(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 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) ----------------------------------------------------------------------------------------------------------------
Registration Coincident
Business activity Controlled DEA Application Application period activities
(i) Manufacturing............. Schedules I-V... New--225 3,047 1 Schedules I-V:
Renewal--225a. 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.(ii) Distributing............. Schedules I-V... New--225 1,523 1 May acquire
Renewal--225a. Schedules II-V
controlled
substances from
collectors for
the purposes of
destruction.(iii) Reverse distributing.... Schedules I-V... New-225 Renewal- 1,523 1
225a.
(iv) Dispensing or instructing Schedules II-V.. New-224 Renewal- 731 3 May conduct
(includes Practitioner, 224a. research and
Hospital/Clinic, Retail instructional
Pharmacy, Central fill activities with
pharmacy, Teaching those substances
Institution). 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.(v) Research.................. Schedule I...... New-225 Renewal- 244 1 A researcher may
225a. 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- 244 1 May conduct
225a. 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 Narcotic Drugs New-363 Renewal- 244 1
Program (including in Schedules II- 363a.
compounder). V.(viii) Importing.............. Schedules I-V... New-225 Renewal- 1,523 1 May distribute
225a. 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- 1,523 1
225a.
(x) Chemical Analysis......... Schedules I-V... New-225 Renewal- 244 1 May manufacture
225a. 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.----------------------------------------------------------------------------------------------------------------
(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 Sec. 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 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.
(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; 74 FR 15622, Apr. 6, 2009; 75 FR 10676, Mar. 9, 2010; 77 FR 15248, Mar. 15, 2012; 79 FR 53560, Sept. 9, 2014]