[Title 21 CFR 1301.13]
[Code of Federal Regulations (annual edition) - April 1, 2002 Edition]
[Title 21 - FOOD AND DRUGS]
[Chapter II - DRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICE]
[Part 1301 - REGISTRATION OF MANUFACTURERS, DISTRIBUTORS, AND DISPENSERS OF CONTROLLED SUBSTANCES]
[Sec. 1301.13 - Application for registration; time for application;]
[From the U.S. Government Printing Office]
21FOOD AND DRUGS92002-04-012002-04-01falseApplication for registration; time for application;1301.13Sec. 1301.13FOOD AND DRUGSDRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICEREGISTRATION OF MANUFACTURERS, DISTRIBUTORS, AND DISPENSERS OF CONTROLLED SUBSTANCES
Sec. 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
[[Page 16]]
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)
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Application Registration
Business activity Controlled DEA application fee period Coincident
substances forms (dollars) (years) activities allowed
----------------------------------------------------------------------------------------------------------------
(i) Manufacturing Schedules I through New--225 875 1 Schedules I through
V Renewal--225a 875 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
through V: May
conduct chemical
analysis and
preclinical
research (including
quality control
analysis) with
substances listed
in those schedules
for which
authorization as a
manufacturer was
issued.
(ii) Distributing Schedules I through New--225 438 1 ....................
V Renewal--225a 438
(iii) Dispensing or Schedules II through New--224 210 3 May conduct research
Instructing (Includes V Renewal--224a 210 and instructional
Practitioner Hospital/ activities with
Clinic, Retail those substances
Pharmacy, Teaching for which
Institution) 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 through
V in a proportion
not exceeding 20
percent of the
complete solution,
compound, or
mixture.
(iv) Research Schedule I New--225 70 1 A researcher may
Renewal--225a 70 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 Section
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.
[[Page 17]]
(v) Research Schedules II through New--225 70 1 May conduct chemical
V Renewal--225a 70 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 Section
1301.24; and
conduct
instructional
activities with
controlled
substances.
(vi) Narcotic Treatment Narcotic Drugs in New--363 70 1 ....................
Program (including Schedules II Renewal--363a 70
compounder) through V
(vii) Importing Schedules I through New--225 438 1 May distribute that
V Renewal--225a 438 substance or class
for which
registration was
issued; may not
distribute any
substance or class
for which not
registered.
(viii) Exporting Schedules I through New--225 438 1 ....................
V Renewal--225a 438
(ix) Chemical Analysis Schedules I through New--225 70 1 May manufacture and
V Renewal--225a 70 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 Section
1301.24; may export
such substances to
persons in other
countries
performing chemical
analysis or
enforcing laws
relating 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 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,
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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]