
From the U.S. Code Online via GPO Access
[wais.access.gpo.gov]
[Laws in effect as of January 2, 2001]
[Document not affected by Public Laws enacted between
  January 2, 2001 and January 28, 2002]
[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.

                  Section Referred to in Other Sections

    This section is referred to in sections 823, 829, 902, 958 of this 
title.
