21 Cfr 1309.21

§ 1309.01

21 CFR Ch. II (4–1–18 Edition)

MODIFICATION, TRANSFER AND TERMINATION
OF REGISTRATION
1309.61
1309.62
1309.63

port, or export a List I chemical, the
applicant shall pay an annual fee of
$1,523.

Modification in registration.
Termination of registration.
Transfer of registration.

[77 FR 15250, Mar. 15, 2012]

SECURITY REQUIREMENTS
1309.71 General security requirements.
1309.72 Felony conviction; employer responsibilities.
1309.73 Employee responsibility to report diversion.
AUTHORITY: 21 U.S.C. 802, 821, 822, 823, 824,
830, 871(b), 875, 877, 886a, 952, 953, 957, 958.
SOURCE: 60 FR 32454, June 22, 1995, unless
otherwise noted.

GENERAL INFORMATION
§ 1309.01 Scope of part 1309.
Procedures governing the registration of manufacturers, distributors,
importers and exporters of List I
chemicals pursuant to Sections 102, 302,
303, 1007 and 1008 of the Act (21 U.S.C.
802, 822, 823, 957 and 958) are set forth
generally by those sections and specifically by the sections of this part.
§ 1309.02 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 13968, Mar. 24, 1997]

§ 1309.03 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.
[75 FR 10680, Mar. 9, 2010]

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FEES FOR REGISTRATION AND
REREGISTRATION
§ 1309.11 Fee amounts.
(a) For each application for registration or reregistration to manufacture
the applicant shall pay an annual fee of
$3,047.
(b) For each application for registration or reregistration to distribute, im-

§ 1309.12 Time and method of payment; refund.
(a) For each application for registration or reregistration to manufacture,
distribute, import, or export, the applicant shall pay the fee when the application for registration or reregistration is submitted for filing.
(b) Payments should be made in the
form of a credit card; a personal, certified, or cashier’s check; or a money
order made payable to ‘‘Drug Enforcement
Administration.’’
Payments
made in the form of stamps, foreign
currency, or third party endorsed
checks will not be accepted. These application fees are not refundable.
[75 FR 4980, Feb. 1, 2010]

REQUIREMENTS FOR REGISTRATION
§ 1309.21

Persons required to register.

(a) Unless exempted by law or under
§§ 1309.24 through 1309.26 or §§ 1310.12
through 1310.13 of this chapter, the following persons must annually obtain a
registration specific to the List I
chemicals to be handled:
(1) Every person who manufactures
or imports or proposes to manufacture
or import a List I chemical or a drug
product
containing
ephedrine,
pseudoephedrine, or phenylpropanolamine.
(2) Every person who distributes or
exports or proposes to distribute or export any List I chemical, other than
those List I chemicals contained in a
product exempted under paragraph
(1)(iv) of the definition of regulated
transaction in § 1300.02 of this chapter.
(b) Only persons actually engaged in
the activities are required to obtain a
registration; related or affiliated persons who are not engaged in the activities are not required to be registered.
(For example, a stockholder or parent
corporation of a corporation distributing List I chemicals is not required
to obtain a registration.)
(c) The registration requirements are
summarized in the following table:

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Drug Enforcement Administration, Justice

§ 1309.23

SUMMARY OF REGISTRATION REQUIREMENTS AND LIMITATIONS
Registration
period
(years)

$3,047

1

Chemicals

DEA Forms

Manufacturing ...

List I ..........................................

New–510 .......

Renewal–
510a.

3,047

Distributing ........

Drug
products
containing
ephedrine, pseudoephedrine,
phenylpropanolamine.
List I ..........................................
Scheduled
listed
chemical
products.
List I ..........................................

New–510 .......
Renewal–
510a.
New–510 .......

1,523
1,523

1

1,523

1

Drug
Products
containing
ephedrine, pseudoephedrine,
phenylpropanolamine.
List I ..........................................
Scheduled
listed
chemical
products.

Renewal–
510a.

1,523

New–510 .......
Renewal–
510a.

1,523
1,523

Importing ...........

Exporting ...........

[75 FR 4980, Feb. 1, 2010, as amended at 77 FR
4236, Jan. 27, 2012; 77 FR 15250, Mar. 15, 2012]

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Application fee

Business
activity

§ 1309.22 Separate
registration
for
independent activities.
(a) The following groups of activities
are deemed to be independent of each
other:
(1) Manufacturing of List I chemicals
or drug products containing ephedrine,
pseudoephedrine, or phenylpropanolamine.
(2) Distributing of List I chemicals
and scheduled listed chemical products.
(3) Importing List I chemicals or
drug products containing ephedrine,
pseudoephedrine, or phenylpropanolamine.
(4) Exporting List I chemicals and
scheduled listed chemical products.
(b) Except as provided in paragraphs
(c) and (d) of this section, every person
who engages in more than one group of
independent activities must obtain a
separate registration for each group of
activities, unless otherwise exempted
by the Act or §§ 1309.24 through 1309.26.
(c) A person registered to import any
List I chemical shall be authorized to
distribute that List I chemical after
importation, but no other chemical
that the person is not registered to import.

Coincident activities allowed
May distribute that chemical for which registration was issued; may
not distribute any
chemical for which not
registered.

May distribute that chemical for which registration was issued; may
not distribute any
chemical for which not
registered.

1

(d) A person registered to manufacture any List I chemical shall be authorized to distribute that List I chemical after manufacture, but no other
chemical that the person is not registered to manufacture.
[75 FR 4981, Feb. 1, 2010]

§ 1309.23 Separate registration for separate locations.
(a) A separate registration is required for each principal place of business at one general physical location
where List I chemicals are manufactured, distributed, imported, or exported by a person.
(b) The following locations shall be
deemed to be places not subject to the
registration requirement:
(1) A warehouse where List I chemicals are stored by or on behalf of a registered person, unless such chemicals
are distributed directly from such
warehouse to locations other than the
registered location from which the
chemicals were originally delivered;
and
(2) An office used by agents of a registrant where sales of List I chemicals
are solicited, made, or supervised but
which neither contains such chemicals

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