§ 1307.13 21 CFR Ch. II (4–1–18 Edition) 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 sec- tion. 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 ex- empt from the requirement of registra- PART 1308—SCHEDULES OF tion pursuant to part 1301 of this chap- CONTROLLED SUBSTANCES ter and, if such incidentally manufac- tured substance is listed in Schedule I GENERAL INFORMATION or II, shall be exempt from the require- ment 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. 110 VerDate Sep<11>2014 13:00 May 22, 2018 Jkt 244078 PO 00000 Frm 00120 Fmt 8010 Sfmt 8010 Y:\SGML\244078.XXX 244078 nshattuck on DSK9F9SC42PROD with CFR Drug Enforcement Administration, Justice § 1308.11 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 ap- propriate 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 ana- bolic 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, 111 VerDate Sep<11>2014 13:00 May 22, 2018 Jkt 244078 PO 00000 Frm 00121 Fmt 8010 Sfmt 8010 Y:\SGML\244078.XXX 244078 nshattuck on DSK9F9SC42PROD with CFR § 1308.11 21 CFR Ch. II (4–1–18 Edition) 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 ...................