Regulations
& Codified CSA > USC > Subchapter
I, Part C > Section 827
Section 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 record keeping requirements of drug conventions
In addition to the reporting and record keeping 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 360b(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.)
EDITORIAL NOTES
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.
Section Referred to in Other Sections
This section is referred to in sections 823, 829, 902, 958 of this title.
Record keeping and reporting requirements, see 21 CFR 1304.01 et seq.
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