21 Cfr 1301.13

§ 1301.13

21 CFR Ch. II (4–1–18 Edition)
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

any such requirements. The Special
Agent in Charge of the DEA Office in
the area where the freight forwarding
facility will be operated will provide
written notice of approval or disapproval to the person within thirty
days after confirmed receipt of the notice. Registrants that are currently operating freight forwarding facilities
under a memorandum of understanding
with the Administration must provide
notice as required by this section no
later than September 18, 2000 and receive written approval from the Special Agent in Charge of the DEA Office
in the area in which the freight forwarding facility is operated in order to
continue operation of the facility.

nshattuck on DSK9F9SC42PROD with CFR

[62 FR 13945, Mar. 24, 1997, as amended at 65
FR 44678, July 19, 2000; 65 FR 45829, July 25,
2000; 71 FR 69480, Dec. 1, 2006; 81 FR 97019,
Dec. 30, 2016]

§ 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,
reverse
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 these

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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)

Application
fee
($)

Registration
period
(years)

Business activity

Controlled substances

(i) Manufacturing

Schedules I–V ...

New—225 Renewal—225a.

3,047

1

(ii) Distributing ....

Schedules I–V ...

New—225 Renewal—225a.

1,523

1

(iii) Reverse distributing.
(iv) Dispensing or
instructing (includes Practitioner, Hospital/
Clinic, Retail
Pharmacy,
Central fill pharmacy, Teaching
Institution).

Schedules I–V ...

New–225 Renewal–225a.
New–224 Renewal–224a.

1,523

1

731

3

(v) Research .......

Schedule I .........

New–225 Renewal–225a.

244

1

Schedules II–V ..

DEA Application
forms

§ 1301.13

Coincident activities allowed
Schedules I–V: May distribute that substance 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.
May acquire Schedules II–V controlled
substances from collectors for the
purposes of destruction.

May conduct research and instructional
activities with those substances for
which registration 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.
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 § 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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§ 1301.13

21 CFR Ch. II (4–1–18 Edition)
DEA Application
forms

Application
fee
($)

Registration
period
(years)

Business activity

Controlled substances

(vi) Research ......

Schedules II–V ..

New–225 Renewal–225a.

244

1

(vii) Narcotic
Treatment Program (including
compounder).
(viii) Importing .....

Narcotic Drugs in New–363 ReSchedules II–V.
newal–363a.

244

1

1

Schedules I–V ...

New–225 Renewal–225a.

1,523

(ix) Exporting ......

Schedules I–V ...

1

Schedules I–V ...

New–225 Renewal–225a.
New–225 Renewal–225a.

1,523

(x) Chemical
Analysis.

244

1

(2) DEA Forms 224, 225, and 363 may
be obtained at any area office of the
Administration or by writing to the
Registration Section, Drug Enforcement Administration. See the Table of
DEA Mailing Addresses in § 1321.01 of
this chapter for the current mailing address.
(3) Registrants will receive renewal
notifications approximately 60 days
prior to the registration expiration
date. DEA Forms 224a, 225a, and 363a
may be mailed, as applicable, to registrants; if any registered person does
not receive such notification within 45
days before the registration expiration
date, the registrant must promptly

Coincident activities allowed
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 § 1301.24; and conduct
instructional activities with controlled
substances.

May distribute that substance or class
for which registration was issued;
may not distribute any substance or
class for which not registered.

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 § 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.

give notice of such fact and may request such forms by writing to the
Registration Section, Drug Enforcement Administration.
(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.

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Drug Enforcement Administration, Justice

§ 1301.14
The power of attorney shall be valid
until revoked by the applicant.

(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.

[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; 74 FR 15622, Apr. 6, 2009; 75 FR
10676, Mar. 9, 2010; 77 FR 15248, Mar. 15, 2012;
79 FR 53560, Sept. 9, 2014]

§ 1301.14 Filing of application; acceptance for filing; defective applications.
(a) All applications for registration
shall be submitted for filing to the
Registration Unit, Drug Enforcement
Administration. The appropriate registration fee and any required attachments must accompany the application. See the Table of DEA Mailing Addresses in § 1321.01 of this chapter for
the current mailing address.
(b) Any person required to obtain
more than one registration may submit
all applications in one package. Each
application must be complete and
should not refer to any accompanying
application for required information.
(c) Applications submitted for filing
are dated upon receipt. If found to be
complete, the application will be accepted for filing. Applications failing
to comply with the requirements of
this part will not generally be accepted
for filing. In the case of minor defects
as to completeness, the Administrator
may accept the application for filing
with a request to the applicant for additional information. A defective application will be returned to the applicant
within 10 days following its receipt
with a statement of the reason for not
accepting the application for filing. A
defective application may be corrected
and resubmitted for filing at any time;
the Administrator shall accept for filing any application upon resubmission
by the applicant, whether complete or
not.
(d) Accepting an application for filing does not preclude any subsequent
request for additional information pursuant to § 1301.15 and has no bearing on
whether the application will be granted.
[62 FR 13948, Mar. 24, 1997, as amended at 75
FR 10676, Mar. 9, 2010]

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