[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.