with horizontal one and cordance with an exemption under sec- one-half inch reinforcements every tion 505(i) of the FFDCA, shall be sixty inches; stored in the following secure storage (ii) Having a mesh construction with areas: openings of not more than two and one- (1) A safe or steel cabinet as de- half inches across the square, scribed in paragraph (a)(1) of this sec- (iii) Having a ceiling constructed of tion; the same material, or in the alter- (2) A vault as described in paragraph native, a cage shall be erected which (a)(2) or (3) of this section equipped reaches and is securely attached to the with an alarm system as described in structural ceiling of the building. A paragraph (b)(4)(v) of this section; lighter gauge mesh may be used for the (3) A building used for storage of ceilings of large enclosed areas if walls Schedules III through V controlled sub- are at least 14 feet in height, stances with perimeter security which (iv) Is equipped with a door con- limits access during working hours and structed of No. 10 gauge steel fabric on provides security after working hours a metal door frame in a metal door and meets the following specifications: flange, and in all other respects con- (i) Has an electronic alarm system as forms to all the requirements of 21 CFR described in paragraph (b)(4)(v) of this 1301.72(b)(3)(ii), and section, (v) Is equipped with an alarm system (ii) Is equipped with self-closing, self- which upon unauthorized entry shall locking doors constructed of substan- transmit a signal directly to a central tial material commensurate with the station protection agency or a local or type of building construction, provided, state police agency, each having a however, a door which is kept closed legal duty to respond, or to a 24-hour and locked at all times when not in use control station operated by the reg- and when in use is kept under direct istrant, or to such other source of pro- observation of a responsible employee tection as the Administrator may ap- or agent of the registrant is permitted prove; in lieu of a self-closing, self-locking (5) An enclosure of masonry or other door. Doors may be sliding or hinged. material, approved in writing by the Regarding hinged doors, where hinges Administrator as providing security are mounted on the outside, such comparable to a cage; hinges shall be sealed, welded or other- (6) A building or enclosure within a wise constructed to inhibit removal. building which has been inspected and Locking devices for such doors shall be approved by DEA or its predecessor either of the multiple-position com- agency, BND, and continues to provide bination or key lock type and: adequate security against the diversion (a) In the case of key locks, shall re- of Schedule III through V controlled quire key control which limits access substances, of which fact written ac- to a limited number of employees, or; knowledgment has been made by the

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Special Agent in Charge of DEA for the § 1301.73 Physical security controls for area in which such building or enclo- non-practitioners; compounders for sure is situated; narcotic treatment programs; man- (7) Such other secure storage areas as ufacturing and compounding areas. may be approved by the Administrator All manufacturing activities (includ- after considering the factors listed in ing processing, packaging and labeling) § 1301.71(b); involving controlled substances listed (8)(i) Schedule III through V con- in any schedule and all activities of trolled substances may be stored with compounders shall be conducted in ac- Schedules I and II controlled sub- cordance with the following: stances under security measures pro- (a) All in-process substances shall be vided by 21 CFR 1301.72(a); returned to the controlled substances (ii) Non-controlled drugs, substances storage area at the termination of the and other materials may be stored with process. If the process is not termi- Schedule III through V controlled sub- nated at the end of a workday (except stances in any of the secure storage where a continuous process or other areas required by 21 CFR 1301.72(b), normal manufacturing operation provided that permission for such stor- should not be interrupted), the proc- age of non-controlled items is obtained essing area or tanks, vessels, bins or in advance, in writing, from the Spe- bulk containers containing such sub- cial Agent in Charge of DEA for the stances shall be securely locked, with area in which such storage area is situ- adequate security for the area or build- ated. Any such permission tendered ing. If such security requires an alarm, must be upon the Special Agent in such alarm, upon unauthorized entry, Charge’s written determination that shall transmit a signal directly to a such non-segregated storage does not central station protection company, or diminish security effectiveness for local or state police agency which has Schedules III through V controlled sub- a legal duty to respond, or a 24-hour stances. control station operated by the reg- (c) Multiple storage areas. Where sev- istrant. eral types or classes of controlled sub- (b) Manufacturing activities with stances are handled separately by the controlled substances shall be con- registrant or applicant for different ducted in an area or areas of clearly de- purposes (e.g., returned goods, or goods fined limited access which is under sur- in process), the controlled substances veillance by an employee or employees may be stored separately, provided designated in writing as responsible for that each storage area complies with the area. ‘‘Limited access’’ may be pro- the requirements set forth in this sec- vided, in the absence of physical divid- tion. ers such as walls or partitions, by traf- (d) Accessibility to storage areas. The fic control lines or restricted space des- controlled substances storage areas ignation. The employee designated as shall be accessible only to an absolute responsible for the area may be en- minimum number of specifically au- gaged in the particular manufacturing thorized employees. When it is nec- operation being conducted: Provided, essary for employee maintenance per- That he is able to provide continuous sonnel, nonemployee maintenance per- surveillance of the area in order that sonnel, business guests, or visitors to unauthorized persons may not enter or be present in or pass through con- leave the area without his knowledge. trolled substances storage areas, the (c) During the production of con- registrant shall provide for adequate trolled substances, the manufacturing observation of the area by an employee areas shall be accessible to only those specifically authorized in writing. employees required for efficient oper- [36 FR 18730, Sept. 21, 1971. Redesignated at ation. When it is necessary for em- 38 FR 26609, Sept. 24, 1973] ployee maintenance personnel, nonemployee maintenance personnel, busi- EDITORIAL NOTE: For FEDERAL REGISTER citations affecting § 1301.72, see the List of CFR ness guests, or visitors to be present in Sections Affected, which appears in the or pass through manufacturing areas Finding Aids section of the printed volume during production of controlled sub- and at www.govinfo.gov. stances, the registrant shall provide for

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adequate observation of the area by an losses of controlled substances by their employee specifically authorized in agent or the common or contract car- writing. rier selected pursuant to paragraph (e) of this section within one business day [36 FR 18731, Sept. 21, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973 and amended at 39 of discovery of such theft or loss, until FR 37984, Oct. 25, 1974] the shipment has been released by the customs officer at the port of export. § 1301.74 Other security controls for The registrant must also complete, and non-practitioners; narcotic treat- submit to the Field Division Office in ment programs and compounders his or her area, DEA Form 106 regard- for narcotic treatment programs. ing the theft or loss. Thefts and signifi- (a) Before distributing a controlled cant losses must be reported whether substance to any person who the reg- or not the controlled substances are istrant does not know to be registered subsequently recovered or the respon- to possess the controlled substance, the sible parties are identified and action registrant shall make a good faith in- taken against them. When determining quiry either with the Administration whether a loss is significant, a reg- or with the appropriate State con- istrant should consider, among others, trolled substances registration agency, the following factors: if any, to determine that the person is (1) The actual quantity of controlled registered to possess the controlled substances lost in relation to the type substance. of business; (b) The registrant shall design and (2) The specific controlled substances operate a system to disclose to the reg- lost; istrant suspicious orders of controlled (3) Whether the loss of the controlled substances. The registrant shall inform substances can be associated with ac- the Field Division Office of the Admin- cess to those controlled substances by istration in his area of suspicious or- specific individuals, or whether the loss ders when discovered by the registrant. can be attributed to unique activities Suspicious orders include orders of unusual size, orders deviating substan- that may take place involving the con- tially from a normal pattern, and or- trolled substances; ders of unusual frequency. (4) A pattern of losses over a specific (c) The registrant must notify the time period, whether the losses appear Field Division Office of the Adminis- to be random, and the results of efforts tration in his or her area, in writing, of taken to resolve the losses; and, if any theft or significant loss of any con- known, trolled substances within one business (5) Whether the specific controlled day of discovery of the theft or loss. substances are likely candidates for di- Unless the theft or loss occurs during version; an import or export transaction, the (6) Local trends and other indicators supplier is responsible for reporting all of the diversion potential of the miss- in-transit losses of controlled sub- ing controlled substance. stances by their agent or the common (d) The registrant shall not dis- or contract carrier selected pursuant tribute any controlled substance listed to paragraph (e) of this section, within in Schedules II through V as a com- one business day of discovery of such plimentary sample to any potential or theft or loss. In an import transaction, current customer (1) without the prior once a shipment has been released by written request of the customer, (2) to the customs officer at the port of be used only for satisfying the legiti- entry, the importer is responsible for mate medical needs of patients of the reporting all in-transit losses of con- customer, and (3) only in reasonable trolled substances by their agent or the quantities. Such request must contain common or contract carrier selected the name, address, and registration pursuant to paragraph (e) of this sec- number of the customer and the name tion, within one business day of dis- and quantity of the specific controlled covery of such theft or loss. In an ex- substance desired. The request shall be port transaction, the exporter is re- preserved by the registrant with other sponsible for reporting all in-transit records of distribution of controlled

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substances. In addition, the require- invoice. Copies of these signed invoices ments of part 1305 of the chapter shall shall be kept by the distributor. be complied with for any distribution (i) Narcotics dispensed or adminis- of a controlled substance listed in tered at a narcotic treatment program Schedule II. For purposes of this para- will be dispensed or administered di- graph, the term ‘‘customer’’ includes a rectly to the patient by either (1) the person to whom a complimentary sam- licensed practitioner, (2) a registered ple of a substance is given in order to nurse under the direction of the li- encourage the prescribing or recom- censed practitioner, (3) a licensed prac- mending of the substance by the per- tical nurse under the direction of the son. licensed practitioner, or (4) a phar- (e) When shipping controlled sub- macist under the direction of the li- stances, a registrant is responsible for censed practitioner. selecting common or contract carriers (j) Persons enrolled in a narcotic which provide adequate security to treatment program will be required to guard against in-transit losses. When wait in an area physically separated storing controlled substances in a pub- from the narcotic storage and dis- lic warehouse, a registrant is respon- pensing area. This requirement will be sible for selecting a warehouseman enforced by the program physician and which will provide adequate security to guard against storage losses; wherever employees. possible, the registrant shall store con- (k) All narcotic treatment programs trolled substances in a public ware- must comply with standards estab- house which complies with the require- lished by the Secretary of Health and ments set forth in § 1301.72. In addition, Human Services (after consultation the registrant shall employ pre- with the Administration) respecting cautions (e.g., assuring that shipping the quantities of narcotic drugs which containers do not indicate that con- may be provided to persons enrolled in tents are controlled substances) to a narcotic treatment program for unsu- guard against storage or in-transit pervised use. losses. (l) DEA may exercise discretion re- (f) When distributing controlled sub- garding the degree of security required stances through agents (e.g., in narcotic treatment programs based detailmen), a registrant is responsible on such factors as the location of a pro- for providing and requiring adequate gram, the number of patients enrolled security to guard against theft and di- in a program and the number of physi- version while the substances are being cians, staff members and security stored or handled by the agent or guards. Similarly, such factors will be agents. taken into consideration when evalu- (g) Before the initial distribution of ating existing security or requiring thiafentanil, carfentanil, etorphine hy- new security at a narcotic treatment drochloride and/or diprenorphine to program. any person, the registrant must verify (m) A reverse distributor shall not that the person is authorized to handle employ, as an agent or employee who the substance(s) by contacting the has access to or influence over con- Drug Enforcement Administration. trolled substances, any person who has (h) The acceptance of delivery of nar- been convicted of any felony offense re- cotic substances by a narcotic treat- lating to controlled substances or who, ment program shall be made only by a at any time, had an application for reg- licensed practitioner employed at the istration with the DEA denied, had a facility or other authorized individuals DEA registration revoked or sus- designated in writing. At the time of pended, or has surrendered a DEA reg- delivery, the licensed practitioner or istration for cause. For purposes of this other authorized individual designated in writing (excluding persons currently subsection, ‘‘for cause’’ means in lieu or previously dependent on narcotic of, or as a consequence of, any Federal drugs), shall sign for the narcotics and place his specific title (if any) on any

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or State administrative, civil, or crimi- for registration with the DEA denied, nal action resulting from an investiga- had a DEA registration revoked or has tion of the individual’s handling of con- surrendered a DEA registration for trolled substances. cause. For purposes of this subsection, [36 FR 7778, Apr. 24, 1971. Redesignated at 38 the term ‘‘for cause’’ means a sur- FR 26609, Sept. 24, 1973] render in lieu of, or as a consequence of, any federal or state administrative, EDITORIAL NOTE: For FEDERAL REGISTER citations affecting § 1301.74, see the List of CFR civil or criminal action resulting from Sections Affected, which appears in the an investigation of the individual’s Finding Aids section of the printed volume handling of controlled substances. and at www.govinfo.gov. (b) The registrant shall notify the Field Division Office of the Adminis- § 1301.75 Physical security controls for practitioners. tration in his area, in writing, of the theft or significant loss of any con- (a) Controlled substances listed in trolled substances within one business Schedule I shall be stored in a securely day of discovery of such loss or theft. locked, substantially constructed cabi- The registrant shall also complete, and net. (b) Controlled substances listed in submit to the Field Division Office in Schedules II, III, IV, and V shall be his area, DEA Form 106 regarding the stored in a securely locked, substan- loss or theft. When determining wheth- tially constructed cabinet. However, er a loss is significant, a registrant pharmacies and institutional practi- should consider, among others, the fol- tioners may disperse such substances lowing factors: throughout the stock of noncontrolled (1) The actual quantity of controlled substances in such a manner as to ob- substances lost in relation to the type struct the theft or diversion of the con- of business; trolled substances. (2) The specific controlled substances (c) Sealed mail-back packages and lost; inner liners collected in accordance (3) Whether the loss of the controlled with part 1317 of this chapter shall only substances can be associated with ac- be stored at the registered location in cess to those controlled substances by a securely locked, substantially con- specific individuals, or whether the loss structed cabinet or a securely locked can be attributed to unique activities room with controlled access, except as that may take place involving the con- authorized by § 1317.80(d). trolled substances; (d) This section shall also apply to (4) A pattern of losses over a specific nonpractitioners authorized to conduct time period, whether the losses appear research or chemical analysis under to be random, and the results of efforts another registration. taken to resolve the losses; and, if (e) Thiafentanil, carfentanil, known, etorphine hydrochloride and (5) Whether the specific controlled diprenorphine shall be stored in a safe substances are likely candidates for di- or steel cabinet equivalent to a U.S. version; Government Class V security container. (6) Local trends and other indicators of the diversion potential of the miss- [39 FR 3674, Jan. 29, 1974, as amended at 39 ing controlled substance. FR 17838, May 21, 1974; 54 FR 33674, Aug. 16, (c) Whenever the registrant distrib- 1989; 62 FR 13957, Mar. 24, 1997; 79 FR 53562, Sept. 9, 2014; 81 FR 58839, Aug. 26, 2016] utes a controlled substance (without being registered as a distributor as per- § 1301.76 Other security controls for mitted in §§ 1301.13(e)(1), 1307.11, 1317.05, practitioners. and/or 1317.10 of this chapter), he/she (a) The registrant shall not employ, shall comply with the requirements as an agent or employee who has access imposed on non-practitioners in to controlled substances, any person § 1301.74(a), (b), and (e). who has been convicted of a felony of- (d) Central fill pharmacies must com- fense relating to controlled substances ply with § 1301.74(e) when selecting pri- or who, at any time, had an application vate, common or contract carriers to

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transport filled prescriptions to a re- by an individual authorized in writing tail pharmacy for delivery to the ulti- by the registrant. mate user. When central fill phar- (c) Controlled substances being trans- macies contract with private, common ferred through a freight forwarding fa- or contract carriers to transport filled cility must be packed in sealed, un- prescriptions to a retail pharmacy, the marked shipping containers. central fill pharmacy is responsible for [65 FR 44678, July 19, 2000; 65 FR 45829, July reporting in-transit losses upon dis- 25, 2000] covery of such loss by use of a DEA Form 106. Retail pharmacies must com- EMPLOYEE SCREENING—NON- ply with § 1301.74(e) when selecting pri- PRACTITIONERS vate, common or contract carriers to retrieve filled prescriptions from a cen- § 1301.90 Employee screening proce- tral fill pharmacy. When retail phar- dures. macies contract with private, common It is the position of DEA that the ob- or contract carriers to retrieve filled taining of certain information by non- prescriptions from a central fill phar- practitioners is vital to fairly assess macy, the retail pharmacy is respon- the likelihood of an employee commit- sible for reporting in-transit losses ting a drug security breach. The need upon discovery of such loss by use of a to know this information is a matter of DEA Form 106. business necessity, essential to overall [36 FR 7778, Apr. 24, 1971, as amended at 36 controlled substances security. In this FR 18731, Sept. 21, 1971; 37 FR 15919, Aug. 8, regard, it is believed that conviction of 1972. Redesignated at 38 FR 26609, Sept. 24, crimes and unauthorized use of con- 1973; 47 FR 41735, Sept. 22, 1982; 56 FR 36728, trolled substances are activities that Aug. 1, 1991; 62 FR 13957, Mar. 24, 1997; 68 FR are proper subjects for inquiry. It is, 37409, June 24, 2003; 70 FR 47097, Aug. 12, 2005; therefore, assumed that the following 79 FR 53562, Sept. 9, 2014] questions will become a part of an em- § 1301.77 Security controls for freight ployer’s comprehensive employee forwarding facilities. screening program: (a) All Schedule II–V controlled sub- Question. Within the past five years, have stances that will be temporarily stored you been convicted of a felony, or within the at the freight forwarding facility must past two years, of any misdemeanor or are be either: you presently formally charged with com- mitting a criminal offense? (Do not include (1) stored in a segregated area under any traffic violations, juvenile offenses or constant observation by designated re- military convictions, except by general sponsible individual(s); or court-martial.) If the answer is yes, furnish (2) stored in a secured area that details of conviction, offense, location, date meets the requirements of Section and sentence. 1301.72(b) of this Part. For purposes of Question. In the past three years, have you this requirement, a facility that may ever knowingly used any narcotics, amphet- be locked down (i.e., secured against amines or barbiturates, other than those pre- physical entry in a manner consistent scribed to you by a physician? If the answer with requirements of Section is yes, furnish details. 1301.72(b)(3)(ii) of this part) and has a Advice. An authorization, in writing, that monitored alarm system or is subject allows inquiries to be made of courts and law to continuous monitoring by security enforcement agencies for possible pending charges or convictions must be executed by a personnel will be deemed to meet the person who is allowed to work in an area requirements of Section 1301.72(b)(3) of where access to controlled substances clear- this Part. ly exists. A person must be advised that any (b) Access to controlled substances false information or omission of information must be kept to an absolute minimum will jeopardize his or her position with re- number of specifically authorized indi- spect to employment. The application for employment should inform a person that in- viduals. Non-authorized individuals formation furnished or recovered as a result may not be present in or pass through of any inquiry will not necessarily preclude controlled substances storage areas employment, but will be considered as part without adequate observation provided of an overall evaluation of the person’s

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qualifications. The maintaining of fair em- Local inquiries. Inquiries should be made by ployment practices, the protection of the name, date and place of birth, and other person’s right of privacy, and the assurance identifying information, to local courts and that the results of such inquiries will be law enforcement agencies for records of treated by the employer in confidence will be pending charges and convictions. Local prac- explained to the employee. tice 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 employer. The employer shall treat PART 1302—LABELING AND PACK- such information as confidential and AGING REQUIREMENTS FOR shall take all reasonable steps to pro- CONTROLLED SUBSTANCES tect the confidentiality of the information and the identity of the employee Sec. furnishing information. A failure to re- 1302.01 Scope of part 1302. port information of drug diversion will 1302.02 Definitions. be considered in determining the feasi- 1302.03 Symbol required; exceptions. bility of continuing to allow an em- 1302.04 Location and size of symbol on label ployee to work in a drug security area. and labeling. The employer shall inform all employ- 1302.05 Effective dates of labeling require- ees concerning this policy. ments. 1302.06 Sealing of controlled substances. [40 FR 17143, Apr. 17, 1975] 1302.07 Labeling and packaging requirements for imported and exported sub- § 1301.92 Illicit activities by employ- stances. ees. AUTHORITY: 21 U.S.C. 821, 825, 871(b), 958(e). It is the position of DEA that employees who possess, sell, use or divert SOURCE: 36 FR 7785, Apr. 24, 1971, unless controlled substances will subject otherwise noted. Redesignated at 38 FR 26609, themselves not only to State or Fed- Sept. 24, 1973. eral prosecution for any illicit activity, but shall also immediately become § 1302.01 Scope of part 1302. the subject of independent action re- Requirements governing the labeling garding their continued employment. and packaging of controlled substances The employer will assess the serious- pursuant to sections 1305 and 1008(d) of ness of the employee’s violation, the the Act (21 U.S.C. 825 and 958(d)) are set position of responsibility held by the forth generally by those sections and employee, past record of employment, specifically by the sections of this part. etc., in determining whether to suspend, transfer, terminate or take other [36 FR 13386, July 21, 1971. Redesignated at 38 action against the employee. FR 26609, Sept. 24, 1973] [40 FR 17143, Apr. 17, 1975] § 1302.02 Definitions.

§ 1301.93 Sources of information for Any term contained in this part shall employee checks. have the definition set forth in section 102 of the Act (21 U.S.C. 802) or part DEA recommends that inquiries con- 1300 of this chapter. cerning employees’ criminal records be made as follows: [62 FR 13958, Mar. 24, 1997]

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§ 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 effective date established in the final Schedule 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 cial container is held if the symbol is a seal to disclose upon inspection any easily legible through such carton or tampering or opening of the container. wrapper. [62 FR 13958, Mar. 24, 1997] (e) The symbol is not required on a commercial container too small or oth- § 1302.07 Labeling and packaging re- erwise unable to accommodate a label, quirements for imported and ex- if the symbol is printed on the box or ported substances. package from which the commercial (a) The symbol requirements of container is removed upon dispensing §§ 1302.03 through 1302.05 apply to every to an ultimate user. commercial container containing, and (f) The symbol is not required on a to all labeling of, controlled substances commercial container containing, or imported into the customs territory of on the labeling of, a controlled sub- the United States from any place out- stance being utilized in clinical re- side thereof (but within the United search involving blind and double blind States), or imported into the United studies. States from any place outside thereof. [36 FR 7785, Apr. 24, 1971, as amended at 36 (b) The symbol requirements of FR 18731, Sept. 21, 1971. Redesignated at 38 §§ 1302.03 through 1302.05 do not apply to FR 26609, Sept. 24, 1973] any commercial containers containing, or any labeling of, a controlled sub- § 1302.04 Location and size of symbol stance intended for export. on label and labeling. (c) The sealing requirements of The symbol shall be prominently lo- § 1302.06 apply to every bottle, multiple cated on the label or the labeling of the dose vial, or other commercial con- commercial container and/or the panel tainer of any controlled substance list- of the commercial container normally ed in schedule I or II, or any narcotic displayed to dispensers of any con- controlled substance listed in schedule

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III or IV imported into the customs GENERAL INFORMATION territory of the United States from any place outside thereof (but within the § 1303.01 Scope of part 1303. United States), or imported into the Procedures governing the establish- United States from any place outside ment of production and manufacturing thereof. The sealing requirements of quotas on basic classes of controlled § 1302.06 apply to every bottle, multiple substances listed in schedules I and II dose vial, or other commercial con- pursuant to section 306 of the Act (21 tainer of any controlled substance list- U.S.C. 826) are governed generally by ed in schedule I or II, or any narcotic that section and specifically by the controlled substance listed in schedule sections of this part. III or IV, exported or intended for ex- [36 FR 7786, Apr. 24, 1971. Redesignated at 38 port from the United States. These FR 26609, Sept. 24, 1973] sealing and labeling requirements are in addition to any sealing requirements § 1303.02 Definitions. required under applicable customs Any term contained in this part shall laws. have the definition set forth in section [81 FR 97020, Dec. 30, 2016] 102 of the Act (21 U.S.C. 802) or part 1300 of this chapter. PART 1303—QUOTAS [62 FR 13958, Mar. 24, 1997]

AGGREGATE PRODUCTION AND GENERAL INFORMATION PROCUREMENT QUOTAS Sec. 1303.01 Scope of part 1303. § 1303.11 Aggregate production quotas. 1303.02 Definitions. (a) The Administrator shall deter- AGGREGATE PRODUCTION AND PROCUREMENT mine the total quantity of each basic QUOTAS class of controlled substance listed in Schedule I or II necessary to be manu- 1303.11 Aggregate production quotas. factured during the following calendar 1303.12 Procurement quotas. year to provide for the estimated med- 1303.13 Adjustments of aggregate production quotas. ical, scientific, research and industrial needs of the United States, for lawful INDIVIDUAL MANUFACTURING QUOTAS export requirements, and for the establishment and maintenance of reserve 1303.21 Individual manufacturing quotas. stocks. 1303.22 Procedure for applying for individual manufacturing quotas. (b) In making his determinations, the 1303.23 Procedure for fixing individual man- Administrator shall consider the fol- ufacturing quotas. lowing factors: 1303.24 Inventory allowance. (1) Total net disposal of the class by 1303.25 Increase in individual manufac- all manufacturers during the current turing quotas. and 2 preceding years; 1303.26 Reduction in individual manufac- (2) Trends in the national rate of net turing quotas. disposal of the class; 1303.27 Abandonment of quota. (3) Total actual (or estimated) inventories of the class and of all substances HEARINGS manufactured from the class, and 1303.31 Hearings generally. trends in inventory accumulation; 1303.32 Purpose of hearing. (4) Projected demand for such class 1303.33 Waiver or modification of rules. as indicated by procurement quotas re- 1303.34 Request for hearing or appearance; quested pursuant to § 1303.12; waiver. (5) The extent of any diversion of the 1303.35 Burden of proof. controlled substance in the class; 1303.36 Time and place of hearing. (6) Relevant information obtained 1303.37 Final order. from the Department of Health and AUTHORITY: 21 U.S.C. 821, 826, 871(b). Human Services, including from the Food and Drug Administration, the

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Centers for Disease Control and Pre- order determining the aggregate pro- vention, and the Centers for Medicare duction quota for the basic class of and Medicaid Services, and relevant in- controlled substances. The order shall formation obtained from the states; include the findings of fact and conclu- and sions of law upon which the order is (7) Other factors affecting medical, based. The order shall specify the date scientific, research, and industrial on which it shall take effect. A copy of needs in the United States and lawful said order shall be mailed simulta- export requirements, as the Adminis- neously to each person registered as a trator finds relevant, including bulk manufacturer of the basic class changes in the currently accepted med- and transmitted to each state attorney ical use in treatment with the class or general. the substances which are manufactured [36 FR 7786, Apr. 24, 1971, as amended at 37 from it, the economic and physical FR 15919, Aug. 8, 1972. Redesignated at 38 FR availability of raw materials for use in 26609, Sept. 24, 1973; 77 FR 4235, Jan. 27, 2012; manufacturing and for inventory pur- 83 FR 32789, July 16, 2018] poses, yield and stability problems, potential disruptions to production (in- § 1303.12 Procurement quotas. cluding possible labor strikes), and re- (a) In order to determine the esti- cent unforeseen emergencies such as mated needs for, and to insure an ade- floods and fires. quate and uninterrupted supply of, (c) The Administrator shall, on or be- basic classes of controlled substances fore May 1 of each year, publish in the listed in Schedules I and II (except raw FEDERAL REGISTER, general notice of opium being imported by the registrant an aggregate production quota for any pursuant to an import permit) the Ad- basic class determined by him under ministrator shall issue procurement this section. A copy of said notice shall quotas authorizing persons to procure be mailed simultaneously to each per- and use quantities of each basic class son registered as a bulk manufacturer of such substances for the purpose of of the basic class and transmitted to manufacturing such class into dosage each state attorney general. The Ad- forms or into other substances. ministrator shall permit any interested (b) Any person who is registered to person to file written comments on or manufacture controlled substances objections to the proposal and shall listed in any schedule and who desires designate in the notice the time during to use during the next calendar year which such filings may be made. The any basic class of controlled substances Administrator may, but shall not be listed in Schedule I or II (except raw required to, hold a public hearing on opium being imported by the registrant one or more issues raised by the com- pursuant to an import permit) for pur- ments and objections filed with him, poses of manufacturing, shall apply on except that the Administrator shall DEA Form 250 for a procurement quota hold a hearing if he determines it is for such basic class. A separate applica- necessary to resolve an issue of mate- tion must be made for each basic class rial fact raised by a state objecting to desired to be procured or used. The ap- the proposed quantity for the class as plicant shall state whether he intends excessive for legitimate United States’ to manufacture the basic class himself needs. In the event the Administrator or purchase it from another manufac- decides to hold a hearing, he shall pub- turer. The applicant shall state sepa- lish notice of the hearing in the FED- rately each purpose for which the basic ERAL REGISTER, which notice shall class is desired, the quantity desired summarize the issues to be heard and for that purpose during the next cal- shall set the time for the hearing, endar year, and the quantities used and which shall not be less than 30 days estimated to be used, if any, for that after the date of publication of the no- purpose during the current and pre- tice. After consideration of any com- ceding 2 calendar years. If the purpose ments or objections, or after a hearing is to manufacture the basic class into if one is ordered by the Administrator, dosage form, the applicant shall state the Administrator shall issue and pub- the official name, common or usual lish in the FEDERAL REGISTER his final name, chemical name, or brand name

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of that form. The Administrator may trator with a statement showing the require additional information from an need for the adjustment. Such applica- applicant which, in the Administra- tion shall be filed with the UN Report- tor’s judgment, may be helpful in de- ing and Quota Section, Diversion Con- tecting or preventing diversion, includ- trol Division. See the Table of DEA ing customer identities and amounts of Mailing Addresses in § 1321.01 of this the controlled substance sold to each chapter for the current mailing ad- customer.If the purpose is to manufac- dress. The Administrator shall increase ture another substance, the applicant or decrease the procurement quota of shall state the official name, common such person if and to the extent that he or usual name, chemical name, or finds, after considering the factors enu- brand name of the substance, and, if a merated in paragraph (c) of this section controlled substance listed in any and any occurrences since the issuance schedule, the schedule number and Ad- of the procurement quota, that the ministration Controlled Substances need justifies an adjustment. Code Number, as set forth in part 1308 (e) The following persons need not of this chapter, of the substance. If the obtain a procurement quota: purpose is to manufacture another (1) Any person who is registered to basic class of controlled substance list- manufacture a basic class of controlled ed in Schedule I or II, the applicant substance listed in Schedule I or II and shall also state the quantity of the who uses all of the quantity he manu- other basic class which the applicant factures in the manufacture of a sub- has applied to manufacture pursuant to stance not controlled under the Act; § 1303.22 and the quantity of the first (2) Any person who is registered or basic class necessary to manufacture a authorized to conduct chemical anal- specified unit of the second basic class. ysis with controlled substances (for DEA Form 250 shall be filed on or be- controlled substances to be used in fore April 1 of the year preceding the such analysis only); and calendar year for which the procurement 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 UN Report- controlled substance listed in Schedule ing and Quota Section, Diversion Con- I or II and who is authorized to manu- trol Division. See the Table of DEA facture a quantity of such class pursu- Mailing Addresses in § 1321.01 of this ant to § 1301.13 of this chapter. chapter for the current mailing ad- (f) Any person to whom a procure- dress. ment quota has been issued, author- (c) The Administrator shall, on or be- izing that person to procure and use a fore July 1 of the year preceding the quantity of a basic class of controlled calendar year during which the quota substances listed in Schedules I or II shall be effective, issue to each quali- during the current calendar year, shall, fied applicant a procurement quota au- at or before the time of giving an order thorizing him to procure and use: to another manufacturer requiring the (1) All quantities of such class nec- distribution of a quantity of such basic essary to manufacture all quantities of class, certify in writing to such other other basic classes of controlled sub- manufacturer that the quantity of such stances listed in Schedules I and II basic class ordered does not exceed the which the applicant is authorized to person’s unused and available procure- manufacture pursuant to § 1303.23; and ment quota of such basic class for the (2) Such other quantities of such current calendar year. The written cer- class as the applicant has applied to tification shall be executed by the procure and use and are consistent same individual who signed the DEA with his past use, his estimated needs, Form 222 transmitting the order. Man- and the total quantity of such class ufacturers shall not fill an order from that will be produced. persons required to apply for a procure- (d) Any person to whom a procurement quota under paragraph (b) of this ment quota has been issued may at any section unless the order is accompanied time request an adjustment in the by a certification as required under quota by applying to the Adminis- this section. The certification required

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by this section shall contain the fol- (3) Whether any increased demand for lowing: The date of the certification; that class can be met through existing the name and address of the bulk man- inventories, increased individual manufacturer to whom the certification is ufacturing quotas, or increased impor- directed; a reference to the number of tation, without increasing the aggre- the DEA Form 222 to which the certifi- gate production quota, taking into ac- cation applies; the name of the person count production delays and the prob- giving the order to which the certifi- ability that other individual manufac- cation applies; the name of the basic turing quotas may be suspended pursu- class specified in the DEA Form 222 to ant to § 1303.24(b); which the certification applies; the ap- (4) Whether any decreased demand propriate schedule within which is list- for that class will result in excessive ed the basic class specified in the DEA inventory accumulation by all persons Form 222 to which the certification ap- registered to handle that class (includ- plies; a statement that the quantity ing manufacturers, distributors, practi- (expressed in grams) of the basic class tioners, importers, and exporters), not- specified in the DEA Form 222 to which withstanding the possibility that indi- the certification applies does not ex- vidual manufacturing quotas may be ceed the unused and available procure- suspended pursuant to § 1303.24(b) or ment quota of such basic class, issued abandoned pursuant to § 1303.27; to the person giving the order, for the (5) Other factors affecting medical, current calendar year; and the signa- scientific, research, and industrial ture of the individual who signed the needs in the United States and lawful DEA Form 222 to which the certifi- export requirements, as the Adminis- cation applies. trator finds relevant, including changes in the currently accepted med- [36 FR 7786, Apr. 24, 1971. Redesignated at 38 ical use in treatment with the class or FR 26609, Sept. 24, 1973] the substances which are manufactured EDITORIAL NOTE: For FEDERAL REGISTER ci- from it, the economic and physical tations affecting § 1303.12, see the List of CFR availability of raw materials for use in Sections Affected, which appears in the manufacturing and for inventory pur- Finding Aids section of the printed volume poses, yield and stability problems, po- and at www.govinfo.gov. tential disruptions to production (including possible labor strikes), and re- § 1303.13 Adjustments of aggregate production quotas. cent unforeseen emergencies such as floods and fires. (a) The Administrator may at any (c) The Administrator in the event he time increase or reduce the aggregate determines to increase or reduce the production quota for a basic class of aggregate production quota for a basic controlled substance listed in Schedule class of controlled substance, shall I or II which he has previously fixed publish in the FEDERAL REGISTER gen- pursuant to § 1303.11. eral notice of an adjustment in the ag- (b) In determining to adjust the aggregate production quota for that class gregate production quota, the Adminis- determined by him under this section. trator shall consider the following fac- A copy of said notice shall be mailed tors: simultaneously to each person reg- (1) Changes in the demand for that istered as a bulk manufacturer of the class, changes in the national rate of basic class and transmitted to each net disposal of the class, changes in the state attorney general. The Adminis- rate of net disposal of the class by reg- trator shall permit any interested per- istrants holding individual manufac- son to file written comments on or ob- turing quotas for that class, and jections to the proposal and shall des- changes in the extent of any diversion ignate in the notice the time during in the class; which such filings may be made. The (2) Whether any increased demand for Administrator may, but shall not be that class, the national and/or indi- required to, hold a public hearing on vidual rates of net disposal of that one or more issues raised by the com- class are temporary, short term, or ments and objections filed with him, long term; except that the Administrator shall

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hold a hearing if he determines it is (b) No individual manufacturing necessary to resolve an issue of mate- quota shall be required for registrants rial fact raised by a state objecting to listed in § 1303.12(e). the proposed adjusted quota as exces- [36 FR 7786, Apr. 24, 1971. Redesignated at 38 sive for legitimate United States’ FR 26609, Sept. 24, 1973, as amended at 62 FR needs. In the event the Administrator 13958, Mar. 24, 1997; 83 FR 32790, July 16, 2018] decides to hold a hearing, he shall publish notice of the hearing in the FED- § 1303.22 Procedure for applying for ERAL REGISTER, which notice shall individual manufacturing quotas. summarize the issues to be heard and Any person who is registered to man- shall set the time for the hearing, ufacture any basic class of controlled which shall not be less than 10 days substance listed in Schedule I or II and after the date of publication of the no- who desires to manufacture a quantity tice. After consideration of any com- of such class shall apply on DEA Form ments or objections, or after a hearing 189 for a manufacturing quota for such if one is ordered by the Administrator, quantity of such class. Copies of DEA the Administrator shall issue and pub- Form 189 may be obtained from, and lish in the FEDERAL REGISTER his final shall be filed (on or before May 1 of the order determining the aggregate pro- year preceding the calendar year for duction for the basic class of controlled which the manufacturing quota is being applied) with, the UN Reporting substance. The order shall include the and Quota Section, Diversion Control findings of fact and conclusions of law Division. See the Table of DEA Mailing upon which the order is based. The Addresses in § 1321.01 of this chapter for order shall specify the date on which it the current mailing address. A separate shall take effect. A copy of said order application must be made for each shall be mailed simultaneously to each basic class desired to be manufactured. person registered as a bulk manufac- The applicant shall state: turer of the basic class and transmitted (a) The name and Administration to each state attorney general. Controlled Substances Code Number, as [37 FR 15919, Aug. 8, 1972. Redesignated at 38 set forth in part 1308 of this chapter, of FR 26609, Sept. 24, 1973; 83 FR 32790, July 16, the basic class. 2018] (b) For the basic class in each of the current and preceding 2 calendar years, INDIVIDUAL MANUFACTURING QUOTAS (1) The authorized individual manufacturing quota, if any; § 1303.21 Individual manufacturing (2) The actual or estimated quantity quotas. manufactured; (a) The Administrator shall, on or be- (3) The actual or estimated net dis- fore July 1 of each year, fix for and posal; issue to each person who is registered (4) The actual or estimated inventory to manufacture a basic class of con- allowance pursuant to § 1303.24; and trolled substance listed in Schedule I (5) The actual or estimated inventory or II, and who applies for a manufac- as of December 31; turing quota, an individual manufac- (c) For the basic class in the next cal- turing quota authorizing that person to endar year, manufacture during the next calendar (1) The desired individual manufac- year a quantity of that basic class. Any turing quota; and manufacturing quota fixed and issued (2) Any additional factors which the by the Administrator shall be subject applicant finds relevant to the fixing of to his authority to reduce or limit it at his individual manufacturing quota, in- a later date pursuant to § 1303.26 and to cluding the trend of (and recent his authority to revoke or suspend it at changes in) his and the national rates any time pursuant to § 1301.36 of this of net disposal, his production cycle chapter. and current inventory position, the economic and physical availability of raw materials for use in manufacturing and for inventory purposes, yield and

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stability problems, potential disrup- to 100 percent of the reasonably esti- tions to production (including possible mated net disposal of that applicant labor strikes) and recent unforeseen for the next calendar year, as deter- emergencies such as floods and fires. mined by the Administrator, ad- (d) The Administrator may require justed— additional information from an appli- (1) By the amount necessary to pro- cant which, in the Administrator’s vide the applicant his estimated inven- judgment, may be helpful in detecting tory allowance for the next calendar or preventing diversion, including cus- year, pursuant to § 1303.24, and tomer identities and amounts of the (2) By any other factors which the controlled substance sold to each cus- Administrator deems relevant to the tomer. fixing of the individual manufacturing quota of the applicant, including the [36 FR 7786, Apr. 24, 1971, as amended at 36 trend of (and recent changes in) the na- FR 13386, July 21, 1971; 37 FR 15920, Aug. 8, tional rate of net disposal, his produc- 1972. Redesignated at 38 FR 26609, Sept. 24, 1973, and amended at 46 FR 28841, May 29, tion cycle and current inventory posi- 1981; 51 FR 5319, Feb. 13, 1986; 62 FR 13958, tion, the economic and physical avail- Mar. 24, 1997; 75 FR 10677, Mar. 9, 2010; 81 FR ability of raw materials for use in man- 97020, Dec. 30, 2016; 83 FR 32790, July 16, 2018] ufacturing and for inventory purposes, yield and stability problems, potential § 1303.23 Procedure for fixing indi- disruptions to production (including vidual manufacturing quotas. possible labor strikes), any risk of di- (a) In fixing individual manufac- version of the controlled substance, turing quotas for a basic class of con- and recent unforeseen emergencies trolled substance listed in Schedule I such as floods and fires. or II, the Administrator shall allocate (c) The Administrator shall, on or be- to each applicant who is currently fore March 1 of each year, adjust the manufacturing such class a quota equal individual manufacturing quota allo- to 100 percent of the estimated net dis- cated for that year to each applicant in posal of that applicant for the next cal- paragraph (a) of this section by the endar year, adjusted— amount necessary to increase or reduce (1) By the amount necessary to in- the actual inventory of the applicant crease or reduce the estimated inven- to December 31 of the preceding year to tory of the applicant on December 31 of his estimated inventory allowance for the current year to his estimated in- the current calendar year, pursuant to ventory allowance for the next cal- § 1303.24. endar year, pursuant to § 1303.24, and [36 FR 7786, Apr. 24, 1971, as amended at 37 (2) By any other factors which the FR 15920, Aug. 8, 1972. Redesignated at 38 FR Administrator deems relevant to the 26609, Sept. 24, 1973; 83 FR 32790, July 16, 2018] fixing of the individual manufacturing quota of the applicant, including the § 1303.24 Inventory allowance. trend of (and recent changes in) his and (a) For the purpose of determining the national rates of net disposal, his individual manufacturing quotas pur- production cycle and current inventory suant to § 1303.23, each registered man- position, the economic and physical ufacturer shall be allowed as a part of availability of raw materials for use in such quota an amount sufficient to manufacturing and for inventory pur- maintain an inventory equal to, poses, yield and stability problems, po- (1) For current manufacturers, 50 per- tential disruptions to production (in- cent of his average estimated net dis- cluding possible labor strikes), the ex- posal for the current calendar year and tent of any diversion of the controlled the last preceding calendar year; or substance, and recent unforeseen emer- (2) For new manufacturers, 50 percent gencies such as floods and fires. of his reasonably estimated net dis- (b) In fixing individual manufac- posal for the next calendar year as de- turing quotas for a basic class of con- termined by the Administrator. trolled substance listed in Schedule I (b) During each calendar year each or II, the Administrator shall allocate registered manufacturer shall be al- to each applicant who is not currently lowed to maintain an inventory of a manufacturing such class a quota equal basic class not exceeding 65 percent of

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his estimated net disposal of that class year. In passing upon such application for that year, as determined at the the Administrator may also take into time his quota for that year was deter- consideration the amount, if any, by mined. At any time the inventory of a which his determination of the total basic class held by a manufacturer ex- quantity for the basic class of con- ceeds 65 percent of his estimated net trolled substance to be manufactured disposal, his quota for that class is under § 1303.11 exceeds the aggregate of automatically suspended and shall re- all the individual manufacturing main suspended until his inventory is quotas for the basic class of controlled less than 60 percent of his estimated substance, and the equitable distribu- net disposal. The Administrator may, tion of such excess among other reg- upon application and for good cause istrants. shown, permit a manufacturer whose quota is, or is likely to be, suspended [36 FR 7786, Apr. 24, 1971, as amended at 36 pursuant to this paragraph to continue FR 13386, July 21, 1971. Redesignated at 38 FR manufacturing and to accumulate an 26609, Sept. 24, 1973] inventory in excess of 65 percent of his § 1303.26 Reduction in individual man- estimated net disposal, upon such con- ufacturing quotas. ditions and within such limitations as the Administrator may find necessary The Administrator may at any time or desirable. reduce an individual manufacturing (c) If, during a calendar year, a reg- quota for a basic class of controlled istrant has manufactured the entire substance listed in Schedule I or II quantity of a basic class allocated to which he has previously fixed in order him under an individual manufacturing to prevent the aggregate of the indi- quota, and his inventory of that class vidual manufacturing quotas and im- is less than 40 percent of his estimated port permits outstanding or to be net disposal of that class for that year, granted from exceeding the aggregate the Administrator may, upon applica- production quota which has been estab- tion pursuant to § 1303.25, increase the lished for that class pursuant of quota of such registrant sufficiently to § 1303.11, as adjusted pursuant to allow restoration of the inventory to 50 § 1303.13. If a quota assigned to a new percent of the estimated net disposal manufacturer pursuant to § 1303.23(b), for that year. or if a quota assigned to any manufacturer is increased pursuant to [36 FR 7786, Apr. 24, 1971, as amended at 36 FR 13386, July 21, 1971. Redesignated at 38 FR § 1303.24(c), or if an import permit 26609, Sept. 24, 1973] issued to an importer pursuant to part 1312 of this chapter, causes the total § 1303.25 Increase in individual manu- quantity of a basic class to be manufacturing quotas. factured and imported during the year (a) Any registrant who holds an indi- to exceed the aggregate production vidual manufacturing quota for a basic quota which has been established for class of controlled substance listed in that class pursuant to § 1303.11, as ad- Schedule I or II may file with the Ad- justed pursuant to § 1303.13, the Admin- ministrator an application on Adminis- istrator may proportionately reduce tration Form 189 for an increase in the individual manufacturing quotas such quota in order for him to meet his and import permits of all other reg- estimated net disposal, inventory and istrants to keep the aggregate produc- other requirements during the remain- tion quota within the limits originally der of such calendar year. established, or, alternatively, the Ad- (b) The Administrator, in passing ministrator may reduce the individual upon a registrant’s application for an manufacturing quota of any registrant increase in his individual manufac- whose quota is suspended pursuant to turing quota, shall take into consider- § 1303.24(b) or § 1301.36 of this chapter, or ation any occurrences since the filing is abandoned pursuant to § 1303.27. 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 during the balance of the calendar 13958, Mar. 24, 1997]

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§ 1303.27 Abandonment of quota. ings under the Act set forth in §§ 1316.41–1316.67 of this chapter. Any manufacturer assigned an individual manufacturing quota for any [36 FR 7786, Apr. 24, 1971, as amended at 37 basic class pursuant to § 1303.23 may at FR 15920, Aug. 8, 1972. Redesignated at 38 FR any time abandon his right to manu- 26609, Sept. 24, 1973] facture all or any part of such quota by filing with the Drug & Chemical Eval- § 1303.32 Purpose of hearing. uation Section a written notice of such (a) The Administrator may, in his abandonment, stating the name and sole discretion, and shall, if determined Administration Controlled Substances by the Administrator to be necessary Code Number, as set forth in part 1308 under § 1303.11(c) or 1303.13(c) based on of this chapter, of the substance and objection by a state, hold a hearing for the amount which he has chosen not to the purpose of receiving factual evi- manufacture. The Administrator may, dence regarding any one or more issues in his discretion, allocate such amount (to be specified by him) involved in the among the other manufacturers in pro- determination or adjustment of any ag- portion to their respective quotas. gregate production quota. [36 FR 7786, Apr. 24, 1971, as amended at 36 (b) If requested by a person applying FR 13386, July 21, 1971. Redesignated at 38 FR for or holding a procurement quota or 26609, Sept. 24, 1973, and amended at 46 FR an individual manufacturing quota, the 28841, May 29, 1981; 51 FR 5319, Feb. 13, 1986; Administrator shall hold a hearing for 62 FR 13958, Mar. 24, 1997] the purpose of receiving factual evidence regarding the issues involved in HEARINGS the issuance, adjustment, suspension, or denial of such quota to such person, § 1303.31 Hearings generally. but the Administrator need not hold a (a) In any case where the Adminis- hearing on the suspension of a quota trator shall hold a hearing regarding pursuant to § 1301.36 of this chapter sep- the determination of an aggregate pro- arate from a hearing on the suspension duction quota pursuant to § 1303.11(c), of registration pursuant to those sec- or regarding the adjustment of an ag- tions. gregate production quota pursuant to (c) Extensive argument should not be § 1303.13(c), the procedures for such offered into evidence but rather prehearing shall be governed generally by sented in opening or closing state- the rule making procedures set forth in ments of counsel or in memoranda or the Administrative Procedure Act (5 proposed findings of fact and conclu- U.S.C. 551–559) and specifically by sec- sions of law. tion 306 of the Act (21 U.S.C. 826), by §§ 1303.32–1303.37, and by the procedures [36 FR 7786, Apr. 24, 1971, as amended at 37 for administrative hearings under the FR 15920, Aug. 8, 1972. Redesignated at 38 FR Act set forth in §§ 1316.41–1316.67 of this 26609, Sept. 24, 1973, as amended at 62 FR 13958, Mar. 24, 1997; 83 FR 32790, July 16, 2018] chapter. (b) In any case where the Adminis- § 1303.33 Waiver or modification of trator shall hold a hearing regarding rules. the issuance, adjustment, suspension, The Administrator or the presiding or denial of a procurement quota pur- officer (with respect to matters pend- suant to § 1303.12, or the issuance, adjustment, suspension, or denial of an ing before him) may modify or waive individual manufacturing quota pursu- any rule in this part by notice in ad- ant to §§ 1303.21–1303.27, the procedures vance of the hearing, if he determines for such hearing shall be governed gen- that no party in the hearing will be un- erally by the adjudication procedures duly prejudiced and the ends of justice set forth in the Administrative Proce- will thereby be served. Such notice of dures Act (5 U.S.C. 551–559) and specifi- modification or waiver shall be made a cally by section 306 of the Act (21 part of the record of the hearing. U.S.C. 826), by §§ 1303.32–1303.37, and by [36 FR 7786, Apr. 24, 1971. Redesignated at 38 the procedures for administrative hear- FR 26609, Sept. 24, 1973]

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§ 1303.34 Request for hearing or ap- hearing, unless he shows good cause for pearance; waiver. such failure. (a) Any applicant or registrant who (e) If all persons entitled to a hearing desires a hearing on the issuance, ad- or to participate in a hearing waive or justment, suspension, or denial of his are deemed to waive their opportunity procurement and/or individual manu- for the hearing or to participate in the facturing quota shall, within 30 days hearing, the Administrator may cancel after the date of receipt of the the hearing, if scheduled, and issue his issuance, adjustment, suspension, or final order pursuant to § 1303.37 without denial of such quota, file with the Ad- a hearing. ministrator a written request for a [36 FR 7786, Apr. 24, 1971, as amended at 36 hearing in the form prescribed in FR 18731, Sept. 21, 1971; 37 FR 15920, Aug. 8, § 1316.47 of this chapter. Any interested 1972. Redesignated at 38 FR 26609, Sept. 24, person who desires a hearing on the de- 1973] termination of an aggregate production quota shall, within the time prescribed § 1303.35 Burden of proof. in § 1303.11(c), file with the Adminis- (a) At any hearing regarding the de- trator a written request for a hearing termination or adjustment of an aggre- in the form prescribed in § 1316.47 of gate production quota, each interested this chapter, including in the request a person participating in the hearing statement of the grounds for a hearing. shall have the burden of proving any (b) Any interested person who desires propositions of fact or law asserted by to participate in a hearing on the de- him in the hearing. termination or adjustment of an aggre- (b) At any hearing regarding the gate production quota, which hearing issuance, adjustment, suspension, or is ordered by the Administrator pursu- denial of a procurement or individual ant to § 1303.11(c) or § 1303.13(c) may do manufacturing quota, the Administra- so by filing with the Administrator, tion shall have the burden of proving within 30 days of the date of publica- that the requirements of this part for tion of notice of the hearing in the such issuance, adjustment, suspension, FEDERAL REGISTER, a written notice of or denial are satisfied. his intention to participate in such hearing in the form prescribed in [36 FR 7786, Apr. 24, 1971, as amended at 37 § 1316.48 of this chapter. FR 15920, Aug. 8, 1972. Redesignated at 38 FR (c) Any person entitled to a hearing 26609, Sept. 24, 1973, as amended at 62 FR or to participate in a hearing pursuant 13958, Mar. 24, 1997] to paragraph (b) of this section, may, within the period permitted for filing a § 1303.36 Time and place of hearing. request for a hearing of notice of ap- (a) If any applicant or registrant re- pearance, file with the Administrator a quests a hearing on the issuance, ad- waiver of an opportunity for a hearing justment, suspension, or denial of his or to participate in a hearing, together procurement and/or individual manu- with a written statement regarding his facturing quota pursuant to § 1303.34, position on the matters of fact and law the Administrator shall hold such involved in such hearing. Such state- hearing. Notice of the hearing shall be ment, if admissible, shall be made a given to the applicant or registrant of part of the record and shall be consid- the time and place at least 30 days ered in light of the lack of opportunity prior to the hearing, unless the appli- for cross-examination in determining cant or registrant waives such notice the weight to be attached to matters of and requests the hearing be held at an fact asserted therein. earlier time, in which case the Admin- (d) If any person entitled to a hearing istrator shall fix a date for such hear- or to participate in a hearing pursuant ing as early as reasonably possible. to paragraph (b) of this section, fails to (b) The hearing will commence at the file a request for a hearing or notice of place and time designated in the notice appearance, or if he so files and fails to given pursuant to paragraph (a) of this appear at the hearing, he shall be section or in the notice of hearing pub- deemed to have waived his opportunity lished in the FEDERAL REGISTER pursu- for the hearing or to participate in the ant to § 1303.11(c) or § 1303.13 (c), but

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thereafter it may be moved to a dif- 1304.24 Records for maintenance treatment ferent place and may be continued programs and detoxification treatment from day to day or recessed to a later programs. 1304.25 Records for treatment programs day without notice other than an- that compound narcotics for treatment nouncement thereof by the presiding programs and other locations. officer at the hearing. 1304.26 Additional recordkeeping requirements applicable to drug products con- [36 FR 7786, Apr. 24, 1971, as amended at 37 taining gamma-hydroxybutyric acid. FR 15920, Aug. 8, 1972. Redesignated at 38 FR 26609, Sept. 24, 1973] REPORTS 1304.31 Reports from manufacturers import- § 1303.37 Final order. ing narcotic raw material. As soon as practicable after the pre- 1304.32 Reports of manufacturers importing siding officer has certified the record coca leaves. to the Administrator, the Adminis- 1304.33 Reports to Automation of Reports and Consolidated Orders System trator shall issue his order on the de- (ARCOS). termination or adjustment of the aggregate production quota or on the ONLINE PHARMACIES issuance, adjustment, suspension, or 1304.40 Notification by online pharmacies. denial of the procurement quota or in- 1304.45 Internet Web site disclosure require- dividual manufacturing quota, as case ments. may be. The order shall include the 1304.50 Disclosure requirements for Web findings of fact and conclusions of law sites of nonpharmacy practitioners that upon which the order is based. The dispense controlled substances by means of the Internet. order shall specify the date on which it 1304.55 Reports by online pharmacies. shall take effect. The Administrator shall serve one copy of his order upon AUTHORITY: 21 U.S.C. 821, 827, 831, 871(b), each party in the hearing. 958(e)–(g), and 965, unless otherwise noted. [36 FR 7786, Apr. 24, 1971, as amended at 37 GENERAL INFORMATION FR 15920, Aug. 8, 1972. Redesignated at 38 FR 26609, Sept. 24, 1973] § 1304.01 Scope of part 1304. Inventory and other records and re- PART 1304—RECORDS AND ports required under section 307, sec- REPORTS OF REGISTRANTS tion 311, or section 1008(e) of the Act (21 U.S.C. 827, 831, and 958(e)) shall be in accordance with, and contain the infor- GENERAL INFORMATION mation required by, those sections and Sec. by the sections of this part. 1304.01 Scope of part 1304. 1304.02 Definitions. [74 FR 15623, Apr. 6, 2009] 1304.03 Persons required to keep records and § 1304.02 Definitions. file reports. 1304.04 Maintenance of records and inven- Any term contained in this part shall tories. have the definition set forth in section 1304.05 Records of authorized central fill 102 of the Act (21 U.S.C. 802) or § 1300.01, pharmacies and retail pharmacies. § 1300.03, § 1300.04, or § 1300.05 of this 1304.06 Records and reports for electronic chapter. prescriptions. [81 FR 97020, Dec. 30, 2016] INVENTORY REQUIREMENTS § 1304.03 Persons required to keep 1304.11 Inventory requirements. records and file reports.

CONTINUING RECORDS (a) Every registrant, including collectors, shall maintain the records and 1304.21 General requirements for continuing records. inventories and shall file the reports 1304.22 Records for manufacturers, distribu- required by this part, except as ex- tors, dispensers, researchers, importers, empted by this section. Any registrant exporters, registrants that reverse dis- that is authorized to conduct other ac- tribute, and collectors. tivities without being registered to 1304.23 Records for chemical analysts. conduct those activities, pursuant to

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§§ 1301.22(b), 1307.11, 1307.13, or part 1317 trolled substances in Schedules II, III, of this chapter, shall maintain the IV, and V that are prescribed in the records and inventories and shall file lawful course of professional practice, the reports required by this part for unless such substances are prescribed persons registered or authorized to in the course of maintenance or detoxi- conduct such activities. This latter re- fication treatment of an individual. quirement should not be construed as (d) A registered individual practi- requiring stocks of controlled sub- tioner is not required to keep records stances being used in various activities of controlled substances listed in under one registration to be stored sep- Schedules II, III, IV and V which are arately, nor that separate records are administered in the lawful course of required for each activity. The intent professional practice unless the practi- of the Administration is to permit the tioner regularly engages in the dis- registrant to keep one set of records pensing or administering of controlled which are adapted by the registrant to substances and charges patients, either account for controlled substances used separately or together with charges for in any activity. Also, the Administra- other professional services, for sub- tion does not wish to require separate stances so dispensed or administered. stocks of the same substance to be pur- Records are required to be kept for chased and stored for separate activi- controlled substances administered in ties. Otherwise, there is no advantage the course of maintenance or detoxi- gained by permitting several activities fication treatment of an individual. under one registration. Thus, when a (e) Each registered mid-level practi- researcher manufactures a controlled tioner shall maintain in a readily re- item, he must keep a record of the quantity manufactured; when he dis- trievable manner those documents re- tributes a quantity of the item, he quired by the state in which he/she must use and keep invoices or order practices which describe the conditions forms to document the transfer; when and extent of his/her authorization to he imports a substance, he keeps as dispense controlled substances and part of his records the documentation shall make such documents available required of an importer; and when sub- for inspection and copying by author- stances are used in chemical analysis, ized employees of the Administration. he need not keep a record of this be- Examples of such documentation in- cause such a record would not be re- clude protocols, practice guidelines or quired of him under a registration to practice agreements. do chemical analysis. All of these (f) Registered persons using any con- records may be maintained in one controlled substances while conducting solidated record system. Similarly, the preclinical research, in teaching at a researcher may store all of his con- registered establishment which main- trolled items in one place, and every tains records with respect to such sub- two years take inventory of all items stances or conducting research in con- on hand, regardless of whether the sub- formity with an exemption granted stances were manufactured by him, im- under section 505(i) or 512(j) of the Fed- ported by him, or purchased domesti- eral Food, Drug, and Cosmetic Act (21 cally by him, of whether the sub- U.S.C. 355(i) or 360b(j)) at a registered stances will be administered to sub- establishment which maintains records jects, distributed to other researchers, in accordance with either of those sec- or destroyed during chemical analysis. tions, are not required to keep records (b) A registered individual practi- if he/she notifies the Administration of tioner is required to keep records, as the name, address, and registration described in § 1304.04, of controlled sub- number of the establishment maintain- stances in Schedules II, III, IV, and V ing such records. This notification which are dispensed, other than by pre- shall be given at the time the person scribing or administering in the lawful applies for registration or reregistra- course of professional practice. tion and shall be made in the form of (c) Except as provided in § 1304.06, a an attachment to the application, registered individual practitioner is which shall be filed with the applica- not required to keep records of con- tion.

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(g) A distributing registrant who uti- central records. Written notification lizes a freight forwarding facility shall must be submitted by registered or cer- maintain records to reflect transfer of tified mail, return receipt requested, in controlled substances through the fa- triplicate, to the Special Agent in cility. These records must contain the Charge of the Administration in the date, time of transfer, number of car- area in which the registrant is located. tons, crates, drums or other packages Unless the registrant is informed by in which commercial containers of con- the Special Agent in Charge that per- trolled substances are shipped and au- mission to keep central records is de- thorized signatures for each transfer. A nied, the registrant may maintain cen- distributing registrant may, as part of tral records commencing 14 days after the initial request to operate a freight receipt of his notification by the Spe- forwarding facility, request permission cial Agent in Charge. All notifications to store records at a central location. must include the following: Approval of the request to maintain (i) The nature of the records to be central records would be implicit in kept centrally. the approval of the request to operate (ii) The exact location where the the facility. Otherwise, a request to records will be kept. maintain records at a central location must be submitted in accordance with (iii) The name, address, DEA reg- § 1304.04 of this part. These records istration number and type of DEA reg- must be maintained for a period of two istration of the registrant whose years. records are being maintained centrally. (h) A person is required to keep the (iv) Whether central records will be records and file the reports specified in maintained in a manual, or computer § 1304.06 and part 1311 of this chapter if readable, form. they are either of the following: (2) A registered retail pharmacy that (1) An electronic prescription appli- possesses additional registrations for cation provider. automated dispensing systems at long (2) An electronic pharmacy applica- term care facilities may keep all tion provider. records required by this part for those additional registered sites at the retail [36 FR 7790, Apr. 24, 1971, as amended at 36 FR 18731, Sept. 21, 1971; 37 FR 15920, Aug. 8, pharmacy or other approved central lo- 1972. Redesignated at 38 FR 26609, Sept. 24, cation. 1973, and amended at 50 FR 40523, Oct. 4, 1985; (3) A collector that is authorized to 51 FR 5320, Feb. 13, 1986; 51 FR 26154, July 21, maintain a collection receptacle at a 1986; 58 FR 31175, June 1, 1993; 62 FR 13958, long-term care facility shall keep all Mar. 24, 1997; 65 FR 44679, July 19, 2000; 75 FR records required by this part relating 16306, Mar. 31, 2010; 77 FR 4235, Jan. 27, 2012; 79 FR 53562, Sept. 9, 2014] to those collection receptacles at the registered location, or other approved § 1304.04 Maintenance of records and central location. inventories. (b) All registrants that are author- (a) Except as provided in paragraphs ized to maintain a central record- (a)(1) and (a)(2) of this section, every keeping system under paragraph (a) of inventory and other records required to this section shall be subject to the fol- be kept under this part must be kept lowing conditions: by the registrant and be available, for (1) The records to be maintained at at least 2 years from the date of such the central record location shall not inventory or records, for inspection include executed order forms and in- and copying by authorized employees ventories, which shall be maintained at of the Administration. each registered location. (1) Financial and shipping records (2) If the records are kept on micro- (such as invoices and packing slips but film, computer media or in any form not executed order forms subject to requiring special equipment to render §§ 1305.17 and 1305.27 of this chapter) the records easily readable, the reg- may be kept at a central location, istrant shall provide access to such rather than at the registered location, equipment with the records. If any if the registrant has notified the Ad- code system is used (other than pricing ministration of his intention to keep information), a key to the code shall be

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provided to make the records under- (2) Inventories and records of con- standable. trolled substances listed in Schedules (3) The registrant agrees to deliver III, IV, and V shall be maintained ei- all or any part of such records to the ther separately from all other records registered location within two business of the registrant or in such form that days upon receipt of a written request the information required is readily re- from the Administration for such trievable from the ordinary business records, and if the Administration records of the registrant. chooses to do so in lieu of requiring de- (g) Each registered individual practi- livery of such records to the registered tioner required to keep records and in- location, to allow authorized employ- stitutional practitioner shall maintain ees of the Administration to inspect inventories and records of controlled such records at the central location substances in the manner prescribed in upon request by such employees with- paragraph (f) of this section. out a warrant of any kind. (4) In the event that a registrant fails (h) Each registered pharmacy shall to comply with these conditions, the maintain the inventories and records of Special Agent in Charge may cancel controlled substances as follows: such central recordkeeping authoriza- (1) Inventories and records of all con- tion, and all other central record- trolled substances listed in Schedule I keeping authorizations held by the reg- and II shall be maintained separately istrant without a hearing or other pro- from all other records of the pharmacy. cedures. In the event of a cancellation (2) Paper prescriptions for Schedule of central recordkeeping authoriza- II controlled substances shall be main- tions under this paragraph the reg- tained at the registered location in a istrant shall, within the time specified separate prescription file. by the Special Agent in Charge, comply (3) Inventories and records of Sched- with the requirements of this section ules III, IV, and V controlled sub- that all records be kept at the reg- stances shall be maintained either sep- istered location. arately from all other records of the (c) Registrants need not notify the pharmacy or in such form that the in- Special Agent in Charge or obtain cen- formation required is readily retriev- tral recordkeeping approval in order to able from ordinary business records of maintain records on an in-house com- the pharmacy. puter system. (4) Paper prescriptions for Schedules (d) ARCOS participants who desire III, IV, and V controlled substances authorization to report from other shall be maintained at the registered than their registered locations must location either in a separate prescrip- obtain a separate central reporting identifier. Request for central report- tion file for Schedules III, IV, and V ing identifiers will be submitted to the controlled substances only or in such ARCOS Unit. See the Table of DEA form that they are readily retrievable Mailing Addresses in § 1321.01 of this from the other prescription records of chapter for the current mailing ad- the pharmacy. Prescriptions will be dress. deemed readily retrievable if, at the (e) All central recordkeeping permits time they are initially filed, the face of previously issued by the Administra- the prescription is stamped in red ink tion expired September 30, 1980. in the lower right corner with the let- (f) Each registered manufacturer, dis- ter ‘‘C’’ no less than 1 inch high and tributor, importer, exporter, narcotic filed either in the prescription file for treatment program and compounder controlled substances listed in Sched- for narcotic treatment program shall ules I and II or in the usual consecu- maintain inventories and records of tively numbered prescription file for controlled substances as follows: noncontrolled substances. However, if a (1) Inventories and records of con- pharmacy employs a computer applica- trolled substances listed in Schedules I tion for prescriptions that permits and II shall be maintained separately identification by prescription number from all of the records of the reg- and retrieval of original documents by istrant; and prescriber name, patient’s name, drug

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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. [68 FR 37410, June 24, 2003] (5) Records of electronic prescriptions for controlled substances shall be § 1304.06 Records and reports for elec- maintained in an application that tronic prescriptions. meets the requirements of part 1311 of (a) As required by § 1311.120 of this this chapter. The computers on which chapter, a practitioner who issues elec- the records are maintained may be lo- tronic prescriptions for controlled sub- cated at another location, but the stances must use an electronic pre- records must be readily retrievable at scription application that retains the the registered location if requested by following information: the Administration or other law en- (1) The digitally signed record of the forcement agent. The electronic appli- information specified in part 1306 of cation must be capable of printing out this chapter. or transferring the records in a format (2) The internal audit trail and any that is readily understandable to an auditable event identified by the inter- Administration or other law enforce- nal audit as required by § 1311.150 of ment agent at the registered location. this chapter. Electronic copies of prescription (b) An institutional practitioner records must be sortable by prescriber must retain a record of identity proof- name, patient name, drug dispensed, ing and issuance of the two-factor au- and date filled. thentication credential, where applicable, as required by § 1311.110 of this (Authority: 21 U.S.C. 821 and 871(b); 28 CFR chapter. 0.100) (c) As required by § 1311.205 of this [36 FR 7790, Apr. 24, 1971, as amended at 36 chapter, a pharmacy that processes FR 13386, July 21, 1971. Redesignated at 38 FR electronic prescriptions for controlled 26609, Sept. 24, 1973, and amended at 39 FR substances must use an application 37985, Oct. 25, 1974; 45 FR 44266, July 1, 1980; that retains the following: 47 FR 41735, Sept. 22, 1982; 51 FR 5320, Feb. 13, (1) All of the information required 1986; 62 FR 13959, Mar. 24, 1997; 70 FR 25466, under § 1304.22(c) and part 1306 of this May 13, 2005; 75 FR 10677, Mar. 9, 2010; 75 FR 16306, Mar. 31, 2010; 79 FR 53562, Sept. 9, 2014] chapter. (2) The digitally signed record of the § 1304.05 Records of authorized cen- prescription as received as required by tral fill pharmacies and retail phar- § 1311.210 of this chapter. macies. (3) The internal audit trail and any (a) Every retail pharmacy that uti- auditable event identified by the internal audit as required by § 1311.215 of lizes the services of a central fill phar- this chapter. macy must keep a record of all central (d) A registrant and application serv- fill pharmacies, including name, ad- ice provider must retain a copy of any dress and DEA number, that are au- security incident report filed with the thorized to fill prescriptions on its be- Administration pursuant to §§ 1311.150 half. The retail pharmacy must also and 1311.215 of this chapter. verify the registration for each central (e) An electronic prescription or fill pharmacy authorized to fill pre- pharmacy application provider must scriptions on its behalf. These records retain third party audit or certifi- must be made available upon request cation reports as required by § 1311.300 for inspection by DEA. of this chapter. (b) Every central fill pharmacy must (f) An application provider must re- keep a record of all retail pharmacies, tain a copy of any notification to the including name, address and DEA num- Administration regarding an adverse ber, for which it is authorized to fill audit or certification report filed with prescriptions. The central fill phar- the Administration on problems identi- macy must also verify the registration fied by the third-party audit or certifi- for all retail pharmacies for which it is cation as required by § 1311.300 of this authorized to fill prescriptions. These chapter.

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(g) Unless otherwise specified, all stocks of controlled substances on records and reports must be retained hand at least every two years. The bi- for two years. ennial inventory may be taken on any [75 FR 16306, Mar. 31, 2010] date which is within two years of the previous biennial inventory date. INVENTORY REQUIREMENTS (d) Inventory date for newly controlled substances. On the effective date of a § 1304.11 Inventory requirements. rule by the Administrator pursuant to (a) General requirements. Each inven- §§ 1308.45, 1308.46, or 1308.47 of this chap- tory shall contain a complete and accu- ter adding a substance to any schedule rate record of all controlled substances of controlled substances, which sub- on hand on the date the inventory is stance was, immediately prior to that taken, and shall be maintained in writ- date, not listed on any such schedule, ten, typewritten, or printed form at every registrant required to keep the registered location. An inventory records who possesses that substance taken by use of an oral recording de- shall take an inventory of all stocks of vice must be promptly transcribed. the substance on hand. Thereafter, Controlled substances shall be deemed such substance shall be included in to be ‘‘on hand’’ if they are in the pos- each inventory made by the registrant session of or under the control of the pursuant to paragraph (c) of this sec- registrant, including substances re- tion. turned by a customer, ordered by a cus- (e) Inventories of manufacturers, dis- tomer but not yet invoiced, stored in a tributors, registrants that reverse dis- warehouse on behalf of the registrant, tribute, importers, exporters, chemical an- and substances in the possession of em- alysts, dispensers, researchers, and collec- ployees of the registrant and intended tors. Each person registered or author- for distribution as complimentary sam- ized (by §§ 1301.13, 1307.11, 1307.13, or ples. A separate inventory shall be part 1317 of this chapter) to manufac- made for each registered location and ture, distribute, reverse distribute, dis- each independent activity registered, pense, import, export, conduct research except as provided in paragraph (e)(4) or chemical analysis with controlled of this section. In the event controlled substances, or collect controlled sub- substances in the possession or under stances from ultimate users, and re- the control of the registrant are stored quired to keep records pursuant to at a location for which he/she is not § 1304.03 shall include in the inventory registered, the substances shall be in- the information listed below. cluded in the inventory of the reg- (1) Inventories of manufacturers. Each istered location to which they are sub- person registered or authorized to man- ject to control or to which the person ufacture controlled substances shall in- possessing the substance is responsible. clude the following information in the The inventory may be taken either as inventory: of opening of business or as of the close (i) For each controlled substance in of business on the inventory date and bulk form to be used in (or capable of it shall be indicated on the inventory. use in) the manufacture of the same or (b) Initial inventory date. Every person other controlled or non-controlled sub- required to keep records shall take an stances in finished form, the inventory inventory of all stocks of controlled shall include: substances on hand on the date he/she (A) The name of the substance and first engages in the manufacture, dis- (B) The total quantity of the sub- tribution, or dispensing of controlled stance to the nearest metric unit substances, in accordance with para- weight consistent with unit size. graph (e) of this section as applicable. (ii) For each controlled substance in In the event a person commences busi- the process of manufacture on the in- ness with no controlled substances on ventory date, the inventory shall in- hand, he/she shall record this fact as clude: the initial inventory. (A) The name of the substance; (c) Biennial inventory date. After the (B) The quantity of the substance in initial inventory is taken, the reg- each batch and/or stage of manufac- istrant shall take a new inventory of ture, identified by the batch number or

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other appropriate identifying number; trolled substances shall include in the and inventory, the following information: (C) The physical form which the sub- (i) The name of the substance, and stance is to take upon completion of (ii) The total quantity of the sub- the manufacturing process (e.g., granu- stance: lations, tablets, capsules, or solutions), (A) For controlled substances in bulk identified by the batch number or form, to the nearest metric unit weight other appropriate identifying number, consistent with unit size; and if possible the finished form of the (B) For each controlled substance in substance (e.g., 10-milligram tablet or finished form: Each finished form of 10-milligram concentration per fluid the substance (e.g., 10-milligram tablet ounce or milliliter) and the number or or 10-milligram concentration per fluid volume thereof. ounce or milliliter); the number of (iii) For each controlled substance in units or volume of each finished form finished form the inventory shall in- in each commercial container (e.g., 100- clude: tablet bottle or 3-milliliter vial); and (A) The name of the substance; the number of commercial containers (B) Each finished form of the sub- of each such finished form (e.g., four stance (e.g., 10-milligram tablet or 10- 100-tablet bottles or six 3-milliliter milligram concentration per fluid vials); and ounce or milliliter); (C) For controlled substances in a (C) The number of units or volume of commercial container, carton, crate, each finished form in each commercial drum, or other receptacle that has been container (e.g., 100-tablet bottle or 3- opened: If the substance is listed in milliliter vial); and Schedule I or II, make an exact count (D) The number of commercial con- or measure of the contents; or if the tainers of each such finished form (e.g. substance is listed in Schedule III, IV, four 100-tablet bottles or six 3-milli- or V, make an estimated count or liter vials). measure of the contents, unless the (iv) For each controlled substance container holds more than 1,000 tablets not included in paragraphs (e)(1) (i), (ii) or capsules in which case an exact or (iii) of this section (e.g., damaged, count of the contents shall be made; or defective or impure substances await- (iii) For controlled substances ac- ing disposal, substances held for qual- quired from collectors and law enforce- ity control purposes, or substances ment: The number and size (e.g., five maintained for extemporaneous 10-gallon liners, etc.) of sealed inner compoundings) the inventories shall liners on hand, or include: (iv) For controlled substances ac- (A) The name of the substance; quired from law enforcement: the num- (B) The total quantity of the sub- ber of sealed mail-back packages on stance to the nearest metric unit hand. weight or the total number of units of (4) Inventories of importers and export- finished form; and ers. Each person registered or author- (C) The reason for the substance ized to import or export controlled sub- being maintained by the registrant and stances shall include in the inventory whether such substance is capable of the same information required of man- use in the manufacture of any con- ufacturers pursuant to paragraphs trolled substance in finished form. (e)(1) (iii) and (iv) of this section. Each (2) Inventories of distributors. Each such person who is also registered as a person registered or authorized to dis- manufacturer or as a distributor shall tribute controlled substances shall in- include in his/her inventory as an im- clude in the inventory the same infor- porter or exporter only those stocks of mation required of manufacturers pur- controlled substances that are actually suant to paragraphs (e)(1)(iii) and (iv) separated from his stocks as a manu- of this section. facturer or as a distributor (e.g., in (3) Inventories of registrants that re- transit or in storage for shipment). verse distribute. Each person registered (5) Inventories of chemical analysts. or authorized to reverse distribute con- Each person registered or authorized to

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conduct chemical analysis with con- back package on hand awaiting de- trolled substances shall include in his struction: inventory the same information re- (A) The date of the inventory; quired of manufacturers pursuant to (B) The number of mail-back pack- paragraphs (e)(1) (iii) and (iv) of this ages; and section as to substances which have (C) The unique identification number been manufactured, imported, or re- of each package on hand, whether un- ceived by such person. If less than 1 used or awaiting destruction. kilogram of any controlled substance (ii) For registrants authorized to col- (other than a hallucinogenic controlled lect through a collection receptacle, substance listed in Schedule I), or less the record shall include the following than 20 grams of a hallucinogenic sub- information about each unused inner stance listed in Schedule I (other than liner on hand and each sealed inner lysergic acid diethylamide), or less liner on hand awaiting destruction: than 0.5 gram of lysergic acid (A) The date of the inventory; diethylamide, is on hand at the time of (B) The number and size of inner lin- inventory, that substance need not be ers (e.g., five 10-gallon liners, etc.); included in the inventory. Laboratories (C) The unique identification number of the Administration may possess up of each inner liner. to 150 grams of any hallucinogenic sub- [62 FR 13959, Mar. 24, 1997, as amended at 68 stance in Schedule I without regard to FR 41228, July 11, 2003; 79 FR 53562, Sept. 9, a need for an inventory of those sub- 2014] stances. No inventory is required of known or suspected controlled sub- CONTINUING RECORDS stances received as evidentiary materials for analysis. § 1304.21 General requirements for (6) Inventories of dispensers and re- continuing records. searchers. Each person registered or au- (a) Every registrant required to keep thorized to dispense or conduct re- records pursuant to § 1304.03 shall main- search with controlled substances shall tain, on a current basis, a complete and include in the inventory the same in- accurate record of each substance man- formation required of manufacturers ufactured, imported, received, sold, de- pursuant to paragraphs (e)(1)(iii) and livered, exported, or otherwise disposed (iv) of this section. In determining the of by him/her, and each inner liner, number of units of each finished form sealed inner liner, and unused and re- of a controlled substance in a commer- turned mail-back package, except that cial container that has been opened, no registrant shall be required to main- the dispenser or researcher shall do as tain a perpetual inventory. follows: (b) Separate records shall be main- (i) If the substance is listed in Sched- tained by a registrant for each reg- ules I or II, make an exact count or istered location except as provided in measure of the contents; or § 1304.04 (a). In the event controlled (ii) If the substance is listed in substances are in the possession or Schedule III, IV, or V, make an esti- under the control of a registrant at a mated count or measure of the con- location for which he is not registered, tents, unless the container holds more the substances shall be included in the than 1,000 tablets or capsules in which records of the registered location to case he/she must make an exact count which they are subject to control or to of the contents. which the person possessing the sub- (7) Inventories of collectors. Each reg- stance is responsible. istrant authorized to collect controlled (c) Separate records shall be main- substances from ultimate users shall tained by a registrant for each inde- include in the inventory the following pendent activity and collection activ- information: ity for which he/she is registered or au- (i) For registrants authorized to col- thorized, except as provided in lect through a mail-back program, the § 1304.22(d). record shall include the following in- (d) In recording dates of receipt, dis- formation about each unused mail- tribution, other transfers, or destruc- back package and each returned mail- tion, the date on which the controlled

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substances are actually received, dis- ufacture controlled substances shall tributed, otherwise transferred, or de- maintain records with the following in- stroyed will be used as the date of re- formation: ceipt, distribution, transfer, or destruc- (1) For each controlled substance in tion (e.g., invoices or packing slips, or bulk form to be used in, or capable of DEA Form 41). In maintaining records use in, or being used in, the manufac- concerning imports and exports, the ture of the same or other controlled or registrant must record the anticipated noncontrolled substances in finished date of release by a customs official for form, permit applications and declarations (i) The name of the substance; and the date on which the controlled (ii) The quantity manufactured in substances are released by a customs bulk form by the registrant, including officer at the port of entry or port of the date, quantity and batch or other export for return information. identifying number of each batch man- (e) Record of destruction. In addition ufactured; to any other recordkeeping require- (iii) The quantity received from ments, any registered person that de- other persons, including the date and stroys a controlled substance pursuant quantity of each receipt and the name, to § 1317.95(d), or causes the destruction address, and registration number of the of a controlled substance pursuant to other person from whom the substance § 1317.95(c), shall maintain a record of was received; destruction on a DEA Form 41. The (iv) The quantity imported directly records shall be complete and accurate, by the registrant (under a registration and include the name and signature of as an importer) for use in manufacture the two employees who witnessed the by him/her, including the date, quan- destruction. Except, destruction of a tity, and import permit or declaration controlled substance dispensed by a number for each importation; practitioner for immediate administra- (v) The quantity used to manufacture tion at the practitioner’s registered lo- the same substance in finished form, cation, when the substance is not fully including: exhausted (e.g., some of the substance (A) The date and batch or other iden- remains in a vial, tube, or syringe after tifying number of each manufacture; administration but cannot or may not (B) The quantity used in the manu- be further utilized), shall be properly facture; recorded in accordance with § 1304.22(c), (C) The finished form (e.g., 10-milli- and such record need not be main- gram tablets or 10-milligram contained on a DEA Form 41. centration per fluid ounce or milli- [36 FR 7792, Apr. 24, 1971, as amended at 36 liter); FR 13386, July 21, 1971. Redesignated at 38 FR (D) The number of units of finished 26609, Sept. 24, 1973, as amended at 62 FR form manufactured; 13960, Mar. 24, 1997; 79 FR 53563, Sept. 9, 2014; (E) The quantity used in quality con- 81 FR 97020, Dec. 30, 2016] trol; § 1304.22 Records for manufacturers, (F) The quantity lost during manu- distributors, dispensers, research- facturing and the causes therefore, if ers, importers, exporters, reg- known; istrants that reverse distribute, and (G) The total quantity of the sub- collectors. stance contained in the finished form; Each person registered or authorized (H) The theoretical and actual yields; (by §§ 1301.13(e), 1307.11, 1307.13, or part and 1317 of this chapter) to manufacture, (I) Such other information as is nec- distribute, dispense, import, export, re- essary to account for all controlled verse distribute, destroy, conduct re- substances used in the manufacturing search with controlled substances, or process; collect controlled substances from ulti- (vi) The quantity used to manufac- mate users, shall maintain records ture other controlled and noncon- with the information listed in para- trolled substances, including the name graphs (a) through (f) of this section. of each substance manufactured and (a) Records for manufacturers. Each the information required in paragraph person registered or authorized to man- (a)(1)(v) of this section;

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(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; and the name, address, and registration (vi) The number of units and/or com- number of each person to whom a dis- mercial containers manufactured by tribution was made; the registrant from units in finished (viii) The quantity exported directly form received from others or imported, by the registrant (under a registration including: as an exporter), including the date, (A) The date and batch or other iden- quantity, and export permit or declara- tifying number of each manufacture; tion number of each exportation; (B) The operation performed (e.g., re- (ix) The quantity distributed or dis- packaging or relabeling); posed of in any other manner by the (C) The number of units of finished registrant (e.g., by distribution of com- form used in the manufacture, the plimentary samples or by destruction), number manufactured and the number including the date and manner of dis- lost during manufacture, with the tribution or disposal, the name, ad- causes for such losses, if known; and dress, and registration number of the person to whom distributed, and the (D) Such other information as is nec- quantity distributed or disposed; and essary to account for all controlled (x) The originals of all written cer- substances used in the manufacturing tifications of available procurement process; quotas submitted by other persons (as (vii) The number of commercial con- required by § 1303.12(f) of this chapter) tainers distributed to other persons, in- relating to each order requiring the cluding the date of and number of con- distribution of a basic class of containers in each reduction from inven- trolled substance listed in Schedule I tory, and the name, address, and reg- or II. istration number of the person to (2) For each controlled substance in whom the containers were distributed; finished form, (viii) The number of commercial con- (i) The name of the substance; tainers exported directly by the reg- (ii) Each finished form (e.g., 10-milli- istrant (under a registration as an ex- gram tablet or 10-milligram concentra- porter), including the date, number of tion per fluid ounce or milliliter) and containers and export permit or dec- the number of units or volume of fin- laration number for each exportation; ished form in each commercial con- and tainer (e.g., 100-tablet bottle or 3-milli- (ix) The number of units of finished liter vial); forms and/or commercial containers (iii) The number of containers of distributed or disposed of in any other each such commercial finished form manner by the registrant (e.g., by dis- manufactured from bulk form by the tribution of complimentary samples or registrant, including the information by destruction), including the date and required pursuant to paragraph manner of distribution or disposal, the (a)(1)(v) of this section; name, address, and registration num- (iv) The number of units of finished ber of the person to whom distributed, forms and/or commercial containers and the quantity in finished form dis- acquired from other persons, including tributed or disposed. the date of and number of units and/or (b) Records for distributors. Except as commercial containers in each acquisi- provided in paragraph (e) of this section to inventory and the name, ad- tion, each person registered or author- dress, and registration number of the ized to distribute controlled substances person from whom the units were ac- shall maintain records with the same quired; information required of manufacturers (v) The number of units of finished pursuant to paragraphs (a)(2)(i), (ii), forms and/or commercial containers (iv), (v), (vii), (viii) and (ix) of this sec- imported directly by the person (under tion. a registration or authorization to im- (c) Records for dispensers and research- port), including the date of, the num- ers. Each person registered or author- ber of units and/or commercial con- ized to dispense or conduct research

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with controlled substances shall main- (i) The date of receipt; the name and tain records with the same information quantity of each controlled substance required of manufacturers pursuant to received; the name, address, and reg- paragraph (a)(2)(i), (ii), (iv), (vii), and istration number of the person from (ix) of this section. In addition, records whom the substance was received; and shall be maintained of the number of the reason for return (e.g., recall or re- units or volume of such finished form turn); and dispensed, including the name and ad- (ii) The date of return to the manu- dress of the person to whom it was dis- facturer or other registrant authorized pensed, the date of dispensing, the by the manufacturer to accept returns number of units or volume dispensed, on the manufacturer’s behalf; the name and the written or typewritten name or and quantity of each controlled sub- initials of the individual who dispensed stance returned; the name, address, or administered the substance on be- and registration number of the person half of the dispenser. In addition to the from whom the substance was received; requirements of this paragraph, practi- the name, address, and registration tioners dispensing gamma-hydroxy- number of the registrant to whom the butyric acid under a prescription must substance was returned; and the meth- also comply with § 1304.26. od of return (e.g., common or contract (d) Records for importers and exporters. carrier). Each person registered or authorized to (2) For controlled substances ac- import or export controlled substances quired from registrant inventory for shall maintain records with the same destruction pursuant to § 1317.05(a)(2), information required of manufacturers (b)(2), and (b)(4) of this chapter: pursuant to paragraphs (a)(2) (i), (iv), (i) The date of receipt; the name and (v) and (vii) of this section. In addition, quantity of each controlled substance the quantity disposed of in any other received; and the name, address, and manner by the registrant (except quan- registration number of the person from tities used in manufacturing by an im- whom the substance was received; and porter under a registration as a manu- (ii) The date, place, and method of facturer), which quantities are to be re- destruction; the name and quantity of corded pursuant to paragraphs (a)(1) each controlled substance destroyed; (iv) and (v) of this section; and the the name, address, and registration quantity (or number of units or volume number of the person from whom the in finished form) exported, including substance was received; and the name the date, quantity (or number of units and signatures of the two employees of or volume), and the export permit or the registrant that witnessed the de- declaration number for each expor- struction. tation, but excluding all quantities (3) The total quantity of each con- (and number of units and volumes) trolled substance shall be recorded in manufactured by an exporter under a accordance with the following: registration as a manufacturer, which (i) For controlled substances in bulk quantities (and numbers of units and form: To the nearest metric unit volumes) are to be recorded pursuant weight or volume consistent with unit to paragraphs (a)(1)(xiii) or (a)(2)(xiii) size; of this section. (ii) For controlled substances in fin- (e) Records for registrants that reverse ished form: Each finished form (e.g., 10- distribute. Each person registered or au- milligram tablet or 10-milligram con- thorized to reverse distribute concentration per fluid ounce or milli- trolled substances shall maintain liter); the number of units or volume of records with the following information finished form in each commercial con- for each controlled substance: tainer (e.g., 100-tablet bottle or 3-milli- (1) For controlled substances ac- liter vial); and the number of commer- quired for the purpose of return or re- cial containers of each such finished call to the manufacturer or another form (e.g., four 100-tablet bottles or six registrant authorized by the manufac- 3-milliliter vials); and turer to accept returns on the manu- (iii) For controlled substances in a facturer’s behalf pursuant to part 1317 commercial container, carton, crate, of this chapter: drum, or other receptacle that has been

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opened: If the substance is listed in number of packages, and the unique Schedule I or II make an exact count identification number of each package; or measure of the contents; or if the (ii) For unused packages provided to substance is listed in Schedule III, IV, a third party to make available to ulti- or V, make an estimated count or mate users and other authorized non- measure of the contents, unless the registrants: The name of the third container holds more than 1,000 tablets party and physical address of the loca- or capsules in which case an exact tion receiving the unused packages, count of the contents shall be made. date sent, and the number of unused (4) For each sealed inner liner ac- packages sent with the corresponding quired from collectors or law enforce- unique identification numbers; ment and each sealed mail-back pack- (iii) For sealed mail-back packages age acquired from law enforcement received by the collector: Date of re- pursuant to § 1317.55 of this chapter: ceipt and the unique identification (i) The number of sealed inner liners number on the individual package; and acquired from other persons, including (iv) For sealed mail-back packages the date of acquisition, the number destroyed on-site by the collector: and, for sealed inner liners the size Number of sealed mail-back packages (e.g., five 10-gallon liners, etc.), of all destroyed, the date and method of de- sealed inner liners and mail-back pack- struction, the unique identification ages acquired to inventory, the unique number of each mail-back package de- identification number of each sealed stroyed, and the names and signatures inner liner and mail-back package, and of the two employees of the registrant the name, address, and, for registrants, who witnessed the destruction. the registration number of the person (2) Collection receptacle inner liners: from whom the sealed inner liners and (i) Date each unused inner liner ac- mail-back packages were received, and quired, unique identification number and size (e.g., 5-gallon, 10-gallon, etc.) (ii) The date, place, and method of of each unused inner liner acquired; destruction; the number of sealed inner (ii) Date each inner liner is installed, liners and mail-back packages de- the address of the location where each stroyed; the name, address, and, for inner liner is installed, the unique registrants, the registration number of identification number and size (e.g., 5- the person from whom the sealed inner gallon, 10-gallon, etc.) of each installed liners and mail-back packages were re- inner liner, the registration number of ceived; the number and, for sealed the collector, and the names and signa- inner liners the size (e.g., five 10-gallon tures of the two employees that wit- liners, etc.), of all sealed inner liners nessed each installation; and mail-back packages destroyed; the (iii) Date each inner liner is removed unique identification number of each and sealed, the address of the location sealed inner liner and sealed mail-back from which each inner liner is repackage destroyed; and the name and moved, the unique identification num- signatures of the two employees of the ber and size (e.g., 5-gallon, 10-gallon, registrant that witnessed the destruc- etc.) of each inner liner removed, the tion. registration number of the collector, (5) For all records, the record of re- and the names and signatures of the ceipt shall be maintained together with two employees that witnessed each re- the corresponding record of return or moval; destruction (DEA Form 41). (iv) Date each sealed inner liner is (f) Records for collectors. Each person transferred to storage, the unique iden- registered or authorized to collect con- tification number and size (e.g., 5-gal- trolled substances from ultimate users lon, 10-gallon, etc.) of each sealed inner shall maintain the following records: liner stored, and the names and signa- (1) Mail-Back Packages: tures of the two employees that trans- (i) For unused packages that the col- ferred each sealed inner liner to stor- lector makes available to ultimate age; users and other authorized non-reg- (v) Date each sealed inner liner is istrants at the collector’s registered transferred for destruction, the address address: The date made available, the and registration number of the reverse

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distributor or distributor to whom (b) Records of controlled substances each sealed inner liner was transferred, used in chemical analysis or other lab- the unique identification number and oratory work are not required. the size (e.g., 5-gallon, 10-gallon, etc.) (c) Records relating to known or sus- of each sealed inner liner transferred, pected controlled substances received and the names and signatures of the as evidentiary material for analysis are two employees that transferred each not required under paragraph (a) of sealed inner liner to the reverse dis- this section. tributor or distributor; and (vi) For sealed inner liners destroyed [36 FR 7793, Apr. 24, 1971, as amended at 36 FR 13386, July 21, 1971; 36 FR 18732, Sept. 21, on-site by the collector: The same in- 1971. Redesignated at 38 FR 26609, Sept. 24, formation required of reverse distribu- 1973, and further redesignated at 62 FR 13961, tors in paragraph (e)(4)(ii) of this sec- Mar. 24, 1997] tion. [62 FR 13960, Mar. 24, 1997, as amended at 68 § 1304.24 Records for maintenance FR 41229, July 11, 2003; 70 FR 293, Jan. 4, 2005; treatment programs and detoxifica- 79 FR 53564, Sept. 9, 2014] tion treatment programs. (a) Each person registered or author- § 1304.23 Records for chemical ana- ized (by § 1301.22 of this chapter) to lysts. maintain and/or detoxify controlled (a) Each person registered or author- substance users in a narcotic treat- ized (by § 1301.22(b) of this chapter) to ment program shall maintain records conduct chemical analysis with con- with the following information for each trolled substances shall maintain narcotic controlled substance: records with the following information (1) Name of substance; (to the extent known and reasonably (2) Strength of substance; ascertainable by him) for each con- (3) Dosage form; trolled substance: (4) Date dispensed; (1) The name of the substance; (5) Adequate identification of patient (2) The form or forms in which the (consumer); substance is received, imported, or (6) Amount consumed; manufactured by the registrant (e.g., (7) Amount and dosage form taken powder, granulation, tablet, capsule, or home by patient; and solution) and the concentration of the (8) Dispenser’s initials. substance in such form (e.g., C.P., (b) The records required by paragraph U.S.P., N.F., 10-milligram tablet or 10- (a) of this section will be maintained in milligram concentration per milli- a dispensing log at the narcotic treat- liter); ment program site and will be main- (3) The total number of the forms retained in compliance with § 1304.22 ceived, imported or manufactured (e.g., without reference to § 1304.03. 100 tablets, thirty 1-milliliter vials, or (c) All sites which compound a bulk 10 grams of powder), including the date narcotic solution from bulk narcotic and quantity of each receipt, importa- powder to liquid for on-site use must tion, or manufacture and the name, ad- keep a separate batch record of the dress, and registration number, if any, compounding. of the person from whom the substance was received; (d) Records of identity, diagnosis, prognosis, or treatment of any patients (4) The quantity distributed, ex- which are maintained in connection ported, or destroyed in any manner by with the performance of a narcotic the registrant (except quantities used treatment program shall be confiden- in chemical analysis or other laboratory work), including the date and tial, except that such records may be manner of distribution, exportation, or disclosed for purposes and under the destruction, and the name, address, circumstances authorized by part 310 and registration number, if any, of and 42 CFR part 2. each person to whom the substance was [39 FR 37985, Oct. 25, 1974. Redesignated and distributed or exported. amended at 62 FR 13961, Mar. 24, 1997]

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§ 1304.25 Records for treatment pro- (6) The quantity used to manufacture grams that compound narcotics for other controlled and non-controlled treatment programs and other loca- substances; including the name of each tions. substance manufactured and the infor- Each person registered or authorized mation required in paragraph (a)(5) of by § 1301.22 of this chapter to compound this section; narcotic drugs for off-site use in a nar- (7) The quantity distributed in bulk cotic treatment program shall main- form to other programs, including the tain records which include the fol- date and quantity of each distribution lowing information for each narcotic and the name, address and registration drug: number of each program to whom a dis- (a) For each narcotic controlled sub- tribution was made; stance in bulk form to be used in, or (8) The quantity exported directly by capable of use in, or being used in, the the registrant (under a registration as compounding of the same or other non- an exporter), including the date, quan- controlled substances in finished form: tity, and export permit or declaration (1) The name of the substance; number of each exploration; and (2) The quantity compounded in bulk (9) The quantity disposed of by de- form by the registrant, including the struction, including the reason, date, date, quantity and batch or other iden- and manner of destruction. tifying number of each batch com- (b) For each narcotic controlled sub- pounded; stance in finished form: (3) The quantity received from other (1) The name of the substance; persons, including the date and quantity of each receipt and the name, ad- (2) Each finished form (e.g., 10-milli- dress and registration number of the gram tablet or 10 milligram concentra- other person from whom the substance tion per fluid ounce or milliliter) and was received; the number of units or volume or fin- (4) The quantity imported directly by ished form in each commercial con- the registrant (under a registration as tainer (e.g., 100-tablet bottle or 3-milli- an importer) for use in compounding by liter vial); him, including the date, quantity and (3) The number of containers of each import permit or declaration number such commercial finished form com- of each importation; pounded from bulk form by the reg- (5) The quantity used to compound istrant, including the information re- the same substance in finished form, quired pursuant to paragraph (a)(5) of including: this section; (i) The date and batch or other iden- (4) The number of units of finished tifying number of each compounding; forms and/or commercial containers re- (ii) The quantity used in the com- ceived from other persons, including pound; the date of and number of units and/or (iii) The finished form (e.g., 10-milli- commercial containers in each receipt gram tablets or 10-milligram con- and the name, address and registration centration per fluid ounce or milliliter; number of the person from whom the (iv) The number of units of finished units were received; form compounded; (5) The number of units of finished (v) The quantity used in quality con- forms and/or commercial containers trol; imported directly by the person (under (vi) The quantity lost during a registration or authorization to im- compounding and the causes therefore, port), including the date of, the num- if known; ber of units and/or commercial con- (vii) The total quantity of the sub- tainers in, and the import permit or stance contained in the finished form; declaration number for, each importa- (viii) The theoretical and actual tion; yields; and (6) The number of units and/or com- (ix) Such other information as is nec- mercial containers compounded by the essary to account for all controlled registrant from units in finished form substances used in the compounding received from others or imported, in- process; cluding:

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(i) The date and batch or other iden- registration to prescribe this con- tifying number of each compounding; trolled substance. (ii) The operation performed (e.g., re- (d) Patient’s name and address. packaging or relabeling); (e) Patient’s insurance provider, if (iii) The number of units of finished available. form used in the compound, the num- [70 FR 293, Jan. 4, 2005] ber compounded and the number lost during compounding, with the causes REPORTS for such losses, if known; and (iv) Such other information as is nec- § 1304.31 Reports from manufacturers essary to account for all controlled importing narcotic raw material. substances used in the compounding (a) Every manufacturer which im- process; ports or manufactures from narcotic (7) The number of containers distrib- raw material (opium, poppy straw, and uted to other programs, including the concentrate of poppy straw) shall sub- date, the number of containers in each mit information which accounts for the distribution, and the name, address and importation and for all manufacturing registration number of the program to operations performed between importa- whom the containers were distributed; tion and the production in bulk or fin- (8) The number of commercial con- ished marketable products, standard- tainers exported directly by the reg- ized in accordance with the U.S. Phar- istrant (under a registration as an ex- macopeia, National Formulary or other porter), including the date, number of recognized medical standards. Reports containers and export permit or dec- shall be signed by the authorized offi- laration number for each exportation; cial and submitted quarterly on com- and pany letterhead to the UN Reporting (9) The number of units of finished and Quota Section, Diversion Control forms and/or commercial containers Division, on or before the 15th day of destroyed in any manner by the reg- the month immediately following the istrant, including the reason, date, and period for which it is submitted. See manner of destruction. the Table of DEA Mailing Addresses in [39 FR 37985, Oct. 25, 1974. Redesignated at 62 § 1321.01 of this chapter for the current FR 13961, Mar. 24, 1997; 79 FR 53564, Sept. 9, mailing address. 2014] (b) The following information shall be submitted for each type of narcotic § 1304.26 Additional recordkeeping re- raw material (quantities are expressed quirements applicable to drug prod- as grams of anhydrous morphine alka- ucts containing gamma-hydroxy- loid): butyric acid. (1) Beginning inventory; In addition to the recordkeeping re- (2) Gains on reweighing; quirements for dispensers and research- (3) Imports; ers provided in § 1304.22, practitioners (4) Other receipts; dispensing gamma-hydroxybutyric acid (5) Quantity put into process; that is manufactured or distributed in (6) Losses on reweighing; accordance with an application under (7) Other dispositions and section 505 of the Federal Food, Drug, (8) Ending inventory. and Cosmetic Act must maintain and (c) The following information shall make available for inspection and be submitted for each narcotic raw ma- copying by the Attorney General, all of terial derivative including morphine, the following information for each pre- codeine, thebaine, oxycodone, scription: hydrocodone, medicinal opium, manu- (a) Name of the prescribing practi- facturing opium, crude alkaloids and tioner. other derivatives (quantities are ex- (b) Prescribing practitioner’s Federal pressed as grams of anhydrous base or and State registration numbers, with anhydrous morphine alkaloid for man- the expiration dates of these registra- ufacturing opium and medicinal tions. opium): (c) Verification that the prescribing (1) Beginning inventory; practitioner possesses the appropriate (2) Gains on reweighing;

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(3) Quantity extracted from narcotic § 1304.32 Reports of manufacturers im- raw material; porting coca leaves. (4) Quantity produced/manufactured/ (a) Every manufacturer importing or synthesized; manufacturing from raw coca leaves (5) Quantity sold; shall submit information accounting (6) Quantity returned to conversion for the importation and for all manu- processes for reworking; facturing operations performed be- (7) Quantity used for conversion; tween the importation and the manu- (8) Quantity placed in process; facture of bulk or finished products (9) Other dispositions; standardized in accordance with U.S. (10) Losses on reweighing and Pharmacopoeia, National Formulary, or other recognized standards. The re- (11) Ending inventory. ports shall be submitted quarterly on (d) The following information shall company letterhead to the UN Report- be submitted for importation of each ing and Quota Section, Diversion Con- narcotic raw material: trol Division, on or before the 15th day (1) Import permit number; of the month immediately following (2) Date shipment arrived at the the period for which it is submitted. United States port of entry; See the Table of DEA Mailing Address- (3) Actual quantity shipped; es in § 1321.01 of this chapter for the (4) Assay (percent) of morphine, co- current mailing address. deine and thebaine and (b) The following information shall (5) Quantity shipped, expressed as an- be submitted for raw coca leaf, ecgo- hydrous morphine alkaloid. nine, ecgonine for conversion or fur- (e) Upon importation of crude opium, ther manufacture, benzoylecgonine, samples will be selected and assays manufacturing coca extracts (list for made by the importing manufacturer tinctures and extracts; and others sep- in the manner and according to the arately), other crude alkaloids and other derivatives (quantities should be method specified in the U.S. Pharma- reported as grams of actual quantity copoeia. Where final assay data is not involved and the cocaine alkaloid con- determined at the time of rendering re- tent or equivalency): port, the report shall be made on the (1) Beginning inventory; basis of the best data available, subject (2) Imports; to adjustment, and the necessary ad- (3) Gains on reweighing; justing entries shall be made on the (4) Quantity purchased; next report. (5) Quantity produced; (f) Where factory procedure is such (6) Other receipts; that partial withdrawals of opium are (7) Quantity returned to processes for made from individual containers, there reworking; shall be attached to each container a (8) Material used in purification for stock record card on which shall be sale; kept a complete record of all with- (9) Material used for manufacture or drawals therefrom. production; (g) All in-process inventories should (10) Losses on reweighing; be expressed in terms of end-products (11) Material used for conversion; and not precursors. Once precursor ma- (12) Other dispositions and terial has been changed or placed into (13) Ending inventory. process for the manufacture of a speci- (c) The following information shall fied end-product, it must no longer be be submitted for importation of coca accounted for as precursor stocks leaves: available for conversion or use, but (1) Import permit number; rather as end-product in-process inven- (2) Date the shipment arrived at the tories. United States port of entry; (3) Actual quantity shipped; [62 FR 13961, Mar. 24, 1997, as amended at 75 (4) Assay (percent) of cocaine alka- FR 10677, Mar. 9, 2010; 81 FR 97020, Dec. 30, loid and 2016] (5) Total cocaine alkaloid content.

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(d) Upon importation of coca leaves, not more frequently than monthly), de- samples will be selected and assays pending on the number of transactions made by the importing manufacturer being reported each time by that reg- in accordance with recognized chem- istrant. Inventories shall provide data ical procedures. These assays shall on the stocks of each reported conform the basis of accounting for such trolled substance on hand as of the coca leaves, which shall be accounted close of business on December 31 of for in terms of their cocaine alkaloid each year, indicating whether the sub- content or equivalency or their total stance is in storage or in process of anhydrous coca alkaloid content. manufacturing. These reports shall be Where final assay data is not deter- filed not later than January 15 of the mined at the time of submission, the following year. Manufacturing trans- report shall be made on the basis of the action reports shall be filed annually best data available, subject to adjust- for each calendar year not later than ment, and the necessary adjusting en- January 15 of the following year, ex- tries shall be made on the next report. cept that a registrant may be given (e) Where factory procedure is such permission to file more frequently (but that partial withdrawals of medicinal not more frequently than quarterly). coca leaves are made from individual (c) Persons reporting. For controlled containers, there shall be attached to substances in Schedules I, II, narcotic the container a stock record card on controlled substances in Schedule III, which shall be kept a complete record and gamma-hydroxybutyric acid drug of withdrawals therefrom. product controlled substances in (f) All in-process inventories should Schedule III, each person who is reg- be expressed in terms of end-products istered to manufacture in bulk or dos- and not precursors. Once precursor ma- age form, or to package, repackage, terial has been changed or placed into label or relabel, and each person who is process for the manufacture of a speci- registered to distribute, including each fied end-product, it must no longer be person who is registered to reverse dis- accounted for as precursor stocks tribute, shall report acquisition/dis- available for conversion or use, but tribution transactions. In addition to rather as end-product in-process inven- reporting acquisition/distribution tories. transactions, each person who is reg- [62 FR 13962, Mar. 24, 1997, as amended at 75 istered to manufacture controlled sub- FR 10678, Mar. 9, 2010; 81 FR 97020, Dec. 30, stances in bulk or dosage form shall re- 2016] port manufacturing transactions on controlled substances in Schedules I § 1304.33 Reports to Automation of Re- and II, each narcotic controlled sub- ports and Consolidated Orders Sys- stance listed in Schedules III, IV, and tem (ARCOS). V, gamma-hydroxybutyric acid drug (a) Reports generally. All reports re- product controlled substances in quired by this section shall be filed Schedule III, and on each psychotropic with the Pharmaceutical Investiga- controlled substance listed in Sched- tions Section, Diversion Control Divi- ules III and IV as identified in para- sion, Drug Enforcement Administra- graph (d) of this section. tion on DEA Form 333, or on media (d) Substances covered. (1) Manufac- which contains the data required by turing and acquisition/distribution DEA Form 333 and which is acceptable transaction reports shall include data to the Administration. See the Table of on each controlled substance listed in DEA Mailing Addresses in § 1321.01 of Schedules I and II, on each narcotic this chapter for the current mailing ad- controlled substance listed in Schedule dress. III (but not on any material, com- (b) Frequency of reports. Acquisition/ pound, mixture or preparation con- Distribution transaction reports shall taining a quantity of a substance hav- be filed every quarter not later than ing a stimulant effect on the central the 15th day of the month succeeding nervous system, which material, com- the quarter for which it is submitted; pound, mixture or preparation is listed except that a registrant may be given in Schedule III or on any narcotic con- permission to file more frequently (but trolled substance listed in Schedule V),

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and on gamma-hydroxybutyric acid Division, Drug Enforcement Adminis- drug products listed in Schedule III. tration. See the Table of DEA Mailing Additionally, reports on manufacturing Addresses in § 1321.01 of this chapter for transactions shall include the fol- the current mailing address. lowing psychotropic controlled sub- (2) Registrants that acquire recalled stances listed in Schedules III and IV: controlled substances from ultimate (i) Schedule III users pursuant to § 1317.85 of this chap- (A) Benzphetamine; ter may report as a single transaction (B) Cyclobarbital; all recalled controlled substances of (C) Methyprylon; and the same name and finished form (e.g., (D) Phendimetrazine. all 10-milligram tablets or all 5-milli- (ii) Schedule IV gram concentration per fluid ounce or (A) Barbital; milliliter) received from ultimate users (B) Diethylpropion (Amfepramone); for the purpose of reporting acquisition (C) Ethchlorvynol; transactions. (D) Ethinamate; (g) Exemptions. (1) Collectors that ac- (E) Lefetamine (SPA); quire controlled substances from ulti- (F) Mazindol; mate users are exempt from the (G) Meprobamate; ARCOS reporting requirements only (H) Methylphenobarbital; with respect to controlled substances (I) Phenobarbital; collected through mail-back programs (J) Phentermine; and and collection receptacles for the pur- (K) Pipradrol. pose of disposal. (2) Data shall be presented in such a (2) Reverse distributors and distribu- manner as to identify the particular tors that acquire controlled substances form, strength, and trade name, if any, pursuant to § 1317.55(a) or (b) of this of the product containing the con- chapter are exempt from the ARCOS trolled substancefor which the report is reporting requirements in this section being made. For this purpose, persons with regard to any controlled sub- filing reports shall utilize the National stances acquired pursuant to § 1317.55(a) Drug Code Number assigned to the or (b) of this chapter. product under the National Drug Code System of the Food and Drug Adminis- (Approved by the Office of Management and tration. Budget under control number 1117–0003) (e) Transactions reported. Acquisition/ [62 FR 13962, Mar. 24, 1997, as amended at 68 distribution transaction reports shall FR 41229, July 11, 2003; 70 FR 294, Jan. 4, 2005; provide data on each acquisition to in- 75 FR 10678, Mar. 9, 2010; 79 FR 53564, Sept. 9, ventory (identifying whether it is, e.g., 2014; 81 FR 97020, Dec. 30, 2016] by purchase or transfer, return from a customer, or supply by the Federal ONLINE PHARMACIES Government) and each reduction from inventory (identifying whether it is, § 1304.40 Notification by online pharmacies. e.g., by sale or transfer, theft, destruction or seizure by Government agen- (a) Thirty days prior to offering a cies). Manufacturing reports shall pro- controlled substance for sale, delivery, vide data on material manufactured, distribution, or dispensing by means of manufacture from other material, use the Internet, an online pharmacy shall: in manufacturing other material and (1) Notify the Administrator of its in- use in producing dosage forms. tent to do so by submitting an applica- (f) Exceptions. (1) A registered institution for a modified registration in ac- tional practitioner that repackages or cordance with §§ 1301.13 and 1301.19 of relabels exclusively for distribution or this chapter, with such application that distributes exclusively to (for dis- containing the information required by pensing by) agents, employees, or af- this section; and filiated institutional practitioners of (2) Notify the State boards of phar- the registrant may be exempted from macy in any States in which the online filing reports under this section by ap- pharmacy offers to sell, deliver, dis- plying to the Pharmaceutical Inves- tribute, or dispense controlled sub- tigations Section, Diversion Control stances.

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(b) The following information must macy is validly registered with a modi- be included in the notification sub- fication of such registration author- mitted under paragraph (a) of this sec- izing such activity. tion: (d) On and after the date an online (1) The pharmacy’s Internet Phar- pharmacy makes the notifications re- macy Site Disclosure information required under this section, each online quired to be posted on the homepage of pharmacy shall display on the home- the online pharmacy’s Internet site page of its Internet site, a declaration under section 311(c) of the Act (21 that it has made such notifications to U.S.C. 831(c)) and § 1304.45 of this part. the Administrator in the following (2) Certification that the information form: ‘‘In accordance with the Con- disclosed on its Internet site under the trolled Substances Act and the DEA Internet Pharmacy Site Disclosure is regulations, this online pharmacy has true and accurate. The statement shall made the notifications to the DEA Ad- be in a form similar to the following: ministrator required by 21 U.S.C. 831 ‘‘The above-named pharmacy, a DEA and 21 CFR 1304.40.’’ registrant, certifies, under penalty of (e)(1) Except as provided in para- perjury, that the information con- graphs (e)(2) and (e)(3) of this section, tained in this statement is true and ac- if any of the information required to be curate.’’ 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 Web site, or any employee or agent [74 FR 15623, Apr. 6, 2009] thereof. (c) An online pharmacy that is in op- § 1304.45 Internet Web site disclosure eration at the time Public Law 110–425 requirements. becomes effective (April 13, 2009) must (a) Each online pharmacy shall dis- make the notifications required in this play, at all times and in a visible and section on or before May 13, 2009. How- clear manner, on its homepage a state- ever, in accordance with section 401(h) ment that it complies with the require- of the Act (21 U.S.C. 841(h)), as of April ments of section 311 of the Act (21 13, 2009, it is unlawful for any online U.S.C. 831) with respect to the delivery pharmacy to deliver, distribute, or dis- or sale or offer for sale of controlled pense a controlled substance by means substances. This statement must in- of the Internet unless such online phar- clude the name of the pharmacy as it

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appears on the DEA Certificate of Reg- least one prior in-person medical eval- istration. uation in accordance with section 309 (b) Each online pharmacy shall clear- of the Controlled Substances Act (21 ly display the following information on U.S.C. 829) or a medical evaluation via the homepage of each Internet site it telemedicine in accordance with sec- operates, or on a page directly linked tion 102(54) of the Controlled Sub- to the homepage. If the information is stances Act (21 U.S.C. 802(54)).’’ displayed on a page directly linked to the homepage, that link on the home- [74 FR 15623, Apr. 6, 2009] page 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 at the request of the owner or operator [74 FR 15623, Apr. 6, 2009] of the Web site, or any employee or agent thereof. § 1304.55 Reports by online phar- (7) The following statement: ‘‘This macies. online pharmacy is obligated to com- (a) Each online pharmacy shall re- ply fully with the Controlled Sub- port to the Administrator the total stances Act and DEA regulations. As quantity of each controlled substance part of this obligation, this online that the pharmacy has dispensed each pharmacy has obtained a modified DEA calendar month. The report must in- registration authorizing it to operate clude the total quantity of such dis- as an online pharmacy. In addition, pensing by any means, regardless of this online pharmacy will only dis- whether the controlled substances are pense a controlled substance to a per- dispensed by means of the Internet. son who has a valid prescription issued Thus, such reporting shall include all for a legitimate medical purpose based controlled substances dispensed via upon a medical relationship with a pre- Internet transactions, mail-order scribing practitioner. This includes at transactions, face-to-face transactions,

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

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§ 1305.02 Definitions. stances and persons registered only to Any term contained in this part shall import controlled substances are not have the definition set forth in the Act entitled to obtain Form 222 or issue or part 1300 of this chapter. electronic orders for these substances. (b) An order for Schedule I or II con- § 1305.03 Distributions requiring a trolled substances may be executed Form 222 or a digitally signed elec- only on behalf of the registrant named tronic order. on the order and only if his or her reg- Either a DEA Form 222 or its elec- istration for the substances being pur- tronic equivalent as set forth in sub- chased has not expired or been revoked part C of this part and Part 1311 of this or suspended. chapter is required for each distribu- § 1305.05 Power of attorney. tion of a Schedule I or II controlled substance except for the following: (a) A registrant may authorize one or (a) Distributions to persons exempted more individuals, whether or not lo- from registration under Part 1301 of cated at his or her registered location, this chapter. to issue orders for Schedule I and II (b) Exports from the United States controlled substances on the reg- that conform with the requirements of istrant’s behalf by executing a power of the Act. attorney for each such individual, if (c) Deliveries to a registered analyt- the power of attorney is retained in the ical laboratory or its agent approved files, with executed Forms 222 where by DEA. applicable, for the same period as any (d) Delivery from a central fill phar- order bearing the signature of the at- macy, as defined in § 1300.01 of this torney. The power of attorney must be chapter, to a retail pharmacy. available for inspection together with (e) Deliveries to an authorized DEA other order records. registrant by an ultimate user, a long- (b) A registrant may revoke any term care facility on behalf of an ulti- power of attorney at any time by exe- mate user who resides or has resided at cuting a notice of revocation. that facility, or a person authorized to (c) The power of attorney and notice dispose of the ultimate user decedent’s of revocation must be similar to the property. following format: (f) Distributions to reverse distribu- Power of Attorney for DEA Forms 222 tors and distributors by collectors and and Electronic Orders law enforcement pursuant to § 1317.55 of this chapter. llllllllllllllllllllllll (g) Deliveries of controlled sub- (Name of registrant) stances from ultimate users for the llllllllllllllllllllllll purpose of recalls pursuant to § 1317.85 (Address of registrant) of this chapter. llllllllllllllllllllllll (DEA registration number) [70 FR 16911, Apr. 1, 2005, as amended at 77 FR 4235, Jan. 27, 2012; 79 FR 53564, Sept. 9, I, llll (name of person granting 2014] 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

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

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or diprenorphine, if he or she deter- tion of the Administration. All requisi- mines that the purchaser is a veteri- tion forms (DEA Form 222a) must be narian engaged in zoo and exotic ani- submitted to the DEA Registration mal practice, wildlife management pro- Section. grams, or research, and is authorized (c) Each requisition must show the by the Administrator to handle these name, address, and registration num- substances, may fill the order in ac- ber of the registrant and the number of cordance with the procedures set forth books of DEA Forms 222 desired. Each in § 1305.17 except that: requisition must be signed and dated (a) A DEA Form 222 or an electronic by the same person who signed the order for thiafentanil, carfentanil, most recent application for registra- etorphine hydrochloride, and tion or for reregistration, or by any diprenorphine must contain only these person authorized to obtain and exe- substances in reasonable quantities. cute DEA Forms 222 by a power of at- (b) The substances must be shipped, torney under § 1305.05. under secure conditions using substan- (d) DEA Forms 222 will be serially tial packaging material with no mark- numbered and issued with the name, ings on the outside that would indicate address, and registration number of the the content, only to the purchaser’s registrant, the authorized activity, and registered location. schedules of the registrant. This infor- [70 FR 16911, Apr. 1, 2005, as amended at 81 mation cannot be altered or changed FR 58839, Aug. 26, 2016] 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 Forms 222. (a) DEA Forms 222 are issued in mailing 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

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

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

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supplier must return Copies 1 and 2 to to state the serial numbers of the DEA the purchaser with a statement as to Forms 222, the supplier must report the the reason (e.g., illegible or altered). date or approximate date of receipt and (c) A supplier may for any reason the names and addresses of the pur- refuse to accept any order and if a sup- chasers. plier refuses to accept the order, a (d) If an entire book of DEA Forms statement that the order is not accept- 222 is lost or stolen, and the purchaser ed is sufficient for purposes of this is unable to state the serial numbers of paragraph. the DEA Forms 222 in the book, the (d) When a purchaser receives an purchaser must report, in lieu of the unaccepted order, Copies 1 and 2 of the numbers of the forms contained in the DEA Form 222 and the statement must book, the date or approximate date of be attached to Copy 3 and retained in issuance. the files of the purchaser in accordance (e) If any unused DEA Form 222 re- with § 1305.17. A defective DEA Form ported stolen or lost is subsequently 222 may not be corrected; it must be re- recovered or found, the Special Agent placed by a new DEA Form 222 for the in Charge of the Drug Enforcement Ad- order to be filled. ministration in the Divisional Office responsible for the area in which the § 1305.16 Lost and stolen DEA Forms registrant is located must immediately 222. be notified. (a) If a purchaser ascertains that an unfilled DEA Form 222 has been lost, § 1305.17 Preservation of DEA Forms 222. he or she must execute another in triplicate and attach a statement con- (a) The purchaser must retain Copy 3 taining the serial number and date of of each executed DEA Form 222 and all the lost form, and stating that the copies of unaccepted or defective forms goods covered by the first DEA Form with each statement attached. 222 were not received through loss of (b) The supplier must retain Copy 1 that DEA Form 222. Copy 3 of the sec- of each DEA Form 222 that it has filled. ond form and a copy of the statement (c) DEA Forms 222 must be main- must be retained with Copy 3 of the tained separately from all other DEA Form 222 first executed. A copy of records of the registrant. DEA Forms the statement must be attached to 222 are required to be kept available for Copies 1 and 2 of the second DEA Form inspection for a period of two years. If 222 sent to the supplier. If the first a purchaser has several registered loca- DEA Form 222 is subsequently received tions, the purchaser must retain Copy 3 by the supplier to whom it was di- of the executed DEA Form 222 and any rected, the supplier must mark upon attached statements or other related the face ‘‘Not accepted’’ and return documents (not including unexecuted Copies 1 and 2 to the purchaser, who DEA Forms 222, which may be kept must attach it to Copy 3 and the state- elsewhere under § 1305.12(e)), at the reg- ment. istered location printed on the DEA (b) Whenever any used or unused Form 222. DEA Forms 222 are stolen or lost (other (d) The supplier of thiafentanil, than in the course of transmission) by carfentanil, etorphine hydrochloride, any purchaser or supplier, the pur- and diprenorphine must maintain DEA chaser or supplier must immediately Forms 222 for these substances sepa- upon discovery of the theft or loss, re- rately from all other DEA Forms 222 port the theft or loss to the Special and records required to be maintained Agent in Charge of the Drug Enforce- by the registrant. ment Administration in the Divisional [70 FR 16911, Apr. 1, 2005, as amended at 81 Office responsible for the area in which FR 58839, Aug. 26, 2016] the registrant is located, stating the serial number of each form stolen or § 1305.18 Return of unused DEA Forms lost. 222. (c) If the theft or loss includes any If the registration of any purchaser original DEA Forms 222 received from terminates (because the purchaser dies, purchasers and the supplier is unable ceases legal existence, discontinues

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

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

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(b) If the purchaser executes an order PART 1306—PRESCRIPTIONS to replace the lost order, the purchaser must electronically link an electronic GENERAL INFORMATION record of the second order and a copy Sec. of the statement with the record of the 1306.01 Scope of part 1306. first order and retain them. 1306.02 Definitions. (c) If the supplier to whom the order 1306.03 Persons entitled to issue prescrip- was directed subsequently receives the tions. first order, the supplier must indicate 1306.04 Purpose of issue of prescription. that it is ‘‘Not Accepted’’ and return it 1306.05 Manner of issuance of prescriptions. to the purchaser. The purchaser must 1306.06 Persons entitled to fill prescriptions. link the returned order to the record of 1306.07 Administering or dispensing of narcotic drugs. that order and the statement. 1306.08 Electronic prescriptions. 1306.09 Prescription requirements for online § 1305.27 Preservation of electronic or- pharmacies. ders. (a) A purchaser must, for each order CONTROLLED SUBSTANCES LISTED IN SCHEDULE II filled, retain the original signed order and all linked records for that order for 1306.11 Requirement of prescription. two years. The purchaser must also re- 1306.12 Refilling prescriptions; issuance of tain all copies of each unaccepted or multiple prescriptions. 1306.13 Partial filling of prescriptions. defective order and each linked state- 1306.14 Labeling of substances and filling of ment. prescriptions. (b) A supplier must retain each origi- 1306.15 Provision of prescription informa- nal order filled and the linked records tion between retail pharmacies and cen- for two years. tral fill pharmacies for prescriptions of (c) If electronic order records are Schedule II controlled substances. maintained on a central server, the CONTROLLED SUBSTANCES LISTED IN records must be readily retrievable at SCHEDULES III, IV, AND V the registered location. 1306.21 Requirement of prescription. 1306.22 Refilling of prescriptions. § 1305.28 Canceling and voiding elec- 1306.23 Partial filling of prescriptions. tronic orders. 1306.24 Labeling of substances and filling of (a) A supplier may void all or part of prescriptions. an electronic order by notifying the 1306.25 Transfer between pharmacies of pre- purchaser of the voiding. If the entire scription information for Schedules III, IV, and V controlled substances for refill order is voided, the supplier must make purposes. an electronic copy of the order, indi- 1306.26 Dispensing without prescription. cate on the copy ‘‘Void,’’ and return it 1306.27 Provision of prescription informa- to the purchaser. The supplier is not tion between retail pharmacies and cen- required to retain a record of orders tral fill pharmacies for initial and refill that are not filled. prescriptions of Schedule III, IV, or V controlled substances. (b) The purchaser must retain an electronic copy of the voided order. AUTHORITY: 21 U.S.C. 821, 829, 831, 871(b), (c) To partially void an order, the unless otherwise noted. supplier must indicate in the linked SOURCE: 36 FR 7799, Apr. 24, 1971; 36 FR record that nothing was shipped for 13386, July 21, 1971, unless otherwise noted. each item voided. Redesignated at 38 FR 26609, Sept. 24, 1973. GENERAL INFORMATION § 1305.29 Reporting to DEA. A supplier must, for each electronic § 1306.01 Scope of part 1306. order filled, forward either a copy of Rules governing the issuance, filling the electronic order or an electronic and filing of prescriptions pursuant to report of the order in a format that section 309 of the Act (21 U.S.C. 829) are DEA specifies to DEA within two busi- set forth generally in that section and ness days. specifically by the sections of this part.

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§ 1306.02 Definitions. the purpose of general dispensing to pa- Any term contained in this part shall tients. have the definition set forth in section (c) A prescription may not be issued 102 of the Act (21 U.S.C. 802) or part for ‘‘detoxification treatment’’ or 1300 of this chapter. ‘‘maintenance treatment,’’ unless the prescription is for a Schedule III, IV, or [62 FR 13964, Mar. 24, 1997] V narcotic drug approved by the Food and Drug Administration specifically § 1306.03 Persons entitled to issue prescriptions. for use in maintenance or detoxification treatment and the practitioner is (a) A prescription for a controlled in compliance with requirements in substance may be issued only by an in- § 1301.28 of this chapter. dividual practitioner who is: (1) Authorized to prescribe controlled [36 FR 7799, Apr. 24, 1971. Redesignated at 38 substances by the jurisdiction in which FR 26609, Sept. 24, 1973, and amended at 39 he is licensed to practice his profession FR 37986, Oct. 25, 1974; 70 FR 36343, June 23, and 2005] (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. (b) A prescription issued by an indi- (a) All prescriptions for controlled vidual practitioner may be commu- substances shall be dated as of, and nicated to a pharmacist by an em- signed on, the day when issued and ployee or agent of the individual prac- shall bear the full name and address of titioner. the patient, the drug name, strength, dosage form, quantity prescribed, di- [36 FR 7799, Apr. 24, 1971, as amended at 36 rections for use, and the name, address FR 18732, Sept. 21, 1971. Redesignated at 38 and registration number of the practi- FR 26609, Sept. 24, 1973, as amended at 62 FR 13966, Mar. 24, 1997] tioner. (b) A prescription for a Schedule III, § 1306.04 Purpose of issue of prescrip- IV, or V narcotic drug approved by tion. FDA specifically for ‘‘detoxification (a) A prescription for a controlled treatment’’ or ‘‘maintenance treat- substance to be effective must be ment’’ must include the identification issued for a legitimate medical purpose number issued by the Administrator by an individual practitioner acting in under § 1301.28(d) of this chapter or a the usual course of his professional written notice stating that the practi- practice. The responsibility for the tioner is acting under the good faith proper prescribing and dispensing of exception of § 1301.28(e) of this chapter. controlled substances is upon the pre- (c) Where a prescription is for scribing practitioner, but a cor- gamma-hydroxybutyric acid, the prac- responding responsibility rests with titioner shall note on the face of the the pharmacist who fills the prescrip- prescription the medical need of the tion. An order purporting to be a pre- patient for the prescription. scription issued not in the usual course (d) A practitioner may sign a paper of professional treatment or in legiti- prescription in the same manner as he mate and authorized research is not a would sign a check or legal document prescription within the meaning and (e.g., J.H. Smith or John H. Smith). intent of section 309 of the Act (21 Where an oral order is not permitted, U.S.C. 829) and the person knowingly paper prescriptions shall be written filling such a purported prescription, as with ink or indelible pencil, type- well as the person issuing it, shall be writer, or printed on a computer print- subject to the penalties provided for er and shall be manually signed by the violations of the provisions of law re- practitioner. A computer-generated lating to controlled substances. prescription that is printed out or (b) A prescription may not be issued faxed by the practitioner must be in order for an individual practitioner manually signed. to obtain controlled substances for sup- (e) Electronic prescriptions shall be plying the individual practitioner for created and signed using an application

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that meets the requirements of part central fill pharmacy, or registered in- 1311 of this chapter. stitutional practitioner. (f) A prescription may be prepared by [68 FR 37410, June 24, 2003, as amended at 70 the secretary or agent for the signa- FR 36343, June 23, 2005] ture of a practitioner, but the prescribing practitioner is responsible in § 1306.07 Administering or dispensing case the prescription does not conform of narcotic drugs. in all essential respects to the law and (a) A practitioner may administer or regulations. A corresponding liability dispense directly (but not prescribe) a rests upon the pharmacist, including a narcotic drug listed in any schedule to pharmacist employed by a central fill a narcotic dependant person for the pharmacy, who fills a prescription not purpose of maintenance or detoxifica- prepared in the form prescribed by tion treatment if the practitioner DEA regulations. meets both of the following conditions: (g) An individual practitioner ex- (1) The practitioner is separately reg- empted from registration under istered with DEA as a narcotic treat- § 1301.22(c) of this chapter shall include ment program. on all prescriptions issued by him the (2) The practitioner is in compliance registration number of the hospital or with DEA regulations regarding treat- other institution and the special inter- ment qualifications, security, records, nal code number assigned to him by and unsupervised use of the drugs pur- the hospital or other institution as suant to the Act. provided in § 1301.22(c) of this chapter, (b) Nothing in this section shall pro- in lieu of the registration number of hibit a physician who is not specifi- the practitioner required by this sec- cally registered to conduct a narcotic tion. Each paper prescription shall treatment program from administering have the name of the practitioner (but not prescribing) narcotic drugs to stamped, typed, or handprinted on it, a person for the purpose of relieving as well as the signature of the practi- acute withdrawal symptoms when nec- tioner. essary while arrangements are being (h) An official exempted from reg- made for referral for treatment. Not istration under § 1301.23(a) of this chap- more than one day’s medication may ter must include on all prescriptions be administered to the person or for issued by him his branch of service or the person’s use at one time. Such agency (e.g., ‘‘U.S. Army’’ or ‘‘Public emergency treatment may be carried Health Service’’) and his service identi- out for not more than three days and fication number, in lieu of the registra- may not be renewed or extended. tion number of the practitioner re- (c) This section is not intended to im- quired by this section. The service pose any limitations on a physician or identification number for a Public authorized hospital staff to administer Health Service employee is his Social or dispense narcotic drugs in a hospital Security identification number. Each to maintain or detoxify a person as an paper prescription shall have the name incidental adjunct to medical or sur- of the officer stamped, typed, or gical treatment of conditions other handprinted on it, as well as the signa- than addiction, or to administer or dis- ture of the officer. pense narcotic drugs to persons with [75 FR 16307, Mar. 31, 2010] intractable pain in which no relief or cure is possible or none has been found § 1306.06 Persons entitled to fill pre- after reasonable efforts. scriptions. (d) A practitioner may administer or A prescription for a controlled sub- dispense (including prescribe) any stance may only be filled by a phar- Schedule III, IV, or V narcotic drug ap- macist, acting in the usual course of proved by the Food and Drug Adminis- his professional practice and either tration specifically for use in mainte- registered individually or employed in nance or detoxification treatment to a a registered pharmacy, a registered

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narcotic dependent person if the practi- practice and is acting on behalf of a tioner complies with the requirements pharmacy whose registration has been of § 1301.28 of this chapter. modified under sections 1301.13 and 1301.19 of this chapter to authorize it to [39 FR 37986, Oct. 25, 1974, as amended at 70 FR 36344, June 23, 2005] operate as an online pharmacy. (c) Any online pharmacy that partici- § 1306.08 Electronic prescriptions. pates in the transfer between pharmacies of prescription information (a) An individual practitioner may must do so in accordance with the re- sign and transmit electronic prescrip- quirements of §§ 1306.15 and 1306.25 of tions for controlled substances pro- this part. vided the practitioner meets all of the following requirements: [74 FR 15624, Apr. 6, 2009] (1) The practitioner must comply with all other requirements for issuing CONTROLLED SUBSTANCES LISTED IN SCHEDULE II controlled substance prescriptions in this part; § 1306.11 Requirement of prescription. (2) The practitioner must use an application that meets the requirements (a) A pharmacist may dispense di- of part 1311 of this chapter; and rectly a controlled substance listed in (3) The practitioner must comply Schedule II that is a prescription drug with the requirements for practitioners as determined under section 503 of the Federal Food, Drug, and Cosmetic Act in part 1311 of this chapter. (21 U.S.C. 353(b)) only pursuant to a (b) A pharmacy may fill an electroni- written prescription signed by the cally transmitted prescription for a practitioner, except as provided in controlled substance provided the phar- paragraph (d) of this section. A paper macy complies with all other require- prescription for a Schedule II con- ments for filling controlled substance trolled substance may be transmitted prescriptions in this part and with the by the practitioner or the practi- requirements of part 1311 of this chap- tioner’s agent to a pharmacy via fac- ter. simile equipment, provided that the (c) To annotate an electronic pre- original manually signed prescription scription, a pharmacist must include is presented to the pharmacist for re- all of the information that this part review prior to the actual dispensing of quires in the prescription record. the controlled substance, except as (d) If the content of any of the infor- noted in paragraph (e), (f), or (g) of this mation required under § 1306.05 for a section. The original prescription shall controlled substance prescription is al- be maintained in accordance with tered during the transmission, the pre- § 1304.04(h) of this chapter. scription is deemed to be invalid and (b) An individual practitioner may the pharmacy may not dispense the administer or dispense directly a con- controlled substance. trolled substance listed in Schedule II [75 FR 16307, Mar. 31, 2010] in the course of his professional practice without a prescription, subject to § 1306.09 Prescription requirements § 1306.07. for online pharmacies. (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

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

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§ 1306.12 Refilling prescriptions; Schedule II is permissible if the phar- issuance of multiple prescriptions. macist is unable to supply the full (a) The refilling of a prescription for quantity called for in a written or a controlled substance listed in Sched- emergency oral prescription and he ule II is prohibited. makes a notation of the quantity sup- (b)(1) An individual practitioner may plied on the face of the written pre- issue multiple prescriptions author- scription, written record of the emer- izing the patient to receive a total of gency oral prescription, or in the elec- up to a 90-day supply of a Schedule II tronic prescription record. The remain- controlled substance provided the fol- ing portion of the prescription may be lowing conditions are met: filled within 72 hours of the first par- (i) Each separate prescription is tial filling; however, if the remaining issued for a legitimate medical purpose portion is not or cannot be filled with- by an individual practitioner acting in in the 72-hour period, the pharmacist the usual course of professional prac- shall notify the prescribing individual tice; practitioner. No further quantity may (ii) The individual practitioner pro- be supplied beyond 72 hours without a vides written instructions on each pre- new prescription. scription (other than the first prescrip- (b) A prescription for a Schedule II tion, if the prescribing practitioner in- controlled substance written for a pa- tends for that prescription to be filled tient in a Long Term Care Facility immediately) indicating the earliest (LTCF) or for a patient with a medical date on which a pharmacy may fill diagnosis documenting a terminal ill- each prescription; ness may be filled in partial quantities (iii) The individual practitioner con- to include individual dosage units. If cludes that providing the patient with there is any question whether a patient multiple prescriptions in this manner may be classified as having a terminal does not create an undue risk of diver- illness, the pharmacist must contact sion or abuse; the practitioner prior to partially fill- (iv) The issuance of multiple pre- ing the prescription. Both the phar- scriptions as described in this section macist and the prescribing practitioner is permissible under the applicable have a corresponding responsibility to state laws; and assure that the controlled substance is (v) The individual practitioner com- for a terminally ill patient. The phar- plies fully with all other applicable re- macist must record on the prescription quirements under the Act and these whether the patient is ‘‘terminally ill’’ regulations as well as any additional or an ‘‘LTCF patient.’’ A prescription requirements under state law. that is partially filled and does not (2) Nothing in this paragraph (b) contain the notation ‘‘terminally ill’’ shall be construed as mandating or en- or ‘‘LTCF patient’’ shall be deemed to couraging individual practitioners to have been filled in violation of the Act. issue multiple prescriptions or to see For each partial filling, the dispensing their patients only once every 90 days pharmacist shall record on the back of 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 [72 FR 64929, Nov. 19, 2007] must not exceed the total quantity prescribed. Schedule II prescriptions for § 1306.13 Partial filling of prescrip- patients in a LTCF or patients with a tions. medical diagnosis documenting a ter- (a) The partial filling of a prescrip- minal illness shall be valid for a period tion for a controlled substance listed in not to exceed 60 days from the issue

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date unless sooner terminated by the central fill pharmacy, in addition to discontinuance of medication. the information required under para- (c) Information pertaining to current graph (a) of this section. Schedule II prescriptions for patients (c) The requirements of paragraph (a) in a LTCF or for patients with a med- of this section do not apply when a ical diagnosis documenting a terminal controlled substance listed in Schedule illness may be maintained in a comput- II is prescribed for administration to erized system if this system has the ca- an ultimate user who is institutional- pability to permit: ized: Provided, That: (1) Output (display or printout) of the (1) Not more than 7-day supply of the original prescription number, date of controlled substance listed in Schedule issue, identification of prescribing indi- II is dispensed at one time; vidual practitioner, identification of (2) The controlled substance listed in patient, address of the LTCF or address Schedule II is not in the possession of of the hospital or residence of the pa- the ultimate user prior to the adminis- tient, identification of medication au- tration; thorized (to include dosage, form, (3) The institution maintains appro- strength and quantity), listing of the priate safeguards and records regarding partial fillings that have been dis- the proper administration, control, dispensed under each prescription and the pensing, and storage of the controlled information required in § 1306.13(b). substance listed in Schedule II; and (2) Immediate (real time) updating of (4) The system employed by the phar- the prescription record each time a macist in filling a prescription is ade- partial filling of the prescription is quate to identify the supplier, the conducted. product, and the patient, and to set (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 [36 FR 7799, Apr. 24, 1971. Redesignated at 38 with requirements of § 1304.04(h) of this FR 26609, Sept. 24, 1973, and amended at 45 chapter. FR 54330, July 15, 1980; 56 FR 25027, June 3, (e) Where a prescription that has 1991; 62 FR 13965, Mar. 24, 1997; 75 FR 16308, been prepared in accordance with sec- Mar. 31, 2010] tion 1306.12(b) contains instructions from the prescribing practitioner indi- § 1306.14 Labeling of substances and cating that the prescription shall not filling of prescriptions. be filled until a certain date, no phar- (a) The pharmacist filling a written macist may fill the prescription before or emergency oral prescription for a that date. controlled substance listed in Schedule II shall affix to the package a label [36 FR 13368, July 21, 1971, as amended at 37 showing date of filling, the pharmacy FR 15921, Aug. 8, 1972. Redesignated at 38 FR 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 by law. for prescriptions of Schedule II con- (b) If the prescription is filled at a trolled substances. 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

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transmitted electronically from a re- (i.e. private, common or contract car- tail pharmacy to a central fill phar- rier). macy including via facsimile. The re- [68 FR 37410, June 24, 2003, as amended at 75 tail pharmacy transmitting the pre- FR 16308, Mar. 31, 2010] scription information must: (1) Write the words ‘‘CENTRAL CONTROLLED SUBSTANCES LISTED IN FILL’’ on the face of the original paper SCHEDULES III, IV, AND V prescription and record the name, ad- § 1306.21 Requirement of prescription. dress, and DEA registration number of the central fill pharmacy to which the (a) A pharmacist may dispense di- prescription has been transmitted, the rectly a controlled substance listed in Schedule III, IV, or V that is a pre- name of the retail pharmacy phar- scription drug as determined under sec- macist transmitting the prescription, tion 503(b) of the Federal Food, Drug, and the date of transmittal. For elec- and Cosmetic Act (21 U.S.C. 353(b)) only tronic prescriptions the name, address, pursuant to either a paper prescription and DEA registration number of the signed by a practitioner, a facsimile of central fill pharmacy to which the pre- a signed paper prescription transmitted scription has been transmitted, the by the practitioner or the practi- name of the retail pharmacy phar- tioner’s agent to the pharmacy, an macist transmitting the prescription, electronic prescription that meets the and the date of transmittal must be requirements of this part and part 1311 added to the electronic prescription of this chapter, or an oral prescription record. made by an individual practitioner and (2) Ensure that all information re- promptly reduced to writing by the quired to be on a prescription pursuant pharmacist containing all information to Section 1306.05 of this part is trans- required in § 1306.05, except for the sig- mitted to the central fill pharmacy (ei- nature of the practitioner. ther on the face of the prescription or (b) An individual practitioner may administer or dispense directly a con- in the electronic transmission of infor- trolled substance listed in Schedule III, mation); IV, or V in the course of his/her profes- (3) Maintain the original prescription sional practice without a prescription, for a period of two years from the date subject to § 1306.07. the prescription was filled; (c) An institutional practitioner may (4) Keep a record of receipt of the administer or dispense directly (but filled prescription, including the date not prescribe) a controlled substance of receipt, the method of delivery (pri- listed in Schedule III, IV, or V only vate, common or contract carrier) and pursuant to a paper prescription signed the name of the retail pharmacy em- by an individual practitioner, a fac- ployee accepting delivery. simile of a paper prescription or order (b) The central fill pharmacy receiv- for medication transmitted by the ing the transmitted prescription must: practitioner or the practitioner’s agent (1) Keep a copy of the prescription (if to the institutional practitioner-phar- sent via facsimile) or an electronic macist, an electronic prescription that 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 [62 FR 13965, Mar. 24, 1997, as amended at 75 pharmacy and the method of delivery FR 16308, Mar. 31, 2010]

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§ 1306.22 Refilling of prescriptions. tion from the prescribing practitioner who issued the original prescription. (a) No prescription for a controlled substance listed in Schedule III or IV (3) The quantity of each additional shall be filled or refilled more than six refill authorized is equal to or less than months after the date on which such the quantity authorized for the initial prescription was issued. No prescrip- filling of the original prescription. tion for a controlled substance listed in (4) The prescribing practitioner must Schedule III or IV authorized to be re- execute a new and separate prescrip- filled may be refilled more than five tion for any additional quantities be- times. yond the five-refill, six-month limita- (b) Each refilling of a prescription tion. shall be entered on the back of the pre- (f) As an alternative to the proce- scription or on another appropriate dures provided by paragraphs (a) document or electronic prescription through (e) of this section, a computer record. If entered on another docu- application may be used for the storage ment, such as a medication record, or and retrieval of refill information for electronic prescription record, the doc- original paper prescription orders for ument or record must be uniformly controlled substances in Schedule III maintained and readily retrievable. and IV, subject to the following condi- (c) The following information must tions: be retrievable by the prescription num- (1) Any such proposed computerized ber: application must provide online re- (1) The name and dosage form of the trieval (via computer monitor or hard- controlled substance. copy printout) of original prescription (2) The date filled or refilled. order information for those prescrip- (3) The quantity dispensed. tion orders that are currently author- (4) The initials of the dispensing ized for refilling. This shall include, pharmacist for each refill. but is not limited to, data such as the (5) The total number of refills for original prescription number; date of that prescription. issuance of the original prescription (d) If the pharmacist merely initials order by the practitioner; full name and dates the back of the prescription and address of the patient; name, ad- or annotates the electronic prescrip- dress, and DEA registration number of tion record, it shall be deemed that the the practitioner; and the name, full face amount of the prescription has strength, dosage form, quantity of the been dispensed. controlled substance prescribed (and (e) The prescribing practitioner may quantity dispensed if different from the authorize additional refills of Schedule quantity prescribed), and the total III or IV controlled substances on the number of refills authorized by the pre- original prescription through an oral scribing practitioner. refill authorization transmitted to the (2) Any such proposed computerized pharmacist provided the following con- application must also provide online ditions are met: retrieval (via computer monitor or (1) The total quantity authorized, in- hard-copy printout) of the current re- cluding the amount of the original pre- fill history for Schedule III or IV con- scription, does not exceed five refills trolled substance prescription orders nor extend beyond six months from the (those authorized for refill during the date of issue of the original prescrip- past six months). This refill history tion. shall include, but is not limited to, the (2) The pharmacist obtaining the oral name of the controlled substance, the authorization records on the reverse of date of refill, the quantity dispensed, the original paper prescription or anno- the identification code, or name or ini- tates 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

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computer each time a pharmacist re- or identification code of the dispensing fills an original paper, fax, or oral pre- pharmacist, and the number of the scription order for a Schedule III or IV original prescription order. In any controlled substance is correct must be computerized application employed by provided by the individual pharmacist a user pharmacy the central record- who makes use of such an application. keeping location must be capable of If such an application provides a hard- sending the printout to the pharmacy copy printout of each day’s controlled within 48 hours, and if a DEA Special substance prescription order refill Agent or Diversion Investigator re- data, that printout shall be verified, quests a copy of such printout from the dated, and signed by the individual user pharmacy, it must, if requested to pharmacist who refilled such a pre- do so by the Agent or Investigator, scription order. The individual phar- verify the printout transmittal capa- macist must verify that the data indicated are correct and then sign this bility of its application by documenta- document in the same manner as he tion (e.g., postmark). would sign a check or legal document (5) In the event that a pharmacy (e.g., J.H. Smith, or John H. Smith). which employs such a computerized ap- This document shall be maintained in a plication experiences system down- separate file at that pharmacy for a pe- time, the pharmacy must have an aux- riod of two years from the dispensing iliary procedure which will be used for date. This printout of the day’s con- documentation of refills of Schedule III trolled substance prescription order re- and IV controlled substance prescrip- fill data must be provided to each phar- tion orders. This auxiliary procedure macy using such a computerized appli- must ensure that refills are authorized cation within 72 hours of the date on by the original prescription order, that which the refill was dispensed. It must the maximum number of refills has not be verified and signed by each phar- been exceeded, and that all of the ap- macist who is involved with such dis- propriate data are retained for online pensing. In lieu of such a printout, the data entry as soon as the computer sys- pharmacy shall maintain a bound log tem is available for use again. book, or separate file, in which each in- (g) When filing refill information for dividual pharmacist involved in such original paper, fax, or oral prescription dispensing shall sign a statement (in orders for Schedule III or IV controlled the manner previously described) each substances, a pharmacy may use only day, attesting to the fact that the refill information entered into the computer one of the two applications described in that day has been reviewed by him and paragraphs (a) through (e) or (f) of this is correct as shown. Such a book or file section. must be maintained at the pharmacy (h) When filing refill information for employing such an application for a pe- electronic prescriptions, a pharmacy riod of two years after the date of dis- must use an application that meets the pensing the appropriately authorized requirements of part 1311 of this chap- refill. ter. (4) Any such computerized applica- [75 FR 16308, Mar. 31, 2010] tion shall have the capability of producing a printout of any refill data § 1306.23 Partial filling of prescrip- that the user pharmacy is responsible tions. for maintaining under the Act and its implementing regulations. For exam- The partial filling of a prescription ple, this would include a refill-by-refill for a controlled substance listed in audit trail for any specified strength Schedule III, IV, or V is permissible, and dosage form of any controlled sub- provided that: stance (by either brand or generic (a) Each partial filling is recorded in name or both). Such a printout must the same manner as a refilling, include name of the prescribing practi- (b) The total quantity dispensed in tioner, name and address of the pa- all partial fillings does not exceed the tient, quantity dispensed on each refill, total quantity prescribed, and date of dispensing for each refill, name

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(c) No dispensing occurs after 6 (d) All prescriptions for controlled months after the date on which the substances listed in Schedules III, IV, prescription was issued. and V shall be kept in accordance with § 1304.04(h) of this chapter. [36 FR 18733, Sept. 21, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973, and amended at 51 [62 FR 13965, Mar. 24, 1997, as amended at 68 FR 5320, Feb. 13, 1986; 62 FR 13965, Mar. 24, FR 37411, June 24, 2003] 1997] § 1306.25 Transfer between pharmacies § 1306.24 Labeling of substances and of prescription information for filling of prescriptions. Schedules III, IV, and V controlled (a) The pharmacist filling a prescrip- substances for refill purposes. tion for a controlled substance listed in (a) The transfer of original prescrip- Schedule III, IV, or V shall affix to the tion information for a controlled sub- package a label showing the pharmacy stance listed in Schedule III, IV, or V name and address, the serial number for the purpose of refill dispensing is and date of initial filling, the name of permissible between pharmacies on a the patient, the name of the practi- one-time basis only. However, phar- tioner issuing the prescription, and di- macies electronically sharing a real- rections for use and cautionary state- time, online database may transfer up ments, if any, contained in such pre- to the maximum refills permitted by scription as required by law. law and the prescriber’s authorization. (b) If the prescription is filled at a (b) Transfers are subject to the fol- central fill pharmacy, the central fill lowing requirements: pharmacy shall affix to the package a (1) The transfer must be commu- label showing the retail pharmacy nicated directly between two licensed name and address and a unique identi- pharmacists. fier, (i.e. the central fill pharmacy’s DEA registration number) indicating (2) The transferring pharmacist must that the prescription was filled at the do the following: central fill pharmacy, in addition to (i) Write the word ‘‘VOID’’ on the the information required under para- face of the invalidated prescription; for graph (a) of this section. electronic prescriptions, information (c) The requirements of paragraph (a) that the prescription has been trans- of this section do not apply when a ferred must be added to the prescrip- controlled substance listed in Schedule tion record. III, IV, or V is prescribed for adminis- (ii) Record on the reverse of the in- tration to an ultimate user who is invalidated prescription the name, ad- stitutionalized: Provided, That: dress, and DEA registration number of (1) Not more than a 34-day supply or the pharmacy to which it was trans- 100 dosage units, whichever is less, of ferred and the name of the pharmacist the controlled substance listed in receiving the prescription information; Schedule III, IV, or V is dispensed at for electronic prescriptions, such infor- one time; mation must be added to the prescrip- (2) The controlled substance listed in tion record. Schedule III, IV, or V is not in the pos- (iii) Record the date of the transfer session of the ultimate user prior to and the name of the pharmacist trans- administration; ferring the information. (3) The institution maintains appro- (3) For paper prescriptions and pre- priate safeguards and records the prop- scriptions received orally and reduced er administration, control, dispensing, to writing by the pharmacist pursuant and storage of the controlled substance to § 1306.21(a), the pharmacist receiving listed in Schedule III, IV, or V; and the transferred prescription informa- (4) The system employed by the phar- tion must write the word ‘‘transfer’’ on macist in filling a prescription is ade- the face of the transferred prescription quate to identify the supplier, the and reduce to writing all information product and the patient, and to set required to be on a prescription pursu- forth the directions for use and cau- ant to § 1306.05 and include: tionary statements, if any, contained (i) Date of issuance of original pre- in the prescription or required by law. scription.

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(ii) Original number of refills author- lowable under existing State or other ized on original prescription. applicable law. (iii) Date of original dispensing. [75 FR 16309, Mar. 31, 2010] (iv) Number of valid refills remaining and date(s) and locations of previous § 1306.26 Dispensing without prescrip- refill(s). tion. (v) Pharmacy’s name, address, DEA A controlled substance listed in registration number, and prescription Schedules II, III, IV, or V which is not number from which the prescription in- a prescription drug as determined formation was transferred. under the Federal Food, Drug, and Cos- (vi) Name of pharmacist who trans- metic Act, may be dispensed by a phar- ferred the prescription. macist without a prescription to a pur- (vii) Pharmacy’s name, address, DEA chaser at retail, provided that: registration number, and prescription (a) Such dispensing is made only by a number from which the prescription pharmacist (as defined in part 1300 of was originally filled. this chapter), and not by a nonphar- macist employee even if under the su- (4) For electronic prescriptions being pervision of a pharmacist (although transferred electronically, the trans- after the pharmacist has fulfilled his ferring pharmacist must provide the professional and legal responsibilities receiving pharmacist with the fol- set forth in this section, the actual lowing information in addition to the cash, credit transaction, or delivery, original electronic prescription data: may be completed by a nonphar- (i) The date of the original dis- macist); pensing. (b) Not more than 240 cc. (8 ounces) of (ii) The number of refills remaining any such controlled substance con- and the date(s) and locations of pre- taining opium, nor more than 120 cc. (4 vious refills. ounces) of any other such controlled (iii) The transferring pharmacy’s substance nor more than 48 dosage name, address, DEA registration num- units of any such controlled substance ber, and prescription number for each containing opium, nor more than 24 dispensing. dosage units of any other such con- (iv) The name of the pharmacist trolled substance may be dispensed at transferring the prescription. retail to the same purchaser in any (v) The name, address, DEA registra- given 48-hour period; tion number, and prescription number (c) The purchaser is at least 18 years from the pharmacy that originally of age; filled the prescription, if different. (d) The pharmacist requires every 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.

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(g) Central fill pharmacies may not (1) Keep a copy of the prescription (if dispense controlled substances to a sent via facsimile) or an electronic purchaser at retail pursuant to this record of all the information trans- section. mitted by the retail pharmacy, includ- [36 FR 7799, Apr. 24, 1971, as amended at 36 ing the name, address, and DEA reg- FR 18733, Sept. 21, 1971. Redesignated at 38 istration number of the retail phar- FR 26609, Sept. 24, 1973, and further redesig- macy transmitting the prescription; nated and amended at 62 FR 13966, Mar. 24, (2) Keep a record of the date of re- 1997; 68 FR 37411, June 24, 2003] ceipt of the transmitted prescription, the name of the licensed pharmacist § 1306.27 Provision of prescription information between retail phar- filling the prescription, and dates of macies and central fill pharmacies filling or refilling of the prescription; for initial and refill prescriptions of (3) Keep a record of the date the filled Schedule III, IV, or V controlled prescription was delivered to the retail substances. pharmacy and the method of delivery Prescription information may be pro- (i.e. private, common or contract car- vided to an authorized central fill phar- rier). macy by a retail pharmacy for dispensing purposes. The following re- [68 FR 37411, June 24, 2003] quirements shall also apply: (a) Prescriptions for controlled sub- PART 1307—MISCELLANEOUS stances listed in Schedule III, IV or V may be transmitted electronically GENERAL INFORMATION from a retail pharmacy to a central fill Sec. pharmacy including via facsimile. The 1307.01 Definitions. retail pharmacy transmitting the pre- 1307.02 Application of State law and other scription information must: Federal law. (1) Write the word ‘‘CENTRAL FILL’’ 1307.03 Exceptions to regulations. on the face of the original prescription and record the name, address, and DEA SPECIAL EXCEPTIONS FOR MANUFACTURE AND registration number of the central fill DISTRIBUTION OF CONTROLLED SUBSTANCES pharmacy to which the prescription 1307.11 Distribution by dispenser to another has been transmitted and the name of practitioner. the retail pharmacy pharmacist trans- 1307.13 Incidental manufacture of controlled mitting the prescription, and the date substances. of transmittal; (2) Ensure that all information re- DISPOSAL OF CONTROLLED SUBSTANCES quired to be on a prescription pursuant 1307.22 Delivery of surrendered and forfeited to § 1306.05 of this part is transmitted controlled substances. to the central fill pharmacy (either on the face of the prescription or in the SPECIAL EXEMPT PERSONS electronic transmission of informa- 1307.31 Native American Church. tion); AUTHORITY: 21 U.S.C. 821, 822(d), 871(b), un- (3) Indicate in the information trans- less otherwise noted. mitted the number of refills already dispensed and the number of refills re- SOURCE: 36 FR 7801, Apr. 24, 1971, unless maining; otherwise noted. Redesignated at 38 FR 26609, (4) Maintain the original prescription Sept. 24, 1973. for a period of two years from the date GENERAL INFORMATION the prescription was last refilled; (5) Keep a record of receipt of the § 1307.01 Definitions. filled prescription, including the date of receipt, the method of delivery (pri- Any term contained in this part shall vate, common or contract carrier) and have the definition set forth in section the name of the retail pharmacy em- 102 of the Act (21 U.S.C. 802) or part ployee accepting delivery. 1300 of this chapter. (b) The central fill pharmacy receiv- [62 FR 13966, Mar. 24, 1997] ing the transmitted prescription must:

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§ 1307.02 Application of State law and cordance with § 1304.22(c) of this chap- other Federal law. ter; Nothing in this chapter shall be con- (iii) If the substance is listed in strued as authorizing or permitting Schedule I or II, an order form is used any person to do any act which such as required in part 1305 of this chapter; person is not authorized or permitted and to do under other Federal laws or obli- (iv) The total number of dosage units gations under international treaties, of all controlled substances distributed conventions or protocols, or under the by the practitioner pursuant to this law of the State in which he/she desires section and § 1301.25 of this chapter dur- to do such act nor shall compliance ing each calendar year in which the with such parts be construed as compli- practitioner is registered to dispense ance with other Federal or State laws does not exceed 5 percent of the total unless expressly provided in such other number of dosage units of all con- laws. trolled substances distributed and dis- [62 FR 13966, Mar. 24, 1997] pensed by the practitioner during the same calendar year. § 1307.03 Exceptions to regulations. (2) [Reserved] Any person may apply for an excep- (b) If, during any calendar year in tion to the application of any provision which the practitioner is registered to of this chapter by filing a written re- dispense, the practitioner has reason to quest with the Office of Diversion Con- believe that the total number of dosage trol, Drug Enforcement Administra- units of all controlled substances tion, stating the reasons for such ex- which will be distributed by him pursu- ception. See the Table of DEA Mailing ant to paragraph (a)(1) of this section Addresses in § 1321.01 of this chapter for and § 1301.25 of this chapter will exceed the current mailing address. The Ad- 5 percent of this total number of dos- ministrator may grant an exception in age units of all controlled substances his discretion, but in no case shall he/ distributed and dispensed by him dur- she be required to grant an exception ing that calendar year, the practitioner to any person which is otherwise re- shall obtain a registration to distribute quired by law or the regulations cited controlled substances. in this section. (c) The distributions that a reg- [75 FR 10678, Mar. 9, 2010] istered retail pharmacy makes to automated dispensing systems at long term SPECIAL EXCEPTIONS FOR MANUFACTURE care facilities for which the retail AND DISTRIBUTION OF CONTROLLED pharmacy also holds registrations do SUBSTANCES not count toward the 5 percent limit in paragraphs (a)(1)(iv) and (b) of this sec- § 1307.11 Distribution by dispenser to tion. another practitioner. (a) A practitioner who is registered [68 FR 41229, July 11, 2003, as amended at 70 to dispense a controlled substance may FR 25466, May 13, 2005; 79 FR 53565, Sept. 9, distribute (without being registered to 2014] distribute) a quantity of such sub- § 1307.13 Incidental manufacture of stance to— controlled substances. (1) Another practitioner for the purpose of general dispensing by the prac- Any registered manufacturer who, in- titioner to patients, provided that— cidentally but necessarily, manufac- (i) The practitioner to whom the con- tures a controlled substance as a result trolled substance is to be distributed is of the manufacture of a controlled sub- registered under the Act to dispense stance or basic class of controlled sub- that controlled substance; stance for which he is registered and (ii) The distribution is recorded by has been issued an individual manufac- the distributing practitioner in accord- turing quota pursuant to part 1303 of ance with § 1304.22(c) of this chapter this chapter (if such substance or class and by the receiving practitioner in ac-

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is listed in Schedule I or II) shall be ex- PART 1308—SCHEDULES OF empt from the requirement of registra- CONTROLLED SUBSTANCES tion pursuant to part 1301 of this chapter and, if such incidentally manufac- GENERAL INFORMATION tured substance is listed in Schedule I or II, shall be exempt from the require- Sec. ment of an individual manufacturing 1308.01 Scope of this part. quota pursuant to part 1303 of this 1308.02 Definitions. 1308.03 Administration Controlled Sub- chapter, if such substances are disposed stances Code Number. of in accordance with part 1317 of this chapter. SCHEDULES [79 FR 53565, Sept. 9, 2014] 1308.11 Schedule I. 1308.12 Schedule II. DISPOSAL OF CONTROLLED SUBSTANCES 1308.13 Schedule III. 1308.14 Schedule IV. § 1307.22 Delivery of surrendered and 1308.15 Schedule V. forfeited controlled substances. EXCLUDED NONNARCOTIC SUBSTANCES Any controlled substance surrendered by delivery to the Administra- 1308.21 Application for exclusion of a non- narcotic substance. tion under part 1317 of this chapter or 1308.22 Excluded substances. forfeited pursuant to section 511 of the Act (21 U.S.C. 881) may be delivered to EXEMPT CHEMICAL PREPARATIONS any department, bureau, or other agen- 1308.23 Exemption of certain chemical prep- cy of the United States or of any State arations; application. upon proper application addressed to 1308.24 Exemption chemical preparations. the Office of Diversion Control, Drug Enforcement Administration. See the EXCLUDED VETERINARY ANABOLIC STEROID Table of DEA Mailing Addresses in IMPLANT PRODUCTS § 1321.01 of this chapter for the current 1308.25 Exclusion of a veterinary anabolic mailing address. The application shall steroid implant product; application. show the name, address, and official 1308.26 Excluded veterinary anabolic steroid title of the person or agency to whom implant products. the controlled drugs are to be deliv- EXEMPTED PRESCRIPTION PRODUCTS ered, including the name and quantity 1308.31 Application for exemption of a non- of the substances desired and the pur- narcotic prescription product. pose for which intended. The delivery 1308.32 Exempted prescription products. of such controlled drugs shall be ordered by the Administrator, if, in his EXEMPT ANABOLIC STEROID PRODUCTS opinion, there exists a medical or sci- 1308.33 Exemption of certain anabolic ster- entific need therefor. oid products; application. 1308.34 Exempt anabolic steroid products. [75 FR 10678, Mar. 9, 2010, as amended at 79 FR 53565, Sept. 9, 2014] EXEMPT CANNABIS PLANT MATERIAL, AND PRODUCTS MADE THEREFROM, THAT CONTAIN SPECIAL EXEMPT PERSONS TETRAHYDROCANNABINOLS § 1307.31 Native American Church. 1308.35 Exemption of certain cannabis plant material, and products made therefrom, The listing of peyote as a controlled that contain tetrahydrocannabinols. substance in Schedule I does not apply to the nondrug use of peyote in bona HEARINGS fide religious ceremonies of the Native 1308.41 Hearings generally. American Church, and members of the 1308.42 Purpose of hearing. Native American Church so using pe- 1308.43 Initiation of proceedings for rule- yote are exempt from registration. Any making. person who manufactures peyote for or 1308.44 Request for hearing or appearance; distributes peyote to the Native Amer- waiver. 1308.45 Final order. ican Church, however, is required to 1308.46 Control required under international obtain registration annually and to treaty. comply with all other requirements of 1308.47 Control of immediate precursors. law. 1308.49 Temporary scheduling.

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AUTHORITY: 21 U.S.C. 811, 812, 871(b), 956(b), Substances Code Number beneath or unless otherwise noted. beside the name of each controlled sub- SOURCE: 38 FR 8254, Mar. 30, 1973, unless stance listed on the DEA Form 236 otherwise noted. Redesignated at 38 FR 26609, (Controlled Substance Import/Export Sept. 24, 1973. Declaration) which is executed for such importation or exportation as required GENERAL INFORMATION in §§ 1312.18(c) and 1312.27(b) of this § 1308.01 Scope of this part. chapter. (b) Except as stated in paragraph (a) Schedules of controlled substances established by section 202 of the Act (21 of this section, no applicant or reg- U.S.C. 812) and nonnarcotic substances, istrant is required to use the Adminis- chemical preparations, veterinary ana- tration Controlled Substances Code bolic steroid implant products, pre- Number for any purpose. scription products, anabolic steroid [38 FR 8254, Mar. 30, 1973. Redesignated at 38 products, and cannabis plant material FR 26609, Sept. 24, 1973 and amended at 51 FR and products made therefrom that con- 15318, Apr. 23, 1986; 62 FR 13968, Mar. 24, 1997] tain tetrahydrocannabinols excluded pursuant to section 201 of the Act (21 SCHEDULES U.S.C. 811), as they are changed, updated, and republished from time to § 1308.11 Schedule I. time, are set forth in this part. (a) Schedule I shall consist of the [81 FR 97021, Dec. 30, 2016] drugs and other substances, by what- ever official name, common or usual § 1308.02 Definitions. name, chemical name, or brand name Any term contained in this part shall designated, listed in this section. Each have the definition set forth in section drug or substance has been assigned 102 of the Act (21 U.S.C. 802) or part the DEA Controlled Substances Code 1300 of this chapter. Number set forth opposite it. (b) Opiates. Unless specifically ex- [62 FR 13967, Mar. 24, 1997] cepted or unless listed in another § 1308.03 Administration Controlled schedule, any of the following opiates, Substances Code Number. including their isomers, esters, ethers, (a) Each controlled substance, or salts, and salts of isomers, esters and basic class thereof, has been assigned ethers, whenever the existence of such an ‘‘Administration Controlled Sub- isomers, esters, ethers and salts is pos- stances Code Number’’ for purposes of sible within the specific chemical des- identification of the substances or ignation (for purposes of paragraph class on certain Certificates of Reg- (b)(39) only, the term isomer includes istration issued by the Administration the optical and geometric isomers): pursuant to §§ 1301.35 of this chapter (1) Acetyl-alpha- and on certain order forms issued by methylfentanyl (N-[1-(1-meth- the Administration pursuant to yl-2-phenethyl)-4- § 1305.05(d) of this chapter. Applicants piperidinyl]-N- for procurement and/or individual man- phenylacetamide) ...... 9815 ufacturing quotas must include the ap- (2) Acetylmethadol ...... 9601 propriate code number on the applica- (3) Acetyl fentanyl (N-(1- tion as required in §§ 1303.12(b) and phenethylpiperidin-4-yl)-N- 1303.22(a) of this chapter. Applicants phenylacetamide) ...... 9821 for import and export permits must include the appropriate code number on (4) Acryl fentanyl (N-(1- the application as required in phenethylpiperidin-4-yl)-N- §§ 1312.12(a) and 1312.22(a) of this chap- phenylacrylamide; other ter. Authorized registrants who desire name: acryloylfentanyl) ...... 9811 to import or export a controlled sub- (5) AH-7921 (3,4-dichloro-N-[(1- stance for which an import or export dimethylamino) permit is not required must include the cyclohexylmethyl]benzamide 9551 appropriate Administration Controlled (6) Allylprodine ...... 9602

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(7) Alphacetylmethadol (except (37) Ketobemidone ...... 9628 levo-alphacetylmethadol also (38) Levomoramide ...... 9629 known as levo-alpha- (39) Levophenacylmorphan ...... 9631 acetylmethadol, (40) 3-Methylfentanyl (N-[3- levomethadyl acetate, or methyl-1-(2-phenylethyl)-4- LAAM) ...... 9603 piperidyl]-N- (8) Alphameprodine ...... 9604 phenylpropanamide) ...... 9813 (9) Alphamethadol ...... 9605 (41) 3-methylthiofentanyl (N- (10) Alpha-methylfentanyl (N- [(3-methyl-1-(2-thienyl)ethyl- [1-(alpha-methyl-beta- 4-piperidinyl]-N- phenyl)ethyl-4-piperidyl] phenylpropanamide) ...... 9833 propionanilide; 1-(1-methyl-2- (42) Morpheridine ...... 9632 phenylethyl)-4-(N- (43) MPPP (1-methyl-4-phenyl- propanilido) piperidine) ...... 9814 4-propionoxypiperidine) ...... 9661 (11) Alpha-methylthiofentanyl (44) MT–45 (1-cyclohexyl-4-(1,2- (N-[1-methyl-2-(2- diphenylethyl)piperazine) ..... (9560) thienyl)ethyl-4-piperidinyl]- (45) Noracymethadol ...... 9633 N-phenylpropanamide) ...... 9832 (46) Norlevorphanol ...... 9634 (12) Benzethidine ...... 9606 (47) Normethadone ...... 9635 (13) Betacetylmethadol ...... 9607 (48) Norpipanone ...... 9636 (14) Beta-hydroxyfentanyl (N- (49) Ocfentanil (N-(2- [1-(2-hydroxy-2-phenethyl)-4- fluorophenyl)-2-methoxy-N- piperidinyl]-N- (1-phenethylpiperidin-4- phenylpropanamide) ...... 9830 yl)acetamide) ...... 9838 (15) Beta-hydroxy-3- (50) Para-fluorofentanyl (N-(4- methylfentanyl (other name: fluorophenyl)-N-[1-(2- N-[1-(2-hydroxy-2-phenethyl)- phenethyl)-4-piperidinyl] 3-methyl-4-piperidinyl]-N- propanamide ...... 9812 phenylpropanamide ...... 9831 (51) PEPAP (1-(-2-phenethyl)-4- (16) Betameprodine ...... 9608 phenyl-4-acetoxypiperidine ... 9663 (17) Betamethadol ...... 9609 (52) Phenadoxone ...... 9637 (18) Betaprodine ...... 9611 (53) Phenampromide ...... 9638 (19) Butyryl fentanyl (N-(1- (54) Phenomorphan ...... 9647 phenethylpiperidin-4-yl)-N- (55) Phenoperidine ...... 9641 phenylbutyramide) ...... 9822 (56) Piritramide ...... 9642 (20) Clonitazene ...... 9612 (57) Proheptazine ...... 9643 (21) Dextromoramide ...... 9613 (58) Properidine ...... 9644 (22) Diampromide ...... 9615 (59) Propiram ...... 9649 (23) Diethylthiambutene ...... 9616 (60) Racemoramide ...... 9645 (24) Difenoxin ...... 9168 (61) Tetrahydrofuranyl fentanyl (25) Dimenoxadol ...... 9617 (N-(1-phenethylpiperidin-4- (26) Dimepheptanol ...... 9618 yl)-N-phenyltetrahydrofuran- (27) Dimethylthiambutene ...... 9619 2-carboxamide) ...... 9843 (28) Dioxaphetyl butyrate ...... 9621 (62) Thiofentanyl (N-phenyl-N- (29) Dipipanone ...... 9622 [1-(2-thienyl)ethyl-4- (30) Ethylmethylthiambutene .. 9623 piperidinyl]-propanamide ...... 9835 (31) Etonitazene ...... 9624 (63) Tilidine ...... 9750 (32) Etoxeridine ...... 9625 (64) Trimeperidine ...... 9646 (65) U–47700 (3,4-Dichloro-N-[2- (33) 4-Fluoroisobutyryl (dimethylamino)cyclohexyl]- fentanyl (N-(4-fluorophenyl)- N-methylbenzamide) ...... 9547 N-(1-phenethylpiperidin-4- yl)isobutyramide; other (c) Opium derivatives. Unless specifi- name: para-fluoroisobutyryl cally excepted or unless listed in an- fentanyl) ...... 9824 other schedule, any of the following (34) Furanyl fentanyl (N-(1- opium derivatives, its salts, isomers, phenethylpiperidin-4-yl)-N- and salts of isomers whenever the ex- phenylfuran-2-carboxamide) .. 9834 istence of such salts, isomers, and salts (35) Furethidine ...... 9626 of isomers is possible within the spe- (36) Hydroxypethidine ...... 9627 cific chemical designation: 113

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(1) Acetorphine ...... 9319 Some trade or other names: (2) Acetyldihydrocodeine ...... 9051 2-(4-bromo-2,5- (3) Benzylmorphine ...... 9052 dimethoxyphenyl)-1- aminoethane; alpha- (4) Codeine methylbromide ...... 9070 desmethyl DOB; 2C-B, (5) Codeine-N-Oxide ...... 9053 Nexus. (6) Cyprenorphine ...... 9054 (4) 2,5-dimethoxyamphetamine 7396 (7) Desomorphine ...... 9055 Some trade or other names: (8) Dihydromorphine ...... 9145 2,5-dimethoxy-a- (9) Drotebanol ...... 9335 methylphenethylamine; (10) Etorphine (except hydro- 2,5-DMA chloride salt) ...... 9056 (5) 2,5-dimethoxy-4- (11) Heroin ...... 9200 ethylamphet-amine ...... 7399 (12) Hydromorphinol ...... 9301 Some trade or other names: (13) Methyldesorphine ...... 9302 DOET (14) Methyldihydromorphine ...... 9304 (6) 2,5-dimethoxy-4-(n)- (15) Morphine methylbromide .... 9305 propylthiophenethylamine (16) Morphine methylsulfonate .. 9306 (other name: 2C–T–7) ...... 7348 (17) Morphine-N-Oxide ...... 9307 (7) 4-methoxyamphetamine ...... 7411 (18) Myrophine ...... 9308 Some trade or other names: (19) Nicocodeine ...... 9309 4-methoxy-a- (20) Nicomorphine ...... 9312 methylphenethylamine; (21) Normorphine ...... 9313 paramethoxyamphetami- ne, PMA (22) Pholcodine ...... 9314 (8) 5-methoxy-3,4- (23) Thebacon ...... 9315 methylenedioxy-amphet- (d) Hallucinogenic substances. Unless amine ...... 7401 specifically excepted or unless listed in (9) 4-methyl-2,5-dimethoxy-am- another schedule, any material, com- phetamine ...... 7395 pound, mixture, or preparation, which Some trade and other contains any quantity of the following names: 4-methyl-2,5- hallucinogenic substances, or which dimethoxy-a- contains any of its salts, isomers, and methylphenethylamine; salts of isomers whenever the existence ‘‘DOM’’; and ‘‘STP’’ of such salts, isomers, and salts of iso- (10) 3,4-methylenedioxy am- mers is possible within the specific phetamine ...... 7400 chemical designation (for purposes of (11) 3,4- this paragraph only, the term ‘‘isomer’’ methylenedioxymethamphet- includes the optical, position and geo- amine (MDMA) ...... 7405 metric isomers): (12) 3,4-methylenedioxy-N- ethylamphetamine (also (1) Alpha-ethyltryptamine ...... 7249 known as N-ethyl-alpha- Some trade or other names: methyl-3,4(methylenedioxy)- etryptamine; Monase; a- phenethylamine, N-ethyl ethyl-1H-indole-3- MDA, MDE, MDEA ...... 7404 ethanamine; 3-(2- (13) N-hydroxy-3,4- aminobutyl) indole; -ET; a methylenedioxyamphetamine and AET. (also known as N-hydroxy- (2) 4-bromo-2,5-dimethoxy-am- alpha-methyl- phetamine ...... 7391 3,4(methylenedioxy)- Some trade or other names: phenethylamine, and N-hy- 4-bromo-2,5-dimethoxy-a- droxy MDA ...... 7402 methylphenethylamine; (14) 3,4,5-trimethoxy amphet- 4-bromo-2,5-DMA amine ...... 7390 (3) 4-Bromo-2,5- dimethoxyphenethylamine .... 7392

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(15) 5-methoxy-N,N- Meaning all parts of the dimethyltryptamine Some plant presently classified trade or other names: 5- botanically as Lophophora methoxy-3-[2- williamsii Lemaire, wheth- (dimethylamino)ethyl]indole; er growing or not, the 5-MeO-DMT ...... 7431 seeds thereof, any extract (16) Alpha-methyltryptamine from any part of such (other name: AMT) ...... 7432 plant, and every com- (17) Bufotenine ...... 7433 pound, manufacture, Some trade and other salts, derivative, mixture, names: 3-(b- or preparation of such Dimethylaminoethyl)-5- plant, its seeds or ex- hydroxyindole; 3-(2- tracts dimethylaminoethyl)-5- (Interprets 21 USC 812(c), indolol; N, N- Schedule I(c) (12)) dimethylserotonin; 5-hy- (27) N-ethyl-3-piperidyl droxy-N,N- benzilate ...... 7482 dimethyltryptamine; (28) N-methyl-3-piperidyl mappine benzilate ...... 7484 (18) Diethyltryptamine ...... 7434 (29) Psilocybin ...... 7437 (30) Psilocyn ...... 7438 Some trade and other (31) Tetrahydrocannabinols ...... 7370 names: N,N- Meaning Diethyltryptamine; DET tetrahydrocannabinols (19) Dimethyltryptamine ...... 7435 naturally contained in a Some trade or other names: plant of the genus Can- DMT nabis (cannabis plant), as (20) 5-methoxy-N,N- well as synthetic equiva- diisopropyltryptamine (other lents of the substances name: 5-MeO-DIPT) ...... 7439 contained in the cannabis (21) Ibogaine ...... 7260 plant, or in the resinous Some trade and other extractives of such plant, names: 7-Ethyl- and/or synthetic sub- 6,6b,7,8,9,10,12,13- stances, derivatives, and octahydro-2-methoxy-6,9- their isomers with simi- methano-5H-pyrido [1′, lar chemical structure 2′:1,2] azepino [5,4-b] and pharmacological ac- indole; Tabernanthe iboga tivity to those substances (22) Lysergic acid diethylamide 7315 contained in the plant, (23) Marihuana ...... 7360 such as the following: (24) Mescaline ...... 7381 1 cis or trans (25) Parahexyl—7374; some tetrahydrocannabinol, trade or other names: 3- and their optical isomers Hexyl-1-hydroxy-7,8,9,10- 6 cis or trans tetrahydro-6,6,9-trimethyl- tetrahydrocannabinol, 6H-dibenzo[b,d]pyran; and their optical isomers Synhexyl. 3, 4 cis or trans (26) Peyote ...... 7415 tetrahydrocannabinol, and its optical isomers (Since nomenclature of these substances is not internationally standardized, compounds of these structures, regardless of numerical designation of atomic positions covered.) (32) Ethylamine analog of phencyclidine ...... 7455 115

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Some trade or other names: (48) (1-pentyl-1H-indol-3- N-ethyl-1- yl)(2,2,3,3- phenylcyclohexylamine, tetramethylcyclopropy- (1- l)methanone (UR-144) ...... (7144) phenylcyclohexy- (49) [1-(5-fluoro-pentyl)-1H- l)ethylamine, N-(1- indol-3-yl](2,2,3,3- phenylcyclohexy- tetramethylcyclopropy- l)ethylamine, l)methanone (5-fluoro-UR-144, cyclohexamine, PCE XLR11) ...... (7011) (33) Pyrrolidine analog of (50) N-(1-adamantyl)-1-pentyl- phencyclidine ...... 7458 1H-indazole-3-carboxamide Some trade or other names: (APINACA, AKB48) ...... (7048) 1-(1-phenylcyclohexyl)- (51) quinolin-8-yl 1-pentyl-1H- pyrrolidine, PCPy, PHP indole-3-carboxylate (PB-22; (34) Thiophene analog of QUPIC) ...... (7222) phencyclidine ...... 7470 (52) quinolin-8-yl 1-(5- Some trade or other names: fluoropentyl)-1H-indole-3- 1-[1-(2-thienyl)- carboxylate (5-fluoro-PB-22; cyclohexyl]-piperidine, 2- 5F-PB-22) ...... (7225) thienylanalog of (53) N-(1-amino-3-methyl-1- phencyclidine, TPCP, oxobutan-2-yl)-1-(4- TCP fluorobenzyl)-1H-indazole-3- (35) 1-[1-(2- carboxamide (AB- thieny- FUBINACA) ...... (7012) l)cyclohexyl]pyrrolidine ...... 7473 (54) N-(1-amino-3,3-dimethyl-1- Some other names: TCPy oxobutan-2-yl)-1-pentyl-1H- (36) 4-methylmethcathinone indazole-3-carboxamide (Mephedrone) ...... 1248 (ADB-PINACA) ...... (7035) (37) 3,4- (55) 2-(4-iodo-2,5- methylenedioxypyrovalerone dimethoxyphenyl)-N-(2-me- (MDPV) ...... 7535 thoxybenzyl)ethanamine (25I- (38) 2-(2,5-Dimethoxy-4- NBOMe, 2C-I-NBOMe) ...... (7538) ethylphenyl)ethanamine (2C– (56) 2-(4-chloro-2,5- E) ...... 7509 dimethoxyphenyl)-N-(2-me- (39) 2-(2,5-Dimethoxy-4- thoxybenzyl)ethanamine methylphenyl)ethanamine (25C-NBOMe, 2C-C-NBOMe) ... (7537) (2C–D) ...... 7508 (57) 2-(4-bromo-2,5- (40) 2-(4-Chloro-2,5- dimethoxyphenyl)-N-(2-me- dimethoxyphenyl)ethanamine thoxybenzyl)ethanamine (2C–C) ...... 7519 (25B-NBOMe, 2C-B-NBOMe) ... (7536) (41) 2-(4-Iodo-2,5- (58) Marihuana Extract—Mean- dimethoxyphenyl)ethanamine ing an extract containing one (2C–I) ...... 7518 or more cannabinoids that (42) 2-[4-(Ethylthio)-2,5- has been derived from any dimethoxyphenyl]ethanamine plant of the genus Cannabis, (2C–T–2) ...... 7385 other than the separated (43) 2-[4-(Isopropylthio)-2,5- resin (whether crude or puri- dimethoxyphenyl]ethanamine fied) obtained from the plant (7350) (2C–T–4) ...... 7532 (59) 4-methyl-N-ethylcathinone (44) 2-(2,5- (4-MEC) ...... (1249) Dimethoxypheny- (60) 4-methyl-alpha- l)ethanamine (2C–H) ...... 7517 pyrrolidinopropiophenone (4- (45) 2-(2,5-Dimethoxy-4-nitro- MePPP) ...... (7498) phenyl)ethanamine (2C–N) .... 7521 (61) alpha- (46) 2-(2,5-Dimethoxy-4-(n)- pyrrolidinopentiophenone (a- propylphenyl)ethanamine PVP) ...... (7545) (2C–P) ...... 7524 (62) 1-(1,3-benzodioxol-5-yl)-2- (47) 3,4-Methylenedioxy-N- (methylamino)butan-1-one methylcathinone (Methylone) 7540 (butylone, bk-MBDB) ...... (7541) 116

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(63) 2-(methylamino)-1- mixture, or preparation which contains phenylpentan-1-one any quantity of the following sub- (pentedrone) ...... (1246) stances having a stimulant effect on (64) 1-(1,3-benzodioxol-5-yl)-2- the central nervous system, including (methylamino)pentan-1-one its salts, isomers, and salts of isomers: (pentylone, bk-MBDP) ...... (7542) (1) Aminorex (Some other (65) 4-fluoro-N-methylcathinone names: aminoxaphen; 2-amino- (4-FMC; flephedrone) ...... (1238) 5-phenyl-2-oxazoline; or 4,5- (66) 3-fluoro-N-methylcathinone dihydro-5-phenly-2- (3-FMC) ...... (1233) oxazolamine) ...... 1585 (67) 1-(naphthalen-2-yl)-2- (2) N-Benzylpiperazine (some (pyrrolidin-1-yl)pentan-1-one other names: BZP, 1- (naphyrone) ...... (1258) benzylpiperazine) ...... 7493 (68) alpha- (3) Cathinone ...... 1235 pyrrolidinobutiophenone (a- Some trade or other names: PBP) ...... (7546) 2-amino-1-phenyl-1- (69) N-(1-amino-3-methyl-1- propanone, alpha- oxobutan-2-yl)-1- aminopropiophenone, 2- (cyclohexylmethyl)-1H-inda- aminopropiophenone, and zole-3-carboxamide (AB- norephedrone CHMINACA) ...... (7031) (4) Fenethylline ...... 1503 (70) N-(1-amino-3-methyl-1- (5) Methcathinone (Some other oxobutan-2-yl)-1-pentyl-1H- names: 2-(methylamino)- indazole-3-carboxamide (AB- propiophenone; alpha- PINACA) ...... (7023) (methylamino)propiophenone; (71) [1-(5-fluoropentyl)-1H- 2-(methylamino)-1- indazol-3-yl](naphthalen-1- phenylpropan-1-one; alpha-N- yl)methanone (THJ-2201) ...... (7024) methylaminopropiophenone; (72) N-(1-amino-3,3-dimethyl-1- monomethylpropion; oxobutan-2-yl)-1- ephedrone; N- (cyclohexylmethyl)-1H-inda- methylcathinone; zole-3-carboxamide (MAB- methylcathinone; AL–464; AL– CHMINACA; ADB- 422; AL–463 and UR1432), its CHMINACA) ...... (7032) salts, optical isomers and salts (e) Depressants. Unless specifically of optical isomers ...... 1237 excepted or unless listed in another (6) (±)cis-4-methylaminorex schedule, any material, compound, ((±)cis-4,5-dihydro-4-methyl-5- mixture, or preparation which contains phenyl-2-oxazolamine) ...... 1590 any quantity of the following sub- (7) N-ethylamphetamine ...... 1475 stances having a depressant effect on (8) N,N-dimethylamphetamine the central nervous system, including (also known as N,N-alpha- its salts, isomers, and salts of isomers trimethyl-benzeneethanamine; whenever the existence of such salts, N,N-alpha- isomers, and salts of isomers is possible trimethylphenethylamine) ..... 1480 within the specific chemical designa- (g) Cannabimimetic agents. Unless spe- tion: cifically exempted or unless listed in (1) gamma-hydroxybutyric acid another schedule, any material, com- (some other names include pound, mixture, or preparation which GHB; gamma- contains any quantity of the following hydroxybutyrate; 4- substances, or which contains their hydroxybutyrate; 4- salts, isomers, and salts of isomers hydroxybutanoic acid; sodium whenever the existence of such salts, oxybate; sodium oxybutyrate) 2010 isomers, and salts of isomers is possible (2) Mecloqualone ...... 2572 within the specific chemical designa- (3) Methaqualone ...... 2565 tion: (f) Stimulants. Unless specifically ex- (1) 5-(1,1-dimethylheptyl)-2- cepted or unless listed in another [(1R,3S)-3-hydroxycyclohexyl]- schedule, any material, compound, phenol (CP–47,497) ...... 7297 117

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(2) 5-(1,1-dimethyloctyl)-2- (6) methyl 2-(1-(5- [(1R,3S)-3-hydroxycyclohexyl]- fluoropentyl)-1H-indazole-3- phenol (cannabicyclohexanol carboxamido)-3,3- or CP–47,497 C8-homolog) ...... 7298 dimethylbutanoate, its opti- (3) 1-pentyl-3-(1-naph- cal, positional, and geo- thoyl)indole (JWH–018 and metric isomers, salts and AM678) ...... 7118 salts of isomers (Other (4) 1-butyl-3-(1-naphthoyl)indole names: 5F–ADB; 5F–MDMB– (JWH–073) ...... 7173 PINACA) ...... (7034) (5) 1-hexyl-3-(1-naphthoyl)indole (7) methyl 2-(1-(5- (JWH–019) ...... 7019 fluoropentyl)-1H-indazole-3- (6) 1-[2-(4-morpholinyl)ethyl]-3- carboxamido)-3- (1-naphthoyl)indole (JWH–200) 7200 methylbutanoate, its opti- (7) 1-pentyl-3-(2- cal, positional, and geo- methoxyphenylacetyl)indole metric isomers, salts and (JWH–250) ...... 6250 salts of isomers (Other names: 5F–AMB)...... (7033) (8) 1-pentyl-3-[1-(4- methoxynaphthoyl)]indole (8) N-(adamantan-1-yl)-1-(5- (JWH–081) ...... 7081 fluoropentyl)-1H-indazole-3- carboxamide, its optical, po- (9) 1-pentyl-3-(4-methyl-1-naph- sitional, and geometric iso- thoyl)indole (JWH–122) ...... 7122 mers, salts and salts of iso- (10) 1-pentyl-3-(4-chloro-1-naph- mers (Other names: 5F– thoyl)indole (JWH–398) ...... 7398 APINACA, 5F–AKB48) ...... (7049) (11) 1-(5-fluoropentyl)-3-(1-naph- (9) N-(1-amino-3,3-dimethyl-1- thoyl)indole (AM2201) ...... 7201 oxobutan-2-yl)-1-(4- (12) 1-(5-fluoropentyl)-3-(2- fluorobenzyl)-1H-indazole-3- iodobenzoyl)indole (AM694) ..... 7694 carboxamide, its optical, po- (13) 1-pentyl-3-[(4-methoxy)-ben- sitional, and geometric iso- zoyl]indole (SR–19 and RCS–4) 7104 mers, salts and salts of iso- (14) 1-cyclohexylethyl-3-(2- mers (Other names: ADB– methoxyphenylacetyl)indole FUBINACA) ...... (7010) 7008 (SR–18 and RCS–8) ...... 7008 (10) methyl 2-(1- (15) 1-pentyl-3-(2- (cyclohexylmethyl)-1H- chlorophenylacetyl)indole indole-3-carboxamido)-3,3- (JWH–203) ...... 7203 dimethylbutanoate, its opti- (h) Temporary listing of substances sub- cal, positional, and geo- ject to emergency scheduling. Any mate- metric isomers, salts and rial, compound, mixture or preparation salts of isomers (Other names: MDMB–CHMICA, which contains any quantity of the fol- MMB–CHMINACA) ...... (7042) lowing substances: (11) methyl 2-(1-(4- (1) [Reserved]. fluorobenzyl)-1H-indazole-3- (2) [Reserved]. carboxamido)-3,3- (3) N-[1-[2-hydroxy-2- dimethylbutanoate, its opti- (thiophen-2- cal, positional, and geo- yl)ethyl]piperidin-4-yl]-N- metric isomers, salts and phenylpropionamide, its iso- salts of isomers (Other mers, esters, ethers, salts names: MDMB–FUBINACA) (7020) and salts of isomers, esters (12) [Reserved]. and ethers (Other names: (13) [Reserved]. beta-hydroxythiofentanyl) .. (9836) (14) [Reserved]. (4) [Reserved]. (15) [Reserved]. (5) [Reserved]. (16) [Reserved]. (17) [Reserved].

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(18) methyl 2-(1-(4- (26) N-(4-chlorophenyl)-N-(1- fluorobenzyl)-1H-indazole-3- phenethylpiperidin-4- carboxamido)-3- yl)isobutyramide, its iso- methylbutanoate, its opti- mers, esters, ethers, salts cal, positional, and geo- and salts of isomers, esters metric isomers, salts and and ethers (Other name: salts of isomers (Other para-chloroisobutyryl names: FUB–AMB, MMB– fentanyl) ...... (9826) FUBINACA, AMB– (27) N-(1-phenethylpiperidin-4- FUBINACA) ...... (7021) yl)-N-phenylisobutyramide, (19) N-(2-fluorophenyl)-N-(1- its isomers, esters, ethers, phenethylpiperidin-4- salts and salts of isomers, yl)propionamide, its iso- esters and ethers (Other mers, esters, ethers, salts name: isobutyryl fentanyl) .. (9827) and salts of isomers, esters (28) N-(1-phenethylpiperidin-4- and ethers (Other names: yl)-N- ortho-fluorofentanyl, 2- phenylcyclopentanecarboxa- fluorofentanyl) ...... (9816) mide, its isomers, esters, (20) [Reserved]. ethers, salts and salts of iso- (21) 2-methoxy-N-(1- mers, esters and ethers phenethylpiperidin-4-yl)-N- (Other name: cyclopentyl phenylacetamide, its iso- fentanyl) ...... (9847) (29) [Reserved]. mers, esters, ethers, salts (30) Fentanyl-related sub- and salts of isomers, esters stances, their isomers, and ethers (Other name: esters, ethers, salts and salts methoxyacetyl fentanyl) ..... (9825) of isomers, esters and ethers 9850 (22) N-(1-phenethylpiperidin-4- yl)-N- (i) Fentanyl-related substance means phenylcyclopropanecarboxa- any substance not otherwise listed mide, its isomers, esters, under another Administration Con- ethers, salts and salts of iso- trolled Substance Code Number, and mers, esters and ethers for which no exemption or approval is (Other name: cyclopropyl in effect under section 505 of the Fed- fentanyl) ...... (9845) eral Food, Drug, and Cosmetic Act [21 (23) N-(1-phenethylpiperidin-4- U.S.C. 355], that is structurally related yl)-N-phenylpentanamide, to fentanyl by one or more of the fol- its isomers, esters, ethers, lowing modifications: salts and salts of isomers, (A) Replacement of the phenyl por- esters and ethers (Other tion of the phenethyl group by any name: Valeryl fentanyl) ...... (9840) monocycle, whether or not further substituted in or on the monocycle; (24) N-(4-fluorophenyl)-N-(1- (B) Substitution in or on the phenethylpiperidin-4- phenethyl group with alkyl, alkenyl, yl)butyramide, its isomers, alkoxyl, hydroxyl, halo, haloalkyl, esters, ethers, salts and salts amino or nitro groups; of isomers, esters and ethers (C) Substitution in or on the piper- (Other name: para- idine ring with alkyl, alkenyl, alkoxyl, fluorobutyryl fentanyl) ...... (9823) ester, ether, hydroxyl, halo, haloalkyl, (25) N-(4-methoxyphenyl)-N-(1- amino or nitro groups; phenethylpiperidin-4- (D) Replacement of the aniline ring yl)butyramide, its isomers, with any aromatic monocycle whether esters, ethers, salts and salts or not further substituted in or on the of isomers, esters and ethers aromatic monocycle; and/or (Other name: para- (E) Replacement of the N-propionyl methoxybutyryl fentanyl) ... (9837) group by another acyl group. (ii) This definition includes, but is not limited to, the following substances: (A)–(B) [Reserved] 119

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EFFECTIVE DATE NOTES: At 82 FR 17123, (31) Naphthalen-1-yl 1-(5- Apr. 10, 2017, § 1308.11 was amended by adding fluoropentyl)-1H-indole-3- paragraphs (h)(10) through (15), effective Apr. carboxylate, its optical, po- 10. 2017 through Apr. 10, 2019. sitional, and geometric iso- 2. At 82 FR 20547, May 3, 2017, § 1308.11 was mers, salts and salts of iso- amended by adding (h)(16), effective May 3, mers (Other names: NM2201; 2017, until May 3, 2019. At 82 FR 47974, Oct. 16, CBL2201) ...... (7221) 2017, § 1308.11 was amended by redesignating (h)(16) as paragraph (h)(13). (32) N-(1-amino-3-methyl-1- 3. At 82 FR 32457, July 14, 2017, § 1308.11 was oxobutan-2-yl)-1-(5- amended by adding (h)(17), effective July 14, fluoropentyl)-1H-indazole-3- 2017, until July 15, 2019. At 82 FR 47974, Oct. carboxamide, its optical, po- 16, 2017, § 1308.11 was amended by redesig- sitional, and geometric iso- nating (h)(17) as paragraph (h)(14). mers, salts and salts of iso- 4. At 82 FR 49508, Oct. 26, 2017, § 1308.11 was mers (Other names: 5F-AB- amended by adding reserved paragraphs PINACA) ...... (7025) (h)(15) through (h)(18) and (h)(19), (20) and (33) 1-(4-cyanobutyl)-N-(2- (21), effective Oct. 26, 2017,, through Oct. 28, 2019. phenylpropan-2-yl)-1H-inda- 5. At 82 FR 51558, Nov. 3, 2017, § 1308.11 was zole-3-carboxamide, its opti- amended by adding paragraph (h)(18), effec- cal, positional, and geo- tive Nov. 3, 2017, through Nov. 4, 2019. metric isomers, salts and 6. At 83 FR 472, Jan. 4, 2018, § 1308.11 was salts of isomers (Other amended by adding paragraph (h)(22), effec- names: 4-CN-CUMYL- tive Jan. 4, 2018, through Jan. 4, 2020. BUTINACA; 4-cyano- 7. At 83 FR 4584, Feb. 1, 2018, § 1308.11 was CUMYL-BUTINACA; 4-CN- amended by adding paragraphs (h)(23) CUMYL BINACA; CUMYL- through (h)(29), effective Feb. 1, 2018, through Feb. 1, 2020. 4CN-BINACA; SGT-78) ...... (7089) 8. At 83 FR 5191, Feb. 6, 2018, § 1308.11 was (34) methyl 2-(1- amended by adding paragraph (h)(30), effec- (cyclohexylmethyl)-1H- tive Feb. 6, 2018, through Feb. 6, 2020. indole-3-carboxamido)-3- 9. At 83 FR 10368, Mar. 9, 2018, § 1308.11 was methylbutanoate, its opti- amended by revising paragraphs (h)(23) and cal, positional, and geo- (h)(29), effective Mar. 9, 2018, through Feb. 1, metric isomers, salts and 2020. salts of isomers (Other 10. At 83 FR 31882, July 10, 2018, § 1308.11 names: MMB-CHMICA, was amended by adding paragraphs (h)(31) through (h)(35) effective July 10, 2018 through AMB-CHMICA) ...... (7044) July 10, 2020. (35) 1-(5-fluoropentyl)-N-(2- 11. At 83 FR 44478, Aug. 31, 2018, § 1308.11 phenylpropan-2-yl)-1H- was amended by adding paragraph (h)(36) ef- pyrrolo[2,3-b]pyridine-3- fective Aug. 31, 2018 through Aug. 31, 2020. carboxamide, its optical, positional, and geometric iso- § 1308.12 Schedule II. mers, salts and salts of iso- (a) Schedule II shall consist of the mers (Other names: 5F- drugs and other substances, by what- CUMYL-P7AICA) ...... (7085) ever official name, common or usual (36) N-Ethylpentylone, its op- name, chemical name, or brand name tical, positional, and geo- designated, listed in this section. Each metric isomers, salts and drug or substance has been assigned salts of isomers (Other the Controlled Substances Code Num- names: ephylone, 1-(1,3- ber set forth opposite it. benzodioxol-5-yl)-2- (b) Substances, vegetable origin or (ethylamino)-pentan-1-one) (7543) chemical synthesis. Unless specifically excepted or unless listed in another [39 FR 22141, June 20, 1974] schedule, any of the following sub- EDITORIAL NOTE: For FEDERAL REGISTER ci- stances whether produced directly or tations affecting § 1308.11, see the List of CFR indirectly by extraction from sub- Sections Affected, which appears in the stances of vegetable origin, or inde- Finding Aids section of the printed volume pendently by means of chemical syn- and at www.govinfo.gov. thesis, or by a combination of extraction and chemical synthesis:

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(1) Opium and opiate, and any salt, its isomers, esters, ethers, salts and compound, derivative, or preparation salts of isomers, esters and ethers of opium or opiate excluding whenever the existence of such iso- apomorphine, thebaine-derived mers, esters, ethers, and salts is pos- butorphanol, dextrorphan, nalbuphine, sible within the specific chemical des- naldemedine, nalmefene, naloxegol, ignation, dextrorphan and naloxone, and naltrexone, and their re- levopropoxyphene excepted: spective salts, but including the fol- (1) Alfentanil ...... 9737 lowing: (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 (6) Carfentanil ...... 9743 (vi) Hydrocodone ...... 9193 (7) Dihydrocodeine ...... 9120 (vii) Hydromorphone ...... 9150 (8) Diphenoxylate ...... 9170 (viii) Metopon ...... 9260 (9) Fentanyl ...... 9801 (ix) Morphine ...... 9300 (10) Isomethadone ...... 9226 (x) Opium extracts ...... 9610 (11) Levo-alphacetylmethadol .... 9648 (xi) Opium fluid ...... 9620 [Some other names: levo- (xii) Oripavine ...... 9330 alpha-acetylmethadol, (xiii) Oxycodone ...... 9143 levomethadyl acetate, (xiv) Oxymorphone ...... 9652 LAAM] (xv) Powdered opium ...... 9639 (12) Levomethorphan ...... 9210 (xvi) Raw opium ...... 9600 (13) Levorphanol ...... 9220 (xvii) Thebaine ...... 9333 (14) Metazocine ...... 9240 (xviii) Tincture of opium ...... 9630 (15) Methadone ...... 9250 (2) Any salt, compound, derivative, or (16) Methadone-Intermediate, 4- preparation thereof which is chemi- cyano-2-dimethylamino-4,4-di- cally equivalent or identical with any phenyl butane ...... 9254 of the substances referred to in para- (17) Moramide-Intermediate, 2- graph (b) (1) of this section, except that methyl-3-morpholino-1, 1- these substances shall not include the diphenylpropane-carboxylic isoquinoline alkaloids of opium. acid ...... 9802 (3) Opium poppy and poppy straw. (18) Pethidine (meperidine) ...... 9230 (4) Coca leaves (9040) and any salt, (19) Pethidine-Intermediate-A, 4- compound, derivative or preparation of cyano-1-methyl-4- coca leaves (including cocaine (9041) phenylpiperidine ...... 9232 and ecgonine (9180) and their salts, iso- (20) Pethidine-Intermediate-B, mers, derivatives and salts of isomers ethyl-4-phenylpiperidine-4- and derivatives), and any salt, com- carboxylate ...... 9233 pound, derivative, or preparation (21) Pethidine-Intermediate-C, 1- thereof which is chemically equivalent methyl-4-phenylpiperidine-4- or identical with any of these sub- carboxylic acid ...... 9234 stances, except that the substances (22) Phenazocine ...... 9715 shall not include: (23) Piminodine ...... 9730 (i) Decocainized coca leaves or ex- (24) Racemethorphan ...... 9732 traction of coca leaves, which extrac- (25) Racemorphan ...... 9733 tions do not contain cocaine or ecgo- (26) Remifentanil ...... 9739 (27) Sufentanil ...... 9740 nine; or (28) Tapentadol ...... 9780 (ii) [123I]ioflupane. (5) Concentrate of poppy straw (the (29) Thiafentanil ...... 9729 crude extract of poppy straw in either (d) Stimulants. Unless specifically ex- liquid, solid or powder form which con- cepted or unless listed in another tains the phenanthrene alkaloids of the schedule, any material, compound, opium poppy), 9670. mixture, or preparation which contains (c) Opiates. Unless specifically ex- any quantity of the following sub- cepted or unless in another schedule stances having a stimulant effect on any of the following opiates, including the central nervous system:

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contains any quantity of the following (1) Amphetamine, its salts, opti- substances: cal isomers, and salts of its optical isomers ...... 1100 (1) Immediate precursor to amphetamine and methamphetamine: (2) Methamphetamine, its salts, isomers, and salts of its iso- (i) Phenylacetone ...... 8501 mers ...... 1105 Some trade or other names: (3) Phenmetrazine and its salts 1631 phenyl-2-propanone; P2P; (4) Methylphenidate ...... 1724 benzyl methyl ketone; methyl benzyl ketone; (5) Lisdexamfetamine, its salts, (2) Immediate precursors to isomers, and salts of its iso- phencyclidine (PCP): mers ...... 1205. (i) 1-phenylcyclohexylamine ...... 7460 (e) Depressants. Unless specifically (ii) 1- excepted or unless listed in another piperidinocyclohexanecarboni- schedule, any material, compound, trile (PCC) ...... 8603 mixture, or preparation which contains (3) Immediate precursor to any quantity of the following sub- fentanyl: stances having a depressant effect on (i) 4-anilino-N- the central nervous system, including phenethylpiperidine (ANPP) ... 8333 its salts, isomers, and salts of isomers (ii) [Reserved] whenever the existence of such salts, isomers, and salts of isomers is possible [39 FR 22142, June 20, 1974] within the specific chemical designa- EDITORIAL NOTE: For FEDERAL REGISTER ci- tion: tations affecting § 1308.12, see the List of CFR (1) Amobarbital ...... 2125 Sections Affected, which appears in the (2) Glutethimide ...... 2550 Finding Aids section of the printed volume and at www.govinfo.gov. (3) Pentobarbital ...... 2270 (4) Phencyclidine ...... 7471 § 1308.13 Schedule III. (5) Secobarbital ...... 2315 (a) Schedule III shall consist of the (f) Hallucinogenic substances. drugs and other substances, by what- ever official name, common or usual (1) Nabilone ...... 7379 name, chemical name, or brand name [Another name for designated, listed in this section. Each ± nabilone: ( )-trans-3-(1,1- drug or substance has been assigned dimethylheptyl)- the DEA Controlled Substances Code 6,6a,7,8,10,10a-hexahydro- Number set forth opposite it. 1-hydroxy-6,6-dimethyl- (b) Stimulants. Unless specifically ex- 9H-dibenzo[b,d]pyran-9- cepted or unless listed in another one] schedule, any material, compound, (2) Dronabinol [(-)-delta-9-trans mixture, or preparation which contains tetrahydrocannabinol] in an any quantity of the following sub- oral solution in a drug prod- stances having a stimulant effect on uct approved for marketing the central nervous system, including by the U.S. Food and Drug its salts, isomers (whether optical, po- Administration ...... (7365) sitional, or geometric), and salts of (g) Immediate precursors. Unless spe- such isomers whenever the existence of cifically excepted or unless listed in such salts, isomers, and salts of iso- another schedule, any material, com- mers is possible within the specific pound, mixture, or preparation which chemical designation:

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(1) Those compounds, mixtures, (4) Chlorhexadol ...... 2510 or preparations in dosage unit (5) Embutramide ...... 2020 form containing any stimu- (6) Any drug product containing lant substances listed in gamma hydroxybutyric acid, schedule II which compounds, including its salts, isomers, mixtures, or preparations were and salts of isomers, for which listed on August 25, 1971, as ex- an application is approved cepted compounds under under section 505 of the Fed- § 1308.32, and any other drug of eral Food, Drug, and Cosmetic the quantitative composition Act ...... 2012 shown in that list for those (7) Ketamine, its salts, isomers, drugs or which is the same ex- and salts of isomers ...... 7285 cept that it contains a lesser [Some other names for quantity of controlled sub- ketamine: (±)-2-(2- stances ...... 1405 chlorophenyl)-2- (2) Benzphetamine ...... 1228 (methylamino)- (3) Chlorphentermine ...... 1645 cyclohexanone] (4) Clortermine ...... 1647 (8) Lysergic acid ...... 7300 (5) Phendimetrazine ...... 1615 (9) Lysergic acid amide ...... 7310 (c) Depressants. Unless specifically (10) Methyprylon ...... 2575 excepted or unless listed in another (11) Perampanel, and its salts, schedule, any material, compound, isomers, and salts of isomers .. 2261 mixture, or preparation which contains (12) Sulfondiethylmethane ...... 2600 any quantity of the following sub- (13) Sulfonethylmethane ...... 2605 stances having a depressant effect on the central nervous system: (14) Sulfonmethane ...... 2610 (15) Tiletamine and zolazepam (1) Any compound, mixture or or any salt thereof ...... 7295 preparation containing: (i) Amobarbital ...... 2126 Some trade or other names (ii) Secobarbital ...... 2316 for a tiletamine-zolazepam combination product: (iii) Pentobarbital ...... 2271 or any salt thereof and one Telazol.. or more other active me- Some trade or other names dicinal ingredients which for tiletamine: are not listed in any 2-(ethylamino)-2-(2- schedule. thienyl)- (2) Any suppository dosage form cyclohexanone.. containing: Some trade or other names (i) Amobarbital ...... 2126 for zolazepam: (ii) Secobarbital ...... 2316 4-(2-fluorophenyl)-6,8- (iii) Pentobarbital ...... 2271 dihydro-1,3,8- or any salt of any of these trimethylpyrazolo-[3,4- drugs and approved by the e] [1,4]-diazepin-7(1H)- Food and Drug Adminis- one, flupyrazapon.. tration for marketing only as a suppository. (d) Nalorphine 9400. (3) Any substance which con- (e) Narcotic drugs. Unless specifically tains any quantity of a deriva- excepted or unless listed in another tive of barbituric acid or any schedule: salt thereof ...... 2100

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(1) Any material, compound, (vi) Not more than 50 mixture, or preparation con- milligrams of mor- taining any of the following phine per 100 milli- narcotic drugs, or their salts liters or per 100 grams, calculated as the free anhy- with one or more ac- drous base or alkaloid, in lim- tive, nonnarcotic in- ited quantities as set forth gredients in recognized below: therapeutic amounts ... 9810 (i) Not more than 1.8 (2) Any material, compound, grams of codeine per mixture, or preparation con- 100 milliliters or not taining any of the following more than 90 milli- narcotic drugs or their salts, grams per dosage unit, as set forth below: with an equal or great- (i) Buprenorphine ...... 9064 er quantity of an (ii) [Reserved]. isoquinoline alkaloid (f) Anabolic Steroids. Unless specifi- of opium ...... 9803 cally excepted or unless listed in an- (ii) Not more than 1.8 other schedule, any material, com- grams of codeine per pound, mixture or preparation con- 100 milliliters or not taining any quantity of the following more than 90 milli- substances, including its salts, esters grams per dosage unit, and ethers: with one or more ac- (1) Anabolic steroids (see § 1300.01 of tive, nonnarcotic in- this chapter)—4000 gredients in recognized (2) [Reserved] therapeutic amounts ... 9804 (iii) Not more than 1.8 (g) Hallucinogenic substances. (1) grams of Dronabinol (synthetic) in sesame oil dihydrocodeine per 100 and encapsulated in a soft gelatin cap- milliliters or not more sule in a U.S. Food and Drug Adminis- than 90 milligrams per tration approved product—7369. dosage unit, with one [Some other names for dronabinol: (6aR- or more active nonnar- trans)-6a,7,8,10a-tetrahydro-6,6,9-trimethyl-3- cotic ingredients in pentyl-6H-dibenzo [b,d]pyran-1-ol] or (-)- recognized therapeutic delta-9-(trans)-tetrahydrocannabinol] amounts ...... 9807 (2) [Reserved] (iv) Not more than 300 milligrams of [39 FR 22142, June 20, 1974] ethylmorphine per 100 EDITORIAL NOTE: For FEDERAL REGISTER ci- milliliters or not more tations affecting § 1308.13, see the List of CFR than 15 milligrams per Sections Affected, which appears in the dosage unit, with one Finding Aids section of the printed volume or more active, non- and at www.govinfo.gov. narcotic ingredients in recognized therapeutic § 1308.14 Schedule IV. amounts ...... 9808 (a) Schedule IV shall consist of the (v) Not more than 500 drugs and other substances, by what- milligrams of opium ever official name, common or usual per 100 milliliters or name, chemical name, or brand name per 100 grams or not designated, listed in this section. Each more than 25 milli- drug or substance has been assigned grams per dosage unit, the DEA Controlled Substances Code with one or more ac- Number set forth opposite it. tive, nonnarcotic in- (b) Narcotic drugs. Unless specifically gredients in recognized excepted or unless listed in another therapeutic amounts ... 9809 schedule, any material, compound, mixture, or preparation containing any of the following narcotic drugs, or 124

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their salts calculated as the free anhy- (31) Lormetazepam ...... 2774 drous base or alkaloid, in limited quan- (32) Mebutamate ...... 2800 tities as set forth below: (33) Medazepam ...... 2836 (1) Not more than 1 milligram of (34) Meprobamate ...... 2820 difenoxin and not less than 25 (35) Methohexital ...... 2264 micrograms of atropine sul- (36) Methylphenobarbital fate per dosage unit ...... 9167 (mephobarbital) ...... 2250 (2) Dextropropoxyphene (alpha- (37) Midazolam ...... 2884 (+)-4-dimethylamino-1,2-di- (38) Nimetazepam ...... 2837 phenyl-3-methyl-2- (39) Nitrazepam ...... 2834 propionoxybutane) ...... 9278 (40) Nordiazepam ...... 2838 (3) 2-[(dimethylamino)methyl]-1- (41) Oxazepam ...... 2835 (3- (42) Oxazolam ...... 2839 methoxyphenyl)cyclohexanol, (43) Paraldehyde ...... 2585 its salts, optical and geo- (44) Petrichloral ...... 2591 metric isomers and salts of (45) Phenobarbital ...... 2285 these isomers (including (46) Pinazepam ...... 2883 tramadol) ...... 9752 (47) Prazepam ...... 2764 (48) Quazepam ...... 2881 (c) Depressants. Unless specifically (49) Suvorexant ...... 2223 excepted or unless listed in another (50) Temazepam ...... 2925 schedule, any material, compound, (51) Tetrazepam ...... 2886 mixture, or preparation which contains (52) Triazolam ...... 2887 any quantity of the following sub- (53) Zaleplon ...... 2781 stances, including its salts, isomers, (54) Zolpidem ...... 2783 and salts of isomers whenever the ex- (55) Zopiclone ...... 2784 istence of such salts, isomers, and salts of isomers is possible within the spe- (d) Fenfluramine. Any material, com- cific chemical designation: pound, mixture, or preparation which contains any quantity of the following (1) Alfaxalone ...... 2731 substances, including its salts, isomers (2) Alprazolam ...... 2882 (whether optical, position, or geo- (3) Barbital ...... 2145 metric), and salts of such isomers, (4) Bromazepam ...... 2748 whenever the existence of such salts, (5) Camazepam ...... 2749 isomers, and salts of isomers is pos- (6) Carisoprodol ...... 8192 sible: (7) Chloral betaine ...... 2460 (8) Chloral hydrate ...... 2465 (1) Fenfluramine ...... 1670 (9) Chlordiazepoxide ...... 2744 (e) Lorcaserin. Any material, com- (10) Clobazam ...... 2751 pound, mixture, or preparation which (11) Clonazepam ...... 2737 contains any quantity of the following (12) Clorazepate ...... 2768 substances, including its salts, isomers, (13) Clotiazepam ...... 2752 and salts of such isomers, whenever the (14) Cloxazolam ...... 2753 existence of such salts, isomers, and (15) Delorazepam ...... 2754 salts of isomers is possible: (16) Diazepam ...... 2765 (1) Lorcaserin ...... 1625 (17) Dichloralphenazone ...... 2467 (18) Estazolam ...... 2756 (f) Stimulants. Unless specifically ex- (19) Ethchlorvynol ...... 2540 cepted or unless listed in another (20) Ethinamate ...... 2545 schedule, any material, compound, (21) Ethyl loflazepate ...... 2758 mixture, or preparation which contains (22) Fludiazepam ...... 2759 any quantity of the following sub- (23) Flunitrazepam ...... 2763 stances having a stimulant effect on (24) Flurazepam ...... 2767 the central nervous system, including (25) Fospropofol ...... 2138 its salts, isomers and salts of isomers: (26) Halazepam ...... 2762 (1) Cathine ((+)- (27) Haloxazolam ...... 2771 norpseudoephedrine) ...... 1230 (28) Ketazolam ...... 2772 (2) Diethylpropion ...... 1610 (29) Loprazolam ...... 2773 (3) Fencamfamin ...... 1760 (30) Lorazepam ...... 2885 (4) Fenproporex ...... 1575 125

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(5) Mazindol ...... 1605 narcotic active medicinal ingredients (6) Mefenorex ...... 1580 in sufficient proportion to confer upon (7)Modafinil ...... 1680 the compound, mixture, or preparation (8) Pemoline (including valuable medicinal qualities other than organometallic complexes and those possessed by narcotic drugs chelates thereof) ...... 1530 alone: (9) Phentermine ...... 1640 (1) Not more than 200 milligrams of (10) Pipradrol ...... 1750 codeine per 100 milliliters or per 100 (11) Sibutramine ...... 1675 grams. (12) SPA ((-)-1-dimethylamino- (2) Not more than 100 milligrams of 1,2-diphenylethane) ...... 1635 dihydrocodeine per 100 milliliters or (g) Other substances. Unless specifi- per 100 grams. cally excepted or unless listed in an- (3) Not more than 100 milligrams of other schedule, any material, com- ethylmorphine per 100 milliliters or per pound, mixture or preparation which 100 grams. contains any quantity of the following (4) Not more than 2.5 milligrams of substances, including its salts: diphenoxylate and not less than 25 (1) Pentazocine ...... 9709 micrograms of atropine sulfate per dos- (2) Butorphanol (including its age unit. optical isomers) ...... 9720 (5) Not more than 100 milligrams of (3) Eluxadoline (5-[[[(2S)-2- opium per 100 milliliters or per 100 amino-3-[4-aminocarbonyl)-2,6- grams. dimethylphenyl]-1- (6) Not more than 0.5 milligram of oxopropyl][(1S)-1-(4-phenyl-1H- difenoxin and not less than 25 imidazol-2- micrograms of atropine sulfate per dos- yl)ethyl]amino]methyl]-2- methoxybenzoic acid) (includ- age unit. ing its optical isomers) and its (d) Stimulants. Unless specifically ex- salts, isomers, and salts of iso- empted or excluded or unless listed in mers (9725).. another schedule, any material, compound, mixture, or preparation which [39 FR 22143, June 20, 1974] contains any quantity of the following EDITORIAL NOTE: For FEDERAL REGISTER ci- substances having a stimulant effect tations affecting § 1308.14, see the List of CFR on the central nervous system, includ- Sections Affected, which appears in the ing its salts, isomers and salts of iso- Finding Aids section of the printed volume mers: and at www.govinfo.gov. (1) Pyrovalerone ...... 1485. § 1308.15 Schedule V. (2) [Reserved]. (a) Schedule V shall consist of the (e) Depressants. Unless specifically drugs and other substances, by what- exempted or excluded or unless listed ever official name, common or usual in another schedule, any material, name, chemical name, or brand name compound, mixture, or preparation designated, listed in this section. which contains any quantity of the fol- (b) Narcotic drugs. Unless specifically lowing substances having a depressant excepted or unless listed in another effect on the central nervous system, schedule, any material, compound, including its salts: mixture, or preparation containing any of the following narcotic drugs and (1) Brivaracetam ((2S)-2-[(4R)-2- their salts, as set forth below: oxo-4-propylpyrrolidin-1-yl] (1) [Reserved] butanamide) (also referred to (c) Narcotic drugs containing non-nar- as BRV; UCB–34714; Briviact) cotic active medicinal ingredients. Any (including its salts) ...... 2710 compound, mixture, or preparation (2) Ezogabine [N-[2-amino-4-(4- containing any of the following nar- fluorobenzylamino)-phenyl]- cotic drugs, or their salts calculated as carbamic acid ethyl ester] ...... 2779 the free anhydrous base or alkaloid, in (3) Lacosamide [(R)-2- limited quantities as set forth below, acetoamido-N-benzyl-3- which shall include one or more non- methoxy-propionamide] ...... 2746 126

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(4) Pregabalin [(S)-3- cepted, the reason therefore. The Ad- (aminomethyl)-5- ministrator need not accept an applica- methylhexanoic acid] ...... 2782 tion for filing if any of the require- (f) Approved cannabidiol drugs. (1) ments prescribed in paragraph (b) of A drug product in finished dos- this section is lacking or is not set age formulation that has been forth as to be readily understood. If the approved by the U.S. Food and applicant desires, he may amend the Drug Administration that con- application to meet the requirements tains cannabidiol (2-[1R-3- of paragraph (b) of this section. If the methyl-6R-(1-methylethenyl)- application is accepted for filing, the 2-cyclohexen-1-yl]-5-pentyl-1,3- Administrator shall issue and publish benzenediol) derived from can- in the FEDERAL REGISTER his order on nabis and no more than 0.1 the application, which shall include a percent (w/w) residual reference to the legal authority under tetrahydrocannabinols ...... 7367 which the order is issued and the find- (2) [Reserved] ings of fact and conclusions of law [39 FR 22143, June 20, 1974, as amended at 43 upon which the order is based. This FR 38383, Aug. 28, 1978; 44 FR 40888, July 13, order shall specify the date on which it 1979; 47 FR 49841, Nov. 3, 1982; 50 FR 8108, Feb. shall take effect. The Administrator 28, 1985; 52 FR 5952, Feb. 27, 1987; 53 FR 10870, shall permit any interested person to Apr. 4, 1988; 56 FR 61372, Dec. 3, 1991; 67 FR file written comments on or objections 62370, Oct. 7, 2002; 70 FR 43635, July 28, 2005; to the order within 60 days of the date 74 FR 23790, May 21, 2009; 76 FR 77899, Dec. 15, 2011; 81 FR 29491, May 12, 2016; 83 FR 48953, of publication of his order in the FED- Sept 28, 2018] ERAL REGISTER. If any such comments or objections raise significant issues EXCLUDED NONNARCOTIC SUBSTANCES regarding any finding of fact or conclusion 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. 811(g)(1)), may apply to the Drug and (d) The Administrator may at any Chemical Evaluation Section, Diver- time revoke any exclusion granted pur- sion Control Division, Drug Enforce- suant to section 201(g) of the Act (21 ment Administration. See the Table of U.S.C. 811(g)) by following the proce- DEA Mailing Addresses in § 1321.01 of dures set forth in paragraph (c) of this 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 fol- [38 FR 8254, Mar. 30, 1973, as amended at 70 lowing information: FR 74657, Dec. 16, 2005; 75 FR 10678, Mar. 9, (1) The name and address of the ap- 2010; 81 FR 97021, Dec. 30, 2016] plicant; (2) The name of the substance for § 1308.22 Excluded substances. which exclusion is sought; and The following nonnarcotic substances (3) The complete quantitative com- which may, under the Federal Food, position of the substance. (c) Within a reasonable period of Drug, and Cosmetic Act (21 U.S.C. 301), time after the receipt of an application be lawfully sold over the counter with- for an exclusion under this section, the out a prescription, are excluded from Administrator shall notify the appli- all schedules pursuant to section 201(g) cant of his acceptance or nonaccept- (1) of the Act (21 U.S.C. 811(g) (1)): ance of his application, and if not ac- 127

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EXCLUDED NONNARCOTIC PRODUCTS

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

Aphena Pharma Solu- Nasal Decongestant In- ...... IN Levmetamfetamine (l-Des- 50.00 tions—New York, LLC. haler/Vapor Inhaler. oxyephedrine). Bioline Laboratories ...... Theophed ...... 00719–1945 TB Phenobarbital ...... 8.00 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 Procter & Gamble Co., The Vicks VapoInhaler ...... 37000–686–01 IN Levmetamfetamine (l-Des- 50.00 oxyephedrine). 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 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; 80 FR 65634, 65637, Oct. 27, 2015; 81 FR 6453, Feb. 8, 2016]

EXEMPT CHEMICAL PREPARATIONS narcotic controlled substance, the preparation or mixture must be formu- § 1308.23 Exemption of certain chem- lated in such a manner that it incor- ical preparations; application. porates methods of denaturing or other (a) The Administrator may, by regu- means so that the preparation or mix- lation, exempt from the application of ture is not liable to be abused or have all or any part of the Act any chemical ill effects, if abused, and so that the preparation or mixture containing one narcotic substance cannot in practice or more controlled substances listed in be removed. any schedule, which preparation or (b) Any person seeking to have any mixture is intended for laboratory, in- preparation or mixture containing a dustrial, educational, or special re- controlled substance and one or more search purposes and not for general ad- noncontrolled substances exempted ministration to a human being or other from the application of all or any part animal, if the preparation or mixture of the Act, pursuant to paragraph (a) of either: this section, may apply to the Drug (1) Contains no narcotic controlled and Chemical Evaluation Section, Di- substance and is packaged in such a version Control Division, Drug En- form or concentration that the pack- forcement Administration. See the aged quantity does not present any sig- Table of DEA Mailing Addresses in nificant potential for abuse (the type of § 1321.01 of this chapter for the current packaging and the history of abuse of mailing address. the same or similar preparations may (c) An application for an exemption be considered in determining the po- under this section shall contain the fol- tential for abuse of the preparation or lowing information: mixture); or (1) The name, address, and registra- (2) Contains either a narcotic or non- tion number, if any, of the applicant; narcotic controlled substance and one (2) The name, address, and registra- or more adulterating or denaturing tion number, if any, of the manufac- agents in such a manner, combination, turer or importer of the preparation or quantity, proportion, or concentration, mixture, if not the applicant; that the preparation or mixture does (3) The exact trade name or other not present any potential for abuse. If designation of the preparation or mix- the preparation or mixture contains a ture;

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(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; 81 FR 97021, necessary to determine whether the ap- Dec. 30, 2016] plication should be granted. (e) Within a reasonable period of § 1308.24 Exempt chemical prepara- time after the receipt of an application tions. for an exemption under this section, (a) The chemical preparations and the Administrator shall notify the ap- mixtures approved pursuant to § 1308.23 plicant of his acceptance or nonaccept- are exempt from application of sec- ance of his application, and if not actions 302, 303, 305, 306, 307, 308, 309, 1002, cepted, the reason therefor. The Ad- 1003 and 1004 of the Act (21 U.S.C. 822– ministrator need not accept an applica- 823, 825–829, 952–954) and § 1301.74 of this tion for filing if any of the require- chapter, to the extent described in ments prescribed in paragraph (c) or re- paragraphs (b) to (h) of this section. quested pursuant to paragraph (d) is Substances set forth in paragraph (j) of lacking or is not set forth as to be this section shall be exempt from the readily understood. If the applicant de- application of sections 305, 306, 307, 308, sires, he may amend the application to 309, 1002, 1003 and 1004 of the Act (21 meet the requirements of paragraphs U.S.C. 825–829, 952–954) and §§ 1301.71– (c) and (d) of this section. If the appli- 1301.73 and 1301.74 (a), (b), (d), (e) and (f) cation is accepted for filing, the Ad- of this chapter to the extent as herein- ministrator shall issue and publish in after may be provided.

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(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 warning the person reading it that (f) Criminal penalties: No exemption human or animal use is not intended. granted pursuant to § 1308.23 affects the The symbol designating the schedule of criminal liability for illegal manufac- the controlled substance is not re- ture, distribution, or possession of con- quired on either the label or the label- trolled substances contained in the ex- ing of the exempt chemical prepara- empt chemical preparation. Distribu- tion, nor is it necessary to list all in- tion, possession, and use of an exempt gredients of the preparation. chemical preparation are lawful for (d) Records and reports: Any person registrants and nonregistrants only as who manufactures an exempt chemical long as such distribution, possession, preparation or mixture must keep com- or use is intended for laboratory, in- plete and accurate records and file all dustrial, or educational purposes and reports required under part 1304 of this not for immediate or subsequent ad- chapter regarding all controlled sub- ministration to a human being or other stances being used in the manufac- animal. turing process until the preparation or (g) Bulk materials: For materials ex- mixture is in the form described in empted in bulk quantities, the Admin- paragraph (i) of this section. In lieu of istrator may prescribe requirements records and reports required under part other than those set forth in para- 1304 of this chapter regarding exempt graphs (b) through (e) of this section on chemical preparations, the manufac- a case-by-case basis. turer need only record the name, ad- (h) Changes in chemical preparations: dress, and registration number, if any, Any change in the quantitative or

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qualitative composition of the prepara- (b) An application for any exclusion tion or mixture after the date of appli- under this section shall be submitted cation, or change in the trade name or in triplicate and contain the following other designation of the preparation or information: mixture, set forth in paragraph (i) of (1) The name and address of the ap- this section, requires a new application plicant; for exemption. (2) The name of the product; (i) A listing of exempt chemical prep- (3) The chemical structural formula arations may be obtained by submit- or description for any anabolic steroid ting a written request to the Drug and contained in the product; Chemical Evaluation Section, Drug En- (4) A complete description of dosage forcement Administration. See the and quantitative composition of the Table of DEA Mailing Addresses in dosage form;. § 1321.01 of this chapter for the current (5) The conditions of use including mailing address. whether or not Federal law restricts (j) The following substances are des- this product to use by or on the order ignated as exempt chemical prepara- of a licensed veterinarian; tions for the purposes set forth in this (6) A description of the delivery sys- section. tem in which the dosage form will be distributed with sufficient detail to (1) Chloral. When packaged in a identify the product (e.g. 20 cartridge sealed, oxygen-free environment, under brown plastic belt); nitrogen pressure, safeguarded against (7) The label and labeling of the im- exposure to the air. R mediate container and the commercial (2) Emit Phenobarbital Enzyme Rea- containers, if any, of the product;. gent B. In one liter quantities each (8) The name and address of the man- with a 5 ml. retention sample for re- ufacturer of the dosage form if dif- packaging as an exempt chemical prep- ferent from that of the applicant; and aration only. (9) Evidence that the product has [38 FR 8255, Mar. 30, 1973] been approved by the Secretary of Health and Human Services for admin- EDITORIAL NOTE: For FEDERAL REGISTER citations affecting § 1308.24, see the List of CFR istration through implant to cattle or Sections Affected, which appears in the other nonhuman species. Finding Aids section of the printed volume (c) Within a reasonable period of and at www.govinfo.gov. time after the receipt of an application for an exclusion under this section, the EXCLUDED VETERINARY ANABOLIC Administrator shall notify the appli- STEROID IMPLANT PRODUCTS cant of his acceptance or nonaccept- ance of the application, and if not ac- § 1308.25 Exclusion of a veterinary an- cepted, the reason therefore. The Ad- abolic steroid implant product; ap- ministrator need not accept an applica- plication. tion for filing if any of the require- (a) Any person seeking to have any ments prescribed in paragraph (b) of anabolic steroid product, which is ex- this section is lacking or is not set pressly intended for administration forth as to be readily understood. The through implants to cattle or other applicant may amend the application nonhuman species and which has been to meet the requirements of paragraph approved by the Secretary of Health (b) of this section. If the application is and Human Services for such adminis- accepted for filing, the Administrator tration, identified as being excluded shall issue and have published in the from any schedule, pursuant to section FEDERAL REGISTER his order on the ap- 102(41)(B)(i) of the Act (21 U.S.C. plication, which shall include a ref- 802(41)(B)(i)), may apply to the Drug erence to the legal authority under and Chemical Evaluation Section, Di- which the order is issued and the find- version Control Division, Drug En- ings of fact and conclusions of law forcement Administration . See the upon which the order is based. This Table of DEA Mailing Addresses in order shall specify the date on which it § 1321.01 of this chapter for the current will take effect. The Administrator mailing address. shall permit any interested person to

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file written comments on or objections EXEMPTED PRESCRIPTION PRODUCTS to the order within 60 days of the date of publication in the FEDERAL REG- § 1308.31 Application for exemption of ISTER. If any such comments or objec- a nonnarcotic prescription product. tions raise significant issues regarding (a) Any person seeking to have any any finding of fact or conclusion of law compound, mixture, or preparation upon which the order is based, the Ad- containing any nonnarcotic controlled ministrator shall immediately suspend substance listed in § 1308.12(e), or in the effectiveness of the order until he § 1308.13(b) or (c), or in § 1308.14, or in may reconsider the application in light § 1308.15, exempted from application of of the comments and objections filed. all or any part of the Act pursuant to Thereafter, the Administrator shall re- section 201(g)(3)(A), of the Act (21 instate, revoke, or amend his original U.S.C. 811(g)(3)(A)) may apply to the order as he determines appropriate. Drug and Chemical Evaluation Section, (d) The Administrator may at any Diversion Control Division, Drug En- time revoke or modify any designation forcement Administration. See the of excluded status granted pursuant to Table of DEA Mailing Addresses in this section by following the proce- § 1321.01 of this chapter for the current dures set forth in paragraph (c) of this mailing address. section for handling an application for (b) An application for an exemption an exclusion which has been accepted under this section shall contain the fol- for filing. lowing information: [56 FR 42936, Aug. 30, 1991, as amended at 75 (1) The complete quantitative com- FR 10679, Mar. 9, 2010; 81 FR 97021, Dec. 30, position of the dosage form. 2016] (2) Description of the unit dosage § 1308.26 Excluded veterinary anabolic form together with complete labeling. steroid implant products. (3) A summary of the pharmacology of the product including animal inves- (a) Products containing an anabolic tigations and clinical evaluations and steroid, that are expressly intended for studies, with emphasis on the psychic administration through implants to and/or physiological dependence liabil- cattle or other nonhuman species and ity (this must be done for each of the which have been approved by the Sec- active ingredients separately and for retary of Health and Human Services the combination product). for such administration are excluded from all schedules pursuant to section (4) Details of synergisms and antag- 102(41)(B)(i) of the Act (21 U.S.C. onisms among ingredients. 802(41)(B)(i)). A listing of the excluded (5) Deterrent effects of the noncon- products may be obtained by submit- trolled ingredients. ting a written request to the Drug and (6) Complete copies of all literature Chemical Evaluation Section, Drug En- in support of claims. forcement Administration. See the (7) Reported instances of abuse. Table of DEA Mailing Addresses in (8) Reported and anticipated adverse § 1321.01 of this chapter for the current effects. mailing address. (9) Number of dosage units produced (b) In accordance with section for the past 2 years. 102(41)(B)(ii) of the Act (21 U.S.C. (c) Within a reasonable period of 802(41)(B)(ii)) if any person prescribes, time after the receipt of an application dispenses, or distributes a product list- for an exemption under this section, ed in paragraph (a) of this section for the Administrator shall notify the ap- human use, such person shall be con- plicant of his acceptance or non-ac- sidered to have prescribed, dispensed, ceptance of the application, and if not or distributed an anabolic steroid with- accepted, the reason therefor. The Ad- in the meaning of section 102(41)(A) of ministrator need not accept an applica- the Act (21 U.S.C. 802(41)(A)). tion for filing if any of the require- [56 FR 42936, Aug. 30, 1991, as amended at 57 ments prescribed in paragraph (b) of FR 19534, May 7, 1992; 58 FR 15088, Mar. 19, this section is lacking or is not set 1993; 62 FR 13967, Mar. 24, 1997; 75 FR 10679, forth so as to be readily understood. If Mar. 9, 2010] the applicant desires, he may amend

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the application to meet the require- ucts have been exempted by the Ad- ments of paragraph (b) of this section. ministrator from the application of If accepted for filing, the Adminis- sections 302 through 305, 307 through trator shall publish in the FEDERAL 309, and 1002 through 1004 of the Act (21 REGISTER general notice of this pro- U.S.C. 822–825, 827–829, and 952–954) and posed rulemaking in granting or deny- §§ 1301.13, 1301.22, and §§ 1301.71 through ing the application. Such notice shall 1301.76 of this chapter for administra- include a reference to the legal author- tive purposes only. An exception to the ity under which the rule is proposed, a above is that those products containing statement of the proposed rule grant- butalbital shall not be exempt from the ing or denying an exemption, and, in requirement of 21 U.S.C. 952–954 con- the discretion of the Administrator, a cerning importation, exportation, summary of the subjects and issues in- transshipment and in-transit shipment volved. The Administrator shall permit of controlled substances. Any deviation any interested person to file written from the quantitative composition of comments on or objections to the pro- any of the listed drugs shall require a posal and shall designate in the notice petition of exemption in order for the of proposed rule making the time dur- product to be exempted. A listing of ing which such filings may be made. the Exempted Prescription Products After consideration of the application may be obtained by submitting a writ- and any comments on or objections to ten request to the Drug and Chemical his proposed rulemaking, the Adminis- Evaluation Section, Drug Enforcement trator shall issue and publish in the Administration. See the Table of DEA FEDERAL REGISTER his final order on Mailing Addresses in § 1321.01 of this the application, which shall set forth chapter for the current mailing ad- the findings of fact and conclusions of dress. law upon which the order is based. This order shall specify the date on which it [75 FR 10679, Mar. 9, 2010] shall take effect, which shall not be less than 30 days from the date of pub- EXEMPT ANABOLIC STEROID PRODUCTS lication in the FEDERAL REGISTER unless the Administrator finds that con- § 1308.33 Exemption of certain anabolic steroid products; application. ditions of public health or safety necessitate an earlier effective date, in (a) The Administrator, upon the rec- which event the Administrator shall ommendation of Secretary of Health specify in the order his findings as to and Human Services, may, by regula- such conditions. tion, exempt from the application of (d) The Administrator may revoke all or any part of the Act any com- any exemption granted pursuant to pound, mixture, or preparation con- section 201(g)(3)(A) of the Act (21 U.S.C. taining an anabolic steroid as defined 811(g)(3)(A)) by following the proce- in part 1300 of this chapter, which is in- dures set forth in paragraph (c) of this tended for administration to a human section for handling an application for being or animal, if, because of its con- an exemption which has been accepted centration, preparation, formulation, for filing. or delivery system, it has no significant potential for abuse. [38 FR 8254, Mar. 30, 1973. Redesignated at 38 FR 26609, Sept. 24, 1973, as amended at 44 FR (b) Any person seeking to have any 18968, Mar. 30, 1979; 52 FR 9803, Mar. 27, 1987; compound, mixture, or preparation 75 FR 10679, Mar. 9, 2010; 81 FR 97021, Dec. 30, containing an anabolic steroid as de- 2016] fined in part 1300 of this chapter exempted from the application of all or § 1308.32 Exempted prescription prod- any part of the Act, pursuant to para- ucts. graph (a) of this section, may apply to The compounds, mixtures, or prep- the Drug and Chemical Evaluation Sec- arations that contain a nonnarcotic tion, Diversion Control Division, Drug controlled substance listed in Enforcement Administration. See the § 1308.12(e) or in § 1308.13(b) or (c) or in Table of DEA Mailing Addresses in § 1308.14 or in § 1308.15 listed in the § 1321.01 of this chapter for the current Table of Exempted Prescription Prod- mailing address.

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(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 applica- [56 FR 42936, Aug. 30, 1991; 57 FR 10815, Mar. tion for an exemption under this sec- 31, 1992, as amended at 62 FR 13968, Mar. 24, tion, the Administrator shall notify 1997; 70 FR 74657, Dec. 16, 2005; 75 FR 10679, the applicant of his acceptance or non- Mar. 9, 2010; 81 FR 97021, Dec. 30, 2016] acceptance of the application, and if § 1308.34 Exempt anabolic steroid not accepted, the reason therefor. The products. Administrator need not accept an application for filing if any of the re- The list of compounds, mixtures, or quirements prescribed in paragraph (c) preparations that contain an anabolic of this section is lacking or is not set steroid that have been exempted by the forth so as to be readily understood. Administrator from application of sec- The applicant may amend the applications 302 through 309 and 1002 through tion to meet the requirements of para- 1004 of the Act (21 U.S.C. 822–829 and graph (c) of this section. If accepted for 952–954) and §§ 1301.13, 1301.22, and filing, the Administrator will request 1301.71 through 1301.76 of this chapter from the Secretary for Health and for administrative purposes only may Human Services his recommendation, be obtained by submitting a written re- as to whether such product which con- quest to the Drug and Chemical Eval- tains an anabolic steroid should be con- uation Section, Drug Enforcement Ad- sidered for exemption from certain por- ministration. See the Table of DEA tions of the Controlled Substances Act. Mailing Addresses in § 1321.01 of this On receipt of the recommendation of chapter for the current mailing ad- the Secretary, the Administrator shall dress. make a determination as to whether [75 FR 10679, Mar. 9, 2010]

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EXEMPT CANNABIS PLANT MATERIAL, (iii) Distributed, exported, or im- AND PRODUCTS MADE THEREFROM, ported, with the intent that it be used THAT CONTAIN for human consumption. TETRAHYDROCANNABINOLS (c) In any proceeding arising under the Act or this chapter, the burden of § 1308.35 Exemption of certain can- going forward with the evidence that a nabis plant material, and products material, compound, mixture, or prepa- made therefrom, that contain ration containing THC is exempt from tetrahydrocannabinols. control pursuant to this section shall (a) Any processed plant material or be upon the person claiming such ex- animal feed mixture containing any emption, as set forth in section amount of tetrahydrocannabinols 515(a)(1) of the Act (21 U.S.C. 885(a)(1)). (THC) that is both: In order to meet this burden with re- (1) Made from any portion of a plant spect to a product or plant material of the genus Cannabis excluded from that has not been expressly exempted the definition of marijuana under the from control by the Administrator pur- Act [i.e., the mature stalks of such suant to § 1308.23, the person claiming plant, fiber produced from such stalks, the exemption must present rigorous oil or cake made from the seeds of such scientific evidence, including well-doc- plant, any other compound, manufac- umented scientific studies by experts ture, salt, derivative, mixture, or prep- trained and qualified to evaluate the aration of such mature stalks (except effects of drugs on humans. the resin extracted therefrom), fiber, [66 FR 51544, Oct. 9, 2001] oil, or cake, or the sterilized seed of such plant which is incapable of germi- HEARINGS nation] and (2) Not used, or intended for use, for § 1308.41 Hearings generally. human consumption, has been exempt- In any case where the Administrator ed by the Administrator from the ap- shall hold a hearing on the issuance, plication of the Act and this chapter. amendment, or repeal of rules pursuant (b) As used in this section, the fol- to section 201 of the Act, the proce- lowing terms shall have the meanings dures for such hearing and accom- specified: panying proceedings shall be governed (1) The term processed plant material generally by the rulemaking proce- means cannabis plant material that dures set forth in the Administrative has been subject to industrial proc- Procedure Act (5 U.S.C. 551–559) and esses, or mixed with other ingredients, specifically by section 201 of the Act (21 such that it cannot readily be con- U.S.C. 811), by §§ 1308.42–1308.51, and by verted into any form that can be used §§ 1316.41–1316.67 of this chapter. for human consumption. (2) The term animal feed mixture § 1308.42 Purpose of hearing. means sterilized cannabis seeds mixed If requested by any interested person with other ingredients (not derived after proceedings are initiated pursu- from the cannabis plant) in a formula- ant to § 1308.43, the Administrator shall tion that is designed, marketed, and hold a hearing for the purpose of re- distributed for animal consumption ceiving factual evidence and expert (and not for human consumption). opinion regarding the issues involved (3) The term used for human consump- in the issuance, amendment or repeal tion means either: of a rule issuable pursuant to section (i) Ingested orally or 201(a) of the Act (21 U.S.C. 811(a)). Ex- (ii) Applied by any means such that tensive argument should not be offered THC enters the human body. into evidence but rather presented in (4) The term intended for use for opening or closing statements of coun- human consumption means any of the sel or in memoranda or proposed find- following: ings of fact and conclusions of law. Ad- (i) Designed by the manufacturer for ditional information relating to hear- human consumption; ings to include waivers or modification (ii) Marketed for human consump- of rules, request for hearing, burden of tion; or proof, time and place, and final order

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are set forth in part 1316 of this chap- desires, he may amend the petition to ter. meet the requirements of paragraph (b) of this section. If accepted for filing, a [62 FR 13968, Mar. 24, 1997] petition may be denied by the Adminis- § 1308.43 Initiation of proceedings for trator within a reasonable period of rulemaking. time thereafter if he finds the grounds (a) Any interested person may sub- upon which the petitioner relies are mit a petition to initiate proceedings not sufficient to justify the initiation for the issuance, amendment, or repeal of proceedings. of any rule or regulation issuable pur- (d) The Administrator shall, before suant to the provisions of section 201 of initiating proceedings for the issuance, the Act. amendment, or repeal of any rule ei- (b) Petitions shall be submitted in ther to control a drug or other sub- quintuplicate to the Administrator. stance, or to transfer a drug or other See the Table of DEA Mailing Address- substance from one schedule to an- es in § 1321.01 of this chapter for the other, or to remove a drug or other current mailing address. Petitions substance entirely from the schedules, shall be in the following form: and after gathering the necessary data, request from the Secretary a scientific llllllllll (Date) and medical evaluation and the Sec- Administrator, Drug Enforcement Adminis- retary’s recommendations as to wheth- tration llllll (Mailing Address) er such drug or other substance should Dear Sir: The undersigned llllllll be so controlled, transferred, or re- hereby petitions the Administrator to ini- moved as a controlled substance. The tiate proceedings for the issuance (amendment or repeal) of a rule or regulation pursu- recommendations of the Secretary to ant to section 201 of the Controlled Sub- the Administrator shall be binding on stances Act. the Administrator as to such scientific Attached hereto and constituting a part of and medical matters, and if the Sec- this petition are the following: retary recommends that a drug or (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 drug or other substance. existing rule, together with a reference to 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 (c) Within a reasonable period of shall publish in the FEDERAL REGISTER time after the receipt of a petition, the general notice of any proposed rule Administrator shall notify the peti- making to issue, amend, or repeal any tioner of his acceptance or nonaccept- rule pursuant to section 201 of the Act. ance of the petition, and if not accept- Such published notice shall include a ed, the reason therefor. The Adminis- statement of the time, place, and na- trator need not accept a petition for ture of any hearings on the proposal in filing if any of the requirements pre- the event a hearing is requested pursu- scribed in paragraph (b) of this section ant to § 1308.44. Such hearings may not is lacking or is not set forth so as to be be commenced until after the expira- readily understood. If the petitioner tion of at least 30 days from the date

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the general notice is published in the files and fails to appear at the hearing, FEDERAL REGISTER. Such published no- he shall be deemed to have waived his tice shall also include a reference to opportunity for the hearing or to par- the legal authority under which the ticipate in the hearing, unless he shows rule is proposed, a statement of the good cause for such failure. proposed rule, and, in the discretion of (e) If all interested persons waive or the Administrator, a summary of the are deemed to waive their opportunity subjects and issues involved. for the hearing or to participate in the (g) The Administrator may permit hearing, the Administrator may cancel any interested persons to file written the hearing, if scheduled, and issue his comments on or objections to the pro- final order pursuant to § 1308.45 without posal and shall designate in the notice a hearing. of proposed rule making the time dur- [38 FR 8254, Mar. 30, 1973. Redesignated at 38 ing which such filings may be made. FR 26609, Sept. 24, 1973, and further redesig- [38 FR 8254, Mar. 30, 1973. Redesignated at 38 nated and amended at 62 FR 13968, Mar. 24, FR 26609, Sept. 24, 1973, and further redesig- 1997] nated and amended at 62 FR 13968, Mar. 24, 1997; 75 FR 10679, Mar. 9, 2010] § 1308.45 Final order. As soon as practicable after the pre- § 1308.44 Request for hearing or ap- siding officer has certified the record pearance; waiver. to the Administrator, the Adminis- (a) Any interested person desiring a trator shall cause to be published in hearing on a proposed rulemaking, the FEDERAL REGISTER his order in the shall, within 30 days after the date of proceeding, which shall set forth the publication of notice of the proposed final rule and the findings of fact and rulemaking in the FEDERAL REGISTER, conclusions of law upon which the rule file with the Administrator a written is based. This order shall specify the request for a hearing in the form pre- date on which it shall take effect, scribed in § 1316.47 of this chapter. which shall not be less than 30 days (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 ment regarding his position on the and publish in the FEDERAL REGISTER matters of fact and law involved in an order controlling such substance such hearing. Such statement, if ad- under the schedule he deems most ap- missible, shall be made a part of the propriate to carry out obligations. record and shall be considered in light Issuance of such an order shall be with- of the lack of opportunity for cross-ex- out regard to the findings required by amination in determining the weight subsections 201(a) or 202(b) of the Act to be attached to matters of fact as- (21 U.S.C. 811(a) or 812(b)) and without serted therein. regard to the procedures prescribed by (d) If any interested person fails to § 1308.41 or subsections 201 (a) and (b) of file a request for a hearing; or if he so the Act (21 U.S.C. 811 (a) and (b)). An

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order controlling a substance shall be- before the expiration of 30 calendar come effective 30 days from the date of days from: publication in the FEDERAL REGISTER, (1) The date of publication by the Ad- unless the Administrator finds that ministration of a notice in the FED- conditions of public health or safety ERAL REGISTER of its intention to issue necessitate an earlier effective date, in such order and the grounds upon which which event the Administrator shall such order is to be issued; and specify in the order his findings as to (2) The date the Administration 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 the Administration’s intention to nated at 62 FR 13968, Mar. 24, 1997] issue such order. (b) An order issued under this section § 1308.47 Control of immediate precur- will be vacated upon the conclusion of sors. a subsequent rulemaking proceeding Pursuant to section 201(e) of the Act initiated under section 201(a) (21 U.S.C. (21 U.S.C. 811(e)), the Administrator 811(a)) with respect to such substance may, without regard to the findings re- or at the end of two years from the ef- quired by subsection 201(a) or 202 (b) of fective date of the order scheduling the the Act (21 U.S.C. 811(a) or 812(b)) and substance, except that during the pend- without regard to the procedures pre- ency of proceedings under section scribed by § 1308.41 or subsections 201 201(a) (21 U.S.C. 811(a)) with respect to (a) and (b) of the Act (21 U.S.C. 811(a) the substance, the Administration may and (b)), issue and publish in the FED- extend the temporary scheduling for up ERAL REGISTER an order controlling an to one year. immediate precursor. The order shall designate the schedule in which the im- [81 FR 97021, Dec. 30, 2016] mediate precursor is to be placed, which shall be the same schedule in PART 1309—REGISTRATION OF which the controlled substance of MANUFACTURERS, DISTRIBUTORS, which it is an immediate precursor is IMPORTERS AND EXPORTERS OF placed or any other schedule with a LIST I CHEMICALS higher numerical designation. An order controlling an immediate precursor GENERAL INFORMATION shall become effective 30 days from the date of publication in the FEDERAL Sec. REGISTER, unless the Administrator 1309.01 Scope of part 1309. finds that conditions of public health 1309.02 Definitions. or safety necessitate an earlier effec- 1309.03 Information; special instructions. tive date, in which event the Adminis- FEES FOR REGISTRATION AND REREGISTRATION trator shall specify in the order his findings as to such conditions. 1309.11 Fee amounts. 1309.12 Time and method of payment; re- [38 FR 8254, Mar. 30, 1973. Redesignated at 38 fund. FR 26609, Sept. 24, 1973, and further redesignated at 62 FR 13968, Mar. 24, 1997] REQUIREMENTS FOR REGISTRATION 1309.21 Persons required to register. § 1308.49 Temporary scheduling. 1309.22 Separate registration for inde- (a) Pursuant to 21 U.S.C. 811(h) and pendent activities. without regard to the requirements of 1309.23 Separate registration for separate 21 U.S.C. 811(b) relating to the sci- locations. entific and medical evaluation of the 1309.24 Waiver of registration requirement Secretary of Health and Human Serv- for certain activities. 1309.25 Temporary exemption from registra- ices, the Drug Enforcement Adminis- tion for chemical registration applicants. tration may place a substance into 1309.26 Exemption of law enforcement offi- Schedule I on a temporary basis, if it cials. determines that such action is necessary to avoid an imminent hazard to APPLICATION FOR REGISTRATION the public safety. An order issued 1309.31 Time for application for registra- under this section may not be effective tion; expiration date.

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1309.32 Application forms; contents, signa- the Act (21 U.S.C. 802) or part 1300 of ture. this chapter. 1309.33 Filing of application; joint filings. 1309.34 Acceptance for filing; defective ap- [62 FR 13968, Mar. 24, 1997] plications. 1309.35 Additional information. § 1309.03 Information; special instruc- 1309.36 Amendments to and withdrawals of tions. applications. Information regarding procedures under these rules and instructions ACTION ON APPLICATIONS FOR REGISTRATION: REVOCATION OR SUSPENSION OF REGISTRATION supplementing these rules will be furnished 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. 1309.43 Suspension or revocation of registra- DEA Mailing Addresses in § 1321.01 of tion. 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 registration or reregistration to distribute, im- MODIFICATION, TRANSFER AND TERMINATION port, or export a List I chemical, the OF REGISTRATION applicant shall pay an annual fee of 1309.61 Modification in registration. $1,523. 1309.62 Termination of registration. 1309.63 Transfer of registration. [77 FR 15250, Mar. 15, 2012]

SECURITY REQUIREMENTS § 1309.12 Time and method of payment; refund. 1309.71 General security requirements. 1309.72 Felony conviction; employer respon- (a) For each application for registra- sibilities. tion or reregistration to manufacture, 1309.73 Employee responsibility to report di- distribute, import, or export, the appli- version. cant shall pay the fee when the appli- AUTHORITY: 21 U.S.C. 802, 821, 822, 823, 824, cation for registration or reregistra- 830, 871(b), 875, 877, 886a, 952, 953, 957, 958. tion is submitted for filing. SOURCE: 60 FR 32454, June 22, 1995, unless (b) Payments should be made in the otherwise noted. form of a credit card; a personal, certified, or cashier’s check; or a money GENERAL INFORMATION order made payable to ‘‘Drug Enforce- ment Administration.’’ Payments § 1309.01 Scope of part 1309. made in the form of stamps, foreign Procedures governing the registra- currency, or third party endorsed tion of manufacturers, distributors, checks will not be accepted. These ap- importers and exporters of List I plication fees are not refundable. chemicals pursuant to Sections 102, 302, [75 FR 4980, Feb. 1, 2010] 303, 1007 and 1008 of the Act (21 U.S.C. 802, 822, 823, 957 and 958) are set forth REQUIREMENTS FOR REGISTRATION generally by those sections and specifically by the sections of this part. § 1309.21 Persons required to register. (a) Unless exempted by law or under § 1309.02 Definitions. §§ 1309.24 through 1309.26 or §§ 1310.12 Any term used in this part shall have through 1310.13 of this chapter, the fol- the definition set forth in section 102 of lowing persons must annually obtain a

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registration specific to the List I (1)(iv) of the definition of regulated chemicals to be handled: transaction in § 1300.02 of this chapter. (1) Every person who manufactures (b) Only persons actually engaged in or imports or proposes to manufacture the activities are required to obtain a or import a List I chemical or a drug registration; related or affiliated per- product containing ephedrine, sons who are not engaged in the activi- pseudoephedrine, or phenylpropanola- ties are not required to be registered. mine. (For example, a stockholder or parent (2) Every person who distributes or corporation of a corporation distrib- exports or proposes to distribute or ex- uting List I chemicals is not required port any List I chemical, other than to obtain a registration.) those List I chemicals contained in a (c) The registration requirements are product exempted under paragraph 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 (4) Exporting List I chemicals and 4236, Jan. 27, 2012; 77 FR 15250, Mar. 15, 2012] scheduled listed chemical products. (b) Except as provided in paragraphs § 1309.22 Separate registration for (c) and (d) of this section, every person independent activities. who engages in more than one group of (a) The following groups of activities independent activities must obtain a are deemed to be independent of each separate registration for each group of other: activities, unless otherwise exempted (1) Manufacturing of List I chemicals by the Act or §§ 1309.24 through 1309.26. or drug products containing ephedrine, (c) A person registered to import any pseudoephedrine, or phenylpropanola- List I chemical shall be authorized to mine. distribute that List I chemical after (2) Distributing of List I chemicals importation, but no other chemical and scheduled listed chemical prod- that the person is not registered to im- ucts. port. (3) Importing List I chemicals or (d) A person registered to manufac- drug products containing ephedrine, ture any List I chemical shall be au- pseudoephedrine, or phenylpropanola- thorized to distribute that List I chem- mine. ical after manufacture, but no other

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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 chemical product or other product con- I chemical, if that chemical is pro- taining a List I chemical that is de- duced solely for internal consumption scribed and included in paragraph by the manufacturer and there is no (1)(iv) of the definition of regulated subsequent distribution or exportation transaction in § 1300.02 of this chapter, of the List I chemical. if that person is registered with the (i) If any person exempted under Administration to engage in the same paragraph (b), (c), (d), (e), or (f) of this activity with a controlled substance. section also engages in the distribu- (c) The requirement of registration is tion, importation, or exportation of a waived for any person who imports or List I chemical, other than as de- exports a scheduled listed chemical scribed in such paragraph, the person product or other product containing a shall obtain a registration for the ac- List I chemical that is described and tivities, as required by § 1309.21.

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(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 customs officer, any July 12, 1997. The exemption will re- officer or employee of the U.S. Food main in effect for each person who has and Drug Administration, and any Fed- made such application until the Ad- eral or Insular officer who is lawfully ministration has approved or denied engaged in the enforcement of any fed- that application. This exemption ap- eral law relating to listed chemicals, plies only to registration; all other controlled substances, drugs, or cus- chemical control requirements set toms, and is duly authorized to possess forth in this part 1309 and parts 1310, and distribute List I chemicals in the and 1313 of this chapter remain in full course of his/her official duties; and force and effect. (2) Any officer or employee of any (b) Each person required by section State, or any political subdivision or 302 of the Act (21 U.S.C. 822) to obtain agency thereof, who is engaged in the a registration to distribute, import, or enforcement of any State or local law export a pseudoephedrine or phenyl- relating to listed chemicals and con- propanolamine drug product is tempo- trolled substances and is duly author- rarily exempted from the registration ized to possess and distribute List I requirement, provided that the person chemicals in the course of his official submits a proper application for reg- duties. istration on or before October 3, 1997. (b) Any official exempted by this sec- The exemption will remain in effect for tion may, when acting in the course of

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official duties, possess any List I chem- tion or by writing to the Registration ical and distribute any such chemical Section, Drug Enforcement Adminis- to any other official who is also ex- tration. See the Table of DEA Mailing empted by this section and acting in Addresses in § 1321.01 of this chapter for the course of official duties. the current mailing address. DEA [60 FR 32454, June 22, 1995, as amended at 81 Form 510a will be mailed to each List I FR 97021, Dec. 30, 2016] chemical registrant approximately 60 days before the expiration date of his APPLICATION FOR REGISTRATION or her registration; if any registered person does not receive such forms § 1309.31 Time for application for registration; expiration date. within 45 days before the expiration date of the registration, notice must be (a) Any person who is required to be promptly given of such fact and DEA registered and who is not so registered Form 510a must be requested by writ- may apply for registration at any time. ing to the Registration Section of the No person required to be registered shall engage in any activity for which Administration at the foregoing ad- registration is required until the appli- dress. cation for registration is approved and (d) Each application for registration a Certificate of Registration is issued must include the Administration by the Administrator to such person. Chemical Code Number, as set forth in (b) Any person who is registered may § 1310.02 of this chapter, for each List I apply to be reregistered not more than chemical to be manufactured, distrib- 60 days before the expiration date of uted, imported, or exported. his registration. (e) Registration shall not entitle a (c) At the time a person is first reg- person to engage in any activity with istered, that person shall be assigned any List I chemical not specified in his to one of twelve groups, which shall or her application. correspond to the months of the year. (f) Each application shall include all The expiration date of the registra- information called for in the form, un- tions of all registrants within any less the item is not applicable, in group will be the last day of the month which case this fact shall be indicated. designated for that group. In assigning (g) Each application, attachment, or any of the above persons to a group, other document filed as part of an ap- the Administration may select a group the expiration date of which is less plication, shall be signed by the appli- than one year from the date such busi- cant, if an individual; by a partner of ness activity was registered. If the per- the applicant, if a partnership; or by an son is assigned to a group which has an officer of the applicant, if a corpora- expiration date less than eleven tion, corporate division, association, months from the date of which the per- trust or other entity. An applicant may son is registered, the registration shall authorize one or more individuals, who not expire until one year from that ex- would not otherwise be authorized to piration date; in all other cases, the do so, to sign applications for the ap- registration shall expire on the expira- plicant by filing with the application tion date following the date on which or other document a power of attorney the person is registered. for each such individual. The power of attorney shall be signed by a person § 1309.32 Application forms; contents; who is authorized to sign applications signature. under this paragraph and shall contain (a) Any person who is required to be the signature of the individual being registered pursuant to § 1309.21 and is authorized to sign the application or not so registered, shall apply on DEA other document. The power of attorney Form 510. shall be valid until revoked by the ap- (b) Any person who is registered pur- plicant. suant to Section 1309.21, shall apply for reregistration on DEA Form 510a. [60 FR 32454, June 22, 1995, as amended at 75 (c) DEA Form 510 may be obtained at FR 10680, Mar. 9, 2010; 81 FR 97021, Dec. 30, any divisional office of the Administra- 2016]

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§ 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 § 1309.36 Amendments to and with- Registration Section, Drug Enforce- drawals of applications. ment Administration. See the Table of DEA Mailing Addresses in § 1321.01 of (a) An application may be amended this chapter for the current mailing ad- or withdrawn without permission of dress. The appropriate registration fee the Administration at any time before and any required attachments must ac- the date on which the applicant re- company the application. ceives an order to show cause pursuant (b) Any person required to obtain to § 1309.46. An application may be more than one registration may submit amended or withdrawn with permission all applications in one package. Each of the Administrator at any time application must be complete and must where good cause is shown by the ap- not refer to any accompanying applica- plicant or where the amendment or tion for required information. withdrawal is in the public interest. (b) After an application has been ac- [60 FR 32454, June 22, 1995, as amended at 75 cepted for filing, the request by the ap- FR 10680, Mar. 9, 2010] plicant that it be returned or the failure of the applicant to respond to offi- § 1309.34 Acceptance for filing; defective applications. cial correspondence regarding the application, including a request that the (a) Applications submitted for filing applicant submit the required fee, are dated upon receipt. If found to be when sent by registered or certified complete, the application will be ac- mail, return receipt requested, shall be cepted for filing. Applications failing deemed to be a withdrawal of the appli- to comply with the requirements of cation. this part will not generally be accepted for filing. In the case of minor defects ACTION ON APPLICATIONS FOR REGISTRA- as to completeness, the Administrator TION: REVOCATION OR SUSPENSION OF may accept the application for filing REGISTRATION with a request to the applicant for additional information. A defective appli- § 1309.41 Administrative review gen- cation will be returned to the applicant erally. within 10 days of receipt with a state- The Administrator may inspect, or ment of the reason for not accepting cause to be inspected, the establish- the application for filing. A defective ment of an applicant or registrant, pur- application may be corrected and re- suant to subpart A of part 1316 of this submitted for filing at any time. chapter. The Administrator shall re- (b) Accepting an application for fil- view the application for registration ing does not preclude any subsequent and other information gathered by the request for additional information pur- Administrator regarding an applicant suant to § 1309.35 and has no bearing on in order to determine whether the ap- whether the application will be grant- plicable standards of Section 303 of the ed. Act (21 U.S.C. 823) have been met by the applicant. § 1309.35 Additional information. The Administrator may require an § 1309.42 Certificate of registration; applicant to submit such documents or denial of registration. written statements of fact relevant to (a) The Administrator shall issue a the application as he deems necessary Certificate of Registration (DEA Form to determine whether the application 511) to an applicant if the issuance of should be granted. The failure of the registration or reregistration is re- applicant to provide such documents or quired under the applicable provisions statements within a reasonable time of section 303 of the Act (21 U.S.C. 823). after being requested to do so shall be In the event that the issuance of reg- deemed to be a waiver by the applicant istration or reregistration is not re- of an opportunity to present such docu- quired, the Administrator shall deny

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the application. Before denying any ap- tion or to authorized agents of the Ad- plication, the Administrator shall issue ministration; or an order to show cause pursuant to (2) Place all such List I chemicals in Section 1309.46 and, if requested by the his or her possession under seal as de- applicant, shall hold a hearing on the scribed in section 304(f) of the Act (21 application pursuant to § 1309.51. U.S.C. 824(f)). (b) The Certificate of Registration (e) In the event that revocation or (DEA Form 511) shall contain the suspension is limited to a particular name, address, and registration num- chemical or chemicals, the registrant ber of the registrant, the activity au- shall be given a new Certificate of Reg- thorized by the registration, the istration for all substances not affected amount of fee paid, and the expiration by such revocation or suspension; no date of the registration. The registrant fee shall be required for the new Cer- shall maintain the certificate of reg- tificate of Registration. The registrant istration at the registered location in a shall deliver the old Certificate of Reg- readily retrievable manner and shall istration to the nearest office of the 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 registration. of the Administration all of the particular 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 of the order of the Administrator re- so suspends, he shall serve with the voking or suspending registration, the order to show cause pursuant to registrant shall, as instructed by the § 1309.46 an order of immediate suspen- Administrator: sion that shall contain a statement of (1) Deliver all List I chemicals in his his findings regarding the danger to or her possession that were obtained public health or safety. under the authority of a registration or (b) Upon service of the order of im- an exemption from registration grant- mediate suspension, the registrant ed by the Administrator by regulation, shall promptly return his Certificate of to the nearest office of the Administra- Registration to the nearest office of

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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 her possession that were obtained (a) If, upon examination of the appli- under the authority of a registration or cation for registration from any appli- an exemption from registration grant- cant and other information gathered ed by the Administrator by regulation, by the Administration regarding the which are affected by the revocation or applicant, the Administrator is unable suspension; or to make the determinations required (2) Place all of such chemicals under by the applicable provisions of section seal as described in section 304(f) of the 303 of the Act (21 U.S.C. 823) to register Act (21 U.S.C. 824(f)). the applicant, the Administrator shall (c) Any suspension shall continue in serve upon the applicant an order to effect until the conclusion of all pro- show cause why the application for reg- ceedings upon the revocation or sus- istration should not be denied. pension, including any judicial review (b) If, upon information gathered by thereof, unless sooner withdrawn by the Administration regarding any reg- the Administrator or dissolved by a istrant, the Administrator determines court of competent jurisdiction. Any that the registration of such registrant registrant whose registration is sus- is subject to suspension or revocation pended under this section may request pursuant to section 304 of the Act (21 a hearing on the revocation or suspension of his registration at a time ear- U.S.C. 824), the Administrator shall lier than specified in the order to show serve upon the registrant an order to cause pursuant to Section 1309.46, show cause why the registration should which request shall be granted by the not be revoked or suspended. Administrator, who shall fix a date for (c) The order to show cause shall call such hearing as early as reasonably upon the applicant or registrant to ap- possible. pear before the Administrator at a time and place stated in the order, [60 FR 32454, June 22, 1995, as amended at 62 FR 5916, Feb. 10, 1997] which shall not be less than 30 days after the date of receipt of the order. § 1309.45 Extension of registration The order to show cause shall also con- pending final order. tain a statement of the legal basis for In the event that an applicant for re- such hearing and for the denial, revoca- registration (who is doing business tion, or suspension of registration and under a registration previously granted a summary of the matters of fact and and not revoked or suspended) has ap- law asserted. plied for reregistration at least 45 days (d) Upon Receipt of an order to show before the date on which the existing cause, the applicant or registrant registration is due to expire, and the must, if he desires a hearing, file a re- Administrator has issued no order on quest for a hearing pursuant to the application on the date on which § 1309.53. If a hearing is requested, the the existing registration is due to ex- Administrator shall hold a hearing at pire, the existing registration of the the time and place stated in the order, applicant shall automatically be ex- pursuant to § 1309.51. tended and continue in effect until the (e) When authorized by the Adminis- date on which the Administrator so trator, any agent of the Administra- issues his order. The Administrator may extend any other existing reg- tion may serve the order to show istration under the circumstances con- cause. templated in this section even though [60 FR 32454, June 22, 1995, as amended at 81 the registrant failed to apply for rereg- FR 97021, Dec. 30, 2016] istration at least 45 days before expira-

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HEARINGS amination in determining the weight to be attached to matters of fact as- § 1309.51 Hearings generally. serted therein. (a) In any case where the Adminis- (c) If any person entitled to a hearing trator shall hold a hearing on any reg- pursuant to §§ 1309.42 and 1309.43 fails to istration or application therefore, the file a request for a hearing, or if he so procedures for such hearing shall be files and fails to appear at the hearing, governed generally by the adjudication he shall be deemed to have waived his procedures set forth in the Administra- opportunity for the hearing, unless he tive Procedure Act (5 U.S.C. 551–559) shows good cause for such failure. and specifically by sections 303 and 304 (d) If any person entitled to a hearing of the Act (21 U.S.C. 823–824), by waives or is deemed to waive his or her §§ 1309.52 through 1309.55, and by the opportunity for the hearing, the Ad- procedures for administrative hearings ministrator may cancel the hearing, if under the Act set forth in §§ 1316.41 scheduled, and issue his final order pur- through 1316.67 of this chapter. suant to § 1309.57 without a hearing. (b) Any hearing under this part shall [60 FR 32454, June 22, 1995. Redesignated at 62 be independent of, and not in lieu of, FR 13968, Mar. 24, 1997] criminal prosecutions or other proceedings under the Act or any other § 1309.54 Burden of proof. law of the United States. (a) At any hearing for the denial of a [60 FR 32454, June 22, 1995, as amended at 81 registration, the Administration shall FR 97021, Dec. 30, 2016] have the burden of proving that the requirements for such registration pursu- § 1309.52 Purpose of hearing. ant to section 303 of the Act (21 U.S.C. If requested by a person entitled to a 823) are not satisfied. hearing, the Administrator shall hold a (b) At any hearing for the revocation hearing for the purpose of receiving or suspension of a registration, the Ad- factual evidence regarding the issues ministration shall have the burden of involved in the denial, revocation, or proving that the requirements for such suspension of any registration. Exten- revocation or suspension pursuant to sive argument should not be offered section 304(a) of the Act (21 U.S.C. into evidence but rather presented in 824(a)) are satisfied. opening or closing statements of counsel or in memoranda or proposed find- [60 FR 32454, June 22, 1995. Redesignated at 62 ings of fact and conclusions of law. FR 13968, Mar. 24, 1997]

§ 1309.53 Request for hearing or ap- § 1309.55 Time and place of hearing. pearance; waiver. The hearing will commence at the (a) Any person entitled to a hearing place and time designated in the order pursuant to §§ 1309.42 and 1309.43 and de- to show cause or notice of hearing pub- siring a hearing shall, within 30 days lished in the FEDERAL REGISTER (unless after the date of receipt of the order to expedited pursuant to Section show cause, file with the Adminis- 1309.44(c)) but thereafter it may be trator a written request for a hearing moved to a different place and may be in the form prescribed in § 1316.47 of continued from day to day or recessed this chapter. to a later day without notice other (b) Any person entitled to a hearing than announcement thereof by the pre- pursuant to §§ 1309.42 and 1309.43 may, siding officer at the hearing. within the period permitted for filing a [60 FR 32454, June 22, 1995. Redesignated at 62 request for a hearing, file with the Ad- FR 13968, Mar. 24, 1997] ministrator a waiver of an opportunity for a hearing, together with a written MODIFICATION, TRANSFER AND statement regarding his position on TERMINATION OF REGISTRATION the matters of fact and law involved in such hearing. Such statement, if ad- § 1309.61 Modification in registration. missible, shall be made a part of the Any registrant may apply to modify record and shall be considered in light his or her registration to authorize the of the lack of opportunity for cross-ex- handling of additional List I chemicals

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or to change his or her name or ad- (1) By transfer to person registered dress, by submitting a letter of request under the Act and authorized to pos- to the Registration Section, Drug En- sess the substances; forcement Administration. See the (2) By delivery to an agent of the Ad- Table of DEA Mailing Addresses in ministration or to the nearest office of § 1321.01 of this chapter for the current the Administration; mailing address. The letter shall con- (3) By such other means as the Spe- tain the registrant’s name, address, cial Agent in Charge may determine to and registration number as printed on assure that the substance does not be- the certificate of registration, and the come available to unauthorized per- List I chemicals to be added to his reg- sons. istration or the new name or address [60 FR 32454, June 22, 1995, as amended at 62 and shall be signed in accordance with FR 5916, Feb. 10, 1997; 76 FR 61564, Oct. 5, 2011; § 1309.32(g). No fee shall be required to 77 FR 4236, Jan. 27, 2012] be paid for the modification. The request for modification shall be handled § 1309.63 Transfer of registration. in the same manner as an application No registration or any authority con- for registration. If the modification in ferred thereby shall be assigned or oth- registration is approved, the Adminis- erwise transferred except upon such trator shall issue a new certificate of conditions as the Administrator may registration (DEA Form 511) to the reg- specifically designate and then only istrant, who shall maintain it with the pursuant to his written consent. 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 stored in sealed containers, access to legal existence or discontinues busi- the chemicals should be controlled ness or professional practice shall through physical means or through promptly notify the Special Agent in human or electronic monitoring. Charge of the Administration in the (b) In evaluating the effectiveness of area in which the person is located of security controls and procedures, the such fact and seek authority and in- Administrator shall consider the fol- structions to dispose of any List I lowing factors: chemicals obtained under the author- (1) The type, form, and quantity of ity of that registration. Any registrant List I chemicals handled; who ceases legal existence or discon- (2) The location of the premises and tinues business or professional practice the relationship such location bears on or wishes to surrender a registration the security needs; shall notify the Special Agent in (3) The type of building construction Charge of the Administration in the comprising the facility and the general area in which the person is located of characteristics of the building or build- such fact and seek authority and in- ings; structions to dispose of any List I (4) The availability of electronic de- chemicals obtained under the author- tection and alarm systems; ity of that registration. (5) The extent of unsupervised public (b) The Special Agent in Charge shall access to the facility; authorize and instruct the person to (6) The adequacy of supervision over dispose of the List I chemical in one of employees having access to List I the following manners: chemicals;

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(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; and ployees who possess, sell, use or divert (8) The adequacy of the registrant’s listed chemicals or controlled sub- or applicant’s systems for monitoring stances will subject themselves not the receipt, distribution, and disposi- only to State or Federal prosecution tion of List I chemicals in its oper- for any illicit activity, but shall also ations. immediately become the subject of (c) Any registrant or applicant desir- independent action regarding their ing to determine whether a proposed continued employment. The employer system of security controls and proce- will assess the seriousness of the em- dures is adequate may submit mate- ployee’s violation, the position of re- rials and plans regarding the proposed sponsibility held by the employee, past security controls and procedures either record of employment, etc., in deter- to the Special Agent in Charge in the mining whether to suspend, transfer, region in which the security controls terminate or take other action against and procedures will be used, or to the the employee. Regulatory Section, Drug Enforcement Administration. See the Table of DEA § 1309.73 Employee responsibility to Mailing Addresses in § 1321.01 of this report diversion. chapter for the current mailing ad- Reports of listed chemical diversion dress. by fellow employees is not only a nec- [60 FR 32454, June 22, 1995, as amended at 62 essary part of an overall employee se- FR 13968, Mar. 24, 1997; 67 FR 14861, Mar. 28, curity program but also serves the pub- 2002; 71 FR 56023, Sept. 26, 2006; 75 FR 10680, lic interest at large. It is, therefore, Mar. 9, 2010; 81 FR 97021, Dec. 30, 2016] 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; IM- istrant should be aware of the circumstances regarding the action PORTATION AND EXPORTATION against the potential employee and the OF CERTAIN MACHINES rehabilitative efforts following the action. The registrant shall assess the Sec. risks involved in employing such per- 1310.01 Definitions. 1310.02 Substances covered. sons, including the potential for action 1310.03 Persons required to keep records and against the registrant pursuant to file reports. § 1309.43, If such person is found to have 1310.04 Maintenance of records. diverted listed chemicals, and, in the 1310.05 Reports.

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1310.06 Content of records and reports. (7) N-Acetylanthranilic acid, its 1310.07 Proof of identity. esters, and its salts ...... 8522 1310.08 Excluded transactions. (8) Norpseudoephedrine, its 1310.09 Temporary exemption from registration. salts, optical isomers, and 1310.10 Removal of the exemption of drugs salts of optical isomers ...... 8317 distributed under the Federal Food, Drug (9) Phenylacetic acid, its esters, and Cosmetic Act. and its salts ...... 8791 1310.11 Reinstatement of exemption for drug (10) Phenylpropanolamine, its products distributed under the Food, salts, optical isomers, and Drug and Cosmetic Act. salts of optical isomers ...... 1225 1310.12 Exempt chemical mixtures. (11) Piperidine and its salts ...... 2704 1310.13 Exemption of chemical mixtures; application. (12) Pseudoephedrine, its salts, 1310.14 Removal of exemption from defini- optical isomers, and salts of tion of regulated transaction. optical isomers ...... 8112 1310.15 Exempt drug products containing (13) 3,4-Methylenedioxyphenyl-2- ephedrine and therapeutically significant propanone ...... 8502 quantities of another active medicinal (14) Methylamine and its salts ... 8520 ingredient. (15) Ethylamine and its salts ..... 8678 1310.21 Sale by Federal departments or (16) Propionic anhydride ...... 8328 agencies of chemicals which could be used to manufacture controlled sub- (17) Isosafrole ...... 8704 stances. (18) Safrole ...... 8323 (19) Piperonal ...... 8750 AUTHORITY: 21 U.S.C. 802, 827(h), 830, 871(b) (20) N-Methylephedrine, its 890. salts, optical isomers, and SOURCE: 54 FR 31665, Aug. 1, 1989, unless salts of optical isomers (N- otherwise noted. Methylephedrine) ...... 8115 (21) N-Methylpseudoephedrine, § 1310.01 Definitions. its salts, optical isomers, and Any term used in this part shall have salts of optical isomers ...... 8119 the definition set forth in section 102 of (22) Hydriodic Acid ...... 6695 the Act (21 U.S.C. 802) or part 1300 of (23) Benzaldehyde ...... 8256 this chapter. (24) Nitroethane ...... 6724 [62 FR 13968, Mar. 24, 1997] (25) Gamma-Butyrolactone (Other names include: GBL; § 1310.02 Substances covered. Dihydro-2 (3H)-furanone; 1,2- The following chemicals have been Butanolide; 1,4-Butanolide; 4- specifically designated by the Adminis- Hydroxybutanoic acid lactone; trator of the Drug Enforcement Admin- gamma-hydroxybutyric acid istration as the listed chemicals sub- lactone) ...... 2011 ject to the provisions of this part and (26) Red phosphorus ...... 6795 parts 1309 and 1313 of this chapter. Each (27) White phosphorus (Other chemical has been assigned the DEA names: Yellow Phosphorus) .... 6796 Chemical Code Number set forth oppo- (28) Hypophosphorous acid and site it. its salts (Including ammonium (a) List I chemicals hypophosphite, calcium hypophosphite, iron (1) Alpha- hypophosphite, potassium phenylacetoacetonitrile and hypophosphite, manganese its salts, optical isomers, and hypophosphite, magnesium salts of optical isomers hypophosphite and sodium (APAAN) ...... 8512 hypophosphite) ...... 6797 (2) Anthranilic acid, its esters, (29) N-phenethyl-4-piperidone and its salts ...... 8530 (NPP) ...... 8332 (3) Benzyl cyanide ...... 8735 (30) Iodine ...... 6699 (4) Ephedrine, its salts, optical (31) Ergocristine and its salts .... 8612 isomers, and salts of optical isomers ...... 8113 (b) List II chemicals: (5) Ergonovine and its salts ...... 8675 (1) Acetic anhydride ...... 8519 (6) Ergotamine and its salts ...... 8676 (2) Acetone ...... 6532 150

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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 sider any comments filed by interested (11) Sodium Permanganate ...... 6588 persons and publish a final rule in accordance with his decision in the mat- (c) The Administrator may add or deter. lete a substance as a listed chemical by publishing a final rule in the FEDERAL [54 FR 31665, Aug. 1, 1989, as amended at 56 REGISTER following a proposal which FR 48733, Sept. 26, 1991; 57 FR 43615, Sept. 22, shall be published at least 30 days prior 1992; 60 FR 19510, Apr. 19, 1995; 60 FR 32460, to the final rule. June 22, 1995; 62 FR 5917, Feb. 10, 1997; 65 FR 21647, Apr. 24, 2000; 65 FR 47316, Aug. 2, 2000; (d) Any person may petition the Ad- 66 FR 52675, Oct. 17, 2001; 71 FR 60826, Oct. 17, ministrator to have any substance 2006; 72 FR 20046, Apr. 23, 2007; 72 FR 35391, added or deleted from paragraphs (a) or July 2, 2007; 72 FR 40238, July 24, 2007; 76 FR (b) of this section. 17781, Mar. 31, 2011; 82 FR 32460, July 14, 2017] (e) Any petition under this section shall contain the following informa- § 1310.03 Persons required to keep tion: records and file reports. (1) The name and address of the peti- (a) Each regulated person who en- tioner; gages in a regulated transaction in- (2) The name of the chemical to volving a listed chemical, a tableting which the petition pertains; machine, or an encapsulating machine (3) The name and address of the man- shall keep a record of the transaction ufacturer(s) of the chemical (if known); as specified by § 1310.04 and file reports (4) A complete statement of the facts as specified by § 1310.05. However, a which the petitioner believes justifies non-regulated person who acquires list- the addition or deletion of the sub- ed chemicals for internal consumption stance from paragraphs (a) or (b) of or ‘‘end use’’ and becomes a regulated this section; person by virtue of infrequent or rare (5) The date of the petition. distribution of a listed chemical from (f) The Administrator may require inventory, shall not be required to the petitioner to submit such docu- maintain receipt records of listed ments or written statements of fact chemicals under this section. relevant to the petition as he deems (b) Each regulated person who manu- necessary in making a determination. factures a List I or List II chemical (g) Within a reasonable period of shall file reports regarding such manu- time after the receipt of the petition, facture as specified in § 1310.05. the Administrator shall notify the pe- (c)(1) Each regulated person who en- titioner of his decision and the reason gages in a transaction with a nonregu- therefor. The Administrator need not lated person which: accept a petition if any of the require- (i) Involves ephedrine, ments prescribed in paragraph (e) of pseudoephedrine, phenylpropanola- this section or requested pursuant to mine, or gamma hydroxybutyric acid paragraph (f) of this section are lack- (including drug products containing ing or are not clearly set forth as to be these chemicals or controlled sub- readily understood. If the petitioner stance); and desires, he may amend and resubmit (ii) Uses or attempts to use the U.S. the petition to meet the requirements Postal Service or any private or com- of paragraphs (e) and (f) of this section. mercial carrier must, on a monthly (h) If a petition is granted or the Ad- basis, report to the Administration ministrator, upon his own motion, pro- each such transaction conducted dur- poses to add or delete substances as ing the previous month as specified in 151

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§§ 1310.05(e) and 1310.06(k) on DEA Form curred, except that records may be 453 through the DEA Diversion Control kept at a single, central location of the Division secure network application. regulated person if the regulated per- (2) Each regulated person who en- son has notified the Administration of gages in an export transaction which: the intention to do so. Written notifi- (i) Involves ephedrine, cation must be submitted by registered pseudoephedrine, phenylpropanola- or certified mail, return receipt re- mine, or gamma hydroxybutyric acid quested, to the Special Agent in Charge (including drug products containing of the DEA Divisional Office for the these chemicals or controlled sub- area in which the records are required stance); and to be kept. (ii) Uses or attempts to use the U.S. (d) The records required to be kept Postal Service or any private or com- under this section shall be readily re- mercial carrier must, on a monthly trievable and available for inspection basis, report each such transaction and copying by authorized employees conducted during the previous month of the Administration under the provi- as specified in §§ 1310.05(e) and 1310.06(k) sions of 21 U.S.C. 880. on DEA Form 453 through the DEA Di- version Control Division secure net- (e) The regulated person with more work application. than one place of business where records are required to be kept shall [54 FR 31665, Aug. 1, 1989, as amended at 56 devise a system to detect any party FR 8277, Feb. 28, 1991; 61 FR 14023, Mar. 29, purchasing from several individual lo- 1996; 67 FR 14861, Mar. 28, 2002; 68 FR 57804, cations of the regulated person thereby Oct. 7, 2003; 70 FR 294, Jan. 4, 2005; 81 FR 97022, Dec. 30, 2016] seeking to avoid the application of the cumulative threshold or evading the § 1310.04 Maintenance of records. requirements of the Act. (a) Every record required to be kept (f) For those listed chemicals for subject to § 1310.03 for a List I chem- which thresholds have been estab- ical, a tableting machine, or an encap- lished, the quantitative threshold or sulating machine shall be kept by the the cumulative amount for multiple regulated person for 2 years after the transactions within a calendar month, date of the transaction. to be utilized in determining whether a (b) Every record required to be kept receipt, sale, importation or expor- subject to Section 1310.03 for List II tation is a regulated transaction is as chemical shall be kept by the regulated follows: person for two years after the date of (1) List I chemicals: the transaction. (i) Except as provided in paragraph (c) A record under this section shall (f)(1)(ii) of this section, the following be kept at the regulated person’s place thresholds have been established for of business where the transaction oc- 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.

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Code Chemical Threshold by base weight

8750 ...... Piperonal (also called heliotropine) ...... 4 kilograms. 8328 ...... Propionic anhydride ...... 1 gram. 8323 ...... Safrole ...... 4 kilograms.

(ii) For List I chemicals that are con- export. Sales of these products at retail tained in scheduled listed chemical are subject to the requirements of part products as defined in § 1300.02 of this 1314 of this chapter. chapter, the thresholds established in (2) List II Chemicals: paragraph (g) of this section apply only (i) Imports and Exports to non-retail distribution, import, and

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 Chemical Threshold by Threshold by applicable to domestic sales of Ace- volume weight tone, 2-Butanone (MEK), and Toluene. (A) Methyl Isobutyl 500 gallons ...... 1523 kilograms. (iv) Exports, Transshipments and Ketone (MIBK). International Transactions to Des- (B) Reserved. ignated Countries as Set Forth in (g) For listed chemicals for which no § 1310.08(b). thresholds have been established, the Threshold by Threshold by size of the transaction is not a factor Chemical volume weight in determining whether the transaction meets the definition of a regu- (A) Hydrochloric acid 50 gallons (1) Anhydrous ...... 27 kilograms. lated transaction as set forth in Hydrogen chlo- § 1300.02 of this chapter. All such trans- ride. actions, regardless of size, are subject (B) Sulfuric acid ...... 50 gallons to recordkeeping and reporting requirements as set forth in this part and no- (v) Export and International Trans- tification provisions as set forth in actions to Designated Countries, and part 1313 of this chapter. Importations for Transshipment or (1) Listed chemicals for which no Transfer to Designated Countries thresholds have been established: (i) Alpha-phenylacetoacetonitrile and its salts, optical isomers, and salts of optical isomers (APAAN)

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(ii) Ephedrine, its salts, optical iso- Finding Aids section of the printed volume mers, and salts of optical isomers; and at www.govinfo.gov. (iii) Ergocristine and its salts (iv) Gamma-Butyrolactone (Other § 1310.05 Reports. names include: GBL; Dihydro-2(3H)- (a)(1) Each regulated person must re- furanone; 1,2-Butanolide; 1,4- port to the Special Agent in Charge of Butanolide; 4-Hydroxybutanoic acid the DEA Divisional Office for the area lactone; gamma-hydroxybutyric acid in which the regulated person making lactone) the report is located any regulated (v) Hypophosphorous acid and its transaction involving an extraordinary salts (including ammonium quantity of a listed chemical, an un- hypophosphite, calcium hypophosphite, common method of payment or deliv- iron hypophosphite, potassium ery, or any other circumstance that hypophosphite, manganese the regulated person believes may indi- hypophosphite, magnesium cate that the listed chemical will be hypophosphite, and sodium used in violation of this part. The regu- hypophosphite) (vi) Iodine lated person will orally report to the (vii) N-phenethyl-4-piperidone (NPP) Special Agent in Charge of the DEA Di- (viii) Pseudoephedrine, its salts, opti- visional Office at the earliest prac- cal isomers, and salts of optical iso- ticable opportunity after the regulated mers person becomes aware of the cir- (ix) Phenylpropanolamine, its salts, cumstances involved and as much in optical isomers, and salts of optical advance of the conclusion of the trans- isomers action as possible. The regulated per- (x) Red phosphorus son must file a written report of the (xi) White phosphorus (Other names: transaction(s) with the Special Agent Yellow Phosphorus) in Charge of the DEA Divisional Office (2) [Reserved] as set forth in § 1310.06 within 15 cal- (h) The thresholds and conditions in endar days after the regulated person paragraphs (f) and (g) of this section becomes aware of the circumstances of will apply to transactions involving the event. regulated chemical mixtures. For pur- (2) Each regulated person must re- poses of determining whether the port to the Special Agent in Charge of 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 the report is located any proposed reg- rules apply: ulated transaction with a person whose (1) For chemical mixtures containing description or other identifying char- List I chemicals or List II chemicals acteristic the Administration has pre- other than those in paragraph (h)(2) of viously furnished to the regulated per- this section, the threshold is deter- son. The regulated person will orally mined by the weight of the listed report to the Special Agent in Charge chemical in the chemical mixture. of the DEA Divisional Office at the ear- (2) For the List II chemicals acetone, liest practicable opportunity after the ethyl ether, 2-butanone, toluene, and regulated person becomes aware of the methyl isobutyl ketone, the threshold circumstances involved. A transaction is determined by the weight of the en- may not be completed with a person tire chemical mixture. whose description or identifying char- (3) If two or more listed chemicals acteristic has previously been fur- are present in a chemical mixture, and nished to the regulated person by the the quantity of any of these chemicals Administration unless the transaction equals or exceeds the threshold appli- is approved by the Administration. cable to that chemical, then the trans- (b)(1) Each regulated person must re- action is regulated. port to the Special Agent in Charge of [54 FR 31665, Aug. 1, 1989] the DEA Divisional Office for the area EDITORIAL NOTE: For FEDERAL REGISTER ci- in which the regulated person making tations affecting § 1310.04, see the List of CFR the report is located any unusual or ex- Sections Affected, which appears in the cessive loss or disappearance of a listed

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chemical under the control of the regu- appear to be random, and the result of lated person. The regulated person will efforts taken to resolve the losses. orally report to the Special Agent in (v) If known, the regulated person Charge of the DEA Divisional Office at should also consider whether the spe- the earliest practicable opportunity cific listed chemical was a likely can- after the regulated person becomes didate for diversion as well as local aware of the circumstances involved. trends and other indicators of the di- Unless the loss or disappearance occurs version potential of the listed chem- during an import or export trans- ical. action, the supplier is responsible for (2) Each regulated person must orally reporting all in-transit losses of any report any domestic regulated trans- listed chemical by their agent or the action in a tableting machine or an en- common or contract carrier. In an im- capsulating machine to the Special port transaction, once a shipment has Agent in Charge of the DEA Divisional been released by the customs officer at the port of entry, the importer is re- Office for the area in which the regu- sponsible for reporting all in-transit lated person making the report is lo- losses of any listed chemical by their cated when the order is placed with the agent or the common or contract car- seller. The regulated person also must rier. In an export transaction, the ex- file a report of the transaction (on DEA porter is responsible for reporting all Form 452) with the Administration in-transit losses of any listed chemical through the DEA Diversion Control Di- by their agent or the common or con- vision secure network application tract carrier until the shipment has within 15 calendar days after the order been released by the customs officer at has been shipped by the seller. A report the port of export. The regulated per- (DEA Form 452) may list more than son must also file a complete and accu- one machine for a single transaction. rate DEA Form 107, in accordance with Upon receipt and review, the Adminis- § 1310.06(d), with the Administration tration will assign a completed report through the DEA Diversion Control Di- a transaction identification number. vision secure network application The report will not be deemed filed within 15 calendar days after becoming until a transaction identification num- aware of the circumstances requiring ber has been issued by the Administra- the report. Unusual or excessive losses tion. or disappearances must be reported (c) Imports and exports of tableting ma- whether or not the listed chemical is chines and encapsulating machines. (1) subsequently recovered or the respon- Each regulated person who imports or sible parties are identified and action exports a tableting machine, or encap- taken against them. When determining sulating machine, must file a report of whether a loss or disappearance of a such importation or exportation on listed chemical was unusual or exces- DEA Form 452 with the Administration sive, the regulated persons should con- through the DEA Diversion Control Di- sider, among others, the following fac- vision secure network application, at tors: (i) The actual quantity of a listed least 15 calendar days before the antici- chemical; pated arrival at the port of entry or (ii) The specific listed chemical in- port of export. In order to facilitate the volved; importation or exportation of any (iii) Whether the loss or disappear- tableting machine or encapsulating ance of the listed chemical can be asso- machine and implement the purpose of ciated with access to those listed the Act, regulated persons may report chemicals by specific individuals, or to the Administration as far in advance whether the loss or disappearance can as possible. A separate report (DEA be attributed to unique activities that Form 452) must be filed for each ship- may take place involving the listed ment, in accordance with § 1310.06(e). chemical; and Upon receipt and review, the Adminis- (iv) A pattern of losses or disappear- tration will assign a completed report ances over a specific time period, a transaction identification number. whether the losses or disappearances The report will not be deemed filed

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until a transaction identification num- mitted annually to the Drug and Chem- ber has been issued by the Administra- ical Evaluation Section, Diversion tion. The importer or exporter may Control Division, Drug Enforcement only proceed with the transaction once Administration, on or before the 15th the transaction identification number day of March of the year immediately has been issued. Any tableting machine following the calendar year for which or encapsulating machine may be im- submitted. See the Table of DEA Mail- ported or exported if that machine is ing Addresses in § 1321.01 of this chapter needed for medical, commercial, sci- for the current mailing address. A busi- entific, or other legitimate uses. How- ness entity which manufactures a list- ever, an importation or exportation of ed chemical may elect to report sepa- a tableting machine or encapsulating rately by individual location or report machine may not be completed with a as an aggregate amount for the entire person whose description or identifying business entity provided that they in- characteristic has previously been fur- form the DEA of which method they nished to the regulated person by the will use. This reporting requirement Administration unless the transaction does not apply to drugs or other prod- is approved by the Administration. ucts that are exempted under para- (2) Denied release at the port of entry. graph (1)(iv) or (v) of the definition of In the event that a shipment of regulated transaction in § 1300.02 of this tableting or encapsulating machine(s) chapter except as set forth in has been denied release by a customs § 1310.06(i)(5). Bulk manufacturers that officer at the port of entry for any rea- produce a listed chemical solely for in- son, the importer who attempted to ternal consumption are not required to import the shipment must, within 5 report for that listed chemical. For business days of the denial, report to purposes of these reporting require- the Administration that the shipment ments, internal consumption consists was denied, the basis for denial, and of any quantity of a listed chemical such other information as is required otherwise not available for further re- by § 1310.06(g). Such report must be sale or distribution. Internal consump- transmitted to the Administration tion includes (but is not limited to) through the DEA Diversion Control Di- quantities used for quality control vision secure network application. testing, quantities consumed in-house, Upon the importer’s report of a denied or production losses. Internal consump- entry, DEA will assign the report a tion does not include the quantities of transaction identification number and a listed chemical consumed in the pro- the original import notification will be duction of exempted products. If an ex- void and of no effect. No shipment of isting standard industry report con- tableting machines or encapsulating tains the information required in machines denied entry for any reason § 1310.06(j) and such information is sep- will be allowed entry without a subse- arate or readily retrievable from the quent refiling of an amended DEA report, that report may be submitted Form 452 by the regulated person. In in satisfaction of this requirement. such circumstances, the regulated per- Each report must be submitted to the son may proceed with the release of the DEA under company letterhead and tableting machines or encapsulating signed by an appropriate, responsible machines upon receipt of a transaction official. For purposes of this paragraph identification number for the refiled (d) only, the term regulated bulk man- and amended DEA Form 452 without ufacturer of a listed chemical means a regard to the 15-day advance filing re- person who manufactures a listed quirement in paragraph (c)(1) of this chemical by means of chemical syn- section, so long as the article is other- thesis or by extraction from other sub- wise cleared for entry under U.S. cus- stances. The term bulk manufacturer toms laws. does not include persons whose sole ac- (d) Each regulated bulk manufac- tivity consists of the repackaging or turer of a listed chemical must submit relabeling of listed chemical products manufacturing, inventory and use data or the manufacture of drug dosage on an annual basis as set forth in forms of products which contain a list- § 1310.06(j). This data must be sub- ed chemical.

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(e) Each regulated person required to ocation, as provided in § 1313.41(a) of report pursuant to § 1310.03(c) must file this chapter. The revocation will be ef- a report containing the transaction fective upon receipt of the notice by identification number for each such the person. The regulated person has transaction (if the regulated person is the right to an expedited hearing re- required to obtain a transaction identi- garding the revocation, as provided in fication number under part 1313of this § 1313.56(a) of this chapter. chapter) and information set forth in [54 FR 31665, Aug. 1, 1989, as amended at 57 § 1310.06(k), on or before the 15th day of FR 2461, Jan. 22, 1992; 61 FR 14024, Mar. 29, each month following the month in 1996; 61 FR 17958, Apr. 23, 1996; 62 FR 13968, which the distributions took place. Mar. 24, 1997; 67 FR 14862, Mar. 28, 2002; 67 FR (f) Except as provided in paragraph 49569, July 31, 2002; 68 FR 57804, Oct. 7, 2003; (g) of this section, the following dis- 71 FR 56024, Sept. 26, 2006; 75 FR 10680, Mar. tributions to nonregulated persons, and 9, 2010; 77 FR 4236, Jan. 27, 2012; 81 FR 97022, the following export transactions, are Dec. 30, 2016] not subject to the reporting requirements in § 1310.03(c): § 1310.06 Content of records and reports. (1) Distributions of sample packages of drug products when those packages (a) Each record required by contain not more than two solid dosage § 1310.03(a) must include the following: units or the equivalent of two dosage (1) The name/business name, address/ units in liquid form, not to exceed 10 business address, and contact informa- milliliters of liquid per package, and tion (e.g., telephone number(s), email not more than one package is distrib- address (es), etc.), and, if required, DEA uted to an individual or residential ad- registration number of each party to dress in any 30-day period. the regulated transaction. (2) Distributions of drug products by (2) The date of the regulated trans- retail distributors that may not in- action. clude face-to-face transactions to the (3) The quantity, chemical name, extent that such distributions are con- and, if applicable, National Drug Code sistent with the activities authorized (NDC) number. If NDC number is not for a retail distributor as defined in applicable, the form of packaging of § 1300.02 of this chapter, except that the listed chemical or a description of this paragraph does not apply to sales the tableting machine or encapsulating of scheduled listed chemical products machine (including make, model, serial at retail. number, if any, and whether the ma- (3) Distributions of drug products to chine is manual or electric). a resident of a long term care facility (4) The method of transfer (company or distributions of drug products to a truck, picked up by customer, etc.). long term care facility for dispensing (5) The type of identification used by to or for use by a resident of that facil- the purchaser and any unique number ity. on that identification. (4) Distributions of drug products in (b) For purposes of this section, nor- accordance with a valid prescription. mal business records will be considered (5) Exports which have been reported adequate if they contain the informa- to the Administrator under §§ 1313.31 tion listed in paragraph (a) of this sec- and 1313.32 of this chapter or which are tion and are readily retrievable from subject to a waiver granted under other business records of the regulated § 1313.21 of this chapter. person. For prescription drug products, (g) The Administrator may revoke prescription and hospital records kept any or all of the exemptions listed in in the normal course of medical treat- paragraph (f) of this section for an indi- ment will be considered adequate for vidual regulated person if the Adminis- satisfying the requirements of para- trator finds that drug products distrib- graph (a) of this section with respect to uted by the regulated person are being dispensing to patients, and records re- used in violation of the regulations in quired to be maintained pursuant to this chapter or the Controlled Sub- the U.S. Food and Drug Administration stances Act. The Administrator will regulations relating to the distribution notify the regulated person of the rev- of prescription drugs, as set forth in 21

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CFR part 205, will be considered ade- superstore, convenience store, spe- quate for satisfying the requirements cialty food store, gas station, mobile of paragraph (a) of this section with re- retail vendor, mail-order, etc.) if the spect to distributions. regulated person is not a DEA reg- (c)(1) Each report required by istrant. § 1310.05(a) must include the informa- (e)(1) Each report of an importation tion as specified by paragraph (a) of of a tableting machine or an encap- this section, the basis for making the sulating machine required by report, and, where obtainable, the reg- § 1310.05(c)(1) (on DEA Form 452) must istration number of the other party, if include the following information: such party is registered. A report of an (i) The name/business name, address/ uncommon method of payment or de- business address, and contact informa- livery submitted in accordance with tion (e.g., telephone number(s), email § 1310.05(a)(1) must also include a rea- address(es), etc.) of the regulated person why the method of payment or de- son; the name/business name, address/ livery was uncommon. business address, and contact informa- (2) A suggested format for the reports tion (e.g., telephone number(s), email in § 1310.05(a)(1) is provided below: address(es), etc.) of the import broker or forwarding agent, if any; Shipping Address (if different than purchaser Address): (ii) A description of each machine (including make, model, serial number, Street llllllllllllllllllll if any, and whether the machine is City lllllllllllllllllllll State llllllllllllllllllll manual or electric) and the number of Zip lllllllllllllllllllll machines being received; Date of Shipment llllllllllllll (iii) The anticipated date of arrival Description of Listed Chemical: at the port of entry, and the antici- Chemical Name lllllllllllllll pated port of entry; Quantity llllllllllllllllll (iv) The name/business name, ad- National Drug Code (NDC) Number(s), or dress/business address, and contact in- Form(s) of Packaging lllllllllll formation (e.g., telephone number(s), Other: email address(es), etc.) of the consignor The basis (i.e., reason) for making the rein the foreign country of exportation; port: llllllllllllllllllll (v) The intended medical, commer- Any additional pertinent information: lll cial, scientific, or other legitimate use (d) Each report of an unusual or ex- of the machine; and cessive loss or disappearance of a listed (vi) Any proposed changes in identi- chemical required by § 1310.05(b)(1) (on fying information of the imported ma- DEA Form 107), must include the fol- chines (e.g., name, brand, serial num- lowing information: ber, if any, etc.) that will take place (1) The name/business name, address/ after importation. business address, and contact informa- (2) Each report of an exportation of a tion (e.g., telephone number(s), email tableting machine or an encapsulating address (es), etc.), and, if applicable, machine required by § 1310.05(c)(1) (on DEA registration number of each party DEA Form 452) must include the fol- to the regulated transaction. lowing information: (2) The date (or estimated date) on (i) The name/business name, address/ which unusual or excessive loss or dis- business address, and contact informa- appearance occurred, and the actual tion (e.g., telephone number(s), email date on which the unusual or excessive address(es), etc.) of the regulated per- loss or disappearance was discovered by son; the name/business name, address/ the regulated person. business address, and contact informa- (3) The quantity, chemical name, and tion (e.g., telephone number(s), email National Drug Code (NDC) number, if address(es), etc.) of the export broker applicable or if not the form of pack- (if applicable); aging of the listed chemical. (ii) A description of each machine (4) The type of business conducted by (including make, model, serial number, the regulated person, (e.g., grocery if any, and whether the machine is store, pharmacy/drug store, discount manual or electric) and the number of department store, warehouse club or machines being received;

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(iii) The anticipated date of arrival version Control Division secure net- at the port of export, the foreign port work application. This report must in- and country of entry; and clude the following information: The (iv) The name/business name, ad- date on which a customs officer at the dress/business address, and contact in- port of entry released the machine(s); formation (e.g., telephone number(s), the date on which the machine(s) ar- email address(es), etc.) of the consignee rived at the final destination; the port in the country where the shipment is of entry where the machine(s) were ac- destined; the name(s)/business name(s) tually released by a customs officer; and address(es)/business address(es), the actual quantity of machines re- and contact information (e.g., tele- leased by a customs officer; the actual phone number(s), email address(es), quantity of machines that arrived at etc.) of the intermediate consignee(s) the final destination; a description of (if any). each tableting or encapsulating ma- (f) Each report of a domestic regu- chine imported (including make, lated transaction in a tableting ma- model, and serial number, if any); any chine or encapsulating machine re- changes in identifying information of quired by § 1310.05(b)(2) (on DEA Form the imported machines (e.g., name, 452) must include the following infor- brand, serial number, if any, etc.) that mation: will take place after importation; and (1) The name/business name, address/ any other information as the Adminis- business address, and contact informa- tration may from time to time specify. tion (e.g., telephone number(s), email Upon receipt and review, the Adminis- address(es), etc.) of the regulated per- tration will assign a transaction iden- son; the name/business name, address/ tification number to a completed re- business address, and contact informa- port. The report will not be deemed tion (e.g., telephone number(s), email address(es), etc.) of the purchaser; filed until the Administration has (2) A description of each machine (in- issued a transaction identification cluding make, model, serial number, if number. A single return declaration any, and whether the machine is man- may include the particulars of both the ual or electric) and the number of ma- importation and distribution. For DEA chines being received; and reporting purposes, import responsibil- (3) Any changes made by the regu- ities are concluded upon the receipt of lated person in identifying information the machines by the importer. Once of the machines (e.g., name, brand, se- machines are received by the importer, rial number, etc.). domestic transaction reporting re- (g) Each report of a denied release by quirements commence. Distributions of a customs officer at the port of entry tableting and encapsulating machines of a tableting machine or an encap- from the importer to their customers sulating machine required by must be reported as domestic regulated § 1310.05(c)(2) must include the fol- transactions in accordance with lowing information: the quantity of § 1310.05(b)(2). machines denied release; a concise de- (2) Within 30 calendar days after the scription of the machines denied re- tableting or encapsulating machine is lease; the date on which release was de- released by a customs officer at the nied; the port where the denial of report of export, or within 10 calendar lease was issued from; and the basis for days after receipt of a written request the denial. by the Administration to the exporter, (h) Return information. (1) Within 30 whichever is sooner, the exporter must calendar days after actual receipt of a file a report with the Administration tableting or encapsulating machine, or (on DEA Form 452) through the DEA within 10 calendar days after receipt of Diversion Control Division secure net- a written request by the Administra- work application specifying the par- tion to the importer, whichever is ticulars of the transaction. This report sooner, the importer must file a report must include the following informa- with the Administration (on DEA tion: The date on which the machine(s) Form 452) specifying the particulars of was (were) released by a customs offi- the transaction utilizing the DEA Di- cer at the port of export; the actual

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quantity of machines released; a de- endar year, unless the chemical is pro- scription of each tableting or encap- duced solely for internal consumption. sulating machine released (including (5) The aggregate quantity of each make, model, serial number, if any, listed chemical manufactured which and whether the machine is manual or becomes a component of a product ex- electric); and any other information as empted from paragraph (1)(iv) or (v) of the Administration may from time to the definition of regulated transaction time specify. in § 1300.02 of this chapter during the (i) Declared exports of machines preceding calendar year. which are refused, rejected, or other- (6) Data shall identify the specific wise deemed undeliverable may be re- isomer, salt or ester when applicable turned to the U.S. exporter of record. A but quantitative data shall be reported brief written report outlining the cir- as anhydrous base or acid in kilogram cumstances must be filed with the Ad- units of measure. ministration through the DEA Diver- sion Control Division secure network (k) Each monthly report required by application, following the return at the §§ 1310.03(c) and 1310.05(e) (on DEA earliest practicable opportunity after Form 453) must provide the following the regulated person becomes aware of information for each transaction: the circumstances involved. This provi- (1) Supplier name/business name, ad- sion does not apply to shipments that dress/business address, and contact in- have cleared foreign customs, been de- formation (e.g., telephone number(s), livered, and accepted by the foreign email address(es), etc.) and registra- consignee. Returns to third parties in tion number. the United States will be regarded as (2) Purchaser’s name/business name, imports. address/business address, and contact (j) Each annual report required by information (e.g., telephone number(s), § 1310.05(d) must provide the following email address(es), etc.). information for each listed chemical (3) Name/business name, address/busi- manufactured: ness address shipped to (if different (1) The name/business name, address/ from purchaser’s name/address). business address, and contact informa- (4) Chemical name, National Drug tion (e.g., telephone number(s), email Code (NDC) number, if applicable, and address(es), etc.) and chemical reg- total amount shipped. istration number (if any) of the manu- (5) Date of shipment. facturer. (2) The aggregate quantity of each (6) Product name (if drug product). listed chemical that the company man- (7) Dosage form (if drug product) ufactured during the preceding cal- (e.g., pill, tablet, liquid). endar year. (8) Dosage strength (if drug product) (3) The year-end inventory of each (e.g., 30mg, 60mg, per dose etc.). listed chemical as of the close of busi- (9) Number of dosage units (if drug ness on the 31st day of December of product) (e.g., 100 doses per package). each year. (For each listed chemical, if (10) Package type (if drug product) the prior period’s ending inventory has (e.g., bottle, blister pack, etc.). not previously been reported to DEA, (11) Number of packages (if drug this report should also detail the begin- product) (e.g., 10 bottles). ning inventory for the period.) For pur- (12) Lot number (if drug product). poses of this requirement, inventory (l) Information provided in reports shall reflect the quantity of listed required by § 1310.05(e) which is exempt chemicals, whether in bulk or non-ex- from disclosure under section 552(a) of empt product form, held in storage for title 5, by reason of section 552(b)(6) of later distribution. Inventory does not title 5, will be provided the same pro- include waste material for destruction, tections from disclosure as are pro- material stored as an in-process inter- vided in section 310(c) of the Act (21 mediate or other in-process material. U.S.C. 830(c)) for confidential business (4) The aggregate quantity of each information. listed chemical used for internal consumption during the preceding cal- [81 FR 97023, Dec. 30, 2016]

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§ 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 party to the regulated person at the and photograph, etc. Any regulated time the order is placed. For export person who fails to adequately prove transactions, this shall be accom- the identity of the other party to the plished by good faith inquiry through transaction may be subject to the spe- reasonably available research docu- cific penalties provided for violations ments or publicly available informa- of law related to regulated trans- tion which would indicate the exist- actions in listed chemicals. (e) For a new customer who is not an ence of the foreign customer. No proof individual or cash customer, the regu- of identity is required for foreign sup- lated person shall establish the iden- pliers. (b) The regulated person must verify tity of the authorized purchasing agent the existence and apparent validity of or agents and have on file that person’s a business entity ordering a listed signature, electronic password, or chemical, tableting machine or encap- other identification. Once the author- sulating machine. For domestic trans- ized purchasing agent has been estab- actions, this may be accomplished by lished, the agent list may be updated such methods as checking the tele- annually rather than on each order. phone directory, the local credit bu- The regulated person must ensure that reau, the local Chamber of Commerce shipments are not made unless the or the local Better Business Bureau, or, order is placed by an authorized agent if the business entity is a registrant, of record. by verification of the registration. For (f) With respect to electronic orders, export transactions, a good faith in- the identity of the purchaser shall con- quiry to verify the existence and appar- sist of a computer password, identifica- ent validity of a foreign business entity tion number or some other means of may be accomplished by such methods identification consistent with elec- as verifying the business telephone tronic orders and with § 1310.07(e). listing through international telephone [54 FR 31665, Aug. 1, 1989, as amended at 60 information, the firm’s listing in inter- FR 32461, June 22, 1995] national or foreign national chemical directories or other commerce direc- § 1310.08 Excluded transactions. tories or trade publications, confirma- Pursuant to 21 U.S.C. 802(39)(A)(iii), tion through foreign subsidiaries of the regulation of the following trans- U.S. regulated person, verification actions has been determined to be un- through the country of destination’s necessary for the enforcement of the embassy Commercial Attache, or offi- Chemical Diversion and Trafficking cial documents provided by the pur- Act and, therefore, they have been ex- chaser which confirm the existence and cluded from the definitions of regu- apparent validity of the business enti- lated transactions: ty. (a) Domestic and import transactions (c) When transacting business with a of hydrochloric and sulfuric acids but new representative of a firm, the regu- not including anhydrous hydrogen lated person must verify the claimed chloride. agency status of the representative. (b) Exports, transshipments, and (d) For sales to individuals or cash international transactions of hydro- purchasers, the type of documents and chloric (including anhydrous hydrogen other evidence of proof must consist of chloride) and sulfuric acids, except for at least a signature of the purchaser, a exports, transshipments and inter- driver’s license and one other form of national transactions to the following identification. Any exports to individ- countries:

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(1) Argentina toluene, unless regulated because of (2) Bolivia being formulated with other List I or (3) Brazil List II chemical(s) above the con- (4) Chile centration limit. (5) Colombia (6) Ecuador [57 FR 43615, Sept. 22, 1992, as amended at 60 FR 19510, Apr. 19, 1995; 60 FR 32461, June 22, (7) French Guiana 1995; 62 FR 13968, Mar. 24, 1997; 65 FR 47316, (8) Guyana Aug. 2, 2000; 66 FR 52675, Oct. 17, 2001; 68 FR (9) Panama 37414, June 24, 2003; 68 FR 53292, Sept. 10, 2003; (10) Paraguay 69 FR 74971, Dec. 15, 2004; 72 FR 10928, Mar. 12, (11) Peru 2007; 72 FR 35931, July 2, 2007] (12) Suriname (13) Uruguay § 1310.09 Temporary exemption from (14) Venezuela registration. (c) Domestic transactions of Methyl (a) Each person required by section Isobutyl Ketone (MIBK). 302 of the act (21 U.S.C. 822) to obtain a (d) Import transactions of Methyl registration to distribute, import, or Isobutyl Ketone (MIBK) destined for export a combination ephedrine prod- the United States. uct is temporarily exempted from the (e) Export transactions, inter- registration requirement, provided national transactions, and import that the person submits a proper appli- transactions for transshipment or cation for registration on or before transfer of Methyl Isobutyl Ketone July 12, 1997. The exemption will re- (MIBK) destined for Canada or any main in effect for each person who has country outside of the Western Hemi- made such application until the Ad- sphere. ministration has approved or denied (f) Domestic and international trans- that application. This exemption ap- actions of Lugol’s Solution (consisting plies only to registration; all other of 5 percent iodine and 10 percent po- chemical control requirements set tassium iodide in an aqueous solution) forth in parts 1309, 1310, and 1313 of this in original manufacturer’s packaging chapter remain in full force and effect. of one-fluid-ounce (30 milliliters) or less, and no greater than one package (b) Each person required by section per transaction. 302 of the Act (21 U.S.C. 822) to obtain (g) Import transactions of anhydrous a registration to distribute, import, or hydrogen chloride. export a drug product that contains (h) Domestic distribution of anhy- pseudoephedrine or phenylpropanola- drous hydrogen chloride weighing mine that is regulated pursuant to 12,000 pounds (net weight) or more in a paragraph (1)(iv) of the definition of single container. regulated transaction in § 1300.02 of this (i) Domestic distribution of anhy- chapter is temporarily exempted from drous hydrogen chloride by pipeline. the registration requirement, provided (j) Domestic and international return that the person submits a proper appli- shipments of reusable containers from cation for registration on or before De- customer to producer containing resid- cember 3, 1997.The exemption will re- ual quantities of red phosphorus or main in effect for each person who has white phosphorus in rail cars and inter- made such application until the Ad- modal tank containers which conform ministration has approved or denied to International Standards Organiza- that application. This exemption ap- tion specifications (with capacities plies only to registration; all other greater than or equal to 2,500 gallons in chemical control requirements set a single container). forth in parts 1309, 1310, and 1313 of this (k) Domestic, import, and export dis- chapter remain in full force and effect. tributions of gamma-butyrolactone (c) Each person required by section weighing 4,000 kilograms (net weight) 302 of the act (21 U.S.C. 822) to obtain a or more in a single container. registration to distribute, import, or (l) Domestic and import transactions export GBL is temporarily exempted in chemical mixtures that contain ace- from the registration requirement, pro- tone, ethyl ether, 2-butanone, and/or vided that the DEA receives a proper

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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 has made such application until the of official DEA notification that the Administration has approved or denied application for exemption has not been that application. This exemption ap- approved. The temporary exemption plies only to registration; all other for such persons will remain in effect chemical control requirements set until DEA takes final action on their forth in parts 1309, 1310, and 1313 of this registration application. chapter remain in full force and effect. (f) Except for chemical mixtures con- (d) Each person required by section taining the listed chemicals in para- 302 of the Act (21 U.S.C. 822) to obtain graph (e) of this section, each person a registration to distribute, import, or required by section 302 of the Act (21 export the List I chemicals red phos- U.S.C. 822) to obtain a registration to phorus, white phosphorus, and distribute, import, or export regulated hypophosphorous acid (and its salts), is chemical mixtures, pursuant to temporarily exempted from the reg- §§ 1310.12 and 1310.13, is temporarily ex- istration requirement, provided that empted from the registration require- the person submits a proper applica- ment, provided that DEA receives a tion for registration on or before De- proper application for registration or cember 17, 2001. The exemption will re- application for exemption on or before main in effect for each person who has February 14, 2005. The exemption will made such application until the Ad- remain in effect for each person who ministration has approved or denied has made such application until the that application. This exemption ap- Administration has approved or denied plies only to registration; all other that application. This exemption ap- chemical control requirements set plies only to registration; all other forth in parts 1309, 1310, and 1313 of this chemical control requirements set chapter remain in full force and effect. forth in parts 1309, 1310, and 1313 of this (e) Each person required by section chapter remain in full force and effect. 302 of the Act (21 U.S.C. 822) to obtain (g) Any person who distributes, im- a registration to distribute, import, or ports, or exports a chemical mixture export regulated chemical mixtures whose application for exemption is sub- which contain ephedrine, N- sequently denied by DEA must obtain a methylephedrine, N- registration with DEA. A temporary methylpseudoephedrine, exemption from the registration re- norpseudoephedrine, phenylpropanola- quirement will also be provided for mine, and/or pseudoephedrine, pursu- these persons, provided that DEA re- ant to §§ 1310.12 and 1310.13, is tempo- ceives a properly completed applica- rarily exempted from the registration tion for registration on or before 30 requirement, provided that DEA re- days following the date of official DEA ceives a proper application for registra- notification that the application for tion or application for exemption on or exemption has not been approved. The before June 30, 2003. The exemption temporary exemption for such persons will remain in effect for each person will remain in effect until DEA takes who has made such application until final action on their registration appli- the Administration has approved or de- cation. nied that application. This exemption (h) Each person required under 21 applies only to registration; all other U.S.C. 822 and 21 U.S.C. 957 to obtain a chemical control requirements set registration to manufacture, dis- forth in parts 1309, 1310, and 1313 of this tribute, import, or export regulated N- chapter remain in full force and effect. phenethyl-4-piperidone (NPP), includ- Any person who distributes, imports or ing regulated chemical mixtures pursu- exports a chemical mixture whose ap- ant to § 1310.12, is temporarily exempt- plication for exemption is subsequently ed from the registration requirement, denied by DEA must obtain a registra- provided that DEA receives a proper tion with DEA. A temporary exemption application for registration or applica- from the registration requirement will tion for exemption for a chemical mix- also be provided for these persons, pro- ture containing NPP pursuant to

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§ 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 cation until the Administration has ap- days following the date of official Ad- proved or denied that application. This ministration notification that the ap- exemption applies only to registration; plication for exemption has not been all other chemical control require- approved. The temporary exemption ments set forth in the Act and parts for such persons will remain in effect 1309, 1310, 1313, and 1316 of this chapter until the Administration takes final remain in full force and effect. Any action on their registration applica- person who manufactures, distributes, tion. imports or exports a chemical mixture (j) Each person required by section containing N-phenethyl-4-piperidone 302 of the Act (21 U.S.C. 822) to obtain (NPP) whose application for exemption a registration to manufacture, dis- is subsequently denied by DEA must tribute, import, or export regulated obtain a registration with DEA. A tem- chemical mixtures which contain porary exemption from the registration ephedrine, and/or pseudoephedrine, pur- requirement will also be provided for suant to Sections 1310.12 and 1310.13, is those persons whose application for ex- temporarily exempted from the reg- emption are denied, provided that DEA istration requirement, provided that receives a properly completed applica- DEA receives a properly completed ap- tion for registration on or before 30 plication for registration or applica- days following the date of official DEA tion for exemption on or before August notification that the application for 24, 2007. The exemption will remain in exemption has been denied. The tem- effect for each person who has made porary exemption for such persons will remain in effect until DEA takes final such application until the Administra- action on their registration application has approved or denied that appli- tion. cation. This exemption applies only to (i) Each person required by section registration; all other chemical control 302 of the Act (21 U.S.C. 822) to obtain requirements set forth in parts 1309, a registration to manufacture, dis- 1310, 1313, and 1315 of this chapter re- tribute, import, or export regulated io- main in full force and effect. Any per- dine, including regulated iodine chem- son who manufactures, distributes, im- ical mixtures pursuant to §§ 1310.12 and ports, or exports a chemical mixture 1310.13, is temporarily exempted from whose application for exemption is sub- the registration requirement, provided sequently denied by DEA must obtain a that the Administration receives a registration with DEA. A temporary proper application for registration or exemption from the registration re- application for exemption for a chem- quirement will also be provided for ical mixture containing iodine on or these persons, provided that DEA re- before August 31, 2007. The exemption ceives a properly completed applica- will remain in effect for each person tion for registration on or before 30 who has made such application until days following the date of official DEA the Administration has approved or de- notification that the application for nied that application. This exemption exemption has not been approved. The applies only to registration; all other temporary exemption for such persons chemical control requirements set will remain in effect until DEA takes forth in the Act and parts 1309, 1310, final action on their registration appli- and 1313 of this chapter remain in full cation. force and effect. Any person who dis- (k)(1) Each person required by sec- tributes, imports, or exports a chem- tions 302 or 1007 of the Act (21 U.S.C. ical mixture containing iodine whose 822, 957) to obtain a registration to application for exemption is subse- manufacture, distribute, import, or ex- quently denied by the Administration port regulated GBL-containing chem- must obtain a registration with the ical mixtures, pursuant to sections Administration. A temporary exemp- 1310.12 and 1310.13, is temporarily ex- tion from the registration requirement empted from the registration require- will also be provided for these persons, ment, provided that DEA receives a

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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 son who has made such application denied, provided that DEA receives a until the Administration has approved properly completed application for reg- or denied that application. This exemp- istration on or before 30 days following tion applies only to registration; all the date of official DEA notification other chemical control requirements that the application for exemption has set forth in parts 1309, 1310, and 1313 of been denied. The temporary exemption this chapter remain in full force and ef- for such persons will remain in effect fect. until DEA takes final action on their (2) Any person who manufactures, registration application. distributes, imports or exports a GBL- (m)(1) Each person required by Sec- containing chemical mixture whose ap- tions 302 or 1007 of the Act (21 U.S.C. plication for exemption is subsequently 822, 957) to obtain a registration to denied by DEA must obtain a registra- manufacture, distribute, import, or ex- tion with DEA. A temporary exemption port regulated chemical mixtures from the registration requirement will which contain red phosphorus, white also be provided for those persons phosphorus, hypophosphorous acid (and whose applications for exemption are its salts), pursuant to §§ 1310.12 and denied, provided that DEA receives a 1310.13, is temporarily exempted from properly completed application for reg- the registration requirement, provided istration on or before 30 days following that DEA receives a properly com- the date of official DEA notification pleted application for registration or that the application for exemption has application for exemption on or before been denied. The temporary exemption July 5, 2011. The exemption will remain for such persons will remain in effect in effect for each person who has made until DEA takes final action on their such application until the Administra- registration application. tion has approved or denied that appli- (l)(1) Each person required under sec- cation. This exemption applies only to tions 302 and 1007 of the Act (21 U.S.C. 822, 957) to obtain a registration to registration; all other chemical control manufacture, distribute, import, or ex- requirements set forth in parts 1309, port regulated ergocristine and its 1310, and 1313 of this chapter remain in salts, including regulated chemical full force and effect. mixtures pursuant to § 1310.12, is tem- (2) Any person who manufactures, porarily exempted from the registra- distributes, imports, or exports a tion requirement, provided that DEA chemical mixture which contains red receives a properly completed applica- phosphorus, white phosphorus, tion for registration or application for hypophosphorous acid (and its salts) exemption for a chemical mixture con- whose application for exemption is sub- taining ergocristine and its salts pur- sequently denied by DEA must obtain a suant to § 1310.13 on or before May 2, registration with DEA. A temporary 2011. The exemption will remain in ef- exemption from the registration re- fect for each person who has made such quirement will also be provided for application until the Administration those persons whose applications are has approved or denied that applica- denied, provided that DEA receives a tion. This exemption applies only to properly completed application for reg- registration; all other chemical control istration on or before 30 days following requirements set forth in the Act and the date of official DEA notification parts 1309, 1310, 1313, and 1316 of this that the application for exemption has chapter remain in full force and effect. not been approved. The temporary ex- (2) Any person who manufactures, emption for such persons will remain distributes, imports, or exports a in effect until DEA takes final action chemical mixture containing on their registration application. ergocristine and its salts whose appli- (n)(1) Each person required under sec- cation for exemption is subsequently tions 302 and 1007 of the Act (21 U.S.C. denied by DEA must obtain a registra- 822, 957) to obtain a registration to

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manufacture, distribute, import, or ex- § 1310.10 Removal of the exemption of port regulated alpha- drugs distributed under the Federal phenylacetoacetonitrile (APAAN) and Food, Drug and Cosmetic Act. its salts, optical isomers, and salts of (a) The Administrator may remove optical isomers, including regulated from exemption under paragraph (1)(iv) chemical mixtures pursuant to § 1310.12, of the definition of regulated trans- is temporarily exempted from the reg- action in § 1300.02 of this chapter any istration requirement, provided that drug or group of drugs that the Admin- the DEA receives a properly completed istrator finds is being diverted to ob- application for registration or applica- tain a listed chemical for use in the il- tion for exemption for a chemical mix- licit production of a controlled sub- ture containing alpha- stance. In removing a drug or group of phenylacetoacetonitrile (APAAN) and drugs from the exemption the Adminis- its salts, optical isomers, and salts of trator shall consider: (1) The scope, duration, and signifi- optical isomers, pursuant to § 1310.13 on cance of the diversion; or before August 14, 2017. The exemp- (2) Whether the drug or group of tion will remain in effect for each per- drugs is formulated in such a way that son who has made such application it cannot be easily used in the illicit until the Administration has approved production of a controlled substance; or denied that application. This exemp- and tion applies only to registration; all (3) Whether the listed chemical can other chemical control requirements be readily recovered from the drug or set forth in the Act and parts 1309, 1310, group of drugs. 1313, and 1316 of this chapter remain in (b) Upon determining that a drug or full force and effect. group of drugs should be removed from (2) Any person who manufactures, the exemption under paragraph (a) of distributes, imports or exports a chem- this section, the Administrator shall ical mixture containing alpha- issue and publish in the FEDERAL REG- phenylacetoacetonitrile (APAAN) and ISTER his proposal to remove the drug its salts, optical isomers, and salts of or group of drugs from the exemption, optical isomers whose application for which shall include a reference to the exemption is subsequently denied by legal authority under which the pro- the DEA must obtain a registration posal is based. The Administrator shall permit any interested person to file with the DEA. A temporary exemption written comments on or objections to from the registration requirement will the proposal. After considering any also be provided for those persons comments or objections filed, the Ad- whose applications for exemption are ministrator shall publish in the FED- denied, provided that the DEA receives ERAL REGISTER his final order. a properly completed application for (c) The Administrator shall limit the registration on or before 30 days fol- removal of a drug or group of drugs lowing the date of official DEA notifi- from exemption under paragraph (a) of cation that the application for exemp- this section to the most identifiable tion has been denied. The temporary type of the drug or group of drugs for exemption for such persons will remain which evidence of diversion exists un- in effect until the DEA takes final ac- less there is evidence, based on the pat- tion on their registration application. tern of diversion and other relevant factors, that the diversion will not be [62 FR 27693, May 21, 1997, as amended at 62 limited to that particular drug or FR 53960, Oct. 17, 1997; 65 FR 21647, Apr. 24, group of drugs. 2000; 66 FR 52675, Oct. 17, 2001; 68 FR 23203, May 1, 2003; 69 FR 74971, Dec. 15, 2004; 72 FR (d) Any manufacturer seeking rein- 20046, Apr. 23, 2007; 72 FR 35931, July 2, 2007; statement of a particular drug product 72 FR 40239, July 24, 2007; 72 FR 40744, July 25, that has been removed from an exemp- 2007; 75 FR 37306, June 29, 2010; 76 FR 17781, tion may apply to the Administrator Mar. 31, 2011; 76 FR 31829, June 2, 2011; 77 FR for reinstatement of the exemption for 4237, Jan. 27, 2012; 82 FR 32460, July 14, 2017] that particular drug product on the grounds that the particular drug product 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. Alpha- 8512 Not exempt at any con- Chemical mixtures containing any amount of APAAN phenylacetoacetonitrile, centration. are not exempt. and its salts, optical isomers, and salts of optical isomers. (APAAN). 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.

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TABLE OF CONCENTRATION LIMITS—Continued

DEA chemical code Concentration Special conditions number

Methylamine and its salts .. 8520 20% by Weight ...... Methylamine or its salts in an inert carrier solvent is not considered a mixture. Weight is based on methylamine in the mixture and not the combined weight of carrier solvent, if any. 3,4-Methylenedioxyphenyl- 8502 20% by Weight. 2-propanone. N-Methylephedrine, its 8115 0.1% by Weight ...... Concentration based on any combination of salts N- salts, optical isomers, methylephedrine, N-methylpseudoephedrine and and salts of optical iso- their salts, optical isomers and salts of optical isomers. mers. N-Methylpseudoephedrine, 8119 0.1% by Weight...... Concentration based on any combination of N- its salts, optical isomers, methylpseudoephedrine, N-methylephedrine, and and salts of optical iso- their salts, optical isomers and salts of optical isomers. mers. Nitroethane ...... 6724 20% by Weight or Volume. Norpseudoephedrine, its 8317 0.6% by Weight...... Concentration based on any combination of salts, optical isomers, norpseudoephedrine, phenylpropanolamine and and salts of optical iso- their salts, optical isomers and salts of optical isomers. mers. N-phenethyl-4-piperidone 8332 Not exempt at any con- Chemical mixtures containing any amount of NPP are (NPP). centration. not exempt. Phenylacetic acid, and its 8791 40% by Weight...... Concentration is based on any combination of salts and esters. phenylacetic acid and its salts and esters. . Phenylpropanolamine, its 1225 0.6% by Weight ...... Concentration based on any combination of phenyl- salts, optical isomers, propanolamine, norpseudoephedrine and their salts, and salts of optical iso- optical isomers and salts of optical isomers. mers. Piperidine, and its salts ...... 2704 20% by Weight or Volume Concentration based on any combination of piperidine and its salts. Concentration based on weight if a solid, weight or volume if a liquid. Piperonal ...... 8750 20% by Weight or Volume. Propionic anhydride ...... 8328 20% by Weight or Volume. Pseudoephedrine, its salts, 8112 Not exempt at any con- Chemical mixtures containing any amount of ephed- optical isomers, and salts centration. rine and/or pseudoephedrine, and their salts, optical of optical isomers. isomers and salts of optical isomers are not exempt due to concentration, unless otherwise exempted. 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.

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TABLE OF CONCENTRATION LIMITS—Continued

DEA chemical code Concentration Special conditions number

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

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

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regarding any finding of fact or conclu- (c) An application for exemption sion of law upon which the order is under this section shall contain the fol- based, the Administrator shall imme- lowing information: diately suspend the effectiveness of the (1) The name, address, and registra- order until he may reconsider the order tion number, if any, of the applicant; in light of comments and objections (2) The date of the application; filed. Thereafter, the Administrator (3) The exact trade name(s) of the ap- shall reinstate, terminate, or amend plicant’s chemical mixture and: the original order as determined appro- (i) If the applicant formulates or priate. manufactures the chemical mixture for (f) The Administrator may modify other entities, the exact trade names of any part of the criteria for exemption the chemical mixtures and the names as specified in paragraphs (c) and (d) of of the entities for which the chemical this section upon evidence of diversion mixtures were prepared; and or attempted diversion. In doing so, the (ii) If a group of mixtures (e.g. formu- Administrator shall issue and publish a lations having identical function and Notice of Proposed Rulemaking in the containing the same listed chem- FEDERAL REGISTER. The Administrator ical(s)), the information required in shall permit any interested persons to paragraph (c)(3)(i) of this section and a file written comments on or objections brief narrative of their use. to the proposal. After considering any (4) (i) The complete qualitative and comments or objections filed, the Ad- quantitative composition of the chem- ministrator shall publish in the FED- ical mixture (including all listed and ERAL REGISTER a final order. all non-listed chemicals); or [68 FR 23204, May 1, 2003, as amended at 69 (ii) If a group of mixtures, the con- FR 74971, Dec. 15, 2004; 71 FR 60826, Oct. 17, centration range for the listed chem- 2006; 72 FR 20047, Apr. 23, 2007; 72 FR 35931, ical and a listing of all non-listed July 2, 2007; 72 FR 40745, July 25, 2007; 75 FR chemicals with respective concentra- 37306, June 29, 2010; 76 FR 17781, Mar. 31, 2011; tion ranges. 76 FR 31830, June 2, 2011; 82 FR 32460, July 14, 2017] (5) (i) The chemical and physical properties of the mixture and how they § 1310.13 Exemption of chemical mix- differ from the properties of the listed tures; application. chemical or chemicals; and (a) The Administrator may, by publi- (ii) If a group of mixtures, how the cation of a Final Rule in the FEDERAL group’s properties differ from the prop- REGISTER, exempt from the application erties of the listed chemical. of all or any part of the Act a chemical (6) A statement that the applicant mixture consisting of two or more believes justifies an exemption for the chemical components, at least one of chemical mixture or group of mixtures. which is not a List I or List II chem- The statement must explain how the ical, if: chemical mixture(s) meets the exemp- (1) The mixture is formulated in such tion criteria set forth in paragraph (a) a way that it cannot be easily used in of this section. the illicit production of a controlled (7) A statement that the applicant substance; and accepts the right of the Administrator (2) The listed chemical or chemicals to terminate exemption from regula- contained in the chemical mixture can- tion for the chemical mixture(s) grant- not be readily recovered. ed exemption under this section. (b) Any manufacturer seeking an ex- (8) The identification of any informa- emption for a chemical mixture, not tion on the application that is consid- exempt under § 1310.12, from the appli- ered by the applicant to be a trade se- cation of all or any part of the Act, cret or confidential and entitled to pro- may apply to the Drug and Chemical tection under U.S. laws restricting the Evaluation Section, Diversion Control public disclosure of such information. Division, Drug Enforcement Adminis- (d) The Administrator may require tration. See the Table of DEA Mailing the applicant to submit such additional Addresses in § 1321.01 of this chapter for documents or written statements of the current mailing address. fact relevant to the application that he

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

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EXEMPT CHEMICAL MIXTURES

Manufacturer Product name 1 Form Date

Cerilliant Corporation ... 1R,2S(-)-Ephedrine hydrochloride 1.0 mg/ml as free base in one of: Liquid ...... 8/2/2007 1,2-dimethoxyethane, acetonitrile, acetonitrile: water (≥50% acetonitrile), dimethylformamide, ethylene glycol, isopropanol, methanol, methanol/water (50:50), methanol/dimethyl sulfoxide (80:20), methylene chloride, or tetrahydrofuran. Cerilliant Corporation ... 1S,2R(+)-Ephedrine-D3 hydrochloride 0.1 mg/ml as free base in one Liquid ...... 8/2/2007 of: 1,2-dimethoxyethane, acetonitrile, acetonitrile: water (≥50% acetonitrile), dimethylformamide, ethylene glycol, isopropanol, methanol, methanol/water (50:50), methanol/dimethyl sulfoxide (80:20), methylene chloride, or tetrahydrofuran. Cerilliant Corporation ... 1S,2R(+)-Ephedrine-D3 hydrochloride 1.0 mg/ml as free base in one Liquid ...... 8/2/2007 of: 1,2-dimethoxyethane, acetonitrile, acetonitrile: water (≥50% acetonitrile), dimethylformamide, ethylene glycol, isopropanol, methanol, methanol/water (50:50), methanol/dimethyl sulfoxide (80:20), methylene chloride, or tetrahydrofuran. Cerilliant Corporation ... 1S,2R(+)-Ephedrine hydrochloride 1.0 mg/ml as free base in one of: Liquid ...... 8/2/2007 1,2-dimethoxyethane, acetonitrile, acetonitrile: water (≥50% acetonitrile), dimethylformamide, ethylene glycol, isopropanol, methanol, methanol/water (50:50), methanol/dimethyl sulfoxide (80:20), methylene chloride, or tetrahydrofuran. Cerilliant Corporation ... Pseudoephedrine-D3 hydrochloride 0.1 mg/ml as free base in one of: Liquid ...... 8/2/2007 1,2-dimethoxyethane, acetonitrile, acetonitrile: water (≥50% acetonitrile), dimethylformamide, ethylene glycol, isopropanol, methanol, methanol/water (50:50), methanol/dimethyl sulfoxide (80:20), methylene chloride, or tetrahydrofuran. Cerilliant Corporation ... R,R(-)-Pseudoephedrine 1.0 mg/ml as free base in one of: 1,2- Liquid ...... 8/2/2007 dimethoxyethane, acetonitrile, acetonitrile: water (≥50% acetonitrile), dimethylformamide, ethylene glycol, isopropanol, methanol, methanol/water (50:50), methanol/dimethyl sulfoxide (80:20) methylene chloride, or tetrahydrofuran. Cerilliant Corporation ... S,S(+)-Pseudoephedrine 1.0 mg/ml as free base in one of: 1,2- Liquid ...... 8/2/2007 dimethoxyethane, acetonitrile, acetonitrile: water (≥50% acetonitrile), dimethylformamide, ethylene glycol, isopropanol, methanol, methanol/water (50:50), methanol/dimethyl sulfoxide (80:20), methylene chloride, or tetrahydrofuran. E.I. DuPont deNemours RC–5156 ...... Liquid ...... 4/22/2005 & Co. E.I. DuPont deNemours VH–6037 ...... Liquid ...... 4/22/2005 & Co. Hawthorne Products, Sole Pack Hoof Dressing ...... Paste ...... 8/14/2007 Inc. Hawthorne Products, Sole Pack Hoof Packing ...... Paste ...... 8/14/2007 Inc. Quality Assurance 10 to 1000 nanograms per milliliter of ephedrine in blood, serum, or Liquid ...... 9/26/2007 Service Corporation. urine. Quality Assurance 10 to 1000 nanograms per milliliter of pseudoephedrine in blood, Liquid ...... 9/26/2007 Service Corporation. serum, or urine. Quality Assurance 10 to 1000 nanograms per milliliter of phenylpropanolamine in blood, Liquid ...... 9/26/2007 Service Corporation. serum, or urine. Reichhold, Inc ...... Beckosol® 12021–00 AA–200, IA–441, P531–T ...... Liquid ...... 5/05/2005 Reichhold, Inc ...... Urotuf® L06–30S, F78–50T ...... Liquid ...... 5/05/2005 Reichhold, Inc ...... Beckosol AA–220 ...... Liquid ...... 6/14/2005 Waterbury Companies, Waterbury 332500 ...... Liquid ...... 4/11/2005 Inc. Waterbury Companies, Waterbury 332762 ...... Liquid ...... 4/11/2005 Inc. Waterbury Companies, Waterbury 332400 ...... Liquid ...... 4/11/2005 Inc. Waterbury Companies, Waterbury 346201 ...... Liquid ...... 4/11/2005 Inc. 1 Designate product line if a group.

[68 FR 23204, May 1, 2003, as amended at 75 § 1310.14 Removal of exemption from FR 10681, Mar. 9, 2010; 75 FR 53869, Sept. 2, definition of regulated transaction. 2010; 76 FR 31830, June 2, 2011; 81 FR 97025, Dec. 30, 2016] The Administrator finds that the following drugs or groups of drugs are

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being diverted to obtain a listed chem- relevant to the application that he ical for use in the illicit production of deems necessary for determining if the a controlled substance and removes the application should be granted. drugs or groups of drugs from exemp- (d) Within a reasonable period of tion under paragraph (1)(iv) of the defi- time after the receipt of a completed nition of regulated transaction in application for an exemption under § 1300.02 of this chapter pursuant to the this section, the Administrator shall criteria listed in § 1310.10 of this part: notify the applicant of acceptance or (a) Nonprescription drugs containing non-acceptance of the application. If ephedrine, its salts, optical isomers, the application is not accepted, an ex- and salts of optical isomers. planation will be provided. The Admin- (b) Nonprescription drugs containing istrator is not required to accept an ap- phenylpropanolamine, its salts, optical plication if any of the information re- isomers, and salts of optical isomers. quired in paragraph (b) of this section (c) Nonprescription drugs containing or requested under paragraph (c) of this pseudoephedrine, its salts, optical iso- section is lacking or not readily under- mers, and salts of optical isomers. stood. The applicant may, however, amend the application to meet the re- [75 FR 38922, July 7, 2010, as amended at 77 FR 4237, Jan. 27, 2012] quirements of paragraphs (b) and (c) of this section. § 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 Thereafter, the Administrator shall re- product. instate, revoke, or amend the original (4) A brief statement of the facts that order as deemed appropriate. the applicant believes justify the [71 FR 56024, Sept. 26, 2006] granting of an exemption under this section. § 1310.21 Sale by Federal departments (5) Certification by the applicant or agencies of chemicals which that the product may be lawfully mar- could be used to manufacture con- keted or distributed under the Federal, trolled substances. Food, Drug, and Cosmetic Act. (a) A Federal department or agency (6) The identification of any informa- may not sell from the stocks of the de- tion on the application that is consid- partment or agency any chemical ered by the applicant to be a trade se- which, as determined by the Adminis- cret or confidential and entitled to pro- trator of the Drug Enforcement Admin- tection under U.S. laws restricting the istration, could be used in the manu- public disclosure of such information facture of a controlled substance, un- by government employees. less the Administrator certifies in (c) The Administrator may require writing to the head of the department the applicant to submit additional doc- or agency that there is no reasonable uments or written statements of fact cause to believe that the sale of the

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specific chemical to a specific person gitimate medical, scientific, and indus- would result in the illegal manufacture trial channels; of a controlled substance. For purposes (2) Compliance of the prospective bid- of this requirement, reasonable cause der or end-user with applicable Fed- to believe means that the Administra- eral, state and local law; tion has knowledge of facts which (3) Prior conviction record of the pro- would cause a reasonable person to rea- spective bidder or end-user relating to sonably conclude that a chemical listed chemicals or controlled sub- would be diverted to the illegal manu- stances under Federal or state laws; facture of a controlled substance. and (b) A Federal department or agency (4) Such other factors as may be rel- must request certification by submit- evant to and consistent with the public ting a written request to the Adminis- trator, Drug Enforcement Administra- health and safety. tion. See the Table of DEA Mailing Ad- (d) If the Administrator certifies to dresses in § 1321.01 of this chapter for the head of a Federal department or the current mailing address. A request agency that there is no reasonable for certification may be transmitted cause to believe that the sale of a spe- directly to the Office of Diversion Con- cific chemical to a prospective bidder trol, Drug Enforcement Administra- and end-user will result in the illegal tion, through electronic facsimile manufacture of a controlled substance, media. A request for certification must that certification will be effective for be submitted no later than fifteen cal- one year from the date of issuance with endar days before the proposed sale is respect to further sales of the same to take place. In order to facilitate the chemical to the same prospective bid- sale of chemicals from Federal depart- der and end-user, unless the Adminis- ments’ or agencies’ stocks, Federal de- trator notifies the head of the Federal partments or agencies may wish to department or agency in writing that submit requests as far in advance of the certification is withdrawn. If the the fifteen calendar days as possible. certification is withdrawn, DEA will The written notification of the pro- also provide written notice to the bid- posed sale must include: der and end-user, which will contain a (1) The name and amount of the statement of the legal and factual basis chemical to be sold; for this determination. (2) The name and address of the pro- (e) If the Administrator determines spective bidder; there is reasonable cause to believe the (3) The name and address of the pro- sale of the specific chemical to a spe- spective end-user, in cases where a sale cific bidder and end-user would result is being brokered; in the illegal manufacture of a con- (4) Point(s) of contact for the pro- trolled substance, DEA will provide spective bidder and, where appropriate, prospective end-user; and written notice to the head of a Federal (5) The end use of the chemical. department or agency refusing to cer- (c) Within fifteen calendar days of re- tify the proposed sale under the au- ceipt of a request for certification, the thority of 21 U.S.C. 890. DEA also will Administrator will certify in writing to provide, within fifteen calendar days of the head of the Federal department or receiving a request for certification agency that there is, or is not, reason- from a Federal department or agency, able cause to believe that the sale of the same written notice to the prospec- the specific chemical to the specific tive bidder and end-user, and this no- bidder and end-user would result in the tice also will contain a statement of illegal manufacture of a controlled the legal and factual basis for the re- substance. In making this determina- fusal of certification. The prospective tion, the following factors must be con- bidder and end-user may, within thirty sidered: calendar days of receipt of notification (1) Past experience of the prospective of the refusal, submit written com- bidder or end-user in the maintenance ments or written objections to the Ad- of effective controls against diversion ministrator’s refusal. At the same of listed chemicals into other than le- time, the prospective bidder and end-

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user also may provide supporting docu- the existing certification will con- mentation to contest the Administra- stitute a final decision for purposes of tor’s refusal. If such written comments judicial review under 21 U.S.C. 877. or written objections raise issues re- [68 FR 62737, Nov. 6, 2003, as amended at 75 garding any finding of fact or conclu- FR 10681, Mar. 9, 2010] sion of law upon which the refusal is based, the Administrator will reconsider the refusal of the proposed sale in PART 1311—REQUIREMENTS FOR light of the written comments or writ- ELECTRONIC ORDERS AND PRE- ten objections filed. Thereafter, within SCRIPTIONS a reasonable time, the Administrator will withdraw or affirm the original re- Subpart A—General fusal of certification as he determines Sec. appropriate. The Administrator will 1311.01 Scope. provide written reasons for any affir- 1311.02 Definitions. mation of the original refusal. Such af- 1311.05 Standards for technologies for elec- firmation of the original refusal will tronic transmission of orders. constitute a final decision for purposes 1311.08 Incorporation by reference. of judicial review under 21 U.S.C. 877. (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 1311.10 Eligibility to obtain a CSOS digital withdrawn, DEA will provide written 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 private key for digitally signing orders. this notice also will contain a state- 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 the withdrawal of the existing certifi- 1311.100 General. 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 institu- isting certification as he determines tional practitioner. 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.

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1311.125 Requirements for establishing log- tion with the signer and subsequently ical access control—Individual practi- demonstrate to a third party, if needed, tioner. that the sender’s identity was properly 1311.130 Requirements for establishing logical access control—Institutional practi- verified. tioner. (2) Nonrepudiation: The system must 1311.135 Requirements for creating a con- ensure that strong and substantial evi- trolled substance prescription. dence is available to the recipient of 1311.140 Requirements for signing a con- the sender’s identity, sufficient to pre- trolled substance prescription. vent the sender from successfully deny- 1311.145 Digitally signing the prescription ing having sent the data. This criterion with the individual practitioner’s private key. includes the ability of a third party to 1311.150 Additional requirements for inter- verify the origin of the document. nal application audits. (3) Message integrity: The system 1311.170 Transmission requirements. must ensure that the recipient, or a 1311.200 Pharmacy responsibilities. third party, can determine whether the 1311.205 Pharmacy application require- contents of the document have been al- ments. tered during transmission or after re- 1311.210 Archiving the initial record. 1311.215 Internal audit trail. ceipt. 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. graph (a) of this section. 1311.305 Recordkeeping. (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 Drug Enforcement Administration, call § 1311.02 Definitions. (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

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Requirements for Cryptographic Mod- al.; incorporation by reference ap- ules, May 25, 2001 (FIPS 140–2) includ- proved for § 1311.116(d). ing Annexes A through D; incorpora- [75 FR 16310, Mar. 31, 2010] tion by reference approved for §§ 1311.30(b), 1311.55(b), 1311.115(b), 1311.120(b), 1311.205(b). Subpart B—Obtaining and Using (i) Annex A: Approved Security Func- Digital Certificates for Elec- tions for FIPS PUB 140–2, Security Re- tronic Orders quirements for Cryptographic Modules, § 1311.10 Eligibility to obtain a CSOS September 23, 2004. digital certificate. (ii) Annex B: Approved Protection The following persons are eligible to Profiles for FIPS PUB 140–2, Security obtain a CSOS digital certificate from Requirements for Cryptographic Mod- the DEA Certification Authority to ules, November 4, 2004. sign electronic orders for controlled (iii) Annex C: Approved Random substances. Number Generators for FIPS PUB 140– (a) The person who signed the most 2, Security Requirements for Cryp- recent DEA registration application or tographic Modules, January 31, 2005. renewal application and a person au- (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 February 25, 2004 (FIPS 180–2); incorpo- certificates. ration 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 that subset of schedules. ration by reference approved for §§ 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

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whom the digital certificate is associ- Certification Authority provides and ated. Even when an individual reg- submit the following: istrant, i.e., an individual practitioner, (1) Two copies of identification, one is applying for a digital certificate to of which must be a government-issued order controlled substances a CSOS Co- photographic identification. ordinator must be designated; though (2) A current listing of DEA registra- in such a case, the individual practi- tions for which the individual has au- tioner may also serve as the coordi- thority to sign controlled substances nator. orders. (b) Once designated, coordinators (3) A copy of the power of attorney must identify themselves, on a one- from the registrant, if applicable. time basis, to the Certification Author- (4) An acknowledgment that the ap- ity. If a designated coordinator plicant has read and understands the changes, the Certification Authority Subscriber Agreement and agrees to must be notified of the change and the the statement of subscriber obligations new responsibilities assumed by each of that DEA provides. the registrant’s coordinators, if applicable. Coordinators must complete the (b) The applicant must provide the application that the DEA Certification completed application to the reg- Authority provides and submit the fol- istrant’s coordinator for CSOS digital lowing: certificate holders who will review the (1) Two copies of identification, one application and submit the completed of which must be a government-issued application and accompanying docu- photographic identification. mentation to the DEA Certification (2) A copy of each current DEA Cer- Authority. tificate of Registration (DEA form 223) (c) When the Certification Authority for each registered location for which approves the application, it will send the coordinator will be responsible or, the applicant a one-time use reference if the applicant (or their employer) has number and access code, via separate not been issued a DEA registration, a channels, and information on how to copy of each application for registra- use them. Using this information, the tion of the applicant or the applicant’s applicant must then electronically sub- employer. mit a request for certification of the (3) The applicant must have the com- public digital signature key. After the pleted application notarized and for- request is approved, the Certification ward the completed application and ac- Authority will provide the applicant companying documentation to the with the signed public key certificate. DEA Certification Authority. (d) Once the applicant has generated (c) Coordinators will communicate the key pair, the Certification Author- with the Certification Authority re- ity must prove that the user has pos- garding digital certificate applications, session of the key. For public keys, the renewals and revocations. For appli- corresponding private key must be cants applying for a digital certificate used to sign the certificate request. from the DEA Certification Authority, Verification of the signature using the and for applicants applying for a power public key in the request will serve as of attorney digital certificate for a proof of possession of the private key. DEA registrant, the registrant’s Coor- dinator must verify the applicant’s § 1311.30 Requirements for storing and identity, review the application pack- using a private key for digitally signing orders. age, and submit the completed package to the Certification Authority. (a) Only the certificate holder may access or use his or her digital certifi- § 1311.25 Requirements for obtaining a cate and private key. CSOS digital certificate. (b) The certificate holder must pro- (a) To obtain a certificate to use for vide FIPS-approved secure storage for signing electronic orders for controlled the private key, as discussed by FIPS substances, a registrant or person with 140–2, 180–2, 186–2, and accompanying power of attorney for a registrant must change notices and annexes, as incor- complete the application that the DEA porated by reference in § 1311.08.

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(c) A certificate holder must ensure (d) If a CSOS certificate expires be- that no one else uses the private key. fore the holder applies for a renewal, While the private key is activated, the the certificate holder must submit a certificate holder must prevent unau- new application and documentation, as thorized use of that private key. provided in § 1311.25. (d) A certificate holder must not make back-up copies of the private § 1311.45 Requirements for registrants key. that allow powers of attorney to obtain CSOS digital certificates under (e) The certificate holder must report their DEA registration. the loss, theft, or compromise of the private key or the password, via a rev- (a) A registrant that grants power of ocation request, to the Certification attorney must report to the DEA Cer- Authority within 24 hours of substan- tification Authority within 6 hours of either of the following (advance notice tiation of the loss, theft, or com- may be provided, where applicable): promise. Upon receipt and verification (1) The person with power of attorney of a signed revocation request, the Cer- has left the employ of the institution. tification Authority will revoke the (2) The person with power of attorney certificate. The certificate holder must has had his or her privileges revoked. apply for a new certificate under the (b) A registrant must maintain a requirements of § 1311.25. record that lists each person granted § 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 reg- (a) The recipient of a digitally signed istered location for which the pur- order must do the following before fill- chaser will order these controlled sub- ing the order: stances. (1) Verify the integrity of the signature and the order by having the sys- § 1311.40 Renewal of CSOS digital cer- tem validate the order. tificates. (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.

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(b) A system used to digitally sign (4) The system must validate the dig- Schedule I or II orders must meet the ital signature using the signer’s public following requirements: key. The system must invalidate any (1) The cryptographic module must order in which the digital signature be FIPS 140–2, Level 1 validated, as in- cannot be validated. corporated by reference in § 1311.08. (5) The system must validate that (2) The digital signature system and the DEA registration number con- hash function must be compliant with tained in the body of the order cor- FIPS 186–2 and FIPS 180–2, as incor- responds to the registration number as- porated by reference in § 1311.08. sociated with the specific certificate by (3) The private key must be stored on separately generating the hash value of a FIPS 140–2 Level 1 validated cryp- the registration number and certificate tographic module using a FIPS-ap- subject distinguished name serial num- proved encryption algorithm, as incor- ber and comparing that hash value to porated by reference in § 1311.08. the hash value contained in the certifi- (4) The system must use either a user cate extension for the DEA registra- identification and password combination number. If the hash values are not tion or biometric authentication to ac- equal the system must invalidate the cess the private key. Activation data order. must not be displayed as they are en- (6) The system must check the Cer- tered. tificate Revocation List automatically (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 to, or use of, the private key. (8) The system must have a time sys- (7) The system must be able to tem that is within five minutes of the digitally sign and transmit an order. official National Institute of Standards (8) The system must have a time sys- and Technology time source. tem that is within five minutes of the (9) The system must check the sub- official National Institute of Standards stances ordered against the schedules and Technology time source. that the registrant is allowed to order (9) The system must archive the and invalidate any order that includes digitally signed orders and any other substances the registrant is not al- records required in part 1305 of this lowed to order. chapter, including any linked data. (10) The system must ensure that an (10) The system must create an order invalid finding cannot be bypassed or that includes all data fields listed ignored and the order filled. under § 1305.21(b) of this chapter. (11) The system must archive the (c) A system used to receive, verify, order and associate with it the digital and create linked records for orders certificate received with the order. signed with a CSOS digital certificate (12) If a registrant sends reports on must meet the following requirements: orders to DEA, the system must create (1) The cryptographic module must a report in the format DEA specifies, be FIPS 140–2, Level 1 validated, as in- as provided in § 1305.29 of this chapter. corporated by reference in § 1311.08. (d) For systems used to process CSOS (2) The digital signature system and orders, the system developer or vendor hash function must be compliant with must have an initial independent third- FIPS 186–2 and FIPS 180–2, as incor- party audit of the system and an addi- porated by reference in § 1311.08. tional independent third-party audit (3) The system must determine that whenever the signing or verifying an order has not been altered during functionality is changed to determine transmission. The system must invali- whether it correctly performs the func- date any order that has been altered. tions listed under paragraphs (b) and

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(c) of this section. The system devel- prescription application that does not oper must retain the most recent audit meet the requirements of this subpart results and retain the results of any is not a valid prescription, as that term other audits of the software completed is defined in § 1300.03 of this chapter. within the previous two years. (d) A controlled substance prescription created using an electronic pre- § 1311.60 Recordkeeping. scription application that meets the re- (a) A supplier and purchaser must quirements of this subpart is not a maintain records of CSOS electronic valid prescription if any of the func- orders and any linked records for two tions required under this subpart were years. Records may be maintained disabled when the prescription was in- electronically. Records regarding con- dicated as ready for signature and trolled substances that are maintained signed. electronically must be readily retriev- (e) A registered pharmacy may proc- able from all other records. ess electronic prescriptions for con- (b) Electronic records must be easily trolled substances only if all of the fol- readable or easily rendered into a for- lowing conditions are met: mat that a person can read. They must (1) The pharmacy uses a pharmacy be made available to the Administra- application that meets all of the appli- tion upon request. cable requirements of this subpart; and (c) CSOS certificate holders must (2) The prescription is otherwise in maintain a copy of the subscriber conformity with the requirements of agreement that the Certification Au- the Act and this chapter. thority provides for the life of the cer- (f) Nothing in this part alters the re- tificate. sponsibilities of the practitioner and pharmacy, specified in part 1306 of this Subpart C—Electronic chapter, to ensure the validity of a Prescriptions controlled substance prescription. § 1311.102 Practitioner responsibil- SOURCE: 75 FR 16310, Mar. 31, 2010, unless ities. otherwise noted. (a) The practitioner must retain sole § 1311.100 General. possession of the hard token, where ap- (a) This subpart addresses the re- plicable, and must not share the pass- quirements that must be met to issue word or other knowledge factor, or bio- and process Schedule II, III, IV, and V metric information, with any other controlled substance prescriptions person. The practitioner must not electronically. allow any other person to use the (b) A practitioner may issue a pre- token or enter the knowledge factor or scription for a Schedule II, III, IV, or V other identification means to sign pre- controlled substance electronically if scriptions for controlled substances. all of the following conditions are met: Failure by the practitioner to secure (1) The practitioner is registered as the hard token, knowledge factor, or an individual practitioner or exempt biometric information may provide a from the requirement of registration basis for revocation or suspension of under part 1301 of this chapter and is registration pursuant to section authorized under the registration or 304(a)(4) of the Act (21 U.S.C. 824(a)(4)). exemption to dispense the controlled (b) The practitioner must notify the substance; individuals designated under § 1311.125 (2) The practitioner uses an elec- or § 1311.130 within one business day of tronic prescription application that discovery that the hard token has been meets all of the applicable require- lost, stolen, or compromised or the au- ments of this subpart; and thentication protocol has been other- (3) The prescription is otherwise in wise compromised. A practitioner who conformity with the requirements of fails to comply with this provision may the Act and this chapter. be held responsible for any controlled (c) An electronic prescription for a substance prescriptions written using Schedule II, III, IV, or V controlled his two-factor authentication creden- substance created using an electronic tial.

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(c) If the practitioner is notified by pliant, the practitioner must do the an intermediary or pharmacy that an following: electronic prescription was not suc- (1) Immediately cease to issue elec- cessfully delivered, as provided in tronic controlled substance prescrip- § 1311.170, he must ensure that any tions using the application. paper or oral prescription (where per- (2) Ensure, for an installed electronic mitted) issued as a replacement of the prescription application at an indi- original electronic prescription individual practitioner’s practice, that the cates that the prescription was origi- individuals designated under § 1311.125 nally transmitted electronically to a terminate access for signing controlled particular pharmacy and that the substance prescriptions. transmission failed. (h) If an electronic prescription ap- (d) Before initially using an elec- plication provider notifies an institu- tronic prescription application to sign tional practitioner that a third-party and transmit controlled substance pre- audit or certification report indicates scriptions, the practitioner must deter- that the application or the application mine that the third-party auditor or provider no longer meets the require- certification organization has found ments of this part or notifies it that that the electronic prescription appli- the application provider has identified cation records, stores, and transmits an issue that makes the application the following accurately and consist- non-compliant, the institutional prac- ently: titioner must ensure that the individ- (1) The information required for a uals designated under § 1311.130 termi- prescription under § 1306.05(a) of this nate access for signing controlled sub- chapter. stance prescriptions. (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 tions for controlled substances via appear to be functioning improperly. electronic means as when issuing a (g) If an electronic prescription appli- paper or oral prescription. Nothing in cation provider notifies an individual this subpart relieves a practitioner of practitioner that a third-party audit or his responsibility to dispense con- certification report indicates that the trolled substances only for a legitimate application or the application provider medical purpose while acting in the no longer meets the requirements of usual course of his professional prac- this part or notifies him that the appli- tice. If an agent enters information at cation provider has identified an issue the practitioner’s direction prior to the that makes the application non-com- practitioner reviewing and approving

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the information and signing and au- tions for controlled substances, the en- thorizing the transmission of that in- tity within a DEA-registered institu- formation, the practitioner is respon- tional practitioner that grants that in- sible in case the prescription does not dividual practitioner privileges at the conform in all essential respects to the institutional practitioner (e.g., a hos- law and regulations. pital credentialing office) may conduct identity proofing and authorize the § 1311.105 Requirements for obtaining issuance of the authentication creden- an authentication credential—Indi- tial. That entity must do the following: vidual practitioners. (1) Ensure that photographic identi- (a) An individual practitioner must fication issued by the Federal Govern- obtain a two-factor authentication cre- ment or a State government matches dential from one of the following: the person presenting the identifica- (1) A credential service provider that tion. has been approved by the General Serv- (2) Ensure that the individual practi- ices Administration Office of Tech- tioner’s State authorization to practice nology Strategy/Division of Identity and, where applicable, State authoriza- Management to conduct identity proof- tion to prescribe controlled substances, ing that meets the requirements of As- is current and in good standing. surance Level 3 or above as specified in (3) Either ensure that the individual NIST SP 800–63–1 as incorporated by practitioner’s DEA registration is cur- reference in § 1311.08. rent and in good standing or ensure (2) For digital certificates, a certifi- that the institutional practitioner has cation authority that is cross-certified granted the individual practitioner ex- with the Federal Bridge certification empt from the requirement of registra- authority and that operates at a Fed- tion under § 1301.22 of this chapter eral Bridge Certification Authority privileges to prescribe controlled sub- basic assurance level or above. stances using the institutional practi- (b) The practitioner must submit tioner’s DEA registration number. identity proofing information to the (4) If the individual practitioner is an credential service provider or certifi- employee of a health care facility that cation authority as specified by the is operated by the Department of Vet- credential service provider or certifi- erans Affairs, confirm that the indication authority. vidual practitioner has been duly ap- (c) The credential service provider or pointed to practice at that facility by certification authority must issue the 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 trolled substances under the registra- an authentication credential—Indi- tion of such facility. vidual practitioners eligible to use (b) An institutional practitioner that an electronic prescription applica- elects to conduct identity proofing tion of an institutional practitioner. must provide authorization to issue the (a) For any registrant or person ex- authentication credentials to a sepa- empted from the requirement of reg- rate entity within the institutional istration under § 1301.22(c) of this chap- practitioner or to an outside credential ter who is eligible to use the institu- Service provider or certification au- tional practitioner’s electronic pre- thority that meets the requirements of scription application to sign prescrip- § 1311.105(a).

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(c) When an institutional practi- (c) If one factor is a biometric, the tioner is conducting identity proofing biometric subsystem must comply with and submitting information to a cre- the requirements of § 1311.116. dential service provider or certification authority to authorize the issuance of § 1311.116 Additional requirements for biometrics. authentication credentials, the institutional practitioner must meet any re- (a) If one of the factors used to au- quirements that the credential service thenticate to the electronic prescrip- provider or certification authority im- tion application is a biometric as de- poses on entities that serve as trusted scribed in § 1311.115, it must comply agents. with the following requirements. (d) An institutional practitioner that (b) The biometric subsystem must operate at a false match rate of 0.001 or elects to conduct identity proofing and lower. authorize the issuance of the authen- (c) The biometric subsystem must tication credential as provided in para- use matching software that has dem- graphs (a) through (c) of this section onstrated performance at the operating must do so in a manner consistent with point corresponding with the false the institutional practitioner’s general match rate described in paragraph (b) obligation to maintain effective con- of this section, or a lower false match trols against diversion. Failure to meet rate. Testing to demonstrate perform- this obligation may result in remedial ance must be conducted by the Na- action consistent with § 1301.36 of this tional Institute of Standards and Tech- chapter. nology or another DEA-approved gov- (e) An institutional practitioner that ernment or nongovernment laboratory. elects to conduct identity proofing Such testing must comply with the re- must retain a record of the identity- quirements of paragraph (h) of this sec- proofing. An institutional practitioner tion. that elects to issue the two-factor au- (d) The biometric subsystem must thentication credential must retain a conform to Personal Identity record of the issuance of the credential. Verification authentication biometric acquisition specifications, pursuant to § 1311.115 Additional requirements for NIST SP 800–76–1 as incorporated by two-factor authentication. reference in § 1311.08, if they exist for (a) To sign a controlled substance the biometric modality of choice. prescription, the electronic prescrip- (e) The biometric subsystem must ei- tion application must require the prac- ther be co-located with a computer or titioner to authenticate to the applica- PDA that the practitioner uses to issue tion using an authentication protocol electronic prescriptions for controlled that uses two of the following three substances, where the computer or factors: PDA is located in a known, controlled 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:

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(1) Cryptographically source authen- (i) Indication that a prescription is ticated; ready for signing and signing con- (2) Combined with a random chal- trolled substance prescriptions. lenge, a nonce, or a time stamp to pre- (ii) Creating, updating, and executing vent replay; the logical access controls for the func- (3) Cryptographically protected for tions specified in paragraph (b)(2)(i) of integrity and confidentiality; and this section. (4) Sent only to authorized systems. (3) Logical access controls must be (h) Testing of the biometric subset by individual user name or role. If the application sets logical access con- system must have the following char- trol by role, it must not allow an indi- acteristics: vidual to be assigned the role of reg- (1) The test is conducted by a labora- istrant unless that individual is linked tory that does not have an interest in to at least one DEA registration num- the outcome (positive or negative) of ber as provided in paragraph (b)(1) of performance of a submission or biomet- this section. ric. (4) The application must require that (2) Test data are sequestered. the setting and changing of logical ac- (3) Algorithms are provided to the cess controls specified under paragraph testing laboratory (as opposed to (b)(2) of this section involve the ac- scores or other information). tions of two individuals as specified in (4) The operating point(s) cor- §§ 1311.125 or 1311.130. Except for institu- responding with the false match rate tional practitioners, a practitioner au- described in paragraph (b) of this sec- thorized to sign controlled substance tion, or a lower false match rate, is prescriptions must approve logical ac- tested so that there is at least 95% con- cess control entries. fidence that the false match and non- (5) The electronic prescription appli- match rates are equal to or less than cation must accept two-factor authen- the observed value. tication that meets the requirements (5) Results of the testing are made of § 1311.115 and require its use for sign- publicly available. ing controlled substance prescriptions and for approving data that set or § 1311.120 Electronic prescription ap- change logical access controls related plication requirements. to reviewing and signing controlled (a) A practitioner may only use an substance prescriptions. electronic prescription application (6) The electronic prescription appli- that meets the requirements in para- cation must be capable of recording all graph (b) of this section to issue elec- of the applicable information required tronic controlled substance prescrip- in part 1306 of this chapter for the con- tions. trolled substance prescription. (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.

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(iv) The dosage strength and form, patient, the electronic prescription ap- quantity prescribed, and directions for plication may allow the practitioner to use. sign multiple prescriptions for a single (v) The number of refills authorized, patient at one time using a single invo- if applicable, for prescriptions for cation of the two-factor authentication Schedule III, IV, and V controlled sub- protocol provided the following has oc- stances. curred: The practitioner has individ- (vi) For prescriptions written in ac- ually indicated that each controlled cordance with the requirements of substance prescription is ready to be § 1306.12(b) of this chapter, the earliest signed while the information required date on which a pharmacy may fill by paragraph (b)(9) of this section for each prescription. each such prescription is displayed (vii) The name, address, and DEA along with the statement required by registration number of the prescribing § 1311.140(a)(3). practitioner. (14) The electronic prescription appli- (viii) The statement required under § 1311.140(a)(3). cation must time and date stamp the (10) The electronic prescription appli- prescription when the signing function cation must require the prescribing is used. practitioner to indicate that each con- (15) When the practitioner uses his trolled substance prescription is ready two-factor authentication credential as for signing. The electronic prescription specified in § 1311.140(a)(4), the elec- application must not permit alteration tronic prescription application must of the DEA elements after the practi- digitally sign at least the information tioner has indicated that a controlled required by part 1306 of this chapter substance prescription is ready to be and electronically archive the digitally signed without requiring another re- signed record. If the practitioner signs view and indication of readiness for the prescription with his own private signing. Any controlled substance pre- key, as provided in § 1311.145, the elec- scription not indicated as ready to be tronic prescription application must signed shall not be signed or trans- electronically archive a copy of the mitted. digitally signed record, but need not (11) While the information required apply the application’s digital signa- by paragraph (b)(9) of this section and ture to the record. the statement required by (16) The digital signature § 1311.140(a)(3) remain displayed, the functionality must meet the following electronic prescription application requirements: must prompt the prescribing practi- (i) The cryptographic module used to tioner to authenticate to the applica- digitally sign the data elements re- tion, using two-factor authentication, quired by part 1306 of this chapter must as specified in § 1311.140(a)(4), which be at least FIPS 140–2 Security Level 1 will constitute the signing of the pre- validated. FIPS 140–2 is incorporated scription by the practitioner for pur- by reference in § 1311.08. poses of § 1306.05(a) and (e) of this chapter. (ii) The digital signature application (12) The electronic prescription appli- and hash function must comply with cation must not permit a practitioner FIPS 186–3 and FIPS 180–3, as incor- other than the prescribing practitioner porated by reference in § 1311.08. whose DEA number (or institutional (iii) The electronic prescription ap- practitioner DEA number and exten- plication’s private key must be stored sion data for the individual practi- encrypted on a FIPS 140–2 Security tioner) is listed on the prescription as Level 1 or higher validated cryp- the prescribing practitioner and who tographic module using a FIPS-ap- has indicated that the prescription is proved encryption algorithm. FIPS 140– ready to be signed to sign the prescrip- 2 is incorporated by reference in tion. § 1311.08. (13) Where a practitioner seeks to (iv) For software implementations, prescribe more than one controlled when the signing module is deacti- substance at one time for a particular vated, the application must clear the

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plain text password from the applica- (ii) Any setting or changing of logical tion memory to prevent the unauthor- access control permissions related to ized access to, or use of, the private the issuance of controlled substance key. prescriptions. (17) Unless the digital signature cre- (iii) Notification of a failed trans- ated by an individual practitioner’s mission. private key is being transmitted to the (iv) Auditable events as specified in pharmacy with the prescription, the § 1311.150. electronic prescription application (24) The electronic prescription appli- must include in the data file trans- cation must record within each audit mitted an indication that the prescrip- record the following information: tion was signed by the prescribing (i) The date and time of the event. practitioner. (ii) The type of event. (18) The electronic prescription appli- (iii) The identity of the person taking cation must not transmit a controlled the action, where applicable. substance prescription unless the sign- (iv) The outcome of the event (suc- ing function described in § 1311.140(a)(4) cess or failure). has been used. (25) The electronic prescription appli- (19) The electronic prescription application must conduct internal audits cation must not allow alteration of any and generate reports on any of the events specified in § 1311.150 in a format of the information required by part that is readable by the practitioner. 1306 of this chapter after the prescrip- Such internal audits may be auto- tion has been digitally signed. Any al- mated and need not require human teration of the information required by intervention to be conducted. 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

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record’s creation and comply with all (2) The individual practitioner’s DEA other requirements of § 1311.305. registration expires, unless the registration has been renewed. § 1311.125 Requirements for estab- (3) The individual practitioner’s DEA lishing logical access control—Indi- registration is terminated, revoked, or vidual practitioner. suspended. (a) At each registered location where (4) The individual practitioner is no one or more individual practitioners longer authorized to use the electronic wish to use an electronic prescription prescription application (e.g., when the application meeting the requirements individual practitioner leaves the prac- of this subpart to issue controlled sub- tice). stance prescriptions, the registrant(s) must designate at least two individuals § 1311.130 Requirements for estab- to manage access control to the appli- lishing logical access control—Insti- cation. At least one of the designated tutional practitioner. individuals must be a registrant who is (a) The entity within an institutional authorized to issue controlled sub- practitioner that conducts the identity stance prescriptions and who has ob- proofing under § 1311.110 must develop a tained a two-factor authentication cre- list of individual practitioners who are dential as provided in § 1311.105. permitted to use the institutional prac- (b) At least one of the individuals titioner’s electronic prescription appli- designated under paragraph (a) of this cation to indicate that controlled subsection must verify that the DEA reg- stances prescriptions are ready to be istration and State authorization(s) to signed and to sign controlled substance practice and, where applicable, State prescriptions. The list must be ap- authorization(s) to dispense controlled proved by two individuals. substances of each registrant being (b) After the list is approved, it must granted permission to sign electronic be sent to a separate entity within the prescriptions for controlled substances institutional practitioner that enters are current and in good standing. permissions for logical access controls (c) After one individual designated into the application. The institutional under paragraph (a) of this section en- practitioner must authorize at least ters data that grants permission for in- two individuals or a role filled by at dividual practitioners to have access to least two individuals to enter the log- the prescription functions that indi- ical access control data. One individual cate readiness for signature and sign- in the separate entity must authen- ing or revokes such authorization, a ticate to the application and enter the second individual designated under data to grant permissions to individual paragraph (a) of this section must use practitioners to indicate that con- his two-factor authentication creden- trolled substances prescriptions are tial to satisfy the logical access con- ready to be signed and to sign controls. The second individual must be a trolled substance prescriptions. A sec- DEA registrant. ond individual must authenticate to (d) A registrant’s permission to indi- the application to execute the logical cate that controlled substances pre- access controls. scriptions are ready to be signed and to (c) The institutional practitioner sign controlled substance prescriptions must retain a record of the individuals must be revoked whenever any of the or roles that are authorized to conduct following occurs, on the date the occur- identity proofing and logical access rence is discovered: control data entry and execution. (1) A hard token or any other authen- (d) Permission to indicate that con- tication factor required by the two-fac- trolled substances prescriptions are tor authentication protocol is lost, sto- ready to be signed and to sign con- len, or compromised. Such access must trolled substance prescriptions must be be terminated immediately upon re- revoked whenever any of the following ceiving notification from the indi- occurs, on the date the occurrence is vidual practitioner. discovered:

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(1) An individual practitioner’s hard (2) The practitioner must indicate token or any other authentication fac- the prescriptions that are ready to be tor required by the practitioner’s two- signed. factor authentication protocol is lost, (3) While the prescription informa- stolen, or compromised. Such access tion required in § 1311.120(b)(9) is dis- must be terminated immediately upon played, the following statement or its receiving notification from the indi- substantial equivalent is displayed: vidual practitioner. ‘‘By completing the two-factor authen- (2) The institutional practitioner’s tication protocol at this time, you are or, where applicable, individual practi- legally signing the prescription(s) and tioner’s DEA registration expires, un- authorizing the transmission of the less the registration has been renewed. above information to the pharmacy for dispensing. The two-factor authentica- (3) The institutional practitioner’s tion protocol may only be completed or, where applicable, individual practi- by the practitioner whose name and tioner’s DEA registration is termi- DEA registration number appear nated, revoked, or suspended. above.’’ (4) An individual practitioner is no (4) While the prescription informa- longer authorized to use the institution required in § 1311.120(b)(9) and the tional practitioner’s electronic pre- statement required by paragraph (a)(3) scription application (e.g., when the in- of this section remain displayed, the dividual practitioner is no longer asso- practitioner must be prompted to com- ciated with the institutional practi- plete the two-factor authentication tioner.) protocol. (5) The completion by the practi- § 1311.135 Requirements for creating a tioner of the two-factor authentication controlled substance prescription. protocol in the manner provided in (a) The electronic prescription appli- paragraph (a)(4) of this section will cation may allow the registrant or his constitute the signing of the prescrip- 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 credential. listed on a prescription, provided the (c) Any prescription not signed in the prescription clearly indicates who is manner required by this section shall the supervisor and who is the pre- not be transmitted. scribing practitioner. § 1311.145 Digitally signing the pre- § 1311.140 Requirements for signing a scription with the individual practi- controlled substance prescription. tioner’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

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practitioner to complete a two-factor (4) Any setting of or change to log- authentication protocol as specified in ical access controls related to the § 1311.140(a)(4) to use his private key. issuance of controlled substance pre- (c) The electronic prescription appli- scriptions. cation must digitally sign at least all (5) Attempted or successful inter- information required under part 1306 of ference with audit trail functions. this chapter. (6) For application service providers, (d) The electronic prescription appli- attempted or successful creation, cation must electronically archive the modification, or destruction of con- digitally signed record. trolled substance prescriptions or log- (e) A prescription that is digitally ical access controls related to consigned with a practitioner’s private trolled substance prescriptions by any key may be transmitted to a pharmacy agent or employee of the application without the digital signature. service provider. (f) If the electronic prescription is (b) The electronic prescription appli- transmitted without the digital signa- cation must analyze the audit trail at ture, the electronic prescription appli- least once every calendar day and gen- cation must check the certificate rev- erate an incident report that identifies ocation list of the certification author- each auditable event. ity that issued the practitioner’s dig- (c) Any person designated to set log- ital certificate. If the digital certifi- ical access controls under §§ 1311.125 or cate is not valid, the electronic pre- 1311.130 must determine whether any scription application must not trans- identified auditable event represents a mit the prescription. The certificate security incident that compromised or revocation list may be cached until the could have compromised the integrity certification authority issues a new of the prescription records. Any such certificate revocation list. incidents must be reported to the elec- (g) When the individual practitioner tronic prescription application pro- digitally signs a controlled substance vider and the Administration within prescription with the private key asso- one business day. ciated with his own digital certificate obtained as provided under § 1311.105, § 1311.170 Transmission requirements. the electronic prescription application (a) The electronic prescription appli- is not required to digitally sign the cation must transmit the electronic prescription using the application’s prescription as soon as possible after private key. signature by the practitioner. (b) The electronic prescription appli- § 1311.150 Additional requirements for cation may print a prescription that internal application audits. has been transmitted only if an inter- (a) The application provider must es- mediary or the designated pharmacy tablish and implement a list of notifies a practitioner that an elec- auditable events. Auditable events tronic prescription was not success- must, at a minimum, include the fol- fully delivered to the designated phar- lowing: macy. If this occurs, the electronic pre- (1) Attempted unauthorized access to scription application may print the the electronic prescription application, prescription for the practitioner’s man- or successful unauthorized access ual signature. The printed prescription where the determination of such is fea- must include information noting that sible. the prescription was originally trans- (2) Attempted unauthorized modifica- mitted electronically to [name of the tion or destruction of any information specific pharmacy] on [date/time] and or records required by this part, or suc- that transmission failed. cessful unauthorized modification or (c) The electronic prescription appli- destruction of any information or cation may print copies of the trans- records required by this part where the mitted prescription if they are clearly determination of such is feasible. labeled: ‘‘Copy only—not valid for dis- (3) Interference with application op- pensing.’’ Data on the prescription may erations of the prescription applica- be electronically transferred to med- tion. ical records, and a list of prescriptions

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written may be printed for patients if for prescriptions under this chapter, the list indicates that it is for informa- the pharmacy must not process elec- tional purposes only and not for dis- tronic prescriptions for controlled sub- pensing. stances that are subject to the addi- (d) The electronic prescription appli- tional information requirements. cation must not allow the transmission (c) If a pharmacy application proof an electronic prescription if an vider notifies a pharmacy that a third- original prescription was printed prior party audit or certification report indi- to attempted transmission. cates that the application or the appli- (e) The contents of the prescription cation provider no longer meets the re- required by part 1306 of this chapter quirements of this part or notifies it must not be altered during trans- that the application provider has iden- mission between the practitioner and tified an issue that makes the applica- pharmacy. Any change to the content tion non-compliant, the pharmacy during transmission, including trunca- must immediately cease to process tion or removal of data, will render the controlled substance prescriptions electronic prescription invalid. The using the application. electronic prescription data may be (d) A pharmacy that receives a notifi- converted from one software version to cation that the pharmacy application another between the electronic pre- is not in compliance with the require- scription application and the pharmacy ments of this part must not use the ap- application; conversion includes alter- plication to process controlled sub- ing the structure of fields or machine stance prescriptions until it is notified language so that the receiving phar- that the application is again compliant macy application can read the pre- and all relevant updates to the applica- scription and import the data. tion have been installed. (f) An electronic prescription must be (e) The pharmacy must determine transmitted from the practitioner to which employees are authorized to 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

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to ensure that the electronic version functionality must meet the following was not received and the prescription requirements: dispensed. If both prescriptions were (i) The cryptographic module used to received, the pharmacist must mark digitally sign the data elements re- one as void. quired by part 1306 of this chapter must (h) When a pharmacist receives a be at least FIPS 140–2 Security Level 1 paper or oral prescription that indi- validated. FIPS 140–2 is incorporated cates that it was originally trans- by reference in § 1311.08. mitted electronically to another phar- (ii) The digital signature application macy, the pharmacist must check with and hash function must comply with that pharmacy to determine whether FIPS 186–3 and FIPS 180–3, as incor- the prescription was received and dis- porated by reference in § 1311.08. pensed. If the pharmacy that received (iii) The pharmacy application’s pri- the original electronic prescription had vate key must be stored encrypted on a not dispensed the prescription, that FIPS 140–2 Security Level 1 or higher pharmacy must mark the electronic validated cryptographic module using version as void or canceled. If the phar- a FIPS-approved encryption algorithm. macy that received the original electronic prescription dispensed the pre- FIPS 140–2 is incorporated by reference scription, the pharmacy with the paper in § 1311.08. version must not dispense the paper (iv) For software implementations, prescription and must mark the pre- when the signing module is deacti- scription as void. vated, the pharmacy application must (i) Nothing in this part relieves a clear the plain text password from the pharmacy and pharmacist of the re- application memory to prevent the un- sponsibility to dispense controlled sub- authorized access to, or use of, the pri- stances only pursuant to a prescription vate key. issued for a legitimate medical purpose (v) The pharmacy application must by a practitioner acting in the usual have a time application that is within course of professional practice. five minutes of the official National In- stitute of Standards and Technology § 1311.205 Pharmacy application re- time source. quirements. (5) The pharmacy application must (a) The pharmacy may only use a verify a practitioner’s digital signature pharmacy application that meets the (if the pharmacy application accepts requirements in paragraph (b) of this prescriptions that were digitally signed section to process electronic controlled with an individual practitioner’s pri- substance prescriptions. vate key and transmitted with the dig- (b) The pharmacy application must ital signature). meet the following requirements: (6) If the prescription received by the (1) The pharmacy application must pharmacy application has not been be capable of setting logical access digitally signed by the practitioner and controls to limit access for the fol- transmitted with the digital signature, lowing functions: the pharmacy application must either: (i) Annotation, alteration, or dele- (i) Verify that the practitioner signed tion of prescription information. the prescription by checking the data (ii) Setting and changing the logical field that indicates the prescription access controls. was signed; or (2) Logical access controls must be (ii) Display the field for the phar- set by individual user name or role. macist’s verification. (3) The pharmacy application must (7) The pharmacy application must digitally sign and archive a prescrip- read and retain the full DEA number tion on receipt or be capable of receiv- including the specific internal code ing and archiving a digitally signed number assigned to individual practi- record. tioners authorized to prescribe con- (4) For pharmacy applications that trolled substances by the hospital or digitally sign prescription records upon other institution as provided in receipt, the digital signature § 1301.22(c) of this chapter.

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(8) The pharmacy application must (16) The pharmacy application must read and store, and be capable of dis- protect the stored audit records from playing, all information required by unauthorized deletion. The pharmacy part 1306 of this chapter. application shall prevent modifications (9) The pharmacy application must to the audit records. read and store in full the information (17) The pharmacy application must required under § 1306.05(a) of this chap- back up the controlled substance pre- ter. The pharmacy application must ei- scription records daily. ther verify that such information is (18) The pharmacy application must present or must display the informa- retain all archived records electroni- tion for the pharmacist’s verification. cally for at least two years from the (10) The pharmacy application must date of their receipt or creation and provide for the following information comply with all other requirements of to be added or linked to each electronic § 1311.305. controlled substance prescription record for each dispensing: § 1311.210 Archiving the initial record. (i) Number of units or volume of drug (a) Except as provided in paragraph dispensed. (c) of this section, a copy of each elec- (ii) Date dispensed. tronic controlled substance prescrip- (iii) Name or initials of the person tion record that a pharmacy receives who dispensed the prescription. must be digitally signed by one of the (11) The pharmacy application must following: be capable of retrieving controlled sub- (1) The last intermediary transmit- stance prescriptions by practitioner ting the record to the pharmacy must name, patient name, drug name, and digitally sign the prescription imme- date dispensed. diately prior to transmission to the (12) The pharmacy application must pharmacy. allow downloading of prescription data (2) The first pharmacy application into a database or spreadsheet that is that receives the electronic prescrip- readable and sortable. tion must digitally sign the prescrip- (13) The pharmacy application must tion immediately on receipt. maintain an audit trail of all actions (b) If the last intermediary digitally related to the following: signs the record, it must forward the (i) The receipt, annotation, alter- digitally signed copy to the pharmacy. ation, or deletion of a controlled sub- (c) If a pharmacy receives a digitally stance prescription. signed prescription that includes the (ii) Any setting or changing of logical individual practitioner’s digital signa- access control permissions related to ture, the pharmacy application must the dispensing of controlled substance do the following: prescriptions. (1) Verify the digital signature as (iii) Auditable events as specified in provided in FIPS 186–3, as incorporated § 1311.215. by reference in § 1311.08. (14) The pharmacy application must (2) Check the validity of the certifi- record within each audit record the fol- cate holder’s digital certificate by lowing information: checking the certificate revocation (i) The date and time of the event. list. The pharmacy may cache the CRL (ii) The type of event. until it expires. (iii) The identity of the person taking (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:

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(1) Attempted unauthorized access to (1) Before the application may be the pharmacy application, or success- used to create, sign, transmit, or proc- ful unauthorized access to the phar- ess controlled substance prescriptions. macy application where the determina- (2) Whenever a functionality related tion of such is feasible. to controlled substance prescription re- (2) Attempted or successful unau- quirements is altered or every two thorized modification or destruction of years, whichever occurs first. any information or records required by (b) The third-party audit must be this part, or successful unauthorized conducted by one of the following: modification or destruction of any in- (1) A person qualified to conduct a formation or records required by this SysTrust, WebTrust, or SAS 70 audit. part where the determination of such is (2) A Certified Information System feasible. Auditor who performs compliance au- (3) Interference with application op- dits as a regular ongoing business ac- erations of the pharmacy application. tivity. (4) Any setting of or change to log- (c) An audit for installed applications ical access controls related to the dis- must address processing integrity and pensing of controlled substance pre- determine that the application meets scriptions. the requirements of this part. (5) Attempted or successful inter- (d) An audit for application service ference with audit trail functions. providers must address processing in- (6) For application service providers, tegrity and physical security and determine that the application meets the attempted or successful annotation, al- requirements of this part. teration, or destruction of controlled substance prescriptions or logical ac- (e) If a certifying organization whose certification process has been approved cess controls related to controlled sub- by DEA verifies and certifies that an stance prescriptions by any agent or electronic prescription or pharmacy employee of the application service application meets the requirements of provider. this part, certification by that organi- (b) The pharmacy application must zation may be used as an alternative to analyze the audit trail at least once the audit requirements of paragraphs every calendar day and generate an in- (b) through (d) of this section, provided cident report that identifies each that the certification that determines auditable event. that the application meets the require- (c) The pharmacy must determine ments of this part occurs at each of the whether any identified auditable event following times: represents a security incident that (1) Before the application may be compromised or could have com- used to create, sign, transmit, or proc- promised the integrity of the prescrip- ess controlled substance prescriptions. tion records. Any such incidents must (2) Whenever a functionality related be reported to the pharmacy applica- to controlled substance prescription re- tion service provider, if applicable, and quirements is altered or every two the Administration within one business years, whichever occurs first. day. (f) The application provider must make the audit or certification report § 1311.300 Application provider re- available to any practitioner or phar- quirements—Third-party audits or macy that uses the application or is certifications. considering use of the application. The (a) Except as provided in paragraph electronic prescription or pharmacy (e) of this section, the application pro- application provider must retain the vider of an electronic prescription ap- most recent audit or certification re- plication or a pharmacy application sults and retain the results of any 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-

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party auditor or certification organiza- cate that the application does not meet tion finds that the application does not the requirements of this part. meet one or more of the requirements (2) If the pharmacy application ac- of this part, the application must not cepts prescriptions with the practi- be used to create, sign, transmit, or tioner’s digital signature, the third- process electronic controlled substance party auditor or certification organiza- prescriptions. The application provider tion must indicate that the application must notify registrants within five does not meet the requirements of this business days of the issuance of the part if the application does not consist- audit or certification report that they ently and accurately import, store, and should not use the application for con- verify the digital signature. trolled substance prescriptions. The ap- (3) If other information required plication provider must also notify the under this chapter cannot be consist- Administration of the adverse audit or ently and accurately imported, stored, certification report and provide the re- and displayed, the third-party auditor port to the Administration within one or certification organization must indi- business day of issuance. cate that the application has failed to (h) For electronic prescription appli- meet the requirements for the specific cations, the third-party auditor or cer- information and should not be used to tification organization must make the process electronic prescriptions that following determinations: require the additional information. (1) If the information required in § 1306.05(a) of this chapter, the indica- § 1311.302 Additional application pro- tion that the prescription was signed vider requirements. as required by § 1311.120(b)(17) or the (a) If an application provider identi- digital signature created by the practi- fies or is made aware of any issue with tioner’s private key, if transmitted, its application that make the applica- and the number of refills as required by tion non-compliant with the require- § 1306.22 of this chapter, cannot be con- ments of this part, the application pro- sistently and accurately recorded, vider must notify practitioners or stored, and transmitted, the third- pharmacies that use the application as 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

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be required now or in the future, by 1312.16 Amendment, cancellation, expira- any other Federal or State law or regu- tion of import permit. lation, applicable to practitioners, 1312.17 Special report from importers. pharmacists, or pharmacies. 1312.18 Import declaration. (c) Records regarding controlled sub- 1312.19 Distribution of import declaration. stances prescriptions must be readily EXPORTATION OF CONTROLLED SUBSTANCES retrievable from all other records. Electronic records must be easily read- 1312.21 Requirement of authorization to ex- able or easily rendered into a format port. that a person can read. 1312.22 Application for export or reexport (d) Records required by this part permit; return information. must be made available to the Admin- 1312.23 Issuance of export permit. istration upon request. 1312.24 Distribution of export permit. (e) If an application service provider 1312.25 Amendment, cancellation, expira- ceases to provide an electronic pre- tion of export permit. scription application or an electronic 1312.26 Records required of exporter. pharmacy application or if a registrant 1312.27 Export/reexport declaration. ceases to use an application service 1312.28 Distribution of export declaration. 1312.29 Domestic release prohibited. provider, the application service pro- 1312.30 Schedule III, IV, and V non-narcotic vider must transfer any records subject controlled substances requiring an im- to this part to the registrant in a for- port and export permit. mat that the registrant’s applications are capable of retrieving, displaying, TRANSSHIPMENT AND IN-TRANSIT SHIPMENT OF and printing in a readable format. CONTROLLED SUBSTANCES (f) If a registrant changes application 1312.31 Schedule I: Application for prior providers, the registrant must ensure written approval. that any records subject to this part 1312.32 Schedules II, III, IV: Advance notice. are migrated to the new application or are stored in a format that can be re- HEARINGS trieved, displayed, and printed in a 1312.41 Hearings generally. readable format. 1312.42 Purpose of hearing. (g) If a registrant transfers its elec- 1312.43 Waiver or modification of rules. tronic prescription files to another reg- 1312.44 Request for hearing or appearance; istrant, both registrants must ensure waiver. that the records are migrated to the 1312.45 Burden of proof. new application or are stored in a for- 1312.46 Time and place of hearing. mat that can be retrieved, displayed, 1312.47 Final order. and printed in a readable format. (h) Digitally signed prescription AUTHORITY: 21 U.S.C. 821, 871(b), 952, 953, records must be transferred or mi- 954, 957, 958. grated with the digital signature. SOURCE: 36 FR 7815, Apr. 24, 1971, unless otherwise noted. Redesignated at 38 FR 26609, PART 1312—IMPORTATION AND Sept. 24, 1973. EXPORTATION OF CONTROLLED § 1312.01 Scope of part 1312. SUBSTANCES Procedures governing the importa- Sec. tion, exportation, transshipment and 1312.01 Scope of part 1312. intransit shipment of controlled sub- 1312.02 Definitions. stances pursuant to section 1002, 1003, 1312.03 Forms applicable to this part. and 1004 of the Act (21 U.S.C. 952, 953, IMPORTATION OF CONTROLLED SUBSTANCES and 954) are governed generally by those sections and specifically by the 1312.11 Requirement of authorization to import. sections of this part. 1312.12 Application for import permit; return information.. § 1312.02 Definitions. 1312.13 Issuance of import permit. Any term contained in this part shall 1312.14 Distribution of import permits. have the definition set forth in section 1312.15 Shipments in greater or less amount than authorized.

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102 of the Act (21 U.S.C. 802) or part § 1312.03 Forms applicable to this part. 1300 of this chapter. [62 FR 13969, Mar. 24, 1997]

Access/ Form submission

DEA Form 35, Permit to Import ...... electronic. DEA Form 36, Permit to Export ...... electronic. DEA Form 161, Application for Permit to Export Controlled Substances ...... electronic. DEA Form 161R, Application for Permit to Export Controlled Substances For Subsequent Reexport ...... electronic. DEA Form 161R–EEA, Application for Permit to Export Controlled Substances for Subsequent Reexport electronic. Among Members of the European Economic Area. DEA Form 236, Controlled Substances Import/Export Declaration ...... electronic. DEA Form 357, Application for Permit to Import Controlled Substances for Domestic And/Or Scientific Pur- electronic. poses.

[81 FR 97025, Dec. 30, 2016] and has filed an import declaration to do so in accordance with § 1312.18. IMPORTATION OF CONTROLLED (c) A separate permit or declaration SUBSTANCES is required for each shipment of a controlled substance to be imported. § 1312.11 Requirement of authorization to import. [81 FR 97026, Dec. 30, 2016] (a) No person shall import, or cause to be imported, into the customs terri- § 1312.12 Application for import permit; return information. tory of the United States from any place outside thereof (but within the (a) Registered importers, other reg- United States), or into the United istrants authorized to import as a coin- States from any place outside thereof, cident activity of their registrations, any controlled substances listed in and persons who in accordance with Schedule I or II, or any narcotic con- part 1301 of this chapter are exempt trolled substance listed in Schedule III, from registration, seeking to import a IV, or V, or any non-narcotic con- controlled substance in schedule I or II; trolled substance listed in Schedule III any narcotic drug in schedule III, IV, which the Administrator has specifi- or V; any non-narcotic drug in schedule cally designated by regulation in III that has been specifically des- § 1312.30 or any non-narcotic controlled ignated by regulation in § 1312.30; or substance listed in Schedule IV or V any non-narcotic substance listed in which is also listed in Schedule I or II schedule IV or V that is also listed in of the Convention on Psychotropic schedule I or II of the Convention on Substances, 1971, unless and until such Psychotropic Substances, 1971, must person is properly registered under the submit an application for a permit to Act (or, in accordance with part 1301 of import controlled substances on DEA this chapter, exempt from registration) Form 357. All applications and sup- and the Administration has issued him porting materials must be submitted to or her a permit to do so in accordance the Administration through the DEA with § 1312.13. Diversion Control Division secure net- (b) No person shall import, or cause work application. The application must to be imported, into the customs terri- be signed and dated by the importer tory of the United States from any and must contain the importer’s reg- place outside thereof (but within the istered address to which the controlled United States), or into the United substances will be imported. States from any place outside thereof, (b) The applicant must include on the any non-narcotic controlled substance DEA Form 357 the registration number listed in Schedule III, IV, or V, exclud- of the importer and a detailed descrip- ing those described in paragraph (a) of tion of each controlled substance to be this section, unless and until such per- imported including the drug name, dos- son is properly registered under the age form, National Drug Code (NDC) Act (or, in accordance with part 1301 of number, the Administration Controlled this chapter, exempt from registration) Substance Code Number as set forth in

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part 1308 of this chapter, the number ports in different countries will not be and size of the packages or containers, authorized in the same permit. the name and quantity of the con- (d) Return information. Within 30 cal- trolled substance contained in any fin- endar days after actual receipt of a ished dosage units, and the quantity of controlled substance at the importer’s any controlled substance (expressed in registered location, or within 10 cal- anhydrous acid, base or alkaloid) given endar days after receipt of a written rein kilograms or parts thereof. The ap- quest by the Administration to the im- plication must also include the fol- porter, whichever is sooner, the im- lowing: porter must file a report with the Ad- (1) The name/business name, address/ ministration through the DEA Diver- business address, contact information sion Control Division secure network (e.g., telephone number(s), email ad- application specifying the particulars dress(es), etc.), and business of the con- of the transaction. This report must in- signor, if known at the time the appli- clude the following information: The cation is submitted, but if unknown at date the controlled substance was re- that time, the fact should be indicated leased by a customs officer at the port and the name and address afterwards of entry; the date on which the con- furnished to the Administration as trolled substance arrived at the reg- soon as ascertained by the importer; istered location; the actual quantity of (2) The foreign port and country of the controlled substance released by a initial exportation (i.e., the place customs officer at the port of entry; where the article will begin its journey and the actual quantity of the con- of exportation to the United States); trolled substance that arrived at the (3) The port of entry into the United registered location. Upon receipt and States; review, the Administration will assign (4) The latest date said shipment will a transaction identification number to leave said foreign port or country; a completed report. The report will not (5) The stock on hand of the con- be deemed filed until the Administra- trolled substance desired to be im- tion has issued a transaction identi- ported; fication number. (6) The name of the importing carrier (e) Denied release at the port of entry. or vessel (if known), or if unknown it In the event that a shipment of con- should be stated whether the shipment trolled substances has been denied re- will be made by express, freight, or lease by a customs officer at the port otherwise, imports of controlled sub- of entry for any reason, the importer stances in Schedules I or II and nar- who attempted to have the shipment cotic drugs in Schedules III, IV, or V released must, within 5 business days by mail being prohibited); of the denial, report to the Administra- (7) The total tentative allotment to tion that the shipment was denied and the importer of such controlled sub- the reason for denial. Such report must stance for the current calendar year; be transmitted to the Administration and through the DEA Diversion Control Di- (8) The total number of kilograms of vision secure network application. This said allotment for which permits have report must include the following in- previously been issued and the total formation: The quantity of the con- quantity of controlled substance actu- trolled substance denied release; the ally imported during the current year date on which release was denied; and to date. the basis for the denied release. Upon (c) If desired, alternative foreign the importer’s report of a denied reports of exportation within the same lease at the port of entry, the DEA will country may be indicated upon the ap- assign the report a transaction identi- plication (e.g., 1. Kolkata, 2. Mumbai). fication number and the import permit If a permit is issued pursuant to such will be void and of no effect. No ship- application, it will bear the names of ment of controlled substances denied the two ports in the order given in the release for any reason will be allowed application and will authorize ship- to be released into the United States ment from either port. Alternative unless the importer submits a new

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DEA Form 357 and the Administration that the substance is being imported issues a new import permit. for medical, scientific or other legitimate uses. [81 FR 97026, Dec. 30, 2016] (c) If a non-narcotic substance listed § 1312.13 Issuance of import permit. in Schedule IV or V is also listed in Schedule I or II of the Convention on (a) The Administrator may authorize Psychotropic Substances, 1971, it shall importation of any controlled sub- be imported only pursuant to the stance listed in Schedule I or II or any issuance of an import permit. The Ad- narcotic drug listed in Schedule III, IV, or V if he finds: ministrator may authorize the impor- (1) That the substance is crude tation of such substances if it is found opium, poppy straw, concentrate of that the substance is being imported poppy straw, or coca leaves, in such for medical, scientific or other legiti- quantity as the Administrator finds mate uses. necessary to provide for medical, sci- (d) The Administrator may require entific, or other legitimate purposes; an applicant to submit such documents (2) That the substance is necessary to or written statements of fact relevant provide for medical and scientific needs to the application as he deems nec- or other legitimate needs of the United essary to determine whether the appli- States during an emergency where do- cation should be granted. The failure of mestic supplies of such substance or the applicant to provide such docu- drug are found to be inadequate, or in ments or statements within a reason- any case in which the Administrator able time after being requested to do so finds that competition among domestic shall be deemed to be a waiver by the manufacturers of the controlled sub- applicant of an opportunity to present stance is inadequate and will not be such documents or facts for consider- rendered adequate by the registration ation by the Administrator in granting of additional manufacturers under sec- or denying the application. tion 303 of the Controlled Substances (e) If an importation is approved, the Act (21 U.S.C. 823); or Administrator will issue an import per- (3) That the domestic supply of any mit bearing his or her signature or controlled substance is inadequate for that of his or her delegate. Each permit scientific studies, and that the impor- will be assigned a unique permit num- tation of that substance for scientific ber. A permit must not be altered or purposes is only for delivery to offi- changed by any person after being cials of the United Nations, of the signed. Any change or alteration upon United States, or of any State, or to the face of any permit after it has been any person registered or exempted signed renders it void and of no effect. from registration under sections 1007 Permits are not transferable. The Ad- and 1008 of the Act (21 U.S.C. 957 and ministrator or his/her delegate will 958). date and certify on each permit that (4) That the importation of the con- the importer named therein is thereby trolled substance is for ballistics or permitted as a registrant under the other analytical or scientific purposes, Act, to import, through the port of and that the importation of that sub- entry named, one shipment of not to stance is only for delivery to officials exceed the specified quantity of the of the United Nations, of the United named controlled substances, shipment States, or of any State, or to any per- to be made before a specified date. son registered or exempted from reg- Only one shipment may be made on a istration under sections 1007 and 1008 of single import permit. A single import the Act (21 U.S.C. 957 and 958). permit shall authorize a quantity of (b) The Administrator may require goods to be imported/exported at one that such non-narcotic controlled sub- place, at one time, for delivery to one stances in Schedule III as he shall des- consignee, on a single conveyance, at ignate by regulation in § 1312.30 of this one place, on one bill of lading, air part be imported only pursuant to the waybill, or commercial loading docu- issuance of an import permit. The Ad- ment; a single permit shall not author- ministrator may authorize the impor- ize a quantity of goods to be imported/ tation of such substances if he finds exported if the goods are divided onto

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two or more conveyances. The permit permit (available from the DEA Diver- must state that the Administration is sion Control Division secure network satisfied that the consignment pro- application after issuance) in accord- posed to be imported is required for le- ance with part 1304 of this chapter as gitimate purposes. the record of authority for the impor- (f) Notwithstanding paragraphs (a)(1) tation and shall transmit an official and (a)(2) of this section, the Adminis- record of the permit to the foreign ex- trator shall permit, pursuant to sec- porter. If required by the foreign com- tion 1002(a)(1) or 1002(a)(2)(A) of the Act petent national authority, the im- (21 U.S.C. 952(a)(1) or (a)(2)(A)), the importer shall ensure that an official portation of approved narcotic raw ma- record of the import permit is provided terial (opium, poppy straw and con- (e.g., by transmitting an official record centrate of poppy straw) having as its of the permit to the foreign exporter source: who shall transmit such record to the (1) Turkey, competent national authority of the (2) India, exporting county). The importer must (3) Spain, ensure that an official record of the (4) France, permit accompanies the shipment of (5) Poland, controlled substances to its final des- (6) Hungary, and tination, the registered location of the (7) Australia. importer (i.e., drop shipments are pro- (g) At least eighty (80) percent of the hibited). narcotic raw material imported into [81 FR 97027, Dec. 30, 2016] the United States shall have as its original source Turkey and India. Ex- § 1312.15 Shipments in greater or less cept under conditions of insufficient amount than authorized. supplies of narcotic raw materials, not (a) If the shipment made under an more than twenty (20) percent of the import permit is greater than the max- narcotic raw material imported into imum amount authorized to be im- the United States annually shall have ported under the permit, as determined as its source Spain, France, Poland, at the weighing by the District Direc- Hungary and Australia. tor of the U.S. Customs and Border Protection or customs service of an In- [36 FR 23624, Dec. 11, 1971, as amended at 37 FR 15923, Aug. 8, 1972. Redesignated at 38 FR sular Area, such difference shall be 26609, Sept. 24, 1973, and amended at 46 FR seized subject to forfeiture, pending an 41776, Aug. 18, 1981; 52 FR 17289, May 7, 1987; explanation; except that shipments of 73 FR 6851, Feb. 6, 2008; 81 FR 97027, Dec. 30, substances exceeding the maximum au- 2016] thorized amount by less than 1 percent may be released to the importer upon § 1312.14 Distribution of import per- the filing by him of an amended import mits. permit in accordance with § 1312.16(a). The Administration shall transmit If the substance is included in Schedule the import permit to the competent I, it will be summarily forfeited to the national authority of the exporting Government. country and shall make an official (b) If the shipment made under the record of the import permit available permit is less than the maximum to the importer through secure elec- amount authorized to be imported tronic means. The importer, or their under the permit as determined at the agent, must submit an official record weighing by the District Director of of the import permit and/or required the U.S. Customs and Border Protec- data concerning the import transaction tion or customs service of an Insular to a customs officer at the port of Area, such difference, when ascertained entry in compliance with all import by the Administration, shall be recred- control requirements of agencies with ited to the tentative allotment against import control authorities under the which the quantity covered by the per- Act or statutory authority other than mit was charged, and the balance of the Controlled Substances Import and any such tentative allotment with any Export Act. The importer must main- such recredits will remain available to tain an official record of the import the importer to whom made (unless

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previously revoked in whole or in part), in accordance with the terms of the for importations pursuant to any per- permit, subject to the shipment being mit or permits as are requested and compliant with all other applicable issued during the remainder of the cal- laws. endar year to which the allotment is (1) An importer may request that an applicable. No permit shall be issued import permit or application for a per- for importation of a quantity of con- mit be amended to change the National trolled substances as a charge against Drug Control number, description of the tentative allotment for a given cal- the packaging, or trade name of the endar year, after the close of such cal- product, so long as the description is endar year, unless the Administrator for the same basic class of controlled decides to make an exception for good substance as in the original permit. cause shown. (2) An importer may request that an [36 FR 7815, Apr. 24, 1971. Redesignated at 38 import permit or application for a per- FR 26609, Sept. 24, 1973, and amended at 46 mit be amended to change the proposed FR 28841, May 29, 1981; 81 FR 97027, Dec. 30, port of entry, the date of release by a 2016] customs officer, or the method of transport. § 1312.16 Amendment, cancellation, ex- (3) An importer may request that an piration of import permit. import permit or application for a per- (a) Importers may only request that mit be amended to change the jus- an import permit or application for an tification provided as to why an import import permit be amended in accord- shipment is needed to meet the legiti- ance with paragraphs (a)(1) through (7) mate scientific or medical needs of the of this section. Requests for an amend- United States. ment must be submitted through the (4) An importer may request that an DEA Diversion Control Division secure import permit or application for a per- network application. Except as pro- mit be amended to change any reg- vided in paragraph (a)(5) of this section istrant notes. and § 1312.15(a), importers must submit (5) Prior to departure of the shipment all requests for an amendment at least from its original foreign location, an one full business day in advance of the importer may request that an import date of release by a customs officer. permit or application for a permit be Importers must specifically request amended to increase the total base that an amendment be made; supple- weight of a controlled substance. At mentary information submitted by an the U.S. port of entry, an importer importer through the DEA Diversion may request that an import permit be Control Division secure network appli- amended in accordance with § 1312.15(a). cation will not automatically trigger Importers are not required to amend an the amendment process. While the re- import permit for the sole purpose of quest for an amendment is being re- decreasing the total base weight of a viewed by the Administration, the controlled substance authorized to be original permit will be temporarily imported. However, the balance of any stayed and may not be used to author- unimported authorized quantity of con- ize entry of a shipment of controlled trolled substances on an import permit substances. If the importer’s request is void upon entry of a shipment on the for an amendment to an issued permit issued permit or upon expiration of the is granted by the Administration, the unused permit in accordance with para- Administration will immediately can- graph (b) of this section, whichever is cel the original permit and re-issue the sooner. Other than for an amendment permit, as amended, with a revised per- to an import permit under § 1312.15(a), mit number. The DEA and importer importers must submit a request for an will distribute the amended permit in amendment to increase the total base accordance with § 1312.14. If a request weight of a controlled substance at for an amendment is denied by the Ad- least three business days in advance of ministration, the temporary stay will the date of release by a customs offi- be lifted; once lifted, the originally cer. issued permit may immediately be (6) An importer may request that an used to authorize entry of a shipment import permit be amended to remove a

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controlled substance from the permit. Administrator may accept the figures However, an importer may not amend given upon the reports subsequent by an import permit to add or replace a said importer under part 1304 of this controlled substance/Administration chapter. controlled substance code number to the item(s) to be imported. Importers [36 FR 7815, Apr. 24, 1971. Redesignated at 38 who desire to import a different con- FR 26609, Sept. 24, 1973, as amended at 62 FR trolled substance than that contained 13969, Mar. 24, 1997] on their issued import permit or per- 1312.18 Import declaration. mit application must submit a request for the permit or permit application to (a) Any non-narcotic controlled sub- be canceled and request a new permit stance listed in Schedule III, IV, or V, in accordance with § 1312.12. not subject to the requirement of an (7) An importer may not amend the import permit pursuant to § 1312.13 (b) importer’s name (as it appears on their or (c) of this chapter, may be imported DEA certificate of registration) or the if that substance is needed for medical, name of the foreign exporter as pro- scientific or other legitimate uses in vided in the DEA Form 357. Importers the United States, and will be imported who need to make any changes to any pursuant to a controlled substances of these fields must submit a request import declaration. for the permit or permit application to (b) Any person registered or author- be canceled and request a new permit ized to import and seeking to import in accordance with § 1312.12. any non-narcotic controlled substance (b) An import permit will be void and listed in Schedules III, IV, or V which of no effect after the expiration date is not subject to the requirement of an specified therein, and in no event will import permit as described in para- the date be more than 180 calendar graph (a) of this section, must file a days after the date the permit is controlled substances import declara- issued. Amended import permits will retain the original expiration date. tion (DEA Form 236) with the Adminis- (c) An import permit may be can- tration through the DEA Diversion celed after being issued, at the request Control Division secure network appli- of the importer submitted to the Ad- cation not later than 15 calendar days ministration through the DEA Diver- prior to the anticipated date of release sion Control Division secure network by a customs officer and distribute an application, provided that no shipment official record of the declaration as has been made thereunder. hereinafter directed in § 1312.19. The Nothing in this part will affect the declaration must be signed and dated right, hereby reserved by the Adminis- by the importer and must specify the tration, to cancel a permit at any time address of the final destination for the for proper cause. shipment, which must be the importer’s registered location. Upon receipt [81 FR 97027, Dec. 30, 2016] and review, the Administration will as- § 1312.17 Special report from import- sign a transaction identification num- ers. ber to each completed declaration. The Whenever requested by the Adminis- import declaration is not deemed filed, trator, importers shall render to him and therefore is not valid, until the Ad- not later than 30 days after receipt of ministration has issued a transaction the request therefor a statement under identification number. The importer oath of the stocks of controlled sub- may only proceed with the import stances on hand as of the date specified transaction once the transaction iden- by the Administrator in his request, tification number has been issued. and, if desired by the Administrator, (c) DEA Form 236 must include the an estimate of the probable require- following information: ments for legitimate uses of the im- (1) The name, address, and registra- porter for any subsequent period that tion number of the importer; and the may be designated by the Adminis- name and address and registration trator. In lieu of any special statement number of the import broker, if any; that may be considered necessary, the and

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(2) A complete description of the con- entry. Upon receipt and review, the Ad- trolled substances to be imported, in- ministration will assign a transaction cluding drug name, dosage form, Na- identification number to a completed tional Drug Code (NDC) number, the report. The report will not be deemed Administration Controlled Substances filed until the Administration has Code Number as set forth in part 1308 issued a transaction identification of this chapter, the number and size of number. packages or containers, the name and (f) An importer may amend an im- quantity of the controlled substance port declaration in the same cir- contained in any finished dosage units, cumstances in which an importer may and the net quantity of any controlled request amendment to an import per- substance (expressed in anhydrous mit, as set forth in § 1312.16(a)(1) acid, base, or alkaloid) given in kilo- through (7). Amendments to declara- grams or parts thereof; and tions must be submitted through the (3) The anticipated date of release by DEA Diversion Control Division secure a customs officer at the port of entry, network application. Except as pro- the foreign port and country of expor- vided in §§ 1312.16(a)(5) and 1312.15(a), tation to the United States, the port of importers must submit all amendments entry, and the name, address, and reg- at least one full business day in ad- istration number of the recipient in the vance of the date of release by a cus- United States; and toms officer. Importers must specifi- (4) The name and address of the con- cally note that an amendment is being signor in the foreign country of expor- made; supplementary information sub- tation, and any registration or license mitted by an importer through the numbers if the consignor is required to DEA Diversion Control Division secure have such numbers either by the country of exportation or under U.S. law. network application will not automati- (d) Notwithstanding the time limita- cally be considered an amendment. tions included in paragraph (b) of this While the amendment is being proc- section, an applicant may obtain a spe- essed by the Administration, the origi- cial waiver of these time limitations in nal declaration will be temporarily emergency or unusual instances, pro- stayed and may not be used to author- vided that a specific confirmation is re- ize release of a shipment of controlled ceived from the Administrator or his substances. Upon receipt and review, delegate advising the registrant to pro- the Administration will assign each ceed pursuant to the special waiver. completed amendment a transaction (e) Return information. Within 30 cal- identification number. The amendment endar days after actual receipt of a will not be deemed filed until the Ad- controlled substance at the importer’s ministration issues a transaction iden- registered location, or within 10 cal- tification number. The DEA and im- endar days after receipt of a written re- porter will distribute the amended dec- quest by the Administration to the im- laration in accordance with § 1312.19. A porter, whichever is sooner, the im- filed amendment will not change the porter must file a report with the Ad- date that the declaration becomes void ministration through the DEA Diver- and of no effect pursuant to paragraph sion Control Division secure network (g) of this section. application specifying the particulars (g) An import declaration may be of the transaction. This report must in- canceled after being filed with the Ad- clude the following information: The ministration, at the request of the im- date on which the controlled substance porter by the importer submitting to was released by a customs officer at the Administration the request the port of entry; the date on which the through the DEA Diversion Control Di- controlled substance arrived at the reg- vision secure network application, pro- istered location; the actual quantity of vided that no shipment has been made the controlled substance released by a thereunder. Import declarations shall customs officer at the port of entry; become void and of no effect 180 cal- the actual quantity of the controlled endar days after the date the declara- substance that arrived at the reg- tion is deemed filed with the Adminis- istered location; and the actual port of tration.

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(h) Denied release at the port of entry. statutory authority other than the In the event that a shipment of con- Controlled Substances Import and Ex- trolled substances has been denied report Act. The importer must ensure lease by a customs officer at the port that an official record of the declara- of entry for any reason, the importer tion accompanies the shipment to its who attempted to have the shipment final destination, which must only be released, within 5 business days of the the registered location of the importer denial, report to the Administration (i.e., drop shipments are prohibited). that the shipment was denied release The importer must maintain an official and the reason for denial. Such report record of the declaration in accordance must be transmitted to the Adminis- with part 1304 of this chapter. tration through the DEA Diversion Control Division secure network appli- [81 FR 97029, Dec. 30, 2016] cation. This report must include the following information: The quantity of EXPORTATION OF CONTROLLED the controlled substance denied re- SUBSTANCES lease; the date on which release was denied; and the basis for the denied re- § 1312.21 Requirement of authorization to export. lease. Upon the importer’s report of a denied release, the DEA will assign the (a) No person shall in any manner ex- report a transaction identification port, or cause to be exported, from the number and the import declaration will United States any controlled substance become void and of no effect. No ship- listed in Schedule I or II, or any nar- ment of controlled substances denied cotic controlled substance listed in release for any reason will be allowed Schedule III or IV, or any non-narcotic to be released into the United States controlled substance in Schedule III until the importer has filed a new im- which the Administrator has specifi- port declaration and the Administra- cally designated by regulation in tion has issued a new transaction iden- § 1312.30 or any non-narcotic controlled tification number. substance in Schedule IV or V which is also listed in Schedule I or II of the [36 FR 7815, Apr. 24, 1971, as amended at 37 FR 15923, Aug. 8, 1972. Redesignated at 38 FR Convention on Psychotropic Sub- 26609, Sept. 24, 1973, and amended at 45 FR stances, 1971, unless and until such per- 74715, Nov. 12, 1980; 51 FR 5319, Feb. 13, 1986; son is properly registered under the 52 FR 17290, May 7, 1987; 62 FR 13969, Mar. 24, Act (or, in accordance with part 1301 of 1997; 75 FR 10682, Mar. 9, 2010; 77 FR 4237, Jan. this chapter, exempt from registration) 27, 2012; 81 FR 97028, Dec. 30, 2016] and the Administrator has issued him or her a permit to do so in accordance § 1312.19 Distribution of import dec- with § 1312.23. laration. (b) No person shall in any manner ex- The importer must furnish an official port, or cause to be exported, from the record of the declaration (available United States any non-narcotic con- through the DEA Diversion Control Di- trolled substance listed in Schedule III, vision secure network application after IV, or V, excluding those described in the Administration issues a trans- paragraph (a) of this section, or any action identification number) to the narcotic controlled substance listed in foreign shipper. The foreign shipper Schedule V, unless and until such per- must submit an official record of the son is properly registered under the declaration to the competent national Act (or, in accordance with part 1301 of authority of the exporting country, if this chapter, exempt from registration) required as a prerequisite to export au- and has furnished an export declara- thorization. The importer, or their tion as provided by section 1003 of the agent, must submit an official record Act (21 U.S.C. 953(e)) to the Adminis- of the declaration and/or required data tration in accordance with § 1312.28. concerning the import transaction to a (c) A separate permit or declaration customs officer at the port of entry in is required for each shipment of con- compliance with all import control re- trolled substance to be exported. quirements of agencies with import control authorities under the Act or [81 FR 97029, Dec. 30, 2016]

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§ 1312.22 Application for export or re- (iv) The name/business name, ad- export permit; return information. dress/business address, contact infor- (a) Registered exporters, and persons mation (e.g., telephone number(s), who in accordance with part 1301 of email address(es), etc.) and business of this chapter are exempt from registra- the consignee in the first country (the tion, seeking to export controlled sub- country to which the controlled substances must submit an application for stance is exported from the United a permit to export controlled sub- States), foreign port and country of stances on DEA Form 161. Registered entry/first country of entry, the port of exporters, and persons who in accord- export, the anticipated date of release ance with part 1301 of this chapter are by a customs officer at the port of ex- exempt from registration, seeking to port, the name of the exporting carrier reexport controlled substances must or vessel (if known), or if unknown it submit an application for a permit to should be stated whether the shipment reexport controlled substances on DEA will be made by express, freight, or Form 161R or DEA Form 161R–EEA, otherwise), the date and number, if whichever applies. All applications and any, of the supporting foreign import supporting materials must be sub- license or permit accompanying the ap- mitted to the Administration through plication, and the authority by whom the DEA Diversion Control Division se- such foreign license or permit was cure network application. The applica- issued; and tion must be signed and dated by the (v) An affidavit that the packages or exporter and contain the exporter’s containers are labeled in conformance registered address from which the con- with obligations of the United States trolled substances will be exported. under international treaties, conven- Controlled substances may not be ex- tions, or protocols in effect at the time ported until a permit number has been of the export or reexport. The affidavit issued. shall further state that to the best of (b) Exports of controlled substances the affiant’s knowledge and belief, the by mail are prohibited. controlled substances therein are to be (c) Applications. (1) Except as pro- applied exclusively to medical or sci- vided in paragraph (c)(2) of this sec- entific uses within the country to tion, each application for a permit to which exported, will not be reexported export or reexport must include the therefrom and that there is an actual following information: need for the controlled substance for (i) The exporter’s name/business medical or scientific uses within such name, address/business address, and country, unless the application is sub- contact information (e.g., telephone mitted for reexport in accordance with number(s), email address (es), etc.); paragraphs (f), (g), and (h) of this sec- (ii) The exporter’s registration num- tion. In the case of exportation of ber, address, and contact information crude cocaine, the affidavit may state (e.g., telephone number(s), etc.) from that to the best of affiant’s knowledge which the controlled substances will be exported; and belief, the controlled substances will be processed within the country to (iii) A detailed description of each which exported, either for medical or controlled substance to be exported including the drug name, dosage form, scientific use within that country or National Drug Code (NDC) number, Ad- for reexportation in accordance with ministration Controlled Substance the laws of that country to another for Code Number as set forth in part 1308 medical or scientific use within that of this chapter, the number and size of country. the packages or containers, the name (2) With respect to reexports among and quantity of the controlled sub- members of the European Economic stance contained in any finished dosage Area in accordance with section 1003(f) units, and the quantity of any con- of the Act (21 U.S.C. 953(f)), the require- trolled substance (expressed in anhy- ments of paragraph (c)(1) of this sec- drous acid, base, or alkaloid) given in tion shall apply only with respect to kilograms or parts thereof; the export from the United States to

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the first country and not to any subse- whichever is sooner, the exporter must quent export from that country to an- report to the Administration through other country of the European Eco- the DEA Diversion Control Division se- nomic Area. cure network application the particu- (d)(1) Except as provided in para- lars of the transaction. This report graph (d)(2) of this section, the appli- must include the following informa- cant must also submit with the appli- tion: The date on which the controlled cation any import license or permit or substance left the registered location; a certified copy of any such license or the date on which the controlled sub- permit issued by the competent na- stance was released by a customs offi- tional authority in the country of des- cer at the port of export; the actual tination, or other documentary evi- quantity of controlled substance that dence deemed adequate by the Admin- left the registered location; and the ac- istration, showing: That the merchan- tual quantity of the controlled sub- dise is consigned to an authorized per- stance released by a customs officer at mittee; that it is to be applied exclu- the port of export; the actual port of sively to medical or scientific use with- export, and any other information as in the country of destination; that it the Administration may from time to will not be reexported from such coun- time specify. Upon receipt and review, try (unless the application is submitted the Administration will assign a trans- for reexport in accordance with para- action identification number to a com- graphs (f), (g), and (h) of this section); pleted report. The report will not be and that there is an actual need for the deemed filed until the Administration controlled substance for medical or sci- has issued a transaction identification entific use within such country or number. countries. If the import license or per- (f) Reexports outside of the European mit, or the certified copy of such, is Economic Area. Except as provided in not written in English or bilingual paragraph (g) of this section, the Ad- with another language and English, the ministration may authorize any con- registrant must also submit with their trolled substance listed in Schedule I application a certified translation of or II, or any narcotic drug listed in the permit or license. For purposes of Schedule III or IV, to be exported from this requirement, certified translation the United States to a country for sub- means that the translator has signed sequent export from that country to the translation legally attesting the another country, if each of the fol- accuracy of the translation. (In the lowing conditions is met, in accordance case of exportation of bulk coca leaf with section 1003(f) of the Act (21 alkaloid, the applicant need only in- U.S.C. 953(f)): clude with the application the material (1) Both the country to which the outlined in paragraph (c) of this sec- controlled substance is exported from tion.) the United States (referred to in this (2) With respect to reexports among section as the ‘‘first country’’) and the members of the European Economic country to which the controlled sub- Area in accordance with section 1003(f) stance is exported from the first coun- of the Act (21 U.S.C. 953(f)), the require- try (referred to in this section as the ments of paragraph (d)(1) of this sec- ‘‘second country’’) are parties to the tion shall apply only with respect to Single Convention on Narcotic Drugs, the export from the United States to 1961, and the Convention on Psycho- the first country and not to any subse- tropic Substances, 1971; quent export from that country to an- (2) The first country and the second other country of the European Eco- country have each instituted and main- nomic Area. tain, in conformity with such Conven- (e) Return information for exports (on a tions, a system of controls of imports DEA Form 161). Within 30 calendar days of controlled substances which the Ad- after the controlled substance is re- ministration deems adequate; leased by a customs officer at the port (3) With respect to the first country, of export, or within 10 calendar days the controlled substance is consigned after receipt of a written request by to a holder of such permits or licenses the Administration to the exporter, as may be required under the laws of

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such country, and a permit or license (ii) Return information for export from to import the controlled substance has a first country that is or is not a member been issued by the country; of the European Economic Area to a (4) With respect to the second coun- country outside of the European Eco- try, substantial evidence is furnished nomic Area; return information for export to the Administration by the applicant from a first country that is not a member for the export permit that— of the European Economic Area to a mem- (i) The controlled substance is to be ber of the European Economic Area. consigned to a holder of such permits Within 30 calendar days after the con- or licenses as may be required under trolled substance is exported from the the laws of such country, and a permit first country to the second country the or license to import the controlled sub- exporter must file a report with the stance is to be issued by the country; Administration through the DEA Di- and version Control Division secure net- (ii) The controlled substance is to be work application specifying the par- applied exclusively to medical, sci- ticulars of the export from the first entific, or other legitimate uses within country. If the permit issued by the the country; Administration authorized the reexport of a controlled substance from the (5) The controlled substance will not first country to more than one second be exported from the second country; country, a report for each individual (6) The exporter has complied with reexport is required. These reports paragraph (h) of this section and a per- must include the following informa- mit to export the controlled substance tion: Name of second country; actual from the United States has been issued quantity of controlled substance by the Administration; and shipped; and the date shipped from the (7) Return information for reexports first country, the actual port from outside of the European Economic Area which the controlled substances were (on DEA Form 161R)—(i) Return informa- shipped from the first country. Upon tion for export from the United States, for receipt and review, the Administration reexport. Within 30 calendar days after will assign each completed report a the controlled substance is released by transaction identification number. The a customs officer at the port of export report will not be deemed filed until the exporter must file a report with the the Administration has issued a trans- Administration through the DEA Di- action identification number. version Control Division secure net- (g) Reexports among members of the Eu- work application specifying the par- ropean Economic Area (on DEA Form ticulars of the transaction. This report 161R–EEA). The Administration may must include the following informa- authorize any controlled substance tion: The date on which the controlled listed in Schedule I or II, or any nar- substance left the registered location; cotic drug listed in Schedule III or IV, the date on which the controlled sub- to be exported from the United States stance was released by a customs offi- to a country of the European Economic cer at the port of export; the actual Area for subsequent export from that quantity of controlled substance re- country to another country of the Eu- leased by a customs officer at the port ropean Economic Area, if the following of export; and the actual port of ex- conditions and the conditions of para- port. Upon receipt and review, the Ad- graphs (f)(1) through (4) and (6) of this ministration will assign a completed section are met, in accordance with report a transaction identification section 1003(f) of the Act (21 U.S.C. number. The report will not be deemed 953(f)): filed until the Administration has (1)(i) The controlled substance will issued a transaction identification not be exported from the second coun- number. In determining whether the try, except that the controlled sub- exporter has complied with the require- stance may be exported from a second ment to file within 30 calendar days, country that is a member of the Euro- the report shall be deemed filed on the pean Economic Area to another coun- first date on which a complete report is try that is a member of the European filed. Economic Area, provided that the first

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country is also a member of the Euro- etc.) and business of the exporter. Upon pean Economic Area; and receipt and review, the Administration (ii) Subsequent to any reexportation will assign each completed report a described in paragraph (g)(1)(i) of this transaction identification number. The section, a controlled substance may report will not be deemed filed until continue to be exported from any coun- the Administration has issued a trans- try that is a member of the European action identification number. Economic Area to any other such coun- (h) Where a person is seeking to ex- try, if— port a controlled substance for reex- (A) The conditions applicable with port outside of the European Economic respect to the first country under para- Area in accordance with paragraph (f) graphs (f)(1) through (4) and (6) of this of this section, the requirements of section and paragraph (g)(2) are met paragraphs (h)(1) through (7) of this with respect to each subsequent coun- section shall apply in addition to (and try from which the controlled sub- not in lieu of) the requirements of stance is exported pursuant to this paragraphs (a) through (d) of this sec- paragraph (g); and tion. Where a person is seeking to ex- (B) The conditions applicable with port a controlled substance for reex- respect to the second country under port among members of the European paragraphs (f)(1) through (4) and (6) of Economic Area in accordance with this section and paragraph (g)(2) of this paragraph (g) of this section, the re- section are met with respect to each quirements of paragraph (h)(4) of this subsequent country to which the con- section shall apply in addition to (and trolled substance is exported pursuant not in lieu of) the requirements of to this paragraph (g). paragraphs (a) through (d) of this sec- (2) Return information for reexports tion. among members of the European Eco- (1) Bulk substances will not be reex- nomic Area—(i) Return information for ported in the same form as exported export from the United States, for reexport from the United States, i.e., the mate- among members of the European Eco- rial must undergo further manufac- nomic Area. Exporters must comply turing process. This further manufac- with the return reporting requirements tured material may only be reexported of paragraph (f)(7)(i) of this section. to a second country. (ii) Reexports among members of the (2) Finished dosage units, if reex- European Economic Area. Within 30 cal- ported, must be in a commercial pack- endar days after the controlled sub- age, properly sealed and labeled for le- stance is exported from the first coun- gitimate medical use in the second try to the second country, and within country. 30 calendar days of each subsequent re- (3) Any proposed reexportation must export within the European Economic be made known to the Administration Area, if any, the U.S. exporter must at the time the initial DEA Form 161R file a report with the Administration is submitted. In addition, the following through the DEA Diversion Control Di- information must also be provided vision secure network application where indicated on the form: specifying the particulars of the ex- (i) Whether the drug or preparation port. These reports must include the will be reexported in bulk or finished name of country to which the con- dosage units; trolled substance was reexported, i.e., (ii) The product name, dosage another member of the European Eco- strength, commercial package size, and nomic Area; the actual quantity of quantity; and controlled substance shipped; the date (iii) The name of consignee, complete shipped from the first country, the address, and expected shipment date, name/business name, address/business as well as the name and address of the address, contact information (e.g., tele- ultimate consignee in the second coun- phone number(s), email address(es), try. etc.) and business of the consignee; and (4) The application must contain an the name/business name, address/busi- affidavit that the consignee in the sec- ness address, contact information (e.g., ond country, and any country of subse- telephone number(s), email address(es), quent reexport within the European

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Economic Area, is authorized under the States upon authorization of the Ad- laws and regulations of the second and/ ministration. In these circumstances, or subsequent country to receive the the exporter in the United States must controlled substances. The affidavit submit a written request for the return must also contain the following state- of the controlled substances to the ments, in addition to the statements United States with a brief summary of required under paragraph (c) of this the facts that warrant the return, section: along with a completed DEA Form 357 (i) That the packages are labeled in through the DEA Diversion Control Di- conformance with the obligations of vision secure network application. The the United States under the Single Administration will evaluate the re- Convention on Narcotic Drugs, 1961, quest after considering all the facts as the Convention on Psychotropic Sub- well as the exporter’s registration sta- stances, 1971, and any amendments to tus with the Administration. If the ex- such treaties in effect; porter provides sufficient justification, (ii) That the controlled substances the Administration may issue an im- are to be applied exclusively to medical port permit for the return of these or scientific uses within the second drugs, and the exporter may then ob- country, or country of subsequent reex- tain an export permit from the country port within the European Economic of original importation. The substance Area; may not be returned to the United (iii) That the controlled substances States until after a permit has been will not be further reexported from the issued by the Administration. second country except as provided by (i) In considering whether to grant an paragraph (f) of section 1003 of the Act application for a permit under para- (21 U.S.C. 953(f)); and (iv) That there is an actual need for graphs (f), (g), and (h) of this section, the controlled substances for medical the Administration shall consider or scientific uses within the second whether the applicant has previously country, or country of subsequent reex- obtained such a permit and, if so, port within the European Economic whether the applicant complied fully Area. with the requirements of this section (5) If the applicant proposes that the with respect to that previous permit. shipment of controlled substances will (j) Denied release at the port of export. be separated into parts after it arrives In the event that a shipment of con- in the first country and then reex- trolled substances has been denied reported to more than one second coun- lease by a customs officer at the port try, the applicant must so indicate on export from the United States for any the DEA Form 161R and provide all the reason, the exporter who attempted to information required in this section for have the shipment released must, with- each second country. in 5 business days of the denial, report (6) Except in the case of reexports to the Administration that the ship- among countries of the European Eco- ment was denied release and the reason nomic Area in accordance with section for denial. Such report must be trans- 1003(f) of the Act (21 U.S.C. 953(f)), the mitted to the Administration through controlled substance will be reexported the DEA Diversion Control Division se- from the first country to the second cure network application. This report country (or second countries) no later must include the following informa- than 180 calendar days after the con- tion: The quantity of the controlled trolled substance was released by a substance denied release; the date on customs officer from the United States. which release was denied; the basis for (7) Shipments that have been ex- the denied release, the port from which ported from the United States and are the denial was issued, and any other in- refused by the consignee in either the formation as the Administration may first or second country, or subsequent from time to time specify. Upon the ex- member of the European Economic porter’s report of a denied release, DEA Area, or are otherwise unacceptable or will assign the report a transaction undeliverable, may be returned to the identification number and the export registered exporter in the United permit will be void and of no effect. No

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shipment of controlled substances de- fier. A permit shall not be altered or nied release for any reason will be al- changed by any person after being lowed to be released from the United signed. Any change or alteration upon States unless the exporter submits a the face of any permit after it has been new DEA Form 161, 161R, or 161R–EEA, signed renders it void and of no effect. as appropriate, and the Administration Permits are not transferable. The Ad- issues a new export permit. ministrator or his/her delegate shall [81 FR 97029, Dec. 30, 2016] date and certify on each permit that the exporter named therein is thereby § 1312.23 Issuance of export permit. permitted as a registrant under the (a) The Administrator may authorize Act, to export, through the port of ex- exportation of any controlled sub- port named, one shipment of not to ex- stance listed in Schedule I or II or any ceed the specified quantity of the narcotic controlled substance listed in named controlled substances, shipment Schedule III or IV if he finds that such to be made before a specified date. exportation is permitted by sub- Only one shipment may be made on a sections 1003(a), (b), (c), (d), or (f) of the single export permit. A single export Act (21 U.S.C. 953(a), (b), (c), (d), or (f). permit shall authorize a quantity of (b) The Administrator may require goods to be exported at one place, at that such non-narcotic controlled sub- one time, for delivery to one consignee, stances in Schedule III as shall be des- on a single conveyance, at one place, ignated by regulation in § 1312.30 of this on one bill of lading, air waybill, or part be exported only pursuant to the commercial loading document; a single issuance of an export permit. The Ad- permit shall not authorize a quantity ministrator may authorize the exportation of such substances if he finds of goods to be exported if the goods are that such exportation is permitted by divided onto two or more conveyances. section 1003(e) of the Act (21 U.S.C. Each export permit shall be predicated 953(e)). upon, inter alia, an import certificate (c) If a non-narcotic substance listed or other documentary evidence issued in Schedule IV or V is also listed in by a foreign competent national au- Schedule I or II of the Convention on thority. Psychotropic Substances, it shall be (f) No export permit shall be issued exported only pursuant to the issuance for the exportation, or reexportation, of an export permit. The Administrator of any controlled substance to any may authorize the exportation of such country when the Administration has substances if he finds that such expor- information to show that the estimates tation is permitted by section 1003(e) of or assessments submitted with respect the Act (21 U.S.C. 953(e)). to that country for the current period, (d) The Administrator may require under the Single Convention on Nar- an applicant to submit such documents cotic Drugs, 1961, or the Convention on or written statements of fact relevant Psychotropic Substances, 1971, have to the application as he deems nec- been, or, considering the quantity pro- essary to determine whether the appli- posed to be imported, will be exceeded. cation should be granted. The failure of If it shall appear through subsequent the applicant to provide such docu- advice received from the International ments or statements within a reasonable time after being requested to do so Narcotics Control Board of the United shall be deemed to be a waiver by the Nations that the estimates or assess- applicant of an opportunity to present ments of the country of destination such documents or facts for consider- have been adjusted to permit further ation by the Administrator in granting importation of the controlled sub- or denying the application. stance, an export permit may then be (e) If an exportation is approved, the issued if otherwise permissible. Administrator shall issue an export [36 FR 23625, Dec. 11, 1971, as amended at 37 permit bearing his or her signature or FR 15923, Aug. 8, 1972. Redesignated at 38 FR that of his or her delegate. Each permit 26609, Sept. 24, 1973, and amended at 52 FR will be assigned a permit number that 17290, May 7, 1987; 72 FR 72929, Dec. 26, 2007; is a unique, randomly generated identi- 81 FR 97032, Dec. 30, 2016]

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§ 1312.24 Distribution of export pervision secure network application will mit. not automatically trigger the amend- The Administration shall transmit ment process. While the request for an the export permit to the competent na- amendment is being reviewed by the tional authority of the importing coun- Administration, the original permit try and shall make available to the ex- will be temporarily stayed and may not porter an official record of the export be used to authorize release of a ship- permit through secure electronic ment of controlled substances. If the means. The exporter, or their agent, exporter’s request for an amendment to must submit an official record of the an issued permit is granted by the Ad- export permit and/or required data con- ministration, the Administration will cerning the export transaction to a immediately cancel the original permit customs officer at the port of export in and re-issue the permit, as amended, compliance with all export control re- with a revised permit number. The quirements of agencies with export DEA and exporter will distribute the control authorities under the Act or amended permit in accordance with statutory authority other than the § 1312.24. If a request for an amendment Controlled Substances Import and Ex- is denied by the Administration, the port Act. The exporter must maintain temporary stay will be lifted; once lift- an official record of the export permit ed, the originally issued permit may (available from the secure network ap- immediately be used to authorize re- plication on the DEA Diversion Control lease of a shipment in accordance with Division Web site after the Administra- the terms of the permit. tion issues a transaction identification (1) An exporter may request that an number) in accordance with part 1304 of export permit or application for a per- this chapter as the record of authority mit be amended to change the National for the exportation and shall transmit Drug Control number, description of an official record of the export permit the packaging, or trade name of the to the foreign importer. The exporter product, so long as the description is must ensure that an official record of for the same basic class of controlled the permit accompanies the shipment substance as in the original permit. to its final destination. No shipment of (2) An exporter may request that an controlled substances denied release export permit or application for a per- for any reason shall be allowed to be mit be amended to change the proposed released from the United States with- port of export, the anticipated date of out subsequent authorization from the release by a customs officer, or the Administration. method of transport. (3) An exporter may request that an [81 FR 97032, Dec. 30, 2016] export permit or application for a permit be amended to change the jus- § 1312.25 Amendment, cancellation, ex- tification provided as to why an export piration of export permit. shipment is needed to meet the legiti- (a) Exporters may only request that mate scientific or medical needs of the an export permit or application for an country of import. export permit be amended in accord- (4) An exporter may request that an ance with paragraphs (a)(1) through (7) export permit or application for a per- of this section. Requests for an amend- mit be amended to change any reg- ment must be submitted through the istrant notes. DEA Diversion Control Division secure (5) Prior to departure of the shipment network application. Except as pro- from the exporter’s registered location, vided in paragraph (a)(5) of this section an exporter may request that an export exporters must submit all requests for permit or application for a permit be an amendment at least one full busi- amended to increase the total base ness day in advance of the date of re- weight of a controlled substance. How- lease from the port of export. Export- ever, the total base weight or the ers must specifically request that an strength of the product (if listed) of a amendment be made; supplementary controlled substance may not exceed information submitted by an exporter that permitted for import as indicated through the DEA Diversion Control Di- on the import permit from the foreign

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competent national authority. Export- tion, provided that no shipment has ers are not required to amend an ex- been made thereunder. Nothing in this port permit for the sole purpose of depart will affect the right, hereby re- creasing the total base weight of a con- served by the Administration, to can- trolled substance authorized to be ex- cel an export permit at any time for ported. However, the balance of any proper cause. unexported authorized quantity of con- [81 FR 97032, Dec. 30, 2016] trolled substances on an export permit is void upon release of a shipment on § 1312.26 Records required of exporter. the issued permit or upon expiration of In addition to any other records re- the unused permit in accordance with quired by this chapter, the exporter paragraph (b) of this section, whichever must keep a record of any serial num- is sooner. Exporters must submit a re- bers that might appear on packages of quest for an amendment to increase narcotic drugs in quantities of one the total base weight of a controlled ounce or more in such a manner as will substance at least three business days identify the foreign consignee, along in advance of the date of release from with an official record of the export the port of export. permit, in accordance with part 1304 of (6) An exporter may request that an this chapter. export permit be amended to remove a controlled substance from the permit. [81 FR 97033, Dec. 30, 2016] However, an exporter may not amend an export permit to add or replace a § 1312.27 Export/reexport declaration. controlled substance to the item(s) to (a) Any person registered or author- be exported. Exporters who desire to ized to export and seeking to export export a different controlled substance any non-narcotic controlled substance than that contained on their issued ex- listed in Schedule III, IV, or V, which port permit or permit application must is not subject to the requirement of an submit a request for the permit or per- export permit pursuant to § 1312.23(b) or mit application to be canceled and re- (c), or any person registered or author- quest a new permit in accordance with ized to export and seeking to export § 1312.22. any controlled substance in Schedule (7) An exporter may not amend the V, must file a controlled substances ex- exporter’s name (as it appears on their port declaration (DEA Form 236) with DEA certificate of registration), the the Administration through the DEA name of the foreign importer(s), or the Diversion Control Division secure net- foreign permit information as provided work application not less than 15 cal- in the DEA Form 161, 161R, or 161R– endar days prior to the anticipated EEA. Exporters who need to make any date of release by a customs officer at changes to any of these fields must the port of export, and distribute an of- submit a request for the permit or per- ficial record of the declaration as here- mit application to be canceled and re- inafter directed in § 1312.28. The dec- quest a new permit in accordance with laration must be signed and dated by § 1312.22. the exporter and must contain the ad- (b) An export permit will be void and dress of the registered location from of no effect after the date specified which the substances will be shipped therein, which date must conform to for exportation. Upon receipt and re- the expiration date specified in the view, the Administration will issue a supporting import certificate or other completed declaration a transaction documentary evidence upon which the identification number. The export dec- export permit is founded, but in no laration is not deemed filed, and there- event will the date be more than 180 fore not valid, until the Administra- calendar days after the date the permit tion has issued a transaction identi- is issued. fication number. The exporter may (c) An export permit may be canceled only proceed with the export trans- after being issued, at the request of the action once the transaction identifica- exporter submitted to the Administra- tion number has been issued. tion through the DEA Diversion Con- (b)(1) DEA Form 236 must include the trol Division secure network applica- following information:

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(i) The name/business name, address/ (A) Bulk substances will not be reex- business address, contact information ported in the same form as exported (e.g., telephone number(s), email ad- from the United States, i.e., the mate- dress(es), etc.), and registration num- rial must undergo further manufac- ber, if any, of the exporter; and the turing process. This further manufac- name/business name, address/business tured material may only be reexported address, contact information (e.g., tele- to a country of ultimate consumption. phone number(s), email address(es), (B) Finished dosage units, if reex- etc.), and registration number of the ported, will be in a commercial pack- export broker, if any. age, properly sealed and labeled for le- (ii) A detailed description of each gitimate medical use in the country of controlled substance to be exported in- destination. cluding the drug name, dosage form, (C) Any reexportation be made National Drug Code (NDC) number, Ad- known to DEA at the time the initial ministration Controlled Substance DEA Form 236, Controlled Substances Code Number as set forth in part 1308 Import/Export Declaration is com- of this chapter, the number and size of pleted, by checking the box marked the packages or containers, the name ‘‘other’’ on the certification. The fol- and quantity of the controlled sub- lowing information will be furnished in stance contained in any finished dosage the remarks section: units, and the quantity of any con- (1) Indicate ‘‘for reexport’’. trolled substance (expressed in anhy- (2) Indicate if reexport is bulk or fin- drous acid, base, or alkaloid) given in ished dosage units. kilograms or parts thereof. (3) Indicate product name, dosage (iii) The anticipated date of release strength, commercial package size, and by a customs officer at the port of ex- quantity. port, the port of export, the foreign (4) Indicate name of consignee, com- port and country of entry, the carriers plete address, and expected shipment and shippers involved, method of ship- date, as well as, the name and address ment, the name of the vessel if applica- of the ultimate consignee in the coun- ble, and the name, address, and reg- try to where the substances will be re- istration number, if any, of any for- exported. warding agent utilized. (5) A statement that the consignee in (iv) The name/business name, ad- the country of ultimate destination is dress/business address, and contact in- authorized under the laws and regula- formation (e.g., telephone number(s), tions of the country of ultimate des- email address(es), etc.) of the consignee tination to receive the controlled sub- in the country of destination, and any stances. registration or license number if the (D) Shipments that have been ex- consignee is required to have such ported from the United States and are numbers either by the country of des- refused by the consignee in either the tination or under United States law. In first or second country, or subsequent addition, documentation must be pro- member of the European Economic vided to show that: Area, or are otherwise unacceptable or (A) The consignee is authorized under undeliverable, may be returned to the the laws and regulations of the country registered exporter in the United of destination to receive the controlled States upon authorization of the Ad- substances; and ministration. In this circumstance, the (B) The substance is being imported exporter in the United States must file for consumption within the importing a written request for reexport, along country to satisfy medical, scientific with a completed DEA Form 236, with or other legitimate purposes. the Administration through the DEA (v) The reexport of non-narcotic con- Diversion Control Division secure net- trolled substances in Schedules III and work application. A brief summary of IV, and controlled substances in Sched- the facts that warrant the return of the ule V is not permitted under the au- substance to the United States along thority of 21 U.S.C. 953(e), except as with an authorization from the coun- provided below and in paragraph try of export must be included with the (b)(1)(vi) of this section: request. DEA will evaluate the request

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after considering all the facts as well (5) A statement that the consignee in as the exporter’s registration status the second country, and any subse- with DEA. The substance may be re- quent consignee within the European turned to the United States only after Economic Area, is authorized under the affirmative authorization is issued in laws and regulations of the second and/ writing by DEA. or subsequent country to receive the (vi) The reexport of non-narcotic con- controlled substances. trolled substances in Schedules III and (2) With respect to reexports among IV, and controlled substances in Sched- members of the European Economic ule V is permitted among members of Area, the requirements of paragraph the European Economic Area only as (b)(1) of this section shall apply only provided below: with respect to the export from the (A) The controlled substance will not United States to the first country and be exported from the second country or not to any subsequent export from that a subsequent country, except that the country to another country of the Eu- controlled substance may be exported ropean Economic Area. from a second country or a subsequent (c) Notwithstanding the time limita- country that is a member of the Euro- tions included in paragraph (a) of this pean Economic Area to another coun- section, a registrant may obtain a spe- try that is a member of the European cial waiver of these time limitations in Economic Area, provided that the first emergency or unusual instances; pro- country is also a member of the Euro- vided that a specific confirmation is re- pean Economic Area; each country is a ceived from the Administrator or his party to the Convention on Psycho- delegate advising the registrant to pro- tropic Substances, 1971, as amended; ceed pursuant to the special waiver. and each country has instituted and (d) Return information—(1) Return in- maintains, in conformity with such formation for exports. Within 30 calendar Convention, a system of controls of im- days after the controlled substance is ports of controlled substances which released by a customs officer at the the Attorney General deems adequate. port of export, or within 10 calendar (B) Each shipment of finished dosage days after receipt of a written request units, if reexported, must be in a com- by the Administration to the exporter, mercial package, properly sealed and whichever is sooner, the exporter must labeled for legitimate medical use in file a report with the Administration the country of destination. through the DEA Diversion Control Di- (C) Any reexportation must be made vision secure network application known to DEA at the time the initial specifying the particulars of the trans- DEA Form 236, Controlled Substances action. This report must include the Import/Export Declaration is com- following information: The date on pleted, by checking the box marked which the controlled substance left the ‘‘other’’ on the certification. In addi- registered location; the date on which tion to the requirements of paragraph the controlled substance was released (b) of this section, the following infor- by a customs officer; the actual quan- mation will be furnished in the re- tity of the controlled substance that marks section: left the registered location; and the ac- (1) Indicate ‘‘for reexport among tual quantity of the controlled sub- members of the European Economic stance released by a customs officer at Area’’. the port of export; the actual port of (2) Indicate if reexport is bulk or fin- export. Upon receipt and review, the ished dosage units. Administration will assign a completed (3) Indicate product name, dosage report a transaction identification strength, commercial package size, and number. The report will not be deemed quantity. filed until the Administration has (4) Indicate the name/business name, issued a transaction identification address/business address, contact infor- number. mation (e.g., telephone number(s), (2) Return information for reexports email address(es) and business of the outside of the European Economic Area— consignee in the first country). (i) Return information for export from the

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United States, for reexport. Within 30 cal- (3) Reexports among members of the Eu- endar days after the controlled sub- ropean Economic Area—(i) Return infor- stance is released by a customs officer mation for exports from the United States, at the port of export the exporter must for reexport among members of the Euro- file a report with the Administration pean Economic Area. Exporters must through the DEA Diversion Control Di- comply with the return reporting revision secure network application quirements of paragraph (d)(2)(i) of this specifying the particulars of the trans- section. action. This report must include the (ii) Reexports among members of the following information: The date on European Economic Area. Within 30 cal- which the controlled substance left the endar days after the controlled sub- registered location; the date on which stance is exported from the first coun- the controlled substance was released try to the second country, and within by a customs officer at the port of ex- 30 calendar days of each subsequent report; the actual quantity of controlled export within the European Economic substance released by a customs officer at the port of export; and the actual Area, if any, the exporter must file a port of export. Upon receipt and re- report with the Administration view, the Administration will assign a through the DEA Diversion Control Di- completed report a transaction identi- vision secure network application fication number. The report will not be specifying the particulars of the ex- deemed filed until the Administration port. These reports must include the has issued a transaction identification name of country to which the con- number. trolled substance was reexported to an- (ii) Return information for export from other member of the European Eco- a first country that is or is not a member nomic Area; the actual quantity of of the European Economic Area to a controlled substance shipped; the date country outside of the European Eco- shipped from the first country, the nomic Area; return information for export name/business name, address/business from a first country that is not a member address, contact information (e.g., tele- of the European Economic Area to a mem- phone number(s), email address(es), ber of the European Economic Area. etc.) and business of the consignee; and Within 30 calendar days after the con- the name/business name, address/busi- trolled substance is exported from the ness address, contact information (e.g., first country to the second country the telephone number(s), email address(es), exporter must file a report with the etc.) and business of the exporter. Upon Administration through the DEA Di- receipt and review, the Administration version Control Division secure net- will assign each completed report a work application specifying the par- transaction identification number. The ticulars of the export from the first report will not be deemed filed until country. If the permit issued by the the Administration has issued a trans- Administration authorized the reex- action identification number. port of a controlled substance from the (e) An exporter may amend an export first country to more than one second declaration in the same circumstances country, a report for each individual reexport is required. These reports in which an exporter may request must include the following informa- amendment to an export permit, as set tion: Name of second country; actual forth in § 1312.25(a)(1) through (7). quantity of controlled substance Amendments to declarations must be shipped; the date shipped from the first submitted through the DEA Diversion country; and the actual port from Control Division secure network appli- which the controlled substances were cation. Except as provided in shipped from the first country. Upon § 1312.25(a)(5) exporters must submit all receipt and review, the Administration amendments at least one full business will assign each completed report a day in advance of the date of release by transaction identification number. The a customs officer. Exporters must spe- report will not be deemed filed until cifically note that an amendment is the Administration has issued a trans- being made; supplementary informa- action identification number. tion submitted by an exporter through

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the DEA Diversion Control Division se- issues a new transaction identification cure network application will not auto- number. matically be considered an amend- [36 FR 7815, Apr. 24, 1971, as amended at 37 ment. Upon receipt and review, the Ad- FR 15923, Aug. 8, 1972. Redesignated at 38 FR ministration will assign each com- 26609, Sept. 24, 1973, and amended at 45 FR pleted amendment a transaction iden- 74715, Nov. 12, 1980; 51 FR 5319, Feb. 13, 1986; tification number. The amendment will 52 FR 17290, May 7, 1987; 62 FR 13969, Mar. 24, not be deemed filed until the Adminis- 1997; 75 FR 10683, Mar. 9, 2010; 81 FR 97033, tration issues a transaction identifica- Dec. 30, 2016] tion number. The DEA and the exporter will distribute the amended dec- § 1312.28 Distribution of export declaration. laration in accordance with § 1312.28. A filed amendment will not change the (a) The exporter must ensure that an date that the declaration becomes void official record of the export declaration and of no effect in accordance with (available from the DEA Diversion paragraph (f) of this section. Control Division secure network appli- (f) An export declaration may be can- cation after the Administration issues celed after being filed with the Admin- a transaction identification number) istration, at the request of the ex- accompanies the shipment of con- porter, provided no shipment has been trolled substances to its destination. made thereunder. Export declarations (b) The exporter, or their agent, must shall become void and of no effect 180 submit an official record of the export calendar days after the date the dec- declaration and/or required data con- laration is deemed filed with the Ad- cerning the export transaction to a ministration. customs officer at the port of export in (g) Denied release at the port of export. compliance with all export control re- In the event that a shipment of con- quirements of agencies with export trolled substances has been denied re- control authorities under the Act or lease by a customs officer at the port statutory authority other than the of export for any reason, the exporter Controlled Substances Import and Ex- who attempted to have the shipment port Act. released must, within 5 business days (c) The exporter must maintain an of the denial, report to the Administra- official record of the export declaration tion that the shipment was denied re- and return information (both available lease and the reason for denial. Such from the Diversion Control Division se- report must be transmitted to the Ad- cure network application after the Ad- ministration through the DEA Diver- ministration issues a transaction iden- sion Control Division secure network tification number) required pursuant application. This report must include to § 1312.27(d) as his or her record of au- the following information: The quan- thority for the exportation, in accord- tity of the controlled substance denied ance with part 1304 of this chapter. release; the date on which release was [81 FR 97035, Dec. 30, 2016] denied; and the basis for the denied release. Upon the exporter’s report of a § 1312.29 Domestic release prohibited. denied release, DEA will assign the re- An exporter or a forwarding agent port a transaction identification num- acting for an exporter must either de- ber and the export declaration will be liver the controlled substances to the void and of no effect. No shipment of port or border, or deliver the controlled controlled substances denied release substances to a bonded carrier ap- for any reason will be allowed to be re- proved by the consignor for delivery to leased unless the exporter files a new the port or border, and may not, under declaration and the Administration any other circumstances, release a shipment of controlled substances to anyone, including the foreign consignee or his agent, within the United States.

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§ 1312.30 Schedule III, IV, and V non- each shipment of controlled substance narcotic controlled substances re- to be imported, transferred, or trans- quiring an import and export per- shipped. Each application must contain mit. the following: The following Schedule III, IV, and V (1) The date of execution; non-narcotic controlled substances (2) The identification and description have been specifically designated by of the controlled substance; the Administrator of the Drug Enforce- (3) The net quantity thereof; ment Administration as requiring im- (4) The number and size of the con- port and export permits pursuant to trolled substance containers; sections 201(d)(1), 1002(b)(2), and (5) The name, address, and business 1003(e)(3) of the Act (21 U.S.C. 811(d)(1), of the foreign exporter; 952(b)(2), and 953(e)(3)): (6) The foreign port of exportation; (a) Dronabinol (synthetic) in sesame (7) The approximate date of expor- oil and encapsulated in a soft gelatin tation; capsule in a U.S. Food and Drug Ad- (8) The identification of the export- ministration approved product. ing carrier; (b) A drug product in finished dosage (9) The name, address and business of formulation that has been approved by the importer, transferor, or the U.S. Food and Drug Administration transshipper; that contains cannabidiol (2-[1R-3- (10) The registration number, if any, methyl-6R-(1-methylethenyl)-2-cyclo- of the importer, transferor or hexen-1-yl]-5-pentyl-1,3-benzenediol) transshipper; derived from cannabis and no more (11) The U.S. port of entry; than 0.1 percent (w/w) residual tetrahydrocannabinols. (12) The approximate date of entry; (13) The name, address and business [52 FR 17291, May 7, 1987, as amended at 64 of the consignee at the foreign port of FR 35930, July 2, 1999; 83 FR 48953, Sept. 28, entry; 2018] (14) The shipping route from the U.S. TRANSSHIPMENT AND IN-TRANSIT port of exportation to the foreign port SHIPMENT OF CONTROLLED SUBSTANCES of entry; (15) The approximate date of receipt § 1312.31 Schedule I: Application for by the consignee at the foreign port of prior written approval. entry; and (a) A controlled substance listed in (16) The signature of the importer, schedule I may be imported into the transferor or transshipper, or his agent United States for transshipment, or accompanied by the agent’s title. may be transferred or transshipped (c) An application shall be accom- within the United States for immediate panied by an export license, permit, or exportation, provided that: a certified copy of the export license, (1) The controlled substance is nec- permit, or other authorization, issued essary for scientific, medical, or other by a competent authority of the coun- legitimate purposes in the country of try of origin (or other documentary destination, and evidence deemed adequate by the Ad- (2) A transshipment permit has been ministrator). issued by the Administrator. (d) An application shall be accom- (b) An application for a trans- panied by an import license or permit shipment permit must be submitted to or a certified copy of such license or the Regulatory Section, Diversion Con- permit issued by a competent author- trol Division, Drug Enforcement Ad- ity of the country of destination (or ministration, at least 30 calendar days, other documentary evidence deemed or in the case of an emergency as soon adequate by the Administrator), indi- as is practicable, prior to the expected cating that the controlled substance: date of arrival at the first port in the (1) Is to be applied exclusively to sci- United States. See the Table of DEA entific, medical or other legitimate Mailing Addresses in § 1321.01 of this uses within the country of destination; chapter for the current mailing ad- (2) Will not be exported from such dress. A separate permit is required for country;

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(3) Is needed therein because there is § 1312.32 Schedules II, III, IV: Advance an actual shortage thereof and a de- notice. mand therefor for scientific, medical or (a) A controlled substance listed in other legitimate uses within such Schedules II, III, or IV may be im- country; and ported into the United States for trans- (4) If the import license or permit, or shipment, or may be transferred or the certified copy of such, is not writ- transshipped within the United States ten in English or bilingual with an- for immediate exportation, provided other language and English, the appli- that written notice is submitted to the cation must include a certified trans- Regulatory Section, Diversion Control lation of the permit or license. For pur- Division, Drug Enforcement Adminis- poses of this requirement, certified tration, at least 15 calendar days prior translation means that the translator to the expected date of date of arrival has signed the translation legally at- at the first port in the United States. testing the accuracy of the translation. See the Table of DEA mailing Address- (e) Verification by an American con- es in § 1321.01 of this chapter for the sular officer of the signatures on a for- current mailing addresses. eign import license or permit shall be (b) A separate advance notice is re- required, if such license or permit does quired for each shipment of controlled not bear the seal of the authority sign- substance to be imported, transferred, or transshipped. Each advance notice ing them. must contain those items required by (f) The Administrator may require an § 1312.31(b) and (c). If the export license, applicant to submit such documents or permit, or other authorization, issued written statements of fact relevant to by a competent national authority of the application as he deems necessary the country of origin, is not written in to determine whether the application English or bilingual with another lan- should be granted. The failure of the guage and English, the notice must be applicant to provide such documents or accompanied by a certified translation statements within a reasonable time of the export license, permit, or other after being requested to do so shall be authorization. For purposes of this re- deemed to be a waiver by the applicant quirement, certified translation means of an opportunity to present such docu- that the translator has signed the ments or facts for consideration by the translation legally attesting the accu- Administrator in granting or denying racy of the translation. the application. [81 FR 97036, Dec. 30, 2016] (g) The Administrator shall, within 21 days from the date of receipt of the HEARINGS application, either grant or deny the application. The applicant shall be ac- § 1312.41 Hearings generally. corded an opportunity to amend the (a) In any case where the Adminis- application, with the Administrator ei- trator shall hold a hearing regarding ther granting or denying the amended the denial of an application for an im- application within 7 days of its receipt. port, export or transshipment permit, If the Administrator does not grant or the procedures for such hearing shall deny the application within 21 days of be governed generally by the adjudica- its receipt, or in the case of an amend- tion procedures set forth in the Admin- ed application, within 7 days of its re- istrative Procedure Act (5 U.S.C. 551– ceipt, the application shall be deemed 559) and specifically by sections 1002 approved and the applicant may pro- and 1003 of the Act (21 U.S.C. 952 and ceed. 953), by §§ 1312.42–1312.47, and by the procedures for administrative hearings [36 FR 7815, Apr. 24, 1971, as amended at 37 under the Act set forth in §§ 1316.41– FR 15923, Aug. 8, 1972. Redesignated at 38 FR 1316.67 of this chapter. 26609, Sept. 24, 1973, and further amended at (b) [Reserved] 45 FR 74715, Nov. 12, 1980; 51 FR 5319, Feb. 13, 1986; 53 FR 48244, Nov. 30, 1988; 62 FR 13969, [36 FR 23625, Dec. 11, 1971, as amended at 37 Mar. 24, 1997; 75 FR 10683, Mar. 9, 2010; 81 FR FR 15923, Aug. 8, 1972. Redesignated at 38 FR 97035, Dec. 30, 2016] 26609, Sept. 24, 1973]

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§ 1312.42 Purpose of hearing. to be attached to matters of fact asserted therein. (a) If requested by a person applying (c) If any applicant entitled to a for an import, export, or transshipment hearing pursuant to § 1312.42 fails to ap- permit, the Administrator shall hold a pear at the hearing, he shall be deemed hearing for the purpose of receiving to have waived his opportunity for the factual evidence regarding the issues hearing unless he shows good cause for involved in the issuance or denial of such failure. such permit to such person. (d) If the applicant waives or is (b) Extensive argument should not be deemed to have waived this oppor- offered into evidence but rather pre- tunity for the hearing, the Adminis- sented in opening or closing state- trator may cancel the hearing, if ments of counsel or in memoranda or scheduled, and issue his final order pur- proposed findings of fact and conclu- suant to § 1312.47 without a hearing. sions of law. [37 FR 15923, Aug. 8, 1972. Redesignated at 38 [36 FR 23625, Dec. 11, 1971, as amended at 37 FR 26609, Sept. 24, 1973] FR 15923, Aug. 8, 1972. Redesignated at 38 FR 26609, Sept. 24, 1973] § 1312.45 Burden of proof. § 1312.43 Waiver or modification of At any hearing on the denial of an rules. application for an import, export, or The Administrator of the presiding transshipment permit, the Adminis- officer (with respect to matters pend- trator shall have the burden of proving ing before him) may modify or waive that the requirements for such permit any rule in this part by notice in ad- pursuant to sections 1002, 1003, and 1004 vance of the hearing, if he determines of the Act (21 U.S.C. 952, 953, and 954) that no party in the hearing will be un- are not satisfied. duly prejudiced and the ends of justice [37 FR 15924, Aug. 8, 1972. Redesignated at 38 will thereby be served. Such notice of FR 26609, Sept. 24, 1973] modification or waiver shall be made a part of the record of the hearing. § 1312.46 Time and place of hearing. (a) If any applicant for an import, ex- [36 FR 23625, Dec. 11, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973] port, or transshipment permit requests a hearing on the issuance or denial of § 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 the period permitted for filing a re- to a different place and may be contin- quest for a hearing, file with the Ad- ued from day to day or recessed to a ministrator a waiver of an opportunity later day without notice other than an- for a hearing, together with a written nouncement thereof by the presiding statement regarding his position on officer at the hearing. 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

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to the Administrator, the Adminis- HEARINGS trator shall issue his order on the 1313.51 Hearings generally. issuance or denial of the application 1313.52 Purpose of hearing. for and import, export, or trans- 1313.53 Waiver of modification of rules. shipment permit. The order shall in- 1313.54 Request for hearing. clude the findings of fact and conclu- 1313.55 Burden of proof. sions of law upon which the order is 1313.56 Time and place of hearing. based. The Administrator shall serve 1313.57 Final order. one copy of his order upon the applicant. AUTHORITY: 21 U.S.C. 802, 830, 871(b), 971. SOURCE: 54 FR 31665, Aug. 1, 1989, unless [37 FR 15924, Aug. 8, 1972. Redesignated at 38 otherwise noted. FR 26609, Sept. 24, 1973] § 1313.01 Scope. PART 1313—IMPORTATION AND EXPORTATION OF LIST I AND LIST Procedures governing the importation, exportation, transshipment and II CHEMICALS in-transit shipment of listed chemicals pursuant to section 1018 of the Act (21 Sec. 1313.01 Scope. U.S.C. 971) are governed generally by 1313.02 Definitions. that section and specifically by the 1313.03 Forms applicable to this part. sections of this part. 1313.05 Requirements for an established business relationship. [54 FR 31665, Aug. 1, 1989, as amended at 60 1313.08 Requirements for establishing a FR 32465, June 22, 1995] record as an importer. § 1313.02 Definitions. IMPORTATION OF LISTED CHEMICALS Any term used in this part shall have 1313.12 Notification prior to import. the definition set forth in section 102 of 1313.13 Requirements of import declaration. the Act (21 U.S.C. 802) or part 1300 of 1313.14 Disposition of import declaration. 1313.15 Qualification of regular importers. this chapter. 1313.16 Updated notice for change in cir- [62 FR 13969, Mar. 24, 1997] cumstances. 1313.17 Return declaration for imports. § 1313.03 Forms applicable to this part. EXPORTATION OF LISTED CHEMICALS Form Access/ 1313.21 Notification prior to export. submission 1313.22 Export declaration. DEA Form 486, Import/Export Declaration electronic. 1313.23 Disposition of export declaration. for List I and List II Chemicals. 1313.24 Waiver of 15-day advance notice for DEA Form 486A Import Declaration for electronic. chemical exporters. ephedrine, pseudoephedrine, and phen- 1313.25 Foreign import restrictions. ylpropanolamine (including drug prod- 1313.26 Updated notice for change in cir- ucts containing these chemicals). cumstances. 1313.27 Return declaration for exports. [81 FR 97036, Dec. 30, 2016] TRANSSHIPMENTS, IN-TRANSIT SHIPMENTS AND INTERNATIONAL TRANSACTIONS INVOLVING § 1313.05 Requirements for an estab- LISTED CHEMICALS lished business relationship. 1313.31 Advance notice of importation for To document that an importer or ex- transshipment or transfer. porter has an established business rela- 1313.32 Notification of international trans- tionship with a customer, the importer actions. or exporter must provide the Adminis- 1313.33 Contents of an international transaction declaration. trator with the following information 1313.34 Disposition of the international in accordance with the waiver of 15-day transaction declaration. advance notice requirements of § 1313.15 1313.35 Return declaration or amendment to or § 1313.24: Form 486 for international transactions. (a) The name and street address of 1313.41 Suspension of shipments. the chemical importer or exporter and 1313.42 Prohibition of shipments from certain foreign sources. of each regular customer;

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(b) The telephone number, contact must notify the Administration of the person, and where available, the fac- intended import by filing an import simile number for the chemical im- declaration (on DEA Form 486/486A) porter or exporter and for each regular not later than 15 calendar days before customer; the date of release by a customs officer (c) The nature of the regular cus- at the port of entry. Regulated persons tomer’s business (i.e., importer, ex- who seek to import a listed chemical porter, distributor, manufacturer, below the threshold quantities identi- etc.), and if known, the use to which fied in § 1310.04(f) are not required to the listed chemical or chemicals will file an import declaration in advance be applied; of the release by a customs officer. (d) The duration of the business rela- (b) A complete and accurate declara- tionship; tion (DEA Form 486/486A) must be filed (e) The frequency and number of with the Administration through the transactions occurring during the pre- DEA Diversion Control Division secure ceding 12-month period; network application not later than 15 (f) The amounts and the listed chem- calendar days prior to the date of re- ical or chemicals involved in regulated lease by a customs officer at the port transactions between the chemical im- of entry. The declaration must be porter or exporter and regular cus- signed and dated by the importer and tomer; must contain the address of the final (g) The method of delivery (direct destination for the shipment, which for shipment or through a broker or for- List I chemicals must be a registered warding agent); and location of the importer. Upon receipt (h) Other information that the chem- and review, the Administration will as- ical importer or exporter considers rel- sign a transaction identification num- evant for determining whether a cus- ber to each completed declaration. The tomer is a regular customer. 15 calendar days shall begin on the date [72 FR 17407, Apr. 9, 2007] that the regulated person submits a completed declaration, without regard § 1313.08 Requirements for estab- to the date that the Administration as- lishing a record as an importer. signs a transaction identification num- To establish a record as an importer, ber. Listed chemicals meeting or ex- the regulated person must provide the ceeding the threshold quantities identi- Administrator with the following infor- fied in § 1310.04(f) of this chapter or for mation in accordance with the waiver which no threshold has been estab- of the 15-day advance notice require- lished may not be imported until a ments of § 1313.15: transaction identification number has (a) The name, DEA registration num- been issued. ber (where applicable), street address, (c) The 15-calendar-day advance noti- telephone number, and, where avail- fication requirement for listed chem- able, the facsimile number of the regu- ical imports may be waived, in whole lated person and of each foreign sup- or in part, for the following: plier; and (1) Any importation that meets both (b) The frequency and number of of the following requirements: transactions occurring during the pre- (i) The regulated person has satisfied ceding 12 month period. the requirements for reporting to the [72 FR 17407, Apr. 9, 2007] Administration as a regular importer of the listed chemicals. IMPORTATION OF LISTED CHEMICALS (ii) The importer intends to transfer the listed chemicals to a person who is § 1313.12 Notification prior to import. a regular customer for the chemical, as (a) Each regulated person who seeks defined in § 1300.02 of this chapter. to import a listed chemical that meets (2) A specific listed chemical, as set or exceeds the threshold quantities forth in paragraph (f) of this section, identified in § 1310.04(f) of this chapter for which the Administrator deter- or is a listed chemical for which no mines that advance notification is not threshold has been established as iden- necessary for effective chemical diver- tified in § 1310.04(g) of this chapter, sion control.

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(d) For imports meeting the require- § 1313.13 Requirements of import dec- ments of paragraph (c)(1) of this sec- laration. tion, the declaration (DEA Form 486/ (a) Any List I or List II chemical list- 486A) must be filed with the Adminis- ed in § 1310.02 of this chapter may be tration through the DEA Diversion imported if that chemical is necessary Control Division secure network appli- for medical, commercial, scientific, or cation at least three business days be- other legitimate uses within the fore the date of release by a customs United States. Chemical importations officer at the port of entry. The dec- into the United States for immediate laration must be signed and dated by transfer/transshipment outside the the importer and must contain the ad- United States must comply with the dress of the final destination for the procedures set forth in § 1313.31 and all shipment, which must be a registered other applicable laws. location of the importer (for List I (b) The DEA Form 486/486A must in- chemicals). Upon receipt and review, clude the following information: the Administration will assign a trans- (1) The name/business name, address/ action identification number to each business address, and contact informa- completed declaration. The importer tion (e.g., telephone number(s), email may proceed with the import trans- address(es), etc.) of the chemical importer; the name/business name, ad- action only once the transaction iden- dress/business address, and contact in- tification number has been issued. formation (e.g., telephone number(s), (e) For importations where advance email address(es), etc.) of the broker or notification is waived pursuant to forwarding agent (if any); and paragraph (c)(2) of this section no DEA (2) The name and description of each Form 486 is required; however, the reg- listed chemical as it appears on the ulated person must submit quarterly label or container, the name of each reports to the Regulatory Section, Di- chemical as it is designated in § 1310.02 version Control Division, Drug En- of this chapter, the size or weight of forcement Administration, not later container, the number of containers, than the 15th day of the month fol- the net weight of each listed chemical lowing the end of each quarter. See the given in kilograms or parts thereof, Table of DEA Mailing Addresses in and the gross weight of the shipment § 1321.01 of this chapter for the current given in kilograms or parts thereof; mailing address. The report shall con- and tain the following information regard- (3) The date of release by a customs ing each individual importation: officer at the port of entry, the foreign (1) The name of the listed chemical; port and country of export, and the (2) The quantity and date imported; port of entry; and (3) The name and full business ad- (4) The name/business name, address/ dress of the supplier; business address, and contact informa- (4) The foreign port of embarkation; tion (e.g., telephone number(s), email and address(es), etc.) of the consignor in (5) The port of entry. the foreign country of exportation; and (5) The name/business name, address/ (f) The 15 day advance notification business address, and contact informa- requirement set forth in paragraph (a) tion (e.g., telephone number(s), email has been waived for imports of the fol- address(es), etc.) of the person or per- lowing listed chemicals: sons to whom the importer intends to (1) Acetone. transfer the listed chemical and the (2) 2-Butanone (or Methyl Ethyl Ke- quantity to be transferred to each tone or MEK). transferee. (3) Toluene. (c) Any regulated person importing ephedrine, pseudoephedrine, or phenyl- [54 FR 31665, Aug. 1, 1989, as amended at 59 FR 51367, Oct. 11, 1994; 60 FR 32464, June 22, propanolamine must submit, on the 1995; 66 FR 46520, Sept. 6, 2001; 67 FR 49569, import declaration (DEA Form 486A), July 31, 2002; 72 FR 17407, Apr. 9, 2007; 75 FR all information known to the importer 10683, Mar. 9, 2010; 77 FR 4237, Jan. 27, 2012; 81 on the chain of distribution of the FR 97036, Dec. 30, 2016] chemical from the manufacturer to the

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importer. Ephedrine, pseudoephedrine, (c) The Administrator, may, at any or phenylpropanolamine include each time, disqualify a regulated person’s of the salts, optical isomers, and salts status as a regular importer on the of optical isomers of the chemical. grounds that the chemical being im- (d) Import declarations shall become ported may be diverted to the clandes- void and of no effect 180 calendar days tine manufacture of a controlled sub- after the date the declaration is stance. deemed filed with the Administration. (d) Unless the Administration notifies the chemical importer to the con- [81 FR 97036, Dec. 30, 2016] trary, the qualification of a regular importer of any one of these three chemi- § 1313.14 Disposition of import dec- cals, acetone, 2-Butanone (MEK), or laration. toluene, qualifies that importer as a The importer, or their agent, must regular importer of all three of these submit an official record of the import chemicals. declaration and/or required data con- (e) All chemical importers shall be cerning the import transaction to a required to file a DEA Form 486 as re- customs officer at the port of entry in quired by Section 1313.12. compliance with all import control re- [60 FR 32464, June 22, 1995, as amended at 62 quirements of agencies with import FR 13969, Mar. 24, 1997; 72 FR 17407, Apr. 9, control authorities under the Act or 2007; 81 FR 97037, Dec. 30, 2016] statutory authority other than the Controlled Substances Import and Ex- § 1313.16 Updated notice for change in port Act. For List I chemicals, the circumstances. final destination of the import trans- (a) In the case of a notice under action must only be the registered lo- § 1313.12(a) submitted by a regulated cation of the importer (i.e., drop ship- person, if the transferee identified in ments are prohibited). A regulated per- the notice is not a regular customer, son must maintain an official record of the importer may not transfer the list- the declaration (available from the ed chemical until after the expiration DEA Diversion Control Division secure of the 15-day period beginning on the network application after the Adminis- date on which the notice is submitted tration issues a transaction identifica- to the Administration. tion number) in accordance with part (b) After a notice under § 1313.12(a) or 1310 of this chapter as the record of the (d) is submitted to the Administration, import. Official records of import dec- if circumstances change and the im- larations involving listed chemicals porter will not be transferring the list- must be retained for two years. ed chemical to the transferee identified in the notice, or will be transferring a [81 FR 97037, Dec. 30, 2016] greater quantity of the chemical than specified in the notice, the importer § 1313.15 Qualification of regular im- must update the notice to identify the porters. most recent prospective transferee or (a) Each regulated person seeking the most recent quantity or both (as designation as a ‘‘regular importer’’ the case may be) and may not transfer shall provide, by certified mail return the listed chemical until after the expi- receipt requested, to the Administra- ration of the 15 calendar day period be- tion such information as is required ginning on the date on which the up- under § 1313.08 documenting their sta- date is filed with the Administration, tus as a regular importer. or, if the import is being made by a (b) Each regulated person making ap- regular importer or intended for trans- plication under paragraph (a) of this fer to a regular customer, three busi- section shall be considered a ‘‘regular ness days. The preceding sentence ap- importer’’ 30 calendar days after re- plies with respect to changing cir- ceipt of the application by the Admin- cumstances regarding a transferee or istration, as indicated on the return re- quantity identified in an update to the ceipt, unless the regulated person is same extent and in the same manner as otherwise notified in writing by the the sentence applies with respect to Administration. changing circumstances regarding a

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transferee or quantity identified in the (1) The term transfer, with respect to original notice under § 1313.12(a) or (d). a listed chemical, includes the sale of Amended declarations must be sub- the chemical. mitted to the Administration through (2) The term transferee means a per- the DEA Diversion Control Division se- son to whom an importer transfers a cure network application. The amend- listed chemical. ment must be signed and dated by the [72 FR 17407, Apr. 9, 2007, as amended at 81 importer. Upon receipt and review, the FR 97037, Dec. 30, 2016] Administration will assign each completed amendment a transaction iden- § 1313.17 Return declaration for im- tification number. Such shipment of ports. listed chemicals may not be imported (a) Return information. Within 30 cal- into the United States until the trans- endar days after actual receipt of a action identification number has been listed chemical at the importer’s reg- issued. istered location or place of business if (c) In the case of a transfer of a listed not required to be registered, the importer must file a report with the Ad- chemical that is subject to a 15-day re- ministration through the DEA Diver- striction, the transferee involved shall, sion Control Division secure network upon the expiration of the 15-day pe- application specifying the particulars riod, be considered to qualify as a reg- of the transaction. This report must in- ular customer, unless the Administra- clude the following information: The tion otherwise notifies the importer in- date on which the listed chemical was volved in writing. released by a customs officer at the (d) With respect to a transfer of a port of entry; the date on which the listed chemical with which a notice or listed chemical arrived at the import- update referred to in § 1313.12(a) or (d) er’s registered location or place of is concerned: business; the actual quantity of the (1) The Administration— listed chemical released; the actual (i) May, in accordance with the same quantity of the listed chemical that ar- procedures as apply under §§ 1313.51 rived at the importer’s location; the through 1313.57, order the suspension of date of any subsequent transfer; a de- the transfer of the listed chemical by scription of the subsequent transfer, the importer involved, except for a including the actual quantity trans- transfer to a regular customer, on the ferred, chemical, container, and name ground that the chemical may be di- of transferees; the actual port of entry; verted to the clandestine manufacture and any other information as the Ad- of a controlled substance (without re- ministration may specify. A single regard to the form of the chemical that port may include the particulars of may be diverted, including the diver- both the importation and distribution. sion of a finished drug product to be If the importer has not distributed all chemicals imported by the end of the manufactured from bulk chemicals to initial 30 calendar day period, the im- be transferred), subject to the Adminis- porter must file supplemental reports tration ordering the suspension before not later than 30 calendar days from the expiration of the 15-day period with the date of any further distribution, respect to the importation (in any case until the distribution or other disposi- in which such a period applies); and tion of all chemicals imported under (ii) May, for purposes of this para- the import declaration or any amend- graph (d), disqualify a regular cus- ment or other update is accounted for. tomer on that ground. Upon receipt and review, the Adminis- (2) From and after the time when the tration will assign each completed re- Administration provides written notice port a transaction identification num- of the order under paragraph (d)(1)(i) of ber. In determining whether the im- this section (including a statement of porter has complied with the require- the legal and factual basis for the ment to file within 30 calendar days, order) to the importer, the importer the report shall be deemed filed on the may not carry out the transfer. first date on which a complete report is (e) For purposes of this section: filed.

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(b) If an importation for which a DEA threshold quantities identified in Form 486/486A has been filed fails to § 1310.04(f) are not required to file an take place, the importer must report to export declaration in advance of the the Administration that the importa- export. tion did not occur through the DEA Di- (b) A complete and accurate declara- version Control Division secure net- tion (DEA Form 486) must be filed with work application. the Administration through the DEA (c) Denied release at the port of entry. Diversion Control Division secure net- In the event that a shipment of listed work application not later than 15 cal- chemicals has been denied release by a endar days prior to the date of release customs officer at the port of entry for by a customs officer at the port of ex- any reason, the importer who at- port. The declaration must be signed tempted to have the shipment released, and dated by the exporter and must within 5 business days of the denial, re- contain the address from which the port to the Administration that the listed chemicals will be shipped for ex- shipment was denied release and the portation. Upon receipt and review, the reason for denial. Such report must be Administration will assign a trans- transmitted to the Administration action identification number to each through the DEA Diversion Control Di- completed declaration. The 15 calendar vision secure network application. This days shall begin on the date that the report must include the following in- regulated person files a completed dec- formation: The quantity of the listed laration without regard to the date chemical denied release; the date on that the Administration assigns a which release was denied; and the basis transaction identification number. Ex- for the denied release. Upon the importers may not request release of a porter’s report of a denied release, the listed chemical until a transaction DEA will assign the report a trans- identification number has been issued. action identification number and the (c) The 15 calendar day advance noti- import declaration will be void and of fication requirement for listed chem- no effect. No shipment of listed chemi- ical exports may be waived, in whole or cals denied release for any reason will in part, for: be allowed entry into the United States (1) Any regulated person who has sat- without a subsequent refiling of an im- isfied the requirements of § 1313.24 for port declaration. Following such re- reporting to the Administration an es- filing the importer may request release tablished business relationship, as de- of the listed chemicals immediately fined in § 1300.02 of this chapter, with a after receipt of a transaction identi- foreign customer. fication number without regard to the (2) A specific listed chemical to a 15 day advance filing requirement in specified country, as set forth in para- § 1313.12(b). graph (f) of this section, for which the [81 FR 97037, Dec. 30, 2016] Administrator determines that advance notification is not necessary for EXPORTATION OF LISTED CHEMICALS effective chemical diversion control. (d) For exports meeting the require- § 1313.21 Notification prior to export. ments of paragraph (c)(1) of this sec- (a) Each regulated person who seeks tion, the declaration (DEA Form 486) to export a listed chemical that meets must be filed with the Administration or exceeds the threshold quantities through the DEA Diversion Control Di- identified in § 1310.04(f) of this chapter, vision secure network application at or is a listed chemical for which no least three business days before the threshold has been established as iden- date of release by a customs officer. tified in § 1310.04(g) of this chapter, The declaration must be signed and must notify the Administration of the dated by the exporter and must contain intended export by filing an export dec- the address from which the listed laration (DEA Form 486) not later than chemicals will be shipped for expor- 15 calendar days before the date of re- tation. Upon receipt and review, the lease by a customs officer at the port Administration will assign a trans- of export. Regulated persons who seek action identification number to each to export a listed chemical below the completed declaration. The exporter

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may only proceed with the export § 1313.22 Export declaration. transaction once the transaction iden- (a) Any List I or List II chemical list- tification number has been issued. ed in § 1310.02 of this chapter which (e) For exportations where advance meets or exceeds the quantitative notification is waived pursuant to threshold criteria established in paragraph (c)(2) of this section no DEA § 1310.04(f) of this chapter or is a listed Form 486 is required; however, the reg- chemical for which no threshold has ulated person must submit quarterly been established as identified in reports with the Regulatory Section, § 1310.04(g) of this chapter, may be ex- Diversion Control Division, Drug En- ported if that chemical is needed for forcement Administration, not later medical, commercial, scientific, or than the 15th day of the month fol- other legitimate uses. lowing the end of each quarter. See the (b) The export declaration (DEA Table of DEA Mailing Addresses in Form 486) must include all the fol- § 1321.01 of this chapter for the current lowing information: mailing address. Such report shall con- (1) The name/business name, address/ tain the following information regard- business address, and contact informa- ing each individual exportation: tion (e.g., telephone number(s), email (1) The name of the listed chemical; address(es), etc.) of the chemical ex- (2) The quantity and date exported; porter; the name/business name, ad- (3) The name and full business address/business address, and contact in- dress of the foreign customer; formation (e.g., telephone number(s), (4) The port of embarkation; and email address(es), etc.) of the export (5) The foreign port of entry. broker, if any; (f) The 15 day advance notification (2) The name and description of each requirement set forth in paragraph (a) listed chemical as it appears on the of this section has been waived for ex- label or container, the name of each ports of the following listed chemicals listed chemical as it is designated in to the following countries: § 1310.02 of this chapter, the size or weight of container, the number of con- Name of Chemical Country tainers, the net weight of each listed chemical given in kilograms or parts [Reserved] ...... thereof, and the gross weight of the shipment given in kilograms or parts (g) No person shall export or cause to thereof; be exported any listed chemical, know- (3) The anticipated date of release by ing or having reasonable cause to be- a customs officer at the port of export, lieve the export is in violation of the the port of export, and the foreign port laws of the country to which the chem- and country of entry; and ical is exported or the chemical will be (4) The name/business name, address/ used to manufacture a controlled sub- business address, and contact informa- stance in violation of the Act or the tion (e.g., telephone number(s), email laws of the country to which the chem- address(es), etc.) of the consignee in ical is exported. The Administration the country where the chemical ship- will publish a notice of foreign import ment is destined; the name(s) and ad- restrictions for listed chemicals of dress(es) of any intermediate con- which DEA has knowledge as provided signee(s); and a copy of the foreign per- in § 1313.25. mit, license or registration issued by (h) Export declarations shall become the competent national authority of void and of no effect 180 calendar days the consignee and any intermediate after the date the declaration is consignees. deemed filed with the Administration. (c) Declared exports of listed chemicals which are refused, rejected, or oth- [54 FR 31665, Aug. 1, 1989, as amended at 59 FR 51367, Oct. 11, 1994; 60 FR 32464, June 22, erwise deemed undeliverable by the 1995; 62 FR 13969, Mar. 24, 1997; 66 FR 46520, foreign competent national authority Sept. 6, 2001; 67 FR 49569, July 31, 2002; 75 FR may be returned to the U.S. chemical 10683, Mar. 9, 2010; 77 FR 4237, Jan. 27, 2012; 81 exporter of record. The regulated per- FR 97038, Dec. 30, 2016] son must provide notification through

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the DEA Diversion Control Division se- (b) Not later than October 31, 1989, cure network application (this does not each regular customer so identified in require a DEA Form 486) outlining the notifications made under § 1313.24(a) circumstances within a reasonable shall be a regular customer for pur- time following the return. Upon receipt poses of waiving the 15-day advance no- and review, the Administration will as- tice requirement, unless the regulated sign the completed notice a trans- person is otherwise notified in writing action identification number. The no- by the Administration. tice will not be deemed filed until the (c) Each foreign customer identified Administration issues a transaction on an initial DEA Form 486 submitted identification number. Listed chemi- after the effective date of the imple- cals so returned may not be reexported mentation of part 1313 shall, after the until the exporter has filed a new DEA expiration of the 15-day period, qualify Form 486 and the Administration has as a regular customer, unless the Ad- issued a new transaction identification ministration otherwise notifies the number. This provision does not apply regulated person in writing. to shipments that have cleared foreign (d) Unless the Administration noti- customs, been delivered, and accepted fies the chemical exporter to the con- by the foreign consignee. Returns to trary, the qualification of a regular third parties in the United States will customer for any one of these three be regarded as imports. chemicals, acetone, 2-Butanone (MEK), or toluene, qualifies that customer as a [81 FR 97038, Dec. 30, 2016] regular customer for all three of these § 1313.23 Disposition of export declara- chemicals. tion. (e) The Administrator may notify any chemical exporter that a regular The exporter, or their agent, must customer has been disqualified or that submit an official record of the export a new customer for whom a notifica- declaration and/or required data con- tion has been submitted is not to be ac- cerning the export transaction to a corded the status of a regular cus- customs officer at the port of export in tomer. In the event of a disqualifica- compliance with all export control re- tion of an established regular cus- quirements of agencies with export tomer, the chemical exporter will be control authorities under the Act or notified in writing of the reasons for statutory authority other than the such action. Controlled Substances Import and Ex- port Act. An official record of the dec- [54 FR 31665, Aug. 1, 1989, as amended at 56 laration (available from the DEA Di- FR 55077, Oct. 24, 1991; 62 FR 13969, Mar. 24, version Control Division secure net- 1997; 75 FR 10684, Mar. 9, 2010; 77 FR 4237, Jan. 27, 2012] work application after the Administra- tion issues a transaction identification § 1313.25 Foreign import restrictions. number) must be maintained by the Any export from the United States in chemical exporter as the official record violation of the law of the country to of the export in accordance with part which the chemical is exported is sub- 1310 of this chapter. Export declara- ject to the penalties of Title 21 United tions involving a listed chemical must States Code 960(d). be retained for two years. [81 FR 97038, Dec. 30, 2016] § 1313.26 Updated notice for change in circumstances. § 1313.24 Waiver of 15-day advance no- (a) In the case of a notice under tice for chemical exporters. § 1313.21(a) submitted by a regulated (a) Each regulated person shall pro- person, if the transferee identified in vide to the Administration the identity the notice, i.e., the foreign importer, is 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.

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(b) After a notice under § 1313.21(a) is the exporter involved, except for a submitted to the Administration, if transfer to a regular customer, on the circumstances change and the exporter ground that the chemical may be di- will not be transferring the listed verted to the clandestine manufacture chemical to the transferee identified in of a controlled substance (without re- the notice, or will be transferring a gard to the form of the chemical that greater quantity of the chemical than may be diverted, including the diver- specified in the notice, the exporter sion of a finished drug product to be must update the notice to identify the manufactured from bulk chemicals to most recent prospective transferee or be transferred), subject to the Adminis- the most recent quantity or both (as tration ordering the suspension before the case may be). The exporter may the expiration of the 15-day period with not transfer the listed chemical until respect to the exportation (in any case after the expiration of the 15 calendar in which such a period applies); and day period beginning on the date on (ii) May, for purposes of this para- which the update is filed with the Ad- graph (d), disqualify a regular cus- ministration. Except, if the listed tomer on that ground. chemical is intended for transfer to a (2) From and after the time when the regular customer, the exporter may Administration provides written notice not transfer the listed chemical until of the order under paragraph (d)(1)(i) of after the expiration of three business this section (including a statement of days. The preceding sentence applies the legal and factual basis for the with respect to changing cir- order) to the exporter, the exporter cumstances regarding a transferee or may not carry out the transfer. quantity identified in an update to the (e) For purposes of this section: same extent and in the same manner as (1) The term transfer, with respect to the sentence applies with respect to a listed chemical, includes the sale of changing circumstances regarding a the chemical. transferee or quantity identified in the (2) The term transferee means a per- original notice under paragraph (a) of son to whom an exporter transfers a this section. Amended declarations listed chemical. must be submitted to the Administra- [72 FR 17408, Apr. 9, 2007, as amended at 81 tion through the DEA Diversion Con- FR 97039, Dec. 30, 2016] trol Division secure network application. The amendment must be signed § 1313.27 Return declaration for ex- and dated by the exporter. Upon reports. ceipt and review, the Administration (a) Return information. Within 30 cal- will assign each completed amendment endar days after a listed chemical is re- a transaction identification number. leased by a customs officer at the port The amendment will not be deemed of export, the exporter must file a refiled until the Administration issues a port with the Administration through transaction identification number. the DEA Diversion Control Division se- (c) In the case of a transfer of a listed cure network application specifying chemical that is subject to a 15-day re- the particulars of the transaction. This striction, the transferee involved shall, report must include the following in- upon the expiration of the 15-day pe- formation: The date on which the list- riod, be considered to qualify as a reg- ed chemical left the registered location ular customer, unless the Administra- or place of business; the date on which tion otherwise notifies the exporter in- the listed chemical was released by a volved in writing. customs officer at the port of export; (d) With respect to a transfer of a the actual quantity of listed chemical listed chemical with which a notice or that left the registered location or update referred to in § 1313.21(a) is con- place of business; the actual quantity cerned: of the listed chemical released by a (1) The Administration— customs officer at the port of export; (i) May, in accordance with the same chemical; container; name of trans- procedures as apply under §§ 1313.51 ferees; and any other information as through 1313.57, order the suspension of the Administration may specify. Upon the transfer of the listed chemical by receipt and review, the Administration

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will assign a completed report a trans- TRANSSHIPMENTS, IN-TRANSIT SHIP- action identification number. The re- MENTS AND INTERNATIONAL TRANS- port will not be deemed filed until the ACTIONS INVOLVING LISTED CHEMI- Administration has issued a trans- CALS action identification number. In determining whether the exporter has com- § 1313.31 Advance notice of importation for transshipment or transfer. plied with the requirement to file within 30 calendar days, the report shall be (a) A quantity of a chemical listed in deemed filed on the first date on which § 1310.02 of this chapter that meets or a complete report is filed. exceeds the threshold reporting re- (b) If an exportation for which a DEA quirements found in § 1310.04(f) of this Form 486 has been filed fails to take chapter may be imported into the place, the exporter must report to the United States for transshipment, or may be transferred or transshipped Administration that the exportation within the United States for immediate did not occur through the DEA Diver- exportation, provided that advance no- sion Control Division secure network tice is given to the Administration. application. (b) Advance notification must be pro- (c) Denied release at the port of export. vided to the Regulatory Section, Diver- In the event that a shipment of listed sion Control Division, Drug Enforce- chemicals has been denied release by a ment Administration, not later than 15 customs officer at the port of export calendar days prior to the proposed for any reason, the exporter who at- date the listed chemical will transship tempted to have the shipment released or transfer through the United States. must, within 5 business days of the de- See the Table of DEA Mailing Address- nial, report to the Administration that es in § 1321.01 of this chapter for the the shipment was denied release and current mailing address. A separate no- the reason for denial. Such report must tification is required for each shipment be transmitted to the Administration of listed chemicals to be transferred or through the DEA Diversion Control Di- transshipped. The written notification vision secure network application. This (not a DEA Form 486) must contain the report must include the following in- following information: formation: The quantity of the listed (1) The date the notice was executed; chemicals denied release; the date on (2) The complete name and descrip- which release was denied; and the basis tion of the listed chemical as it ap- for the denied release. Upon the export- pears on the label or container. er’s report of a denied release, DEA (3) The name of the listed chemical will assign the report a transaction as designated by § 1310.02 of this chap- identification number and the export ter. declaration will be void and of no ef- (4) The number of containers and the fect. No shipment of listed chemicals size or weight of the container for each denied release for any reason will be al- listed item; lowed to be released from the United (5) The net weight of each listed States without a subsequent refiling of chemical given in kilograms or parts a complete and accurate export dec- thereof; laration. Following such refiling, the (6) The gross weight of the shipment exporter may request the release of the given in kilograms or parts thereof; listed chemicals immediately after re- (7) The name/business name, address/ ceipt of a transaction identification business address, and contact informa- number without regard to the 15 day tion (e.g., telephone number(s), email address(es), etc.) and type of business advance filing required by § 1313.21(b). of the foreign exporter; [81 FR 97039, Dec. 30, 2016] (8) The foreign port and country of export; (9) The approximate date of exportation; (10) The complete identification of the exporting carrier;

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(11) The name, address, business, (b) A completed DEA Form 486 must telephone number, and, where avail- be submitted to the Administration able, the facsimile number of the im- through the DEA Diversion Control Di- porter, transferor, or transshipper; vision secure network application, not (12) The U.S. port of entry; later than 15 calendar days prior to the (13) The approximate date of entry; international transaction. The DEA (14) The name/business name, ad- Form 486 must be signed and dated by dress/business address, and contact in- the broker or trader. Upon receipt and formation (e.g., telephone number(s), review, the Administration will assign email address(es), etc.) and type of a transaction identification number to business of the consignee at the foreign each completed notification. A notifi- port or country of entry; cation is not deemed filed, and there- (15) The shipping route from the U.S. fore is not valid, until the Administra- port of export to the foreign port or tion assigns the notification a trans- country of entry at final destination; action identification number. An inter- (16) The approximate date of receipt national transaction may not take by the consignee at the foreign port of place until after a transaction identi- entry; and fication number has been assigned and (17) The signature of the importer, the expiration of the 15 calendar day transferor or transshipper, or his period beginning on the date on which agent, accompanied by the agent’s the broker or trader submits a com- title. plete notification to the Administra- (c) Unless notified to the contrary tion. prior to the expected date of delivery, (c) No person shall serve as a broker the importation for transshipment or or trader for an international trans- transfer is considered approved. action involving a listed chemical (d) No waiver of the 15-day advance knowing or having reasonable cause to notice will be given for imports of list- believe that the transaction is in viola- ed chemicals in quantities meeting or tion of the laws of the country to exceeding threshold quantities for which the chemical is exported or the transshipment or transfer outside the chemical will be used to manufacture a United States. controlled substance in violation of the [54 FR 31665, Aug. 1, 1989, as amended at 67 laws of the country to which the chem- FR 49569, July 31, 2002; 75 FR 10684, Mar. 9, ical is exported. The Administration 2010; 77 FR 4237, Jan. 27, 2012; 81 FR 97039, will publish a notice of foreign import Dec. 30, 2016] restrictions for listed chemicals of which DEA has knowledge as provided § 1313.32 Notification of international in § 1313.25. transactions. (d) After a notice under paragraph (a) (a) A broker or trader must notify of this section is submitted to the Ad- the Administration prior to an inter- ministration, if circumstances change national transaction involving a listed and the broker or trader will not be chemical which meets or exceeds the transferring the listed chemical to the threshold quantities identified in transferee identified in the notice, or § 1310.04(f) of this chapter or is a listed will be transferring a greater quantity chemical for which no threshold has of the chemical than specified in the been established as identified in notice, the broker or trader must § 1310.04(g) of this chapter, in which the amend the notice through the DEA Di- broker or trader participates. Notifica- version Control Division secure net- tion must be made not later than 15 work application to identify the most calendar days before the transaction is recent prospective transferee or the to take place. In order to facilitate an most recent quantity or both (as appli- international transaction involving cable) and may not transfer the listed listed chemicals and implement the chemical until after the expiration of purpose of the Act, regulated persons the 15 calendar day period beginning on may wish to provide advance notifica- the date on which the update is sub- tion to the Administration as far in admitted to the Administration. The pre- vance of the 15 calendar days as pos- ceding sentence applies with respect to sible. changing circumstances regarding a

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transferee or quantity identified in an port, and the foreign port and country amendment to the same extent and in of entry; and the same manner as the sentence ap- (4) The name/business name, address/ plies with respect to changing cir- business address, and contact informa- cumstances regarding a transferee or tion (e.g., telephone number(s), email quantity identified in the original no- address(es), etc.) of the consignee in tice under paragraph (a) of this section. the country where the chemical ship- (e) For purposes of this section: ment is destined; the name(s) and ad- (1) The term transfer, with respect to dress(es) of any intermediate con- a listed chemical, includes the sale of signee(s). the chemical. [60 FR 32465, June 22, 1995, as amended at 77 (2) The term transferee means a per- FR 4238, Jan. 27, 2012; 81 FR 97040, Dec. 30, son to whom an exporter transfers a 2016] listed chemical. § 1313.34 Disposition of the inter- [81 FR 97039, Dec. 30, 2016] national transaction declaration. The broker or trader must retain an § 1313.33 Contents of an international transaction declaration. official record of the declaration (DEA Form 486) (available from the DEA Di- (a) An international transaction in- version Control Division secure net- volving a chemical listed in § 1310.02 of work application after the Administra- this chapter which meets the threshold tion issues a transaction identification criteria established in § 1310.04 of this number) as the official record of the chapter may be arranged by a broker international transaction. In accord- or trader if the chemical is needed for ance with part 1310 of this chapter, dec- medical, commercial, scientific, or larations involving listed chemicals other legitimate uses. must be retained for two years. (b) Any broker or trader who desires [81 FR 97040, Dec. 30, 2016] to arrange an international transaction, defined in 21 U.S.C. 802(42), in- § 1313.35 Return declaration or volving a listed chemical which meets amendment to Form 486 for inter- the threshold criteria set forth in national transactions. § 1310.04 of this chapter must notify the (a) Within 30 calendar days after an Administration through the procedures international transaction is completed, outlined in § 1313.32(b). the broker or trader must file a report (c) The DEA Form 486 must include: with the Administration through the (1) The name/business name, address/ DEA Diversion Control Division secure business address, and contact informa- network application about the particu- tion (e.g., telephone number(s), email lars of the transaction. This report address(es), etc.) of the chemical ex- must include the following informa- porter; the name/business name, ad- tion: The date(s) on which the listed dress/business address, and contact in- chemical was released by the foreign formation (e.g., telephone number(s), customs officer(s) at the port(s); the email address(es), etc.) of the chemical actual quantity of listed chemical that importer; left the country of export; the actual (2) The name and description of each quantity of the listed chemical re- listed chemical as it appears on the leased by a customs officer at the port label or container, the name of each of entry; chemical; container; name of listed chemical as it is designated in transferees; and the transaction identi- § 1310.02 of this chapter, the size or fication and any other information as weight of container, the number of con- the Administration may specify. Upon tainers, the net weight of each listed receipt and review, the Administration chemical given in kilograms or parts will assign a completed report a trans- thereof, and the gross weight of the action identification number. The re- shipment given in kilograms or parts port will not be deemed filed until the thereof; Administration has issued a trans- (3) The anticipated date of release at action identification number. the foreign port of export, the antici- (b) If an international transaction for pated foreign port and country of ex- which a DEA Form 486 has been filed

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fails to take place, the broker or trader HEARINGS must report to the Administration that the international transaction did not § 1313.51 Hearings generally. occur utilizing the DEA Diversion Con- In any case where a regulated person trol Division secure network applica- requests a hearing regarding the sus- tion as soon as the broker or trader be- pension of a shipment of a listed chem- comes aware of the circumstances. ical, the procedures for such hearing shall be governed generally by the pro- [81 FR 97040, Dec. 30, 2016] cedures set forth in the Administrative Procedure Act (5 U.S.C. 551–559) and § 1313.41 Suspension of shipments. specifically by section 6053 of the (a) The Administrator may suspend Chemical Diversion and Trafficking any importation or exportation of a Act (Pub. L. 100–690), by 21 CFR 1313.52– chemical listed in § 1310.02 of this chap- 1313.57, and by the procedures for ad- ter based on evidence that the chem- ministrative hearings under the Con- ical proposed to be imported or ex- trolled Substances Act set forth in ported may be diverted to the clandes- §§ 1316.41–1316.67 of this chapter. tine manufacture of a controlled sub- § 1313.52 Purpose of hearing. stance. If the Administrator so sus- If requested by a person entitled to a pends, he shall provide written notice hearing, the Administrator shall cause of such suspension to the regulated a hearing to be held for the purpose of person. Such notice shall contain a receiving factual evidence regarding statement of the legal and factual basis the issues involved in the suspension of for the order. shipments within 45 days of the date of (b) Upon service of the order of sus- the request, unless the requesting pension, the regulated person to whom party requests an extension of time. the order applies under paragraph (a) of this section must, if he desires a hear- § 1313.53 Waiver of modification of ing, file a written request for a hearing rules. pursuant to §§ 1313.51–1313.57. The Administrator or the presiding officer (with respect to matters pend- § 1313.42 Prohibition of shipments ing before him) may modify or waive from certain foreign sources. any rule in this part by notice in ad- (a) If the Administrator determines vance of the hearing, if he determines that a foreign manufacturer or dis- that no party in the hearing will be un- tributor of ephedrine, pseudoephedrine, duly prejudiced and the ends of justice or phenylpropanolamine has refused to will thereby be served. Such notice of cooperate with a request by the Admin- modification or waiver shall be made a istrator for information known to the part of the record of the hearing. manufacturer or distributor on the dis- § 1313.54 Request for hearing. tribution of the chemical, including (a) Any person entitled to a hearing sales, the Administrator may issue an pursuant to § 1313.52 and desiring a order prohibiting the importation of hearing shall, within 30 days after re- the chemical in any case where the ceipt of the notice to suspend the ship- manufacturer or distributor is part of ment, file with the Administrator a the chain of distribution. written request for a hearing in the (b) Not later than 60 days prior to form prescribed in § 1316.47 of this chap- issuing the order to prohibit importa- ter. tion, the Administrator shall publish (b) If any person entitled to a hearing in the FEDERAL REGISTER a notice of or to participate in a hearing pursuant intent to issue the order. During the 60- to § 1313.41 fails to file a request for a day period, imports from the foreign hearing or a notice of appearance, or if manufacturer or distributor may not he so files and fails to appear at the be restricted under this section. hearing, he shall be deemed to have waived his opportunity for the hearing [75 FR 10172, Mar. 5, 2010] or to participate in the hearing, unless he shows good cause for such failure.

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(c) If all persons entitled to a hearing Subpart B—Sales by Regulated Sellers or to participate in a hearing waive or are deemed to waive their opportunity 1314.20 Restrictions on sales quantity. 1314.25 Requirements for retail trans- for the hearing or to participate in the actions. hearing, the Administrator may cancel 1314.30 Recordkeeping for retail trans- the hearing, if scheduled, and issue his actions. final order pursuant to § 1313.57. 1314.35 Training of sales personnel. 1314.40 Self-certification. § 1313.55 Burden of proof. 1314.42 Self-certification fee; time and At any hearing regarding the suspen- method of fee payment. sion of shipments, the Agency shall 1314.45 Privacy protections. 1314.50 Employment measures. have the burden of proving that the requirements of this part for such sus- Subpart C—Mail-Order Sales pension are satisfied. 1314.100 Sales limits for mail-order sales. § 1313.56 Time and place of hearing. 1314.101 Training of sales personnel. 1314.102 Self-certification. (a) If any regulated person requests a 1314.103 Self-certification fee; time and hearing on the suspension of ship- method of fee payment. ments, a hearing will be scheduled no 1314.105 Verification of identity for mail- later than 45 days after the request is order sales. made, unless the regulated person re- 1314.110 Reports for mail-order sales. quests an extension to this date. 1314.115 Distributions not subject to report- (b) The hearing will commence at the ing requirements. place and time designated in the notice given pursuant to paragraph (a) of this Subpart D—Order To Show Cause section but thereafter it may be moved 1314.150 Order to show cause. to a different place and may be contin- 1314.155 Suspension pending final order. ued from day to day or recessed to a AUTHORITY: 21 U.S.C. 802, 830, 842, 871(b), later day without notice other than an- 875, 877, 886a. nouncement thereof by the presiding officer at the hearing. SOURCE: 71 FR 56024, Sept. 26, 2006, unless otherwise noted. § 1313.57 Final order. As soon as practicable after the pre- Subpart A—General siding officer has certified the record § 1314.01 Scope. to the Administrator, the Adminis- trator shall issue his order regarding This part specifies the requirements the suspension of shipment. The order for retail sales of scheduled listed shall include the findings of fact and chemical products to individuals for conclusions of law upon which the personal use. order is based. The Administrator shall serve one copy of his order upon each § 1314.02 Applicability. party in the hearing. (a) This part applies to the following regulated persons who sell scheduled PART 1314—RETAIL SALE OF listed chemical products for personal SCHEDULED LISTED CHEMICAL use: (1) Regulated sellers of scheduled PRODUCTS listed chemical products sold at retail for personal use through face-to-face Subpart A—General sales at stores or mobile retail vendors. Sec. (2) Regulated persons who engage in 1314.01 Scope. a transaction with a non-regulated per- 1314.02 Applicability. son and who ship the products to the 1314.03 Definitions. non-regulated person by the U.S. Post- 1314.05 Requirements regarding packaging al Service or by private or common of nonliquid forms. carriers. 1314.10 Effect on state laws. (b) The requirements in subpart A 1314.15 Loss reporting. apply to all regulated persons subject

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to this part. The requirements in sub- lated person becomes aware of the cir- part B apply to regulated sellers as de- cumstances involved. fined in § 1300.02 of this chapter. The re- (c) Written reports of losses must be quirements in subpart C apply to regu- filed within 15 days after the regulated lated persons who ship the products to person becomes aware of the cir- the customer by the U.S. Postal Serv- cumstances of the event. ice or by private or common carriers. (d) A report submitted under this section must include a description of the § 1314.03 Definitions. circumstances of the loss (in-transit, As used in this part, the term ‘‘mail- theft from premises, etc.). order sale’’ means a retail sale of (e) A suggested format for the report scheduled listed chemical products for is provided below: personal use where a regulated person uses or attempts to use the U.S. Postal Regulated Person Service or any private or commercial Registration number (if applicable) llll carrier to deliver the product to the Name llllllllllllllllllll customer. Mail-order sale includes pur- Business address llllllllllllll chase orders submitted by phone, mail, City lllllllllllllllllllll State llllllllllllllllllll fax, Internet, or any method other Zip lllllllllllllllllllll than face-to-face transaction. Business phone lllllllllllllll Date of loss lllllllllllllllll § 1314.05 Requirements regarding Type of loss lllllllllllllllll packaging of nonliquid forms. Description of circumstances llllllll A regulated seller or mail order distributor may not sell a scheduled listed Subpart B—Sales by Regulated chemical product in nonliquid form (in- Sellers cluding gel caps) unless the product is packaged either in blister packs, with § 1314.20 Restrictions on sales quan- each blister containing no more than tity. two dosage units or, if blister packs are (a) Without regard to the number of technically infeasible, in unit dose transactions, a regulated seller (includ- packets or pouches. ing a mobile retail vendor) may not in a single calendar day sell any pur- § 1314.10 Effect on State laws. chaser more than 3.6 grams of ephed- Nothing in this part preempts State rine base, 3.6 grams of pseudoephedrine law on the same subject matter unless base, or 3.6 grams of phenylpropanola- there is a positive conflict between this mine base in scheduled listed chemical part and a State law so that the two products. cannot consistently stand together. (b) A mobile retail vendor may not in any 30-day period sell an individual § 1314.15 Loss reporting. purchaser more than 7.5 grams of (a) Each regulated person must re- ephedrine base, 7.5 grams of port to the Special Agent in Charge of pseudoephedrine base, or 7.5 grams of the DEA Divisional Office for the area phenylpropanolamine base in scheduled in which the regulated person making listed chemical products. the report is located, any unusual or excessive loss or disappearance of a § 1314.25 Requirements for retail scheduled listed chemical product transactions. under the control of the regulated per- (a) Each regulated seller must ensure son. The regulated person responsible that sales of a scheduled listed chem- for reporting a loss in-transit is the ical product at retail are made in ac- supplier. cordance with this section and § 1314.20. (b) Each report submitted under (b) The regulated seller must place paragraph (a) of this section must, the product so that customers do not whenever possible, be made orally to have direct access to the product be- the DEA Divisional Office for the area fore the sale is made (in this paragraph in which the regulated person making referred to as ‘‘behind-the-counter’’ the report is located at the earliest placement). For purposes of this para- practicable opportunity after the regu- graph, a behind-the-counter placement

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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 cabinet that is located in an area of the that either displays the name of each facility where customers do have direct product sold, the quantity sold, the access. Mobile retail vendors must name and address of the purchaser, and place the product in a locked cabinet. the date and time of the sale, or a (c) The regulated seller must deliver unique identifier which can be linked the product directly into the custody to that electronic information, or of the purchaser. (ii) A unique identifier that can be linked to that information and that is § 1314.30 Recordkeeping for retail written into the book by the seller at transactions. the time of sale. (a) Except for purchase by an indi- (2) The purchaser must sign adjacent vidual of a single sales package con- to the printed sticker or written taining not more than 60 milligrams of unique identifier related to that sale. pseudoephedrine, the regulated seller The bound paper book must display the must maintain, in accordance with cri- warning notice in paragraph (d) of this teria issued by the Administrator, a section. written or electronic list of each sched- (C) Signing a printed document that uled listed chemical product sale that includes, for the purchaser, the name identifies the products by name, the of each product sold, the quantity sold, quantity sold, the names and addresses the name and address of the purchaser, of the purchasers, and the dates and and the date and time of the sale. The times of the sales (referred to as the document must be printed by the seller ‘‘logbook’’). at the time of the sale. The document (b) The regulated seller must not sell must contain a clearly identified signa- a scheduled listed chemical product at ture line for a purchaser to sign. The retail unless the sale is made in accord- printed document must display the ance with the following: warning notice in paragraph (d) of this (1) The purchaser presents an identi- section. Each signed document must be fication card that provides a photo- inserted into a binder or other secure graph and is issued by a State or the means of document storage imme- Federal Government, or a document diately after the purchaser signs the that, with respect to identification, is document. considered acceptable for purposes of 8 (3) The regulated seller must enter in CFR 274a.2(b)(1)(v)(A) and the logbook the name of the product 274a.2(b)(1)(v)(B). and the quantity sold. Examples of (2) The purchaser signs the logbook methods of recording the quantity sold as follows: include the weight of the product per (i) For written logbooks, enters in package and number of packages of the logbook his name, address, and the each chemical, the cumulative weight date and time of the sale. of the product for each chemical, or (ii) For electronic logbooks, provides quantity of product by Universal Prod- a signature using one of the following uct Code. These examples do not ex- means: clude other methods of displaying the (A) Signing a device presented by the quantity sold. Such information may seller that captures signatures in an be captured through electronic means, electronic format. The device must dis- including through electronic data cap- play the warning notice in paragraph ture through bar code reader or similar (d) of this section. Any device used technology. Such electronic records must preserve each signature in a man- must be provided pursuant to para- ner that clearly links that signature to graph (g) of this section in a human the other electronically captured log- readable form such that the require- book information relating to the pro- ments of paragraph (a) of this section spective purchaser providing that sig- are satisfied. nature. (c) The logbook maintained by the (B) Signing a bound paper book. seller must include the prospective (1) The bound paper book must in- purchaser’s name, address, and the clude, for such purchaser, either— date and time of the sale, as follows:

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(1) If the purchaser enters the infor- be used to meet the requirements of mation, the seller must determine that this section if the record includes the the name entered in the logbook cor- information specified in this section. responds to the name provided on the identification and that the date and [76 FR 74698, Dec. 1, 2011] time entered are correct. (2) If the seller enters the informa- § 1314.35 Training of sales personnel. tion, the prospective purchaser must Each regulated seller must ensure verify that the information is correct. that its sales of a scheduled listed (3) Such information may be cap- chemical product at retail are made in tured through electronic means, in- accordance with the following: cluding through electronic data cap- (a) In the case of individuals who are ture through bar code reader or similar responsible for delivering the products technology. into the custody of purchasers or who (d) The regulated seller must include deal directly with purchasers by ob- in the written or electronic logbook or taining payments for the products, the display by the logbook, the following regulated seller has submitted to the notice: Administration a self-certification WARNING: Section 1001 of Title 18, United that all such individuals have, in ac- States Code, states that whoever, with re- cordance with criteria issued by the spect to the logbook, knowingly and will- Administration, undergone training fully falsifies, conceals, or covers up by any provided by the regulated seller to en- trick, scheme, or device a material fact, or makes any materially false, fictitious, or sure that the individuals understand fraudulent statement or representation, or the requirements that apply under this makes or uses any false writing or document part. knowing the same to contain any materially (b) The regulated seller maintains a false, fictitious, or fraudulent statement or copy of each self-certification and all entry, shall be fined not more than $250,000 if records demonstrating that individuals an individual or $500,000 if an organization, referred to in paragraph (a) of this sec- imprisoned not more than five years, or both. tion have undergone the training. (e) The regulated seller must main- § 1314.40 Self-certification. tain each entry in the written or electronic logbook for not fewer than two (a) A regulated seller must submit to years after the date on which the entry the Administration the self-certifi- is made. cation referred to in § 1314.35(a) in order (f) A record under this section must to sell any scheduled listed chemical be kept at the regulated seller’s place product. The certification is not effec- of business where the transaction oc- tive for purposes of this section unless, curred, except that records may be in addition to provisions regarding the kept at a single, central location of the training of individuals referred to in regulated seller if the regulated seller § 1314.35(a), the certification includes a has notified the Administration of the statement that the regulated seller un- intention to do so. Written notification derstands each of the requirements must be submitted by registered or cer- that apply under this part and agrees tified mail, return receipt requested, to to comply with the requirements. the Special Agent in Charge of the (b) When a regulated seller files the DEA Divisional Office for the area in initial self-certification, the Adminis- which the records are required to be tration will assign the regulated seller kept. to one of twelve groups. The expiration (g) The records required to be kept date of the self-certification for all reg- under this section must be readily re- ulated sellers in any group will be the trievable and available for inspection last day of the month designated for and copying by authorized employees that group. In assigning a regulated of the Administration under the provi- seller to a group, the Administration sions of section 510 of the Act (21 U.S.C. may select a group with an expiration 880). date that is not less than 12 months or (h) A record developed and main- more than 23 months from the date of tained to comply with a State law may the self-certification. After the initial

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certification period, the regulated sell- § 1314.50 Employment measures. er must update the self-certifications A regulated seller may take reason- annually. able measures to guard against em- (c) The regulated seller must provide ploying individuals who may present a a separate certification for each place risk with respect to the theft and di- of business at which the regulated sell- version of scheduled listed chemical er sells scheduled listed chemical prod- products, which may include, notwith- ucts at retail. standing State law, asking applicants for employment whether they have § 1314.42 Self-certification fee; time and method of fee payment. been convicted of any crime involving or related to such products or con- (a) A regulated seller must pay a fee trolled substances. for each self-certification. For each initial application to self-certify, and for Subpart C—Mail-Order Sales the renewal of each existing self-certification, a regulated seller shall pay § 1314.100 Sales limits for mail-order a fee of $21. sales. (b) The fee for self-certification shall (a) Each regulated person who makes be waived for any person holding a cur- a sale at retail of a scheduled listed rent, DEA registration in good stand- chemical product and is required under ing as a pharmacy to dispense con- § 1310.03(c) of this chapter to submit a trolled substances. report of the sales transaction to the (c) A regulated seller shall pay the Administration may not in a single fee at the time of self-certification. calendar day sell to any purchaser (d) Payment shall be made by credit more than 3.6 grams of ephedrine base, card. 3.6 grams of pseudoephedrine base, or (e) The self-certification fee is not re- 3.6 grams of phenylpropanolamine base fundable. in scheduled listed chemical products. [73 FR 79323, Dec. 29, 2008] (b) Each regulated person who makes a sale at retail of a scheduled listed § 1314.45 Privacy protections. chemical product and is required under § 1310.03(c) of this chapter to submit a To protect the privacy of individuals report of the sales transaction to the who purchase scheduled listed chem- Administration may not in any 30-day ical products, the disclosure of infor- period sell to an individual purchaser mation in logbooks under § 1314.30 is re- more than 7.5 grams of ephedrine base, stricted as follows: 7.5 grams of pseudoephedrine base, or (a) The information shall be disclosed 7.5 grams of phenylpropanolamine base as appropriate to the Administration in scheduled listed chemical products. and to State and local law enforcement agencies. § 1314.101 Training of sales personnel. (b) The information in the logbooks Each regulated person who makes a shall not be accessed, used, or shared sale at retail of a scheduled listed for any purpose other than to ensure chemical product and is required under compliance with this title or to facili- § 1310.03(c) of this chapter to submit a tate a product recall to protect public report of the sales transaction to the health and safety. Administration must ensure that its (c) A regulated seller who in good sales of a scheduled listed chemical faith releases information in a logbook product at retail are made in accord- to Federal, State, or local law enforce- ance with the following: ment authorities is immune from civil (a) In the case of individuals who are liability for the release unless the re- responsible for preparing and pack- lease constitutes gross negligence or aging scheduled listed chemical prod- intentional, wanton, or willful mis- ucts for delivery to purchasers through conduct. the Postal Service or any private or [71 FR 56024, Sept. 26, 2006, as amended at 77 commercial carrier or who deal either FR 4238, Jan. 27, 2012] directly or indirectly with purchasers

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by obtaining payments for the prod- at which the regulated person sells ucts, the regulated person has sub- scheduled listed chemical products at mitted to the Administration a self- retail. certification that all such individuals have, in accordance with criteria [76 FR 20523, Apr. 13, 2011] issued by the Administration, under- § 1314.103 Self-certification fee; time gone training provided by the regu- and method of fee payment. lated person to ensure that the individuals understand the requirements that (a) Each regulated person who makes apply under this part. a sale at retail of a scheduled listed (b) The regulated person maintains a chemical product and is required under copy of each self-certification and all § 1310.03 of this chapter to submit a re- records demonstrating that individuals port of the sales transaction to the Ad- referred to in paragraph (a) of this sec- ministration must pay a fee for each tion have undergone the training. self-certification. For each initial application to self-certify, and for the re- [76 FR 20523, Apr. 13, 2011] newal of each existing self-certifi- § 1314.102 Self-certification. cation, a regulated seller shall pay a fee of $21. (a) A regulated person who makes a sale at retail of a scheduled listed (b) The fee for self-certification shall chemical product and is required under be waived for any person holding a cur- § 1310.03 of this chapter to submit a re- rent, DEA registration in good stand- port of the sales transaction to the At- ing as a pharmacy to dispense con- torney General must submit to the Ad- trolled substances. ministration the self-certification re- (c) A regulated person shall pay the ferred to in § 1314.101(a) in order to sell fee at the time of self-certification. any scheduled listed chemical product. (d) Payment shall be made by credit The certification is not effective for card. purposes of this section unless, in addi- (e) The self-certification fee is not re- tion to provisions regarding the train- fundable. ing of individuals referred to in § 1314.101(a), the certification includes a [76 FR 20523, Apr. 13, 2011] statement that the regulated person understands each of the requirements § 1314.105 Verification of identity for mail-order sales. that apply in this part and agrees to comply with the requirements. (a) Each regulated person who makes (b) When a regulated person files the a sale at retail of a scheduled listed initial self-certification, the Adminis- chemical product and is required under tration will assign the regulated person § 1310.03(c) of this chapter to submit a to one of twelve groups. The expiration report of the sales transaction to the date of the self-certification for all reg- Administration must, prior to shipping ulated persons in any group will be the the product, receive from the purchaser last day of the month designated for a copy of an identification card that that group. In assigning a regulated provides a photograph and is issued by person to a group, the Administration a State or the Federal Government, or may select a group with an expiration a document that, with respect to iden- date that is not less than 12 months or tification, is considered acceptable for more than 23 months from the date of purposes of 8 CFR 274a.2(b)(1)(v)(A) and self-certification. After the initial cer- 274a.2(b)(1)(v)(B). Prior to shipping the tification period, the regulated person product, the regulated person must de- must update the self-certification an- termine that the name and address on nually. the identification correspond to the (c) The regulated person who makes a name and address provided by the pur- sale at retail of a scheduled listed chaser as part of the sales transaction. chemical product and is required under If the regulated person cannot verify § 1310.03 of this chapter to submit a re- the identities of both the purchaser port of the sales transaction to the At- and the recipient, the person may not torney General must provide a separate ship the scheduled listed chemical certification for each place of business product.

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(b) If the product is being shipped to (6) Date of shipment; a third party, the regulated person (7) Product name; must comply with the requirements of (8) Dosage form (e.g., tablet, liquid); paragraph (a) to verify that both the (9) Dosage strength (e.g., 30mg, 60mg, purchaser and the person to whom the per dose etc.); product is being shipped live at the ad- (10) Number of dosage units (e.g., 100 dresses provided. If the regulated per- doses per package); son cannot verify the identities of both (11) Package type (blister pack, etc.); the purchaser and the recipient, the person may not ship the scheduled list- (12) Number of packages; ed chemical product. (13) Lot number. [71 FR 56024, Sept. 26, 2006, as amended at 75 § 1314.110 Reports for mail-order sales. FR 10684, Mar. 9, 2010; 81 FR 97040, Dec. 30, (a) Each regulated person required to 2016] report under § 1310.03(c) of this chapter must either: § 1314.115 Distributions not subject to (1) Submit a written report, con- reporting requirements. taining the information set forth in (a) The following distributions to paragraph (b) of this section, on or be- nonregulated persons are not subject to fore the 15th day of each month fol- the reporting requirements in § 1314.110: lowing the month in which the dis- (1) Distributions of sample packages tributions took place. The report must when those packages contain not more be submitted under company letter- than two solid dosage units or the head, signed by the person authorized equivalent of two dosage units in liquid to sign on behalf of the regulated sell- form, not to exceed 10 milliliters of liq- er, to the Regulatory Section, Diver- uid per package, and not more than one sion Control Division, Drug Enforce- ment Administration (see the Table of package is distributed to an individual DEA Mailing Addresses in § 1321.01 of or residential address in any 30-day pe- this chapter for the current mailing ad- riod. dress); or (2) Distributions by retail distribu- (2) Upon request to and approval by tors that may not include face-to-face the Administration, submit the report transactions to the extent that such in electronic form, either via computer distributions are consistent with the disk or direct electronic data trans- activities authorized for a retail dis- mission, in such form as the Adminis- tributor as specified in the definition tration shall direct. Requests to sub- of retail distributor in § 1300.02 of this mit reports in electronic form should chapter, except that this paragraph be submitted to the Regulatory Sec- (a)(2) does not apply to sales of sched- tion, Diversion Control Division, Drug uled listed chemical products at retail. Enforcement Administration. See the (3) Distributions to a resident of a Table of DEA Mailing Addresses in long term care facility or distributions § 1321.01 of this chapter for the current to a long term care facility for dis- mailing address. pensing to or for use by a resident of (b) Each monthly report must pro- that facility. vide the following information for each (4) Distributions in accordance with a distribution: valid prescription. (1) Supplier name and registration (b) The Administrator may revoke number; any or all of the exemptions listed in (2) Purchaser’s name and address; paragraph (a) of this section for an in- (3) Name/address shipped to (if dif- dividual regulated person if the Admin- ferent from purchaser’s name/address); istrator finds that drug products dis- (4) Method used to verify the identity tributed by the regulated person are of the purchaser and, where applicable, being used in violation of the regula- person to whom product is shipped; tions in this chapter or the Controlled (5) Name of the chemical contained in the scheduled listed chemical prod- Substances Act. uct and total quantity shipped (e.g. [[71 FR 56024, Sept. 26, 2006, as amended at 77 pseudoephedrine, 3 grams); FR 4238, Jan. 27, 2012]

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Subpart D—Order to Show Cause health or safety. If the Administrator so suspends, he shall serve with the § 1314.150 Order To show cause. order to show cause under § 1314.150 an (a) If, upon information gathered by order of immediate suspension that the Administration regarding any reg- shall contain a statement of his find- ulated seller or a distributor required ings regarding the danger to public to submit reports under § 1310.03(c) of health or safety. this chapter, the Administrator deter- (b) Upon service of the order of im- mines that a regulated seller or dis- mediate suspension, the regulated sell- tributor required to submit reports er or distributor shall, as instructed by under § 1310.03(c) of this chapter has the Administrator: sold a scheduled listed chemical prod- (1) Deliver to the nearest office of the uct in violation of Section 402 of the Administration or to authorized agents Act (21 U.S.C. 842(a)(12) or (13)), the Ad- of the Administration all of the sched- ministrator will serve upon the regu- uled listed chemical products in his or lated seller or distributor an order to her possession; or show cause why the regulated seller or (2) Place all of the scheduled listed distributor should not be prohibited chemical products under seal as de- from selling scheduled listed chemical scribed in Section 304 of the Act (21 products. U.S.C. 824(f)). (b) The order to show cause shall call (c) Any suspension shall continue in upon the regulated seller or distributor effect until the conclusion of all pro- to appear before the Administrator at a ceedings upon the prohibition, includ- time and place stated in the order, ing any judicial review, unless sooner which shall not be less than 30 days withdrawn by the Administrator or dis- after the date of receipt of the order. solved by a court of competent juris- The order to show cause shall also con- diction. Any regulated seller or dis- tain a statement of the legal basis for tributor whose right to sell scheduled such hearing and for the prohibition listed chemical products is suspended and a summary of the matters of fact under this section may request a hear- and law asserted. ing on the suspension at a time earlier (c) Upon receipt of an order to show than specified in the order to show cause, the regulated seller or dis- cause under § 1314.150, which request tributor must, if he desires a hearing, shall be granted by the Administrator, file a request for a hearing as specified who shall fix a date for such hearing as in subpart D of part 1316 of this chap- early as reasonably possible. ter. If a hearing is requested, the Ad- ministrator shall hold a hearing at the PART 1315—IMPORTATION AND time and place stated in the order, as provided in part 1316 of this chapter. PRODUCTION QUOTAS FOR (d) When authorized by the Adminis- EPHEDRINE, PSEUDOEPHEDRINE, trator, any agent of the Administra- AND PHENYLPROPANOLAMINE tion may serve the order to show cause. Subpart A—General Information

§ 1314.155 Suspension pending final Sec. order. 1315.01 Scope. 1315.02 Definitions. (a) The Administrator may suspend 1315.03 Personal use exemption. the right to sell scheduled listed chem- 1315.05 Applicability. ical products simultaneously with, or at any time subsequent to, the service Subpart B—Assessment of Annual Needs upon the seller or distributor required to file reports under § 1310.03(c) of this 1315.11 Assessment of annual needs. chapter of an order to show cause why 1315.13 Adjustments of assessment of annual the regulated seller or distributor needs. should not be prohibited from selling Subpart C—Individual Manufacturing scheduled listed chemical products, in Quotas any case where he finds that there is an imminent danger to the public 1315.21 Individual manufacturing quotas.

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1315.22 Procedure for applying for individual (1) The quantity of ephedrine, manufacturing quotas. pseudoephedrine, or phenylpropanola- 1315.23 Procedure for fixing individual man- mine distributed by the registrant to ufacturing quotas. 1315.24 Inventory allowance. another person. 1315.25 Increase in individual manufac- (2) The quantity of that chemical turing quotas. used by the registrant in the produc- 1315.26 Reduction in individual manufac- tion of (or converted by the registrant turing quotas. into) another chemical or product. 1315.27 Abandonment of quota. (3) The quantity of that chemical Subpart D—Procurement and Import otherwise disposed of by the registrant. Quotas (4) The quantity of that chemical returned to the registrant by any pur- 1315.30 Procurement and import quotas. chaser. 1315.32 Obtaining a procurement quota. (5) The quantity of that chemical dis- 1315.33 Power of attorney. 1315.34 Obtaining an import quota. tributed by the registrant to a reg- 1315.36 Amending an import quota. istered manufacturer of that chemical for purposes other than use in the pro- Subpart E—Hearings duction of, or conversion into, another chemical or in the manufacture of dos- 1315.50 Hearings generally. age forms of that chemical. 1315.52 Purpose of hearing. 1315.54 Waiver or modification of rules. (c) Ephedrine, pseudoephedrine, and 1315.56 Request for hearing or appearance; phenylpropanolamine include their waiver. salts, optical isomers, and salts of opti- 1315.58 Burden of proof. cal isomers. 1315.60 Time and place of hearing. 1315.62 Final order. § 1315.03 Personal use exemption. AUTHORITY: 21 U.S.C. 802, 821, 826, 871(b), A person need not register as an im- 952. porter, file an import declaration, and SOURCE: 72 FR 37448, July 10, 2007, unless obtain an import quota if both of the otherwise noted. following conditions are met: EDITORIAL NOTE: Nomenclature changes to (a) The person purchases scheduled part appear at 82 FR 97041, Dec. 30, 2016. listed chemical products at retail and imports them for personal use, by Subpart A—General Information means of shipping through any private or commercial carrier or the Postal § 1315.01 Scope. Service. This part specifies procedures gov- (b) In any 30-day period, the person erning the establishment of an assess- imports no more than 7.5 grams of ment of annual needs, procurement and ephedrine base, 7.5 grams of manufacturing quotas pursuant to sec- pseudoephedrine base, and 7.5 grams of tion 306 of the Act (21 U.S.C. 826), and phenylpropanolamine base in scheduled import quotas pursuant to section 1002 listed chemical products. of the Act (21 U.S.C. 952) for ephedrine, pseudoephedrine, and phenylpropanola- § 1315.05 Applicability. mine. This part applies to all of the following: § 1315.02 Definitions. (a) Persons registered to manufac- (a) Except as specified in paragraphs ture (including repackaging or re- (b) and (c) of this section, any term labeling) or to import ephedrine, contained in this part shall have the pseudoephedrine, or phenylpropanola- definition set forth in section 102 of the mine as bulk chemicals. Act (21 U.S.C. 802) or part 1300 of this (b) Persons registered to manufac- chapter. ture (including repackaging or re- (b) The term net disposal means, for a labeling) or to import prescription and stated period, the sum of paragraphs over-the-counter drug products con- (b)(1) through (b)(3) of this section taining ephedrine, pseudoephedrine, or minus the sum of paragraphs (b)(4) and phenylpropanolamine that may be law- (b)(5) of this section: fully marketed and distributed in the

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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 taining ephedrine, pseudoephedrine, shall designate in the notice the time and phenylpropanolamine, necessary to during which the filings may be made. be manufactured and imported during (e) The Administrator may, but is the following calendar year to provide not required to, hold a public hearing for the estimated medical, scientific, on one or more issues raised by the research, and industrial needs of the comments and objections filed with United States, for lawful export re- him. In the event the Administrator quirements, and for the establishment decides to hold such a hearing, he shall and maintenance of reserve stocks. publish a notice of the hearing in the (b) In making his determinations, the Administrator shall consider the fol- FEDERAL REGISTER. The notice shall lowing factors: summarize the issues to be heard and (1) Total net disposal of the chemical set the time for the hearing, which by all manufacturers and importers shall not be less than 30 days after the during the current and 2 preceding date of publication of the notice. years; (f) After consideration of any com- (2) Trends in the national rate of net ments or objections, or after a hearing disposal of each chemical; if one is ordered by the Administrator, (3) Total actual (or estimated) inven- the Administrator shall issue and pub- tories of the chemical and of all sub- lish in the FEDERAL REGISTER the final stances manufactured from the chem- order determining the assessment of ical, and trends in inventory accumula- annual needs for the chemicals. The tion; order shall include the findings of fact (4) Projected demand for each chem- and conclusions of law upon which the ical as indicated by procurement and order is based. The order shall specify import quotas requested pursuant to the date on which it shall take effect. § 1315.32; and A notice of the publication shall be (5) Other factors affecting medical, mailed simultaneously to each person scientific, research, and industrial registered as a manufacturer or im- needs in the United States, lawful exporter of the chemical. port requirements, and the establishment and maintenance of reserve § 1315.13 Adjustments of the assess- stocks, as the Administrator finds rel- ment of annual needs. evant, including changes in the currently accepted medical use in treat- (a) The Administrator may at any ment with the chemicals or the sub- time increase or reduce the assessment stances which are manufactured from of annual needs for ephedrine, them, the economic and physical avail- pseudoephedrine, or phenylpropanola- ability of raw materials for use in man- mine that has been previously fixed ufacturing and for inventory purposes, pursuant to § 1315.11. yield and stability problems, potential (b) In determining to adjust the as- disruptions to production (including sessment of annual needs, the Adminis- possible labor strikes), and recent un- trator shall consider the following fac- foreseen emergencies such as floods tors: and fires. (1) Changes in the demand for that (c) The Administrator shall, on or be- chemical, changes in the national rate fore May 1 of each year, publish in the of net disposal of the chemical, and FEDERAL REGISTER, general notice of changes in the rate of net disposal of

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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 sessment of annual needs, taking into set the time for the hearing, which account production delays and the shall not be less than 10 days after the probability that other individual man- date of publication of the notice. ufacturing quotas may be suspended (f) After consideration of any com- pursuant to § 1315.24(b); ments or objections, or after a hearing (4) Whether any decreased demand if one is ordered by the Administrator, for that chemical will result in exces- the Administrator shall issue and pub- sive inventory accumulation by all per- lish in the FEDERAL REGISTER the final sons registered to handle that chemical order determining the assessment of (including manufacturers, distributors, annual needs for the chemical. The importers, and exporters), notwith- order shall include the findings of fact standing the possibility that individual and conclusions of law upon which the manufacturing quotas may be sus- order is based. The order shall specify pended pursuant to § 1315.24(b) or aban- the date on which it shall take effect. doned pursuant to § 1315.27; A notice of the publication shall be (5) Other factors affecting medical, mailed simultaneously to each person scientific, research, industrial, and im- registered as a manufacturer or importation needs in the United States, porter of the chemical. lawful export requirements, and reserve stocks, as the Administrator Subpart C—Individual finds relevant, including changes in the Manufacturing Quotas currently accepted medical use in treatment with the chemical or the § 1315.21 Individual manufacturing substances that are manufactured from quotas. it, the economic and physical avail- The Administrator shall, on or before ability of raw materials for use in man- July 1 of each year, fix for and issue to ufacturing and for inventory purposes, each person registered to manufacture yield and stability problems, potential in bulk ephedrine, pseudoephedrine, or disruptions to production (including phenylpropanolamine who applies for a possible labor strikes), and recent un- manufacturing quota an individual foreseen emergencies such as floods manufacturing quota authorizing that and fires. person to manufacture during the next (c) In the event that the Adminis- calendar year a quantity of that chem- trator determines to increase or reduce ical. Any manufacturing quota fixed the assessment of annual needs for a and issued by the Administrator is sub- chemical, the Administrator shall pub- ject to his authority to reduce or limit lish in the FEDERAL REGISTER general it at a later date pursuant to § 1315.26 notice of an adjustment in the assess- and to his authority to revoke or sus- ment of annual needs for that chemical pend it at any time pursuant to as determined under this section. A no- §§ 1301.36, 1309.43, 1309.44, or 1309.45 of tice of the publication shall be mailed this chapter. simultaneously to each person registered as a manufacturer or importer § 1315.22 Procedure for applying for of the chemical. individual manufacturing quotas. (d) The Administrator shall permit Any person who is registered to man- any interested person to file written ufacture ephedrine, pseudoephedrine,

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or phenylpropanolamine and who de- § 1315.23 Procedure for fixing indi- sires to manufacture a quantity of the vidual manufacturing quotas. chemical must apply on DEA Form 189 (a) In fixing individual manufac- for a manufacturing quota for the turing quotas for ephedrine, quantity of the chemical. Copies of pseudoephedrine, and phenylpropanola- DEA Form 189 may be obtained from mine, the Administrator shall allocate the Office of Diversion Control Web to each applicant who is currently site, and must be filed (on or before manufacturing the chemical a quota April 1 of the year preceding the cal- equal to 100 percent of the estimated endar year for which the manufac- net disposal of that applicant for the turing quota is being applied) with the next calendar year, adjusted— UN Reporting & Quota Section, Diver- sion Control Division, Drug Enforce- (1) By the amount necessary to in- ment Administration. See the Table of crease or reduce the estimated inven- DEA Mailing Addresses in § 1321.01 of tory of the applicant on December 31 of this chapter for the current mailing ad- the current year to his estimated in- dress. A separate application must be ventory allowance for the next cal- made for each chemical desired to be endar year, pursuant to § 1315.24, and manufactured. The applicant must (2) By any other factors which the state the following: Administrator deems relevant to the (a) The name and DEA Chemical fixing of the individual manufacturing Code Number, as set forth in part 1310 quota of the applicant, including: of this chapter, of the chemical. (i) The trend of (and recent changes (b) For the chemical in each of the in) the applicant’s and the national current and preceding 2 calendar years, rates of net disposal, (1) The authorized individual manu- (ii) The applicant’s production cycle facturing quota, if any; and current inventory position, (2) The actual or estimated quantity (iii) The economic and physical avail- manufactured; ability of raw materials for use in man- (3) The actual or estimated net dis- ufacturing and for inventory purposes, posal; (iv) Yield and stability problems, (4) The actual or estimated inventory (v) Potential disruptions to produc- allowance pursuant to § 1315.24; and tion (including possible labor strikes), (5) The actual or estimated inventory and as of December 31. (vi) Recent unforeseen emergencies (c) For the chemical in the next cal- such as floods and fires. endar year, (1) The desired individual manufac- (b) In fixing individual manufacturing quota; and turing quotas for a chemical, the Ad- (2) Any additional factors that the ministrator shall allocate to each ap- applicant finds relevant to the fixing of plicant who is not currently manufac- the individual manufacturing quota, turing the chemical a quota equal to including any of the following: 100 percent of the reasonably estimated (i) The trend of (and recent changes net disposal of that applicant for the in) the applicant’s and the national next calendar year, as determined by rates of net disposal. the Administrator, adjusted— (ii) The applicant’s production cycle (1) By the amount necessary to pro- and current inventory position. vide the applicant his estimated inven- (iii) The economic and physical avail- tory allowance for the next calendar ability of raw materials for use in man- year, pursuant to § 1315.24; and ufacturing and for inventory purposes. (2) By any other factors which the (iv) Yield and stability problems. Administrator deems relevant to the (v) Potential disruptions to produc- fixing of the individual manufacturing tion (including possible labor strikes). quota of the applicant, including any of (vi) Recent unforeseen emergencies the following: such as floods and fires. (i) The trend of (and recent changes [72 FR 37448, July 10, 2007, as amended at 73 in) the national rate of net disposal. FR 73555, Dec. 3, 2008; 75 FR 10684, Mar. 9, (ii) The applicant’s production cycle 2010] and current inventory position.

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(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 amount necessary to increase or reduce inventory to 50 percent of the esti- the actual inventory of the applicant mated net disposal for that year. to December 31 of the preceding year to his estimated inventory allowance for § 1315.25 Increase in individual manu- the current calendar year, pursuant to facturing quotas. § 1315.24. (a) Any registrant who holds an individual manufacturing quota for a § 1315.24 Inventory allowance. chemical may file with the Adminis- (a) For the purpose of determining trator an application on DEA Form 189 individual manufacturing quotas pur- for an increase in the registrant’s suant to § 1315.23, each registered man- quota to meet the registrant’s esti- ufacturer shall be allowed as a part of mated net disposal, inventory, and the quota an amount sufficient to other requirements during the remain- maintain an inventory equal to either der of that calendar year. of the following: (b) The Administrator, in passing (1) For current manufacturers, 50 per- upon a registrant’s application for an cent of his average estimated net dis- increase in the individual manufac- posal for the current calendar year and turing quota, shall take into consider- the last preceding calendar year; or ation any occurrences since the filing (2) For new manufacturers, 50 percent of the registrant’s initial quota appli- of his reasonably estimated net dis- cation that may require an increased posal for the next calendar year as de- manufacturing rate by the registrant termined by the Administrator. during the balance of the calendar (b) During each calendar year each year. In passing upon the application registered manufacturer shall be al- the Administrator may also take into lowed to maintain an inventory of a consideration the amount, if any, by chemical not exceeding 65 percent of which his determination of the total his estimated net disposal of that quantity for the chemical to be manu- chemical for that year, as determined factured under § 1315.11 exceeds the ag- at the time his quota for that year was gregate of all the individual manufac- determined. At any time the inventory turing quotas for the chemical, and the of a chemical held by a manufacturer equitable distribution of such excess exceeds 65 percent of his estimated net among other registrants. disposal, his quota for that chemical is automatically suspended and shall re- § 1315.26 Reduction in individual man- main suspended until his inventory is ufacturing quotas. less than 60 percent of his estimated The Administrator may at any time net disposal. The Administrator may, reduce an individual manufacturing upon application and for good cause quota for a chemical that he has pre- shown, permit a manufacturer whose viously fixed to prevent the aggregate quota is, or is likely to be, suspended of the individual manufacturing quotas under this paragraph to continue man- and import quotas outstanding or to be ufacturing and to accumulate an inven- granted from exceeding the assessment tory in excess of 65 percent of his esti- of annual needs that has been estab- mated net disposal, upon such condi- lished for that chemical pursuant to tions and within such limitations as § 1315.11, as adjusted pursuant to

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§ 1315.13. If a quota assigned to a new use quantities of each chemical for the manufacturer pursuant to § 1315.23(b), following purposes: or if a quota assigned to any manufac- (1) Manufacturing the bulk chemical turer is increased pursuant to into dosage forms. § 1315.24(c), or if an import quota issued (2) Manufacturing the bulk chemical to an importer pursuant to § 1315.34, into other substances. causes the total quantity of a chemical (3) Repackaging or relabeling the to be manufactured and imported dur- chemical or dosage forms. ing the year to exceed the assessment (c) An import quota authorizes a reg- of annual needs that has been estab- istered importer to import quantities lished for that chemical pursuant to of the chemical for the following pur- § 1315.11, as adjusted pursuant to poses: § 1315.13, the Administrator may pro- (1) Distribution of the chemical to a portionately reduce the individual registered manufacturer that has a manufacturing quotas and import procurement quota for the chemical. quotas of all other registrants to keep (2) Other distribution of the chemical the assessment of annual needs within consistent with the legitimate medical the limits originally established, or, al- and scientific needs of the United ternatively, the Administrator may re- States. duce the individual manufacturing quota of any registrant whose quota is § 1315.32 Obtaining a procurement suspended pursuant to § 1315.24(b) or quota. §§ 1301.36, 1309.43, 1309.44, or 1309.45 of (a) Any person who is registered to this chapter or is abandoned pursuant manufacture ephedrine, to § 1315.27. pseudoephedrine, or phenylpropanolamine, or whose requirement of reg- § 1315.27 Abandonment of quota. istration is waived pursuant to § 1309.24 Any manufacturer assigned an indi- of this chapter, and who desires to use vidual manufacturing quota for a during the next calendar year any chemical pursuant to § 1315.23 may at ephedrine, pseudoephedrine, or phenyl- any time abandon his right to manu- propanolamine for purposes of manufacture all or any part of the quota by facturing (including repackaging or refiling with the UN Reporting & Quota labeling), must apply on DEA Form 250 Section, Diversion Control Division, for a procurement quota for the chem- Drug Enforcement Administration a ical. A separate application must be written notice of the abandonment, made for each chemical desired to be stating the name and DEA Chemical procured or used. Code Number, as set forth in part 1310 (b) The applicant must state sepa- of this chapter, of the chemical and the rately all of the following: amount which he has chosen not to (1) Each purpose for which the chem- manufacture. The Administrator may, ical is desired. in his discretion, allocate the amount (2) The quantity desired for each pur- among the other manufacturers in pro- pose during the next calendar year. portion to their respective quotas. (3) The quantities used and estimated to be used, if any, for that purpose during the current and preceding 2 cal- Subpart D—Procurement and endar years. Import Quotas (c) If the purpose is to manufacture the chemical into dosage form, the ap- § 1315.30 Procurement and import plicant must state the official name, quotas. common or usual name, chemical (a) To determine the estimated needs name, or brand name of that form. If for, and to insure an adequate and un- the dosage form produced is a con- interrupted supply of, ephedrine, trolled substance listed in any sched- pseudoephedrine, and phenylpropanola- ule, the applicant must also state the mine the Administrator shall issue pro- schedule number and National Drug curement and import quotas. Code Number, of the substance. (b) A procurement quota authorizes a (d) If the purpose is to manufacture registered manufacturer to procure and another chemical, the applicant must

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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 UN Re- rent calendar year. The written certifi- porting & Quota Section, Diversion cation must be executed by a person Control Division, Drug Enforcement authorized to sign the registration ap- Administration. See the Table of DEA plication pursuant to § 1301.13 or Mailing Addresses in § 1321.01 of this § 1309.32(g) of this chapter or by a per- chapter for the current mailing ad- son granted power of attorney under dress. § 1315.33 to sign the certifications. A (f) The Administrator shall, on or be- copy of such certification must be re- fore July 1 of the year preceding the tained by the person procuring the calendar year during which the quota quantity of ephedrine, shall be effective, issue to each quali- pseudoephedrine, or phenylpropanola- fied applicant a procurement quota au- mine for two years from the date of the thorizing him to procure and use: certification. Registrants must not fill (1) All quantities of the chemical an order from persons required to apply necessary to manufacture products for a procurement quota under para- that the applicant is authorized to graph (b) of this section unless the manufacture pursuant to § 1315.23; and order is accompanied by a certification (2) Such other quantities of the as required under this section. chemical as the applicant has applied (i) The certification required by para- to procure and use and are consistent graph (h) of this section must contain with his past use, his estimated needs, all of the following: and the total quantity of the chemical (1) The date of the certification. that will be produced. (2) The name and address of the reg- (g) Any person to whom a procure- istrant to whom the certification is di- ment quota has been issued may at any rected. time request an adjustment in the (3) A reference to the purchase order quota by applying to the Adminis- number to which the certification ap- trator with a statement showing the plies. need for the adjustment. The applica- (4) The name of the person giving the tion must be filed with the UN Report- order to which the certification ap- ing & Quota Section, Diversion Control plies. Division, Drug Enforcement Adminis- (5) The name of the chemical to tration. See the Table of DEA Mailing which the certification applies. Addresses in § 1321.01 of this chapter for the current mailing address. The Ad- (6) A statement that the quantity ministrator shall increase or decrease (expressed in grams) of the chemical to the procurement quota of the person if which the certification applies does not and to the extent that he finds, after exceed the unused and available pro- considering the factors enumerated in curement quota of the chemical, issued paragraph (f) of this section and any to the person giving the order, for the occurrences since the issuance of the current calendar year. procurement quota, that the need jus- (7) The signature of the individual tifies an adjustment. authorized to sign a certification as (h) Any person to whom a procure- provided in paragraph (h) of this sec- ment quota has been issued, author- tion. izing that person to procure and use a [72 FR 37448, July 10, 2007, as amended at 73 quantity of ephedrine, FR 73555, Dec. 3, 2008; 75 FR 10684, Mar. 9, pseudoephedrine, or phenylpropanola- 2010]

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§ 1315.33 Power of attorney. Notice of Revocation (a) A registrant may authorize one or The foregoing power of attorney is hereby more individuals, whether or not lo- revoked by the undersigned, who is authorized to sign the current application for reg- cated at his registered location, to sign istration of the above-named registrant certifications required under § 1315.32(h) under the Controlled Substances Act or the on the registrant’s behalf by executing Controlled Substances Import and Export a power of attorney for each such indi- Act. Written notice of this revocation has vidual. The registrant shall retain the been given to the attorney-in-fact power of attorney in the files, with cer- llllll this same day. tifications required by § 1315.32(h), for llllllllllllllllllllllll the same period as any certification (Signature of person revoking power) bearing the signature of the attorney. Witnesses: The power of attorney must be avail- 1. llllll able for inspection together with other 2. llllll certification records. Signed and dated on the ll day of l, (b) A registrant may revoke any (year), at llllll. power of attorney at any time by exe- (d) A power of attorney must be executing a notice of revocation. cuted by the person who signed the (c) The power of attorney and notice most recent application for DEA reg- of revocation must be similar to the istration or reregistration; the person following format: to whom the power of attorney is being Power of Attorney for certifications granted; and two witnesses. of quota for procurement of ephedrine, (e) A power of attorney must be re- pseudoephedrine, and phenylpropanola- voked by the person who signed the mine most recent application for DEA registration or reregistration, and two llllll (Name of registrant) witnesses. llllll (Address of registrant) llllll (DEA registration number) [73 FR 73555, Dec. 3, 2008] I, llllll (name of person granting power), the undersigned, who am authorized § 1315.34 Obtaining an import quota. to sign the current application for registra- (a) Any person who is registered to tion of the above-named registrant under the import ephedrine, pseudoephedrine, or Controlled Substances Act or Controlled phenylpropanolamine, or whose re- Substances Import and Export Act, have made, constituted, and appointed, and by quirement of registration is waived these presents, do make, constitute, and ap- pursuant to § 1309.24(c) of this chapter, point llllll (name of attorney-in-fact), and who desires to import during the my true and lawful attorney for me in my next calendar year any ephedrine, name, place, and stead, to sign certifications pseudoephedrine, or phenylpropanola- of quota for procurement of ephedrine, mine or drug products containing these pseudoephedrine, and phenylpropanolamine chemicals, must apply on DEA Form in accordance with Part 1315 of Title 21 of 488 for an import quota for the chem- the Code of Federal Regulations. I hereby ical. A separate application must be ratify and confirm all that said attorney made for each chemical desired to be must lawfully do or cause to be done by vir- imported. tue hereof. llllllllllllllllllllllll (b) The applicant must provide the following information in the applica- (Signature of person granting power) tion: I, llllll (name of attorney-in-fact), (1) The applicant’s name and DEA hereby affirm that I am the person named registration number. herein as attorney-in-fact and that the signature affixed hereto is my signature. (2) The name and address of a contact person and contact information (tele- (Signature of attorney-in-fact) phone number, fax number, e-mail ad- Witnesses: dress). 1. llllll (3) Name of the chemical and DEA 2. llllll Chemical Code number. Signed and dated on the ll day of l, (4) Type of product (bulk or finished (year), at llllll. dosage forms).

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(5) For finished dosage forms, the of- stocks, and the total quantity of the ficial name, common or usual name, chemical that will be produced. chemical name, or brand name, NDC [72 FR 37448, July 10, 2007, as amended at 75 number, and the authority to market FR 10684, Mar. 9, 2010] the drug product under the Federal Food, Drug and Cosmetic Act of each § 1315.36 Amending an import quota. form to be imported. (a) An import quota authorizes the (6) The amount requested expressed registered importer to import up to the in terms of base. set quantity of ephedrine, (7) For the current and preceding two pseudoephedrine, or phenylpropanola- calendar years, expressed in terms of mine and distribute the chemical or base: drug products on the DEA Form 488. An (i) Distribution/Sales—name, address, importer must apply to change the and registration number (if applicable) quantity to be imported. of each customer and the amount sold. (b) Any person to whom an import quota has been issued may at any time (ii) Inventory as of December 31 (each request an increase in the quota quan- form—bulk, in-process, finished dosage tity by applying to the Administrator form). with a statement showing the need for (iii) Acquisition—imports. the adjustment. The application must (c) For each form of the chemical be filed with the UN Reporting & Quota (bulk or dosage unit), the applicant Section, Diversion Control Division, must state the quantity desired for im- Drug Enforcement Administration. See port during the next calendar year. the Table of DEA Mailing Addresses in (d) DEA Form 488 must be filed on or § 1321.01 of this chapter for the current before April 1 of the year preceding the mailing address. The Administrator calendar year for which the import may increase the import quota of the quota is being applied. Copies of DEA person if and to the extent that he de- Form 488 may be obtained from the Of- termines that the approval is necessary fice of Diversion Control Web site, and to provide for medical, scientific, or must be filed with the UN Reporting & other legitimate purposes regarding Quota Section, Diversion Control Divi- the chemical. The Administrator shall sion, Drug Enforcement Administra- specify a period of time for which the tion . See the Table of DEA Mailing approval is in effect or shall provide Addresses in § 1321.01 of this chapter for that the approval is in effect until the the current mailing address. Administrator notifies the applicant in writing that the approval is termi- (e) The Administrator may at his dis- nated. cretion request additional information (c) With respect to the application from an applicant. under paragraph (b) of this section, the (f) On or before July 1 of the year Administrator shall approve or deny preceding the calendar year during the application within 60 days of re- which the quota shall be effective, the ceiving the application. If the Adminis- Administrator shall issue to each trator does not approve or deny the ap- qualified applicant an import quota au- plication within 60 days of receiving it, thorizing him to import: the application is deemed to be ap- (1) All quantities of the chemical proved and the approval remains in ef- necessary to manufacture products fect until the Administrator notifies that registered manufacturers are au- the applicant in writing that the ap- thorized to manufacture pursuant to proval is terminated. § 1315.23; and [72 FR 37448, July 10, 2007, as amended at 75 (2) Such other quantities of the FR 10685, Mar. 9, 2010] chemical that the applicant has applied to import and that are consistent Subpart E—Hearings with his past imports, the estimated medical, scientific, and industrial § 1315.50 Hearings generally. needs of the United States, the estab- The procedures for the hearing re- lishment and maintenance of reserve lated to assessment of annual needs or

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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 or individual manufacturing quota, the under § 1315.11(c) or § 1315.13(c), may do Administrator shall hold a hearing for so by filing with the Administrator, the purpose of receiving factual evi- within 30 days of the date of publica- dence regarding the issues involved in tion of notice of the hearing in the the issuance, adjustment, suspension, FEDERAL REGISTER, a written notice of or denial of the quota to the person, his intention to participate in the but the Administrator need not hold a hearing in the form prescribed in hearing on suspension of a quota under § 1316.48 of this chapter. § 1301.36 or § 1309.43 of this chapter sepa- (d) Any person entitled to a hearing rate from a hearing on the suspension under § 1315.52 or entitled to participate of registration under that section. in a hearing under paragraph (c) of this (c) Extensive argument should not be section may, within the period per- offered into evidence, but rather pre- mitted for filing a request for a hearing sented in opening or closing state- or notice of appearance, file with the ments of counsel or in memoranda or Administrator a waiver of an oppor- proposed findings of fact and conclu- tunity for a hearing, together with a sions of law. written statement regarding his position on the matters of fact and law in- § 1315.54 Waiver or modification of volved in such hearing. The statement, rules. if admissible, shall be made a part of The Administrator or the presiding the record and shall be considered in officer (with respect to matters pend- light of the lack of opportunity for ing before him) may modify or waive cross-examination in determining the any rule in this part by notice in ad- weight to be attached to matters of vance of the hearing, if he determines fact asserted. that no party in the hearing will be un- (e) If any person entitled to a hearing duly prejudiced and the ends of justice under § 1315.52 or entitled to participate will thereby be served. Such notice of in a hearing under paragraph (c) of this modification or waiver shall be made a section fails to file a request for a hear- part of the record of the hearing. ing or notice of appearance or if he so files and fails to appear at the hearing, § 1315.56 Request for hearing or ap- he shall be deemed to have waived his pearance; waiver. opportunity for the hearing unless he (a) Any applicant or registrant enti- shows good cause for such failure. tled to a hearing under § 1315.52 and (f) If all persons entitled to a hearing who desires a hearing on the issuance, or to participate in a hearing waive or

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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 (a) At any hearing regarding the de- shall take effect. The Administrator termination or adjustment of an as- shall serve one copy of his order upon sessment of annual needs each inter- each party in the hearing. ested 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. (b) At any hearing regarding the PROCEDURES issuance, adjustment, suspension, or Subpart A—Administrative Inspections denial of a procurement, import, or individual manufacturing quota, the Ad- Sec. ministration shall have the burden of 1316.01 Scope of subpart A. proving that the requirements of this 1316.02 Definitions. part for such issuance, adjustment, 1316.03 Authority to make inspections. suspension, or denial are satisfied. 1316.04 Exclusion from inspection. 1316.05 Entry. 1316.06 Notice of inspection. § 1315.60 Time and place of hearing. 1316.07 Requirement for administrative in- (a) If any applicant or registrant re- spection warrant; exceptions. quests a hearing on the issuance, ad- 1316.08 Consent to inspection. justment, suspension, or denial of his 1316.09 Application for administrative in- procurement, import, or individual spection warrant. manufacturing quota under § 1315.54, 1316.10 Administrative probable cause. 1316.11 Execution of warrants. the Administrator shall hold a hearing. 1316.12 Refusal to allow inspection with an (b) Notice of the hearing shall be administrative warrant. given to the applicant or registrant of 1316.13 Frequency of administrative inspec- the time and place at least 30 days tions. prior to the hearing, unless the applicant or registrant waives such notice Subpart B—Protection of Researchers and and requests the hearing be held at an Research Subjects earlier time, in which case the Admin- 1316.21 Definitions. istrator shall fix a date for such hear- 1316.22 Exemption. ing as early as reasonably possible. 1316.23 Confidentiality of identity of re- (c) The hearing shall commence at search subjects. the place and time designated in the 1316.24 Exemption from prosecution for re- notice given under paragraph (b) of this searchers. section or in the notice of hearing pub- Subpart C—Enforcement Proceedings lished in the FEDERAL REGISTER pursuant to § 1315.11(c) or § 1315.13(c), but 1316.31 Authority for enforcement pro- thereafter it may be moved to a dif- ceeding. ferent place and may be continued 1316.32 Notice of proceeding; time and place. from day to day or recessed to a later 1316.33 Conduct of proceeding. day without notice other than an- 1316.34 Records of proceeding. nouncement by the presiding officer at Subpart D—Administrative Hearings the hearing. 1316.41 Scope of subpart D. § 1315.62 Final order. 1316.42 Definitions. As soon as practicable after the pre- 1316.43 Information; special instructions. 1316.44 Waiver or modification of rules. siding officer has certified the record 1316.45 Filings; address; hours. to the Administrator, the Adminis- 1316.46 Inspection of record. trator shall issue his order on the de- 1316.47 Request for hearing. termination or adjustment of the as- 1316.48 Notice of appearance.

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1316.49 Waiver of hearing. (1) Places where original or other 1316.50 Appearance; representation; author- records or documents required under ization. the Act are kept or required to be kept, 1316.51 Conduct of hearing and parties; ex and parte communications. 1316.52 Presiding officer. (2) Places, including factories, ware- 1316.53 Time and place of hearing. houses, or other establishments and 1316.54 Prehearing conference. conveyances, where persons registered 1316.55 Prehearing ruling. under the Act or exempted from reg- 1316.56 Burden of proof. istration under the Act, or regulated 1316.57 Submission of documentary evidence persons may lawfully hold, manufac- and affidavits and identification of wit- ture, or distribute, dispense, admin- nesses subsequent to prehearing con- ister, or otherwise dispose of controlled ference. 1316.58 Summary of testimony; affidavits. substances or listed chemicals or where 1316.59 Submission and receipt of evidence. records relating to those activities are 1316.60 Objections; offer of proof. maintained. 1316.61 Exceptions to rulings. (d) The term Administrator means the 1316.62 Appeal from ruling of presiding offi- Administrator of the Administration. cer. The Administrator has been delegated 1316.63 Official transcript; index; correc- authority under the Act by the Attor- tions. ney General (28 CFR 0.100). 1316.64 Proposed findings of fact and conclusions of law. (e) The term inspector means an offi- 1316.65 Report and record. cer or employee of the Administration 1316.66 Exceptions. authorized by the Administrator to 1316.67 Final order. make inspections under the Act. 1316.68 Copies of petitions for judicial re- (f) The term register and registration view. refer to registration required and per- SOURCE: 36 FR 7820, Apr. 24, 1971, unless mitted by sections 303 and 1008 of the otherwise noted. Redesignated at 38 FR 26609, Act (21 U.S.C. 823 and 958). Sept. 24, 1973. (g) Any term not defined in this part shall have the definition set forth in Subpart A—Administrative section 102 of the Act (21 U.S.C. 802) or Inspections part 1300 of this chapter. [36 FR 7820, Apr. 24, 1971. Redesignated at 38 AUTHORITY: 21 U.S.C. 822(f), 830(a), 871(b), FR 26609, Sept. 24, 1973, as amended at 60 FR 880, 958(f), 965. 32465, June 22, 1995; 60 FR 36334, July 14, 1995; 62 FR 13969, Mar. 24, 1997] § 1316.01 Scope of subpart A. Procedures regarding administrative § 1316.03 Authority to make inspec- inspections and warrants pursuant to tions. sections 302(f), 510, 1008(d), and 1015 of In carrying out his functions under the Act (21 U.S.C. 822(f), 880, 958(d), and the Act, the Administrator, through 965) are governed generally by those his inspectors, is authorized in accord- sections and specifically by the sec- ance with sections 510 and 1015 of the tions of this subpart. Act (21 U.S.C. 880 and 965) to enter controlled premises and conduct adminis- § 1316.02 Definitions. trative inspections thereof, for the pur- As used in this subpart, the following pose of: terms shall have the meanings speci- (a) Inspecting, copying, and verifying fied: the correctness of records, reports, or (a) The term Act means the Con- other documents required to be kept or trolled Substances Act (84 Stat. 1242; 21 made under the Act and regulations U.S.C. 801) and/or the Controlled Sub- promulgated under the Act, including, stances Import and Export Act (84 but not limited to, inventory and other Stat. 1285; 21 U.S.C. 951). records required to be kept pursuant to (b) The term Administration means part 1304 of this chapter, order form the Drug Enforcement Administration. records required to be kept pursuant to (c) The term controlled premises part 1305 of this chapter, prescription means— and distribution records required to be

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kept pursuant to part 1306 of this chap- (1) Financial data: ter, records of listed chemicals, (2) Sales data other than shipping tableting machines, and encapsulating data; or machines required to be kept pursuant (3) Pricing data. to part 1310 of this chapter, import/ex- (b) [Reserved] port records of listed chemicals required to be kept pursuant to part 1313 § 1316.05 Entry. of this chapter, shipping records identi- An inspection shall be carried out by fying the name of each carrier used and an inspector. Any such inspector, upon the date and quantity of each ship- (a) stating his purpose and (b) pre- ment, and storage records identifying senting to the owner, operator or agent the name of each warehouse used and in charge of the premises to be in- the date and quantity of each storage. spected (1) appropriate credentials, and (b) Inspecting within reasonable lim- (2) written notice of his inspection au- its and to a reasonable manner all per- thority under § 1316.06 of this chapter, tinent equipment, finished and unfin- and (c) receiving informed consent ished controlled substances, listed under § 1316.08 or through the use of ad- chemicals, and other substances or ma- ministrative warrant issued under terials, containers, and labeling found §§ 1316.09–1316.13, shall have the right to at the controlled premises relating to enter such premises and conduct in- this Act; spections at reasonable times and in a (c) Making a physical inventory of reasonable manner. all controlled substances and listed [36 FR 7820, Apr. 24, 1971, as amended at 36 chemicals on-hand at the premises; FR 13387, July 21, 1971. Redesignated at 38 FR (d) Collecting samples of controlled 26609, Sept. 24, 1973; 62 FR 13970, Mar. 24, 1997] substances or listed chemicals (in the event any samples are collected during § 1316.06 Notice of inspection. an inspection, the inspector shall issue The notice of inspection (DEA (or a receipt for such samples on DEA DNB) Form 82) shall contain: Form 400 to the owner, operator, or (a) The name and title of the owner, agent in charge of the premises); operator, or agent in charge of the con- (e) Checking of records and informa- trolled premises; tion on distribution of controlled sub- (b) The controlled premises name; stances or listed chemicals by the reg- (c) The address of the controlled istrant or regulated person (i.e., has premises to be inspected; the distribution of controlled sub- (d) The date and time of the inspec- stances or listed chemicals increased tion; markedly within the past year, and if (e) A statement that a notice of in- so why); spection is given pursuant to section (f) Except as provided in § 1316.04, all 510 of the Act (21 U.S.C. 880); other things therein (including records, (f) A reproduction of the pertinent files, papers, processes, controls and fa- parts of section 510 of the Act; and cilities) appropriate for verification of (g) The signature of the inspector. the records, reports, documents referred to above or otherwise bearing on § 1316.07 Requirement for administra- the provisions of the Act and the regu- tive inspection warrant; exceptions. lations thereunder. In all cases where an inspection is [36 FR 7820, Apr. 24, 1971. Redesignated at 38 contemplated, an administrative in- FR 26609, Sept. 24, 1973, and amended at 51 spection warrant is required pursuant FR 5319, Feb. 13, 1986; 55 FR 50827, Dec. 11, to section 510 of the Act (21 U.S.C. 880), 1990; 60 FR 32465, June 22, 1995; 77 FR 4238, except that such warrant shall not be Jan. 27, 2012] required for establishments applying for initial registration under the Act, § 1316.04 Exclusion from inspection. for the inspection of books and records (a) Unless the owner, operator or pursuant to an administrative sub- agent in charge of the controlled prem- poena issued in accordance with sec- ises so consents in writing, no inspection 506 of the Act (21 U.S.C. 876) nor tion authorized by these regulations for entries in administrative inspec- shall extend to: tions (including seizures of property):

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

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required by, and any inventory or sei- § 1316.21 Definitions. zure made shall comply with the re- As used in this part, the following quirements of, section 510(d)(3) of the terms shall have the meanings speci- Act (21 U.S.C. 880(d)(3)). The inspection fied: shall begin as soon as is practicable (a) The term investigative personnel after the issuance of the administra- includes managers, Diversion Inves- tive inspection warrant and shall be tigators, attorneys, analysts and sup- completed with reasonable promptness. port personnel employed by the Drug The inspection shall be conducted dur- Enforcement Administration who are ing regular business hours and shall be involved in the processing, reviewing completed in a reasonable manner. and analyzing of declarations and other relevant documents or data relative to § 1316.12 Refusal to allow inspection regulated transactions or are involved with an administrative warrant. in conducting investigations initiated If a registrant or any person subject pursuant to the receipt of such declara- to the Act refuses to permit execution tions, documents or data. of an administrative warrant or im- (b) The term law enforcement per- pedes the inspector in the execution of sonnel means Special Agents employed that warrant, he shall be advised that by the Drug Enforcement Administra- such refusal or action constitutes a tion who, in the course of their official violation of section 402(a)(6) of the Act duties, gain knowledge of information (21 U.S.C. 842(a)(6)). If he persists and which is confidential under such sec- the circumstances warrant, he shall be tion. arrested and the inspection shall com- [54 FR 31670, Aug. 1, 1989] mence or continue. § 1316.22 Exemption. [36 FR 7820, Apr. 24, 1971. Redesignated at 38 (a) Any person who is aggrieved by a FR 26609, Sept. 24, 1973, as amended at 62 FR 13970, Mar. 24, 1997] disclosure of information in violation of subsection (c)(1) of Section 310 of the § 1316.13 Frequency of administrative Controlled Substances Act (21 U.S.C. inspections. 830) may bring a civil action against the violator for appropriate relief. Except where circumstances other- (b) Notwithstanding the provision of wise dictate, it is the intent of the Ad- paragraph (a), a civil action may not be ministration to inspect all manufactur- brought under such paragraph against ers of controlled substances listed in investigative or law enforcement per- Schedules I and II and distributors of sonnel of the Drug Enforcement Ad- controlled substances listed in Sched- ministration. ule I once each year. Distributors of controlled substances listed in Sched- [54 FR 31670, Aug. 1, 1989] ules II through V and manufacturers of § 1316.23 Confidentiality of identity of controlled substances listed in Sched- research subjects. ules III through V shall be inspected as circumstances may require, based in (a) Any person conducting a bona fide part on the registrant’s history of com- research project directly related to the enforcement of the laws under the ju- pliance with the requirements of this risdiction of the Attorney General con- chapter and maintenance of effective cerning drugs or other substances controls and procedures to guard which are or may be subject to control against the diversion of controlled sub- under the Controlled Substances Act stances. (84 Stat. 1242; 21 U.S.C. 801) who intends [62 FR 13969, Mar. 24, 1997] to maintain the confidentiality of the identity of those persons who are the Subpart B—Protection of Re- subjects of such research may petition the Administrator of the Drug Enforce- searchers and Research Sub- ment Administration for a grant of jects confidentiality: Providing, That: (1) The Attorney General is author- AUTHORITY: 21 U.S.C. 830, 871(b). ized to carry out such research under

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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. (1) A statement as to whether the re- (6) The limits of this authorization, if search protocol requires the manufac- any. ture, production, import, export, dis- (7) A statement to the effect that the tribution, dispensing, administration, grant of confidentiality of identity of or possession of controlled substances, research subjects shall be perpetual but and if so the researcher’s registration shall pertain only to the subjects of the number or a statement that an applica- research described in the research pro- tion for such registration has been sub- tocol, the description of the research mitted to DEA; submitted to DEA, or as otherwise es- (2) The location of the research tablished by DEA. project; (d) Within 30 days of the date of com- (3) The qualifications of the principal pletion of the research project, the re- investigator; searcher shall so notify the Adminis- (4) A general description of the re- trator. The Administrator shall issue search or a copy of the research pro- another letter including the informa- tocol; tion required in paragraph (c) of this (5) The source of funding for the re- section and stating the starting and search project; finishing dates of the research for (6) A statement as to the risks posed which the confidentiality of identity of to the research subjects by the re- research subjects was granted; upon research procedures and what protection ceipt of this letter, the research shall will be afforded to the research sub- return the original letter of exemption. jects; [42 FR 54946, Oct. 12, 1977. Redesignated at 54 (7) A statement as to the risks posed FR 31670, Aug. 1, 1989, as amended at 62 FR to society in general by the research 13970, Mar. 24, 1997; 75 FR 10685, Mar. 9, 2010] procedures and what measures will be taken to protect the interests of soci- § 1316.24 Exemption from prosecution ety; for researchers. (8) A specific request to withhold the (a) Upon registration of an individual names and/or any other identifying to engage in research in controlled sub- characteristics of the research substances under the Controlled Sub- jects; and stances Act (84 Stat. 1242; 21 U.S.C. (9) Statements establishing that a 801), the Administrator of the Drug En- grant of confidentiality is necessary to forcement Administration, on his own the successful completion of the re- motion or upon request in writing from search project. the Secretary or from the researcher or (c) The grant of confidentiality of researching practitioner, may exempt identity of research subjects shall con- the registrant when acting within the

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scope of his registration, from prosecu- (d) The exemption shall consist of a tion under Federal, State, or local laws letter issued by the Administrator, for offenses relating to possession, dis- which shall include: tribution or dispensing of those con- (1) The researcher’s name and ad- trolled substances within the scope of dress; his exemption. However, this exemp- (2) The researcher’s registration tion does not diminish any require- number for the research project; ment of compliance with the Federal (3) The location of the research Food, Drug and Cosmetic Act (21 U.S.C. project; 301). (4) A concise statement of the scope (b) All petitions for Grants of Exemp- of the researcher’s registration; tion from Prosecution for the Re- (5) Any limits of the exemption; and searcher shall be addressed to the Ad- (6) A statement that the exemption ministrator, Drug Enforcement Admin- shall apply to all acts done in the scope istration, (see the Table of DEA Mail- of the exemption while the exemption ing Addresses in § 1321.01 of this chapter is in effect. The exemption shall re- for the current mailing address) and main in effect until completion of the shall contain the following: research project or until the registra- (1) The researcher’s registration tion of the researcher is either revoked or suspended or his renewal of registra- number if any, for the project; tion is denied. However, the protection (2) The location of the research afforded by the grant of exemption project; from prosecution during the research (3) The qualifications of the principal period shall be perpetual. investigator; (e) Within 30 days of the date of com- (4) A general description of the re- pletion of the research project, the research or a copy of the research pro- searcher shall so notify the Adminis- tocol; trator. The Administrator shall issue (5) The source of funding for the re- another letter including the informa- search project; tion required in paragraph (d) of this (6) A statement as to the risks posed section and stating the date of which to the research subjects by the re- the period of exemption concluded; search procedures and what protection upon receipt of this letter the re- will be afforded to the research sub- searcher shall return the original let- jects; ter of exemption. (7) A statement as to the risks posed [42 FR 54946, Oct. 12, 1977. Redesignated at 54 to society in general by the research FR 31670, Aug. 1, 1989, as amended at 62 FR procedures and what measures will be 13970, Mar. 24, 1997; 75 FR 10685, Mar. 9, 2010] taken to protect the interests of society; Subpart C—Enforcement (8) A specific request for exemption Proceedings from prosecution by Federal, State, or local authorities for offenses related to AUTHORITY: 21 U.S.C. 871(b), 883. the possession, distribution, and dispensing of controlled substances in ac- § 1316.31 Authority for enforcement cord with the procedures described in proceeding. the research protocol; A hearing may be ordered or granted (9) A statement establishing that a by any Special Agent in Charge of the grant of exemption from prosecution is Drug Enforcement Administration, at necessary to the successful completion his discretion, to permit any person of the research project. against whom criminal and/or civil ac- (c) Any researcher or practitioner tion is contemplated under the Con- proposing to engage in research re- trolled Substances Act (84 Stat. 1242; 21 questing both exemption from prosecu- U.S.C. 801) or the Controlled Sub- tion and confidentiality of identity of stances Import and Export Act (84 research subjects may submit a single Stat. 1285; 21 U.S.C. 951) an opportunity petition incorporating the information to present his views and his proposals required in §§ 1316.23(b) and 1316.24(b). for bringing his alleged violations into

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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) given to the person. Upon request, apply. 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: Special Agent in Charge who issued the (a) The term Act means the Con- notice. trolled Substances Act (84 Stat. 1242; 21 U.S.C. 801) and/or the Controlled Sub- [36 FR 7820, Apr. 24, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973, and amended at 47 stances Import and Export Act (84 FR 41735, Sept. 22, 1982] Stat. 1285; 21 U.S.C. 951). (b) The term Administrator means the § 1316.33 Conduct of proceeding. Administrator of the Administration. The Administrator has been delegated Presentation of views at a hearing authority under the Act by the Attor- under this subpart shall be private and ney General (28 CFR 0.100). informal. The views presented shall be (c) The term hearing means any hear- confined to matters relevant to bringing held pursuant to the Act. ing violations into compliance with the (d) The term Hearing Clerk means the Act or to other contemplated pro- hearing clerk of the Administration. ceedings under the Act. These views (e) The term person includes an indi- may be presented orally or in writing vidual, corporation, government or by the person to whom the notice was governmental subdivision or agency, given, or by his authorized representa- business trust, partnership, association tive. or other legal entity. (f) The term presiding officer means § 1316.34 Records of proceeding. an administrative law judge qualified A formal record, either verbatim or and appointed as provided in the Ad- summarized, of the hearing may be ministrative Procedure Act (5 U.S.C. made at the discretion of the Special 556). Agent in Charge. If a verbatim record (g) The term proceeding means all ac- is to be made, the person attending the tions involving a hearing, commencing hearing will be so advised prior to the with the publication by the Adminis- start of the hearing. trator of the notice of proposed rulemaking or the issuance of an order to [37 FR 15924, Aug. 8, 1972. Redesignated at 38 show cause. FR 26609, Sept. 24, 1973, and amended at 47 (h) Any term not defined in this part FR 41735, Sept. 22, 1982] shall have the definition set forth in section 102 of the Act (21 U.S.C. 802) or Subpart D—Administrative part 1300 of this chapter. Hearings [36 FR 7820, Apr. 24, 1971, as amended at 38 FR 757, Jan. 4, 1973. Redesignated at 38 FR AUTHORITY: 21 U.S.C. 811, 812, 871(b), 875, 26609, Sept. 24, 1973, as amended at 62 FR 958(d), 965. 13969, Mar. 24, 1997; 77 FR 4238, Jan. 27, 2012]

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§ 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. made a part of the record of the hear- 842(a) (8)) or any other law restricting ing. public disclosure of information; and (4) Any material contained in any in- § 1316.45 Filings; address; hours. vestigatory report, memorandum, or file, or case report compiled by the Ad- Documents required or permitted to ministration. be filed in, and correspondence relating to, hearings governed by the regula- [36 FR 7820, Apr. 24, 1971. Redesignated at 38 tions in this chapter shall be filed with FR 26609, Sept. 24, 1973, as amended at 62 FR the Hearing Clerk, Drug Enforcement 13970, Mar. 24, 1997; 75 FR 10645, Mar. 9, 2010] Administration. See the Table of DEA § 1316.47 Request for hearing. Mailing Addresses in § 1321.01 of this chapter for the current mailing ad- (a) Any person entitled to a hearing dress. This office is open Monday and desiring a hearing shall, within the through Friday from 8:30 a.m. to 5 p.m. period permitted for filing, file a re- eastern standard or daylight saving quest for a hearing and/or an answer time, whichever is effective in the Dis- that complies with the following for- trict of Columbia at the time, except mat (see the Table of DEA Mailing Ad- on national legal holidays. Documents dresses in § 1321.01 of this chapter for shall be dated and deemed filed upon the current mailing address): receipt by the Hearing Clerk. (Date) llllllllllllllllllll Drug Enforcement Administration, Attn: [75 FR 10685, Mar. 9, 2010] Hearing Clerk/OALJ § 1316.46 Inspection of record. (Mailing Address) llllllllllllll Subject: Request for Hearing (a) The record bearing on any pro- Dear Sir: ceeding, except for material described The undersigned llllll (Name of the in subsection (b) of this section, shall Person) hereby requests a hearing in the be available for inspection and copying matter of: llllll (Identification of the by any person entitled to participate in proceeding). such proceeding, during office hours in (A) (State with particularity the interest the office of the Hearing Clerk, Drug of the person in the proceeding.) Enforcement Administration. See the (B) (State with particularity the objections Table of DEA Mailing Addresses in or issues, if any, concerning which the per- § 1321.01 of this chapter for the current son desires to be heard.) (C) (State briefly the position of the person mailing address. with regard to the particular objections or (b) The following material shall not issues.) be available for inspection as part of All notices to be sent pursuant to the pro- the record: ceeding should be addressed to: (1) A research protocol filed with an (Name) lllllllllllllllllll application for registration to conduct (Street Address) lllllllllllllll

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(City and State) lllllllllllllll for a hearing, together with a written Respectfully yours, statement regarding his position on (Signature of Person) llllllllllll the matters of fact and law involved in (b) The Administrative Law Judge, such hearing. Such statement, if ad- upon request and showing of good missible, shall be made a part of the cause, may grant a reasonable exten- record and shall be considered in light sion of the time allowed for response to of the lack of opportunity for cross-ex- an Order to Show Cause. amination in determining the weight to be attached to matters of fact as- [36 FR 7820, Apr. 24, 1971, as amended at 36 serted therein. FR 13387, July 21, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973] § 1316.50 Appearance; representation; EDITORIAL NOTE: For FEDERAL REGISTER ci- authorization. tations affecting § 1316.47, see the List of CFR Any person entitled to appear in a Sections Affected, which appears in the hearing may appear in person or by a Finding Aids section of the printed volume and at www.govinfo.gov. representative in any proceeding or hearing and may be heard with respect § 1316.48 Notice of appearance. to matters relevant to the issues under Any person entitled to a hearing and consideration. A representative must desiring to appear in any hearing, either be an employee of the person or shall, if he or she has not filed a re- an attorney at law who is a member of quest for hearing, file within the time the bar, in good standing, of any State, specified in the notice of proposed rule- territory, or the District of Columbia, making, a written notice of appearance and admitted to practice before the in the following format (see the Table highest court of that jurisdiction. Any of DEA Mailing Addresses in § 1321.01 of representative may be required by the this chapter for the current mailing ad- Administrator or the presiding officer dress): to present a notarized power of attorney showing his authority to act in (Date) llllllllllllllllllll such representative capacity and/or an Drug Enforcement Administration, Attn: affidavit or certificate of admission to Hearing Clerk/OALJ practice. (Mailing Address) llllllllllllll Subject: Notice of Appearance [36 FR 7820, Apr. 24, 1971, as amended at 36 Dear Sir: FR 13387, July 21, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973] Please take notice that llllll (Name of person) will appear in the matter of: llllll (Identification of the pro- § 1316.51 Conduct of hearing and par- ceeding). ties; ex parte communications. (A) (State with particularity the interest (a) Hearings shall be conducted in an of the person in the proceeding.). informal but orderly manner in accord- (B) (State with particularity the objections ance with law and the directions of the or issues, if any, concerning which the per- presiding officer. son desires to be heard.). (C) (State briefly the position of the person (b) Participants in any hearing and with regard to the particular objections or their representatives, whether or not issues.). members of the bar, shall conduct All notices to be sent pursuant to this ap- themselves in accordance with judicial pearance should be addressed to: standards of practice and ethics and (Name) lllllllllllllllllll the directions of the presiding officer. (Street Address) lllllllllllllll Refusal to comply with this section (City and State) lllllllllllllll shall constitute grounds for immediate Respectfully yours, exclusion from any hearing. (Signature of Person) llllllllllll (c) If any official of the Administra- [81 FR 97041, Dec. 30, 2016] tion is contacted by any individual in private or public life concerning any § 1316.49 Waiver of hearing. substantive matter which is the sub- Any person entitled to a hearing ject of any hearing, at any time after may, within the period permitted for the date on which the proceedings com- filing a request for hearing or notice of mence, the official who is contacted appearance, waiver of an opportunity shall prepare a memorandum setting

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forth the substance of the conversation § 1316.53 Time and place of hearing. and shall file this memorandum in the The hearing will commence at the appropriate public docket file. The pre- place and time designated in the notice siding officer and employees of the Ad- of hearing published in the FEDERAL ministration shall comply with the re- REGISTER but thereafter it may be quirements of 5 U.S.C. 554(d) regarding moved to a different place and may be ex parte communications and partici- continued from day to day or recessed pation in any hearing. to a later day without notice other than announcement thereof by the pre- § 1316.52 Presiding officer. siding officer at the hearing. A presiding officer, designated by the Administrator, shall preside over all § 1316.54 Prehearing conference. hearings. The functions of the pre- The presiding officer on his own mo- siding officer shall commence upon his tion, or on the motion of any party for designation and terminate upon the good cause shown, may direct all par- certification of the record to the Ad- ties to appear at a specified time and ministrator. The presiding officer shall place for a conference for: have the duty to conduct a fair hear- (a) The simplification of the issues. ing, to take all necessary action to (b) The possibility of obtaining stipu- avoid delay, and to maintain order. He lations, admission of facts, and docu- shall have all powers necessary to ments. these ends, including (but not limited (c) The possibility of limiting the to) the power to: number of expert witnesses. (a) Arrange and change the date, (d) The identification and, if prac- time, and place of hearings (other than ticable, the scheduling of all witnesses the time and place prescribed in to be called. § 1301.56) and prehearing conferences (e) The advance submission at the and issue notice thereof. prehearing conference of all documen- (b) Hold conferences to settle, sim- tary evidence and affidavits to be plify, or determine the issues in a hear- marked for identification. ing, or to consider other matters that (f) Such other matters as may aid in may aid in the expeditious disposition the expeditious disposition of the hear- of the hearing. ing. (c) Require parties to state their position in writing with respect to the § 1316.55 Prehearing ruling. various issues in the hearing and to ex- The presiding officer may have the change such statements with all other prehearing conference reported ver- parties. batim and shall make a ruling reciting (d) Sign and issue subpoenas to com- the action taken at the conference, the pel the attendance of witnesses and the agreements made by the parties, the production of documents and materials schedule of witnesses, and a statement to the extent necessary to conduct ad- of the issues for hearing. Such ruling ministrative hearings pending before shall control the subsequent course of him. the hearing unless modified by a subse- (e) Examine witnesses and direct wit- quent ruling. nesses to testify. (f) Receive, rule on, exclude, or limit § 1316.56 Burden of proof. evidence. At any hearing, the proponent for the (g) Rule on procedural items pending issuance, amendment, or repeal of any before him. rule shall have the burden of proof. (h) Take any action permitted to the presiding officer as authorized by this § 1316.57 Submission of documentary part or by the provisions of the Admin- evidence and affidavits and identi- istrative Procedure Act (5 U.S.C. 551– fication of witnesses subsequent to 559). prehearing conference. [36 FR 7820, Apr. 24, 1971. Redesignated at 38 All documentary evidence and affida- FR 26609, Sept. 24, 1973, and amended at 42 vits not submitted and all witnesses FR 57457, Nov. 3, 1977; 62 FR 13970, Mar. 24, not identified at the prehearing con- 1997] ference shall be submitted or identified

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

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shall accompany the records as the § 1316.64 Proposed findings of fact and offer of proof. conclusions of law. Any party in the hearing may file in § 1316.61 Exceptions to rulings. quintuplicate proposed findings of fact Exceptions to rulings of the presiding and conclusions of law within the time officer are unnecessary. It is sufficient fixed by the presiding officer. Any that a party, at the time the ruling of party so filing shall also serve one copy the presiding officer is sought, makes of his proposed findings and conclusion known the action that he desires the upon each other party in the hearing. presiding officer to take, or his objec- The party shall include a statement of tion to an action taken, and his supporting reasons for the proposed grounds therefor. findings and conclusions, together with evidence of record (including specific § 1316.62 Appeal from ruling of pre- and complete citations of the pages of siding officer. the transcript and exhibits) and cita- Rulings of the presiding officer may tions of authorities relied upon. not be appealed to the Administrator prior to his consideration of the entire § 1316.65 Report and record. hearing, except with the consent of the (a) As soon as practicable after the presiding officer and where he certifies time for the parties to file proposed on the record or in writing that the al- findings of fact and conclusions of law lowance of an interlocutory appeal is has expired, the presiding officer shall clearly necessary to prevent excep- prepare a report containing the fol- tional delay, expense, or prejudice to lowing: any party or substantial detriment to (1) His recommended rulings on the the public interest. If an appeal is al- proposed findings of fact and conclu- lowed, any party in the hearing may sions of law; file a brief in quintuplicate with the (2) His recommended findings of fact Administrator within such period that and conclusions of law, with the rea- the presiding officer directs. No oral sons therefore; and argument will be heard unless the Ad- (3) His recommended decision. ministrator directs otherwise. (b) The presiding officer shall serve a copy of his report upon each party in § 1316.63 Official transcript; index; the hearing. The report shall be consid- corrections. ered to have been served when it is (a) Testimony given at a hearing mailed to such party or its attorney of shall be reported verbatim. The Admin- record. istration will make provision for a (c) Not less than twenty-five days stenographic record of the testimony after the date on which he caused cop- and for such copies of the transcript ies of his report to be served upon the thereof as it requires for its own pur- parties, the presiding officer shall cer- pose. tify to the Administrator the record, (b) At the close of the hearing, the which shall contain the transcript of presiding officer shall afford the par- testimony, exhibits, the findings of ties and witnesses time (not longer fact and conclusions of law proposed by than 30 days, except in unusual cases) the parties, the presiding officer’s rein which to submit written proposed port, and any exceptions thereto which corrections of the transcript, pointing may have been filed by the parties. out errors that may have been made in [36 FR 7778, Apr. 24, 1971. Redesignated at 38 transcribing the testimony. The pre- FR 26609, Sept. 24, 1973 and amended at 44 FR siding officer shall promptly thereafter 55332, Sept. 26, 1979] order such corrections made as in his judgment are required to make the § 1316.66 Exceptions. transcript conform to the testimony. (a) Within twenty days after the date [36 FR 7820, Apr. 24, 1971, as amended at 36 upon which a party is served a copy of FR 13387, July 21, 1971. Redesignated at 38 FR the report of the presiding officer, such 26609, Sept. 24, 1973, and amended at 50 FR party may file with the Hearing Clerk, 2046, Jan. 15, 1985] Office of the Administrative Law

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Judge, exceptions to the recommended ered to and served upon the Adminis- decision, findings of fact and conclu- trator in quintuplicate. The Adminis- sions of law contained in the report. trator shall certify the record of the The party shall include a statement of hearing and shall file the certified supporting reasons for such exceptions, record in the appropriate U.S. Court of together with evidence of record (in- Appeals. cluding specific and complete citations [36 FR 7820, Apr. 24, 1971. Redesignated at 44 of the pages of the transcript and ex- FR 42179, July 19, 1979] hibits) and citations of the authorities relied upon. PART 1317—DISPOSAL (b) The Hearing Clerk shall cause such filings to become part of the Sec. record of the proceeding. 1317.01 Scope. (c) The Administrative Law Judge may, upon the request of any party to Subpart A—Disposal of Controlled a proceeding, grant time beyond the Substances by Registrants twenty days provided in paragraph (a) 1317.05 Registrant disposal. of this section for the filing of a re- 1317.10 Registrant return or recall. sponse to the exceptions filed by an- 1317.15 Reverse distributor registration re- other party if he determines that no quirements and authorized activities. party in the hearing will be unduly prejudiced and that the ends of justice Subpart B—Disposal of Controlled Sub- will be served thereby. Provided how- stances Collected From Ultimate Users ever, that each party shall be entitled and Other Non-Registrants to only one filing under this section; 1317.30 Authorization to collect from non- that is, either a set of exceptions or a registrants. response thereto. 1317.35 Collection by law enforcement. 1317.40 Registrants authorized to collect [44 FR 55332, Sept. 26, 1979] and authorized collection activities. 1317.55 Reverse distributor and distributor § 1316.67 Final order. acquisition of controlled substances from As soon as practicable after the pre- collectors or law enforcement. siding officer has certified the record 1317.60 Inner liner requirements. to the Administrator, the Adminis- 1317.65 Take-back events. trator shall cause to be published in 1317.70 Mail-back programs. 1317.75 Collection receptacles. the FEDERAL REGISTER his final order 1317.80 Collection receptacles at long-term in the proceeding, which shall set forth care facilities. the final rule and the findings of fact 1317.85 Ultimate user delivery for the pur- and conclusions of law upon which the pose of recall or investigational use of rule is based. This order shall specify drugs. the date on which it shall take effect, which date shall not be less than 30 Subpart C—Destruction of Controlled days from the date of publication in Substances the FEDERAL REGISTER unless the Ad- 1317.90 Methods of destruction. ministrator finds that the public inter- 1317.95 Destruction procedures. est in the matter necessitates an ear- AUTHORITY: 21 U.S.C. 821, 822, 823, 827, 828, lier effective date, in which event the 871(b), and 958. Administrator shall specify in the SOURCE: 79 FR 33565, Sept. 9, 2014, unless order his findings as to the conditions otherwise noted. which led him to conclude that an earlier effective date was required. § 1317.01 Scope. [44 FR 42179, July 19, 1979, as amended at 44 This part sets forth the rules for the FR 55332, Sept. 26, 1979] delivery, collection, and destruction of damaged, expired, returned, recalled, § 1316.68 Copies of petitions for judi- unused, or otherwise unwanted con- cial review. trolled substances that are lawfully Copies of petitions for judicial re- possessed by registrants (subpart A) view, filed pursuant to section 507 of and non-registrants (subpart B). The the Act (21 U.S.C. 877) shall be deliv- purpose of such rules is to provide

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prompt, safe, and effective disposal (C) By destruction in the presence of methods while providing effective con- an agent of the Administration or trols against the diversion of con- other authorized person. trolled substances. (5) In the event that a practitioner is required regularly to dispose of con- Subpart A—Disposal of Controlled trolled substances, the Special Agent in Charge may authorize the practi- Substances by Registrants tioner to dispose of such substances, in § 1317.05 Registrant disposal. accordance with subparagraph (a)(4) of this section, without prior application (a) Practitioner inventory. Any reg- in each instance, on the condition that istered practitioner in lawful posses- the practitioner keep records of such sion of a controlled substance in its in- disposals and file periodic reports with ventory that desires to dispose of that the Special Agent in Charge summa- substance shall do so in one of the fol- rizing the disposals. The Special Agent lowing ways: in Charge may place such conditions as (1) Promptly destroy that controlled he/she deems proper on practitioner substance in accordance with subpart C procedures regarding the disposal of of this part using an on-site method of controlled substances. destruction; (b) Non-practitioner inventory. Any (2) Promptly deliver that controlled registrant that is a non-practitioner in substance to a reverse distributor’s lawful possession of a controlled sub- registered location by common or con- stance in its inventory that desires to tract carrier pick-up or by reverse dis- dispose of that substance shall do so in tributor pick-up at the registrant’s one of the following ways: registered location; (1) Promptly destroy that controlled (3) For the purpose of return or re- substance in accordance with subpart C call, promptly deliver that controlled of this part using an on-site method of substance by common or contract car- destruction; rier pick-up or pick-up by other reg- (2) Promptly deliver that controlled istrants at the registrant’s registered substance to a reverse distributor’s location to: The registered person from registered location by common or con- whom it was obtained, the registered tract carrier or by reverse distributor manufacturer of the substance, or an- pick-up at the registrant’s registered other registrant authorized by the location; manufacturer to accept returns or re- (3) For the purpose of return or recalls on the manufacturer’s behalf; or call, promptly deliver that controlled substance by common or contract car- (4) Request assistance from the Spe- rier or pick-up at the registrant’s reg- cial Agent in Charge of the Adminis- istered location to: The registered per- tration in the area in which the practi- son from whom it was obtained, the tioner is located. registered manufacturer of the sub- (i) The request shall be made by substance, or another registrant author- mitting one copy of the DEA Form 41 ized by the manufacturer to accept re- to the Special Agent in Charge in the turns or recalls on the manufacturer’s practitioner’s area. The DEA Form 41 behalf; or shall list the controlled substance or (4) Promptly transport that con- substances which the registrant desires trolled substance by its own means to to dispose. the registered location of a reverse dis- (ii) The Special Agent in Charge shall tributor, the location of destruction, or instruct the registrant to dispose of the registered location of any person the controlled substance in one of the authorized to receive that controlled following manners: substance for the purpose of return or (A) By transfer to a registrant au- recall as described in paragraph (b)(3) thorized to transport or destroy the of this section. substance; (i) If a non-practitioner transports (B) By delivery to an agent of the Ad- controlled substances by its own means ministration or to the nearest office of to an unregistered location for destruc- the Administration; or tion, the non-practitioner shall do so in

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accordance with the procedures set shall dispose of sealed inner liners and forth at § 1317.95(c). their contents by utilizing any method (ii) If a non-practitioner transports in paragraph (a)(1), (a)(2), or (a)(4) of controlled substances by its own means this section, or by delivering sealed to a registered location for any author- inner liners and their contents to a dis- ized purpose, transportation shall be tributor’s registered location by com- directly to the authorized registered mon or contract carrier pick-up or by location and two employees of the distributor pick-up at the collector’s transporting non-practitioner shall ac- authorized collection location. company the controlled substances to (v) Non-practitioner methods of destruc- the registered destination location. Di- tion. Collectors that are non-practi- rectly transported means the sub- tioners (i.e., manufacturers, distribu- stances shall be constantly moving to- tors, narcotic treatment programs, and wards their final location and unneces- reverse distributors) shall dispose of sary or unrelated stops and stops of an sealed inner liners and their contents extended duration shall not occur. by utilizing any method in paragraph (c) Collected controlled substances. Any (b)(1), (b)(2), or (b)(4) of this section, or collector in lawful possession of a con- by delivering sealed inner liners and trolled substance acquired by collec- their contents to a distributor’s reg- tion from an ultimate user or other au- istered location by common or con- thorized non-registrant person shall tract carrier or by distributor pick-up dispose of that substance in the fol- at the collector’s authorized collection lowing ways: location for destruction. Freight for- (1) Mail-back program. Upon receipt of warding facilities may not be utilized a sealed mail-back package, the col- to transfer sealed inner liners and their lector shall promptly: contents. (i) Destroy the package in accordance with subpart C of this part using an on- § 1317.10 Registrant return or recall. site method of destruction; or (ii) Securely store the package and (a) Each registrant shall maintain a its contents at the collector’s reg- record of each return or recall trans- istered location in a manner consistent action in accordance with the informa- with § 1301.75(c) of this chapter (for tion required of manufacturers in practitioners), or in a manner con- § 1304.22(a)(2)(iv) of this chapter. sistent with the security requirements (b) Each registrant that delivers a for Schedule II controlled substances controlled substance in Schedule I or II (for non-practitioners) until prompt for the purpose of return or recall shall on-site destruction can occur. use an order form in the manner de- (2) Collection receptacles. Upon re- scribed in part 1305 of this chapter. moval from the permanent outer con- (c) Deliveries for the purpose of re- tainer, the collector shall seal it and turn or recall may be made through a promptly: freight forwarding facility operated by (i) Destroy the sealed inner liner and the person to whom the controlled sub- its contents; stance is being returned provided that (ii) Securely store the sealed inner advance notice of the return is pro- liner and its contents at the collector’s vided and delivery is directly to an registered location in a manner con- agent or employee of the person to sistent with § 1301.75(c) of this chapter whom the controlled substance is being (for practitioners), or in a manner con- returned. sistent with § 1301.72(a) of this chapter (for non-practitioners) until prompt de- § 1317.15 Reverse distributor registra- struction can occur; or tion requirements and authorized (iii) Securely store the sealed inner activities. liner and its contents at a long-term (a) Any person that reverse distrib- care facility in accordance with utes a controlled substance shall be § 1317.80(d). registered with the Administration as (iv) Practitioner methods of destruction. a reverse distributor, unless exempted Collectors that are practitioners (i.e., by law or otherwise authorized pursu- retail pharmacies and hospitals/clinics) ant to this chapter.

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(b) A reverse distributor shall acquire Subpart B—Disposal of Controlled controlled substances from a registrant Substances Collected From pursuant to §§ 1317.05 and 1317.55(a) and Ultimate Users and Other Non- (c) in the following manner: Registrants (1) Pick-up controlled substances from a registrant at the registrant’s § 1317.30 Authorization to collect from registered location or authorized col- non-registrants. lection site; or (a) The following persons are author- (2) Receive controlled substances de- ized to collect controlled substances livered by common or contract carrier from ultimate users and other non-reg- or delivered directly by a non-practi- istrants for destruction in compliance tioner registrant. with this chapter: (i) Delivery to the reverse distributor (1) Any registrant authorized by the by an authorized registrant directly or Administration to be a collector pursu- by common or contract carrier may ant to § 1317.40; and only be made to the reverse distributor (2) Federal, State, tribal, or local law at the reverse distributor’s registered enforcement when in the course of offi- location. Once en route, such deliveries cial duties and pursuant to § 1317.35. may not be re-routed to any other loca- (b) The following non-registrant per- tion or person, regardless of registra- sons in lawful possession of a con- tion status. trolled substance in Schedules II, III, (ii) All controlled substance deliv- IV, or V may transfer that substance to eries to a reverse distributor shall be the authorized persons listed in para- personally received by an employee of graph (a) of this section, and in a man- the reverse distributor at the reg- ner authorized by this part, for the pur- istered location. pose of disposal: (c) Upon acquisition of a controlled (1) An ultimate user in lawful possession of a controlled substance; substance by delivery or pick-up, a re- (2) Any person lawfully entitled to verse distributor shall: dispose of a decedent’s property if that (1) Immediately store the controlled decedent was an ultimate user who substance, in accordance with the secu- died while in lawful possession of a rity controls in parts 1301 and 1317 of controlled substance; and this chapter, at the reverse distribu- (3) A long-term care facility on be- tor’s registered location or imme- half of an ultimate user who resides or diately transfer the controlled sub- resided at such long-term care facility stance to the reverse distributor’s reg- and is/was in lawful possession of a istered location for secure storage, in controlled substance, in accordance accordance with the security controls with § 1317.80 only. in parts 1301 and 1317 of this chapter, until timely destruction or prompt re- § 1317.35 Collection by law enforce- turn of the controlled substance to the ment. registered manufacturer or other reg- (a) Federal, State, tribal, or local law istrant authorized by the manufacturer enforcement may collect controlled to accept returns or recalls on the substances from ultimate users and manufacturer’s behalf; persons lawfully entitled to dispose of (2) Promptly deliver the controlled an ultimate user decedent’s property substance to the manufacturer or an- using the following collection methods: other registrant authorized by the (1) Take-back events in accordance manufacturer to accept returns or re- with § 1317.65; calls on the manufacturer’s behalf; or (2) Mail-back programs in accordance (3) Timely destroy the controlled with § 1317.70; or substance in a manner authorized in (3) Collection receptacles located in- subpart C of this part. side law enforcement’s physical ad- (d) A reverse distributor shall de- dress. stroy or cause the destruction of any (b) Law enforcement that conducts a controlled substance received for the take-back event or a mail-back pro- purpose of destruction no later than 30 gram or maintains a collection recep- calendar days after receipt. tacle should maintain any records of

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removal, storage, or destruction of the the Administration in accordance with controlled substances collected in a § 1301.52(f) of this chapter. manner that is consistent with that (b) Collection by registrants shall agency’s recordkeeping requirements occur only at the following locations: for illicit controlled substances evi- (1) Those registered locations of man- dence. ufacturers, distributors, reverse dis- (c) Any controlled substances col- tributors, narcotic treatment pro- lected by law enforcement through a grams, hospitals/clinics with an on-site take-back event, mail-back program, pharmacy, and retail pharmacies that or collection receptacle should be are authorized for collection; and stored in a manner that prevents the (2) Long-term care facilities at which diversion of controlled substances and registered hospitals/clinics or retail is consistent with that agency’s stand- pharmacies are authorized to maintain ard procedures for storing illicit con- collection receptacles. trolled substances. (c) Collectors may conduct the fol- (d) Any controlled substances col- lowing activities: lected by law enforcement through a (1) Receive and destroy mail-back take-back event, mail-back program, packages pursuant to § 1317.70 at an au- or collection receptacle should be thorized registered location that has transferred to a destruction location in an on-site method of destruction; a manner that prevents the diversion (2) Install, manage, and maintain col- of controlled substances and is con- lection receptacles located at their au- sistent with that agency’s standard thorized collection location(s) pursu- procedures for transferring illicit con- ant to §§ 1317.75 and 1317.80; and trolled substances. (3) Promptly dispose of sealed inner (e) Law enforcement that transfers liners and their contents as provided controlled substances collected from for in § 1317.05(c)(2). ultimate users pursuant to this part to § 1317.55 Reverse distributor and dis- a reverse distributor for destruction tributor acquisition of controlled should maintain a record that contains substances from collectors or law the following information: If a sealed enforcement. inner liner as described in § 1317.60 is (a) A reverse distributor is author- used, the unique identification number ized to acquire controlled substances of the sealed inner liner transferred, from law enforcement that collected and the size of the sealed inner liner the substances from ultimate users. A transferred (e.g., 5-gallon, 10-gallon, reverse distributor is authorized to ac- etc.); if a mail-back package as de- quire controlled substances collected scribed in § 1317.70 is used, the unique through a collection receptacle in ac- identification number of each package; cordance with §§ 1317.75 and 1317.80. the date of the transfer; and the name, (b) A distributor is authorized to ac- address, and registration number of the quire controlled substances collected reverse distributor to whom the con- through a collection receptacle in ac- trolled substances were transferred. cordance with §§ 1317.75 and 1317.80. (c) A reverse distributor or a dis- § 1317.40 Registrants authorized to col- tributor that acquires controlled sub- lect and authorized collection ac- stances in accordance with paragraph tivities. (a) or (b) of this section shall: (a) Manufacturers, distributors, re- (1) Acquire the controlled substances verse distributors, narcotic treatment in the manner authorized for reverse programs, hospitals/clinics with an on- distributors in § 1317.15(b)(1) and (2); site pharmacy, and retail pharmacies (2) Dispose of the controlled sub- that desire to be collectors shall mod- stances in the manner authorized for ify their registration to obtain author- reverse distributors § 1317.15(c) and (d); ization to be a collector in accordance and with § 1301.51 of this chapter. Author- (3) Securely store the controlled sub- ization to be a collector is subject to stances in a manner consistent with renewal. If a registrant that is author- the security requirements for Schedule ized to collect ceases activities as a II controlled substances until timely collector, such registrant shall notify destruction can occur.

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§ 1317.60 Inner liner requirements. lection receptacle should be a securely (a) An inner liner shall meet the fol- locked, substantially constructed con- lowing requirements: tainer with an outer container and a (1) The inner liner shall be water- removable inner liner as specified in proof, tamper-evident, and tear-resist- § 1317.60 of this chapter. The outer con- ant; tainer should include a small opening (2) The inner liner shall be removable that allows contents to be added to the and sealable immediately upon re- inner liner, but that does not allow removal without emptying or touching moval of the inner liner’s contents. the contents; (d) Only those controlled substances (3) The contents of the inner liner listed in Schedule II, III, IV, or V that shall not be viewable from the outside are lawfully possessed by an ultimate when sealed; user or person entitled to dispose of an (4) The size of the inner liner shall be ultimate user decedent’s property may clearly marked on the outside of the be collected. Controlled and non-con- liner (e.g., 5-gallon, 10-gallon, etc.); and trolled substances may be collected to- (5) The inner liner shall bear a per- gether and be comingled, although co- manent, unique identification number mingling is not required. that enables the inner liner to be (e) Only ultimate users and persons tracked. entitled to dispose of an ultimate user (b) Access to the inner liner shall be decedent’s property in lawful posses- restricted to employees of the col- sion of a controlled substance in Sched- lector. ule II, III, IV, or V may transfer such (c) The inner liner shall be sealed by substances to law enforcement during two employees immediately upon re- the take-back event. No other person moval from the permanent outer con- may handle the controlled substances tainer and the sealed inner liner shall at any time. not be opened, x-rayed, analyzed, or otherwise penetrated. § 1317.70 Mail-back programs. § 1317.65 Take-back events. (a) A mail-back program may be con- (a) Federal, State, tribal, or local law ducted by Federal, State, tribal, or enforcement may conduct a take-back local law enforcement or any collector. event and collect controlled substances A collector conducting a mail-back from ultimate users and persons law- program shall have and utilize at their fully entitled to dispose of an ultimate registered location a method of de- user decedent’s property in accordance struction consistent with § 1317.90 of with this section. Any person may this chapter. partner with law enforcement to hold a (b) Only those controlled substances collection take-back event in accord- listed in Schedule II, III, IV, or V that ance with this section. are lawfully possessed by an ultimate (b) Law enforcement shall appoint a user or person lawfully entitled to dis- law enforcement officer employed by pose of an ultimate user decedent’s the agency to oversee the collection. property may be collected. Controlled Law enforcement officers employed and non-controlled substances may be and authorized by the law enforcement collected together and be comingled, agency or law enforcement component although comingling is not required. of a Federal agency conducting a take- (c) Collectors or law enforcement back event shall maintain control and that conduct a mail-back program custody of the collected substances shall make packages available (for sale from the time the substances are col- or for free) as specified in this para- lected from the ultimate user or person graph to ultimate users and persons authorized to dispose of the ultimate lawfully entitled to dispose of an ulti- user decedent’s property until secure mate user decedent’s property, for the transfer, storage, or destruction of the collection of controlled substances by controlled substances has occurred. common or contract carrier. Any per- (c) Each take-back event should have son may partner with a collector or at least one receptacle for the collec- law enforcement to make such pack- tion of controlled substances. The col- ages available in accordance with this

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section. The packages made available contains controlled substances that the shall meet the following specifications: collector did not make available or did (1) The package shall be nondescript not agree to receive pursuant to sub- and shall not include any markings or paragraph (e)(3) of this section. other information that might indicate (3) When discontinuing activities as a that the package contains controlled collector or ceasing an authorized substances; mail-back program: (2) The package shall be water- and (i) Make a reasonable effort to notify spill-proof; tamper-evident; tear-resist- the public prior to discontinuing such ant; and sealable; activities or ceasing the authorized (3) The package shall be preaddressed mail-back program; and with and delivered to the collector’s (ii) Obtain the written agreement of registered address or the participating another collector that has and utilizes law enforcement’s physical address; at its registered location a method of (4) The cost of shipping the package destruction consistent with § 1317.90 of shall be postage paid; this chapter to receive all remaining (5) The package shall have a unique mail-back packages that were dissemi- identification number that enables the nated but not returned and arrange for package to be tracked; and the forwarding of only such packages (6) The package shall include instruc- to that location. tions for the user that indicate the (f) Only law enforcement officers em- process for mailing back the package, ployed by the law enforcement agency the substances that can be sent, notice or law enforcement component of a that packages may only be mailed Federal agency and employees of the from within the customs territory of collector shall handle packages re- the United States (the 50 States, the ceived through an authorized mail- District of Columbia, and Puerto Rico), back program. Upon receipt of a mail- and notice that only packages provided back package by a collector conducting by the collector will be accepted for de- a mail-back program, the package struction. shall not be opened, x-rayed, analyzed, (d) Ultimate users and persons law- or otherwise penetrated. fully entitled to dispose of an ultimate user decedent’s property shall not be § 1317.75 Collection receptacles. required to provide any personally (a) Collectors or Federal, State, trib- identifiable information when mailing al, or local law enforcement may man- back controlled substances to a col- age and maintain collection recep- lector. The collector or law enforce- tacles for disposal. ment may implement a system that al- (b) Only those controlled substances lows ultimate users or persons lawfully listed in Schedule II, III, IV, or V that entitled to dispose of an ultimate user are lawfully possessed by an ultimate decedent’s property to notify the col- user or other authorized non-registrant lector or law enforcement that they person may be collected. Controlled are sending one of the designated pack- and non-controlled substances may be ages by giving the unique identifica- collected together and be comingled, tion number on the package. although comingling is not required. (e) A collector that conducts a mail- (c) Collectors shall only allow ulti- back program pursuant to paragraph mate users and other authorized non- (a) shall: registrant persons in lawful possession (1) Accept only those controlled sub- of a controlled substance in Schedule stances contained within packages that II, III, IV, or V to deposit such sub- the collector made available for the stances in a collection receptacle at a collection of controlled substances by registered location. Collectors shall mail and packages that are lawfully not permit an ultimate user to transfer forwarded to the collector pursuant to such substance to any person for any paragraph (e)(3) of this section. reason. Once a substance has been de- (2) Within three business days of re- posited into a collection receptacle, ceipt, notify the Field Division Office the substance shall not be counted, of the Administration in their area of sorted, inventoried, or otherwise indi- the receipt of a package that likely vidually handled.

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(d) Collection receptacles shall be se- inaccessible to the public when an em- curely placed and maintained: ployee is not present (e.g., when the (1) Inside a collector’s registered lo- pharmacy is closed), or when the col- cation, inside law enforcement’s phys- lection receptacle is not being regu- ical location, or at an authorized long- larly monitored by long-term care fa- term care facility; cility employees. (2) At a registered location, be lo- (g) The installation and removal of cated in the immediate proximity of a the inner liner of the collection recep- designated area where controlled sub- tacle shall be performed by or under stances are stored and at which an em- the supervision of at least two employ- ployee is present (e.g., can be seen from ees of the authorized collector. the pharmacy counter). Except as follows: § 1317.80 Collection receptacles at (i) At a hospital/clinic: A collection long-term care facilities. receptacle shall be located in an area (a) A long-term care facility may dis- regularly monitored by employees, and pose of controlled substances in Sched- shall not be located in the proximity of ules II, III, IV, and V on behalf of an ul- any area where emergency or urgent timate user who resides, or has resided, care is provided; at such long-term care facility by (ii) At a narcotic treatment program: transferring those controlled sub- A collection receptacle shall be located stances into an authorized collection in a room: That does not contain any receptacle located at that long-term other controlled substances and is se- care facility. When disposing of such curely locked with controlled access; controlled substances by transferring (iii) At a long-term care facility: A those substances into a collection re- collection receptacle shall be located ceptacle, such disposal shall occur im- in a secured area regularly monitored mediately, but no longer than three by long-term care facility employees. business days after the discontinuation (e) A controlled substance collection of use by the ultimate user. Dis- receptacle shall meet the following de- continuation of use includes a perma- sign specifications: nent discontinuation of use as directed (1) Be securely fastened to a perma- by the prescriber, as a result of the nent structure so that it cannot be re- resident’s transfer from the long-term moved; care facility, or as a result of death. (2) Be a securely locked, substan- (b) Only authorized retail pharmacies tially constructed container with a and hospitals/clinics with an on-site permanent outer container and a re- pharmacy may install, manage, and movable inner liner as specified in maintain collection receptacles at § 1317.60 of this chapter; long-term care facilities and remove, (3) The outer container shall include seal, transfer, and store, or supervise a small opening that allows contents to the removal, sealing, transfer, and be added to the inner liner, but does storage of sealed inner liners at long- not allow removal of the inner liner’s term care facilities. Collectors author- contents; ized to install, manage, and maintain (4) The outer container shall promi- collection receptacles at long-term nently display a sign indicating that care facilities shall comply with all re- only Schedule II–V controlled and non- quirements of this chapter, including controlled substances, if a collector §§ 1317.60, 1317.75, and 1317.80. chooses to comingle substances, are ac- (c) The installation, removal, trans- ceptable substances (Schedule I confer, and storage of inner liners shall be trolled substances, controlled sub- performed either: By or under the su- stances that are not lawfully possessed pervision of one employee of the au- by the ultimate user, and other illicit thorized collector and one supervisor- or dangerous substances are not per- level employee of the long-term care mitted); and facility (e.g., a charge nurse or super- (f) Except at a narcotic treatment visor) designated by the authorized col- program, the small opening in the lector; or, by or under the supervision outer container of the collection recep- of two employees of the authorized col- tacle shall be locked or made otherwise lector.

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(d) Upon removal, sealed inner liners controlled substances, the method of may only be stored at the long-term destruction shall be sufficient to care facility for up to three business render non-retrievable any controlled days in a securely locked, substantially substance likely to be present. constructed cabinet or a securely (c) The method of destruction shall locked room with controlled access be consistent with the purpose of ren- until transfer in accordance with dering all controlled substances to a § 1317.05(c)(2)(iv). non-retrievable state in order to pre- (e) Neither a hospital/clinic with an vent diversion of any such substance to on-site pharmacy nor a retail phar- illicit purposes and to protect the pub- macy shall operate a collection recep- lic health and safety. tacle at a long-term care facility until its registration has been modified in § 1317.95 Destruction procedures. accordance with § 1301.51 of this chap- The destruction of any controlled ter. substance shall be in accordance with the following requirements: § 1317.85 Ultimate user delivery for (a) Transfer to a person registered or the purpose of recall or investigational use of drugs. authorized to accept controlled substances for the purpose of destruction. If the con- (a) In the event of a product recall, trolled substances are transferred to a an ultimate user in lawful possession of person registered or authorized to ac- a controlled substance listed in Sched- cept the controlled substances for the ule II, III, IV, or V may deliver the re- purpose of destruction, two employees called substance to the manufacturer of the transferring registrant shall load of the substance or another registrant and unload or observe the loading and authorized by the manufacturer to ac- unloading of any controlled substances cept recalled controlled substances on until transfer is complete. the manufacturer’s behalf. (b) Transport to a registered location. If (b) An ultimate user who is partici- the controlled substances are trans- pating in an investigational use of ported by a registrant to a registered drugs pursuant to 21 U.S.C. 355(i) and location for subsequent destruction, 360b(j) and wishes to deliver any un- the following procedures shall be fol- used controlled substances received as lowed: part of that research to the registered (1) Transportation shall be directly dispenser from which the ultimate user to the registered location (the sub- obtained those substances may do so in stances shall be constantly moving to- accordance with regulations promul- wards their final location and unneces- gated by the Secretary of Health and sary or unrelated stops and stops of an Human Services pursuant to 21 U.S.C. extended duration shall not occur); 355(i) and 360b(j). (2) Two employees of the transporting registrant shall accompany the Subpart C—Destruction of controlled substances to the registered Controlled Substances location; (3) Two employees of the trans- § 1317.90 Methods of destruction. porting registrant shall load and un- (a) All controlled substances to be de- load or observe the loading and unload- stroyed by a registrant, or caused to be ing of the controlled substances until destroyed by a registrant pursuant to transfer is complete; § 1317.95(c), shall be destroyed in com- (c) Transport to a non-registered loca- pliance with applicable Federal, State, tion. If the controlled substances are tribal, and local laws and regulations transported by a registrant to a de- and shall be rendered non-retrievable. struction location that is not a reg- (b) Where multiple controlled sub- istered location, the following proce- stances are comingled, the method of dures shall be followed: destruction shall be sufficient to (1) Transportation shall be directly render all such controlled substances to the destruction location (the sub- non-retrievable. When the actual substances shall be constantly moving to- stances collected for destruction are wards their final destruction location unknown but may reasonably include and unnecessary or unrelated stops and

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stops of an extended duration shall not the following procedures shall be fol- occur); lowed: (2) Two employees of the trans- (1) Two employees of the registrant porting registrant shall accompany the shall handle or observe the handling of controlled substances to the destruc- any controlled substance until the sub- tion location; stance is rendered non-retrievable; and (3) Two employees of the trans- (2) Two employees of the registrant porting registrant shall load and un- shall personally witness the destruc- load or observe the loading and unload- tion of the controlled substance until it is rendered non-retrievable. ing of the controlled substances; (4) Two employees of the transporting registrant shall handle or ob- PART 1321—DEA MAILING serve the handling of any controlled ADDRESSES substance until the substance is rendered non-retrievable; and AUTHORITY: 21 U.S.C. 871(b).

(5) Two employees of the trans- SOURCE: 75 FR 10685, Mar. 9, 2010, unless porting registrant shall personally wit- otherwise noted. ness the destruction of the controlled substance until it is rendered non-re- § 1321.01 DEA mailing addresses. trievable. The following table provides informa- (d) On-site destruction. If the con- tion regarding mailing addresses to be trolled substances are destroyed at a used when sending specified cor- registrant’s registered location uti- respondence to the Drug Enforcement lizing an on-site method of destruction, Administration.

TABLE OF DEA MAILING ADDRESSES

Code of Federal Regulations Section—Topic DEA mailing address

DEA Administrator

1308.43(b)—Petition to initiate proceedings for rulemaking. Drug Enforcement Administration, Attn: Administrator, 8701 1316.23(b)—Petition for grant of confidentiality for research Morrissette Drive, Springfield, VA 22152. subjects. 1316.24(b)—Petition for exemption from prosecution for researchers.

DEA Diversion Control Division

1307.03—Exception request filing. Drug Enforcement Administration, Attn: Diversion Control Divi- 1307.22—Delivery of surrendered and forfeited controlled sub- sion/DC, 8701 Morrissette Drive, Springfield, VA 22152. stances. 1310.21(b)—Sale by Federal departments or agencies of chemicals which could be used to manufacture controlled substances certification request.2

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TABLE OF DEA MAILING ADDRESSES—Continued

Code of Federal Regulations Section—Topic DEA mailing address

DEA Regulatory Section

1301.71(d)—Security system compliance review for controlled Drug Enforcement Administration, Attn: Regulatory Section/ substances. DRG, 8701 Morrissette Drive, Springfield, VA 22152. 1309.71(c)—Security system compliance review for List I chemicals. 1310.03(c)—Mail-Order reports involving transactions with non- regulated persons or exports.1 1310.05(b)(1)—Unusual or excessive loss or disappearance of listed chemicals. 1310.05(b)(2)—Reports of domestic regulated transactions in a tableting machine or an encapsulating machine.1 1310.05(c)(1)—Reports of imports and exports of a tableting machine or an encapsulating machine.1 1310.05(c)(2)—Report of declared exports of machines refused, rejected, or returned. 1312.12(a)—Application for import permit (DEA Form 357).1 1312.18(b)—Import declaration (DEA Form 236) submission.1 1312.22(g)(8)—Request for return of unacceptable or undeliverable exported controlled substances.1 1312.27(a)—Controlled substances export declaration (DEA Form 236) filing.1 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 486/486A).1 1313.12(e)—Quarterly reports of listed chemicals importation. 1313.21(b)—Authorization to export listed chemicals (DEA Form 486).1 1313.21(e)—Quarterly reports of listed chemicals exportation. 1313.22(c)—Notice of declared exports of listed chemicals refused, rejected or undeliverable.1 1313.31(b)—Advanced notice of importation for transshipment or transfer of listed chemicals. 1313.32(b)(1)—International transaction authorization (DEA Form 486).1 1314.110(a)(1)—Reports for mail-order sales. 1314.110(a)(2)—Request to submit mail-order sales reports.

DEA Drug & Chemical Evaluation Section

1308.21(a)—Exclusion of nonnarcotic substance. Drug Enforcement Administration, Attn: Drug & Chemical Eval- 1308.23(b)—Exemption for chemical preparations. uation Section/DRE, 8701 Morrissette Drive, Springfield, VA 1308.24(d)—Exempt narcotic chemical preparations importer/ 22152. exporter reporting. 1308.24(i)—Exempted chemical preparations listing. 1308.25(a)—Exclusion of veterinary anabolic steroid implant product application. 1308.26(a)—Excluded veterinary anabolic steroid implant products listing. 1308.31(a)—Exemption of a nonnarcotic prescription product application. 1308.32—Exempted prescription products listing. 1308.33(b)—Exemption of certain anabolic steroid products application. 1308.34—Exempted anabolic steroid products listing. 1310.13(b)—Exemption for chemical preparations. 1310.05(d)—Bulk manufacturer of listed chemicals reporting.

UN Reporting & Quota Section

1303.12(b)—Application for controlled substances procurement Drug Enforcement Administration, Attn: UN Reporting & Quota quota (DEA Form 250) filing and request. Section/DRQ, 8701 Morrissette Drive, Springfield, VA 22152.

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TABLE OF DEA MAILING ADDRESSES—Continued

Code of Federal Regulations Section—Topic DEA mailing address

1303.12(d)—Controlled substances quota adjustment request. 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. 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, and 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.

Pharmaceutical Investigations Section

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

DEA Registration Section

1301.03—Procedures information request (controlled sub- Drug Enforcement Administration, Attn: Registration Section/ stances registration). DRR P.O. Box 2639, Springfield, VA 22152–2639. 1301.13(e)(2)—Request DEA Forms 224, 225, and 363. 1301.14(a)—Controlled substances registration application submission. 1301.18(c)—Research project controlled substance increase request. 1301.51—Controlled substances registration modification request. 1301.52(b)—Controlled substances registration transfer request. 1301.52(c)—Controlled substances registration discontinuance of business activities notification. 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

1301.43—Request for hearing or appearance; waiver. Drug Enforcement Administration, Attn: Hearing Clerk/OALJ, 1303.34—Request for hearing or appearance; waiver. 8701 Morrissette Drive, Springfield, VA 22152. 1308.44—Request for hearing or appearance; waiver. 1316.45—Hearings documentation filing. 1316.46(a)—Inspection of record. 1316.47(a)—Request for hearing. 1316.48—Notice of appearance.

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TABLE OF DEA MAILING ADDRESSES—Continued

Code of Federal Regulations Section—Topic DEA mailing address

DEA Federal Register Representative

1301.33(a)—Filing of written comments regarding application Drug Enforcement Administration, Attn: Federal Register Rep- for bulk manufacture of Schedule I and II substances.2 resentative/DRW, 8701 Morrissette Drive, Springfield, VA 1301.34(a)—Filing of written comments regarding application 22152. for importation of Schedule I and II substances.2 http://www.regulations.gov/. 1303.11(c)—Filing of written comments regarding notice of an aggregate production quota.2 1303.13(c)—Filing of written comments regarding adjustments of aggregate production quotas.2 1303.13(c)—Filing of written comments regarding adjustments of aggregate production quotas.2 1308.43(g)—Filing of written comments regarding initiation of proceedings for rulemaking.2 1 Applications/filings/reports are required to be filed electronically in accordance with this chapter. 2 Applications/filings/reports may be filed electronically in accordance with this chapter.

[81 97041, Dec. 30, 2016] PARTS 1322–1399 [RESERVED]

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Part Page 1400 [Reserved] 1401 Public availability of information ...... 281 1402 Mandatory declassification review ...... 284 1403–1499 [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. Planning, Budget, and Administration of ONDCP will forward the request and All requests for the mandatory de- a copy of the document(s) along with classification review of classified infor- any other related materials, to the ap- mation in ONDCP files should be ad- propriate agency for review and deter- dressed to the Security Officer, Office mination as to release. Recommenda- of National Drug Control Policy, Exec- tions as to release or denial may be utive Office of the President, Wash- made if appropriate. The requester will ington, DC 20500, who will acknowledge be notified of the referral, unless the receipt of the request. When a request receiving agency objects on the does not reasonably describe the infor- grounds that its association with the mation sought, the requester shall be information requires protection. notified that unless additional information is provided, or the scope of the § 1402.5 Appeal procedure. request is narrowed, no further action will be taken. Appeals reviewed as a result of a denial will be routed to the Director of § 1402.3 Information in the custody of ONDCP, who will take action as nec- ONDCP. essary to determine whether any part Information contained in ONDCP of the information may be declassified. files and under the exclusive declas- If so, the Director shall notify the re- sification jurisdiction of ONDCP will quester of this determination and shall be reviewed by the Director of the Of- make any information available that is fice of Planning, Budget, and Adminis- declassified and is otherwise releas- tration of ONDCP and/or the office of able. If continued classification is re- primary interest to determine whether, quired, the requester shall be notified under the declassification provisions of by the Director of ONDCP of the rea- section 3.1 of Executive Order 12356 (3 sons therefore. CFR, 1982 Comp., p. 166), the requested § 1402.6 Fees. information may be declassified. If the information may not be released, in There will normally be no fees whole or in part, the requester shall be charged for the mandatory review of given a brief statement as to the rea- classified material for declassification sons for denial, a notice of the right to under this part. appeal the determination to the Direc- tor of ONDCP, and a notice that such § 1402.7 Suggestions and complaints. an appeal must be filed within 60 days Suggestions and complaints regard- in order to be considered. ing the information security program of ONDCP should be submitted, in writ- § 1402.4 Information classified by an- ing, to the Security Officer, Office of other agency. National Drug Control Policy, Wash- When a request is received for infor- ington, DC 20500. mation that was classified by another agency, the Director of the Office of PARTS 1403–1499 [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—599) VI National Capital Planning Commission (Parts 600—699)

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) X Department of the Treasury (Parts 1000—1099) 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 Department of Housing and Urban Development (Parts 2400— 2499) XXV National Science Foundation (Parts 2500—2599) XXVI National Archives and Records Administration (Parts 2600—2699)

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XXVII Small Business Administration (Parts 2700—2799) XXVIII Department of Justice (Parts 2800—2899) XXIX Department of Labor (Parts 2900—2999) 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) XXXVI Office of National Drug Control Policy, Executive Office of the President (Parts 3600—3699) XXXVII Peace Corps (Parts 3700—3799) LVIII Election Assistance Commission (Parts 5800—5899) LIX Gulf Coast Ecosystem Restoration Council (Parts 5900—5999)

Title 3—The President

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

Title 4—Accounts

I Government Accountability Office (Parts 1—199)

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) IV Office of Personnel Management and Office of the Director of National Intelligence (Parts 1400—1499) 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) 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)

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XXVIII Department of Justice (Parts 3800—3899) XXIX Federal Communications Commission (Parts 3900—3999) XXX Farm Credit System Insurance Corporation (Parts 4000—4099) XXXI Farm Credit Administration (Parts 4100—4199) XXXIII Overseas Private Investment Corporation (Parts 4300—4399) XXXIV Securities and Exchange Commission (Parts 4400—4499) XXXV Office of Personnel Management (Parts 4500—4599) XXXVI Department of Homeland Security (Parts 4600—4699) 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)

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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) 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) XCVIII Council of the Inspectors General on Integrity and Efficiency (Parts 9800—9899) XCIX Military Compensation and Retirement Modernization Commis- sion (Parts 9900—9999) C National Council on Disability (Parts 10000—10049) CI National Mediation Board (Part 10101)

Title 6—Domestic Security

I Department of Homeland Security, Office of the Secretary (Parts 1—199) 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)

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IX Agricultural Marketing Service (Marketing Agreements and Or- ders; Fruits, Vegetables, Nuts), Department of Agriculture (Parts 900—999) X Agricultural Marketing Service (Marketing Agreements and Or- ders; Milk), Department of Agriculture (Parts 1000—1199) XI Agricultural Marketing Service (Marketing Agreements and Or- ders; Miscellaneous Commodities), Department of Agriculture (Parts 1200—1299) XIV Commodity Credit Corporation, Department of Agriculture (Parts 1400—1499) XV Foreign Agricultural Service, Department of Agriculture (Parts 1500—1599) XVI Rural Telephone Bank, Department of Agriculture (Parts 1600— 1699) XVII Rural Utilities Service, Department of Agriculture (Parts 1700— 1799) XVIII Rural Housing Service, Rural Business-Cooperative Service, Rural Utilities Service, and Farm Service Agency, Depart- ment of Agriculture (Parts 1800—2099) XX Local Television Loan Guarantee Board (Parts 2200—2299) 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)

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

Title 9—Animals and Animal Products

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

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 (Parts 500—599) [Reserved] 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)

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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)

Title 13—Business Credit and Assistance

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

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 National Technical Information Service, Department of Com- merce (Parts 1100—1199)

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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) [Reserved]

Title 16—Commercial Practices

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) [Reserved]

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)

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IV Employees’ Compensation Appeals Board, Department of Labor (Parts 500—599) V Employment and Training Administration, Department of Labor (Parts 600—699) VI Office of Workers’ Compensation Programs, Department of Labor (Parts 700—799) VII Benefits Review Board, Department of Labor (Parts 800—899) VIII Joint Board for the Enrollment of Actuaries (Parts 900—999) IX Office of the Assistant Secretary for Veterans’ Employment and Training Service, Department of Labor (Parts 1000—1099)

Title 21—Food and Drugs

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

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)

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

Title 24—Housing and Urban Development

SUBTITLE A—OFFICE OF THE SECRETARY, DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT (PARTS 0—99) SUBTITLE B—REGULATIONS RELATING TO HOUSING AND URBAN DE- VELOPMENT I Office of Assistant Secretary for Equal Opportunity, Department of Housing and Urban Development (Parts 100—199) II Office of Assistant Secretary for Housing-Federal 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) 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) [Reserved] 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) [Reserved] XXV Neighborhood Reinvestment Corporation (Parts 4100—4199)

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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—899) V Bureau of Indian Affairs, Department of the Interior, and Indian Health Service, Department of Health and Human Services (Part 900—999) 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)

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

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VIII Office of Investment Security, 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) 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, Department of De- fense (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)

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IV Office of Career, Technical and Adult Education, Department of Education (Parts 400—499) V Office of Bilingual Education and Minority Languages Affairs, Department of Education (Parts 500—599) [Reserved] 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 (Parts 1100—1199) [Reserved] XII National Council on Disability (Parts 1200—1299)

Title 35 [Reserved]

Title 36—Parks, Forests, and Public Property

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

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

Title 40—Protection of Environment

I Environmental Protection Agency (Parts 1—1099) IV Environmental Protection Agency and Department of Justice (Parts 1400—1499) V Council on Environmental Quality (Parts 1500—1599) VI Chemical Safety and Hazard Investigation Board (Parts 1600— 1699) VII Environmental Protection Agency and Department of Defense; Uniform National Discharge Standards for Vessels of the Armed Forces (Parts 1700—1799) VIII Gulf Coast Ecosystem Restoration Council (Parts 1800—1899)

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)

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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) II—III [Reserved] IV Centers for Medicare & Medicaid Services, Department of Health and Human Services (Parts 400—699) V Office of Inspector General-Health Care, Department of Health and Human Services (Parts 1000—1099)

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)

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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) IX Denali Commission (Parts 900—999) 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 Administration for Children and Families, Department of Health and Human Services (Parts 1300—1399) XVI Legal Services Corporation (Parts 1600—1699) XVII National Commission on Libraries and Information Science (Parts 1700—1799) XVIII Harry S. Truman Scholarship Foundation (Parts 1800—1899) XXI Commission of Fine Arts (Parts 2100—2199) XXIII Arctic Research Commission (Parts 2300—2399) 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) V The First Responder Network Authority (Parts 500—599)

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1 Federal Acquisition Regulation (Parts 1—99) 2 Defense Acquisition Regulations System, Department of Defense (Parts 200—299) 3 Department of Health and Human Services (Parts 300—399) 4 Department of Agriculture (Parts 400—499) 5 General Services Administration (Parts 500—599) 6 Department of State (Parts 600—699) 7 Agency for International Development (Parts 700—799) 8 Department of Veterans Affairs (Parts 800—899) 9 Department of Energy (Parts 900—999) 10 Department of the Treasury (Parts 1000—1099) 12 Department of Transportation (Parts 1200—1299) 13 Department of Commerce (Parts 1300—1399) 14 Department of the Interior (Parts 1400—1499) 15 Environmental Protection Agency (Parts 1500—1599) 16 Office of Personnel Management, Federal Employees Health Benefits Acquisition Regulation (Parts 1600—1699) 17 Office of Personnel Management (Parts 1700—1799) 18 National Aeronautics and Space Administration (Parts 1800— 1899) 19 Broadcasting Board of Governors (Parts 1900—1999) 20 Nuclear Regulatory Commission (Parts 2000—2099) 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) 99 Cost Accounting Standards Board, Office of Federal Procure- ment Policy, Office of Management and Budget (Parts 9900— 9999)

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SUBTITLE A—OFFICE OF THE SECRETARY OF TRANSPORTATION (PARTS 1—99) SUBTITLE B—OTHER REGULATIONS RELATING TO TRANSPORTATION I Pipeline and Hazardous Materials Safety Administration, De- partment of Transportation (Parts 100—199) II Federal Railroad Administration, Department of Transportation (Parts 200—299) III Federal Motor Carrier Safety Administration, Department of Transportation (Parts 300—399) IV Coast Guard, Department of Homeland Security (Parts 400—499) V National Highway Traffic Safety Administration, Department of Transportation (Parts 500—599) VI Federal Transit Administration, Department of Transportation (Parts 600—699) VII National Railroad Passenger Corporation (AMTRAK) (Parts 700—799) VIII National Transportation Safety Board (Parts 800—999) X Surface Transportation Board (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 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 5, 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 of 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 Rural Development Administration 7, XLII Rural Housing Service 7, XVIII, XXXV Rural Telephone Bank 7, XVI Rural Utilities Service 7, XVII, XVIII, XLII Secretary of Agriculture, Office of 7, Subtitle A Transportation, Office of 7, XXXIII World Agricultural Outlook Board 7, XXXVIII Air Force, Department of 32, VII Federal Acquisition Regulation Supplement 48, 53 Air Transportation Stabilization Board 14, VI Alcohol and Tobacco Tax and Trade Bureau 27, I Alcohol, Tobacco, Firearms, and Explosives, Bureau of 27, II AMTRAK 49, VII American Battle Monuments Commission 36, IV American Indians, Office of the Special Trustee 25, VII Animal and Plant Health Inspection Service 7, III; 9, I

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2014 21 CFR—Continued 79 FR Page 21 CFR 79 FR Chapter II—Continued Page 1304.22 Heading, introductory Chapter II text and (e) revised; (f) 1300 Authority citation re- added...... 53563 vised...... 53559 1304.25 Heading, (a)(9) and (b)(9) 1300.01 Introductory text revised; revised ...... 53564 1304.33 Heading and (f) revised; (g) amended...... 53559 added...... 53564 1300.05 Added ...... 53560 1305.03 (e), (f) and (g) added ...... 53564 1301 Authority citation re- 1307.11 Heading revised; (a)(2) revised...... 53560 moved ...... 53565 1301.13 (e)(1)(i) and (ii) revised ...... 53560 1307.12 Removed ...... 53565 1301.25 (i) revised ...... 53561 1307.13 Revised ...... 53565 1301.29 Added; interim ...... 70089 1307.21 Removed ...... 53565 1301.51 Revised ...... 53561 1307.22 Heading revised; amend- 1301.52 (c) amended; (f) added...... 53561 ed ...... 53565 1301.71 (f) added...... 53561 1308.11 (h)(15) through (18) 1301.72 (a) introductory text re- added ...... 7582 vised...... 53562 (h)(19) through (28) added...... 12942 1308.13 (e)(1)(iii) and (iv) removed; 1301.74 (m) added...... 53562 (e)(1)(v) through (viii) redesig- 1301.75 (c) and (d) redesignated as nated as new (e)(1)(iii) through (d) and (e); new (c) added ...... 53562 (vi) ...... 49682 1301.76 (c) revised...... 53562 1308.14 (b)(3) added ...... 37629 1304 Authority citation re- (c)(49) through (54) redesignated vised...... 53562 as (c)(50) through (55); new 1304.03 (a) amended ...... 53562 (c)(49) added ...... 51247 1304.04 (a)(3) added ...... 53562 (c)(1) through (53) redesignated 1304.11 (e) introductory text, (2) as (c)(2) through (54); new (c)(1) and (3) revised; (e)(6) and (7) added ...... 10989 added...... 53562 1317 Added ...... 53565 1304.21 (a), (c) and (d) revised; (e) Chapter III added...... 53563 1403 Removed; interim...... 76106

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21 CFR—Continued 79 FR 21 CFR—Continued 81 FR Page Page Chapter III—Continued 1305.17 (d) revised; interim ...... 58839 1404 Removed; interim...... 76106 1308 Authority citation re- 1405 Removed; interim...... 76106 vised...... 97021\ 1308 Policy statement ...... 6175, 11429 2015 1308.01 Revised ...... 97021 1308.11 (b)(3) through (55) redesig- 21 CFR 80 FR Page nated as (b)(4) through (56); new (b)(3) added ...... 22025 Chapter II (d)(48), (49) and (50) added; (h)(1), 1308 Policy statement...... 27854, 70658 (2) and (3) removed; (h)(4) Technical correction ...... 70680, 78657 through (25) redesignated as 1308.11 (h)(29), (30) and (31) new (h)(1) through (22) ...... 29145 added ...... 5047 (h)(26) and (27) added...... 29496 (h)(1) through (8) removed; (h)(9) (d)(51) through (54) added; (h)(4) through (31) redesignated as through (7) removed; (h)(8) new (h)(1) through (23) ...... 14844 through (22), (26) and (27) redes- (h)(24) added...... 42385 ignated as new (h)(4) through 1308.12 (b)(1) introductory text re- (18), (19) and (20)...... 61133 vised ...... 3470 (d)(55), (56) and (57) added; (h)(1), (b)(4) revised ...... 54718 1308.14 (g)(3) added ...... 69864 (2) and (3) removed; (h)(4) 1308.22 Table amended; in- through (20) redesignated as terim...... 65634, 65637 new (h)(1) through (17) ...... 66184 (h)(18) added...... 79393 Chapter III (h)(19) added...... 85877 1403 Regulation at 79 FR 76106 (d)(58) added ...... 90196 confirmed...... 57383 (h)(23) through (28) added...... 93599 1404 Regulation at 79 FR 76106 (h)(25) added ...... 6175 confirmed...... 57383 1308.12 (c)(29) added; interim ...... 58839 1405 Regulation at 79 FR 76106 1308.15 (e)(1), (2) and (3) redesig- confirmed...... 57383 nated as (e)(2), (3) and (4); new (e)(1) added; interim...... 29491 2016 1308.21 (a) amended ...... 97021 1308.22 Regulation at 80 FR 65637 21 CFR 81 FR Page confirmed; table correctly 1300.01 (b) amended ...... 97018 amended ...... 6453 1300.02 (b) amended ...... 97019 Regulation at 80 FR 65634 con- 1301 Policy statement...... 53846 firmed ...... 6454 1301.12 (b)(3) revised...... 97019 1308.23 (b) amended ...... 97021 1301.24 (a)(1) revised...... 97019 1308.25 (a) amended ...... 97021 1301.26 (b) introductory text re- 1308.31 (a) amended ...... 97021 vised...... 97019 1308.33 (b) amended ...... 97021 1301.29 Removed...... 9766 1308.49 Revised ...... 97021 1301.34 (c)(2) revised ...... 97019 1309.26 (a)(1) revised...... 97021 1301.74 (g) revised; interim ...... 58839 1309.32 (d) revised...... 97021 (c) introductory text revised ...... 97020 1309.46 (d) amended ...... 97021 1301.75 (e) revised; interim ...... 58839 1309.51 (a) amended ...... 97021 1302.07 Revised ...... 97020 1309.71 (b)(5) and (7) revised ...... 97021 1303.12 (b) and (d) amended ...... 97020 1310 Heading revised ...... 97022 1303.22 Introductory text amend- 1310.03 (b) amended; (c) revised...... 97022 ed ...... 97020 1310.05 (a) through (e) revised ...... 97022 1304.02 Revised ...... 97020 1310.06 Revised ...... 97023 1304.21 (d) revised...... 97020 1310.13 (b) amended ...... 97025 1304.31 (a) amended ...... 97020 1312.03 Added ...... 97025 1304.32 (a) amended ...... 97020 1312.11 Revised ...... 97026 1304.33 (a) and (f)(1) revised...... 97020 1312.12 Revised ...... 97026 1305.07 Introductory text and (a) 1312.13 (e) revised...... 97027 revised; interim...... 58839 1312.14 Revised ...... 97027

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21 CFR—Continued 81 FR 2017 Page 1312.15 (a) and (b) amended ...... 97027 21 CFR 82 FR Page 1312.16 Revised ...... 97027 1312.18 Heading, (b), (c) introduc- Chapter II tory text and (3) revised; (e) 1300.01 Regulation at 81 FR 97018 through (h) added...... 97028 eff. date delayed to 3-21-17 ...... 8688 1312.19 Revised ...... 97029 1300.02 Regulation at 81 FR 97019 1312.21 Revised ...... 97029 eff. date delayed to 3-21-17 ...... 8688 1312.22 Revised ...... 97029 1301.12 Regulation at 81 FR 97019 1312.23 (e) revised...... 97032 eff. date delayed to 3-21-17 ...... 8688 1312.24 Revised ...... 97032 1301.24 Regulation at 81 FR 97019 1312.25 Revised ...... 97032 eff. date delayed to 3-21-17 ...... 8688 1312.26 Revised ...... 97033 1301.26 Regulation at 81 FR 97019 1312.27 Heading, (a) and (b) re- eff. date delayed to 3-21-17 ...... 8688 vised; (d) through (g) added ...... 97033 1301.34 Regulation at 81 FR 97019 1312.28 Revised ...... 97035 eff. date delayed to 3-21-17 ...... 8688 1312.31 (b) introductory text re- 1301.74 Regulation at 81 FR 97020 vised; (d)(2) and (3) amended; eff. date delayed to 3-21-17 ...... 8688 (d)(4) added ...... 97035 1302.07 Regulation at 81 FR 97020 1312.32 Revised ...... 97036 eff. date delayed to 3-21-17 ...... 8688 1313.03 Added ...... 97036 1303.12 Regulation at 81 FR 97020 eff. date delayed to 3-21-17 ...... 8688 1313.12 Heading, (a), (b), (c) introductory text, (d) and (e) intro- 1303.22 Regulation at 81 FR 97020 ductory text revised...... 97036 eff. date delayed to 3-21-17 ...... 8688 1313.13 Revised ...... 97036 1304.02 Regulation at 81 FR 97020 eff. date delayed to 3-21-17 ...... 8688 1313.14 Revised ...... 97037 1304.21 Regulation at 81 FR 97020 1313.15 Heading and (b) revised ...... 97037 eff. date delayed to 3-21-17 ...... 8688 1313.16 Heading and (b) revised ...... 97037 1304.31 Regulation at 81 FR 97020 1313.17 Revised ...... 97037 eff. date delayed to 3-21-17 ...... 8688 1313.21 Heading, (a), (b), (c) intro- 1304.32 Regulation at 81 FR 97020 ductory text, (d) and (e) intro- eff. date delayed to 3-21-17 ...... 8688 ductory text revised; (h) 1304.33 Regulation at 81 FR 97020 added...... 97038 eff. date delayed to 3-21-17 ...... 8688 1313.22 Revised ...... 97038 1308 Policy statement ...... 8590 1313.23 Revised ...... 97038 Regulation at 81 FR 97021 eff. 1313.26 Heading and (b) revised ...... 97039 date delayed to 3-21-17...... 8688 1313.27 Revised ...... 97039 1308.01 Regulation at 81 FR 97021 1313.31 (b) introductory text, (7), eff. date delayed to 3-21-17 ...... 8688 (8), (14) and (15) revised ...... 97039 1308.11 (h)(23) through (28) cor- 1313.32 Revised ...... 97039 rectly removed...... 2218 1313.33 (b) and (c) revised ...... 97040 (d)(59) through (68) added; (h)(1) 1313.34 Revised ...... 97040 through (10), (20), (21) and (22) 1313.35 Revised ...... 97040 removed; (h)(11) through (19) 1314.101 Regulation at 76 FR 20523 redesignated as new (h)(1) confirmed ...... 3959 through (9) ...... 12177 1314.102 Regulation at 76 FR 20523 (h)(10) through (15) added (tem- confirmed ...... 3959 porary) ...... 17123 1314.103 Regulation at 76 FR 20524 (h)(16) added (temporary) ...... 20547 confirmed ...... 3959 (h)(4) removed; (b)(3) through (56) 1314.110 (a)(1) and (2) amended ...... 97040 and (h)(5) through (15) redesig- 1315 Nomenclature change...... 97041 nated as (b)(4) through (57) and 1316.47 (a) revised...... 97041 (h)(4) through (14); new (b)(3) 1316.48 Revised ...... 97041 and new (15) added ...... 26351 1321.01 Revised ...... 97041 (h)(17) added (temporary) ...... 32457

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21 CFR—Continued 82 FR 21 CFR—Continued 82 FR Page Page Chapter II—Continued Chapter II—Continued (d)(69), (70) and (71) added; (h)(1), 1310.13 Regulation at 81 FR 97025 (2) and (3) removed; (h)(4) eff. date delayed to 3-21-17 ...... 8688 through (17) redesignated as 1312.03 Regulation at 81 FR 97025 (h)(1) through (14)...... 47974 eff. date delayed to 3-21-17 ...... 8688 (h)(15) through (21) added (tem- 1312.11 Regulation at 81 FR 97026 porary) ...... 49508 eff. date delayed to 3-21-17 ...... 8688 (h)(18) added (temporary) ...... 51158 1312.12 Regulation at 81 FR 97026 (b)(40) through (57) redesignated eff. date delayed to 3-21-17 ...... 8688 as (b)(41) through (58); new 1312.13 Regulation at 81 FR 97027 (b)(40) added...... 58559 eff. date delayed to 3-21-17 ...... 8688 1308.12 (f)(2) added; interim ...... 14820 1312.14 Regulation at 81 FR 97027 (b)(1) introductory text revised eff. date delayed to 3-21-17 ...... 8688 ...... 45438 1312.15 Regulation at 81 FR 97027 Regulation at 82 FR 14820 con- eff. date delayed to 3-21-17 ...... 8688 firmed...... 55506 1312.16 Regulation at 81 FR 97027 1308.15 Regulation at 81 FR 29491 eff. date delayed to 3-21-17 ...... 8688 confirmed...... 13069 1312.18 Regulation at 81 FR 97028 eff. date delayed to 3-21-17 ...... 8688 1308.21 Regulation at 81 FR 97021 1312.19 Regulation at 81 FR 97029 eff. date delayed to 3-21-17 ...... 8688 eff. date delayed to 3-21-17 ...... 8688 1308.23 Regulation at 81 FR 97021 1312.21 Regulation at 81 FR 97029 eff. date delayed to 3-21-17 ...... 8688 eff. date delayed to 3-21-17 ...... 8688 1308.25 Regulation at 81 FR 97021 1312.22 Regulation at 81 FR 97029 eff. date delayed to 3-21-17 ...... 8688 eff. date delayed to 3-21-17 ...... 8688 1308.31 Regulation at 81 FR 97021 1312.23 Regulation at 81 FR 97032 eff. date delayed to 3-21-17 ...... 8688 eff. date delayed to 3-21-17 ...... 8688 1308.33 Regulation at 81 FR 97021 1312.24 Regulation at 81 FR 97032 eff. date delayed to 3-21-17 ...... 8688 eff. date delayed to 3-21-17 ...... 8688 1308.49 Regulation at 81 FR 97021 1312.25 Regulation at 81 FR 97032 eff. date delayed to 3-21-17 ...... 8688 eff. date delayed to 3-21-17 ...... 8688 1309.26 Regulation at 81 FR 97021 1312.26 Regulation at 81 FR 97033 eff. date delayed to 3-21-17 ...... 8688 eff. date delayed to 3-21-17 ...... 8688 1309.32 Regulation at 81 FR 97021 1312.27 Regulation at 81 FR 97033 eff. date delayed to 3-21-17 ...... 8688 eff. date delayed to 3-21-17 ...... 8688 1309.46 Regulation at 81 FR 97021 1312.28 Regulation at 81 FR 97035 eff. date delayed to 3-21-17 ...... 8688 eff. date delayed to 3-21-17 ...... 8688 1309.51 Regulation at 81 FR 97021 1312.31 Regulation at 81 FR 97035 eff. date delayed to 3-21-17 ...... 8688 eff. date delayed to 3-21-17 ...... 8688 1309.71 Regulation at 81 FR 97021 1312.32 Regulation at 81 FR 97036 eff. date delayed to 3-21-17 ...... 8688 eff. date delayed to 3-21-17 ...... 8688 1310 Regulation at 81 FR 97022 eff. 1313.03 Regulation at 81 FR 97036 date delayed to 3-21-17 ...... 8688 eff. date delayed to 3-21-17 ...... 8688 1310.02 (a)(1) through (30) redesig- 1313.12 Regulation at 81 FR 97036 nated as (a)(2) through (31); eff. date delayed to 3-21-17 ...... 8688 new (a)(1) added ...... 32460 1313.13 Regulation at 81 FR 97036 1310.03 Regulation at 81 FR 97022 eff. date delayed to 3-21-17 ...... 8688 eff. date delayed to 3-21-17 ...... 8688 1313.14 Regulation at 81 FR 97037 1310.04 (g)(1)(i) through (x) redes- eff. date delayed to 3-21-17 ...... 8688 ignated as (g)(1)(ii) through 1313.15 Regulation at 81 FR 97037 (xi); new (g)(1)(i) added...... 32460 eff. date delayed to 3-21-17 ...... 8688 1310.05 Regulation at 81 FR 97022 1313.16 Regulation at 81 FR 97037 eff. date delayed to 3-21-17 ...... 8688 eff. date delayed to 3-21-17 ...... 8688 1310.06 Regulation at 81 FR 97023 1313.17 Regulation at 81 FR 97037 eff. date delayed to 3-21-17 ...... 8688 eff. date delayed to 3-21-17 ...... 8688 1310.09 (n) added...... 32460 1313.21 Regulation at 81 FR 97038 1310.12 (c) table amended...... 32460 eff. date delayed to 3-21-17 ...... 8688

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21 CFR—Continued 82 FR 21 CFR—Continued 83 FR Page Page Chapter II—Continued Chapter II—Continued 1313.22 Regulation at 81 FR 97038 1303.32 (a) amended ...... 32790 eff. date delayed to 3-21-17 ...... 8688 1308 Policy statement ...... 4411, 21834 1313.23 Regulation at 81 FR 97038 1308.11 (h)(22) added (tem- eff. date delayed to 3-21-17 ...... 8688 porary) ...... 472 1313.26 Regulation at 81 FR 97039 (h)(23) through (29) added (tem- eff. date delayed to 3-21-17 ...... 8688 1313.27 Regulation at 81 FR 97039 porary)...... 4584 eff. date delayed to 3-21-17 ...... 8688 (h)(30) added (temporary)...... 5191 1313.31 Regulation at 81 FR 97039 (h)(23) and (29) revised; eff. eff. date delayed to 3-21-17 ...... 8688 through 2-1-20 ...... 10368 1313.32 Regulation at 81 FR 97039 (b)(18) through (58) redesignated eff. date delayed to 3-21-17 ...... 8688 as (b)(19) through (59); new 1313.33 Regulation at 81 FR 97040 (b)(18) and (60) added; (h)(2) and eff. date delayed to 3-21-17 ...... 8688 (4) removed ...... 17488 1313.34 Regulation at 81 FR 97040 (h)(31) through (35) added (tem- eff. date delayed to 3-21-17 ...... 8688 porary) ...... 31882 1313.35 Regulation at 81 FR 97040 (b) introductory text amended; eff. date delayed to 3-21-17 ...... 8688 (b)(57) through (60) redesig- 1314.110 Regulation at 81 FR 97040 nated as (b)(62) through (65); eff. date delayed to 3-21-17 ...... 8688 (b)(46) through (56) redesig- 1315 Regulation at 81 FR 97041 eff. nated as (b)(50) through new date delayed to 3-21-17 ...... 8688 (60); (b)(32) through (45) redes- 1316.47 Regulation at 81 FR 97041 ignated as (b)(35) through (48); eff. date delayed to 3-21-17 ...... 8688 (b)(4) through (31) redesignated 1316.48 Regulation at 81 FR 97041 as (b)(5) through (32); new eff. date delayed to 3-21-17 ...... 8688 (b)(4), new (33), new (34), new 1321.01 Regulation at 81 FR 97041 (49), and new (61) added; (h)(5), eff. date delayed to 3-21-17 ...... 8688 (13), (14), (20), and (29) removed ...... 61323 2018 (h)(36) added (temporary) ...... 44478 21 CFR 83 FR 1308.15 (f) added...... 48953 Page 1312 Authority citation re- Chapter II vised...... 48953 1301 Authority citation re- 1312.30 Introductory text revised; vised ...... 3074 (b) added ...... 48953 1301.28 (b)(1)(i), (ii) and (iii) revised ...... 3074 2019 1303.11 (b)(4) amended; (b)(5) redesignated as (b)(7); new (b)(5) (Regulations published from January 1, and (6) added; (c) revised...... 32789 2019, through April 1, 2019) 1303.12 (b) amended ...... 32790 21 CFR 84 FR 1303.13 (b)(1) and (c) revised ...... 32790 Page 1303.21 (a) amended ...... 32790 1303.22 (c)(2) amended; (d) Chapter II added...... 32790 1308.11 (d)(72) added; (h)(1) re- 1303.23 (a)(2) and (b)(2) amend- moved ...... 448 ed ...... 32790 1308.12 (g)(3) revised ...... 2449 Æ

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