Title 21–Food and Drugs

Home , Fencamfamin, Levopropoxyphene, Naphyrone

(This book contains part 1300 to End)

Part

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

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

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Part Page 1300 Definitions ...... 5 1301 Registration of manufacturers, distributors, and dispensers of controlled substances ...... 23 1302 Labeling and packaging requirements for controlled substances ...... 58 1303 Quotas ...... 60 1304 Records and reports of registrants ...... 68 1305 Orders for schedule I and II controlled substances 88 1306 Prescriptions ...... 96 1307 Miscellaneous ...... 108 1308 Schedules of controlled substances ...... 110 1309 Registration of manufacturers, distributors, importers and exporters of list I chemicals ...... 137 1310 Records and reports of listed chemicals and certain machines; importation and exportation of certain machines ...... 148 1311 Requirements for electronic orders and prescriptions ...... 175 1312 Importation and exportation of controlled substances ...... 196 1313 Importation and exportation of list I and list II chemicals ...... 219 1314 Retail sale of scheduled listed chemical products ... 232 1315 Importation and production quotas for ephedrine, pseudoephedrine, and phenylpropanolamine ...... 240 1316 Administrative functions, practices, and procedures ...... 251 1317 Disposal ...... 264 1321 DEA Mailing addresses ...... 272 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- may purchase controlled substances scribed in paragraph (d) of this section, from a registered manufacturer or dis- controlled substances may be held for tributor, or from an authorized phar- stocking, be maintained in, and dis- macy as described in paragraph (f) of pensed from medicine chests, first aid this section, by following the procedure packets, or dispensaries: outlined below: (1) On board any vessel engaged in (1) The master or first officer of the international trade or in trade between vessel must personally appear at the ports of the United States and any vendor’s place of business, present merchant vessel belonging to the U.S. proper identification (e.g., Seaman’s Government; photographic identification card) and a (2) On board any aircraft operated by written requisition for the controlled an air carrier under a certificate of per- substances. mit issued pursuant to the Federal (2) The written requisition must be Aviation Act of 1958 (49 U.S.C. 1301); on the vessel’s official stationery or 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 reg- (4) The vendor’s record of sale should istrations pursuant to paragraph be similar to, and must include all the (b)(3)(ii) of this section. information contained in, the below (d) If no medical officer is employed listed format. by the owner or operator of a vessel, or in the event such medical officer is not SALE OF CONTROLLED SUBSTANCES TO VESSELS accessible and the acquisition of controlled substances is required, the mas- (Name of registrant) llllllllllll ter or first officer of the vessel, who (Address of registrant) lllllllllll shall not be registered under the Act, (DEA registration number) lllllllll

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

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

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

Number of lines completed lllllllll year in which the pharmacy is reg- Name of vessel lllllllllllllll istered to dispense does not exceed the Vessel’s official number lllllllllll limitations imposed upon such dis- Vessel’s country of registry lllllllll Owner or operator of the vessel lllllll tribution by § 1307.11(a)(4) and (b) of this chapter. Name and title of vessel’s officer who presented the requisition llll (g) Owners or operators of vessels, Signature of vessel’s officer who presented aircraft, or other entities described in the requisition llll this section shall not be deemed to possess or dispense any controlled sub- (e) Any medical officer described in stance acquired, stored and dispensed paragraph (b) of this section shall, in in accordance with this section. Addi- addition to complying with all require- tionally, owners or operators of ves- ments and duties prescribed for reg- sels, aircraft, or other entities de- istrants generally, prepare an annual scribed in this section or in Article 32 report as of the date on which his/her of the Single Convention on Narcotic registration expires, which shall give in detail an accounting for each vessel, Drugs, 1961, or in Article 14 of the Con- aircraft, or other entity, and a sum- vention on Psychotropic Substances, mary accounting for all vessels, air- 1971, shall not be deemed to import or craft, or other entities under his/her export any controlled substances pur- supervision for all controlled sub- chased and stored in accordance with stances purchased, dispensed or dis- that section or applicable article. posed of during the year. The medical (h) The Master of a vessel shall pre- officer shall maintain this report with pare a report for each calendar year other records required to be kept under which shall give in detail an account- the Act and, upon request, deliver a ing for all controlled substances pur- copy of the report to the Administra- chased, dispensed, or disposed of during tion. The medical officer need not be the year. The Master shall file this 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] macy as well as the date upon which such activity will commence; and § 1301.26 Exemptions from import or (2) Such activity is authorized by export requirements for personal state law; and medical use. (3) The total number of dosage units Any individual who has in his/her of all controlled substances distributed possession a controlled substance listed by the pharmacy during any calendar in schedules II, III, IV, or V, which he/

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

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

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(i) The Administrator receives a posi- (f) If an individual practitioner dis- tive determination from the Secretary penses or prescribes Schedule III, IV, or of Health and Human Services before V narcotic drugs approved by the Food the conclusion of the 45-day review pe- and Drug Administration specifically riod, or for maintenance or detoxification (ii) The 45-day review period has con- treatment in violation of any of the cluded and no determination by the conditions specified in paragraphs (b), Secretary of Health and Human Serv- (c) or (e) of this section, the Adminis- ices has been made. trator may revoke the individual prac- (2) If the Secretary denies certifi- titioner’s registration in accordance cation to an individual practitioner or with § 1301.36. withdraws such certification once it is issued, then DEA will not issue the in- [70 FR 36342, June 23, 2005, as amended at 73 dividual practitioner an identification FR 29688, May 22, 2008; 83 FR 3074, Jan. 23, number, or will withdraw the identi- 2018] fication number if one has been issued. (3) The individual practitioner must § 1301.29 [Reserved] include the identification number on ACTION ON APPLICATION FOR REGISTRA- all records when dispensing and on all TION: REVOCATION OR SUSPENSION OF prescriptions when prescribing narcotic REGISTRATION drugs under this section. (e) An individual practitioner may § 1301.31 Administrative review gen- begin to prescribe or dispense narcotic erally. drugs to a specific individual patient under this section before receiving an The Administrator may inspect, or identification number from the Admin- cause to be inspected, the establish- istrator if the following conditions are ment of an applicant or registrant, pur- met: suant to subpart A of part 1316 of this (1) The individual practitioner has chapter. The Administrator shall resubmitted a written notification under view the application for registration paragraph (b) of this section in good and other information gathered by the faith to the Secretary of Health and Administrator regarding an applicant Human Services. in order to determine whether the ap- (2) The individual practitioner rea- plicable standards of section 303 (21 sonably believes that the conditions U.S.C. 823) or section 1008 (21 U.S.C. 958) specified in paragraphs (b) and (c) of of the Act have been met by the appli- this section have been met. cant. (3) The individual practitioner rea- [62 FR 13953, Mar. 24, 1997] sonably believes that the treatment of an individual patient would be facili- § 1301.32 Action on applications for re- tated if narcotic drugs are prescribed search in Schedule I substances. or dispensed under this section before the sooner of: (a) In the case of an application for (i) Receipt of an identification num- registration to conduct research with ber from the Administrator, or controlled substances listed in Sched- (ii) Expiration of the 45-day period. ule I, the Administrator shall process (4) The individual practitioner has the application and protocol and for- notified both the Secretary of Health ward a copy of each to the Secretary of and Human Services and the Adminis- Health and Human Services (Secretary) trator of his or her intent to begin pre- within 7 days after receipt. The Sec- scribing or dispensing the narcotic retary shall determine the qualifica- drugs before expiration of the 45-day tions and competency of the applicant, period. as well as the merits of the protocol (5) The Secretary has not notified the (and shall notify the Administrator of registrant that he/she is not qualified his/her determination) within 21 days under paragraph (d) of this section. after receipt of the application and (6) The individual practitioner has complete protocol, except that in the the appropriate registration under case of a clinical investigation, the § 1301.13. Secretary shall have 30 days to make

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

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bulk manufacturer of that controlled (3) Promotion of technical advances substance and to any other applicant in the art of manufacturing these sub- therefor. Any such person may, within stances and the development of new 30 days from the date of publication of substances; the notice in the FEDERAL REGISTER, (4) Prior conviction record of appli- file written comments on or objections cant under Federal and State laws re- to the issuance of the proposed reg- lating to the manufacture, distribu- istration, and may, at the same time, tion, or dispensing of such substances; file a written request for a hearing on (5) Past experience in the manufac- the application pursuant to § 1301.43. If ture of controlled substances, and the a hearing is requested, the Adminis- existence in the establishment of effec- trator shall hold a hearing on the ap- tive control against diversion; plication in accordance with § 1301.41. (6) That the applicant will be per- Notice of the hearing shall be published mitted to import only: in the FEDERAL REGISTER, and shall be (i) Such amounts of crude opium, mailed simultaneously to the applicant poppy straw, concentrate of poppy and to all persons to whom notice of straw, and coca leaves as the Adminis- the application was mailed. Any such trator finds to be necessary to provide person may participate in the hearing for medical, scientific, or other legiti- by filing a notice of appearance in ac- mate purposes; or cordance with § 1301.43 of this chapter. (ii) Such amounts of any controlled Notice of the hearing shall contain a substances listed in Schedule I or II as summary of all comments and objec- the Administrator shall find to be nec- tions filed regarding the application essary to provide for the medical, sci- and shall state the time and place for entific, or other legitimate needs of the the hearing, which shall not be less United States during an emergency in than 30 days after the date of publica- which domestic supplies of such sub- tion of such notice in the FEDERAL stances are found by the Administrator REGISTER. A hearing pursuant to this to be inadequate; or section may be consolidated with a (iii) Such amounts of any controlled hearing held pursuant to § 1301.35 or substance listed in Schedule I or II as § 1301.36 of this part. the Administrator shall find to be nec- (b) The Administrator shall register essary to provide for the medical, sci- an applicant to import a controlled entific, or other legitimate needs of the substance listed in Schedule I or II if United States in any case in which the he/she determines that such registra- Administrator finds that competition tion is consistent with the public inter- among domestic manufacturers of the est and with U.S. obligations under controlled substance is inadequate and international treaties, conventions, or will not be rendered adequate by the protocols in effect on May 1, 1971. In registration of additional manufactur- determining the public interest, the ers under section 303 of the Act (21 following factors shall be considered: U.S.C. 823); or (1) Maintenance of effective controls (iv) Such limited quantities of any against diversion of particular con- controlled substance listed in Schedule trolled substances and any controlled I or II as the Administrator shall find substance in Schedule I or II com- to be necessary for scientific, analyt- pounded therefrom into other than le- ical or research uses; and gitimate medical, scientific research, (7) Such other factors as may be rel- or industrial channels, by limiting the evant to and consistent with the public importation and bulk manufacture of health and safety. such controlled substances to a number (c) In determining whether the appli- of establishments which can produce cant can and will maintain effective an adequate and uninterrupted supply controls against diversion within the of these substances under adequately meaning of paragraph (b) of this sec- competitive conditions for legitimate tion, the Administrator shall consider medical, scientific, research, and in- among other factors: dustrial purposes; (1) Compliance with the security re- (2) Compliance with applicable State quirements set forth in §§ 1301.71– and local law; 1301.76; and

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

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

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

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governed generally by the adjudication a hearing need not also file a notice of procedures set forth in the Administra- appearance. tive Procedure Act (5 U.S.C. 551–559) (c) Any person entitled to a hearing and specifically by sections 303, 304, or to participate in a hearing pursuant and 1008 of the Act (21 U.S.C. 823–824 to § 1301.32 or §§ 1301.34–1301.36 may, and 958), by §§ 1301.42–1301.46 of this within the period permitted for filing a part, and by the procedures for admin- request for a hearing or a notice of ap- istrative hearings under the Act set pearance, file with the Administrator a forth in §§ 1316.41–1316.67 of this chap- waiver of an opportunity for a hearing ter. or to participate in a hearing, together (b) Any hearing under this part shall with a written statement regarding be independent of, and not in lieu of, such person’s position on the matters criminal prosecutions or other proof fact and law involved in such hear- ceedings under the Act or any other ing. Such statement, if admissible, law of the United States. shall be made a part of the record and [62 FR 13956, Mar. 24, 1997] shall be considered in light of the lack of opportunity for cross-examination in § 1301.42 Purpose of hearing. determining the weight to be attached to matters of fact asserted therein. If requested by a person entitled to a hearing, the Administrator shall hold a (d) If any person entitled to a hearing hearing for the purpose of receiving or to participate in a hearing pursuant factual evidence regarding the issues to § 1301.32 or §§ 1301.34–1301.36 fails to involved in the denial, revocation, or file a request for a hearing or a notice suspension of any registration, and the of appearance, or if such person so files granting of any application for reg- and fails to appear at the hearing, such istration to import or to manufacture person shall be deemed to have waived in bulk a basic class of controlled sub- the opportunity for a hearing or to par- stance listed in Schedule I or II. Exten- ticipate in the hearing, unless such sive argument should not be offered person shows good cause for such fail- into evidence but rather presented in ure. opening or closing statements of coun- (e) If all persons entitled to a hearing sel or in memoranda or proposed find- or to participate in a hearing waive or ings of fact and conclusions of law. are deemed to waive their opportunity for the hearing or to participate in the [62 FR 13956, Mar. 24, 1997] hearing, the Administrator may cancel the hearing, if scheduled, and issue his/ § 1301.43 Request for hearing or ap- her final order pursuant to § 1301.46 pearance; waiver. without a hearing. (a) Any person entitled to a hearing pursuant to § 1301.32 or §§ 1301.34–1301.36 [62 FR 13956, Mar. 24, 1997] and desiring a hearing shall, within 30 days after the date of receipt of the § 1301.44 Burden of proof. order to show cause (or the date of pub- (a) At any hearing on an application lication of notice of the application for to manufacture any controlled sub- registration in the FEDERAL REGISTER stance listed in Schedule I or II, the ap- in the case of § 1301.34), file with the plicant shall have the burden of prov- Administrator a written request for a ing that the requirements for such reg- hearing in the form prescribed in istration pursuant to section 303(a) of § 1316.47 of this chapter. the Act (21 U.S.C. 823(a)) are satisfied. (b) Any person entitled to participate Any other person participating in the in a hearing pursuant to § 1301.34 or hearing pursuant to § 1301.35(b) shall § 1301.35(b) and desiring to do so shall, have the burden of proving any propo- within 30 days of the date of publica- sitions of fact or law asserted by such tion of notice of the request for a hear- person in the hearing. ing in the FEDERAL REGISTER, file with (b) At any hearing on the granting or the Administrator a written notice of denial of an applicant to be registered intent to participate in such hearing in to conduct a narcotic treatment pro- the form prescribed in § 1316.48 of this gram or as a compounder, the appli- chapter. Any person filing a request for cant shall have the burden of proving

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

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

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

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

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

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

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Special Agent in Charge of DEA for the § 1301.73 Physical security controls for area in which such building or enclo- non-practitioners; compounders for sure is situated; narcotic treatment programs; man- (7) Such other secure storage areas as ufacturing and compounding areas. may be approved by the Administrator All manufacturing activities (includ- after considering the factors listed in ing processing, packaging and labeling) § 1301.71(b); involving controlled substances listed (8)(i) Schedule III through V con- in any schedule and all activities of trolled substances may be stored with compounders shall be conducted in ac- Schedules I and II controlled sub- cordance with the following: stances under security measures pro- (a) All in-process substances shall be vided by 21 CFR 1301.72(a); returned to the controlled substances (ii) Non-controlled drugs, substances storage area at the termination of the and other materials may be stored with process. If the process is not termi- Schedule III through V controlled sub- nated at the end of a workday (except stances in any of the secure storage where a continuous process or other areas required by 21 CFR 1301.72(b), normal manufacturing operation provided that permission for such stor- should not be interrupted), the proc- age of non-controlled items is obtained essing area or tanks, vessels, bins or in advance, in writing, from the Spe- bulk containers containing such sub- cial Agent in Charge of DEA for the stances shall be securely locked, with area in which such storage area is situ- adequate security for the area or build- ated. Any such permission tendered ing. If such security requires an alarm, must be upon the Special Agent in such alarm, upon unauthorized entry, Charge’s written determination that shall transmit a signal directly to a such non-segregated storage does not central station protection company, or diminish security effectiveness for local or state police agency which has Schedules III through V controlled sub- a legal duty to respond, or a 24-hour stances. control station operated by the reg- (c) Multiple storage areas. Where sev- istrant. eral types or classes of controlled sub- (b) Manufacturing activities with stances are handled separately by the controlled substances shall be con- registrant or applicant for different ducted in an area or areas of clearly de- purposes (e.g., returned goods, or goods fined limited access which is under sur- in process), the controlled substances veillance by an employee or employees may be stored separately, provided designated in writing as responsible for that each storage area complies with the area. ‘‘Limited access’’ may be pro- the requirements set forth in this sec- vided, in the absence of physical divid- tion. ers such as walls or partitions, by traf- (d) Accessibility to storage areas. The fic control lines or restricted space des- controlled substances storage areas ignation. The employee designated as shall be accessible only to an absolute responsible for the area may be en- minimum number of specifically au- gaged in the particular manufacturing thorized employees. When it is nec- operation being conducted: Provided, essary for employee maintenance per- That he is able to provide continuous sonnel, nonemployee maintenance per- surveillance of the area in order that sonnel, business guests, or visitors to unauthorized persons may not enter or be present in or pass through con- leave the area without his knowledge. trolled substances storage areas, the (c) During the production of con- registrant shall provide for adequate trolled substances, the manufacturing observation of the area by an employee areas shall be accessible to only those specifically authorized in writing. employees required for efficient oper- [36 FR 18730, Sept. 21, 1971. Redesignated at ation. When it is necessary for em- 38 FR 26609, Sept. 24, 1973] ployee maintenance personnel, nonemployee maintenance personnel, busi- EDITORIAL NOTE: For FEDERAL REGISTER citations affecting § 1301.72, see the List of CFR ness guests, or visitors to be present in Sections Affected, which appears in the or pass through manufacturing areas Finding Aids section of the printed volume during production of controlled sub- and at www.fdsys.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.fdsys.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 102 of the Act (21 U.S.C. 802) or part [81 FR 97020, Dec. 30, 2016] 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 determine the total quantity of each basic AGGREGATE PRODUCTION AND PROCUREMENT class of controlled substance listed in QUOTAS 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 produc- ical, scientific, research and industrial tion quotas. needs of the United States, for lawful export requirements, and for the estab- INDIVIDUAL MANUFACTURING QUOTAS lishment and maintenance of reserve 1303.21 Individual manufacturing quotas. stocks. 1303.22 Procedure for applying for individual (b) In making his determinations, the manufacturing quotas. Administrator shall consider the fol- 1303.23 Procedure for fixing individual man- lowing factors: ufacturing quotas. (1) Total net disposal of the class by 1303.24 Inventory allowance. all manufacturers during the current 1303.25 Increase in individual manufac- and 2 preceding years; turing quotas. (2) Trends in the national rate of net 1303.26 Reduction in individual manufac- disposal of the class; turing quotas. (3) Total actual (or estimated) inven- 1303.27 Abandonment of quota. tories of the class and of all substances HEARINGS manufactured from the class, and trends in inventory accumulation; 1303.31 Hearings generally. (4) Projected demand for such class 1303.32 Purpose of hearing. as indicated by procurement quotas re- 1303.33 Waiver or modification of rules. quested pursuant to § 1303.12; and 1303.34 Request for hearing or appearance; (5) Other factors affecting medical, waiver. scientific, research, and industrial 1303.35 Burden of proof. needs in the United States and lawful 1303.36 Time and place of hearing. export requirements, as the Adminis- 1303.37 Final order. trator finds relevant, including AUTHORITY: 21 U.S.C. 821, 826, 871(b). changes in the currently accepted medical use in treatment with the class or

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the substances which are manufactured listed in Schedules I and II (except raw from it, the economic and physical opium being imported by the registrant availability of raw materials for use in pursuant to an import permit) the Ad- manufacturing and for inventory pur- ministrator shall issue procurement poses, yield and stability problems, po- quotas authorizing persons to procure tential disruptions to production (in- and use quantities of each basic class cluding possible labor strikes), and re- of such substances for the purpose of cent unforeseen emergencies such as manufacturing such class into dosage floods and fires. forms or into other substances. (c) The Administrator shall, on or be- (b) Any person who is registered to fore May 1 of each year, publish in the manufacture controlled substances FEDERAL REGISTER, general notice of listed in any schedule and who desires an aggregate production quota for any to use during the next calendar year basic class determined by him under any basic class of controlled substances this section. A copy of said notice shall listed in Schedule I or II (except raw be mailed simultaneously to each person registered as a bulk manufacturer opium being imported by the registrant of the basic class. The Administrator pursuant to an import permit) for pur- shall permit any interested person to poses of manufacturing, shall apply on file written comments on or objections DEA Form 250 for a procurement quota to the proposal and shall designate in for such basic class. A separate applica- the notice the time during which such tion must be made for each basic class filings may be made. The Adminis- desired to be procured or used. The ap- trator may, but shall not be required plicant shall state whether he intends to, hold a public hearing on one or to manufacture the basic class himself more issues raised by the comments or purchase it from another manufac- and objections filed with him. In the turer. The applicant shall state sepa- event the Administrator decides to rately each purpose for which the basic hold such a hearing, he shall publish class is desired, the quantity desired notice of the hearing in the FEDERAL for that purpose during the next cal- REGISTER, which notice shall summa- endar year, and the quantities used and rize the issues to be heard and shall set estimated to be used, if any, for that the time for the hearing which shall purpose during the current and pre- not be less than 30 days after the date ceding 2 calendar years. If the purpose of publication of the notice. After con- is to manufacture the basic class into sideration of any comments or objec- dosage form, the applicant shall state tions, or after a hearing if one is or- the official name, common or usual dered by the Administrator shall issue name, chemical name, or brand name and publish in the FEDERAL REGISTER of that form. If the purpose is to manu- his final order determining the aggre- facture another substance, the appli- gate production quota for the basic cant shall state the official name, com- class of controlled substances. The mon or usual name, chemical name, or order shall include the findings of fact brand name of the substance, and, if a and conclusions of law upon which the controlled substance listed in any order is based. The order shall specify schedule, the schedule number and Ad- the date on which it shall take effect. ministration Controlled Substances A copy of said order shall be mailed si- Code Number, as set forth in part 1308 multaneously to each person registered of this chapter, of the substance. If the as a bulk manufacturer of the basic purpose is to manufacture another class. basic class of controlled substance list- [36 FR 7786, Apr. 24, 1971, as amended at 37 ed in Schedule I or II, the applicant FR 15919, Aug. 8, 1972. Redesignated at 38 FR shall also state the quantity of the 26609, Sept. 24, 1973; 77 FR 4235, Jan. 27, 2012] other basic class which the applicant has applied to manufacture pursuant to § 1303.12 Procurement quotas. § 1303.22 and the quantity of the first (a) In order to determine the esti- basic class necessary to manufacture a mated needs for, and to insure an ade- specified unit of the second basic class. quate and uninterrupted supply of, DEA Form 250 shall be filed on or be- basic classes of controlled substances fore April 1 of the year preceding the

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calendar year for which the procure- (3) Any person who is registered to ment quota is being applied. Copies of conduct research with a basic class of DEA Form 250 may be obtained from, controlled substance listed in Schedule and shall be filed with, the UN Report- I or II and who is authorized to manu- ing and Quota Section, Diversion Con- facture a quantity of such class pursu- trol Division. See the Table of DEA ant to § 1301.13 of this chapter. Mailing Addresses in § 1321.01 of this (f) Any person to whom a procure- chapter for the current mailing ad- ment quota has been issued, author- dress. izing that person to procure and use a (c) The Administrator shall, on or be- quantity of a basic class of controlled fore July 1 of the year preceding the substances listed in Schedules I or II calendar year during which the quota during the current calendar year, shall, shall be effective, issue to each quali- at or before the time of giving an order fied applicant a procurement quota au- to another manufacturer requiring the thorizing him to procure and use: distribution of a quantity of such basic (1) All quantities of such class nec- class, certify in writing to such other essary to manufacture all quantities of manufacturer that the quantity of such other basic classes of controlled sub- basic class ordered does not exceed the stances listed in Schedules I and II person’s unused and available procure- which the applicant is authorized to ment quota of such basic class for the manufacture pursuant to § 1303.23; and current calendar year. The written cer- (2) Such other quantities of such tification shall be executed by the class as the applicant has applied to same individual who signed the DEA procure and use and are consistent Form 222 transmitting the order. Man- with his past use, his estimated needs, ufacturers shall not fill an order from and the total quantity of such class persons required to apply for a procure- that will be produced. ment quota under paragraph (b) of this (d) Any person to whom a procure- section unless the order is accompanied ment quota has been issued may at any by a certification as required under time request an adjustment in the this section. The certification required quota by applying to the Adminis- by this section shall contain the fol- trator with a statement showing the lowing: The date of the certification; need for the adjustment. Such applica- the name and address of the bulk man- tion shall be filed with the UN Report- ufacturer to whom the certification is ing and Quota Section, Diversion Con- directed; a reference to the number of trol Division. See the Table of DEA the DEA Form 222 to which the certifi- Mailing Addresses in § 1321.01 of this cation applies; the name of the person chapter for the current mailing ad- giving the order to which the certifi- dress. The Administrator shall increase cation applies; the name of the basic class specified in the DEA Form 222 to or decrease the procurement quota of which the certification applies; the ap- such person if and to the extent that he propriate schedule within which is list- finds, after considering the factors enu- ed the basic class specified in the DEA merated in paragraph (c) of this section Form 222 to which the certification ap- and any occurrences since the issuance plies; a statement that the quantity of the procurement quota, that the (expressed in grams) of the basic class need justifies an adjustment. specified in the DEA Form 222 to which (e) The following persons need not the certification applies does not ex- obtain a procurement quota: ceed the unused and available procure- (1) Any person who is registered to ment quota of such basic class, issued manufacture a basic class of controlled to the person giving the order, for the substance listed in Schedule I or II and current calendar year; and the signa- who uses all of the quantity he manu- ture of the individual who signed the factures in the manufacture of a sub- DEA Form 222 to which the certifi- stance not controlled under the Act; cation applies. (2) Any person who is registered or authorized to conduct chemical anal- [36 FR 7786, Apr. 24, 1971. Redesignated at 38 ysis with controlled substances (for FR 26609, Sept. 24, 1973] controlled substances to be used in EDITORIAL NOTE: For FEDERAL REGISTER ci- such analysis only); and tations affecting § 1303.12, see the List of CFR

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Sections Affected, which appears in the cluding possible labor strikes), and re- Finding Aids section of the printed volume cent unforeseen emergencies such as and at www.fdsys.gov. floods and fires. § 1303.13 Adjustments of aggregate (c) The Administrator in the event he production quotas. determines to increase or reduce the aggregate production quota for a basic (a) The Administrator may at any time increase or reduce the aggregate class of controlled substance, shall production quota for a basic class of publish in the FEDERAL REGISTER gen- controlled substance listed in Schedule eral notice of an adjustment in the ag- I or II which he has previously fixed gregate production quota for that class pursuant to § 1303.11. determined by him under this section. (b) In determining to adjust the ag- A copy of said notice shall be mailed gregate production quota, the Adminis- simultaneously to each person reg- trator shall consider the following fac- istered as a bulk manufacturer of the tors: basic class. The Administrator shall (1) Changes in the demand for that permit any interested person to file class, changes in the national rate of written comments on or objections to net disposal of the class, and changes the proposal and shall designate in the in the rate of net disposal of the class notice the time during which such fil- by registrants holding individual man- ings may be made. The Administrator ufacturing quotas for that class; may, but shall not be required to, hold (2) Whether any increased demand for a public hearing on one or more issues that class, the national and/or indi- raised by the comments and objections vidual rates of net disposal of that filed with him. In the event the Admin- class are temporary, short term, or istrator decides to hold such a hearing, long term; he shall publish notice of the hearing (3) Whether any increased demand for in the FEDERAL REGISTER, which notice that class can be met through existing shall summarize the issues to be heard inventories, increased individual man- and shall set the time for the hearing, ufacturing quotas, or increased impor- which shall not be less than 10 days tation, without increasing the aggre- after the date of publication of the no- gate production quota, taking into ac- tice. After consideration of any com- count production delays and the prob- ments or objections, or after a hearing ability that other individual manufac- if one is ordered by the Administrator, turing quotas may be suspended pursu- the Administrator shall issue and pub- ant to § 1303.24(b); lish in the FEDERAL REGISTER his final (4) Whether any decreased demand order determining the aggregate pro- for that class will result in excessive duction for the basic class of controlled inventory accumulation by all persons substance. The order shall include the registered to handle that class (includ- findings of fact and conclusions of law ing manufacturers, distributors, practi- upon which the order is based. The tioners, importers, and exporters), not- order shall specify the date on which it withstanding the possibility that indi- shall take effect. A copy of said order vidual manufacturing quotas may be shall be mailed simultaneously to each suspended pursuant to § 1303.24(b) or person registered as a bulk manufac- abandoned pursuant to § 1303.27; turer of the basic class. (5) Other factors affecting medical, scientific, research, and industrial [37 FR 15919, Aug. 8, 1972. Redesignated at 38 needs in the United States and lawful FR 26609, Sept. 24, 1973] export requirements, as the Adminis- trator finds relevant, including INDIVIDUAL MANUFACTURING QUOTAS changes in the currently accepted medical use in treatment with the class or § 1303.21 Individual manufacturing the substances which are manufactured quotas. from it, the economic and physical (a) The Administrator shall, on or be- availability of raw materials for use in fore July 1 of each year, fix for and manufacturing and for inventory pur- issue to each person who is registered poses, yield and stability problems, po- to manufacture a basic class of con- tential disruptions to production (in- trolled substance listed in Schedule I

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or II, and who applies for a manufac- (1) The desired individual manufacturing quota, an individual manufacturing quota; and turing quota authorizing that person to (2) Any additional factors which the manufacture during the next calendar applicant finds relevant to the fixing of year a quantity of that basic class. Any his individual manufacturing quota, in- manufacturing quota fixed and issued cluding the trend of (and recent by the Administrator shall be subject changes in) his and the national rates to his authority to reduce or limit it at of net disposal, his production cycle a later date pursuant to § 1303.26 and to and current inventory position, the his authority to revoke or suspend it at econolic and physical availability of any time pursuant to §§ 1301.36 of this raw materials for use in manufacturing chapter. and for inventory purposes, yield and (b) No individual manufacturing stability problems, potential disrup- quota shall be required for registrants tions to production (including possible listed in § 1303.12(e). labor strikes) and recent unforeseen emergencies such as floods and fires. [36 FR 7786, Apr. 24, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973, as amended at 62 FR [36 FR 7786, Apr. 24, 1971, as amended at 36 13958, Mar. 24, 1997] FR 13386, July 21, 1971; 37 FR 15920, Aug. 8, 1972. Redesignated at 38 FR 26609, Sept. 24, § 1303.22 Procedure for applying for 1973, and amended at 46 FR 28841, May 29, individual manufacturing quotas. 1981; 51 FR 5319, Feb. 13, 1986; 62 FR 13958, Mar. 24, 1997; 75 FR 10677, Mar. 9, 2010; 81 FR Any person who is registered to man- 97020, Dec. 30, 2016] ufacture any basic class of controlled substance listed in Schedule I or II and § 1303.23 Procedure for fixing indi- who desires to manufacture a quantity vidual manufacturing quotas. of such class shall apply on DEA Form (a) In fixing individual manufac- 189 for a manufacturing quota for such turing quotas for a basic class of con- quantity of such class. Copies of DEA trolled substance listed in Schedule I Form 189 may be obtained from, and or II, the Administrator shall allocate shall be filed (on or before May 1 of the to each applicant who is currently year preceding the calendar year for manufacturing such class a quota equal which the manufacturing quota is to 100 percent of the estimated net dis- being applied) with, the UN Reporting posal of that applicant for the next cal- and Quota Section, Diversion Control endar year, adjusted— Division. See the Table of DEA Mailing (1) By the amount necessary to in- Addresses in § 1321.01 of this chapter for crease or reduce the estimated inven- the current mailing address. A separate tory of the applicant on December 31 of application must be made for each the current year to his estimated in- basic class desired to be manufactured. ventory allowance for the next cal- The applicant shall state: endar year, pursuant to § 1303.24, and (a) The name and Administration (2) By any other factors which the Controlled Substances Code Number, as Administrator deems relevant to the set forth in part 1308 of this chapter, of fixing of the individual manufacturing the basic class. quota of the applicant, including the (b) For the basic class in each of the trend of (and recent changes in) his and current and preceding 2 calendar years, the national rates of net disposal, his (1) The authorized individual manu- production cycle and current inventory facturing quota, if any; position, the economic and physical (2) The actual or estimated quantity availability of raw materials for use in manufactured; manufacturing and for inventory pur- (3) The actual or estimated net dis- poses, yield and stability problems, po- posal; tential disruptions to production (in- (4) The actual or estimated inventory cluding possible labor strikes), and re- allowance pursuant to § 1303.24; and cent unforeseen emergencies such as (5) The actual or estimated inventory floods and fires. as of December 31; (b) In fixing individual manufac- (c) For the basic class in the next cal- turing quotas for a basic class of con- endar year, trolled substance listed in Schedule I

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or II, the Administrator shall allocate lowed to maintain an inventory of a to each applicant who is not currently basic class not exceeding 65 percent of manufacturing such class a quota equal his estimated net disposal of that class to 100 percent of the reasonably esti- for that year, as determined at the mated net disposal of that applicant time his quota for that year was deter- for the next calendar year, as determined. At any time the inventory of a mined by the Administrator, ad- basic class held by a manufacturer ex- justed— ceeds 65 percent of his estimated net (1) By the amount necessary to pro- disposal, his quota for that class 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 § 1303.24, 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 the quota is, or is likely to be, suspended trend of (and recent changes in) the na- pursuant to this paragraph to continue tional rate of net disposal, his produc- manufacturing and to accumulate an tion cycle and current inventory posi- inventory in excess of 65 percent of his tion, the economic and physical avail- estimated net disposal, upon such con- ability of raw materials for use in man- ditions and within such limitations as ufacturing and for inventory purposes, the Administrator may find necessary yield and stability problems, potential or desirable. disruptions to production (including (c) If, during a calendar year, a reg- possible labor strikes), and recent un- istrant has manufactured the entire foreseen emergencies such as floods quantity of a basic class allocated to and fires. him under an individual manufacturing (c) The Administrator shall, on or be- quota, and his inventory of that class fore March 1 of each year, adjust the is less than 40 percent of his estimated individual manufacturing quota allo- net disposal of that class for that year, cated for that year to each applicant in the Administrator may, upon applica- paragraph (a) of this section by the tion pursuant to § 1303.25, increase the amount necessary to increase or reduce quota of such registrant sufficiently to the actual inventory of the applicant allow restoration of the inventory to 50 to December 31 of the preceding year to percent of the estimated net disposal his estimated inventory allowance for for that year. the current calendar year, pursuant to [36 FR 7786, Apr. 24, 1971, as amended at 36 § 1303.24. FR 13386, July 21, 1971. Redesignated at 38 FR [36 FR 7786, Apr. 24, 1971, as amended at 37 26609, Sept. 24, 1973] FR 15920, Aug. 8, 1972. Redesignated at 38 FR 26609, Sept. 24, 1973] § 1303.25 Increase in individual manufacturing quotas. § 1303.24 Inventory allowance. (a) Any registrant who holds an indi- (a) For the purpose of determining vidual manufacturing quota for a basic individual manufacturing quotas pur- class of controlled substance listed in suant to § 1303.23, each registered man- Schedule I or II may file with the Ad- ufacturer shall be allowed as a part of ministrator an application on Adminis- such quota an amount sufficient to tration Form 189 for an increase in maintain an inventory equal to, such quota in order for him to meet his (1) For current manufacturers, 50 per- estimated net disposal, inventory and cent of his average estimated net dis- other requirements during the remain- posal for the current calendar year and der of such calendar year. the last preceding calendar year; or (b) The Administrator, in passing (2) For new manufacturers, 50 percent upon a registrant’s application for an of his reasonably estimated net dis- increase in his individual manufac- posal for the next calendar year as de- turing quota, shall take into consider- termined by the Administrator. ation any occurrences since the filing (b) During each calendar year each of such registrant’s initial quota appli- registered manufacturer shall be al- cation that may require an increased

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manufacturing rate by such registrant § 1303.24(b) or § 1301.36 of this chapter, or during the balance of the calendar is abandoned pursuant to § 1303.27. year. In passing upon such application [36 FR 7786, Apr. 24, 1971, as amended at 37 the Administrator may also take into FR 15920, Aug. 8, 1972. Redesignated at 38 FR consideration the amount, if any, by 26609, Sept. 24, 1973, as amended at 62 FR which his determination of the total 13958, Mar. 24, 1997] quantity for the basic class of controlled substance to be manufactured § 1303.27 Abandonment of quota. under § 1303.11 exceeds the aggregate of Any manufacturer assigned an indi- all the individual manufacturing vidual manufacturing quota for any quotas for the basic class of controlled basic class pursuant to § 1303.23 may at substance, and the equitable distribu- any time abandon his right to manu- tion of such excess among other reg- facture all or any part of such quota by istrants. filing with the Drug & Chemical Eval- uation Section a written notice of such [36 FR 7786, Apr. 24, 1971, as amended at 36 abandonment, stating the name and FR 13386, July 21, 1971. Redesignated at 38 FR Administration Controlled Substances 26609, Sept. 24, 1973] Code Number, as set forth in part 1308 of this chapter, of the substance and § 1303.26 Reduction in individual man- the amount which he has chosen not to ufacturing quotas. manufacture. The Administrator may, The Administrator may at any time in his discretion, allocate such amount reduce an individual manufacturing among the other manufacturers in pro- quota for a basic class of controlled portion to their respective quotas. substance listed in Schedule I or II [36 FR 7786, Apr. 24, 1971, as amended at 36 which he has previously fixed in order FR 13386, July 21, 1971. Redesignated at 38 FR to prevent the aggregate of the indi- 26609, Sept. 24, 1973, and amended at 46 FR vidual manufacturing quotas and im- 28841, May 29, 1981; 51 FR 5319, Feb. 13, 1986; port permits outstanding or to be 62 FR 13958, Mar. 24, 1997] granted from exceeding the aggregate HEARINGS production quota which has been established for that class pursuant of § 1303.31 Hearings generally. § 1303.11, as adjusted pursuant to (a) In any case where the Adminis- § 1303.13. If a quota assigned to a new trator shall hold a hearing regarding manufacturer pursuant to § 1303.23(b), the determination of an aggregate pro- or if a quota assigned to any manufac- duction quota pursuant to § 1303.11(c), turer is increased pursuant to or regarding the adjustment of an ag- § 1303.24(c), or if an import permit gregate production quota pursuant to issued to an importer pursuant to part § 1303.13(c), the procedures for such 1312 of this chapter, causes the total hearing shall be governed generally by quantity of a basic class to be manu- the rule making procedures set forth in factured and imported during the year the Administrative Procedure Act (5 to exceed the aggregate production U.S.C. 551–559) and specifically by sec- quota which has been established for tion 306 of the Act (21 U.S.C. 826), by that class pursuant to § 1303.11, as ad- §§ 1303.32–1303.37, and by the procedures justed pursuant to § 1303.13, the Admin- for administrative hearings under the istrator may proportionately reduce Act set forth in §§ 1316.41–1316.67 of this the individual manufacturing quotas chapter. and import permits of all other reg- (b) In any case where the Adminis- istrants to keep the aggregate produc- trator shall hold a hearing regarding the issuance, adjustment, suspension, tion quota within the limits originally or denial of a procurement quota pur- established, or, alternatively, the Ad- suant to § 1303.12, or the issuance, administrator may reduce the individual justment, suspension, or denial of an manufacturing quota of any registrant individual manufacturing quota pursu- whose quota is suspended pursuant to ant to §§ 1303.21–1303.27, the procedures for such hearing shall be governed generally by the adjudication procedures

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

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hearing, unless he shows good cause for ferent place and may be continued such failure. from day to day or recessed to a later (e) If all persons entitled to a hearing day without notice other than an- or to participate in a hearing waive or nouncement thereof by the presiding are deemed to waive their opportunity officer at the hearing. for the hearing or to participate in the hearing, the Administrator may cancel [36 FR 7786, Apr. 24, 1971, as amended at 37 FR 15920, Aug. 8, 1972. Redesignated at 38 FR the hearing, if scheduled, and issue his 26609, Sept. 24, 1973] final order pursuant to § 1303.37 without a hearing. § 1303.37 Final order. [36 FR 7786, Apr. 24, 1971, as amended at 36 As soon as practicable after the pre- FR 18731, Sept. 21, 1971; 37 FR 15920, Aug. 8, siding officer has certified the record 1972. Redesignated at 38 FR 26609, Sept. 24, to the Administrator, the Adminis- 1973] trator shall issue his order on the de- § 1303.35 Burden of proof. termination or adjustment of the aggregate production quota or on the (a) At any hearing regarding the de- issuance, adjustment, suspension, or termination or adjustment of an aggre- denial of the procurement quota or in- gate production quota, each interested dividual manufacturing quota, as case person participating in the hearing may be. The order shall include the shall have the burden of proving any findings of fact and conclusions of law propositions of fact or law asserted by upon which the order is based. The him in the hearing. order shall specify the date on which it (b) At any hearing regarding the shall take effect. The Administrator issuance, adjustment, suspension, or shall serve one copy of his order upon denial of a procurement or individual each party in the hearing. manufacturing quota, the Administra- tion shall have the burden of proving [36 FR 7786, Apr. 24, 1971, as amended at 37 that the requirements of this part for FR 15920, Aug. 8, 1972. Redesignated at 38 FR such issuance, adjustment, suspension, 26609, Sept. 24, 1973] or denial are satisfied. [36 FR 7786, Apr. 24, 1971, as amended at 37 PART 1304—RECORDS AND FR 15920, Aug. 8, 1972. Redesignated at 38 FR REPORTS OF REGISTRANTS 26609, Sept. 24, 1973, as amended at 62 FR 13958, Mar. 24, 1997] GENERAL INFORMATION

§ 1303.36 Time and place of hearing. Sec. 1304.01 Scope of part 1304. (a) If any applicant or registrant re- 1304.02 Definitions. quests a hearing on the issuance, ad- 1304.03 Persons required to keep records and justment, suspension, or denial of his file reports. procurement and/or individual manu- 1304.04 Maintenance of records and inven- facturing quota pursuant to § 1303.34, tories. the Administrator shall hold such 1304.05 Records of authorized central fill pharmacies and retail pharmacies. hearing. Notice of the hearing shall be 1304.06 Records and reports for electronic given to the applicant or registrant of prescriptions. the time and place at least 30 days prior to the hearing, unless the appli- INVENTORY REQUIREMENTS cant or registrant waives such notice 1304.11 Inventory requirements. and requests the hearing be held at an earlier time, in which case the Admin- CONTINUING RECORDS istrator shall fix a date for such hear- 1304.21 General requirements for continuing ing as early as reasonably possible. records. (b) The hearing will commence at the 1304.22 Records for manufacturers, distribu- place and time designated in the notice tors, dispensers, researchers, importers, given pursuant to paragraph (a) of this exporters, registrants that reverse distribute, and collectors. section or in the notice of hearing pub- 1304.23 Records for chemical analysts. lished in the FEDERAL REGISTER pursu- 1304.24 Records for maintenance treatment ant to § 1303.11(c) or § 1303.13 (c), but programs and detoxification treatment thereafter it may be moved to a dif- programs.

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1304.25 Records for treatment programs the reports required by this part for that compound narcotics for treatment persons registered or authorized to programs and other locations. conduct such activities. This latter re- 1304.26 Additional recordkeeping requirements applicable to drug products con- quirement should not be construed as taining gamma-hydroxybutyric acid. requiring stocks of controlled substances being used in various activities REPORTS under one registration to be stored sep- 1304.31 Reports from manufacturers import- arately, nor that separate records are ing narcotic raw material. required for each activity. The intent 1304.32 Reports of manufacturers importing of the Administration is to permit the coca leaves. registrant to keep one set of records 1304.33 Reports to Automation of Reports which are adapted by the registrant to and Consolidated Orders System (ARCOS). account for controlled substances used in any activity. Also, the Administra- ONLINE PHARMACIES tion does not wish to require separate 1304.40 Notification by online pharmacies. stocks of the same substance to be pur- 1304.45 Internet Web site disclosure require- chased and stored for separate activi- ments. ties. Otherwise, there is no advantage 1304.50 Disclosure requirements for Web gained by permitting several activities sites of nonpharmacy practitioners that under one registration. Thus, when a dispense controlled substances by means researcher manufactures a controlled of the Internet. 1304.55 Reports by online pharmacies. item, he must keep a record of the quantity manufactured; when he dis- AUTHORITY: 21 U.S.C. 821, 827, 831, 871(b), tributes a quantity of the item, he 958(e)–(g), and 965, unless otherwise noted. must use and keep invoices or order GENERAL INFORMATION forms to document the transfer; when he imports a substance, he keeps as § 1304.01 Scope of part 1304. part of his records the documentation Inventory and other records and re- required of an importer; and when sub- ports required under section 307, sec- stances are used in chemical analysis, tion 311, or section 1008(e) of the Act (21 he need not keep a record of this be- U.S.C. 827, 831, and 958(e)) shall be in cause such a record would not be re- accordance with, and contain the infor- quired of him under a registration to mation required by, those sections and do chemical analysis. All of these by the sections of this part. records may be maintained in one consolidated record system. Similarly, the [74 FR 15623, Apr. 6, 2009] researcher may store all of his controlled items in one place, and every § 1304.02 Definitions. two years take inventory of all items Any term contained in this part shall on hand, regardless of whether the sub- have the definition set forth in section stances were manufactured by him, im- 102 of the Act (21 U.S.C. 802) or § 1300.01, ported by him, or purchased domesti- § 1300.03, § 1300.04, or § 1300.05 of this cally by him, of whether the sub- chapter. stances will be administered to sub- [81 FR 97020, Dec. 30, 2016] jects, distributed to other researchers, or destroyed during chemical analysis. § 1304.03 Persons required to keep (b) A registered individual practi- records and file reports. tioner is required to keep records, as (a) Every registrant, including col- described in § 1304.04, of controlled sub- lectors, shall maintain the records and stances in Schedules II, III, IV, and V inventories and shall file the reports which are dispensed, other than by pre- required by this part, except as ex- scribing or administering in the lawful empted by this section. Any registrant course of professional practice. that is authorized to conduct other ac- (c) Except as provided in § 1304.06, a tivities without being registered to registered individual practitioner is conduct those activities, pursuant to not required to keep records of con- §§ 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,

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unless such substances are prescribed cility. These records must contain the in the course of maintenance or detoxi- date, time of transfer, number of car- fication treatment of an individual. tons, crates, drums or other packages (d) A registered individual practi- in which commercial containers of con- tioner is not required to keep records trolled substances are shipped and au- of controlled substances listed in thorized signatures for each transfer. A Schedules II, III, IV and V which are distributing registrant may, as part of administered in the lawful course of the initial request to operate a freight professional practice unless the practi- forwarding facility, request permission tioner regularly engages in the dis- to store records at a central location. pensing or administering of controlled Approval of the request to maintain substances and charges patients, either central records would be implicit in separately or together with charges for the approval of the request to operate other professional services, for sub- the facility. Otherwise, a request to stances so dispensed or administered. maintain records at a central location Records are required to be kept for must be submitted in accordance with controlled substances administered in § 1304.04 of this part. These records the course of maintenance or detoxi- must be maintained for a period of two fication treatment of an individual. years. (e) Each registered mid-level practi- (h) A person is required to keep the tioner shall maintain in a readily re- records and file the reports specified in trievable manner those documents re- § 1304.06 and part 1311 of this chapter if quired by the state in which he/she they are either of the following: practices which describe the conditions (1) An electronic prescription appli- and extent of his/her authorization to cation provider. dispense controlled substances and (2) An electronic pharmacy applica- shall make such documents available tion provider. for inspection and copying by author- [36 FR 7790, Apr. 24, 1971, as amended at 36 ized employees of the Administration. FR 18731, Sept. 21, 1971; 37 FR 15920, Aug. 8, Examples of such documentation in- 1972. Redesignated at 38 FR 26609, Sept. 24, clude protocols, practice guidelines or 1973, and amended at 50 FR 40523, Oct. 4, 1985; practice agreements. 51 FR 5320, Feb. 13, 1986; 51 FR 26154, July 21, 1986; 58 FR 31175, June 1, 1993; 62 FR 13958, (f) Registered persons using any con- Mar. 24, 1997; 65 FR 44679, July 19, 2000; 75 FR trolled substances while conducting 16306, Mar. 31, 2010; 77 FR 4235, Jan. 27, 2012; preclinical research, in teaching at a 79 FR 53562, Sept. 9, 2014] registered establishment which maintains records with respect to such sub- § 1304.04 Maintenance of records and stances or conducting research in con- inventories. formity with an exemption granted (a) Except as provided in paragraphs under section 505(i) or 512(j) of the Fed- (a)(1) and (a)(2) of this section, every eral Food, Drug, and Cosmetic Act (21 inventory and other records required to U.S.C. 355(i) or 360b(j)) at a registered be kept under this part must be kept establishment which maintains records by the registrant and be available, for in accordance with either of those sec- at least 2 years from the date of such tions, are not required to keep records inventory or records, for inspection if he/she notifies the Administration of and copying by authorized employees the name, address, and registration of the Administration. number of the establishment maintain- (1) Financial and shipping records ing such records. This notification (such as invoices and packing slips but shall be given at the time the person not executed order forms subject to applies for registration or reregistra- §§ 1305.17 and 1305.27 of this chapter) tion and shall be made in the form of may be kept at a central location, an attachment to the application, rather than at the registered location, which shall be filed with the applica- if the registrant has notified the Ad- tion. ministration of his intention to keep (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

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Charge of the Administration in the days upon receipt of a written request area in which the registrant is located. from the Administration for such Unless the registrant is informed by records, and if the Administration the Special Agent in Charge that per- chooses to do so in lieu of requiring de- mission to keep central records is delivery of such records to the registered nied, the registrant may maintain cen- location, to allow authorized employ- tral records commencing 14 days after ees of the Administration to inspect receipt of his notification by the Spe- such records at the central location cial Agent in Charge. All notifications upon request by such employees with- must include the following: out a warrant of any kind. (i) The nature of the records to be (4) In the event that a registrant fails kept centrally. to comply with these conditions, the (ii) The exact location where the Special Agent in Charge may cancel records will be kept. such central recordkeeping authoriza- (iii) The name, address, DEA reg- tion, and all other central record- istration number and type of DEA reg- keeping authorizations held by the registration of the registrant whose istrant without a hearing or other pro- records are being maintained centrally. cedures. In the event of a cancellation (iv) Whether central records will be of central recordkeeping authoriza- maintained in a manual, or computer tions under this paragraph the reg- readable, form. istrant shall, within the time specified (2) A registered retail pharmacy that by the Special Agent in Charge, comply possesses additional registrations for with the requirements of this section automated dispensing systems at long that all records be kept at the reg- term care facilities may keep all istered location. records required by this part for those (c) Registrants need not notify the additional registered sites at the retail Special Agent in Charge or obtain cen- pharmacy or other approved central lo- tral recordkeeping approval in order to cation. maintain records on an in-house com- (3) A collector that is authorized to puter system. maintain a collection receptacle at a (d) ARCOS participants who desire long-term care facility shall keep all authorization to report from other records required by this part relating than their registered locations must to those collection receptacles at the obtain a separate central reporting registered location, or other approved identifier. Request for central report- central location. ing identifiers will be submitted to the (b) All registrants that are author- ARCOS Unit. See the Table of DEA ized to maintain a central record- Mailing Addresses in § 1321.01 of this keeping system under paragraph (a) of chapter for the current mailing ad- this section shall be subject to the fol- dress. lowing conditions: (e) All central recordkeeping permits (1) The records to be maintained at previously issued by the Administra- the central record location shall not tion expired September 30, 1980. include executed order forms and in- (f) Each registered manufacturer, dis- ventories, which shall be maintained at tributor, importer, exporter, narcotic each registered location. treatment program and compounder (2) If the records are kept on micro- for narcotic treatment program shall film, computer media or in any form maintain inventories and records of requiring special equipment to render controlled substances as follows: the records easily readable, the reg- (1) Inventories and records of con- istrant shall provide access to such trolled substances listed in Schedules I equipment with the records. If any and II shall be maintained separately code system is used (other than pricing from all of the records of the reg- information), a key to the code shall be istrant; and 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

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the information required is readily re- this chapter. The computers on which trievable from the ordinary business the records are maintained may be lo- records of the registrant. cated at another location, but the (g) Each registered individual practi- records must be readily retrievable at tioner required to keep records and in- the registered location if requested by stitutional practitioner shall maintain the Administration or other law en- inventories and records of controlled forcement agent. The electronic appli- substances in the manner prescribed in cation must be capable of printing out paragraph (f) of this section. or transferring the records in a format (h) Each registered pharmacy shall that is readily understandable to an maintain the inventories and records of Administration or other law enforce- controlled substances as follows: ment agent at the registered location. (1) Inventories and records of all con- Electronic copies of prescription trolled substances listed in Schedule I and II shall be maintained separately records must be sortable by prescriber from all other records of the pharmacy. name, patient name, drug dispensed, (2) Paper prescriptions for Schedule and date filled. II controlled substances shall be main- (Authority: 21 U.S.C. 821 and 871(b); 28 CFR tained at the registered location in a 0.100) separate prescription file. (3) Inventories and records of Sched- [36 FR 7790, Apr. 24, 1971, as amended at 36 FR 13386, July 21, 1971. Redesignated at 38 FR ules III, IV, and V controlled sub- 26609, Sept. 24, 1973, and amended at 39 FR stances shall be maintained either sep- 37985, Oct. 25, 1974; 45 FR 44266, July 1, 1980; arately from all other records of the 47 FR 41735, Sept. 22, 1982; 51 FR 5320, Feb. 13, pharmacy or in such form that the in- 1986; 62 FR 13959, Mar. 24, 1997; 70 FR 25466, formation required is readily retriev- May 13, 2005; 75 FR 10677, Mar. 9, 2010; 75 FR able from ordinary business records of 16306, Mar. 31, 2010; 79 FR 53562, Sept. 9, 2014] the pharmacy. (4) Paper prescriptions for Schedules § 1304.05 Records of authorized cen- III, IV, and V controlled substances tral fill pharmacies and retail phar- shall be maintained at the registered macies. location either in a separate prescrip- (a) Every retail pharmacy that uti- tion file for Schedules III, IV, and V lizes the services of a central fill phar- controlled substances only or in such macy must keep a record of all central form that they are readily retrievable fill pharmacies, including name, ad- from the other prescription records of dress and DEA number, that are au- the pharmacy. Prescriptions will be thorized to fill prescriptions on its be- deemed readily retrievable if, at the half. The retail pharmacy must also time they are initially filed, the face of verify the registration for each central the prescription is stamped in red ink in the lower right corner with the let- fill pharmacy authorized to fill pre- ter ‘‘C’’ no less than 1 inch high and scriptions on its behalf. These records filed either in the prescription file for must be made available upon request controlled substances listed in Sched- for inspection by DEA. ules I and II or in the usual consecu- (b) Every central fill pharmacy must tively numbered prescription file for keep a record of all retail pharmacies, noncontrolled substances. However, if a including name, address and DEA num- pharmacy employs a computer applica- ber, for which it is authorized to fill tion for prescriptions that permits prescriptions. The central fill phar- identification by prescription number macy must also verify the registration and retrieval of original documents by for all retail pharmacies for which it is prescriber name, patient’s name, drug authorized to fill prescriptions. These dispensed, and date filled, then the re- records must be made available upon quirement to mark the hard copy pre- request for inspection by DEA. scription with a red ‘‘C’’ is waived. (5) Records of electronic prescrip- [68 FR 37410, June 24, 2003] tions for controlled substances shall be maintained in an application that meets the requirements of part 1311 of

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

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(d) Inventory date for newly controlled lations, tablets, capsules, or solutions), substances. On the effective date of a identified by the batch number or rule by the Administrator pursuant to other appropriate identifying number, §§ 1308.45, 1308.46, or 1308.47 of this chap- and if possible the finished form of the ter adding a substance to any schedule substance (e.g., 10-milligram tablet or of controlled substances, which sub- 10-milligram concentration per fluid stance was, immediately prior to that ounce or milliliter) and the number or date, not listed on any such schedule, volume thereof. every registrant required to keep (iii) For each controlled substance in records who possesses that substance finished form the inventory shall in- shall take an inventory of all stocks of clude: the substance on hand. Thereafter, (A) The name of the substance; such substance shall be included in (B) Each finished form of the sub- each inventory made by the registrant stance (e.g., 10-milligram tablet or 10- pursuant to paragraph (c) of this sec- milligram concentration per fluid tion. ounce or milliliter); (e) Inventories of manufacturers, dis- (C) The number of units or volume of tributors, registrants that reverse dis- each finished form in each commercial tribute, importers, exporters, chemical an- container (e.g., 100-tablet bottle or 3- alysts, dispensers, researchers, and collec- milliliter vial); and tors. Each person registered or author- (D) The number of commercial con- ized (by §§ 1301.13, 1307.11, 1307.13, or tainers of each such finished form (e.g. part 1317 of this chapter) to manufac- four 100-tablet bottles or six 3-milli- ture, distribute, reverse distribute, dis- liter vials). pense, import, export, conduct research (iv) For each controlled substance or chemical analysis with controlled not included in paragraphs (e)(1) (i), (ii) substances, or collect controlled sub- or (iii) of this section (e.g., damaged, stances from ultimate users, and re- defective or impure substances await- quired to keep records pursuant to ing disposal, substances held for qual- § 1304.03 shall include in the inventory ity control purposes, or substances the information listed below. maintained for extemporaneous (1) Inventories of manufacturers. Each compoundings) the inventories shall person registered or authorized to man- include: ufacture controlled substances shall in- (A) The name of the substance; clude the following information in the inventory: (B) The total quantity of the sub- (i) For each controlled substance in stance to the nearest metric unit bulk form to be used in (or capable of weight or the total number of units of use in) the manufacture of the same or finished form; and other controlled or non-controlled sub- (C) The reason for the substance stances in finished form, the inventory being maintained by the registrant and shall include: whether such substance is capable of (A) The name of the substance and use in the manufacture of any con- (B) The total quantity of the sub- trolled substance in finished form. stance to the nearest metric unit (2) Inventories of distributors. Each weight consistent with unit size. person registered or authorized to dis- (ii) For each controlled substance in tribute controlled substances shall in- the process of manufacture on the include in the inventory the same infor- ventory date, the inventory shall in- mation required of manufacturers pur- clude: suant to paragraphs (e)(1)(iii) and (iv) (A) The name of the substance; of this section. (B) The quantity of the substance in (3) Inventories of registrants that re- each batch and/or stage of manufac- verse distribute. Each person registered ture, identified by the batch number or or authorized to reverse distribute con- 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:

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(A) For controlled substances in bulk been manufactured, imported, or re- form, to the nearest metric unit weight ceived by such person. If less than 1 consistent with unit size; kilogram of any controlled substance (B) For each controlled substance in (other than a hallucinogenic controlled finished form: Each finished form of substance listed in Schedule I), or less the substance (e.g., 10-milligram tablet than 20 grams of a hallucinogenic sub- or 10-milligram concentration per fluid stance listed in Schedule I (other than ounce or milliliter); the number of lysergic acid diethylamide), or less units or volume of each finished form than 0.5 gram of lysergic acid in each commercial container (e.g., 100- diethylamide, is on hand at the time of tablet bottle or 3-milliliter vial); and inventory, that substance need not be the number of commercial containers included in the inventory. Laboratories of each such finished form (e.g., four of the Administration may possess up 100-tablet bottles or six 3-milliliter to 150 grams of any hallucinogenic sub- vials); and stance in Schedule I without regard to (C) For controlled substances in a a need for an inventory of those sub- commercial container, carton, crate, stances. No inventory is required of drum, or other receptacle that has been known or suspected controlled sub- opened: If the substance is listed in stances received as evidentiary mate- Schedule I or II, make an exact count rials for analysis. or measure of the contents; or if the (6) Inventories of dispensers and re- substance is listed in Schedule III, IV, searchers. Each person registered or au- or V, make an estimated count or thorized to dispense or conduct re- measure of the contents, unless the search with controlled substances shall container holds more than 1,000 tablets include in the inventory the same in- or capsules in which case an exact formation required of manufacturers count of the contents shall be made; or pursuant to paragraphs (e)(1)(iii) and (iii) For controlled substances ac- (iv) of this section. In determining the quired from collectors and law enforce- number of units of each finished form ment: The number and size (e.g., five of a controlled substance in a commer- 10-gallon liners, etc.) of sealed inner cial container that has been opened, liners on hand, or the dispenser or researcher shall do as (iv) For controlled substances ac- follows: quired from law enforcement: the num- (i) If the substance is listed in Sched- ber of sealed mail-back packages on ules I or II, make an exact count or hand. measure of the contents; or (4) Inventories of importers and exporters. Each person registered or author- (ii) If the substance is listed in ized to import or export controlled sub- Schedule III, IV, or V, make an esti- stances shall include in the inventory mated count or measure of the con- the same information required of man- tents, unless the container holds more ufacturers pursuant to paragraphs than 1,000 tablets or capsules in which (e)(1) (iii) and (iv) of this section. Each case he/she must make an exact count such person who is also registered as a of the contents. manufacturer or as a distributor shall (7) Inventories of collectors. Each reg- include in his/her inventory as an im- istrant authorized to collect controlled porter or exporter only those stocks of substances from ultimate users shall controlled substances that are actually include in the inventory the following separated from his stocks as a manu- information: facturer or as a distributor (e.g., in (i) For registrants authorized to col- transit or in storage for shipment). lect through a mail-back program, the (5) Inventories of chemical analysts. record shall include the following in- Each person registered or authorized to formation about each unused mail- conduct chemical analysis with con- back package and each returned mail- trolled substances shall include in his back package on hand awaiting de- inventory the same information re- struction: quired of manufacturers pursuant to (A) The date of the inventory; paragraphs (e)(1) (iii) and (iv) of this (B) The number of mail-back pack- section as to substances which have ages; and

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(C) The unique identification number DEA Form 41). In maintaining records of each package on hand, whether un- concerning imports and exports, the used or awaiting destruction. registrant must record the anticipated (ii) For registrants authorized to col- date of release by a customs official for lect through a collection receptacle, permit applications and declarations the record shall include the following and the date on which the controlled information about each unused inner substances are released by a customs liner on hand and each sealed inner officer at the port of entry or port of liner on hand awaiting destruction: export for return information. (A) The date of the inventory; (e) Record of destruction. In addition (B) The number and size of inner lin- to any other recordkeeping require- ers (e.g., five 10-gallon liners, etc.); ments, any registered person that de- (C) The unique identification number stroys a controlled substance pursuant of each inner liner. to § 1317.95(d), or causes the destruction of a controlled substance pursuant to [62 FR 13959, Mar. 24, 1997, as amended at 68 § 1317.95(c), shall maintain a record of FR 41228, July 11, 2003; 79 FR 53562, Sept. 9, destruction on a DEA Form 41. The 2014] records shall be complete and accurate, CONTINUING RECORDS and include the name and signature of the two employees who witnessed the § 1304.21 General requirements for destruction. Except, destruction of a continuing records. controlled substance dispensed by a (a) Every registrant required to keep practitioner for immediate administra- records pursuant to § 1304.03 shall main- tion at the practitioner’s registered lo- tain, on a current basis, a complete and cation, when the substance is not fully accurate record of each substance man- exhausted (e.g., some of the substance ufactured, imported, received, sold, de- remains in a vial, tube, or syringe after livered, exported, or otherwise disposed administration but cannot or may not of by him/her, and each inner liner, be further utilized), shall be properly sealed inner liner, and unused and re- recorded in accordance with § 1304.22(c), turned mail-back package, except that and such record need not be main- no registrant shall be required to maintained on a DEA Form 41. tain a perpetual inventory. [36 FR 7792, Apr. 24, 1971, as amended at 36 (b) Separate records shall be main- FR 13386, July 21, 1971. Redesignated at 38 FR tained by a registrant for each reg- 26609, Sept. 24, 1973, as amended at 62 FR istered location except as provided in 13960, Mar. 24, 1997; 79 FR 53563, Sept. 9, 2014; § 1304.04 (a). In the event controlled 81 FR 97020, Dec. 30, 2016] substances are in the possession or § 1304.22 Records for manufacturers, under the control of a registrant at a distributors, dispensers, research- location for which he is not registered, ers, importers, exporters, reg- the substances shall be included in the istrants that reverse distribute, and records of the registered location to collectors. which they are subject to control or to Each person registered or authorized which the person possessing the sub- (by §§ 1301.13(e), 1307.11, 1307.13, or part stance is responsible. 1317 of this chapter) to manufacture, (c) Separate records shall be main- distribute, dispense, import, export, retained by a registrant for each inde- verse distribute, destroy, conduct re- pendent activity and collection activ- search with controlled substances, or ity for which he/she is registered or au- collect controlled substances from ulti- thorized, except as provided in mate users, shall maintain records § 1304.22(d). with the information listed in para- (d) In recording dates of receipt, dis- graphs (a) through (f) of this section. tribution, other transfers, or destruc- (a) Records for manufacturers. Each tion, the date on which the controlled person registered or authorized to man- 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

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use in, or being used in, the manufac- number of each person to whom a dis- ture of the same or other controlled or tribution was made; noncontrolled substances in finished (viii) The quantity exported directly form, by the registrant (under a registration (i) The name of the substance; as an exporter), including the date, (ii) The quantity manufactured in quantity, and export permit or declara- bulk form by the registrant, including tion number of each exportation; the date, quantity and batch or other (ix) The quantity distributed or dis- identifying number of each batch man- posed of in any other manner by the ufactured; registrant (e.g., by distribution of com- (iii) The quantity received from plimentary samples or by destruction), other persons, including the date and including the date and manner of dis- quantity of each receipt and the name, tribution or disposal, the name, ad- address, and registration number of the dress, and registration number of the other person from whom the substance person to whom distributed, and the was received; quantity distributed or disposed; and (iv) The quantity imported directly (x) The originals of all written cer- by the registrant (under a registration tifications of available procurement as an importer) for use in manufacture quotas submitted by other persons (as by him/her, including the date, quan- required by § 1303.12(f) of this chapter) tity, and import permit or declaration relating to each order requiring the number for each importation; distribution of a basic class of con- (v) The quantity used to manufacture trolled substance listed in Schedule I the same substance in finished form, or II. including: (2) For each controlled substance in (A) The date and batch or other iden- finished form, tifying number of each manufacture; (i) The name of the substance; (B) The quantity used in the manu- (ii) Each finished form (e.g., 10-milli- facture; gram tablet or 10-milligram concentra- (C) The finished form (e.g., 10-milli- tion per fluid ounce or milliliter) and gram tablets or 10-milligram con- the number of units or volume of fin- centration per fluid ounce or milli- ished form in each commercial con- liter); tainer (e.g., 100-tablet bottle or 3-milli- (D) The number of units of finished liter vial); form manufactured; (iii) The number of containers of (E) The quantity used in quality con- each such commercial finished form trol; manufactured from bulk form by the (F) The quantity lost during manu- registrant, including the information facturing and the causes therefore, if required pursuant to paragraph known; (a)(1)(v) of this section; (G) The total quantity of the sub- (iv) The number of units of finished stance contained in the finished form; forms and/or commercial containers (H) The theoretical and actual yields; acquired from other persons, including and the date of and number of units and/or (I) Such other information as is nec- commercial containers in each acquisi- essary to account for all controlled tion to inventory and the name, ad- substances used in the manufacturing dress, and registration number of the process; person from whom the units were ac- (vi) The quantity used to manufac- quired; ture other controlled and noncon- (v) The number of units of finished trolled substances, including the name forms and/or commercial containers of each substance manufactured and imported directly by the person (under the information required in paragraph a registration or authorization to im- (a)(1)(v) of this section; port), including the date of, the num- (vii) The quantity distributed in bulk ber of units and/or commercial conform to other persons, including the tainers in, and the import permit or date and quantity of each distribution declaration number for, each importa- and the name, address, and registration tion;

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(vi) The number of units and/or com- (ix) of this section. In addition, records mercial containers manufactured by shall be maintained of the number of the registrant from units in finished units or volume of such finished form form received from others or imported, dispensed, including the name and ad- including: dress of the person to whom it was dis- (A) The date and batch or other iden- pensed, the date of dispensing, the tifying number of each manufacture; number of units or volume dispensed, (B) The operation performed (e.g., re- and the written or typewritten name or packaging or relabeling); initials of the individual who dispensed (C) The number of units of finished or administered the substance on be- form used in the manufacture, the half of the dispenser. In addition to the number manufactured and the number requirements of this paragraph, practi- lost during manufacture, with the tioners dispensing gamma-hydroxy- causes for such losses, if known; and butyric acid under a prescription must (D) Such other information as is nec- also comply with § 1304.26. essary to account for all controlled (d) Records for importers and exporters. substances used in the manufacturing Each person registered or authorized to process; import or export controlled substances (vii) The number of commercial con- shall maintain records with the same tainers distributed to other persons, in- information required of manufacturers cluding the date of and number of con- pursuant to paragraphs (a)(2) (i), (iv), tainers in each reduction from inven- (v) and (vii) of this section. In addition, tory, and the name, address, and reg- the quantity disposed of in any other istration number of the person to manner by the registrant (except quan- whom the containers were distributed; tities used in manufacturing by an im- (viii) The number of commercial con- porter under a registration as a manu- tainers exported directly by the reg- facturer), which quantities are to be re- istrant (under a registration as an ex- corded pursuant to paragraphs (a)(1) porter), including the date, number of (iv) and (v) of this section; and the containers and export permit or dec- quantity (or number of units or volume laration number for each exportation; in finished form) exported, including and the date, quantity (or number of units (ix) The number of units of finished or volume), and the export permit or forms and/or commercial containers declaration number for each expor- distributed or disposed of in any other tation, but excluding all quantities manner by the registrant (e.g., by dis- (and number of units and volumes) tribution of complimentary samples or manufactured by an exporter under a by destruction), including the date and registration as a manufacturer, which manner of distribution or disposal, the quantities (and numbers of units and name, address, and registration num- volumes) are to be recorded pursuant ber of the person to whom distributed, to paragraphs (a)(1)(xiii) or (a)(2)(xiii) and the quantity in finished form dis- of this section. tributed or disposed. (e) Records for registrants that reverse (b) Records for distributors. Except as distribute. Each person registered or au- provided in paragraph (e) of this sec- thorized to reverse distribute con- tion, each person registered or author- trolled substances shall maintain ized to distribute controlled substances records with the following information shall maintain records with the same for each controlled substance: information required of manufacturers (1) For controlled substances ac- pursuant to paragraphs (a)(2)(i), (ii), quired for the purpose of return or re- (iv), (v), (vii), (viii) and (ix) of this sec- call to the manufacturer or another tion. registrant authorized by the manufac- (c) Records for dispensers and research- turer to accept returns on the manu- ers. Each person registered or author- facturer’s behalf pursuant to part 1317 ized to dispense or conduct research of this chapter: 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

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whom the substance was received; and or V, make an estimated count or the reason for return (e.g., recall or re- measure of the contents, unless the turn); and container holds more than 1,000 tablets (ii) The date of return to the manu- or capsules in which case an exact facturer or other registrant authorized count of the contents shall be made. by the manufacturer to accept returns (4) For each sealed inner liner ac- on the manufacturer’s behalf; the name quired from collectors or law enforce- and quantity of each controlled sub- ment and each sealed mail-back pack- stance returned; the name, address, age acquired from law enforcement and registration number of the person pursuant to § 1317.55 of this chapter: from whom the substance was received; (i) The number of sealed inner liners the name, address, and registration acquired from other persons, including number of the registrant to whom the the date of acquisition, the number substance was returned; and the meth- and, for sealed inner liners the size od of return (e.g., common or contract (e.g., five 10-gallon liners, etc.), of all carrier). sealed inner liners and mail-back pack- (2) For controlled substances ac- ages acquired to inventory, the unique quired from registrant inventory for identification number of each sealed destruction pursuant to § 1317.05(a)(2), inner liner and mail-back package, and (b)(2), and (b)(4) of this chapter: the name, address, and, for registrants, (i) The date of receipt; the name and the registration number of the person quantity of each controlled substance from whom the sealed inner liners and received; and the name, address, and mail-back packages were received, and registration number of the person from (ii) The date, place, and method of whom the substance was received; and destruction; the number of sealed inner (ii) The date, place, and method of liners and mail-back packages de- destruction; the name and quantity of stroyed; the name, address, and, for each controlled substance destroyed; registrants, the registration number of the name, address, and registration the person from whom the sealed inner number of the person from whom the liners and mail-back packages were re- substance was received; and the name ceived; the number and, for sealed and signatures of the two employees of inner liners the size (e.g., five 10-gallon the registrant that witnessed the de- liners, etc.), of all sealed inner liners struction. and mail-back packages destroyed; the (3) The total quantity of each con- unique identification number of each trolled substance shall be recorded in sealed inner liner and sealed mail-back accordance with the following: package destroyed; and the name and (i) For controlled substances in bulk signatures of the two employees of the form: To the nearest metric unit registrant that witnessed the destruc- weight or volume consistent with unit tion. size; (5) For all records, the record of re- (ii) For controlled substances in fin- ceipt shall be maintained together with ished form: Each finished form (e.g., 10- the corresponding record of return or milligram tablet or 10-milligram con- destruction (DEA Form 41). centration per fluid ounce or milli- (f) Records for collectors. Each person liter); the number of units or volume of registered or authorized to collect con- finished form in each commercial controlled substances from ultimate users tainer (e.g., 100-tablet bottle or 3-milli- shall maintain the following records: liter vial); and the number of commer- (1) Mail-Back Packages: cial containers of each such finished (i) For unused packages that the col- form (e.g., four 100-tablet bottles or six lector makes available to ultimate 3-milliliter vials); and users and other authorized non-reg- (iii) For controlled substances in a istrants at the collector’s registered commercial container, carton, crate, address: The date made available, the drum, or other receptacle that has been number of packages, and the unique opened: If the substance is listed in identification number of each package; Schedule I or II make an exact count (ii) For unused packages provided to or measure of the contents; or if the a third party to make available to ulti- substance is listed in Schedule III, IV, mate users and other authorized non-

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registrants: The name of the third and the names and signatures of the party and physical address of the loca- two employees that transferred each tion receiving the unused packages, sealed inner liner to the reverse dis- date sent, and the number of unused tributor or distributor; and packages sent with the corresponding (vi) For sealed inner liners destroyed unique identification numbers; on-site by the collector: The same in- (iii) For sealed mail-back packages formation required of reverse distribu- received by the collector: Date of re- tors in paragraph (e)(4)(ii) of this sec- ceipt and the unique identification tion. number on the individual package; and (iv) For sealed mail-back packages [62 FR 13960, Mar. 24, 1997, as amended at 68 FR 41229, July 11, 2003; 70 FR 293, Jan. 4, 2005; destroyed on-site by the collector: 79 FR 53564, Sept. 9, 2014] Number of sealed mail-back packages destroyed, the date and method of de- § 1304.23 Records for chemical ana- struction, the unique identification lysts. number of each mail-back package de- (a) Each person registered or author- stroyed, and the names and signatures ized (by § 1301.22(b) of this chapter) to of the two employees of the registrant conduct chemical analysis with con- who witnessed the destruction. trolled substances shall maintain (2) Collection receptacle inner liners: records with the following information (i) Date each unused inner liner ac- (to the extent known and reasonably quired, unique identification number ascertainable by him) for each con- and size (e.g., 5-gallon, 10-gallon, etc.) trolled substance: of each unused inner liner acquired; (ii) Date each inner liner is installed, (1) The name of the substance; the address of the location where each (2) The form or forms in which the inner liner is installed, the unique substance is received, imported, or identification number and size (e.g., 5- manufactured by the registrant (e.g., gallon, 10-gallon, etc.) of each installed powder, granulation, tablet, capsule, or inner liner, the registration number of solution) and the concentration of the the collector, and the names and signa- substance in such form (e.g., C.P., tures of the two employees that wit- U.S.P., N.F., 10-milligram tablet or 10- nessed each installation; milligram concentration per milli- (iii) Date each inner liner is removed liter); and sealed, the address of the location (3) The total number of the forms re- from which each inner liner is received, imported or manufactured (e.g., moved, the unique identification num- 100 tablets, thirty 1-milliliter vials, or ber and size (e.g., 5-gallon, 10-gallon, 10 grams of powder), including the date etc.) of each inner liner removed, the and quantity of each receipt, importa- registration number of the collector, tion, or manufacture and the name, ad- and the names and signatures of the dress, and registration number, if any, two employees that witnessed each re- of the person from whom the substance moval; was received; (iv) Date each sealed inner liner is (4) The quantity distributed, ex- transferred to storage, the unique iden- ported, or destroyed in any manner by tification number and size (e.g., 5-gal- the registrant (except quantities used lon, 10-gallon, etc.) of each sealed inner in chemical analysis or other labora- liner stored, and the names and signa- tory work), including the date and tures of the two employees that trans- manner of distribution, exportation, or ferred each sealed inner liner to stor- destruction, and the name, address, age; and registration number, if any, of (v) Date each sealed inner liner is each person to whom the substance was transferred for destruction, the address distributed or exported. and registration number of the reverse (b) Records of controlled substances distributor or distributor to whom used in chemical analysis or other lab- each sealed inner liner was transferred, oratory work are not required. the unique identification number and (c) Records relating to known or sus- the size (e.g., 5-gallon, 10-gallon, etc.) pected controlled substances received of each sealed inner liner transferred, as evidentiary material for analysis are

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

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date and quantity of each distribution (iv) Such other information as is nec- and the name, address and registration essary to account for all controlled number of each program to whom a dis- substances used in the compounding tribution was made; process; (8) The quantity exported directly by (7) The number of containers distrib- the registrant (under a registration as uted to other programs, including the an exporter), including the date, quan- date, the number of containers in each tity, and export permit or declaration distribution, and the name, address and number of each exploration; and registration number of the program to (9) The quantity disposed of by de- whom the containers were distributed; struction, including the reason, date, (8) The number of commercial con- and manner of destruction. (b) For each narcotic controlled sub- tainers exported directly by the reg- stance in finished form: istrant (under a registration as an ex- (1) The name of the substance; porter), including the date, number of (2) Each finished form (e.g., 10-milli- containers and export permit or dec- gram tablet or 10 milligram concentra- laration number for each exportation; tion per fluid ounce or milliliter) and and the number of units or volume or fin- (9) The number of units of finished ished form in each commercial con- forms and/or commercial containers tainer (e.g., 100-tablet bottle or 3-milli- destroyed in any manner by the reg- liter vial); istrant, including the reason, date, and (3) The number of containers of each manner of destruction. such commercial finished form com- [39 FR 37985, Oct. 25, 1974. Redesignated at 62 pounded from bulk form by the reg- FR 13961, Mar. 24, 1997; 79 FR 53564, Sept. 9, istrant, including the information re- 2014] quired pursuant to paragraph (a)(5) of this section; § 1304.26 Additional recordkeeping re- (4) The number of units of finished quirements applicable to drug prod- forms and/or commercial containers re- ucts containing gamma-hydroxy- ceived from other persons, including butyric acid. the date of and number of units and/or In addition to the recordkeeping re- commercial containers in each receipt quirements for dispensers and research- and the name, address and registration ers provided in § 1304.22, practitioners number of the person from whom the dispensing gamma-hydroxybutyric acid units were received; that is manufactured or distributed in (5) The number of units of finished forms and/or commercial containers accordance with an application under imported directly by the person (under section 505 of the Federal Food, Drug, a registration or authorization to im- and Cosmetic Act must maintain and port), including the date of, the num- make available for inspection and ber of units and/or commercial con- copying by the Attorney General, all of tainers in, and the import permit or the following information for each pre- declaration number for, each importa- scription: tion; (a) Name of the prescribing practi- (6) The number of units and/or com- tioner. mercial containers compounded by the (b) Prescribing practitioner’s Federal registrant from units in finished form and State registration numbers, with received from others or imported, in- the expiration dates of these registra- cluding: tions. (i) The date and batch or other iden- (c) Verification that the prescribing tifying number of each compounding; practitioner possesses the appropriate (ii) The operation performed (e.g., reregistration to prescribe this con- packaging or relabeling); trolled substance. (iii) The number of units of finished (d) Patient’s name and address. form used in the compound, the num- (e) Patient’s insurance provider, if ber compounded and the number lost available. during compounding, with the causes for such losses, if known; and [70 FR 293, Jan. 4, 2005]

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REPORTS (7) Quantity used for conversion; (8) Quantity placed in process; § 1304.31 Reports from manufacturers (9) Other dispositions; importing narcotic raw material. (10) Losses on reweighing and (a) Every manufacturer which im- (11) Ending inventory. ports or manufactures from narcotic (d) The following information shall raw material (opium, poppy straw, and be submitted for importation of each concentrate of poppy straw) shall sub- narcotic raw material: mit information which accounts for the (1) Import permit number; importation and for all manufacturing (2) Date shipment arrived at the operations performed between importa- United States port of entry; tion and the production in bulk or fin- (3) Actual quantity shipped; ished marketable products, standard- (4) Assay (percent) of morphine, co- ized in accordance with the U.S. Phar- deine and thebaine and macopeia, National Formulary or other (5) Quantity shipped, expressed as an- recognized medical standards. Reports hydrous morphine alkaloid. shall be signed by the authorized offi- (e) Upon importation of crude opium, cial and submitted quarterly on com- samples will be selected and assays pany letterhead to the UN Reporting made by the importing manufacturer and Quota Section, Diversion Control in the manner and according to the Division, on or before the 15th day of method specified in the U.S. Pharma- the month immediately following the copoeia. Where final assay data is not period for which it is submitted. See determined at the time of rendering re- the Table of DEA Mailing Addresses in port, the report shall be made on the § 1321.01 of this chapter for the current basis of the best data available, subject mailing address. to adjustment, and the necessary ad- (b) The following information shall justing entries shall be made on the be submitted for each type of narcotic next report. raw material (quantities are expressed (f) Where factory procedure is such as grams of anhydrous morphine alka- that partial withdrawals of opium are loid): made from individual containers, there (1) Beginning inventory; shall be attached to each container a (2) Gains on reweighing; stock record card on which shall be (3) Imports; kept a complete record of all with- (4) Other receipts; drawals therefrom. (5) Quantity put into process; (g) All in-process inventories should (6) Losses on reweighing; be expressed in terms of end-products (7) Other dispositions and and not precursors. Once precursor ma- (8) Ending inventory. terial has been changed or placed into (c) The following information shall process for the manufacture of a speci- be submitted for each narcotic raw ma- fied end-product, it must no longer be terial derivative including morphine, accounted for as precursor stocks codeine, thebaine, oxycodone, available for conversion or use, but hydrocodone, medicinal opium, manu- rather as end-product in-process inven- facturing opium, crude alkaloids and tories. other derivatives (quantities are ex- [62 FR 13961, Mar. 24, 1997, as amended at 75 pressed as grams of anhydrous base or FR 10677, Mar. 9, 2010; 81 FR 97020, Dec. 30, anhydrous morphine alkaloid for man- 2016] ufacturing opium and medicinal opium): § 1304.32 Reports of manufacturers im- (1) Beginning inventory; porting coca leaves. (2) Gains on reweighing; (a) Every manufacturer importing or (3) Quantity extracted from narcotic manufacturing from raw coca leaves raw material; shall submit information accounting (4) Quantity produced/manufactured/ for the importation and for all manu- synthesized; facturing operations performed be- (5) Quantity sold; tween the importation and the manu- (6) Quantity returned to conversion facture of bulk or finished products processes for reworking; standardized in accordance with U.S.

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Pharmacopoeia, National Formulary, mined at the time of submission, the or other recognized standards. The re- report shall be made on the basis of the ports shall be submitted quarterly on best data available, subject to adjust- company letterhead to the UN Report- ment, and the necessary adjusting en- ing and Quota Section, Diversion Con- tries shall be made on the next report. trol Division, on or before the 15th day (e) Where factory procedure is such of the month immediately following that partial withdrawals of medicinal the period for which it is submitted. coca leaves are made from individual See the Table of DEA Mailing Address- containers, there shall be attached to es in § 1321.01 of this chapter for the the container a stock record card on current mailing address. which shall be kept a complete record (b) The following information shall of withdrawals therefrom. be submitted for raw coca leaf, ecgo- (f) All in-process inventories should nine, ecgonine for conversion or fur- be expressed in terms of end-products ther manufacture, benzoylecgonine, and not precursors. Once precursor ma- manufacturing coca extracts (list for terial has been changed or placed into tinctures and extracts; and others sep- process for the manufacture of a speci- arately), other crude alkaloids and fied end-product, it must no longer be other derivatives (quantities should be accounted for as precursor stocks reported as grams of actual quantity available for conversion or use, but involved and the cocaine alkaloid con- rather as end-product in-process inven- tent or equivalency): tories. (1) Beginning inventory; [62 FR 13962, Mar. 24, 1997, as amended at 75 (2) Imports; FR 10678, Mar. 9, 2010; 81 FR 97020, Dec. 30, (3) Gains on reweighing; 2016] (4) Quantity purchased; (5) Quantity produced; § 1304.33 Reports to Automation of Re- (6) Other receipts; ports and Consolidated Orders Sys- (7) Quantity returned to processes for tem (ARCOS). reworking; (a) Reports generally. All reports re- (8) Material used in purification for quired by this section shall be filed sale; with the Pharmaceutical Investiga- (9) Material used for manufacture or tions Section, Diversion Control Divi- production; sion, Drug Enforcement Administra- (10) Losses on reweighing; tion on DEA Form 333, or on media (11) Material used for conversion; which contains the data required by (12) Other dispositions and DEA Form 333 and which is acceptable (13) Ending inventory. to the Administration. See the Table of (c) The following information shall DEA Mailing Addresses in § 1321.01 of be submitted for importation of coca this chapter for the current mailing ad- leaves: dress. (1) Import permit number; (b) Frequency of reports. Acquisition/ (2) Date the shipment arrived at the Distribution transaction reports shall United States port of entry; be filed every quarter not later than (3) Actual quantity shipped; the 15th day of the month succeeding (4) Assay (percent) of cocaine alka- the quarter for which it is submitted; loid and except that a registrant may be given (5) Total cocaine alkaloid content. permission to file more frequently (but (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

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following year. Manufacturing trans- (ii) Schedule IV action reports shall be filed annually (A) Barbital; for each calendar year not later than (B) Diethylpropion (Amfepramone); January 15 of the following year, ex- (C) Ethchlorvynol; cept that a registrant may be given (D) Ethinamate; permission to file more frequently (but (E) Lefetamine (SPA); not more frequently than quarterly). (F) Mazindol; (c) Persons reporting. For controlled (G) Meprobamate; substances in Schedules I, II, narcotic (H) Methylphenobarbital; controlled substances in Schedule III, and gamma-hydroxybutyric acid drug (I) Phenobarbital; product controlled substances in (J) Phentermine; and Schedule III, each person who is reg- (K) Pipradrol. istered to manufacture in bulk or dos- (2) Data shall be presented in such a age form, or to package, repackage, manner as to identify the particular label or relabel, and each person who is form, strength, and trade name, if any, registered to distribute, including each of the product containing the con- person who is registered to reverse dis- trolled substancefor which the report is tribute, shall report acquisition/dis- being made. For this purpose, persons tribution transactions. In addition to filing reports shall utilize the National reporting acquisition/distribution Drug Code Number assigned to the transactions, each person who is reg- product under the National Drug Code istered to manufacture controlled sub- System of the Food and Drug Adminis- stances in bulk or dosage form shall re- tration. port manufacturing transactions on (e) Transactions reported. Acquisition/ controlled substances in Schedules I distribution transaction reports shall and II, each narcotic controlled sub- provide data on each acquisition to instance listed in Schedules III, IV, and ventory (identifying whether it is, e.g., V, gamma-hydroxybutyric acid drug by purchase or transfer, return from a product controlled substances in customer, or supply by the Federal Schedule III, and on each psychotropic Government) and each reduction from controlled substance listed in Sched- inventory (identifying whether it is, ules III and IV as identified in para- e.g., by sale or transfer, theft, destruc- graph (d) of this section. tion or seizure by Government agen- (d) Substances covered. (1) Manufac- cies). Manufacturing reports shall pro- turing and acquisition/distribution vide data on material manufactured, transaction reports shall include data manufacture from other material, use on each controlled substance listed in in manufacturing other material and Schedules I and II, on each narcotic use in producing dosage forms. controlled substance listed in Schedule (f) Exceptions. (1) A registered institu- III (but not on any material, com- tional practitioner that repackages or pound, mixture or preparation con- relabels exclusively for distribution or taining a quantity of a substance hav- that distributes exclusively to (for dis- ing a stimulant effect on the central pensing by) agents, employees, or af- nervous system, which material, com- filiated institutional practitioners of pound, mixture or preparation is listed the registrant may be exempted from in Schedule III or on any narcotic con- filing reports under this section by ap- trolled substance listed in Schedule V), plying to the Pharmaceutical Inves- and on gamma-hydroxybutyric acid tigations Section, Diversion Control drug products listed in Schedule III. Division, Drug Enforcement Adminis- Additionally, reports on manufacturing tration. See the Table of DEA Mailing transactions shall include the fol- Addresses in § 1321.01 of this chapter for lowing psychotropic controlled sub- the current mailing address. stances listed in Schedules III and IV: (2) Registrants that acquire recalled (i) Schedule III controlled substances from ultimate (A) Benzphetamine; users pursuant to § 1317.85 of this chap- (B) Cyclobarbital; ter may report as a single transaction (C) Methyprylon; and all recalled controlled substances of (D) Phendimetrazine. the same name and finished form (e.g.,

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all 10-milligram tablets or all 5-milli- (2) Certification that the information gram concentration per fluid ounce or disclosed on its Internet site under the milliliter) received from ultimate users Internet Pharmacy Site Disclosure is for the purpose of reporting acquisition true and accurate. The statement shall transactions. be in a form similar to the following: (g) Exemptions. (1) Collectors that ac- ‘‘The above-named pharmacy, a DEA quire controlled substances from ulti- registrant, certifies, under penalty of mate users are exempt from the perjury, that the information con- ARCOS reporting requirements only tained in this statement is true and ac- with respect to controlled substances curate.’’ collected through mail-back programs (3) Each Internet site address utilized and collection receptacles for the pur- by the online pharmacy and a certifi- pose of disposal. cation that the online pharmacy shall (2) Reverse distributors and distribu- notify the Administrator of any change tors that acquire controlled substances in any such Internet address at least 30 pursuant to § 1317.55(a) or (b) of this days in advance. In the event that a chapter are exempt from the ARCOS pharmacy delivers, distributes, or dis- reporting requirements in this section penses controlled substances pursuant with regard to any controlled sub- to orders made on, through, or on be- stances acquired pursuant to § 1317.55(a) half of, more than one Web site, the or (b) of this chapter. pharmacy shall provide, for purposes of complying with this paragraph, the (Approved by the Office of Management and Internet site address of each such site. Budget under control number 1117–0003) (4) The DEA registration numbers of: [62 FR 13962, Mar. 24, 1997, as amended at 68 (i) Every pharmacy that delivers, dis- FR 41229, July 11, 2003; 70 FR 294, Jan. 4, 2005; tributes, or dispenses controlled sub- 75 FR 10678, Mar. 9, 2010; 79 FR 53564, Sept. 9, stances pursuant to orders made on, 2014; 81 FR 97020, Dec. 30, 2016] through, or on behalf of, each Web site referred to in paragraph (b)(3) of this ONLINE PHARMACIES section; and § 1304.40 Notification by online phar- (ii) Every practitioner who has a con- macies. tractual relationship to provide medical evaluations or issue prescriptions (a) Thirty days prior to offering a for controlled substances, through re- controlled substance for sale, delivery, ferrals from the Web site or at the re- distribution, or dispensing by means of quest of the owner or operator of the the Internet, an online pharmacy shall: Web site, or any employee or agent (1) Notify the Administrator of its in- thereof. tent to do so by submitting an applica- (c) An online pharmacy that is in op- tion for a modified registration in ac- eration at the time Public Law 110–425 cordance with §§ 1301.13 and 1301.19 of becomes effective (April 13, 2009) must this chapter, with such application make the notifications required in this containing the information required by section on or before May 13, 2009. How- this section; and ever, in accordance with section 401(h) (2) Notify the State boards of phar- of the Act (21 U.S.C. 841(h)), as of April macy in any States in which the online 13, 2009, it is unlawful for any online pharmacy offers to sell, deliver, dis- pharmacy to deliver, distribute, or distribute, or dispense controlled sub- pense a controlled substance by means stances. of the Internet unless such online phar- (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

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form: ‘‘In accordance with the Con- pharmacy that delivers, distributes, or trolled Substances Act and the DEA dispenses controlled substances pursu- regulations, this online pharmacy has ant to orders made on, through, or on made the notifications to the DEA Ad- behalf of that Web site. ministrator required by 21 U.S.C. 831 (1) The name and address of the phar- and 21 CFR 1304.40.’’ macy as it appears on the pharmacy’s (e)(1) Except as provided in para- DEA Certificate of Registration. graphs (e)(2) and (e)(3) of this section, (2) The pharmacy’s telephone number if any of the information required to be and e-mail address. submitted under this section changes after the online pharmacy submits the (3) The name, professional degree, notification to the Administrator, the and States of licensure of the phar- online pharmacy shall notify the Ad- macist-in-charge, and a telephone ministrator of the updated information number at which the pharmacist-in- no later than 30 days before the change charge can be contacted. becomes effective via the online proc- (4) A list of the States in which the ess. pharmacy is licensed to dispense con- (2) If a pharmacy referred to in para- trolled substances. graph (b)(4)(i) of this section ceases to (5) A certification that the pharmacy deliver, distribute, or dispense con- is registered under part 1301 of this trolled substances pursuant to orders chapter with a modification of its reg- made on, through, or on behalf of, each istration authorizing it to deliver, dis- Web site referred to in paragraph (b)(3) tribute, or dispense controlled sub- of this section, the online pharmacy stances by means of the Internet. shall notify the Administrator no later than 30 days after the change becomes (6) The name, address, telephone effective via the online process. number, professional degree, and (3) If a practitioner referred to in States of licensure with State license paragraph (b)(4)(ii) of this section number of any practitioner who has a ceases to have a contractual relation- contractual relationship to provide ship with the online pharmacy, the on- medical evaluations or issue prescrip- line pharmacy shall notify the Admin- tions for controlled substances, istrator no later than 30 days after the through referrals from the Web site or change becomes effective via the online at the request of the owner or operator process. of the Web site, or any employee or [74 FR 15623, Apr. 6, 2009] agent thereof. (7) The following statement: ‘‘This § 1304.45 Internet Web site disclosure online pharmacy is obligated to com- requirements. ply fully with the Controlled Sub- (a) Each online pharmacy shall dis- stances Act and DEA regulations. As play, at all times and in a visible and part of this obligation, this online clear manner, on its homepage a state- pharmacy has obtained a modified DEA ment that it complies with the require- registration authorizing it to operate ments of section 311 of the Act (21 as an online pharmacy. In addition, U.S.C. 831) with respect to the delivery this online pharmacy will only dis- or sale or offer for sale of controlled pense a controlled substance to a per- substances. This statement must in- son who has a valid prescription issued clude the name of the pharmacy as it for a legitimate medical purpose based appears on the DEA Certificate of Reg- upon a medical relationship with a pre- istration. scribing practitioner. This includes at (b) Each online pharmacy shall clear- least one prior in-person medical eval- ly display the following information on uation in accordance with section 309 the homepage of each Internet site it of the Controlled Substances Act (21 operates, or on a page directly linked U.S.C. 829) or a medical evaluation via to the homepage. If the information is telemedicine in accordance with sec- displayed on a page directly linked to tion 102(54) of the Controlled Sub- the homepage, that link on the home- stances Act (21 U.S.C. 802(54)).’’ page must be visible and clear. The information must be displayed for each [74 FR 15623, Apr. 6, 2009]

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§ 1304.50 Disclosure requirements for (1) 100 or more prescriptions for con- Web sites of nonpharmacy practi- trolled substances filled; or tioners that dispense controlled (2) 5,000 or more dosage units dis- substances by means of the Inter- pensed of all controlled substances net. combined. For a Web site to identify itself as (b) Each online pharmacy shall re- being exempt from the definition of an port a negative response if, during a online pharmacy by virtue of section given calendar month, its total dis- 102(52)(B)(ii) of the Act (21 U.S.C. pensing of controlled substances falls 802(52)(B)(ii)) and § 1300.04(h)(2) of this below both of the thresholds in para- chapter, the Web site shall post in a graph (a) of this section. visible and clear manner on its home- (c) The reporting requirements of page, or on a page directly linked this section apply to every pharmacy thereto in which the hyperlink is also that, at any time during a calendar visible and clear on the homepage, a month, holds a modified registration list of the DEA-registered nonphar- authorizing it to operate as an online macy practitioners who are affiliated pharmacy, regardless of whether the with the Web site. Any nonpharmacy online pharmacy dispenses any con- practitioner affiliated with such a Web trolled substances by means of the site is responsible for compliance with Internet during the month. this section. An institutional practi- (d) Reports will be submitted to DEA tioner that otherwise complies with electronically via online reporting, the requirements of the Act and this electronic file upload, or other means chapter will be deemed to meet the re- as approved by DEA. quirements of this section if, in lieu of (e) Reports shall be filed every month posting the names of each affiliated in- not later than the fifteenth day of the dividual practitioner, it posts its name month succeeding the month for which (as it appears on its Certificate of Reg- they are submitted. istration) in a visible and clear manner (f) An online pharmacy filing a report on its homepage and in a manner that under paragraph (a) of this section identifies itself as being responsible for shall utilize the National Drug Code the operation of the Web site. number assigned to the product under the National Drug Code System of the [74 FR 15623, Apr. 6, 2009] Food and Drug Administration, and indicate the total number of dosage units § 1304.55 Reports by online phar- dispensed for each such National Drug macies. Code number. (a) Each online pharmacy shall re- (g) Records required to be kept under port to the Administrator the total this section must be kept by the reg- quantity of each controlled substance istrant for at least two years from the that the pharmacy has dispensed each date of such records. The information calendar month. The report must in- shall be readily retrievable from the clude the total quantity of such dis- ordinary business records of the reg- pensing by any means, regardless of istrant and available for inspection and whether the controlled substances are copying by authorized employees of the dispensed by means of the Internet. Administration. Thus, such reporting shall include all [74 FR 15623, Apr. 6, 2009] controlled substances dispensed via Internet transactions, mail-order transactions, face-to-face transactions, PART 1305—ORDERS FOR SCHED- or any other means. However, the phar- ULE I AND II CONTROLLED SUB- macy is not required to describe in its STANCES report to the Administrator such means of dispensing. Such reporting is Subpart A—General Requirements required for every calendar month in Sec. which the total quantity of controlled 1305.01 Scope of part 1305. substances dispensed by the pharmacy 1305.02 Definitions. meets or exceeds one of the following 1305.03 Distributions requiring a Form 222 thresholds: or digitally signed electronic order.

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1305.04 Persons entitled to order Schedule I § 1305.03 Distributions requiring a and II controlled substances. Form 222 or a digitally signed elec- 1305.05 Power of attorney. tronic order. 1305.06 Persons entitled to fill orders for Either a DEA Form 222 or its elec- Schedule I and II controlled substances. 1305.07 Special procedure for filling certain tronic equivalent as set forth in sub- orders. part C of this part and Part 1311 of this chapter is required for each distribu- Subpart B—DEA Form 222 tion of a Schedule I or II controlled substance except for the following: 1305.11 Procedure for obtaining DEA Forms (a) Distributions to persons exempted 222. from registration under Part 1301 of 1305.12 Procedure for executing DEA Forms this chapter. 222. (b) Exports from the United States 1305.13 Procedure for filling DEA Forms 222. that conform with the requirements of 1305.14 Procedure for endorsing DEA Forms the Act. 222. 1305.15 Unaccepted and defective DEA (c) Deliveries to a registered analyt- Forms 222. ical laboratory or its agent approved 1305.16 Lost and stolen DEA Forms 222. by DEA. 1305.17 Preservation of DEA Forms 222. (d) Delivery from a central fill phar- 1305.18 Return of unused DEA Forms 222. macy, as defined in § 1300.01 of this 1305.19 Cancellation and voiding of DEA chapter, to a retail pharmacy. Forms 222. (e) Deliveries to an authorized DEA registrant by an ultimate user, a long- Subpart C—Electronic Orders term care facility on behalf of an ultimate user who resides or has resided at 1305.21 Requirements for electronic orders. that facility, or a person authorized to 1305.22 Procedure for filling electronic or- dispose of the ultimate user decedent’s ders. property. 1305.23 Endorsing electronic orders. 1305.24 Central processing of orders. (f) Distributions to reverse distribu- 1305.25 Unaccepted and defective electronic tors and distributors by collectors and orders. law enforcement pursuant to § 1317.55 of 1305.26 Lost electronic orders. this chapter. 1305.27 Preservation of electronic orders. (g) Deliveries of controlled sub- 1305.28 Canceling and voiding electronic or- stances from ultimate users for the ders. purpose of recalls pursuant to § 1317.85 1305.29 Reporting to DEA. of this chapter.

AUTHORITY: 21 U.S.C. 821, 828, 871(b), unless [70 FR 16911, Apr. 1, 2005, as amended at 77 otherwise noted. FR 4235, Jan. 27, 2012; 79 FR 53564, Sept. 9, 2014] SOURCE: 70 FR 16911, Apr. 1, 2005, unless otherwise noted. § 1305.04 Persons entitled to order Schedule I and II controlled sub- Subpart A—General Requirements stances. (a) Only persons who are registered § 1305.01 Scope of part 1305. with DEA under section 303 of the Act Procedures governing the issuance, (21 U.S.C. 823) to handle Schedule I or use, and preservation of orders for II controlled substances, and persons Schedule I and II controlled substances who are registered with DEA under sec- are set forth generally by section 308 of tion 1008 of the Act (21 U.S.C. 958) to the Act (21 U.S.C. 828) and specifically export these substances may obtain by the sections of this part. and use DEA Form 222 (order forms) or issue electronic orders for these sub- § 1305.02 Definitions. stances. Persons not registered to handle Schedule I or II controlled sub- Any term contained in this part shall stances and persons registered only to have the definition set forth in the Act import controlled substances are not or part 1300 of this chapter. entitled to obtain Form 222 or issue electronic orders for these substances.

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(b) An order for Schedule I or II con- fully do or cause to be done by virtue trolled substances may be executed hereof. only on behalf of the registrant named llllllllllllllllllllllll on the order and only if his or her reg- (Signature of person granting power) istration for the substances being pur- I, llll (name of attorney-in-fact), chased has not expired or been revoked hereby affirm that I am the person or suspended. named herein as attorney-in-fact and that the signature affixed hereto is my § 1305.05 Power of attorney. signature. (a) A registrant may authorize one or (signature of attorney-in-fact) more individuals, whether or not located at his or her registered location, Witnesses: to issue orders for Schedule I and II 1. llllll controlled substances on the reg- 2. llllll istrant’s behalf by executing a power of Signed and dated on the llll day of attorney for each such individual, if llll, (year), at llll . the power of attorney is retained in the files, with executed Forms 222 where Notice of Revocation applicable, for the same period as any order bearing the signature of the at- The foregoing power of attorney is torney. The power of attorney must be hereby revoked by the undersigned, available for inspection together with who is authorized to sign the current other order records. application for registration of the (b) A registrant may revoke any above-named registrant under the Con- power of attorney at any time by exe- trolled Substances Act or the Con- cuting a notice of revocation. trolled Substances Import and Export (c) The power of attorney and notice Act. Written notice of this revocation of revocation must be similar to the has been given to the attorney-in-fact following format: llll this same day. llllllllllllllllllllllll Power of Attorney for DEA Forms 222 (Signature of person revoking power) and Electronic Orders Witnesses: 1. llllll llllllllllllllllllllllll 2. llllll (Name of registrant) Signed and dated on the llll day of llllllllllllllllllllllll llll, (year), at llll. (Address of registrant) (d) A power of attorney must be exe- llllllllllllllllllllllll cuted by the person who signed the (DEA registration number) most recent application for DEA reg- I, llll (name of person granting istration or reregistration; the person power), the undersigned, who am au- to whom the power of attorney is being thorized to sign the current application granted; and two witnesses. for registration of the above-named (e) A power of attorney must be re- registrant under the Controlled Sub- voked by the person who signed the stances Act or Controlled Substances most recent application for DEA reg- Import and Export Act, have made, istration or reregistration, and two constituted, and appointed, and by witnesses. these presents, do make, constitute, and appoint llll (name of attorney- § 1305.06 Persons entitled to fill orders in-fact), my true and lawful attorney for Schedule I and II controlled for me in my name, place, and stead, to substances. execute applications for Forms 222 and An order for Schedule I and II con- to sign orders for Schedule I and II controlled substances, whether on a DEA trolled substances, whether these or- Form 222 or an electronic order, may ders be on Form 222 or electronic, in be filled only by a person registered accordance with 21 U.S.C. 828 and Part with DEA as a manufacturer or dis- 1305 of Title 21 of the Code of Federal tributor of controlled substances listed Regulations. I hereby ratify and con- in Schedule I or II pursuant to section firm all that said attorney must law- 303 of the Act (21 U.S.C. 823) or as an

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importer of such substances pursuant by the Administrator to handle these to section 1008 of the Act (21 U.S.C. substances, may fill the order in ac- 958), except for the following: cordance with the procedures set forth (a) A person registered with DEA to in § 1305.17 except that: dispense the substances, or to export (a) A DEA Form 222 or an electronic the substances, if he/she is disorder for thiafentanil, carfentanil, continuing business or if his/her reg- etorphine hydrochloride, and istration is expiring without rereg- diprenorphine must contain only these istration, may dispose of any Schedule substances in reasonable quantities. I or II controlled substances in his/her (b) The substances must be shipped, possession with a DEA Form 222 or an under secure conditions using substan- electronic order in accordance with tial packaging material with no mark- § 1301.52 of this chapter. ings on the outside that would indicate (b) A purchaser who has obtained any the content, only to the purchaser’s Schedule I or II controlled substance registered location. by either a DEA Form 222 or an electronic order may return the substance [70 FR 16911, Apr. 1, 2005, as amended at 81 to the supplier of the substance with FR 58839, Aug. 26, 2016] either a DEA Form 222 or an electronic order from the supplier. Subpart B—DEA Form 222 (c) A person registered to dispense Schedule II substances may distribute § 1305.11 Procedure for obtaining DEA the substances to another dispenser Forms 222. with either a DEA Form 222 or an elec- (a) DEA Forms 222 are issued in mail- tronic order only in the circumstances ing envelopes containing either seven described in § 1307.11 of this chapter. or fourteen forms, each form con- (d) A person registered or authorized taining an original, duplicate, and trip- to conduct chemical analysis or re- licate copy (respectively, Copy 1, Copy search with controlled substances may 2, and Copy 3). A limit, which is based distribute a Schedule I or II controlled on the business activity of the reg- substance to another person registered istrant, will be imposed on the number or authorized to conduct chemical of DEA Forms 222, which will be fur- analysis, instructional activities, or re- nished on any requisition unless addi- search with the substances with either tional forms are specifically requested a DEA Form 222 or an electronic order, and a reasonable need for such addi- if the distribution is for the purpose of tional forms is shown. furthering the chemical analysis, in- (b) Any person applying for a reg- structional activities, or research. istration that would entitle him or her (e) A person registered as a to obtain a DEA Form 222 may requisi- compounder of narcotic substances for tion the forms by so indicating on the use at off-site locations in conjunction application form; a DEA Form 222 will with a narcotic treatment program at be supplied upon the registration of the the compounding location, who is au- applicant. Any person holding a reg- thorized to handle Schedule II nar- istration entitling him or her to obtain cotics, is authorized to fill either a a DEA Form 222 may requisition the DEA Form 222 or an electronic order forms for the first time by contacting for distribution of narcotic drugs to any Division Office or the Registration off-site narcotic treatment programs Section of the Administration. Any only. person already holding a DEA Form 222 may requisition additional forms on § 1305.07 Special procedure for filling DEA Form 222a, which is mailed to a certain orders. registrant approximately 30 days after A supplier of thiafentanil, each shipment of DEA Forms 222 to carfentanil, etorphine hydrochloride, that registrant, or by contacting any or diprenorphine, if he or she deter- Division Office or the Registration Sec- mines that the purchaser is a veteri- tion of the Administration. All requisi- narian engaged in zoo and exotic ani- tion forms (DEA Form 222a) must be mal practice, wildlife management pro- submitted to the DEA Registration grams, or research, and is authorized Section.

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(c) Each requisition must show the tion other than the registered location name, address, and registration num- printed on the form, provided that all ber of the registrant and the number of unexecuted forms are delivered books of DEA Forms 222 desired. Each promptly to the registered location requisition must be signed and dated upon an inspection of the location by by the same person who signed the any officer authorized to make inspec- most recent application for registrations, or to enforce, any Federal, State, tion or for reregistration, or by any or local law regarding controlled sub- person authorized to obtain and exe- stances. cute DEA Forms 222 by a power of attorney under § 1305.05. § 1305.13 Procedure for filling DEA (d) DEA Forms 222 will be serially Forms 222. numbered and issued with the name, (a) A purchaser must submit Copy 1 address, and registration number of the and Copy 2 of the DEA Form 222 to the registrant, the authorized activity, and supplier and retain Copy 3 in the pur- schedules of the registrant. This infor- chaser’s files. mation cannot be altered or changed (b) A supplier may fill the order, if by the registrant; any errors must be possible and if the supplier desires to corrected by the Registration Section do so, and must record on Copies 1 and of the Administration by returning the 2 the number of commercial or bulk forms with notification of the error. containers furnished on each item and the date on which the containers are § 1305.12 Procedure for executing DEA shipped to the purchaser. If an order Forms 222. cannot be filled in its entirety, it may (a) A purchaser must prepare and be filled in part and the balance sup- execute a DEA Form 222 simulta- plied by additional shipments within 60 neously in triplicate by means of days following the date of the DEA interleaved carbon sheets that are part Form 222. No DEA Form 222 is valid of the DEA Form 222. DEA Form 222 more than 60 days after its execution must be prepared by use of a type- by the purchaser, except as specified in writer, pen, or indelible pencil. paragraph (f) of this section. (b) Only one item may be entered on (c) The controlled substances must be each numbered line. An item must con- shipped only to the purchaser and the sist of one or more commercial or bulk location printed by the Administration containers of the same finished or bulk on the DEA Form 222, except as speci- form and quantity of the same sub- fied in paragraph (f) of this section. stance. The number of lines completed (d) The supplier must retain Copy 1 must be noted on that form at the bot- of the DEA Form 222 for his or her files tom of the form, in the space provided. and forward Copy 2 to the Special DEA Forms 222 for carfentanil, Agent in Charge of the Drug Enforce- etorphine hydrochloride, and ment Administration in the area in diprenorphine must contain only these which the supplier is located. Copy 2 substances. must be forwarded at the close of the (c) The name and address of the sup- month during which the order is filled. plier from whom the controlled sub- If an order is filled by partial ship- stances are being ordered must be en- ments, Copy 2 must be forwarded at the tered on the form. Only one supplier close of the month during which the may be listed on any form. final shipment is made or the 60-day (d) Each DEA Form 222 must be validity period expires. signed and dated by a person author- (e) The purchaser must record on ized to sign an application for registra- Copy 3 of the DEA Form 222 the num- tion or a person granted power of at- ber of commercial or bulk containers torney to sign a Form 222 under furnished on each item and the dates § 1305.05. The name of the purchaser, if on which the containers are received different from the individual signing by the purchaser. the DEA Form 222, must also be in- (f) DEA Forms 222 submitted by reg- serted in the signature space. istered procurement officers of the De- (e) Unexecuted DEA Forms 222 may fense Supply Center of the Defense Lo- be kept and may be executed at a loca- gistics Agency for delivery to armed

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services establishments within the (c) A supplier may for any reason United States may be shipped to loca- refuse to accept any order and if a sup- tions other than the location printed plier refuses to accept the order, a on the DEA Form 222, and in partial statement that the order is not accept- shipments at different times not to ex- ed is sufficient for purposes of this ceed six months from the date of the paragraph. order, as designated by the procure- (d) When a purchaser receives an ment officer when submitting the unaccepted order, Copies 1 and 2 of the order. DEA Form 222 and the statement must be attached to Copy 3 and retained in § 1305.14 Procedure for endorsing DEA the files of the purchaser in accordance Forms 222. with § 1305.17. A defective DEA Form (a) A DEA Form 222, made out to any 222 may not be corrected; it must be re- supplier who cannot fill all or a part of placed by a new DEA Form 222 for the the order within the time limitation order to be filled. set forth in § 1305.13, may be endorsed § 1305.16 Lost and stolen DEA Forms to another supplier for filling. The en- 222. dorsement must be made only by the supplier to whom the DEA Form 222 (a) If a purchaser ascertains that an was first made, must state (in the unfilled DEA Form 222 has been lost, spaces provided on the reverse sides of he or she must execute another in trip- Copies 1 and 2 of the DEA Form 222) the licate and attach a statement con- name and address of the second sup- taining the serial number and date of plier, and must be signed by a person the lost form, and stating that the authorized to obtain and execute DEA goods covered by the first DEA Form Forms 222 on behalf of the first sup- 222 were not received through loss of plier. The first supplier may not fill that DEA Form 222. Copy 3 of the sec- any part of an order on an endorsed ond form and a copy of the statement must be retained with Copy 3 of the form. The second supplier may fill the DEA Form 222 first executed. A copy of order, if possible and if the supplier de- the statement must be attached to sires to do so, in accordance with Copies 1 and 2 of the second DEA Form § 1305.13(b), (c), and (d), including ship- 222 sent to the supplier. If the first ping all substances directly to the pur- DEA Form 222 is subsequently received chaser. by the supplier to whom it was di- (b) Distributions made on endorsed rected, the supplier must mark upon DEA Forms 222 must be reported by the the face ‘‘Not accepted’’ and return second supplier in the same manner as Copies 1 and 2 to the purchaser, who all other distributions except that must attach it to Copy 3 and the state- where the name of the supplier is re- ment. quested on the reporting form, the sec- (b) Whenever any used or unused ond supplier must record the name, ad- DEA Forms 222 are stolen or lost (other dress, and registration number of the than in the course of transmission) by first supplier. any purchaser or supplier, the purchaser or supplier must immediately § 1305.15 Unaccepted and defective DEA Forms 222. upon discovery of the theft or loss, report the theft or loss to the Special (a) A DEA Form 222 must not be Agent in Charge of the Drug Enforce- filled if either of the following apply: ment Administration in the Divisional (1) The order is not complete, legible, Office responsible for the area in which or properly prepared, executed, or en- the registrant is located, stating the dorsed. serial number of each form stolen or (2) The order shows any alteration, lost. erasure, or change of any description. (c) If the theft or loss includes any (b) If a DEA Form 222 cannot be filled original DEA Forms 222 received from for any reason under this section, the purchasers and the supplier is unable supplier must return Copies 1 and 2 to to state the serial numbers of the DEA the purchaser with a statement as to Forms 222, the supplier must report the the reason (e.g., illegible or altered). date or approximate date of receipt and

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the names and addresses of the pur- suspended or revoked under § 1301.36 of chasers. this chapter for all Schedule I and II (d) If an entire book of DEA Forms controlled substances for which the 222 is lost or stolen, and the purchaser purchaser is registered, the purchaser is unable to state the serial numbers of must return all unused DEA Forms 222 the DEA Forms 222 in the book, the to the nearest office of the Administra- purchaser must report, in lieu of the tion. numbers of the forms contained in the book, the date or approximate date of § 1305.19 Cancellation and voiding of issuance. DEA Forms 222. (e) If any unused DEA Form 222 re- (a) A purchaser may cancel part or ported stolen or lost is subsequently all of an order on a DEA Form 222 by recovered or found, the Special Agent notifying the supplier in writing of the in Charge of the Drug Enforcement Ad- cancellation. The supplier must indi- ministration in the Divisional Office cate the cancellation on Copies 1 and 2 responsible for the area in which the of the DEA Form 222 by drawing a line registrant is located must immediately through the canceled items and print- be notified. ing ‘‘canceled’’ in the space provided for number of items shipped. § 1305.17 Preservation of DEA Forms (b) A supplier may void part or all of 222. an order on a DEA Form 222 by noti- (a) The purchaser must retain Copy 3 fying the purchaser in writing of the of each executed DEA Form 222 and all voiding. The supplier must indicate the copies of unaccepted or defective forms voiding in the manner prescribed for with each statement attached. cancellation in paragraph (a) of this (b) The supplier must retain Copy 1 section. of each DEA Form 222 that it has filled. (c) DEA Forms 222 must be main- Subpart C—Electronic Orders tained separately from all other records of the registrant. DEA Forms § 1305.21 Requirements for electronic 222 are required to be kept available for orders. inspection for a period of two years. If (a) To be valid, the purchaser must a purchaser has several registered loca- sign an electronic order for a Schedule tions, the purchaser must retain Copy 3 I or II controlled substance with a dig- of the executed DEA Form 222 and any ital signature issued to the purchaser, attached statements or other related or the purchaser’s agent, by DEA as documents (not including unexecuted provided in part 1311 of this chapter. DEA Forms 222, which may be kept (b) The following data fields must be elsewhere under § 1305.12(e)), at the reg- included on an electronic order for istered location printed on the DEA Schedule I and II controlled sub- Form 222. stances: (d) The supplier of thiafentanil, (1) A unique number the purchaser carfentanil, etorphine hydrochloride, assigns to track the order. The number and diprenorphine must maintain DEA must be in the following 9-character Forms 222 for these substances sepa- format: the last two digits of the year, rately from all other DEA Forms 222 X, and six characters as selected by the and records required to be maintained purchaser. by the registrant. (2) The purchaser’s DEA registration [70 FR 16911, Apr. 1, 2005, as amended at 81 number. FR 58839, Aug. 26, 2016] (3) The name of the supplier. (4) The complete address of the sup- § 1305.18 Return of unused DEA Forms plier (may be completed by either the 222. purchaser or the supplier). If the registration of any purchaser (5) The supplier’s DEA registration terminates (because the purchaser dies, number (may be completed by either ceases legal existence, discontinues the purchaser or the supplier). business or professional practice, or (6) The date the order is signed. changes the name or address as shown (7) The name (including strength on the purchaser’s registration) or is where appropriate) of the controlled

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substance product or the National the original order that the supplier Drug Code (NDC) number (the NDC completes. Software used to handle number may be completed by either digitally signed orders must comply the purchaser or the supplier). with part 1311 of this chapter. (8) The quantity in a single package (e) If an order cannot be filled in its or container. entirety, a supplier may fill it in part (9) The number of packages or con- and supply the balance by additional tainers of each item ordered. shipments within 60 days following the (c) An electronic order may include date of the order. No order is valid controlled substances that are not in more than 60 days after its execution schedules I and II and non-controlled by the purchaser, except as specified in substances. paragraph (h) of this section. § 1305.22 Procedure for filling elec- (f) A supplier must ship the con- tronic orders. trolled substances to the registered location associated with the digital cer- (a) A purchaser must submit the tificate used to sign the order, except order to a specific supplier. The sup- as specified in paragraph (h) of this sec- plier may initially process the order tion. (e.g., entry of the order into the computer system, billing functions, inven- (g) When a purchaser receives a ship- tory identification, etc.) centrally at ment, the purchaser must create a any location, regardless of the loca- record of the quantity of each item re- tion’s registration with DEA. Fol- ceived and the date received. The lowing centralized processing, the sup- record must be electronically linked to plier may distribute the order to one or the original order and archived. more registered locations maintained (h) Registered procurement officers by the supplier for filling. The reg- of the Defense Supply Center of the De- istrant must maintain control of the fense Logistics Agency may order con- processing of the order at all times. trolled substances for delivery to (b) A supplier may fill the order for a armed services establishments within Schedule I or II controlled substance, if the United States. These orders may be possible and if the supplier desires to shipped to locations other than the do so and is authorized to do so under registered location, and in partial ship- § 1305.06. ments at different times not to exceed (c) A supplier must do the following six months from the date of the order, before filling the order: as designated by the procurement offi- (1) Verify the integrity of the signa- cer when submitting the order. ture and the order by using software that complies with Part 1311 of this § 1305.23 Endorsing electronic orders. chapter to validate the order. A supplier may not endorse an elec- (2) Verify that the digital certificate tronic order to another supplier to fill. has not expired. (3) Check the validity of the certifi- § 1305.24 Central processing of orders. cate holder’s certificate by checking the Certificate Revocation List. The (a) A supplier that has one or more supplier may cache the Certificate registered locations and maintains a Revocation List until it expires. central processing computer system in (4) Verify the registrant’s eligibility which orders are stored may have one to order the controlled substances by or more of the supplier’s registered lo- checking the certificate extension cations fill an electronic order if the data. supplier does the following: (d) The supplier must retain an elec- (1) Assigns each item on the order to tronic record of every order, and, a specific registered location for fill- linked to each order, a record of the ing. number of commercial or bulk con- (2) Creates a record linked to the cen- tainers furnished on each item and the tral file noting both which items a lo- date on which the supplier shipped the cation filled and the location identity. containers to the purchaser. The linked (3) Ensures that no item is filled by record must also include any data on more than one location.

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(4) Maintains the original order with record of the second order and a copy all linked records on the central com- of the statement with the record of the puter system. first order and retain them. (b) A company that has central proc- (c) If the supplier to whom the order essing of orders must assign responsi- was directed subsequently receives the bility for filling parts of orders only to first order, the supplier must indicate registered locations that the company that it is ‘‘Not Accepted’’ and return it owns and operates. to the purchaser. The purchaser must link the returned order to the record of § 1305.25 Unaccepted and defective that order and the statement. electronic orders. (a) No electronic order may be filled § 1305.27 Preservation of electronic or- if: ders. (1) The required data fields have not (a) A purchaser must, for each order been completed. filled, retain the original signed order (2) The order is not signed using a and all linked records for that order for digital certificate issued by DEA. two years. The purchaser must also re- (3) The digital certificate used had tain all copies of each unaccepted or expired or had been revoked prior to defective order and each linked state- signature. ment. (4) The purchaser’s public key will (b) A supplier must retain each origi- not validate the digital signature. nal order filled and the linked records (5) The validation of the order shows for two years. that the order is invalid for any reason. (c) If electronic order records are (b) If an order cannot be filled for any maintained on a central server, the reason under this section, the supplier records must be readily retrievable at must notify the purchaser and provide the registered location. a statement as to the reason (e.g., improperly prepared or altered). A sup- § 1305.28 Canceling and voiding electronic orders. plier may, for any reason, refuse to accept any order, and if a supplier refuses (a) A supplier may void all or part of to accept the order, a statement that an electronic order by notifying the the order is not accepted is sufficient purchaser of the voiding. If the entire for purposes of this paragraph. order is voided, the supplier must make (c) When a purchaser receives an an electronic copy of the order, indi- unaccepted electronic order from the cate on the copy ‘‘Void,’’ and return it supplier, the purchaser must electroni- to the purchaser. The supplier is not cally link the statement of nonaccept- required to retain a record of orders ance to the original order. The original that are not filled. order and the statement must be re- (b) The purchaser must retain an tained in accordance with § 1305.27. electronic copy of the voided order. (d) Neither a purchaser nor a supplier (c) To partially void an order, the may correct a defective order; the pur- supplier must indicate in the linked chaser must issue a new order for the record that nothing was shipped for order to be filled. each item voided.

§ 1305.26 Lost electronic orders. § 1305.29 Reporting to DEA. (a) If a purchaser determines that an A supplier must, for each electronic unfilled electronic order has been lost order filled, forward either a copy of before or after receipt, the purchaser the electronic order or an electronic must provide, to the supplier, a signed report of the order in a format that statement containing the unique DEA specifies to DEA within two busi- tracking number and date of the lost ness days. order and stating that the goods covered by the first order were not re- PART 1306—PRESCRIPTIONS ceived through loss of that order. (b) If the purchaser executes an order GENERAL INFORMATION to replace the lost order, the purchaser Sec. must electronically link an electronic 1306.01 Scope of part 1306.

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1306.02 Definitions. § 1306.03 Persons entitled to issue pre- 1306.03 Persons entitled to issue prescrip- scriptions. tions. 1306.04 Purpose of issue of prescription. (a) A prescription for a controlled 1306.05 Manner of issuance of prescriptions. substance may be issued only by an in- 1306.06 Persons entitled to fill prescriptions. dividual practitioner who is: 1306.07 Administering or dispensing of nar- (1) Authorized to prescribe controlled cotic drugs. substances by the jurisdiction in which 1306.08 Electronic prescriptions. he is licensed to practice his profession 1306.09 Prescription requirements for online pharmacies. and (2) Either registered or exempted CONTROLLED SUBSTANCES LISTED IN SCHEDULE from registration pursuant to II §§ 1301.22(c) and 1301.23 of this chapter. 1306.11 Requirement of prescription. (b) A prescription issued by an indi- 1306.12 Refilling prescriptions; issuance of vidual practitioner may be commu- multiple prescriptions. nicated to a pharmacist by an em- 1306.13 Partial filling of prescriptions. ployee or agent of the individual prac- 1306.14 Labeling of substances and filling of titioner. prescriptions. 1306.15 Provision of prescription informa- [36 FR 7799, Apr. 24, 1971, as amended at 36 tion between retail pharmacies and cen- FR 18732, Sept. 21, 1971. Redesignated at 38 tral fill pharmacies for prescriptions of FR 26609, Sept. 24, 1973, as amended at 62 FR Schedule II controlled substances. 13966, Mar. 24, 1997]

CONTROLLED SUBSTANCES LISTED IN § 1306.04 Purpose of issue of prescrip- SCHEDULES III, IV, AND V tion. 1306.21 Requirement of prescription. (a) A prescription for a controlled 1306.22 Refilling of prescriptions. substance to be effective must be 1306.23 Partial filling of prescriptions. issued for a legitimate medical purpose 1306.24 Labeling of substances and filling of by an individual practitioner acting in prescriptions. 1306.25 Transfer between pharmacies of pre- the usual course of his professional scription information for Schedules III, practice. The responsibility for the IV, and V controlled substances for refill proper prescribing and dispensing of purposes. controlled substances is upon the pre- 1306.26 Dispensing without prescription. scribing practitioner, but a cor- 1306.27 Provision of prescription informa- responding responsibility rests with tion between retail pharmacies and cen- the pharmacist who fills the prescrip- tral fill pharmacies for initial and refill prescriptions of Schedule III, IV, or V tion. An order purporting to be a pre- controlled substances. scription issued not in the usual course of professional treatment or in legiti- AUTHORITY: 21 U.S.C. 821, 829, 831, 871(b), mate and authorized research is not a unless otherwise noted. prescription within the meaning and SOURCE: 36 FR 7799, Apr. 24, 1971; 36 FR intent of section 309 of the Act (21 13386, July 21, 1971, unless otherwise noted. U.S.C. 829) and the person knowingly Redesignated at 38 FR 26609, Sept. 24, 1973. filling such a purported prescription, as GENERAL INFORMATION well as the person issuing it, shall be subject to the penalties provided for § 1306.01 Scope of part 1306. violations of the provisions of law re- Rules governing the issuance, filling lating to controlled substances. (b) A prescription may not be issued and filing of prescriptions pursuant to in order for an individual practitioner section 309 of the Act (21 U.S.C. 829) are to obtain controlled substances for sup- set forth generally in that section and plying the individual practitioner for specifically by the sections of this part. the purpose of general dispensing to pa- § 1306.02 Definitions. tients. (c) A prescription may not be issued Any term contained in this part shall for ‘‘detoxification treatment’’ or have the definition set forth in section ‘‘maintenance treatment,’’ unless the 102 of the Act (21 U.S.C. 802) or part prescription is for a Schedule III, IV, or 1300 of this chapter. V narcotic drug approved by the Food [62 FR 13964, Mar. 24, 1997] and Drug Administration specifically

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for use in maintenance or detoxifica- rests upon the pharmacist, including a tion treatment and the practitioner is pharmacist employed by a central fill in compliance with requirements in pharmacy, who fills a prescription not § 1301.28 of this chapter. prepared in the form prescribed by DEA regulations. [36 FR 7799, Apr. 24, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973, and amended at 39 (g) An individual practitioner ex- FR 37986, Oct. 25, 1974; 70 FR 36343, June 23, empted from registration under 2005] § 1301.22(c) of this chapter shall include on all prescriptions issued by him the § 1306.05 Manner of issuance of pre- registration number of the hospital or scriptions. other institution and the special inter- (a) All prescriptions for controlled nal code number assigned to him by substances shall be dated as of, and the hospital or other institution as signed on, the day when issued and provided in § 1301.22(c) of this chapter, shall bear the full name and address of in lieu of the registration number of the patient, the drug name, strength, the practitioner required by this sec- dosage form, quantity prescribed, di- tion. Each paper prescription shall rections for use, and the name, address have the name of the practitioner and registration number of the practi- stamped, typed, or handprinted on it, tioner. as well as the signature of the practi- (b) A prescription for a Schedule III, tioner. IV, or V narcotic drug approved by (h) An official exempted from reg- FDA specifically for ‘‘detoxification istration under § 1301.23(a) of this chap- treatment’’ or ‘‘maintenance treat- ter must include on all prescriptions ment’’ must include the identification issued by him his branch of service or number issued by the Administrator agency (e.g., ‘‘U.S. Army’’ or ‘‘Public under § 1301.28(d) of this chapter or a Health Service’’) and his service identi- written notice stating that the practi- fication number, in lieu of the registra- tioner is acting under the good faith tion number of the practitioner re- exception of § 1301.28(e) of this chapter. quired by this section. The service (c) Where a prescription is for identification number for a Public gamma-hydroxybutyric acid, the prac- Health Service employee is his Social titioner shall note on the face of the Security identification number. Each prescription the medical need of the paper prescription shall have the name patient for the prescription. of the officer stamped, typed, or (d) A practitioner may sign a paper handprinted on it, as well as the signa- prescription in the same manner as he ture of the officer. would sign a check or legal document (e.g., J.H. Smith or John H. Smith). [75 FR 16307, Mar. 31, 2010] Where an oral order is not permitted, § 1306.06 Persons entitled to fill pre- paper prescriptions shall be written scriptions. with ink or indelible pencil, type- writer, or printed on a computer print- A prescription for a controlled sub- er and shall be manually signed by the stance may only be filled by a phar- practitioner. A computer-generated macist, acting in the usual course of prescription that is printed out or his professional practice and either faxed by the practitioner must be registered individually or employed in manually signed. a registered pharmacy, a registered (e) Electronic prescriptions shall be central fill pharmacy, or registered in- created and signed using an application stitutional practitioner. that meets the requirements of part [68 FR 37410, June 24, 2003, as amended at 70 1311 of this chapter. FR 36343, June 23, 2005] (f) A prescription may be prepared by the secretary or agent for the signa- § 1306.07 Administering or dispensing ture of a practitioner, but the pre- of narcotic drugs. scribing practitioner is responsible in (a) A practitioner may administer or case the prescription does not conform dispense directly (but not prescribe) a in all essential respects to the law and narcotic drug listed in any schedule to regulations. A corresponding liability a narcotic dependant person for the

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purpose of maintenance or detoxifica- controlled substance prescriptions in tion treatment if the practitioner this part; meets both of the following conditions: (2) The practitioner must use an ap- (1) The practitioner is separately reg- plication that meets the requirements istered with DEA as a narcotic treat- of part 1311 of this chapter; and ment program. (3) The practitioner must comply (2) The practitioner is in compliance with the requirements for practitioners with DEA regulations regarding treat- in part 1311 of this chapter. ment qualifications, security, records, (b) A pharmacy may fill an electroni- and unsupervised use of the drugs pur- cally transmitted prescription for a suant to the Act. controlled substance provided the phar- (b) Nothing in this section shall pro- macy complies with all other require- hibit a physician who is not specifi- ments for filling controlled substance cally registered to conduct a narcotic prescriptions in this part and with the treatment program from administering requirements of part 1311 of this chap- (but not prescribing) narcotic drugs to ter. a person for the purpose of relieving acute withdrawal symptoms when nec- (c) To annotate an electronic pre- essary while arrangements are being scription, a pharmacist must include made for referral for treatment. Not all of the information that this part re- more than one day’s medication may quires in the prescription record. be administered to the person or for (d) If the content of any of the infor- the person’s use at one time. Such mation required under § 1306.05 for a emergency treatment may be carried controlled substance prescription is al- out for not more than three days and tered during the transmission, the pre- may not be renewed or extended. scription is deemed to be invalid and (c) This section is not intended to im- the pharmacy may not dispense the pose any limitations on a physician or controlled substance. authorized hospital staff to administer [75 FR 16307, Mar. 31, 2010] or dispense narcotic drugs in a hospital to maintain or detoxify a person as an § 1306.09 Prescription requirements incidental adjunct to medical or sur- for online pharmacies. gical treatment of conditions other (a) No controlled substance that is a than addiction, or to administer or dispense narcotic drugs to persons with prescription drug may be delivered, intractable pain in which no relief or distributed, or dispensed by means of cure is possible or none has been found the Internet without a valid prescrip- after reasonable efforts. tion. (d) A practitioner may administer or (b) In accordance with the Act, it is dispense (including prescribe) any unlawful for any person to knowingly Schedule III, IV, or V narcotic drug ap- or intentionally fill a prescription for a proved by the Food and Drug Adminis- controlled substance that was issued in tration specifically for use in mainte- a manner that constitutes dispensing nance or detoxification treatment to a by means of the Internet unless such narcotic dependent person if the practi- person is a pharmacist who is acting in tioner complies with the requirements the usual course of his professional of § 1301.28 of this chapter. practice and is acting on behalf of a pharmacy whose registration has been [39 FR 37986, Oct. 25, 1974, as amended at 70 modified under sections 1301.13 and FR 36344, June 23, 2005] 1301.19 of this chapter to authorize it to § 1306.08 Electronic prescriptions. operate as an online pharmacy. (c) Any online pharmacy that partici- (a) An individual practitioner may pates in the transfer between phar- sign and transmit electronic prescrip- macies of prescription information tions for controlled substances pro- must do so in accordance with the re- vided the practitioner meets all of the quirements of §§ 1306.15 and 1306.25 of following requirements: this part. (1) The practitioner must comply with all other requirements for issuing [74 FR 15624, Apr. 6, 2009]

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CONTROLLED SUBSTANCES LISTED IN macist and shall contain all informa- SCHEDULE II tion required in § 1306.05, except for the signature of the prescribing individual § 1306.11 Requirement of prescription. practitioner; (a) A pharmacist may dispense di- (3) If the prescribing individual prac- rectly a controlled substance listed in titioner is not known to the phar- Schedule II that is a prescription drug macist, he must make a reasonable ef- as determined under section 503 of the fort to determine that the oral author- Federal Food, Drug, and Cosmetic Act ization came from a registered indi- (21 U.S.C. 353(b)) only pursuant to a vidual practitioner, which may include written prescription signed by the a callback to the prescribing individual practitioner, except as provided in practitioner using his phone number as paragraph (d) of this section. A paper listed in the telephone directory and/or prescription for a Schedule II con- other good faith efforts to insure his trolled substance may be transmitted identity; and by the practitioner or the practi- (4) Within 7 days after authorizing an tioner’s agent to a pharmacy via fac- emergency oral prescription, the pre- simile equipment, provided that the scribing individual practitioner shall original manually signed prescription cause a written prescription for the is presented to the pharmacist for re- emergency quantity prescribed to be view prior to the actual dispensing of delivered to the dispensing pharmacist. the controlled substance, except as In addition to conforming to the re- noted in paragraph (e), (f), or (g) of this quirements of § 1306.05, the prescription section. The original prescription shall shall have written on its face ‘‘Author- be maintained in accordance with ization for Emergency Dispensing,’’ § 1304.04(h) of this chapter. and the date of the oral order. The (b) An individual practitioner may paper prescription may be delivered to administer or dispense directly a con- the pharmacist in person or by mail, trolled substance listed in Schedule II but if delivered by mail it must be in the course of his professional prac- postmarked within the 7-day period. tice without a prescription, subject to Upon receipt, the dispensing phar- § 1306.07. macist must attach this paper prescrip- (c) An institutional practitioner may tion to the oral emergency prescription administer or dispense directly (but that had earlier been reduced to writ- not prescribe) a controlled substance listed in Schedule II only pursuant to a ing. For electronic prescriptions, the written prescription signed by the pre- pharmacist must annotate the record scribing individual practitioner or to of the electronic prescription with the an order for medication made by an in- original authorization and date of the dividual practitioner that is dispensed oral order. The pharmacist must notify for immediate administration to the the nearest office of the Administra- ultimate user. tion if the prescribing individual prac- (d) In the case of an emergency situa- titioner fails to deliver a written pre- tion, as defined by the Secretary in scription to him; failure of the phar- § 290.10 of this title, a pharmacist may macist to do so shall void the author- dispense a controlled substance listed ity conferred by this paragraph to dis- 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

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to a patient by parenteral, intra- by an individual practitioner acting in venous, intramuscular, subcutaneous the usual course of professional prac- or intraspinal infusion may be trans- tice; mitted by the practitioner or the prac- (ii) The individual practitioner pro- titioner’s agent to the pharmacy by vides written instructions on each pre- facsimile. The facsimile serves as the scription (other than the first prescrip- original written prescription for pur- tion, if the prescribing practitioner in- poses of this paragraph (e) and it shall tends for that prescription to be filled be maintained in accordance with immediately) indicating the earliest § 1304.04(h) of this chapter. date on which a pharmacy may fill (f) A prescription prepared in accord- each prescription; ance with § 1306.05 written for Schedule (iii) The individual practitioner con- II substance for a resident of a Long cludes that providing the patient with Term Care Facility may be trans- multiple prescriptions in this manner mitted by the practitioner or the prac- does not create an undue risk of diver- titioner’s agent to the dispensing phar- sion or abuse; macy by facsimile. The facsimile (iv) The issuance of multiple pre- serves as the original written prescrip- scriptions as described in this section tion for purposes of this paragraph (f) is permissible under the applicable and it shall be maintained in accord- state laws; and ance with § 1304.04(h). (v) The individual practitioner com- (g) A prescription prepared in accord- plies fully with all other applicable re- ance with § 1306.05 written for a Sched- quirements under the Act and these ule II narcotic substance for a patient regulations as well as any additional enrolled in a hospice care program cer- requirements under state law. tified and/or paid for by Medicare under (2) Nothing in this paragraph (b) Title XVIII or a hospice program which shall be construed as mandating or en- is licensed by the state may be trans- couraging individual practitioners to mitted by the practitioner or the prac- issue multiple prescriptions or to see their patients only once every 90 days titioner’s agent to the dispensing phar- when prescribing Schedule II con- macy by facsimile. The practitioner or trolled substances. Rather, individual the practitioner’s agent will note on practitioners must determine on their the prescription that the patient is a own, based on sound medical judgment, hospice patient. The facsimile serves as and in accordance with established the original written prescription for medical standards, whether it is appro- purposes of this paragraph (g) and it priate to issue multiple prescriptions shall be maintained in accordance with and how often to see their patients § 1304.04(h). when doing so. [36 FR 7799, Apr. 24, 1971, as amended at 36 [72 FR 64929, Nov. 19, 2007] FR 18733, Sept. 21, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973 and amended at 53 FR 4964, Feb. 19, 1988; 59 FR 26111, May 19, 1994; § 1306.13 Partial filling of prescrip- 59 FR 30832, June 15, 1994; 62 FR 13964, Mar. tions. 24, 1997; 65 FR 45713, July 25, 2000; 68 FR 37410, (a) The partial filling of a prescrip- June 24, 2003; 75 FR 16307, Mar. 31, 2010] tion for a controlled substance listed in Schedule II is permissible if the phar- § 1306.12 Refilling prescriptions; macist is unable to supply the full issuance of multiple prescriptions. quantity called for in a written or (a) The refilling of a prescription for emergency oral prescription and he a controlled substance listed in Sched- makes a notation of the quantity sup- ule II is prohibited. plied on the face of the written pre- (b)(1) An individual practitioner may scription, written record of the emer- issue multiple prescriptions author- gency oral prescription, or in the elec- izing the patient to receive a total of tronic prescription record. The remain- up to a 90-day supply of a Schedule II ing portion of the prescription may be controlled substance provided the fol- filled within 72 hours of the first par- lowing conditions are met: tial filling; however, if the remaining (i) Each separate prescription is portion is not or cannot be filled with- issued for a legitimate medical purpose in the 72-hour period, the pharmacist

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shall notify the prescribing individual tient, identification of medication au- practitioner. No further quantity may thorized (to include dosage, form, be supplied beyond 72 hours without a strength and quantity), listing of the new prescription. partial fillings that have been dis- (b) A prescription for a Schedule II pensed under each prescription and the controlled substance written for a pa- information required in § 1306.13(b). tient in a Long Term Care Facility (2) Immediate (real time) updating of (LTCF) or for a patient with a medical the prescription record each time a diagnosis documenting a terminal ill- partial filling of the prescription is ness may be filled in partial quantities conducted. to include individual dosage units. If (3) Retrieval of partially filled Sched- there is any question whether a patient ule II prescription information is the may be classified as having a terminal same as required by § 1306.22(b) (4) and illness, the pharmacist must contact (5) for Schedule III and IV prescription the practitioner prior to partially fill- refill information. ing the prescription. Both the pharmacist and the prescribing practitioner (Authority: 21 U.S.C. 801, et seq.) have a corresponding responsibility to [36 FR 7799, Apr. 24, 1971. Redesignated at 38 assure that the controlled substance is FR 26609, Sept. 24, 1973, and amended at 45 for a terminally ill patient. The phar- FR 54330, July 15, 1980; 56 FR 25027, June 3, macist must record on the prescription 1991; 62 FR 13965, Mar. 24, 1997; 75 FR 16308, whether the patient is ‘‘terminally ill’’ Mar. 31, 2010] or an ‘‘LTCF patient.’’ A prescription § 1306.14 Labeling of substances and that is partially filled and does not filling of prescriptions. contain the notation ‘‘terminally ill’’ or ‘‘LTCF patient’’ shall be deemed to (a) The pharmacist filling a written have been filled in violation of the Act. or emergency oral prescription for a For each partial filling, the dispensing controlled substance listed in Schedule pharmacist shall record on the back of II shall affix to the package a label the prescription (or on another appro- showing date of filling, the pharmacy priate record, uniformly maintained, name and address, the serial number of and readily retrievable) the date of the the prescription, the name of the pa- partial filling, quantity dispensed, re- tient, the name of the prescribing prac- maining quantity authorized to be dis- titioner, and directions for use and pensed, and the identification of the cautionary statements, if any, con- dispensing pharmacist. The total quan- tained in such prescription or required tity of Schedule II controlled sub- by law. stances dispensed in all partial fillings (b) If the prescription is filled at a must not exceed the total quantity pre- central fill pharmacy, the central fill scribed. Schedule II prescriptions for pharmacy shall affix to the package a patients in a LTCF or patients with a label showing the retail pharmacy medical diagnosis documenting a ter- name and address and a unique identi- minal illness shall be valid for a period fier, (i.e. the central fill pharmacy’s not to exceed 60 days from the issue DEA registration number) indicating date unless sooner terminated by the that the prescription was filled at the discontinuance of medication. central fill pharmacy, in addition to (c) Information pertaining to current the information required under para- Schedule II prescriptions for patients graph (a) of this section. in a LTCF or for patients with a med- (c) The requirements of paragraph (a) ical diagnosis documenting a terminal of this section do not apply when a illness may be maintained in a comput- controlled substance listed in Schedule erized system if this system has the ca- II is prescribed for administration to pability to permit: an ultimate user who is institutional- (1) Output (display or printout) of the ized: Provided, That: original prescription number, date of (1) Not more than 7-day supply of the issue, identification of prescribing indi- controlled substance listed in Schedule vidual practitioner, identification of II is dispensed at one time; patient, address of the LTCF or address (2) The controlled substance listed in of the hospital or residence of the pa- Schedule II is not in the possession of

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the ultimate user prior to the adminis- and DEA registration number of the tration; central fill pharmacy to which the pre- (3) The institution maintains appro- scription has been transmitted, the priate safeguards and records regarding name of the retail pharmacy phar- the proper administration, control, dis- macist transmitting the prescription, pensing, and storage of the controlled and the date of transmittal must be substance listed in Schedule II; and added to the electronic prescription (4) The system employed by the phar- record. macist in filling a prescription is ade- (2) Ensure that all information re- quate to identify the supplier, the quired to be on a prescription pursuant product, and the patient, and to set to Section 1306.05 of this part is trans- forth the directions for use and cau- mitted to the central fill pharmacy (ei- tionary statements, if any, contained ther on the face of the prescription or in the prescription or required by law. in the electronic transmission of infor- (d) All written prescriptions and mation); written records of emergency oral pre- (3) Maintain the original prescription scriptions shall be kept in accordance for a period of two years from the date with requirements of § 1304.04(h) of this the prescription was filled; chapter. (4) Keep a record of receipt of the (e) Where a prescription that has filled prescription, including the date been prepared in accordance with sec- of receipt, the method of delivery (pri- tion 1306.12(b) contains instructions vate, common or contract carrier) and from the prescribing practitioner indi- the name of the retail pharmacy em- cating that the prescription shall not ployee accepting delivery. be filled until a certain date, no phar- (b) The central fill pharmacy receiv- macist may fill the prescription before ing the transmitted prescription must: that date. (1) Keep a copy of the prescription (if [36 FR 13368, July 21, 1971, as amended at 37 sent via facsimile) or an electronic FR 15921, Aug. 8, 1972. Redesignated at 38 FR record of all the information trans- 26609, Sept. 24, 1973, as amended at 62 FR mitted by the retail pharmacy, includ- 13965, Mar. 24, 1997; 68 FR 37410, June 24, 2003; ing the name, address, and DEA reg- 72 FR 64930, Nov. 19, 2007] istration number of the retail pharmacy transmitting the prescription; § 1306.15 Provision of prescription information between retail phar- (2) Keep a record of the date of re- macies and central fill pharmacies ceipt of the transmitted prescription, for prescriptions of Schedule II con- the name of the pharmacist filling the trolled substances. prescription, and the date of filling of Prescription information may be pro- the prescription; vided to an authorized central fill phar- (3) Keep a record of the date the filled macy by a retail pharmacy for dis- prescription was delivered to the retail pensing purposes. The following re- pharmacy and the method of delivery quirements shall also apply: (i.e. private, common or contract car- (a) Prescriptions for controlled sub- rier). stances listed in Schedule II may be [68 FR 37410, June 24, 2003, as amended at 75 transmitted electronically from a re- FR 16308, Mar. 31, 2010] tail pharmacy to a central fill pharmacy including via facsimile. The re- CONTROLLED SUBSTANCES LISTED IN tail pharmacy transmitting the pre- SCHEDULES III, IV, AND V scription information must: (1) Write the words ‘‘CENTRAL § 1306.21 Requirement of prescription. FILL’’ on the face of the original paper (a) A pharmacist may dispense di- prescription and record the name, ad- rectly a controlled substance listed in dress, and DEA registration number of Schedule III, IV, or V that is a pre- the central fill pharmacy to which the scription drug as determined under sec- prescription has been transmitted, the tion 503(b) of the Federal Food, Drug, name of the retail pharmacy phar- and Cosmetic Act (21 U.S.C. 353(b)) only macist transmitting the prescription, pursuant to either a paper prescription and the date of transmittal. For elec- signed by a practitioner, a facsimile of tronic prescriptions the name, address, a signed paper prescription transmitted

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by the practitioner or the practi- ument or record must be uniformly tioner’s agent to the pharmacy, an maintained and readily retrievable. electronic prescription that meets the (c) The following information must requirements of this part and part 1311 be retrievable by the prescription num- of this chapter, or an oral prescription ber: made by an individual practitioner and (1) The name and dosage form of the promptly reduced to writing by the controlled substance. pharmacist containing all information (2) The date filled or refilled. required in § 1306.05, except for the sig- (3) The quantity dispensed. nature of the practitioner. (4) The initials of the dispensing (b) An individual practitioner may pharmacist for each refill. administer or dispense directly a con- (5) The total number of refills for trolled substance listed in Schedule III, that prescription. IV, or V in the course of his/her profes- (d) If the pharmacist merely initials sional practice without a prescription, and dates the back of the prescription subject to § 1306.07. or annotates the electronic prescrip- (c) An institutional practitioner may tion record, it shall be deemed that the administer or dispense directly (but full face amount of the prescription has not prescribe) a controlled substance been dispensed. listed in Schedule III, IV, or V only (e) The prescribing practitioner may pursuant to a paper prescription signed authorize additional refills of Schedule by an individual practitioner, a fac- III or IV controlled substances on the simile of a paper prescription or order original prescription through an oral for medication transmitted by the refill authorization transmitted to the practitioner or the practitioner’s agent pharmacist provided the following con- to the institutional practitioner-phar- ditions are met: macist, an electronic prescription that (1) The total quantity authorized, in- meets the requirements of this part cluding the amount of the original pre- and part 1311 of this chapter, or an oral scription, does not exceed five refills prescription made by an individual nor extend beyond six months from the practitioner and promptly reduced to date of issue of the original prescrip- writing by the pharmacist (containing tion. all information required in § 1306.05 ex- (2) The pharmacist obtaining the oral cept for the signature of the individual authorization records on the reverse of practitioner), or pursuant to an order the original paper prescription or anno- for medication made by an individual tates the electronic prescription record practitioner that is dispensed for im- with the date, quantity of refill, num- mediate administration to the ulti- ber of additional refills authorized, and mate user, subject to § 1306.07. initials the paper prescription or anno- [62 FR 13965, Mar. 24, 1997, as amended at 75 tates the electronic prescription record FR 16308, Mar. 31, 2010] showing who received the authorization from the prescribing practitioner § 1306.22 Refilling of prescriptions. who issued the original prescription. (a) No prescription for a controlled (3) The quantity of each additional substance listed in Schedule III or IV refill authorized is equal to or less than shall be filled or refilled more than six the quantity authorized for the initial months after the date on which such filling of the original prescription. prescription was issued. No prescrip- (4) The prescribing practitioner must tion for a controlled substance listed in execute a new and separate prescrip- Schedule III or IV authorized to be re- tion for any additional quantities be- filled may be refilled more than five yond the five-refill, six-month limita- times. tion. (b) Each refilling of a prescription (f) As an alternative to the proce- shall be entered on the back of the pre- dures provided by paragraphs (a) scription or on another appropriate through (e) of this section, a computer document or electronic prescription application may be used for the storage record. If entered on another docu- and retrieval of refill information for ment, such as a medication record, or original paper prescription orders for electronic prescription record, the doc- controlled substances in Schedule III

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and IV, subject to the following condi- separate file at that pharmacy for a pe- tions: riod of two years from the dispensing (1) Any such proposed computerized date. This printout of the day’s con- application must provide online re- trolled substance prescription order retrieval (via computer monitor or hard- fill data must be provided to each phar- copy printout) of original prescription macy using such a computerized appli- order information for those prescrip- cation within 72 hours of the date on tion orders that are currently author- which the refill was dispensed. It must ized for refilling. This shall include, be verified and signed by each phar- but is not limited to, data such as the macist who is involved with such dis- original prescription number; date of pensing. In lieu of such a printout, the issuance of the original prescription pharmacy shall maintain a bound log order by the practitioner; full name book, or separate file, in which each in- and address of the patient; name, ad- dividual pharmacist involved in such dress, and DEA registration number of dispensing shall sign a statement (in the practitioner; and the name, the manner previously described) each strength, dosage form, quantity of the day, attesting to the fact that the refill controlled substance prescribed (and information entered into the computer quantity dispensed if different from the that day has been reviewed by him and quantity prescribed), and the total is correct as shown. Such a book or file number of refills authorized by the pre- must be maintained at the pharmacy scribing practitioner. employing such an application for a pe- (2) Any such proposed computerized riod of two years after the date of dis- application must also provide online pensing the appropriately authorized retrieval (via computer monitor or refill. hard-copy printout) of the current refill history for Schedule III or IV con- (4) Any such computerized applica- trolled substance prescription orders tion shall have the capability of pro- (those authorized for refill during the ducing a printout of any refill data past six months). This refill history that the user pharmacy is responsible shall include, but is not limited to, the for maintaining under the Act and its name of the controlled substance, the implementing regulations. For exam- date of refill, the quantity dispensed, ple, this would include a refill-by-refill the identification code, or name or ini- audit trail for any specified strength tials of the dispensing pharmacist for and dosage form of any controlled sub- each refill and the total number of re- stance (by either brand or generic fills dispensed to date for that prescrip- name or both). Such a printout must tion order. include name of the prescribing practi- (3) Documentation of the fact that tioner, name and address of the pa- the refill information entered into the tient, quantity dispensed on each refill, computer each time a pharmacist re- date of dispensing for each refill, name fills an original paper, fax, or oral pre- or identification code of the dispensing scription order for a Schedule III or IV pharmacist, and the number of the controlled substance is correct must be original prescription order. In any provided by the individual pharmacist computerized application employed by who makes use of such an application. a user pharmacy the central record- If such an application provides a hard- keeping location must be capable of copy printout of each day’s controlled sending the printout to the pharmacy substance prescription order refill within 48 hours, and if a DEA Special data, that printout shall be verified, Agent or Diversion Investigator re- dated, and signed by the individual quests a copy of such printout from the pharmacist who refilled such a pre- user pharmacy, it must, if requested to scription order. The individual phar- do so by the Agent or Investigator, macist must verify that the data indi- verify the printout transmittal capa- cated 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-

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time, the pharmacy must have an aux- (b) If the prescription is filled at a iliary procedure which will be used for central fill pharmacy, the central fill documentation of refills of Schedule III pharmacy shall affix to the package a and IV controlled substance prescrip- label showing the retail pharmacy tion orders. This auxiliary procedure name and address and a unique identi- must ensure that refills are authorized fier, (i.e. the central fill pharmacy’s by the original prescription order, that DEA registration number) indicating the maximum number of refills has not that the prescription was filled at the been exceeded, and that all of the ap- central fill pharmacy, in addition to propriate data are retained for online the information required under para- data entry as soon as the computer sys- graph (a) of this section. tem is available for use again. (c) The requirements of paragraph (a) (g) When filing refill information for of this section do not apply when a original paper, fax, or oral prescription controlled substance listed in Schedule orders for Schedule III or IV controlled III, IV, or V is prescribed for adminis- substances, a pharmacy may use only tration to an ultimate user who is in- one of the two applications described in stitutionalized: Provided, That: paragraphs (a) through (e) or (f) of this (1) Not more than a 34-day supply or section. 100 dosage units, whichever is less, of (h) When filing refill information for the controlled substance listed in electronic prescriptions, a pharmacy Schedule III, IV, or V is dispensed at must use an application that meets the one time; requirements of part 1311 of this chap- (2) The controlled substance listed in ter. Schedule III, IV, or V is not in the possession of the ultimate user prior to [75 FR 16308, Mar. 31, 2010] administration; (3) The institution maintains appro- § 1306.23 Partial filling of prescriptions. priate safeguards and records the proper administration, control, dispensing, The partial filling of a prescription and storage of the controlled substance for a controlled substance listed in listed in Schedule III, IV, or V; and Schedule III, IV, or V is permissible, (4) The system employed by the phar- provided that: macist in filling a prescription is ade- (a) Each partial filling is recorded in quate to identify the supplier, the the same manner as a refilling, product and the patient, and to set (b) The total quantity dispensed in forth the directions for use and cau- all partial fillings does not exceed the tionary statements, if any, contained total quantity prescribed, and in the prescription or required by law. (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 [36 FR 18733, Sept. 21, 1971. Redesignated at § 1304.04(h) of this chapter. 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.

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(b) Transfers are subject to the fol- (i) The date of the original dis- lowing requirements: pensing. (1) The transfer must be commu- (ii) The number of refills remaining nicated directly between two licensed and the date(s) and locations of pre- pharmacists. vious refills. (2) The transferring pharmacist must (iii) The transferring pharmacy’s do the following: name, address, DEA registration num- (i) Write the word ‘‘VOID’’ on the ber, and prescription number for each face of the invalidated prescription; for dispensing. electronic prescriptions, information (iv) The name of the pharmacist that the prescription has been trans- transferring the prescription. ferred must be added to the prescrip- (v) The name, address, DEA registration record. tion number, and prescription number (ii) Record on the reverse of the in- from the pharmacy that originally validated prescription the name, ad- filled the prescription, if different. dress, and DEA registration number of (5) The pharmacist receiving a trans- the pharmacy to which it was transferred electronic prescription must cre- ferred and the name of the pharmacist ate an electronic record for the pre- receiving the prescription information; scription that includes the receiving for electronic prescriptions, such infor- pharmacist’s name and all of the information must be added to the prescrip- mation transferred with the prescription record. tion under paragraph (b)(4) of this sec- (iii) Record the date of the transfer tion. and the name of the pharmacist trans- (c) The original and transferred pre- ferring the information. scription(s) must be maintained for a (3) For paper prescriptions and pre- period of two years from the date of scriptions received orally and reduced last refill. to writing by the pharmacist pursuant (d) Pharmacies electronically access- to § 1306.21(a), the pharmacist receiving ing the same prescription record must the transferred prescription informa- satisfy all information requirements of tion must write the word ‘‘transfer’’ on a manual mode for prescription trans- the face of the transferred prescription feral. and reduce to writing all information (e) The procedure allowing the trans- required to be on a prescription pursu- fer of prescription information for re- ant to § 1306.05 and include: fill purposes is permissible only if al- (i) Date of issuance of original pre- lowable under existing State or other scription. applicable law. (ii) Original number of refills author- [75 FR 16309, Mar. 31, 2010] ized on original prescription. (iii) Date of original dispensing. § 1306.26 Dispensing without prescrip- (iv) Number of valid refills remaining tion. and date(s) and locations of previous A controlled substance listed in refill(s). Schedules II, III, IV, or V which is not (v) Pharmacy’s name, address, DEA a prescription drug as determined registration number, and prescription under the Federal Food, Drug, and Cos- number from which the prescription in- metic Act, may be dispensed by a phar- formation was transferred. macist without a prescription to a pur- (vi) Name of pharmacist who trans- chaser at retail, provided that: ferred the prescription. (a) Such dispensing is made only by a (vii) Pharmacy’s name, address, DEA pharmacist (as defined in part 1300 of registration number, and prescription this chapter), and not by a nonphar- number from which the prescription macist employee even if under the su- was originally filled. pervision of a pharmacist (although (4) For electronic prescriptions being after the pharmacist has fulfilled his transferred electronically, the trans- professional and legal responsibilities ferring pharmacist must provide the set forth in this section, the actual receiving pharmacist with the fol- cash, credit transaction, or delivery, lowing information in addition to the may be completed by a nonphar- original electronic prescription data: macist);

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(b) Not more than 240 cc. (8 ounces) of pharmacy including via facsimile. The any such controlled substance con- retail pharmacy transmitting the pre- taining opium, nor more than 120 cc. (4 scription information must: ounces) of any other such controlled (1) Write the word ‘‘CENTRAL FILL’’ substance nor more than 48 dosage on the face of the original prescription units of any such controlled substance and record the name, address, and DEA containing opium, nor more than 24 registration number of the central fill dosage units of any other such con- pharmacy to which the prescription trolled substance may be dispensed at has been transmitted and the name of retail to the same purchaser in any the retail pharmacy pharmacist trans- given 48-hour period; mitting the prescription, and the date (c) The purchaser is at least 18 years of transmittal; of age; (2) Ensure that all information re- (d) The pharmacist requires every quired to be on a prescription pursuant purchaser of a controlled substance to § 1306.05 of this part is transmitted under this section not known to him to to the central fill pharmacy (either on furnish suitable identification (includ- the face of the prescription or in the ing proof of age where appropriate); electronic transmission of informa- (e) A bound record book for dis- tion); pensing of controlled substances under (3) Indicate in the information trans- this section is maintained by the phar- mitted the number of refills already macist, which book shall contain the dispensed and the number of refills re- name and address of the purchaser, the maining; name and quantity of controlled sub- (4) Maintain the original prescription stance purchased, the date of each pur- for a period of two years from the date chase, and the name or initials of the the prescription was last refilled; pharmacist who dispensed the sub- (5) Keep a record of receipt of the stance to the purchaser (the book shall filled prescription, including the date be maintained in accordance with the of receipt, the method of delivery (pri- recordkeeping requirement of § 1304.04 vate, common or contract carrier) and of this chapter); and the name of the retail pharmacy em- (f) A prescription is not required for ployee accepting delivery. distribution or dispensing of the sub- (b) The central fill pharmacy receiv- stance pursuant to any other Federal, ing the transmitted prescription must: State or local law. (1) Keep a copy of the prescription (if (g) Central fill pharmacies may not sent via facsimile) or an electronic dispense controlled substances to a record of all the information trans- purchaser at retail pursuant to this mitted by the retail pharmacy, includ- section. ing the name, address, and DEA reg- [36 FR 7799, Apr. 24, 1971, as amended at 36 istration number of the retail phar- FR 18733, Sept. 21, 1971. Redesignated at 38 macy transmitting the prescription; FR 26609, Sept. 24, 1973, and further redesig- (2) Keep a record of the date of re- nated and amended at 62 FR 13966, Mar. 24, ceipt of the transmitted prescription, 1997; 68 FR 37411, June 24, 2003] the name of the licensed pharmacist § 1306.27 Provision of prescription in- filling the prescription, and dates of formation between retail phar- filling or refilling of the prescription; macies and central fill pharmacies (3) Keep a record of the date the filled for initial and refill prescriptions of prescription was delivered to the retail Schedule III, IV, or V controlled pharmacy and the method of delivery substances. (i.e. private, common or contract car- Prescription information may be pro- rier). vided to an authorized central fill pharmacy by a retail pharmacy for dis- [68 FR 37411, June 24, 2003] pensing purposes. The following requirements shall also apply: PART 1307—MISCELLANEOUS (a) Prescriptions for controlled substances listed in Schedule III, IV or V GENERAL INFORMATION may be transmitted electronically Sec. from a retail pharmacy to a central fill 1307.01 Definitions.

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1307.02 Application of State law and other ministrator may grant an exception in Federal law. his discretion, but in no case shall he/ 1307.03 Exceptions to regulations. she be required to grant an exception SPECIAL EXCEPTIONS FOR MANUFACTURE AND to any person which is otherwise re- DISTRIBUTION OF CONTROLLED SUBSTANCES quired by law or the regulations cited in this section. 1307.11 Distribution by dispenser to another practitioner. [75 FR 10678, Mar. 9, 2010] 1307.13 Incidental manufacture of controlled substances. SPECIAL EXCEPTIONS FOR MANUFACTURE DISPOSAL OF CONTROLLED SUBSTANCES AND DISTRIBUTION OF CONTROLLED SUBSTANCES 1307.22 Delivery of surrendered and forfeited controlled substances. § 1307.11 Distribution by dispenser to SPECIAL EXEMPT PERSONS another practitioner. 1307.31 Native American Church. (a) A practitioner who is registered to dispense a controlled substance may AUTHORITY: 21 U.S.C. 821, 822(d), 871(b), un- distribute (without being registered to less otherwise noted. distribute) a quantity of such sub- SOURCE: 36 FR 7801, Apr. 24, 1971, unless stance to— otherwise noted. Redesignated at 38 FR 26609, (1) Another practitioner for the pur- Sept. 24, 1973. pose of general dispensing by the prac- GENERAL INFORMATION titioner to patients, provided that— (i) The practitioner to whom the con- § 1307.01 Definitions. trolled substance is to be distributed is Any term contained in this part shall registered under the Act to dispense have the definition set forth in section that controlled substance; 102 of the Act (21 U.S.C. 802) or part (ii) The distribution is recorded by 1300 of this chapter. the distributing practitioner in accordance with § 1304.22(c) of this chapter [62 FR 13966, Mar. 24, 1997] and by the receiving practitioner in accordance with § 1304.22(c) of this chap- § 1307.02 Application of State law and other Federal law. ter; (iii) If the substance is listed in Nothing in this chapter shall be con- Schedule I or II, an order form is used strued as authorizing or permitting as required in part 1305 of this chapter; any person to do any act which such and person is not authorized or permitted (iv) The total number of dosage units to do under other Federal laws or obli- of all controlled substances distributed gations under international treaties, by the practitioner pursuant to this conventions or protocols, or under the section and § 1301.25 of this chapter dur- law of the State in which he/she desires ing each calendar year in which the to do such act nor shall compliance practitioner is registered to dispense with such parts be construed as compli- does not exceed 5 percent of the total ance with other Federal or State laws number of dosage units of all con- unless expressly provided in such other trolled substances distributed and dis- laws. pensed by the practitioner during the [62 FR 13966, Mar. 24, 1997] same calendar year. (2) [Reserved] § 1307.03 Exceptions to regulations. (b) If, during any calendar year in Any person may apply for an excep- which the practitioner is registered to tion to the application of any provision dispense, the practitioner has reason to of this chapter by filing a written re- believe that the total number of dosage quest with the Office of Diversion Con- units of all controlled substances trol, Drug Enforcement Administra- which will be distributed by him pursu- tion, stating the reasons for such ex- ant to paragraph (a)(1) of this section ception. See the Table of DEA Mailing and § 1301.25 of this chapter will exceed Addresses in § 1321.01 of this chapter for 5 percent of this total number of dos- the current mailing address. The Ad- age units of all controlled substances

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distributed and dispensed by him dur- the controlled drugs are to be deliv- ing that calendar year, the practitioner ered, including the name and quantity shall obtain a registration to distribute of the substances desired and the pur- controlled substances. pose for which intended. The delivery (c) The distributions that a reg- of such controlled drugs shall be or- istered retail pharmacy makes to auto- dered by the Administrator, if, in his mated dispensing systems at long term opinion, there exists a medical or sci- care facilities for which the retail entific need therefor. pharmacy also holds registrations do [75 FR 10678, Mar. 9, 2010, as amended at 79 not count toward the 5 percent limit in FR 53565, Sept. 9, 2014] paragraphs (a)(1)(iv) and (b) of this section. SPECIAL EXEMPT PERSONS [68 FR 41229, July 11, 2003, as amended at 70 FR 25466, May 13, 2005; 79 FR 53565, Sept. 9, § 1307.31 Native American Church. 2014] The listing of peyote as a controlled substance in Schedule I does not apply § 1307.13 Incidental manufacture of to the nondrug use of peyote in bona controlled substances. fide religious ceremonies of the Native Any registered manufacturer who, in- American Church, and members of the cidentally but necessarily, manufac- Native American Church so using pe- tures a controlled substance as a result yote are exempt from registration. Any of the manufacture of a controlled sub- person who manufactures peyote for or stance or basic class of controlled sub- distributes peyote to the Native Amer- stance for which he is registered and ican Church, however, is required to has been issued an individual manufac- obtain registration annually and to turing quota pursuant to part 1303 of comply with all other requirements of this chapter (if such substance or class law. is listed in Schedule I or II) shall be exempt from the requirement of registra- PART 1308—SCHEDULES OF tion pursuant to part 1301 of this chap- CONTROLLED SUBSTANCES ter and, if such incidentally manufactured substance is listed in Schedule I GENERAL INFORMATION or II, shall be exempt from the requirement of an individual manufacturing Sec. quota pursuant to part 1303 of this 1308.01 Scope of this part. 1308.02 Definitions. chapter, if such substances are disposed 1308.03 Administration Controlled Sub- of in accordance with part 1317 of this stances Code Number. chapter. SCHEDULES [79 FR 53565, Sept. 9, 2014] 1308.11 Schedule I. DISPOSAL OF CONTROLLED SUBSTANCES 1308.12 Schedule II. 1308.13 Schedule III. § 1307.22 Delivery of surrendered and 1308.14 Schedule IV. forfeited controlled substances. 1308.15 Schedule V. Any controlled substance surren- EXCLUDED NONNARCOTIC SUBSTANCES dered by delivery to the Administra- 1308.21 Application for exclusion of a non- tion under part 1317 of this chapter or narcotic substance. forfeited pursuant to section 511 of the 1308.22 Excluded substances. Act (21 U.S.C. 881) may be delivered to any department, bureau, or other agen- EXEMPT CHEMICAL PREPARATIONS cy of the United States or of any State 1308.23 Exemption of certain chemical prep- upon proper application addressed to arations; application. the Office of Diversion Control, Drug 1308.24 Exemption chemical preparations. Enforcement Administration. See the EXCLUDED VETERINARY ANABOLIC STEROID Table of DEA Mailing Addresses in IMPLANT PRODUCTS § 1321.01 of this chapter for the current 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.

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EXEMPTED PRESCRIPTION PRODUCTS § 1308.03 Administration Controlled 1308.31 Application for exemption of a non- Substances Code Number. narcotic prescription product. (a) Each controlled substance, or 1308.32 Exempted prescription products. basic class thereof, has been assigned an ‘‘Administration Controlled Sub- EXEMPT ANABOLIC STEROID PRODUCTS stances Code Number’’ for purposes of 1308.33 Exemption of certain anabolic ster- identification of the substances or oid products; application. class on certain Certificates of Reg- 1308.34 Exempt anabolic steroid products. istration issued by the Administration EXEMPT CANNABIS PLANT MATERIAL, AND pursuant to §§ 1301.35 of this chapter PRODUCTS MADE THEREFROM, THAT CONTAIN and on certain order forms issued by TETRAHYDROCANNABINOLS the Administration pursuant to § 1305.05(d) of this chapter. Applicants 1308.35 Exemption of certain cannabis plant material, and products made therefrom, for procurement and/or individual man- that contain tetrahydrocannabinols. ufacturing quotas must include the appropriate code number on the applica- HEARINGS tion as required in §§ 1303.12(b) and 1308.41 Hearings generally. 1303.22(a) of this chapter. Applicants 1308.42 Purpose of hearing. for import and export permits must in- 1308.43 Initiation of proceedings for rule- clude the appropriate code number on making. the application as required in 1308.44 Request for hearing or appearance; §§ 1312.12(a) and 1312.22(a) of this chap- waiver. ter. Authorized registrants who desire 1308.45 Final order. to import or export a controlled sub- 1308.46 Control required under international stance for which an import or export treaty. permit is not required must include the 1308.47 Control of immediate precursors. appropriate Administration Controlled 1308.49 Temporary scheduling. Substances Code Number beneath or AUTHORITY: 21 U.S.C. 811, 812, 871(b), 956(b), beside the name of each controlled sub- unless otherwise noted. stance listed on the DEA Form 236 SOURCE: 38 FR 8254, Mar. 30, 1973, unless (Controlled Substance Import/Export otherwise noted. Redesignated at 38 FR 26609, Declaration) which is executed for such Sept. 24, 1973. importation or exportation as required in §§ 1312.18(c) and 1312.27(b) of this GENERAL INFORMATION chapter. (b) Except as stated in paragraph (a) § 1308.01 Scope of this part. of this section, no applicant or reg- Schedules of controlled substances istrant is required to use the Adminis- established by section 202 of the Act (21 tration Controlled Substances Code U.S.C. 812) and nonnarcotic substances, Number for any purpose. chemical preparations, veterinary anabolic steroid implant products, pre- [38 FR 8254, Mar. 30, 1973. Redesignated at 38 FR 26609, Sept. 24, 1973 and amended at 51 FR scription products, anabolic steroid 15318, Apr. 23, 1986; 62 FR 13968, Mar. 24, 1997] products, and cannabis plant material and products made therefrom that con- SCHEDULES tain tetrahydrocannabinols excluded pursuant to section 201 of the Act (21 § 1308.11 Schedule I. U.S.C. 811), as they are changed, up- (a) Schedule I shall consist of the dated, and republished from time to drugs and other substances, by what- time, are set forth in this part. ever official name, common or usual [81 FR 97021, Dec. 30, 2016] name, chemical name, or brand name designated, listed in this section. Each § 1308.02 Definitions. drug or substance has been assigned the DEA Controlled Substances Code Any term contained in this part shall Number set forth opposite it. have the definition set forth in section (b) Opiates. Unless specifically ex- 102 of the Act (21 U.S.C. 802) or part cepted or unless listed in another 1300 of this chapter. schedule, any of the following opiates, [62 FR 13967, Mar. 24, 1997] including their isomers, esters, ethers,

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salts, and salts of isomers, esters and (27) Dipipanone ...... 9622 ethers, whenever the existence of such (28) Ethylmethylthiambutene .... 9623 isomers, esters, ethers and salts is pos- (29) Etonitazene ...... 9624 sible within the specific chemical des- (30) Etoxeridine ...... 9625 ignation (for purposes of paragraph (31) Furethidine ...... 9626 (b)(34) only, the term isomer includes (32) Hydroxypethidine ...... 9627 the optical and geometric isomers): (33) Ketobemidone ...... 9628 (1) Acetyl-alpha-methylfentanyl (34) Levomoramide ...... 9629 (N-[1-(1-methyl-2-phenethyl)-4- (35) Levophenacylmorphan ...... 9631 piperidinyl]-N- (36) 3-Methylfentanyl (N-[3- phenylacetamide) ...... 9815 methyl-1-(2-phenylethyl)-4- (2) Acetylmethadol ...... 9601 piperidyl]-N- (3) Acetyl fentanyl (N-(1- phenylpropanamide) ...... 9813 phenethylpiperidin-4-yl)-N- (37) 3-methylthiofentanyl (N-[(3- phenylacetamide) ...... 9821 methyl-1-(2-thienyl)ethyl-4- (4) AH-7921 (3,4-dichloro-N-[(1- piperidinyl]-N- dimethylamino) phenylpropanamide) ...... 9833 cyclohexylmethyl]benzamide 9551 (38) Morpheridine ...... 9632 (5) Allylprodine ...... 9602 (39) MPPP (1-methyl-4-phenyl-4- (6) Alphacetylmethadol (except propionoxypiperidine) ...... 9661 levo-alphacetylmethadol also (40) MT–45 (1-cyclohexyl-4-(1,2- known as levo-alpha- diphenylethyl)piperazine) ...... 9560 acetylmethadol, levomethadyl (41) Noracymethadol ...... 9633 (42) Norlevorphanol ...... 9634 acetate, or LAAM) ...... 9603 (43) Normethadone ...... 9635 (7) Alphameprodine ...... 9604 (44) Norpipanone ...... 9636 (8) Alphamethadol ...... 9605 (45) Para-fluorofentanyl (N-(4- (9) Alpha-methylfentanyl (N-[1- fluorophenyl)-N-[1-(2- (alpha-methyl-beta- phenethyl)-4-piperidinyl] phenyl)ethyl-4-piperidyl] propanamide ...... 9812 propionanilide; 1-(1-methyl-2- (46) PEPAP (1-(-2-phenethyl)-4- phenylethyl)-4-(N-propanilido) phenyl-4-acetoxypiperidine ..... 9663 piperidine) ...... 9814 (47) Phenadoxone ...... 9637 (10) Alpha-methylthiofentanyl (48) Phenampromide ...... 9638 (N-[1-methyl-2-(2- (49) Phenomorphan ...... 9647 thienyl)ethyl-4-piperidinyl]-N- (50) Phenoperidine ...... 9641 phenylpropanamide) ...... 9832 (51) Piritramide ...... 9642 (11) Benzethidine ...... 9606 (52) Proheptazine ...... 9643 (12) Betacetylmethadol ...... 9607 (53) Properidine ...... 9644 (13) Beta-hydroxyfentanyl (N-[1- (54) Propiram ...... 9649 (2-hydroxy-2-phenethyl)-4- (55) Racemoramide ...... 9645 piperidinyl]-N- (56) Thiofentanyl (N-phenyl-N-[1- phenylpropanamide) ...... 9830 (2-thienyl)ethyl-4-piperidinyl]- (14) Beta-hydroxy-3- propanamide ...... 9835 methylfentanyl (other name: (57) Tilidine ...... 9750 N-[1-(2-hydroxy-2-phenethyl)- (58) Trimeperidine ...... 9646 3-methyl-4-piperidinyl]-N- phenylpropanamide ...... 9831 (c) Opium derivatives. Unless specifi- (15) Betameprodine ...... 9608 cally excepted or unless listed in an- (16) Betamethadol ...... 9609 other schedule, any of the following (17) Betaprodine ...... 9611 opium derivatives, its salts, isomers, (18) Clonitazene ...... 9612 and salts of isomers whenever the ex- (19) Dextromoramide ...... 9613 istence of such salts, isomers, and salts (20) Diampromide ...... 9615 of isomers is possible within the spe- (21) Diethylthiambutene ...... 9616 cific chemical designation: (22) Difenoxin ...... 9168 (1) Acetorphine ...... 9319 (23) Dimenoxadol ...... 9617 (2) Acetyldihydrocodeine ...... 9051 (24) Dimepheptanol ...... 9618 (3) Benzylmorphine ...... 9052 (25) Dimethylthiambutene ...... 9619 (4) Codeine methylbromide ...... 9070 (26) Dioxaphetyl butyrate ...... 9621 (5) Codeine-N-Oxide ...... 9053 112

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(6) Cyprenorphine ...... 9054 Some trade or other (7) Desomorphine ...... 9055 names: 2,5-dimethoxy-a- (8) Dihydromorphine ...... 9145 methylphenethylamine; (9) Drotebanol ...... 9335 2,5-DMA (10) Etorphine (except hydro- (5) 2,5-dimethoxy-4- chloride salt) ...... 9056 ethylamphet-amine ...... 7399 (11) Heroin ...... 9200 Some trade or other (12) Hydromorphinol ...... 9301 names: DOET (13) Methyldesorphine ...... 9302 (6) 2,5-dimethoxy-4-(n)- (14) Methyldihydromorphine ...... 9304 propylthiophenethylamine (other name: 2C–T–7) ...... 7348 (15) Morphine methylbromide .... 9305 (7) 4-methoxyamphetamine ..... 7411 (16) Morphine methylsulfonate .. 9306 Some trade or other (17) Morphine-N-Oxide ...... 9307 names: 4-methoxy-a- (18) Myrophine ...... 9308 methylphenethylamine; (19) Nicocodeine ...... 9309 paramethoxyamphetami- (20) Nicomorphine ...... 9312 ne, PMA (21) Normorphine ...... 9313 (8) 5-methoxy-3,4- (22) Pholcodine ...... 9314 methylenedioxy-amphet- (23) Thebacon ...... 9315 amine ...... 7401 (d) Hallucinogenic substances. Unless (9) 4-methyl-2,5-dimethoxy- specifically excepted or unless listed in amphetamine ...... 7395 another schedule, any material, com- Some trade and other pound, mixture, or preparation, which names: 4-methyl-2,5- contains any quantity of the following dimethoxy-a- hallucinogenic substances, or which methylphenethylamine; contains any of its salts, isomers, and ‘‘DOM’’; and ‘‘STP’’ salts of isomers whenever the existence (10) 3,4-methylenedioxy am- of such salts, isomers, and salts of iso- phetamine ...... 7400 mers is possible within the specific (11) 3,4- chemical designation (for purposes of methylenedioxymethamphe- this paragraph only, the term ‘‘isomer’’ tamine (MDMA) ...... 7405 includes the optical, position and geo- (12) 3,4-methylenedioxy-N- metric isomers): ethylamphetamine (also known as N-ethyl-alpha- (1) Alpha-ethyltryptamine ...... 7249 methyl-3,4(methylenedioxy)- Some trade or other phenethylamine, N-ethyl names: etryptamine; MDA, MDE, MDEA ...... 7404 Monase; -ethyl-1H- a (13) N-hydroxy-3,4- indole-3-ethanamine; 3- methylenedioxyamphetami- (2-aminobutyl) indole; - a ne (also known as N-hy- ET; and AET. droxy-alpha-methyl- (2) 4-bromo-2,5-dimethoxy-am- 3,4(methylenedioxy)- phetamine ...... 7391 phenethylamine, and N-hy- Some trade or other droxy MDA ...... 7402 names: 4-bromo-2,5- (14) 3,4,5-trimethoxy amphet- dimethoxy-a- amine ...... 7390 methylphenethylamine; (15) 5-methoxy-N,N- 4-bromo-2,5-DMA dimethyltryptamine Some (3) 4-Bromo-2,5- trade or other names: 5- dimethoxyphenethylamine .. 7392 methoxy-3-[2- Some trade or other (dimethylamin- names: 2-(4-bromo-2,5- o)ethyl]indole; 5-MeO-DMT .. 7431 dimethoxyphenyl)-1- (16) Alpha-methyltryptamine aminoethane; alpha- (other name: AMT) ...... 7432 desmethyl DOB; 2C-B, (17) Bufotenine ...... 7433 Nexus. (4) 2,5-dimethoxyamphetamine 7396 113

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Some trade and other (28) N-methyl-3-piperidyl names: 3-(b- benzilate ...... 7484 Dimethylaminoethyl)-5- (29) Psilocybin ...... 7437 hydroxyindole; 3-(2- (30) Psilocyn ...... 7438 dimethylaminoethyl)-5- (31) Tetrahydrocannabinols .... 7370 indolol; N, N- Meaning dimethylserotonin; 5-hy- tetrahydrocannabinols droxy-N,N- naturally contained in a dimethyltryptamine; plant of the genus Can- mappine nabis (cannabis plant), (18) Diethyltryptamine ...... 7434 as well as synthetic Some trade and other equivalents of the sub- names: N,N- stances contained in the Diethyltryptamine; DET cannabis plant, or in the (19) Dimethyltryptamine ...... 7435 resinous extractives of Some trade or other such plant, and/or syn- names: DMT thetic substances, de- (20) 5-methoxy-N,N- rivatives, and their iso- diisopropyltryptamine mers with similar chem- (other name: 5-MeO-DIPT) ... 7439 ical structure and phar- (21) Ibogaine ...... 7260 macological activity to Some trade and other those substances con- names: 7-Ethyl- tained in the plant, such 6,6b,7,8,9,10,12,13- as the following: octahydro-2-methoxy- 1 cis or trans 6,9-methano-5H-pyrido tetrahydrocannabinol, [1′, 2′:1,2] azepino [5,4-b] and their optical isomers indole; Tabernanthe 6 cis or trans iboga tetrahydrocannabinol, (22) Lysergic acid and their optical isomers diethylamide ...... 7315 3, 4 cis or trans (23) Marihuana ...... 7360 tetrahydrocannabinol, (24) Mescaline ...... 7381 and its optical isomers (25) Parahexyl—7374; some (Since nomenclature of trade or other names: 3- these substances is not Hexyl-1-hydroxy-7,8,9,10- internationally stand- tetrahydro-6,6,9-trimethyl- ardized, compounds of 6H-dibenzo[b,d]pyran; these structures, regard- Synhexyl. less of numerical des- (26) Peyote ...... 7415 ignation of atomic posi- Meaning all parts of the tions covered.) plant presently classified (32) Ethylamine analog of botanically as phencyclidine ...... 7455 Lophophora williamsii Some trade or other Lemaire, whether grow- names: N-ethyl-1- ing or not, the seeds phenylcyclohexylamine, thereof, any extract (1- from any part of such phenylcyclohexy- plant, and every com- l)ethylamine, N-(1- pound, manufacture, phenylcyclohexy- salts, derivative, mix- l)ethylamine, ture, or preparation of cyclohexamine, PCE such plant, its seeds or (33) Pyrrolidine analog of extracts phencyclidine ...... 7458 (Interprets 21 USC 812(c), Schedule I(c) (12)) (27) N-ethyl-3-piperidyl benzilate ...... 7482 114

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Some trade or other (50) N-(1-adamantyl)-1-pentyl- names: 1-(1- 1H-indazole-3-carboxamide phenylcyclohexyl)-pyr- (APINACA, AKB48) ...... (7048) rolidine, PCPy, PHP (51) quinolin-8-yl 1-pentyl-1H- (34) Thiophene analog of indole-3-carboxylate (PB-22; phencyclidine ...... 7470 QUPIC) ...... (7222) Some trade or other (52) quinolin-8-yl 1-(5- names: 1-[1-(2-thienyl)- fluoropentyl)-1H-indole-3- cyclohexyl]-piperidine, 2- carboxylate (5-fluoro-PB-22; thienylanalog of 5F-PB-22) ...... (7225) phencyclidine, TPCP, (53) N-(1-amino-3-methyl-1- TCP oxobutan-2-yl)-1-(4- (35) 1-[1-(2- fluorobenzyl)-1H-indazole-3- thieny- carboxamide (AB- l)cyclohexyl]pyrrolidine ...... 7473 FUBINACA) ...... (7012) Some other names: TCPy (54) N-(1-amino-3,3-dimethyl-1- (36) 4-methylmethcathinone oxobutan-2-yl)-1-pentyl-1H- (Mephedrone) ...... 1248 indazole-3-carboxamide (37) 3,4- (ADB-PINACA) ...... (7035) methylenedioxypyrovaleron- (55) 2-(4-iodo-2,5- e (MDPV) ...... 7535 dimethoxyphenyl)-N-(2-me- (38) 2-(2,5-Dimethoxy-4- thoxybenzyl)ethanamine ethylphenyl)ethanamine (25I-NBOMe, 2C-I-NBOMe) .... (7538) (2C–E) ...... 7509 (39) 2-(2,5-Dimethoxy-4- (56) 2-(4-chloro-2,5- methylphenyl)ethanamine dimethoxyphenyl)-N-(2-me- (2C–D) ...... 7508 thoxybenzyl)ethanamine (40) 2-(4-Chloro-2,5- (25C-NBOMe, 2C-C-NBOMe) .. (7537) dimethoxypheny- (57) 2-(4-bromo-2,5- l)ethanamine (2C–C) ...... 7519 dimethoxyphenyl)-N-(2-me- (41) 2-(4-Iodo-2,5- thoxybenzyl)ethanamine dimethoxypheny- (25B-NBOMe, 2C-B-NBOMe) .. (7536) l)ethanamine (2C–I) ...... 7518 (58) Marihuana Extract— (42) 2-[4-(Ethylthio)-2,5- Meaning an extract con- dimethoxypheny- taining one or more l]ethanamine (2C–T–2) ...... 7385 cannabinoids that has been (43) 2-[4-(Isopropylthio)-2,5- derived from any plant of dimethoxypheny- the genus Cannabis, other l]ethanamine (2C–T–4) ...... 7532 than the separated resin (44) 2-(2,5- (whether crude or purified) Dimethoxypheny- obtained from the plant ...... (7350) l)ethanamine (2C–H) ...... 7517 (59) 4-methyl-N- (45) 2-(2,5-Dimethoxy-4-nitro- ethylcathinone (4-MEC) ...... (1249) phenyl)ethanamine (2C–N) ... 7521 (60) 4-methyl-alpha- (46) 2-(2,5-Dimethoxy-4-(n)- pyrrolidinopropiophenone (4- propylphenyl)ethanamine MePPP) ...... (7498) (2C–P) ...... 7524 (61) alpha- (47) 3,4-Methylenedioxy-N- pyrrolidinopentiophenone methylcathinone (a-PVP) ...... (7545) (Methylone) ...... 7540 (62) 1-(1,3-benzodioxol-5-yl)-2- (48) (1-pentyl-1H-indol-3- (methylamino)butan-1-one yl)(2,2,3,3- (butylone, bk-MBDB) ...... (7541) tetramethylcyclopropy- (63) 2-(methylamino)-1- l)methanone (UR-144) ...... (7144) phenylpentan-1-one (49) [1-(5-fluoro-pentyl)-1H- (pentedrone) ...... (1246) indol-3-yl](2,2,3,3- (64) 1-(1,3-benzodioxol-5-yl)-2- tetramethylcyclopropy- (methylamino)pentan-1-one l)methanone (5-fluoro-UR- (pentylone, bk-MBDP) ...... (7542) 144, XLR11) ...... (7011) 115

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(65) 4-fluoro-N- (2) N-Benzylpiperazine (some methylcathinone (4-FMC; other names: BZP, 1- flephedrone) ...... (1238) benzylpiperazine) ...... 7493 (66) 3-fluoro-N- (3) Cathinone ...... 1235 methylcathinone (3-FMC) .... (1233) Some trade or other names: (67) 1-(naphthalen-2-yl)-2- 2-amino-1-phenyl-1- (pyrrolidin-1-yl)pentan-1-one propanone, alpha- (naphyrone) ...... (1258) aminopropiophenone, 2- (68) alpha- aminopropiophenone, and pyrrolidinobutiophenone (a- norephedrone PBP) ...... (7546) (4) Fenethylline ...... 1503 (69) N-(1-amino-3-methyl-1- (5) Methcathinone (Some other oxobutan-2-yl)-1- names: 2-(methylamino)- (cyclohexylmethyl)-1H-inda- propiophenone; alpha- zole-3-carboxamide (AB- (methylamino)propiophenone; CHMINACA) ...... (7031) 2-(methylamino)-1- (70) N-(1-amino-3-methyl-1- phenylpropan-1-one; alpha-N- oxobutan-2-yl)-1-pentyl-1H- methylaminopropiophenone; indazole-3-carboxamide (AB- monomethylpropion; PINACA) ...... (7023) ephedrone; N- (71) [1-(5-fluoropentyl)-1H- methylcathinone; indazol-3-yl](naphthalen-1- methylcathinone; AL–464; AL– yl)methanone (THJ-2201) ..... (7024) 422; AL–463 and UR1432), its (e) Depressants. Unless specifically salts, optical isomers and salts excepted or unless listed in another of optical isomers ...... 1237 ± schedule, any material, compound, (6) ( )cis-4-methylaminorex ± mixture, or preparation which contains (( )cis-4,5-dihydro-4-methyl-5- any quantity of the following sub- phenyl-2-oxazolamine) ...... 1590 stances having a depressant effect on (7) N-ethylamphetamine ...... 1475 the central nervous system, including (8) N,N-dimethylamphetamine its salts, isomers, and salts of isomers (also known as N,N-alpha- whenever the existence of such salts, trimethyl-benzeneethanamine; isomers, and salts of isomers is possible N,N-alpha- within the specific chemical designa- trimethylphenethylamine) ..... 1480 tion: (g) Cannabimimetic agents. Unless spe- (1) gamma-hydroxybutyric acid cifically exempted or unless listed in (some other names include another schedule, any material, com- GHB; gamma- pound, mixture, or preparation which hydroxybutyrate; 4- contains any quantity of the following hydroxybutyrate; 4- substances, or which contains their hydroxybutanoic acid; sodium salts, isomers, and salts of isomers oxybate; sodium oxybutyrate) 2010 whenever the existence of such salts, (2) Mecloqualone ...... 2572 isomers, and salts of isomers is possible (3) Methaqualone ...... 2565 within the specific chemical designa- (f) Stimulants. Unless specifically ex- tion: cepted or unless listed in another (1) 5-(1,1-dimethylheptyl)-2- schedule, any material, compound, [(1R,3S)-3-hydroxycyclohexyl]- mixture, or preparation which contains phenol (CP–47,497) ...... 7297 any quantity of the following sub- (2) 5-(1,1-dimethyloctyl)-2- stances having a stimulant effect on [(1R,3S)-3-hydroxycyclohexyl]- the central nervous system, including phenol (cannabicyclohexanol its salts, isomers, and salts of isomers: or CP–47,497 C8-homolog) ...... 7298 (1) Aminorex (Some other (3) 1-pentyl-3-(1-naph- names: aminoxaphen; 2-amino- thoyl)indole (JWH–018 and 5-phenyl-2-oxazoline; or 4,5- AM678) ...... 7118 dihydro-5-phenly-2- (4) 1-butyl-3-(1-naphthoyl)indole oxazolamine) ...... 1585 (JWH–073) ...... 7173 116

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(5) 1-hexyl-3-(1-naphthoyl)indole (4) 3,4-Dichloro-N-[2- (JWH–019) ...... 7019 (dimethylamin- (6) 1-[2-(4-morpholinyl)ethyl]-3- o)cyclohexyl]-N- (1-naphthoyl)indole (JWH–200) 7200 methylbenzamide, its iso- (7) 1-pentyl-3-(2- mers, esters, ethers, salts methoxyphenylacetyl)indole and salts of isomers, esters (JWH–250) ...... 6250 and ethers (Other name: U– (8) 1-pentyl-3-[1-(4- 47700) ...... (9547) methoxynaphthoyl)]indole (5) N-(1-phenethylpiperidin-4- (JWH–081) ...... 7081 yl)-N-phenylfuran-2- (9) 1-pentyl-3-(4-methyl-1-naph- carboxamide, its isomers, thoyl)indole (JWH–122) ...... 7122 esters, ethers, salts and salts (10) 1-pentyl-3-(4-chloro-1-naph- of isomers, esters and ethers thoyl)indole (JWH–398) ...... 7398 (Other name: Furanyl fentanyl) ...... (9834). (11) 1-(5-fluoropentyl)-3-(1-naphthoyl)indole (AM2201) ...... 7201 (6) methyl 2-(1-(5- fluoropentyl)-1 -indazole-3- (12) 1-(5-fluoropentyl)-3-(2- H carboxamido)-3,3- iodobenzoyl)indole (AM694) ..... 7694 dimethylbutanoate, its opti- (13) 1-pentyl-3-[(4-methoxy)-ben- cal, positional, and geo- zoyl]indole (SR–19 and RCS–4) 7104 metric isomers, salts and (14) 1-cyclohexylethyl-3-(2- salts of isomers (Other methoxyphenylacetyl)indole names: 5F–ADB; 5F–MDMB– 7008 (SR–18 and RCS–8) ...... 7008 PINACA) ...... (7034) (15) 1-pentyl-3-(2- (7) methyl 2-(1-(5- chlorophenylacetyl)indole fluoropentyl)-1H-indazole-3- (JWH–203) ...... 7203 carboxamido)-3- (h) Temporary listing of substances sub- methylbutanoate, its opti- ject to emergency scheduling. Any mate- cal, positional, and geo- rial, compound, mixture or preparation metric isomers, salts and which contains any quantity of the fol- salts of isomers (Other lowing substances: names: 5F–AMB)...... (7033) (8) N-(adamantan-1-yl)-1-(5- (1) N-(1-amino-3,3-dimethyl-1- fluoropentyl)-1H-indazole-3- oxobutan-2-yl)-1- carboxamide, its optical, po- (cyclohexylmethyl)-1H-inda- sitional, and geometric iso- zole-3-carboxamide, its opti- mers, salts and salts of iso- cal, positional, and geo- mers (Other names: 5F– metric isomers, salts and APINACA, 5F–AKB48) ...... (7049) salts of isomers (Other (9) N-(1-amino-3,3-dimethyl-1- names: MAB-CHMINACA; oxobutan-2-yl)-1-(4- ADB-CHMINACA) ...... (7032) fluorobenzyl)-1H-indazole-3- (2) N-(1-phenethylpiperidin-4- carboxamide, its optical, po- yl)-N-phenylbutyramide, its sitional, and geometric iso- isomers, esters, ethers, salts mers, salts and salts of iso- and salts of isomers, esters mers (Other names: ADB– and ethers (Other names: FUBINACA) ...... (7010) Butyryl fentanyl) ...... (9822) (10) methyl 2-(1- (3) N-[1-[2-hydroxy-2- (cyclohexylmethyl)-1H- (thiophen-2- indole-3-carboxamido)-3,3- yl)ethyl]piperidin-4-yl]-N- dimethylbutanoate, its opti- phenylpropionamide, its iso- cal, positional, and geo- mers, esters, ethers, salts metric isomers, salts and and salts of isomers, esters salts of isomers (Other and ethers (Other names: names: MDMB–CHMICA, beta-hydroxythiofentanyl) .. (9836) MMB–CHMINACA) ...... (7042)

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(11) methyl 2-(1-(4- (21) 2-methoxy-N-(1- fluorobenzyl)-1H-indazole-3- phenethylpiperidin-4-yl)-N- carboxamido)-3,3- phenylacetamide, its iso- dimethylbutanoate, its opti- mers, esters, ethers, salts cal, positional, and geo- and salts of isomers, esters metric isomers, salts and and ethers (Other name: salts of isomers (Other methoxyacetyl fentanyl) ..... (9825) names: MDMB–FUBINACA) (7020) (22) N-(1-phenethylpiperidin-4- (12) [Reserved]. yl)-N- (13) N-(4-fluorophenyl)-N-(1- phenylcyclopropanecarboxa- phenethylpiperidin-4- mide, its isomers, esters, yl)isobutyramide, its iso- ethers, salts and salts of isomers, esters, ethers, salts mers, esters and ethers and salts of isomers, esters (Other name: cyclopropyl and ethers (Other names: 4- fentanyl) ...... (9845) fluoroisobutyryl fentanyl, (23) N-(1-phenethylpiperidin-4- para-fluoroisobutyryl yl)-N-phenylpentanamide, fentanyl) ...... (9824) its isomers, esters, ethers, (14) N-(1-phenethylpiperidin-4- salts and salts of isomers, yl)-N-phenylacrylamide, its esters and ethers (Other isomers, esters, ethers, salts name: Valeryl fentanyl) ...... (9840) and salts of isomers, esters (24) N-(4-fluorophenyl)-N-(1- and ethers (Other names: phenethylpiperidin-4- acryl fentanyl, yl)butyramide, its isomers, acryloylfentanyl) ...... (9811) esters, ethers, salts and salts (15) [Reserved]. of isomers, esters and ethers (16) [Reserved]. (Other name: para- (17) [Reserved]. fluorobutyryl fentanyl) ...... (9823) (18) methyl 2-(1-(4- (25) N-(4-methoxyphenyl)-N-(1- fluorobenzyl)-1H-indazole-3- phenethylpiperidin-4- carboxamido)-3- yl)butyramide, its isomers, methylbutanoate, its opti- esters, ethers, salts and salts cal, positional, and geo- of isomers, esters and ethers metric isomers, salts and (Other name: para- salts of isomers (Other methoxybutyryl fentanyl) ... (9837) names: FUB–AMB, MMB– (26) N-(4-chlorophenyl)-N-(1- FUBINACA, AMB– phenethylpiperidin-4- FUBINACA) ...... (7021) yl)isobutyramide, its iso- (19) N-(2-fluorophenyl)-N-(1- mers, esters, ethers, salts phenethylpiperidin-4- and salts of isomers, esters yl)propionamide, its iso- and ethers (Other name: mers, esters, ethers, salts para-chloroisobutyryl and salts of isomers, esters fentanyl) ...... (9826) and ethers (Other names: (27) N-(1-phenethylpiperidin-4- ortho-fluorofentanyl, 2- yl)-N-phenylisobutyramide, fluorofentanyl) ...... (9816) its isomers, esters, ethers, (20) N-(1-phenethylpiperidin-4- salts and salts of isomers, yl)-N- esters and ethers (Other phenyltetrahydrofuran-2- name: isobutyryl fentanyl) .. (9827) carboxamide, its isomers, (28) N-(1-phenethylpiperidin-4- esters, ethers, salts and salts yl)-N- of isomers, esters and ethers phenylcyclopentanecarboxa- (Other name: mide, its isomers, esters, tetrahydrofuranyl fentanyl) (9843) ethers, salts and salts of isomers, esters and ethers (Other name: cyclopentyl fentanyl) ...... (9847)

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(29) N-(2-fluorophenyl)-2- 16, 2017, § 1308.11 was amended by redesig- methoxy-N-(1- nating (h)(17) as paragraph (h)(14). 3. At 82 FR 49508, Oct. 26, 2017, § 1308.11 was phenethylpiperidin-4- amended by adding reserved paragraphs yl)acetamide, its isomers, (h)(15) through (h)(18) and (h)(19), (20) and esters, ethers, salts and salts (21), effective Oct. 26, 2017,, through Oct. 28, of isomers, esters and ethers 2019. (Other name: Ocfentanil) ..... (9838) 4. At 82 FR 51558, Nov. 3, 2017, § 1308.11 was (30) Fentanyl-related sub- amended by adding paragraph (h)(18), effective Nov. 3, 2017, through Nov. 4, 2019. stances, their isomers, 5. At 83 FR 472, Jan. 4, 2018, § 1308.11 was esters, ethers, salts and salts amended by adding paragraph (h)(22), effec- of isomers, esters and ethers 9850 tive Jan. 4, 2018, through Jan. 4, 2020. 6. At 83 FR 4584, Feb. 1, 2018, § 1308.11 was (i) Fentanyl-related substance means amended by adding paragraphs (h)(23) any substance not otherwise listed through (h)(29), effective Feb. 1, 2018, under another Administration Con- through Feb. 1, 2020. trolled Substance Code Number, and 7. At 83 FR 5191, Feb. 6, 2018, § 1308.11 was for which no exemption or approval is amended by adding paragraph (h)(30), effec- in effect under section 505 of the Fed- tive Feb. 6, 2018, through Feb. 6, 2020. eral Food, Drug, and Cosmetic Act [21 8. At 83 FR 10368, Mar. 9, 2018, § 1308.11 was amended by revising paragraphs (h)(23) and U.S.C. 355], that is structurally related (h)(29), effective Mar. 9, 2018, through Feb. 1, to fentanyl by one or more of the fol- 2020. lowing modifications: (A) Replacement of the phenyl por- § 1308.12 Schedule II. tion of the phenethyl group by any (a) Schedule II shall consist of the monocycle, whether or not further sub- drugs and other substances, by what- stituted in or on the monocycle; ever official name, common or usual (B) Substitution in or on the name, chemical name, or brand name phenethyl group with alkyl, alkenyl, designated, listed in this section. Each alkoxyl, hydroxyl, halo, haloalkyl, drug or substance has been assigned amino or nitro groups; the Controlled Substances Code Num- (C) Substitution in or on the piper- ber set forth opposite it. idine ring with alkyl, alkenyl, alkoxyl, (b) Substances, vegetable origin or ester, ether, hydroxyl, halo, haloalkyl, chemical synthesis. Unless specifically amino or nitro groups; excepted or unless listed in another (D) Replacement of the aniline ring schedule, any of the following sub- with any aromatic monocycle whether stances whether produced directly or or not further substituted in or on the indirectly by extraction from sub- aromatic monocycle; and/or stances of vegetable origin, or inde- (E) Replacement of the N-propionyl pendently by means of chemical syn- group by another acyl group. thesis, or by a combination of extrac- (ii) This definition includes, but is tion and chemical synthesis: not limited to, the following sub- (1) Opium and opiate, and any salt, stances: compound, derivative, or preparation (A)–(B) [Reserved] of opium or opiate excluding apomorphine, thebaine-derived [39 FR 22141, June 20, 1974] butorphanol, dextrorphan, nalbuphine, EDITORIAL NOTE: For FEDERAL REGISTER ci- naldemedine, nalmefene, naloxegol, tations affecting § 1308.11, see the List of CFR naloxone, and naltrexone, and their re- Sections Affected, which appears in the spective salts, but including the fol- Finding Aids section of the printed volume lowing: and at www.fdsys.gov. (i) Codeine ...... 9050 EFFECTIVE DATE NOTES: At 82 FR 20547, (ii) Dihydroetorphine ...... 9334 May 3, 2017, § 1308.11 was amended by adding (iii) Ethylmorphine ...... 9190 (h)(16), effective May 3, 2017, until May 3, (iv) Etorphine hydrochloride ..... 9059 2019. At 82 FR 47974, Oct. 16, 2017, § 1308.11 was (v) Granulated opium ...... 9640 amended by redesignating (h)(16) as paragraph (h)(13). (vi) Hydrocodone ...... 9193 2. At 82 FR 32457, July 14, 2017, § 1308.11 was (vii) Hydromorphone ...... 9150 amended by adding (h)(17), effective July 14, (viii) Metopon ...... 9260 2017, until July 15, 2019. At 82 FR 47974, Oct. (ix) Morphine ...... 9300 119

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(x) Opium extracts ...... 9610 (11) Levo-alphacetylmethadol .... 9648 (xi) Opium fluid ...... 9620 [Some other names: levo- (xii) Oripavine ...... 9330 alpha-acetylmethadol, (xiii) Oxycodone ...... 9143 levomethadyl acetate, (xiv) Oxymorphone ...... 9652 LAAM] (xv) Powdered opium ...... 9639 (12) Levomethorphan ...... 9210 (xvi) Raw opium ...... 9600 (13) Levorphanol ...... 9220 (xvii) Thebaine ...... 9333 (14) Metazocine ...... 9240 (xviii) Tincture of opium ...... 9630 (15) Methadone ...... 9250 (2) Any salt, compound, derivative, or (16) Methadone-Intermediate, 4- preparation thereof which is chemi- cyano-2-dimethylamino-4,4-di- cally equivalent or identical with any phenyl butane ...... 9254 of the substances referred to in para- (17) Moramide-Intermediate, 2- graph (b) (1) of this section, except that methyl-3-morpholino-1, 1- these substances shall not include the diphenylpropane-carboxylic isoquinoline alkaloids of opium. acid ...... 9802 (3) Opium poppy and poppy straw. (18) Pethidine (meperidine) ...... 9230 (4) Coca leaves (9040) and any salt, (19) Pethidine-Intermediate-A, 4- compound, derivative or preparation of cyano-1-methyl-4- coca leaves (including cocaine (9041) phenylpiperidine ...... 9232 and ecgonine (9180) and their salts, iso- (20) Pethidine-Intermediate-B, mers, derivatives and salts of isomers ethyl-4-phenylpiperidine-4- and derivatives), and any salt, com- carboxylate ...... 9233 pound, derivative, or preparation (21) Pethidine-Intermediate-C, 1- thereof which is chemically equivalent methyl-4-phenylpiperidine-4- or identical with any of these sub- carboxylic acid ...... 9234 stances, except that the substances (22) Phenazocine ...... 9715 shall not include: (23) Piminodine ...... 9730 (i) Decocainized coca leaves or ex- (24) Racemethorphan ...... 9732 traction of coca leaves, which extrac- (25) Racemorphan ...... 9733 tions do not contain cocaine or ecgo- (26) Remifentanil ...... 9739 nine; or (27) Sufentanil ...... 9740 (ii) [123I]ioflupane. (28) Tapentadol ...... 9780 (5) Concentrate of poppy straw (the (29) Thiafentanil ...... 9729 crude extract of poppy straw in either (d) Stimulants. Unless specifically ex- liquid, solid or powder form which con- cepted or unless listed in another tains the phenanthrene alkaloids of the schedule, any material, compound, opium poppy), 9670. mixture, or preparation which contains (c) Opiates. Unless specifically ex- any quantity of the following sub- cepted or unless in another schedule stances having a stimulant effect on any of the following opiates, including the central nervous system: its isomers, esters, ethers, salts and salts of isomers, esters and ethers (1) Amphetamine, its salts, opti- whenever the existence of such iso- cal isomers, and salts of its mers, esters, ethers, and salts is pos- optical isomers ...... 1100 sible within the specific chemical des- (2) Methamphetamine, its salts, ignation, dextrorphan and isomers, and salts of its iso- levopropoxyphene excepted: mers ...... 1105 (3) Phenmetrazine and its salts 1631 (1) Alfentanil ...... 9737 (4) Methylphenidate ...... 1724 (2) Alphaprodine ...... 9010 (5) Lisdexamfetamine, its salts, (3) Anileridine ...... 9020 isomers, and salts of its iso- (4) Bezitramide ...... 9800 mers ...... 1205. (5) Bulk dextropropoxyphene (non-dosage forms) ...... 9273 (e) Depressants. Unless specifically (6) Carfentanil ...... 9743 excepted or unless listed in another (7) Dihydrocodeine ...... 9120 schedule, any material, compound, (8) Diphenoxylate ...... 9170 mixture, or preparation which contains (9) Fentanyl ...... 9801 any quantity of the following sub- (10) Isomethadone ...... 9226 stances having a depressant effect on 120

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the central nervous system, including § 1308.13 Schedule III. its salts, isomers, and salts of isomers (a) Schedule III shall consist of the whenever the existence of such salts, isomers, and salts of isomers is possible drugs and other substances, by what- within the specific chemical designa- ever official name, common or usual tion: name, chemical name, or brand name designated, listed in this section. Each (1) Amobarbital ...... 2125 drug or substance has been assigned (2) Glutethimide ...... 2550 the DEA Controlled Substances Code (3) Pentobarbital ...... 2270 Number set forth opposite it. (4) Phencyclidine ...... 7471 (5) Secobarbital ...... 2315 (b) Stimulants. Unless specifically excepted or unless listed in another (f) Hallucinogenic substances. schedule, any material, compound, (1) Nabilone ...... 7379 mixture, or preparation which contains [Another name for any quantity of the following sub- nabilone: (±)-trans-3-(1,1- stances having a stimulant effect on dimethylheptyl)- the central nervous system, including 6,6a,7,8,10,10a-hexahydro- its salts, isomers (whether optical, po- 1-hydroxy-6,6-dimethyl- sitional, or geometric), and salts of 9H-dibenzo[b,d]pyran-9- such isomers whenever the existence of one] such salts, isomers, and salts of iso- (2) Dronabinol [(-)-delta-9- mers is possible within the specific trans tetrahydrocannabinol] chemical designation: in an oral solution in a drug product approved for mar- (1) Those compounds, mixtures, keting by the U.S. Food and or preparations in dosage unit Drug Administration ...... (7365) form containing any stimulant substances listed in (g) Immediate precursors. Unless spe- schedule II which compounds, cifically excepted or unless listed in mixtures, or preparations were another schedule, any material, com- listed on August 25, 1971, as ex- pound, mixture, or preparation which cepted compounds under contains any quantity of the following § 1308.32, and any other drug of substances: the quantitative composition (1) Immediate precursor to amphet- shown in that list for those amine and methamphetamine: drugs or which is the same ex- (i) Phenylacetone ...... 8501 cept that it contains a lesser Some trade or other names: quantity of controlled sub- phenyl-2-propanone; P2P; stances ...... 1405 benzyl methyl ketone; (2) Benzphetamine ...... 1228 methyl benzyl ketone; (3) Chlorphentermine ...... 1645 (2) Immediate precursors to (4) Clortermine ...... 1647 phencyclidine (PCP): (5) Phendimetrazine ...... 1615 (i) 1-phenylcyclohexylamine ...... 7460 (c) Depressants. Unless specifically (ii) 1- excepted or unless listed in another piperidinocyclohexanecarboni- schedule, any material, compound, trile (PCC) ...... 8603 mixture, or preparation which contains (3) Immediate precursor to fentanyl: any quantity of the following sub- (i) 4-anilino-N-phenethyl-4-pi- stances having a depressant effect on peridine (ANPP) ...... 8333 the central nervous system: (ii) [Reserved] (1) Any compound, mixture or preparation containing: [39 FR 22142, June 20, 1974] (i) Amobarbital ...... 2126 EDITORIAL NOTE: For FEDERAL REGISTER ci- (ii) Secobarbital ...... 2316 tations affecting § 1308.12, see the List of CFR (iii) Pentobarbital ...... 2271 Sections Affected, which appears in the Finding Aids section of the printed volume and at www.fdsys.gov.

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or any salt thereof and one Some trade or other names or more other active me- for zolazepam: dicinal ingredients which 4-(2-fluorophenyl)-6,8- are not listed in any dihydro-1,3,8- schedule. trimethylpyrazolo-[3,4- (2) Any suppository dosage form e] [1,4]-diazepin-7(1H)- containing: one, flupyrazapon.. (i) Amobarbital ...... 2126 (d) Nalorphine 9400. (ii) Secobarbital ...... 2316 (e) Narcotic drugs. Unless specifically (iii) Pentobarbital ...... 2271 excepted or unless listed in another or any salt of any of these schedule: drugs and approved by the Food and Drug Adminis- (1) Any material, compound, tration for marketing only mixture, or preparation con- as a suppository. taining any of the following (3) Any substance which con- narcotic drugs, or their salts tains any quantity of a deriva- calculated as the free anhy- tive of barbituric acid or any drous base or alkaloid, in lim- salt thereof ...... 2100 ited quantities as set forth below: (4) Chlorhexadol ...... 2510 (i) Not more than 1.8 (5) Embutramide ...... 2020 grams of codeine per (6) Any drug product containing 100 milliliters or not gamma hydroxybutyric acid, more than 90 milli- including its salts, isomers, grams per dosage unit, and salts of isomers, for which with an equal or great- an application is approved er quantity of an under section 505 of the Fed- isoquinoline alkaloid eral Food, Drug, and Cosmetic of opium ...... 9803 Act ...... 2012 (ii) Not more than 1.8 (7) Ketamine, its salts, isomers, grams of codeine per and salts of isomers ...... 7285 100 milliliters or not [Some other names for more than 90 milli- ± ketamine: ( )-2-(2- grams per dosage unit, chlorophenyl)-2- with one or more ac- (methylamino)- tive, nonnarcotic in- cyclohexanone] gredients in recognized (8) Lysergic acid ...... 7300 therapeutic amounts ... 9804 (9) Lysergic acid amide ...... 7310 (iii) Not more than 1.8 (10) Methyprylon ...... 2575 grams of (11) Perampanel, and its salts, dihydrocodeine per 100 isomers, and salts of isomers .. 2261 milliliters or not more (12) Sulfondiethylmethane ...... 2600 than 90 milligrams per (13) Sulfonethylmethane ...... 2605 dosage unit, with one (14) Sulfonmethane ...... 2610 or more active nonnar- (15) Tiletamine and zolazepam cotic ingredients in or any salt thereof ...... 7295 recognized therapeutic Some trade or other names amounts ...... 9807 for a tiletamine-zolazepam (iv) Not more than 300 combination product: milligrams of Telazol.. ethylmorphine per 100 Some trade or other names milliliters or not more for tiletamine: than 15 milligrams per dosage unit, with one 2-(ethylamino)-2-(2- or more active, non- thienyl)- narcotic ingredients in cyclohexanone.. recognized therapeutic amounts ...... 9808

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(v) Not more than 500 designated, listed in this section. Each milligrams of opium drug or substance has been assigned per 100 milliliters or the DEA Controlled Substances Code per 100 grams or not Number set forth opposite it. more than 25 milli- (b) Narcotic drugs. Unless specifically grams per dosage unit, excepted or unless listed in another with one or more ac- schedule, any material, compound, tive, nonnarcotic in- mixture, or preparation containing any gredients in recognized of the following narcotic drugs, or therapeutic amounts ... 9809 their salts calculated as the free anhy- (vi) Not more than 50 drous base or alkaloid, in limited quan- milligrams of mor- tities as set forth below: phine per 100 milli- (1) Not more than 1 milligram of liters or per 100 grams, difenoxin and not less than 25 with one or more ac- micrograms of atropine sul- tive, nonnarcotic in- fate per dosage unit ...... 9167 gredients in recognized (2) Dextropropoxyphene (alpha- therapeutic amounts ... 9810 (+)-4-dimethylamino-1,2-di- (2) Any material, compound, phenyl-3-methyl-2- mixture, or preparation con- propionoxybutane) ...... 9278 taining any of the following (3) 2-[(dimethylamino)methyl]-1- narcotic drugs or their salts, (3- as set forth below: methoxyphenyl)cyclohexanol, (i) Buprenorphine ...... 9064 its salts, optical and geo- (ii) [Reserved]. metric isomers and salts of (f) Anabolic Steroids. Unless specifi- these isomers (including cally excepted or unless listed in an- tramadol) ...... 9752 other schedule, any material, com- (c) Depressants. Unless specifically pound, mixture or preparation con- excepted or unless listed in another taining any quantity of the following schedule, any material, compound, substances, including its salts, esters mixture, or preparation which contains and ethers: any quantity of the following sub- (1) Anabolic steroids (see § 1300.01 of stances, including its salts, isomers, this chapter)—4000 and salts of isomers whenever the ex- (2) [Reserved] istence of such salts, isomers, and salts (g) Hallucinogenic substances. (1) of isomers is possible within the spe- Dronabinol (synthetic) in sesame oil cific chemical designation: and encapsulated in a soft gelatin cap- (1) Alfaxalone ...... 2731 sule in a U.S. Food and Drug Adminis- (2) Alprazolam ...... 2882 tration approved product—7369. (3) Barbital ...... 2145 (4) Bromazepam ...... 2748 [Some other names for dronabinol: (6aR- (5) Camazepam ...... 2749 trans)-6a,7,8,10a-tetrahydro-6,6,9-trimethyl-3- pentyl-6H-dibenzo [b,d]pyran-1-ol] or (-)- (6) Carisoprodol ...... 8192 delta-9-(trans)-tetrahydrocannabinol] (7) Chloral betaine ...... 2460 (8) Chloral hydrate ...... 2465 (2) [Reserved] (9) Chlordiazepoxide ...... 2744 [39 FR 22142, June 20, 1974] (10) Clobazam ...... 2751 (11) Clonazepam ...... 2737 EDITORIAL NOTE: For FEDERAL REGISTER citations affecting § 1308.13, see the List of CFR (12) Clorazepate ...... 2768 Sections Affected, which appears in the (13) Clotiazepam ...... 2752 Finding Aids section of the printed volume (14) Cloxazolam ...... 2753 and at www.fdsys.gov. (15) Delorazepam ...... 2754 (16) Diazepam ...... 2765 § 1308.14 Schedule IV. (17) Dichloralphenazone ...... 2467 (a) Schedule IV shall consist of the (18) Estazolam ...... 2756 drugs and other substances, by what- (19) Ethchlorvynol ...... 2540 ever official name, common or usual (20) Ethinamate ...... 2545 name, chemical name, or brand name (21) Ethyl loflazepate ...... 2758 123

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(22) Fludiazepam ...... 2759 stances having a stimulant effect on (23) Flunitrazepam ...... 2763 the central nervous system, including (24) Flurazepam ...... 2767 its salts, isomers and salts of isomers: (25) Fospropofol ...... 2138 (1) Cathine ((+)- (26) Halazepam ...... 2762 norpseudoephedrine) ...... 1230 (27) Haloxazolam ...... 2771 (2) Diethylpropion ...... 1610 (28) Ketazolam ...... 2772 (3) Fencamfamin ...... 1760 (29) Loprazolam ...... 2773 (4) Fenproporex ...... 1575 (30) Lorazepam ...... 2885 (5) Mazindol ...... 1605 (31) Lormetazepam ...... 2774 (6) Mefenorex ...... 1580 (32) Mebutamate ...... 2800 (7)Modafinil ...... 1680 (33) Medazepam ...... 2836 (8) Pemoline (including (34) Meprobamate ...... 2820 (35) Methohexital ...... 2264 organometallic complexes and (36) Methylphenobarbital chelates thereof) ...... 1530 (mephobarbital) ...... 2250 (9) Phentermine ...... 1640 (37) Midazolam ...... 2884 (10) Pipradrol ...... 1750 (38) Nimetazepam ...... 2837 (11) Sibutramine ...... 1675 (39) Nitrazepam ...... 2834 (12) SPA ((-)-1-dimethylamino- (40) Nordiazepam ...... 2838 1,2-diphenylethane) ...... 1635 (41) Oxazepam ...... 2835 (g) Other substances. Unless specifi- (42) Oxazolam ...... 2839 cally excepted or unless listed in an- (43) Paraldehyde ...... 2585 other schedule, any material, com- (44) Petrichloral ...... 2591 pound, mixture or preparation which (45) Phenobarbital ...... 2285 contains any quantity of the following (46) Pinazepam ...... 2883 substances, including its salts: (47) Prazepam ...... 2764 (48) Quazepam ...... 2881 (1) Pentazocine ...... 9709 (49) Suvorexant ...... 2223 (2) Butorphanol (including its (50) Temazepam ...... 2925 optical isomers) ...... 9720 (51) Tetrazepam ...... 2886 (3) Eluxadoline (5-[[[(2S)-2- (52) Triazolam ...... 2887 amino-3-[4-aminocarbonyl)-2,6- (53) Zaleplon ...... 2781 dimethylphenyl]-1- (54) Zolpidem ...... 2783 oxopropyl][(1S)-1-(4-phenyl-1H- (55) Zopiclone ...... 2784 imidazol-2- yl)ethyl]amino]methyl]-2- (d) Fenfluramine. Any material, com- methoxybenzoic acid) (includ- pound, mixture, or preparation which ing its optical isomers) and its contains any quantity of the following salts, isomers, and salts of iso- substances, including its salts, isomers mers (9725).. (whether optical, position, or geometric), and salts of such isomers, [39 FR 22143, June 20, 1974] whenever the existence of such salts, isomers, and salts of isomers is pos- EDITORIAL NOTE: For FEDERAL REGISTER citations affecting § 1308.14, see the List of CFR sible: Sections Affected, which appears in the (1) Fenfluramine ...... 1670 Finding Aids section of the printed volume and at www.fdsys.gov. (e) Lorcaserin. Any material, compound, mixture, or preparation which § 1308.15 Schedule V. contains any quantity of the following substances, including its salts, isomers, (a) Schedule V shall consist of the and salts of such isomers, whenever the drugs and other substances, by what- existence of such salts, isomers, and ever official name, common or usual salts of isomers is possible: name, chemical name, or brand name designated, listed in this section. (1) Lorcaserin ...... 1625 (b) Narcotic drugs. Unless specifically (f) Stimulants. Unless specifically ex- excepted or unless listed in another cepted or unless listed in another schedule, any material, compound, schedule, any material, compound, mixture, or preparation containing any mixture, or preparation which contains of the following narcotic drugs and any quantity of the following sub- their salts, as set forth below: 124

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(1) [Reserved] (1) Brivaracetam ((2S)-2-[(4R)-2- (c) Narcotic drugs containing non-nar- oxo-4-propylpyrrolidin-1-yl] cotic active medicinal ingredients. Any butanamide) (also referred to compound, mixture, or preparation as BRV; UCB–34714; Briviact) containing any of the following nar- (including its salts) ...... 2710 cotic drugs, or their salts calculated as (2) Ezogabine [N-[2-amino-4-(4- the free anhydrous base or alkaloid, in fluorobenzylamino)-phenyl]- limited quantities as set forth below, carbamic acid ethyl ester] ...... 2779 which shall include one or more non- (3) Lacosamide [(R)-2- narcotic active medicinal ingredients acetoamido-N-benzyl-3- in sufficient proportion to confer upon methoxy-propionamide] ...... 2746 the compound, mixture, or preparation (4) Pregabalin [(S)-3- valuable medicinal qualities other than (aminomethyl)-5- those possessed by narcotic drugs methylhexanoic acid] ...... 2782 alone: (1) Not more than 200 milligrams of [39 FR 22143, June 20, 1974, as amended at 43 codeine per 100 milliliters or per 100 FR 38383, Aug. 28, 1978; 44 FR 40888, July 13, grams. 1979; 47 FR 49841, Nov. 3, 1982; 50 FR 8108, Feb. 28, 1985; 52 FR 5952, Feb. 27, 1987; 53 FR 10870, (2) Not more than 100 milligrams of Apr. 4, 1988; 56 FR 61372, Dec. 3, 1991; 67 FR dihydrocodeine per 100 milliliters or 62370, Oct. 7, 2002; 70 FR 43635, July 28, 2005; per 100 grams. 74 FR 23790, May 21, 2009; 76 FR 77899, Dec. 15, (3) Not more than 100 milligrams of 2011; 81 FR 29491, May 12, 2016] ethylmorphine per 100 milliliters or per 100 grams. EXCLUDED NONNARCOTIC SUBSTANCES (4) Not more than 2.5 milligrams of diphenoxylate and not less than 25 § 1308.21 Application for exclusion of a nonnarcotic substance. micrograms of atropine sulfate per dosage unit. (a) Any person seeking to have any (5) Not more than 100 milligrams of nonnarcotic drug that may, under the opium per 100 milliliters or per 100 Federal Food, Drug, and Cosmetic Act grams. (21 U.S.C. 301), be lawfully sold over the (6) Not more than 0.5 milligram of counter without a prescription, ex- difenoxin and not less than 25 cluded from any schedule, pursuant to micrograms of atropine sulfate per dos- section 201(g)(1) of the Act (21 U.S.C. age unit. 811(g)(1)), may apply to the Drug and (d) Stimulants. Unless specifically ex- Chemical Evaluation Section, Diver- empted or excluded or unless listed in sion Control Division, Drug Enforce- another schedule, any material, com- ment Administration. See the Table of pound, mixture, or preparation which DEA Mailing Addresses in § 1321.01 of contains any quantity of the following this chapter for the current mailing ad- substances having a stimulant effect dress. on the central nervous system, includ- (b) An application for an exclusion ing its salts, isomers and salts of iso- under this section shall contain the fol- mers: lowing information: (1) The name and address of the ap- (1) Pyrovalerone ...... 1485. plicant; (2) [Reserved]. (2) The name of the substance for (e) Depressants. Unless specifically which exclusion is sought; and exempted or excluded or unless listed (3) The complete quantitative com- in another schedule, any material, position of the substance. compound, mixture, or preparation (c) Within a reasonable period of which contains any quantity of the fol- time after the receipt of an application lowing substances having a depressant for an exclusion under this section, the effect on the central nervous system, including its salts:

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Administrator shall notify the appli- sion of law upon which the order is cant of his acceptance or nonaccept- based, the Administrator shall imme- ance of his application, and if not ac- diately suspend the effectiveness of the cepted, the reason therefore. The Ad- order until he may reconsider the ap- ministrator need not accept an applica- plication in light of the comments and tion for filing if any of the require- objections filed. Thereafter, the Ad- ments prescribed in paragraph (b) of ministrator shall reinstate, revoke, or this section is lacking or is not set amend his original order as he deter- forth as to be readily understood. If the mines appropriate. applicant desires, he may amend the (d) The Administrator may at any application to meet the requirements time revoke any exclusion granted pur- of paragraph (b) of this section. If the suant to section 201(g) of the Act (21 application is accepted for filing, the U.S.C. 811(g)) by following the proce- Administrator shall issue and publish dures set forth in paragraph (c) of this in the FEDERAL REGISTER his order on section for handling an application for the application, which shall include a an exclusion which has been accepted reference to the legal authority under for filing. which the order is issued and the find- [38 FR 8254, Mar. 30, 1973, as amended at 70 ings of fact and conclusions of law FR 74657, Dec. 16, 2005; 75 FR 10678, Mar. 9, upon which the order is based. This 2010; 81 FR 97021, Dec. 30, 2016] order shall specify the date on which it shall take effect. The Administrator § 1308.22 Excluded substances. shall permit any interested person to The following nonnarcotic substances file written comments on or objections which may, under the Federal Food, to the order within 60 days of the date Drug, and Cosmetic Act (21 U.S.C. 301), of publication of his order in the FED- be lawfully sold over the counter with- ERAL REGISTER. If any such comments out a prescription, are excluded from or objections raise significant issues all schedules pursuant to section 201(g) regarding any finding of fact or conclu- (1) of the Act (21 U.S.C. 811(g) (1)):

EXCLUDED NONNARCOTIC PRODUCTS

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

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]

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EXEMPT CHEMICAL PREPARATIONS (1) The name, address, and registration number, if any, of the applicant; § 1308.23 Exemption of certain chem- (2) The name, address, and registra- ical preparations; application. tion number, if any, of the manufac- (a) The Administrator may, by regu- turer or importer of the preparation or lation, exempt from the application of mixture, if not the applicant; all or any part of the Act any chemical (3) The exact trade name or other preparation or mixture containing one designation of the preparation or mix- or more controlled substances listed in ture; any schedule, which preparation or (4) The complete qualitative and mixture is intended for laboratory, industrial, educational, or special re- quantitative composition of the prepa- search purposes and not for general ad- ration or mixture (including all active ministration to a human being or other and inactive ingredients and all con- animal, if the preparation or mixture trolled and noncontrolled substances); either: (5) The form of the immediate con- (1) Contains no narcotic controlled tainer in which the preparation or mix- substance and is packaged in such a ture will be distributed with sufficient form or concentration that the pack- descriptive detail to identify the prepa- aged quantity does not present any sig- ration or mixture (e.g., bottle, packet, nificant potential for abuse (the type of vial, soft plastic pillow, agar gel plate, packaging and the history of abuse of etc.); the same or similar preparations may (6) The dimensions or capacity of the be considered in determining the po- immediate container of the prepara- tential for abuse of the preparation or tion or mixture; mixture); or (7) The label and labeling, as defined (2) Contains either a narcotic or non- in part 1300 of this chapter, of the im- narcotic controlled substance and one mediate container and the commercial or more adulterating or denaturing containers, if any, of the preparation agents in such a manner, combination, or mixture; quantity, proportion, or concentration, that the preparation or mixture does (8) A brief statement of the facts not present any potential for abuse. If which the applicant believes justify the the preparation or mixture contains a granting of an exemption under this narcotic controlled substance, the paragraph, including information on preparation or mixture must be formu- the use to which the preparation or lated in such a manner that it incor- mixture will be put; porates methods of denaturing or other (9) The date of the application; and means so that the preparation or mix- (10) Which of the information sub- ture is not liable to be abused or have mitted on the application, if any, is ill effects, if abused, and so that the deemed by the applicant to be a trade narcotic substance cannot in practice secret or otherwise confidential and en- be removed. titled to protection under subsection (b) Any person seeking to have any 402(a)(8) of the Act (21 U.S.C. 842(a) (8)) preparation or mixture containing a or any other law restricting public dis- controlled substance and one or more closure of information. noncontrolled substances exempted (d) The Administrator may require from the application of all or any part the applicant to submit such docu- of the Act, pursuant to paragraph (a) of ments or written statements of fact this section, may apply to the Drug relevant to the application as he deems and Chemical Evaluation Section, Di- version Control Division, Drug En- necessary to determine whether the ap- forcement Administration. See the plication should be granted. Table of DEA Mailing Addresses in (e) Within a reasonable period of § 1321.01 of this chapter for the current time after the receipt of an application mailing address. for an exemption under this section, (c) An application for an exemption under this section shall contain the following information:

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the Administrator shall notify the ap- § 1308.24 Exempt chemical prepara- plicant of his acceptance or nonaccept- tions. ance of his application, and if not ac- (a) The chemical preparations and cepted, the reason therefor. The Ad- mixtures approved pursuant to § 1308.23 ministrator need not accept an applica- are exempt from application of section for filing if any of the require- tions 302, 303, 305, 306, 307, 308, 309, 1002, ments prescribed in paragraph (c) or re- 1003 and 1004 of the Act (21 U.S.C. 822– quested pursuant to paragraph (d) is 823, 825–829, 952–954) and § 1301.74 of this lacking or is not set forth as to be chapter, to the extent described in readily understood. If the applicant de- paragraphs (b) to (h) of this section. sires, he may amend the application to Substances set forth in paragraph (j) of meet the requirements of paragraphs this section shall be exempt from the (c) and (d) of this section. If the appli- application of sections 305, 306, 307, 308, cation is accepted for filing, the Ad- 309, 1002, 1003 and 1004 of the Act (21 ministrator shall issue and publish in U.S.C. 825–829, 952–954) and §§ 1301.71– the FEDERAL REGISTER his order on the 1301.73 and 1301.74 (a), (b), (d), (e) and (f) application, which shall include a ref- of this chapter to the extent as herein- erence to the legal authority under after may be provided. which the order is based. This order (b) Registration and security: Any shall specify the date on which it shall person who manufactures an exempt take effect. The Administrator shall chemical preparation or mixture must permit any interested person to file be registered under the Act and comply written comments on or objections to with all relevant security requirements the order within 60 days of the date of regarding controlled substances being publication of his order in the FEDERAL used in the manufacturing process REGISTER. If any such comments or ob- until the preparation or mixture is in jections raise significant issues regard- the form described in paragraph (i) of ing any finding of fact or conclusion of this section. Any other person who law upon which the order is based, the handles an exempt chemical prepara- Administrator shall immediately sus- tion after it is in the form described in pend the effectiveness of the order paragraph (i) of this section is not re- until he may reconsider the application quired to be registered under the Act in light of the comments and objec- to handle that preparation, and the tions filed. Thereafter, the Adminis- preparation is not required to be stored trator shall reinstate, revoke, or in accordance with security require- amend his original order as he deter- ments regarding controlled substances. mines appropriate. (c) Labeling: In lieu of the require- (f) The Administrator may at any ments set forth in part 1302 of this time revoke or modify any exemption chapter, the label and the labeling of granted pursuant to this section by fol- an exempt chemical preparation must lowing the procedures set forth in para- be prominently marked with its full graph (e) of this section for handling an trade name or other description and application for an exemption which has the name of the manufacturer or sup- been accepted for filing. The Adminis- plier as set forth in paragraph (i) of trator may also modify or revoke the this section, in such a way that the criteria by which exemptions are product can be readily identified as an granted (and thereby modify or revoke exempt chemical preparation. The all preparations and mixtures granted label and labeling must also include in under the old criteria) and modify the a prominent manner the statement scope of exemptions at any time. ‘‘For industrial use only’’ or ‘‘For chemical use only’’ or ‘‘For in vitro use [38 FR 8254, Mar. 30, 1973. Redesignated at 38 only—not for human or animal use’’ or FR 26609, Sept. 24, 1973, and amended at 46 ‘‘Diagnostic reagent—for professional FR 28841, May 29, 1981; 62 FR 13968, Mar. 24, use only’’ or a comparable statement 1997; 75 FR 10678, Mar. 9, 2010; 81 FR 97021, warning the person reading it that Dec. 30, 2016] human or animal use is not intended. The symbol designating the schedule of

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the controlled substance is not re- trolled substances contained in the ex- quired on either the label or the label- empt chemical preparation. Distribu- ing of the exempt chemical preparation, possession, and use of an exempt tion, nor is it necessary to list all in- chemical preparation are lawful for gredients of the preparation. registrants and nonregistrants only as (d) Records and reports: Any person long as such distribution, possession, who manufactures an exempt chemical or use is intended for laboratory, in- preparation or mixture must keep com- dustrial, or educational purposes and plete and accurate records and file all not for immediate or subsequent ad- reports required under part 1304 of this ministration to a human being or other chapter regarding all controlled sub- animal. stances being used in the manufac- (g) Bulk materials: For materials ex- turing process until the preparation or mixture is in the form described in empted in bulk quantities, the Admin- paragraph (i) of this section. In lieu of istrator may prescribe requirements records and reports required under part other than those set forth in para- 1304 of this chapter regarding exempt graphs (b) through (e) of this section on chemical preparations, the manufac- a case-by-case basis. turer need only record the name, ad- (h) Changes in chemical preparations: dress, and registration number, if any, Any change in the quantitative or of each person to whom the manufac- qualitative composition of the prepara- turer distributes any exempt chemical tion or mixture after the date of appli- preparation. Each importer or exporter cation, or change in the trade name or of an exempt narcotic chemical prepa- other designation of the preparation or ration must submit a semiannual re- mixture, set forth in paragraph (i) of port of the total quantity of each sub- this section, requires a new application stance imported or exported in each for exemption. calendar half-year within 30 days of the (i) A listing of exempt chemical prep- close of the period to the Drug and arations may be obtained by submit- Chemical Evaluation Section, Drug En- ting a written request to the Drug and forcement Administration. See the Chemical Evaluation Section, Drug En- Table of DEA Mailing Addresses in forcement Administration. See the § 1321.01 of this chapter for the current Table of DEA Mailing Addresses in mailing address. Any other person who § 1321.01 of this chapter for the current handles an exempt chemical preparation after it is in the form described in mailing address. paragraph (i) of this section is not re- (j) The following substances are des- quired to maintain records or file re- ignated as exempt chemical prepara- ports. tions for the purposes set forth in this (e) Quotas, order forms, prescrip- section. tions, import, export, and trans- (1) Chloral. When packaged in a shipment requirements: Once an ex- sealed, oxygen-free environment, under empt chemical preparation is in the nitrogen pressure, safeguarded against form described in paragraph (i) of this exposure to the air. section, the requirements regarding (2) EmitR Phenobarbital Enzyme Rea- quotas, order forms, prescriptions, im- gent B. In one liter quantities each port permits and declarations, export with a 5 ml. retention sample for re- permit and declarations, and trans- packaging as an exempt chemical prep- shipment and intransit permits and aration only. declarations do not apply. These requirements do apply, however, to any [38 FR 8255, Mar. 30, 1973] controlled substances used in manufac- EDITORIAL NOTE: For FEDERAL REGISTER ci- turing the exempt chemical prepara- tations affecting § 1308.24, see the List of CFR tion before it is in the form described Sections Affected, which appears in the in paragraph (i) of this section. Finding Aids section of the printed volume (f) Criminal penalties: No exemption and at www.fdsys.gov. granted pursuant to § 1308.23 affects the criminal liability for illegal manufacture, distribution, or possession of con-

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EXCLUDED VETERINARY ANABOLIC Administrator shall notify the appli- STEROID IMPLANT PRODUCTS cant of his acceptance or nonaccept- ance of the application, and if not ac- § 1308.25 Exclusion of a veterinary an- cepted, the reason therefore. The Ad- abolic steroid implant product; ap- ministrator need not accept an applica- plication. tion for filing if any of the require- (a) Any person seeking to have any ments prescribed in paragraph (b) of anabolic steroid product, which is ex- this section is lacking or is not set pressly intended for administration forth as to be readily understood. The through implants to cattle or other applicant may amend the application nonhuman species and which has been to meet the requirements of paragraph approved by the Secretary of Health (b) of this section. If the application is and Human Services for such adminis- accepted for filing, the Administrator tration, identified as being excluded shall issue and have published in the from any schedule, pursuant to section FEDERAL REGISTER his order on the ap- 102(41)(B)(i) of the Act (21 U.S.C. plication, which shall include a ref- 802(41)(B)(i)), may apply to the Drug erence to the legal authority under and Chemical Evaluation Section, Di- which the order is issued and the find- version Control Division, Drug En- ings of fact and conclusions of law forcement Administration . See the upon which the order is based. This Table of DEA Mailing Addresses in order shall specify the date on which it § 1321.01 of this chapter for the current will take effect. The Administrator mailing address. shall permit any interested person to (b) An application for any exclusion file written comments on or objections under this section shall be submitted to the order within 60 days of the date in triplicate and contain the following of publication in the FEDERAL REG- information: ISTER. If any such comments or objec- (1) The name and address of the ap- tions raise significant issues regarding plicant; any finding of fact or conclusion of law (2) The name of the product; upon which the order is based, the Ad- (3) The chemical structural formula ministrator shall immediately suspend or description for any anabolic steroid the effectiveness of the order until he contained in the product; may reconsider the application in light (4) A complete description of dosage of the comments and objections filed. and quantitative composition of the Thereafter, the Administrator shall re- dosage form;. instate, revoke, or amend his original (5) The conditions of use including order as he determines appropriate. whether or not Federal law restricts (d) The Administrator may at any this product to use by or on the order time revoke or modify any designation of a licensed veterinarian; of excluded status granted pursuant to (6) A description of the delivery sys- this section by following the proce- tem in which the dosage form will be dures set forth in paragraph (c) of this distributed with sufficient detail to section for handling an application for identify the product (e.g. 20 cartridge an exclusion which has been accepted brown plastic belt); for filing. (7) The label and labeling of the im- [56 FR 42936, Aug. 30, 1991, as amended at 75 mediate container and the commercial FR 10679, Mar. 9, 2010; 81 FR 97021, Dec. 30, containers, if any, of the product;. 2016] (8) The name and address of the manufacturer of the dosage form if dif- § 1308.26 Excluded veterinary anabolic ferent from that of the applicant; and steroid implant products. (9) Evidence that the product has (a) Products containing an anabolic been approved by the Secretary of steroid, that are expressly intended for Health and Human Services for admin- administration through implants to istration through implant to cattle or cattle or other nonhuman species and other nonhuman species. which have been approved by the Sec- (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

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102(41)(B)(i) of the Act (21 U.S.C. (4) Details of synergisms and antag- 802(41)(B)(i)). A listing of the excluded onisms among ingredients. products may be obtained by submit- (5) Deterrent effects of the noncon- ting a written request to the Drug and trolled ingredients. Chemical Evaluation Section, Drug En- (6) Complete copies of all literature forcement Administration. See the in support of claims. Table of DEA Mailing Addresses in (7) Reported instances of abuse. § 1321.01 of this chapter for the current (8) Reported and anticipated adverse mailing address. effects. (b) In accordance with section (9) Number of dosage units produced 102(41)(B)(ii) of the Act (21 U.S.C. for the past 2 years. 802(41)(B)(ii)) if any person prescribes, (c) Within a reasonable period of dispenses, or distributes a product list- time after the receipt of an application ed in paragraph (a) of this section for for an exemption under this section, human use, such person shall be con- the Administrator shall notify the ap- sidered to have prescribed, dispensed, plicant of his acceptance or non-ac- or distributed an anabolic steroid with- ceptance of the application, and if not in the meaning of section 102(41)(A) of accepted, the reason therefor. The Ad- the Act (21 U.S.C. 802(41)(A)). ministrator need not accept an application for filing if any of the require- [56 FR 42936, Aug. 30, 1991, as amended at 57 ments prescribed in paragraph (b) of FR 19534, May 7, 1992; 58 FR 15088, Mar. 19, this section is lacking or is not set 1993; 62 FR 13967, Mar. 24, 1997; 75 FR 10679, forth so as to be readily understood. If Mar. 9, 2010] the applicant desires, he may amend the application to meet the require- EXEMPTED PRESCRIPTION PRODUCTS ments of paragraph (b) of this section. § 1308.31 Application for exemption of If accepted for filing, the Adminis- a nonnarcotic prescription product. trator shall publish in the FEDERAL REGISTER general notice of this pro- (a) Any person seeking to have any posed rulemaking in granting or deny- compound, mixture, or preparation ing the application. Such notice shall containing any nonnarcotic controlled include a reference to the legal author- substance listed in § 1308.12(e), or in ity under which the rule is proposed, a § 1308.13(b) or (c), or in § 1308.14, or in statement of the proposed rule grant- § 1308.15, exempted from application of ing or denying an exemption, and, in all or any part of the Act pursuant to the discretion of the Administrator, a section 201(g)(3)(A), of the Act (21 summary of the subjects and issues in- U.S.C. 811(g)(3)(A)) may apply to the volved. The Administrator shall permit Drug and Chemical Evaluation Section, any interested person to file written Diversion Control Division, Drug En- comments on or objections to the pro- forcement Administration. See the posal and shall designate in the notice Table of DEA Mailing Addresses in of proposed rule making the time dur- § 1321.01 of this chapter for the current ing which such filings may be made. mailing address. After consideration of the application (b) An application for an exemption and any comments on or objections to under this section shall contain the fol- his proposed rulemaking, the Adminis- lowing information: trator shall issue and publish in the (1) The complete quantitative com- FEDERAL REGISTER his final order on position of the dosage form. the application, which shall set forth (2) Description of the unit dosage the findings of fact and conclusions of form together with complete labeling. law upon which the order is based. This (3) A summary of the pharmacology order shall specify the date on which it of the product including animal inves- shall take effect, which shall not be tigations and clinical evaluations and less than 30 days from the date of pub- studies, with emphasis on the psychic lication in the FEDERAL REGISTER un- and/or physiological dependence liabil- less the Administrator finds that con- ity (this must be done for each of the ditions of public health or safety neces- active ingredients separately and for sitate an earlier effective date, in the combination product). which event the Administrator shall

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specify in the order his findings as to tion, exempt from the application of such conditions. all or any part of the Act any com- (d) The Administrator may revoke pound, mixture, or preparation con- any exemption granted pursuant to taining an anabolic steroid as defined section 201(g)(3)(A) of the Act (21 U.S.C. in part 1300 of this chapter, which is in- 811(g)(3)(A)) by following the proce- tended for administration to a human dures set forth in paragraph (c) of this being or animal, if, because of its con- section for handling an application for centration, preparation, formulation, an exemption which has been accepted or delivery system, it has no signifi- for filing. cant potential for abuse. [38 FR 8254, Mar. 30, 1973. Redesignated at 38 (b) Any person seeking to have any FR 26609, Sept. 24, 1973, as amended at 44 FR compound, mixture, or preparation 18968, Mar. 30, 1979; 52 FR 9803, Mar. 27, 1987; containing an anabolic steroid as de- 75 FR 10679, Mar. 9, 2010; 81 FR 97021, Dec. 30, fined in part 1300 of this chapter ex- 2016] empted from the application of all or § 1308.32 Exempted prescription prod- any part of the Act, pursuant to para- ucts. graph (a) of this section, may apply to The compounds, mixtures, or prep- the Drug and Chemical Evaluation Sec- arations that contain a nonnarcotic tion, Diversion Control Division, Drug controlled substance listed in Enforcement Administration. See the § 1308.12(e) or in § 1308.13(b) or (c) or in Table of DEA Mailing Addresses in § 1308.14 or in § 1308.15 listed in the § 1321.01 of this chapter for the current Table of Exempted Prescription Prod- mailing address. ucts have been exempted by the Ad- (c) An application for an exemption ministrator from the application of under this section shall be submitted sections 302 through 305, 307 through in triplicate and contain the following 309, and 1002 through 1004 of the Act (21 information: U.S.C. 822–825, 827–829, and 952–954) and (1) The name and address of the ap- §§ 1301.13, 1301.22, and §§ 1301.71 through plicant; 1301.76 of this chapter for administra- (2) The name of the product; tive purposes only. An exception to the (3) The chemical structural formula above is that those products containing or description for any anabolic steroid butalbital shall not be exempt from the contained in the product; requirement of 21 U.S.C. 952–954 con- (4) The complete description of dos- cerning importation, exportation, age and quantitative composition of transshipment and in-transit shipment the dosage form; of controlled substances. Any deviation (5) A description of the delivery sys- from the quantitative composition of tem, if applicable; any of the listed drugs shall require a (6) The indications and conditions for petition of exemption in order for the use in which species, including whether product to be exempted. A listing of or not this product is a prescription the Exempted Prescription Products drug; may be obtained by submitting a written request to the Drug and Chemical (7) Information to facilitate identi- Evaluation Section, Drug Enforcement fication of the dosage form, such as Administration. See the Table of DEA shape, color, coating, and scoring; Mailing Addresses in § 1321.01 of this (8) The label and labeling of the im- chapter for the current mailing ad- mediate container and the commercial dress. containers, if any, of the product; (9) The units in which the dosage [75 FR 10679, Mar. 9, 2010] form is ordinarily available; and EXEMPT ANABOLIC STEROID PRODUCTS (10) The facts which the applicant believes justify: § 1308.33 Exemption of certain ana- (i) A determination that the product bolic steroid products; application. has no significant potential for abuse (a) The Administrator, upon the rec- and ommendation of Secretary of Health (ii) a granting of an exemption under and Human Services, may, by regula- this section.

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(d) Within a reasonable period of dling an application for an exemption time after the receipt of the applica- which has been accepted for filing. tion for an exemption under this sec- [56 FR 42936, Aug. 30, 1991; 57 FR 10815, Mar. tion, the Administrator shall notify 31, 1992, as amended at 62 FR 13968, Mar. 24, the applicant of his acceptance or non- 1997; 70 FR 74657, Dec. 16, 2005; 75 FR 10679, acceptance of the application, and if Mar. 9, 2010; 81 FR 97021, Dec. 30, 2016] not accepted, the reason therefor. The Administrator need not accept an ap- § 1308.34 Exempt anabolic steroid plication for filing if any of the re- products. quirements prescribed in paragraph (c) The list of compounds, mixtures, or of this section is lacking or is not set preparations that contain an anabolic forth so as to be readily understood. steroid that have been exempted by the The applicant may amend the applica- Administrator from application of section to meet the requirements of para- tions 302 through 309 and 1002 through graph (c) of this section. If accepted for 1004 of the Act (21 U.S.C. 822–829 and filing, the Administrator will request 952–954) and §§ 1301.13, 1301.22, and from the Secretary for Health and 1301.71 through 1301.76 of this chapter Human Services his recommendation, for administrative purposes only may as to whether such product which con- be obtained by submitting a written retains an anabolic steroid should be con- quest to the Drug and Chemical Eval- sidered for exemption from certain por- uation Section, Drug Enforcement Ad- tions of the Controlled Substances Act. ministration. See the Table of DEA On receipt of the recommendation of Mailing Addresses in § 1321.01 of this the Secretary, the Administrator shall chapter for the current mailing ad- make a determination as to whether dress. the evidence submitted or otherwise available sufficiently establishes that [75 FR 10679, Mar. 9, 2010] the product possesses no significant potential for abuse. The Administrator EXEMPT CANNABIS PLANT MATERIAL, shall issue and publish in the FEDERAL AND PRODUCTS MADE THEREFROM, REGISTER his order on the application, THAT CONTAIN which shall include a reference to the TETRAHYDROCANNABINOLS legal authority under which the order is issued, and the findings of fact and § 1308.35 Exemption of certain can- conclusions of law upon which the nabis plant material, and products made therefrom, that contain order is based. This order shall specify tetrahydrocannabinols. the date on which it will take effect. The Administrator shall permit any in- (a) Any processed plant material or terested person to file written com- animal feed mixture containing any ments on or objections to the order amount of tetrahydrocannabinols within 60 days of the date of publica- (THC) that is both: tion of his order in the FEDERAL REG- (1) Made from any portion of a plant ISTER. If any such comments or objec- of the genus Cannabis excluded from tions raise significant issues regarding the definition of marijuana under the any finding of fact or conclusion of law Act [i.e., the mature stalks of such upon which the order is based, the Ad- plant, fiber produced from such stalks, ministrator shall immediately suspend oil or cake made from the seeds of such the effectiveness of the order until he plant, any other compound, manufac- may reconsider the application in light ture, salt, derivative, mixture, or prep- of the comments and objections filed. aration of such mature stalks (except Thereafter, the Administrator shall re- the resin extracted therefrom), fiber, instate, revoke, or amend his original oil, or cake, or the sterilized seed of order as he determines appropriate. such plant which is incapable of germi- (e) The Administrator may revoke nation] and any exemption granted pursuant to (2) Not used, or intended for use, for section 1903(a) of Public Law 101–647 by human consumption, has been exempt- following the procedures set forth in ed by the Administrator from the ap- paragraph (d) of this section for han- plication of the Act and this chapter.

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(b) As used in this section, the fol- to section 201 of the Act, the proce- lowing terms shall have the meanings dures for such hearing and accom- specified: panying proceedings shall be governed (1) The term processed plant material generally by the rulemaking proce- means cannabis plant material that dures set forth in the Administrative has been subject to industrial proc- Procedure Act (5 U.S.C. 551–559) and esses, or mixed with other ingredients, specifically by section 201 of the Act (21 such that it cannot readily be con- U.S.C. 811), by §§ 1308.42–1308.51, and by verted into any form that can be used §§ 1316.41–1316.67 of this chapter. for human consumption. (2) The term animal feed mixture § 1308.42 Purpose of hearing. means sterilized cannabis seeds mixed If requested by any interested person with other ingredients (not derived after proceedings are initiated pursu- from the cannabis plant) in a formula- ant to § 1308.43, the Administrator shall tion that is designed, marketed, and hold a hearing for the purpose of re- distributed for animal consumption ceiving factual evidence and expert (and not for human consumption). opinion regarding the issues involved (3) The term used for human consump- in the issuance, amendment or repeal tion means either: of a rule issuable pursuant to section (i) Ingested orally or 201(a) of the Act (21 U.S.C. 811(a)). Ex- (ii) Applied by any means such that tensive argument should not be offered THC enters the human body. into evidence but rather presented in (4) The term intended for use for opening or closing statements of coun- human consumption means any of the sel or in memoranda or proposed find- following: ings of fact and conclusions of law. Ad- (i) Designed by the manufacturer for ditional information relating to hear- human consumption; ings to include waivers or modification (ii) Marketed for human consump- of rules, request for hearing, burden of tion; or proof, time and place, and final order (iii) Distributed, exported, or im- are set forth in part 1316 of this chap- ported, with the intent that it be used ter. for human consumption. (c) In any proceeding arising under [62 FR 13968, Mar. 24, 1997] the Act or this chapter, the burden of going forward with the evidence that a § 1308.43 Initiation of proceedings for material, compound, mixture, or prepa- rulemaking. ration containing THC is exempt from (a) Any interested person may sub- control pursuant to this section shall mit a petition to initiate proceedings be upon the person claiming such ex- for the issuance, amendment, or repeal emption, as set forth in section of any rule or regulation issuable pur- 515(a)(1) of the Act (21 U.S.C. 885(a)(1)). suant to the provisions of section 201 of In order to meet this burden with re- the Act. spect to a product or plant material (b) Petitions shall be submitted in that has not been expressly exempted quintuplicate to the Administrator. from control by the Administrator pur- See the Table of DEA Mailing Address- suant to § 1308.23, the person claiming es in § 1321.01 of this chapter for the the exemption must present rigorous current mailing address. Petitions scientific evidence, including well-doc- shall be in the following form: umented scientific studies by experts trained and qualified to evaluate the llllllllll (Date) effects of drugs on humans. Administrator, Drug Enforcement Adminis- tration llllll (Mailing Address) [66 FR 51544, Oct. 9, 2001] Dear Sir: The undersigned llllllll HEARINGS hereby petitions the Administrator to initiate proceedings for the issuance (amend- § 1308.41 Hearings generally. ment or repeal) of a rule or regulation pursuant to section 201 of the Controlled Sub- In any case where the Administrator stances Act. shall hold a hearing on the issuance, Attached hereto and constituting a part of amendment, or repeal of rules pursuant this petition are the following:

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(A) The proposed rule in the form proposed other substance not be controlled, the by the petitioner. (If the petitioner seeks the Administrator shall not control that amendment or repeal of an existing rule, the drug or other substance. existing rule, together with a reference to (e) If the Administrator determines the section in the Code of Federal Regula- tions where it appears, should be included.) that the scientific and medical evalua- (B) A statement of the grounds which the tion and recommendations of the Sec- petitioner relies for the issuance (amend- retary and all other relevant data con- ment or repeal) of the rule. (Such grounds stitute substantial evidence of poten- shall include a reasonably concise statement tial for abuse such as to warrant con- of the facts relied upon by the petitioner, in- trol or additional control over the drug cluding a summary of any relevant medical or other substance, or substantial evi- or scientific evidence known to the peti- dence that the drug or other sub- tioner.) All notices to be sent regarding this peti- stances should be subjected to lesser tion should be addressed to: control or removed entirely from the llllllllll (Name) schedules, he shall initiate proceedings llllllllll (Street Address) for control, transfer, or removal as the llllllllll (City and State) case may be. Respectfully yours, (f) If and when the Administrator de- llllllllll (Signature of petitioner) termines to initiate proceedings, he (c) Within a reasonable period of shall publish in the FEDERAL REGISTER time after the receipt of a petition, the general notice of any proposed rule Administrator shall notify the peti- making to issue, amend, or repeal any tioner of his acceptance or nonaccept- rule pursuant to section 201 of the Act. ance of the petition, and if not accept- Such published notice shall include a ed, the reason therefor. The Adminis- statement of the time, place, and na- trator need not accept a petition for ture of any hearings on the proposal in filing if any of the requirements pre- the event a hearing is requested pursu- scribed in paragraph (b) of this section ant to § 1308.44. Such hearings may not is lacking or is not set forth so as to be be commenced until after the expira- readily understood. If the petitioner tion of at least 30 days from the date desires, he may amend the petition to the general notice is published in the meet the requirements of paragraph (b) FEDERAL REGISTER. Such published no- of this section. If accepted for filing, a tice shall also include a reference to petition may be denied by the Adminis- the legal authority under which the trator within a reasonable period of rule is proposed, a statement of the time thereafter if he finds the grounds proposed rule, and, in the discretion of upon which the petitioner relies are the Administrator, a summary of the not sufficient to justify the initiation subjects and issues involved. of proceedings. (g) The Administrator may permit (d) The Administrator shall, before any interested persons to file written initiating proceedings for the issuance, comments on or objections to the pro- amendment, or repeal of any rule ei- posal and shall designate in the notice ther to control a drug or other sub- of proposed rule making the time dur- stance, or to transfer a drug or other ing which such filings may be made. substance from one schedule to an- [38 FR 8254, Mar. 30, 1973. Redesignated at 38 other, or to remove a drug or other FR 26609, Sept. 24, 1973, and further redesig- substance entirely from the schedules, nated and amended at 62 FR 13968, Mar. 24, and after gathering the necessary data, 1997; 75 FR 10679, Mar. 9, 2010] request from the Secretary a scientific and medical evaluation and the Sec- § 1308.44 Request for hearing or ap- retary’s recommendations as to wheth- pearance; waiver. er such drug or other substance should (a) Any interested person desiring a be so controlled, transferred, or re- hearing on a proposed rulemaking, moved as a controlled substance. The shall, within 30 days after the date of 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.

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(b) Any interested person desiring to from the date of publication in the participate in a hearing pursuant to FEDERAL REGISTER unless the Adminis- § 1308.41 shall, within 30 days after the trator finds that conditions of public date of publication of the notice of health or safety necessitate an earlier hearing in the FEDERAL REGISTER, file effective date, in which event the Ad- with the Administrator a written no- ministrator shall specify in the order tice of his intention to participate in his findings as to such conditions. such hearing in the form prescribed in [38 FR 8254, Mar. 30, 1973. Redesignated at 38 § 1316.48 of this chapter. Any person fil- FR 26609, Sept. 24, 1973, and further redesig- ing a request for a hearing need not nated at 62 FR 13968, Mar. 24, 1997] also file a notice of appearance; the request for a hearing shall be deemed to § 1308.46 Control required under inter- be a notice of appearance. national treaty. (c) Any interested person may, with- Pursuant to section 201(d) of the Act in the period permitted for filing a re- (21 U.S.C. 811(d)), where control of a quest for a hearing, file with the Ad- substance is required by U.S. obliga- ministrator a waiver of an opportunity tions under international treaties, con- for a hearing or to participate in a ventions, or protocols in effect on May hearing, together with a written state- 1, 1971, the Administrator shall issue ment regarding his position on the and publish in the FEDERAL REGISTER matters of fact and law involved in an order controlling such substance such hearing. Such statement, if ad- under the schedule he deems most ap- missible, shall be made a part of the propriate to carry out obligations. record and shall be considered in light Issuance of such an order shall be with- of the lack of opportunity for cross-ex- out regard to the findings required by amination in determining the weight subsections 201(a) or 202(b) of the Act to be attached to matters of fact as- (21 U.S.C. 811(a) or 812(b)) and without serted therein. regard to the procedures prescribed by (d) If any interested person fails to § 1308.41 or subsections 201 (a) and (b) of file a request for a hearing; or if he so the Act (21 U.S.C. 811 (a) and (b)). An files and fails to appear at the hearing, order controlling a substance shall be- he shall be deemed to have waived his come effective 30 days from the date of opportunity for the hearing or to par- publication in the FEDERAL REGISTER, ticipate in the hearing, unless he shows unless the Administrator finds that good cause for such failure. conditions of public health or safety (e) If all interested persons waive or necessitate an earlier effective date, in are deemed to waive their opportunity which event the Administrator shall for the hearing or to participate in the specify in the order his findings as to hearing, the Administrator may cancel such conditions. the hearing, if scheduled, and issue his [38 FR 8254, Mar. 30, 1973. Redesignated at 38 final order pursuant to § 1308.45 without FR 26609, Sept. 24, 1973, and further redesig- a hearing. nated at 62 FR 13968, Mar. 24, 1997] [38 FR 8254, Mar. 30, 1973. Redesignated at 38 FR 26609, Sept. 24, 1973, and further redesig- § 1308.47 Control of immediate precur- nated and amended at 62 FR 13968, Mar. 24, sors. 1997] Pursuant to section 201(e) of the Act (21 U.S.C. 811(e)), the Administrator § 1308.45 Final order. may, without regard to the findings re- As soon as practicable after the pre- quired by subsection 201(a) or 202 (b) of siding officer has certified the record the Act (21 U.S.C. 811(a) or 812(b)) and to the Administrator, the Adminis- without regard to the procedures pre- trator shall cause to be published in scribed by § 1308.41 or subsections 201 the FEDERAL REGISTER his order in the (a) and (b) of the Act (21 U.S.C. 811(a) proceeding, which shall set forth the and (b)), issue and publish in the FED- 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

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which the controlled substance of PART 1309—REGISTRATION OF which it is an immediate precursor is MANUFACTURERS, DISTRIBUTORS, placed or any other schedule with a IMPORTERS AND EXPORTERS OF higher numerical designation. An order LIST I CHEMICALS controlling an immediate precursor shall become effective 30 days from the GENERAL INFORMATION date of publication in the FEDERAL REGISTER, unless the Administrator Sec. finds that conditions of public health 1309.01 Scope of part 1309. or safety necessitate an earlier effec- 1309.02 Definitions. tive date, in which event the Adminis- 1309.03 Information; special instructions. trator shall specify in the order his FEES FOR REGISTRATION AND REREGISTRATION findings as to such conditions. 1309.11 Fee amounts. [38 FR 8254, Mar. 30, 1973. Redesignated at 38 1309.12 Time and method of payment; re- FR 26609, Sept. 24, 1973, and further redesig- fund. nated at 62 FR 13968, Mar. 24, 1997] REQUIREMENTS FOR REGISTRATION § 1308.49 Temporary scheduling. 1309.21 Persons required to register. (a) Pursuant to 21 U.S.C. 811(h) and 1309.22 Separate registration for independent activities. without regard to the requirements of 1309.23 Separate registration for separate 21 U.S.C. 811(b) relating to the sci- locations. entific and medical evaluation of the 1309.24 Waiver of registration requirement Secretary of Health and Human Serv- for certain activities. ices, the Drug Enforcement Adminis- 1309.25 Temporary exemption from registra- tration may place a substance into tion for chemical registration applicants. Schedule I on a temporary basis, if it 1309.26 Exemption of law enforcement offi- determines that such action is nec- cials. essary to avoid an imminent hazard to APPLICATION FOR REGISTRATION the public safety. An order issued 1309.31 Time for application for registra- under this section may not be effective tion; expiration date. before the expiration of 30 calendar 1309.32 Application forms; contents, signa- days from: ture. (1) The date of publication by the Ad- 1309.33 Filing of application; joint filings. ministration of a notice in the FED- 1309.34 Acceptance for filing; defective ap- ERAL REGISTER of its intention to issue plications. such order and the grounds upon which 1309.35 Additional information. such order is to be issued; and 1309.36 Amendments to and withdrawals of applications. (2) The date the Administration has transmitted notification to the Sec- ACTION ON APPLICATIONS FOR REGISTRATION: retary of Health and Human Services REVOCATION OR SUSPENSION OF REGISTRATION of the Administration’s intention to 1309.41 Administrative review generally. issue such order. 1309.42 Certificate of registration; denial of (b) An order issued under this section registration. will be vacated upon the conclusion of 1309.43 Suspension or revocation of registra- a subsequent rulemaking proceeding tion. 1309.44 Suspension of registration pending initiated under section 201(a) (21 U.S.C. final order. 811(a)) with respect to such substance 1309.45 Extension of registration pending or at the end of two years from the ef- final order. fective date of the order scheduling the 1309.46 Order to show cause. substance, except that during the pend- ency of proceedings under section HEARINGS 201(a) (21 U.S.C. 811(a)) with respect to 1309.51 Hearings generally. the substance, the Administration may 1309.52 Purpose of hearing. extend the temporary scheduling for up 1309.53 Request for hearing or appearance; to one year. waiver. 1309.54 Burden of proof. [81 FR 97021, Dec. 30, 2016] 1309.55 Time and place of hearing.

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MODIFICATION, TRANSFER AND TERMINATION port, or export a List I chemical, the OF REGISTRATION applicant shall pay an annual fee of 1309.61 Modification in registration. $1,523. 1309.62 Termination of registration. 1309.63 Transfer of registration. [77 FR 15250, Mar. 15, 2012]

SECURITY REQUIREMENTS § 1309.12 Time and method of pay- 1309.71 General security requirements. ment; refund. 1309.72 Felony conviction; employer respon- (a) For each application for registra- sibilities. tion or reregistration to manufacture, 1309.73 Employee responsibility to report di- distribute, import, or export, the appli- version. cant shall pay the fee when the appli- AUTHORITY: 21 U.S.C. 802, 821, 822, 823, 824, cation for registration or reregistra- 830, 871(b), 875, 877, 886a, 952, 953, 957, 958. tion is submitted for filing. SOURCE: 60 FR 32454, June 22, 1995, unless (b) Payments should be made in the otherwise noted. form of a credit card; a personal, certified, or cashier’s check; or a money GENERAL INFORMATION order made payable to ‘‘Drug Enforce- § 1309.01 Scope of part 1309. ment Administration.’’ Payments made in the form of stamps, foreign Procedures governing the registra- currency, or third party endorsed tion of manufacturers, distributors, checks will not be accepted. These ap- importers and exporters of List I plication fees are not refundable. chemicals pursuant to Sections 102, 302, 303, 1007 and 1008 of the Act (21 U.S.C. [75 FR 4980, Feb. 1, 2010] 802, 822, 823, 957 and 958) are set forth generally by those sections and specifi- REQUIREMENTS FOR REGISTRATION cally by the sections of this part. § 1309.21 Persons required to register. § 1309.02 Definitions. (a) Unless exempted by law or under Any term used in this part shall have §§ 1309.24 through 1309.26 or §§ 1310.12 the definition set forth in section 102 of through 1310.13 of this chapter, the fol- the Act (21 U.S.C. 802) or part 1300 of lowing persons must annually obtain a this chapter. registration specific to the List I [62 FR 13968, Mar. 24, 1997] chemicals to be handled: (1) Every person who manufactures § 1309.03 Information; special instruc- or imports or proposes to manufacture tions. or import a List I chemical or a drug Information regarding procedures product containing ephedrine, under these rules and instructions pseudoephedrine, or phenylpropanola- supplementing these rules will be fur- mine. nished upon request by writing to the (2) Every person who distributes or Registration Section, Drug Enforce- exports or proposes to distribute or ex- ment Administration. See the Table of port any List I chemical, other than DEA Mailing Addresses in § 1321.01 of those List I chemicals contained in a this chapter for the current mailing ad- product exempted under paragraph dress. (1)(iv) of the definition of regulated [75 FR 10680, Mar. 9, 2010] transaction in § 1300.02 of this chapter. (b) Only persons actually engaged in FEES FOR REGISTRATION AND the activities are required to obtain a REREGISTRATION registration; related or affiliated persons who are not engaged in the activi- § 1309.11 Fee amounts. ties are not required to be registered. (a) For each application for registra- (For example, a stockholder or parent tion or reregistration to manufacture corporation of a corporation distrib- the applicant shall pay an annual fee of uting List I chemicals is not required $3,047. to obtain a registration.) (b) For each application for registra- (c) The registration requirements are tion or reregistration to distribute, im- summarized in the following table:

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SUMMARY OF REGISTRATION REQUIREMENTS AND LIMITATIONS

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

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

[75 FR 4980, Feb. 1, 2010, as amended at 77 FR (d) A person registered to manufac- 4236, Jan. 27, 2012; 77 FR 15250, Mar. 15, 2012] ture any List I chemical shall be authorized to distribute that List I chem- § 1309.22 Separate registration for independent activities. ical after manufacture, but no other chemical that the person is not reg- (a) The following groups of activities istered to manufacture. are deemed to be independent of each other: [75 FR 4981, Feb. 1, 2010] (1) Manufacturing of List I chemicals or drug products containing ephedrine, § 1309.23 Separate registration for sep- pseudoephedrine, or phenylpropanola- arate locations. mine. (a) A separate registration is re- (2) Distributing of List I chemicals quired for each principal place of busi- and scheduled listed chemical prod- ness at one general physical location ucts. where List I chemicals are manufac- (3) Importing List I chemicals or drug products containing ephedrine, tured, distributed, imported, or ex- pseudoephedrine, or phenylpropanola- ported by a person. mine. (b) The following locations shall be (4) Exporting List I chemicals and deemed to be places not subject to the scheduled listed chemical products. registration requirement: (b) Except as provided in paragraphs (1) A warehouse where List I chemi- (c) and (d) of this section, every person cals are stored by or on behalf of a reg- who engages in more than one group of istered person, unless such chemicals independent activities must obtain a are distributed directly from such separate registration for each group of warehouse to locations other than the activities, unless otherwise exempted registered location from which the by the Act or §§ 1309.24 through 1309.26. chemicals were originally delivered; (c) A person registered to import any and List I chemical shall be authorized to (2) An office used by agents of a reg- distribute that List I chemical after importation, but no other chemical istrant where sales of List I chemicals that the person is not registered to im- are solicited, made, or supervised but port. which neither contains such chemicals

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(other than chemicals for display pur- quantities of chemical returned to the poses) nor serves as a distribution producer, in reusable rail cars and point for filling sales orders. intermodal tank containers which con- [60 FR 32454, June 22, 1995, as amended at 75 form to International Standards Orga- FR 4981, Feb. 1, 2010] nization specifications (with capacities greater than or equal to 2,500 gallons in § 1309.24 Waiver of registration re- a single container). quirement for certain activities. (g) The requirement of registration is (a) The requirement of registration is waived for any person whose activities waived for any agent or employee of a with respect to List I chemicals are person who is registered to engage in limited solely to the distribution of any group of independent activities, if Lugol’s Solution (consisting of 5 per- the agent or employee is acting in the cent iodine and 10 percent potassium usual course of his or her business or iodide in an aqueous solution) in origi- employment. nal manufacturer’s packaging of one (b) The requirement of registration is fluid ounce (30 ml) or less. waived for any person who manufac- (h) The requirement of registration is tures or distributes a scheduled listed waived for any manufacturer of a List chemical product or other product con- I chemical, if that chemical is pro- taining a List I chemical that is de- duced solely for internal consumption scribed and included in paragraph by the manufacturer and there is no (1)(iv) of the definition of regulated subsequent distribution or exportation transaction in § 1300.02 of this chapter, of the List I chemical. if that person is registered with the (i) If any person exempted under Administration to engage in the same paragraph (b), (c), (d), (e), or (f) of this activity with a controlled substance. section also engages in the distribu- (c) The requirement of registration is tion, importation, or exportation of a waived for any person who imports or List I chemical, other than as de- exports a scheduled listed chemical scribed in such paragraph, the person product or other product containing a shall obtain a registration for the ac- List I chemical that is described and tivities, as required by § 1309.21. included in paragraph (1)(iv) of the def- (j) The Administrator may, upon inition of regulated transaction in finding that continuation of the waiver § 1300.02 of this chapter, if that person would not be in the public interest, is registered with the Administration suspend or revoke a waiver granted to engage in the same activity with a under paragraph (b), (c), (d), (e), or (f) controlled substance. of this section pursuant to the proce- (d) The requirement of registration is dures set forth in §§ 1309.43 through waived for any person who only distrib- 1309.46 and §§ 1309.51 through 1309.55. In utes a prescription drug product con- considering the revocation or suspen- taining a List I chemical that is regu- sion of a person’s waiver granted pur- lated pursuant to paragraph (1)(iv) of suant to paragraph (b) or (c) of this the definition of regulated transaction section, the Administrator shall also in § 1300.02 of this chapter. consider whether action to revoke or (e) The requirement of registration is suspend the person’s controlled sub- waived for any person whose activities stance registration pursuant to section with respect to List I chemicals are 304 of the Act (21 U.S.C. 824) is war- limited to the distribution of red phos- ranted. phorus, white phosphorus, or hypophosphorous acid (and its salts) to (k) Any person exempted from the another location operated by the same registration requirement under this firm solely for internal end-use, or an section must comply with the security EPA or State licensed waste treatment requirements set forth in §§ 1309.71 or disposal firm for the purpose of through 1309.73 and the recordkeeping waste disposal. and reporting requirements set forth (f) The requirement of registration is under Parts 1310, 1313, 1314, and 1315 of waived for any person whose distribu- this chapter. tion of red phosphorus or white phos- [75 FR 4981, Feb. 1, 2010, as amended at 77 FR phorus is limited solely to residual 4236, Jan. 25, 2012]

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§ 1309.25 Temporary exemption from this chapter remain in full force and ef- registration for chemical registra- fect. tion applicants. [67 FR 14860, Mar. 28, 2002, as amended at 75 (a) Each person required by section FR 4982, Feb. 1, 2010] 302 of the Act (21 U.S.C. 822) to obtain a registration to distribute, import, or § 1309.26 Exemption of law enforce- export a combination ephedrine prod- ment officials. uct is temporarily exempted from the (a) The requirement of registration is registration requirement, provided waived for the following persons in the that the person submits a proper appli- circumstances described in this sec- cation for registration on or before tion: July 12, 1997. The exemption will re- (1) Any officer or employee of the Ad- main in effect for each person who has ministration, any customs officer, any made such application until the Ad- officer or employee of the U.S. Food ministration has approved or denied and Drug Administration, and any Fed- that application. This exemption ap- eral or Insular officer who is lawfully plies only to registration; all other engaged in the enforcement of any fed- chemical control requirements set eral law relating to listed chemicals, forth in this part 1309 and parts 1310, controlled substances, drugs, or cus- and 1313 of this chapter remain in full toms, and is duly authorized to possess force and effect. and distribute List I chemicals in the course of his/her official duties; and (b) Each person required by section (2) Any officer or employee of any 302 of the Act (21 U.S.C. 822) to obtain State, or any political subdivision or a registration to distribute, import, or agency thereof, who is engaged in the export a pseudoephedrine or phenyl- enforcement of any State or local law propanolamine drug product is tempo- relating to listed chemicals and con- rarily exempted from the registration trolled substances and is duly author- requirement, provided that the person ized to possess and distribute List I submits a proper application for reg- chemicals in the course of his official istration on or before October 3, 1997. duties. The exemption will remain in effect for (b) Any official exempted by this sec- each person who has made such appli- tion may, when acting in the course of cation until the Administration has ap- official duties, possess any List I chem- proved or denied that application. This ical and distribute any such chemical exemption applies only to registration; to any other official who is also ex- all other chemical control require- empted by this section and acting in ments set forth in this part 1309 and the course of official duties. parts 1310 and 1313 of this chapter remain in full force and effect. [60 FR 32454, June 22, 1995, as amended at 81 FR 97021, Dec. 30, 2016] (c) Each person required by sections 302 or 1007 of the Act (21 U.S.C. 822 or APPLICATION FOR REGISTRATION 957) to obtain a registration to manufacture or import prescription drug § 1309.31 Time for application for reg- products containing ephedrine, istration; expiration date. pseudoephedrine, or phenylpropanola- (a) Any person who is required to be mine is temporarily exempted from the registered and who is not so registered registration requirement, provided may apply for registration at any time. that the person submits a proper appli- No person required to be registered cation for registration on or before shall engage in any activity for which March 3, 2010. The exemption will reregistration is required until the appli- main in effect for each person who has cation for registration is approved and made such application until the Ad- a Certificate of Registration is issued ministration has approved or denied by the Administrator to such person. 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.

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(c) At the time a person is first reg- any List I chemical not specified in his istered, that person shall be assigned or her application. to one of twelve groups, which shall (f) Each application shall include all correspond to the months of the year. information called for in the form, un- The expiration date of the registra- less the item is not applicable, in tions of all registrants within any which case this fact shall be indicated. group will be the last day of the month (g) Each application, attachment, or designated for that group. In assigning other document filed as part of an ap- any of the above persons to a group, plication, shall be signed by the appli- the Administration may select a group cant, if an individual; by a partner of the expiration date of which is less the applicant, if a partnership; or by an than one year from the date such busi- officer of the applicant, if a corpora- ness activity was registered. If the per- tion, corporate division, association, son is assigned to a group which has an trust or other entity. An applicant may expiration date less than eleven authorize one or more individuals, who months from the date of which the per- would not otherwise be authorized to son is registered, the registration shall do so, to sign applications for the ap- not expire until one year from that ex- plicant by filing with the application piration date; in all other cases, the or other document a power of attorney registration shall expire on the expira- for each such individual. The power of tion date following the date on which attorney shall be signed by a person the person is registered. who is authorized to sign applications under this paragraph and shall contain § 1309.32 Application forms; contents; the signature of the individual being signature. authorized to sign the application or (a) Any person who is required to be other document. The power of attorney registered pursuant to § 1309.21 and is shall be valid until revoked by the ap- not so registered, shall apply on DEA plicant. Form 510. [60 FR 32454, June 22, 1995, as amended at 75 (b) Any person who is registered pur- FR 10680, Mar. 9, 2010; 81 FR 97021, Dec. 30, suant to Section 1309.21, shall apply for 2016] reregistration on DEA Form 510a. (c) DEA Form 510 may be obtained at § 1309.33 Filing of application; joint filings. any divisional office of the Administra- tion or by writing to the Registration (a) All applications for registration Section, Drug Enforcement Adminis- shall be submitted for filing to the tration. See the Table of DEA Mailing Registration Section, Drug Enforce- Addresses in § 1321.01 of this chapter for ment Administration. See the Table of the current mailing address. DEA DEA Mailing Addresses in § 1321.01 of Form 510a will be mailed to each List I this chapter for the current mailing ad- chemical registrant approximately 60 dress. The appropriate registration fee days before the expiration date of his and any required attachments must ac- or her registration; if any registered company the application. person does not receive such forms (b) Any person required to obtain within 45 days before the expiration more than one registration may submit date of the registration, notice must be all applications in one package. Each promptly given of such fact and DEA application must be complete and must Form 510a must be requested by writ- not refer to any accompanying applica- ing to the Registration Section of the tion for required information. Administration at the foregoing ad- [60 FR 32454, June 22, 1995, as amended at 75 dress. FR 10680, Mar. 9, 2010] (d) Each application for registration must include the Administration § 1309.34 Acceptance for filing; defec- Chemical Code Number, as set forth in tive applications. § 1310.02 of this chapter, for each List I (a) Applications submitted for filing chemical to be manufactured, distrib- are dated upon receipt. If found to be uted, imported, or exported. complete, the application will be ac- (e) Registration shall not entitle a cepted for filing. Applications failing person to engage in any activity with to comply with the requirements of

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this part will not generally be accepted ACTION ON APPLICATIONS FOR REGISTRA- for filing. In the case of minor defects TION: REVOCATION OR SUSPENSION OF as to completeness, the Administrator REGISTRATION may accept the application for filing with a request to the applicant for ad- § 1309.41 Administrative review gen- ditional information. A defective appli- erally. cation will be returned to the applicant The Administrator may inspect, or within 10 days of receipt with a state- cause to be inspected, the establishment of the reason for not accepting ment of an applicant or registrant, pur- the application for filing. A defective suant to subpart A of part 1316 of this application may be corrected and re- chapter. The Administrator shall resubmitted for filing at any time. view the application for registration (b) Accepting an application for fil- and other information gathered by the ing does not preclude any subsequent Administrator regarding an applicant request for additional information pur- in order to determine whether the ap- suant to § 1309.35 and has no bearing on plicable standards of Section 303 of the whether the application will be grant- Act (21 U.S.C. 823) have been met by ed. the applicant.

§ 1309.35 Additional information. § 1309.42 Certificate of registration; The Administrator may require an denial of registration. applicant to submit such documents or (a) The Administrator shall issue a written statements of fact relevant to Certificate of Registration (DEA Form the application as he deems necessary 511) to an applicant if the issuance of to determine whether the application registration or reregistration is re- should be granted. The failure of the quired under the applicable provisions applicant to provide such documents or of section 303 of the Act (21 U.S.C. 823). statements within a reasonable time In the event that the issuance of reg- after being requested to do so shall be istration or reregistration is not re- deemed to be a waiver by the applicant quired, the Administrator shall deny of an opportunity to present such docu- the application. Before denying any ap- ments or facts for consideration by the plication, the Administrator shall issue Administrator in granting or denying an order to show cause pursuant to the application. Section 1309.46 and, if requested by the applicant, shall hold a hearing on the § 1309.36 Amendments to and with- application pursuant to § 1309.51. drawals of applications. (b) The Certificate of Registration (a) An application may be amended (DEA Form 511) shall contain the or withdrawn without permission of name, address, and registration num- the Administration at any time before ber of the registrant, the activity au- the date on which the applicant re- thorized by the registration, the ceives an order to show cause pursuant amount of fee paid, and the expiration to § 1309.46. An application may be date of the registration. The registrant amended or withdrawn with permission shall maintain the certificate of reg- of the Administrator at any time istration at the registered location in a where good cause is shown by the ap- readily retrievable manner and shall plicant or where the amendment or permit inspection of the certificate by withdrawal is in the public interest. any official, agent or employee of the (b) After an application has been ac- Administration or of any Federal, cepted for filing, the request by the ap- State, or local agency engaged in en- plicant that it be returned or the fail- forcement of laws relating to List I ure of the applicant to respond to offi- chemicals or controlled substances. cial correspondence regarding the application, including a request that the § 1309.43 Suspension or revocation of applicant submit the required fee, registration. when sent by registered or certified (a) The Administrator may suspend mail, return receipt requested, shall be any registration pursuant to section deemed to be a withdrawal of the appli- 304(a) of the Act (21 U.S.C. 824(a)) for cation. any period of time he determines.

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(b) The Administrator may revoke which are affected by the revocation or any registration pursuant to section suspension; or 304(a) of the Act (21 U.S.C. 824(a)). (2) Place all of such chemicals under (c) Before revoking or suspending any seal as described in section 304(f) of the registration, the Administrator shall Act (21 U.S.C. 824(f)). issue an order to show cause pursuant [60 FR 32454, June 22, 1995, as amended at 62 to Section 1309.46 and, if requested by FR 5916, Feb. 10, 1997] the registrant, shall hold a hearing pursuant to Section 1309.51. Notwith- § 1309.44 Suspension of registration standing the requirements of this Sec- pending final order. tion, however, the Administrator may (a) The Administrator may suspend suspend any registration pending a any registration simultaneously with final order pursuant to § 1309.44. or at any time subsequent to the serv- (d) Upon service of the order of the ice upon the registrant of an order to Administrator suspending or revoking show cause why such registration registration, the registrant shall im- should not be revoked or suspended, in mediately deliver his or her Certificate any case where he finds that there is of Registration to the nearest office of an imminent danger to the public the Administration. Also, upon service health or safety. If the Administrator of the order of the Administrator re- so suspends, he shall serve with the voking or suspending registration, the order to show cause pursuant to registrant shall, as instructed by the § 1309.46 an order of immediate suspen- Administrator: sion that shall contain a statement of (1) Deliver all List I chemicals in his his findings regarding the danger to or her possession that were obtained public health or safety. under the authority of a registration or (b) Upon service of the order of im- an exemption from registration grant- mediate suspension, the registrant ed by the Administrator by regulation, shall promptly return his Certificate of to the nearest office of the Administra- Registration to the nearest office of tion or to authorized agents of the Ad- the Administration. Also, upon service ministration; or of the order of immediate suspension, (2) Place all such List I chemicals in the registrant shall, as instructed by his or her possession under seal as de- the Administrator: scribed in section 304(f) of the Act (21 (1) Deliver to the nearest office of the U.S.C. 824(f)). Administration or to authorized agents (e) In the event that revocation or of the Administration all of the par- suspension is limited to a particular ticular chemical or chemicals in his or chemical or chemicals, the registrant her possession that were obtained shall be given a new Certificate of Reg- under the authority of a registration or istration for all substances not affected an exemption from registration grant- by such revocation or suspension; no ed by the Administrator by regulation, fee shall be required for the new Cer- which are affected by the revocation or tificate of Registration. The registrant suspension; or shall deliver the old Certificate of Reg- (2) Place all of such chemicals under istration to the nearest office of the seal as described in section 304(f) of the Administration. Also, upon service of Act (21 U.S.C. 824(f)). 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,

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which request shall be granted by the (c) The order to show cause shall call Administrator, who shall fix a date for upon the applicant or registrant to ap- such hearing as early as reasonably pear before the Administrator at a possible. time and place stated in the order, which shall not be less than 30 days [60 FR 32454, June 22, 1995, as amended at 62 after the date of receipt of the order. FR 5916, Feb. 10, 1997] The order to show cause shall also con- § 1309.45 Extension of registration tain a statement of the legal basis for pending final order. such hearing and for the denial, revocation, or suspension of registration and In the event that an applicant for re- a summary of the matters of fact and registration (who is doing business law asserted. under a registration previously granted (d) Upon Receipt of an order to show and not revoked or suspended) has ap- cause, the applicant or registrant plied for reregistration at least 45 days must, if he desires a hearing, file a re- before the date on which the existing quest for a hearing pursuant to registration is due to expire, and the § 1309.53. If a hearing is requested, the Administrator has issued no order on Administrator shall hold a hearing at the application on the date on which the time and place stated in the order, the existing registration is due to ex- pursuant to § 1309.51. pire, the existing registration of the (e) When authorized by the Adminis- applicant shall automatically be ex- trator, any agent of the Administra- tended and continue in effect until the tion may serve the order to show date on which the Administrator so cause. issues his order. The Administrator [60 FR 32454, June 22, 1995, as amended at 81 may extend any other existing reg- FR 97021, Dec. 30, 2016] istration under the circumstances contemplated in this section even though HEARINGS the registrant failed to apply for reregistration at least 45 days before expira- § 1309.51 Hearings generally. tion of the existing registration, with (a) In any case where the Adminis- or without request by the registrant, if trator shall hold a hearing on any reg- the Administrator finds that such ex- istration or application therefore, the tension is not inconsistent with the procedures for such hearing shall be public health and safety. governed generally by the adjudication procedures set forth in the Administra- § 1309.46 Order to show cause. tive Procedure Act (5 U.S.C. 551–559) (a) If, upon examination of the appli- and specifically by sections 303 and 304 cation for registration from any appli- of the Act (21 U.S.C. 823–824), by cant and other information gathered §§ 1309.52 through 1309.55, and by the by the Administration regarding the procedures for administrative hearings applicant, the Administrator is unable under the Act set forth in §§ 1316.41 to make the determinations required through 1316.67 of this chapter. by the applicable provisions of section (b) Any hearing under this part shall 303 of the Act (21 U.S.C. 823) to register be independent of, and not in lieu of, the applicant, the Administrator shall criminal prosecutions or other pro- serve upon the applicant an order to ceedings under the Act or any other show cause why the application for reg- law of the United States. istration should not be denied. [60 FR 32454, June 22, 1995, as amended at 81 (b) If, upon information gathered by FR 97021, Dec. 30, 2016] the Administration regarding any registrant, the Administrator determines § 1309.52 Purpose of hearing. that the registration of such registrant If requested by a person entitled to a is subject to suspension or revocation hearing, the Administrator shall hold a pursuant to section 304 of the Act (21 hearing for the purpose of receiving U.S.C. 824), the Administrator shall factual evidence regarding the issues serve upon the registrant an order to involved in the denial, revocation, or show cause why the registration should suspension of any registration. Exten- not be revoked or suspended. sive argument should not be offered

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into evidence but rather presented in section 304(a) of the Act (21 U.S.C. opening or closing statements of coun- 824(a)) are satisfied. sel or in memoranda or proposed findings of fact and conclusions of law. [60 FR 32454, June 22, 1995. Redesignated at 62 FR 13968, Mar. 24, 1997]

§ 1309.53 Request for hearing or ap- § 1309.55 Time and place of hearing. pearance; waiver. The hearing will commence at the (a) Any person entitled to a hearing place and time designated in the order pursuant to §§ 1309.42 and 1309.43 and de- to show cause or notice of hearing pub- siring a hearing shall, within 30 days lished in the FEDERAL REGISTER (unless after the date of receipt of the order to expedited pursuant to Section show cause, file with the Adminis- 1309.44(c)) but thereafter it may be trator a written request for a hearing moved to a different place and may be in the form prescribed in § 1316.47 of continued from day to day or recessed this chapter. to a later day without notice other (b) Any person entitled to a hearing than announcement thereof by the pre- pursuant to §§ 1309.42 and 1309.43 may, siding officer at the hearing. within the period permitted for filing a request for a hearing, file with the Ad- [60 FR 32454, June 22, 1995. Redesignated at 62 ministrator a waiver of an opportunity FR 13968, Mar. 24, 1997] for a hearing, together with a written statement regarding his position on MODIFICATION, TRANSFER AND the matters of fact and law involved in TERMINATION OF REGISTRATION such hearing. Such statement, if admissible, shall be made a part of the § 1309.61 Modification in registration. record and shall be considered in light Any registrant may apply to modify of the lack of opportunity for cross-ex- his or her registration to authorize the amination in determining the weight handling of additional List I chemicals to be attached to matters of fact as- or to change his or her name or ad- serted therein. dress, by submitting a letter of request (c) If any person entitled to a hearing to the Registration Section, Drug En- pursuant to §§ 1309.42 and 1309.43 fails to forcement Administration. See the file a request for a hearing, or if he so Table of DEA Mailing Addresses in files and fails to appear at the hearing, § 1321.01 of this chapter for the current he shall be deemed to have waived his mailing address. The letter shall con- opportunity for the hearing, unless he tain the registrant’s name, address, shows good cause for such failure. and registration number as printed on (d) If any person entitled to a hearing the certificate of registration, and the waives or is deemed to waive his or her List I chemicals to be added to his reg- opportunity for the hearing, the Ad- istration or the new name or address ministrator may cancel the hearing, if and shall be signed in accordance with scheduled, and issue his final order pur- § 1309.32(g). No fee shall be required to suant to § 1309.57 without a hearing. be paid for the modification. The request for modification shall be handled [60 FR 32454, June 22, 1995. Redesignated at 62 in the same manner as an application FR 13968, Mar. 24, 1997] for registration. If the modification in § 1309.54 Burden of proof. registration is approved, the Adminis- 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. 823) are not satisfied. [75 FR 10680, Mar. 9, 2010] (b) At any hearing for the revocation or suspension of a registration, the Ad- § 1309.62 Termination of registration. ministration shall have the burden of (a) The registration of any person proving that the requirements for such shall terminate, without any further revocation or suspension pursuant to action by the Administration, if and

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when such person dies, ceases legal ex- sealed in such a manner as to indicate istence, discontinues business or pro- any attempts at tampering with the fessional practice, or surrenders a reg- container. Where chemicals cannot be istration. Any registrant who ceases stored in sealed containers, access to legal existence or discontinues busi- the chemicals should be controlled ness or professional practice shall through physical means or through promptly notify the Special Agent in human or electronic monitoring. Charge of the Administration in the (b) In evaluating the effectiveness of area in which the person is located of security controls and procedures, the such fact and seek authority and in- Administrator shall consider the fol- structions to dispose of any List I lowing factors: chemicals obtained under the authority of that registration. Any registrant (1) The type, form, and quantity of who ceases legal existence or discon- List I chemicals handled; tinues business or professional practice (2) The location of the premises and or wishes to surrender a registration the relationship such location bears on shall notify the Special Agent in the security needs; Charge of the Administration in the (3) The type of building construction area in which the person is located of comprising the facility and the general such fact and seek authority and in- characteristics of the building or build- structions to dispose of any List I ings; chemicals obtained under the author- (4) The availability of electronic de- ity of that registration. tection and alarm systems; (b) The Special Agent in Charge shall (5) The extent of unsupervised public authorize and instruct the person to access to the facility; dispose of the List I chemical in one of (6) The adequacy of supervision over the following manners: employees having access to List I (1) By transfer to person registered chemicals; under the Act and authorized to possess the substances; (7) The procedures for handling busi- (2) By delivery to an agent of the Ad- ness guests, visitors, maintenance per- ministration or to the nearest office of sonnel, and nonemployee service per- the Administration; sonnel in areas where List I chemicals (3) By such other means as the Spe- are processed or stored; and cial Agent in Charge may determine to (8) The adequacy of the registrant’s assure that the substance does not be- or applicant’s systems for monitoring come available to unauthorized per- the receipt, distribution, and disposi- sons. tion of List I chemicals in its oper- [60 FR 32454, June 22, 1995, as amended at 62 ations. FR 5916, Feb. 10, 1997; 76 FR 61564, Oct. 5, 2011; (c) Any registrant or applicant desir- 77 FR 4236, Jan. 27, 2012] ing to determine whether a proposed system of security controls and proce- § 1309.63 Transfer of registration. dures is adequate may submit mate- No registration or any authority con- rials and plans regarding the proposed ferred thereby shall be assigned or oth- security controls and procedures either erwise transferred except upon such to the Special Agent in Charge in the conditions as the Administrator may region in which the security controls specifically designate and then only and procedures will be used, or to the pursuant to his written consent. Regulatory Section, Drug Enforcement Administration. See the Table of DEA SECURITY REQUIREMENTS Mailing Addresses in § 1321.01 of this § 1309.71 General security require- chapter for the current mailing ad- ments. dress. (a) All applicants and registrants [60 FR 32454, June 22, 1995, as amended at 62 must provide effective controls and FR 13968, Mar. 24, 1997; 67 FR 14861, Mar. 28, procedures to guard against theft and 2002; 71 FR 56023, Sept. 26, 2006; 75 FR 10680, diversion of List I chemicals. Chemi- Mar. 9, 2010; 81 FR 97021, Dec. 30, 2016] cals must be stored in containers

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§ 1309.72 Felony conviction; employer his employer by a fellow employee has responsibilities. an obligation to report such informa- (a) The registrant shall exercise cau- tion to a responsible security official of tion in the consideration of employ- the employer. The employer shall treat ment of persons who will have access such information as confidential and to listed chemicals, who have been con- shall take all reasonable steps to pro- victed of a felony offense relating to tect the confidentiality of the informa- controlled substances or listed chemi- tion and the identity of the employee cals, or who have, at any time, had an furnishing information. A failure to re- application for registration with the port information of chemical diversion DEA denied, had a DEA registration re- will be considered in determining the voked, or surrendered a DEA registra- feasibility of continuing to allow an tion for cause. (For purposes of this employee to work in an area with ac- subsection, the term ‘‘for cause’’ means cess to chemicals. The employer shall a surrender in lieu of, or as a con- inform all employees concerning this sequence of, any Federal or State ad- policy. ministrative, civil or criminal action resulting from an investigation of the PART 1310—RECORDS AND RE- individual’s handling of controlled sub- PORTS OF LISTED CHEMICALS stances or listed chemicals.) The reg- AND CERTAIN MACHINES; IM- istrant should be aware of the cir- PORTATION AND EXPORTATION cumstances regarding the action OF CERTAIN MACHINES against the potential employee and the rehabilitative efforts following the ac- Sec. tion. The registrant shall assess the 1310.01 Definitions. risks involved in employing such per- 1310.02 Substances covered. sons, including the potential for action 1310.03 Persons required to keep records and against the registrant pursuant to file reports. § 1309.43, If such person is found to have 1310.04 Maintenance of records. diverted listed chemicals, and, in the 1310.05 Reports. 1310.06 Content of records and reports. event of employment, shall institute 1310.07 Proof of identity. procedures to limit the potential for 1310.08 Excluded transactions. diversion of List I chemicals. 1310.09 Temporary exemption from registra- (b) It is the position of DEA that em- tion. ployees who possess, sell, use or divert 1310.10 Removal of the exemption of drugs listed chemicals or controlled sub- distributed under the Federal Food, Drug stances will subject themselves not and Cosmetic Act. 1310.11 Reinstatement of exemption for drug only to State or Federal prosecution products distributed under the Food, for any illicit activity, but shall also Drug and Cosmetic Act. immediately become the subject of 1310.12 Exempt chemical mixtures. independent action regarding their 1310.13 Exemption of chemical mixtures; ap- continued employment. The employer plication. will assess the seriousness of the em- 1310.14 Removal of exemption from definition of regulated transaction. ployee’s violation, the position of re- 1310.15 Exempt drug products containing sponsibility held by the employee, past ephedrine and therapeutically significant record of employment, etc., in deter- quantities of another active medicinal mining whether to suspend, transfer, ingredient. terminate or take other action against 1310.21 Sale by Federal departments or the employee. agencies of chemicals which could be used to manufacture controlled sub- § 1309.73 Employee responsibility to stances. report diversion. AUTHORITY: 21 U.S.C. 802, 827(h), 830, 871(b) Reports of listed chemical diversion 890. by fellow employees is not only a nec- SOURCE: 54 FR 31665, Aug. 1, 1989, unless essary part of an overall employee se- otherwise noted. curity program but also serves the public interest at large. It is, therefore, § 1310.01 Definitions. the position of DEA that an employee Any term used in this part shall have who has knowledge of diversion from the definition set forth in section 102 of

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the Act (21 U.S.C. 802) or part 1300 of (23) Benzaldehyde ...... 8256 this chapter. (24) Nitroethane ...... 6724 [62 FR 13968, Mar. 24, 1997] (25) Gamma-Butyrolactone (Other names include: GBL; § 1310.02 Substances covered. Dihydro-2 (3H)-furanone; 1,2- The following chemicals have been Butanolide; 1,4-Butanolide; 4- specifically designated by the Adminis- Hydroxybutanoic acid lactone; trator of the Drug Enforcement Admin- gamma-hydroxybutyric acid istration as the listed chemicals sub- lactone) ...... 2011 ject to the provisions of this part and (26) Red phosphorus ...... 6795 parts 1309 and 1313 of this chapter. Each (27) White phosphorus (Other chemical has been assigned the DEA names: Yellow Phosphorus) .... 6796 Chemical Code Number set forth oppo- (28) Hypophosphorous acid and site it. its salts (Including ammonium (a) List I chemicals hypophosphite, calcium hypophosphite, iron (1) Alpha- hypophosphite, potassium phenylacetoacetonitrile and hypophosphite, manganese its salts, optical isomers, and hypophosphite, magnesium salts of optical isomers hypophosphite and sodium (APAAN) ...... 8512 hypophosphite) ...... 6797 (2) Anthranilic acid, its esters, (29) N-phenethyl-4-piperidone and its salts ...... 8530 (NPP) ...... 8332 (3) Benzyl cyanide ...... 8735 (30) Iodine ...... 6699 (4) Ephedrine, its salts, optical (31) Ergocristine and its salts .... 8612 isomers, and salts of optical isomers ...... 8113 (b) List II chemicals: (5) Ergonovine and its salts ...... 8675 (1) Acetic anhydride ...... 8519 (6) Ergotamine and its salts ...... 8676 (2) Acetone ...... 6532 (7) N-Acetylanthranilic acid, its (3) Benzyl chloride ...... 8570 esters, and its salts ...... 8522 (4) Ethyl ether ...... 6584 (8) Norpseudoephedrine, its (5) Potassium permanganate ..... 6579 salts, optical isomers, and (6) 2-Butanone (or Methyl Ethyl salts of optical isomers ...... 8317 Ketone or MEK) ...... 6714 (9) Phenylacetic acid, its esters, (7) Toluene ...... 6594 and its salts ...... 8791 (8) Hydrochloric acid (including (10) Phenylpropanolamine, its anhydrous hydrogen chloride) 6545 salts, optical isomers, and (9) Sulfuric acid ...... 6552 salts of optical isomers ...... 1225 (10) Methyl Isobutyl Ketone (11) Piperidine and its salts ...... 2704 (MIBK) ...... 6715 (12) Pseudoephedrine, its salts, (11) Sodium Permanganate ...... 6588 optical isomers, and salts of optical isomers ...... 8112 (c) The Administrator may add or de- (13) 3,4-Methylenedioxyphenyl-2- lete a substance as a listed chemical by propanone ...... 8502 publishing a final rule in the FEDERAL (14) Methylamine and its salts ... 8520 REGISTER following a proposal which (15) Ethylamine and its salts ..... 8678 shall be published at least 30 days prior (16) Propionic anhydride ...... 8328 to the final rule. (17) Isosafrole ...... 8704 (d) Any person may petition the Ad- (18) Safrole ...... 8323 ministrator to have any substance (19) Piperonal ...... 8750 added or deleted from paragraphs (a) or (20) N-Methylephedrine, its (b) of this section. salts, optical isomers, and (e) Any petition under this section salts of optical isomers (N- shall contain the following informa- Methylephedrine) ...... 8115 tion: (21) N-Methylpseudoephedrine, (1) The name and address of the peti- its salts, optical isomers, and tioner; salts of optical isomers ...... 8119 (2) The name of the chemical to (22) Hydriodic Acid ...... 6695 which the petition pertains; 149

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(3) The name and address of the man- shall keep a record of the transaction ufacturer(s) of the chemical (if known); as specified by § 1310.04 and file reports (4) A complete statement of the facts as specified by § 1310.05. However, a which the petitioner believes justifies non-regulated person who acquires list- the addition or deletion of the sub- ed chemicals for internal consumption stance from paragraphs (a) or (b) of or ‘‘end use’’ and becomes a regulated this section; person by virtue of infrequent or rare (5) The date of the petition. distribution of a listed chemical from (f) The Administrator may require inventory, shall not be required to the petitioner to submit such docu- maintain receipt records of listed ments or written statements of fact relevant to the petition as he deems chemicals under this section. necessary in making a determination. (b) Each regulated person who manu- (g) Within a reasonable period of factures a List I or List II chemical time after the receipt of the petition, shall file reports regarding such manu- the Administrator shall notify the pe- facture as specified in § 1310.05. titioner of his decision and the reason (c)(1) Each regulated person who en- therefor. The Administrator need not gages in a transaction with a nonregu- accept a petition if any of the require- lated person which: ments prescribed in paragraph (e) of (i) Involves ephedrine, this section or requested pursuant to pseudoephedrine, phenylpropanola- paragraph (f) of this section are lack- mine, or gamma hydroxybutyric acid ing or are not clearly set forth as to be (including drug products containing readily understood. If the petitioner these chemicals or controlled sub- desires, he may amend and resubmit stance); and the petition to meet the requirements of paragraphs (e) and (f) of this section. (ii) Uses or attempts to use the U.S. (h) If a petition is granted or the Ad- Postal Service or any private or com- ministrator, upon his own motion, pro- mercial carrier must, on a monthly poses to add or delete substances as basis, report to the Administration listed chemicals as set forth in para- each such transaction conducted dur- graph (c) of this section, he shall issue ing the previous month as specified in and publish in the FEDERAL REGISTER a §§ 1310.05(e) and 1310.06(k) on DEA Form proposal to add or delete a substance as 453 through the DEA Diversion Control a listed chemical. The Administrator Division secure network application. shall permit any interested person to (2) Each regulated person who en- file written comments regarding the gages in an export transaction which: proposal within 30 days of the date of (i) Involves ephedrine, publication of his order in the FEDERAL pseudoephedrine, phenylpropanola- REGISTER. The Administrator will con- mine, or gamma hydroxybutyric acid sider any comments filed by interested (including drug products containing persons and publish a final rule in ac- these chemicals or controlled sub- cordance with his decision in the mat- stance); and ter. (ii) Uses or attempts to use the U.S. [54 FR 31665, Aug. 1, 1989, as amended at 56 Postal Service or any private or com- FR 48733, Sept. 26, 1991; 57 FR 43615, Sept. 22, mercial carrier must, on a monthly 1992; 60 FR 19510, Apr. 19, 1995; 60 FR 32460, June 22, 1995; 62 FR 5917, Feb. 10, 1997; 65 FR basis, report each such transaction 21647, Apr. 24, 2000; 65 FR 47316, Aug. 2, 2000; conducted during the previous month 66 FR 52675, Oct. 17, 2001; 71 FR 60826, Oct. 17, as specified in §§ 1310.05(e) and 1310.06(k) 2006; 72 FR 20046, Apr. 23, 2007; 72 FR 35391, on DEA Form 453 through the DEA Di- July 2, 2007; 72 FR 40238, July 24, 2007; 76 FR version Control Division secure net- 17781, Mar. 31, 2011; 82 FR 32460, July 14, 2017] work application. § 1310.03 Persons required to keep [54 FR 31665, Aug. 1, 1989, as amended at 56 records and file reports. FR 8277, Feb. 28, 1991; 61 FR 14023, Mar. 29, (a) Each regulated person who en- 1996; 67 FR 14861, Mar. 28, 2002; 68 FR 57804, gages in a regulated transaction in- Oct. 7, 2003; 70 FR 294, Jan. 4, 2005; 81 FR volving a listed chemical, a tableting 97022, Dec. 30, 2016] machine, or an encapsulating machine

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§ 1310.04 Maintenance of records. trievable and available for inspection (a) Every record required to be kept and copying by authorized employees subject to § 1310.03 for a List I chem- of the Administration under the provi- ical, a tableting machine, or an encap- sions of 21 U.S.C. 880. sulating machine shall be kept by the (e) The regulated person with more regulated person for 2 years after the than one place of business where date of the transaction. records are required to be kept shall (b) Every record required to be kept devise a system to detect any party subject to Section 1310.03 for List II purchasing from several individual lo- chemical shall be kept by the regulated cations of the regulated person thereby person for two years after the date of seeking to avoid the application of the the transaction. cumulative threshold or evading the (c) A record under this section shall requirements of the Act. be kept at the regulated person’s place (f) For those listed chemicals for of business where the transaction oc- which thresholds have been estab- curred, except that records may be lished, the quantitative threshold or kept at a single, central location of the the cumulative amount for multiple regulated person if the regulated per- transactions within a calendar month, son has notified the Administration of to be utilized in determining whether a the intention to do so. Written notification must be submitted by registered receipt, sale, importation or expor- or certified mail, return receipt re- tation is a regulated transaction is as quested, to the Special Agent in Charge follows: of the DEA Divisional Office for the (1) List I chemicals: area in which the records are required (i) Except as provided in paragraph to be kept. (f)(1)(ii) of this section, the following (d) The records required to be kept thresholds have been established for under this section shall be readily re- List I chemicals.

Code Chemical Threshold by base weight

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

(ii) For List I chemicals that are con- 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

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Chemical Threshold by volume Threshold by weight

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

(ii) Domestic Sales

Chemical Threshold by volume Threshold by weight

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

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

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(h) The thresholds and conditions in becomes aware of the circumstances of paragraphs (f) and (g) of this section the event. will apply to transactions involving (2) Each regulated person must re- regulated chemical mixtures. For pur- port to the Special Agent in Charge of poses of determining whether the the DEA Divisional Office for the area weight or volume of a chemical mix- in which the regulated person making ture meets or exceeds the applicable the report is located any proposed reg- quantitative threshold, the following ulated transaction with a person whose rules apply: description or other identifying char- (1) For chemical mixtures containing acteristic the Administration has pre- List I chemicals or List II chemicals viously furnished to the regulated per- other than those in paragraph (h)(2) of son. The regulated person will orally this section, the threshold is deter- report to the Special Agent in Charge mined by the weight of the listed of the DEA Divisional Office at the ear- chemical in the chemical mixture. (2) For the List II chemicals acetone, liest practicable opportunity after the ethyl ether, 2-butanone, toluene, and regulated person becomes aware of the methyl isobutyl ketone, the threshold circumstances involved. A transaction is determined by the weight of the en- may not be completed with a person tire chemical mixture. whose description or identifying char- (3) If two or more listed chemicals acteristic has previously been fur- are present in a chemical mixture, and nished to the regulated person by the the quantity of any of these chemicals Administration unless the transaction equals or exceeds the threshold appli- is approved by the Administration. cable to that chemical, then the trans- (b)(1) Each regulated person must re- action is regulated. port to the Special Agent in Charge of the DEA Divisional Office for the area [54 FR 31665, Aug. 1, 1989] in which the regulated person making EDITORIAL NOTE: For FEDERAL REGISTER ci- the report is located any unusual or ex- tations affecting § 1310.04, see the List of CFR cessive loss or disappearance of a listed Sections Affected, which appears in the Finding Aids section of the printed volume chemical under the control of the regu- and at www.fdsys.gov. lated person. The regulated person will orally report to the Special Agent in § 1310.05 Reports. Charge of the DEA Divisional Office at (a)(1) Each regulated person must re- the earliest practicable opportunity port to the Special Agent in Charge of after the regulated person becomes the DEA Divisional Office for the area aware of the circumstances involved. in which the regulated person making Unless the loss or disappearance occurs the report is located any regulated during an import or export trans- transaction involving an extraordinary action, the supplier is responsible for quantity of a listed chemical, an un- reporting all in-transit losses of any common method of payment or deliv- listed chemical by their agent or the ery, or any other circumstance that common or contract carrier. In an im- the regulated person believes may indi- port transaction, once a shipment has cate that the listed chemical will be been released by the customs officer at used in violation of this part. The regu- the port of entry, the importer is related person will orally report to the sponsible for reporting all in-transit Special Agent in Charge of the DEA Di- losses of any listed chemical by their visional Office at the earliest prac- agent or the common or contract car- ticable opportunity after the regulated rier. In an export transaction, the ex- person becomes aware of the cir- porter is responsible for reporting all cumstances involved and as much in in-transit losses of any listed chemical advance of the conclusion of the trans- by their agent or the common or con- action as possible. The regulated per- tract carrier until the shipment has son must file a written report of the been released by the customs officer at transaction(s) with the Special Agent the port of export. The regulated per- in Charge of the DEA Divisional Office son must also file a complete and accu- as set forth in § 1310.06 within 15 cal- rate DEA Form 107, in accordance with endar days after the regulated person § 1310.06(d), with the Administration

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through the DEA Diversion Control Di- The report will not be deemed filed vision secure network application until a transaction identification num- within 15 calendar days after becoming ber has been issued by the Administra- aware of the circumstances requiring tion. the report. Unusual or excessive losses (c) Imports and exports of tableting ma- or disappearances must be reported chines and encapsulating machines. (1) whether or not the listed chemical is Each regulated person who imports or subsequently recovered or the respon- exports a tableting machine, or encap- sible parties are identified and action sulating machine, must file a report of taken against them. When determining such importation or exportation on whether a loss or disappearance of a DEA Form 452 with the Administration listed chemical was unusual or exces- through the DEA Diversion Control Di- sive, the regulated persons should con- vision secure network application, at sider, among others, the following fac- least 15 calendar days before the antici- tors: pated arrival at the port of entry or (i) The actual quantity of a listed port of export. In order to facilitate the chemical; importation or exportation of any (ii) The specific listed chemical in- tableting machine or encapsulating volved; machine and implement the purpose of (iii) Whether the loss or disappear- the Act, regulated persons may report ance of the listed chemical can be asso- to the Administration as far in advance ciated with access to those listed as possible. A separate report (DEA chemicals by specific individuals, or Form 452) must be filed for each ship- whether the loss or disappearance can ment, in accordance with § 1310.06(e). be attributed to unique activities that Upon receipt and review, the Adminis- may take place involving the listed tration will assign a completed report chemical; and a transaction identification number. (iv) A pattern of losses or disappear- The report will not be deemed filed ances over a specific time period, until a transaction identification num- whether the losses or disappearances ber has been issued by the Administra- appear to be random, and the result of tion. The importer or exporter may efforts taken to resolve the losses. only proceed with the transaction once (v) If known, the regulated person the transaction identification number should also consider whether the spe- has been issued. Any tableting machine cific listed chemical was a likely can- or encapsulating machine may be im- didate for diversion as well as local ported or exported if that machine is trends and other indicators of the di- needed for medical, commercial, sci- version potential of the listed chem- entific, or other legitimate uses. How- ical. ever, an importation or exportation of (2) Each regulated person must orally a tableting machine or encapsulating report any domestic regulated trans- machine may not be completed with a action in a tableting machine or an en- person whose description or identifying capsulating machine to the Special characteristic has previously been fur- Agent in Charge of the DEA Divisional nished to the regulated person by the Office for the area in which the regu- Administration unless the transaction lated person making the report is lo- is approved by the Administration. cated when the order is placed with the (2) Denied release at the port of entry. seller. The regulated person also must In the event that a shipment of 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

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through the DEA Diversion Control Di- quantities used for quality control vision secure network application. testing, quantities consumed in-house, Upon the importer’s report of a denied or production losses. Internal consump- entry, DEA will assign the report a tion does not include the quantities of transaction identification number and a listed chemical consumed in the pro- the original import notification will be duction of exempted products. If an ex- void and of no effect. No shipment of isting standard industry report con- tableting machines or encapsulating tains the information required in machines denied entry for any reason § 1310.06(j) and such information is sep- will be allowed entry without a subse- arate or readily retrievable from the quent refiling of an amended DEA report, that report may be submitted Form 452 by the regulated person. In in satisfaction of this requirement. such circumstances, the regulated per- Each report must be submitted to the son may proceed with the release of the DEA under company letterhead and tableting machines or encapsulating signed by an appropriate, responsible machines upon receipt of a transaction official. For purposes of this paragraph identification number for the refiled (d) only, the term regulated bulk man- and amended DEA Form 452 without ufacturer of a listed chemical means a regard to the 15-day advance filing re- person who manufactures a listed quirement in paragraph (c)(1) of this chemical by means of chemical syn- section, so long as the article is other- thesis or by extraction from other sub- wise cleared for entry under U.S. cus- stances. The term bulk manufacturer toms laws. does not include persons whose sole ac- (d) Each regulated bulk manufac- tivity consists of the repackaging or turer of a listed chemical must submit relabeling of listed chemical products manufacturing, inventory and use data or the manufacture of drug dosage on an annual basis as set forth in forms of products which contain a list- § 1310.06(j). This data must be sub- ed chemical. mitted annually to the Drug and Chem- (e) Each regulated person required to ical Evaluation Section, Diversion report pursuant to § 1310.03(c) must file Control Division, Drug Enforcement a report containing the transaction Administration, on or before the 15th identification number for each such day of March of the year immediately transaction (if the regulated person is following the calendar year for which required to obtain a transaction identi- submitted. See the Table of DEA Mail- fication number under part 1313of this ing Addresses in § 1321.01 of this chapter chapter) and information set forth in for the current mailing address. A busi- § 1310.06(k), on or before the 15th day of ness entity which manufactures a list- each month following the month in ed chemical may elect to report sepa- which the distributions took place. rately by individual location or report (f) Except as provided in paragraph as an aggregate amount for the entire (g) of this section, the following dis- business entity provided that they in- tributions to nonregulated persons, and form the DEA of which method they the following export transactions, are will use. This reporting requirement not subject to the reporting require- does not apply to drugs or other prod- ments in § 1310.03(c): ucts that are exempted under para- (1) Distributions of sample packages graph (1)(iv) or (v) of the definition of of drug products when those packages regulated transaction in § 1300.02 of this contain not more than two solid dosage 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

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for a retail distributor as defined in the listed chemical or a description of § 1300.02 of this chapter, except that the tableting machine or encapsulating this paragraph does not apply to sales machine (including make, model, serial of scheduled listed chemical products number, if any, and whether the ma- at retail. chine is manual or electric). (3) Distributions of drug products to (4) The method of transfer (company a resident of a long term care facility truck, picked up by customer, etc.). or distributions of drug products to a (5) The type of identification used by long term care facility for dispensing the purchaser and any unique number to or for use by a resident of that facil- on that identification. ity. (b) For purposes of this section, nor- (4) Distributions of drug products in mal business records will be considered accordance with a valid prescription. adequate if they contain the informa- (5) Exports which have been reported tion listed in paragraph (a) of this sec- to the Administrator under §§ 1313.31 tion and are readily retrievable from and 1313.32 of this chapter or which are other business records of the regulated subject to a waiver granted under person. For prescription drug products, § 1313.21 of this chapter. prescription and hospital records kept (g) The Administrator may revoke in the normal course of medical treat- any or all of the exemptions listed in ment will be considered adequate for paragraph (f) of this section for an indi- satisfying the requirements of para- vidual regulated person if the Adminis- graph (a) of this section with respect to trator finds that drug products distrib- dispensing to patients, and records re- uted by the regulated person are being quired to be maintained pursuant to used in violation of the regulations in the U.S. Food and Drug Administration this chapter or the Controlled Sub- regulations relating to the distribution stances Act. The Administrator will of prescription drugs, as set forth in 21 notify the regulated person of the rev- CFR part 205, will be considered ade- ocation, as provided in § 1313.41(a) of quate for satisfying the requirements this chapter. The revocation will be ef- of paragraph (a) of this section with re- fective upon receipt of the notice by spect to distributions. the person. The regulated person has (c)(1) Each report required by the right to an expedited hearing re- § 1310.05(a) must include the informa- garding the revocation, as provided in tion as specified by paragraph (a) of § 1313.56(a) of this chapter. this section, the basis for making the report, and, where obtainable, the reg- [54 FR 31665, Aug. 1, 1989, as amended at 57 FR 2461, Jan. 22, 1992; 61 FR 14024, Mar. 29, istration number of the other party, if 1996; 61 FR 17958, Apr. 23, 1996; 62 FR 13968, such party is registered. A report of an Mar. 24, 1997; 67 FR 14862, Mar. 28, 2002; 67 FR uncommon method of payment or de- 49569, July 31, 2002; 68 FR 57804, Oct. 7, 2003; livery submitted in accordance with 71 FR 56024, Sept. 26, 2006; 75 FR 10680, Mar. § 1310.05(a)(1) must also include a rea- 9, 2010; 77 FR 4236, Jan. 27, 2012; 81 FR 97022, son why the method of payment or de- Dec. 30, 2016] livery was uncommon. (2) A suggested format for the reports § 1310.06 Content of records and reports. in § 1310.05(a)(1) is provided below: (a) Each record required by Shipping Address (if different than pur- § 1310.03(a) must include the following: chaser Address): (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 registration number of each party to Date of Shipment llllllllllllll the regulated transaction. Description of Listed Chemical: 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

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Any additional pertinent information: lll (v) The intended medical, commer- (d) Each report of an unusual or ex- cial, scientific, or other legitimate use cessive loss or disappearance of a listed of the machine; and chemical required by § 1310.05(b)(1) (on (vi) Any proposed changes in identi- DEA Form 107), must include the fol- fying information of the imported ma- lowing information: chines (e.g., name, brand, serial num- (1) The name/business name, address/ ber, if any, etc.) that will take place business address, and contact informa- after importation. tion (e.g., telephone number(s), email (2) Each report of an exportation of a address (es), etc.), and, if applicable, tableting machine or an encapsulating DEA registration number of each party machine required by § 1310.05(c)(1) (on to the regulated transaction. DEA Form 452) must include the fol- (2) The date (or estimated date) on lowing information: which unusual or excessive loss or dis- (i) The name/business name, address/ appearance occurred, and the actual business address, and contact informa- date on which the unusual or excessive tion (e.g., telephone number(s), email loss or disappearance was discovered by address(es), etc.) of the regulated per- the regulated person. son; the name/business name, address/ (3) The quantity, chemical name, and business address, and contact informa- National Drug Code (NDC) number, if tion (e.g., telephone number(s), email applicable or if not the form of pack- address(es), etc.) of the export broker aging of the listed chemical. (if applicable); (4) The type of business conducted by (ii) A description of each machine the regulated person, (e.g., grocery (including make, model, serial number, store, pharmacy/drug store, discount if any, and whether the machine is department store, warehouse club or manual or electric) and the number of superstore, convenience store, spe- machines being received; cialty food store, gas station, mobile (iii) The anticipated date of arrival retail vendor, mail-order, etc.) if the at the port of export, the foreign port regulated person is not a DEA reg- and country of entry; and istrant. (iv) The name/business name, ad- (e)(1) Each report of an importation dress/business address, and contact in- of a tableting machine or an encap- formation (e.g., telephone number(s), sulating machine required by § 1310.05(c)(1) (on DEA Form 452) must email address(es), etc.) of the consignee include the following information: in the country where the shipment is destined; the name(s)/business name(s) (i) The name/business name, address/ business address, and contact informa- and address(es)/business address(es), tion (e.g., telephone number(s), email and contact information (e.g., tele- address(es), etc.) of the regulated per- phone number(s), email address(es), son; the name/business name, address/ etc.) of the intermediate consignee(s) business address, and contact informa- (if any). tion (e.g., telephone number(s), email (f) Each report of a domestic regu- address(es), etc.) of the import broker lated transaction in a tableting ma- or forwarding agent, if any; chine or encapsulating machine re- (ii) A description of each machine quired by § 1310.05(b)(2) (on DEA Form (including make, model, serial number, 452) must include the following infor- if any, and whether the machine is mation: manual or electric) and the number of (1) The name/business name, address/ machines being received; business address, and contact informa- (iii) The anticipated date of arrival tion (e.g., telephone number(s), email at the port of entry, and the antici- address(es), etc.) of the regulated per- pated port of entry; son; the name/business name, address/ (iv) The name/business name, ad- business address, and contact informa- dress/business address, and contact in- tion (e.g., telephone number(s), email formation (e.g., telephone number(s), address(es), etc.) of the purchaser; email address(es), etc.) of the consignor (2) A description of each machine (in- in the foreign country of exportation; cluding make, model, serial number, if

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any, and whether the machine is man- importation and distribution. For DEA ual or electric) and the number of ma- reporting purposes, import responsibil- chines being received; and ities are concluded upon the receipt of (3) Any changes made by the regu- the machines by the importer. Once lated person in identifying information machines are received by the importer, of the machines (e.g., name, brand, se- domestic transaction reporting re- rial number, etc.). quirements commence. Distributions of (g) Each report of a denied release by tableting and encapsulating machines a customs officer at the port of entry from the importer to their customers of a tableting machine or an encap- must be reported as domestic regulated sulating machine required by transactions in accordance with § 1310.05(c)(2) must include the fol- § 1310.05(b)(2). lowing information: the quantity of (2) Within 30 calendar days after the machines denied release; a concise de- tableting or encapsulating machine is scription of the machines denied re- released by a customs officer at the lease; the date on which release was de- port of export, or within 10 calendar nied; the port where the denial of re- days after receipt of a written request lease was issued from; and the basis for by the Administration to the exporter, the denial. whichever is sooner, the exporter must (h) Return information. (1) Within 30 file a report with the Administration calendar days after actual receipt of a (on DEA Form 452) through the DEA tableting or encapsulating machine, or Diversion Control Division secure net- within 10 calendar days after receipt of work application specifying the par- a written request by the Administra- ticulars of the transaction. This report tion to the importer, whichever is must include the following informa- sooner, the importer must file a report tion: The date on which the machine(s) with the Administration (on DEA was (were) released by a customs offi- Form 452) specifying the particulars of cer at the port of export; the actual the transaction utilizing the DEA Di- quantity of machines released; a de- version Control Division secure net- scription of each tableting or encap- work application. This report must in- sulating machine released (including clude the following information: The date on which a customs officer at the make, model, serial number, if any, port of entry released the machine(s); and whether the machine is manual or the date on which the machine(s) ar- electric); and any other information as rived at the final destination; the port the Administration may from time to of entry where the machine(s) were ac- time specify. tually released by a customs officer; (i) Declared exports of machines the actual quantity of machines re- which are refused, rejected, or other- leased by a customs officer; the actual wise deemed undeliverable may be re- quantity of machines that arrived at turned to the U.S. exporter of record. A the final destination; a description of brief written report outlining the cir- each tableting or encapsulating ma- cumstances must be filed with the Ad- chine imported (including make, ministration through the DEA Diver- model, and serial number, if any); any sion Control Division secure network changes in identifying information of application, following the return at the the imported machines (e.g., name, earliest practicable opportunity after brand, serial number, if any, etc.) that the regulated person becomes aware of will take place after importation; and the circumstances involved. This provi- any other information as the Adminis- sion does not apply to shipments that tration may from time to time specify. have cleared foreign customs, been de- Upon receipt and review, the Adminis- livered, and accepted by the foreign tration will assign a transaction iden- consignee. Returns to third parties in tification number to a completed re- the United States will be regarded as port. The report will not be deemed imports. filed until the Administration has (j) Each annual report required by issued a transaction identification § 1310.05(d) must provide the following number. A single return declaration information for each listed chemical may include the particulars of both the manufactured:

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(1) The name/business name, address/ (4) Chemical name, National Drug business address, and contact informa- Code (NDC) number, if applicable, and tion (e.g., telephone number(s), email total amount shipped. address(es), etc.) and chemical reg- (5) Date of shipment. istration number (if any) of the manu- (6) Product name (if drug product). facturer. (7) Dosage form (if drug product) (2) The aggregate quantity of each (e.g., pill, tablet, liquid). listed chemical that the company man- (8) Dosage strength (if drug product) ufactured during the preceding cal- (e.g., 30mg, 60mg, per dose etc.). endar year. (9) Number of dosage units (if drug (3) The year-end inventory of each product) (e.g., 100 doses per package). listed chemical as of the close of busi- (10) Package type (if drug product) ness on the 31st day of December of (e.g., bottle, blister pack, etc.). each year. (For each listed chemical, if (11) Number of packages (if drug the prior period’s ending inventory has product) (e.g., 10 bottles). not previously been reported to DEA, (12) Lot number (if drug product). this report should also detail the begin- (l) Information provided in reports ning inventory for the period.) For pur- required by § 1310.05(e) which is exempt poses of this requirement, inventory from disclosure under section 552(a) of shall reflect the quantity of listed title 5, by reason of section 552(b)(6) of chemicals, whether in bulk or non-ex- title 5, will be provided the same pro- empt product form, held in storage for tections from disclosure as are pro- later distribution. Inventory does not vided in section 310(c) of the Act (21 include waste material for destruction, U.S.C. 830(c)) for confidential business material stored as an in-process inter- information. mediate or other in-process material. (4) The aggregate quantity of each [81 FR 97023, Dec. 30, 2016] listed chemical used for internal consumption during the preceding cal- § 1310.07 Proof of identity. endar year, unless the chemical is pro- (a) Each regulated person who en- duced solely for internal consumption. gages in a regulated transaction must (5) The aggregate quantity of each identify the other party to the trans- listed chemical manufactured which action. For domestic transaction, this becomes a component of a product ex- shall be accomplished by having the empted from paragraph (1)(iv) or (v) of other party present documents which the definition of regulated transaction would verify the identity, or registra- in § 1300.02 of this chapter during the tion status if a registrant, of the other preceding calendar year. party to the regulated person at the (6) Data shall identify the specific time the order is placed. For export isomer, salt or ester when applicable transactions, this shall be accom- but quantitative data shall be reported plished by good faith inquiry through as anhydrous base or acid in kilogram reasonably available research docu- units of measure. ments or publicly available informa- (k) Each monthly report required by tion which would indicate the exist- §§ 1310.03(c) and 1310.05(e) (on DEA ence of the foreign customer. No proof Form 453) must provide the following of identity is required for foreign sup- information for each transaction: pliers. (1) Supplier name/business name, ad- (b) The regulated person must verify dress/business address, and contact in- the existence and apparent validity of formation (e.g., telephone number(s), a business entity ordering a listed email address(es), etc.) and registra- chemical, tableting machine or encap- tion number. sulating machine. For domestic trans- (2) Purchaser’s name/business name, actions, this may be accomplished by address/business address, and contact such methods as checking the tele- information (e.g., telephone number(s), phone directory, the local credit bu- email address(es), etc.). reau, the local Chamber of Commerce (3) Name/business name, address/busi- or the local Better Business Bureau, or, ness address shipped to (if different if the business entity is a registrant, from purchaser’s name/address). by verification of the registration. For

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export transactions, a good faith in- (f) With respect to electronic orders, quiry to verify the existence and appar- the identity of the purchaser shall con- ent validity of a foreign business entity sist of a computer password, identifica- may be accomplished by such methods tion number or some other means of as verifying the business telephone identification consistent with elec- listing through international telephone tronic orders and with § 1310.07(e). information, the firm’s listing in inter- [54 FR 31665, Aug. 1, 1989, as amended at 60 national or foreign national chemical FR 32461, June 22, 1995] directories or other commerce directories or trade publications, confirma- § 1310.08 Excluded transactions. tion through foreign subsidiaries of the Pursuant to 21 U.S.C. 802(39)(A)(iii), U.S. regulated person, verification regulation of the following trans- through the country of destination’s actions has been determined to be un- embassy Commercial Attache, or offi- necessary for the enforcement of the cial documents provided by the pur- Chemical Diversion and Trafficking chaser which confirm the existence and Act and, therefore, they have been ex- apparent validity of the business enti- cluded from the definitions of regu- ty. lated transactions: (c) When transacting business with a (a) Domestic and import transactions new representative of a firm, the regu- of hydrochloric and sulfuric acids but lated person must verify the claimed not including anhydrous hydrogen agency status of the representative. chloride. (d) For sales to individuals or cash (b) Exports, transshipments, and purchasers, the type of documents and international transactions of hydro- other evidence of proof must consist of chloric (including anhydrous hydrogen at least a signature of the purchaser, a chloride) and sulfuric acids, except for driver’s license and one other form of exports, transshipments and inter- identification. Any exports to individ- national transactions to the following uals or exports paid in cash are suspect countries: and should be handled as such. For (1) Argentina such exports, the regulated person (2) Bolivia shall diligently obtain from the pur- (3) Brazil chaser or independently seek to con- (4) Chile firm clear documentation which proves (5) Colombia (6) Ecuador the person is properly identified such (7) French Guiana as through foreign identity documents, (8) Guyana driver’s license, passport information (9) Panama and photograph, etc. Any regulated (10) Paraguay person who fails to adequately prove (11) Peru the identity of the other party to the (12) Suriname transaction may be subject to the spe- (13) Uruguay cific penalties provided for violations (14) Venezuela of law related to regulated trans- (c) Domestic transactions of Methyl actions in listed chemicals. Isobutyl Ketone (MIBK). (e) For a new customer who is not an (d) Import transactions of Methyl individual or cash customer, the regu- Isobutyl Ketone (MIBK) destined for lated person shall establish the iden- the United States. tity of the authorized purchasing agent (e) Export transactions, inter- or agents and have on file that person’s national transactions, and import signature, electronic password, or transactions for transshipment or 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)

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in original manufacturer’s packaging forth in parts 1309, 1310, and 1313 of this of one-fluid-ounce (30 milliliters) or chapter remain in full force and effect. less, and no greater than one package (b) Each person required by section per transaction. 302 of the Act (21 U.S.C. 822) to obtain (g) Import transactions of anhydrous a registration to distribute, import, or hydrogen chloride. export a drug product that contains (h) Domestic distribution of anhy- pseudoephedrine or phenylpropanola- drous hydrogen chloride weighing mine that is regulated pursuant to 12,000 pounds (net weight) or more in a paragraph (1)(iv) of the definition of single container. regulated transaction in § 1300.02 of this (i) Domestic distribution of anhy- chapter is temporarily exempted from drous hydrogen chloride by pipeline. the registration requirement, provided (j) Domestic and international return that the person submits a proper appli- shipments of reusable containers from cation for registration on or before De- customer to producer containing resid- cember 3, 1997.The exemption will re- ual quantities of red phosphorus or main in effect for each person who has white phosphorus in rail cars and inter- made such application until the Ad- modal tank containers which conform ministration has approved or denied to International Standards Organiza- that application. This exemption ap- tion specifications (with capacities plies only to registration; all other greater than or equal to 2,500 gallons in chemical control requirements set a single container). forth in parts 1309, 1310, and 1313 of this (k) Domestic, import, and export dis- chapter remain in full force and effect. tributions of gamma-butyrolactone (c) Each person required by section weighing 4,000 kilograms (net weight) 302 of the act (21 U.S.C. 822) to obtain a or more in a single container. registration to distribute, import, or (l) Domestic and import transactions export GBL is temporarily exempted in chemical mixtures that contain ace- from the registration requirement, pro- tone, ethyl ether, 2-butanone, and/or vided that the DEA receives a proper toluene, unless regulated because of application for registration on or be- being formulated with other List I or fore July 24, 2000. The exemption will List II chemical(s) above the con- remain in effect for each person who centration limit. has made such application until the Administration has approved or denied [57 FR 43615, Sept. 22, 1992, as amended at 60 that application. This exemption ap- FR 19510, Apr. 19, 1995; 60 FR 32461, June 22, plies only to registration; all other 1995; 62 FR 13968, Mar. 24, 1997; 65 FR 47316, Aug. 2, 2000; 66 FR 52675, Oct. 17, 2001; 68 FR chemical control requirements set 37414, June 24, 2003; 68 FR 53292, Sept. 10, 2003; forth in parts 1309, 1310, and 1313 of this 69 FR 74971, Dec. 15, 2004; 72 FR 10928, Mar. 12, chapter remain in full force and effect. 2007; 72 FR 35931, July 2, 2007] (d) Each person required by section 302 of the Act (21 U.S.C. 822) to obtain § 1310.09 Temporary exemption from a registration to distribute, import, or registration. export the List I chemicals red phos- (a) Each person required by section phorus, white phosphorus, and 302 of the act (21 U.S.C. 822) to obtain a hypophosphorous acid (and its salts), is registration to distribute, import, or temporarily exempted from the reg- export a combination ephedrine prod- istration requirement, provided that uct is temporarily exempted from the the person submits a proper applica- registration requirement, provided tion for registration on or before De- that the person submits a proper appli- cember 17, 2001. The exemption will re- cation for registration on or before main in effect for each person who has July 12, 1997. The exemption will re- made such application until the Ad- main in effect for each person who has ministration has approved or denied made such application until the Ad- that application. This exemption ap- ministration has approved or denied plies only to registration; all other that application. This exemption ap- chemical control requirements set plies only to registration; all other forth in parts 1309, 1310, and 1313 of this chemical control requirements set chapter remain in full force and effect.

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(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 (g) Any person who distributes, im- export regulated chemical mixtures ports, or exports a chemical mixture which contain ephedrine, N- whose application for exemption is sub- methylephedrine, N- sequently denied by DEA must obtain a methylpseudoephedrine, registration with DEA. A temporary norpseudoephedrine, phenylpropanola- exemption from the registration re- mine, and/or pseudoephedrine, pursu- quirement will also be provided for ant to §§ 1310.12 and 1310.13, is tempo- these persons, provided that DEA re- rarily exempted from the registration ceives a properly completed applica- requirement, provided that DEA re- tion for registration on or before 30 ceives a proper application for registra- days following the date of official DEA tion or application for exemption on or notification that the application for before June 30, 2003. 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 parts 1309, 1310, and 1313 of this registration to manufacture, dis- chapter remain in full force and effect. tribute, import, or export regulated N- Any person who distributes, imports or phenethyl-4-piperidone (NPP), includ- exports a chemical mixture whose ap- ing regulated chemical mixtures pursu- plication for exemption is subsequently ant to § 1310.12, is temporarily exempt- denied by DEA must obtain a registra- ed from the registration requirement, tion with DEA. A temporary exemption provided that DEA receives a proper from the registration requirement will application for registration or applica- also be provided for these persons, pro- tion for exemption for a chemical mix- vided that DEA receives a properly ture containing NPP pursuant to completed application for registration § 1310.13 on or before June 22, 2007. The on or before 30 days following the date exemption will remain in effect for of official DEA notification that the each person who has made such appli- application for exemption has not been cation until the Administration has ap- approved. The temporary exemption proved or denied that application. This for such persons will remain in effect exemption applies only to registration; until DEA takes final action on their all other chemical control require- registration application. ments set forth in the Act and parts (f) Except for chemical mixtures con- 1309, 1310, 1313, and 1316 of this chapter taining the listed chemicals in para- remain in full force and effect. Any graph (e) of this section, each person person who manufactures, distributes, required by section 302 of the Act (21 imports or exports a chemical mixture U.S.C. 822) to obtain a registration to containing N-phenethyl-4-piperidone distribute, import, or export regulated (NPP) whose application for exemption chemical mixtures, pursuant to is subsequently denied by DEA must §§ 1310.12 and 1310.13, is temporarily ex- obtain a registration with DEA. A tem- empted from the registration require- porary exemption from the registration ment, provided that DEA receives a requirement will also be provided for proper application for registration or those persons whose application for ex- application for exemption on or before emption are denied, provided that DEA February 14, 2005. The exemption will receives a properly completed applica- remain in effect for each person who tion for registration on or before 30 has made such application until the days following the date of official DEA Administration has approved or denied notification that the application for that application. This exemption ap- exemption has been denied. The tem- plies only to registration; all other porary exemption for such persons will chemical control requirements set remain in effect until DEA takes final

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action on their registration applica- cation. This exemption applies only to tion. registration; all other chemical control (i) Each person required by section requirements set forth in parts 1309, 302 of the Act (21 U.S.C. 822) to obtain 1310, 1313, and 1315 of this chapter re- a registration to manufacture, dis- main in full force and effect. Any per- tribute, import, or export regulated io- son who manufactures, distributes, im- dine, including regulated iodine chem- ports, or exports a chemical mixture ical mixtures pursuant to §§ 1310.12 and whose application for exemption is sub- 1310.13, is temporarily exempted from sequently denied by DEA must obtain a the registration requirement, provided registration with DEA. A temporary that the Administration receives a exemption from the registration re- proper application for registration or quirement will also be provided for application for exemption for a chem- these persons, provided that DEA re- ical mixture containing iodine on or ceives a properly completed applica- before August 31, 2007. The exemption tion for registration on or before 30 will remain in effect for each person days following the date of official DEA who has made such application until notification that the application for the Administration has approved or de- exemption has not been approved. The nied that application. This exemption temporary exemption for such persons applies only to registration; all other will remain in effect until DEA takes chemical control requirements set final action on their registration appli- forth in the Act and parts 1309, 1310, cation. and 1313 of this chapter remain in full (k)(1) Each person required by sec- force and effect. Any person who dis- tions 302 or 1007 of the Act (21 U.S.C. tributes, imports, or exports a chem- 822, 957) to obtain a registration to ical mixture containing iodine whose manufacture, distribute, import, or ex- application for exemption is subse- port regulated GBL-containing chem- quently denied by the Administration ical mixtures, pursuant to sections must obtain a registration with the 1310.12 and 1310.13, is temporarily ex- Administration. A temporary exemp- empted from the registration require- tion from the registration requirement ment, provided that DEA receives a will also be provided for these persons, properly completed application for reg- provided that the Administration re- istration or application for exemption ceives a properly completed applica- on or before July 29, 2010. The exemption for registration on or before 30 tion will remain in effect for each per- days following the date of official Ad- son who has made such application ministration notification that the ap- until the Administration has approved plication for exemption has not been or denied that application. This exemp- approved. The temporary exemption tion applies only to registration; all for such persons will remain in effect other chemical control requirements until the Administration takes final set forth in parts 1309, 1310, and 1313 of action on their registration applica- this chapter remain in full force and ef- tion. fect. (j) Each person required by section (2) Any person who manufactures, 302 of the Act (21 U.S.C. 822) to obtain distributes, imports or exports a GBL- a registration to manufacture, dis- containing chemical mixture whose ap- tribute, import, or export regulated plication for exemption is subsequently chemical mixtures which contain denied by DEA must obtain a registra- ephedrine, and/or pseudoephedrine, pur- tion with DEA. A temporary exemption suant to Sections 1310.12 and 1310.13, is from the registration requirement will temporarily exempted from the reg- also be provided for those persons istration requirement, provided that whose applications for exemption are DEA receives a properly completed ap- denied, provided that DEA receives a plication for registration or applica- properly completed application for reg- tion for exemption on or before August istration on or before 30 days following 24, 2007. The exemption will remain in the date of official DEA notification effect for each person who has made that the application for exemption has such application until the Administra- been denied. The temporary exemption tion has approved or denied that appli- for such persons will remain in effect

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until DEA takes final action on their such application until the Administra- registration application. tion has approved or denied that appli- (l)(1) Each person required under sec- cation. This exemption applies only to tions 302 and 1007 of the Act (21 U.S.C. registration; all other chemical control 822, 957) to obtain a registration to requirements set forth in parts 1309, manufacture, distribute, import, or ex- 1310, and 1313 of this chapter remain in port regulated ergocristine and its full force and effect. salts, including regulated chemical (2) Any person who manufactures, mixtures pursuant to § 1310.12, is tem- distributes, imports, or exports a porarily exempted from the registra- chemical mixture which contains red tion requirement, provided that DEA phosphorus, white phosphorus, receives a properly completed applica- hypophosphorous acid (and its salts) tion for registration or application for whose application for exemption is sub- exemption for a chemical mixture con- sequently denied by DEA must obtain a taining ergocristine and its salts pur- registration with DEA. A temporary suant to § 1310.13 on or before May 2, exemption from the registration re- 2011. The exemption will remain in ef- quirement will also be provided for fect for each person who has made such those persons whose applications are application until the Administration denied, provided that DEA receives a has approved or denied that applica- properly completed application for reg- tion. This exemption applies only to istration on or before 30 days following registration; all other chemical control the date of official DEA notification requirements set forth in the Act and that the application for exemption has parts 1309, 1310, 1313, and 1316 of this not been approved. The temporary ex- chapter remain in full force and effect. emption for such persons will remain (2) Any person who manufactures, in effect until DEA takes final action distributes, imports, or exports a on their registration application. chemical mixture containing (n)(1) Each person required under sec- ergocristine and its salts whose appli- tions 302 and 1007 of the Act (21 U.S.C. cation for exemption is subsequently 822, 957) to obtain a registration to denied by DEA must obtain a registra- manufacture, distribute, import, or ex- tion with DEA. A temporary exemption port regulated alpha- from the registration requirement will phenylacetoacetonitrile (APAAN) and also be provided for those persons its salts, optical isomers, and salts of whose applications for exemption are optical isomers, including regulated denied, provided that DEA receives a chemical mixtures pursuant to § 1310.12, properly completed application for reg- is temporarily exempted from the registration on or before 30 days following istration requirement, provided that the date of official DEA notification the DEA receives a properly completed that the application for exemption has application for registration or applica- been denied. The temporary exemption tion for exemption for a chemical mix- for such persons will remain in effect ture containing alpha- until DEA takes final action on their phenylacetoacetonitrile (APAAN) and registration application. its salts, optical isomers, and salts of (m)(1) Each person required by Sec- optical isomers, pursuant to § 1310.13 on tions 302 or 1007 of the Act (21 U.S.C. or before August 14, 2017. The exemp- 822, 957) to obtain a registration to tion will remain in effect for each per- manufacture, distribute, import, or ex- son who has made such application port regulated chemical mixtures until the Administration has approved which contain red phosphorus, white or denied that application. This exemp- phosphorus, hypophosphorous acid (and tion applies only to registration; all its salts), pursuant to §§ 1310.12 and other chemical control requirements 1310.13, is temporarily exempted from set forth in the Act and parts 1309, 1310, the registration requirement, provided 1313, and 1316 of this chapter remain in that DEA receives a properly com- full force and effect. pleted application for registration or (2) Any person who manufactures, application for exemption on or before distributes, imports or exports a chem- July 5, 2011. The exemption will remain ical mixture containing alpha- in effect for each person who has made phenylacetoacetonitrile (APAAN) and

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its salts, optical isomers, and salts of posal is based. The Administrator shall optical isomers whose application for permit any interested person to file exemption is subsequently denied by written comments on or objections to the DEA must obtain a registration the proposal. After considering any with the DEA. A temporary exemption comments or objections filed, the Ad- from the registration requirement will ministrator shall publish in the FED- also be provided for those persons ERAL REGISTER his final order. whose applications for exemption are (c) The Administrator shall limit the denied, provided that the DEA receives removal of a drug or group of drugs a properly completed application for from exemption under paragraph (a) of registration on or before 30 days fol- this section to the most identifiable lowing the date of official DEA notifi- type of the drug or group of drugs for cation that the application for exemp- which evidence of diversion exists un- tion has been denied. The temporary less there is evidence, based on the pat- exemption for such persons will remain tern of diversion and other relevant in effect until the DEA takes final ac- factors, that the diversion will not be tion on their registration application. limited to that particular drug or [62 FR 27693, May 21, 1997, as amended at 62 group of drugs. FR 53960, Oct. 17, 1997; 65 FR 21647, Apr. 24, (d) Any manufacturer seeking rein- 2000; 66 FR 52675, Oct. 17, 2001; 68 FR 23203, statement of a particular drug product May 1, 2003; 69 FR 74971, Dec. 15, 2004; 72 FR that has been removed from an exemp- 20046, Apr. 23, 2007; 72 FR 35931, July 2, 2007; tion may apply to the Administrator 72 FR 40239, July 24, 2007; 72 FR 40744, July 25, for reinstatement of the exemption for 2007; 75 FR 37306, June 29, 2010; 76 FR 17781, Mar. 31, 2011; 76 FR 31829, June 2, 2011; 77 FR that particular drug product on the 4237, Jan. 27, 2012; 82 FR 32460, July 14, 2017] grounds that the particular drug product is manufactured and distributed in § 1310.10 Removal of the exemption of a manner that prevents diversion. In drugs distributed under the Federal determining whether the exemption Food, Drug and Cosmetic Act. should be reinstated the Administrator (a) The Administrator may remove shall consider: from exemption under paragraph (1)(iv) (1) The package sizes and manner of of the definition of regulated trans- packaging of the drug product; action in § 1300.02 of this chapter any (2) The manner of distribution and drug or group of drugs that the Admin- advertising of the drug product; istrator finds is being diverted to ob- (3) Evidence of diversion of the drug tain a listed chemical for use in the il- product; licit production of a controlled sub- (4) Any actions taken by the manu- stance. In removing a drug or group of facturer to prevent diversion of the drugs from the exemption the Adminis- drug product; and trator shall consider: (5) Such other factors as are relevant (1) The scope, duration, and signifi- to and consistent with the public cance of the diversion; health and safety, including the factors (2) Whether the drug or group of described in paragraph (a) of this sec- drugs is formulated in such a way that tion as applied to the drug product. it cannot be easily used in the illicit (e) Within a reasonable period of production of a controlled substance; time after receipt of the application for and reinstatement of the exemption, the (3) Whether the listed chemical can Administrator shall notify the appli- be readily recovered from the drug or cant of his acceptance or non-accept- group of drugs. ance of his application, and if not ac- (b) Upon determining that a drug or cepted, the reason therefor. If the ap- group of drugs should be removed from plication is accepted for filing, the Ad- the exemption under paragraph (a) of ministrator shall issue and publish in 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

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shall take effect. The Administrator from application of sections 302, 303, shall permit any interested person to 310, 1007, and 1008 of the Act (21 U.S.C. file written comments on or objections 822–823, 830, and 957–958), to the extent to the order. If any such comments described in paragraphs (b), (c), and (d) raise significant issues regarding any of this section. finding of fact or conclusion of law (b) No reinstated exemption granted upon which the order is based, the Ad- pursuant to 1310.10 affects the criminal ministrator shall immediately suspend liability for illegal possession or dis- the effectiveness of the order until he tribution of listed chemicals contained may reconsider the application in light in the exempt drug product. of the comments and objections filed. (c) Changes in exempt drug product Thereafter, the Administrator shall re- compositions: Any change in the quan- instate, revoke, or amend his original titative or qualitative composition, order as he determines appropriate. trade name or other designation of an (f) Unless the Administrator has evi- exempt drug product listed in para- dence that the drug product is being di- graph (d) requires a new application for verted, as determined by applying the reinstatement of the exemption. factors set forth in paragraph (a) of (d) The following drug products, in this section, and the Administrator so the form and quantity listed in the ap- notifies the applicant, transactions in- plication submitted (indicated as the volving a specific drug product will not ‘‘date’’) are designated as reinstated be considered regulated transactions exempt drug products for the purposes during the following periods: set forth in this section: (1) While a bonafide application for reinstatement of exemption under EXEMPT DRUG PRODUCTS paragraph (d) of this section for the specific drug product is pending resolu- Supplier Product name Form Date tion, provided that the application for [Reserved] ...... reinstatement is filed not later than 60 days after the publication of the final order removing the exemption; and [60 FR 32462, June 22, 1995] (2) For a period of 60 days following § 1310.12 Exempt chemical mixtures. the Administrator’s denial of an application for reinstatement. (a) The chemical mixtures meeting (g) An order published by the Admin- the criteria in paragraphs (c) or (d) of istrator in the FEDERAL REGISTER, pur- this section are exempted by the Ad- suant to paragraph (e) of this section, ministrator from application of sec- to reinstate an exemption may be tions 302, 303, 310, 1007, 1008, and 1018 of modified or revoked with respect to a the Act (21 U.S.C. 822, 823, 830, 957, 958, particular drug product upon a finding and 971) to the extent described in that: paragraphs (b) and (c) of this section. (1) Applying the factors set forth in (b) No exemption granted pursuant to paragraph (a) of this section to the par- this § 1310.12 or § 1310.13 affects the ticular drug product, the drug product criminal liability for illegal possession, is being diverted; or distribution, exportation, or importa- (2) There is a significant change in tion of listed chemicals contained in the data that led to the issuance of the the exempt chemical mixture or the final rule. civil liability for unlawful acts related to exempt chemical mixtures, includ- [60 FR 32461, June 22, 1995, as amended at 62 ing distribution in violation of 21 FR 13968, Mar. 24, 1997; 67 FR 14862, Mar. 28, 2002; 75 FR 38922, July 7, 2010; 77 FR 4237, Jan. U.S.C. 842(a)(11). 27, 2012] (c) Mixtures containing a listed chemical in concentrations equal to or § 1310.11 Reinstatement of exemption less than those specified in the ‘‘Table for drug products distributed under of Concentration Limits’’ are des- the Food, Drug and Cosmetic Act. ignated as exempt chemical mixtures (a) The Administrator has reinstated for the purpose set forth in this sec- the exemption for the drug products tion. The concentration is determined listed in paragraph (e) of this section for liquid-liquid mixtures by using the

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volume or weight and for mixtures containing solids or gases by using the unit of weight.

TABLE OF CONCENTRATION LIMITS

DEA chemical code Concentration Special conditions number

List I Chemicals

N-Acetylanthranilic acid, its 8522 20% by Weight...... Concentration based on any combination of N- salts and esters. acetylanthranilic acid and its salts and esters. Alpha- 8512 Not exempt at any con- Chemical mixtures containing any amount of APAAN phenylacetoacetonitrile, centration. are not exempt. and its salts, optical isomers, and salts of optical isomers. (APAAN). Anthranilic acid, and its 8530 50% by Weight ...... Concentration is based on any combination of anthra- salts and esters. nilic acid and its salts and esters. Benzaldehyde ...... 8256 50% by Weight or Volume. Benzyl cyanide ...... 8570 20% by Weight or Volume. Ephedrine, its salts, optical 8113 Not exempt at any con- Chemical mixtures containing any amount of ephed- isomers, and salts of op- centration. rine and/or pseudoephedrine, and their salts, optical tical isomers. isomers and salts of optical isomers are not exempt due to concentration, unless otherwise exempted. Ergocristine and its salts .... 8612 Not exempt at any con- Chemical mixtures containing any amount of centration. ergocristine and its salts are not exempt. Ergonovine and its salts .... 8675 Not exempt at any con- Chemical mixtures containing any amount of ergo- centration. novine, including its salts, are not exempt. Ergotamine and its salts .... 8676 Not exempt at any con- Chemical mixtures containing amount of any ergot- centration. amine, including its salts, are not exempt. Ethylamine and its salts ..... 8678 20% by Weight or Volume Ethylamine or its salts in an inert carrier solvent is not considered a mixture. Concentration is based on ethylamine in the mixture and not the combination of ethylamine and carrier solvent, if any. Gamma-Butyrolactone ...... 2011 70% by weight or volume. Hydriodic acid ...... 6695 20% by Weight or Volume. Hypophosphorous acid and 6797 30% by weight if a solid, The weight is determined by measuring the mass of its salts. weight or volume if a liq- hypophosphorous acid and its salts in the mixture, uid. the concentration limit is calculated by summing the concentrations of all forms of hypophosphorous acid and its salts in the mixture. The Administration does not consider a chemical mixture to mean the combination of a listed chemical and an inert carrier. Therefore, any solution consisting of hypophosphorous acid (and its salts), dispersed in water, alcohol, or another inert carrier, is not considered a chemical mixture and is therefore subject to chemical regulatory controls at all concentrations. Iodine ...... 6699 2.2 ...... Calculated as weight/volume (w/v). Isosafrole ...... 8704 20% by Weight or Volume Concentration in a mixture cannot exceed 20% if taken alone or in any combination with safrole. 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.

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TABLE OF CONCENTRATION LIMITS—Continued

DEA chemical code Concentration Special conditions number

Phenylacetic acid, and its 8791 40% by Weight...... Concentration is based on any combination of salts and esters. phenylacetic acid and its salts and esters. . Phenylpropanolamine, its 1225 0.6% by Weight ...... Concentration based on any combination of phenyl- salts, optical isomers, propanolamine, norpseudoephedrine and their salts, and salts of optical iso- optical isomers and salts of optical isomers. mers. Piperidine, and its salts ...... 2704 20% by Weight or Volume Concentration based on any combination of piperidine and its salts. Concentration based on weight if a solid, weight or volume if a liquid. Piperonal ...... 8750 20% by Weight or Volume. Propionic anhydride ...... 8328 20% by Weight or Volume. Pseudoephedrine, its salts, 8112 Not exempt at any con- Chemical mixtures containing any amount of ephed- optical isomers, and salts centration. rine and/or pseudoephedrine, and their salts, optical of optical isomers. isomers and salts of optical isomers are not exempt due to concentration, unless otherwise exempted. Red Phosphorus ...... 6795 80% by weight. Safrole ...... 8323 20% by Volume...... Concentration in a mixture cannot exceed 20% if taken alone or in any combination with isosafrole. White phosphorus ...... 6796 Not exempt at any con- Chemical mixtures containing any amount of white centration. phosphorus are not exempt due to concentration, unless otherwise exempted. List II Chemicals

Acetic Anhydride ...... 8519 20% by Weight or Volume. Acetone ...... 6532 35% by Weight or Volume Exports only; Limit applies to acetone or any combination of acetone, ethyl ether, 2-butanone, methyl isobutyl ketone, and toluene if present in the mixture by summing the concentrations for each chemical. Benzyl chloride ...... 8568 20% by Weight or Volume. 2-butanone ...... 6714 35% by Weight or Volume Exports only; Limit applies to 2-butanone or any combination of acetone, ethyl ether, 2-butanone, methyl isobutyl ketone, and toluene if present in the mixture by summing the concentrations for each chemical. Ethyl ether ...... 6584 35% by Weight or Volume Exports only; Limit applies to ethyl ether or any combination of acetone, ethyl ether, 2-butanone, methyl isobutyl ketone, and toluene if present in the mixture by summing the concentrations for each chemical. Hydrochloric acid ...... 6545 20% by Weight or Volume Hydrogen chloride in an inert carrier solvent, such as aqueous or alcoholic solutions, is not considered a mixture. Weight is based on hydrogen chloride in the mixture and not the combined weight of the carrier solvent, if any. Methyl isobutyl ketone ...... 6715 35% by Weight or Volume Exports only pursuant to § 1310.08; Limit applies to methyl isobutyl ketone or any combination of acetone, ethyl ether, 2-butanone, methyl isobutyl ketone, and toluene if present in the mixture by summing the concentrations for each chemical. Potassium permanganate .. 6579 15% by Weight. Sodium Permanganate ...... 6588 15% by Weight. 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- trolled Substances Act as described in ical mixtures are automatically ex- paragraph (a) of this section: empt from the provisions of the Con-

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(1) Chemical mixtures that are dis- exemption, the Administrator shall tributed directly to an incinerator for issue, and publish in the FEDERAL REG- destruction or directly to an author- ISTER, notification of the removal of an ized waste recycler or reprocessor exemption for a product or group of where such distributions are docu- products for which evidence of diver- mented on United States Environ- sion has been found, as well as the date mental Protection Agency Form 8700– on which the termination of exemption 22; persons distributing the mixture to shall take effect. The Administrator the incinerator or recycler must main- shall permit any interested party to tain and make available to agents of file written comments on or objections the Administration, upon request, such to the order within 60 days of the date documentation for a period of no less of publication of the order in the FED- than two years. ERAL REGISTER. If any such comments (2) Completely formulated paints and or objections raise significant issues coatings: Completely formulated regarding any finding of fact or conclu- paints and coatings are only those for- sion of law upon which the order is mulations that contain all of the com- based, the Administrator shall imme- ponents of the paint or coating for use diately suspend the effectiveness of the in the final application without the order until he may reconsider the order need to add any additional substances in light of comments and objections except a thinner if needed in certain filed. Thereafter, the Administrator cases. A completely formulated paint shall reinstate, terminate, or amend or coating is defined as any clear or the original order as determined appro- pigmented liquid, liquefiable or mastic priate. composition designed for application to (f) The Administrator may modify a substrate in a thin layer that is converted to a clear or opaque solid pro- any part of the criteria for exemption tective, decorative, or functional ad- as specified in paragraphs (c) and (d) of herent film after application. Included this section upon evidence of diversion in this category are clear coats, top- or attempted diversion. In doing so, the coats, primers, varnishes, sealers, ad- Administrator shall issue and publish a hesives, lacquers, stains, shellacs, inks, Notice of Proposed Rulemaking in the temporary protective coatings and FEDERAL REGISTER. The Administrator film-forming agents. shall permit any interested persons to (3) Iodine products classified as file written comments on or objections iodophors that exist as an iodine com- to the proposal. After considering any plex to include poloxamer-iodine com- comments or objections filed, the Ad- plex, polyvinyl pyrrolidone-iodine com- ministrator shall publish in the FED- plex (i.e., povidone-iodine), ERAL REGISTER a final order. undecoylium chloride iodine, [68 FR 23204, May 1, 2003, as amended at 69 nonylphenoxypoly (ethyleneoxy) eth- FR 74971, Dec. 15, 2004; 71 FR 60826, Oct. 17, anol-iodine complex, iodine complex 2006; 72 FR 20047, Apr. 23, 2007; 72 FR 35931, with phosphate ester of alkylaryloxy July 2, 2007; 72 FR 40745, July 25, 2007; 75 FR polyethylene glycol, and iodine com- 37306, June 29, 2010; 76 FR 17781, Mar. 31, 2011; plex with ammonium ether sulfate/ 76 FR 31830, June 2, 2011; 82 FR 32460, July 14, polyoxyethylene sorbitan monolaurate. 2017] (4) Iodine products that consist of or- § 1310.13 Exemption of chemical mix- ganically bound iodine (a non-ionic tures; application. complex) (e.g., iopamidol, iohexol, and amiodarone.) (a) The Administrator may, by publi- (e) The Administrator may, at any cation of a Final Rule in the FEDERAL time, terminate or modify the exemp- REGISTER, exempt from the application tion for any chemical mixture which of all or any part of the Act a chemical has been granted an exemption pursu- mixture consisting of two or more ant to the concentration limits as spec- chemical components, at least one of ified in paragraph (c) of this section or which is not a List I or List II chem- pursuant to the category exemption as ical, if: specified in paragraph (d) of this sec- (1) The mixture is formulated in such tion. In terminating or modifying an a way that it cannot be easily used in

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the illicit production of a controlled (7) A statement that the applicant substance; and accepts the right of the Administrator (2) The listed chemical or chemicals to terminate exemption from regula- contained in the chemical mixture can- tion for the chemical mixture(s) grant- not be readily recovered. ed exemption under this section. (b) Any manufacturer seeking an ex- (8) The identification of any informa- emption for a chemical mixture, not tion on the application that is consid- exempt under § 1310.12, from the appli- ered by the applicant to be a trade se- cation of all or any part of the Act, cret or confidential and entitled to pro- may apply to the Drug and Chemical tection under U.S. laws restricting the Evaluation Section, Diversion Control public disclosure of such information. Division, Drug Enforcement Adminis- (d) The Administrator may require tration. See the Table of DEA Mailing the applicant to submit such additional Addresses in § 1321.01 of this chapter for documents or written statements of the current mailing address. fact relevant to the application that he (c) An application for exemption deems necessary for determining if the under this section shall contain the fol- application should be granted. lowing information: (e) Within a reasonable period of (1) The name, address, and registra- time after the receipt of an application tion number, if any, of the applicant; for an exemption under this section, (2) The date of the application; the Administrator will notify the applicant in writing of the acceptance or (3) The exact trade name(s) of the ap- rejection of the application for filing. plicant’s chemical mixture and: If the application is not accepted for (i) If the applicant formulates or filing, an explanation will be provided. manufactures the chemical mixture for The Administrator is not required to other entities, the exact trade names of accept an application if any informa- the chemical mixtures and the names tion required pursuant to paragraph (c) of the entities for which the chemical of this section or requested pursuant to mixtures were prepared; and paragraph (d) of this section is lacking (ii) If a group of mixtures (e.g. formu- or not readily understood. The appli- lations having identical function and cant may, however, amend the applica- containing the same listed chem- tion to meet the requirements of para- ical(s)), the information required in graphs (c) and (d) of this section. If the paragraph (c)(3)(i) of this section and a exemption is subsequently granted, the brief narrative of their use. applicant shall again be notified in (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

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

EXEMPT CHEMICAL MIXTURES

Manufacturer Product name 1 Form Date

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

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

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

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

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EXEMPT CHEMICAL MIXTURES—Continued

Manufacturer Product name 1 Form Date

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

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

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

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(3) The name and address of the pro- cific bidder and end-user would result spective end-user, in cases where a sale in the illegal manufacture of a con- is being brokered; trolled substance, DEA will provide (4) Point(s) of contact for the pro- written notice to the head of a Federal spective bidder and, where appropriate, department or agency refusing to cer- prospective end-user; and tify the proposed sale under the au- (5) The end use of the chemical. thority of 21 U.S.C. 890. DEA also will (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- eral, state and local law; sion of law upon which the refusal is (3) Prior conviction record of the pro- based, the Administrator will recon- spective bidder or end-user relating to sider the refusal of the proposed sale in listed chemicals or controlled sub- light of the written comments or writ- stances under Federal or state laws; ten objections filed. Thereafter, within and a reasonable time, the Administrator (4) Such other factors as may be rel- will withdraw or affirm the original re- evant to and consistent with the public fusal of certification as he determines health and safety. appropriate. The Administrator will (d) If the Administrator certifies to provide written reasons for any affir- the head of a Federal department or mation of the original refusal. Such af- agency that there is no reasonable firmation of the original refusal will cause to believe that the sale of a spe- constitute a final decision for purposes cific chemical to a prospective bidder of judicial review under 21 U.S.C. 877. and end-user will result in the illegal (f) If the Administrator determines manufacture of a controlled substance, there is reasonable cause to believe that certification will be effective for that an existing certification should be one year from the date of issuance with withdrawn, DEA will provide written respect to further sales of the same notice to the head of a Federal depart- chemical to the same prospective bid- ment or agency of such withdrawal der and end-user, unless the Adminis- under the authority of 21 U.S.C. 890. trator notifies the head of the Federal DEA also will provide, within fifteen department or agency in writing that calendar days of withdrawal of an ex- the certification is withdrawn. If the isting certification, the same written certification is withdrawn, DEA will notice to the bidder and end-user, and also provide written notice to the bid- this notice also will contain a state- der and end-user, which will contain a ment of the legal and factual basis for statement of the legal and factual basis the withdrawal. The bidder and end- for this determination. user may, within thirty calendar days (e) If the Administrator determines of receipt of notification of the with- there is reasonable cause to believe the drawal of the existing certification, sale of the specific chemical to a spe- submit written comments or written

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objections to the Administrator’s with- 1311.50 Requirements for recipients of drawal. At the same time, the bidder digitally signed orders. and end-user also may provide sup- 1311.55 Requirements for systems used to porting documentation to contest the process digitally signed orders. 1311.60 Recordkeeping. Administrator’s withdrawal. If such written comments or written objec- Subpart C—Electronic Prescriptions tions raise issues regarding any finding of fact or conclusion of law upon which 1311.100 General. the withdrawal of the existing certifi- 1311.102 Practitioner responsibilities. 1311.105 Requirements for obtaining an au- cation is based, the Administrator will thentication credential—Individual prac- reconsider the withdrawal of the exist- titioners. ing certification in light of the written 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- factor authentication. appropriate. The Administrator will 1311.116 Additional requirements for bio- provide written reasons for any affir- metrics. 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. 1311.140 Requirements for signing a con- PART 1311—REQUIREMENTS FOR trolled 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 certifi- AUTHORITY: 21 U.S.C. 821, 828, 829, 871(b), cates. 958(e), 965, unless otherwise noted. 1311.20 Coordinators for CSOS digital certificate 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 scriptions. digital certificates under their DEA registration. [75 FR 16310, Mar. 31, 2010]

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§ 1311.02 Definitions. Drug Enforcement Administration, call (202) 307–1000. For information on the Any term contained in this part shall availability of this material at NARA, have the definition set forth in section call (202) 741–6030 or go to: http:// 102 of the Act (21 U.S.C. 802) or part www.archives.gov/federal register/ 1300 of this chapter. l codeloflfederallregulations/ [75 FR 16310, Mar. 31, 2010] ibrllocations.html. (b) These standards are available § 1311.05 Standards for technologies from the National Institute of Stand- for electronic transmission of or- ards and Technology, Computer Secu- ders. rity Division, Information Technology (a) A registrant or a person with Laboratory, National Institute of power of attorney to sign orders for Standards and Technology, 100 Bureau Schedule I and II controlled substances Drive, Gaithersburg, MD 20899–8930, may use any technology to sign and (301) 975–6478 or TTY (301) 975–8295, electronically transmit orders if the [email protected], and are available at technology provides all of the fol- http://csrc.nist.gov/. The following stand- lowing: ards are incorporated by reference: (1) Authentication: The system must (1) Federal Information Processing enable a recipient to positively verify Standard Publication (FIPS PUB) 140– the signer without direct communica- 2, Change Notices (12–03–2002), Security tion with the signer and subsequently Requirements for Cryptographic Mod- demonstrate to a third party, if needed, ules, May 25, 2001 (FIPS 140–2) includ- that the sender’s identity was properly ing Annexes A through D; incorpora- verified. tion by reference approved for (2) Nonrepudiation: The system must §§ 1311.30(b), 1311.55(b), 1311.115(b), ensure that strong and substantial evi- 1311.120(b), 1311.205(b). dence is available to the recipient of (i) Annex A: Approved Security Func- the sender’s identity, sufficient to pre- tions for FIPS PUB 140–2, Security Re- vent the sender from successfully deny- quirements for Cryptographic Modules, ing having sent the data. This criterion September 23, 2004. includes the ability of a third party to (ii) Annex B: Approved Protection verify the origin of the document. Profiles for FIPS PUB 140–2, Security (3) Message integrity: The system Requirements for Cryptographic Mod- must ensure that the recipient, or a ules, November 4, 2004. third party, can determine whether the (iii) Annex C: Approved Random contents of the document have been al- Number Generators for FIPS PUB 140– tered during transmission or after re- 2, Security Requirements for Cryp- ceipt. tographic Modules, January 31, 2005. (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

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27, 2000, as amended by Change Notice tificate holder signs orders only for 1, October 5, 2001 (FIPS 186–2); incorpo- that subset of schedules. ration by reference approved for §§ 1311.30(b) and 1311.55(b). § 1311.20 Coordinators for CSOS dig- (5) Federal Information Processing ital certificate holders. Standard Publication (FIPS PUB) 186– (a) Each registrant, regardless of 3, Digital Signature Standard (DSS), number of digital certificates issued, June 2009 (FIPS 186–3); incorporation must designate one or more responsible by reference approved for §§ 1311.120(b), persons to serve as that registrant’s 1311.205(b), and 1311.210(c). CSOS coordinator regarding issues per- (6) Draft NIST Special Publication taining to issuance of, revocation of, 800–63–1, Electronic Authentication and changes to digital certificates Guideline, December 8, 2008 (NIST SP issued under that registrant’s DEA reg- 800–63–1); Burr, W. et al.; incorporation istration. While the coordinator will be by reference approved for § 1311.105(a). the main point of contact between one (7) NIST Special Publication 800–76–1, or more DEA registered locations and Biometric Data Specification for Per- sonal Identity Verification, January the CSOS Certification Authority, all 2007 (NIST SP 800–76–1); Wilson, C. et digital certificate activities are the real.; incorporation by reference ap- sponsibility of the registrant with proved for § 1311.116(d). whom the digital certificate is associated. Even when an individual reg- [75 FR 16310, Mar. 31, 2010] istrant, i.e., an individual practitioner, is applying for a digital certificate to Subpart B—Obtaining and Using order controlled substances a CSOS Co- Digital Certificates for Elec- ordinator must be designated; though tronic Orders in such a case, the individual practitioner may also serve as the coordi- § 1311.10 Eligibility to obtain a CSOS nator. digital certificate. (b) Once designated, coordinators The following persons are eligible to must identify themselves, on a one- obtain a CSOS digital certificate from time basis, to the Certification Author- the DEA Certification Authority to ity. If a designated coordinator sign electronic orders for controlled changes, the Certification Authority substances. must be notified of the change and the (a) The person who signed the most new responsibilities assumed by each of recent DEA registration application or the registrant’s coordinators, if appli- renewal application and a person au- cable. Coordinators must complete the thorized to sign a registration applica- application that the DEA Certification tion. Authority provides and submit the fol- (b) A person granted power of attor- lowing: ney by a DEA registrant to sign orders (1) Two copies of identification, one for one or more schedules of controlled of which must be a government-issued substances. photographic identification. § 1311.15 Limitations on CSOS digital (2) A copy of each current DEA Cer- certificates. tificate of Registration (DEA form 223) (a) A CSOS digital certificate issued for each registered location for which by the DEA Certification Authority the coordinator will be responsible or, will authorize the certificate holder to if the applicant (or their employer) has sign orders for only those schedules of not been issued a DEA registration, a controlled substances covered by the copy of each application for registra- registration under which the certifi- tion of the applicant or the applicant’s cate is issued. employer. (b) When a registrant, in a power of (3) The applicant must have the com- attorney letter, limits a certificate ap- pleted application notarized and for- plicant to a subset of the registrant’s ward the completed application and ac- authorized schedules, the registrant is companying documentation to the responsible for ensuring that the cer- DEA Certification Authority.

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

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name and address, the subscriber’s (4) Check the certificate extension name, and the schedules the registrant data to determine whether the sender is authorized to handle. A CSOS certifi- has the authority to order the con- cate will expire on the date on which trolled substance. the DEA registration on which the cer- (b) A recipient may cache Certificate tificate is based expires. Revocation Lists for use until they ex- (b) The Certification Authority will pire. notify each CSOS certificate holder 45 days in advance of the expiration of the § 1311.55 Requirements for systems certificate holder’s CSOS digital cer- used to process digitally signed or- tificate. ders. (c) If a CSOS certificate holder ap- (a) A CSOS certificate holder and re- plies for a renewal before the certifi- cipient of an electronic order may use cate expires, the certificate holder may any system to write, track, or main- renew electronically twice. For every tain orders provided that the system third renewal, the CSOS certificate has been enabled to process digitally holder must submit a new application signed documents and that it meets the and documentation, as provided in requirements of paragraph (b) or (c) of § 1311.25. this section. (d) If a CSOS certificate expires be- (b) A system used to digitally sign fore the holder applies for a renewal, Schedule I or II orders must meet the the certificate holder must submit a following requirements: new application and documentation, as (1) The cryptographic module must provided in § 1311.25. be FIPS 140–2, Level 1 validated, as incorporated by reference in § 1311.08. § 1311.45 Requirements for registrants that allow powers of attorney to ob- (2) The digital signature system and tain CSOS digital certificates under hash function must be compliant with their DEA registration. FIPS 186–2 and FIPS 180–2, as incorporated by reference in § 1311.08. (a) A registrant that grants power of attorney must report to the DEA Cer- (3) The private key must be stored on tification Authority within 6 hours of a FIPS 140–2 Level 1 validated cryp- either of the following (advance notice tographic module using a FIPS-ap- may be provided, where applicable): proved encryption algorithm, as incor- (1) The person with power of attorney porated by reference in § 1311.08. has left the employ of the institution. (4) The system must use either a user (2) The person with power of attorney identification and password combina- has had his or her privileges revoked. tion or biometric authentication to ac- (b) A registrant must maintain a cess the private key. Activation data record that lists each person granted must not be displayed as they are en- power of attorney to sign controlled tered. substances orders. (5) The system must set a 10-minute inactivity time period after which the § 1311.50 Requirements for recipients certificate holder must reauthenticate of digitally signed orders. the password to access the private key. (a) The recipient of a digitally signed (6) For software implementations, order must do the following before fill- when the signing module is deacti- ing the order: vated, the system must clear the plain (1) Verify the integrity of the signa- text private key from the system mem- ture and the order by having the sys- ory to prevent the unauthorized access tem validate the order. to, or use of, the private key. (2) Verify that the certificate hold- (7) The system must be able to er’s CSOS digital certificate has not digitally sign and transmit an order. expired by checking the expiration (8) The system must have a time sys- date against the date the order was tem that is within five minutes of the signed. official National Institute of Standards (3) Check the validity of the certifi- and Technology time source. cate holder’s certificate by checking (9) The system must archive the the Certificate Revocation List. digitally signed orders and any other

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records required in part 1305 of this (10) The system must ensure that an chapter, including any linked data. invalid finding cannot be bypassed or (10) The system must create an order ignored and the order filled. that includes all data fields listed (11) The system must archive the under § 1305.21(b) of this chapter. order and associate with it the digital (c) A system used to receive, verify, certificate received with the order. and create linked records for orders (12) If a registrant sends reports on signed with a CSOS digital certificate orders to DEA, the system must create must meet the following requirements: a report in the format DEA specifies, (1) The cryptographic module must as provided in § 1305.29 of this chapter. be FIPS 140–2, Level 1 validated, as in- (d) For systems used to process CSOS corporated by reference in § 1311.08. orders, the system developer or vendor (2) The digital signature system and must have an initial independent third- hash function must be compliant with party audit of the system and an addi- FIPS 186–2 and FIPS 180–2, as incor- tional independent third-party audit porated by reference in § 1311.08. whenever the signing or verifying (3) The system must determine that functionality is changed to determine an order has not been altered during whether it correctly performs the func- transmission. The system must invali- tions listed under paragraphs (b) and date any order that has been altered. (c) of this section. The system devel- (4) The system must validate the dig- oper must retain the most recent audit ital signature using the signer’s public results and retain the results of any key. The system must invalidate any other audits of the software completed order in which the digital signature within the previous two years. cannot be validated. § 1311.60 Recordkeeping. (5) The system must validate that the DEA registration number con- (a) A supplier and purchaser must tained in the body of the order cor- maintain records of CSOS electronic responds to the registration number as- orders and any linked records for two sociated with the specific certificate by years. Records may be maintained separately generating the hash value of electronically. Records regarding con- the registration number and certificate trolled substances that are maintained subject distinguished name serial num- electronically must be readily retriev- ber and comparing that hash value to able from all other records. the hash value contained in the certifi- (b) Electronic records must be easily cate extension for the DEA registra- readable or easily rendered into a for- tion number. If the hash values are not mat that a person can read. They must equal the system must invalidate the be made available to the Administra- order. tion upon request. (6) The system must check the Cer- (c) CSOS certificate holders must tificate Revocation List automatically maintain a copy of the subscriber and invalidate any order with a certifi- agreement that the Certification Au- cate listed on the Certificate Revoca- thority provides for the life of the cer- tion List. tificate. (7) The system must check the validity of the certificate and the Certifi- Subpart C—Electronic cation Authority certificate and invali- Prescriptions date any order that fails these validity checks. SOURCE: 75 FR 16310, Mar. 31, 2010, unless (8) The system must have a time sys- otherwise noted. tem that is within five minutes of the official National Institute of Standards § 1311.100 General. and Technology time source. (a) This subpart addresses the re- (9) The system must check the sub- quirements that must be met to issue stances ordered against the schedules and process Schedule II, III, IV, and V that the registrant is allowed to order controlled substance prescriptions and invalidate any order that includes electronically. substances the registrant is not al- (b) A practitioner may issue a pre- lowed to order. scription for a Schedule II, III, IV, or V

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controlled substance electronically if scriptions for controlled substances. all of the following conditions are met: Failure by the practitioner to secure (1) The practitioner is registered as the hard token, knowledge factor, or an individual practitioner or exempt biometric information may provide a from the requirement of registration basis for revocation or suspension of under part 1301 of this chapter and is registration pursuant to section authorized under the registration or 304(a)(4) of the Act (21 U.S.C. 824(a)(4)). exemption to dispense the controlled (b) The practitioner must notify the substance; individuals designated under § 1311.125 (2) The practitioner uses an elec- or § 1311.130 within one business day of tronic prescription application that discovery that the hard token has been meets all of the applicable require- lost, stolen, or compromised or the au- ments of this subpart; and thentication protocol has been other- (3) The prescription is otherwise in wise compromised. A practitioner who conformity with the requirements of fails to comply with this provision may the Act and this chapter. be held responsible for any controlled (c) An electronic prescription for a substance prescriptions written using Schedule II, III, IV, or V controlled his two-factor authentication creden- substance created using an electronic tial. 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

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that are subject to the additional infor- that were issued under a DEA registra- mation requirements. tion held by that practitioner were pre- (f) The practitioner must not use the scriptions the practitioner had not electronic prescription application to signed or were not consistent with the sign and transmit electronic controlled prescriptions he signed. substance prescriptions if any of the (k) The practitioner has the same re- functions of the application required sponsibilities when issuing prescrip- by this subpart have been disabled or tions for controlled substances via appear to be functioning improperly. electronic means as when issuing a (g) If an electronic prescription appli- paper or oral prescription. Nothing in cation provider notifies an individual this subpart relieves a practitioner of practitioner that a third-party audit or his responsibility to dispense con- certification report indicates that the trolled substances only for a legitimate application or the application provider medical purpose while acting in the no longer meets the requirements of usual course of his professional prac- this part or notifies him that the appli- tice. If an agent enters information at cation provider has identified an issue the practitioner’s direction prior to the that makes the application non-com- practitioner reviewing and approving 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

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hard token that is being enabled to Affairs on a contractual basis pursuant sign controlled substances prescrip- to 38 U.S.C. 8153 and, in the perform- tions, the credential service provider or ance of his duties, prescribes controlled certification authority must issue two substances, confirm that the individual pieces of information used to generate practitioner meets the criteria for eli- or activate the authentication creden- gibility for appointment under 38 tial using two channels. U.S.C. 7401–7408 and is prescribing controlled substances under the registra- § 1311.110 Requirements for obtaining tion of such facility. an authentication credential—Indi- 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 exempt from the requirement of registra- (e) An institutional practitioner that tion under § 1301.22 of this chapter elects to conduct identity proofing privileges to prescribe controlled sub- must retain a record of the identity- stances using the institutional practi- proofing. An institutional practitioner tioner’s DEA registration number. that elects to issue the two-factor au- (4) If the individual practitioner is an thentication credential must retain a employee of a health care facility that record of the issuance of the credential. is operated by the Department of Vet- erans Affairs, confirm that the indi- § 1311.115 Additional requirements for vidual practitioner has been duly ap- two-factor authentication. pointed to practice at that facility by (a) To sign a controlled substance the Secretary of the Department of prescription, the electronic prescrip- Veterans Affairs pursuant to 38 U.S.C. tion application must require the prac- 7401–7408. titioner to authenticate to the applica- (5) If the individual practitioner is tion using an authentication protocol working at a health care facility oper- that uses two of the following three ated by the Department of Veterans factors:

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

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

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will constitute the signing of the pre- validated. FIPS 140–2 is incorporated scription by the practitioner for pur- by reference in § 1311.08. poses of § 1306.05(a) and (e) of this chap- (ii) The digital signature application ter. and hash function must comply with (12) The electronic prescription appli- FIPS 186–3 and FIPS 180–3, as incor- cation must not permit a practitioner porated by reference in § 1311.08. other than the prescribing practitioner (iii) The electronic prescription ap- whose DEA number (or institutional plication’s private key must be stored practitioner DEA number and exten- encrypted on a FIPS 140–2 Security sion data for the individual practi- Level 1 or higher validated cryp- tioner) is listed on the prescription as tographic module using a FIPS-ap- the prescribing practitioner and who proved encryption algorithm. FIPS 140– has indicated that the prescription is 2 is incorporated by reference in ready to be signed to sign the prescrip- § 1311.08. tion. (iv) For software implementations, (13) Where a practitioner seeks to when the signing module is deacti- prescribe more than one controlled vated, the application must clear the substance at one time for a particular plain text password from the applica- patient, the electronic prescription ap- tion memory to prevent the unauthor- plication may allow the practitioner to ized access to, or use of, the private sign multiple prescriptions for a single key. patient at one time using a single invo- (17) Unless the digital signature cre- cation of the two-factor authentication ated by an individual practitioner’s protocol provided the following has oc- private key is being transmitted to the curred: The practitioner has individ- pharmacy with the prescription, the ually indicated that each controlled electronic prescription application substance prescription is ready to be must include in the data file transmitted 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.

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

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(d) A registrant’s permission to indi- (c) The institutional practitioner cate that controlled substances pre- must retain a record of the individuals scriptions are ready to be signed and to or roles that are authorized to conduct sign controlled substance prescriptions identity proofing and logical access must be revoked whenever any of the control data entry and execution. following occurs, on the date the occur- (d) Permission to indicate that con- rence is discovered: trolled substances prescriptions are (1) A hard token or any other authen- ready to be signed and to sign con- tication factor required by the two-fac- trolled substance prescriptions must be tor authentication protocol is lost, sto- revoked whenever any of the following len, or compromised. Such access must occurs, on the date the occurrence is be terminated immediately upon re- discovered: ceiving notification from the indi- (1) An individual practitioner’s hard vidual practitioner. token or any other authentication fac- (2) The individual practitioner’s DEA tor required by the practitioner’s two- registration expires, unless the reg- factor authentication protocol is lost, istration has been renewed. stolen, or compromised. Such access (3) The individual practitioner’s DEA must be terminated immediately upon registration is terminated, revoked, or receiving notification from the indi- suspended. vidual practitioner. (4) The individual practitioner is no (2) The institutional practitioner’s longer authorized to use the electronic or, where applicable, individual practi- prescription application (e.g., when the tioner’s DEA registration expires, un- individual practitioner leaves the prac- less the registration has been renewed. tice). (3) The institutional practitioner’s § 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 controlled substance prescription. prescriptions. The list must be approved 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 con- chapter. trolled substances prescriptions are (c) If required by State law, a super- ready to be signed and to sign con- visor’s name and DEA number may be trolled substance prescriptions. A sec- listed on a prescription, provided the ond individual must authenticate to prescription clearly indicates who is the application to execute the logical the supervisor and who is the pre- access controls. scribing practitioner.

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§ 1311.140 Requirements for signing a § 1311.145 Digitally signing the pre- controlled substance prescription. scription with the individual practitioner’s private key. (a) For a practitioner to sign an electronic prescription for a controlled (a) An individual practitioner who substance the following must occur: has obtained a digital certificate as (1) The practitioner must access a provided in § 1311.105 may digitally sign list of one or more controlled sub- a controlled substance prescription stance prescriptions for a single pa- using the private key associated with tient. The list must display the infor- his digital certificate. mation required by § 1311.120(b)(9). (b) The electronic prescription appli- (2) The practitioner must indicate cation must require the individual the prescriptions that are ready to be practitioner to complete a two-factor signed. authentication protocol as specified in § 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

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

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(2) Import, store, and display the in- macist must make the same notation dication of signing as required by electronically when filling an elec- § 1311.120(b)(17). tronic prescription and retain the an- (3) Import, store, and display the notation electronically in the prescrip- number of refills as required by § 1306.22 tion record or in linked files. When a of this chapter. prescription is received electronically, (4) Import, store, and verify the prac- the prescription and all required anno- titioner’s digital signature, as provided tations must be retained electroni- in § 1311.210(c), where applicable. cally. (b) If the third-party auditor or cer- (g) When a pharmacist receives a tification organization has found that paper or oral prescription that indi- a pharmacy application does not accu- cates that it was originally trans- rately and consistently import, store, mitted electronically to the pharmacy, and display other information required the pharmacist must check its records for prescriptions under this chapter, to ensure that the electronic version the pharmacy must not process elec- was not received and the prescription tronic prescriptions for controlled sub- dispensed. If both prescriptions were stances that are subject to the addi- received, the pharmacist must mark tional information requirements. one as void. (c) If a pharmacy application pro- (h) When a pharmacist receives a vider notifies a pharmacy that a third- paper or oral prescription that indi- party audit or certification report indicates that it was originally trans- cates that the application or the appli- mitted electronically to another phar- cation provider no longer meets the re- macy, the pharmacist must check with quirements of this part or notifies it that pharmacy to determine whether that the application provider has iden- the prescription was received and dis- tified an issue that makes the applica- pensed. If the pharmacy that received tion non-compliant, the pharmacy the original electronic prescription had must immediately cease to process not dispensed the prescription, that controlled substance prescriptions pharmacy must mark the electronic using the application. version as void or canceled. If the phar- (d) A pharmacy that receives a notifi- macy that received the original elec- cation that the pharmacy application tronic prescription dispensed the pre- is not in compliance with the require- scription, the pharmacy with the paper ments of this part must not use the ap- version must not dispense the paper plication to process controlled sub- prescription and must mark the pre- stance prescriptions until it is notified 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 course of professional practice. records of these prescriptions (to the extent such alterations are permitted § 1311.205 Pharmacy application requirements. under this chapter). The pharmacy must ensure that logical access con- (a) The pharmacy may only use a trols in the pharmacy application are pharmacy application that meets the set so that only such employees are requirements in paragraph (b) of this granted access to perform these func- section to process electronic controlled tions. substance prescriptions. (f) When a pharmacist fills a pre- (b) The pharmacy application must scription in a manner that would re- meet the following requirements: quire, under part 1306 of this chapter, (1) The pharmacy application must the pharmacist to make a notation on be capable of setting logical access the prescription if the prescription controls to limit access for the fol- were a paper prescription, the phar- lowing functions:

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(i) Annotation, alteration, or dele- field that indicates the prescription tion of prescription information. was signed; or (ii) Setting and changing the logical (ii) Display the field for the phar- access controls. macist’s verification. (2) Logical access controls must be (7) The pharmacy application must set by individual user name or role. read and retain the full DEA number (3) The pharmacy application must including the specific internal code digitally sign and archive a prescrip- number assigned to individual practi- tion on receipt or be capable of receiv- tioners authorized to prescribe con- ing and archiving a digitally signed trolled substances by the hospital or record. other institution as provided in (4) For pharmacy applications that § 1301.22(c) of this chapter. digitally sign prescription records upon (8) The pharmacy application must receipt, the digital signature read and store, and be capable of dis- functionality must meet the following playing, all information required by requirements: part 1306 of this chapter. (i) The cryptographic module used to (9) The pharmacy application must digitally sign the data elements re- read and store in full the information quired by part 1306 of this chapter must required under § 1306.05(a) of this chap- be at least FIPS 140–2 Security Level 1 ter. The pharmacy application must ei- validated. FIPS 140–2 is incorporated ther verify that such information is by reference in § 1311.08. present or must display the informa- (ii) The digital signature application tion for the pharmacist’s verification. and hash function must comply with (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.

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(iii) The identity of the person taking (3) Archive the digitally signed the action, where applicable. record. The pharmacy record must re- (iv) The outcome of the event (suc- tain an indication that the prescription cess or failure). was verified upon receipt. No addi- (15) The pharmacy application must tional digital signature is required. conduct internal audits and generate reports on any of the events specified § 1311.215 Internal audit trail. in § 1311.215 in a format that is readable (a) The pharmacy application pro- by the pharmacist. Such an internal vider must establish and implement a audit may be automated and need not require human intervention to be con- list of auditable events. The auditable ducted. events must, at a minimum, include (16) The pharmacy application must the following: protect the stored audit records from (1) Attempted unauthorized access to unauthorized deletion. The pharmacy the pharmacy application, or success- application shall prevent modifications ful unauthorized access to the phar- to the audit records. macy application where the determina- (17) The pharmacy application must tion of such is feasible. back up the controlled substance pre- (2) Attempted or successful unau- scription records daily. thorized modification or destruction of (18) The pharmacy application must any information or records required by retain all archived records electroni- this part, or successful unauthorized cally for at least two years from the modification or destruction of any in- date of their receipt or creation and formation or records required by this comply with all other requirements of part where the determination of such is § 1311.305. feasible. § 1311.210 Archiving the initial record. (3) Interference with application operations of the pharmacy application. (a) Except as provided in paragraph (4) Any setting of or change to log- (c) of this section, a copy of each elec- ical access controls related to the dis- tronic controlled substance prescription record that a pharmacy receives pensing of controlled substance pre- must be digitally signed by one of the scriptions. following: (5) Attempted or successful inter- (1) The last intermediary transmit- ference with audit trail functions. ting the record to the pharmacy must (6) For application service providers, digitally sign the prescription imme- attempted or successful annotation, al- diately prior to transmission to the teration, or destruction of controlled pharmacy. substance prescriptions or logical ac- (2) The first pharmacy application cess controls related to controlled sub- that receives the electronic prescrip- stance prescriptions by any agent or tion must digitally sign the prescrip- employee of the application service tion immediately on receipt. provider. (b) If the last intermediary digitally (b) The pharmacy application must signs the record, it must forward the analyze the audit trail at least once digitally signed copy to the pharmacy. every calendar day and generate an in- (c) If a pharmacy receives a digitally cident report that identifies each signed prescription that includes the auditable event. individual practitioner’s digital signa- (c) The pharmacy must determine ture, the pharmacy application must do the following: whether any identified auditable event (1) Verify the digital signature as represents a security incident that provided in FIPS 186–3, as incorporated compromised or could have com- by reference in § 1311.08. promised the integrity of the prescrip- (2) Check the validity of the certifi- tion records. Any such incidents must cate holder’s digital certificate by be reported to the pharmacy applica- checking the certificate revocation tion service provider, if applicable, and list. The pharmacy may cache the CRL the Administration within one business until it expires. day.

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§ 1311.300 Application provider re- macy that uses the application or is quirements—Third-party audits or considering use of the application. The certifications. electronic prescription or pharmacy (a) Except as provided in paragraph application provider must retain the (e) of this section, the application pro- most recent audit or certification re- vider of an electronic prescription ap- sults and retain the results of any plication or a pharmacy application other audits or certifications of the ap- must have a third-party audit of the plication completed within the pre- application that determines that the vious two years. application meets the requirements of (g) Except as provided in paragraphs this part at each of the following (h) and (i) of this section, if the third- times: party auditor or certification organiza- (1) Before the application may be tion finds that the application does not used to create, sign, transmit, or proc- meet one or more of the requirements ess controlled substance prescriptions. of this part, the application must not (2) Whenever a functionality related be used to create, sign, transmit, or to controlled substance prescription re- process electronic controlled substance quirements is altered or every two prescriptions. The application provider years, whichever occurs first. must notify registrants within five (b) The third-party audit must be conducted by one of the following: business days of the issuance of the (1) A person qualified to conduct a audit or certification report that they SysTrust, WebTrust, or SAS 70 audit. should not use the application for con- (2) A Certified Information System trolled substance prescriptions. The ap- Auditor who performs compliance au- plication provider must also notify the dits as a regular ongoing business ac- Administration of the adverse audit or tivity. certification report and provide the re- (c) An audit for installed applications port to the Administration within one must address processing integrity and business day of issuance. determine that the application meets (h) For electronic prescription appli- the requirements of this part. cations, the third-party auditor or cer- (d) An audit for application service tification organization must make the providers must address processing in- following determinations: tegrity and physical security and de- (1) If the information required in termine that the application meets the § 1306.05(a) of this chapter, the indica- requirements of this part. tion that the prescription was signed (e) If a certifying organization whose as required by § 1311.120(b)(17) or the certification process has been approved digital signature created by the practi- by DEA verifies and certifies that an tioner’s private key, if transmitted, electronic prescription or pharmacy and the number of refills as required by application meets the requirements of § 1306.22 of this chapter, cannot be con- this part, certification by that organi- sistently and accurately recorded, zation may be used as an alternative to stored, and transmitted, the third- the audit requirements of paragraphs party auditor or certification organiza- (b) through (d) of this section, provided that the certification that determines tion must indicate that the application that the application meets the require- does not meet the requirements of this ments of this part occurs at each of the part. following times: (2) If other information required (1) Before the application may be under this chapter cannot be consist- used to create, sign, transmit, or proc- ently and accurately recorded, stored, ess controlled substance prescriptions. and transmitted, the third-party audi- (2) Whenever a functionality related tor or certification organization must to controlled substance prescription re- indicate that the application has failed quirements is altered or every two to meet the requirements for the spe- years, whichever occurs first. cific information and should not be (f) The application provider must used to create, sign, and transmit pre- make the audit or certification report scriptions that require the additional available to any practitioner or phar- information.

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(i) For pharmacy applications, the § 1311.305 Recordkeeping. third-party auditor or certification or- (a) If a prescription is created, ganization must make the following determinations: signed, transmitted, and received elec- (1) If the information required in tronically, all records related to that § 1306.05(a) of this chapter, the indica- prescription must be retained elec- tion that the prescription was signed tronically. as required by § 1311.205(b)(6), and the (b) Records required by this subpart number of refills as required by § 1306.22 must be maintained electronically for of this chapter, cannot be consistently two years from the date of their cre- and accurately imported, stored, and ation or receipt. This record retention displayed, the third-party auditor or requirement shall not pre-empt any certification organization must indi- longer period of retention which may cate that the application does not meet be required now or in the future, by the requirements of this part. any other Federal or State law or regu- (2) If the pharmacy application ac- lation, applicable to practitioners, cepts prescriptions with the practi- pharmacists, or pharmacies. tioner’s digital signature, the third- (c) Records regarding controlled sub- party auditor or certification organiza- stances prescriptions must be readily tion must indicate that the application retrievable from all other records. does not meet the requirements of this Electronic records must be easily read- part if the application does not consist- able or easily rendered into a format ently and accurately import, store, and that a person can read. verify the digital signature. (3) If other information required (d) Records required by this part under this chapter cannot be consist- must be made available to the Admin- ently and accurately imported, stored, istration upon request. and displayed, the third-party auditor (e) If an application service provider or certification organization must indi- ceases to provide an electronic pre- cate that the application has failed to scription application or an electronic meet the requirements for the specific pharmacy application or if a registrant information and should not be used to ceases to use an application service process electronic prescriptions that provider, the application service pro- require the additional information. vider must transfer any records subject to this part to the registrant in a for- § 1311.302 Additional application pro- mat that the registrant’s applications vider requirements. are capable of retrieving, displaying, (a) If an application provider identi- and printing in a readable format. fies or is made aware of any issue with (f) If a registrant changes application its application that make the applica- providers, the registrant must ensure tion non-compliant with the require- that any records subject to this part ments of this part, the application pro- are migrated to the new application or vider must notify practitioners or are stored in a format that can be re- pharmacies that use the application as trieved, displayed, and printed in a soon as feasible, but no later than five business days after discovery, that the readable format. application should not be used to issue (g) If a registrant transfers its elec- or process electronic controlled sub- tronic prescription files to another reg- stance prescriptions. istrant, both registrants must ensure (b) When providing practitioners or that the records are migrated to the pharmacies with updates to any issue new application or are stored in a for- that makes the application non-com- mat that can be retrieved, displayed, pliant with the requirements of this and printed in a readable format. part, the application provider must in- (h) Digitally signed prescription dicate that the updates must be in- records must be transferred or mi- stalled before the practitioner or phar- grated with the digital signature. macy may use the application to issue or process electronic controlled substance prescriptions.

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PART 1312—IMPORTATION AND TRANSSHIPMENT AND IN-TRANSIT SHIPMENT OF EXPORTATION OF CONTROLLED CONTROLLED SUBSTANCES SUBSTANCES 1312.31 Schedule I: Application for prior written approval. 1312.32 Schedules II, III, IV: Advance notice. Sec. 1312.01 Scope of part 1312. HEARINGS 1312.02 Definitions. 1312.41 Hearings generally. 1312.03 Forms applicable to this part. 1312.42 Purpose of hearing. 1312.43 Waiver or modification of rules. IMPORTATION OF CONTROLLED SUBSTANCES 1312.44 Request for hearing or appearance; 1312.11 Requirement of authorization to im- waiver. port. 1312.45 Burden of proof. 1312.12 Application for import permit; re- 1312.46 Time and place of hearing. turn information.. 1312.47 Final order. 1312.13 Issuance of import permit. AUTHORITY: 21 U.S.C. 952, 953, 954, 957, 958. 1312.14 Distribution of import permits. 1312.15 Shipments in greater or less amount SOURCE: 36 FR 7815, Apr. 24, 1971, unless than authorized. otherwise noted. Redesignated at 38 FR 26609, 1312.16 Amendment, cancellation, expira- Sept. 24, 1973. tion of import permit. 1312.17 Special report from importers. § 1312.01 Scope of part 1312. 1312.18 Import declaration. Procedures governing the importa- 1312.19 Distribution of import declaration. tion, exportation, transshipment and EXPORTATION OF CONTROLLED SUBSTANCES intransit shipment of controlled substances pursuant to section 1002, 1003, 1312.21 Requirement of authorization to ex- and 1004 of the Act (21 U.S.C. 952, 953, port. 1312.22 Application for export or reexport and 954) are governed generally by permit; return information. those sections and specifically by the 1312.23 Issuance of export permit. sections of this part. 1312.24 Distribution of export permit. 1312.25 Amendment, cancellation, expira- § 1312.02 Definitions. tion of export permit. Any term contained in this part shall 1312.26 Records required of exporter. have the definition set forth in section 1312.27 Export/reexport declaration. 102 of the Act (21 U.S.C. 802) or part 1312.28 Distribution of export declaration. 1300 of this chapter. 1312.29 Domestic release prohibited. 1312.30 Schedule III, IV, and V non-narcotic [62 FR 13969, Mar. 24, 1997] controlled substances requiring an import and export permit. § 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] tory of the United States from any place outside thereof (but within the IMPORTATION OF CONTROLLED United States), or into the United SUBSTANCES States from any place outside thereof, § 1312.11 Requirement of authoriza- any controlled substances listed in tion to import. Schedule I or II, or any narcotic controlled substance listed in Schedule III, (a) No person shall import, or cause to be imported, into the customs terri-

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IV, or V, or any non-narcotic con- be signed and dated by the importer trolled substance listed in Schedule III and must contain the importer’s reg- which the Administrator has specifi- istered address to which the controlled cally designated by regulation in substances will be imported. § 1312.30 or any non-narcotic controlled (b) The applicant must include on the substance listed in Schedule IV or V DEA Form 357 the registration number which is also listed in Schedule I or II of the importer and a detailed descrip- of the Convention on Psychotropic tion of each controlled substance to be Substances, 1971, unless and until such imported including the drug name, dos- person is properly registered under the age form, National Drug Code (NDC) Act (or, in accordance with part 1301 of number, the Administration Controlled this chapter, exempt from registration) Substance Code Number as set forth in and the Administration has issued him part 1308 of this chapter, the number 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, excluding those described in paragraph (a) of (1) The name/business name, address/ this section, unless and until such per- business address, contact information son is properly registered under the (e.g., telephone number(s), email ad- Act (or, in accordance with part 1301 of dress(es), etc.), and business of the con- this chapter, exempt from registration) signor, if known at the time the appli- and has filed an import declaration to cation is submitted, but if unknown at do so in accordance with § 1312.18. that time, the fact should be indicated (c) A separate permit or declaration and the name and address afterwards is required for each shipment of a con- furnished to the Administration as trolled substance to be imported. soon as ascertained by the importer; (2) The foreign port and country of [81 FR 97026, Dec. 30, 2016] initial exportation (i.e., the place § 1312.12 Application for import per- where the article will begin its journey mit; return information. of exportation to the United States); (a) Registered importers, other reg- (3) The port of entry into the United istrants authorized to import as a coin- States; cident activity of their registrations, (4) The latest date said shipment will and persons who in accordance with leave said foreign port or country; part 1301 of this chapter are exempt (5) The stock on hand of the con- from registration, seeking to import a trolled substance desired to be im- controlled substance in schedule I or II; ported; any narcotic drug in schedule III, IV, (6) The name of the importing carrier or V; any non-narcotic drug in schedule or vessel (if known), or if unknown it III that has been specifically des- should be stated whether the shipment ignated by regulation in § 1312.30; or will be made by express, freight, or any non-narcotic substance listed in otherwise, imports of controlled sub- schedule IV or V that is also listed in stances in Schedules I or II and nar- schedule I or II of the Convention on cotic drugs in Schedules III, IV, or V Psychotropic Substances, 1971, must by mail being prohibited); submit an application for a permit to (7) The total tentative allotment to import controlled substances on DEA the importer of such controlled sub- Form 357. All applications and sup- stance for the current calendar year; porting materials must be submitted to and the Administration through the DEA (8) The total number of kilograms of Diversion Control Division secure net- said allotment for which permits have work application. The application must previously been issued and the total

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

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States, or of any State, or to any per- to be made before a specified date. son registered or exempted from reg- Only one shipment may be made on a istration under sections 1007 and 1008 of single import permit. A single import the Act (21 U.S.C. 957 and 958). permit shall authorize a quantity of (b) The Administrator may require goods to be imported/exported at one that such non-narcotic controlled sub- place, at one time, for delivery to one stances in Schedule III as he shall des- consignee, on a single conveyance, at ignate by regulation in § 1312.30 of this one place, on one bill of lading, air part be imported only pursuant to the waybill, or commercial loading docu- issuance of an import permit. The Ad- ment; a single permit shall not author- ministrator may authorize the impor- ize a quantity of goods to be imported/ tation of such substances if he finds exported if the goods are divided onto that the substance is being imported two or more conveyances. The permit for medical, scientific or other legiti- must state that the Administration is mate uses. satisfied that the consignment pro- (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

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to the importer through secure elec- amount authorized to be imported tronic means. The importer, or their under the permit as determined at the agent, must submit an official record weighing by the District Director of of the import permit and/or required the U.S. Customs and Border Protec- data concerning the import transaction tion or customs service of an Insular to a customs officer at the port of Area, such difference, when ascertained entry in compliance with all import by the Administration, shall be recred- control requirements of agencies with ited to the tentative allotment against import control authorities under the which the quantity covered by the per- Act or statutory authority other than mit was charged, and the balance of the Controlled Substances Import and any such tentative allotment with any Export Act. The importer must main- such recredits will remain available to tain an official record of the import the importer to whom made (unless permit (available from the DEA Diver- previously revoked in whole or in part), sion Control Division secure network for importations pursuant to any per- 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 competent national authority of the [36 FR 7815, Apr. 24, 1971. Redesignated at 38 exporting county). The importer must FR 26609, Sept. 24, 1973, and amended at 46 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

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for an amendment to an issued permit issued permit or upon expiration of the is granted by the Administration, the unused permit in accordance with para- Administration will immediately can- graph (b) of this section, whichever is cel the original permit and re-issue the sooner. Other than for an amendment permit, as amended, with a revised per- to an import permit under § 1312.15(a), mit number. The DEA and importer importers must submit a request for an will distribute the amended permit in amendment to increase the total base accordance with § 1312.14. If a request weight of a controlled substance at for an amendment is denied by the Ad- least three business days in advance of ministration, the temporary stay will the date of release by a customs offi- be lifted; once lifted, the originally cer. issued permit may immediately be (6) An importer may request that an used to authorize entry of a shipment in accordance with the terms of the import permit be amended to remove a permit, subject to the shipment being controlled substance from the permit. compliant with all other applicable However, an importer may not amend laws. an import permit to add or replace a (1) An importer may request that an controlled substance/Administration import permit or application for a per- controlled substance code number to mit be amended to change the National the item(s) to be imported. Importers Drug Control number, description of who desire to import a different con- the packaging, or trade name of the trolled substance than that contained product, so long as the description is on their issued import permit or per- for the same basic class of controlled mit application must submit a request substance as in the original permit. for the permit or permit application to (2) An importer may request that an be canceled and request a new permit import permit or application for a per- in accordance with § 1312.12. mit be amended to change the proposed (7) An importer may not amend the port of entry, the date of release by a importer’s name (as it appears on their customs officer, or the method of DEA certificate of registration) or the transport. name of the foreign exporter as pro- (3) An importer may request that an vided in the DEA Form 357. Importers import permit or application for a per- who need to make any changes to any mit be amended to change the jus- of these fields must submit a request tification provided as to why an import for the permit or permit application to shipment is needed to meet the legitimate scientific or medical needs of the be canceled and request a new permit United States. in accordance with § 1312.12. (4) An importer may request that an (b) An import permit will be void and import permit or application for a per- of no effect after the expiration date mit be amended to change any reg- specified therein, and in no event will istrant notes. the date be more than 180 calendar (5) Prior to departure of the shipment days after the date the permit is from its original foreign location, an issued. Amended import permits will importer may request that an import retain the original expiration date. permit or application for a permit be (c) An import permit may be can- amended to increase the total base celed after being issued, at the request weight of a controlled substance. At of the importer submitted to the Ad- the U.S. port of entry, an importer ministration through the DEA Diver- may request that an import permit be sion Control Division secure network amended in accordance with § 1312.15(a). application, provided that no shipment Importers are not required to amend an has been made thereunder. import permit for the sole purpose of Nothing in this part will affect the decreasing the total base weight of a right, hereby reserved by the Adminis- controlled substance authorized to be tration, to cancel a permit at any time imported. However, the balance of any unimported authorized quantity of con- for proper cause. trolled substances on an import permit [81 FR 97027, Dec. 30, 2016] is void upon entry of a shipment on the

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§ 1312.17 Special report from import- import declaration is not deemed filed, ers. and therefore is not valid, until the Ad- Whenever requested by the Adminis- ministration has issued a transaction trator, importers shall render to him identification number. The importer not later than 30 days after receipt of may only proceed with the import the request therefor a statement under transaction once the transaction iden- oath of the stocks of controlled sub- tification number has been issued. stances on hand as of the date specified (c) DEA Form 236 must include the by the Administrator in his request, following information: and, if desired by the Administrator, (1) The name, address, and registra- an estimate of the probable require- tion number of the importer; and the ments for legitimate uses of the im- name and address and registration porter for any subsequent period that number of the import broker, if any; may be designated by the Adminis- and trator. In lieu of any special statement that may be considered necessary, the (2) A complete description of the con- Administrator may accept the figures trolled substances to be imported, in- given upon the reports subsequent by cluding drug name, dosage form, Na- said importer under part 1304 of this tional Drug Code (NDC) number, the chapter. Administration Controlled Substances Code Number as set forth in part 1308 [36 FR 7815, Apr. 24, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973, as amended at 62 FR of this chapter, the number and size of 13969, Mar. 24, 1997] packages or containers, the name and quantity of the controlled substance 1312.18 Import declaration. contained in any finished dosage units, (a) Any non-narcotic controlled sub- and the net quantity of any controlled stance listed in Schedule III, IV, or V, substance (expressed in anhydrous not subject to the requirement of an acid, base, or alkaloid) given in kilo- import permit pursuant to § 1312.13 (b) grams or parts thereof; and or (c) of this chapter, may be imported (3) The anticipated date of release by if that substance is needed for medical, a customs officer at the port of entry, scientific or other legitimate uses in the foreign port and country of expor- the United States, and will be imported tation to the United States, the port of pursuant to a controlled substances entry, and the name, address, and reg- import declaration. istration number of the recipient in the (b) Any person registered or author- United States; and ized to import and seeking to import any non-narcotic controlled substance (4) The name and address of the con- listed in Schedules III, IV, or V which signor in the foreign country of expor- is not subject to the requirement of an tation, and any registration or license import permit as described in para- numbers if the consignor is required to graph (a) of this section, must file a have such numbers either by the coun- controlled substances import declara- try of exportation or under U.S. law. tion (DEA Form 236) with the Adminis- (d) Notwithstanding the time limita- tration through the DEA Diversion tions included in paragraph (b) of this Control Division secure network appli- section, an applicant may obtain a spe- cation not later than 15 calendar days cial waiver of these time limitations in prior to the anticipated date of release emergency or unusual instances, pro- by a customs officer and distribute an vided that a specific confirmation is re- official record of the declaration as ceived from the Administrator or his hereinafter directed in § 1312.19. The delegate advising the registrant to pro- declaration must be signed and dated ceed pursuant to the special waiver. by the importer and must specify the (e) Return information. Within 30 cal- address of the final destination for the endar days after actual receipt of a shipment, which must be the importer’s registered location. Upon receipt controlled substance at the importer’s and review, the Administration will assign a transaction identification number to each completed declaration. The

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registered location, or within 10 cal- porter will distribute the amended dec- endar days after receipt of a written re- laration in accordance with § 1312.19. A quest by the Administration to the im- filed amendment will not change the porter, whichever is sooner, the im- date that the declaration becomes void porter must file a report with the Ad- and of no effect pursuant to paragraph ministration through the DEA Diver- (g) of this section. sion Control Division secure network (g) An import declaration may be application specifying the particulars canceled after being filed with the Ad- of the transaction. This report must in- ministration, at the request of the im- clude the following information: The porter by the importer submitting to date on which the controlled substance the Administration the request was released by a customs officer at through the DEA Diversion Control Di- the port of entry; the date on which the controlled substance arrived at the reg- vision secure network application, pro- istered location; the actual quantity of vided that no shipment has been made the controlled substance released by a thereunder. Import declarations shall customs officer at the port of entry; become void and of no effect 180 cal- the actual quantity of the controlled endar days after the date the declara- substance that arrived at the reg- tion is deemed filed with the Adminis- istered location; and the actual port of tration. entry. Upon receipt and review, the Ad- (h) Denied release at the port of entry. ministration will assign a transaction In the event that a shipment of con- identification number to a completed trolled substances has been denied re- report. The report will not be deemed lease by a customs officer at the port filed until the Administration has of entry for any reason, the importer issued a transaction identification who attempted to have the shipment number. released, within 5 business days of the (f) An importer may amend an im- denial, report to the Administration port declaration in the same cir- that the shipment was denied release cumstances in which an importer may and the reason for denial. Such report request amendment to an import per- must be transmitted to the Adminis- mit, as set forth in § 1312.16(a)(1) tration through the DEA Diversion through (7). Amendments to declara- Control Division secure network appli- tions must be submitted through the cation. This report must include the DEA Diversion Control Division secure following information: The quantity of network application. Except as provided in §§ 1312.16(a)(5) and 1312.15(a), the controlled substance denied re- importers must submit all amendments lease; the date on which release was de- at least one full business day in ad- nied; and the basis for the denied re- vance of the date of release by a cus- lease. Upon the importer’s report of a toms officer. Importers must specifi- denied release, the DEA will assign the cally note that an amendment is being report a transaction identification made; supplementary information sub- number and the import declaration will mitted by an importer through the become void and of no effect. No ship- DEA Diversion Control Division secure ment of controlled substances denied network application will not automati- release for any reason will be allowed cally be considered an amendment. to be released into the United States While the amendment is being proc- until the importer has filed a new im- essed by the Administration, the origi- port declaration and the Administra- nal declaration will be temporarily tion has issued a new transaction iden- stayed and may not be used to author- tification number. ize release of a shipment of controlled substances. Upon receipt and review, [36 FR 7815, Apr. 24, 1971, as amended at 37 the Administration will assign each FR 15923, Aug. 8, 1972. Redesignated at 38 FR completed amendment a transaction 26609, Sept. 24, 1973, and amended at 45 FR identification number. The amendment 74715, Nov. 12, 1980; 51 FR 5319, Feb. 13, 1986; 52 FR 17290, May 7, 1987; 62 FR 13969, Mar. 24, will not be deemed filed until the Ad- 1997; 75 FR 10682, Mar. 9, 2010; 77 FR 4237, Jan. ministration issues a transaction iden- 27, 2012; 81 FR 97028, Dec. 30, 2016] tification number. The DEA and im-

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§ 1312.19 Distribution of import dec- (b) No person shall in any manner ex- laration. port, or cause to be exported, from the The importer must furnish an official United States any non-narcotic con- record of the declaration (available trolled substance listed in Schedule III, through the DEA Diversion Control Di- IV, or V, excluding those described in vision secure network application after paragraph (a) of this section, or any the Administration issues a trans- narcotic controlled substance listed in action identification number) to the Schedule V, unless and until such per- foreign shipper. The foreign shipper son is properly registered under the must submit an official record of the Act (or, in accordance with part 1301 of declaration to the competent national this chapter, exempt from registration) authority of the exporting country, if and has furnished an export declara- required as a prerequisite to export au- tion as provided by section 1003 of the thorization. The importer, or their Act (21 U.S.C. 953(e)) to the Adminis- agent, must submit an official record tration in accordance with § 1312.28. of the declaration and/or required data (c) A separate permit or declaration concerning the import transaction to a is required for each shipment of con- customs officer at the port of entry in trolled substance to be exported. compliance with all import control re- [81 FR 97029, Dec. 30, 2016] quirements of agencies with import control authorities under the Act or § 1312.22 Application for export or re- statutory authority other than the export permit; return information. Controlled Substances Import and Ex- (a) Registered exporters, and persons port Act. The importer must ensure who in accordance with part 1301 of that an official record of the declara- this chapter are exempt from registration accompanies the shipment to its tion, seeking to export controlled sub- 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.);

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(ii) The exporter’s registration num- crude cocaine, the affidavit may state ber, address, and contact information that to the best of affiant’s knowledge (e.g., telephone number(s), etc.) from and belief, the controlled substances which the controlled substances will be will be processed within the country to exported; which exported, either for medical or (iii) A detailed description of each scientific use within that country or controlled substance to be exported infor reexportation in accordance with cluding the drug name, dosage form, the laws of that country to another for National Drug Code (NDC) number, Ad- medical or scientific use within that ministration Controlled Substance country. Code Number as set forth in part 1308 (2) With respect to reexports among of this chapter, the number and size of members of the European Economic the packages or containers, the name Area in accordance with section 1003(f) and quantity of the controlled sub- of the Act (21 U.S.C. 953(f)), the require- stance contained in any finished dosage ments of paragraph (c)(1) of this sec- units, and the quantity of any con- tion shall apply only with respect to trolled substance (expressed in anhy- the export from the United States to drous acid, base, or alkaloid) given in the first country and not to any subse- kilograms or parts thereof; quent export from that country to an- (iv) The name/business name, ad- other country of the European Eco- dress/business address, contact infor- nomic Area. mation (e.g., telephone number(s), email address(es), etc.) and business of (d)(1) Except as provided in para- the consignee in the first country (the graph (d)(2) of this section, the appli- country to which the controlled sub- cant must also submit with the appli- stance is exported from the United cation any import license or permit or States), foreign port and country of a certified copy of any such license or entry/first country of entry, the port of permit issued by the competent na- export, the anticipated date of release tional authority in the country of des- by a customs officer at the port of ex- tination, or other documentary evi- port, the name of the exporting carrier dence deemed adequate by the Admin- or vessel (if known), or if unknown it istration, showing: That the merchan- should be stated whether the shipment dise is consigned to an authorized per- will be made by express, freight, or mittee; that it is to be applied exclu- otherwise), the date and number, if sively to medical or scientific use with- any, of the supporting foreign import in the country of destination; that it license or permit accompanying the ap- will not be reexported from such coun- plication, and the authority by whom try (unless the application is submitted such foreign license or permit was for reexport in accordance with para- issued; and graphs (f), (g), and (h) of this section); (v) An affidavit that the packages or and that there is an actual need for the containers are labeled in conformance controlled substance for medical or sci- with obligations of the United States entific use within such country or under international treaties, conven- countries. If the import license or per- tions, or protocols in effect at the time mit, or the certified copy of such, is of the export or reexport. The affidavit not written in English or bilingual shall further state that to the best of with another language and English, the the affiant’s knowledge and belief, the registrant must also submit with their controlled substances therein are to be application a certified translation of applied exclusively to medical or sci- the permit or license. For purposes of entific uses within the country to this requirement, certified translation which exported, will not be reexported means that the translator has signed therefrom and that there is an actual the translation legally attesting the need for the controlled substance for accuracy of the translation. (In the medical or scientific uses within such case of exportation of bulk coca leaf country, unless the application is sub- alkaloid, the applicant need only in- mitted for reexport in accordance with clude with the application the material paragraphs (f), (g), and (h) of this sec- outlined in paragraph (c) of this section. In the case of exportation of tion.)

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(2) With respect to reexports among section as the ‘‘first country’’) and the members of the European Economic country to which the controlled sub- Area in accordance with section 1003(f) stance is exported from the first coun- of the Act (21 U.S.C. 953(f)), the require- try (referred to in this section as the ments of paragraph (d)(1) of this sec- ‘‘second country’’) are parties to the tion shall apply only with respect to Single Convention on Narcotic Drugs, the export from the United States to 1961, and the Convention on Psycho- the first country and not to any subse- tropic Substances, 1971; quent export from that country to an- (2) The first country and the second other country of the European Eco- country have each instituted and main- nomic Area. tain, in conformity with such Conven- (e) Return information for exports (on a tions, a system of controls of imports DEA Form 161). Within 30 calendar days of controlled substances which the Ad- after the controlled substance is re- ministration deems adequate; leased by a customs officer at the port (3) With respect to the first country, of export, or within 10 calendar days the controlled substance is consigned after receipt of a written request by to a holder of such permits or licenses the Administration to the exporter, as may be required under the laws of whichever is sooner, the exporter must such country, and a permit or license report to the Administration through to import the controlled substance has the DEA Diversion Control Division se- been issued by the country; cure network application the particu- (4) With respect to the second coun- lars of the transaction. This report try, substantial evidence is furnished must include the following informa- to the Administration by the applicant tion: The date on which the controlled for the export permit that— substance left the registered location; 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 (1) Both the country to which the must include the following informa- controlled substance is exported from tion: The date on which the controlled the United States (referred to in this substance left the registered location;

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the date on which the controlled sub- to be exported from the United States stance was released by a customs offi- to a country of the European Economic cer at the port of export; the actual Area for subsequent export from that quantity of controlled substance re- country to another country of the Eu- leased by a customs officer at the port ropean Economic Area, if the following of export; and the actual port of ex- conditions and the conditions of para- port. Upon receipt and review, the Ad- graphs (f)(1) through (4) and (6) of this ministration will assign a completed section are met, in accordance with report a transaction identification section 1003(f) of the Act (21 U.S.C. number. The report will not be deemed 953(f)): filed until the Administration has (1)(i) The controlled substance will issued a transaction identification not be exported from the second coun- number. In determining whether the try, except that the controlled sub- exporter has complied with the require- stance may be exported from a second ment to file within 30 calendar days, country that is a member of the Euro- the report shall be deemed filed on the pean Economic Area to another coun- first date on which a complete report is try that is a member of the European filed. Economic Area, provided that the first (ii) Return information for export from country is also a member of the Euro- a first country that is or is not a member pean Economic Area; and of the European Economic Area to a (ii) Subsequent to any reexportation country outside of the European Eco- described in paragraph (g)(1)(i) of this nomic Area; return information for export section, a controlled substance may from a first country that is not a member continue to be exported from any coun- of the European Economic Area to a mem- try that is a member of the European ber of the European Economic Area. Economic Area to any other such coun- Within 30 calendar days after the con- try, if— trolled substance is exported from the (A) The conditions applicable with first country to the second country the respect to the first country under para- exporter must file a report with the graphs (f)(1) through (4) and (6) of this Administration through the DEA Di- section and paragraph (g)(2) are met version Control Division secure net- with respect to each subsequent coun- work application specifying the par- try from which the controlled sub- ticulars of the export from the first stance is exported pursuant to this country. If the permit issued by the paragraph (g); and Administration authorized the reex- (B) The conditions applicable with port of a controlled substance from the respect to the second country under first country to more than one second paragraphs (f)(1) through (4) and (6) of country, a report for each individual this section and paragraph (g)(2) of this reexport is required. These reports section are met with respect to each must include the following informa- subsequent country to which the con- tion: Name of second country; actual trolled substance is exported pursuant quantity of controlled substance to this paragraph (g). shipped; and the date shipped from the (2) Return information for reexports first country, the actual port from among members of the European Eco- which the controlled substances were nomic Area—(i) Return information for shipped from the first country. Upon export from the United States, for reexport receipt and review, the Administration among members of the European Eco- will assign each completed report a nomic Area. Exporters must comply transaction identification number. The with the return reporting requirements report will not be deemed filed until of paragraph (f)(7)(i) of this section. the Administration has issued a trans- (ii) Reexports among members of the action identification number. 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

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file a report with the Administration is submitted. In addition, the following through the DEA Diversion Control Di- information must also be provided vision secure network application where indicated on the form: specifying the particulars of the ex- (i) Whether the drug or preparation port. These reports must include the will be reexported in bulk or finished name of country to which the con- dosage units; trolled substance was reexported, i.e., (ii) The product name, dosage another member of the European Eco- strength, commercial package size, and nomic Area; the actual quantity of quantity; and controlled substance shipped; the date (iii) The name of consignee, complete shipped from the first country, the address, and expected shipment date, name/business name, address/business as well as the name and address of the address, contact information (e.g., tele- ultimate consignee in the second coun- phone number(s), email address(es), try. etc.) and business of the consignee; and (4) The application must contain an the name/business name, address/busi- affidavit that the consignee in the sec- ness address, contact information (e.g., ond country, and any country of subse- telephone number(s), email address(es), quent reexport within the European etc.) and business of the exporter. Upon Economic Area, is authorized under the receipt and review, the Administration laws and regulations of the second and/ will assign each completed report a or subsequent country to receive the transaction identification number. The controlled substances. The affidavit report will not be deemed filed until must also contain the following state- the Administration has issued a trans- ments, in addition to the statements action identification number. required under paragraph (c) of this (h) Where a person is seeking to ex- section: port a controlled substance for reex- (i) That the packages are labeled in port outside of the European Economic conformance with the obligations of Area in accordance with paragraph (f) the United States under the Single of this section, the requirements of Convention on Narcotic Drugs, 1961, paragraphs (h)(1) through (7) of this the Convention on Psychotropic Sub- section shall apply in addition to (and stances, 1971, and any amendments to not in lieu of) the requirements of such treaties in effect; paragraphs (a) through (d) of this sec- (ii) That the controlled substances tion. Where a person is seeking to ex- are to be applied exclusively to medical port a controlled substance for reex- or scientific uses within the second port among members of the European country, or country of subsequent reex- Economic Area in accordance with port within the European Economic paragraph (g) of this section, the re- Area; quirements of paragraph (h)(4) of this (iii) That the controlled substances section shall apply in addition to (and will not be further reexported from the not in lieu of) the requirements of second country except as provided by paragraphs (a) through (d) of this sec- paragraph (f) of section 1003 of the Act tion. (21 U.S.C. 953(f)); and (1) Bulk substances will not be reex- (iv) That there is an actual need for ported in the same form as exported the controlled substances for medical from the United States, i.e., the mate- or scientific uses within the second rial must undergo further manufac- country, or country of subsequent reex- turing process. This further manufac- port within the European Economic tured material may only be reexported Area. to a second country. (5) If the applicant proposes that the (2) Finished dosage units, if reex- 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.

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(6) Except in the case of reexports ment was denied release and the reason among countries of the European Eco- for denial. Such report must be trans- nomic Area in accordance with section mitted to the Administration through 1003(f) of the Act (21 U.S.C. 953(f)), the the DEA Diversion Control Division se- controlled substance will be reexported cure network application. This report from the first country to the second must include the following informa- country (or second countries) no later tion: The quantity of the controlled than 180 calendar days after the con- substance denied release; the date on trolled substance was released by a which release was denied; the basis for customs officer from the United States. the denied release, the port from which (7) Shipments that have been ex- the denial was issued, and any other in- ported from the United States and are formation as the Administration may refused by the consignee in either the from time to time specify. Upon the ex- first or second country, or subsequent porter’s report of a denied release, DEA member of the European Economic will assign the report a transaction Area, or are otherwise unacceptable or identification number and the export undeliverable, may be returned to the permit will be void and of no effect. No registered exporter in the United shipment of controlled substances de- States upon authorization of the Ad- nied release for any reason will be al- ministration. In these circumstances, lowed to be released from the United the exporter in the United States must States unless the exporter submits a submit a written request for the return new DEA Form 161, 161R, or 161R–EEA, of the controlled substances to the as appropriate, and the Administration United States with a brief summary of issues a new export permit. the facts that warrant the return, [81 FR 97029, Dec. 30, 2016] along with a completed DEA Form 357 through the DEA Diversion Control Di- § 1312.23 Issuance of export permit. vision secure network application. The (a) The Administrator may authorize Administration will evaluate the reexportation of any controlled sub- quest after considering all the facts as stance listed in Schedule I or II or any well as the exporter’s registration sta- narcotic controlled substance listed in tus with the Administration. If the ex- Schedule III or IV if he finds that such porter provides sufficient justification, exportation is permitted by sub- the Administration may issue an im- sections 1003(a), (b), (c), (d), or (f) of the port permit for the return of these Act (21 U.S.C. 953(a), (b), (c), (d), or (f). drugs, and the exporter may then ob- (b) The Administrator may require tain an export permit from the country that such non-narcotic controlled sub- of original importation. The substance stances in Schedule III as shall be des- may not be returned to the United ignated by regulation in § 1312.30 of this States until after a permit has been part be exported only pursuant to the issued by the Administration. issuance of an export permit. The Ad- (i) In considering whether to grant an ministrator may authorize the expor- application for a permit under para- tation of such substances if he finds graphs (f), (g), and (h) of this section, that such exportation is permitted by the Administration shall consider section 1003(e) of the Act (21 U.S.C. whether the applicant has previously 953(e)). obtained such a permit and, if so, (c) If a non-narcotic substance listed whether the applicant complied fully in Schedule IV or V is also listed in with the requirements of this section Schedule I or II of the Convention on with respect to that previous permit. Psychotropic Substances, it shall be (j) Denied release at the port of export. exported only pursuant to the issuance In the event that a shipment of con- of an export permit. The Administrator trolled substances has been denied re- may authorize the exportation of such lease by a customs officer at the port substances if he finds that such expor- export from the United States for any tation is permitted by section 1003(e) of reason, the exporter who attempted to the Act (21 U.S.C. 953(e)). have the shipment released must, with- (d) The Administrator may require in 5 business days of the denial, report an applicant to submit such documents to the Administration that the ship- or written statements of fact relevant

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to the application as he deems nec- posed to be imported, will be exceeded. essary to determine whether the appli- If it shall appear through subsequent cation should be granted. The failure of advice received from the International the applicant to provide such docu- Narcotics Control Board of the United ments or statements within a reason- Nations that the estimates or assess- able time after being requested to do so ments of the country of destination shall be deemed to be a waiver by the have been adjusted to permit further applicant of an opportunity to present importation of the controlled sub- such documents or facts for consider- stance, an export permit may then be ation by the Administrator in granting issued if otherwise permissible. or denying the application. [36 FR 23625, Dec. 11, 1971, as amended at 37 (e) If an exportation is approved, the FR 15923, Aug. 8, 1972. Redesignated at 38 FR Administrator shall issue an export 26609, Sept. 24, 1973, and amended at 52 FR permit bearing his or her signature or 17290, May 7, 1987; 72 FR 72929, Dec. 26, 2007; that of his or her delegate. Each permit 81 FR 97032, Dec. 30, 2016] will be assigned a permit number that is a unique, randomly generated identi- § 1312.24 Distribution of export permit. fier. A permit shall not be altered or changed by any person after being The Administration shall transmit signed. Any change or alteration upon the export permit to the competent na- the face of any permit after it has been tional authority of the importing coun- signed renders it void and of no effect. try and shall make available to the ex- 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 [81 FR 97032, Dec. 30, 2016] to that country for the current period, under the Single Convention on Nar- § 1312.25 Amendment, cancellation, ex- cotic Drugs, 1961, or the Convention on piration of export permit. Psychotropic Substances, 1971, have (a) Exporters may only request that been, or, considering the quantity pro- an export permit or application for an

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export permit be amended in accord- (4) An exporter may request that an ance with paragraphs (a)(1) through (7) export permit or application for a per- of this section. Requests for an amend- mit be amended to change any reg- ment must be submitted through the istrant notes. DEA Diversion Control Division secure (5) Prior to departure of the shipment network application. Except as pro- from the exporter’s registered location, vided in paragraph (a)(5) of this section an exporter may request that an export exporters must submit all requests for permit or application for a permit be an amendment at least one full busi- amended to increase the total base ness day in advance of the date of re- weight of a controlled substance. How- lease from the port of export. Export- ever, the total base weight or the ers must specifically request that an strength of the product (if listed) of a amendment be made; supplementary controlled substance may not exceed information submitted by an exporter that permitted for import as indicated through the DEA Diversion Control Di- on the import permit from the foreign vision secure network application will competent national authority. Export- not automatically trigger the amend- ers are not required to amend an ex- ment process. While the request for an port permit for the sole purpose of de- amendment is being reviewed by the creasing the total base weight of a con- Administration, the original permit trolled substance authorized to be ex- will be temporarily stayed and may not ported. However, the balance of any 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 lift- (6) An exporter may request that an ed, the originally issued permit may export permit be amended to remove a immediately be used to authorize re- controlled substance from the permit. lease of a shipment in accordance with However, an exporter may not amend the terms of the permit. an export permit to add or replace a (1) An exporter may request that an controlled substance to the item(s) to export permit or application for a per- be exported. Exporters who desire to mit be amended to change the National export a different controlled substance Drug Control number, description of than that contained on their issued ex- the packaging, or trade name of the port permit or permit application must product, so long as the description is submit a request for the permit or per- for the same basic class of controlled mit application to be canceled and re- substance as in the original permit. quest a new permit in accordance with (2) An exporter may request that an § 1312.22. export permit or application for a per- (7) An exporter may not amend the mit be amended to change the proposed exporter’s name (as it appears on their port of export, the anticipated date of DEA certificate of registration), the release by a customs officer, or the name of the foreign importer(s), or the method of transport. foreign permit information as provided (3) An exporter may request that an in the DEA Form 161, 161R, or 161R– export permit or application for a per- EEA. Exporters who need to make any mit be amended to change the jus- changes to any of these fields must tification provided as to why an export submit a request for the permit or per- shipment is needed to meet the legiti- mit application to be canceled and re- mate scientific or medical needs of the quest a new permit in accordance with country of import. § 1312.22.

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(b) An export permit will be void and dress of the registered location from of no effect after the date specified which the substances will be shipped therein, which date must conform to for exportation. Upon receipt and re- the expiration date specified in the view, the Administration will issue a supporting import certificate or other completed declaration a transaction documentary evidence upon which the identification number. The export dec- export permit is founded, but in no laration is not deemed filed, and there- event will the date be more than 180 fore not valid, until the Administra- calendar days after the date the permit tion has issued a transaction identi- is issued. fication number. The exporter may (c) An export permit may be canceled only proceed with the export trans- after being issued, at the request of the action once the transaction identifica- exporter submitted to the Administra- tion number has been issued. tion through the DEA Diversion Con- (b)(1) DEA Form 236 must include the trol Division secure network applica- following information: tion, provided that no shipment has (i) The name/business name, address/ been made thereunder. Nothing in this business address, contact information 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 [81 FR 97032, Dec. 30, 2016] address, contact information (e.g., telephone 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:

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(A) The consignee is authorized under undeliverable, may be returned to the the laws and regulations of the country registered exporter in the United of destination to receive the controlled States upon authorization of the Ad- substances; and ministration. In this circumstance, the (B) The substance is being imported exporter in the United States must file for consumption within the importing a written request for reexport, along country to satisfy medical, scientific with a completed DEA Form 236, with or other legitimate purposes. the Administration through the DEA (v) The reexport of non-narcotic con- Diversion Control Division secure net- trolled substances in Schedules III and work application. A brief summary of IV, and controlled substances in Sched- the facts that warrant the return of the ule V is not permitted under the au- substance to the United States along thority of 21 U.S.C. 953(e), except as with an authorization from the coun- provided below and in paragraph try of export must be included with the (b)(1)(vi) of this section: request. DEA will evaluate the request (A) Bulk substances will not be reex- after considering all the facts as well ported in the same form as exported as the exporter’s registration status from the United States, i.e., the material must undergo further manufac- with DEA. The substance may be re- turing process. This further manufac- turned to the United States only after tured material may only be reexported affirmative authorization is issued in to a country of ultimate consumption. writing by DEA. (B) Finished dosage units, if reex- (vi) The reexport of non-narcotic con- ported, will be in a commercial pack- trolled substances in Schedules III and age, properly sealed and labeled for le- IV, and controlled substances in Sched- gitimate medical use in the country of ule V is permitted among members of destination. the European Economic Area only as (C) Any reexportation be made provided below: known to DEA at the time the initial (A) The controlled substance will not DEA Form 236, Controlled Substances be exported from the second country or Import/Export Declaration is com- a subsequent country, except that the pleted, by checking the box marked controlled substance may be exported ‘‘other’’ on the certification. The fol- from a second country or a subsequent lowing information will be furnished in country that is a member of the Euro- the remarks section: pean Economic Area to another coun- (1) Indicate ‘‘for reexport’’. try that is a member of the European (2) Indicate if reexport is bulk or fin- Economic Area, provided that the first ished dosage units. country is also a member of the Euro- (3) Indicate product name, dosage pean Economic Area; each country is a strength, commercial package size, and party to the Convention on Psycho- quantity. tropic Substances, 1971, as amended; ( ) Indicate name of consignee, com- 4 and each country has instituted and plete address, and expected shipment maintains, in conformity with such date, as well as, the name and address Convention, a system of controls of im- of the ultimate consignee in the coun- ports of controlled substances which try to where the substances will be reexported. the Attorney General deems adequate. (5) A statement that the consignee in (B) Each shipment of finished dosage the country of ultimate destination is units, if reexported, must be in a com- authorized under the laws and regula- mercial package, properly sealed and tions of the country of ultimate des- labeled for legitimate medical use in tination to receive the controlled sub- the country of destination. stances. (C) Any reexportation must be made (D) Shipments that have been ex- known to DEA at the time the initial ported from the United States and are DEA Form 236, Controlled Substances refused by the consignee in either the Import/Export Declaration is com- first or second country, or subsequent pleted, by checking the box marked member of the European Economic ‘‘other’’ on the certification. In addi- Area, or are otherwise unacceptable or tion to the requirements of paragraph

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(b) of this section, the following infor- tity of the controlled substance that mation will be furnished in the re- left the registered location; and the ac- marks section: tual quantity of the controlled sub- (1) Indicate ‘‘for reexport among stance released by a customs officer at members of the European Economic the port of export; the actual port of Area’’. export. Upon receipt and review, the (2) Indicate if reexport is bulk or fin- Administration will assign a completed ished dosage units. report a transaction identification (3) Indicate product name, dosage number. The report will not be deemed strength, commercial package size, and filed until the Administration has quantity. issued a transaction identification (4) Indicate the name/business name, number. address/business address, contact infor- (2) Return information for reexports mation (e.g., telephone number(s), outside of the European Economic Area— email address(es) and business of the (i) Return information for export from the consignee in the first country). United States, for reexport. Within 30 cal- (5) A statement that the consignee in endar days after the controlled sub- the second country, and any subse- stance is released by a customs officer quent consignee within the European at the port of export the exporter must 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 nomic Area; return information for export released by a customs officer at the from a first country that is not a member port of export, or within 10 calendar of the European Economic Area to a mem- days after receipt of a written request ber of the European Economic Area. by the Administration to the exporter, Within 30 calendar days after the con- whichever is sooner, the exporter must trolled substance is exported from the file a report with the Administration first country to the second country the through the DEA Diversion Control Di- exporter must file a report with the vision secure network application Administration through the DEA Di- specifying the particulars of the trans- version Control Division secure net- action. This report must include the work application specifying the par- following information: The date on ticulars of the export from the first which the controlled substance left the country. If the permit issued by the registered location; the date on which Administration authorized the reex- the controlled substance was released port of a controlled substance from the by a customs officer; the actual quan- first country to more than one second

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country, a report for each individual amendment to an export permit, as set reexport is required. These reports forth in § 1312.25(a)(1) through (7). must include the following informa- Amendments to declarations must be tion: Name of second country; actual submitted through the DEA Diversion quantity of controlled substance Control Division secure network appli- shipped; the date shipped from the first cation. Except as provided in country; and the actual port from § 1312.25(a)(5) exporters must submit all which the controlled substances were amendments at least one full business shipped from the first country. Upon day in advance of the date of release by receipt and review, the Administration a customs officer. Exporters must spe- will assign each completed report a cifically note that an amendment is transaction identification number. The being made; supplementary informa- report will not be deemed filed until tion submitted by an exporter through the Administration has issued a trans- the DEA Diversion Control Division se- action identification number. cure network application will not auto- (3) Reexports among members of the Eu- matically be considered an amend- ropean Economic Area—(i) Return infor- ment. Upon receipt and review, the Ad- mation for exports from the United States, for reexport among members of the Euro- ministration will assign each com- pean Economic Area. Exporters must pleted amendment a transaction iden- comply with the return reporting re- tification number. The amendment will quirements of paragraph (d)(2)(i) of this not be deemed filed until the Adminis- section. tration issues a transaction identifica- (ii) Reexports among members of the tion number. The DEA and the ex- European Economic Area. Within 30 cal- porter will distribute the amended dec- endar days after the controlled sub- laration in accordance with § 1312.28. A stance is exported from the first coun- filed amendment will not change the try to the second country, and within date that the declaration becomes void 30 calendar days of each subsequent re- and of no effect in accordance with export within the European Economic paragraph (f) of this section. Area, if any, the exporter must file a (f) An export declaration may be can- 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), etc.) and business of the consignee; and who attempted to have the shipment the name/business name, address/busi- released must, within 5 business days ness address, contact information (e.g., of the denial, report to the Administra- telephone number(s), email address(es), tion that the shipment was denied re- etc.) and business of the exporter. Upon lease and the reason for denial. Such receipt and review, the Administration report must be transmitted to the Ad- will assign each completed report a ministration through the DEA Diver- transaction identification number. The sion Control Division secure network report will not be deemed filed until application. This report must include 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

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denied release, DEA will assign the re- any other circumstances, release a port a transaction identification num- shipment of controlled substances to ber and the export declaration will be anyone, including the foreign con- void and of no effect. No shipment of signee or his agent, within the United controlled substances denied release States. for any reason will be allowed to be released unless the exporter files a new § 1312.30 Schedule III, IV, and V non- declaration and the Administration narcotic controlled substances re- issues a new transaction identification quiring an import and export per- number. mit. The following Schedule III, IV, and V [36 FR 7815, Apr. 24, 1971, as amended at 37 FR 15923, Aug. 8, 1972. Redesignated at 38 FR non-narcotic controlled substances 26609, Sept. 24, 1973, and amended at 45 FR have been specifically designated by 74715, Nov. 12, 1980; 51 FR 5319, Feb. 13, 1986; the Administrator of the Drug Enforce- 52 FR 17290, May 7, 1987; 62 FR 13969, Mar. 24, ment Administration as requiring im- 1997; 75 FR 10683, Mar. 9, 2010; 81 FR 97033, port and export permits pursuant to Dec. 30, 2016] sections 1002(b)(2) and 1003(e)(3) of the Act (21 U.S.C. 952(b)(2) and 953(e)(3)): § 1312.28 Distribution of export dec- (a) Dronabinol (synthetic) in sesame laration. oil and encapsulated in a soft gelatin (a) The exporter must ensure that an capsule in a U.S. Food and Drug Ad- official record of the export declaration ministration approved product. (available from the DEA Diversion (b) [Reserved] Control Division secure network application after the Administration issues [52 FR 17291, May 7, 1987, as amended at 64 a transaction identification number) FR 35930, July 2, 1999] accompanies the shipment of con- TRANSSHIPMENT AND IN-TRANSIT trolled substances to its destination. SHIPMENT OF CONTROLLED SUBSTANCES (b) The exporter, or their agent, must submit an official record of the export § 1312.31 Schedule I: Application for declaration and/or required data con- prior written approval. cerning the export transaction to a (a) A controlled substance listed in customs officer at the port of export in schedule I may be imported into the compliance with all export control re- United States for transshipment, or quirements of agencies with export may be transferred or transshipped control authorities under the Act or within the United States for immediate statutory authority other than the exportation, provided that: Controlled Substances Import and Ex- (1) The controlled substance is nec- port Act. essary for scientific, medical, or other (c) The exporter must maintain an legitimate purposes in the country of official record of the export declaration destination, and and return information (both available (2) A transshipment permit has been from the Diversion Control Division se- issued by the Administrator. cure network application after the Ad- (b) An application for a trans- ministration issues a transaction iden- shipment permit must be submitted to tification number) required pursuant the Regulatory Section, Diversion Con- to § 1312.27(d) as his or her record of au- trol Division, Drug Enforcement Ad- thority for the exportation, in accord- ministration, at least 30 calendar days, ance with part 1304 of this chapter. or in the case of an emergency as soon [81 FR 97035, Dec. 30, 2016] as is practicable, prior to the expected date of arrival at the first port in the § 1312.29 Domestic release prohibited. United States. See the Table of DEA An exporter or a forwarding agent Mailing Addresses in § 1321.01 of this acting for an exporter must either de- chapter for the current mailing ad- liver the controlled substances to the dress. A separate permit is required for port or border, or deliver the controlled each shipment of controlled substance substances to a bonded carrier ap- to be imported, transferred, or trans- proved by the consignor for delivery to shipped. Each application must contain the port or border, and may not, under the following:

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(1) The date of execution; (4) If the import license or permit, or (2) The identification and description the certified copy of such, is not writ- of the controlled substance; ten in English or bilingual with an- (3) The net quantity thereof; other language and English, the appli- (4) The number and size of the con- cation must include a certified trans- trolled substance containers; lation of the permit or license. For pur- (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

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transshipped within the United States involved in the issuance or denial of for immediate exportation, provided such permit to such person. that written notice is submitted to the (b) Extensive argument should not be Regulatory Section, Diversion Control offered into evidence but rather pre- Division, Drug Enforcement Adminis- sented in opening or closing state- tration, at least 15 calendar days prior ments of counsel or in memoranda or 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 current mailing addresses. FR 15923, Aug. 8, 1972. Redesignated at 38 FR 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 must contain those items required by The Administrator of the presiding § 1312.31(b) and (c). If the export license, officer (with respect to matters pend- permit, or other authorization, issued ing before him) may modify or waive by a competent national authority of any rule in this part by notice in ad- the country of origin, is not written in vance of the hearing, if he determines 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

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hearing unless he shows good cause for sions of law upon which the order is such failure. based. The Administrator shall serve (d) If the applicant waives or is one copy of his order upon the appli- deemed to have waived this oppor- cant. tunity for the hearing, the Adminis- [37 FR 15924, Aug. 8, 1972. Redesignated at 38 trator may cancel the hearing, if FR 26609, Sept. 24, 1973] scheduled, and issue his final order pursuant to § 1312.47 without a hearing. PART 1313—IMPORTATION AND [37 FR 15923, Aug. 8, 1972. Redesignated at 38 EXPORTATION OF LIST I AND LIST FR 26609, Sept. 24, 1973] II CHEMICALS § 1312.45 Burden of proof. Sec. At any hearing on the denial of an 1313.01 Scope. application for an import, export, or 1313.02 Definitions. transshipment permit, the Adminis- 1313.03 Forms applicable to this part. trator shall have the burden of proving 1313.05 Requirements for an established that the requirements for such permit business relationship. pursuant to sections 1002, 1003, and 1004 1313.08 Requirements for establishing a of the Act (21 U.S.C. 952, 953, and 954) record as an importer. are not satisfied. IMPORTATION OF LISTED CHEMICALS [37 FR 15924, Aug. 8, 1972. Redesignated at 38 1313.12 Notification prior to import. FR 26609, Sept. 24, 1973] 1313.13 Requirements of import declaration. 1313.14 Disposition of import declaration. § 1312.46 Time and place of hearing. 1313.15 Qualification of regular importers. (a) If any applicant for an import, ex- 1313.16 Updated notice for change in cir- port, or transshipment permit requests cumstances. a hearing on the issuance or denial of 1313.17 Return declaration for imports. 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 Form 486 for international transactions. § 1312.47 Final order. 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- HEARINGS trator shall issue his order on the 1313.51 Hearings generally. issuance or denial of the application 1313.52 Purpose of hearing. for and import, export, or trans- 1313.53 Waiver of modification of rules. shipment permit. The order shall in- 1313.54 Request for hearing. clude the findings of fact and conclu- 1313.55 Burden of proof.

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1313.56 Time and place of hearing. the listed chemical or chemicals will 1313.57 Final order. be applied; AUTHORITY: 21 U.S.C. 802, 830, 871(b), 971. (d) The duration of the business relationship; SOURCE: 54 FR 31665, Aug. 1, 1989, unless otherwise noted. (e) The frequency and number of transactions occurring during the pre- § 1313.01 Scope. ceding 12-month period; Procedures governing the importa- (f) The amounts and the listed chem- tion, exportation, transshipment and ical or chemicals involved in regulated in-transit shipment of listed chemicals transactions between the chemical im- pursuant to section 1018 of the Act (21 porter or exporter and regular cus- U.S.C. 971) are governed generally by tomer; that section and specifically by the (g) The method of delivery (direct sections of this part. shipment or through a broker or forwarding agent); and [54 FR 31665, Aug. 1, 1989, as amended at 60 FR 32465, June 22, 1995] (h) Other information that the chemical importer or exporter considers rel- § 1313.02 Definitions. evant for determining whether a customer is a regular customer. Any term used in this part shall have the definition set forth in section 102 of [72 FR 17407, Apr. 9, 2007] the Act (21 U.S.C. 802) or part 1300 of this chapter. § 1313.08 Requirements for establishing a record as an importer. [62 FR 13969, Mar. 24, 1997] To establish a record as an importer, § 1313.03 Forms applicable to this part. the regulated person must provide the Administrator with the following infor- Access/ Form submission mation in accordance with the waiver of the 15-day advance notice require- DEA Form 486, Import/Export Declaration electronic. ments of § 1313.15: for List I and List II Chemicals. DEA Form 486A Import Declaration for electronic. (a) The name, DEA registration num- ephedrine, pseudoephedrine, and phen- ber (where applicable), street address, ylpropanolamine (including drug prod- telephone number, and, where avail- ucts containing these chemicals). able, the facsimile number of the regulated person and of each foreign sup- [81 FR 97036, Dec. 30, 2016] plier; and (b) The frequency and number of § 1313.05 Requirements for an established business relationship. transactions occurring during the preceding 12 month period. To document that an importer or exporter has an established business rela- [72 FR 17407, Apr. 9, 2007] tionship with a customer, the importer 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 (a) Each regulated person who seeks or § 1313.24: 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

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below the threshold quantities identi- fore the date of release by a customs fied in § 1310.04(f) are not required to officer at the port of entry. The dec- file an import declaration in advance laration must be signed and dated by of the release by a customs officer. the importer and must contain the ad- (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 (f) The 15 day advance notification of the following requirements: requirement set forth in paragraph (a) (i) The regulated person has satisfied has been waived for imports of the fol- the requirements for reporting to the lowing listed chemicals: Administration as a regular importer (1) Acetone. of the listed chemicals. (2) 2-Butanone (or Methyl Ethyl Ke- (ii) The importer intends to transfer tone or MEK). the listed chemicals to a person who is (3) Toluene. a regular customer for the chemical, as defined in § 1300.02 of this chapter. [54 FR 31665, Aug. 1, 1989, as amended at 59 FR 51367, Oct. 11, 1994; 60 FR 32464, June 22, (2) A specific listed chemical, as set 1995; 66 FR 46520, Sept. 6, 2001; 67 FR 49569, forth in paragraph (f) of this section, July 31, 2002; 72 FR 17407, Apr. 9, 2007; 75 FR for which the Administrator deter- 10683, Mar. 9, 2010; 77 FR 4237, Jan. 27, 2012; 81 mines that advance notification is not FR 97036, Dec. 30, 2016] necessary for effective chemical diversion control. § 1313.13 Requirements of import dec- (d) For imports meeting the require- laration. ments of paragraph (c)(1) of this sec- (a) Any List I or List II chemical list- tion, the declaration (DEA Form 486/ ed in § 1310.02 of this chapter may be 486A) must be filed with the Adminis- imported if that chemical is necessary tration through the DEA Diversion for medical, commercial, scientific, or Control Division secure network appli- other legitimate uses within the cation at least three business days be- United States. Chemical importations

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

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

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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.fdsys.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 Appeal from ruling of pre- pearing in the evidence of record, any siding officer. party, on timely request, shall be af- Rulings of the presiding officer may forded opportunity to controvert such not be appealed to the Administrator fact. prior to his consideration of the entire (f) The presiding officer shall file as hearing, except with the consent of the exhibits copies of the following docu- presiding officer and where he certifies ments: on the record or in writing that the al- (1) The order to show cause or notice lowance of an interlocutory appeal is of hearing; clearly necessary to prevent excep- (2) Any notice of waiver or modifica- tional delay, expense, or prejudice to tion of rules made pursuant to § 1316.44 any party or substantial detriment to or otherwise; the public interest. If an appeal is al- (3) Any waiver of hearing (together lowed, any party in the hearing may with any statement filed therewith) file a brief in quintuplicate with the filed pursuant to § 1316.49 or otherwise; Administrator within such period that (4) The prehearing ruling, if any, the presiding officer directs. No oral made pursuant to § 1316.55; argument will be heard unless the Ad- (5) Any other document necessary to ministrator directs otherwise. show the basis for the hearing. § 1316.63 Official transcript; index; § 1316.60 Objections; offer of proof. corrections. If any party in the hearing objects to (a) Testimony given at a hearing the admission or rejection of any evi- shall be reported verbatim. The Admin- dence or to other limitation of the istration will make provision for a scope of any examination or cross-ex- stenographic record of the testimony amination, he shall state briefly the and for such copies of the transcript grounds for such objection without ex- thereof as it requires for its own pur- tended argument or debate thereon ex- pose. cept as permitted by the presiding offi- (b) At the close of the hearing, the cer. A ruling of the presiding officer on presiding officer shall afford the par- any such objection shall be a part of ties and witnesses time (not longer the transcript together with such offer than 30 days, except in unusual cases) of proof as has been made if a proper in which to submit written proposed

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corrections of the transcript, pointing port, and any exceptions thereto which out errors that may have been made in may have been filed by the parties. transcribing the testimony. The pre- [36 FR 7778, Apr. 24, 1971. Redesignated at 38 siding officer shall promptly thereafter FR 26609, Sept. 24, 1973 and amended at 44 FR order such corrections made as in his 55332, Sept. 26, 1979] judgment are required to make the transcript conform to the testimony. § 1316.66 Exceptions. [36 FR 7820, Apr. 24, 1971, as amended at 36 (a) Within twenty days after the date FR 13387, July 21, 1971. Redesignated at 38 FR upon which a party is served a copy of 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 [44 FR 55332, Sept. 26, 1979] and conclusions of law, with the reasons therefore; and § 1316.67 Final order. (3) His recommended decision. As soon as practicable after the pre- (b) The presiding officer shall serve a siding officer has certified the record copy of his report upon each party in to the Administrator, the Adminis- the hearing. The report shall be consid- trator shall cause to be published in ered to have been served when it is the FEDERAL REGISTER his final order mailed to such party or its attorney of in the proceeding, which shall set forth record. the final rule and the findings of fact (c) Not less than twenty-five days and conclusions of law upon which the after the date on which he caused cop- rule is based. This order shall specify ies of his report to be served upon the the date on which it shall take effect, parties, the presiding officer shall cer- which date shall not be less than 30 tify to the Administrator the record, days from the date of publication in which shall contain the transcript of the FEDERAL REGISTER unless the Ad- testimony, exhibits, the findings of ministrator finds that the public inter- fact and conclusions of law proposed by est in the matter necessitates an ear- the parties, the presiding officer’s re- lier effective date, in which event the

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Administrator shall specify in the SOURCE: 79 FR 33565, Sept. 9, 2014, unless order his findings as to the conditions otherwise noted. which led him to conclude that an earlier effective date was required. § 1317.01 Scope. This part sets forth the rules for the [44 FR 42179, July 19, 1979, as amended at 44 delivery, collection, and destruction of FR 55332, Sept. 26, 1979] damaged, expired, returned, recalled, § 1316.68 Copies of petitions for judi- unused, or otherwise unwanted con- cial review. trolled substances that are lawfully Copies of petitions for judicial re- possessed by registrants (subpart A) view, filed pursuant to section 507 of and non-registrants (subpart B). The the Act (21 U.S.C. 877) shall be deliv- purpose of such rules is to provide 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 Substances by Registrants [36 FR 7820, Apr. 24, 1971. Redesignated at 44 FR 42179, July 19, 1979] § 1317.05 Registrant disposal. (a) Practitioner inventory. Any reg- PART 1317—DISPOSAL istered practitioner in lawful possession of a controlled substance in its in- Sec. 1317.01 Scope. ventory that desires to dispose of that substance shall do so in one of the fol- Subpart A—Disposal of Controlled lowing ways: Substances by Registrants (1) Promptly destroy that controlled substance in accordance with subpart C 1317.05 Registrant disposal. of this part using an on-site method of 1317.10 Registrant return or recall. 1317.15 Reverse distributor registration re- destruction; quirements and authorized activities. (2) Promptly deliver that controlled substance to a reverse distributor’s Subpart B—Disposal of Controlled Sub- registered location by common or con- stances Collected From Ultimate Users tract carrier pick-up or by reverse dis- and Other Non-Registrants tributor pick-up at the registrant’s registered location; 1317.30 Authorization to collect from non- (3) For the purpose of return or re- registrants. 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. rier pick-up or pick-up by other reg- 1317.55 Reverse distributor and distributor istrants at the registrant’s registered acquisition of controlled substances from location to: The registered person from collectors or law enforcement. whom it was obtained, the registered 1317.60 Inner liner requirements. manufacturer of the substance, or an- 1317.65 Take-back events. 1317.70 Mail-back programs. other registrant authorized by the 1317.75 Collection receptacles. manufacturer to accept returns or re- 1317.80 Collection receptacles at long-term calls on the manufacturer’s behalf; or care facilities. (4) Request assistance from the Spe- 1317.85 Ultimate user delivery for the pur- cial Agent in Charge of the Adminis- pose of recall or investigational use of tration in the area in which the practi- drugs. tioner is located. Subpart C—Destruction of Controlled (i) The request shall be made by sub- Substances mitting one copy of the DEA Form 41 to the Special Agent in Charge in the 1317.90 Methods of destruction. practitioner’s area. The DEA Form 41 1317.95 Destruction procedures. shall list the controlled substance or AUTHORITY: 21 U.S.C. 821, 822, 823, 827, 828, substances which the registrant desires 871(b), and 958. to dispose.

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(ii) The Special Agent in Charge shall tributor, the location of destruction, or instruct the registrant to dispose of the registered location of any person the controlled substance in one of the authorized to receive that controlled following manners: substance for the purpose of return or (A) By transfer to a registrant au- recall as described in paragraph (b)(3) thorized to transport or destroy the of this section. substance; (i) If a non-practitioner transports (B) By delivery to an agent of the Ad- controlled substances by its own means ministration or to the nearest office of to an unregistered location for destruc- the Administration; or tion, the non-practitioner shall do so in (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 one of the following ways: (1) Mail-back program. Upon receipt of (1) Promptly destroy that controlled a sealed mail-back package, the col- substance in accordance with subpart C lector shall promptly: of this part using an on-site method of (i) Destroy the package in accordance destruction; with subpart C of this part using an on- (2) Promptly deliver that controlled site method of destruction; or substance to a reverse distributor’s (ii) Securely store the package and registered location by common or con- its contents at the collector’s reg- tract carrier or by reverse distributor istered location in a manner consistent pick-up at the registrant’s registered with § 1301.75(c) of this chapter (for location; practitioners), or in a manner con- (3) For the purpose of return or re- sistent with the security requirements call, promptly deliver that controlled for Schedule II controlled substances substance by common or contract car- (for non-practitioners) until prompt rier or pick-up at the registrant’s reg- on-site destruction can occur. istered location to: The registered per- (2) Collection receptacles. Upon re- son from whom it was obtained, the moval from the permanent outer con- registered manufacturer of the sub- tainer, the collector shall seal it and stance, or another registrant author- promptly: ized by the manufacturer to accept re- (i) Destroy the sealed inner liner and turns or recalls on the manufacturer’s its contents; behalf; or (ii) Securely store the sealed inner (4) Promptly transport that con- liner and its contents at the collector’s trolled substance by its own means to registered location in a manner con- the registered location of a reverse dis- sistent with § 1301.75(c) of this chapter

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(for practitioners), or in a manner con- § 1317.15 Reverse distributor registra- sistent with § 1301.72(a) of this chapter tion requirements and authorized (for non-practitioners) until prompt de- activities. struction can occur; or (a) Any person that reverse distrib- (iii) Securely store the sealed inner utes a controlled substance shall be liner and its contents at a long-term registered with the Administration as care facility in accordance with a reverse distributor, unless exempted § 1317.80(d). by law or otherwise authorized pursu- (iv) Practitioner methods of destruction. ant to this chapter. Collectors that are practitioners (i.e., (b) A reverse distributor shall acquire retail pharmacies and hospitals/clinics) controlled substances from a registrant shall dispose of sealed inner liners and pursuant to §§ 1317.05 and 1317.55(a) and their contents by utilizing any method (c) in the following manner: in paragraph (a)(1), (a)(2), or (a)(4) of (1) Pick-up controlled substances this section, or by delivering sealed from a registrant at the registrant’s inner liners and their contents to a dis- registered location or authorized col- tributor’s registered location by com- lection site; or mon or contract carrier pick-up or by (2) Receive controlled substances de- distributor pick-up at the collector’s livered by common or contract carrier authorized collection location. or delivered directly by a non-practi- (v) Non-practitioner methods of destruc- tioner registrant. tion. Collectors that are non-practi- (i) Delivery to the reverse distributor tioners (i.e., manufacturers, distribu- by an authorized registrant directly or tors, narcotic treatment programs, and by common or contract carrier may reverse distributors) shall dispose of only be made to the reverse distributor sealed inner liners and their contents at the reverse distributor’s registered by utilizing any method in paragraph location. Once en route, such deliveries (b)(1), (b)(2), or (b)(4) of this section, or may not be re-routed to any other loca- by delivering sealed inner liners and tion or person, regardless of registra- their contents to a distributor’s reg- tion status. istered location by common or con- (ii) All controlled substance deliv- tract carrier or by distributor pick-up eries to a reverse distributor shall be at the collector’s authorized collection personally received by an employee of location for destruction. Freight for- the reverse distributor at the reg- warding facilities may not be utilized istered location. to transfer sealed inner liners and their (c) Upon acquisition of a controlled contents. substance by delivery or pick-up, a reverse distributor shall: § 1317.10 Registrant return or recall. (1) Immediately store the controlled (a) Each registrant shall maintain a substance, in accordance with the secu- record of each return or recall trans- rity controls in parts 1301 and 1317 of action in accordance with the informa- this chapter, at the reverse distribution required of manufacturers in tor’s registered location or imme- § 1304.22(a)(2)(iv) of this chapter. diately transfer the controlled sub- (b) Each registrant that delivers a stance to the reverse distributor’s reg- controlled substance in Schedule I or II istered location for secure storage, in for the purpose of return or recall shall accordance with the security controls use an order form in the manner de- in parts 1301 and 1317 of this chapter, scribed in part 1305 of this chapter. until timely destruction or prompt re- (c) Deliveries for the purpose of return of the controlled substance to the turn or recall may be made through a registered manufacturer or other reg- freight forwarding facility operated by istrant authorized by the manufacturer the person to whom the controlled sub- to accept returns or recalls on the stance is being returned provided that manufacturer’s behalf; advance notice of the return is pro- (2) Promptly deliver the controlled vided and delivery is directly to an substance to the manufacturer or an- agent or employee of the person to other registrant authorized by the whom the controlled substance is being manufacturer to accept returns or re- returned. calls on the manufacturer’s behalf; or

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(3) Timely destroy the controlled (2) Mail-back programs in accordance substance in a manner authorized in with § 1317.70; or subpart C of this part. (3) Collection receptacles located in- (d) A reverse distributor shall de- side law enforcement’s physical ad- stroy or cause the destruction of any dress. controlled substance received for the (b) Law enforcement that conducts a purpose of destruction no later than 30 take-back event or a mail-back pro- calendar days after receipt. gram or maintains a collection receptacle should maintain any records of Subpart B—Disposal of Controlled 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 died while in lawful possession of a inner liner as described in § 1317.60 is controlled substance; and used, the unique identification number (3) A long-term care facility on be- of the sealed inner liner transferred, half of an ultimate user who resides or and the size of the sealed inner liner resided at such long-term care facility transferred (e.g., 5-gallon, 10-gallon, and is/was in lawful possession of a etc.); if a mail-back package as de- controlled substance, in accordance scribed in § 1317.70 is used, the unique with § 1317.80 only. identification number of each package; the date of the transfer; and the name, § 1317.35 Collection by law enforce- address, and registration number of the ment. reverse distributor to whom the con- (a) Federal, State, tribal, or local law trolled substances were transferred. enforcement may collect controlled substances from ultimate users and § 1317.40 Registrants authorized to col- persons lawfully entitled to dispose of lect and authorized collection ac- an ultimate user decedent’s property tivities. using the following collection methods: (a) Manufacturers, distributors, re- (1) Take-back events in accordance verse distributors, narcotic treatment with § 1317.65; programs, hospitals/clinics with an on-

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site pharmacy, and retail pharmacies (2) Dispose of the controlled sub- that desire to be collectors shall mod- stances in the manner authorized for ify their registration to obtain author- reverse distributors § 1317.15(c) and (d); ization to be a collector in accordance and with § 1301.51 of this chapter. Author- (3) Securely store the controlled sub- ization to be a collector is subject to stances in a manner consistent with renewal. If a registrant that is author- the security requirements for Schedule ized to collect ceases activities as a II controlled substances until timely collector, such registrant shall notify destruction can occur. the Administration in accordance with § 1301.52(f) of this chapter. § 1317.60 Inner liner requirements. (b) Collection by registrants shall (a) An inner liner shall meet the fol- occur only at the following locations: lowing requirements: (1) Those registered locations of man- (1) The inner liner shall be water- ufacturers, distributors, reverse dis- proof, tamper-evident, and tear-resist- tributors, narcotic treatment pro- ant; grams, hospitals/clinics with an on-site (2) The inner liner shall be removable pharmacy, and retail pharmacies that and sealable immediately upon re- are authorized for collection; and moval without emptying or touching (2) Long-term care facilities at which the contents; registered hospitals/clinics or retail (3) The contents of the inner liner pharmacies are authorized to maintain shall not be viewable from the outside collection receptacles. when sealed; (c) Collectors may conduct the fol- (4) The size of the inner liner shall be lowing activities: clearly marked on the outside of the (1) Receive and destroy mail-back liner (e.g., 5-gallon, 10-gallon, etc.); and packages pursuant to § 1317.70 at an au- (5) The inner liner shall bear a per- thorized registered location that has manent, unique identification number an on-site method of destruction; that enables the inner liner to be (2) Install, manage, and maintain col- tracked. lection receptacles located at their au- (b) Access to the inner liner shall be thorized collection location(s) pursu- restricted to employees of the col- ant to §§ 1317.75 and 1317.80; and lector. (3) Promptly dispose of sealed inner (c) The inner liner shall be sealed by liners and their contents as provided two employees immediately upon re- for in § 1317.05(c)(2). moval from the permanent outer con- § 1317.55 Reverse distributor and dis- tainer and the sealed inner liner shall tributor acquisition of controlled not be opened, x-rayed, analyzed, or substances from collectors or law otherwise penetrated. enforcement. § 1317.65 Take-back events. (a) A reverse distributor is authorized to acquire controlled substances (a) Federal, State, tribal, or local law from law enforcement that collected enforcement may conduct a take-back the substances from ultimate users. A event and collect controlled substances reverse distributor is authorized to ac- from ultimate users and persons law- quire controlled substances collected fully entitled to dispose of an ultimate through a collection receptacle in ac- user decedent’s property in accordance cordance with §§ 1317.75 and 1317.80. with this section. Any person may (b) A distributor is authorized to ac- partner with law enforcement to hold a quire controlled substances collected collection take-back event in accord- through a collection receptacle in ac- ance with this section. cordance with §§ 1317.75 and 1317.80. (b) Law enforcement shall appoint a (c) A reverse distributor or a dis- law enforcement officer employed by tributor that acquires controlled sub- the agency to oversee the collection. stances in accordance with paragraph Law enforcement officers employed (a) or (b) of this section shall: and authorized by the law enforcement (1) Acquire the controlled substances agency or law enforcement component in the manner authorized for reverse of a Federal agency conducting a take- distributors in § 1317.15(b)(1) and (2); back event shall maintain control and

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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 substances to law enforcement during from within the customs territory of the take-back event. No other person the United States (the 50 States, the may handle the controlled substances District of Columbia, and Puerto Rico), at any time. and notice that only packages provided by the collector will be accepted for de- § 1317.70 Mail-back programs. struction. (a) A mail-back program may be con- (d) Ultimate users and persons law- ducted by Federal, State, tribal, or fully entitled to dispose of an ultimate local law enforcement or any collector. user decedent’s property shall not be A collector conducting a mail-back required to provide any personally program shall have and utilize at their identifiable information when mailing registered location a method of de- back controlled substances to a col- struction consistent with § 1317.90 of lector. The collector or law enforce- this chapter. 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 person lawfully entitled to dis- lector or law enforcement that they pose of an ultimate user decedent’s are sending one of the designated pack- property may be collected. Controlled ages by giving the unique identifica- and non-controlled substances may be tion number on the package. collected together and be comingled, (e) A collector that conducts a mail- although comingling is not required. back program pursuant to paragraph (c) Collectors or law enforcement (a) shall: that conduct a mail-back program (1) Accept only those controlled sub- shall make packages available (for sale stances contained within packages that

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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: (i) Make a reasonable effort to notify (2) At a registered location, be lo- the public prior to discontinuing such cated in the immediate proximity of a activities or ceasing the authorized designated area where controlled sub- mail-back program; and stances are stored and at which an em- (ii) Obtain the written agreement of ployee is present (e.g., can be seen from another collector that has and utilizes the pharmacy counter). Except as fol- at its registered location a method of lows: destruction consistent with § 1317.90 of (i) At a hospital/clinic: A collection this chapter to receive all remaining receptacle shall be located in an area mail-back packages that were dissemi- regularly monitored by employees, and nated but not returned and arrange for shall not be located in the proximity of the forwarding of only such packages any area where emergency or urgent to that location. care is provided; (f) Only law enforcement officers em- (ii) At a narcotic treatment program: ployed by the law enforcement agency A collection receptacle shall be located or law enforcement component of a in a room: That does not contain any Federal agency and employees of the other controlled substances and is se- collector shall handle packages re- curely locked with controlled access; ceived through an authorized mail- (iii) At a long-term care facility: A back program. Upon receipt of a mail- collection receptacle shall be located back package by a collector conducting in a secured area regularly monitored a mail-back program, the package by long-term care facility employees. shall not be opened, x-rayed, analyzed, (e) A controlled substance collection or otherwise penetrated. receptacle shall meet the following de- § 1317.75 Collection receptacles. sign specifications: (1) Be securely fastened to a perma- (a) Collectors or Federal, State, trib- nent structure so that it cannot be real, or local law enforcement may man- moved; age and maintain collection recep- (2) Be a securely locked, substan- tacles for disposal. (b) Only those controlled substances tially constructed container with a listed in Schedule II, III, IV, or V that permanent outer container and a re- are lawfully possessed by an ultimate movable inner liner as specified in user or other authorized non-registrant § 1317.60 of this chapter; person may be collected. Controlled (3) The outer container shall include and non-controlled substances may be a small opening that allows contents to collected together and be comingled, be added to the inner liner, but does although comingling is not required. not allow removal of the inner liner’s (c) Collectors shall only allow ulti- contents; mate users and other authorized non- (4) The outer container shall promi- registrant persons in lawful possession nently display a sign indicating that of a controlled substance in Schedule only Schedule II–V controlled and non- II, III, IV, or V to deposit such sub- controlled substances, if a collector

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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 the purpose of recall or investiga- timate user who resides, or has resided, tional use of drugs. at such long-term care facility by 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 those substances into a collection re- of the substance or another registrant ceptacle, such disposal shall occur im- authorized by the manufacturer to ac- mediately, but no longer than three cept recalled controlled substances on business days after the discontinuation the manufacturer’s behalf. of use by the ultimate user. Dis- (b) An ultimate user who is partici- continuation of use includes a perma- pating in an investigational use of nent discontinuation of use as directed drugs pursuant to 21 U.S.C. 355(i) and by the prescriber, as a result of the 360b(j) and wishes to deliver any un- resident’s transfer from the long-term used controlled substances received as care facility, or as a result of death. part of that research to the registered (b) Only authorized retail pharmacies dispenser from which the ultimate user and hospitals/clinics with an on-site obtained those substances may do so in pharmacy may install, manage, and accordance with regulations promul- maintain collection receptacles at gated by the Secretary of Health and long-term care facilities and remove, Human Services pursuant to 21 U.S.C. seal, transfer, and store, or supervise 355(i) and 360b(j). the removal, sealing, transfer, and storage of sealed inner liners at long- Subpart C—Destruction of term care facilities. Collectors author- Controlled Substances ized to install, manage, and maintain collection receptacles at long-term § 1317.90 Methods of destruction. care facilities shall comply with all re- (a) All controlled substances to be de- quirements of this chapter, including stroyed by a registrant, or caused to be §§ 1317.60, 1317.75, and 1317.80. destroyed by a registrant pursuant to

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§ 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 non-retrievable state in order to pre- (3) Two employees of the trans- vent diversion of any such substance to porting registrant shall load and un- illicit purposes and to protect the pub- load or observe the loading and unload- lic health and safety. ing of the controlled substances; (4) Two employees of the trans- § 1317.95 Destruction procedures. porting registrant shall handle or ob- The destruction of any controlled serve the handling of any controlled substance shall be in accordance with substance until the substance is ren- the following requirements: dered non-retrievable; and (a) Transfer to a person registered or (5) Two employees of the trans- authorized to accept controlled substances porting registrant shall personally wit- for the purpose of destruction. If the con- ness the destruction of the controlled trolled substances are transferred to a substance until it is rendered non-re- person registered or authorized to ac- trievable. cept the controlled substances for the (d) On-site destruction. If the con- purpose of destruction, two employees trolled substances are destroyed at a of the transferring registrant shall load registrant’s registered location uti- and unload or observe the loading and lizing an on-site method of destruction, unloading of any controlled substances the following procedures shall be fol- until transfer is complete. lowed: (b) Transport to a registered location. If (1) Two employees of the registrant the controlled substances are trans- shall handle or observe the handling of ported by a registrant to a registered any controlled substance until the sub- location for subsequent destruction, stance is rendered non-retrievable; and the following procedures shall be fol- (2) Two employees of the registrant lowed: shall personally witness the destruc- (1) Transportation shall be directly tion of the controlled substance until to the registered location (the sub- it is rendered non-retrievable. stances shall be constantly moving to- wards their final location and unnecessary or unrelated stops and stops of an PART 1321—DEA MAILING extended duration shall not occur); ADDRESSES (2) Two employees of the transporting registrant shall accompany the AUTHORITY: 21 U.S.C. 871(b). controlled substances to the registered location; SOURCE: 75 FR 10685, Mar. 9, 2010, unless (3) Two employees of the trans- otherwise noted. porting registrant shall load and unload or observe the loading and unload- § 1321.01 DEA mailing addresses. ing of the controlled substances until The following table provides informa- transfer is complete; tion regarding mailing addresses to be

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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 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.

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TABLE OF DEA MAILING ADDRESSES—Continued

Code of Federal Regulations Section—Topic DEA mailing address

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. 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.

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TABLE OF DEA MAILING ADDRESSES—Continued

Code of Federal Regulations Section—Topic DEA mailing address

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.

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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