[Title 21 CFR 1301.32] [Code of Federal Regulations (annual edition) - April 1, 1996 Edition] [Title 21 - FOOD AND DRUGS] [Chapter II - DRUG ENFORCEMENT] [Part 1300 - [RESERVED]] [Sec. 1301.32 - Application forms; contents; signature.] [From the U.S. Government Publishing Office]21 FOOD AND DRUGS 9 1996-04-01 1996-04-01 false Application forms; contents; signature. 1301.32 Sec. 1301.32 FOOD AND DRUGS DRUG ENFORCEMENT [RESERVED] Sec. 1301.32 Application forms; contents; signature. (a) If any person is required to be registered, and is not so registered and is applying for registration: (1) To manufacture or distribute controlled substances, he shall apply on DEA Form 225; (2) To dispense controlled substances listed in Schedules II through V, he shall apply on DEA Form 224; (3) To conduct instructional activities with controlled substances listed in Schedules II through V, he shall apply on DEA Form 224; (4) To conduct research with controlled substances listed in Schedules II through V (other than research described in Secs. 1301.22(a)(6), he shall apply on DEA Form 225; (5) To conduct research with narcotic drugs listed in Schedules II through V, as described in Sec. 1301.22(a)(6), he shall apply on DEA Form 225; (6) To conduct research with controlled substances listed in Schedule I, he shall apply on DEA Form 225, with three copies of a research protocol as described in Sec. 301.33(a) attached to the form, or, in the case of a clinical investigation, with three copies of a certificate of submission of an IND as described in Sec. 1301.33(b) attached to the form (the researcher also submitting to the Food and Drug Administration three copies of a Notice of Claimed Investigational Exemption for a New Drug as required in Sec. 1301.33(b) ); (7) To conduct instructional activities with controlled substances listed in Schedule I, he shall apply as a researcher on DEA Form 225 with two copies of a statement describing the nature, extent, and duration of such instructional activities attached to the form; (8) To conduct chemical analysis with controlled substances listed in any Schedule, he shall apply on DEA Form 225; and (9) To conduct a narcotic treatment program, including a compounder, shall apply on DEA Form 363. (b) If any person is registered and is applying for reregistration: (1) To manufacture or distribute controlled substances, he shall apply on DEA Form 225a; (2) To dispense controlled substances listed in Schedules II through V, he shall apply on DEA Form 224a; (3) To conduct instructional activities with controlled substances listed i Schedules II through V, he shall apply on DEA Form 224a; (4) To conduct research with controlled substances listed in Schedules II through V (other than research described in Sec. 1301.22(a) (6), he shall apply on DEA Form 225a; (5) To conduct research with narcotic drugs listed in Schedules II through V, as described in Sec. 1301.22(a) (6), he shall apply on DEA Form 225a; (6) To continue to conduct research with controlled substances listed in Schedule I under one or more approved research protocols, he shall apply on DEA Form 225a; (7) To continue to conduct instructional activities with controlled substances listed in Schedule I under one or more approved instructional statements, he shall apply as a researcher on DEA Form 225a; (8) To conduct chemical analysis with controlled substances listed in any Schedule, he shall apply on DEA Form 225a; and (9) To conduct a narcotic treatment program, including a compounder, shall apply on DEA Form 363a (Renewal Form). (c) DEA (or BND) Forms 224 and 225 may be obtained at any regional office of the Administration or by writing to the Registration Unit, Drug Enforcement Administration, Department of Justice, Post Office Box 28083, Central Station, Washington, DC 20005. DEA Forms 224a, 225a and 363a will be mailed, as applicable, to each registered person approximately 60 days [[Page 15]] before the expiration date of his registration; if any registered person does not receive such forms within 45 days before the expiration date of his registration, he must promptly give notice of such fact and request such forms by writing to the Registration Unit of the Administration at the foregoing address. (d) Each application for registration to handle any basic class of controlled substance listed in Schedule I (except to conduct chemical analysis with such classes) and each application for registration to manufacture a basic class of controlled substance listed in Schedule II shall include the Administration Controlled Substances Code Number, as set forth in part 1308 of this chapter, for each basic class to be covered by such registration. (e) Each application for registration to conduct research with any basic class of controlled substance listed in Schedule II shall include the Administration Controlled Substances Code Number, as set forth in part 1308 of this chapter, for each such basic class to be manufactured or imported as a coincident activity of that registration. A statement listing the quantity of each such basic class or controlled substance to be imported or manufactured during the registration period for which application is being made shall be included with each such application. For purposes of this paragraph only, manufacturing is defined as the production of a controlled substance by synthesis, extraction or by agricultural/horticultural means. (f) Each application shall include all information called for in the form, unless the item is not applicable, in which case this fact shall be indicated. (g) Each application, attachment, or other document filed as part of an application, shall be signed by the applicant, if an individual; by a partner of the applicant, if a partnership; or by an officer of the applicant, if a corporation, corporate division, association, trust or other entity. An applicant may authorize one or more individuals, who would not otherwise be authorized to do so, to sign applications for the applicant by filing with the Registration Unit of the Administration a power of attorney for each such individual. The power of attorney shall be signed by a person who is authorized to sign applications under this paragraph and shall contain the signature of the individual being authorized to sign applications. The power of attornex shall be valid until revoked by the applicant. [36 FR 7778, Apr. 24, 1971, as amended at 36 FR 18729, Sept. 21, 1971; 37 FR 15918, Aug. 8, 1972; 37 FR 28712, Dec. 29, 1972. Redesignated at 38 FR 26609, Sept. 24, l973] Editorial Note: For FR citations affecting Sec. 1301.32, see the List of CFR Sections Affected in the Finding Aids section of this volume.