Title 21–Food and Drugs

(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 ...... 100 1307 Miscellaneous ...... 112 1308 Schedules of controlled substances ...... 114 1309 Registration of manufacturers, distributors, importers and exporters of list I chemicals ...... 142 1310 Records and reports of listed chemicals and certain machines; importation and exportation of certain machines ...... 153 1311 Requirements for electronic orders and prescriptions ...... 180 1312 Importation and exportation of controlled substances ...... 200 1313 Importation and exportation of list I and list II chemicals ...... 224 1314 Retail sale of scheduled listed chemical products ... 237 1315 Importation and production quotas for ephedrine, pseudoephedrine, and phenylpropanolamine ...... 245 1316 Administrative functions, practices, and procedures ...... 256 1317 Disposal ...... 269 1321 DEA Mailing addresses ...... 278 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 porate officer or official signing the af- pharmacy business of llllllllll (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)(1)(iv) 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 registrants generally, prepare an annual sels, aircraft, or other entities de- report as of the date on which his/her scribed in this section or in Article 32 registration expires, which shall give of the Single Convention on Narcotic 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 re- present 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; 84 FR 68342, Dec. 16, macy as well as the date upon which 2019] such activity will commence; and (2) Such activity is authorized by § 1301.26 Exemptions from import or state law; and export requirements for personal (3) The total number of dosage units medical use. of all controlled substances distributed Any individual who has in his/her by the pharmacy during any calendar possession a controlled substance listed

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in schedules II, III, IV, or V, which he/ pharmacy may install and operate an 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 (c) A registered retail pharmacy ap- possessed for his/her personal use, or plying for a separate registration to for an animal accompanying him/her; operate an automated dispensing sys- and tem for the dispensing of controlled (2) The trade or chemical name and substances at a long term care facility the symbol designating the schedule of is exempt from application fees for any the controlled substance if it appears such additional registrations. on the container label, or, if such name 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 approved by the Food and Drug Ad- tion, a United States resident may im- ministration specifically for use in port into the United States no more maintenance or detoxification than 50 dosage units combined of all treatment. such controlled substances in the individual’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 reg- (1) The individual practitioner meets istrant. the conditions specified in paragraph (b) of this section. [69 FR 55347, Sept. 14, 2004, as amended at 81 (2) The narcotic drugs or combina- FR 97019, Dec. 30, 2016] tion of narcotic drugs meet the condi- § 1301.27 Separate registration by re- tions specified in paragraph (c) of this tail pharmacies for installation and section. operation of automated dispensing (3) The individual practitioner is in systems at long term care facilities. compliance with either paragraph (d) (a) A retail pharmacy may install or paragraph (e) of this section. and operate automated dispensing sys- (b)(1) The individual practitioner tems, as defined in § 1300.01 of this must submit notification to the Sec- chapter, at long term care facilities, retary of Health and Human Services under the requirements of § 1301.17. No stating the individual practitioner’s in- person other than a registered retail tent to dispense or prescribe narcotic

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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 FR32790, 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. meets or exceeds one of the following 1305.01 Scope of part 1305. 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 dispensing of controlled substances falls Subpart B—DEA Form 222 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 this section apply to every pharmacy 222. 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. online pharmacy dispenses any con- 1305.16 Lost and stolen DEA Forms 222. 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, electronic file upload, or other means Subpart C—Electronic Orders as approved by DEA. 1305.20 Transition provisions allowing con- (e) Reports shall be filed every month tinued use of existing stocks of triplicate not later than the fifteenth day of the DEA Forms 222. month succeeding the month for which 1305.21 Requirements for electronic orders. they are submitted. 1305.22 Procedure for filling electronic orders. (f) An online pharmacy filing a report 1305.23 Endorsing electronic orders. under paragraph (a) of this section 1305.24 Central processing of orders. shall utilize the National Drug Code 1305.25 Unaccepted and defective electronic number assigned to the product under orders. the National Drug Code System of the 1305.26 Lost electronic orders. Food and Drug Administration, and in- 1305.27 Preservation of electronic orders. 1305.28 Canceling and voiding electronic or- dicate the total number of dosage units ders. dispensed for each such National Drug 1305.29 Reporting to DEA. Code number. AUTHORITY: 21 U.S.C. 821, 828, 871(b), unless (g) Records required to be kept under otherwise noted. this section must be kept by the reg- SOURCE: 70 FR 16911, Apr. 1, 2005, unless istrant for at least two years from the otherwise noted. date of such records. The information shall be readily retrievable from the ordinary business records of the reg- Subpart A—General Requirements istrant and available for inspection and § 1305.01 Scope of part 1305. copying by authorized employees of the Procedures governing the issuance, Administration. use, and preservation of orders for [74 FR 15623, Apr. 6, 2009] Schedule I and II controlled substances

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are set forth generally by section 308 of and use DEA Form 222 (order forms) or the Act (21 U.S.C. 828) and specifically issue electronic orders for these sub- by the sections of this part. stances. Persons not registered to handle Schedule I or II controlled sub- § 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 distribution of a Schedule I or II controlled § 1305.05 Power of attorney. 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 distributors and distributors by collectors and Power of Attorney for DEA Forms 222 law enforcement pursuant to § 1317.55 of and Electronic Orders 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

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to sign orders for Schedule I and II con- (f) A power of attorney executed trolled substances, whether these or- under this section may be signed elec- ders be on Form 222 or electronic, in tronically, by any or all of the persons accordance with 21 U.S.C. 828 and Part required to sign. 1305 of Title 21 of the Code of Federal [70 FR 16911, Apr. 1, 2005, as amended at 84 Regulations. I hereby ratify and con- FR 51374, Sept. 30, 2019] firm all that said attorney must lawfully do or cause to be done by virtue § 1305.06 Persons entitled to fill orders hereof. for Schedule I and II controlled llllllllllllllllllllllll substances. (Signature of person granting power) An order for Schedule I and II con- I, llll (name of attorney-in-fact), trolled substances, whether on a DEA hereby affirm that I am the person Form 222 or an electronic order, may named herein as attorney-in-fact and be filled only by a person registered that the signature affixed hereto is my with DEA as a manufacturer or dis- signature. tributor of controlled substances listed in Schedule I or II pursuant to section (signature of attorney-in-fact) 303 of the Act (21 U.S.C. 823) or as an Witnesses: importer of such substances pursuant 1. llllll to section 1008 of the Act (21 U.S.C. 958), except for the following: 2. llllll (a) A person registered with DEA to Signed and dated on the llll day of dispense the substances, or to export llll, (year), at llll . the substances, if he/she is discontinuing business or if his/her reg- Notice of Revocation istration is expiring without rereg- The foregoing power of attorney is istration, may dispose of any Schedule hereby revoked by the undersigned, I or II controlled substances in his/her who is authorized to sign the current possession with a DEA Form 222 or an application for registration of the electronic order in accordance with above-named registrant under the Con- § 1301.52 of this chapter. trolled Substances Act or the Con- (b) A purchaser who has obtained any trolled Substances Import and Export Schedule I or II controlled substance Act. Written notice of this revocation by either a DEA Form 222 or an elec- has been given to the attorney-in-fact tronic order may return the substance llll this same day. to the supplier of the substance with llllllllllllllllllllllll either a DEA Form 222 or an electronic (Signature of person revoking power) order from the supplier. (c) A person registered to dispense Witnesses: Schedule II substances may distribute 1. llllll the substances to another dispenser 2. llllll with either a DEA Form 222 or an elec- Signed and dated on the llll day of tronic order only in the circumstances llll, (year), at llll. described in § 1307.11 of this chapter. (d) A power of attorney must be exe- (d) A person registered or authorized cuted by: to conduct chemical analysis or re- (1) The registrant, if an individual; a search with controlled substances may partner of the registrant, if a partner- distribute a Schedule I or II controlled ship; or an officer of the registrant, if substance to another person registered a corporation, corporate division, asso- or authorized to conduct chemical ciation, trust or other entity; analysis, instructional activities, or re- (2) The person to whom the power of search with the substances with either attorney is being granted; and a DEA Form 222 or an electronic order, (3) Two witnesses. if the distribution is for the purpose of (e) A power of attorney must be re- furthering the chemical analysis, in- voked by the person who signed the structional activities, or research. most recent application for DEA reg- (e) A person registered as a istration or reregistration, and two compounder of narcotic substances for witnesses. use at off-site locations in conjunction

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with a narcotic treatment program at Any person holding a registration au- the compounding location, who is authorizing the person to obtain a DEA thorized to handle Schedule II nar- Form 222 may requisition the forms cotics, is authorized to fill either a through a DEA secured network con- DEA Form 222 or an electronic order nection or by contacting any Division for distribution of narcotic drugs to Office or the Registration Section of off-site narcotic treatment programs the Administration through the cus- only. tomer service center. (c) Each requisition must show the § 1305.07 Special procedure for filling certain orders. name, address, and registration number of the registrant and the number of A supplier of thiafentanil, DEA Forms 222 desired. carfentanil, etorphine hydrochloride, (d) DEA Forms 222 will have an order or diprenorphine, if he or she determines that the purchaser is a veteri- form number and be issued with the narian engaged in zoo and exotic ani- name, address and registration number mal practice, wildlife management proof the registrant, the authorized activ- grams, or research, and is authorized ity, and schedules of the registrant. by the Administrator to handle these This information cannot be altered or substances, may fill the order in ac- changed by the registrant; the reg- cordance with the procedures set forth istrant must report any errors to the in § 1305.17 except that: local Division Office or the Registra- (a) A DEA Form 222 or an electronic tion Section of the Administration to order for thiafentanil, carfentanil, modify the registration. etorphine hydrochloride, and [84 FR 51374, Sept. 30, 2019] diprenorphine must contain only these substances in reasonable quantities. § 1305.12 Procedure for executing DEA (b) The substances must be shipped, Forms 222. under secure conditions using substantial packaging material with no mark- (a) A purchaser must prepare and ings on the outside that would indicate execute a DEA Form 222 by use of a the content, only to the purchaser’s typewriter, computer printer, pen, or registered location. indelible pencil. (b) Only one item may be entered on [70 FR 16911, Apr. 1, 2005, as amended at 81 FR 58839, Aug. 26, 2016] each numbered line. An item must consist of one or more commercial or bulk containers of the same finished or bulk Subpart B—DEA Form 222 form and quantity of the same sub- § 1305.11 Procedure for obtaining DEA stance. The number of lines completed Forms 222. must be noted on that form at the bot- (a) DEA Forms 222 are issued in mail- tom of the form, in the space provided. ing envelopes containing a predeter- DEA Forms 222 for carfentanil, mined number of forms based on the etorphine hydrochloride, and business activity of the registrant, diprenorphine must contain only these each form consisting of one single- substances. sheet. A limit, which is based on the (c) The name and address of the sup- business activity of the registrant, will plier from whom the controlled sub- be imposed on the number of DEA stances are being ordered must be en- Forms 222 that will be furnished upon a tered on the form. Only one supplier requisition for order forms unless addi- may be listed on any form. tional forms are specifically requested (d) Each DEA Form 222 must be and a reasonable need for such addi- signed and dated by a person author- tional forms is shown. ized to sign an application for registra- (b) Any person with an active reg- tion or a person granted power of at- istration that is authorized to order torney to sign a Form 222 under schedule I and II controlled substances § 1305.05. The name of the purchaser, if is entitled to obtain a DEA Form 222, different from the individual signing which will be supplied at any time the DEA Form 222, must also be inafter the DEA registration is granted. serted in the signature space.

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(e) Unexecuted DEA Forms 222 may If an order is filled by partial ship- be kept and may be executed at a loca- ments, the copy must be forwarded at tion other than the registered location the close of the month during which printed on the form, provided that all the final shipment is made or the 60- unexecuted forms are delivered day validity period expires. promptly to the registered location (e) The purchaser must record on its upon an inspection of the location by copy of the DEA Form 222 the number any officer authorized to make inspec- of commercial or bulk containers fur- tions, or to enforce, any Federal, State, nished on each item and the dates on or local law regarding controlled sub- which the containers are received by stances. the purchaser. [70 FR 16911, Apr. 1, 2005, as amended at 84 (f) DEA Forms 222 submitted by reg- FR 51374, Sept. 30, 2019] istered procurement officers of the De- § 1305.13 Procedure for filling DEA fense Supply Center of the Defense Lo- Forms 222. gistics Agency for delivery to armed (a) A purchaser must make a copy of services establishments within the the original DEA Form 222 for its United States may be shipped to loca- records and then submit the original to tions other than the location printed the supplier. The copy retained by the on the DEA Form 222, and in partial purchaser may be in paper or elec- shipments at different times not to ex- tronic form. ceed six months from the date of the (b) A supplier may fill the order, if order, as designated by the procure- possible and if the supplier desires to ment officer when submitting the do so, and must record on the original order. DEA Form 222 its DEA registration [70 FR 16911, Apr. 1, 2005, as amended at 84 number and the number of commercial FR 51374, Sept. 30, 2019] or bulk containers furnished on each item and the date on which the con- § 1305.14 Procedure for endorsing DEA tainers are shipped to the purchaser. If Forms 222. an order cannot be filled in its entirety, it may be filled in part and the (a) A DEA Form 222, made out to any balance supplied by additional ship- supplier who cannot fill all or a part of ments within 60 days following the the order within the time limitation date of the DEA Form 222. No DEA set forth in § 1305.13, may be endorsed Form 222 is valid more than 60 days to another supplier for filling. The en- after its execution by the purchaser, dorsement must be made only by the except as specified in paragraph (f) of supplier to whom the DEA Form 222 this section. was first made, must state (in the (c) The controlled substances must be spaces provided in Part 3 on the origi- shipped only to the purchaser and the nal DEA Form 222) the DEA number of location printed by the Administration the second supplier, and must be signed on the DEA Form 222, except as speci- and dated by a person authorized to ob- fied in paragraph (f) of this section. tain and execute DEA Forms 222 on be- (d) The supplier must retain the half of the first supplier. The first sup- original DEA Form 222 for the supplier may not fill any part of an order plier’s files in accordance with on an endorsed form. The second sup- § 1305.17(c). Any supplier who is not re- plier may fill the order, if possible and quired to report acquisition/disposition if the supplier desires to do so, in ac- transactions to the Automation of Re- cordance with § 1305.13(b), (c), and (d), ports and Consolidated Orders System including shipping all substances di- (ARCOS) under § 1304.33(c) (such as a rectly to the purchaser. practitioner) must make and submit a (b) Distributions made on endorsed copy of the original DEA Form 222 to DEA Forms 222 must be reported by the DEA, either by mail to the Registra- second supplier in the same manner as tion Section, or by email to all other distributions. [email protected]. The copy must be forwarded at the close of the [70 FR 16911, Apr. 1, 2005, as amended at 84 month during which the order is filled. FR 51375, Sept. 30, 2019]

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§ 1305.15 Unaccepted and defective chaser or supplier must immediately DEA Forms 222. upon discovery of the theft or loss, re- (a) A DEA Form 222 must not be port the theft or loss to the Special filled if either of the following apply: Agent in Charge of the Drug Enforce- (1) The order is not complete, legible, ment Administration in the Divisional or properly prepared, executed, or en- Office responsible for the area in which dorsed. the registrant is located, stating the (2) The order shows any alteration, serial number of each form stolen or erasure, or change of any description. lost. (b) If a DEA Form 222 cannot be filled (c) If the theft or loss includes any for any reason under this section, the original DEA Forms 222 received from supplier must return the original DEA purchasers and the supplier is unable Form 222 to the purchaser with a state- to state the serial numbers of the DEA ment as to the reason (e.g., illegible or Forms 222, the supplier must report the 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 any DEA Forms 222 are lost or statement that the order is not accept- stolen, and the purchaser is unable to ed is sufficient for purposes of this state the order form numbers of the paragraph. DEA Forms 222, the purchaser must re- (d) When a purchaser receives an port, in lieu of numbers of the forms, unaccepted order, the original DEA the date or approximate date of Form 222 and the statement must be issuance. retained in the files of the purchaser in (e) If any unused DEA Form 222 re- accordance with § 1305.17. A defective ported stolen or lost is subsequently DEA Form 222 may not be corrected; it recovered or found, the Special Agent must be replaced by a new DEA Form in Charge of the Drug Enforcement Ad- 222 for the order to be filled. ministration in the Divisional Office [70 FR 16911, Apr. 1, 2005, as amended at 84 responsible for the area in which the FR 51375, Sept. 30, 2019] registrant is located must immediately be notified. § 1305.16 Lost and stolen DEA Forms 222. [70 FR 16911, Apr. 1, 2005, as amended at 84 FR 51375, Sept. 30, 2019] (a) If a purchaser ascertains that an unfilled DEA Form 222 has been lost, § 1305.17 Preservation of DEA Forms the purchaser must execute another 222. and attach a statement containing the order form number and date of the lost (a) The purchaser must retain a copy form, and stating that the goods cov- of each executed DEA Form 222 and all ered by the first DEA Form 222 were copies of unaccepted or defective forms not received through loss of that DEA with each statement attached. Form 222. A copy of the second form (b) The supplier must retain the and a copy of the statement must be original of each DEA Form 222 that it retained with a copy of the DEA Form has filled. 222 first executed. A copy of the state- (c) DEA Forms 222 must be main- ment must be attached to a copy of the tained separately from all other second DEA Form 222 sent to the sup- records of the registrant. DEA Forms plier. If the first DEA Form 222 is sub- 222 are required to be kept available for sequently received by the supplier to inspection for a period of two years. If whom it was directed, the supplier a purchaser has several registered loca- must mark upon the face ‘‘Not accept- tions, the purchaser must retain a copy ed’’ and return the original DEA Form of the executed DEA Form 222 and any 222 to the purchaser, who must attach attached statements or other related it to the statement. documents (not including unexecuted (b) Whenever any used or unused DEA Forms 222, which may be kept DEA Forms 222 are stolen or lost (other elsewhere under § 1305.12(e)), at the reg- than in the course of transmission) by istered location printed on the DEA any purchaser or supplier, the pur- Form 222.

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(d) The supplier of thiafentanil, cancellation in paragraph (a) of this carfentanil, etorphine hydrochloride, section. and diprenorphine must maintain DEA [70 FR 16911, Apr. 1, 2005, as amended at 84 Forms 222 for these substances sepa- FR 51375, Sept. 30, 2019] rately from all other DEA Forms 222 and records required to be maintained § 1305.20 Transition provisions allow- by the registrant. ing continued use of existing stocks (e) Electronic copies of DEA Forms of triplicate DEA Forms 222. 222 will be deemed to be maintained Registrants may continue to use ex- separately from all other records of the isting stocks of the triplicate DEA registrant, for the purposes of this sec- Form 222 until October 30, 2021. In any tion, if such copies are readily retriev- case, as soon as a registrant’s supply of able separately from all other records. triplicate DEA Forms 222 is exhausted, Electronic copies of DEA Forms 222 the registrant must use the new single- may be stored on a system at a loca- sheet DEA Form 222. The provisions of tion different from the registered loca- this part are applicable to the use of tion, provided such copies are readily triplicate forms, except for the specific retrievable at the registered location. rules as provided in this section. (a) Procedure for obtaining triplicate [70 FR 16911, Apr. 1, 2005, as amended at 81 DEA Forms 222. The DEA will no longer FR 58839, Aug. 26, 2016; 84 FR 51375, Sept. 30, issue triplicate forms. Triplicate DEA 2019] Forms 222 will not be accepted after October 30, 2021. § 1305.18 Return of unused DEA Forms 222. (b) Procedure for executing triplicate DEA Forms 222. (1) A purchaser must If the registration of any purchaser prepare and execute a triplicate DEA terminates (because the purchaser dies, Form 222 simultaneously by means of ceases legal existence, discontinues interleaved carbon sheets that are part business or professional practice, or of the triplicate DEA Form 222. Trip- changes the name or address as shown licate DEA Form 222 must be prepared on the purchaser’s registration) or is by use of a typewriter, pen, or indelible suspended or revoked under § 1301.36 of pencil. this chapter for all Schedule I and II (2) Only one item may be entered on controlled substances for which the each numbered line. An item must con- purchaser is registered, the purchaser sist of one or more commercial or bulk must return all unused DEA Forms 222 containers of the same finished or bulk to the Registration Section. form and quantity of the same substance. The number of lines completed [84 FR 51375, Sept. 30, 2019] must be noted on that form at the bot- tom of the form, in the space provided. § 1305.19 Cancellation and voiding of Triplicate DEA Forms 222 for DEA Forms 222. carfentanil, etorphine hydrochloride, (a) A purchaser may cancel part or and diprenorphine must contain only all of an order on a DEA Form 222 by these substances. notifying the supplier in writing of the (3) The name and address of the sup- cancellation. The supplier must indi- plier from whom the controlled sub- cate the cancellation on the original stances are being ordered must be en- DEA Form 222 sent by the purchaser by tered on the form. Only one supplier drawing a line through the canceled may be listed on any form. items and printing ‘‘canceled’’ in the (4) Each triplicate DEA Form 222 space provided for the number of items must be signed and dated by a person shipped. authorized to sign an application for (b) A supplier may void part or all of registration or a person granted power an order on a DEA Form 222 by noti- of attorney to sign a DEA Form 222 fying the purchaser in writing of the under § 1305.05. The name of the pur- voiding. The supplier must indicate the chaser, if different from the individual voiding in the manner prescribed for signing the DEA Form 222, must also be inserted in the signature space.

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(5) Unexecuted DEA Forms 222 may (6) DEA triplicate Forms 222 sub- be kept and may be executed at a loca- mitted by registered procurement offi- tion other than the registered location cers of the Defense Supply Center of printed on the form, provided that all the Defense Logistics Agency for deliv- unexecuted forms are delivered ery to armed services establishments promptly to the registered location within the United States may be upon an inspection of the location by shipped to locations other than the lo- any officer authorized to make inspec- cation printed on the triplicate DEA tions, or to enforce, any Federal, State, Form 222, and in partial shipments at or local law regarding controlled sub- different times not to exceed six stances. months from the date of the order, as (c) Procedure for filling triplicate DEA designated by the procurement officer Forms 222. (1) A purchaser must submit when submitting the order. Copy 1 and Copy 2 of the triplicate (d) Procedure for endorsing triplicate DEA Form 222 to the supplier and re- DEA Forms 222. (1) A triplicate DEA tain Copy 3 in the purchaser’s files. Form 222, made out to any supplier (2) A supplier may fill the order, if who cannot fill all or a part of the possible and if the supplier desires to order within the time limitation set do so, and must record on Copies 1 and forth in paragraph (c) of this section, 2 the number of commercial or bulk may be endorsed to another supplier containers furnished on each item and for filling. The endorsement must be the date on which the containers are made only by the supplier to whom the shipped to the purchaser. If an order triplicate DEA Form 222 was first cannot be filled in its entirety, it may made, must state (in the spaces pro- be filled in part and the balance sup- vided on the reverse sides of Copies 1 plied by additional shipments within 60 and 2 of the triplicate DEA Form 222) days following the date of the trip- the name and address of the second licate DEA Form 222. No triplicate supplier, and must be signed by a per- DEA Form 222 is valid more than 60 son authorized to obtain and execute days after its execution by the pur- triplicate DEA Forms 222 on behalf of chaser, except as specified in paragraph (c)(6) of this section. the first supplier. The first supplier may not fill any part of an order on an (3) The controlled substances must be endorsed form. The second supplier shipped only to the purchaser and the may fill the order, if possible and if the location printed by the Administration on the triplicate DEA Form 222, except supplier desires to do so, in accordance as specified in paragraph (c)(6) of this with paragraphs (c)(2) through (4) of section. this section, including shipping all substances directly to the purchaser. (4) The supplier must retain Copy 1 of the triplicate DEA Form 222 for his or (2) Distributions made on endorsed her files in accordance with paragraph triplicate DEA Forms 222 must be re- (g)(3) of this section and forward Copy ported by the second supplier in the 2 to the Special Agent in Charge of the same manner as all other distributions. Drug Enforcement Administration in (e) Unaccepted and defective triplicate the area in which the supplier is lo- DEA Forms 222. (1) A triplicate DEA cated. Copy 2 must be forwarded at the Form 222 must not be filled if either of close of the month during which the the following apply: order is filled. If an order is filled by (i) The order is not complete, legible, partial shipments, Copy 2 must be for- or properly prepared, executed, or en- warded at the close of the month dur- dorsed. ing which the final shipment is made (ii) The order shows any alteration, or the 60-day validity period expires. erasure, or change of any description. (5) The purchaser must record on (2) If a triplicate DEA Form 222 can- Copy 3 of the triplicate DEA Form 222 not be filled for any reason under this the number of commercial or bulk con- section, the supplier must return Cop- tainers furnished on each item and the ies 1 and 2 to the purchaser with a dates on which the containers are re- statement as to the reason (e.g. illegi- ceived by the purchaser. ble or altered).

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(3) A supplier may for any reason ceived from purchasers and the sup- refuse to accept any order and if a supplier is unable to state the serial num- plier refuses to accept the order, a bers of the triplicate DEA Forms 222, statement that the order is not accept- the supplier must report the date or ed is sufficient for purposes of this approximate date of receipt and the paragraph. names and addresses of the purchasers. (4) When a purchaser receives an (4) If an entire book of triplicate DEA unaccepted order, Copies 1 and 2 of the Forms 222 is lost or stolen, and the pur- triplicate DEA Form 222 and the state- chaser is unable to state the serial ment must be attached to Copy 3 and numbers of the triplicate DEA Forms retained in the files of the purchaser in 222 in the book, the purchaser must re- accordance with paragraph (g) of this port, in lieu of the numbers of the section. A defective triplicate DEA forms contained in the book, the date Form 222 may not be corrected; it must or approximate date of issuance. be replaced by a new triplicate DEA Form 222 for the order to be filled. (5) If any unused triplicate DEA (f) Lost and stolen triplicate DEA Forms Form 222 reported stolen or lost is sub- 222. (1) If a purchaser ascertains that sequently recovered or found, the Spe- an unfilled triplicate DEA Form 222 cial Agent in Charge of the Drug En- has been lost, the purchaser must exe- forcement Administration in the Divi- cute another in triplicate and attach a sional Office responsible for the area in statement containing the serial num- which the registrant is located must ber and date of the lost form, and stat- immediately be notified. ing that the goods covered by the first (g) Preservation of triplicate DEA triplicate DEA Form 222 were not re- Forms 222. (1) The purchaser must received through loss of that triplicate tain Copy 3 of each executed triplicate DEA Form 222. Copy 3 of the second DEA Form 222 and all copies of form and a copy of the statement must unaccepted or defective forms with be retained with Copy 3 of the trip- each statement attached. licate DEA Form 222 first executed. A (2) The supplier must retain Copy 1 of copy of the statement must be at- each triplicate DEA Form 222 that it tached to Copies 1 and 2 of the second has filled. triplicate DEA Form 222 sent to the (3) Triplicate DEA Forms 222 must be supplier. If the first triplicate DEA maintained separately from all other Form 222 is subsequently received by records of the registrant. Triplicate the supplier to whom it was directed, DEA Forms 222 are required to be kept the supplier must mark upon the face available for inspection for a period of ‘‘Not accepted’’ and return Copies 1 and two years. If a purchaser has several 2 to the purchaser, who must attach it registered locations, the purchaser to Copy 3 and the statement. However, must retain Copy 3 of the executed if the registrant no longer can use trip- triplicate DEA Form 222 and any at- licate forms, then the registrant shall tached statements or other related doc- proceed by issuing a new single-sheet uments (not including unexecuted trip- form in accordance with § 1305.16. (2) Whenever any used or unused triplicate DEA Forms 222, which may be licate DEA Forms 222 are stolen or lost kept elsewhere under paragraph (b)(5) (other than in the course of trans- of this section), at the registered loca- mission) by any purchaser or supplier, tion printed on the triplicate DEA the purchaser or supplier must imme- Form 222. diately upon discovery of the theft or (4) The supplier of thiafentanil, loss, report the theft or loss to the Spe- carfentanil, etorphine hydrochloride, cial Agent in Charge of the Drug En- and diprenorphine must maintain trip- forcement Administration in the Divi- licate DEA Forms 222 for these sub- sional Office responsible for the area in stances separately from all other DEA which the registrant is located, stating triplicate Forms 222 and records re- the serial number of each form stolen quired to be maintained by the reg- or lost. istrant. (3) If the theft or loss includes any (h) Return of unused triplicate DEA original triplicate DEA Forms 222 re- Forms 222. If the registration of any

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purchaser terminates (because the pur- (5) The supplier’s DEA registration chaser dies, ceases legal existence, dis- number (may be completed by either continues business or professional the purchaser or the supplier). practice, or changes the name or ad- (6) The date the order is signed. dress as shown on the purchaser’s reg- (7) The name (including strength istration) or is suspended or revoked where appropriate) of the controlled under § 1301.36 of this chapter for all substance product or the National schedule I and II controlled substances Drug Code (NDC) number (the NDC for which the purchaser is registered, number may be completed by either the purchaser must return all unused the purchaser or the supplier). triplicate DEA Forms 222 to the Reg- (8) The quantity in a single package istration Section. or container. (i) Cancellation and voiding of trip- (9) The number of packages or con- licate DEA Forms 222. (1) A purchaser tainers of each item ordered. may cancel part or all of an order on a (c) An electronic order may include triplicate DEA Form 222 by notifying controlled substances that are not in the supplier in writing of the cancella- schedules I and II and non-controlled tion. The supplier must indicate the substances. cancellation on Copies 1 and 2 of the triplicate DEA Form 222 by drawing a § 1305.22 Procedure for filling elec- line through the canceled items and tronic orders. printing ‘‘canceled’’ in the space pro- (a) A purchaser must submit the vided for the number of items shipped. order to a specific supplier. The sup- (2) A supplier may void part or all of plier may initially process the order an order on a triplicate DEA Form 222 (e.g., entry of the order into the com- by notifying the purchaser in writing puter system, billing functions, inven- of the voiding. The supplier must indi- tory identification, etc.) centrally at cate the voiding in the manner pre- any location, regardless of the loca- scribed for cancellation in paragraph tion’s registration with DEA. Fol- (i)(1) of this section. lowing centralized processing, the supplier may distribute the order to one or [84 FR 51375, Sept. 30, 2019] 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,

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linked to each order, a record of the (2) Creates a record linked to the cen- number of commercial or bulk con- tral file noting both which items a lo- tainers furnished on each item and the cation filled and the location identity. 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

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order and stating that the goods cov- PART 1306—PRESCRIPTIONS ered by the first order were not received through loss of that order. GENERAL INFORMATION (b) If the purchaser executes an order to replace the lost order, the purchaser Sec. must electronically link an electronic 1306.01 Scope of part 1306. record of the second order and a copy 1306.02 Definitions. 1306.03 Persons entitled to issue prescrip- of the statement with the record of the tions. first order and retain them. 1306.04 Purpose of issue of prescription. (c) If the supplier to whom the order 1306.05 Manner of issuance of prescriptions. was directed subsequently receives the 1306.06 Persons entitled to fill prescriptions. first order, the supplier must indicate 1306.07 Administering or dispensing of nar- that it is ‘‘Not Accepted’’ and return it cotic drugs. to the purchaser. The purchaser must 1306.08 Electronic prescriptions. link the returned order to the record of 1306.09 Prescription requirements for online that order and the statement. pharmacies.

§ 1305.27 Preservation of electronic or- CONTROLLED SUBSTANCES LISTED IN SCHEDULE ders. II (a) A purchaser must, for each order 1306.11 Requirement of prescription. filled, retain the original signed order 1306.12 Refilling prescriptions; issuance of and all linked records for that order for multiple prescriptions. two years. The purchaser must also re- 1306.13 Partial filling of prescriptions. 1306.14 Labeling of substances and filling of tain all copies of each unaccepted or prescriptions. defective order and each linked state- 1306.15 Provision of prescription informa- ment. tion between retail pharmacies and cen- (b) A supplier must retain each origi- tral fill pharmacies for prescriptions of nal order filled and the linked records Schedule II controlled substances. for two years. (c) If electronic order records are CONTROLLED SUBSTANCES LISTED IN SCHEDULES III, IV, AND V maintained on a central server, the records must be readily retrievable at 1306.21 Requirement of prescription. the registered location. 1306.22 Refilling of prescriptions. 1306.23 Partial filling of prescriptions. § 1305.28 Canceling and voiding elec- 1306.24 Labeling of substances and filling of tronic orders. prescriptions. (a) A supplier may void all or part of 1306.25 Transfer between pharmacies of prescription information for Schedules III, an electronic order by notifying the IV, and V controlled substances for refill purchaser of the voiding. If the entire purposes. order is voided, the supplier must make 1306.26 Dispensing without prescription. an electronic copy of the order, indi- 1306.27 Provision of prescription informa- cate on the copy ‘‘Void,’’ and return it tion between retail pharmacies and cen- to the purchaser. The supplier is not tral fill pharmacies for initial and refill required to retain a record of orders prescriptions of Schedule III, IV, or V that are not filled. controlled substances. (b) The purchaser must retain an AUTHORITY: 21 U.S.C. 821, 829, 831, 871(b), electronic copy of the voided order. unless otherwise noted. (c) To partially void an order, the SOURCE: 36 FR 7799, Apr. 24, 1971; 36 FR supplier must indicate in the linked 13386, July 21, 1971, unless otherwise noted. record that nothing was shipped for Redesignated at 38 FR 26609, Sept. 24, 1973. each item voided. 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 sub- scription(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 of this section, no applicant or reg- established by section 202 of the Act (21 istrant is required to use the Adminis- U.S.C. 812) and nonnarcotic substances, tration Controlled Substances Code chemical preparations, veterinary ana- Number for any purpose. bolic steroid implant products, prescription 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 drugs and other substances, by what- [81 FR 97021, Dec. 30, 2016] ever official name, common or usual § 1308.02 Definitions. name, chemical name, or brand name designated, listed in this section. Each Any term contained in this part shall drug or substance has been assigned have the definition set forth in section the DEA Controlled Substances Code 102 of the Act (21 U.S.C. 802) or part Number set forth opposite it. 1300 of this chapter. (b) Opiates. Unless specifically ex- [62 FR 13967, Mar. 24, 1997] cepted or unless listed in another schedule, any of the following opiates, § 1308.03 Administration Controlled including their isomers, esters, ethers, Substances Code Number. salts, and salts of isomers, esters and (a) Each controlled substance, or ethers, whenever the existence of such basic class thereof, has been assigned isomers, esters, ethers and salts is pos- an ‘‘Administration Controlled Sub- sible within the specific chemical des- stances Code Number’’ for purposes of ignation (for purposes of 3- identification of the substances or methylthiofentanyl only, the term iso- class on certain Certificates of Reg- mer includes the optical and geometric istration issued by the Administration isomers): pursuant to §§ 1301.35 of this chapter (1) Acetyl-alpha- and on certain order forms issued by methylfentanyl ( -[1-(1-meth- the Administration pursuant to N yl-2-phenethyl)-4- § 1305.05(d) of this chapter. Applicants piperidinyl]- - for procurement and/or individual man- N phenylacetamide) ...... 9815 ufacturing quotas must include the appropriate code number on the applica- (2) Acetylmethadol ...... 9601 tion as required in §§ 1303.12(b) and (3) Acetyl fentanyl (N-(1- 1303.22(a) of this chapter. Applicants phenethylpiperidin-4-yl)-N- for import and export permits must in- phenylacetamide) ...... 9821 clude 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 (35) 4-Fluoroisobutyryl levo-alphacetylmethadol also fentanyl (N-(4-fluorophenyl)- known as levo-alpha- N-(1-phenethylpiperidin-4- acetylmethadol, yl)isobutyramide; other levomethadyl acetate, or name: para-fluoroisobutyryl LAAM) ...... 9603 fentanyl) ...... 9824 (8) Alphameprodine ...... 9604 (36) Furanyl fentanyl (N-(1- (9) Alphamethadol ...... 9605 phenethylpiperidin-4-yl)-N- (10) Alpha-methylfentanyl (N- phenylfuran-2-carboxamide) .. 9834 [1-(alpha-methyl-beta- (37) Furethidine ...... 9626 phenyl)ethyl-4-piperidyl] (38) Hydroxypethidine ...... 9627 propionanilide; 1-(1-methyl-2- (39) Ketobemidone ...... 9628 phenylethyl)-4-(N- (40) Levomoramide ...... 9629 propanilido) piperidine) ...... 9814 (41) Levophenacylmorphan ...... 9631 (11) Alpha-methylthiofentanyl (42) Methoxyacetyl fentanyl (2- (N-[1-methyl-2-(2- methoxy-N-(1- thienyl)ethyl-4-piperidinyl]- phenethylpiperidin-4-yl)-N- N-phenylpropanamide) ...... 9832 phenylacetamide) ...... 9825 (12) Benzethidine ...... 9606 (43) 3-Methylfentanyl (N-[3- (13) Betacetylmethadol ...... 9607 methyl-1-(2-phenylethyl)-4- (14) Beta-hydroxyfentanyl (N- piperidyl]-N- [1-(2-hydroxy-2-phenethyl)-4- phenylpropanamide) ...... 9813 piperidinyl]-N- (44) 3-methylthiofentanyl (N- phenylpropanamide) ...... 9830 [(3-methyl-1-(2-thienyl)ethyl- (15) Beta-hydroxy-3- 4-piperidinyl]-N- methylfentanyl (other name: phenylpropanamide) ...... 9833 N-[1-(2-hydroxy-2-phenethyl)- (45) Morpheridine ...... 9632 3-methyl-4-piperidinyl]-N- (46) MPPP (1-methyl-4-phenyl- phenylpropanamide ...... 9831 4-propionoxypiperidine) ...... 9661 (16) N-[1-[2-hydroxy-2- (47) MT–45 (1-cyclohexyl-4-(1,2- (thiophen-2- diphenylethyl)piperazine) ..... (9560) yl)ethyl]piperidin-4-yl]-N- (48) Noracymethadol ...... 9633 phenylpropionamide (Other (49) Norlevorphanol ...... 9634 name: beta- (50) Normethadone ...... 9635 Hydroxythiofentanyl) ...... 9836 (51) Norpipanone ...... 9636 (52) Ocfentanil (N-(2- (17) Betameprodine ...... 9608 fluorophenyl)-2-methoxy-N- (18) Betamethadol ...... 9609 (1-phenethylpiperidin-4- (19) Betaprodine ...... 9611 yl)acetamide) ...... 9838 (20) Butyryl fentanyl (N-(1- (53) ortho-Fluorofentanyl (N-(2- phenethylpiperidin-4-yl)-N- fluorophenyl)-N-(1- phenylbutyramide) ...... 9822 phenethylpiperidin-4- (21) Clonitazene ...... 9612 yl)propionamide); other (22) Cyclopropyl fentanyl (N-(1- name: 2-fluorofentanyl) ...... 9816 phenethylpiperidin-4-yl)-N- (54) para-Fluorobutyryl phenylcyclopropanecarboxa- fentanyl (N-(4-fluorophenyl)- mide) ...... 9845 N-(1-phenethylpiperidin-4- (23) Dextromoramide ...... 9613 yl)butyramide) ...... 9823 (24) Diampromide ...... 9615 (55) Para-fluorofentanyl (N-(4- (25) Diethylthiambutene ...... 9616 fluorophenyl)-N-[1-(2- (26) Difenoxin ...... 9168 phenethyl)-4-piperidinyl] (27) Dimenoxadol ...... 9617 propanamide ...... 9812 (28) Dimepheptanol ...... 9618 (56) PEPAP (1-(-2-phenethyl)-4- (29) Dimethylthiambutene ...... 9619 phenyl-4-acetoxypiperidine ... 9663 (30) Dioxaphetyl butyrate ...... 9621 (57) Phenadoxone ...... 9637 (31) Dipipanone ...... 9622 (58) Phenampromide ...... 9638 (32) Ethylmethylthiambutene .. 9623 (59) Phenomorphan ...... 9647 (33) Etonitazene ...... 9624 (60) Phenoperidine ...... 9641 (34) Etoxeridine ...... 9625 (61) Piritramide ...... 9642 116

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(62) Proheptazine ...... 9643 chemical designation (for purposes of (63) Properidine ...... 9644 this paragraph only, the term ‘‘isomer’’ (64) Propiram ...... 9649 includes the optical, position and geo- (65) Racemoramide ...... 9645 metric isomers): (66) Tetrahydrofuranyl fentanyl (1) Alpha-ethyltryptamine ...... 7249 (N-(1-phenethylpiperidin-4- Some trade or other names: yl)-N-phenyltetrahydrofuran- etryptamine; Monase; a- 2-carboxamide) ...... 9843 ethyl-1H-indole-3- (67) Thiofentanyl (N-phenyl-N- ethanamine; 3-(2- [1-(2-thienyl)ethyl-4- aminobutyl) indole; a-ET; piperidinyl]-propanamide ...... 9835 and AET. (68) Tilidine ...... 9750 (2) 4-bromo-2,5-dimethoxy-am- (69) Trimeperidine ...... 9646 phetamine ...... 7391 (70) U–47700 (3,4-Dichloro-N-[2- Some trade or other names: (dimethylamino)cyclohexyl]- 4-bromo-2,5-dimethoxy-a- N-methylbenzamide) ...... 9547 methylphenethylamine; (c) Opium derivatives. Unless specifi- 4-bromo-2,5-DMA cally excepted or unless listed in an- (3) 4-Bromo-2,5- other schedule, any of the following dimethoxyphenethylamine .... 7392 opium derivatives, its salts, isomers, Some trade or other names: and salts of isomers whenever the ex- 2-(4-bromo-2,5- istence of such salts, isomers, and salts dimethoxyphenyl)-1- of isomers is possible within the spe- aminoethane; alpha- cific chemical designation: desmethyl DOB; 2C-B, (1) Acetorphine ...... 9319 Nexus. (2) Acetyldihydrocodeine ...... 9051 (4) 2,5-dimethoxyamphetamine 7396 (3) Benzylmorphine ...... 9052 Some trade or other names: (4) Codeine methylbromide ...... 9070 2,5-dimethoxy-a- (5) Codeine-N-Oxide ...... 9053 methylphenethylamine; (6) Cyprenorphine ...... 9054 2,5-DMA (7) Desomorphine ...... 9055 (5) 2,5-dimethoxy-4- (8) Dihydromorphine ...... 9145 ethylamphet-amine ...... 7399 (9) Drotebanol ...... 9335 Some trade or other names: (10) Etorphine (except hydro- DOET chloride salt) ...... 9056 (6) 2,5-dimethoxy-4-(n)- (11) Heroin ...... 9200 propylthiophenethylamine (12) Hydromorphinol ...... 9301 (other name: 2C–T–7) ...... 7348 (13) Methyldesorphine ...... 9302 (7) 4-methoxyamphetamine ...... 7411 (14) Methyldihydromorphine .... 9304 Some trade or other names: (15) Morphine methylbromide .. 9305 4-methoxy-a- (16) Morphine methylsulfonate 9306 methylphenethylamine; (17) Morphine-N-Oxide ...... 9307 paramethoxyamphetami- (18) Myrophine ...... 9308 ne, PMA (19) Nicocodeine ...... 9309 (8) 5-methoxy-3,4- (20) Nicomorphine ...... 9312 methylenedioxy-amphet- (21) Normorphine ...... 9313 amine ...... 7401 (22) Pholcodine ...... 9314 (9) 4-methyl-2,5-dimethoxy-am- (23) Thebacon ...... 9315 phetamine ...... 7395 (d) Hallucinogenic substances. Unless Some trade and other specifically excepted or unless listed in names: 4-methyl-2,5- another schedule, any material, com- dimethoxy-a- pound, mixture, or preparation, which methylphenethylamine; contains any quantity of the following ‘‘DOM’’; and ‘‘STP’’ hallucinogenic substances, or which (10) 3,4-methylenedioxy am- contains any of its salts, isomers, and phetamine ...... 7400 salts of isomers whenever the existence (11) 3,4- of such salts, isomers, and salts of iso- methylenedioxymethamphet- mers is possible within the specific amine (MDMA) ...... 7405 117

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

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Meaning Some trade or other names: tetrahydrocannabinols 1-[1-(2-thienyl)- naturally contained in a cyclohexyl]-piperidine, 2- plant of the genus Can- thienylanalog of nabis (cannabis plant), as phencyclidine, TPCP, well as synthetic equiva- TCP lents of the substances (35) 1-[1-(2- contained in the cannabis thieny- plant, or in the resinous l)cyclohexyl]pyrrolidine ...... 7473 extractives of such plant, Some other names: TCPy and/or synthetic sub- (36) 4-methylmethcathinone stances, derivatives, and (Mephedrone) ...... 1248 their isomers with simi- (37) 3,4- lar chemical structure methylenedioxypyrovalerone and pharmacological ac- (MDPV) ...... 7535 tivity to those substances (38) 2-(2,5-Dimethoxy-4- contained in the plant, ethylphenyl)ethanamine (2C– such as the following: E) ...... 7509 1 cis or trans (39) 2-(2,5-Dimethoxy-4- tetrahydrocannabinol, methylphenyl)ethanamine and their optical isomers (2C–D) ...... 7508 6 cis or trans (40) 2-(4-Chloro-2,5- tetrahydrocannabinol, dimethoxyphenyl)ethanamine and their optical isomers (2C–C) ...... 7519 3, 4 cis or trans (41) 2-(4-Iodo-2,5- tetrahydrocannabinol, dimethoxyphenyl)ethanamine and its optical isomers (2C–I) ...... 7518 (Since nomenclature of (42) 2-[4-(Ethylthio)-2,5- these substances is not dimethoxyphenyl]ethanamine internationally standard- (2C–T–2) ...... 7385 ized, compounds of these (43) 2-[4-(Isopropylthio)-2,5- structures, regardless of dimethoxyphenyl]ethanamine numerical designation of (2C–T–4) ...... 7532 atomic positions cov- (44) 2-(2,5- ered.) Dimethoxypheny- (32) Ethylamine analog of l)ethanamine (2C–H) ...... 7517 phencyclidine ...... 7455 (45) 2-(2,5-Dimethoxy-4-nitro- Some trade or other names: phenyl)ethanamine (2C–N) .... 7521 N-ethyl-1- (46) 2-(2,5-Dimethoxy-4-(n)- phenylcyclohexylamine, propylphenyl)ethanamine (1- (2C–P) ...... 7524 phenylcyclohexy- (47) 3,4-Methylenedioxy-N- l)ethylamine, N-(1- methylcathinone (Methylone) 7540 phenylcyclohexy- (48) (1-pentyl-1H-indol-3- l)ethylamine, yl)(2,2,3,3- cyclohexamine, PCE tetramethylcyclopropy- (33) Pyrrolidine analog of l)methanone (UR-144) ...... (7144) phencyclidine ...... 7458 (49) [1-(5-fluoro-pentyl)-1H- Some trade or other names: indol-3-yl](2,2,3,3- 1-(1-phenylcyclohexyl)- tetramethylcyclopropy- pyrrolidine, PCPy, PHP l)methanone (5-fluoro-UR-144, (34) Thiophene analog of XLR11) ...... (7011) phencyclidine ...... 7470 (50) N-(1-adamantyl)-1-pentyl- 1H-indazole-3-carboxamide (APINACA, AKB48) ...... (7048) (51) quinolin-8-yl 1-pentyl-1H- indole-3-carboxylate (PB-22; QUPIC) ...... (7222) 119

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(52) quinolin-8-yl 1-(5- (68) alpha- fluoropentyl)-1H-indole-3- pyrrolidinobutiophenone (a- carboxylate (5-fluoro-PB-22; PBP) ...... (7546) 5F-PB-22) ...... (7225) (69) N-(1-amino-3-methyl-1- (53) N-(1-amino-3-methyl-1- oxobutan-2-yl)-1- oxobutan-2-yl)-1-(4- (cyclohexylmethyl)-1H-inda- fluorobenzyl)-1H-indazole-3- zole-3-carboxamide (AB- carboxamide (AB- CHMINACA) ...... (7031) FUBINACA) ...... (7012) (70) N-(1-amino-3-methyl-1- (54) N-(1-amino-3,3-dimethyl-1- oxobutan-2-yl)-1-pentyl-1H- oxobutan-2-yl)-1-pentyl-1H- indazole-3-carboxamide (AB- indazole-3-carboxamide PINACA) ...... (7023) (ADB-PINACA) ...... (7035) (71) [1-(5-fluoropentyl)-1H- (55) 2-(4-iodo-2,5- indazol-3-yl](naphthalen-1- dimethoxyphenyl)-N-(2-me- yl)methanone (THJ-2201) ...... (7024) thoxybenzyl)ethanamine (25I- (72) N-(1-amino-3,3-dimethyl-1- NBOMe, 2C-I-NBOMe) ...... (7538) oxobutan-2-yl)-1- (56) 2-(4-chloro-2,5- (cyclohexylmethyl)-1H-inda- dimethoxyphenyl)-N-(2-me- zole-3-carboxamide (MAB- thoxybenzyl)ethanamine CHMINACA; ADB- (25C-NBOMe, 2C-C-NBOMe) ... (7537) CHMINACA) ...... (7032) (57) 2-(4-bromo-2,5- (73) methyl 2-(1-(5- dimethoxyphenyl)-N-(2-me- fluoropentyl)-1H-indazole-3- thoxybenzyl)ethanamine carboxamido)-3,3- (25B-NBOMe, 2C-B-NBOMe) ... (7536) dimethylbutanoate (Other (58) Marihuana Extract—Mean- names: 5F-ADB; 5F-MDMB- ing an extract containing one PINACA) ...... 7034 or more cannabinoids that (74) methyl 2-(1-(5- has been derived from any fluoropentyl)-1H-indazole-3- plant of the genus Cannabis, carboxamido)-3- other than the separated methylbutanoate (Other resin (whether crude or puri- names: 5F-AMB) ...... 7033 fied) obtained from the plant (7350) (75) N-(adamantan-1-yl)-1-(5- (59) 4-methyl-N-ethylcathinone fluoropentyl)-1H-indazole-3- (4-MEC) ...... (1249) carboxamide (Other names: (60) 4-methyl-alpha- 5F-APINACA, 5F-AKB48) ...... 7049 pyrrolidinopropiophenone (4- (76) N-(1-amino-3,3-dimethyl-1- MePPP) ...... (7498) oxobutan-2-yl)-1-(4- (61) alpha- fluorobenzyl)-1H-indazole-3- pyrrolidinopentiophenone (a- carboxamide (Other names: PVP) ...... (7545) ADB-FUBINACA) ...... 7010 (62) 1-(1,3-benzodioxol-5-yl)-2- (77) methyl 2-(1- (methylamino)butan-1-one (cyclohexylmethyl)-1H- (butylone, bk-MBDB) ...... (7541) indole-3-carboxamido)-3,3- (63) 2-(methylamino)-1- dimethylbutanoate (Other phenylpentan-1-one names: MDMB-CHMICA, (pentedrone) ...... (1246) MMB-CHMINACA) ...... 7042 (64) 1-(1,3-benzodioxol-5-yl)-2- (78) methyl 2-(1-(4- (methylamino)pentan-1-one fluorobenzyl)-1H-indazole-3- (pentylone, bk-MBDP) ...... (7542) carboxamido)-3,3- (65) 4-fluoro-N-methylcathinone dimethylbutanoate (Other (4-FMC; flephedrone) ...... (1238) names: MDMB-FUBINACA) ... 7020 (66) 3-fluoro-N-methylcathinone (79) methyl 2-(1-(4- (3-FMC) ...... (1233) fluorobenzyl)-1H-indazole-3- (67) 1-(naphthalen-2-yl)-2- carboxamido)-3- (pyrrolidin-1-yl)pentan-1-one methylbutanoate, (FUB– (naphyrone) ...... (1258) AMB, MMB–FUBINACA, AMB–FUBINACA) ...... (7021) 120

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(e) Depressants. Unless specifically (5) Methcathinone (Some other excepted or unless listed in another names: 2-(methylamino)- schedule, any material, compound, propiophenone; alpha- mixture, or preparation which contains (methylamin- any quantity of the following sub- o)propiophenone; 2- stances having a depressant effect on (methylamino)-1- the central nervous system, including phenylpropan-1-one; alpha-N- its salts, isomers, and salts of isomers methylaminopropiophenone; whenever the existence of such salts, monomethylpropion; isomers, and salts of isomers is possible ephedrone; N- within the specific chemical designa- methylcathinone; tion: methylcathinone; AL–464; AL–422; AL–463 and UR1432), (1) gamma-hydroxybutyric acid its salts, optical isomers and (some other names include salts of optical isomers ...... 1237 GHB; gamma- (6) (±)cis-4-methylaminorex hydroxybutyrate; 4- ((±)cis-4,5-dihydro-4-methyl-5- hydroxybutyrate; 4- phenyl-2-oxazolamine) ...... 1590 hydroxybutanoic acid; so- (7) N-ethylamphetamine ...... 1475 dium oxybate; sodium (8) N,N-dimethylamphetamine oxybutyrate) ...... 2010 (also known as N,N-alpha- (2) Mecloqualone ...... 2572 trimethyl- (3) Methaqualone ...... 2565 benzeneethanamine; N,N- (f) Stimulants. Unless specifically ex- alpha- cepted or unless listed in another trimethylphenethylamine) .... 1480 schedule, any material, compound, (g) Cannabimimetic agents. Unless spe- mixture, or preparation which contains cifically exempted or unless listed in any quantity of the following sub- another schedule, any material, com- stances having a stimulant effect on pound, mixture, or preparation which the central nervous system, including contains any quantity of the following its salts, isomers, and salts of isomers: substances, or which contains their salts, isomers, and salts of isomers (1) Aminorex (Some other whenever the existence of such salts, names: aminoxaphen; 2- isomers, and salts of isomers is possible amino-5-phenyl-2-oxazoline; within the specific chemical designa- or 4,5-dihydro-5-phenly-2- tion: oxazolamine) ...... 1585 (2) N-Benzylpiperazine (some (1) 5-(1,1-dimethylheptyl)-2- other names: BZP, 1- [(1R,3S)-3- benzylpiperazine) ...... 7493 hydroxycyclohexyl]-phenol (3) Cathinone ...... 1235 (CP–47,497) ...... 7297 (2) 5-(1,1-dimethyloctyl)-2- Some trade or other names: [(1R,3S)-3- 2-amino-1-phenyl-1- hydroxycyclohexyl]-phenol propanone, alpha- (cannabicyclohexanol or CP– aminopropiophenone, 2- 47,497 C8-homolog) ...... 7298 aminopropiophenone, and norephedrone (3) 1-pentyl-3-(1-naphthoyl)indole (JWH–018 and (4) Fenethylline ...... 1503 AM678) ...... 7118 (4) 1-butyl-3-(1-naphthoyl)indole (JWH–073) ...... 7173 (5) 1-hexyl-3-(1-naphthoyl)indole (JWH–019) ...... 7019 (6) 1-[2-(4-morpholinyl)ethyl]-3- (1-naphthoyl)indole (JWH– 200) ...... 7200 (7) 1-pentyl-3-(2- methoxyphenylacetyl)indole (JWH–250) ...... 6250 121

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(8) 1-pentyl-3-[1-(4- (27) N-(1-phenethylpiperidin-4- methoxynaphthoyl)]indole yl)-N-phenylisobutyramide, (JWH–081) ...... 7081 its isomers, esters, ethers, (9) 1-pentyl-3-(4-methyl-1-naph- salts and salts of isomers, thoyl)indole (JWH–122) ...... 7122 esters and ethers (Other (10) 1-pentyl-3-(4-chloro-1-naph- name: isobutyryl fentanyl) .. (9827) thoyl)indole (JWH–398) ...... 7398 (28) N-(1-phenethylpiperidin-4- (11) 1-(5-fluoropentyl)-3-(1-naph- yl)-N- thoyl)indole (AM2201) ...... 7201 phenylcyclopentanecarboxa- mide, its isomers, esters, (12) 1-(5-fluoropentyl)-3-(2- ethers, salts and salts of iso- iodobenzoyl)indole (AM694) ... 7694 mers, esters and ethers (13) 1-pentyl-3-[(4-methoxy)- (Other name: cyclopentyl benzoyl]indole (SR–19 and fentanyl) ...... (9847) RCS–4) ...... 7104 (29) [Reserved]. (14) 1-cyclohexylethyl-3-(2- (30) [Reserved]. methoxyphenylacetyl)indole (31) Naphthalen-1-yl 1-(5- 7008 (SR–18 and RCS–8) ...... 7008 fluoropentyl)-1H-indole-3- (15) 1-pentyl-3-(2- carboxylate, its optical, po- chlorophenylacetyl)indole sitional, and geometric iso- (JWH–203) ...... 7203 mers, salts and salts of iso- (h) Temporary listing of substances sub- mers (Other names: NM2201; ject to emergency scheduling. Any mate- CBL2201) ...... (7221) rial, compound, mixture or preparation (32) N-(1-amino-3-methyl-1- which contains any quantity of the fol- oxobutan-2-yl)-1-(5- lowing substances: fluoropentyl)-1H-indazole-3- carboxamide, its optical, po- (1)–(17) [Reserved]. sitional, and geometric iso- (18) [Reserved]. mers, salts and salts of iso- (19) [Reserved]. mers (Other names: 5F-AB- (20) [Reserved]. PINACA) ...... (7025) (21) [Reserved]. (33) 1-(4-cyanobutyl)-N-(2- (22) [Reserved]. phenylpropan-2-yl)-1H-inda- (23) N-(1-phenethylpiperidin-4- zole-3-carboxamide, its opti- yl)-N-phenylpentanamide, cal, positional, and geo- its isomers, esters, ethers, metric isomers, salts and salts and salts of isomers, salts of isomers (Other esters and ethers (Other names: 4-CN-CUMYL- name: Valeryl fentanyl) ...... (9840) BUTINACA; 4-cyano- (24) [Reserved]. CUMYL-BUTINACA; 4-CN- CUMYL BINACA; CUMYL- (25) N-(4-methoxyphenyl)-N-(1- 4CN-BINACA; SGT-78) ...... (7089) phenethylpiperidin-4- (34) methyl 2-(1- yl)butyramide, its isomers, (cyclohexylmethyl)-1H- esters, ethers, salts and salts indole-3-carboxamido)-3- of isomers, esters and ethers methylbutanoate, its opti- (Other name: para- cal, positional, and geo- methoxybutyryl fentanyl) ... (9837) metric isomers, salts and (26) N-(4-chlorophenyl)-N-(1- salts of isomers (Other phenethylpiperidin-4- names: MMB-CHMICA, yl)isobutyramide, its iso- AMB-CHMICA) ...... (7044) mers, esters, ethers, salts (35) 1-(5-fluoropentyl)-N-(2- and salts of isomers, esters phenylpropan-2-yl)-1H- and ethers (Other name: pyrrolo[2,3-b]pyridine-3- para-chloroisobutyryl carboxamide, its optical, po- fentanyl) ...... (9826) sitional, and geometric isomers, salts and salts of isomers (Other names: 5F- CUMYL-P7AICA) ...... (7085) 122

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(36) N-Ethylpentylone, its op- (43) alpha- tical, positional, and geo- Pyrrolidinohexanophenone, metric isomers, salts and its optical, positional, and salts of isomers (Other geometric isomers, salts and names: ephylone, 1-(1,3- salts of isomers (Other benzodioxol-5-yl)-2- names: a-PHP; alpha- (ethylamino)-pentan-1-one) (7543) pyrrolidinohexiophenone; 1- (37) ethyl 2-(1-(5-fluoropentyl)- phenyl-2-(pyrrolidin-1- 1H-indazole-3-carboxamido)- yl)hexan-1-one) ...... 7544 3,3-dimethylbutanoate, its (44) 4-Methyl-alpha- optical, positional, and geo- ethylaminopentiophenone, metric isomers, salts and its optical, positional, and salts of isomers (trivial geometric isomers, salts and name: 5F-EDMB-PINACA) ... 7036 salts of isomers (Other (38) methyl 2-(1-(5- names: 4–MEAP; 2- fluoropentyl)-1H-indole-3- (ethylamino)-1-(4- carboxamido)-3,3- methylphenyl)pentan-1-one) 7245 dimethylbutanoate, its opti- (45) 4′-Methyl-alpha- cal, positional, and geo- pyrrolidinohexiophenone, its metric isomers, salts and optical, positional, and geo- salts of isomers (trivial metric isomers, salts and name: 5F-MDMB-PICA) ...... 7041 salts of isomers (Other (39) N-(adamantan-1-yl)-1-(4- names: MPHP; 4′-methyl- fluorobenzyl)-1H-indazole-3- alpha- carboxamide, its optical, po- pyrrolidinohexanophenone; sitional, and geometric iso- 1-(4-methylphenyl)-2- mers, salts and salts of iso- (pyrrolidin-1-yl)hexan-1-one) 7446 mers (trivial names: FUB- (46) alpha- AKB48; FUB-APINACA; Pyrrolidinoheptaphenone, AKB48 N-(4- its optical, positional, and FLUOROBENZYL)) ...... 7047 geometric isomers, salts and (40) 1-(5-fluoropentyl)-N-(2- salts of isomers (Other phenylpropan-2-yl)-1H-inda- names: PV8; 1-phenyl-2- zole-3-carboxamide, its opti- (pyrrolidin-1-yl)heptan-1- cal, positional, and geo- one) ...... 7548 metric isomers, salts and (47) 4′-Chloro-alpha- salts of isomers (trivial pyrrolidinovalerophenone, names: 5F-CUMYL-PINACA; its optical, positional, and SGT-25) ...... 7083 geometric isomers, salts and (41) (1-(4-fluorobenzyl)-1H- salts of isomers (Other indol-3-yl)(2,2,3,3- names: 4-chloro-a-PVP; 4′- tetramethylcyclopropyl) chloro-alpha- methanone, its optical, posi- pyrrolidinopentiophenone; 1- tional, and geometric iso- (4-chlorophenyl)-2- mers, salts and salts of iso- (pyrrolidin-1-yl)pentan-1- mers (trivial name: FUB-144) 7014 one) ...... 7443 (42) N-Ethylhexedrone, its optical, positional, and geo- [39 FR 22141, June 20, 1974] metric isomers, salts and EDITORIAL NOTE: For FEDERAL REGISTER ci- salts of isomers (Other tations affecting § 1308.11, see the List of CFR name: 2-(ethylamino)-1- Sections Affected, which appears in the phenylhexan-1-one) ...... 7246 Finding Aids section of the printed volume and at www.govinfo.gov.

EFFECTIVE DATE NOTES: 1. At 83 FR 31882, July 10, 2018, § 1308.11 was amended by adding paragraphs (h)(31) through (h)(35) effective July 10, 2018 through July 10, 2020.

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2. At 83 FR 44478, Aug. 31, 2018, § 1308.11 was (xiv) Oxycodone ...... 9143 amended by adding paragraph (h)(36) effec- (xv) Oxymorphone ...... 9652 tive Aug. 31, 2018 through Aug. 31, 2020. 3. At 84 FR 13796, Apr. 10, 2019,§ 1308.11 was (xvi) Powdered opium ...... 9639 amended by extending the order at 82 FR (xvii) Raw opium ...... 9600 17119, Apr. 10, 2017, is effective Apr. 10, 2019 (xviii) Thebaine ...... 9333 and will expire on Apr. 10, 2020. (xix) Tincture of opium ...... 9630 4. At 84 FR 15511, Apr. 16, 2019, § 1308.11 was amended by adding paragraphs (h)(37) (2) Any salt, compound, derivative, or through (h)(41) effective Apr. 16, 2019 through preparation thereof which is chemi- Apr. 16, 2021. cally equivalent or identical with any 5. At 84 FR 34297, July 17, 2019, § 1308.11 was of the substances referred to in para- amended by adding paragraphs (h)(42) graph (b) (1) of this section, except that through (h)(47) effective July 18, 2019 through July 18, 2021. these substances shall not include the 6. At 85 FR 5322, Jan. 30, 2020, § 1308.11 was isoquinoline alkaloids of opium. amended by extending the order at 83 FR (3) Opium poppy and poppy straw. 4580, Feb. 1, 2018, is effective Feb. 1, 2020 and (4) Coca leaves (9040) and any salt, expires Feb. 1. 2021. compound, derivative or preparation of coca leaves (including cocaine (9041) § 1308.12 Schedule II. and ecgonine (9180) and their salts, iso- (a) Schedule II shall consist of the mers, derivatives and salts of isomers drugs and other substances, by what- and derivatives), and any salt, com- ever official name, common or usual pound, derivative, or preparation name, chemical name, or brand name thereof which is chemically equivalent designated, listed in this section. Each or identical with any of these sub- drug or substance has been assigned stances, except that the substances the Controlled Substances Code Num- shall not include: ber set forth opposite it. (i) Decocainized coca leaves or ex- (b) Substances, vegetable origin or traction of coca leaves, which extrac- chemical synthesis. Unless specifically tions do not contain cocaine or ecgo- excepted or unless listed in another nine; or schedule, any of the following sub- (ii) [123I]ioflupane. stances whether produced directly or (5) Concentrate of poppy straw (the indirectly by extraction from sub- crude extract of poppy straw in either stances of vegetable origin, or inde- liquid, solid or powder form which con- pendently by means of chemical syn- tains the phenanthrene alkaloids of the thesis, or by a combination of extrac- opium poppy), 9670. tion and chemical synthesis: (c) Opiates. Unless specifically ex- (1) Opium and opiate, and any salt, cepted or unless in another schedule compound, derivative, or preparation any of the following opiates, including of opium or opiate excluding its isomers, esters, ethers, salts and apomorphine, thebaine-derived salts of isomers, esters and ethers butorphanol, dextrorphan, nalbuphine, whenever the existence of such iso- naldemedine, nalmefene, naloxegol, mers, esters, ethers, and salts is pos- naloxone, 6b-naltrexol and naltrexone, sible within the specific chemical des- and their respective salts, but includ- ignation, dextrorphan and ing the following: levopropoxyphene excepted: (i) Codeine ...... 9050 (1) Alfentanil ...... 9737 (ii) Dihydroetorphine ...... 9334 (iii) Ethylmorphine ...... 9190 (2) Alphaprodine ...... 9010 (iv) Etorphine hydrochloride ..... 9059 (3) Anileridine ...... 9020 (v) Granulated opium ...... 9640 (4) Bezitramide ...... 9800 (vi) Hydrocodone ...... 9193 (5) Bulk dextropropoxyphene (vii) Hydromorphone ...... 9150 (non-dosage forms) ...... 9273 (viii) Metopon ...... 9260 (6) Carfentanil ...... 9743 (ix) Morphine ...... 9300 (7) Dihydrocodeine ...... 9120 (x) Noroxymorphone ...... 9668 (8) Diphenoxylate ...... 9170 (xi) Opium extracts ...... 9610 (9) Fentanyl ...... 9801 (xii) Opium fluid ...... 9620 (10) Isomethadone ...... 9226 (xiii) Oripavine ...... 9330 (11) Levo-alphacetylmethadol .... 9648 124

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[Some other names: levo- its salts, isomers, and salts of isomers alpha-acetylmethadol, whenever the existence of such salts, levomethadyl acetate, isomers, and salts of isomers is possible LAAM] within the specific chemical designa- (12) Levomethorphan ...... 9210 tion: (13) Levorphanol ...... 9220 (1) Amobarbital ...... 2125 (14) Metazocine ...... 9240 (2) Glutethimide ...... 2550 (15) Methadone ...... 9250 (3) Pentobarbital ...... 2270 (16) Methadone-Intermediate, 4- (4) Phencyclidine ...... 7471 cyano-2-dimethylamino-4,4-di- (5) Secobarbital ...... 2315 phenyl butane ...... 9254 (17) Moramide-Intermediate, 2- (f) Hallucinogenic substances. methyl-3-morpholino-1, 1- (1) Nabilone ...... 7379 diphenylpropane-carboxylic [Another name for acid ...... 9802 nabilone: (±)-trans-3-(1,1- (18) Pethidine (meperidine) ...... 9230 dimethylheptyl)- (19) Pethidine-Intermediate-A, 4- 6,6a,7,8,10,10a-hexahydro- cyano-1-methyl-4- 1-hydroxy-6,6-dimethyl- phenylpiperidine ...... 9232 9H-dibenzo[b,d]pyran-9- (20) Pethidine-Intermediate-B, one] ethyl-4-phenylpiperidine-4- (2) Dronabinol [(-)-delta-9-trans carboxylate ...... 9233 tetrahydrocannabinol] in an (21) Pethidine-Intermediate-C, 1- oral solution in a drug prod- methyl-4-phenylpiperidine-4- uct approved for marketing carboxylic acid ...... 9234 (22) Phenazocine ...... 9715 by the U.S. Food and Drug (23) Piminodine ...... 9730 Administration ...... (7365) (24) Racemethorphan ...... 9732 (g) Immediate precursors. Unless spe- (25) Racemorphan ...... 9733 cifically excepted or unless listed in (26) Remifentanil ...... 9739 another schedule, any material, com- (27) Sufentanil ...... 9740 pound, mixture, or preparation which (28) Tapentadol ...... 9780 contains any quantity of the following (29) Thiafentanil ...... 9729 substances: (d) Stimulants. Unless specifically ex- (1) Immediate precursor to amphet- cepted or unless listed in another amine and methamphetamine: schedule, any material, compound, (i) Phenylacetone ...... 8501 mixture, or preparation which contains Some trade or other names: any quantity of the following sub- phenyl-2-propanone; P2P; stances having a stimulant effect on benzyl methyl ketone; the central nervous system: methyl benzyl ketone; (1) Amphetamine, its salts, opti- (2) Immediate precursors to cal isomers, and salts of its phencyclidine (PCP): optical isomers ...... 1100 (2) Methamphetamine, its salts, (i) 1-phenylcyclohexylamine ...... 7460 isomers, and salts of its iso- (ii) 1- mers ...... 1105 piperidinocyclohexanecarboni- (3) Phenmetrazine and its salts 1631 trile (PCC) ...... 8603 (4) Methylphenidate ...... 1724 (3) Immediate precursor to fentanyl: (5) Lisdexamfetamine, its salts, (i) 4-anilino-N- isomers, and salts of its iso- phenethylpiperidine (ANPP) ... 8333 mers ...... 1205. (ii) [Reserved]. (e) Depressants. Unless specifically excepted or unless listed in another [39 FR 22142, June 20, 1974] schedule, any material, compound, EDITORIAL NOTE: For FEDERAL REGISTER ci- mixture, or preparation which contains tations affecting § 1308.12, see the List of CFR any quantity of the following sub- Sections Affected, which appears in the stances having a depressant effect on Finding Aids section of the printed volume the central nervous system, including and at www.govinfo.gov. 125

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

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Some trade or other names (v) Not more than 500 for zolazepam: milligrams of opium 4-(2-fluorophenyl)-6,8- per 100 milliliters or dihydro-1,3,8- per 100 grams or not trimethylpyrazolo-[3,4- more than 25 milli- e] [1,4]-diazepin-7(1H)- grams per dosage unit, one, flupyrazapon. with one or more active, nonnarcotic in- (d) Nalorphine 9400. gredients in recognized (e) Narcotic drugs. Unless specifically therapeutic amounts ... 9809 excepted or unless listed in another (vi) Not more than 50 schedule: milligrams of mor- (1) Any material, compound, phine per 100 milli- mixture, or preparation con- liters or per 100 grams, taining any of the following with one or more ac- narcotic drugs, or their salts tive, nonnarcotic in- calculated as the free anhy- gredients in recognized drous base or alkaloid, in lim- therapeutic amounts ... 9810 ited quantities as set forth (2) Any material, compound, below: mixture, or preparation con- (i) Not more than 1.8 taining any of the following grams of codeine per narcotic drugs or their salts, 100 milliliters or not as set forth below: more than 90 milli- (i) Buprenorphine ...... 9064 grams per dosage unit, (ii) [Reserved] ...... with an equal or great- (f) Anabolic Steroids. Unless specifi- er quantity of an cally excepted or unless listed in an- isoquinoline alkaloid other schedule, any material, com- of opium ...... 9803 pound, mixture or preparation con- (ii) Not more than 1.8 taining any quantity of the following grams of codeine per substances, including its salts, esters 100 milliliters or not and ethers: more than 90 milli- (1) Anabolic steroids (see § 1300.01 of grams per dosage unit, this chapter)—4000 with one or more ac- (2) [Reserved] tive, nonnarcotic ingredients in recognized (g) Hallucinogenic substances. (1) therapeutic amounts ... 9804 Dronabinol (synthetic) in sesame oil and encapsulated in a soft gelatin cap- (iii) Not more than 1.8 sule in a U.S. Food and Drug Adminis- grams of tration approved product—7369. dihydrocodeine per 100 milliliters or not more [Some other names for dronabinol: (6aR- than 90 milligrams per trans)-6a,7,8,10a-tetrahydro-6,6,9-trimethyl-3- dosage unit, with one pentyl-6H-dibenzo [b,d]pyran-1-ol] or (-)- or more active nonnar- delta-9-(trans)-tetrahydrocannabinol] cotic ingredients in (2) [Reserved] recognized therapeutic [39 FR 22142, June 20, 1974] amounts ...... 9807 (iv) Not more than 300 EDITORIAL NOTE: For FEDERAL REGISTER ci- milligrams of tations affecting § 1308.13, see the List of CFR Sections Affected, which appears in the ethylmorphine per 100 Finding Aids section of the printed volume milliliters or not more and at www.govinfo.gov. than 15 milligrams per dosage unit, with one § 1308.14 Schedule IV. or more active, non- (a) Schedule IV shall consist of the narcotic ingredients in drugs and other substances, by what- recognized therapeutic ever official name, common or usual amounts ...... 9808 name, chemical name, or brand name 127

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designated, listed in this section. Each (22) Ethyl loflazepate ...... 2758 drug or substance has been assigned (23) Fludiazepam ...... 2759 the DEA Controlled Substances Code (24) Flunitrazepam ...... 2763 Number set forth opposite it. (25) Flurazepam ...... 2767 (b) Narcotic drugs. Unless specifically (26) Fospropofol ...... 2138 excepted or unless listed in another (27) Halazepam ...... 2762 schedule, any material, compound, (28) Haloxazolam ...... 2771 mixture, or preparation containing any (29) Ketazolam ...... 2772 of the following narcotic drugs, or (30) Loprazolam ...... 2773 their salts calculated as the free anhy- (31) Lorazepam ...... 2885 drous base or alkaloid, in limited quan- (32) Lormetazepam ...... 2774 tities as set forth below: (33) Mebutamate ...... 2800 (34) Medazepam ...... 2836 (1) Not more than 1 milligram of (35) Meprobamate ...... 2820 difenoxin and not less than 25 (36) Methohexital ...... 2264 micrograms of atropine sul- (37) Methylphenobarbital fate per dosage unit ...... 9167 (mephobarbital) ...... 2250 (2) Dextropropoxyphene (alpha- (38) Midazolam ...... 2884 (+)-4-dimethylamino-1,2-di- (39) Nimetazepam ...... 2837 phenyl-3-methyl-2- (40) Nitrazepam ...... 2834 propionoxybutane) ...... 9278 (41) Nordiazepam ...... 2838 (3) 2-[(dimethylamino)methyl]-1- (42) Oxazepam ...... 2835 (3- (43) Oxazolam ...... 2839 methoxyphenyl)cyclohexanol, (44) Paraldehyde ...... 2585 its salts, optical and geo- (45) Petrichloral ...... 2591 metric isomers and salts of (46) Phenobarbital ...... 2285 these isomers (including (47) Pinazepam ...... 2883 tramadol) ...... 9752 (48) Prazepam ...... 2764 (c) Depressants. Unless specifically (49) Quazepam ...... 2881 excepted or unless listed in another (50) Suvorexant ...... 2223 schedule, any material, compound, (51) Temazepam ...... 2925 mixture, or preparation which contains (52) Tetrazepam ...... 2886 any quantity of the following sub- (53) Triazolam ...... 2887 stances, including its salts, isomers, (54) Zaleplon ...... 2781 and salts of isomers whenever the ex- (55) Zolpidem ...... 2783 istence of such salts, isomers, and salts (56) Zopiclone ...... 2784 of isomers is possible within the spe- (d) Fenfluramine. Any material, com- cific chemical designation: pound, mixture, or preparation which (1) Alfaxalone ...... 2731 contains any quantity of the following (2) Alprazolam ...... 2882 substances, including its salts, isomers (3) Barbital ...... 2145 (whether optical, position, or geo- (4) Brexanolone ...... 2400 metric), and salts of such isomers, (5) Bromazepam ...... 2748 whenever the existence of such salts, (6) Camazepam ...... 2749 isomers, and salts of isomers is pos- (7) Carisoprodol ...... 8192 sible: (8) Chloral betaine ...... 2460 (1) Fenfluramine ...... 1670 (9) Chloral hydrate ...... 2465 (e) Lorcaserin. Any material, com- (10) Chlordiazepoxide ...... 2744 pound, mixture, or preparation which (11) Clobazam ...... 2751 contains any quantity of the following (12) Clonazepam ...... 2737 substances, including its salts, isomers, (13) Clorazepate ...... 2768 and salts of such isomers, whenever the (14) Clotiazepam ...... 2752 existence of such salts, isomers, and (15) Cloxazolam ...... 2753 salts of isomers is possible: (16) Delorazepam ...... 2754 (17) Diazepam ...... 2765 (1) Lorcaserin ...... 1625 (18) Dichloralphenazone ...... 2467 (f) Stimulants. Unless specifically ex- (19) Estazolam ...... 2756 cepted or unless listed in another (20) Ethchlorvynol ...... 2540 schedule, any material, compound, (21) Ethinamate ...... 2545 mixture, or preparation which contains 128

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any quantity of the following sub- (b) Narcotic drugs. Unless specifically stances having a stimulant effect on excepted or unless listed in another the central nervous system, including schedule, any material, compound, its salts, isomers and salts of isomers: mixture, or preparation containing any (1) Cathine ((+)- of the following narcotic drugs and norpseudoephedrine) ...... 1230 their salts, as set forth below: (2) Diethylpropion ...... 1610 (1) [Reserved] (3) Fencamfamin ...... 1760 (c) Narcotic drugs containing non-narcotic active medicinal ingredients. Any (4) Fenproporex ...... 1575 compound, mixture, or preparation (5) Mazindol ...... 1605 containing any of the following nar- (6) Mefenorex ...... 1580 cotic drugs, or their salts calculated as (7)Modafinil ...... 1680 the free anhydrous base or alkaloid, in (8) Pemoline (including limited quantities as set forth below, organometallic complexes and which shall include one or more non- chelates thereof) ...... 1530 narcotic active medicinal ingredients (9) Phentermine ...... 1640 in sufficient proportion to confer upon (10) Pipradrol ...... 1750 the compound, mixture, or preparation (11) Sibutramine ...... 1675 valuable medicinal qualities other than (12) Solriamfetol (2-amino-3- those possessed by narcotic drugs phenylpropyl carbamate; alone: benzenepropanol, beta-amino-, (1) Not more than 200 milligrams of carbamate (ester)) ...... 1650 codeine per 100 milliliters or per 100 (13) SPA ((-)-1-dimethylamino- grams. 1,2-diphenylethane) ...... 1635 (2) Not more than 100 milligrams of dihydrocodeine per 100 milliliters or (g) Other substances. Unless specifi- per 100 grams. cally excepted or unless listed in another schedule, any material, com- (3) Not more than 100 milligrams of pound, mixture or preparation which ethylmorphine per 100 milliliters or per contains any quantity of the following 100 grams. substances, including its salts: (4) Not more than 2.5 milligrams of 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- age unit. methoxybenzoic acid) (includ- (d) Stimulants. Unless specifically ex- ing its optical isomers) and its empted or excluded or unless listed in salts, isomers, and salts of iso- another schedule, any material, com- mers (9725).. pound, mixture, or preparation which contains any quantity of the following [39 FR 22143, June 20, 1974] substances having a stimulant effect EDITORIAL NOTE: For FEDERAL REGISTER ci- on the central nervous system, includ- tations affecting § 1308.14, see the List of CFR ing its salts, isomers and salts of iso- Sections Affected, which appears in the mers: Finding Aids section of the printed volume and at www.govinfo.gov. (1) Pyrovalerone ...... 1485. (2) [Reserved]. § 1308.15 Schedule V. (e) Depressants. Unless specifically (a) Schedule V shall consist of the exempted or excluded or unless listed drugs and other substances, by what- in another schedule, any material, ever official name, common or usual compound, mixture, or preparation name, chemical name, or brand name which contains any quantity of the fol- designated, listed in this section. lowing substances having a depressant

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effect on the central nervous system, (21 U.S.C. 301), be lawfully sold over the including its salts: counter without a prescription, ex- (1) Brivaracetam ((2S)-2-[(4R)-2- cluded from any schedule, pursuant to oxo-4-propylpyrrolidin-1-yl] section 201(g)(1) of the Act (21 U.S.C. butanamide) (also referred to 811(g)(1)), may apply to the Drug and as BRV; UCB–34714; Briviact) Chemical Evaluation Section, Diver- (including its salts) ...... 2710 sion Control Division, Drug Enforce- (2) Cenobamate ([(1R)-1-(2- ment Administration. See the Table of chlorophenyl)-2-(tetrazol-2- DEA Mailing Addresses in § 1321.01 of yl)ethyl] carbamate; 2H- this chapter for the current mailing ad- tetrazole-2-ethanol, alpha-(2- dress. chlorophenyl)-, carbamate (b) An application for an exclusion (ester), (alphaR)-; carbamic under this section shall contain the fol- acid (R)-(+)-1-(2-chlorophenyl)- lowing information: 2-(2H-tetrazol-2-yl)ethyl ester) 2720 (1) The name and address of the ap- (3) Ezogabine [N-[2-amino-4-(4- plicant; fluorobenzylamino)-phenyl]- (2) The name of the substance for carbamic acid ethyl ester] ...... 2779 which exclusion is sought; and (4) Lacosamide [(R)-2- (3) The complete quantitative com- acetoamido-N-benzyl-3- position of the substance. methoxy-propionamide] ...... 2746 (c) Within a reasonable period of (5) Lasmiditan [2,4,6-trifluoro-N- time after the receipt of an application (6-(1-methylpiperidine-4-car- for an exclusion under this section, the bonyl)pyridine-2-yl-benz- Administrator shall notify the appli- amide] ...... 2790 cant of his acceptance or nonaccept- (6) Pregabalin [(S)-3- ance of his application, and if not ac- (aminomethyl)-5- cepted, the reason therefore. The Ad- methylhexanoic acid] ...... 2782 ministrator need not accept an applica- (f) Approved cannabidiol drugs. (1) tion for filing if any of the require- A drug product in finished dos- ments prescribed in paragraph (b) of age formulation that has been this section is lacking or is not set approved by the U.S. Food and forth as to be readily understood. If the Drug Administration that con- applicant desires, he may amend the tains cannabidiol (2-[1R-3- application to meet the requirements methyl-6R-(1-methylethenyl)- of paragraph (b) of this section. If the 2-cyclohexen-1-yl]-5-pentyl-1,3- application is accepted for filing, the benzenediol) derived from can- Administrator shall issue and publish nabis and no more than 0.1 in the FEDERAL REGISTER his order on percent (w/w) residual the application, which shall include a tetrahydrocannabinols ...... 7367 reference to the legal authority under 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, of publication of his order in the FED- 2011; 81 FR 29491, May 12, 2016; 83 FR 48953, Sept 28, 2018; 85 FR 5562, Jan. 31, 2020; 85 FR ERAL REGISTER. If any such comments 13746, Mar. 10, 2020] or objections raise significant issues regarding any finding of fact or conclu- EXCLUDED NONNARCOTIC SUBSTANCES sion of law upon which the order is based, the Administrator shall imme- § 1308.21 Application for exclusion of a diately suspend the effectiveness of the nonnarcotic substance. order until he may reconsider the ap- (a) Any person seeking to have any plication in light of the comments and nonnarcotic drug that may, under the objections filed. Thereafter, the Ad- Federal Food, Drug, and Cosmetic Act ministrator shall reinstate, revoke, or

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amend his original order as he deter- § 1308.22 Excluded substances. mines appropriate. (d) The Administrator may at any The following nonnarcotic substances time revoke any exclusion granted pur- which may, under the Federal Food, suant to section 201(g) of the Act (21 Drug, and Cosmetic Act (21 U.S.C. 301), U.S.C. 811(g)) by following the proce- be lawfully sold over the counter with- dures set forth in paragraph (c) of this out a prescription, are excluded from section for handling an application for all schedules pursuant to section 201(g) an exclusion which has been accepted (1) of the Act (21 U.S.C. 811(g) (1)): for filing. [38 FR 8254, Mar. 30, 1973, as amended at 70 FR 74657, Dec. 16, 2005; 75 FR 10678, Mar. 9, 2010; 81 FR 97021, Dec. 30, 2016]

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

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

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granted (and thereby modify or revoke ‘‘For industrial use only’’ or ‘‘For all preparations and mixtures granted chemical use only’’ or ‘‘For in vitro use under the old criteria) and modify the only—not for human or animal use’’ or scope of exemptions at any time. ‘‘Diagnostic reagent—for professional use only’’ or a comparable statement [38 FR 8254, Mar. 30, 1973. Redesignated at 38 FR 26609, Sept. 24, 1973, and amended at 46 warning the person reading it that FR 28841, May 29, 1981; 62 FR 13968, Mar. 24, human or animal use is not intended. 1997; 75 FR 10678, Mar. 9, 2010; 81 FR 97021, The symbol designating the schedule of Dec. 30, 2016] the controlled substance is not required on either the label or the label- § 1308.24 Exempt chemical prepara- ing of the exempt chemical preparations. tion, nor is it necessary to list all in- (a) The chemical preparations and gredients of the preparation. mixtures approved pursuant to § 1308.23 (d) Records and reports: Any person are exempt from application of sec- who manufactures an exempt chemical tions 302, 303, 305, 306, 307, 308, 309, 1002, preparation or mixture must keep com- 1003 and 1004 of the Act (21 U.S.C. 822– plete and accurate records and file all 823, 825–829, 952–954) and § 1301.74 of this reports required under part 1304 of this chapter, to the extent described in chapter regarding all controlled sub- paragraphs (b) to (h) of this section. stances being used in the manufac- Substances set forth in paragraph (j) of turing process until the preparation or this section shall be exempt from the mixture is in the form described in application of sections 305, 306, 307, 308, paragraph (i) of this section. In lieu of 309, 1002, 1003 and 1004 of the Act (21 records and reports required under part U.S.C. 825–829, 952–954) and §§ 1301.71– 1304 of this chapter regarding exempt 1301.73 and 1301.74 (a), (b), (d), (e) and (f) chemical preparations, the manufac- of this chapter to the extent as herein- turer need only record the name, ad- after may be provided. dress, and registration number, if any, (b) Registration and security: Any of each person to whom the manufac- person who manufactures an exempt turer distributes any exempt chemical chemical preparation or mixture must preparation. Each importer or exporter be registered under the Act and comply of an exempt narcotic chemical prepa- with all relevant security requirements ration must submit a semiannual re- regarding controlled substances being port of the total quantity of each sub- used in the manufacturing process stance imported or exported in each until the preparation or mixture is in calendar half-year within 30 days of the the form described in paragraph (i) of close of the period to the Drug and this section. Any other person who Chemical Evaluation Section, Drug En- handles an exempt chemical prepara- forcement Administration. See the tion after it is in the form described in Table of DEA Mailing Addresses in paragraph (i) of this section is not re- § 1321.01 of this chapter for the current quired to be registered under the Act mailing address. Any other person who to handle that preparation, and the handles an exempt chemical prepara- preparation is not required to be stored tion after it is in the form described in in accordance with security require- paragraph (i) of this section is not re- ments regarding controlled substances. quired to maintain records or file re- (c) Labeling: In lieu of the require- ports. ments set forth in part 1302 of this (e) Quotas, order forms, prescrip- chapter, the label and the labeling of tions, import, export, and trans- an exempt chemical preparation must shipment requirements: Once an ex- be prominently marked with its full empt chemical preparation is in the trade name or other description and form described in paragraph (i) of this the name of the manufacturer or sup- section, the requirements regarding plier as set forth in paragraph (i) of quotas, order forms, prescriptions, im- this section, in such a way that the port permits and declarations, export product can be readily identified as an permit and declarations, and trans- exempt chemical preparation. The shipment and intransit permits and label and labeling must also include in declarations do not apply. These re- a prominent manner the statement quirements do apply, however, to any

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controlled substances used in manufac- Finding Aids section of the printed volume turing the exempt chemical prepara- and at www.govinfo.gov. tion before it is in the form described in paragraph (i) of this section. EXCLUDED VETERINARY ANABOLIC (f) Criminal penalties: No exemption STEROID IMPLANT PRODUCTS granted pursuant to § 1308.23 affects the § 1308.25 Exclusion of a veterinary an- criminal liability for illegal manufac- abolic steroid implant product; ap- ture, distribution, or possession of con- plication. trolled substances contained in the exempt chemical preparation. Distribu- (a) Any person seeking to have any tion, possession, and use of an exempt anabolic steroid product, which is ex- chemical preparation are lawful for pressly intended for administration registrants and nonregistrants only as through implants to cattle or other long as such distribution, possession, nonhuman species and which has been or use is intended for laboratory, in- approved by the Secretary of Health dustrial, or educational purposes and and Human Services for such adminis- not for immediate or subsequent ad- tration, identified as being excluded ministration to a human being or other from any schedule, pursuant to section animal. 102(41)(B)(i) of the Act (21 U.S.C. (g) Bulk materials: For materials ex- 802(41)(B)(i)), may apply to the Drug empted in bulk quantities, the Admin- and Chemical Evaluation Section, Di- istrator may prescribe requirements version Control Division, Drug En- other than those set forth in para- forcement Administration . See the graphs (b) through (e) of this section on Table of DEA Mailing Addresses in a case-by-case basis. § 1321.01 of this chapter for the current (h) Changes in chemical preparations: mailing address. Any change in the quantitative or (b) An application for any exclusion qualitative composition of the prepara- under this section shall be submitted tion or mixture after the date of appli- in triplicate and contain the following cation, or change in the trade name or information: other designation of the preparation or (1) The name and address of the ap- mixture, set forth in paragraph (i) of plicant; this section, requires a new application (2) The name of the product; for exemption. (3) The chemical structural formula (i) A listing of exempt chemical prep- or description for any anabolic steroid arations may be obtained by submit- contained in the product; ting a written request to the Drug and (4) A complete description of dosage Chemical Evaluation Section, Drug En- and quantitative composition of the forcement Administration. See the dosage form;. Table of DEA Mailing Addresses in (5) The conditions of use including § 1321.01 of this chapter for the current whether or not Federal law restricts mailing address. this product to use by or on the order (j) The following substances are des- of a licensed veterinarian; ignated as exempt chemical prepara- (6) A description of the delivery sys- tions for the purposes set forth in this tem in which the dosage form will be section. 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. mediate container and the commercial (2) R 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 EDITORIAL NOTE: For FEDERAL REGISTER ci- Health and Human Services for admin- tations affecting § 1308.24, see the List of CFR istration through implant to cattle or Sections Affected, which appears in the other nonhuman species.

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(c) Within a reasonable period of retary of Health and Human Services time after the receipt of an application for such administration are excluded for an exclusion under this section, the from all schedules pursuant to section Administrator shall notify the appli- 102(41)(B)(i) of the Act (21 U.S.C. cant of his acceptance or nonaccept- 802(41)(B)(i)). A listing of the excluded ance of the application, and if not ac- products may be obtained by submit- cepted, the reason therefore. The Ad- ting a written request to the Drug and ministrator need not accept an applica- Chemical Evaluation Section, Drug En- tion for filing if any of the require- forcement Administration. See the ments prescribed in paragraph (b) of Table of DEA Mailing Addresses in this section is lacking or is not set § 1321.01 of this chapter for the current forth as to be readily understood. The mailing address. applicant may amend the application (b) In accordance with section to meet the requirements of paragraph 102(41)(B)(ii) of the Act (21 U.S.C. (b) of this section. If the application is 802(41)(B)(ii)) if any person prescribes, accepted for filing, the Administrator dispenses, or distributes a product list- shall issue and have published in the ed in paragraph (a) of this section for FEDERAL REGISTER his order on the ap- human use, such person shall be con- plication, which shall include a ref- sidered to have prescribed, dispensed, erence to the legal authority under or distributed an anabolic steroid with- which the order is issued and the find- in the meaning of section 102(41)(A) of ings of fact and conclusions of law the Act (21 U.S.C. 802(41)(A)). upon which the order is based. This order shall specify the date on which it [56 FR 42936, Aug. 30, 1991, as amended at 57 FR 19534, May 7, 1992; 58 FR 15088, Mar. 19, will take effect. The Administrator 1993; 62 FR 13967, Mar. 24, 1997; 75 FR 10679, shall permit any interested person to Mar. 9, 2010] file written comments on or objections to the order within 60 days of the date EXEMPTED PRESCRIPTION PRODUCTS of publication in the FEDERAL REG- ISTER. If any such comments or objec- § 1308.31 Application for exemption of tions raise significant issues regarding a nonnarcotic prescription product. any finding of fact or conclusion of law (a) Any person seeking to have any upon which the order is based, the Ad- compound, mixture, or preparation ministrator shall immediately suspend containing any nonnarcotic controlled the effectiveness of the order until he substance listed in § 1308.12(e), or in may reconsider the application in light § 1308.13(b) or (c), or in § 1308.14, or in of the comments and objections filed. § 1308.15, exempted from application of Thereafter, the Administrator shall re- all or any part of the Act pursuant to instate, revoke, or amend his original section 201(g)(3)(A), of the Act (21 order as he determines appropriate. U.S.C. 811(g)(3)(A)) may apply to the (d) The Administrator may at any Drug and Chemical Evaluation Section, time revoke or modify any designation Diversion Control Division, Drug En- of excluded status granted pursuant to forcement Administration. See the this section by following the proce- Table of DEA Mailing Addresses in dures set forth in paragraph (c) of this § 1321.01 of this chapter for the current section for handling an application for mailing address. an exclusion which has been accepted (b) An application for an exemption for filing. under this section shall contain the fol- [56 FR 42936, Aug. 30, 1991, as amended at 75 lowing information: FR 10679, Mar. 9, 2010; 81 FR 97021, Dec. 30, (1) The complete quantitative com- 2016] position of the dosage form. (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 (a) Products containing an anabolic of the product including animal inves- steroid, that are expressly intended for tigations and clinical evaluations and administration through implants to studies, with emphasis on the psychic cattle or other nonhuman species and and/or physiological dependence liabil- which have been approved by the Sec- ity (this must be done for each of the

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active ingredients separately and for sitate an earlier effective date, in the combination product). which event the Administrator shall (4) Details of synergisms and antag- specify in the order his findings as to onisms among ingredients. such conditions. (5) Deterrent effects of the noncon- (d) The Administrator may revoke trolled ingredients. any exemption granted pursuant to (6) Complete copies of all literature section 201(g)(3)(A) of the Act (21 U.S.C. in support of claims. 811(g)(3)(A)) by following the proce- (7) Reported instances of abuse. dures set forth in paragraph (c) of this (8) Reported and anticipated adverse effects. section for handling an application for (9) Number of dosage units produced an exemption which has been accepted for the past 2 years. for filing. (c) Within a reasonable period of [38 FR 8254, Mar. 30, 1973. Redesignated at 38 time after the receipt of an application FR 26609, Sept. 24, 1973, as amended at 44 FR for an exemption under this section, 18968, Mar. 30, 1979; 52 FR 9803, Mar. 27, 1987; the Administrator shall notify the ap- 75 FR 10679, Mar. 9, 2010; 81 FR 97021, Dec. 30, plicant of his acceptance or non-ac- 2016] ceptance of the application, and if not accepted, the reason therefor. The Ad- § 1308.32 Exempted prescription prod- ministrator need not accept an applica- ucts. tion for filing if any of the require- The compounds, mixtures, or prep- ments prescribed in paragraph (b) of arations that contain a nonnarcotic this section is lacking or is not set controlled substance listed in forth so as to be readily understood. If § 1308.12(e) or in § 1308.13(b) or (c) or in the applicant desires, he may amend § 1308.14 or in § 1308.15 listed in the the application to meet the require- Table of Exempted Prescription Prod- ments of paragraph (b) of this section. If accepted for filing, the Adminis- ucts have been exempted by the Ad- trator shall publish in the FEDERAL ministrator from the application of REGISTER general notice of this pro- sections 302 through 305, 307 through posed rulemaking in granting or deny- 309, and 1002 through 1004 of the Act (21 ing the application. Such notice shall U.S.C. 822–825, 827–829, and 952–954) and include a reference to the legal author- §§ 1301.13, 1301.22, and §§ 1301.71 through ity under which the rule is proposed, a 1301.76 of this chapter for administra- statement of the proposed rule grant- tive purposes only. An exception to the ing or denying an exemption, and, in above is that those products containing the discretion of the Administrator, a butalbital shall not be exempt from the summary of the subjects and issues in- requirement of 21 U.S.C. 952–954 con- volved. The Administrator shall permit cerning importation, exportation, any interested person to file written transshipment and in-transit shipment comments on or objections to the proof controlled substances. Any deviation posal and shall designate in the notice from the quantitative composition of of proposed rule making the time dur- any of the listed drugs shall require a ing which such filings may be made. petition of exemption in order for the After consideration of the application product to be exempted. A listing of and any comments on or objections to his proposed rulemaking, the Adminis- the Exempted Prescription Products trator shall issue and publish in the may be obtained by submitting a writ- FEDERAL REGISTER his final order on ten request to the Drug and Chemical the application, which shall set forth Evaluation Section, Drug Enforcement the findings of fact and conclusions of Administration. See the Table of DEA law upon which the order is based. This Mailing Addresses in § 1321.01 of this order shall specify the date on which it chapter for the current mailing ad- shall take effect, which shall not be dress. less than 30 days from the date of pub- [75 FR 10679, Mar. 9, 2010] lication in the FEDERAL REGISTER unless the Administrator finds that conditions of public health or safety neces-

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EXEMPT ANABOLIC STEROID PRODUCTS (i) A determination that the product has no significant potential for abuse § 1308.33 Exemption of certain ana- and bolic steroid products; application. (ii) a granting of an exemption under (a) The Administrator, upon the rec- this section. ommendation of Secretary of Health (d) Within a reasonable period of and Human Services, may, by regula- time after the receipt of the application, exempt from the application of tion for an exemption under this sec- all or any part of the Act any com- tion, the Administrator shall notify pound, mixture, or preparation con- the applicant of his acceptance or non- taining an anabolic steroid as defined acceptance of the application, and if in part 1300 of this chapter, which is in- not accepted, the reason therefor. The tended for administration to a human Administrator need not accept an ap- being or animal, if, because of its con- plication for filing if any of the re- centration, preparation, formulation, quirements prescribed in paragraph (c) or delivery system, it has no signifi- of this section is lacking or is not set cant potential for abuse. forth so as to be readily understood. (b) Any person seeking to have any The applicant may amend the applica- compound, mixture, or preparation tion to meet the requirements of para- containing an anabolic steroid as de- graph (c) of this section. If accepted for fined in part 1300 of this chapter exempted from the application of all or filing, the Administrator will request any part of the Act, pursuant to para- from the Secretary for Health and graph (a) of this section, may apply to Human Services his recommendation, the Drug and Chemical Evaluation Sec- as to whether such product which con- tion, Diversion Control Division, Drug tains an anabolic steroid should be con- Enforcement Administration. See the sidered for exemption from certain por- Table of DEA Mailing Addresses in tions of the Controlled Substances Act. § 1321.01 of this chapter for the current On receipt of the recommendation of mailing address. the Secretary, the Administrator shall (c) An application for an exemption make a determination as to whether under this section shall be submitted the evidence submitted or otherwise in triplicate and contain the following available sufficiently establishes that information: the product possesses no significant po- (1) The name and address of the ap- tential for abuse. The Administrator plicant; shall issue and publish in the FEDERAL (2) The name of the product; REGISTER his order on the application, (3) The chemical structural formula which shall include a reference to the or description for any anabolic steroid legal authority under which the order contained in the product; is issued, and the findings of fact and (4) The complete description of dos- conclusions of law upon which the age and quantitative composition of order is based. This order shall specify the dosage form; the date on which it will take effect. (5) A description of the delivery sys- The Administrator shall permit any in- tem, if applicable; terested person to file written com- (6) The indications and conditions for ments on or objections to the order use in which species, including whether within 60 days of the date of publica- or not this product is a prescription tion of his order in the FEDERAL REG- drug; ISTER. If any such comments or objec- (7) Information to facilitate identi- tions raise significant issues regarding fication of the dosage form, such as any finding of fact or conclusion of law shape, color, coating, and scoring; upon which the order is based, the Ad- (8) The label and labeling of the im- ministrator shall immediately suspend mediate container and the commercial the effectiveness of the order until he containers, if any, of the product; may reconsider the application in light (9) The units in which the dosage of the comments and objections filed. form is ordinarily available; and Thereafter, the Administrator shall re- (10) The facts which the applicant be- instate, revoke, or amend his original lieves justify: order as he determines appropriate.

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(e) The Administrator may revoke (2) Not used, or intended for use, for any exemption granted pursuant to human consumption, has been exempt- section 1903(a) of Public Law 101–647 by ed by the Administrator from the ap- following the procedures set forth in plication of the Act and this chapter. paragraph (d) of this section for han- (b) As used in this section, the fol- dling an application for an exemption lowing terms shall have the meanings which has been accepted for filing. specified: [56 FR 42936, Aug. 30, 1991; 57 FR 10815, Mar. (1) The term processed plant material 31, 1992, as amended at 62 FR 13968, Mar. 24, means cannabis plant material that 1997; 70 FR 74657, Dec. 16, 2005; 75 FR 10679, has been subject to industrial proc- Mar. 9, 2010; 81 FR 97021, Dec. 30, 2016] esses, or mixed with other ingredients, such that it cannot readily be con- § 1308.34 Exempt anabolic steroid verted into any form that can be used products. for human consumption. The list of compounds, mixtures, or (2) The term animal feed mixture preparations that contain an anabolic means sterilized cannabis seeds mixed steroid that have been exempted by the with other ingredients (not derived Administrator from application of sec- from the cannabis plant) in a formula- tions 302 through 309 and 1002 through tion that is designed, marketed, and 1004 of the Act (21 U.S.C. 822–829 and distributed for animal consumption 952–954) and §§ 1301.13, 1301.22, and (and not for human consumption). 1301.71 through 1301.76 of this chapter (3) The term used for human consump- for administrative purposes only may tion means either: be obtained by submitting a written re- (i) Ingested orally or quest to the Drug and Chemical Eval- uation Section, Drug Enforcement Ad- (ii) Applied by any means such that ministration. See the Table of DEA THC enters the human body. Mailing Addresses in § 1321.01 of this (4) The term intended for use for chapter for the current mailing ad- human consumption means any of the dress. following: (i) Designed by the manufacturer for [75 FR 10679, Mar. 9, 2010] human consumption; EXEMPT CANNABIS PLANT MATERIAL, (ii) Marketed for human consump- AND PRODUCTS MADE THEREFROM, tion; or THAT CONTAIN (iii) Distributed, exported, or im- TETRAHYDROCANNABINOLS ported, with the intent that it be used for human consumption. § 1308.35 Exemption of certain can- (c) In any proceeding arising under nabis plant material, and products the Act or this chapter, the burden of made therefrom, that contain going forward with the evidence that a tetrahydrocannabinols. material, compound, mixture, or prepa- (a) Any processed plant material or ration containing THC is exempt from animal feed mixture containing any control pursuant to this section shall amount of tetrahydrocannabinols be upon the person claiming such ex- (THC) that is both: emption, as set forth in section (1) Made from any portion of a plant 515(a)(1) of the Act (21 U.S.C. 885(a)(1)). of the genus Cannabis excluded from In order to meet this burden with re- the definition of marijuana under the spect to a product or plant material Act [i.e., the mature stalks of such that has not been expressly exempted plant, fiber produced from such stalks, from control by the Administrator pur- oil or cake made from the seeds of such suant to § 1308.23, the person claiming plant, any other compound, manufac- the exemption must present rigorous ture, salt, derivative, mixture, or prep- scientific evidence, including well-doc- aration of such mature stalks (except umented scientific studies by experts the resin extracted therefrom), fiber, trained and qualified to evaluate the oil, or cake, or the sterilized seed of effects of drugs on humans. such plant which is incapable of germi- nation] and [66 FR 51544, Oct. 9, 2001]

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HEARINGS tiate proceedings for the issuance (amendment or repeal) of a rule or regulation pursu- § 1308.41 Hearings generally. ant to section 201 of the Controlled Sub- stances Act. In any case where the Administrator Attached hereto and constituting a part of shall hold a hearing on the issuance, this petition are the following: amendment, or repeal of rules pursuant (A) The proposed rule in the form proposed to section 201 of the Act, the proce- by the petitioner. (If the petitioner seeks the dures for such hearing and accom- amendment or repeal of an existing rule, the panying proceedings shall be governed existing rule, together with a reference to the section in the Code of Federal Regula- generally by the rulemaking proce- tions where it appears, should be included.) dures set forth in the Administrative (B) A statement of the grounds which the Procedure Act (5 U.S.C. 551–559) and petitioner relies for the issuance (amend- specifically by section 201 of the Act (21 ment or repeal) of the rule. (Such grounds U.S.C. 811), by §§ 1308.42–1308.51, and by shall include a reasonably concise statement §§ 1316.41–1316.67 of this chapter. of the facts relied upon by the petitioner, including a summary of any relevant medical § 1308.42 Purpose of hearing. or scientific evidence known to the petitioner.) If requested by any interested person All notices to be sent regarding this peti- after proceedings are initiated pursu- tion should be addressed to: ant to § 1308.43, the Administrator shall llllllllll (Name) hold a hearing for the purpose of re- llllllllll (Street Address) ceiving factual evidence and expert llllllllll (City and State) Respectfully yours, opinion regarding the issues involved llllllllll (Signature of petitioner) in the issuance, amendment or repeal of a rule issuable pursuant to section (c) Within a reasonable period of 201(a) of the Act (21 U.S.C. 811(a)). Ex- time after the receipt of a petition, the tensive argument should not be offered Administrator shall notify the peti- into evidence but rather presented in tioner of his acceptance or nonaccept- opening or closing statements of coun- ance of the petition, and if not accept- sel or in memoranda or proposed find- ed, the reason therefor. The Adminis- ings of fact and conclusions of law. Ad- trator need not accept a petition for ditional information relating to hear- filing if any of the requirements pre- ings to include waivers or modification scribed in paragraph (b) of this section of rules, request for hearing, burden of is lacking or is not set forth so as to be proof, time and place, and final order readily understood. If the petitioner 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- trator within a reasonable period of § 1308.43 Initiation of proceedings for rulemaking. time thereafter if he finds the grounds upon which the petitioner relies are (a) Any interested person may sub- not sufficient to justify the initiation mit a petition to initiate proceedings of proceedings. for the issuance, amendment, or repeal (d) The Administrator shall, before of any rule or regulation issuable pur- initiating proceedings for the issuance, suant to the provisions of section 201 of amendment, or repeal of any rule ei- the Act. ther to control a drug or other sub- (b) Petitions shall be submitted in stance, or to transfer a drug or other quintuplicate to the Administrator. substance from one schedule to an- See the Table of DEA Mailing Address- other, or to remove a drug or other es in § 1321.01 of this chapter for the substance entirely from the schedules, current mailing address. Petitions and after gathering the necessary data, shall be in the following form: 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

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

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final rule and the findings of fact and ERAL REGISTER an order controlling an conclusions of law upon which the rule immediate precursor. The order shall is based. This order shall specify the designate the schedule in which the im- date on which it shall take effect, mediate precursor is to be placed, which shall not be less than 30 days which shall be the same schedule in from the date of publication in the which the controlled substance of FEDERAL REGISTER unless the Adminis- which it is an immediate precursor is trator finds that conditions of public placed or any other schedule with a health or safety necessitate an earlier higher numerical designation. An order effective date, in which event the Ad- controlling an immediate precursor ministrator shall specify in the order shall become effective 30 days from the his findings as to such conditions. date of publication in the FEDERAL [38 FR 8254, Mar. 30, 1973. Redesignated at 38 REGISTER, unless the Administrator FR 26609, Sept. 24, 1973, and further redesig- finds that conditions of public health nated at 62 FR 13968, Mar. 24, 1997] or safety necessitate an earlier effective date, in which event the Adminis- § 1308.46 Control required under inter- trator shall specify in the order his national treaty. findings as to such conditions. Pursuant to section 201(d) of the Act (21 U.S.C. 811(d)), where control of a [38 FR 8254, Mar. 30, 1973. Redesignated at 38 substance is required by U.S. obliga- FR 26609, Sept. 24, 1973, and further redesignated at 62 FR 13968, Mar. 24, 1997] tions under international treaties, conventions, or protocols in effect on May § 1308.49 Temporary scheduling. 1, 1971, the Administrator shall issue and publish in the FEDERAL REGISTER (a) Pursuant to 21 U.S.C. 811(h) and an order controlling such substance without regard to the requirements of under the schedule he deems most ap- 21 U.S.C. 811(b) relating to the sci- propriate to carry out obligations. entific and medical evaluation of the Issuance of such an order shall be with- Secretary of Health and Human Serv- out regard to the findings required by ices, the Drug Enforcement Adminis- subsections 201(a) or 202(b) of the Act tration may place a substance into (21 U.S.C. 811(a) or 812(b)) and without Schedule I on a temporary basis, if it regard to the procedures prescribed by determines that such action is nec- § 1308.41 or subsections 201 (a) and (b) of essary to avoid an imminent hazard to the Act (21 U.S.C. 811 (a) and (b)). An the public safety. An order issued order controlling a substance shall be- under this section may not be effective come effective 30 days from the date of before the expiration of 30 calendar publication in the FEDERAL REGISTER, days from: unless the Administrator finds that (1) The date of publication by the Ad- conditions of public health or safety ministration of a notice in the FED- necessitate an earlier effective date, in ERAL REGISTER of its intention to issue which event the Administrator shall such order and the grounds upon which specify in the order his findings as to such order is to be issued; and such conditions. (2) The date the Administration has [38 FR 8254, Mar. 30, 1973. Redesignated at 38 transmitted notification to the Sec- FR 26609, Sept. 24, 1973, and further redesig- retary of Health and Human Services nated at 62 FR 13968, Mar. 24, 1997] of the Administration’s intention to issue such order. § 1308.47 Control of immediate precur- (b) An order issued under this section sors. will be vacated upon the conclusion of Pursuant to section 201(e) of the Act a subsequent rulemaking proceeding (21 U.S.C. 811(e)), the Administrator initiated under section 201(a) (21 U.S.C. may, without regard to the findings re- 811(a)) with respect to such substance quired by subsection 201(a) or 202 (b) of or at the end of two years from the ef- the Act (21 U.S.C. 811(a) or 812(b)) and fective date of the order scheduling the without regard to the procedures pre- substance, except that during the pend- scribed by § 1308.41 or subsections 201 ency of proceedings under section (a) and (b) of the Act (21 U.S.C. 811(a) 201(a) (21 U.S.C. 811(a)) with respect to and (b)), issue and publish in the FED- the substance, the Administration may

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extend the temporary scheduling for up 1309.54 Burden of proof. to one year. 1309.55 Time and place of hearing.

[81 FR 97021, Dec. 30, 2016] MODIFICATION, TRANSFER AND TERMINATION OF REGISTRATION PART 1309—REGISTRATION OF 1309.61 Modification in registration. MANUFACTURERS, DISTRIBUTORS, 1309.62 Termination of registration. IMPORTERS AND EXPORTERS OF 1309.63 Transfer of registration. LIST I CHEMICALS SECURITY REQUIREMENTS 1309.71 General security requirements. GENERAL INFORMATION 1309.72 Felony conviction; employer respon- Sec. sibilities. 1309.01 Scope of part 1309. 1309.73 Employee responsibility to report di- 1309.02 Definitions. version. 1309.03 Information; special instructions. AUTHORITY: 21 U.S.C. 802, 821, 822, 823, 824, FEES FOR REGISTRATION AND REREGISTRATION 830, 871(b), 875, 877, 886a, 952, 953, 957, 958.

1309.11 Fee amounts. SOURCE: 60 FR 32454, June 22, 1995, unless 1309.12 Time and method of payment; re- otherwise noted. fund. GENERAL INFORMATION REQUIREMENTS FOR REGISTRATION 1309.21 Persons required to register. § 1309.01 Scope of part 1309. 1309.22 Separate registration for independent activities. Procedures governing the registra- 1309.23 Separate registration for separate tion of manufacturers, distributors, locations. importers and exporters of List I 1309.24 Waiver of registration requirement chemicals pursuant to Sections 102, 302, for certain activities. 303, 1007 and 1008 of the Act (21 U.S.C. 1309.25 Temporary exemption from registra- 802, 822, 823, 957 and 958) are set forth tion for chemical registration applicants. generally by those sections and specifi- 1309.26 Exemption of law enforcement officials. cally by the sections of this part.

APPLICATION FOR REGISTRATION § 1309.02 Definitions. 1309.31 Time for application for registra- Any term used in this part shall have tion; expiration date. the definition set forth in section 102 of 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 ACTION ON APPLICATIONS FOR REGISTRATION: under these rules and instructions REVOCATION OR SUSPENSION OF REGISTRATION supplementing these rules will be fur- 1309.41 Administrative review generally. nished upon request by writing to the 1309.42 Certificate of registration; denial of Registration Section, Drug Enforce- registration. ment Administration. See the Table of 1309.43 Suspension or revocation of registra- DEA Mailing Addresses in § 1321.01 of tion. this chapter for the current mailing ad- 1309.44 Suspension of registration pending final order. dress. 1309.45 Extension of registration pending [75 FR 10680, Mar. 9, 2010] final order. 1309.46 Order to show cause. FEES FOR REGISTRATION AND HEARINGS REREGISTRATION 1309.51 Hearings generally. § 1309.11 Fee amounts. 1309.52 Purpose of hearing. 1309.53 Request for hearing or appearance; (a) For each application for registra- waiver. tion or reregistration to manufacture

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the applicant shall pay an annual fee of REQUIREMENTS FOR REGISTRATION $3,047. (b) For each application for registra- § 1309.21 Persons required to register. tion or reregistration to distribute, im- (a) Unless exempted by law or under port, or export a List I chemical, the §§ 1309.24 through 1309.26 or §§ 1310.12 applicant shall pay an annual fee of through 1310.13 of this chapter, the fol- $1,523. lowing persons must annually obtain a registration specific to the List I [77 FR 15250, Mar. 15, 2012] chemicals to be handled: (1) Every person who manufactures § 1309.12 Time and method of pay- or imports or proposes to manufacture ment; refund. or import a List I chemical or a drug (a) For each application for registra- product containing ephedrine, tion or reregistration to manufacture, pseudoephedrine, or phenylpropanola- distribute, import, or export, the appli- mine. cant shall pay the fee when the appli- (2) Every person who distributes or cation for registration or reregistra- exports or proposes to distribute or ex- tion is submitted for filing. port any List I chemical, other than (b) Payments should be made in the those List I chemicals contained in a form of a credit card; a personal, cer- product exempted under paragraph tified, or cashier’s check; or a money (1)(iv) of the definition of regulated order made payable to ‘‘Drug Enforce- transaction in § 1300.02 of this chapter. ment Administration.’’ Payments (b) Only persons actually engaged in the activities are required to obtain a made in the form of stamps, foreign registration; related or affiliated per- currency, or third party endorsed sons who are not engaged in the activi- checks will not be accepted. These ap- ties are not required to be registered. plication fees are not refundable. (For example, a stockholder or parent [75 FR 4980, Feb. 1, 2010] corporation of a corporation distributing List I chemicals is not required to obtain a registration.) (c) The registration requirements are 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.

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[75 FR 4980, Feb. 1, 2010, as amended at 77 FR chemicals were originally delivered; 4236, Jan. 27, 2012; 77 FR 15250, Mar. 15, 2012] and (2) An office used by agents of a reg- § 1309.22 Separate registration for istrant where sales of List I chemicals independent activities. are solicited, made, or supervised but (a) The following groups of activities which neither contains such chemicals are deemed to be independent of each (other than chemicals for display pur- other: poses) nor serves as a distribution (1) Manufacturing of List I chemicals point for filling sales orders. or drug products containing ephedrine, pseudoephedrine, or phenylpropanola- [60 FR 32454, June 22, 1995, as amended at 75 FR 4981, Feb. 1, 2010] mine. (2) Distributing of List I chemicals § 1309.24 Waiver of registration re- and scheduled listed chemical prod- quirement for certain activities. ucts. (a) The requirement of registration is (3) Importing List I chemicals or waived for any agent or employee of a drug products containing ephedrine, person who is registered to engage in pseudoephedrine, or phenylpropanola- any group of independent activities, if mine. the agent or employee is acting in the (4) Exporting List I chemicals and usual course of his or her business or scheduled listed chemical products. employment. (b) Except as provided in paragraphs (b) The requirement of registration is (c) and (d) of this section, every person waived for any person who manufac- who engages in more than one group of tures or distributes a scheduled listed independent activities must obtain a chemical product or other product con- separate registration for each group of taining a List I chemical that is de- activities, unless otherwise exempted scribed and included in paragraph by the Act or §§ 1309.24 through 1309.26. (1)(iv) of the definition of regulated (c) A person registered to import any transaction in § 1300.02 of this chapter, List I chemical shall be authorized to if that person is registered with the distribute that List I chemical after Administration to engage in the same importation, but no other chemical activity with a controlled substance. that the person is not registered to im- (c) The requirement of registration is port. waived for any person who imports or (d) A person registered to manufac- exports a scheduled listed chemical ture any List I chemical shall be au- product or other product containing a thorized to distribute that List I chem- List I chemical that is described and ical after manufacture, but no other included in paragraph (1)(iv) of the def- chemical that the person is not reg- inition of regulated transaction in istered to manufacture. § 1300.02 of this chapter, if that person [75 FR 4981, Feb. 1, 2010] is registered with the Administration to engage in the same activity with a § 1309.23 Separate registration for sep- controlled substance. arate locations. (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

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or disposal firm for the purpose of and reporting requirements set forth waste disposal. under Parts 1310, 1313, 1314, and 1315 of (f) The requirement of registration is this chapter. waived for any person whose distribu- [75 FR 4981, Feb. 1, 2010, as amended at 77 FR tion of red phosphorus or white phos- 4236, Jan. 25, 2012] phorus is limited solely to residual quantities of chemical returned to the § 1309.25 Temporary exemption from producer, in reusable rail cars and registration for chemical registra- intermodal tank containers which con- tion applicants. form to International Standards Orga- (a) Each person required by section nization specifications (with capacities 302 of the Act (21 U.S.C. 822) to obtain greater than or equal to 2,500 gallons in a registration to distribute, import, or a single container). export a combination ephedrine prod- (g) The requirement of registration is uct is temporarily exempted from the waived for any person whose activities registration requirement, provided with respect to List I chemicals are that the person submits a proper appli- limited solely to the distribution of cation for registration on or before Lugol’s Solution (consisting of 5 per- July 12, 1997. The exemption will recent iodine and 10 percent potassium main in effect for each person who has iodide in an aqueous solution) in origi- made such application until the Ad- nal manufacturer’s packaging of one ministration has approved or denied fluid ounce (30 ml) or less. that application. This exemption ap- (h) The requirement of registration is plies only to registration; all other waived for any manufacturer of a List chemical control requirements set I chemical, if that chemical is pro- forth in this part 1309 and parts 1310, duced solely for internal consumption and 1313 of this chapter remain in full by the manufacturer and there is no force and effect. subsequent distribution or exportation (b) Each person required by section of the List I chemical. 302 of the Act (21 U.S.C. 822) to obtain (i) If any person exempted under a registration to distribute, import, or paragraph (b), (c), (d), (e), or (f) of this export a pseudoephedrine or phenyl- section also engages in the distribu- propanolamine drug product is tempo- tion, importation, or exportation of a rarily exempted from the registration List I chemical, other than as de- requirement, provided that the person scribed in such paragraph, the person submits a proper application for reg- shall obtain a registration for the ac- istration on or before October 3, 1997. tivities, as required by § 1309.21. The exemption will remain in effect for (j) The Administrator may, upon each person who has made such appli- finding that continuation of the waiver cation until the Administration has ap- would not be in the public interest, proved or denied that application. This suspend or revoke a waiver granted exemption applies only to registration; under paragraph (b), (c), (d), (e), or (f) all other chemical control require- of this section pursuant to the proce- ments set forth in this part 1309 and dures set forth in §§ 1309.43 through parts 1310 and 1313 of this chapter re- 1309.46 and §§ 1309.51 through 1309.55. In main in full force and effect. considering the revocation or suspen- (c) Each person required by sections sion of a person’s waiver granted pur- 302 or 1007 of the Act (21 U.S.C. 822 or suant to paragraph (b) or (c) of this 957) to obtain a registration to manu- section, the Administrator shall also facture or import prescription drug consider whether action to revoke or products containing ephedrine, suspend the person’s controlled sub- pseudoephedrine, or phenylpropanola- stance registration pursuant to section mine is temporarily exempted from the 304 of the Act (21 U.S.C. 824) is war- registration requirement, provided ranted. that the person submits a proper appli- (k) Any person exempted from the cation for registration on or before registration requirement under this March 3, 2010. The exemption will re- section must comply with the security main in effect for each person who has requirements set forth in §§ 1309.71 made such application until the Ad- through 1309.73 and the recordkeeping ministration has approved or denied

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

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chemical to be manufactured, distrib- § 1309.34 Acceptance for filing; defec- uted, imported, or exported. tive applications. (e) Registration shall not entitle a (a) Applications submitted for filing person to engage in any activity with are dated upon receipt. If found to be any List I chemical not specified in his complete, the application will be ac- or her application. cepted for filing. Applications failing (f) Each application shall include all to comply with the requirements of information called for in the form, un- this part will not generally be accepted less the item is not applicable, in for filing. In the case of minor defects which case this fact shall be indicated. as to completeness, the Administrator (g) Each application, attachment, or may accept the application for filing other document filed as part of an ap- with a request to the applicant for ad- plication, shall be signed by the appli- ditional information. A defective applicant, if an individual; by a partner of cation will be returned to the applicant the applicant, if a partnership; or by an within 10 days of receipt with a state- officer of the applicant, if a corpora- ment of the reason for not accepting tion, corporate division, association, the application for filing. A defective trust or other entity. An applicant may application may be corrected and re- authorize one or more individuals, who submitted for filing at any time. would not otherwise be authorized to (b) Accepting an application for fil- do so, to sign applications for the ap- ing does not preclude any subsequent plicant by filing with the application request for additional information pur- or other document a power of attorney suant to § 1309.35 and has no bearing on for each such individual. The power of whether the application will be grant- attorney shall be signed by a person ed. who is authorized to sign applications under this paragraph and shall contain § 1309.35 Additional information. the signature of the individual being The Administrator may require an authorized to sign the application or applicant to submit such documents or other document. The power of attorney written statements of fact relevant to shall be valid until revoked by the ap- the application as he deems necessary plicant. to determine whether the application [60 FR 32454, June 22, 1995, as amended at 75 should be granted. The failure of the FR 10680, Mar. 9, 2010; 81 FR 97021, Dec. 30, applicant to provide such documents or 2016] statements within a reasonable time after being requested to do so shall be § 1309.33 Filing of application; joint fil- deemed to be a waiver by the applicant ings. of an opportunity to present such docu- (a) All applications for registration ments or facts for consideration by the shall be submitted for filing to the Administrator in granting or denying Registration Section, Drug Enforce- the application. ment Administration. See the Table of DEA Mailing Addresses in § 1321.01 of § 1309.36 Amendments to and with- this chapter for the current mailing ad- drawals of applications. dress. The appropriate registration fee (a) An application may be amended and any required attachments must ac- or withdrawn without permission of company the application. the Administration at any time before (b) Any person required to obtain the date on which the applicant re- more than one registration may submit ceives an order to show cause pursuant all applications in one package. Each to § 1309.46. An application may be application must be complete and must amended or withdrawn with permission not refer to any accompanying applica- of the Administrator at any time tion for required information. where good cause is shown by the ap- [60 FR 32454, June 22, 1995, as amended at 75 plicant or where the amendment or FR 10680, Mar. 9, 2010] withdrawal is in the public interest.

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(b) After an application has been ac- any official, agent or employee of the cepted for filing, the request by the ap- Administration or of any Federal, plicant that it be returned or the fail- State, or local agency engaged in en- ure of the applicant to respond to offi- forcement of laws relating to List I cial correspondence regarding the ap- chemicals or controlled substances. plication, including a request that the applicant submit the required fee, § 1309.43 Suspension or revocation of when sent by registered or certified registration. mail, return receipt requested, shall be (a) The Administrator may suspend deemed to be a withdrawal of the appli- any registration pursuant to section cation. 304(a) of the Act (21 U.S.C. 824(a)) for any period of time he determines. ACTION ON APPLICATIONS FOR REGISTRA- (b) The Administrator may revoke TION: REVOCATION OR SUSPENSION OF any registration pursuant to section REGISTRATION 304(a) of the Act (21 U.S.C. 824(a)). § 1309.41 Administrative review gen- (c) Before revoking or suspending any erally. registration, the Administrator shall The Administrator may inspect, or issue an order to show cause pursuant cause to be inspected, the establish- to Section 1309.46 and, if requested by ment of an applicant or registrant, pur- the registrant, shall hold a hearing suant to subpart A of part 1316 of this pursuant to Section 1309.51. Notwith- chapter. The Administrator shall re- standing the requirements of this Sec- view the application for registration tion, however, the Administrator may and other information gathered by the suspend any registration pending a Administrator regarding an applicant final order pursuant to § 1309.44. in order to determine whether the ap- (d) Upon service of the order of the plicable standards of Section 303 of the Administrator suspending or revoking Act (21 U.S.C. 823) have been met by registration, the registrant shall im- the applicant. mediately deliver his or her Certificate of Registration to the nearest office of § 1309.42 Certificate of registration; the Administration. Also, upon service denial of registration. of the order of the Administrator re- (a) The Administrator shall issue a voking or suspending registration, the Certificate of Registration (DEA Form registrant shall, as instructed by the 511) to an applicant if the issuance of Administrator: registration or reregistration is re- (1) Deliver all List I chemicals in his quired under the applicable provisions or her possession that were obtained of section 303 of the Act (21 U.S.C. 823). under the authority of a registration or In the event that the issuance of reg- an exemption from registration grant- istration or reregistration is not re- ed by the Administrator by regulation, quired, the Administrator shall deny to the nearest office of the Administra- 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 permit inspection of the certificate by Administration. Also, upon service of

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

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show cause why the application for reg- ceedings under the Act or any other istration should not be denied. law of the United States. (b) If, upon information gathered by [60 FR 32454, June 22, 1995, as amended at 81 the Administration regarding any reg- FR 97021, Dec. 30, 2016] istrant, the Administrator determines that the registration of such registrant § 1309.52 Purpose of hearing. is subject to suspension or revocation If requested by a person entitled to a pursuant to section 304 of the Act (21 hearing, the Administrator shall hold a U.S.C. 824), the Administrator shall hearing for the purpose of receiving serve upon the registrant an order to factual evidence regarding the issues show cause why the registration should involved in the denial, revocation, or not be revoked or suspended. suspension of any registration. Exten- (c) The order to show cause shall call sive argument should not be offered upon the applicant or registrant to ap- into evidence but rather presented in pear before the Administrator at a opening or closing statements of coun- time and place stated in the order, sel or in memoranda or proposed find- which shall not be less than 30 days ings of fact and conclusions of law. after the date of receipt of the order. The order to show cause shall also con- § 1309.53 Request for hearing or ap- tain a statement of the legal basis for pearance; waiver. such hearing and for the denial, revoca- (a) Any person entitled to a hearing tion, or suspension of registration and pursuant to §§ 1309.42 and 1309.43 and de- a summary of the matters of fact and siring a hearing shall, within 30 days law asserted. after the date of receipt of the order to (d) Upon Receipt of an order to show show cause, file with the Adminis- cause, the applicant or registrant trator a written request for a hearing must, if he desires a hearing, file a rein the form prescribed in § 1316.47 of quest for a hearing pursuant to this chapter. § 1309.53. If a hearing is requested, the (b) Any person entitled to a hearing Administrator shall hold a hearing at pursuant to §§ 1309.42 and 1309.43 may, the time and place stated in the order, within the period permitted for filing a pursuant to § 1309.51. request for a hearing, file with the Ad- (e) When authorized by the Adminis- ministrator a waiver of an opportunity trator, any agent of the Administra- for a hearing, together with a written tion may serve the order to show statement regarding his position on cause. the matters of fact and law involved in [60 FR 32454, June 22, 1995, as amended at 81 such hearing. Such statement, if ad- FR 97021, Dec. 30, 2016] missible, shall be made a part of the record and shall be considered in light HEARINGS of the lack of opportunity for cross-examination in determining the weight § 1309.51 Hearings generally. to be attached to matters of fact as- (a) In any case where the Adminis- serted therein. trator shall hold a hearing on any reg- (c) If any person entitled to a hearing istration or application therefore, the pursuant to §§ 1309.42 and 1309.43 fails to procedures for such hearing shall be file a request for a hearing, or if he so governed generally by the adjudication files and fails to appear at the hearing, procedures set forth in the Administra- he shall be deemed to have waived his tive Procedure Act (5 U.S.C. 551–559) opportunity for the hearing, unless he and specifically by sections 303 and 304 shows good cause for such failure. of the Act (21 U.S.C. 823–824), by (d) If any person entitled to a hearing §§ 1309.52 through 1309.55, and by the waives or is deemed to waive his or her procedures for administrative hearings opportunity for the hearing, the Ad- under the Act set forth in §§ 1316.41 ministrator may cancel the hearing, if through 1316.67 of this chapter. scheduled, and issue his final order pur- (b) Any hearing under this part shall suant to § 1309.57 without a hearing. be independent of, and not in lieu of, [60 FR 32454, June 22, 1995. Redesignated at 62 criminal prosecutions or other pro- FR 13968, Mar. 24, 1997]

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§ 1309.54 Burden of proof. trator shall issue a new certificate of (a) At any hearing for the denial of a registration (DEA Form 511) to the reg- registration, the Administration shall istrant, who shall maintain it with the have the burden of proving that the re- old certificate of registration until ex- quirements for such registration pursu- piration. ant to section 303 of the Act (21 U.S.C. [75 FR 10680, Mar. 9, 2010] 823) are not satisfied. (b) At any hearing for the revocation § 1309.62 Termination of registration. or suspension of a registration, the Ad- (a) The registration of any person ministration shall have the burden of shall terminate, without any further proving that the requirements for such action by the Administration, if and revocation or suspension pursuant to when such person dies, ceases legal ex- section 304(a) of the Act (21 U.S.C. istence, discontinues business or pro- 824(a)) are satisfied. fessional practice, or surrenders a reg- [60 FR 32454, June 22, 1995. Redesignated at 62 istration. Any registrant who ceases FR 13968, Mar. 24, 1997] legal existence or discontinues business or professional practice shall § 1309.55 Time and place of hearing. promptly notify the Special Agent in The hearing will commence at the Charge of the Administration in the place and time designated in the order area in which the person is located of to show cause or notice of hearing pub- such fact and seek authority and in- lished in the FEDERAL REGISTER (unless structions to dispose of any List I expedited pursuant to Section chemicals obtained under the author- 1309.44(c)) but thereafter it may be ity of that registration. Any registrant moved to a different place and may be who ceases legal existence or discon- continued from day to day or recessed tinues business or professional practice to a later day without notice other or wishes to surrender a registration than announcement thereof by the pre- shall notify the Special Agent in siding officer at the hearing. Charge of the Administration in the area in which the person is located of [60 FR 32454, June 22, 1995. Redesignated at 62 such fact and seek authority and in- FR 13968, Mar. 24, 1997] structions to dispose of any List I MODIFICATION, TRANSFER AND chemicals obtained under the author- TERMINATION OF REGISTRATION ity of that registration. (b) The Special Agent in Charge shall § 1309.61 Modification in registration. authorize and instruct the person to Any registrant may apply to modify dispose of the List I chemical in one of his or her registration to authorize the the following manners: handling of additional List I chemicals (1) By transfer to person registered or to change his or her name or ad- under the Act and authorized to pos- dress, by submitting a letter of request sess the substances; to the Registration Section, Drug En- (2) By delivery to an agent of the Ad- forcement Administration. See the ministration or to the nearest office of Table of DEA Mailing Addresses in the Administration; § 1321.01 of this chapter for the current (3) By such other means as the Spe- mailing address. The letter shall con- cial Agent in Charge may determine to tain the registrant’s name, address, assure that the substance does not be- and registration number as printed on come available to unauthorized per- the certificate of registration, and the sons. List I chemicals to be added to his reg- [60 FR 32454, June 22, 1995, as amended at 62 istration or the new name or address FR 5916, Feb. 10, 1997; 76 FR 61564, Oct. 5, 2011; and shall be signed in accordance with 77 FR 4236, Jan. 27, 2012] § 1309.32(g). No fee shall be required to be paid for the modification. The re- § 1309.63 Transfer of registration. quest for modification shall be handled No registration or any authority con- in the same manner as an application ferred thereby shall be assigned or oth- for registration. If the modification in erwise transferred except upon such registration is approved, the Adminis- conditions as the Administrator may

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specifically designate and then only Mailing Addresses in § 1321.01 of this pursuant to his written consent. chapter for the current mailing address. SECURITY REQUIREMENTS [60 FR 32454, June 22, 1995, as amended at 62 § 1309.71 General security require- FR 13968, Mar. 24, 1997; 67 FR 14861, Mar. 28, ments. 2002; 71 FR 56023, Sept. 26, 2006; 75 FR 10680, (a) All applicants and registrants Mar. 9, 2010; 81 FR 97021, Dec. 30, 2016] must provide effective controls and procedures to guard against theft and § 1309.72 Felony conviction; employer responsibilities. diversion of List I chemicals. Chemi- cals must be stored in containers (a) The registrant shall exercise cau- sealed in such a manner as to indicate tion in the consideration of employ- any attempts at tampering with the ment of persons who will have access container. Where chemicals cannot be to listed chemicals, who have been con- stored in sealed containers, access to victed of a felony offense relating to the chemicals should be controlled controlled substances or listed chemi- through physical means or through cals, or who have, at any time, had an human or electronic monitoring. application for registration with the (b) In evaluating the effectiveness of DEA denied, had a DEA registration re- security controls and procedures, the voked, or surrendered a DEA registra- Administrator shall consider the fol- tion for cause. (For purposes of this lowing factors: subsection, the term ‘‘for cause’’ means (1) The type, form, and quantity of a surrender in lieu of, or as a con- List I chemicals handled; (2) The location of the premises and sequence of, any Federal or State ad- the relationship such location bears on ministrative, civil or criminal action the security needs; resulting from an investigation of the (3) The type of building construction individual’s handling of controlled sub- comprising the facility and the general stances or listed chemicals.) The reg- characteristics of the building or build- istrant should be aware of the cir- ings; cumstances regarding the action (4) The availability of electronic de- against the potential employee and the tection and alarm systems; rehabilitative efforts following the ac- (5) The extent of unsupervised public tion. The registrant shall assess the access to the facility; risks involved in employing such per- (6) The adequacy of supervision over sons, including the potential for action employees having access to List I against the registrant pursuant to chemicals; § 1309.43, If such person is found to have (7) The procedures for handling busi- diverted listed chemicals, and, in the ness guests, visitors, maintenance per- event of employment, shall institute sonnel, and nonemployee service per- procedures to limit the potential for sonnel in areas where List I chemicals diversion of List I chemicals. are processed or stored; and (b) It is the position of DEA that em- (8) The adequacy of the registrant’s ployees who possess, sell, use or divert or applicant’s systems for monitoring the receipt, distribution, and disposi- listed chemicals or controlled sub- tion of List I chemicals in its oper- stances will subject themselves not ations. only to State or Federal prosecution (c) Any registrant or applicant desir- for any illicit activity, but shall also ing to determine whether a proposed immediately become the subject of system of security controls and proce- independent action regarding their dures is adequate may submit mate- continued employment. The employer rials and plans regarding the proposed will assess the seriousness of the em- security controls and procedures either ployee’s violation, the position of re- to the Special Agent in Charge in the sponsibility held by the employee, past region in which the security controls record of employment, etc., in deter- and procedures will be used, or to the mining whether to suspend, transfer, Regulatory Section, Drug Enforcement terminate or take other action against Administration. See the Table of DEA the employee.

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§ 1309.73 Employee responsibility to used to manufacture controlled sub- report diversion. stances. Reports of listed chemical diversion AUTHORITY: 21 U.S.C. 802, 827(h), 830, 871(b) by fellow employees is not only a nec- 890. essary part of an overall employee se- SOURCE: 54 FR 31665, Aug. 1, 1989, unless curity program but also serves the pub- otherwise noted. lic interest at large. It is, therefore, the position of DEA that an employee § 1310.01 Definitions. who has knowledge of diversion from Any term used in this part shall have his employer by a fellow employee has the definition set forth in section 102 of an obligation to report such informa- the Act (21 U.S.C. 802) or part 1300 of tion to a responsible security official of this chapter. the employer. The employer shall treat [62 FR 13968, Mar. 24, 1997] such information as confidential and shall take all reasonable steps to pro- § 1310.02 Substances covered. tect the confidentiality of the informa- The following chemicals have been tion and the identity of the employee specifically designated by the Adminis- furnishing information. A failure to re- trator of the Drug Enforcement Admin- port information of chemical diversion istration as the listed chemicals sub- will be considered in determining the ject to the provisions of this part and feasibility of continuing to allow an parts 1309 and 1313 of this chapter. Each employee to work in an area with ac- chemical has been assigned the DEA cess to chemicals. The employer shall Chemical Code Number set forth oppo- inform all employees concerning this site it. policy. (a) List I chemicals (1) Alpha- PART 1310—RECORDS AND RE- phenylacetoacetonitrile and PORTS OF LISTED CHEMICALS its salts, optical isomers, and AND CERTAIN MACHINES; IM- salts of optical isomers PORTATION AND EXPORTATION (APAAN) ...... 8512 OF CERTAIN MACHINES (2) Anthranilic acid, its esters, and its salts ...... 8530 Sec. (3) Benzyl cyanide ...... 8735 1310.01 Definitions. (4) Ephedrine, its salts, optical 1310.02 Substances covered. isomers, and salts of optical 1310.03 Persons required to keep records and isomers ...... 8113 file reports. (5) Ergonovine and its salts ...... 8675 1310.04 Maintenance of records. (6) Ergotamine and its salts ...... 8676 1310.05 Reports. 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 registra- salts, optical isomers, and tion. salts of optical isomers ...... 8317 1310.10 Removal of the exemption of drugs (9) Phenylacetic acid, its esters, distributed under the Federal Food, Drug and its salts ...... 8791 and Cosmetic Act. (10) Phenylpropanolamine, its 1310.11 Reinstatement of exemption for drug 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; ap- (12) Pseudoephedrine, its salts, plication. optical isomers, and salts of 1310.14 Removal of exemption from defini- optical isomers ...... 8112 tion of regulated transaction. (13) 3,4-Methylenedioxyphenyl-2- 1310.15 Exempt drug products containing propanone ...... 8502 ephedrine and therapeutically significant 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 (17) Isosafrole ...... 8704

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(18) Safrole ...... 8323 shall be published at least 30 days prior (19) Piperonal ...... 8750 to the final rule. (20) N-Methylephedrine, its (d) Any person may petition the Ad- salts, optical isomers, and ministrator to have any substance salts of optical isomers (N- added or deleted from paragraphs (a) or Methylephedrine) ...... 8115 (b) of this section. (21) N-Methylpseudoephedrine, (e) Any petition under this section its salts, optical isomers, and shall contain the following informa- salts of optical isomers ...... 8119 tion: (22) Hydriodic Acid ...... 6695 (1) The name and address of the peti- (23) Benzaldehyde ...... 8256 tioner; (24) Nitroethane ...... 6724 (2) The name of the chemical to (25) Gamma-Butyrolactone which the petition pertains; (Other names include: GBL; (3) The name and address of the man- Dihydro-2 (3H)-furanone; 1,2- ufacturer(s) of the chemical (if known); Butanolide; 1,4-Butanolide; 4- Hydroxybutanoic acid lactone; (4) A complete statement of the facts gamma-hydroxybutyric acid which the petitioner believes justifies lactone) ...... 2011 the addition or deletion of the sub- (26) Red phosphorus ...... 6795 stance from paragraphs (a) or (b) of (27) White phosphorus (Other this section; names: Yellow Phosphorus) .... 6796 (5) The date of the petition. (28) Hypophosphorous acid and (f) The Administrator may require its salts (Including ammonium the petitioner to submit such docu- hypophosphite, calcium ments or written statements of fact hypophosphite, iron relevant to the petition as he deems hypophosphite, potassium necessary in making a determination. hypophosphite, manganese (g) Within a reasonable period of hypophosphite, magnesium time after the receipt of the petition, hypophosphite and sodium the Administrator shall notify the pe- hypophosphite) ...... 6797 titioner of his decision and the reason (29) N-phenethyl-4-piperidone therefor. The Administrator need not (NPP) ...... 8332 accept a petition if any of the require- (30) Iodine ...... 6699 ments prescribed in paragraph (e) of (31) Ergocristine and its salts .... 8612 this section or requested pursuant to (b) List II chemicals: paragraph (f) of this section are lacking or are not clearly set forth as to be (1) Acetic anhydride ...... 8519 readily understood. If the petitioner (2) Acetone ...... 6532 desires, he may amend and resubmit (3) Benzyl chloride ...... 8570 the petition to meet the requirements (4) Ethyl ether ...... 6584 of paragraphs (e) and (f) of this section. (5) Potassium permanganate ..... 6579 (h) If a petition is granted or the Ad- (6) 2-Butanone (or Methyl Ethyl ministrator, upon his own motion, pro- Ketone or MEK) ...... 6714 poses to add or delete substances as (7) Toluene ...... 6594 listed chemicals as set forth in para- (8) Hydrochloric acid (including graph (c) of this section, he shall issue anhydrous hydrogen chloride) 6545 and publish in the FEDERAL REGISTER a (9) Sulfuric acid ...... 6552 proposal to add or delete a substance as (10) Methyl Isobutyl Ketone a listed chemical. The Administrator (MIBK) ...... 6715 shall permit any interested person to (11) Sodium Permanganate ...... 6588 file written comments regarding the (c) The Administrator may add or de- proposal within 30 days of the date of lete a substance as a listed chemical by publication of his order in the FEDERAL publishing a final rule in the FEDERAL REGISTER. The Administrator will con- REGISTER following a proposal which sider any comments filed by interested

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persons and publish a final rule in ac- (ii) Uses or attempts to use the U.S. cordance with his decision in the mat- Postal Service or any private or com- ter. mercial carrier must, on a monthly [54 FR 31665, Aug. 1, 1989, as amended at 56 basis, report each such transaction FR 48733, Sept. 26, 1991; 57 FR 43615, Sept. 22, conducted during the previous month 1992; 60 FR 19510, Apr. 19, 1995; 60 FR 32460, as specified in §§ 1310.05(e) and 1310.06(k) June 22, 1995; 62 FR 5917, Feb. 10, 1997; 65 FR on DEA Form 453 through the DEA Di- 21647, Apr. 24, 2000; 65 FR 47316, Aug. 2, 2000; version Control Division secure net- 66 FR 52675, Oct. 17, 2001; 71 FR 60826, Oct. 17, work application. 2006; 72 FR 20046, Apr. 23, 2007; 72 FR 35391, July 2, 2007; 72 FR 40238, July 24, 2007; 76 FR [54 FR 31665, Aug. 1, 1989, as amended at 56 17781, Mar. 31, 2011; 82 FR 32460, July 14, 2017] FR 8277, Feb. 28, 1991; 61 FR 14023, Mar. 29, 1996; 67 FR 14861, Mar. 28, 2002; 68 FR 57804, § 1310.03 Persons required to keep Oct. 7, 2003; 70 FR 294, Jan. 4, 2005; 81 FR records and file reports. 97022, Dec. 30, 2016] (a) Each regulated person who en- § 1310.04 Maintenance of records. gages in a regulated transaction involving a listed chemical, a tableting (a) Every record required to be kept machine, or an encapsulating machine subject to § 1310.03 for a List I chem- shall keep a record of the transaction ical, a tableting machine, or an encap- as specified by § 1310.04 and file reports sulating machine shall be kept by the as specified by § 1310.05. However, a regulated person for 2 years after the non-regulated person who acquires list- date of the transaction. ed chemicals for internal consumption (b) Every record required to be kept or ‘‘end use’’ and becomes a regulated subject to Section 1310.03 for List II person by virtue of infrequent or rare chemical shall be kept by the regulated distribution of a listed chemical from person for two years after the date of inventory, shall not be required to the transaction. maintain receipt records of listed (c) A record under this section shall chemicals under this section. be kept at the regulated person’s place (b) Each regulated person who manu- of business where the transaction oc- factures a List I or List II chemical curred, except that records may be shall file reports regarding such manu- kept at a single, central location of the facture as specified in § 1310.05. regulated person if the regulated per- (c)(1) Each regulated person who en- son has notified the Administration of gages in a transaction with a nonregu- the intention to do so. Written notifi- lated person which: cation must be submitted by registered (i) Involves ephedrine, or certified mail, return receipt re- pseudoephedrine, phenylpropanola- quested, to the Special Agent in Charge mine, or gamma hydroxybutyric acid of the DEA Divisional Office for the (including drug products containing area in which the records are required these chemicals or controlled sub- to be kept. stance); and (d) The records required to be kept (ii) Uses or attempts to use the U.S. under this section shall be readily re- Postal Service or any private or com- trievable and available for inspection mercial carrier must, on a monthly and copying by authorized employees basis, report to the Administration of the Administration under the provi- each such transaction conducted dur- sions of 21 U.S.C. 880. ing the previous month as specified in (e) The regulated person with more §§ 1310.05(e) and 1310.06(k) on DEA Form than one place of business where 453 through the DEA Diversion Control records are required to be kept shall Division secure network application. devise a system to detect any party (2) Each regulated person who en- purchasing from several individual lo- gages in an export transaction which: cations of the regulated person thereby (i) Involves ephedrine, seeking to avoid the application of the pseudoephedrine, phenylpropanola- cumulative threshold or evading the mine, or gamma hydroxybutyric acid requirements of the Act. (including drug products containing (f) For those listed chemicals for these chemicals or controlled sub- which thresholds have been estab- stance); and lished, the quantitative threshold or

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the cumulative amount for multiple (1) List I chemicals: transactions within a calendar month, (i) Except as provided in paragraph to be utilized in determining whether a (f)(1)(ii) of this section, the following receipt, sale, importation or expor- thresholds have been established for tation is a regulated transaction is as List I chemicals. follows:

Code Chemical Threshold by base weight

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

(ii) For List I chemicals that are con- 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

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(iii) The cumulative threshold is not (vi) Iodine applicable to domestic sales of Ace- (vii) N-phenethyl-4-piperidone (NPP) tone, 2-Butanone (MEK), and Toluene. (viii) Pseudoephedrine, its salts, opti- (iv) Exports, Transshipments and cal isomers, and salts of optical iso- International Transactions to Des- mers ignated Countries as Set Forth in (ix) Phenylpropanolamine, its salts, § 1310.08(b). optical isomers, and salts of optical isomers Threshold by Threshold by (x) Red phosphorus Chemical volume weight (xi) White phosphorus (Other names: (A) Hydrochloric acid 50 gallons Yellow Phosphorus) (1) Anhydrous ...... 27 kilograms. (2) [Reserved] Hydrogen chloride. (h) The thresholds and conditions in (B) Sulfuric acid ...... 50 gallons paragraphs (f) and (g) of this section will apply to transactions involving (v) Export and International Trans- regulated chemical mixtures. For pur- actions to Designated Countries, and poses of determining whether the Importations for Transshipment or weight or volume of a chemical mix- Transfer to Designated Countries ture meets or exceeds the applicable quantitative threshold, the following Threshold by Threshold by Chemical volume weight rules apply: (1) For chemical mixtures containing (A) Methyl Isobutyl 500 gallons ...... 1523 kilograms. List I chemicals or List II chemicals Ketone (MIBK). (B) Reserved. other than those in paragraph (h)(2) of this section, the threshold is deter- (g) For listed chemicals for which no mined by the weight of the listed thresholds have been established, the chemical in the chemical mixture. size of the transaction is not a factor (2) For the List II chemicals acetone, in determining whether the trans- ethyl ether, 2-butanone, toluene, and action meets the definition of a regu- methyl isobutyl ketone, the threshold lated transaction as set forth in is determined by the weight of the en- § 1300.02 of this chapter. All such trans- tire chemical mixture. actions, regardless of size, are subject (3) If two or more listed chemicals to recordkeeping and reporting require- are present in a chemical mixture, and ments as set forth in this part and no- the quantity of any of these chemicals tification provisions as set forth in equals or exceeds the threshold appli- part 1313 of this chapter. cable to that chemical, then the trans- (1) Listed chemicals for which no action is regulated. thresholds have been established: [54 FR 31665, Aug. 1, 1989] (i) Alpha-phenylacetoacetonitrile and EDITORIAL NOTE: For FEDERAL REGISTER ci- its salts, optical isomers, and salts of tations affecting § 1310.04, see the List of CFR optical isomers (APAAN) Sections Affected, which appears in the (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) lated person will orally report to the

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Special Agent in Charge of the DEA Di- agent or the common or contract car- visional Office at the earliest prac- rier. In an export transaction, the ex- ticable opportunity after the regulated porter is responsible for reporting all person becomes aware of the cir- in-transit losses of any listed chemical cumstances involved and as much in by their agent or the common or con- advance of the conclusion of the trans- tract carrier until the shipment has action as possible. The regulated per- been released by the customs officer at son must file a written report of the the port of export. The regulated per- transaction(s) with the Special Agent son must also file a complete and accu- in Charge of the DEA Divisional Office rate DEA Form 107, in accordance with as set forth in § 1310.06 within 15 cal- § 1310.06(d), with the Administration endar days after the regulated person through the DEA Diversion Control Di- becomes aware of the circumstances of vision secure network application the event. within 15 calendar days after becoming (2) Each regulated person must re- aware of the circumstances requiring port to the Special Agent in Charge of the report. Unusual or excessive losses the DEA Divisional Office for the area or disappearances must be reported in which the regulated person making whether or not the listed chemical is the report is located any proposed reg- subsequently recovered or the respon- ulated transaction with a person whose sible parties are identified and action description or other identifying char- taken against them. When determining acteristic the Administration has pre- whether a loss or disappearance of a viously furnished to the regulated per- listed chemical was unusual or exces- son. The regulated person will orally sive, the regulated persons should con- report to the Special Agent in Charge sider, among others, the following fac- of the DEA Divisional Office at the ear- tors: liest practicable opportunity after the (i) The actual quantity of a listed regulated person becomes aware of the chemical; circumstances involved. A transaction (ii) The specific listed chemical in- may not be completed with a person volved; whose description or identifying char- (iii) Whether the loss or disappear- acteristic has previously been fur- ance of the listed chemical can be asso- nished to the regulated person by the ciated with access to those listed Administration unless the transaction chemicals by specific individuals, or is approved by the Administration. whether the loss or disappearance can (b)(1) Each regulated person must re- be attributed to unique activities that port to the Special Agent in Charge of may take place involving the listed the DEA Divisional Office for the area chemical; and in which the regulated person making (iv) A pattern of losses or disappear- the report is located any unusual or ex- ances over a specific time period, cessive loss or disappearance of a listed whether the losses or disappearances 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 Office for the area in which the regu- the port of entry, the importer is related person making the report is lo- sponsible for reporting all in-transit cated when the order is placed with the losses of any listed chemical by their seller. The regulated person also must

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file a report of the transaction (on DEA tableting or encapsulating machine(s) Form 452) with the Administration has been denied release by a customs through the DEA Diversion Control Di- officer at the port of entry for any rea- vision secure network application son, the importer who attempted to within 15 calendar days after the order import the shipment must, within 5 has been shipped by the seller. A report business days of the denial, report to (DEA Form 452) may list more than the Administration that the shipment one machine for a single transaction. was denied, the basis for denial, and Upon receipt and review, the Adminis- such other information as is required tration will assign a completed report by § 1310.06(g). Such report must be a transaction identification number. transmitted to the Administration The report will not be deemed filed through the DEA Diversion Control Di- until a transaction identification num- vision secure network application. ber has been issued by the Administra- Upon the importer’s report of a denied tion. entry, DEA will assign the report a (c) Imports and exports of tableting ma- transaction identification number and chines and encapsulating machines. (1) the original import notification will be Each regulated person who imports or void and of no effect. No shipment of exports a tableting machine, or encap- tableting machines or encapsulating sulating machine, must file a report of machines denied entry for any reason such importation or exportation on will be allowed entry without a subse- DEA Form 452 with the Administration quent refiling of an amended DEA through the DEA Diversion Control Di- Form 452 by the regulated person. In vision secure network application, at such circumstances, the regulated per- least 15 calendar days before the antici- son may proceed with the release of the pated arrival at the port of entry or tableting machines or encapsulating port of export. In order to facilitate the machines upon receipt of a transaction importation or exportation of any identification number for the refiled tableting machine or encapsulating and amended DEA Form 452 without machine and implement the purpose of regard to the 15-day advance filing re- the Act, regulated persons may report quirement in paragraph (c)(1) of this to the Administration as far in advance section, so long as the article is other- as possible. A separate report (DEA wise cleared for entry under U.S. cus- Form 452) must be filed for each ship- toms laws. ment, in accordance with § 1310.06(e). (d) Each regulated bulk manufac- Upon receipt and review, the Adminis- turer of a listed chemical must submit tration will assign a completed report manufacturing, inventory and use data a transaction identification number. on an annual basis as set forth in The report will not be deemed filed § 1310.06(j). This data must be sub- 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

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chapter except as set forth in units or the equivalent of two dosage § 1310.06(i)(5). Bulk manufacturers that units in liquid form, not to exceed 10 produce a listed chemical solely for in- milliliters of liquid per package, and ternal consumption are not required to not more than one package is distrib- report for that listed chemical. For uted to an individual or residential ad- purposes of these reporting require- dress in any 30-day period. ments, internal consumption consists (2) Distributions of drug products by of any quantity of a listed chemical retail distributors that may not in- otherwise not available for further re- clude face-to-face transactions to the sale or distribution. Internal consump- extent that such distributions are con- tion includes (but is not limited to) sistent with the activities authorized quantities used for quality control for a retail distributor as defined in testing, quantities consumed in-house, § 1300.02 of this chapter, except that or production losses. Internal consump- this paragraph does not apply to sales tion does not include the quantities of of scheduled listed chemical products a listed chemical consumed in the pro- at retail. duction of exempted products. If an ex- (3) Distributions of drug products to isting standard industry report con- a resident of a long term care facility tains the information required in or distributions of drug products to a § 1310.06(j) and such information is sep- long term care facility for dispensing arate or readily retrievable from the to or for use by a resident of that facil- report, that report may be submitted ity. in satisfaction of this requirement. (4) Distributions of drug products in Each report must be submitted to the accordance with a valid prescription. DEA under company letterhead and (5) Exports which have been reported signed by an appropriate, responsible to the Administrator under §§ 1313.31 official. For purposes of this paragraph and 1313.32 of this chapter or which are (d) only, the term regulated bulk man- subject to a waiver granted under ufacturer of a listed chemical means a § 1313.21 of this chapter. person who manufactures a listed (g) The Administrator may revoke chemical by means of chemical syn- any or all of the exemptions listed in thesis or by extraction from other subparagraph (f) of this section for an indi- stances. The term bulk manufacturer vidual regulated person if the Adminis- does not include persons whose sole ac- trator finds that drug products distrib- tivity consists of the repackaging or uted by the regulated person are being relabeling of listed chemical products used in violation of the regulations in or the manufacture of drug dosage this chapter or the Controlled Sub- forms of products which contain a list- stances Act. The Administrator will ed chemical. notify the regulated person of the rev- (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 § 1310.06(k), on or before the 15th day of [54 FR 31665, Aug. 1, 1989, as amended at 57 each month following the month in FR 2461, Jan. 22, 1992; 61 FR 14024, Mar. 29, 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 re- (1) Distributions of sample packages ports. 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:

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(1) The name/business name, address/ Street llllllllllllllllllll business address, and contact informa- City lllllllllllllllllllll tion (e.g., telephone number(s), email State llllllllllllllllllll address (es), etc.), and, if required, DEA Zip lllllllllllllllllllll Date of Shipment llllllllllllll registration number of each party to Description of Listed Chemical: the regulated transaction. Chemical Name lllllllllllllll (2) The date of the regulated trans- Quantity llllllllllllllllll action. National Drug Code (NDC) Number(s), or (3) The quantity, chemical name, Form(s) of Packaging lllllllllll and, if applicable, National Drug Code Other: (NDC) number. If NDC number is not The basis (i.e., reason) for making the re- applicable, the form of packaging of port: llllllllllllllllllll the listed chemical or a description of Any additional pertinent information: lll the tableting machine or encapsulating (d) Each report of an unusual or ex- machine (including make, model, serial cessive loss or disappearance of a listed number, if any, and whether the ma- chemical required by § 1310.05(b)(1) (on chine is manual or electric). DEA Form 107), must include the fol- (4) The method of transfer (company lowing information: truck, picked up by customer, etc.). (1) The name/business name, address/ (5) The type of identification used by business address, and contact informa- the purchaser and any unique number tion (e.g., telephone number(s), email on that identification. address (es), etc.), and, if applicable, (b) For purposes of this section, nor- DEA registration number of each party mal business records will be considered to the regulated transaction. adequate if they contain the informa- (2) The date (or estimated date) on tion listed in paragraph (a) of this sec- which unusual or excessive loss or dis- tion and are readily retrievable from appearance occurred, and the actual other business records of the regulated date on which the unusual or excessive person. For prescription drug products, loss or disappearance was discovered by prescription and hospital records kept the regulated person. in the normal course of medical treat- (3) The quantity, chemical name, and ment will be considered adequate for National Drug Code (NDC) number, if satisfying the requirements of para- applicable or if not the form of pack- graph (a) of this section with respect to aging of the listed chemical. dispensing to patients, and records re- (4) The type of business conducted by quired to be maintained pursuant to the regulated person, (e.g., grocery the U.S. Food and Drug Administration store, pharmacy/drug store, discount regulations relating to the distribution department store, warehouse club or of prescription drugs, as set forth in 21 superstore, convenience store, spe- CFR part 205, will be considered ade- cialty food store, gas station, mobile quate for satisfying the requirements retail vendor, mail-order, etc.) if the of paragraph (a) of this section with re- regulated person is not a DEA reg- spect to distributions. istrant. (c)(1) Each report required by (e)(1) Each report of an importation § 1310.05(a) must include the informa- of a tableting machine or an encap- tion as specified by paragraph (a) of sulating machine required by this section, the basis for making the § 1310.05(c)(1) (on DEA Form 452) must report, and, where obtainable, the reg- include the following information: istration number of the other party, if (i) The name/business name, address/ such party is registered. A report of an business address, and contact informa- uncommon method of payment or de- tion (e.g., telephone number(s), email livery submitted in accordance with address(es), etc.) of the regulated per- § 1310.05(a)(1) must also include a reason; the name/business name, address/ son why the method of payment or de- business address, and contact informa- livery was uncommon. tion (e.g., telephone number(s), email (2) A suggested format for the reports address(es), etc.) of the import broker in § 1310.05(a)(1) is provided below: or forwarding agent, if any; Shipping Address (if different than pur- (ii) A description of each machine chaser Address): (including make, model, serial number,

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if any, and whether the machine is (1) The name/business name, address/ manual or electric) and the number of business address, and contact informa- machines being received; tion (e.g., telephone number(s), email (iii) The anticipated date of arrival address(es), etc.) of the regulated per- at the port of entry, and the antici- son; the name/business name, address/ pated port of entry; business address, and contact informa- (iv) The name/business name, ad- tion (e.g., telephone number(s), email dress/business address, and contact in- address(es), etc.) of the purchaser; formation (e.g., telephone number(s), (2) A description of each machine (in- email address(es), etc.) of the consignor cluding make, model, serial number, if in the foreign country of exportation; any, and whether the machine is man- (v) The intended medical, commer- ual or electric) and the number of ma- cial, scientific, or other legitimate use chines being received; and of the machine; and (3) Any changes made by the regulated person in identifying information (vi) Any proposed changes in identi- of the machines (e.g., name, brand, se- fying information of the imported ma- rial number, etc.). chines (e.g., name, brand, serial num- (g) Each report of a denied release by ber, if any, etc.) that will take place a customs officer at the port of entry after importation. of a tableting machine or an encap- (2) Each report of an exportation of a sulating machine required by tableting machine or an encapsulating § 1310.05(c)(2) must include the fol- machine required by § 1310.05(c)(1) (on lowing information: the quantity of DEA Form 452) must include the fol- machines denied release; a concise de- lowing information: scription of the machines denied re- (i) The name/business name, address/ lease; the date on which release was de- business address, and contact informa- nied; the port where the denial of re- tion (e.g., telephone number(s), email lease was issued from; and the basis for address(es), etc.) of the regulated per- the denial. son; the name/business name, address/ (h) Return information. (1) Within 30 business address, and contact informa- calendar days after actual receipt of a tion (e.g., telephone number(s), email tableting or encapsulating machine, or address(es), etc.) of the export broker within 10 calendar days after receipt of (if applicable); a written request by the Administra- (ii) A description of each machine tion to the importer, whichever is (including make, model, serial number, sooner, the importer must file a report if any, and whether the machine is with the Administration (on DEA manual or electric) and the number of Form 452) specifying the particulars of machines being received; the transaction utilizing the DEA Di- (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

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any other information as the Adminis- have cleared foreign customs, been de- tration may from time to time specify. livered, and accepted by the foreign Upon receipt and review, the Adminis- consignee. Returns to third parties in tration will assign a transaction iden- the United States will be regarded as tification number to a completed re- imports. port. The report will not be deemed (j) Each annual report required by filed until the Administration has § 1310.05(d) must provide the following issued a transaction identification information for each listed chemical number. A single return declaration manufactured: may include the particulars of both the (1) The name/business name, address/ importation and distribution. For DEA business address, and contact informa- reporting purposes, import responsibil- tion (e.g., telephone number(s), email ities are concluded upon the receipt of address(es), etc.) and chemical reg- the machines by the importer. Once istration number (if any) of the manu- machines are received by the importer, facturer. domestic transaction reporting re- (2) The aggregate quantity of each quirements commence. Distributions of listed chemical that the company man- tableting and encapsulating machines ufactured during the preceding cal- from the importer to their customers endar year. must be reported as domestic regulated (3) The year-end inventory of each transactions in accordance with listed chemical as of the close of busi- § 1310.05(b)(2). ness on the 31st day of December of (2) Within 30 calendar days after the each year. (For each listed chemical, if tableting or encapsulating machine is the prior period’s ending inventory has released by a customs officer at the not previously been reported to DEA, port of export, or within 10 calendar this report should also detail the begin- days after receipt of a written request ning inventory for the period.) For pur- by the Administration to the exporter, poses of this requirement, inventory whichever is sooner, the exporter must shall reflect the quantity of listed file a report with the Administration chemicals, whether in bulk or non-ex- (on DEA Form 452) through the DEA empt product form, held in storage for Diversion Control Division secure net- later distribution. Inventory does not work application specifying the par- include waste material for destruction, ticulars of the transaction. This report material stored as an in-process inter- must include the following informa- mediate or other in-process material. tion: The date on which the machine(s) (4) The aggregate quantity of each was (were) released by a customs offi- listed chemical used for internal con- cer at the port of export; the actual sumption during the preceding cal- 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- (k) Each monthly report required by sion Control Division secure network §§ 1310.03(c) and 1310.05(e) (on DEA application, following the return at the Form 453) must provide the following earliest practicable opportunity after information for each transaction: the regulated person becomes aware of (1) Supplier name/business name, ad- the circumstances involved. This provi- dress/business address, and contact in- sion does not apply to shipments that formation (e.g., telephone number(s),

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email address(es), etc.) and registra- sulating machine. For domestic trans- tion number. actions, this may be accomplished by (2) Purchaser’s name/business name, such methods as checking the tele- address/business address, and contact phone directory, the local credit bu- information (e.g., telephone number(s), reau, the local Chamber of Commerce email address(es), etc.). or the local Better Business Bureau, or, (3) Name/business name, address/busi- if the business entity is a registrant, ness address shipped to (if different by verification of the registration. For from purchaser’s name/address). export transactions, a good faith in- (4) Chemical name, National Drug quiry to verify the existence and appar- Code (NDC) number, if applicable, and ent validity of a foreign business entity total amount shipped. may be accomplished by such methods (5) Date of shipment. as verifying the business telephone (6) Product name (if drug product). listing through international telephone (7) Dosage form (if drug product) information, the firm’s listing in inter- (e.g., pill, tablet, liquid). (8) Dosage strength (if drug product) national or foreign national chemical (e.g., 30mg, 60mg, per dose etc.). directories or other commerce direc- (9) Number of dosage units (if drug tories or trade publications, confirma- product) (e.g., 100 doses per package). tion through foreign subsidiaries of the (10) Package type (if drug product) U.S. regulated person, verification (e.g., bottle, blister pack, etc.). through the country of destination’s (11) Number of packages (if drug embassy Commercial Attache, or offi- product) (e.g., 10 bottles). cial documents provided by the pur- (12) Lot number (if drug product). chaser which confirm the existence and (l) Information provided in reports apparent validity of the business enti- required by § 1310.05(e) which is exempt ty. from disclosure under section 552(a) of (c) When transacting business with a title 5, by reason of section 552(b)(6) of new representative of a firm, the regu- title 5, will be provided the same pro- lated person must verify the claimed tections from disclosure as are pro- agency status of the representative. vided in section 310(c) of the Act (21 (d) For sales to individuals or cash U.S.C. 830(c)) for confidential business purchasers, the type of documents and information. other evidence of proof must consist of [81 FR 97023, Dec. 30, 2016] at least a signature of the purchaser, a driver’s license and one other form of § 1310.07 Proof of identity. identification. Any exports to individ- (a) Each regulated person who en- uals or exports paid in cash are suspect gages in a regulated transaction must and should be handled as such. For identify the other party to the trans- such exports, the regulated person action. For domestic transaction, this shall diligently obtain from the pur- shall be accomplished by having the chaser or independently seek to con- other party present documents which firm clear documentation which proves would verify the identity, or registra- the person is properly identified such tion status if a registrant, of the other as through foreign identity documents, party to the regulated person at the driver’s license, passport information time the order is placed. For export and photograph, etc. Any regulated transactions, this shall be accom- person who fails to adequately prove plished by good faith inquiry through the identity of the other party to the reasonably available research docu- transaction may be subject to the spe- ments or publicly available informa- cific penalties provided for violations tion which would indicate the exist- of law related to regulated trans- ence of the foreign customer. No proof actions in listed chemicals. of identity is required for foreign sup- (e) For a new customer who is not an pliers. individual or cash customer, the regu- (b) The regulated person must verify lated person shall establish the iden- the existence and apparent validity of tity of the authorized purchasing agent a business entity ordering a listed or agents and have on file that person’s chemical, tableting machine or encap- signature, electronic password, or

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other identification. Once the author- transfer of Methyl Isobutyl Ketone ized purchasing agent has been estab- (MIBK) destined for Canada or any lished, the agent list may be updated country outside of the Western Hemi- annually rather than on each order. sphere. The regulated person must ensure that (f) Domestic and international transshipments are not made unless the actions of Lugol’s Solution (consisting order is placed by an authorized agent of 5 percent iodine and 10 percent po- of record. tassium iodide in an aqueous solution) (f) With respect to electronic orders, in original manufacturer’s packaging the identity of the purchaser shall con- of one-fluid-ounce (30 milliliters) or sist of a computer password, identifica- less, and no greater than one package tion number or some other means of per transaction. identification consistent with elec- (g) Import transactions of anhydrous tronic orders and with § 1310.07(e). hydrogen chloride. [54 FR 31665, Aug. 1, 1989, as amended at 60 (h) Domestic distribution of anhy- FR 32461, June 22, 1995] drous hydrogen chloride weighing 12,000 pounds (net weight) or more in a § 1310.08 Excluded transactions. single container. Pursuant to 21 U.S.C. 802(39)(A)(iii), (i) Domestic distribution of anhy- regulation of the following trans- drous hydrogen chloride by pipeline. actions has been determined to be un- (j) Domestic and international return necessary for the enforcement of the shipments of reusable containers from Chemical Diversion and Trafficking customer to producer containing resid- Act and, therefore, they have been ex- ual quantities of red phosphorus or cluded from the definitions of regu- white phosphorus in rail cars and inter- lated transactions: modal tank containers which conform (a) Domestic and import transactions to International Standards Organiza- of hydrochloric and sulfuric acids but tion specifications (with capacities not including anhydrous hydrogen greater than or equal to 2,500 gallons in chloride. a single container). (b) Exports, transshipments, and (k) Domestic, import, and export dis- international transactions of hydro- tributions of gamma-butyrolactone chloric (including anhydrous hydrogen weighing 4,000 kilograms (net weight) chloride) and sulfuric acids, except for or more in a single container. exports, transshipments and inter- (l) Domestic and import transactions national transactions to the following in chemical mixtures that contain ace- countries: tone, ethyl ether, 2-butanone, and/or (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 [57 FR 43615, Sept. 22, 1992, as amended at 60 (6) Ecuador 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

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July 12, 1997. The exemption will re- ministration has approved or denied main in effect for each person who has that application. This exemption ap- made such application until the Ad- plies only to registration; all other ministration has approved or denied chemical control requirements set that application. This exemption ap- forth in parts 1309, 1310, and 1313 of this plies only to registration; all other chapter remain in full force and effect. chemical control requirements set (e) Each person required by section forth in parts 1309, 1310, and 1313 of this 302 of the Act (21 U.S.C. 822) to obtain chapter remain in full force and effect. a registration to distribute, import, or (b) Each person required by section export regulated chemical mixtures 302 of the Act (21 U.S.C. 822) to obtain which contain ephedrine, N- a registration to distribute, import, or methylephedrine, N- export a drug product that contains methylpseudoephedrine, pseudoephedrine or phenylpropanola- norpseudoephedrine, phenylpropanolamine that is regulated pursuant to mine, and/or pseudoephedrine, pursu- paragraph (1)(iv) of the definition of ant to §§ 1310.12 and 1310.13, is tempo- regulated transaction in § 1300.02 of this rarily exempted from the registration chapter is temporarily exempted from requirement, provided that DEA re- the registration requirement, provided ceives a proper application for registra- that the person submits a proper appli- tion or application for exemption on or cation for registration on or before De- before June 30, 2003. The exemption cember 3, 1997.The exemption will re- will remain in effect for each person main in effect for each person who has who has made such application until made such application until the Ad- the Administration has approved or de- ministration has approved or denied nied that application. This exemption that application. This exemption ap- applies only to registration; all other plies only to registration; all other chemical control requirements set chemical control requirements set forth in parts 1309, 1310, and 1313 of this forth in parts 1309, 1310, and 1313 of this chapter remain in full force and effect. chapter remain in full force and effect. Any person who distributes, imports or (c) Each person required by section exports a chemical mixture whose ap- 302 of the act (21 U.S.C. 822) to obtain a plication for exemption is subsequently registration to distribute, import, or denied by DEA must obtain a registra- export GBL is temporarily exempted tion with DEA. A temporary exemption from the registration requirement, pro- from the registration requirement will vided that the DEA receives a proper also be provided for these persons, pro- application for registration on or be- vided that DEA receives a properly fore July 24, 2000. The exemption will completed application for registration remain in effect for each person who on or before 30 days following the date 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

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

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24, 2007. The exemption will remain in the date of official DEA notification effect for each person who has made that the application for exemption has such application until the Administra- been denied. The temporary exemption tion has approved or denied that appli- for such persons will remain in effect cation. This exemption applies only to until DEA takes final action on their registration; all other chemical control registration application. requirements set forth in parts 1309, (l)(1) Each person required under sec- 1310, 1313, and 1315 of this chapter re- tions 302 and 1007 of the Act (21 U.S.C. main in full force and effect. Any per- 822, 957) to obtain a registration to son who manufactures, distributes, im- manufacture, distribute, import, or exports, or exports a chemical mixture port regulated ergocristine and its whose application for exemption is sub- salts, including regulated chemical sequently denied by DEA must obtain a mixtures pursuant to § 1310.12, is tem- registration with DEA. A temporary porarily exempted from the registra- exemption from the registration re- tion requirement, provided that DEA quirement will also be provided for receives a properly completed applica- these persons, provided that DEA re- tion for registration or application for ceives a properly completed applica- exemption for a chemical mixture con- tion for registration on or before 30 taining ergocristine and its salts pur- days following the date of official DEA suant to § 1310.13 on or before May 2, notification that the application for 2011. The exemption will remain in ef- exemption has not been approved. The fect for each person who has made such temporary exemption for such persons application until the Administration will remain in effect until DEA takes has approved or denied that applica- final action on their registration appli- tion. This exemption applies only to cation. registration; all other chemical control (k)(1) Each person required by sec- requirements set forth in the Act and tions 302 or 1007 of the Act (21 U.S.C. parts 1309, 1310, 1313, and 1316 of this 822, 957) to obtain a registration to chapter remain in full force and effect. manufacture, distribute, import, or export regulated GBL-containing chem- (2) Any person who manufactures, ical mixtures, pursuant to sections distributes, imports, or exports a 1310.12 and 1310.13, is temporarily ex- chemical mixture containing empted from the registration require- ergocristine and its salts whose appli- ment, provided that DEA receives a cation for exemption is subsequently properly completed application for reg- denied by DEA must obtain a registra- istration or application for exemption tion with DEA. A temporary exemption on or before July 29, 2010. The exemp- from the registration requirement will tion will remain in effect for each per- also be provided for those persons son who has made such application whose applications for exemption are until the Administration has approved denied, provided that DEA receives a or denied that application. This exemp- properly completed application for reg- tion applies only to registration; all istration on or before 30 days following other chemical control requirements the date of official DEA notification set forth in parts 1309, 1310, and 1313 of that the application for exemption has this chapter remain in full force and ef- been denied. The temporary exemption fect. for such persons will remain in effect (2) Any person who manufactures, until DEA takes final action on their distributes, imports or exports a GBL- registration application. containing chemical mixture whose ap- (m)(1) Each person required by Sec- plication for exemption is subsequently tions 302 or 1007 of the Act (21 U.S.C. denied by DEA must obtain a registra- 822, 957) to obtain a registration to tion with DEA. A temporary exemption manufacture, distribute, import, or ex- from the registration requirement will port regulated chemical mixtures also be provided for those persons which contain red phosphorus, white whose applications for exemption are phosphorus, hypophosphorous acid (and denied, provided that DEA receives a its salts), pursuant to §§ 1310.12 and properly completed application for reg- 1310.13, is temporarily exempted from istration on or before 30 days following the registration requirement, provided

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that DEA receives a properly com- 1313, and 1316 of this chapter remain in pleted application for registration or full force and effect. application for exemption on or before (2) Any person who manufactures, July 5, 2011. The exemption will remain distributes, imports or exports a chem- in effect for each person who has made ical mixture containing alpha- such application until the Administra- phenylacetoacetonitrile (APAAN) and tion has approved or denied that appli- its salts, optical isomers, and salts of cation. This exemption applies only to optical isomers whose application for registration; all other chemical control exemption is subsequently denied by requirements set forth in parts 1309, the DEA must obtain a registration 1310, and 1313 of this chapter remain in with the DEA. A temporary exemption full force and effect. from the registration requirement will also be provided for those persons (2) Any person who manufactures, whose applications for exemption are distributes, imports, or exports a denied, provided that the DEA receives chemical mixture which contains red a properly completed application for phosphorus, white phosphorus, registration on or before 30 days fol- hypophosphorous acid (and its salts) lowing the date of official DEA notifi- whose application for exemption is sub- cation that the application for exemp- sequently denied by DEA must obtain a tion has been denied. The temporary registration with DEA. A temporary exemption for such persons will remain exemption from the registration rein effect until the DEA takes final ac- quirement will also be provided for tion on their registration application. those persons whose applications are denied, provided that DEA receives a [62 FR 27693, May 21, 1997, as amended at 62 FR 53960, Oct. 17, 1997; 65 FR 21647, Apr. 24, properly completed application for reg- 2000; 66 FR 52675, Oct. 17, 2001; 68 FR 23203, istration on or before 30 days following May 1, 2003; 69 FR 74971, Dec. 15, 2004; 72 FR the date of official DEA notification 20046, Apr. 23, 2007; 72 FR 35931, July 2, 2007; that the application for exemption has 72 FR 40239, July 24, 2007; 72 FR 40744, July 25, not been approved. The temporary ex- 2007; 75 FR 37306, June 29, 2010; 76 FR 17781, emption for such persons will remain Mar. 31, 2011; 76 FR 31829, June 2, 2011; 77 FR in effect until DEA takes final action 4237, Jan. 27, 2012; 82 FR 32460, July 14, 2017] on their registration application. § 1310.10 Removal of the exemption of (n)(1) Each person required under sec- drugs distributed under the Federal tions 302 and 1007 of the Act (21 U.S.C. Food, Drug and Cosmetic Act. 822, 957) to obtain a registration to (a) The Administrator may remove manufacture, distribute, import, or ex- from exemption under paragraph (1)(iv) port regulated alpha- of the definition of regulated trans- phenylacetoacetonitrile (APAAN) and action in § 1300.02 of this chapter any its salts, optical isomers, and salts of drug or group of drugs that the Admin- optical isomers, including regulated istrator finds is being diverted to ob- chemical mixtures pursuant to § 1310.12, tain a listed chemical for use in the il- is temporarily exempted from the reg- licit production of a controlled sub- istration requirement, provided that stance. In removing a drug or group of the DEA receives a properly completed drugs from the exemption the Adminis- application for registration or applica- trator shall consider: tion for exemption for a chemical mix- (1) The scope, duration, and signifi- ture containing alpha- cance of the diversion; phenylacetoacetonitrile (APAAN) and (2) Whether the drug or group of its salts, optical isomers, and salts of drugs is formulated in such a way that optical isomers, pursuant to § 1310.13 on it cannot be easily used in the illicit or before August 14, 2017. The exemp- production of a controlled substance; tion will remain in effect for each per- and son who has made such application (3) Whether the listed chemical can until the Administration has approved be readily recovered from the drug or or denied that application. This exemp- group of drugs. tion applies only to registration; all (b) Upon determining that a drug or other chemical control requirements group of drugs should be removed from set forth in the Act and parts 1309, 1310, the exemption under paragraph (a) of

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this section, the Administrator shall the FEDERAL REGISTER his order on the issue and publish in the FEDERAL REG- reinstatement of the exemption for the ISTER his proposal to remove the drug particular drug product, which shall in- or group of drugs from the exemption, clude a reference to the legal authority which shall include a reference to the under which the order is based. This legal authority under which the pro- order shall specify the date on which it posal is based. The Administrator shall shall take effect. The Administrator permit any interested person to file shall permit any interested person to written comments on or objections to file written comments on or objections the proposal. After considering any to the order. If any such comments comments or objections filed, the Ad- raise significant issues regarding any ministrator shall publish in the FED- finding of fact or conclusion of law ERAL REGISTER his final order. upon which the order is based, the Ad- (c) The Administrator shall limit the ministrator shall immediately suspend removal of a drug or group of drugs the effectiveness of the order until he from exemption under paragraph (a) of may reconsider the application in light this section to the most identifiable of the comments and objections filed. type of the drug or group of drugs for Thereafter, the Administrator shall re- which evidence of diversion exists un- instate, revoke, or amend his original less there is evidence, based on the pat- order as he determines appropriate. tern of diversion and other relevant (f) Unless the Administrator has evi- factors, that the diversion will not be dence that the drug product is being di- limited to that particular drug or verted, as determined by applying the group of drugs. factors set forth in paragraph (a) of (d) Any manufacturer seeking rein- this section, and the Administrator so statement of a particular drug product notifies the applicant, transactions in- that has been removed from an exemp- volving a specific drug product will not tion may apply to the Administrator be considered regulated transactions for reinstatement of the exemption for during the following periods: that particular drug product on the (1) While a bonafide application for grounds that the particular drug prod- reinstatement of exemption under uct is manufactured and distributed in paragraph (d) of this section for the 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 product; (g) An order published by the Admin- (4) Any actions taken by the manu- istrator in the FEDERAL REGISTER, pur- facturer to prevent diversion of the suant to paragraph (e) of this section, 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 ac- [60 FR 32461, June 22, 1995, as amended at 62 cepted, the reason therefor. If the ap- FR 13968, Mar. 24, 1997; 67 FR 14862, Mar. 28, plication is accepted for filing, the Ad- 2002; 75 FR 38922, July 7, 2010; 77 FR 4237, Jan. ministrator shall issue and publish in 27, 2012]

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§ 1310.11 Reinstatement of exemption [60 FR 32462, June 22, 1995] for drug products distributed under the Food, Drug and Cosmetic Act. § 1310.12 Exempt chemical mixtures. (a) The Administrator has reinstated (a) The chemical mixtures meeting the exemption for the drug products the criteria in paragraphs (c) or (d) of listed in paragraph (e) of this section this section are exempted by the Ad- from application of sections 302, 303, ministrator from application of sec- 310, 1007, and 1008 of the Act (21 U.S.C. tions 302, 303, 310, 1007, 1008, and 1018 of 822–823, 830, and 957–958), to the extent the Act (21 U.S.C. 822, 823, 830, 957, 958, described in paragraphs (b), (c), and (d) and 971) to the extent described in of this section. paragraphs (b) and (c) of this section. (b) No reinstated exemption granted (b) No exemption granted pursuant to pursuant to 1310.10 affects the criminal this § 1310.12 or § 1310.13 affects the liability for illegal possession or dis- criminal liability for illegal possession, tribution of listed chemicals contained distribution, exportation, or importa- in the exempt drug product. tion of listed chemicals contained in (c) Changes in exempt drug product compositions: Any change in the quan- the exempt chemical mixture or the titative or qualitative composition, civil liability for unlawful acts related trade name or other designation of an to exempt chemical mixtures, includ- exempt drug product listed in para- ing distribution in violation of 21 graph (d) requires a new application for U.S.C. 842(a)(11). reinstatement of the exemption. (c) Mixtures containing a listed (d) The following drug products, in chemical in concentrations equal to or the form and quantity listed in the ap- less than those specified in the ‘‘Table plication submitted (indicated as the of Concentration Limits’’ are des- ‘‘date’’) are designated as reinstated ignated as exempt chemical mixtures exempt drug products for the purposes for the purpose set forth in this sec- set forth in this section: tion. The concentration is determined for liquid-liquid mixtures by using the EXEMPT DRUG PRODUCTS volume or weight and for mixtures con- Supplier Product name Form Date taining solids or gases by using the unit of weight. [Reserved] ......

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.

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TABLE OF CONCENTRATION LIMITS—Continued

DEA chemical code Concentration Special conditions number

Ethylamine and its salts ..... 8678 20% by Weight or Volume Ethylamine or its salts in an inert carrier solvent is not considered a mixture. Concentration is based on ethylamine in the mixture and not the combination of ethylamine and carrier solvent, if any. Gamma-Butyrolactone ...... 2011 70% by weight or volume. Hydriodic acid ...... 6695 20% by Weight or Volume. Hypophosphorous acid and 6797 30% by weight if a solid, The weight is determined by measuring the mass of its salts. weight or volume if a liq- hypophosphorous acid and its salts in the mixture, uid. the concentration limit is calculated by summing the concentrations of all forms of hypophosphorous acid and its salts in the mixture. The Administration does not consider a chemical mixture to mean the combination of a listed chemical and an inert carrier. Therefore, any solution consisting of hypophosphorous acid (and its salts), dispersed in water, alcohol, or another inert carrier, is not considered a chemical mixture and is therefore subject to chemical regulatory controls at all concentrations. Iodine ...... 6699 2.2 ...... Calculated as weight/volume (w/v). Isosafrole ...... 8704 20% by Weight or Volume Concentration in a mixture cannot exceed 20% if taken alone or in any combination with safrole. Methylamine and its salts .. 8520 20% by Weight ...... Methylamine or its salts in an inert carrier solvent is not considered a mixture. Weight is based on methylamine in the mixture and not the combined weight of carrier solvent, if any. 3,4-Methylenedioxyphenyl- 8502 20% by Weight. 2-propanone. 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.

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TABLE OF CONCENTRATION LIMITS—Continued

DEA chemical code Concentration Special conditions number

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

(d) The following categories of chem- in the final application without the ical mixtures are automatically ex- need to add any additional substances empt from the provisions of the Con- except a thinner if needed in certain trolled Substances Act as described in cases. A completely formulated paint paragraph (a) of this section: or coating is defined as any clear or (1) Chemical mixtures that are dis- pigmented liquid, liquefiable or mastic tributed directly to an incinerator for composition designed for application to destruction or directly to an author- a substrate in a thin layer that is con- ized waste recycler or reprocessor verted to a clear or opaque solid pro- where such distributions are docu- tective, decorative, or functional ad- mented on United States Environ- herent film after application. Included mental Protection Agency Form 8700– in this category are clear coats, top- 22; persons distributing the mixture to coats, primers, varnishes, sealers, ad- the incinerator or recycler must main- hesives, lacquers, stains, shellacs, inks, tain and make available to agents of temporary protective coatings and the Administration, upon request, such documentation for a period of no less film-forming agents. than two years. (3) Iodine products classified as (2) Completely formulated paints and iodophors that exist as an iodine com- coatings: Completely formulated plex to include poloxamer-iodine com- paints and coatings are only those for- plex, polyvinyl pyrrolidone-iodine com- mulations that contain all of the complex (i.e., povidone-iodine), ponents of the paint or coating for use undecoylium chloride iodine,

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nonylphenoxypoly (ethyleneoxy) eth- ministrator shall publish in the FED- anol-iodine complex, iodine complex ERAL REGISTER a final order. with phosphate ester of alkylaryloxy [68 FR 23204, May 1, 2003, as amended at 69 polyethylene glycol, and iodine com- FR 74971, Dec. 15, 2004; 71 FR 60826, Oct. 17, plex with ammonium ether sulfate/ 2006; 72 FR 20047, Apr. 23, 2007; 72 FR 35931, polyoxyethylene sorbitan monolaurate. July 2, 2007; 72 FR 40745, July 25, 2007; 75 FR (4) Iodine products that consist of or- 37306, June 29, 2010; 76 FR 17781, Mar. 31, 2011; ganically bound iodine (a non-ionic 76 FR 31830, June 2, 2011; 82 FR 32460, July 14, complex) (e.g., iopamidol, iohexol, and 2017] amiodarone.) § 1310.13 Exemption of chemical mix- (e) The Administrator may, at any tures; application. time, terminate or modify the exemption for any chemical mixture which (a) The Administrator may, by publi- has been granted an exemption pursu- cation of a Final Rule in the FEDERAL ant to the concentration limits as spec- REGISTER, exempt from the application ified in paragraph (c) of this section or of all or any part of the Act a chemical pursuant to the category exemption as mixture consisting of two or more specified in paragraph (d) of this sec- chemical components, at least one of tion. In terminating or modifying an which is not a List I or List II chem- exemption, the Administrator shall ical, if: issue, and publish in the FEDERAL REG- (1) The mixture is formulated in such ISTER, notification of the removal of an a way that it cannot be easily used in exemption for a product or group of the illicit production of a controlled products for which evidence of diver- substance; and sion has been found, as well as the date (2) The listed chemical or chemicals on which the termination of exemption contained in the chemical mixture can- shall take effect. The Administrator not be readily recovered. shall permit any interested party to (b) Any manufacturer seeking an ex- file written comments on or objections emption for a chemical mixture, not to the order within 60 days of the date exempt under § 1310.12, from the application of all or any part of the Act, of publication of the order in the FED- may apply to the Drug and Chemical ERAL REGISTER. If any such comments or objections raise significant issues Evaluation Section, Diversion Control Division, Drug Enforcement Adminis- regarding any finding of fact or conclu- tration. See the Table of DEA Mailing sion of law upon which the order is Addresses in § 1321.01 of this chapter for based, the Administrator shall imme- the current mailing address. diately suspend the effectiveness of the (c) An application for exemption order until he may reconsider the order under this section shall contain the fol- in light of comments and objections lowing information: filed. Thereafter, the Administrator (1) The name, address, and registra- shall reinstate, terminate, or amend tion number, if any, of the applicant; the original order as determined appro- (2) The date of the application; priate. (3) The exact trade name(s) of the ap- (f) The Administrator may modify plicant’s chemical mixture and: any part of the criteria for exemption as specified in paragraphs (c) and (d) of (i) If the applicant formulates or manufactures the chemical mixture for this section upon evidence of diversion other entities, the exact trade names of or attempted diversion. In doing so, the the chemical mixtures and the names Administrator shall issue and publish a of the entities for which the chemical Notice of Proposed Rulemaking in the mixtures were prepared; and FEDERAL REGISTER. The Administrator (ii) If a group of mixtures (e.g. formu- shall permit any interested persons to lations having identical function and file written comments on or objections containing the same listed chem- to the proposal. After considering any ical(s)), the information required in comments or objections filed, the Ad- paragraph (c)(3)(i) of this section and a brief narrative of their use.

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(4) (i) The complete qualitative and writing and the Administrator shall quantitative composition of the chem- issue, and publish in the FEDERAL REG- ical mixture (including all listed and ISTER, an order on the application. This all non-listed chemicals); or order shall specify the date on which it (ii) If a group of mixtures, the con- shall take effect. The Administrator centration range for the listed chem- shall permit any interested person to ical and a listing of all non-listed file written comments on or objections chemicals with respective concentra- to the order. If any comments or objection ranges. tions raise significant issues regarding (5) (i) The chemical and physical any findings of fact or conclusions of properties of the mixture and how they law upon which the order is based, the differ from the properties of the listed Administrator may suspend the effec- chemical or chemicals; and tiveness of the order until he has re- (ii) If a group of mixtures, how the considered the application in light of group’s properties differ from the prop- the comments and objections filed. erties of the listed chemical. Thereafter, the Administrator shall re- (6) A statement that the applicant instate, terminate, or amend the origi- believes justifies an exemption for the nal order as deemed appropriate. chemical mixture or group of mixtures. (f) The Administrator may, at any The statement must explain how the time, terminate or modify an exemp- chemical mixture(s) meets the exemption for any product pursuant to para- tion criteria set forth in paragraph (a) graph (e) of this section. In termi- of this section. nating or modifying an exemption, the (7) A statement that the applicant Administrator shall issue, and publish accepts the right of the Administrator in the FEDERAL REGISTER, notification to terminate exemption from regula- of the removal of an exempt product or tion for the chemical mixture(s) grant- group of exempt products for which ed exemption under this section. evidence of diversion has been found. (8) The identification of any informa- This order shall specify the date on tion on the application that is consid- which the termination of exemption ered by the applicant to be a trade se- shall take effect. The Administrator cret or confidential and entitled to pro- shall permit any interested party to tection under U.S. laws restricting the file written comments on or objections public disclosure of such information. to the order within 60 days of the date (d) The Administrator may require of publication of the order in the FED- the applicant to submit such additional ERAL REGISTER. If any such comments documents or written statements of or objections raise significant issues fact relevant to the application that he regarding any finding of fact or conclu- deems necessary for determining if the sion of law upon which the order is application should be granted. based, the Administrator may suspend (e) Within a reasonable period of the effectiveness of the order until he time after the receipt of an application has reconsidered the order in light of for an exemption under this section, comments and objections filed. There- the Administrator will notify the ap- after, the Administrator shall rein- plicant in writing of the acceptance or state, terminate, or amend the original rejection of the application for filing. order as determined appropriate. If the application is not accepted for (g) A manufacturer of an exempted filing, an explanation will be provided. chemical mixture shall notify DEA in The Administrator is not required to writing, of any change in the quan- accept an application if any informa- titative or qualitative composition of a tion required pursuant to paragraph (c) chemical mixture that has been grant- of this section or requested pursuant to ed an exemption by application. paragraph (d) of this section is lacking Changes include those greater than the or not readily understood. The appli- range of concentration given in the ap- cant may, however, amend the applica- plication or that remove non-listed tion to meet the requirements of para- chemical(s) given in the application as graphs (c) and (d) of this section. If the part of the formulation. A new applica- exemption is subsequently granted, the tion will be required only if reformula- applicant shall again be notified in tion results in a new product having a

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different commercial application or tion. A formulation granted exemption can no longer be defined as part of a by publication in the FEDERAL REG- group of exempted chemicals. DEA ISTER will not be exempted for all man- must be notified of reformulation at ufacturers. least 30 days in advance of marketing (i) The following chemical mixtures, the reformulated mixture. For a in the form and quantity listed in the change in name or other designation, application submitted (indicated as the code, or any identifier, a written notifi- ‘‘date’’) are designated as exempt cation is required. DEA must be noti- chemical mixtures for the purposes set fied of any changes at least 60 days in forth in this section and are exempted advance of the effective date for the by the Administrator from application change. of Sections 302, 303, 310, 1007, 1008, and (h) Each manufacturer seeking ex- 1018 of the Act (21 U.S.C. 822, 823, 830, emption must apply for such an exemp- 957, 958, and 971):

TABLE 1 TO PARAGRAPH (i)—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. GFS Chemicals ...... WaterMark® Karl-Fisher Reagent, Pyridine-Free Single Solution, 5 Liquid ...... 11/26/2018 mg/ml. GFS Chemicals ...... WaterMark® Karl-Fisher Reagent, 5 mg/ml Single Solution NON–HAZ Liquid ...... 11/26/2018 GFS Chemicals ...... WaterMark® Karl-Fisher Reagent, Pyridine-Free Single Solution, 2 Liquid ...... 11/26/2018 mg/ml. GFS Chemicals ...... WaterMark® Karl-Fisher Reagent, 2 mg/ml Single Solution NON–HAZ Liquid ...... 11/26/2018 GFS Chemicals ...... WaterMark® Karl-Fisher Reagent, 5 mg/ml, Stabilized, Pyridine-Based Liquid ...... 11/26/2018 Hawthorne Products, Sole Pack Hoof Dressing ...... Paste ...... 8/14/2007 Inc. Hawthorne Products, Sole Pack Hoof Packing ...... Paste ...... 8/14/2007 Inc. Lord Corporation ...... Chemlok TS701–52 ...... Liquid ...... 05/03/2018 Lord Corporation ...... Chemlok TS701–53 ...... Liquid ...... 05/03/2018

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TABLE 1 TO PARAGRAPH (i)—EXEMPT CHEMICAL MIXTURES—Continued

Manufacturer Product name 1 Form Date

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 Sigma-Aldrich ...... Hydranal®-Composite 1 ...... Liquid ...... 5/29/2013 Sigma-Aldrich ...... Hydranal®-Composite 2 ...... Liquid ...... 5/29/2013 Sigma-Aldrich ...... Hydranal®-Composite 5K ...... Liquid ...... 5/29/2013 Sigma-Aldrich ...... Hydranal®-Composite 5 ...... Liquid ...... 5/29/2013 Standard Homeopathic Baby Cough Syrup ...... Liquid ...... 9/28/2012 Co. Standard Homeopathic Defend Cough & Cold Night ...... Liquid ...... 9/28/2012 Co. Standard Homeopathic Defend Cough & Cold ...... Liquid ...... 9/28/2012 Co. Standard Homeopathic Diarrex ...... Liquid ...... 9/28/2012 Co. Waterbury Companies, Waterbury 332500 ...... Liquid ...... 4/11/2005 Inc. Waterbury Companies, Waterbury 332762 ...... Liquid ...... 4/11/2005 Inc. Waterbury Companies, Waterbury 332400 ...... Liquid ...... 4/11/2005 Inc. Waterbury Companies, Waterbury 346201 ...... Liquid ...... 4/11/2005 Inc. 1 Designate product line if a group.

[68 FR 23204, May 1, 2003, as amended at 75 § 1310.16 Exemptions for certain FR 10681, Mar. 9, 2010; 75 FR 53869, Sept. 2, scheduled listed chemical products. 2010; 76 FR 31830, June 2, 2011; 81 FR 97025, Dec. 30, 2016; 85 FR 4586, Jan. 27, 2020] (a) Upon the application of a manufacturer of a scheduled listed chemical § 1310.14 Removal of exemption from product, the Administrator may by definition of regulated transaction. regulation provide that the product is The Administrator finds that the fol- exempt from part 1314 of this chapter if the Administrator determines that the lowing drugs or groups of drugs are product cannot be used in the illicit being diverted to obtain a listed chem- manufacture of a controlled substance. ical for use in the illicit production of (b) An application for an exemption a controlled substance and removes the under this section must contain all of drugs or groups of drugs from exemp- the following information: tion under paragraph (1)(iv) of the defi- (1) The name and address of the ap- nition of regulated transaction in plicant. § 1300.02 of this chapter pursuant to the (2) The exact trade name of the criteria listed in § 1310.10 of this part: scheduled listed chemical product for (a) Nonprescription drugs containing which exemption is sought. ephedrine, its salts, optical isomers, (3) The complete quantitative and and salts of optical isomers. qualitative composition of the drug (b) Nonprescription drugs containing product. phenylpropanolamine, its salts, optical (4) A brief statement of the facts that isomers, and salts of optical isomers. the applicant believes justify the (c) Nonprescription drugs containing granting of an exemption under this pseudoephedrine, its salts, optical iso- section. mers, and salts of optical isomers. (5) Certification by the applicant [75 FR 38922, July 7, 2010, as amended at 77 that the product may be lawfully mar- FR 4237, Jan. 27, 2012] keted or distributed under the Federal, Food, Drug, and Cosmetic Act.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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of this chapter, cannot be consistently two years from the date of their cre- and accurately imported, stored, and ation or receipt. This record retention displayed, the third-party auditor or requirement shall not pre-empt any certification organization must indi- longer period of retention which may cate that the application does not meet be required now or in the future, by the requirements of this part. any other Federal or State law or regu- (2) If the pharmacy application ac- lation, applicable to practitioners, cepts prescriptions with the practi- pharmacists, or pharmacies. tioner’s digital signature, the third- (c) Records regarding controlled sub- party auditor or certification organiza- stances prescriptions must be readily tion must indicate that the application retrievable from all other records. does not meet the requirements of this Electronic records must be easily read- part if the application does not consist- able or easily rendered into a format ently and accurately import, store, and that a person can read. verify the digital signature. (d) Records required by this part (3) If other information required must be made available to the Admin- under this chapter cannot be consist- istration upon request. ently and accurately imported, stored, (e) If an application service provider and displayed, the third-party auditor ceases to provide an electronic pre- or certification organization must indi- scription application or an electronic cate that the application has failed to pharmacy application or if a registrant meet the requirements for the specific ceases to use an application service information and should not be used to provider, the application service pro- process electronic prescriptions that vider must transfer any records subject require the additional information. to this part to the registrant in a format that the registrant’s applications § 1311.302 Additional application pro- are capable of retrieving, displaying, vider requirements. and printing in a readable format. (a) If an application provider identi- (f) If a registrant changes application fies or is made aware of any issue with providers, the registrant must ensure its application that make the applica- that any records subject to this part tion non-compliant with the require- are migrated to the new application or ments of this part, the application pro- are stored in a format that can be re- vider must notify practitioners or trieved, displayed, and printed in a pharmacies that use the application as readable format. soon as feasible, but no later than five (g) If a registrant transfers its elec- business days after discovery, that the tronic prescription files to another reg- application should not be used to issue istrant, both registrants must ensure or process electronic controlled sub- that the records are migrated to the stance prescriptions. new application or are stored in a for- (b) When providing practitioners or mat that can be retrieved, displayed, pharmacies with updates to any issue and printed in a readable format. that makes the application non-com- (h) Digitally signed prescription pliant with the requirements of this records must be transferred or mi- part, the application provider must in- grated with the digital signature. dicate that the updates must be installed before the practitioner or phar- PART 1312—IMPORTATION AND macy may use the application to issue EXPORTATION OF CONTROLLED or process electronic controlled sub- SUBSTANCES stance prescriptions. Sec. § 1311.305 Recordkeeping. 1312.01 Scope of part 1312. (a) If a prescription is created, 1312.02 Definitions. 1312.03 Forms applicable to this part. signed, transmitted, and received electronically, all records related to that IMPORTATION OF CONTROLLED SUBSTANCES prescription must be retained elec- 1312.11 Requirement of authorization to im- tronically. port. (b) Records required by this subpart 1312.12 Application for import permit; re- must be maintained electronically for turn information..

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1312.13 Issuance of import permit. 1312.42 Purpose of hearing. 1312.14 Distribution of import permits. 1312.43 Waiver or modification of rules. 1312.15 Shipments in greater or less amount 1312.44 Request for hearing or appearance; than authorized. waiver. 1312.16 Amendment, cancellation, expira- 1312.45 Burden of proof. tion of import permit. 1312.46 Time and place of hearing. 1312.17 Special report from importers. 1312.47 Final order. 1312.18 Import declaration. 1312.19 Distribution of import declaration. AUTHORITY: 21 U.S.C. 821, 871(b), 952, 953, 954, 957, 958. EXPORTATION OF CONTROLLED SUBSTANCES SOURCE: 36 FR 7815, Apr. 24, 1971, unless 1312.21 Requirement of authorization to ex- otherwise noted. Redesignated at 38 FR 26609, port. Sept. 24, 1973. 1312.22 Application for export or reexport permit; return information. § 1312.01 Scope of part 1312. 1312.23 Issuance of export permit. 1312.24 Distribution of export permit. Procedures governing the importa- 1312.25 Amendment, cancellation, expiration, exportation, transshipment and tion of export permit. intransit shipment of controlled sub- 1312.26 Records required of exporter. stances pursuant to section 1002, 1003, 1312.27 Export/reexport declaration. and 1004 of the Act (21 U.S.C. 952, 953, 1312.28 Distribution of export declaration. 1312.29 Domestic release prohibited. and 954) are governed generally by 1312.30 Schedule III, IV, and V non-narcotic those sections and specifically by the controlled substances requiring an im- sections of this part. port and export permit. § 1312.02 Definitions. TRANSSHIPMENT AND IN-TRANSIT SHIPMENT OF CONTROLLED SUBSTANCES Any term contained in this part shall have the definition set forth in section 1312.31 Schedule I: Application for prior 102 of the Act (21 U.S.C. 802) or part written approval. 1312.32 Schedules II, III, IV: Advance notice. 1300 of this chapter. [62 FR 13969, Mar. 24, 1997] HEARINGS 1312.41 Hearings generally. § 1312.03 Forms applicable to this part.

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] trolled substance listed in Schedule III, IV, or V, or any non-narcotic con- IMPORTATION OF CONTROLLED trolled substance listed in Schedule III SUBSTANCES which the Administrator has specifically designated by regulation in § 1312.11 Requirement of authorization to import. § 1312.30 or any non-narcotic controlled substance listed in Schedule IV or V (a) No person shall import, or cause which is also listed in Schedule I or II to be imported, into the customs terri- of the Convention on Psychotropic tory of the United States from any Substances, 1971, unless and until such place outside thereof (but within the person is properly registered under the United States), or into the United Act (or, in accordance with part 1301 of States from any place outside thereof, this chapter, exempt from registration) any controlled substances listed in and the Administration has issued him Schedule I or II, or any narcotic con-

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or her a permit to do so in accordance and size of the packages or containers, with § 1312.13. the name and quantity of the con- (b) No person shall import, or cause trolled substance contained in any fin- to be imported, into the customs terri- ished dosage units, and the quantity of tory of the United States from any any controlled substance (expressed in place outside thereof (but within the anhydrous acid, base or alkaloid) given United States), or into the United in kilograms or parts thereof. The ap- States from any place outside thereof, plication must also include the fol- any non-narcotic controlled substance lowing: listed in Schedule III, IV, or V, exclud- (1) The name/business name, address/ ing those described in paragraph (a) of business address, contact information this section, unless and until such per- (e.g., telephone number(s), email ad- son is properly registered under the dress(es), etc.), and business of the con- Act (or, in accordance with part 1301 of signor, if known at the time the appli- this chapter, exempt from registration) cation is submitted, but if unknown at and has filed an import declaration to that time, the fact should be indicated do so in accordance with § 1312.18. and the name and address afterwards (c) A separate permit or declaration furnished to the Administration as is required for each shipment of a con- soon as ascertained by the importer; trolled substance to be imported. (2) The foreign port and country of [81 FR 97026, Dec. 30, 2016] initial exportation (i.e., the place where the article will begin its journey § 1312.12 Application for import per- of exportation to the United States); mit; return information. (3) The port of entry into the United (a) Registered importers, other reg- States; istrants authorized to import as a coin- (4) The latest date said shipment will cident activity of their registrations, leave said foreign port or country; and persons who in accordance with (5) The stock on hand of the con- part 1301 of this chapter are exempt trolled substance desired to be im- from registration, seeking to import a ported; controlled substance in schedule I or II; (6) The name of the importing carrier any narcotic drug in schedule III, IV, or vessel (if known), or if unknown it or V; any non-narcotic drug in schedule should be stated whether the shipment III that has been specifically des- will be made by express, freight, or ignated by regulation in § 1312.30; or otherwise, imports of controlled sub- any non-narcotic substance listed in stances in Schedules I or II and nar- schedule IV or V that is also listed in cotic drugs in Schedules III, IV, or V schedule I or II of the Convention on by mail being prohibited); Psychotropic Substances, 1971, must (7) The total tentative allotment to submit an application for a permit to the importer of such controlled sub- import controlled substances on DEA stance for the current calendar year; Form 357. All applications and sup- and porting materials must be submitted to (8) The total number of kilograms of the Administration through the DEA said allotment for which permits have Diversion Control Division secure net- previously been issued and the total work application. The application must quantity of controlled substance actu- be signed and dated by the importer ally imported during the current year and must contain the importer’s reg- to date. istered address to which the controlled (c) If desired, alternative foreign substances will be imported. ports of exportation within the same (b) The applicant must include on the country may be indicated upon the ap- DEA Form 357 the registration number plication (e.g., 1. Kolkata, 2. Mumbai). of the importer and a detailed descrip- If a permit is issued pursuant to such tion of each controlled substance to be application, it will bear the names of imported including the drug name, dos- the two ports in the order given in the age form, National Drug Code (NDC) application and will authorize ship- number, the Administration Controlled ment from either port. Alternative Substance Code Number as set forth in ports in different countries will not be part 1308 of this chapter, the number authorized in the same permit.

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(d) Return information. Within 30 cal- § 1312.13 Issuance of import permit. endar days after actual receipt of a controlled substance at the importer’s (a) The Administrator may authorize registered location, or within 10 cal- importation of any controlled sub- endar days after receipt of a written re- stance listed in Schedule I or II or any quest by the Administration to the im- narcotic drug listed in Schedule III, IV, porter, whichever is sooner, the im- or V if he finds: porter must file a report with the Ad- (1) That the substance is crude ministration through the DEA Diver- opium, poppy straw, concentrate of sion Control Division secure network poppy straw, or coca leaves, in such application specifying the particulars quantity as the Administrator finds of the transaction. This report must in- necessary to provide for medical, sci- clude the following information: The entific, or other legitimate purposes; date the controlled substance was re- (2) That the substance is necessary to leased by a customs officer at the port provide for medical and scientific needs of entry; the date on which the con- or other legitimate needs of the United trolled substance arrived at the reg- States during an emergency where do- istered location; the actual quantity of mestic supplies of such substance or the controlled substance released by a drug are found to be inadequate, or in customs officer at the port of entry; any case in which the Administrator and the actual quantity of the con- finds that competition among domestic trolled substance that arrived at the manufacturers of the controlled sub- registered location. Upon receipt and stance is inadequate and will not be review, the Administration will assign rendered adequate by the registration a transaction identification number to of additional manufacturers under sec- a completed report. The report will not tion 303 of the Controlled Substances be deemed filed until the Administra- Act (21 U.S.C. 823); or tion has issued a transaction identi- (3) That the domestic supply of any fication number. controlled substance is inadequate for (e) Denied release at the port of entry. scientific studies, and that the impor- In the event that a shipment of con- tation of that substance for scientific trolled substances has been denied re- purposes is only for delivery to offi- lease by a customs officer at the port cials of the United Nations, of the of entry for any reason, the importer United States, or of any State, or to who attempted to have the shipment any person registered or exempted released must, within 5 business days from registration under sections 1007 of the denial, report to the Administra- and 1008 of the Act (21 U.S.C. 957 and tion that the shipment was denied and 958). the reason for denial. Such report must (4) That the importation of the con- be transmitted to the Administration trolled substance is for ballistics or through the DEA Diversion Control Di- other analytical or scientific purposes, vision secure network application. This and that the importation of that sub- report must include the following instance is only for delivery to officials formation: The quantity of the con- of the United Nations, of the United trolled substance denied release; the States, or of any State, or to any per- date on which release was denied; and son registered or exempted from reg- the basis for the denied release. Upon istration under sections 1007 and 1008 of the importer’s report of a denied re- the Act (21 U.S.C. 957 and 958). lease at the port of entry, the DEA will (b) The Administrator may require assign the report a transaction identi- that such non-narcotic controlled sub- fication number and the import permit stances in Schedule III as he shall des- will be void and of no effect. No ship- ignate by regulation in § 1312.30 of this ment of controlled substances denied part be imported only pursuant to the release for any reason will be allowed issuance of an import permit. The Ad- to be released into the United States ministrator may authorize the impor- unless the importer submits a new tation of such substances if he finds DEA Form 357 and the Administration that the substance is being imported issues a new import permit. for medical, scientific or other legiti- [81 FR 97026, Dec. 30, 2016] mate uses.

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(c) If a non-narcotic substance listed posed to be imported is required for le- in Schedule IV or V is also listed in gitimate purposes. Schedule I or II of the Convention on (f) Notwithstanding paragraphs (a)(1) Psychotropic Substances, 1971, it shall and (a)(2) of this section, the Adminis- be imported only pursuant to the trator shall permit, pursuant to sec- issuance of an import permit. The Ad- tion 1002(a)(1) or 1002(a)(2)(A) of the Act ministrator may authorize the impor- (21 U.S.C. 952(a)(1) or (a)(2)(A)), the im- tation of such substances if it is found portation of approved narcotic raw ma- that the substance is being imported terial (opium, poppy straw and con- for medical, scientific or other legiti- centrate of poppy straw) having as its mate uses. source: (d) The Administrator may require (1) Turkey, an applicant to submit such documents (2) India, or written statements of fact relevant (3) Spain, to the application as he deems nec- (4) France, essary to determine whether the application should be granted. The failure of (5) Poland, the applicant to provide such docu- (6) Hungary, and ments or statements within a reason- (7) Australia. able time after being requested to do so (g) At least eighty (80) percent of the shall be deemed to be a waiver by the narcotic raw material imported into applicant of an opportunity to present the United States shall have as its such documents or facts for consider- original source Turkey and India. Ex- ation by the Administrator in granting cept under conditions of insufficient or denying the application. supplies of narcotic raw materials, not (e) If an importation is approved, the more than twenty (20) percent of the Administrator will issue an import per- narcotic raw material imported into mit bearing his or her signature or the United States annually shall have that of his or her delegate. Each permit as its source Spain, France, Poland, will be assigned a unique permit num- Hungary and Australia. ber. A permit must not be altered or [36 FR 23624, Dec. 11, 1971, as amended at 37 changed by any person after being FR 15923, Aug. 8, 1972. Redesignated at 38 FR signed. Any change or alteration upon 26609, Sept. 24, 1973, and amended at 46 FR the face of any permit after it has been 41776, Aug. 18, 1981; 52 FR 17289, May 7, 1987; signed renders it void and of no effect. 73 FR 6851, Feb. 6, 2008; 81 FR 97027, Dec. 30, Permits are not transferable. The Ad- 2016] ministrator or his/her delegate will date and certify on each permit that § 1312.14 Distribution of import per- the importer named therein is thereby mits. permitted as a registrant under the The Administration shall transmit Act, to import, through the port of the import permit to the competent entry named, one shipment of not to national authority of the exporting exceed the specified quantity of the country and shall make an official named controlled substances, shipment record of the import permit available to be made before a specified date. to the importer through secure elec- Only one shipment may be made on a tronic means. The importer, or their single import permit. A single import agent, must submit an official record permit shall authorize a quantity of of the import permit and/or required goods to be imported/exported at one data concerning the import transaction place, at one time, for delivery to one to a customs officer at the port of consignee, on a single conveyance, at entry in compliance with all import one place, on one bill of lading, air control requirements of agencies with waybill, or commercial loading docu- import control authorities under the ment; a single permit shall not author- Act or statutory authority other than ize a quantity of goods to be imported/ the Controlled Substances Import and exported if the goods are divided onto Export Act. The importer must main- two or more conveyances. The permit tain an official record of the import must state that the Administration is permit (available from the DEA Diver- satisfied that the consignment pro- sion Control Division secure network

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application after issuance) in accord- mit or permits as are requested and ance with part 1304 of this chapter as issued during the remainder of the cal- the record of authority for the impor- endar year to which the allotment is tation and shall transmit an official applicable. No permit shall be issued record of the permit to the foreign ex- for importation of a quantity of con- porter. If required by the foreign com- trolled substances as a charge against petent national authority, the im- the tentative allotment for a given cal- porter shall ensure that an official endar year, after the close of such cal- record of the import permit is provided endar year, unless the Administrator (e.g., by transmitting an official record decides to make an exception for good of the permit to the foreign exporter cause shown. who shall transmit such record to the [36 FR 7815, Apr. 24, 1971. Redesignated at 38 competent national authority of the FR 26609, Sept. 24, 1973, and amended at 46 exporting county). The importer must FR 28841, May 29, 1981; 81 FR 97027, Dec. 30, ensure that an official record of the 2016] permit accompanies the shipment of controlled substances to its final des- § 1312.16 Amendment, cancellation, ex- tination, the registered location of the piration of import permit. importer (i.e., drop shipments are pro- (a) Importers may only request that hibited). an import permit or application for an [81 FR 97027, Dec. 30, 2016] import permit be amended in accordance with paragraphs (a)(1) through (7) § 1312.15 Shipments in greater or less of this section. Requests for an amend- amount than authorized. ment must be submitted through the (a) If the shipment made under an DEA Diversion Control Division secure import permit is greater than the max- network application. Except as pro- imum amount authorized to be im- vided in paragraph (a)(5) of this section ported under the permit, as determined and § 1312.15(a), importers must submit at the weighing by the District Direc- all requests for an amendment at least tor of the U.S. Customs and Border one full business day in advance of the Protection or customs service of an In- date of release by a customs officer. sular Area, such difference shall be Importers must specifically request seized subject to forfeiture, pending an that an amendment be made; supple- explanation; except that shipments of mentary information submitted by an substances exceeding the maximum au- importer through the DEA Diversion thorized amount by less than 1 percent Control Division secure network appli- may be released to the importer upon cation will not automatically trigger the filing by him of an amended import the amendment process. While the re- permit in accordance with § 1312.16(a). quest for an amendment is being re- If the substance is included in Schedule viewed by the Administration, the I, it will be summarily forfeited to the original permit will be temporarily Government. stayed and may not be used to author- (b) If the shipment made under the ize entry of a shipment of controlled permit is less than the maximum substances. If the importer’s request amount authorized to be imported for an amendment to an issued permit under the permit as determined at the is granted by the Administration, the weighing by the District Director of Administration will immediately can- the U.S. Customs and Border Protec- cel the original permit and re-issue the tion or customs service of an Insular permit, as amended, with a revised per- Area, such difference, when ascertained mit number. The DEA and importer by the Administration, shall be recred- will distribute the amended permit in ited to the tentative allotment against accordance with § 1312.14. If a request which the quantity covered by the per- for an amendment is denied by the Ad- mit was charged, and the balance of ministration, the temporary stay will any such tentative allotment with any be lifted; once lifted, the originally such recredits will remain available to issued permit may immediately be the importer to whom made (unless used to authorize entry of a shipment 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

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compliant with all other applicable an import permit to add or replace a laws. controlled substance/Administration (1) An importer may request that an controlled substance code number to import permit or application for a per- the item(s) to be imported. Importers mit be amended to change the National who desire to import a different con- Drug Control number, description of trolled substance than that contained the packaging, or trade name of the on their issued import permit or per- product, so long as the description is mit application must submit a request for the same basic class of controlled for the permit or permit application to substance as in the original permit. be canceled and request a new permit (2) An importer may request that an in accordance with § 1312.12. import permit or application for a per- (7) An importer may not amend the mit be amended to change the proposed importer’s name (as it appears on their port of entry, the date of release by a DEA certificate of registration) or the customs officer, or the method of name of the foreign exporter as pro- transport. vided in the DEA Form 357. Importers (3) An importer may request that an who need to make any changes to any import permit or application for a per- of these fields must submit a request mit be amended to change the jus- for the permit or permit application to tification provided as to why an import be canceled and request a new permit shipment is needed to meet the legiti- in accordance with § 1312.12. mate scientific or medical needs of the (b) An import permit will be void and United States. of no effect after the expiration date (4) An importer may request that an specified therein, and in no event will import permit or application for a per- the date be more than 180 calendar mit be amended to change any reg- days after the date the permit is istrant notes. issued. Amended import permits will (5) Prior to departure of the shipment retain the original expiration date. from its original foreign location, an (c) An import permit may be can- importer may request that an import celed after being issued, at the request permit or application for a permit be of the importer submitted to the Ad- amended to increase the total base ministration through the DEA Diver- weight of a controlled substance. At sion Control Division secure network the U.S. port of entry, an importer application, provided that no shipment may request that an import permit be has been made thereunder. amended in accordance with § 1312.15(a). Nothing in this part will affect the Importers are not required to amend an right, hereby reserved by the Adminis- import permit for the sole purpose of tration, to cancel a permit at any time decreasing the total base weight of a for proper cause. controlled substance authorized to be [81 FR 97027, Dec. 30, 2016] imported. However, the balance of any unimported authorized quantity of con- § 1312.17 Special report from import- trolled substances on an import permit ers. is void upon entry of a shipment on the Whenever requested by the Adminis- issued permit or upon expiration of the trator, importers shall render to him unused permit in accordance with para- not later than 30 days after receipt of graph (b) of this section, whichever is the request therefor a statement under sooner. Other than for an amendment oath of the stocks of controlled sub- to an import permit under § 1312.15(a), stances on hand as of the date specified importers must submit a request for an by the Administrator in his request, amendment to increase the total base and, if desired by the Administrator, weight of a controlled substance at an estimate of the probable require- least three business days in advance of ments for legitimate uses of the im- the date of release by a customs offi- porter for any subsequent period that cer. may be designated by the Adminis- (6) An importer may request that an trator. In lieu of any special statement import permit be amended to remove a that may be considered necessary, the controlled substance from the permit. Administrator may accept the figures However, an importer may not amend given upon the reports subsequent by

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said importer under part 1304 of this Administration Controlled Substances chapter. Code Number as set forth in part 1308 of this chapter, the number and size of [36 FR 7815, Apr. 24, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973, as amended at 62 FR packages or containers, the name and 13969, Mar. 24, 1997] quantity of the controlled substance contained in any finished dosage units, § 1312.18 Import declaration. and the net quantity of any controlled (a) Any non-narcotic controlled sub- substance (expressed in anhydrous stance listed in Schedule III, IV, or V, acid, base, or alkaloid) given in kilo- not subject to the requirement of an grams or parts thereof; and import permit pursuant to § 1312.13 (b) (3) The anticipated date of release by or (c) of this chapter, may be imported a customs officer at the port of entry, if that substance is needed for medical, the foreign port and country of expor- scientific or other legitimate uses in tation to the United States, the port of the United States, and will be imported entry, and the name, address, and reg- pursuant to a controlled substances istration number of the recipient in the import declaration. United States; and (b) Any person registered or author- (4) The name and address of the con- ized to import and seeking to import signor in the foreign country of expor- any non-narcotic controlled substance tation, and any registration or license listed in Schedules III, IV, or V which numbers if the consignor is required to is not subject to the requirement of an have such numbers either by the coun- import permit as described in para- try of exportation or under U.S. law. graph (a) of this section, must file a (d) Notwithstanding the time limita- controlled substances import declarations included in paragraph (b) of this tion (DEA Form 236) with the Adminis- section, an applicant may obtain a spe- tration through the DEA Diversion cial waiver of these time limitations in Control Division secure network appli- emergency or unusual instances, pro- cation not later than 15 calendar days vided that a specific confirmation is re- prior to the anticipated date of release ceived from the Administrator or his by a customs officer and distribute an delegate advising the registrant to pro- official record of the declaration as ceed pursuant to the special waiver. hereinafter directed in § 1312.19. The (e) Return information. Within 30 cal- declaration must be signed and dated endar days after actual receipt of a by the importer and must specify the controlled substance at the importer’s address of the final destination for the registered location, or within 10 cal- shipment, which must be the import- endar days after receipt of a written re- er’s registered location. Upon receipt quest by the Administration to the im- and review, the Administration will as- porter, whichever is sooner, the im- sign a transaction identification num- porter must file a report with the Ad- ber to each completed declaration. The ministration through the DEA Diver- import declaration is not deemed filed, sion Control Division secure network and therefore is not valid, until the Ad- application specifying the particulars ministration has issued a transaction of the transaction. This report must in- identification number. The importer clude the following information: The may only proceed with the import date on which the controlled substance transaction once the transaction iden- was released by a customs officer at tification number has been issued. the port of entry; the date on which the (c) DEA Form 236 must include the controlled substance arrived at the reg- following information: istered location; the actual quantity of (1) The name, address, and registra- the controlled substance released by a tion number of the importer; and the customs officer at the port of entry; name and address and registration the actual quantity of the controlled number of the import broker, if any; substance that arrived at the reg- and istered location; and the actual port of (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

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filed until the Administration has who attempted to have the shipment issued a transaction identification released, within 5 business days of the number. denial, report to the Administration (f) An importer may amend an im- that the shipment was denied release port declaration in the same cir- and the reason for denial. Such report cumstances in which an importer may must be transmitted to the Adminis- request amendment to an import per- tration through the DEA Diversion mit, as set forth in § 1312.16(a)(1) Control Division secure network appli- through (7). Amendments to declara- cation. This report must include the tions must be submitted through the following information: The quantity of DEA Diversion Control Division secure the controlled substance denied re- network application. Except as pro- lease; the date on which release was de- vided in §§ 1312.16(a)(5) and 1312.15(a), nied; and the basis for the denied re- importers must submit all amendments lease. Upon the importer’s report of a at least one full business day in ad- denied release, the DEA will assign the vance of the date of release by a cus- report a transaction identification toms officer. Importers must specifi- number and the import declaration will cally note that an amendment is being become void and of no effect. No ship- made; supplementary information sub- ment of controlled substances denied mitted by an importer through the release for any reason will be allowed DEA Diversion Control Division secure to be released into the United States network application will not automati- until the importer has filed a new im- cally be considered an amendment. port declaration and the Administra- While the amendment is being proc- tion has issued a new transaction iden- essed by the Administration, the origi- tification number. nal declaration will be temporarily stayed and may not be used to author- [36 FR 7815, Apr. 24, 1971, as amended at 37 FR 15923, Aug. 8, 1972. Redesignated at 38 FR ize release of a shipment of controlled 26609, Sept. 24, 1973, and amended at 45 FR substances. Upon receipt and review, 74715, Nov. 12, 1980; 51 FR 5319, Feb. 13, 1986; the Administration will assign each 52 FR 17290, May 7, 1987; 62 FR 13969, Mar. 24, completed amendment a transaction 1997; 75 FR 10682, Mar. 9, 2010; 77 FR 4237, Jan. identification number. The amendment 27, 2012; 81 FR 97028, Dec. 30, 2016] will not be deemed filed until the Ad- ministration issues a transaction iden- § 1312.19 Distribution of import dec- tification number. The DEA and im- laration. porter will distribute the amended dec- The importer must furnish an official laration in accordance with § 1312.19. A record of the declaration (available filed amendment will not change the through the DEA Diversion Control Di- date that the declaration becomes void vision secure network application after and of no effect pursuant to paragraph the Administration issues a trans- (g) of this section. action identification number) to the (g) An import declaration may be foreign shipper. The foreign shipper canceled after being filed with the Ad- must submit an official record of the ministration, at the request of the im- declaration to the competent national porter by the importer submitting to authority of the exporting country, if the Administration the request required as a prerequisite to export au- through the DEA Diversion Control Di- thorization. The importer, or their vision secure network application, pro- agent, must submit an official record vided that no shipment has been made of the declaration and/or required data thereunder. Import declarations shall concerning the import transaction to a become void and of no effect 180 cal- customs officer at the port of entry in endar days after the date the declara- compliance with all import control re- tion is deemed filed with the Adminis- quirements of agencies with import tration. control authorities under the Act or (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

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final destination, which must only be stances must submit an application for the registered location of the importer a permit to export controlled sub- (i.e., drop shipments are prohibited). stances on DEA Form 161. Registered The importer must maintain an official exporters, and persons who in accord- record of the declaration in accordance ance with part 1301 of this chapter are with part 1304 of this chapter. exempt from registration, seeking to [81 FR 97029, Dec. 30, 2016] reexport controlled substances must submit an application for a permit to EXPORTATION OF CONTROLLED reexport controlled substances on DEA SUBSTANCES Form 161R or DEA Form 161R–EEA, whichever applies. All applications and § 1312.21 Requirement of authoriza- supporting materials must be sub- tion to export. mitted to the Administration through (a) No person shall in any manner ex- the DEA Diversion Control Division se- port, or cause to be exported, from the cure network application. The applica- United States any controlled substance tion must be signed and dated by the listed in Schedule I or II, or any nar- exporter and contain the exporter’s cotic controlled substance listed in registered address from which the con- Schedule III or IV, or any non-narcotic trolled substances will be exported. controlled substance in Schedule III Controlled substances may not be ex- which the Administrator has specifi- ported until a permit number has been cally designated by regulation in issued. § 1312.30 or any non-narcotic controlled (b) Exports of controlled substances substance in Schedule IV or V which is by mail are prohibited. also listed in Schedule I or II of the (c) Applications. (1) Except as pro- Convention on Psychotropic Sub- vided in paragraph (c)(2) of this sec- stances, 1971, unless and until such per- tion, each application for a permit to son is properly registered under the export or reexport must include the Act (or, in accordance with part 1301 of following information: this chapter, exempt from registration) (i) The exporter’s name/business and the Administrator has issued him name, address/business address, and or her a permit to do so in accordance contact information (e.g., telephone with § 1312.23. number(s), email address (es), etc.); (b) No person shall in any manner ex- (ii) The exporter’s registration num- port, or cause to be exported, from the ber, address, and contact information United States any non-narcotic con- (e.g., telephone number(s), etc.) from trolled substance listed in Schedule III, which the controlled substances will be IV, or V, excluding those described in exported; paragraph (a) of this section, or any (iii) A detailed description of each narcotic controlled substance listed in controlled substance to be exported in- Schedule V, unless and until such per- cluding the drug name, dosage form, son is properly registered under the National Drug Code (NDC) number, Ad- Act (or, in accordance with part 1301 of ministration Controlled Substance this chapter, exempt from registration) Code Number as set forth in part 1308 and has furnished an export declara- of this chapter, the number and size of tion as provided by section 1003 of the the packages or containers, the name Act (21 U.S.C. 953(e)) to the Adminis- and quantity of the controlled sub- tration in accordance with § 1312.28. stance contained in any finished dosage (c) A separate permit or declaration units, and the quantity of any con- is required for each shipment of controlled substance (expressed in anhy- trolled substance to be exported. drous acid, base, or alkaloid) given in [81 FR 97029, Dec. 30, 2016] kilograms or parts thereof; (iv) The name/business name, ad- § 1312.22 Application for export or re- dress/business address, contact infor- export permit; return information. mation (e.g., telephone number(s), (a) Registered exporters, and persons email address(es), etc.) and business of who in accordance with part 1301 of the consignee in the first country (the this chapter are exempt from registra- country to which the controlled sub- tion, seeking to export controlled substance is exported from the United

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States), foreign port and country of permit issued by the competent na- entry/first country of entry, the port of tional authority in the country of des- export, the anticipated date of release tination, or other documentary evi- by a customs officer at the port of ex- dence deemed adequate by the Admin- port, the name of the exporting carrier istration, showing: That the merchan- or vessel (if known), or if unknown it dise is consigned to an authorized per- should be stated whether the shipment mittee; that it is to be applied exclu- will be made by express, freight, or sively to medical or scientific use with- otherwise), the date and number, if in the country of destination; that it any, of the supporting foreign import will not be reexported from such coun- license or permit accompanying the ap- try (unless the application is submitted plication, and the authority by whom for reexport in accordance with para- such foreign license or permit was graphs (f), (g), and (h) of this section); issued; and and that there is an actual need for the (v) An affidavit that the packages or controlled substance for medical or sci- containers are labeled in conformance entific use within such country or with obligations of the United States countries. If the import license or per- under international treaties, conven- mit, or the certified copy of such, is tions, or protocols in effect at the time not written in English or bilingual of the export or reexport. The affidavit with another language and English, the shall further state that to the best of registrant must also submit with their the affiant’s knowledge and belief, the application a certified translation of controlled substances therein are to be the permit or license. For purposes of applied exclusively to medical or sci- this requirement, certified translation entific uses within the country to means that the translator has signed which exported, will not be reexported the translation legally attesting the therefrom and that there is an actual accuracy of the translation. (In the need for the controlled substance for case of exportation of bulk coca leaf medical or scientific uses within such alkaloid, the applicant need only in- country, unless the application is sub- clude with the application the material mitted for reexport in accordance with outlined in paragraph (c) of this sec- paragraphs (f), (g), and (h) of this section. In the case of exportation of tion.) crude cocaine, the affidavit may state (2) With respect to reexports among that to the best of affiant’s knowledge members of the European Economic and belief, the controlled substances Area in accordance with section 1003(f) will be processed within the country to of the Act (21 U.S.C. 953(f)), the require- which exported, either for medical or ments of paragraph (d)(1) of this sec- scientific use within that country or tion shall apply only with respect to for reexportation in accordance with the export from the United States to the laws of that country to another for the first country and not to any subse- medical or scientific use within that quent export from that country to an- country. other country of the European Eco- (2) With respect to reexports among nomic Area. members of the European Economic (e) Return information for exports (on a Area in accordance with section 1003(f) DEA Form 161). Within 30 calendar days of the Act (21 U.S.C. 953(f)), the require- after the controlled substance is re- ments of paragraph (c)(1) of this sec- leased by a customs officer at the port tion shall apply only with respect to of export, or within 10 calendar days the export from the United States to after receipt of a written request by the first country and not to any subse- the Administration to the exporter, quent export from that country to an- whichever is sooner, the exporter must other country of the European Eco- report to the Administration through nomic Area. the DEA Diversion Control Division se- (d)(1) Except as provided in para- cure network application the particu- graph (d)(2) of this section, the appli- lars of the transaction. This report cant must also submit with the appli- must include the following informa- cation any import license or permit or tion: The date on which the controlled a certified copy of any such license or substance left the registered location;

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the date on which the controlled sub- (i) The controlled substance is to be stance was released by a customs offi- consigned to a holder of such permits cer at the port of export; the actual or licenses as may be required under quantity of controlled substance that the laws of such country, and a permit left the registered location; and the ac- or license to import the controlled sub- tual quantity of the controlled substance is to be issued by the country; stance released by a customs officer at and the port of export; the actual port of (ii) The controlled substance is to be export, and any other information as applied exclusively to medical, sci- the Administration may from time to entific, or other legitimate uses within time specify. Upon receipt and review, the country; the Administration will assign a trans- (5) The controlled substance will not action identification number to a com- be exported from the second country; pleted report. The report will not be (6) The exporter has complied with deemed filed until the Administration paragraph (h) of this section and a per- has issued a transaction identification mit to export the controlled substance number. from the United States has been issued (f) Reexports outside of the European by the Administration; and Economic Area. Except as provided in (7) Return information for reexports paragraph (g) of this section, the Ad- outside of the European Economic Area ministration may authorize any con- (on DEA Form 161R)—(i) Return informa- trolled substance listed in Schedule I tion for export from the United States, for or II, or any narcotic drug listed in reexport. Within 30 calendar days after Schedule III or IV, to be exported from the controlled substance is released by the United States to a country for sub- a customs officer at the port of export sequent export from that country to the exporter must file a report with the another country, if each of the fol- Administration through the DEA Di- lowing conditions is met, in accordance version Control Division secure net- with section 1003(f) of the Act (21 work application specifying the par- U.S.C. 953(f)): ticulars of the transaction. This report must include the following informa- (1) Both the country to which the tion: The date on which the controlled controlled substance is exported from substance left the registered location; the United States (referred to in this the date on which the controlled subsection as the ‘‘first country’’) and the stance was released by a customs offi- country to which the controlled sub- cer at the port of export; the actual stance is exported from the first coun- quantity of controlled substance re- try (referred to in this section as the leased by a customs officer at the port ‘‘second country’’) are parties to the of export; and the actual port of ex- Single Convention on Narcotic Drugs, port. Upon receipt and review, the Ad- 1961, and the Convention on Psycho- ministration will assign a completed tropic Substances, 1971; report a transaction identification (2) The first country and the second number. The report will not be deemed country have each instituted and main- filed until the Administration has tain, in conformity with such Conven- issued a transaction identification tions, a system of controls of imports number. In determining whether the of controlled substances which the Ad- exporter has complied with the require- ministration deems adequate; ment to file within 30 calendar days, (3) With respect to the first country, the report shall be deemed filed on the the controlled substance is consigned first date on which a complete report is to a holder of such permits or licenses filed. as may be required under the laws of (ii) Return information for export from such country, and a permit or license a first country that is or is not a member to import the controlled substance has of the European Economic Area to a been issued by the country; country outside of the European Eco- (4) With respect to the second coun- nomic Area; return information for export try, substantial evidence is furnished from a first country that is not a member to the Administration by the applicant of the European Economic Area to a mem- for the export permit that— ber of the European Economic Area.

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Within 30 calendar days after the con- Economic Area to any other such coun- trolled substance is exported from the try, if— first country to the second country the (A) The conditions applicable with exporter must file a report with the respect to the first country under para- Administration through the DEA Di- graphs (f)(1) through (4) and (6) of this version Control Division secure net- section and paragraph (g)(2) are met work application specifying the par- with respect to each subsequent coun- ticulars of the export from the first try from which the controlled sub- country. If the permit issued by the stance is exported pursuant to this Administration authorized the reex- paragraph (g); and port of a controlled substance from the (B) The conditions applicable with first country to more than one second respect to the second country under country, a report for each individual paragraphs (f)(1) through (4) and (6) of reexport is required. These reports this section and paragraph (g)(2) of this must include the following informa- section are met with respect to each tion: Name of second country; actual subsequent country to which the con- quantity of controlled substance trolled substance is exported pursuant shipped; and the date shipped from the to this paragraph (g). first country, the actual port from (2) Return information for reexports which the controlled substances were among members of the European Eco- shipped from the first country. Upon nomic Area—(i) Return information for receipt and review, the Administration export from the United States, for reexport will assign each completed report a among members of the European Eco- transaction identification number. The nomic Area. Exporters must comply report will not be deemed filed until with the return reporting requirements the Administration has issued a trans- of paragraph (f)(7)(i) of this section. action identification number. (ii) Reexports among members of the European Economic Area. Within 30 cal- (g) Reexports among members of the Eu- endar days after the controlled sub- ropean Economic Area (on DEA Form stance is exported from the first coun- 161R–EEA). The Administration may try to the second country, and within authorize any controlled substance 30 calendar days of each subsequent re- listed in Schedule I or II, or any nar- export within the European Economic cotic drug listed in Schedule III or IV, Area, if any, the U.S. exporter must to be exported from the United States file a report with the Administration to a country of the European Economic through the DEA Diversion Control Di- Area for subsequent export from that vision secure network application country to another country of the Eu- specifying the particulars of the ex- ropean Economic Area, if the following port. These reports must include the conditions and the conditions of para- name of country to which the con- graphs (f)(1) through (4) and (6) of this trolled substance was reexported, i.e., section are met, in accordance with another member of the European Eco- section 1003(f) of the Act (21 U.S.C. nomic Area; the actual quantity of 953(f)): controlled substance shipped; the date (1)(i) The controlled substance will shipped from the first country, the not be exported from the second coun- name/business name, address/business try, except that the controlled sub- address, contact information (e.g., tele- stance may be exported from a second phone number(s), email address(es), country that is a member of the Euro- etc.) and business of the consignee; and pean Economic Area to another coun- the name/business name, address/busi- try that is a member of the European ness address, contact information (e.g., Economic Area, provided that the first telephone number(s), email address(es), 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.

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(h) Where a person is seeking to ex- required under paragraph (c) of this port a controlled substance for reex- section: port outside of the European Economic (i) That the packages are labeled in Area in accordance with paragraph (f) conformance with the obligations of of this section, the requirements of the United States under the Single paragraphs (h)(1) through (7) of this Convention on Narcotic Drugs, 1961, section shall apply in addition to (and the Convention on Psychotropic Sub- not in lieu of) the requirements of stances, 1971, and any amendments to paragraphs (a) through (d) of this sec- such treaties in effect; tion. Where a person is seeking to ex- (ii) That the controlled substances port a controlled substance for reex- are to be applied exclusively to medical port among members of the European or scientific uses within the second Economic Area in accordance with country, or country of subsequent reex- paragraph (g) of this section, the report within the European Economic quirements of paragraph (h)(4) of this Area; section shall apply in addition to (and (iii) That the controlled substances not in lieu of) the requirements of will not be further reexported from the paragraphs (a) through (d) of this sec- second country except as provided by tion. paragraph (f) of section 1003 of the Act (1) Bulk substances will not be reex- (21 U.S.C. 953(f)); and ported in the same form as exported (iv) That there is an actual need for from the United States, i.e., the mate- the controlled substances for medical rial must undergo further manufac- or scientific uses within the second turing process. This further manufac- country, or country of subsequent reex- tured material may only be reexported port within the European Economic to a second country. Area. (2) Finished dosage units, if reex- (5) If the applicant proposes that the shipment of controlled substances will ported, must be in a commercial pack- be separated into parts after it arrives age, properly sealed and labeled for le- in the first country and then reex- gitimate medical use in the second ported to more than one second coun- country. try, the applicant must so indicate on (3) Any proposed reexportation must the DEA Form 161R and provide all the be made known to the Administration information required in this section for at the time the initial DEA Form 161R each second country. is submitted. In addition, the following (6) Except in the case of reexports information must also be provided among countries of the European Eco- where indicated on the form: nomic Area in accordance with section (i) Whether the drug or preparation 1003(f) of the Act (21 U.S.C. 953(f)), the will be reexported in bulk or finished controlled substance will be reexported dosage units; from the first country to the second (ii) The product name, dosage country (or second countries) no later strength, commercial package size, and than 180 calendar days after the con- quantity; and trolled substance was released by a (iii) The name of consignee, complete customs officer from the United States. address, and expected shipment date, (7) Shipments that have been ex- as well as the name and address of the ported from the United States and are ultimate consignee in the second coun- refused by the consignee in either the try. first or second country, or subsequent (4) The application must contain an member of the European Economic affidavit that the consignee in the sec- Area, or are otherwise unacceptable or ond country, and any country of subse- undeliverable, may be returned to the quent reexport within the European registered exporter in the United 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

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the facts that warrant the return, as appropriate, and the Administration along with a completed DEA Form 357 issues a new export permit. through the DEA Diversion Control Di- [81 FR 97029, Dec. 30, 2016] vision secure network application. The Administration will evaluate the re- § 1312.23 Issuance of export permit. quest after considering all the facts as (a) The Administrator may authorize well as the exporter’s registration sta- exportation of any controlled sub- tus with the Administration. If the ex- stance listed in Schedule I or II or any porter provides sufficient justification, narcotic controlled substance listed in the Administration may issue an im- Schedule III or IV if he finds that such port permit for the return of these exportation is permitted by sub- drugs, and the exporter may then ob- sections 1003(a), (b), (c), (d), or (f) of the tain an export permit from the country Act (21 U.S.C. 953(a), (b), (c), (d), or (f). of original importation. The substance (b) The Administrator may require may not be returned to the United that such non-narcotic controlled sub- States until after a permit has been stances in Schedule III as shall be des- issued by the Administration. ignated by regulation in § 1312.30 of this (i) In considering whether to grant an part be exported only pursuant to the application for a permit under para- issuance of an export permit. The Ad- graphs (f), (g), and (h) of this section, ministrator may authorize the exportation of such substances if he finds the Administration shall consider that such exportation is permitted by whether the applicant has previously section 1003(e) of the Act (21 U.S.C. obtained such a permit and, if so, 953(e)). whether the applicant complied fully (c) If a non-narcotic substance listed with the requirements of this section in Schedule IV or V is also listed in with respect to that previous permit. Schedule I or II of the Convention on (j) Denied release at the port of export. Psychotropic Substances, it shall be In the event that a shipment of con- exported only pursuant to the issuance trolled substances has been denied re- of an export permit. The Administrator lease by a customs officer at the port may authorize the exportation of such export from the United States for any substances if he finds that such expor- reason, the exporter who attempted to tation is permitted by section 1003(e) of have the shipment released must, with- the Act (21 U.S.C. 953(e)). in 5 business days of the denial, report (d) The Administrator may require to the Administration that the ship- an applicant to submit such documents ment was denied release and the reason or written statements of fact relevant for denial. Such report must be trans- to the application as he deems nec- mitted to the Administration through essary to determine whether the appli- the DEA Diversion Control Division se- cation should be granted. The failure of cure network application. This report the applicant to provide such docu- must include the following informa- ments or statements within a reasonable time after being requested to do so tion: The quantity of the controlled shall be deemed to be a waiver by the substance denied release; the date on applicant of an opportunity to present which release was denied; the basis for such documents or facts for consider- the denied release, the port from which ation by the Administrator in granting the denial was issued, and any other in- or denying the application. formation as the Administration may (e) If an exportation is approved, the from time to time specify. Upon the ex- Administrator shall issue an export porter’s report of a denied release, DEA permit bearing his or her signature or will assign the report a transaction that of his or her delegate. Each permit identification number and the export will be assigned a permit number that permit will be void and of no effect. No is a unique, randomly generated identi- 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.

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Permits are not transferable. The Ad- porter an official record of the export ministrator or his/her delegate shall permit through secure electronic date and certify on each permit that means. The exporter, or their agent, the exporter named therein is thereby must submit an official record of the permitted as a registrant under the export permit and/or required data con- Act, to export, through the port of ex- cerning the export transaction to a port named, one shipment of not to ex- customs officer at the port of export in ceed the specified quantity of the compliance with all export control re- named controlled substances, shipment quirements of agencies with export to be made before a specified date. control authorities under the Act or Only one shipment may be made on a statutory authority other than the single export permit. A single export Controlled Substances Import and Ex- permit shall authorize a quantity of port Act. The exporter must maintain goods to be exported at one place, at an official record of the export permit one time, for delivery to one consignee, (available from the secure network ap- on a single conveyance, at one place, plication on the DEA Diversion Control on one bill of lading, air waybill, or Division Web site after the Administra- commercial loading document; a single tion issues a transaction identification permit shall not authorize a quantity number) in accordance with part 1304 of of goods to be exported if the goods are this chapter as the record of authority divided onto two or more conveyances. for the exportation and shall transmit Each export permit shall be predicated an official record of the export permit upon, inter alia, an import certificate to the foreign importer. The exporter or other documentary evidence issued must ensure that an official record of by a foreign competent national au- the permit accompanies the shipment thority. to its final destination. No shipment of (f) No export permit shall be issued controlled substances denied release for the exportation, or reexportation, for any reason shall be allowed to be of any controlled substance to any released from the United States with- country when the Administration has out subsequent authorization from the information to show that the estimates Administration. or assessments submitted with respect to that country for the current period, [81 FR 97032, Dec. 30, 2016] under the Single Convention on Nar- cotic Drugs, 1961, or the Convention on § 1312.25 Amendment, cancellation, ex- Psychotropic Substances, 1971, have piration of export permit. been, or, considering the quantity pro- (a) Exporters may only request that posed to be imported, will be exceeded. an export permit or application for an If it shall appear through subsequent export permit be amended in accord- advice received from the International ance with paragraphs (a)(1) through (7) Narcotics Control Board of the United of this section. Requests for an amend- Nations that the estimates or assessment must be submitted through the ments of the country of destination DEA Diversion Control Division secure have been adjusted to permit further network application. Except as pro- importation of the controlled sub- vided in paragraph (a)(5) of this section stance, an export permit may then be exporters must submit all requests for issued if otherwise permissible. an amendment at least one full business day in advance of the date of re- [36 FR 23625, Dec. 11, 1971, as amended at 37 FR 15923, Aug. 8, 1972. Redesignated at 38 FR lease from the port of export. Export- 26609, Sept. 24, 1973, and amended at 52 FR ers must specifically request that an 17290, May 7, 1987; 72 FR 72929, Dec. 26, 2007; amendment be made; supplementary 81 FR 97032, Dec. 30, 2016] information submitted by an exporter through the DEA Diversion Control Di- § 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

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be used to authorize release of a ship- unexported authorized quantity of con- ment of controlled substances. If the trolled substances on an export permit exporter’s request for an amendment to is void upon release of a shipment on an issued permit is granted by the Ad- the issued permit or upon expiration of ministration, the Administration will the unused permit in accordance with immediately cancel the original permit paragraph (b) of this section, whichever and re-issue the permit, as amended, is sooner. Exporters must submit a re- with a revised permit number. The quest for an amendment to increase DEA and exporter will distribute the the total base weight of a controlled amended permit in accordance with substance at least three business days § 1312.24. If a request for an amendment in advance of the date of release from is denied by the Administration, the the port of export. temporary stay will be lifted; once lifted, the originally issued permit may (6) An exporter may request that an immediately be used to authorize reexport permit be amended to remove a lease of a shipment in accordance with controlled substance from the permit. the terms of the permit. However, an exporter may not amend (1) An exporter may request that an an export permit to add or replace a export permit or application for a per- controlled substance to the item(s) to mit be amended to change the National be exported. Exporters who desire to Drug Control number, description of export a different controlled substance the packaging, or trade name of the than that contained on their issued ex- product, so long as the description is port permit or permit application must for the same basic class of controlled submit a request for the permit or per- substance as in the original permit. mit application to be canceled and re- (2) An exporter may request that an quest a new permit in accordance with export permit or application for a per- § 1312.22. mit be amended to change the proposed (7) An exporter may not amend the port of export, the anticipated date of exporter’s name (as it appears on their release by a customs officer, or the DEA certificate of registration), the method of transport. name of the foreign importer(s), or the (3) An exporter may request that an foreign permit information as provided export permit or application for a per- in the DEA Form 161, 161R, or 161R– mit be amended to change the jus- EEA. Exporters who need to make any tification provided as to why an export changes to any of these fields must shipment is needed to meet the legitimate scientific or medical needs of the submit a request for the permit or per- country of import. mit application to be canceled and re- (4) An exporter may request that an quest a new permit in accordance with export permit or application for a per- § 1312.22. mit be amended to change any reg- (b) An export permit will be void and istrant notes. of no effect after the date specified (5) Prior to departure of the shipment therein, which date must conform to from the exporter’s registered location, the expiration date specified in the an exporter may request that an export supporting import certificate or other permit or application for a permit be documentary evidence upon which the amended to increase the total base export permit is founded, but in no weight of a controlled substance. How- event will the date be more than 180 ever, the total base weight or the calendar days after the date the permit strength of the product (if listed) of a is issued. controlled substance may not exceed (c) An export permit may be canceled that permitted for import as indicated after being issued, at the request of the on the import permit from the foreign exporter submitted to the Administra- competent national authority. Export- tion through the DEA Diversion Con- ers are not required to amend an ex- trol Division secure network applica- port permit for the sole purpose of de- tion, provided that no shipment has creasing the total base weight of a controlled substance authorized to be ex- been made thereunder. Nothing in this ported. However, the balance of any

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part will affect the right, hereby re- (e.g., telephone number(s), email ad- served by the Administration, to can- dress(es), etc.), and registration num- cel an export permit at any time for ber, if any, of the exporter; and the proper cause. name/business name, address/business address, contact information (e.g., tele- [81 FR 97032, Dec. 30, 2016] phone number(s), email address(es), § 1312.26 Records required of exporter. etc.), and registration number of the export broker, if any. In addition to any other records re- (ii) A detailed description of each quired by this chapter, the exporter controlled substance to be exported in- must keep a record of any serial num- cluding the drug name, dosage form, bers that might appear on packages of National Drug Code (NDC) number, Ad- narcotic drugs in quantities of one ministration Controlled Substance ounce or more in such a manner as will Code Number as set forth in part 1308 identify the foreign consignee, along of this chapter, the number and size of with an official record of the export the packages or containers, the name permit, in accordance with part 1304 of and quantity of the controlled sub- this chapter. stance contained in any finished dosage [81 FR 97033, Dec. 30, 2016] units, and the quantity of any controlled substance (expressed in anhy- § 1312.27 Export/reexport declaration. drous acid, base, or alkaloid) given in (a) Any person registered or author- kilograms or parts thereof. ized to export and seeking to export (iii) The anticipated date of release any non-narcotic controlled substance by a customs officer at the port of ex- listed in Schedule III, IV, or V, which port, the port of export, the foreign is not subject to the requirement of an port and country of entry, the carriers export permit pursuant to § 1312.23(b) or and shippers involved, method of ship- (c), or any person registered or author- ment, the name of the vessel if applica- ized to export and seeking to export ble, and the name, address, and reg- any controlled substance in Schedule istration number, if any, of any for- V, must file a controlled substances ex- warding agent utilized. port declaration (DEA Form 236) with (iv) The name/business name, ad- the Administration through the DEA dress/business address, and contact in- Diversion Control Division secure net- formation (e.g., telephone number(s), work application not less than 15 cal- email address(es), etc.) of the consignee endar days prior to the anticipated in the country of destination, and any date of release by a customs officer at registration or license number if the the port of export, and distribute an of- consignee is required to have such ficial record of the declaration as here- numbers either by the country of des- inafter directed in § 1312.28. The dec- tination or under United States law. In laration must be signed and dated by addition, documentation must be pro- the exporter and must contain the ad- vided to show that: dress of the registered location from (A) The consignee is authorized under which the substances will be shipped the laws and regulations of the country for exportation. Upon receipt and re- of destination to receive the controlled view, the Administration will issue a substances; and completed declaration a transaction (B) The substance is being imported identification number. The export dec- for consumption within the importing laration is not deemed filed, and there- country to satisfy medical, scientific fore not valid, until the Administra- or other legitimate purposes. tion has issued a transaction identi- (v) The reexport of non-narcotic con- fication number. The exporter may trolled substances in Schedules III and only proceed with the export trans- IV, and controlled substances in Sched- action once the transaction identifica- ule V is not permitted under the au- tion number has been issued. thority of 21 U.S.C. 953(e), except as (b)(1) DEA Form 236 must include the provided below and in paragraph following information: (b)(1)(vi) of this section: (i) The name/business name, address/ (A) Bulk substances will not be reex- business address, contact information ported in the same form as exported

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from the United States, i.e., the mate- with DEA. The substance may be re- rial must undergo further manufac- turned to the United States only after turing process. This further manufac- affirmative authorization is issued in tured material may only be reexported writing by DEA. to a country of ultimate consumption. (vi) The reexport of non-narcotic con- (B) Finished dosage units, if reex- trolled substances in Schedules III and ported, will be in a commercial pack- IV, and controlled substances in Sched- age, properly sealed and labeled for le- ule V is permitted among members of gitimate medical use in the country of the European Economic Area only as destination. provided below: (C) Any reexportation be made (A) The controlled substance will not known to DEA at the time the initial be exported from the second country or DEA Form 236, Controlled Substances a subsequent country, except that the Import/Export Declaration is com- controlled substance may be exported pleted, by checking the box marked from a second country or a subsequent ‘‘other’’ on the certification. The fol- country that is a member of the Euro- lowing information will be furnished in pean Economic Area to another coun- the remarks section: try that is a member of the European (1) Indicate ‘‘for reexport’’. Economic Area, provided that the first (2) Indicate if reexport is bulk or fin- country is also a member of the Euro- ished dosage units. pean Economic Area; each country is a (3) Indicate product name, dosage party to the Convention on Psycho- strength, commercial package size, and tropic Substances, 1971, as amended; quantity. and each country has instituted and (4) Indicate name of consignee, com- maintains, in conformity with such plete address, and expected shipment Convention, a system of controls of im- date, as well as, the name and address ports of controlled substances which of the ultimate consignee in the coun- the Attorney General deems adequate. try to where the substances will be re- (B) Each shipment of finished dosage exported. units, if reexported, must be in a com- (5) A statement that the consignee in mercial package, properly sealed and the country of ultimate destination is labeled for legitimate medical use in authorized under the laws and regula- the country of destination. tions of the country of ultimate des- (C) Any reexportation must be made tination to receive the controlled sub- known to DEA at the time the initial stances. DEA Form 236, Controlled Substances (D) Shipments that have been ex- Import/Export Declaration is com- ported from the United States and are pleted, by checking the box marked refused by the consignee in either the ‘‘other’’ on the certification. In addi- first or second country, or subsequent tion to the requirements of paragraph member of the European Economic (b) of this section, the following infor- Area, or are otherwise unacceptable or mation will be furnished in the re- undeliverable, may be returned to the marks section: registered exporter in the United (1) Indicate ‘‘for reexport among States upon authorization of the Ad- members of the European Economic ministration. In this circumstance, the Area’’. exporter in the United States must file (2) Indicate if reexport is bulk or fin- a written request for reexport, along ished dosage units. with a completed DEA Form 236, with (3) Indicate product name, dosage the Administration through the DEA strength, commercial package size, and Diversion Control Division secure net- quantity. work application. A brief summary of (4) Indicate the name/business name, the facts that warrant the return of the address/business address, contact infor- substance to the United States along mation (e.g., telephone number(s), with an authorization from the coun- email address(es) and business of the try of export must be included with the consignee in the first country). request. DEA will evaluate the request (5) A statement that the consignee in after considering all the facts as well the second country, and any subse- as the exporter’s registration status quent consignee within the European

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Economic Area, is authorized under the file a report with the Administration laws and regulations of the second and/ through the DEA Diversion Control Di- or subsequent country to receive the vision secure network application controlled substances. specifying the particulars of the trans- (2) With respect to reexports among action. This report must include the members of the European Economic following information: The date on Area, the requirements of paragraph which the controlled substance left the (b)(1) of this section shall apply only registered location; the date on which with respect to the export from the the controlled substance was released United States to the first country and by a customs officer at the port of ex- not to any subsequent export from that port; the actual quantity of controlled country to another country of the Eu- substance released by a customs officer ropean Economic Area. at the port of export; and the actual (c) Notwithstanding the time limita- port of export. Upon receipt and re- tions included in paragraph (a) of this view, the Administration will assign a section, a registrant may obtain a spe- completed report a transaction identi- cial waiver of these time limitations in fication number. The report will not be emergency or unusual instances; pro- deemed filed until the Administration vided that a specific confirmation is re- has issued a transaction identification ceived from the Administrator or his number. delegate advising the registrant to pro- (ii) Return information for export from ceed pursuant to the special waiver. a first country that is or is not a member (d) Return information—(1) Return in- of the European Economic Area to a formation for exports. Within 30 calendar country outside of the European Eco- days after the controlled substance is released by a customs officer at the nomic Area; return information for export port of export, or within 10 calendar from a first country that is not a member days after receipt of a written request of the European Economic Area to a mem- by the Administration to the exporter, ber of the European Economic Area. whichever is sooner, the exporter must Within 30 calendar days after the con- file a report with the Administration trolled substance is exported from the through the DEA Diversion Control Di- first country to the second country the vision secure network application exporter must file a report with the specifying the particulars of the trans- Administration through the DEA Di- action. This report must include the version Control Division secure net- following information: The date on work application specifying the par- which the controlled substance left the ticulars of the export from the first registered location; the date on which country. If the permit issued by the the controlled substance was released Administration authorized the reex- by a customs officer; the actual quan- port of a controlled substance from the tity of the controlled substance that first country to more than one second left the registered location; and the ac- country, a report for each individual tual quantity of the controlled sub- reexport is required. These reports stance released by a customs officer at must include the following informa- the port of export; the actual port of tion: Name of second country; actual export. Upon receipt and review, the quantity of controlled substance Administration will assign a completed shipped; the date shipped from the first report a transaction identification country; and the actual port from number. The report will not be deemed which the controlled substances were filed until the Administration has shipped from the first country. Upon issued a transaction identification receipt and review, the Administration number. will assign each completed report a (2) Return information for reexports transaction identification number. The outside of the European Economic Area— report will not be deemed filed until (i) Return information for export from the the Administration has issued a trans- United States, for reexport. Within 30 cal- action identification number. endar days after the controlled sub- (3) Reexports among members of the Eu- stance is released by a customs officer ropean Economic Area—(i) Return infor- at the port of export the exporter must mation for exports from the United States,

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for reexport among members of the Euro- pleted amendment a transaction iden- pean Economic Area. Exporters must tification number. The amendment will comply with the return reporting re- not be deemed filed until the Adminis- quirements of paragraph (d)(2)(i) of this tration issues a transaction identifica- section. tion number. The DEA and the ex- (ii) Reexports among members of the porter will distribute the amended dec- European Economic Area. Within 30 cal- laration in accordance with § 1312.28. A endar days after the controlled sub- filed amendment will not change the stance is exported from the first coun- date that the declaration becomes void try to the second country, and within and of no effect in accordance with 30 calendar days of each subsequent re- paragraph (f) of this section. export within the European Economic (f) An export declaration may be can- Area, if any, the exporter must file a report with the Administration celed after being filed with the Admin- through the DEA Diversion Control Di- istration, at the request of the ex- vision secure network application porter, provided no shipment has been specifying the particulars of the ex- made thereunder. Export declarations port. These reports must include the shall become void and of no effect 180 name of country to which the con- calendar days after the date the dec- trolled substance was reexported to an- laration is deemed filed with the Ad- other member of the European Eco- ministration. nomic Area; the actual quantity of (g) Denied release at the port of export. controlled substance shipped; the date In the event that a shipment of con- shipped from the first country, the trolled substances has been denied re- name/business name, address/business lease by a customs officer at the port address, contact information (e.g., tele- of export for any reason, the exporter phone number(s), email address(es), who attempted to have the shipment etc.) and business of the consignee; and released must, within 5 business days the name/business name, address/busi- of the denial, report to the Administra- ness address, contact information (e.g., tion that the shipment was denied re- telephone number(s), email address(es), lease and the reason for denial. Such etc.) and business of the exporter. Upon report must be transmitted to the Ad- receipt and review, the Administration ministration through the DEA Diver- will assign each completed report a sion Control Division secure network transaction identification number. The application. This report must include report will not be deemed filed until the Administration has issued a trans- the following information: The quan- action identification number. tity of the controlled substance denied (e) An exporter may amend an export release; the date on which release was declaration in the same circumstances denied; and the basis for the denied rein which an exporter may request lease. Upon the exporter’s report of a amendment to an export permit, as set denied release, DEA will assign the re- forth in § 1312.25(a)(1) through (7). port a transaction identification num- Amendments to declarations must be ber and the export declaration will be submitted through the DEA Diversion void and of no effect. No shipment of Control Division secure network appli- controlled substances denied release cation. Except as provided in for any reason will be allowed to be re- § 1312.25(a)(5) exporters must submit all leased unless the exporter files a new amendments at least one full business declaration and the Administration day in advance of the date of release by issues a new transaction identification a customs officer. Exporters must spe- number. cifically note that an amendment is being made; supplementary informa- [36 FR 7815, Apr. 24, 1971, as amended at 37 tion submitted by an exporter through FR 15923, Aug. 8, 1972. Redesignated at 38 FR the DEA Diversion Control Division se- 26609, Sept. 24, 1973, and amended at 45 FR cure network application will not auto- 74715, Nov. 12, 1980; 51 FR 5319, Feb. 13, 1986; 52 FR 17290, May 7, 1987; 62 FR 13969, Mar. 24, matically be considered an amend- 1997; 75 FR 10683, Mar. 9, 2010; 81 FR 97033, ment. Upon receipt and review, the Ad- Dec. 30, 2016] ministration will assign each com-

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§ 1312.28 Distribution of export dec- 1003(e)(3) of the Act (21 U.S.C. 811(d)(1), laration. 952(b)(2), and 953(e)(3)): (a) The exporter must ensure that an (a) Dronabinol (synthetic) in sesame official record of the export declaration oil and encapsulated in a soft gelatin (available from the DEA Diversion capsule in a U.S. Food and Drug Ad- Control Division secure network appli- ministration approved product. cation after the Administration issues (b) A drug product in finished dosage a transaction identification number) formulation that has been approved by accompanies the shipment of con- the U.S. Food and Drug Administration trolled substances to its destination. that contains cannabidiol (2-[1R-3- (b) The exporter, or their agent, must methyl-6R-(1-methylethenyl)-2-cyclo- submit an official record of the export hexen-1-yl]-5-pentyl-1,3-benzenediol) declaration and/or required data con- derived from cannabis and no more cerning the export transaction to a than 0.1 percent (w/w) residual customs officer at the port of export in tetrahydrocannabinols. compliance with all export control re- [52 FR 17291, May 7, 1987, as amended at 64 quirements of agencies with export FR 35930, July 2, 1999; 83 FR 48953, Sept. 28, control authorities under the Act or 2018] statutory authority other than the Controlled Substances Import and Ex- TRANSSHIPMENT AND IN-TRANSIT port Act. SHIPMENT OF CONTROLLED SUBSTANCES (c) The exporter must maintain an official record of the export declaration § 1312.31 Schedule I: Application for and return information (both available prior written approval. from the Diversion Control Division se- (a) A controlled substance listed in cure network application after the Ad- schedule I may be imported into the ministration issues a transaction iden- United States for transshipment, or tification number) required pursuant may be transferred or transshipped to § 1312.27(d) as his or her record of au- within the United States for immediate thority for the exportation, in accord- exportation, provided that: ance with part 1304 of this chapter. (1) The controlled substance is necessary for scientific, medical, or other [81 FR 97035, Dec. 30, 2016] legitimate purposes in the country of § 1312.29 Domestic release prohibited. destination, and (2) A transshipment permit has been An exporter or a forwarding agent issued by the Administrator. acting for an exporter must either de- (b) An application for a trans- liver the controlled substances to the shipment permit must be submitted to port or border, or deliver the controlled the Regulatory Section, Diversion Con- substances to a bonded carrier ap- trol Division, Drug Enforcement Ad- proved by the consignor for delivery to ministration, at least 30 calendar days, the port or border, and may not, under or in the case of an emergency as soon any other circumstances, release a as is practicable, prior to the expected shipment of controlled substances to date of arrival at the first port in the anyone, including the foreign con- United States. See the Table of DEA signee or his agent, within the United Mailing Addresses in § 1321.01 of this States. chapter for the current mailing ad- § 1312.30 Schedule III, IV, and V non- dress. A separate permit is required for narcotic controlled substances re- each shipment of controlled substance quiring an import and export per- to be imported, transferred, or transmit. shipped. Each application must contain The following Schedule III, IV, and V the following: non-narcotic controlled substances (1) The date of execution; have been specifically designated by (2) The identification and description the Administrator of the Drug Enforce- of the controlled substance; ment Administration as requiring im- (3) The net quantity thereof; port and export permits pursuant to (4) The number and size of the con- sections 201(d)(1), 1002(b)(2), and trolled substance containers;

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(5) The name, address, and business poses of this requirement, certified of the foreign exporter; translation means that the translator (6) The foreign port of exportation; has signed the translation legally at- (7) The approximate date of expor- testing the accuracy of the translation. tation; (e) Verification by an American con- (8) The identification of the export- sular officer of the signatures on a for- ing carrier; eign import license or permit shall be (9) The name, address and business of required, if such license or permit does the importer, transferor, or not bear the seal of the authority sign- transshipper; ing them. (10) The registration number, if any, (f) The Administrator may require an of the importer, transferor or applicant to submit such documents or transshipper; written statements of fact relevant to (11) The U.S. port of entry; the application as he deems necessary (12) The approximate date of entry; to determine whether the application (13) The name, address and business should be granted. The failure of the of the consignee at the foreign port of applicant to provide such documents or entry; statements within a reasonable time (14) The shipping route from the U.S. after being requested to do so shall be port of exportation to the foreign port deemed to be a waiver by the applicant of entry; of an opportunity to present such docu- (15) The approximate date of receipt ments or facts for consideration by the by the consignee at the foreign port of Administrator in granting or denying entry; and the application. (16) The signature of the importer, (g) The Administrator shall, within transferor or transshipper, or his agent 21 days from the date of receipt of the accompanied by the agent’s title. application, either grant or deny the (c) An application shall be accom- application. The applicant shall be ac- panied by an export license, permit, or corded an opportunity to amend the a certified copy of the export license, application, with the Administrator ei- permit, or other authorization, issued ther granting or denying the amended by a competent authority of the coun- application within 7 days of its receipt. try of origin (or other documentary If the Administrator does not grant or evidence deemed adequate by the Ad- deny the application within 21 days of ministrator). its receipt, or in the case of an amend- (d) An application shall be accom- ed application, within 7 days of its re- panied by an import license or permit ceipt, the application shall be deemed or a certified copy of such license or approved and the applicant may pro- permit issued by a competent author- ceed. ity of the country of destination (or other documentary evidence deemed [36 FR 7815, Apr. 24, 1971, as amended at 37 FR 15923, Aug. 8, 1972. Redesignated at 38 FR adequate by the Administrator), indi- 26609, Sept. 24, 1973, and further amended at cating that the controlled substance: 45 FR 74715, Nov. 12, 1980; 51 FR 5319, Feb. 13, (1) Is to be applied exclusively to sci- 1986; 53 FR 48244, Nov. 30, 1988; 62 FR 13969, entific, medical or other legitimate Mar. 24, 1997; 75 FR 10683, Mar. 9, 2010; 81 FR uses within the country of destination; 97035, Dec. 30, 2016] (2) Will not be exported from such country; § 1312.32 Schedules II, III, IV: Advance (3) Is needed therein because there is notice. an actual shortage thereof and a de- (a) A controlled substance listed in mand therefor for scientific, medical or Schedules II, III, or IV may be im- other legitimate uses within such ported into the United States for trans- country; and shipment, or may be transferred or (4) If the import license or permit, or transshipped within the United States the certified copy of such, is not writ- for immediate exportation, provided ten in English or bilingual with an- that written notice is submitted to the other language and English, the appli- Regulatory Section, Diversion Control cation must include a certified trans- Division, Drug Enforcement Adminis- lation of the permit or license. For pur- tration, at least 15 calendar days prior

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to the expected date of date of arrival proposed findings of fact and conclu- at the first port in the United States. sions of law. See the Table of DEA mailing Address- es in § 1321.01 of this chapter for the [36 FR 23625, Dec. 11, 1971, as amended at 37 FR 15923, Aug. 8, 1972. Redesignated at 38 FR current mailing addresses. 26609, Sept. 24, 1973] (b) A separate advance notice is required for each shipment of controlled § 1312.43 Waiver or modification of substance to be imported, transferred, rules. or transshipped. Each advance notice The Administrator of the presiding must contain those items required by officer (with respect to matters pend- § 1312.31(b) and (c). If the export license, ing before him) may modify or waive permit, or other authorization, issued any rule in this part by notice in ad- by a competent national authority of vance of the hearing, if he determines the country of origin, is not written in English or bilingual with another lan- that no party in the hearing will be un- guage and English, the notice must be duly prejudiced and the ends of justice accompanied by a certified translation will thereby be served. Such notice of of the export license, permit, or other modification or waiver shall be made a authorization. For purposes of this re- part of the record of the hearing. quirement, certified translation means [36 FR 23625, Dec. 11, 1971. Redesignated at 38 that the translator has signed the FR 26609, Sept. 24, 1973] translation legally attesting the accuracy of the translation. § 1312.44 Request for hearing or appearance; waiver. [81 FR 97036, Dec. 30, 2016] (a) Any applicant entitled to a hear- HEARINGS ing pursuant to § 1312.42 and who desires a hearing on the denial of his ap- § 1312.41 Hearings generally. plication for an import, export, or (a) In any case where the Adminis- transshipment permit shall, within 30 trator shall hold a hearing regarding days after the date of receipt of the de- the denial of an application for an im- nial of his application, file with the Ad- port, export or transshipment permit, ministrator a written request for a the procedures for such hearing shall hearing in the form prescribed in be governed generally by the adjudica- § 1316.47 of this chapter. tion procedures set forth in the Admin- (b) Any applicant entitled to a hear- istrative Procedure Act (5 U.S.C. 551– ing pursuant to § 1312.42 may, within 559) and specifically by sections 1002 the period permitted for filing a re- and 1003 of the Act (21 U.S.C. 952 and quest for a hearing, file with the Ad- 953), by §§ 1312.42–1312.47, and by the ministrator a waiver of an opportunity procedures for administrative hearings for a hearing, together with a written under the Act set forth in §§ 1316.41– statement regarding his position on 1316.67 of this chapter. the matters of fact and law involved in (b) [Reserved] such hearing. Such statement, if ad- [36 FR 23625, Dec. 11, 1971, as amended at 37 missible, shall be made a part of the FR 15923, Aug. 8, 1972. Redesignated at 38 FR record and shall be considered in light 26609, Sept. 24, 1973] of the lack of opportunity for cross-examination in determining the weight § 1312.42 Purpose of hearing. to be attached to matters of fact as- (a) If requested by a person applying serted therein. for an import, export, or transshipment (c) If any applicant entitled to a permit, the Administrator shall hold a hearing pursuant to § 1312.42 fails to ap- hearing for the purpose of receiving pear at the hearing, he shall be deemed factual evidence regarding the issues to have waived his opportunity for the involved in the issuance or denial of hearing unless he shows good cause for such permit to such person. such failure. (b) Extensive argument should not be (d) If the applicant waives or is offered into evidence but rather pre- deemed to have waived this oppor- sented in opening or closing state- tunity for the hearing, the Adminis- ments of counsel or in memoranda or trator may cancel the hearing, if

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scheduled, and issue his final order pur- PART 1313—IMPORTATION AND suant to § 1312.47 without a hearing. EXPORTATION OF LIST I AND LIST [37 FR 15923, Aug. 8, 1972. Redesignated at 38 II CHEMICALS FR 26609, Sept. 24, 1973] Sec. § 1312.45 Burden of proof. 1313.01 Scope. At any hearing on the denial of an 1313.02 Definitions. application for an import, export, or 1313.03 Forms applicable to this part. transshipment permit, the Adminis- 1313.05 Requirements for an established trator shall have the burden of proving business relationship. that the requirements for such permit 1313.08 Requirements for establishing a pursuant to sections 1002, 1003, and 1004 record as an importer. of the Act (21 U.S.C. 952, 953, and 954) IMPORTATION OF LISTED CHEMICALS are not satisfied. 1313.12 Notification prior to import. [37 FR 15924, Aug. 8, 1972. Redesignated at 38 1313.13 Requirements of import declaration. FR 26609, Sept. 24, 1973] 1313.14 Disposition of import declaration. 1313.15 Qualification of regular importers. § 1312.46 Time and place of hearing. 1313.16 Updated notice for change in cir- (a) If any applicant for an import, ex- cumstances. port, or transshipment permit requests 1313.17 Return declaration for imports. a hearing on the issuance or denial of his application, the Administrator EXPORTATION OF LISTED CHEMICALS shall hold such hearing. Notice of the 1313.21 Notification prior to export. hearing shall be given to the applicant 1313.22 Export declaration. of the time and place at least 30 days 1313.23 Disposition of export declaration. prior to the hearing, unless the appli- 1313.24 Waiver of 15-day advance notice for cant waives such notice and requests chemical exporters. the hearing be held at an earlier time, 1313.25 Foreign import restrictions. in which case the Administrator shall 1313.26 Updated notice for change in cir- fix a date for such hearing as early as cumstances. reasonably possible. 1313.27 Return declaration for exports. (b) The hearing will commence at the TRANSSHIPMENTS, IN-TRANSIT SHIPMENTS AND place and time designated in the notice INTERNATIONAL TRANSACTIONS INVOLVING given pursuant to paragraph (a) of this LISTED CHEMICALS section but thereafter it may be moved 1313.31 Advance notice of importation for to a different place and may be contin- transshipment or transfer. ued from day to day or recessed to a 1313.32 Notification of international trans- later day without notice other than an- actions. nouncement thereof by the presiding 1313.33 Contents of an international trans- officer at the hearing. action declaration. 1313.34 Disposition of the international [37 FR 15924, Aug. 8, 1972. Redesignated at 38 transaction declaration. FR 26609, Sept. 24, 1973] 1313.35 Return declaration or amendment to § 1312.47 Final order. Form 486 for international transactions. 1313.41 Suspension of shipments. As soon as practicable after the pre- 1313.42 Prohibition of shipments from cer- siding officer has certified the record tain foreign sources. to the Administrator, the Adminis- trator shall issue his order on the HEARINGS issuance or denial of the application 1313.51 Hearings generally. for and import, export, or trans- 1313.52 Purpose of hearing. shipment permit. The order shall in- 1313.53 Waiver of modification of rules. clude the findings of fact and conclu- 1313.54 Request for hearing. sions of law upon which the order is 1313.55 Burden of proof. based. The Administrator shall serve 1313.56 Time and place of hearing. one copy of his order upon the appli- 1313.57 Final order. cant. AUTHORITY: 21 U.S.C. 802, 830, 871(b), 971.

[37 FR 15924, Aug. 8, 1972. Redesignated at 38 SOURCE: 54 FR 31665, Aug. 1, 1989, unless FR 26609, Sept. 24, 1973] otherwise noted.

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§ 1313.01 Scope. (e) The frequency and number of transactions occurring during the pre- Procedures governing the importa- ceding 12-month period; tion, exportation, transshipment and (f) The amounts and the listed chem- in-transit shipment of listed chemicals ical or chemicals involved in regulated pursuant to section 1018 of the Act (21 transactions between the chemical im- U.S.C. 971) are governed generally by porter or exporter and regular cus- that section and specifically by the tomer; sections of this part. (g) The method of delivery (direct [54 FR 31665, Aug. 1, 1989, as amended at 60 shipment or through a broker or for- FR 32465, June 22, 1995] warding agent); and (h) Other information that the chem- § 1313.02 Definitions. ical importer or exporter considers rel- Any term used in this part shall have evant for determining whether a cus- the definition set forth in section 102 of tomer is a regular customer. the Act (21 U.S.C. 802) or part 1300 of [72 FR 17407, Apr. 9, 2007] this chapter. [62 FR 13969, Mar. 24, 1997] § 1313.08 Requirements for establishing a record as an importer. § 1313.03 Forms applicable to this part. To establish a record as an importer, the regulated person must provide the Access/ Form submission Administrator with the following information in accordance with the waiver DEA Form 486, Import/Export Declaration electronic. of the 15-day advance notice require- for List I and List II Chemicals. DEA Form 486A Import Declaration for electronic. ments of § 1313.15: ephedrine, pseudoephedrine, and phen- (a) The name, DEA registration num- ylpropanolamine (including drug prod- ber (where applicable), street address, ucts containing these chemicals). telephone number, and, where available, the facsimile number of the regu- [81 FR 97036, Dec. 30, 2016] lated person and of each foreign supplier; and § 1313.05 Requirements for an estab- (b) The frequency and number of lished business relationship. transactions occurring during the pre- To document that an importer or ex- ceding 12 month period. porter has an established business relationship with a customer, the importer [72 FR 17407, Apr. 9, 2007] or exporter must provide the Adminis- IMPORTATION OF LISTED CHEMICALS trator with the following information in accordance with the waiver of 15-day § 1313.12 Notification prior to import. advance notice requirements of § 1313.15 or § 1313.24: (a) Each regulated person who seeks to import a listed chemical that meets (a) The name and street address of or exceeds the threshold quantities the chemical importer or exporter and identified in § 1310.04(f) of this chapter of each regular customer; or is a listed chemical for which no (b) The telephone number, contact threshold has been established as iden- person, and where available, the fac- tified in § 1310.04(g) of this chapter, simile number for the chemical im- must notify the Administration of the porter or exporter and for each regular intended import by filing an import customer; declaration (on DEA Form 486/486A) (c) The nature of the regular cus- not later than 15 calendar days before tomer’s business (i.e., importer, ex- the date of release by a customs officer porter, distributor, manufacturer, at the port of entry. Regulated persons etc.), and if known, the use to which who seek to import a listed chemical the listed chemical or chemicals will below the threshold quantities identi- be applied; fied in § 1310.04(f) are not required to (d) The duration of the business rela- file an import declaration in advance tionship; of the release by a customs officer.

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(b) A complete and accurate declara- dress of the final destination for the tion (DEA Form 486/486A) must be filed shipment, which must be a registered with the Administration through the location of the importer (for List I DEA Diversion Control Division secure chemicals). Upon receipt and review, network application not later than 15 the Administration will assign a trans- calendar days prior to the date of re- action identification number to each lease by a customs officer at the port completed declaration. The importer of entry. The declaration must be may proceed with the import trans- signed and dated by the importer and action only once the transaction iden- must contain the address of the final tification number has been issued. destination for the shipment, which for (e) For importations where advance List I chemicals must be a registered notification is waived pursuant to location of the importer. Upon receipt paragraph (c)(2) of this section no DEA and review, the Administration will as- Form 486 is required; however, the reg- sign a transaction identification num- ulated person must submit quarterly ber to each completed declaration. The reports to the Regulatory Section, Di- 15 calendar days shall begin on the date version Control Division, Drug En- that the regulated person submits a forcement Administration, not later completed declaration, without regard than the 15th day of the month fol- to the date that the Administration as- lowing the end of each quarter. See the signs a transaction identification num- Table of DEA Mailing Addresses in ber. Listed chemicals meeting or ex- § 1321.01 of this chapter for the current ceeding the threshold quantities identi- mailing address. The report shall con- fied in § 1310.04(f) of this chapter or for tain the following information regard- which no threshold has been estab- ing each individual importation: lished may not be imported until a (1) The name of the listed chemical; transaction identification number has (2) The quantity and date imported; been issued. (3) The name and full business ad- (c) The 15-calendar-day advance noti- dress of the supplier; fication requirement for listed chem- (4) The foreign port of embarkation; ical imports may be waived, in whole and or in part, for the following: (5) The port of entry. (1) Any importation that meets both of the following requirements: (f) The 15 day advance notification (i) The regulated person has satisfied requirement set forth in paragraph (a) the requirements for reporting to the has been waived for imports of the fol- Administration as a regular importer lowing listed chemicals: of the listed chemicals. (1) Acetone. (ii) The importer intends to transfer (2) 2-Butanone (or Methyl Ethyl Ke- the listed chemicals to a person who is tone or MEK). a regular customer for the chemical, as (3) Toluene. defined in § 1300.02 of this chapter. [54 FR 31665, Aug. 1, 1989, as amended at 59 (2) A specific listed chemical, as set FR 51367, Oct. 11, 1994; 60 FR 32464, June 22, forth in paragraph (f) of this section, 1995; 66 FR 46520, Sept. 6, 2001; 67 FR 49569, for which the Administrator deter- July 31, 2002; 72 FR 17407, Apr. 9, 2007; 75 FR mines that advance notification is not 10683, Mar. 9, 2010; 77 FR 4237, Jan. 27, 2012; 81 necessary for effective chemical diver- FR 97036, Dec. 30, 2016] sion control. (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

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procedures set forth in § 1313.31 and all § 1313.14 Disposition of import dec- other applicable laws. laration. (b) The DEA Form 486/486A must in- The importer, or their agent, must clude the following information: submit an official record of the import (1) The name/business name, address/ declaration and/or required data con- business address, and contact informa- cerning the import transaction to a tion (e.g., telephone number(s), email customs officer at the port of entry in address(es), etc.) of the chemical im- compliance with all import control re- porter; the name/business name, ad- quirements of agencies with import dress/business address, and contact in- control authorities under the Act or formation (e.g., telephone number(s), statutory authority other than the email address(es), etc.) of the broker or Controlled Substances Import and Ex- forwarding agent (if any); and port Act. For List I chemicals, the (2) The name and description of each final destination of the import trans- listed chemical as it appears on the action must only be the registered lo- label or container, the name of each cation of the importer (i.e., drop ship- chemical as it is designated in § 1310.02 ments are prohibited). A regulated per- of this chapter, the size or weight of son must maintain an official record of container, the number of containers, the declaration (available from the the net weight of each listed chemical given in kilograms or parts thereof, DEA Diversion Control Division secure and the gross weight of the shipment network application after the Adminis- given in kilograms or parts thereof; tration issues a transaction identifica- and tion number) in accordance with part (3) The date of release by a customs 1310 of this chapter as the record of the officer at the port of entry, the foreign import. Official records of import dec- port and country of export, and the larations involving listed chemicals port of entry; and must be retained for two years. (4) The name/business name, address/ [81 FR 97037, Dec. 30, 2016] business address, and contact information (e.g., telephone number(s), email § 1313.15 Qualification of regular im- address(es), etc.) of the consignor in porters. the foreign country of exportation; and (a) Each regulated person seeking (5) The name/business name, address/ designation as a ‘‘regular importer’’ business address, and contact informa- shall provide, by certified mail return tion (e.g., telephone number(s), email receipt requested, to the Administra- address(es), etc.) of the person or per- tion such information as is required sons to whom the importer intends to under § 1313.08 documenting their sta- transfer the listed chemical and the tus as a regular importer. quantity to be transferred to each (b) Each regulated person making ap- transferee. plication under paragraph (a) of this (c) Any regulated person importing section shall be considered a ‘‘regular ephedrine, pseudoephedrine, or phenyl- importer’’ 30 calendar days after re- propanolamine must submit, on the ceipt of the application by the Admin- import declaration (DEA Form 486A), all information known to the importer istration, as indicated on the return re- on the chain of distribution of the ceipt, unless the regulated person is chemical from the manufacturer to the otherwise notified in writing by the importer. Ephedrine, pseudoephedrine, Administration. or phenylpropanolamine include each (c) The Administrator, may, at any of the salts, optical isomers, and salts time, disqualify a regulated person’s of optical isomers of the chemical. status as a regular importer on the (d) Import declarations shall become grounds that the chemical being im- void and of no effect 180 calendar days ported may be diverted to the clandes- after the date the declaration is tine manufacture of a controlled sub- deemed filed with the Administration. stance. [81 FR 97036, Dec. 30, 2016]

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(d) Unless the Administration noti- importer. Upon receipt and review, the fies the chemical importer to the con- Administration will assign each com- trary, the qualification of a regular im- pleted amendment a transaction iden- porter of any one of these three chemi- tification number. Such shipment of cals, acetone, 2-Butanone (MEK), or listed chemicals may not be imported toluene, qualifies that importer as a into the United States until the trans- regular importer of all three of these action identification number has been chemicals. issued. (e) All chemical importers shall be (c) In the case of a transfer of a listed required to file a DEA Form 486 as re- chemical that is subject to a 15-day required by Section 1313.12. striction, the transferee involved shall, [60 FR 32464, June 22, 1995, as amended at 62 upon the expiration of the 15-day pe- FR 13969, Mar. 24, 1997; 72 FR 17407, Apr. 9, riod, be considered to qualify as a reg- 2007; 81 FR 97037, Dec. 30, 2016] ular customer, unless the Administra- tion otherwise notifies the importer in- § 1313.16 Updated notice for change in volved in writing. circumstances. (d) With respect to a transfer of a (a) In the case of a notice under listed chemical with which a notice or § 1313.12(a) submitted by a regulated update referred to in § 1313.12(a) or (d) person, if the transferee identified in is concerned: the notice is not a regular customer, (1) The Administration— the importer may not transfer the list- (i) May, in accordance with the same ed chemical until after the expiration procedures as apply under §§ 1313.51 of the 15-day period beginning on the through 1313.57, order the suspension of date on which the notice is submitted the transfer of the listed chemical by to the Administration. the importer involved, except for a (b) After a notice under § 1313.12(a) or transfer to a regular customer, on the (d) is submitted to the Administration, ground that the chemical may be di- if circumstances change and the im- verted to the clandestine manufacture porter will not be transferring the list- of a controlled substance (without re- ed chemical to the transferee identified gard to the form of the chemical that in the notice, or will be transferring a may be diverted, including the diver- greater quantity of the chemical than sion of a finished drug product to be specified in the notice, the importer manufactured from bulk chemicals to must update the notice to identify the be transferred), subject to the Adminis- most recent prospective transferee or tration ordering the suspension before the most recent quantity or both (as the expiration of the 15-day period with the case may be) and may not transfer respect to the importation (in any case the listed chemical until after the expi- in which such a period applies); and ration of the 15 calendar day period be- (ii) May, for purposes of this para- ginning on the date on which the up- graph (d), disqualify a regular cus- date is filed with the Administration, tomer on that ground. or, if the import is being made by a (2) From and after the time when the regular importer or intended for trans- Administration provides written notice fer to a regular customer, three busi- of the order under paragraph (d)(1)(i) of ness days. The preceding sentence ap- this section (including a statement of plies with respect to changing cir- the legal and factual basis for the cumstances regarding a transferee or order) to the importer, the importer quantity identified in an update to the may not carry out the transfer. same extent and in the same manner as (e) For purposes of this section: the sentence applies with respect to (1) The term transfer, with respect to changing circumstances regarding a a listed chemical, includes the sale of transferee or quantity identified in the the chemical. original notice under § 1313.12(a) or (d). Amended declarations must be sub- (2) The term transferee means a permitted to the Administration through son to whom an importer transfers a the DEA Diversion Control Division se- listed chemical. cure network application. The amend- [72 FR 17407, Apr. 9, 2007, as amended at 81 ment must be signed and dated by the FR 97037, Dec. 30, 2016]

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§ 1313.17 Return declaration for im- chemicals has been denied release by a ports. customs officer at the port of entry for (a) Return information. Within 30 cal- any reason, the importer who at- endar days after actual receipt of a tempted to have the shipment released, listed chemical at the importer’s reg- within 5 business days of the denial, re- istered location or place of business if port to the Administration that the not required to be registered, the im- shipment was denied release and the porter must file a report with the Ad- reason for denial. Such report must be ministration through the DEA Diver- transmitted to the Administration sion Control Division secure network through the DEA Diversion Control Di- application specifying the particulars vision secure network application. This of the transaction. This report must in- report must include the following include the following information: The formation: The quantity of the listed date on which the listed chemical was chemical denied release; the date on released by a customs officer at the which release was denied; and the basis port of entry; the date on which the for the denied release. Upon the im- listed chemical arrived at the import- porter’s report of a denied release, the er’s registered location or place of DEA will assign the report a trans- business; the actual quantity of the action identification number and the listed chemical released; the actual import declaration will be void and of quantity of the listed chemical that ar- no effect. No shipment of listed chemi- rived at the importer’s location; the cals denied release for any reason will date of any subsequent transfer; a description of the subsequent transfer, be allowed entry into the United States including the actual quantity trans- without a subsequent refiling of an im- ferred, chemical, container, and name port declaration. Following such re- of transferees; the actual port of entry; filing the importer may request release and any other information as the Ad- of the listed chemicals immediately ministration may specify. A single re- after receipt of a transaction identi- port may include the particulars of fication number without regard to the both the importation and distribution. 15 day advance filing requirement in If the importer has not distributed all § 1313.12(b). chemicals imported by the end of the [81 FR 97037, Dec. 30, 2016] initial 30 calendar day period, the importer must file supplemental reports EXPORTATION OF LISTED CHEMICALS not later than 30 calendar days from the date of any further distribution, § 1313.21 Notification prior to export. until the distribution or other disposi- (a) Each regulated person who seeks tion of all chemicals imported under to export a listed chemical that meets the import declaration or any amend- or exceeds the threshold quantities ment or other update is accounted for. identified in § 1310.04(f) of this chapter, Upon receipt and review, the Adminis- or is a listed chemical for which no tration will assign each completed report a transaction identification num- threshold has been established as iden- ber. In determining whether the im- tified in § 1310.04(g) of this chapter, porter has complied with the require- must notify the Administration of the ment to file within 30 calendar days, intended export by filing an export dec- the report shall be deemed filed on the laration (DEA Form 486) not later than first date on which a complete report is 15 calendar days before the date of refiled. lease by a customs officer at the port (b) If an importation for which a DEA of export. Regulated persons who seek Form 486/486A has been filed fails to to export a listed chemical below the take place, the importer must report to threshold quantities identified in the Administration that the importa- § 1310.04(f) are not required to file an tion did not occur through the DEA Di- export declaration in advance of the version Control Division secure net- export. work application. (b) A complete and accurate declara- (c) Denied release at the port of entry. tion (DEA Form 486) must be filed with In the event that a shipment of listed the Administration through the DEA

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Diversion Control Division secure net- ulated person must submit quarterly work application not later than 15 cal- reports with the Regulatory Section, endar days prior to the date of release Diversion Control Division, Drug En- by a customs officer at the port of ex- forcement Administration, not later port. The declaration must be signed than the 15th day of the month fol- and dated by the exporter and must lowing the end of each quarter. See the contain the address from which the Table of DEA Mailing Addresses in listed chemicals will be shipped for ex- § 1321.01 of this chapter for the current portation. Upon receipt and review, the mailing address. Such report shall con- Administration will assign a trans- tain the following information regard- action identification number to each ing each individual exportation: completed declaration. The 15 calendar (1) The name of the listed chemical; days shall begin on the date that the (2) The quantity and date exported; regulated person files a completed dec- (3) The name and full business ad- laration without regard to the date dress of the foreign customer; that the Administration assigns a (4) The port of embarkation; and transaction identification number. Ex- (5) The foreign port of entry. porters may not request release of a (f) The 15 day advance notification listed chemical until a transaction requirement set forth in paragraph (a) identification number has been issued. of this section has been waived for ex- (c) The 15 calendar day advance noti- ports of the following listed chemicals fication requirement for listed chem- to the following countries: ical exports may be waived, in whole or in part, for: Name of Chemical Country (1) Any regulated person who has sat- [Reserved] ...... isfied the requirements of § 1313.24 for reporting to the Administration an es- (g) No person shall export or cause to tablished business relationship, as de- be exported any listed chemical, know- fined in § 1300.02 of this chapter, with a ing or having reasonable cause to be- foreign customer. lieve the export is in violation of the (2) A specific listed chemical to a laws of the country to which the chem- specified country, as set forth in para- ical is exported or the chemical will be graph (f) of this section, for which the used to manufacture a controlled sub- Administrator determines that ad- stance in violation of the Act or the vance notification is not necessary for laws of the country to which the chem- effective chemical diversion control. ical is exported. The Administration (d) For exports meeting the require- will publish a notice of foreign import ments of paragraph (c)(1) of this sec- restrictions for listed chemicals of tion, the declaration (DEA Form 486) which DEA has knowledge as provided must be filed with the Administration in § 1313.25. through the DEA Diversion Control Di- (h) Export declarations shall become vision secure network application at void and of no effect 180 calendar days least three business days before the after the date the declaration is date of release by a customs officer. deemed filed with the Administration. The declaration must be signed and [54 FR 31665, Aug. 1, 1989, as amended at 59 dated by the exporter and must contain FR 51367, Oct. 11, 1994; 60 FR 32464, June 22, the address from which the listed 1995; 62 FR 13969, Mar. 24, 1997; 66 FR 46520, chemicals will be shipped for expor- Sept. 6, 2001; 67 FR 49569, July 31, 2002; 75 FR tation. Upon receipt and review, the 10683, Mar. 9, 2010; 77 FR 4237, Jan. 27, 2012; 81 Administration will assign a trans- FR 97038, Dec. 30, 2016] action identification number to each completed declaration. The exporter § 1313.22 Export declaration. may only proceed with the export (a) Any List I or List II chemical list- transaction once the transaction iden- ed in § 1310.02 of this chapter which tification number has been issued. meets or exceeds the quantitative (e) For exportations where advance threshold criteria established in notification is waived pursuant to § 1310.04(f) of this chapter or is a listed paragraph (c)(2) of this section no DEA chemical for which no threshold has Form 486 is required; however, the reg- been established as identified in

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§ 1310.04(g) of this chapter, may be ex- Administration issues a transaction ported if that chemical is needed for identification number. Listed chemi- medical, commercial, scientific, or cals so returned may not be reexported other legitimate uses. until the exporter has filed a new DEA (b) The export declaration (DEA Form 486 and the Administration has Form 486) must include all the fol- issued a new transaction identification lowing information: number. This provision does not apply (1) The name/business name, address/ to shipments that have cleared foreign business address, and contact informa- customs, been delivered, and accepted tion (e.g., telephone number(s), email by the foreign consignee. Returns to address(es), etc.) of the chemical ex- third parties in the United States will porter; the name/business name, ad- be regarded as imports. dress/business address, and contact information (e.g., telephone number(s), [81 FR 97038, Dec. 30, 2016] email address(es), etc.) of the export broker, if any; § 1313.23 Disposition of export declaration. (2) The name and description of each listed chemical as it appears on the The exporter, or their agent, must label or container, the name of each submit an official record of the export listed chemical as it is designated in declaration and/or required data con- § 1310.02 of this chapter, the size or cerning the export transaction to a weight of container, the number of con- customs officer at the port of export in tainers, the net weight of each listed compliance with all export control re- chemical given in kilograms or parts quirements of agencies with export thereof, and the gross weight of the control authorities under the Act or shipment given in kilograms or parts statutory authority other than the thereof; Controlled Substances Import and Ex- (3) The anticipated date of release by port Act. An official record of the dec- a customs officer at the port of export, laration (available from the DEA Di- the port of export, and the foreign port version Control Division secure net- and country of entry; and work application after the Administra- (4) The name/business name, address/ tion issues a transaction identification business address, and contact informa- number) must be maintained by the tion (e.g., telephone number(s), email chemical exporter as the official record address(es), etc.) of the consignee in of the export in accordance with part the country where the chemical ship- 1310 of this chapter. Export declara- ment is destined; the name(s) and ad- tions involving a listed chemical must dress(es) of any intermediate con- be retained for two years. signee(s); and a copy of the foreign permit, license or registration issued by [81 FR 97038, Dec. 30, 2016] the competent national authority of § 1313.24 Waiver of 15-day advance no- the consignee and any intermediate tice for chemical exporters. consignees. (c) Declared exports of listed chemi- (a) Each regulated person shall pro- cals which are refused, rejected, or oth- vide to the Administration the identity erwise deemed undeliverable by the and information listed in the definition foreign competent national authority of established business relationship in may be returned to the U.S. chemical § 1300.02 of this chapter for an estab- exporter of record. The regulated per- lished business relationship with a for- son must provide notification through eign customer not later than August the DEA Diversion Control Division se- 31, 1989. cure network application (this does not (b) Not later than October 31, 1989, require a DEA Form 486) outlining the each regular customer so identified in circumstances within a reasonable notifications made under § 1313.24(a) time following the return. Upon receipt shall be a regular customer for pur- and review, the Administration will as- poses of waiving the 15-day advance no- sign the completed notice a trans- tice requirement, unless the regulated action identification number. The no- person is otherwise notified in writing tice will not be deemed filed until the by the Administration.

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(c) Each foreign customer identified must update the notice to identify the on an initial DEA Form 486 submitted most recent prospective transferee or after the effective date of the imple- the most recent quantity or both (as mentation of part 1313 shall, after the the case may be). The exporter may expiration of the 15-day period, qualify not transfer the listed chemical until as a regular customer, unless the Ad- after the expiration of the 15 calendar ministration otherwise notifies the day period beginning on the date on regulated person in writing. which the update is filed with the Ad- (d) Unless the Administration noti- ministration. Except, if the listed fies the chemical exporter to the con- chemical is intended for transfer to a trary, the qualification of a regular regular customer, the exporter may customer for any one of these three not transfer the listed chemical until chemicals, acetone, 2-Butanone (MEK), after the expiration of three business or toluene, qualifies that customer as a days. The preceding sentence applies regular customer for all three of these with respect to changing cir- chemicals. cumstances regarding a transferee or (e) The Administrator may notify quantity identified in an update to the any chemical exporter that a regular same extent and in the same manner as customer has been disqualified or that the sentence applies with respect to a new customer for whom a notifica- changing circumstances regarding a tion has been submitted is not to be ac- transferee or quantity identified in the corded the status of a regular cus- original notice under paragraph (a) of tomer. In the event of a disqualifica- this section. Amended declarations tion of an established regular cus- must be submitted to the Administra- tomer, the chemical exporter will be tion through the DEA Diversion Con- notified in writing of the reasons for trol Division secure network applica- such action. tion. The amendment must be signed [54 FR 31665, Aug. 1, 1989, as amended at 56 and dated by the exporter. Upon re- FR 55077, Oct. 24, 1991; 62 FR 13969, Mar. 24, ceipt and review, the Administration 1997; 75 FR 10684, Mar. 9, 2010; 77 FR 4237, Jan. will assign each completed amendment 27, 2012] a transaction identification number. The amendment will not be deemed § 1313.25 Foreign import restrictions. filed until the Administration issues a Any export from the United States in transaction identification number. violation of the law of the country to (c) In the case of a transfer of a listed which the chemical is exported is sub- chemical that is subject to a 15-day reject to the penalties of Title 21 United striction, the transferee involved shall, States Code 960(d). upon the expiration of the 15-day period, be considered to qualify as a reg- § 1313.26 Updated notice for change in ular customer, unless the Administra- circumstances. tion otherwise notifies the exporter in- (a) In the case of a notice under volved in writing. § 1313.21(a) submitted by a regulated (d) With respect to a transfer of a person, if the transferee identified in listed chemical with which a notice or the notice, i.e., the foreign importer, is update referred to in § 1313.21(a) is con- not a regular customer, the regulated cerned: person may not transfer the listed (1) The Administration— chemical until after the expiration of (i) May, in accordance with the same the 15-day period beginning on the date procedures as apply under §§ 1313.51 on which the notice is submitted to the through 1313.57, order the suspension of Administration. the transfer of the listed chemical by (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

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manufactured from bulk chemicals to deemed filed on the first date on which be transferred), subject to the Adminis- a complete report is filed. tration ordering the suspension before (b) If an exportation for which a DEA the expiration of the 15-day period with Form 486 has been filed fails to take respect to the exportation (in any case place, the exporter must report to the in which such a period applies); and Administration that the exportation (ii) May, for purposes of this para- did not occur through the DEA Diver- graph (d), disqualify a regular cus- sion Control Division secure network tomer on that ground. application. (2) From and after the time when the (c) Denied release at the port of export. Administration provides written notice In the event that a shipment of listed of the order under paragraph (d)(1)(i) of chemicals has been denied release by a this section (including a statement of customs officer at the port of export the legal and factual basis for the for any reason, the exporter who at- order) to the exporter, the exporter tempted to have the shipment released may not carry out the transfer. must, within 5 business days of the de- (e) For purposes of this section: nial, report to the Administration that (1) The term transfer, with respect to the shipment was denied release and a listed chemical, includes the sale of the reason for denial. Such report must the chemical. be transmitted to the Administration (2) The term transferee means a per- through the DEA Diversion Control Di- son to whom an exporter transfers a vision secure network application. This listed chemical. report must include the following in- [72 FR 17408, Apr. 9, 2007, as amended at 81 formation: The quantity of the listed FR 97039, Dec. 30, 2016] chemicals denied release; the date on which release was denied; and the basis § 1313.27 Return declaration for ex- for the denied release. Upon the export- ports. er’s report of a denied release, DEA (a) Return information. Within 30 cal- will assign the report a transaction endar days after a listed chemical is re- identification number and the export leased by a customs officer at the port declaration will be void and of no ef- of export, the exporter must file a re- fect. No shipment of listed chemicals port with the Administration through denied release for any reason will be al- the DEA Diversion Control Division se- lowed to be released from the United cure network application specifying States without a subsequent refiling of the particulars of the transaction. This a complete and accurate export dec- report must include the following in- laration. Following such refiling, the formation: The date on which the list- exporter may request the release of the ed chemical left the registered location listed chemicals immediately after re- or place of business; the date on which ceipt of a transaction identification the listed chemical was released by a number without regard to the 15 day customs officer at the port of export; advance filing required by § 1313.21(b). the actual quantity of listed chemical [81 FR 97039, Dec. 30, 2016] that left the registered location or place of business; the actual quantity TRANSSHIPMENTS, IN-TRANSIT SHIP- of the listed chemical released by a MENTS AND INTERNATIONAL TRANS- customs officer at the port of export; ACTIONS INVOLVING LISTED CHEMI- chemical; container; name of trans- CALS ferees; and any other information as the Administration may specify. Upon § 1313.31 Advance notice of importa- receipt and review, the Administration tion for transshipment or transfer. will assign a completed report a trans- (a) A quantity of a chemical listed in action identification number. The re- § 1310.02 of this chapter that meets or port will not be deemed filed until the exceeds the threshold reporting re- Administration has issued a trans- quirements found in § 1310.04(f) of this action identification number. In deter- chapter may be imported into the mining whether the exporter has com- United States for transshipment, or plied with the requirement to file with- may be transferred or transshipped in 30 calendar days, the report shall be within the United States for immediate

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exportation, provided that advance no- (16) The approximate date of receipt tice is given to the Administration. by the consignee at the foreign port of (b) Advance notification must be pro- entry; and vided to the Regulatory Section, Diver- (17) The signature of the importer, sion Control Division, Drug Enforce- transferor or transshipper, or his ment Administration, not later than 15 agent, accompanied by the agent’s calendar days prior to the proposed title. date the listed chemical will transship (c) Unless notified to the contrary or transfer through the United States. prior to the expected date of delivery, See the Table of DEA Mailing Address- the importation for transshipment or es in § 1321.01 of this chapter for the transfer is considered approved. current mailing address. A separate notification is required for each shipment (d) No waiver of the 15-day advance of listed chemicals to be transferred or notice will be given for imports of list- transshipped. The written notification ed chemicals in quantities meeting or (not a DEA Form 486) must contain the exceeding threshold quantities for following information: transshipment or transfer outside the (1) The date the notice was executed; United States. (2) The complete name and descrip- [54 FR 31665, Aug. 1, 1989, as amended at 67 tion of the listed chemical as it ap- FR 49569, July 31, 2002; 75 FR 10684, Mar. 9, pears on the label or container. 2010; 77 FR 4237, Jan. 27, 2012; 81 FR 97039, (3) The name of the listed chemical Dec. 30, 2016] as designated by § 1310.02 of this chapter. § 1313.32 Notification of international (4) The number of containers and the transactions. size or weight of the container for each (a) A broker or trader must notify listed item; the Administration prior to an inter- (5) The net weight of each listed national transaction involving a listed chemical given in kilograms or parts chemical which meets or exceeds the thereof; threshold quantities identified in (6) The gross weight of the shipment § 1310.04(f) of this chapter or is a listed given in kilograms or parts thereof; chemical for which no threshold has (7) The name/business name, address/ been established as identified in business address, and contact informa- § 1310.04(g) of this chapter, in which the tion (e.g., telephone number(s), email broker or trader participates. Notifica- address(es), etc.) and type of business tion must be made not later than 15 of the foreign exporter; calendar days before the transaction is (8) The foreign port and country of to take place. In order to facilitate an export; international transaction involving (9) The approximate date of expor- listed chemicals and implement the tation; purpose of the Act, regulated persons (10) The complete identification of may wish to provide advance notifica- the exporting carrier; tion to the Administration as far in ad- (11) The name, address, business, vance of the 15 calendar days as pos- telephone number, and, where avail- sible. able, the facsimile number of the im- (b) A completed DEA Form 486 must porter, transferor, or transshipper; be submitted to the Administration (12) The U.S. port of entry; through the DEA Diversion Control Di- (13) The approximate date of entry; vision secure network application, not (14) The name/business name, address/business address, and contact in- later than 15 calendar days prior to the formation (e.g., telephone number(s), international transaction. The DEA email address(es), etc.) and type of Form 486 must be signed and dated by business of the consignee at the foreign the broker or trader. Upon receipt and port or country of entry; review, the Administration will assign (15) The shipping route from the U.S. a transaction identification number to port of export to the foreign port or country of entry at final destination;

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each completed notification. A notifi- (1) The term transfer, with respect to cation is not deemed filed, and there- a listed chemical, includes the sale of fore is not valid, until the Administra- the chemical. tion assigns the notification a trans- (2) The term transferee means a per- action identification number. An inter- son to whom an exporter transfers a national transaction may not take listed chemical. place until after a transaction identification number has been assigned and [81 FR 97039, Dec. 30, 2016] the expiration of the 15 calendar day § 1313.33 Contents of an international period beginning on the date on which transaction declaration. the broker or trader submits a complete notification to the Administra- (a) An international transaction in- tion. volving a chemical listed in § 1310.02 of (c) No person shall serve as a broker this chapter which meets the threshold or trader for an international trans- criteria established in § 1310.04 of this action involving a listed chemical chapter may be arranged by a broker knowing or having reasonable cause to or trader if the chemical is needed for believe that the transaction is in viola- medical, commercial, scientific, or tion of the laws of the country to other legitimate uses. which the chemical is exported or the (b) Any broker or trader who desires chemical will be used to manufacture a to arrange an international trans- controlled substance in violation of the action, defined in 21 U.S.C. 802(42), in- laws of the country to which the chem- volving a listed chemical which meets ical is exported. The Administration the threshold criteria set forth in will publish a notice of foreign import § 1310.04 of this chapter must notify the restrictions for listed chemicals of Administration through the procedures which DEA has knowledge as provided outlined in § 1313.32(b). in § 1313.25. (c) The DEA Form 486 must include: (d) After a notice under paragraph (a) (1) The name/business name, address/ of this section is submitted to the Ad- business address, and contact informa- ministration, if circumstances change tion (e.g., telephone number(s), email and the broker or trader will not be address(es), etc.) of the chemical ex- transferring the listed chemical to the porter; the name/business name, ad- transferee identified in the notice, or dress/business address, and contact in- will be transferring a greater quantity formation (e.g., telephone number(s), of the chemical than specified in the email address(es), etc.) of the chemical notice, the broker or trader must importer; amend the notice through the DEA Di- (2) The name and description of each version Control Division secure net- listed chemical as it appears on the work application to identify the most label or container, the name of each recent prospective transferee or the listed chemical as it is designated in most recent quantity or both (as appli- § 1310.02 of this chapter, the size or cable) and may not transfer the listed weight of container, the number of con- chemical until after the expiration of tainers, the net weight of each listed the 15 calendar day period beginning on chemical given in kilograms or parts the date on which the update is sub- thereof, and the gross weight of the mitted to the Administration. The pre- shipment given in kilograms or parts ceding sentence applies with respect to thereof; changing circumstances regarding a (3) The anticipated date of release at transferee or quantity identified in an the foreign port of export, the antici- amendment to the same extent and in pated foreign port and country of ex- the same manner as the sentence ap- port, and the foreign port and country plies with respect to changing cir- of entry; and cumstances regarding a transferee or (4) The name/business name, address/ quantity identified in the original no- business address, and contact informa- tice under paragraph (a) of this section. tion (e.g., telephone number(s), email (e) For purposes of this section: address(es), etc.) of the consignee in

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the country where the chemical ship- tion as soon as the broker or trader be- ment is destined; the name(s) and ad- comes aware of the circumstances. dress(es) of any intermediate consignee(s). [81 FR 97040, Dec. 30, 2016] [60 FR 32465, June 22, 1995, as amended at 77 § 1313.41 Suspension of shipments. FR 4238, Jan. 27, 2012; 81 FR 97040, Dec. 30, (a) The Administrator may suspend 2016] any importation or exportation of a § 1313.34 Disposition of the inter- chemical listed in § 1310.02 of this chap- national transaction declaration. ter based on evidence that the chemical proposed to be imported or ex- The broker or trader must retain an ported may be diverted to the clandes- official record of the declaration (DEA tine manufacture of a controlled sub- Form 486) (available from the DEA Di- stance. If the Administrator so sus- version Control Division secure net- pends, he shall provide written notice work application after the Administra- of such suspension to the regulated tion issues a transaction identification person. Such notice shall contain a number) as the official record of the statement of the legal and factual basis international transaction. In accord- for the order. ance with part 1310 of this chapter, declarations involving listed chemicals (b) Upon service of the order of sus- must be retained for two years. pension, the regulated person to whom the order applies under paragraph (a) of [81 FR 97040, Dec. 30, 2016] this section must, if he desires a hearing, file a written request for a hearing § 1313.35 Return declaration or pursuant to §§ 1313.51–1313.57. amendment to Form 486 for international transactions. § 1313.42 Prohibition of shipments (a) Within 30 calendar days after an from certain foreign sources. international transaction is completed, (a) If the Administrator determines the broker or trader must file a report that a foreign manufacturer or dis- with the Administration through the tributor of ephedrine, pseudoephedrine, DEA Diversion Control Division secure or phenylpropanolamine has refused to network application about the particu- cooperate with a request by the Admin- lars of the transaction. This report istrator for information known to the must include the following informa- manufacturer or distributor on the dis- tion: The date(s) on which the listed tribution of the chemical, including chemical was released by the foreign sales, the Administrator may issue an customs officer(s) at the port(s); the order prohibiting the importation of actual quantity of listed chemical that the chemical in any case where the left the country of export; the actual manufacturer or distributor is part of quantity of the listed chemical re- the chain of distribution. leased by a customs officer at the port (b) Not later than 60 days prior to of entry; chemical; container; name of issuing the order to prohibit importa- transferees; and the transaction identi- tion, the Administrator shall publish fication and any other information as in the FEDERAL REGISTER a notice of the Administration may specify. Upon intent to issue the order. During the 60- receipt and review, the Administration day period, imports from the foreign will assign a completed report a trans- manufacturer or distributor may not action identification number. The re- be restricted under this section. port will not be deemed filed until the Administration has issued a trans- [75 FR 10172, Mar. 5, 2010] action identification number. (b) If an international transaction for HEARINGS which a DEA Form 486 has been filed fails to take place, the broker or trader § 1313.51 Hearings generally. must report to the Administration that In any case where a regulated person the international transaction did not requests a hearing regarding the sus- occur utilizing the DEA Diversion Con- pension of a shipment of a listed chem- trol Division secure network applica- ical, the procedures for such hearing

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shall be governed generally by the pro- § 1313.55 Burden of proof. cedures set forth in the Administrative At any hearing regarding the suspen- Procedure Act (5 U.S.C. 551–559) and sion of shipments, the Agency shall specifically by section 6053 of the have the burden of proving that the re- Chemical Diversion and Trafficking quirements of this part for such sus- Act (Pub. L. 100–690), by 21 CFR 1313.52– pension are satisfied. 1313.57, and by the procedures for administrative hearings under the Con- § 1313.56 Time and place of hearing. trolled Substances Act set forth in §§ 1316.41–1316.67 of this chapter. (a) If any regulated person requests a hearing on the suspension of ship- § 1313.52 Purpose of hearing. ments, a hearing will be scheduled no If requested by a person entitled to a later than 45 days after the request is hearing, the Administrator shall cause made, unless the regulated person re- a hearing to be held for the purpose of quests an extension to this date. receiving factual evidence regarding (b) The hearing will commence at the the issues involved in the suspension of place and time designated in the notice shipments within 45 days of the date of given pursuant to paragraph (a) of this the request, unless the requesting section but thereafter it may be moved party requests an extension of time. to a different place and may be continued from day to day or recessed to a § 1313.53 Waiver of modification of later day without notice other than an- rules. nouncement thereof by the presiding The Administrator or the presiding officer at the hearing. officer (with respect to matters pend- § 1313.57 Final order. ing before him) may modify or waive any rule in this part by notice in ad- As soon as practicable after the pre- vance of the hearing, if he determines siding officer has certified the record that no party in the hearing will be un- to the Administrator, the Adminis- duly prejudiced and the ends of justice trator shall issue his order regarding will thereby be served. Such notice of the suspension of shipment. The order modification or waiver shall be made a shall include the findings of fact and part of the record of the hearing. conclusions of law upon which the order is based. The Administrator shall § 1313.54 Request for hearing. serve one copy of his order upon each (a) Any person entitled to a hearing party in the hearing. pursuant to § 1313.52 and desiring a hearing shall, within 30 days after re- PART 1314—RETAIL SALE OF ceipt of the notice to suspend the ship- SCHEDULED LISTED CHEMICAL ment, file with the Administrator a PRODUCTS written request for a hearing in the form prescribed in § 1316.47 of this chap- Subpart A—General ter. (b) If any person entitled to a hearing Sec. or to participate in a hearing pursuant 1314.01 Scope. to § 1313.41 fails to file a request for a 1314.02 Applicability. hearing or a notice of appearance, or if 1314.03 Definitions. 1314.05 Requirements regarding packaging he so files and fails to appear at the of nonliquid forms. hearing, he shall be deemed to have 1314.10 Effect on state laws. waived his opportunity for the hearing 1314.15 Loss reporting. or to participate in the hearing, unless he shows good cause for such failure. Subpart B—Sales by Regulated Sellers (c) If all persons entitled to a hearing or to participate in a hearing waive or 1314.20 Restrictions on sales quantity. 1314.25 Requirements for retail trans- are deemed to waive their opportunity actions. for the hearing or to participate in the 1314.30 Recordkeeping for retail trans- hearing, the Administrator may cancel actions. the hearing, if scheduled, and issue his 1314.35 Training of sales personnel. final order pursuant to § 1313.57. 1314.40 Self-certification.

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1314.42 Self-certification fee; time and § 1314.03 Definitions. method of fee payment. 1314.45 Privacy protections. As used in this part, the term ‘‘mail- 1314.50 Employment measures. order sale’’ means a retail sale of scheduled listed chemical products for Subpart C—Mail-Order Sales personal use where a regulated person uses or attempts to use the U.S. Postal 1314.100 Sales limits for mail-order sales. Service or any private or commercial 1314.101 Training of sales personnel. carrier to deliver the product to the 1314.102 Self-certification. customer. Mail-order sale includes pur- 1314.103 Self-certification fee; time and chase orders submitted by phone, mail, method of fee payment. fax, Internet, or any method other 1314.105 Verification of identity for mail- than face-to-face transaction. order sales. 1314.110 Reports for mail-order sales. § 1314.05 Requirements regarding 1314.115 Distributions not subject to report- packaging of nonliquid forms. ing requirements. A regulated seller or mail order dis- Subpart D—Order To Show Cause tributor may not sell a scheduled listed chemical product in nonliquid form (in- 1314.150 Order to show cause. cluding gel caps) unless the product is 1314.155 Suspension pending final order. packaged either in blister packs, with each blister containing no more than AUTHORITY: 21 U.S.C. 802, 830, 842, 871(b), 875, 877, 886a. two dosage units or, if blister packs are technically infeasible, in unit dose SOURCE: 71 FR 56024, Sept. 26, 2006, unless packets or pouches. otherwise noted. § 1314.10 Effect on State laws. Subpart A—General Nothing in this part preempts State law on the same subject matter unless § 1314.01 Scope. there is a positive conflict between this This part specifies the requirements part and a State law so that the two for retail sales of scheduled listed cannot consistently stand together. chemical products to individuals for § 1314.15 Loss reporting. personal use. (a) Each regulated person must re- § 1314.02 Applicability. port to the Special Agent in Charge of the DEA Divisional Office for the area (a) This part applies to the following in which the regulated person making regulated persons who sell scheduled the report is located, any unusual or listed chemical products for personal excessive loss or disappearance of a use: scheduled listed chemical product (1) Regulated sellers of scheduled under the control of the regulated per- listed chemical products sold at retail son. The regulated person responsible for personal use through face-to-face for reporting a loss in-transit is the sales at stores or mobile retail vendors. supplier. (2) Regulated persons who engage in (b) Each report submitted under a transaction with a non-regulated per- paragraph (a) of this section must, son and who ship the products to the whenever possible, be made orally to non-regulated person by the U.S. Post- the DEA Divisional Office for the area al Service or by private or common in which the regulated person making carriers. the report is located at the earliest (b) The requirements in subpart A practicable opportunity after the regu- apply to all regulated persons subject lated person becomes aware of the cir- to this part. The requirements in sub- cumstances involved. part B apply to regulated sellers as de- (c) Written reports of losses must be fined in § 1300.02 of this chapter. The refiled within 15 days after the regulated quirements in subpart C apply to regu- person becomes aware of the cir- lated persons who ship the products to cumstances of the event. the customer by the U.S. Postal Serv- (d) A report submitted under this sec- ice or by private or common carriers. tion must include a description of the

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

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unique identifier which can be linked (2) If the seller enters the informa- to that electronic information, or tion, the prospective purchaser must (ii) A unique identifier that can be verify that the information is correct. linked to that information and that is (3) Such information may be cap- written into the book by the seller at tured through electronic means, in- the time of sale. cluding through electronic data cap- (2) The purchaser must sign adjacent ture through bar code reader or similar to the printed sticker or written technology. unique identifier related to that sale. (d) The regulated seller must include The bound paper book must display the in the written or electronic logbook or warning notice in paragraph (d) of this display by the logbook, the following section. notice: (C) Signing a printed document that includes, for the purchaser, the name WARNING: Section 1001 of Title 18, United of each product sold, the quantity sold, States Code, states that whoever, with re- the name and address of the purchaser, spect to the logbook, knowingly and will- fully falsifies, conceals, or covers up by any and the date and time of the sale. The trick, scheme, or device a material fact, or document must be printed by the seller makes any materially false, fictitious, or at the time of the sale. The document fraudulent statement or representation, or must contain a clearly identified signa- makes or uses any false writing or document ture line for a purchaser to sign. The knowing the same to contain any materially printed document must display the false, fictitious, or fraudulent statement or warning notice in paragraph (d) of this entry, shall be fined not more than $250,000 if section. Each signed document must be an individual or $500,000 if an organization, inserted into a binder or other secure imprisoned not more than five years, or both. means of document storage immediately after the purchaser signs the (e) The regulated seller must main- document. tain each entry in the written or elec- (3) The regulated seller must enter in tronic logbook for not fewer than two the logbook the name of the product years after the date on which the entry and the quantity sold. Examples of is made. methods of recording the quantity sold (f) A record under this section must include the weight of the product per be kept at the regulated seller’s place package and number of packages of of business where the transaction oc- each chemical, the cumulative weight curred, except that records may be of the product for each chemical, or kept at a single, central location of the quantity of product by Universal Prod- regulated seller if the regulated seller uct Code. These examples do not ex- has notified the Administration of the clude other methods of displaying the intention to do so. Written notification quantity sold. Such information may must be submitted by registered or cer- be captured through electronic means, tified mail, return receipt requested, to including through electronic data cap- the Special Agent in Charge of the ture through bar code reader or similar DEA Divisional Office for the area in technology. Such electronic records which the records are required to be must be provided pursuant to para- kept. graph (g) of this section in a human (g) The records required to be kept readable form such that the require- under this section must be readily re- ments of paragraph (a) of this section trievable and available for inspection are satisfied. and copying by authorized employees (c) The logbook maintained by the of the Administration under the provi- seller must include the prospective sions of section 510 of the Act (21 U.S.C. purchaser’s name, address, and the 880). date and time of the sale, as follows: (h) A record developed and main- (1) If the purchaser enters the infor- tained to comply with a State law may mation, the seller must determine that be used to meet the requirements of the name entered in the logbook cor- this section if the record includes the responds to the name provided on the information specified in this section. identification and that the date and time entered are correct. [76 FR 74698, Dec. 1, 2011]

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§ 1314.35 Training of sales personnel. er sells scheduled listed chemical products at retail. Each regulated seller must ensure that its sales of a scheduled listed § 1314.42 Self-certification fee; time chemical product at retail are made in and method of fee payment. accordance with the following: (a) In the case of individuals who are (a) A regulated seller must pay a fee responsible for delivering the products for each self-certification. For each ini- into the custody of purchasers or who tial application to self-certify, and for deal directly with purchasers by ob- the renewal of each existing self-cer- taining payments for the products, the tification, a regulated seller shall pay regulated seller has submitted to the a fee of $21. Administration a self-certification (b) The fee for self-certification shall that all such individuals have, in ac- be waived for any person holding a cur- cordance with criteria issued by the rent, DEA registration in good stand- Administration, undergone training ing as a pharmacy to dispense con- provided by the regulated seller to en- trolled substances. sure that the individuals understand (c) A regulated seller shall pay the the requirements that apply under this fee at the time of self-certification. part. (d) Payment shall be made by credit (b) The regulated seller maintains a card. copy of each self-certification and all (e) The self-certification fee is not re- records demonstrating that individuals fundable. referred to in paragraph (a) of this sec- [73 FR 79323, Dec. 29, 2008] tion have undergone the training. § 1314.45 Privacy protections. § 1314.40 Self-certification. To protect the privacy of individuals (a) A regulated seller must submit to who purchase scheduled listed chem- the Administration the self-certifi- ical products, the disclosure of infor- cation referred to in § 1314.35(a) in order mation in logbooks under § 1314.30 is re- to sell any scheduled listed chemical stricted as follows: product. The certification is not effec- (a) The information shall be disclosed tive for purposes of this section unless, as appropriate to the Administration in addition to provisions regarding the and to State and local law enforcement training of individuals referred to in agencies. § 1314.35(a), the certification includes a (b) The information in the logbooks statement that the regulated seller un- shall not be accessed, used, or shared derstands each of the requirements for any purpose other than to ensure that apply under this part and agrees compliance with this title or to facili- to comply with the requirements. tate a product recall to protect public (b) When a regulated seller files the health and safety. initial self-certification, the Adminis- (c) A regulated seller who in good tration will assign the regulated seller faith releases information in a logbook to one of twelve groups. The expiration to Federal, State, or local law enforce- date of the self-certification for all reg- ment authorities is immune from civil ulated sellers in any group will be the liability for the release unless the re- last day of the month designated for lease constitutes gross negligence or that group. In assigning a regulated intentional, wanton, or willful mis- seller to a group, the Administration conduct. may select a group with an expiration date that is not less than 12 months or [71 FR 56024, Sept. 26, 2006, as amended at 77 more than 23 months from the date of FR 4238, Jan. 27, 2012] the self-certification. After the initial 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

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

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

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(10) Number of dosage units (e.g., 100 to submit reports under § 1310.03(c) of doses per package); this chapter, the Administrator deter- (11) Package type (blister pack, etc.); mines that a regulated seller or dis- (12) Number of packages; tributor required to submit reports (13) Lot number. under § 1310.03(c) of this chapter has [71 FR 56024, Sept. 26, 2006, as amended at 75 sold a scheduled listed chemical prod- FR 10684, Mar. 9, 2010; 81 FR 97040, Dec. 30, uct in violation of Section 402 of the 2016] Act (21 U.S.C. 842(a)(12) or (13)), the Ad- ministrator will serve upon the regu- § 1314.115 Distributions not subject to lated seller or distributor an order to reporting requirements. show cause why the regulated seller or (a) The following distributions to distributor should not be prohibited nonregulated persons are not subject to from selling scheduled listed chemical the reporting requirements in § 1314.110: products. (1) Distributions of sample packages (b) The order to show cause shall call when those packages contain not more upon the regulated seller or distributor than two solid dosage units or the to appear before the Administrator at a equivalent of two dosage units in liquid time and place stated in the order, form, not to exceed 10 milliliters of liq- which shall not be less than 30 days uid per package, and not more than one after the date of receipt of the order. package is distributed to an individual The order to show cause shall also con- or residential address in any 30-day pe- tain a statement of the legal basis for riod. such hearing and for the prohibition (2) Distributions by retail distribu- and a summary of the matters of fact tors that may not include face-to-face and law asserted. transactions to the extent that such distributions are consistent with the (c) Upon receipt of an order to show activities authorized for a retail dis- cause, the regulated seller or distributor as specified in the definition tributor must, if he desires a hearing, of retail distributor in § 1300.02 of this file a request for a hearing as specified chapter, except that this paragraph in subpart D of part 1316 of this chap- (a)(2) does not apply to sales of sched- ter. If a hearing is requested, the Ad- uled listed chemical products at retail. ministrator shall hold a hearing at the (3) Distributions to a resident of a time and place stated in the order, as long term care facility or distributions provided in part 1316 of this chapter. to a long term care facility for dis- (d) When authorized by the Adminis- pensing to or for use by a resident of trator, any agent of the Administra- that facility. tion may serve the order to show (4) Distributions in accordance with a cause. valid prescription. (b) The Administrator may revoke § 1314.155 Suspension pending final any or all of the exemptions listed in order. paragraph (a) of this section for an in- (a) The Administrator may suspend dividual regulated person if the Admin- the right to sell scheduled listed chem- istrator finds that drug products dis- ical products simultaneously with, or tributed by the regulated person are at any time subsequent to, the service being used in violation of the regula- upon the seller or distributor required tions in this chapter or the Controlled to file reports under § 1310.03(c) of this Substances Act. chapter of an order to show cause why [[71 FR 56024, Sept. 26, 2006, as amended at 77 the regulated seller or distributor FR 4238, Jan. 27, 2012] should not be prohibited from selling scheduled listed chemical products, in Subpart D—Order to Show Cause any case where he finds that there is an imminent danger to the public § 1314.150 Order To show cause. health or safety. If the Administrator (a) If, upon information gathered by so suspends, he shall serve with the the Administration regarding any reg- order to show cause under § 1314.150 an ulated seller or a distributor required order of immediate suspension that

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shall contain a statement of his find- 1315.25 Increase in individual manufac- ings regarding the danger to public turing quotas. health or safety. 1315.26 Reduction in individual manufac- (b) Upon service of the order of im- turing quotas. 1315.27 Abandonment of quota. mediate suspension, the regulated seller or distributor shall, as instructed by Subpart D—Procurement and Import the Administrator: Quotas (1) Deliver to the nearest office of the Administration or to authorized agents 1315.30 Procurement and import quotas. of the Administration all of the sched- 1315.32 Obtaining a procurement quota. 1315.33 Power of attorney. uled listed chemical products in his or 1315.34 Obtaining an import quota. her possession; or 1315.36 Amending an import quota. (2) Place all of the scheduled listed chemical products under seal as de- Subpart E—Hearings scribed in Section 304 of the Act (21 U.S.C. 824(f)). 1315.50 Hearings generally. 1315.52 Purpose of hearing. (c) Any suspension shall continue in 1315.54 Waiver or modification of rules. effect until the conclusion of all pro- 1315.56 Request for hearing or appearance; ceedings upon the prohibition, includ- waiver. ing any judicial review, unless sooner 1315.58 Burden of proof. withdrawn by the Administrator or dis- 1315.60 Time and place of hearing. solved by a court of competent juris- 1315.62 Final order. diction. Any regulated seller or dis- AUTHORITY: 21 U.S.C. 802, 821, 826, 871(b), tributor whose right to sell scheduled 952. listed chemical products is suspended SOURCE: 72 FR 37448, July 10, 2007, unless under this section may request a hear- otherwise noted. ing on the suspension at a time earlier than specified in the order to show EDITORIAL NOTE: Nomenclature changes to part appear at 82 FR 97041, Dec. 30, 2016. cause under § 1314.150, which request shall be granted by the Administrator, who shall fix a date for such hearing as Subpart A—General Information early as reasonably possible. § 1315.01 Scope. PART 1315—IMPORTATION AND This part specifies procedures governing the establishment of an assess- PRODUCTION QUOTAS FOR ment of annual needs, procurement and EPHEDRINE, PSEUDOEPHEDRINE, manufacturing quotas pursuant to sec- AND PHENYLPROPANOLAMINE tion 306 of the Act (21 U.S.C. 826), and import quotas pursuant to section 1002 Subpart A—General Information of the Act (21 U.S.C. 952) for ephedrine, Sec. pseudoephedrine, and phenylpropanola- 1315.01 Scope. mine. 1315.02 Definitions. 1315.03 Personal use exemption. § 1315.02 Definitions. 1315.05 Applicability. (a) Except as specified in paragraphs (b) and (c) of this section, any term Subpart B—Assessment of Annual Needs contained in this part shall have the 1315.11 Assessment of annual needs. definition set forth in section 102 of the 1315.13 Adjustments of assessment of annual Act (21 U.S.C. 802) or part 1300 of this needs. chapter. (b) The term net disposal means, for a Subpart C—Individual Manufacturing stated period, the sum of paragraphs Quotas (b)(1) through (b)(3) of this section minus the sum of paragraphs (b)(4) and 1315.21 Individual manufacturing quotas. 1315.22 Procedure for applying for individual (b)(5) of this section: manufacturing quotas. (1) The quantity of ephedrine, 1315.23 Procedure for fixing individual man- pseudoephedrine, or phenylpropanola- ufacturing quotas. mine distributed by the registrant to 1315.24 Inventory allowance. another person.

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

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under this section. A notice of the pub- changes in individual rates of net dis- lication shall be mailed simultaneously posal of that chemical are temporary, to each person registered to manufac- short term, or long term; ture or import the chemical. (3) Whether any increased demand for (d) The Administrator shall permit that chemical can be met through ex- any interested person to file written isting inventories, increased individual comments on or objections to the pro- manufacturing quotas, or increased imposed assessment of annual needs and portation, without increasing the as- shall designate in the notice the time sessment of annual needs, taking into during which the filings may be made. account production delays and the (e) The Administrator may, but is probability that other individual man- not required to, hold a public hearing ufacturing quotas may be suspended on one or more issues raised by the pursuant to § 1315.24(b); comments and objections filed with (4) Whether any decreased demand him. In the event the Administrator for that chemical will result in exces- decides to hold such a hearing, he shall sive inventory accumulation by all per- publish a notice of the hearing in the sons registered to handle that chemical FEDERAL REGISTER. The notice shall (including manufacturers, distributors, summarize the issues to be heard and importers, and exporters), notwith- set the time for the hearing, which standing the possibility that individual shall not be less than 30 days after the manufacturing quotas may be sus- date of publication of the notice. pended pursuant to § 1315.24(b) or aban- (f) After consideration of any com- doned pursuant to § 1315.27; ments or objections, or after a hearing (5) Other factors affecting medical, if one is ordered by the Administrator, scientific, research, industrial, and im- the Administrator shall issue and pub- portation needs in the United States, lish in the FEDERAL REGISTER the final lawful export requirements, and re- order determining the assessment of serve stocks, as the Administrator annual needs for the chemicals. The finds relevant, including changes in the order shall include the findings of fact and conclusions of law upon which the currently accepted medical use in order is based. The order shall specify treatment with the chemical or the the date on which it shall take effect. substances that are manufactured from A notice of the publication shall be it, the economic and physical avail- mailed simultaneously to each person ability of raw materials for use in man- registered as a manufacturer or im- ufacturing and for inventory purposes, porter of the chemical. yield and stability problems, potential disruptions to production (including § 1315.13 Adjustments of the assess- possible labor strikes), and recent un- ment of annual needs. foreseen emergencies such as floods (a) The Administrator may at any and fires. time increase or reduce the assessment (c) In the event that the Adminis- of annual needs for ephedrine, trator determines to increase or reduce pseudoephedrine, or phenylpropanola- the assessment of annual needs for a mine that has been previously fixed chemical, the Administrator shall pub- pursuant to § 1315.11. lish in the FEDERAL REGISTER general (b) In determining to adjust the as- notice of an adjustment in the assess- sessment of annual needs, the Adminis- ment of annual needs for that chemical trator shall consider the following fac- as determined under this section. A no- tors: tice of the publication shall be mailed (1) Changes in the demand for that simultaneously to each person reg- chemical, changes in the national rate istered as a manufacturer or importer of net disposal of the chemical, and of the chemical. changes in the rate of net disposal of (d) The Administrator shall permit the chemical by registrants holding in- any interested person to file written dividual manufacturing or import comments on or objections to the pro- quotas for that chemical; posal and shall designate in the notice (2) Whether any increased demand for the time during which such filings may that chemical, the national and/or be made.

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(e) The Administrator may, but is quantity of the chemical. Copies of not required to, hold a public hearing DEA Form 189 may be obtained from on one or more issues raised by the the Office of Diversion Control Web comments and objections filed with site, and must be filed (on or before him. In the event the Administrator April 1 of the year preceding the cal- decides to hold such a hearing, he shall endar year for which the manufac- publish a notice of the hearing in the turing quota is being applied) with the FEDERAL REGISTER. The notice shall UN Reporting & Quota Section, Diver- summarize the issues to be heard and sion Control Division, Drug Enforce- set the time for the hearing, which ment Administration. See the Table of shall not be less than 10 days after the date of publication of the notice. DEA Mailing Addresses in § 1321.01 of (f) After consideration of any com- this chapter for the current mailing ad- ments or objections, or after a hearing dress. A separate application must be if one is ordered by the Administrator, made for each chemical desired to be the Administrator shall issue and pub- manufactured. The applicant must lish in the FEDERAL REGISTER the final state the following: order determining the assessment of (a) The name and DEA Chemical annual needs for the chemical. The Code Number, as set forth in part 1310 order shall include the findings of fact of this chapter, of the chemical. and conclusions of law upon which the (b) For the chemical in each of the order is based. The order shall specify current and preceding 2 calendar years, the date on which it shall take effect. (1) The authorized individual manu- A notice of the publication shall be facturing quota, if any; mailed simultaneously to each person (2) The actual or estimated quantity registered as a manufacturer or im- manufactured; porter of the chemical. (3) The actual or estimated net disposal; Subpart C—Individual (4) The actual or estimated inventory Manufacturing Quotas allowance pursuant to § 1315.24; and § 1315.21 Individual manufacturing (5) The actual or estimated inventory quotas. as of December 31. The Administrator shall, on or before (c) For the chemical in the next cal- July 1 of each year, fix for and issue to endar year, each person registered to manufacture (1) The desired individual manufac- in bulk ephedrine, pseudoephedrine, or turing quota; and phenylpropanolamine who applies for a (2) Any additional factors that the manufacturing quota an individual applicant finds relevant to the fixing of manufacturing quota authorizing that the individual manufacturing quota, person to manufacture during the next including any of the following: calendar year a quantity of that chem- (i) The trend of (and recent changes ical. Any manufacturing quota fixed in) the applicant’s and the national and issued by the Administrator is sub- rates of net disposal. ject to his authority to reduce or limit (ii) The applicant’s production cycle it at a later date pursuant to § 1315.26 and current inventory position. and to his authority to revoke or sus- (iii) The economic and physical avail- pend it at any time pursuant to ability of raw materials for use in man- §§ 1301.36, 1309.43, 1309.44, or 1309.45 of this chapter. ufacturing and for inventory purposes. (iv) Yield and stability problems. § 1315.22 Procedure for applying for (v) Potential disruptions to produc- individual manufacturing quotas. tion (including possible labor strikes). Any person who is registered to man- (vi) Recent unforeseen emergencies ufacture ephedrine, pseudoephedrine, such as floods and fires. or phenylpropanolamine and who de- [72 FR 37448, July 10, 2007, as amended at 73 sires to manufacture a quantity of the FR 73555, Dec. 3, 2008; 75 FR 10684, Mar. 9, chemical must apply on DEA Form 189 2010] for a manufacturing quota for the

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§ 1315.23 Procedure for fixing indi- (iii) The economic and physical avail- vidual manufacturing quotas. ability of raw materials for use in man- (a) In fixing individual manufac- ufacturing and for inventory purposes. (iv) Yield and stability problems. turing quotas for ephedrine, (v) Potential disruptions to produc- pseudoephedrine, and phenylpropanola- tion (including possible labor strikes). mine, the Administrator shall allocate (vi) Recent unforeseen emergencies to each applicant who is currently such as floods and fires. manufacturing the chemical a quota (c) On or before March 1 of each year equal to 100 percent of the estimated the Administrator shall adjust the in- net disposal of that applicant for the dividual manufacturing quota allo- next calendar year, adjusted— cated for that year to each applicant in (1) By the amount necessary to in- paragraph (a) of this section by the crease or reduce the estimated inven- amount necessary to increase or reduce tory of the applicant on December 31 of the actual inventory of the applicant the current year to his estimated in- to December 31 of the preceding year to ventory allowance for the next cal- his estimated inventory allowance for endar year, pursuant to § 1315.24, and the current calendar year, pursuant to (2) By any other factors which the § 1315.24. Administrator deems relevant to the fixing of the individual manufacturing § 1315.24 Inventory allowance. quota of the applicant, including: (a) For the purpose of determining (i) The trend of (and recent changes individual manufacturing quotas pur- in) the applicant’s and the national suant to § 1315.23, each registered man- rates of net disposal, ufacturer shall be allowed as a part of (ii) The applicant’s production cycle the quota an amount sufficient to and current inventory position, maintain an inventory equal to either (iii) The economic and physical avail- of the following: ability of raw materials for use in man- (1) For current manufacturers, 50 per- ufacturing and for inventory purposes, cent of his average estimated net dis- (iv) Yield and stability problems, posal for the current calendar year and (v) Potential disruptions to produc- the last preceding calendar year; or tion (including possible labor strikes), (2) For new manufacturers, 50 percent and of his reasonably estimated net dis- (vi) Recent unforeseen emergencies posal for the next calendar year as de- such as floods and fires. termined by the Administrator. (b) During each calendar year each (b) In fixing individual manufac- registered manufacturer shall be al- turing quotas for a chemical, the Ad- lowed to maintain an inventory of a ministrator shall allocate to each ap- chemical not exceeding 65 percent of plicant who is not currently manufac- his estimated net disposal of that turing the chemical a quota equal to chemical for that year, as determined 100 percent of the reasonably estimated at the time his quota for that year was net disposal of that applicant for the determined. At any time the inventory next calendar year, as determined by of a chemical held by a manufacturer the Administrator, adjusted— exceeds 65 percent of his estimated net (1) By the amount necessary to pro- disposal, his quota for that chemical is vide the applicant his estimated inven- automatically suspended and shall re- tory allowance for the next calendar main suspended until his inventory is year, pursuant to § 1315.24; and less than 60 percent of his estimated (2) By any other factors which the net disposal. The Administrator may, Administrator deems relevant to the upon application and for good cause fixing of the individual manufacturing shown, permit a manufacturer whose quota of the applicant, including any of quota is, or is likely to be, suspended the following: under this paragraph to continue man- (i) The trend of (and recent changes ufacturing and to accumulate an inven- in) the national rate of net disposal. tory in excess of 65 percent of his esti- (ii) The applicant’s production cycle mated net disposal, upon such condi- and current inventory position. tions and within such limitations as

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the Administrator may find necessary § 1315.13. If a quota assigned to a new or desirable. manufacturer pursuant to § 1315.23(b), (c) If, during a calendar year, a reg- or if a quota assigned to any manufac- istrant has manufactured the entire turer is increased pursuant to quantity of a chemical allocated to § 1315.24(c), or if an import quota issued him under an individual manufacturing to an importer pursuant to § 1315.34, quota, and his inventory of that chem- causes the total quantity of a chemical ical is less than 40 percent of his esti- to be manufactured and imported dur- mated net disposal of that chemical for ing the year to exceed the assessment that year, the Administrator may, of annual needs that has been estab- upon application pursuant to § 1315.25, lished for that chemical pursuant to increase the quota of such registrant § 1315.11, as adjusted pursuant to sufficiently to allow restoration of the § 1315.13, the Administrator may pro- inventory to 50 percent of the esti- portionately reduce the individual mated net disposal for that year. manufacturing quotas and import quotas of all other registrants to keep § 1315.25 Increase in individual manu- the assessment of annual needs within facturing quotas. the limits originally established, or, al- (a) Any registrant who holds an indi- ternatively, the Administrator may re- vidual manufacturing quota for a duce the individual manufacturing chemical may file with the Adminis- quota of any registrant whose quota is trator an application on DEA Form 189 suspended pursuant to § 1315.24(b) or for an increase in the registrant’s §§ 1301.36, 1309.43, 1309.44, or 1309.45 of quota to meet the registrant’s esti- this chapter or is abandoned pursuant mated net disposal, inventory, and to § 1315.27. other requirements during the remainder of that calendar year. § 1315.27 Abandonment of quota. (b) The Administrator, in passing Any manufacturer assigned an indi- upon a registrant’s application for an vidual manufacturing quota for a increase in the individual manufac- chemical pursuant to § 1315.23 may at turing quota, shall take into consider- any time abandon his right to manu- ation any occurrences since the filing facture all or any part of the quota by of the registrant’s initial quota appli- filing with the UN Reporting & Quota cation that may require an increased Section, Diversion Control Division, manufacturing rate by the registrant Drug Enforcement Administration a during the balance of the calendar written notice of the abandonment, year. In passing upon the application stating the name and DEA Chemical the Administrator may also take into Code Number, as set forth in part 1310 consideration the amount, if any, by of this chapter, of the chemical and the which his determination of the total amount which he has chosen not to quantity for the chemical to be manu- manufacture. The Administrator may, factured under § 1315.11 exceeds the ag- in his discretion, allocate the amount gregate of all the individual manufac- among the other manufacturers in pro- turing quotas for the chemical, and the portion to their respective quotas. equitable distribution of such excess among other registrants. Subpart D—Procurement and § 1315.26 Reduction in individual man- Import Quotas ufacturing quotas. The Administrator may at any time § 1315.30 Procurement and import quotas. reduce an individual manufacturing quota for a chemical that he has pre- (a) To determine the estimated needs viously fixed to prevent the aggregate for, and to insure an adequate and un- of the individual manufacturing quotas interrupted supply of, ephedrine, and import quotas outstanding or to be pseudoephedrine, and phenylpropanola- granted from exceeding the assessment mine the Administrator shall issue proof annual needs that has been estab- curement and import quotas. lished for that chemical pursuant to (b) A procurement quota authorizes a § 1315.11, as adjusted pursuant to registered manufacturer to procure and

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

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

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

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stocks, and the total quantity of the to the issuance, adjustment, suspen- chemical that will be produced. sion, or denial of a manufacturing, procurement, or import quota are gov- [72 FR 37448, July 10, 2007, as amended at 75 FR 10684, Mar. 9, 2010] erned generally by the adjudication procedures set forth in the Administra- § 1315.36 Amending an import quota. tive Procedure Act (5 U.S.C. 551–559) (a) An import quota authorizes the and specifically by section 1002 of the registered importer to import up to the Act (21 U.S.C. 952), by §§ 1315.52 through set quantity of ephedrine, 1315.62 of this part, and by the proce- pseudoephedrine, or phenylpropanola- dures for administrative hearings mine and distribute the chemical or under the Act set forth in §§ 1316.41 drug products on the DEA Form 488. An through 1316.67 of this chapter. importer must apply to change the § 1315.52 Purpose of hearing. quantity to be imported. (b) Any person to whom an import (a) The Administrator may, in his quota has been issued may at any time sole discretion, hold a hearing for the request an increase in the quota quan- purpose of receiving factual evidence tity by applying to the Administrator regarding any one or more issues (to be with a statement showing the need for specified by him) involved in the deter- the adjustment. The application must mination or adjustment of any assess- be filed with the UN Reporting & Quota ment of national needs. Section, Diversion Control Division, (b) If requested by a person applying Drug Enforcement Administration. See for or holding a procurement, import, the Table of DEA Mailing Addresses in or individual manufacturing quota, the § 1321.01 of this chapter for the current Administrator shall hold a hearing for mailing address. The Administrator the purpose of receiving factual evi- may increase the import quota of the dence regarding the issues involved in person if and to the extent that he de- the issuance, adjustment, suspension, termines that the approval is necessary or denial of the quota to the person, to provide for medical, scientific, or but the Administrator need not hold a other legitimate purposes regarding hearing on suspension of a quota under the chemical. The Administrator shall § 1301.36 or § 1309.43 of this chapter sepa- specify a period of time for which the rate from a hearing on the suspension approval is in effect or shall provide of registration under that section. that the approval is in effect until the (c) Extensive argument should not be Administrator notifies the applicant in offered into evidence, but rather pre- writing that the approval is termi- sented in opening or closing state- nated. ments of counsel or in memoranda or (c) With respect to the application proposed findings of fact and conclu- under paragraph (b) of this section, the sions of law. Administrator shall approve or deny § 1315.54 Waiver or modification of the application within 60 days of re- rules. ceiving the application. If the Adminis- trator does not approve or deny the ap- The Administrator or the presiding plication within 60 days of receiving it, officer (with respect to matters pend- the application is deemed to be ap- ing before him) may modify or waive proved and the approval remains in ef- any rule in this part by notice in ad- fect until the Administrator notifies vance of the hearing, if he determines the applicant in writing that the ap- that no party in the hearing will be un- proval is terminated. duly prejudiced and the ends of justice will thereby be served. Such notice of [72 FR 37448, July 10, 2007, as amended at 75 modification or waiver shall be made a FR 10685, Mar. 9, 2010] part of the record of the hearing. Subpart E—Hearings § 1315.56 Request for hearing or appearance; waiver. § 1315.50 Hearings generally. (a) Any applicant or registrant enti- The procedures for the hearing re- tled to a hearing under § 1315.52 and lated to assessment of annual needs or who desires a hearing on the issuance,

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

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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. 1316.49 Waiver of hearing. sessment of annual needs or on the 1316.50 Appearance; representation; author- issuance, adjustment, suspension, or ization. denial of the procurement, import, or 1316.51 Conduct of hearing and parties; ex individual manufacturing quota, as the parte communications. case may be. The order shall include 1316.52 Presiding officer. the findings of fact and conclusions of 1316.53 Time and place of hearing. law upon which the order is based. The 1316.54 Prehearing conference. order shall specify the date on which it 1316.55 Prehearing ruling. 1316.56 Burden of proof. shall take effect. The Administrator 1316.57 Submission of documentary evidence shall serve one copy of his order upon and affidavits and identification of wit- each party in the hearing. nesses subsequent to prehearing conference. PART 1316—ADMINISTRATIVE 1316.58 Summary of testimony; affidavits. 1316.59 Submission and receipt of evidence. FUNCTIONS, PRACTICES, AND 1316.60 Objections; offer of proof. PROCEDURES 1316.61 Exceptions to rulings. 1316.62 Interlocutory appeals from rulings Subpart A—Administrative Inspections of the presiding officer. 1316.63 Official transcript; index; correc- Sec. tions. 1316.01 Scope of subpart A. 1316.64 Proposed findings of fact and conclu- 1316.02 Definitions. sions of law. 1316.03 Authority to make inspections. 1316.65 Report and record. 1316.04 Exclusion from inspection. 1316.66 Exceptions. 1316.05 Entry. 1316.67 Final order. 1316.06 Notice of inspection. 1316.68 Copies of petitions for judicial re- 1316.07 Requirement for administrative in- view. spection warrant; exceptions. 1316.08 Consent to inspection. SOURCE: 36 FR 7820, Apr. 24, 1971, unless 1316.09 Application for administrative in- otherwise noted. Redesignated at 38 FR 26609, spection warrant. Sept. 24, 1973. 1316.10 Administrative probable cause. 1316.11 Execution of warrants. Subpart A—Administrative 1316.12 Refusal to allow inspection with an administrative warrant. Inspections 1316.13 Frequency of administrative inspections. AUTHORITY: 21 U.S.C. 822(f), 830(a), 871(b), 880, 958(f), 965. Subpart B—Protection of Researchers and Research Subjects § 1316.01 Scope of subpart A. 1316.21 Definitions. Procedures regarding administrative 1316.22 Exemption. inspections and warrants pursuant to 1316.23 Confidentiality of identity of re- sections 302(f), 510, 1008(d), and 1015 of search subjects. the Act (21 U.S.C. 822(f), 880, 958(d), and 1316.24 Exemption from prosecution for re- 965) are governed generally by those searchers. sections and specifically by the sec- Subpart C—Enforcement Proceedings tions of this subpart. 1316.31 Authority for enforcement pro- § 1316.02 Definitions. ceeding. As used in this subpart, the following 1316.32 Notice of proceeding; time and place. 1316.33 Conduct of proceeding. terms shall have the meanings speci- 1316.34 Records of proceeding. fied: (a) The term Act means the Con- Subpart D—Administrative Hearings trolled Substances Act (84 Stat. 1242; 21 U.S.C. 801) and/or the Controlled Sub- 1316.41 Scope of subpart D. 1316.42 Definitions. stances Import and Export Act (84 1316.43 Information; special instructions. Stat. 1285; 21 U.S.C. 951). 1316.44 Waiver or modification of rules. (b) The term Administration means 1316.45 Filings; address; hours. the Drug Enforcement Administration.

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(c) The term controlled premises part 1305 of this chapter, prescription means— and distribution records required to be (1) Places where original or other kept pursuant to part 1306 of this chap- records or documents required under ter, records of listed chemicals, the Act are kept or required to be kept, tableting machines, and encapsulating and machines required to be kept pursuant (2) Places, including factories, ware- to part 1310 of this chapter, import/ex- houses, or other establishments and port records of listed chemicals re- conveyances, where persons registered quired to be kept pursuant to part 1313 under the Act or exempted from reg- of this chapter, shipping records identi- istration under the Act, or regulated fying the name of each carrier used and persons may lawfully hold, manufac- the date and quantity of each ship- ture, or distribute, dispense, admin- ment, and storage records identifying ister, or otherwise dispose of controlled the name of each warehouse used and substances or listed chemicals or where the date and quantity of each storage. records relating to those activities are maintained. (b) Inspecting within reasonable lim- (d) The term Administrator means the its and to a reasonable manner all per- Administrator of the Administration. tinent equipment, finished and unfin- The Administrator has been delegated ished controlled substances, listed authority under the Act by the Attor- chemicals, and other substances or ma- ney General (28 CFR 0.100). terials, containers, and labeling found (e) The term inspector means an offi- at the controlled premises relating to cer or employee of the Administration this Act; authorized by the Administrator to (c) Making a physical inventory of make inspections under the Act. all controlled substances and listed (f) The term register and registration chemicals on-hand at the premises; refer to registration required and per- (d) Collecting samples of controlled mitted by sections 303 and 1008 of the substances or listed chemicals (in the Act (21 U.S.C. 823 and 958). event any samples are collected during (g) Any term not defined in this part an inspection, the inspector shall issue shall have the definition set forth in a receipt for such samples on DEA section 102 of the Act (21 U.S.C. 802) or Form 400 to the owner, operator, or part 1300 of this chapter. agent in charge of the premises); [36 FR 7820, Apr. 24, 1971. Redesignated at 38 (e) Checking of records and informa- FR 26609, Sept. 24, 1973, as amended at 60 FR tion on distribution of controlled sub- 32465, June 22, 1995; 60 FR 36334, July 14, 1995; stances or listed chemicals by the reg- 62 FR 13969, Mar. 24, 1997] istrant or regulated person (i.e., has § 1316.03 Authority to make inspec- the distribution of controlled sub- tions. stances or listed chemicals increased In carrying out his functions under markedly within the past year, and if the Act, the Administrator, through so why); his inspectors, is authorized in accord- (f) Except as provided in § 1316.04, all ance with sections 510 and 1015 of the other things therein (including records, Act (21 U.S.C. 880 and 965) to enter con- files, papers, processes, controls and fa- trolled premises and conduct adminis- cilities) appropriate for verification of trative inspections thereof, for the pur- the records, reports, documents re- pose of: ferred to above or otherwise bearing on (a) Inspecting, copying, and verifying the provisions of the Act and the regu- the correctness of records, reports, or lations thereunder. other documents required to be kept or made under the Act and regulations [36 FR 7820, Apr. 24, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973, and amended at 51 promulgated under the Act, including, FR 5319, Feb. 13, 1986; 55 FR 50827, Dec. 11, but not limited to, inventory and other 1990; 60 FR 32465, June 22, 1995; 77 FR 4238, records required to be kept pursuant to Jan. 27, 2012] part 1304 of this chapter, order form records required to be kept pursuant to

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§ 1316.04 Exclusion from inspection. for initial registration under the Act, (a) Unless the owner, operator or for the inspection of books and records agent in charge of the controlled prem- pursuant to an administrative sub- ises so consents in writing, no inspec- poena issued in accordance with section authorized by these regulations tion 506 of the Act (21 U.S.C. 876) nor shall extend to: for entries in administrative inspec- (1) Financial data: tions (including seizures of property): (2) Sales data other than shipping (a) With the consent of the owner, op- data; or erator, or agent in charge of the con- (3) Pricing data. trolled premises as set forth in § 1316.08; (b) [Reserved] (b) In situations presenting imminent danger to health or safety; § 1316.05 Entry. (c) In situations involving inspection An inspection shall be carried out by of conveyances where there is reason- an inspector. Any such inspector, upon able cause to obtain a warrant; (a) stating his purpose and (b) pre- (d) In any other exceptional or emer- senting to the owner, operator or agent gency circumstance or time or oppor- in charge of the premises to be in- tunity to apply for a warrant is lack- spected (1) appropriate credentials, and ing; or (2) written notice of his inspection au- (e) In any other situations where a thority under § 1316.06 of this chapter, warrant is not constitutionally re- and (c) receiving informed consent quired. under § 1316.08 or through the use of administrative warrant issued under § 1316.08 Consent to inspection. §§ 1316.09–1316.13, shall have the right to (a) An administrative inspection war- enter such premises and conduct in- rant shall not be required if informed spections at reasonable times and in a consent is obtained from the owner, op- reasonable manner. erator, or agent in charge of the con- [36 FR 7820, Apr. 24, 1971, as amended at 36 trolled premises to be inspected. FR 13387, July 21, 1971. Redesignated at 38 FR (b) Wherever possible, informed con- 26609, Sept. 24, 1973; 62 FR 13970, Mar. 24, 1997] sent shall consist of a written statement signed by the owner, operator, or § 1316.06 Notice of inspection. agent in charge of the premises to be The notice of inspection (DEA (or inspected and witnessed by two per- DNB) Form 82) shall contain: sons. The written consent shall contain (a) The name and title of the owner, the following information: operator, or agent in charge of the con- (1) That he (the owner, operator, or trolled premises; agent in charge of the premises) has (b) The controlled premises name; been informed of his constitutional (c) The address of the controlled right not to have an administrative in- premises to be inspected; spection made without an administra- (d) The date and time of the inspec- tive inspection warrant; tion; (2) That he has right to refuse to con- (e) A statement that a notice of in- sent to such an inspection; spection is given pursuant to section 510 of the Act (21 U.S.C. 880); (3) That anything of an incriminating (f) A reproduction of the pertinent nature which may be found may be parts of section 510 of the Act; and seized and used against him in a crimi- (g) The signature of the inspector. nal prosecution; (4) That he has been presented with a § 1316.07 Requirement for administra- notice of inspection as set forth in tive inspection warrant; exceptions. § 1316.06; In all cases where an inspection is (5) That the consent is given by him contemplated, an administrative in- is voluntary and without threats of any spection warrant is required pursuant kind; and to section 510 of the Act (21 U.S.C. 880), (6) That he may withdraw his consent except that such warrant shall not be at any time during the course of in- required for establishments applying spection.

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(c) The written consent shall be pro- § 1316.11 Execution of warrants. duced in duplicate and be distributed An administrative inspection war- as follows: rant shall be executed and returned as (1) The original will be retained by the inspector; and required by, and any inventory or sei- (2) The duplicate will be given to the zure made shall comply with the re- person inspected. quirements of, section 510(d)(3) of the Act (21 U.S.C. 880(d)(3)). The inspection [36 FR 7820, Apr. 24, 1971, as amended at 37 shall begin as soon as is practicable FR 15924, Aug. 8, 1972. Redesignated at 38 FR after the issuance of the administra- 26609, Sept. 24, 1973] tive inspection warrant and shall be § 1316.09 Application for administra- completed with reasonable promptness. tive inspection warrant. The inspection shall be conducted dur- (a) An administrative inspection war- ing regular business hours and shall be rant application shall be submitted to completed in a reasonable manner. any judge of the United States or of a § 1316.12 Refusal to allow inspection State court of record, or any United with an administrative warrant. States magistrate and shall contain the following information: If a registrant or any person subject (1) The name and address of the con- to the Act refuses to permit execution trolled premises to be inspected; of an administrative warrant or im- (2) A statement of statutory author- pedes the inspector in the execution of ity for the administrative inspection that warrant, he shall be advised that warrant, and that the fact that the par- such refusal or action constitutes a ticular inspection in question is de- violation of section 402(a)(6) of the Act signed to insure compliance with the (21 U.S.C. 842(a)(6)). If he persists and Act and the regulations promulgated the circumstances warrant, he shall be thereunder; arrested and the inspection shall com- (3) A statement relating to the na- mence or continue. ture and extent of the administrative inspection, including, where necessary, [36 FR 7820, Apr. 24, 1971. Redesignated at 38 a request to seize specified items and/or FR 26609, Sept. 24, 1973, as amended at 62 FR to collect samples of finished or unfin- 13970, Mar. 24, 1997] ished controlled substances or listed § 1316.13 Frequency of administrative chemicals; inspections. (4) A statement that the establishment either: Except where circumstances other- (i) Has not been previously inspected, wise dictate, it is the intent of the Ad- or ministration to inspect all manufactur- (ii) Was last inspected on a particular ers of controlled substances listed in date. Schedules I and II and distributors of (b) The application shall be sub- controlled substances listed in Sched- mitted under oath to an appropriate ule I once each year. Distributors of judge or magistrate. controlled substances listed in Sched- ules II through V and manufacturers of [36 FR 7820, Apr. 24, 1971, as amended at 36 FR 13387, July 21, 1971. Redesignated at 38 FR controlled substances listed in Sched- 26609, Sept. 24, 1973; 60 FR 32466, June 22, 1995] ules III through V shall be inspected as circumstances may require, based in § 1316.10 Administrative probable part on the registrant’s history of com- cause. pliance with the requirements of this If the judge or magistrate is satisfied chapter and maintenance of effective that ‘‘administrative probable cause,’’ controls and procedures to guard as defined in section 510(d)(1) of the Act against the diversion of controlled sub- (21 U.S.C. 880(d)(1)) exists, he shall stances. issue an administrative warrant. Ad- ministrative probable cause shall not [62 FR 13969, Mar. 24, 1997] mean criminal probable cause as defined by Federal statute or case law.

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Subpart B—Protection of Re- identity of those persons who are the searchers and Research Sub- subjects of such research may petition jects the Administrator of the Drug Enforce- ment Administration for a grant of confidentiality: Providing, That: AUTHORITY: 21 U.S.C. 830, 871(b). (1) The Attorney General is author- § 1316.21 Definitions. ized to carry out such research under the provisions of Section 502(a) (2–6) of As used in this part, the following the Controlled Substances Act of 1970 terms shall have the meanings speci- (21 U.S.C. 872(a) (2–6)); and the research fied: is being conducted with funds provided (a) The term investigative personnel in whole or part by the Department of includes managers, Diversion Inves- Justice; or tigators, attorneys, analysts and sup- (2) The research is of a nature that port personnel employed by the Drug the Attorney General would be author- Enforcement Administration who are ized to carry out under the provisions involved in the processing, reviewing of Section 502(a) (2–6) of the Controlled and analyzing of declarations and other Substances Act (21 U.S.C. 872(a) (2–6), relevant documents or data relative to and is being conducted with funds pro- regulated transactions or are involved vided from sources outside the Depart- in conducting investigations initiated ment of Justice. pursuant to the receipt of such declara- (b) All petitions for Grants of Con- tions, documents or data. fidentiality shall be addressed to the (b) The term law enforcement per- Administrator, Drug Enforcement Ad- sonnel means Special Agents employed ministration (see the Table of DEA by the Drug Enforcement Administra- Mailing Addresses in § 1321.01 of this tion who, in the course of their official chapter for the current mailing ad- duties, gain knowledge of information dress): which is confidential under such sec- (1) A statement as to whether the re- tion. search protocol requires the manufac- [54 FR 31670, Aug. 1, 1989] ture, production, import, export, distribution, dispensing, administration, § 1316.22 Exemption. or possession of controlled substances, (a) Any person who is aggrieved by a and if so the researcher’s registration disclosure of information in violation number or a statement that an applica- of subsection (c)(1) of Section 310 of the tion for such registration has been sub- Controlled Substances Act (21 U.S.C. mitted to DEA; 830) may bring a civil action against (2) The location of the research the violator for appropriate relief. project; (b) Notwithstanding the provision of (3) The qualifications of the principal paragraph (a), a civil action may not be investigator; brought under such paragraph against (4) A general description of the re- investigative or law enforcement per- search or a copy of the research pro- sonnel of the Drug Enforcement Ad- tocol; ministration. (5) The source of funding for the re- [54 FR 31670, Aug. 1, 1989] search project; (6) A statement as to the risks posed § 1316.23 Confidentiality of identity of to the research subjects by the re- research subjects. search procedures and what protection (a) Any person conducting a bona fide will be afforded to the research sub- research project directly related to the jects; enforcement of the laws under the ju- (7) A statement as to the risks posed risdiction of the Attorney General con- to society in general by the research cerning drugs or other substances procedures and what measures will be which are or may be subject to control taken to protect the interests of soci- under the Controlled Substances Act ety; (84 Stat. 1242; 21 U.S.C. 801) who intends (8) A specific request to withhold the to maintain the confidentiality of the names and/or any other identifying

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

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(c) Any researcher or practitioner tion is contemplated under the Con- proposing to engage in research re- trolled Substances Act (84 Stat. 1242; 21 questing both exemption from prosecu- U.S.C. 801) or the Controlled Sub- tion and confidentiality of identity of stances Import and Export Act (84 research subjects may submit a single Stat. 1285; 21 U.S.C. 951) an opportunity petition incorporating the information to present his views and his proposals required in §§ 1316.23(b) and 1316.24(b). for bringing his alleged violations into (d) The exemption shall consist of a compliance with the law. Such hearing letter issued by the Administrator, will also permit him to show cause why which shall include: prosecution should not be instituted, (1) The researcher’s name and ad- or to present his views on the con- dress; templated proceeding. (2) The researcher’s registration number for the research project; [36 FR 7820, Apr. 24, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973, and amended at 47 (3) The location of the research FR 41735, Sept. 22, 1982] project; (4) A concise statement of the scope § 1316.32 Notice of proceeding; time of the researcher’s registration; and place. (5) Any limits of the exemption; and Appropriate notice designating the (6) A statement that the exemption time and place for the hearing shall be shall apply to all acts done in the scope given to the person. Upon request, of the exemption while the exemption timely and properly made, by the per- is in effect. The exemption shall re- son to whom notice has been given, the main in effect until completion of the time or place of the hearing, or both, research project or until the registration of the researcher is either revoked may be changed if the request states or suspended or his renewal of registra- reasonable grounds for such change. tion is denied. However, the protection Such request shall be addressed to the afforded by the grant of exemption Special Agent in Charge who issued the from prosecution during the research notice. period shall be perpetual. [36 FR 7820, Apr. 24, 1971. Redesignated at 38 (e) Within 30 days of the date of com- FR 26609, Sept. 24, 1973, and amended at 47 pletion of the research project, the re- FR 41735, Sept. 22, 1982] searcher shall so notify the Adminis- trator. The Administrator shall issue § 1316.33 Conduct of proceeding. another letter including the informa- Presentation of views at a hearing tion required in paragraph (d) of this under this subpart shall be private and section and stating the date of which informal. The views presented shall be the period of exemption concluded; confined to matters relevant to bring- upon receipt of this letter the re- ing violations into compliance with the searcher shall return the original let- Act or to other contemplated pro- ter of exemption. ceedings under the Act. These views [42 FR 54946, Oct. 12, 1977. Redesignated at 54 may be presented orally or in writing FR 31670, Aug. 1, 1989, as amended at 62 FR by the person to whom the notice was 13970, Mar. 24, 1997; 75 FR 10685, Mar. 9, 2010] given, or by his authorized representative. Subpart C—Enforcement Proceedings § 1316.34 Records of proceeding. A formal record, either verbatim or AUTHORITY: 21 U.S.C. 871(b), 883. summarized, of the hearing may be made at the discretion of the Special § 1316.31 Authority for enforcement Agent in Charge. If a verbatim record proceeding. is to be made, the person attending the A hearing may be ordered or granted hearing will be so advised prior to the by any Special Agent in Charge of the start of the hearing. Drug Enforcement Administration, at [37 FR 15924, Aug. 8, 1972. Redesignated at 38 his discretion, to permit any person FR 26609, Sept. 24, 1973, and amended at 47 against whom criminal and/or civil ac- FR 41735, Sept. 22, 1982]

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Subpart D—Administrative section 102 of the Act (21 U.S.C. 802) or Hearings part 1300 of this chapter. [36 FR 7820, Apr. 24, 1971, as amended at 38 AUTHORITY: 21 U.S.C. 811, 812, 871(b), 875, FR 757, Jan. 4, 1973. Redesignated at 38 FR 958(d), 965. 26609, Sept. 24, 1973, as amended at 62 FR 13969, Mar. 24, 1997; 77 FR 4238, Jan. 27, 2012] § 1316.41 Scope of subpart D. § 1316.43 Information; special instruc- Procedures in any administrative tions. hearing held under the Act are governed generally by the rule making Information regarding procedure and/or adjudication procedures set under these rules and instructions forth in the Administrative Procedure supplementing these rules in special Act (5 U.S.C. 551–559) and specifically instances will be furnished by the by the procedures set forth in this sub- Hearing Clerk upon request. part, except where more specific regu- § 1316.44 Waiver or modification of lations (set forth in §§ 1301.51–1301.57, rules. §§ 1303.31–1303.37, §§ 1308.41–1308.51, §§ 1311.51–1311.53, §§ 1312.41–1312.47, The Administrator or the presiding §§ 1313.51–1313.57, or §§ 1315.50–1315.62) officer (with respect to matters pend- apply. ing before him) may modify or waive any rule in this subpart by notice in [73 FR 73556, Dec. 3, 2008] advance of the hearing, if he determines that no party in the hearing will § 1316.42 Definitions. be unduly prejudiced and the ends of As used in this subpart, the following justice will thereby be served. Such no- terms shall have the meanings speci- tice of modification or waiver shall be fied: made a part of the record of the hear- (a) The term Act means the Con- ing. trolled Substances Act (84 Stat. 1242; 21 U.S.C. 801) and/or the Controlled Sub- § 1316.45 Filings; address; hours. stances Import and Export Act (84 Documents required or permitted to Stat. 1285; 21 U.S.C. 951). be filed in, and correspondence relating (b) The term Administrator means the to, hearings governed by the regula- Administrator of the Administration. tions in this chapter shall be filed with The Administrator has been delegated the Hearing Clerk, Drug Enforcement authority under the Act by the Attor- Administration. See the Table of DEA ney General (28 CFR 0.100). Mailing Addresses in § 1321.01 of this (c) The term hearing means any hear- chapter for the current mailing ad- ing held pursuant to the Act. dress. This office is open Monday (d) The term Hearing Clerk means the through Friday from 8:30 a.m. to 5 p.m. hearing clerk of the Administration. eastern standard or daylight saving (e) The term person includes an indi- time, whichever is effective in the Dis- vidual, corporation, government or trict of Columbia at the time, except governmental subdivision or agency, on national legal holidays. Documents business trust, partnership, association shall be dated and deemed filed upon or other legal entity. receipt by the Hearing Clerk. (f) The term presiding officer means an administrative law judge qualified [75 FR 10685, Mar. 9, 2010] and appointed as provided in the Ad- ministrative Procedure Act (5 U.S.C. § 1316.46 Inspection of record. 556). (a) The record bearing on any pro- (g) The term proceeding means all ac- ceeding, except for material described tions involving a hearing, commencing in subsection (b) of this section, shall with the publication by the Adminis- be available for inspection and copying trator of the notice of proposed rule- by any person entitled to participate in making or the issuance of an order to such proceeding, during office hours in show cause. the office of the Hearing Clerk, Drug (h) Any term not defined in this part Enforcement Administration. See the shall have the definition set forth in Table of DEA Mailing Addresses in

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§ 1321.01 of this chapter for the current (B) (State with particularity the objections mailing address. or issues, if any, concerning which the per- (b) The following material shall not son desires to be heard.) (C) (State briefly the position of the person be available for inspection as part of with regard to the particular objections or the record: issues.) (1) A research protocol filed with an All notices to be sent pursuant to the pro- application for registration to conduct ceeding should be addressed to: research with controlled substances (Name) lllllllllllllllllll listed in Schedule I, pursuant to (Street Address) lllllllllllllll § 1301.32 (a)(6) of this chapter, if the ap- (City and State) lllllllllllllll plicant requests that the protocol be Respectfully yours, kept confidential; (Signature of Person) llllllllllll (2) An outline of a production or (b) The Administrative Law Judge, manufacturing process filed with an upon request and showing of good application for registration to manu- cause, may grant a reasonable exten- facture a new narcotic controlled sub- sion of the time allowed for response to stance, pursuant to § 1301.33 of this an Order to Show Cause. chapter, if the applicant requests that [36 FR 7820, Apr. 24, 1971, as amended at 36 the outline be kept confidential; FR 13387, July 21, 1971. Redesignated at 38 FR (3) Any confidential or trade secret 26609, Sept. 24, 1973] information disclosed in conjunction EDITORIAL NOTE: For FEDERAL REGISTER ci- with an application for registration, or tations affecting § 1316.47, see the List of CFR in reports filed while registered, or ac- Sections Affected, which appears in the quired in the course of an investiga- Finding Aids section of the printed volume tion, entitled to protection under sub- and at www.govinfo.gov. section 402(a) (8) of the Act (21 U.S.C. § 1316.48 Notice of appearance. 842(a) (8)) or any other law restricting public disclosure of information; and Any person entitled to a hearing and (4) Any material contained in any in- desiring to appear in any hearing, vestigatory report, memorandum, or shall, if he or she has not filed a re- file, or case report compiled by the Ad- quest for hearing, file within the time ministration. specified in the notice of proposed rulemaking, a written notice of appearance [36 FR 7820, Apr. 24, 1971. Redesignated at 38 in the following format (see the Table FR 26609, Sept. 24, 1973, as amended at 62 FR of DEA Mailing Addresses in § 1321.01 of 13970, Mar. 24, 1997; 75 FR 10645, Mar. 9, 2010] this chapter for the current mailing address): § 1316.47 Request for hearing. (Date) llllllllllllllllllll (a) Any person entitled to a hearing Drug Enforcement Administration, Attn: and desiring a hearing shall, within the Hearing Clerk/OALJ period permitted for filing, file a re- (Mailing Address) llllllllllllll quest for a hearing and/or an answer Subject: Notice of Appearance that complies with the following for- Dear Sir: mat (see the Table of DEA Mailing Ad- Please take notice that llllll (Name dresses in § 1321.01 of this chapter for of person) will appear in the matter of: the current mailing address): llllll (Identification of the proceeding). (Date) llllllllllllllllllll (A) (State with particularity the interest Drug Enforcement Administration, Attn: of the person in the proceeding.). Hearing Clerk/OALJ (B) (State with particularity the objections (Mailing Address) llllllllllllll or issues, if any, concerning which the per- Subject: Request for Hearing son desires to be heard.). (C) (State briefly the position of the person Dear Sir: with regard to the particular objections or The undersigned llllll (Name of the issues.). Person) hereby requests a hearing in the All notices to be sent pursuant to this ap- matter of: llllll (Identification of the pearance should be addressed to: proceeding). (Name) lllllllllllllllllll (A) (State with particularity the interest (Street Address) lllllllllllllll of the person in the proceeding.) (City and State) lllllllllllllll

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Respectfully yours, shall constitute grounds for immediate (Signature of Person) llllllllllll exclusion from any hearing. [81 FR 97041, Dec. 30, 2016] (c) If any official of the Administra- tion is contacted by any individual in § 1316.49 Waiver of hearing. private or public life concerning any Any person entitled to a hearing substantive matter which is the sub- may, within the period permitted for ject of any hearing, at any time after filing a request for hearing or notice of the date on which the proceedings com- appearance, waiver of an opportunity mence, the official who is contacted for a hearing, together with a written shall prepare a memorandum setting statement regarding his position on forth the substance of the conversation the matters of fact and law involved in and shall file this memorandum in the such hearing. Such statement, if ad- appropriate public docket file. The pre- missible, shall be made a part of the siding officer and employees of the Ad- record and shall be considered in light ministration shall comply with the re- of the lack of opportunity for cross-ex- quirements of 5 U.S.C. 554(d) regarding amination in determining the weight ex parte communications and partici- to be attached to matters of fact as- pation in any hearing. serted therein. § 1316.52 Presiding officer. § 1316.50 Appearance; representation; A presiding officer, designated by the authorization. Administrator, shall preside over all Any person entitled to appear in a hearings. The functions of the prehearing may appear in person or by a siding officer shall commence upon his representative in any proceeding or designation and terminate upon the hearing and may be heard with respect certification of the record to the Ad- to matters relevant to the issues under ministrator. The presiding officer shall consideration. A representative must have the duty to conduct a fair hear- either be an employee of the person or ing, to take all necessary action to an attorney at law who is a member of avoid delay, and to maintain order. He the bar, in good standing, of any State, shall have all powers necessary to territory, or the District of Columbia, these ends, including (but not limited and admitted to practice before the to) the power to: highest court of that jurisdiction. Any (a) Arrange and change the date, representative may be required by the time, and place of hearings (other than Administrator or the presiding officer the time and place prescribed in to present a notarized power of attor- § 1301.56) and prehearing conferences ney showing his authority to act in and issue notice thereof. such representative capacity and/or an (b) Hold conferences to settle, sim- affidavit or certificate of admission to plify, or determine the issues in a hear- practice. ing, or to consider other matters that may aid in the expeditious disposition [36 FR 7820, Apr. 24, 1971, as amended at 36 FR 13387, July 21, 1971. Redesignated at 38 FR of the hearing. 26609, Sept. 24, 1973] (c) Require parties to state their position in writing with respect to the § 1316.51 Conduct of hearing and par- various issues in the hearing and to ex- ties; ex parte communications. change such statements with all other (a) Hearings shall be conducted in an parties. informal but orderly manner in accord- (d) Sign and issue subpoenas to com- ance with law and the directions of the pel the attendance of witnesses and the presiding officer. production of documents and materials (b) Participants in any hearing and to the extent necessary to conduct ad- their representatives, whether or not ministrative hearings pending before members of the bar, shall conduct him. themselves in accordance with judicial (e) Examine witnesses and direct wit- standards of practice and ethics and nesses to testify. the directions of the presiding officer. (f) Receive, rule on, exclude, or limit Refusal to comply with this section evidence.

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(g) Rule on procedural items pending § 1316.56 Burden of proof. before him. At any hearing, the proponent for the (h) Take any action permitted to the issuance, amendment, or repeal of any presiding officer as authorized by this rule shall have the burden of proof. part or by the provisions of the Admin- istrative Procedure Act (5 U.S.C. 551– § 1316.57 Submission of documentary 559). evidence and affidavits and identification of witnesses subsequent to [36 FR 7820, Apr. 24, 1971. Redesignated at 38 prehearing conference. FR 26609, Sept. 24, 1973, and amended at 42 FR 57457, Nov. 3, 1977; 62 FR 13970, Mar. 24, All documentary evidence and affida- 1997] vits not submitted and all witnesses not identified at the prehearing con- § 1316.53 Time and place of hearing. ference shall be submitted or identified The hearing will commence at the to the presiding officer as soon as pos- place and time designated in the notice sible, with a showing that the offering of hearing published in the FEDERAL party had good cause for failing to so REGISTER but thereafter it may be submit or identify at the prehearing moved to a different place and may be conference. If the presiding officer de- continued from day to day or recessed termines that good cause does exist, to a later day without notice other the documents or affidavits shall be than announcement thereof by the pre- submitted or witnesses identified to all siding officer at the hearing. parties sufficiently in advance of the offer of such documents or affidavits or § 1316.54 Prehearing conference. witnesses at the hearing to avoid prejudice or surprise to the other parties. If The presiding officer on his own mo- the presiding officer determines that tion, or on the motion of any party for good cause does not exist, he may good cause shown, may direct all par- refuse to admit as evidence such docu- ties to appear at a specified time and ments or affidavits or the testimony of place for a conference for: such witnesses. (a) The simplification of the issues. (b) The possibility of obtaining stipu- § 1316.58 Summary of testimony; affi- lations, admission of facts, and docu- davits. ments. (a) The presiding officer may direct (c) The possibility of limiting the that summaries of the direct testimony number of expert witnesses. of witnesses be prepared in writing and (d) The identification and, if prac- served on all parties in advance of the ticable, the scheduling of all witnesses hearing. Witnesses will not be per- to be called. mitted to read summaries of their tes- (e) The advance submission at the timony into the record and all wit- prehearing conference of all documen- nesses shall be available for cross-ex- tary evidence and affidavits to be amination. Each witness shall, before marked for identification. proceeding to testify, be sworn or make (f) Such other matters as may aid in affirmation. the expeditious disposition of the hear- (b) Affidavits submitted at the pre- ing. hearing conference or pursuant to § 1316.57 with good cause may be exam- § 1316.55 Prehearing ruling. ined by all parties and opposing affida- The presiding officer may have the vits may be submitted to the presiding prehearing conference reported ver- officer within a period of time fixed by batim and shall make a ruling reciting him. Affidavits admitted into evidence the action taken at the conference, the shall be considered in light of the lack agreements made by the parties, the of opportunity for cross-examination in schedule of witnesses, and a statement determining the weight to be attached of the issues for hearing. Such ruling to statements made therein. shall control the subsequent course of [36 FR 7820, Apr. 24, 1971, as amended at 36 the hearing unless modified by a subse- FR 13387, July 21, 1971. Redesignated at 38 FR quent ruling. 26609, Sept. 24, 1973]

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§ 1316.59 Submission and receipt of foundation has been laid for its admis- evidence. sion. An offer of proof made in connec- (a) The presiding officer shall admit tion with an objection taken to any only evidence that is competent, rel- ruling of the presiding officer rejecting evant, material and not unduly repeti- or excluding proffered oral testimony tious. shall consist of a statement of the sub- (b) Opinion testimony shall be admit- stance of the evidence which the party ted when the presiding officer is satis- contends would be adduced by such tes- fied that the witness is properly quali- timony; and, if the excluded evidence fied. consists of evidence in documentary or (c) The authenticity of all documents written form a copy of such evidence submitted in advance shall be deemed shall be marked for identification and admitted unless written objection shall accompany the records as the thereto is filed with the presiding offi- offer of proof. cer, except that a party will be permitted to challenge such authenticity § 1316.61 Exceptions to rulings. at a later time upon a showing of good Exceptions to rulings of the presiding cause for failure to have filed such officer are unnecessary. It is sufficient written objection. that a party, at the time the ruling of (d) Samples, if otherwise admissible the presiding officer is sought, makes into evidence, may be displayed at the known the action that he desires the hearing and may be described for pur- presiding officer to take, or his objec- poses of the record, or may be admitted tion to an action taken, and his in evidence as exhibits. grounds therefor. (e) Where official notice is taken or is to be taken of a material fact not ap- § 1316.62 Interlocutory appeals from pearing in the evidence of record, any rulings of the presiding officer. party, on timely request, shall be af- Rulings of the presiding officer may forded opportunity to controvert such not be appealed to the Administrator fact. prior to his consideration of the entire (f) The presiding officer shall file as hearing without first requesting the exhibits copies of the following docu- consent of the presiding officer. Within ments: ten (10) business days of receipt of a (1) The order to show cause or notice party’s request for such consent, the of hearing; presiding officer shall certify on the (2) Any notice of waiver or modifica- record or in writing his determination tion of rules made pursuant to § 1316.44 of whether the allowance of an inter- or otherwise; locutory appeal is clearly necessary to (3) Any waiver of hearing (together prevent exceptional delay, expense or with any statement filed therewith) prejudice to any party, or substantial filed pursuant to § 1316.49 or otherwise; detriment to the public interest. If the (4) The prehearing ruling, if any, presiding officer denies an interlocu- made pursuant to § 1316.55; tory appeal, he shall, within three (3) (5) Any other document necessary to business days, transmit his determina- show the basis for the hearing. tion and the parties’ filings related to § 1316.60 Objections; offer of proof. the interlocutory appeal to the Admin- istrator for the Administrator’s discre- If any party in the hearing objects to tionary review. If an interlocutory ap- the admission or rejection of any evi- peal is allowed by the presiding officer dence or to other limitation of the or if the Administrator determines scope of any examination or cross-ex- that an appeal is warranted under this amination, he shall state briefly the section, any party to the hearing may grounds for such objection without ex- file a brief in quintuplicate with the tended argument or debate thereon ex- Administrator within such period that cept as permitted by the presiding offi- the Administrator directs. No oral ar- cer. A ruling of the presiding officer on gument will be heard unless the Ad- any such objection shall be a part of ministrator directs otherwise. the transcript together with such offer of proof as has been made if a proper [84 FR 18140, Apr. 30, 2019]

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§ 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 transcribing the testimony. The pre- [36 FR 7778, Apr. 24, 1971. Redesignated at 38 siding officer shall promptly thereafter FR 26609, Sept. 24, 1973 and amended at 44 FR 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 26609, Sept. 24, 1973, and amended at 50 FR the report of the presiding officer, such 2046, Jan. 15, 1985] party may file with the Hearing Clerk, Office of the Administrative Law § 1316.64 Proposed findings of fact and Judge, exceptions to the recommended conclusions of law. decision, findings of fact and conclu- Any party in the hearing may file in sions of law contained in the report. quintuplicate proposed findings of fact The party shall include a statement of and conclusions of law within the time supporting reasons for such exceptions, fixed by the presiding officer. Any together with evidence of record (in- party so filing shall also serve one copy cluding specific and complete citations of his proposed findings and conclusion of the pages of the transcript and ex- upon each other party in the hearing. hibits) and citations of the authorities The party shall include a statement of relied upon. supporting reasons for the proposed (b) The Hearing Clerk shall cause findings and conclusions, together with such filings to become part of the evidence of record (including specific record of the proceeding. and complete citations of the pages of (c) The Administrative Law Judge the transcript and exhibits) and cita- may, upon the request of any party to tions of authorities relied upon. a proceeding, grant time beyond the twenty days provided in paragraph (a) § 1316.65 Report and record. of this section for the filing of a re- (a) As soon as practicable after the sponse to the exceptions filed by an- time for the parties to file proposed other party if he determines that no findings of fact and conclusions of law party in the hearing will be unduly has expired, the presiding officer shall prejudiced and that the ends of justice prepare a report containing the fol- will be served thereby. Provided how- lowing: ever, that each party shall be entitled (1) His recommended rulings on the to only one filing under this section; proposed findings of fact and conclu- that is, either a set of exceptions or a sions of law; response thereto. (2) His recommended findings of fact and conclusions of law, with the rea- [44 FR 55332, Sept. 26, 1979] sons therefore; and (3) His recommended decision. § 1316.67 Final order. (b) The presiding officer shall serve a As soon as practicable after the pre- copy of his report upon each party in siding officer has certified the record

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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 order his findings as to the conditions SOURCE: 79 FR 33565, Sept. 9, 2014, unless which led him to conclude that an ear- otherwise noted. lier 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 judicial review. unused, or otherwise unwanted controlled 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 ered to and served upon the Adminis- prompt, safe, and effective disposal trator in quintuplicate. The Adminis- methods while providing effective con- trator shall certify the record of the trols against the diversion of con- hearing and shall file the certified trolled substances. record in the appropriate U.S. Court of Appeals. Subpart A—Disposal of Controlled [36 FR 7820, Apr. 24, 1971. Redesignated at 44 Substances by Registrants FR 42179, July 19, 1979] § 1317.05 Registrant disposal. PART 1317—DISPOSAL (a) Practitioner inventory. Any registered practitioner in lawful posses- Sec. sion of a controlled substance in its in- 1317.01 Scope. ventory that desires to dispose of that Subpart A—Disposal of Controlled substance shall do so in one of the fol- Substances by Registrants lowing ways: (1) Promptly destroy that controlled 1317.05 Registrant disposal. substance in accordance with subpart C 1317.10 Registrant return or recall. of this part using an on-site method of 1317.15 Reverse distributor registration re- destruction; quirements and authorized activities. (2) Promptly deliver that controlled Subpart B—Disposal of Controlled Sub- substance to a reverse distributor’s stances Collected From Ultimate Users registered location by common or con- and Other Non-Registrants tract carrier pick-up or by reverse distributor pick-up at the registrant’s 1317.30 Authorization to collect from non- registered location; registrants. (3) For the purpose of return or re- 1317.35 Collection by law enforcement. call, promptly deliver that controlled 1317.40 Registrants authorized to collect substance by common or contract car- and authorized collection activities. 1317.55 Reverse distributor and distributor rier pick-up or pick-up by other reg- acquisition of controlled substances from istrants at the registrant’s registered collectors or law enforcement. location to: The registered person from 1317.60 Inner liner requirements. whom it was obtained, the registered

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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 (4) Request assistance from the Spe- substance by common or contract car- cial Agent in Charge of the Adminis- rier or pick-up at the registrant’s reg- tration in the area in which the practi- istered location to: The registered per- tioner is located. son from whom it was obtained, the (i) The request shall be made by sub- registered manufacturer of the submitting one copy of the DEA Form 41 stance, or another registrant author- to the Special Agent in Charge in the ized by the manufacturer to accept re- practitioner’s area. The DEA Form 41 turns or recalls on the manufacturer’s shall list the controlled substance or behalf; or substances which the registrant desires (4) Promptly transport that con- to dispose. trolled substance by its own means to (ii) The Special Agent in Charge shall the registered location of a reverse dis- instruct the registrant to dispose of tributor, the location of destruction, or the controlled substance in one of the the registered location of any person following manners: authorized to receive that controlled 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 (C) By destruction in the presence of accordance with the procedures set an agent of the Administration or forth at § 1317.95(c). other authorized person. (ii) If a non-practitioner transports (5) In the event that a practitioner is controlled substances by its own means required regularly to dispose of con- to a registered location for any author- trolled substances, the Special Agent ized purpose, transportation shall be in Charge may authorize the practi- directly to the authorized registered tioner to dispose of such substances, in location and two employees of the accordance with subparagraph (a)(4) of transporting non-practitioner shall ac- this section, without prior application company the controlled substances to in each instance, on the condition that the registered destination location. Di- the practitioner keep records of such rectly transported means the sub- disposals and file periodic reports with stances shall be constantly moving to- the Special Agent in Charge summa- wards their final location and unneces- rizing the disposals. The Special Agent sary or unrelated stops and stops of an in Charge may place such conditions as extended duration shall not occur. he/she deems proper on practitioner (c) Collected controlled substances. Any procedures regarding the disposal of collector in lawful possession of a con- controlled substances. trolled substance acquired by collec- (b) Non-practitioner inventory. Any tion from an ultimate user or other au- registrant that is a non-practitioner in thorized non-registrant person shall lawful possession of a controlled sub- dispose of that substance in the fol- stance in its inventory that desires to lowing ways: dispose of that substance shall do so in (1) Mail-back program. Upon receipt of one of the following ways: a sealed mail-back package, the col- (1) Promptly destroy that controlled lector shall promptly: substance in accordance with subpart C (i) Destroy the package in accordance of this part using an on-site method of with subpart C of this part using an on- destruction; site method of destruction; or (2) Promptly deliver that controlled (ii) Securely store the package and substance to a reverse distributor’s its contents at the collector’s reg- registered location by common or con- istered location in a manner consistent tract carrier or by reverse distributor with § 1301.75(c) of this chapter (for

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practitioners), or in a manner con- (b) Each registrant that delivers a sistent with the security requirements controlled substance in Schedule I or II for Schedule II controlled substances for the purpose of return or recall shall (for non-practitioners) until prompt use an order form in the manner de- on-site destruction can occur. scribed in part 1305 of this chapter. (2) Collection receptacles. Upon re- (c) Deliveries for the purpose of removal from the permanent outer con- turn or recall may be made through a tainer, the collector shall seal it and freight forwarding facility operated by promptly: the person to whom the controlled sub- (i) Destroy the sealed inner liner and stance is being returned provided that its contents; advance notice of the return is pro- (ii) Securely store the sealed inner vided and delivery is directly to an liner and its contents at the collector’s agent or employee of the person to registered location in a manner con- whom the controlled substance is being sistent with § 1301.75(c) of this chapter (for practitioners), or in a manner con- returned. sistent with § 1301.72(a) of this chapter § 1317.15 Reverse distributor registra- (for non-practitioners) until prompt de- tion requirements and authorized struction can occur; or activities. (iii) Securely store the sealed inner 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. shall dispose of sealed inner liners and (b) A reverse distributor shall acquire their contents by utilizing any method controlled substances from a registrant in paragraph (a)(1), (a)(2), or (a)(4) of pursuant to §§ 1317.05 and 1317.55(a) and this section, or by delivering sealed (c) in the following manner: inner liners and their contents to a dis- (1) Pick-up controlled substances tributor’s registered location by com- from a registrant at the registrant’s mon or contract carrier pick-up or by registered location or authorized col- distributor pick-up at the collector’s lection site; or authorized collection location. (2) Receive controlled substances de- (v) Non-practitioner methods of destruc- livered by common or contract carrier tion. Collectors that are non-practi- or delivered directly by a non-practitioners (i.e., manufacturers, distribu- tioner registrant. tors, narcotic treatment programs, and (i) Delivery to the reverse distributor reverse distributors) shall dispose of by an authorized registrant directly or sealed inner liners and their contents by common or contract carrier may by utilizing any method in paragraph only be made to the reverse distributor (b)(1), (b)(2), or (b)(4) of this section, or by delivering sealed inner liners and at the reverse distributor’s registered their contents to a distributor’s reg- location. Once en route, such deliveries istered location by common or con- may not be re-routed to any other loca- tract carrier or by distributor pick-up tion or person, regardless of registra- at the collector’s authorized collection tion status. location for destruction. Freight for- (ii) All controlled substance deliv- warding facilities may not be utilized eries to a reverse distributor shall be to transfer sealed inner liners and their personally received by an employee of contents. the reverse distributor at the registered location. § 1317.10 Registrant return or recall. (c) Upon acquisition of a controlled (a) Each registrant shall maintain a substance by delivery or pick-up, a re- record of each return or recall trans- verse distributor shall: action in accordance with the informa- (1) Immediately store the controlled tion required of manufacturers in substance, in accordance with the secu- § 1304.22(a)(2)(iv) of this chapter. rity controls in parts 1301 and 1317 of

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this chapter, at the reverse distribu- died while in lawful possession of a tor’s registered location or imme- controlled substance; and diately transfer the controlled sub- (3) A long-term care facility on be- stance to the reverse distributor’s reg- half of an ultimate user who resides or istered location for secure storage, in resided at such long-term care facility accordance with the security controls and is/was in lawful possession of a in parts 1301 and 1317 of this chapter, controlled substance, in accordance until timely destruction or prompt re- with § 1317.80 only. turn of the controlled substance to the registered manufacturer or other reg- § 1317.35 Collection by law enforce- istrant authorized by the manufacturer ment. to accept returns or recalls on the (a) Federal, State, tribal, or local law manufacturer’s behalf; enforcement may collect controlled (2) Promptly deliver the controlled substances from ultimate users and substance to the manufacturer or an- persons lawfully entitled to dispose of other registrant authorized by the an ultimate user decedent’s property manufacturer to accept returns or re- using the following collection methods: calls on the manufacturer’s behalf; or (1) Take-back events in accordance (3) Timely destroy the controlled with § 1317.65; substance in a manner authorized in (2) Mail-back programs in accordance subpart C of this part. with § 1317.70; or (d) A reverse distributor shall de- (3) Collection receptacles located in- stroy or cause the destruction of any side law enforcement’s physical ad- controlled substance received for the dress. purpose of destruction no later than 30 (b) Law enforcement that conducts a calendar days after receipt. take-back event or a mail-back program or maintains a collection recep- Subpart B—Disposal of Controlled tacle should maintain any records of removal, storage, or destruction of the Substances Collected From controlled substances collected in a Ultimate Users and Other Non- manner that is consistent with that Registrants agency’s recordkeeping requirements for illicit controlled substances evi- § 1317.30 Authorization to collect from dence. non-registrants. (c) Any controlled substances col- (a) The following persons are author- lected by law enforcement through a ized to collect controlled substances take-back event, mail-back program, from ultimate users and other non-reg- or collection receptacle should be istrants for destruction in compliance stored in a manner that prevents the with this chapter: diversion of controlled substances and (1) Any registrant authorized by the is consistent with that agency’s stand- Administration to be a collector pursu- ard procedures for storing illicit con- ant to § 1317.40; and trolled substances. (2) Federal, State, tribal, or local law (d) Any controlled substances col- enforcement when in the course of offi- lected by law enforcement through a cial duties and pursuant to § 1317.35. take-back event, mail-back program, (b) The following non-registrant per- or collection receptacle should be sons in lawful possession of a con- transferred to a destruction location in trolled substance in Schedules II, III, a manner that prevents the diversion IV, or V may transfer that substance to of controlled substances and is con- the authorized persons listed in para- sistent with that agency’s standard graph (a) of this section, and in a man- procedures for transferring illicit con- ner authorized by this part, for the pur- trolled substances. pose of disposal: (e) Law enforcement that transfers (1) An ultimate user in lawful posses- controlled substances collected from sion of a controlled substance; ultimate users pursuant to this part to (2) Any person lawfully entitled to a reverse distributor for destruction dispose of a decedent’s property if that should maintain a record that contains decedent was an ultimate user who the following information: If a sealed

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inner liner as described in § 1317.60 is § 1317.55 Reverse distributor and dis- used, the unique identification number tributor acquisition of controlled of the sealed inner liner transferred, substances from collectors or law and the size of the sealed inner liner enforcement. transferred (e.g., 5-gallon, 10-gallon, (a) A reverse distributor is author- etc.); if a mail-back package as de- ized to acquire controlled substances scribed in § 1317.70 is used, the unique from law enforcement that collected identification number of each package; the substances from ultimate users. A the date of the transfer; and the name, reverse 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. (b) A distributor is authorized to ac- § 1317.40 Registrants authorized to col- quire controlled substances collected lect and authorized collection ac- through a collection receptacle in activities. cordance with §§ 1317.75 and 1317.80. (a) Manufacturers, distributors, re- (c) A reverse distributor or a dis- verse distributors, narcotic treatment tributor that acquires controlled sub- programs, hospitals/clinics with an on- stances in accordance with paragraph site pharmacy, and retail pharmacies (a) or (b) of this section shall: that desire to be collectors shall mod- (1) Acquire the controlled substances ify their registration to obtain author- in the manner authorized for reverse ization to be a collector in accordance distributors in § 1317.15(b)(1) and (2); with § 1301.51 of this chapter. Author- (2) Dispose of the controlled sub- ization to be a collector is subject to stances in the manner authorized for renewal. If a registrant that is author- reverse distributors § 1317.15(c) and (d); ized to collect ceases activities as a and collector, such registrant shall notify (3) Securely store the controlled sub- the Administration in accordance with stances in a manner consistent with § 1301.52(f) of this chapter. the security requirements for Schedule (b) Collection by registrants shall II controlled substances until timely occur only at the following locations: destruction can occur. (1) Those registered locations of manufacturers, distributors, reverse dis- § 1317.60 Inner liner requirements. tributors, narcotic treatment pro- (a) An inner liner shall meet the fol- grams, hospitals/clinics with an on-site lowing requirements: pharmacy, and retail pharmacies that (1) The inner liner shall be water- are authorized for collection; and proof, tamper-evident, and tear-resist- (2) Long-term care facilities at which ant; registered hospitals/clinics or retail (2) The inner liner shall be removable pharmacies are authorized to maintain and sealable immediately upon re- collection receptacles. moval without emptying or touching (c) Collectors may conduct the fol- the contents; lowing activities: (3) The contents of the inner liner (1) Receive and destroy mail-back shall not be viewable from the outside packages pursuant to § 1317.70 at an au- when sealed; thorized registered location that has (4) The size of the inner liner shall be an on-site method of destruction; clearly marked on the outside of the (2) Install, manage, and maintain col- liner (e.g., 5-gallon, 10-gallon, etc.); and lection receptacles located at their au- (5) The inner liner shall bear a per- thorized collection location(s) pursu- manent, unique identification number ant to §§ 1317.75 and 1317.80; and that enables the inner liner to be (3) Promptly dispose of sealed inner tracked. liners and their contents as provided (b) Access to the inner liner shall be for in § 1317.05(c)(2). restricted to employees of the collector.

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(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. (a) A mail-back program may be con- § 1317.65 Take-back events. ducted by Federal, State, tribal, or (a) Federal, State, tribal, or local law local law enforcement or any collector. enforcement may conduct a take-back A collector conducting a mail-back event and collect controlled substances program shall have and utilize at their from ultimate users and persons law- registered location a method of de- fully entitled to dispose of an ultimate struction consistent with § 1317.90 of user decedent’s property in accordance this chapter. with this section. Any person may (b) Only those controlled substances partner with law enforcement to hold a listed in Schedule II, III, IV, or V that collection take-back event in accord- are lawfully possessed by an ultimate ance with this section. user or person lawfully entitled to dis- (b) Law enforcement shall appoint a pose of an ultimate user decedent’s law enforcement officer employed by property may be collected. Controlled the agency to oversee the collection. and non-controlled substances may be Law enforcement officers employed collected together and be comingled, and authorized by the law enforcement although comingling is not required. agency or law enforcement component (c) Collectors or law enforcement of a Federal agency conducting a take- that conduct a mail-back program back event shall maintain control and shall make packages available (for sale custody of the collected substances or for free) as specified in this para- from the time the substances are col- graph to ultimate users and persons lected from the ultimate user or person lawfully entitled to dispose of an ulti- authorized to dispose of the ultimate mate user decedent’s property, for the user decedent’s property until secure collection of controlled substances by transfer, storage, or destruction of the common or contract carrier. Any per- controlled substances has occurred. son may partner with a collector or (c) Each take-back event should have law enforcement to make such pack- at least one receptacle for the collec- ages available in accordance with this tion of controlled substances. The col- section. The packages made available lection receptacle should be a securely shall meet the following specifications: locked, substantially constructed con- (1) The package shall be nondescript tainer with an outer container and a and shall not include any markings or removable inner liner as specified in other information that might indicate § 1317.60 of this chapter. The outer con- that the package contains controlled tainer should include a small opening substances; that allows contents to be added to the (2) The package shall be water- and inner liner, but that does not allow re- spill-proof; tamper-evident; tear-resist- moval of the inner liner’s contents. ant; and sealable; (d) Only those controlled substances (3) The package shall be preaddressed listed in Schedule II, III, IV, or V that with and delivered to the collector’s are lawfully possessed by an ultimate registered address or the participating user or person entitled to dispose of an law enforcement’s physical address; ultimate user decedent’s property may (4) The cost of shipping the package be collected. Controlled and non-con- shall be postage paid; trolled substances may be collected to- (5) The package shall have a unique gether and be comingled, although co- identification number that enables the mingling is not required. package to be tracked; and (e) Only ultimate users and persons (6) The package shall include instruc- entitled to dispose of an ultimate user tions for the user that indicate the decedent’s property in lawful posses- process for mailing back the package, sion of a controlled substance in Sched- the substances that can be sent, notice ule II, III, IV, or V may transfer such that packages may only be mailed

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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. contains controlled substances that the (d) Collection receptacles shall be se- collector did not make available or did curely placed and maintained: not agree to receive pursuant to sub- (1) Inside a collector’s registered lo- paragraph (e)(3) of this section. cation, inside law enforcement’s phys- (3) When discontinuing activities as a ical location, or at an authorized long- collector or ceasing an authorized term care facility; mail-back program: (2) At a registered location, be lo- (i) Make a reasonable effort to notify cated in the immediate proximity of a the public prior to discontinuing such designated area where controlled sub- activities or ceasing the authorized stances are stored and at which an em- mail-back program; and ployee is present (e.g., can be seen from (ii) Obtain the written agreement of the pharmacy counter). Except as fol- another collector that has and utilizes lows: at its registered location a method of (i) At a hospital/clinic: A collection destruction consistent with § 1317.90 of receptacle shall be located in an area this chapter to receive all remaining regularly monitored by employees, and mail-back packages that were dissemi- shall not be located in the proximity of nated but not returned and arrange for any area where emergency or urgent the forwarding of only such packages care is provided; to that location. (ii) At a narcotic treatment program: (f) Only law enforcement officers em- A collection receptacle shall be located ployed by the law enforcement agency in a room: That does not contain any or law enforcement component of a other controlled substances and is se- Federal agency and employees of the curely locked with controlled access;

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(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. inaccessible to the public when an em- (d) Upon removal, sealed inner liners ployee is not present (e.g., when the may only be stored at the long-term pharmacy is closed), or when the col- care facility for up to three business lection receptacle is not being regu- days in a securely locked, substantially larly monitored by long-term care fa- constructed cabinet or a securely cility employees. locked room with controlled access (g) The installation and removal of until transfer in accordance with the inner liner of the collection recep- § 1317.05(c)(2)(iv). tacle shall be performed by or under (e) Neither a hospital/clinic with an the supervision of at least two employ- on-site pharmacy nor a retail phar- ees of the authorized collector. macy shall operate a collection receptacle at a long-term care facility until § 1317.80 Collection receptacles at its registration has been modified in long-term care facilities. accordance with § 1301.51 of this chap- (a) A long-term care facility may dis- ter. pose of controlled substances in Sched- ules II, III, IV, and V on behalf of an ul- § 1317.85 Ultimate user delivery for timate user who resides, or has resided, the purpose of recall or investiga- at such long-term care facility by tional use of drugs. transferring those controlled sub- (a) In the event of a product recall, stances into an authorized collection an ultimate user in lawful possession of receptacle located at that long-term a controlled substance listed in Sched- care facility. When disposing of such ule II, III, IV, or V may deliver the re- controlled substances by transferring called substance to the manufacturer

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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 controlled substances, the method of stops of an extended duration shall not destruction shall be sufficient to occur); render non-retrievable any controlled (2) Two employees of the trans- substance likely to be present. porting registrant shall accompany the (c) The method of destruction shall controlled substances to the destruc- be consistent with the purpose of ren- tion location; dering all controlled substances to a (3) Two employees of the trans- non-retrievable state in order to pre- porting registrant shall load and un- vent diversion of any such substance to load or observe the loading and unload- illicit purposes and to protect the pub- ing of the controlled substances; lic health and safety. (4) Two employees of the transporting registrant shall handle or ob- § 1317.95 Destruction procedures. serve the handling of any controlled The destruction of any controlled substance until the substance is ren- substance shall be in accordance with dered non-retrievable; and the following requirements: (5) Two employees of the trans- (a) Transfer to a person registered or porting registrant shall personally wit- authorized to accept controlled substances ness the destruction of the controlled for the purpose of destruction. If the con- substance until it is rendered non-re- trolled substances are transferred to a trievable. person registered or authorized to ac- (d) On-site destruction. If the con- cept the controlled substances for the trolled substances are destroyed at a purpose of destruction, two employees registrant’s registered location uti- of the transferring registrant shall load lizing an on-site method of destruction,

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the following procedures shall be fol- PART 1321—DEA MAILING lowed: ADDRESSES (1) Two employees of the registrant shall handle or observe the handling of AUTHORITY: 21 U.S.C. 871(b). any controlled substance until the substance is rendered non-retrievable; and SOURCE: 75 FR 10685, Mar. 9, 2010, unless (2) Two employees of the registrant otherwise noted. shall personally witness the destruc- § 1321.01 DEA mailing addresses. tion of the controlled substance until it is rendered non-retrievable. The following table provides information regarding mailing addresses to be used when sending specified correspondence to the Drug Enforcement 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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