21 USC 827 Records and Reports of Registrants

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[Laws in effect as of January 3, 2005]

[Document not affected by Public Laws enacted between

January 3, 2005 and March 20, 2006]

[CITE: 21USC827]

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

Sec. 827. Records and reports of registrants

(a) Inventory

Except as provided in subsection (c) of this section--

(1) every registrant under this subchapter shall, on May 1,

1971, or as soon thereafter as such registrant first engages in the

manufacture, distribution, or dispensing of controlled substances,

and every second year thereafter, make a complete and accurate

record of all stocks thereof on hand, except that the regulations

prescribed under this section shall permit each such biennial

inventory (following the initial inventory required by this

paragraph) to be prepared on such registrant's regular general

physical inventory date (if any) which is nearest to and does not

vary by more than six months from the biennial date that would

otherwise apply;

(2) on the effective date of each regulation of the Attorney

General controlling a substance that immediately prior to such date

was not a controlled substance, each registrant under this

subchapter manufacturing, distributing, or dispensing such substance

shall make a complete and accurate record of all stocks thereof on

hand; and

(3) on and after May 1, 1971, every registrant under this

subchapter manufacturing, distributing, or dispensing a controlled

substance or substances shall maintain, on a current basis, a

complete and accurate record of each such substance manufactured,

received, sold, delivered, or otherwise disposed of by him, except

that this paragraph shall not require the maintenance of a perpetual

inventory.

(b) Availability of records

Every inventory or other record required under this section (1)

shall be in accordance with, and contain such relevant information as

may be required by, regulations of the Attorney General, (2) shall (A)

be maintained separately from all other records of the registrant, or

(B) alternatively, in the case of nonnarcotic controlled substances, be

in such form that information required by the Attorney General is

readily retrievable from the ordinary business records of the

registrant, and (3) shall be kept and be available, for at least two

years, for inspection and copying by officers or employees of the United

States authorized by the Attorney General.

(c) Nonapplicability

The foregoing provisions of this section shall not apply--

(1)(A) to the prescribing of controlled substances in schedule

II, III, IV, or V by practitioners acting in the lawful course of

their professional practice unless such substance is prescribed in

the course of maintenance or detoxification treatment of an

individual; or

(B) to the administering of a controlled substance in schedule

II, III, IV, or V unless the practitioner regularly engages in the

dispensing or administering of controlled substances and charges his

patients, either separately or together with charges for other

professional services, for substances so dispensed or administered

or unless such substance is administered in the course of

maintenance treatment or detoxification treatment of an individual;

(2)(A) to the use of controlled substances, at establishments

registered under this subchapter which keep records with respect to

such substances, in research conducted in conformity with an

exemption granted under section 355(i) or 360b(j) of this title;

(B) to the use of controlled substances, at establishments

registered under this subchapter which keep records with respect to

such substances, in preclinical research or in teaching; or

(3) to the extent of any exemption granted to any person, with

respect to all or part of such provisions, by the Attorney General

by or pursuant to regulation on the basis of a finding that the

application of such provisions (or part thereof) to such person is

not necessary for carrying out the purposes of this subchapter.

Nothing in the Convention on Psychotropic Substances shall be construed

as superseding or otherwise affecting the provisions of paragraph

(1)(B), (2), or (3) of this subsection.

(d) Periodic reports to Attorney General

Every manufacturer registered under section 823 of this title shall,

at such time or times and in such form as the Attorney General may

require, make periodic reports to the Attorney General of every sale,

delivery or other disposal by him of any controlled substance, and each

distributor shall make such reports with respect to narcotic controlled

substances, identifying by the registration number assigned under this

subchapter the person or establishment (unless exempt from registration

under section 822(d) of this title) to whom such sale, delivery, or

other disposal was made.

(e) Reporting and recordkeeping requirements of drug conventions

In addition to the reporting and recordkeeping requirements under

any other provision of this subchapter, each manufacturer registered

under section 823 of this title shall, with respect to narcotic and

nonnarcotic controlled substances manufactured by it, make such reports

to the Attorney General, and maintain such records, as the Attorney

General may require to enable the United States to meet its obligations

under articles 19 and 20 of the Single Convention on Narcotic Drugs and

article 16 of the Convention on Psychotropic Substances. The Attorney

General shall administer the requirements of this subsection in such a

manner as to avoid the unnecessary imposition of duplicative

requirements under this subchapter on manufacturers subject to the

requirements of this subsection.

(f) Investigational uses of drugs; procedures

Regulations under sections 355(i) and 360(j) of this title, relating

to investigational use of drugs, shall include such procedures as the

Secretary, after consultation with the Attorney General, determines are

necessary to insure the security and accountability of controlled

substances used in research to which such regulations apply.

(g) Change of address

Every registrant under this subchapter shall be required to report

any change of professional or business address in such manner as the

Attorney General shall by regulation require.

(h) Reporting requirements for GHB

In the case of a drug product containing gamma hydroxybutyric acid

for which an application has been approved under section 355 of this

title, the Attorney General may, in addition to any other requirements

that apply under this section with respect to such a drug product,

establish any of the following as reporting requirements:

(1) That every person who is registered as a manufacturer of

bulk or dosage form, as a packager, repackager, labeler, relabeler,

or distributor shall report acquisition and distribution

transactions quarterly, not later than the 15th day of the month

succeeding the quarter for which the report is submitted, and

annually report end-of-year inventories.

(2) That all annual inventory reports shall be filed no later

than January 15 of the year following that for which the report is

submitted and include data on the stocks of the drug product, drug

substance, bulk drug, and dosage forms on hand as of the close of

business December 31, indicating whether materials reported are in

storage or in process of manufacturing.

(3) That every person who is registered as a manufacturer of

bulk or dosage form shall report all manufacturing transactions both

inventory increases, including purchases, transfers, and returns,

and reductions from inventory, including sales, transfers, theft,

destruction, and seizure, and shall provide data on material

manufactured, manufactured from other material, use in manufacturing

other material, and use in manufacturing dosage forms.

(4) That all reports under this section must include the

registered person's registration number as well as the registration

numbers, names, and other identifying information of vendors,

suppliers, and customers, sufficient to allow the Attorney General

to track the receipt and distribution of the drug.

(5) That each dispensing practitioner shall maintain for each

prescription the name of the prescribing practitioner, the

prescribing practitioner's Federal and State registration numbers,

with the expiration dates of these registrations, verification that

the prescribing practitioner possesses the appropriate registration

to prescribe this controlled substance, the patient's name and

address, the name of the patient's insurance provider and

documentation by a medical practitioner licensed and registered to

prescribe the drug of the patient's medical need for the drug. Such

information shall be available for inspection and copying by the

Attorney General.

(6) That section 830(b)(3) of this title (relating to mail order

reporting) applies with respect to gamma hydroxybutyric acid to the

same extent and in the same manner as such section applies with

respect to the chemicals and drug products specified in subparagraph

(A)(i) of such section.

(Pub. L. 91-513, title II, Sec. 307, Oct. 27, 1970, 84 Stat. 1258; Pub.

L. 93-281, Sec. 5, May 14, 1974, 88 Stat. 125; Pub. L. 95-633, title I,

Secs. 104, 110, Nov. 10, 1978, 92 Stat. 3772, 3773; Pub. L. 98-473,

title II, Secs. 514, 515, Oct. 12, 1984, 98 Stat. 2074; Pub. L. 106-172,

Sec. 4, Feb. 18, 2000, 114 Stat. 9.)

References in Text

Schedules II, III, IV, and V, referred to in subsec. (c), are set

out in section 812(c) of this title.

Amendments

2000--Subsec. (h). Pub. L. 106-172 added subsec. (h).

1984--Subsec. (c)(1)(A). Pub. L. 98-473, Sec. 514(a), substituted

``to the prescribing of controlled substances in schedule II, III, IV,

or V by practitioners acting in the lawful course of their professional

practice unless such substance is prescribed in the course of

maintenance or detoxification treatment of an individual'' for ``with

respect to any narcotic controlled substance in schedule II, III, IV, or

V, to the prescribing or administering of such substance by a

practitioner in the lawful course of his professional practice unless

such substance was prescribed or administered in the course of

maintenance treatment or detoxification treatment of an individual''.

Subsec. (c)(1)(B). Pub. L. 98-473, Sec. 514(b), substituted ``to the

administering of a controlled substance in schedule II, III, IV, or V

unless the practitioner regularly engages in the dispensing or

administering of controlled substances and charges his patients, either

separately or together with charges for other professional services, for

substances so dispensed or administered or unless such substance is

administered in the course of maintenance treatment or detoxification

treatment of an individual'' for ``with respect to nonnarcotic

controlled substances in schedule II, III, IV, or V, to any practitioner

who dispenses such substances to his patients, unless the practitioner

is regularly engaged in charging his patients, either separately or

together with charges for other professional services, for substances so

dispensed''.

Subsec. (g). Pub. L. 98-473, Sec. 515, added subsec. (g).

1978--Subsec. (c). Pub. L. 95-633, Sec. 110, inserted provision

following par. (3) relating to the construction of the Convention on

Psychotropic Substances.

Subsecs. (e), (f). Pub. L. 95-633 added subsec. (e) and redesignated

former subsec. (e) as (f).

1974--Subsec. (c)(1)(A). Pub. L. 93-281 substituted ``any narcotic

controlled substance'' for ``narcotic controlled substances'' and made

section applicable to any narcotic controlled substance prescribed or

administered in the course of maintenance treatment or detoxification

treatment of an individual.

Effective Date of 1978 Amendment

Amendment by Pub. L. 95-633 effective on date the Convention on

Psychotropic Substances enters into force in the United States [July 15,

1980], see section 112 of Pub. L. 95-633, set out as an Effective Date

note under section 801a of this title.