21 Cfr 1301.11

§ 1301.01

21 CFR Ch. II (4–1–18 Edition)

1301.33 Application for bulk manufacture of
Schedule I and II substances.
1301.34 Application
for
importation
of
Schedule I and II substances.
1301.35 Certificate of registration; denial of
registration.
1301.36 Suspension or revocation of registration; suspension of registration pending
final order; extension of registration
pending final order.
1301.37 Order to show cause.

GENERAL INFORMATION
§ 1301.01 Scope of this part 1301.
Procedures governing the registration of manufacturers, distributors,
dispensers, importers, and exporters of
controlled substances pursuant to sections 301–304 and 1007–1008 of the Act (21
U.S.C. 821–824 and 957–958) are set forth
generally by those sections and specifically by the sections of this part.

HEARINGS

[62 FR 13945, Mar. 24, 1997]

1301.41 Hearings generally.
1301.42 Purpose of hearing.
1301.43 Request for hearing or appearance;
waiver.
1301.44 Burden of proof.
1301.45 Time and place of hearing.
1301.46 Final order.

§ 1301.02 Definitions.
Any term used in this part shall have
the definition set forth in section 102 of
the Act (21 U.S.C. 802) or part 1300 of
this chapter.
[62 FR 13945, Mar. 24, 1997]

MODIFICATION, TRANSFER, AND TERMINATION
OF REGISTRATION

§ 1301.03 Information; special instructions.
Information regarding procedures
under these rules and instructions
supplementing these rules will be furnished upon request 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.

1301.51 Modification in registration.
1301.52 Termination of registration; transfer
of registration; distribution upon discontinuance of business.
SECURITY REQUIREMENTS
1301.71 Security requirements generally.
1301.72 Physical security controls for nonpractitioners; narcotic treatment programs and compounders for narcotic
treatment programs; storage areas.
1301.73 Physical security controls for nonpractitioners; compounders for narcotic
treatment programs; manufacturing and
compounding areas.
1301.74 Other security controls for nonpractitioners; narcotic treatment programs and compounders for narcotic
treatment programs.
1301.75 Physical security controls for practitioners.
1301.76 Other security controls for practitioners.
1301.77 Security controls for freight forwarding facilities.

[75 FR 10676, Mar. 9, 2010]

REGISTRATION
§ 1301.11 Persons required to register;
requirement of modification of registration authorizing activity as an
online pharmacy.
(a) Every person who manufactures,
distributes, dispenses, imports, or exports any controlled substance or who
proposes to engage in the manufacture,
distribution, dispensing, importation
or exportation of any controlled substance shall obtain a registration unless exempted by law or pursuant to
§§ 1301.22 through 1301.26. Except as provided in paragraph (b) of this section,
only persons actually engaged in such
activities are required to obtain a registration; related or affiliated persons
who are not engaged in such activities
are not required to be registered. (For
example, a stockholder or parent corporation of a corporation manufacturing controlled substances is not required to obtain a registration.)

EMPLOYEE SCREENING—NON-PRACTITIONERS

nshattuck on DSK9F9SC42PROD with CFR

1301.90 Employee screening procedures.
1301.91 Employee responsibility to report
drug diversion.
1301.92 Illicit activities by employees.
1301.93 Sources of information for employee
checks.
AUTHORITY: 21 U.S.C. 821, 822, 823, 824, 831,
871(b), 875, 877, 886a, 951, 952, 956, 957, 958, 965
unless otherwise noted.
SOURCE: 36 FR 7778, Apr. 24, 1971, unless
otherwise noted. Redesignated at 38 FR 26609,
Sept. 24, 1973.

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Drug Enforcement Administration, Justice

(1) A warehouse where controlled
substances are stored by or on behalf of
a registered person, unless such substances are distributed directly from
such warehouse to registered locations
other than the registered location from
which the substances were delivered or
to persons not required to register by
virtue of subsection 302(c)(2) or subsection 1007(b)(1)(B) of the Act (21
U.S.C. 822(c)(2) or 957(b)(1)(B));
(2) An office used by agents of a registrant where sales of controlled substances are solicited, made, or supervised but which neither contains such
substances (other than substances for
display purposes or lawful distribution
as samples only) nor serves as a distribution point for filling sales orders;
and
(3) An office used by a practitioner
(who is registered at another location
in the same State in which he or she
practices) where controlled substances
are prescribed but neither administered nor otherwise dispensed as a regular part of the professional practice of
the practitioner at such office, and
where no supplies of controlled substances are maintained.
(4) A freight forwarding facility, as
defined in § 1300.01 of this part, provided
that the distributing registrant operating the facility has submitted written notice of intent to operate the facility by registered mail, return receipt requested (or other suitable
means of documented delivery) and
such notice has been approved. The notice shall be submitted to the Special
Agent in Charge of the Administration’s offices in both the area in which
the facility is located and each area in
which the distributing registrant maintains a registered location that will
transfer controlled substances through
the facility. The notice shall detail the
registered locations that will utilize
the facility, the location of the facility, the hours of operation, the individual(s) responsible for the controlled
substances, the security and recordkeeping procedures that will be employed, and whether controlled substances returns will be processed
through the facility. The notice must
also detail what state licensing requirements apply to the facility and
the registrant’s actions to comply with

(b) As provided in sections 303(f) and
401(h) of the Act (21 U.S.C. 823(f) and
841(h)), it is unlawful for any person
who falls within the definition of ‘‘online pharmacy’’ (as set forth in section
102(52) of the Act (21 U.S.C. 802(52)) and
§ 1300.04(h) of this chapter) to deliver,
distribute, or dispense a controlled substance by means of the Internet if such
person is not validly registered with a
modification of such registration authorizing such activity (unless such
person is exempt from such modified
registration requirement under the Act
or this chapter). The Act further provides that the Administrator may only
issue such modification of registration
to a person who is registered as a pharmacy under section 303(f) of the Act (21
U.S.C. 823(f)). Accordingly, any pharmacy registered pursuant to § 1301.13 of
this part that falls within the definition of an online pharmacy and proposes to dispense controlled substances
by means of the Internet must obtain a
modification of its registration authorizing such activity following the submission of an application in accordance
with § 1301.19 of this part. This requirement does not apply to a registered
pharmacy that does not fall within the
definition of an online pharmacy set
forth in § 1300.04(h). Under the Act, persons other than registered pharmacies
are not eligible to obtain such a modification of registration but remain liable under section 401(h) of the Act (21
U.S.C. 841(h)) if they deliver, distribute, or dispense a controlled substance while acting as an online pharmacy without being validly registered
with a modification authorizing such
activity.
[74 FR 15621, Apr. 6, 2009]

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§ 1301.12 Separate registrations
separate locations.

§ 1301.12

for

(a) A separate registration is required for each principal place of business or professional practice at one
general physical location where controlled substances are manufactured,
distributed, imported, exported, or dispensed by a person.
(b) The following locations shall be
deemed not to be places where controlled substances are manufactured,
distributed, or dispensed:

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