Except as provided in subsection (c)-
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.
The foregoing provisions of this section shall not apply-
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.
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.
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.
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.
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:
All of the reports required under this section shall be provided in an electronic format.
21 U.S.C. § 827
EDITORIAL NOTES
REFERENCES IN TEXTSchedules II, III, IV, and V, referred to in subsec. (c), are set out in section 812(c) of this title.
AMENDMENTS2022-Subsec. (d)(2). Pub. L. 117-215 substituted "823(g)" for "823(f)" in introductory provisions. 2018-Subsecs. (f) to (i). Pub. L. 115-271, §3273(a)(1), (2), added subsec. (f) and redesignated former subsecs. (f) to (h) as (g) to (i), respectively.Subsec. (j). Pub. L. 115-271, §3273(a)(3), added subsec. (j). 2008-Subsec. (d). Pub. L. 110-425 designated existing provisions as par. (1) and added par. (2). 2000-Subsec. (h). Pub. L. 106-172 added subsec. (h).1984-Subsec. (c)(1)(A). Pub. L. 98-473, §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, §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, §515, added subsec. (g). 1978-Subsec. (c). Pub. L. 95-633, §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.
STATUTORY NOTES AND RELATED SUBSIDIARIES
EFFECTIVE DATE OF 2008 AMENDMENT Amendment by Pub. L. 110-425 effective 180 days after Oct. 15, 2008, except as otherwise provided, see section 3(j) of Pub. L. 110-425 set out as a note under section 802 of this title.
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.
EFFECTIVE DATESection effective on first day of seventh calendar month that begins after Oct. 26, 1970, see section 704 of Pub. L. 91-513 set out as a note under section 801 of this title.
PURPOSE Pub. L. 115-271, title III, §32723272,, 132 Stat. 3952, provided that: "(a) IN GENERAL.-The purpose of this chapter [see section 3271 of Pub. L. 115-271 set out as a Short Title of 2018 Amendment note under section 801 of this title] is to provide drug manufacturers and distributors with access to anonymized information through the Automated Reports and Consolidated Orders System to help drug manufacturers and distributors identify, report, and stop suspicious orders of opioids and reduce diversion rates."(b) RULE OF CONSTRUCTION.-Nothing in this chapter should be construed to absolve a drug manufacturer, drug distributor, or other Drug Enforcement Administration registrant from the responsibility of the manufacturer, distributor, or other registrant to-"(1) identify, stop, and report suspicious orders; or"(2) maintain effective controls against diversion in accordance with section 303 of the Controlled Substances Act (21 U.S.C. 823) or any successor law or associated regulation."