-CITE-
21 USC Sec. 827 01/22/02
-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. 827. Records and reports of
registrants
-STATUTE-
(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.
-SOURCE-
(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, Sec. 104, 110, Nov. 10, 1978, 92 Stat. 3772, 3773; Pub. L. 98-473,
title II, Sec. 514, 515, Oct. 12, 1984, 98 Stat. 2074; Pub. L.
106-172, Sec. 4, Feb. 18, 2000, 114 Stat. 9.)
-REFTEXT-
REFERENCES IN TEXT
Schedules II, III, IV, and V, referred
to in subsec. (c), are set out in section 812(c)
of this title.
-MISC2-
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.
-SECREF-
SECTION REFERRED
TO IN OTHER SECTIONS
This section is referred to in
sections 823, 829, 902,
958 of this
title.
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