21 U.s.c. 822

21 U.S.C. 822.doc

Application for Registration (DEA Form 363) and Application for Registration Renewal (DEA Form 363a)

21 U.S.C. 822

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21 U.S.C. 822


-CITE-

21 USC Sec. 822 01/06/03

-EXPCITE-

TITLE 21 - FOOD AND DRUGS

CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL

SUBCHAPTER I - CONTROL AND ENFORCEMENT

Part C - Registration of Manufacturers, Distributors, and

Dispensers of Controlled Substances

-HEAD-

Sec. 822. Persons required to register

-STATUTE-

(a) Period of registration

(1) Every person who manufactures or distributes any controlled

substance or list I chemical, or who proposes to engage in the

manufacture or distribution of any controlled substance or list I

chemical, shall obtain annually a registration issued by the

Attorney General in accordance with the rules and regulations

promulgated by him.

(2) Every person who dispenses, or who proposes to dispense, any

controlled substance, shall obtain from the Attorney General a

registration issued in accordance with the rules and regulations

promulgated by him. The Attorney General shall, by regulation,

determine the period of such registrations. In no event, however,

shall such registrations be issued for less than one year nor for

more than three years.

(b) Authorized activities

Persons registered by the Attorney General under this subchapter

to manufacture, distribute, or dispense controlled substances or

list I chemicals are authorized to possess, manufacture,

distribute, or dispense such substances or chemicals (including any

such activity in the conduct of research) to the extent authorized

by their registration and in conformity with the other provisions

of this subchapter.

(c) Exceptions

The following persons shall not be required to register and may

lawfully possess any controlled substance or list I chemical under

this subchapter:

(1) An agent or employee of any registered manufacturer,

distributor, or dispenser of any controlled substance or list I

chemical if such agent or employee is acting in the usual course

of his business or employment.

(2) A common or contract carrier or warehouseman, or an

employee thereof, whose possession of the controlled substance or

list I chemical is in the usual course of his business or

employment.

(3) An ultimate user who possesses such substance for a purpose

specified in section 802(25) (FOOTNOTE 1) of this title.

(FOOTNOTE 1) See References in Text note below.

(d) Waiver

The Attorney General may, by regulation, waive the requirement

for registration of certain manufacturers, distributors, or

dispensers if he finds it consistent with the public health and

safety.

(e) Separate registration

A separate registration shall be required at each principal place

of business or professional practice where the applicant

manufactures, distributes, or dispenses controlled substances or

list I chemicals.

(f) Inspection

The Attorney General is authorized to inspect the establishment

of a registrant or applicant for registration in accordance with

the rules and regulations promulgated by him.

-SOURCE-

(Pub. L. 91-513, title II, Sec. 302, Oct. 27, 1970, 84 Stat. 1253;

Pub. L. 98-473, title II, Sec. 510, Oct. 12, 1984, 98 Stat. 2072;

Pub. L. 103-200, Sec. 3(b), Dec. 17, 1993, 107 Stat. 2336.)

-REFTEXT-

REFERENCES IN TEXT

This subchapter, referred to in subsecs. (b) and (c), was in the

original ''this title'', meaning title II of Pub. L. 91-513, Oct.

27, 1970, 84 Stat. 1242, as amended, and is popularly known as the

''Controlled Substances Act''. For complete classification of title

II to the Code, see second paragraph of Short Title note set out

under section 801 of this title and Tables.

Section 802(25) of this title, referred to in subsec. (c)(3), was

redesignated section 802(26) of this title by Pub. L. 98-473, title

II, Sec. 507(a), Oct. 12, 1984, 98 Stat. 2071, and was further

redesignated section 802(27) of this title by Pub. L. 99-570, title

I, Sec. 1003(b)(2), Oct. 27, 1986, 100 Stat. 3207-6.

-MISC2-

AMENDMENTS

1993 - Subsec. (a)(1). Pub. L. 103-200, Sec. 3(b)(1), inserted

''or list I chemical'' after ''controlled substance'' in two

places.

Subsec. (b). Pub. L. 103-200, Sec. 3(b)(2), inserted ''or list I

chemicals'' after ''controlled substances'' and ''or chemicals''

after ''such substances''.

Subsec. (c). Pub. L. 103-200, Sec. 3(b)(3), inserted ''or list I

chemical'' after ''controlled substance'' wherever appearing.

Subsec. (e). Pub. L. 103-200, Sec. 3(b)(4), inserted ''or list I

chemicals'' after ''controlled substances''.

1984 - Subsec. (a). Pub. L. 98-473 designated existing provisions

as par. (1), struck out provisions relating to dispensing

controlled substances, and added par. (2).

EFFECTIVE DATE OF 1993 AMENDMENT

Amendment by Pub. L. 103-200 effective on date that is 120 days

after Dec. 17, 1993, see section 11 of Pub. L. 103-200, set out as

a note under section 802 of this title.

PROVISIONAL REGISTRATION

Section 703 of Pub. L. 91-513, as amended by Pub. L. 99-514, Sec.

2, Oct. 22, 1986, 100 Stat. 2095, provided that:

''(a)(1) Any person who -

''(A) is engaged in manufacturing, distributing, or dispensing

any controlled substance on the day before the effective date of

section 302 (this section), and

''(B) is registered on such day under section 510 of the

Federal Food, Drug, and Cosmetic Act (section 360 of this title)

or under section 4722 of the Internal Revenue Code of 1986

(formerly I.R.C. 1954, section 4722 of Title 26),

shall, with respect to each establishment for which such

registration is in effect under any such section, be deemed to have

a provisional registration under section 303 (section 823 of this

title) for the manufacture, distribution, or dispensing (as the

case may be) of controlled substances.

''(2) During the period his provisional registration is in effect

under this section, the registration number assigned such person

under such section 510 (section 360 of this title) or under such

section 4722 (section 4722 of Title 26) (as the case may be) shall

be his registration number for purposes of section 303 of this

title (section 823 of this title).

''(b) The provisions of section 304 (section 824 of this title),

relating to suspension and revocation of registration, shall apply

to a provisional registration under this section.

''(c) Unless sooner suspended or revoked under subsection (b), a

provisional registration of a person under subsection (a)(1) of

this section shall be in effect until -

''(1) the date on which such person has registered with the

Attorney General under section 303 (section 823 of this title) or

has had his registration denied under such section, or

''(2) such date as may be prescribed by the Attorney General

for registration of manufacturers, distributors, or dispensers,

as the case may be,

whichever occurs first.''

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in sections 827, 828, 880, 958, 965

of this title; title 18 section 2118.


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