Regulations &
Codified CSA > CFR > Section
1301 > Section 1301.13
Section 1301.13 Application for registration; time for application;
expiration date; registration for independent activities; application
forms, fees, contents and signature; coincident activities.
(a) Any person who is required to be registered and who is not so registered may apply for
registration at any time. No person required to be registered shall engage in any activity for which
registration is required until the application for registration is granted and a Certificate of
Registration is issued by the Administrator to such person.
(b) Any person who is registered may apply to be reregistered not more than 60 days before the
expiration date of his/her registration, except that a bulk manufacturer of Schedule I or II
controlled substances or an importer of Schedule I or II controlled substances may apply to be
reregistered no more than 120 days before the expiration date of their registration.
(c) At the time a manufacturer, distributor, researcher, analytical lab, importer, exporter or
narcotic treatment program is first registered, that business activity shall be assigned to one of
twelve groups, which shall correspond to the months of the year. The expiration date of the
registrations of all registrants within any group will be the last date of the month designated for
that group. In assigning any of the above business activities to a group, the Administration may
select a group the expiration date of which is less than one year from the date such business
activity was registered. If the business activity is assigned to a group which has an expiration date
less than three months from the date of which the business activity is registered, the registration
shall not expire until one year from that expiration date; in all other cases, the registration shall
expire on the expiration date following the date on which the business activity is registered.
(d) At the time a retail pharmacy, hospital/clinic, practitioner or teaching institution is first
registered, that business activity shall be assigned to one of twelve groups, which shall
correspond to the months of the year. The expiration date of the registrations of all registrants
within any group will be the last day of the month designated for that group. In assigning any of
the above business activities to a group, the Administration may select a group the expiration
date of which is not less than 28 months nor more than 39 months from the date such business
activity was registered. After the initial registration period, the registration shall expire 36
months from the initial expiration date.
(e) Any person who is required to be registered and who is not so registered, shall make
application for registration for one of the following groups of controlled substances activities,
which are deemed to be independent of each other. Application for each registration shall be
made on the indicated form, and shall be accompanied by the indicated fee. Fee payments shall
be made in the form of a personal, certified, or cashier's check or money order made payable to
the "Drug Enforcement Administration". The application fees are not refundable. Any person,
when registered to engage in the activities described in each subparagraph in this paragraph, shall
be authorized to engage in the coincident activities described without obtaining a registration to
engage in such coincident activities, provided that, unless specifically exempted, he/she complies
with all requirements and duties prescribed by law for persons registered to engage in such
coincident activities. Any person who engages in more than one group of independent activities
shall obtain a separate registration for each group of activities, except as provided in this
paragraph under coincident activities. A single registration to engage in any group of independent
activities listed below may include one or more controlled substances listed in the schedules
authorized in that group of independent activities. A person registered to conduct research with
controlled substances listed in Schedule I may conduct research with any substances listed in
Schedule I for which he/she has filed and had approved a research protocol.
(1)
Business activity
|
Controlled substances
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DEA application forms
|
Application fee (dollars) |
Registration period (years) |
Coincident activities allowed
|
(i) Manufacturing
|
Schedules I-V
|
New--225
Renewal--225a
|
2,293
2,293
|
1
|
Schedules I-V: May distribute that substance or class for which
registration was issued; may not distribute or dispose any
substance or class for which not registered. Schedules II- V:
except a person registered to dispose of any controlled
substance may conduct chemical analysis and preclinical research
(including quality control analysis) with substances listed in
those schedules for which authorization as a mfg. was issued.
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(ii) Distributing.
|
Schedules I-V
|
New--225
Renewal--225a
|
1,147
1,147
|
1
|
|
(iii) Reverse distributing
|
Schedules I-V
|
New--225
Renewal--225a
|
1,147
1,147
|
1
|
|
(iv) Dispensing or instructing (includes Practitioner,
Hospital/Clinic, Retail Pharmacy, Central fill pharmacy,
Teaching for which registration Institution). |
Schedules II-V
|
New--224
Renewal--224a |
551
551 |
3
|
May conduct research and instructional activities
with those substances was granted, except that a mid-level
practitioner may conduct such research only to the extent
expressly authorized under state statute. A pharmacist may
manufacture an aqueous or oleaginous 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
Renewal--225a |
184
184 |
1
|
A researcher may manufacture or import 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 Sec. 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.
|
(vi) Research
|
Schedules II-V
|
New--225
Renewal--225a
|
184
184
|
1
|
May conduct chemical analysis with 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 Sec. 1301.24;
and conduct instructional activities with controlled
substances.
|
(vii) Narcotic Treatment Program (including compounder).
|
Narcotic Drugs in Schedules II-V. |
New--363
Renewal--363a
|
184
184 |
1
|
|
(viii) Importing
|
Schedules I-V
|
New--225
Renewal--225a
|
1,147
1,147 |
1
|
May distribute that substance or class for which registration
was issued; may not distribute any substance or class for which
not registered.
|
(ix) Exporting
|
Schedules I-V
|
New--225
Renewal--225a
|
1,147
1,147
|
1
|
|
(x) Chemical Analysis
|
Schedules I-V
|
New--225
Renewal--225a |
184
184
|
1
|
May manufacture and import controlled 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 Sec. 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.
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(2) DEA Forms 224, 225, and 363 may be obtained at any area 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.
(3) DEA Forms 224a, 225a, and 363a will be mailed, as applicable, to each
registered person approximately 60 days before the expiration date of his/her
registration; if any registered person does not receive such forms within 45 days
before the expiration date of his/her registration, he/she must promptly give notice
of such fact and request such forms by writing to the Registration Unit of the
Administration at the foregoing address.
(f) 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.
(g) Each application for registration to import or export controlled substances shall include the
Administration Controlled Substances Code Number, as set forth in part 1308 of this chapter,
for each controlled substance whose importation or exportation is to be authorized by such
registration. Registration as an importer or exporter shall not entitle a registrant to import or
export any controlled substance not specified in such registration.
(h) 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 of 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.
(i) 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.
(j) 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 attorney shall be valid until
revoked by the applicant.
[62 FR 13946, Mar. 24, 1997; as amended at 68 FR 37409, June 24, 2003; 68 FR 41228, July 11, 2003; 68 FR 58598, Oct. 10,
2003; 71 FR 51112, Aug. 29, 2006]
NOTICE: This is an
unofficial version. An official version of this publication may be obtained
directly from the Government Printing Office (GPO).
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