57 TITLES II AND III OF THE COMPREHENSIVE DRUG ABUSE... Sec. 307
RECORDS AND REPORTS OF REGISTRANTS
SEC. 307. ΓΈ21 U.S.C. 827¿ (a) Except as provided in subsection (c)—
(1) every registrant under this title shall, on the effective date of this section, 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 in- ventory 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 title manufacturing, distributing, or dispensing such substance shall make a complete and accurate record of all stocks thereof on hand; and
(3) on and after the effective date of this section, every reg- istrant under this title manufacturing, distributing, or dis- pensing 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 re- quire the maintenance of a perpetual inventory.
(b) Every inventory or other record required under this section
(b) Every inventory or other record required under this section
(1) shall be in accordance with, and contain such relevant informa- tion as may be required by, regulations of the Attorney General, (2) shall (A) be maintained separately from all other records of the reg- istrant, or (B) alternatively, in the case of nonnarcotic controlled substances, be in such form that information required by the Attor- ney 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 employ- ees of the United States authorized by the Attorney General.
(c) The foregoing provisions of this section shall not apply— (1)(A) to the prescribing of controlled substances in sched- ule II, III, IV, or V by practitioners acting in the lawful course of their professional practice unless such substance is pre- scribed in the course of maintenance or detoxification treat-
ment of an individual; or
(B) to the administering of a controlled substance in sched-
(B) to the administering of a controlled substance in sched-
ule 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 establish- ments registered under this title which keep records with re-
As Amended Through P.L. 115-91, Enacted December 12, 2017
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Sec. 307 TITLES II AND III OF THE COMPREHENSIVE DRUG ABUSE... 58
spect to such substances, in research conducted in conformity with an exemption granted under section 505(i) or 512(j) of the Federal Food, Drug, and Cosmetic Act;
(B) to the use of controlled substances, at establishments registered under this title 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 title.
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. 31
(d)(1) Every manufacturer registered under section 303 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 sub- stance, and each distributor shall make such reports with respect to narcotic controlled substances, identifying by the registration number assigned under this title the person or establishment (un- less exempt from registration under section 302(d) to whom such sale, delivery, or other disposal was made.
(2) Each pharmacy with a modified registration under section 303(f) that authorizes the dispensing of controlled substances by means of the Internet shall report to the Attorney General the con- trolled substances it dispenses, in the amount specified, and in such time and manner as the Attorney General by regulation shall require, except that the Attorney General, under this paragraph, may not require any pharmacy to report any information other than the total quantity of each controlled substance that the phar- macy has dispensed each month. For purposes of this paragraph, no reporting shall be required unless the pharmacy has met 1 of the following thresholds in the month for which the reporting is re- quired:
(A) 100 or more prescriptions dispensed.
(B) 5,000 or more dosage units of all controlled substances combined.
(e)31 In addition to the reporting and recordkeeping require- ments under any other provision of this title, each manufacturer registered under section 303 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 require- ments of this subsection in such a manner as to avoid the unneces-
31 Sentence at end of subsection (c), and subsection (e) in its entirety, were added by title I of Public Law 95–633. Section 112 of such Public Law provided as follows: ‘‘This title shall take effect on the date the Convention on Psychotropic Substances, signed at Vienna, Austria on Feb- ruary 21, 1971, enters into force in respect to the United States.’’. The Convention entered into force in respect to the United States on July 15, 1980.
January 16, 2018 As Amended Through P.L. 115-91, Enacted December 12, 2017
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59 TITLES II AND III OF THE COMPREHENSIVE DRUG ABUSE... Sec. 307
sary imposition of duplicative requirements under this title on manufacturers subject to the requirements of this subsection.
(f) Regulations under sections 505(i) and 512(j) of the Federal Food, Drug, and Cosmetic Act, relating to investigational use of drugs, shall include such procedures as the Secretary, after con- sultation 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) Every registrant under this title shall be required to report any change of professional or business address in such manner as the Attorney General shall by regulation require.
(h) In the case of a drug product containing gamma hydroxy- butyric acid for which an application has been approved under sec- tion 505 of the Federal Food, Drug, and Cosmetic Act, 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, re- labeler, 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 sub- mitted, 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 prod- uct, drug substance, bulk drug, and dosage forms on hand as of the close of business December 31, indicating whether mate- rials 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 trans- actions both inventory increases, including purchases, trans- fers, and returns, and reductions from inventory, including sales, transfers, theft, destruction, and seizure, and shall pro- vide 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 registra- tion numbers, names, and other identifying information of ven- dors, 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 num- bers, with the expiration dates of these registrations, verification that the prescribing practitioner possesses the ap- propriate registration to prescribe this controlled substance, the patient’s name and address, the name of the patient’s in- surance 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.
As Amended Through P.L. 115-91, Enacted December 12, 2017
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