§ 827. Records and reports of registrants

Legislative history

Reconstructed from this section’s Code source credit and amendment notes, resolved against the local Statutes at Large. Editorial notes are evidence, not the law that made the change.

1. 1970

   Controlled Substances Act

   Pub. L. 91–513 title II § 307 · 84 Stat. 1236

   Enacted · 21 U.S.C. § 827

   Pub. L. 91–513, title II, § 307, Oct. 27, 1970, 84 Stat. 1258

   Source evidence

   Code source credit
   Pub. L. 91–513, title II, § 307, Oct. 27, 1970, 84 Stat. 1258

   Enacted provision · exact public law section
   Sec. 307. records and reports of registrants (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 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 title manufacturing, distributing, or dispensing such substance shall make a complete and accurate record of all stocks thereof on band; and (3) on and after the effective date of this section, every registrant under this title 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) Every inventory or other record required under this section (1) shall be in accordance with, and contain such relevant information as may lie 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 Availability. the registrant, and (3) shall be kept and lie available, for at least two years, for inspection and copying by officers or employees of the United States authorized by the Attorney General. (c) The foregoing provisions of this section shall not apply— (1) (A) with respect to narcotic controlled substances in schedule II, III, IV, or V, to the prescribing or administering of such substances by a practitioner in the lawful course of his professional practice; or (B) 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; (2) (A) to the use of controlled substances, at establishments registered under this title which keep records with respect to such substances, in research conducted hi conformity with an exemption granted under section 505(f) or 512(j) of the Federal Food, 21 USC 355, 360b. 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. (d) 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 substance, 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 (unless exempt from registration under section 302(d)) to whom such sale, delivery, or other disposal was made. (e) Regulations under sections S05(i) and 512(j) of the Federal Food, Drag, and Cosmetic Act, relating to investigational use of drugs, 52 stat. 1052; 76 Stat. 783. 82 Stat. 343. 21 USC 355, 360b. 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.

2. 1974

   Pub. L. 93–281 § 5 · 88 Stat. 124

   Substituted · 21 U.S.C. § 827(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

   Source evidence

   Code amendment note
   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.

   Enacted provision · exact public law section
   Sec. 5. Section 307(c) (1) (A) of the Controlled Substances Act (21 U.S.C. 827(c)(1)(A)) is amended to read as follows: “(1) (A) 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; or”.

3. 1978

   Psychotropic Substances Act of 1978

   Pub. L. 95–633 § 110 · 92 Stat. 3768

   Inserted · 21 U.S.C. § 827(c)

   Pub. L. 95–633, § 110, inserted provision following par. (3) relating to the construction of the Convention on Psychotropic Substances

   Source evidence

   Code amendment note
   Subsec. (c). Pub. L. 95–633, § 110, inserted provision following par. (3) relating to the construction of the Convention on Psychotropic Substances.

   Enacted provision · exact public law section
   Sec. 110. Subsection (c) of section 307 of the Controlled Substances Act (21 U.S.C. 827(c)) is amended by adding the following after and below paragraph (3): “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.”.

4. 1978

   Psychotropic Substances Act of 1978

   Pub. L. 95–633 title I · 92 Stat. 3768

   1. Added · 21 U.S.C. § 827(e); 21 U.S.C. § 827(f)

      Pub. L. 95–633 added subsec. (e)

   2. Redesignated · 21 U.S.C. § 827(e); 21 U.S.C. § 827(f)

      Pub. L. 95–633 redesignated former subsec. (e) as (f)

   Source evidence

   Code amendment note
   Subsecs. (e), (f). Pub. L. 95–633 added subsec. (e) and redesignated former subsec. (e) as (f).

   Enacted provision · exact public law
   TITLE I— ENABLING PROVISIONS FOR THE CONVENTION ON PSYCHOTROPIC SUBSTANCES Sec. 101. The Congress makes the following findings and declarations: (1) The Congress has long recognized the danger involved in the manufacture, distribution, and use of certain psychotropic substances for nonscientific and nonmedical purposes, and has provided strong and effective legislation to control illicit trafficking and to regulate legitimate uses of psychotropic substances in this country. Abuse of psychotropic substances has become a phenomenon common to many countries, however, and is not confined to national borders. It is, therefore, essential that the United States cooperate with other nations in establishing effective controls over international traffic in such substances. (2) The United States has joined with other countries in executing an international treaty, entitled the Convention on Psychotropic Substances and signed at Vienna, Austria, on February 21, 1971, which is designed to establish suitable controls over the manufacture, distribution, transfer, and use of certain psychotropic substances. The Convention is not self-executing, and the obligations of the United States thereunder may only be performed pursuant to appropriate legislation. It is the intent of the Congress that the amendments made by this Act, together with existing law, will enable the United States to meet all of its obligations under the Convention and that no further legislation will be necessary for that purpose. (3) In implementing the Convention on Psychotropic Substances, the Congress intends that, consistent with the obligations of the United States under the Convention, control of psychotropic substances in the United States should be accomplished within the framework of the procedures and criteria for classification of substances provided in the Comprehensive Drug Abuse 21 USC 801 note. Prevention and Control Act of 1970. This will insure that (A) the availability of psychotropic substances to manufacturers, distributors, dispensers, and researchers for useful and legitimate medical and scientific purposes will not be unduly restricted; (B) nothing in the Convention will interfere with bona fide research activities; and (C) nothing in the Convention will interfere with ethical medical practice in this country as determined by the Sec-retary of Health, Education, and Welfare on the basis of a consensus of the views of the American medical and scientific community. Sec. 102. (a) Subsection (d) of section 201 of the Controlled Substances Act (21 U.S.C. 811(d)) is amended by inserting “(1)” after “(d)” and by adding the following new paragraphs at the end thereof: “(2) (A) Whenever the Secretary of State receives notification from the Secretary-General of the United Nations that information has been transmitted by or to the World Health Organization, pursuant to article 2 of the Convention on Psychotropic Substances, which may justify adding a drug or other substance to one of the schedules of the Convention, transferring a drug or substance from one schedule to another, or deleting it from the schedules, the Secretary of State shall immediately transmit the notice to the Secretary of Health, Education, and Welfare who shall publish it in the Federal Register Publication in Federal Register. and provide opportunity to interested persons to submit to him comments respecting the scientific and medical evaluations which he is to prepare respecting such drug or substance. The Secretary of Health, Education, and Welfare shall prepare for transmission through the Secretary of State to the World Health Organization such medical and scientific evaluations as may be appropriate regarding the possible action that could be proposed by the World Health Organization respecting the drug or substance with respect to which a not ice was transmitted under this subparagraph. “(B) Whenever the Secretary of State receives information that the Commission on Narcotic. Drugs of the United Nations proposes to decide, whether to add a drug or other substance to one of the schedules of the Convention, transfer a drug or substance from one schedule to another, or delete it from the schedules, the Secretary of State shall transmit timely notice to the Secretary of Health. Education, and Welfare of such information who shall publish a summary of such information in the Federal Register and provide opportunity Publication in Federal Register. to interested persons to submit to him comments respecting the recommendation which he is to furnish, pursuant to this subparagraph. respecting such proposal. The Secretary of Health. Education, and Welfare shall evaluate the proposal and furnish a recommendation to the Secretary of State which shall be binding on the representative of the United States in discussions and negotiations relating to the proposal. “(3) When the United States receives notification of a scheduling decision pursuant to article 2 of the Convention on Psychotropic. Substances that a drug or other substance has been added or transferred to a schedule specified in the notification or receives notification (referred to in this subsection as a ‘schedule notice’) that existing legal controls applicable under this title to a drug or substance and the controls required by the Federal Food, Drug, and Cosmetic Act do not 21 USC 301. meet the requirements of the schedule of the Convention in which such drug or substance has been placed, the Secretary of Health, Education, and Welfare, after consultation with the Attorney General, shall first determine whether existing legal controls under this title applicable to the drug or substance and the controls required by the Federal Food. Drug, and Cosmetic Act, meet the requirements of the schedule specified in the notification or schedule notice and shall take the following action: “(A) If such requirements are met by such existing controls but the Secretary of Health. Education, and Welfare nonetheless believes that more stringent controls should be applied to the drug or substance, the Secretary shall recommend to the Attorney General that he initiate proceedings for scheduling the drug or substance, pursuant to subsections (a) and (b) of this section, to apply to such controls. “(B) If such requirements are not met by such existing controls and the Secretary of Health, Education, and Welfare concurs in the scheduling decision or schedule notice transmitted by the notification, the Secretary shall recommend to the Attorney General that he initiate proceedings for scheduling the drug or substance under the appropriate schedule pursuant to subsections (a) and (b) of this section. “(C) If such requirements are not met by such existing controls and the Secretary of Health, Education, and Welfare does not concur in the scheduling decision or schedule notice transmitted by the notification, the Secretary shall— “(i) if he deems that additional controls are necessary to protect the public health and safety, recommend to the Attorney General that he initiate proceedings for scheduling the drug or substance pursuant to subsections (a) and (b) of this section, to apply such additional controls; “(ii) request the Secretary of State to transmit a notice of qualified acceptance, within the period specified in the Convention, pursuant to paragraph 7 of article 2 of the Convention, to the Secretary-General of the United Nations; “(iii) request the Secretary of State to transmit a notice of qualified acceptance as prescribed in clause (ii) and request the Secretary of State to ask for a review by the Economic and Social Council of the United Nations, in accordance with paragraph 8 of article 2 of the Convention, of the scheduling decision; or “(iv) in the case of a schedule notice, request the Secretary of State to take appropriate action under the Convention to initiate proceedings to remove the drug or substance from the schedules under the Convention or to transfer the drug or substance to a schedule under the Convention different from the one specified in the schedule notice. “(4) (A) If the Attorney General determines, after consultation with the Secretary of Health, Education, and Welfare, that proceedings initiated under recommendations made under paragraph (B) or (C)(i) of paragraph (3) will not be completed within the time period required by paragraph 7 of article 2 of the Convention, the Attorney General, after consultation with the Secretary and after providing interested persons opportunity to submit comments respecting the requirements of the temporary order to be issued under this sentence, shall issue a temporary order controlling the drug or substance under schedule IV or V, whichever is most appropriate to carry out the minimum United States obligations under paragraph 7 of article 2 of the Convention. As a part of such order, the Attorney General shall, after consultation with the Secretary, except such drug or substance from the application of any provision of part C of this title which he finds is not required to carry out the United States obligations under paragraph 7 of article 2 of the Convention. Notice. In the case of proceedings initiated under subparagraph (B) of paragraph (3), the Attorney General, concurrently with the issu-ance of such order, shall request the Secretary of State to transmit a notice of qualified acceptance to the Secretary-General of the United Nations pursuant to paragraph 7 of article 2 of the Convention. A temporary order issued under this subparagraph controlling a drug or other substance subject to proceedings initiated under subsections (a) and (b) of this section shall expire upon the effective date of the application to the drug or substance of the controls resulting from such proceedings. “(B) After a notice of qualified acceptance of a scheduling decision with respect to a drug or other substance is transmitted to the Secretary-General of the United Nations in accordance with clause (ii) or (iii) of paragraph (3)(C) or after a request has been made under clause (iv) of such paragraph with respect to a drug or substance described in a schedule notice, the Attorney General, after consultation with the Secretary of Health, Education, and Welfare and after providing interested persons opportunity to submit comments respecting the requirements of the order to be issued under this sentence, shall issue an order controlling the drug or substance under schedule IV or V, whichever is most appropriate to carry out the minimum United States obligations under paragraph 7 of article 2 of the Convention in the case of a drug or substance for which a notice of qualified acceptance was transmitted or whichever the Attorney General determines is appropriate in the case of a drug or substance described in a schedule notice. As a part of such order, the Attorney General shall, after consultation with the Secretary, except such drug or substance from the application of any provision of part C of this title which he finds is not required to carry out the United States obligations under paragraph 7 of article 2 of the Convention. If. as a result of a review under paragraph 8 of article 2 of the Convention of the scheduling decision with respect to which a notice of qualified acceptance was transmitted in accordance with clause (ii) or (iii) of paragraph (3)(C)— “(i) the decision is reversed, and “(ii) the drug or substance subject to such decision is not required to be controlled under schedule IV or V to carry out the minimum United States obligations under paragraph 7 of article 2 of the Convention, the order issued under this subparagraph with respect to such drug or substance shall expire upon receipt by the United States of the review decision. If, as a result of action taken pursuant to action initiated under a request transmitted under clause (iv) of paragraph (3)(C), the drug or substance with respect to which such action was taken is not required to be controlled under schedule IV or V, the order issued under this paragraph with respect to such drug or substance shall expire upon receipt by the United States of a notice of the action taken with respect to such drug or substance under the Convention. “(C) An order issued under subparagraph (A) or (B) may be issued without regard to the findings required by subsection (a) of this section or by section 202(b) and without regard to the procedures prescribed by subsection (a) or (b) of this section. “(5) Nothing in the amendments made by the Psychotropic Substances Act of 1978 or the regulations or orders promulgated thereunder Ante, p. 3768. shall be construed to preclude requests by the Secretary of Health, Education, and Welfare or the Attorney General through the Secretary of State, pursuant to article 2 or other applicable provisions of the Convention, for review of scheduling decisions under such Convention, based on new or additional information.”. (b) Section 102 of the Controlled Substances Act (21 U.S.C. 802) is amended by adding at the end the following: “(29) The term ‘Convention on Psychotropic Substances’ means the Convention on Psychotropic Substances signed at Vienna, Austria, on February 21, 1971; and the term ‘Single Convention on Narcotic Drugs’ means the Single Convention on Narcotic Drugs signed at New York, New York, on March 30, 1961.”. (c) For the purpose of carrying out the minimum United States obligations under paragraph 7 of article 2 of the Convention on Psychotropic Substances, signed at Vienna, Austria, on February 21, 1971, with respect to pipradrol and SPA (also known as (-)-1- dimethylamino–1,2-diphenylethane), the Attorney General shall by 21 USC 811, 812. order, made without regard to sections 201 and 202 of the Controlled Substances Act, place such drugs in schedule IV of such Act. Sec. 103. Subsection (d) of section 202 of the Controlled Substances Act (21 U.S.C. 812(d)) is amended by striking out “and” before “(2)” and by adding the following before the period at the end thereof: “, and (3) such exception does not conflict with United States obligations under the Convention on Psychotropic Substances”. Sec. 104. Section 307 of the Controlled Substances Act (21 U.S.C. 827) is amended by redesignating subsection (e) as subsection (f) and by inserting after subsection (d) the following new subsection: “(e) In addition to the reporting and recordkeeping requirements under any other provision of this title, each manufacturer registered 21 USC 823. 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 requirements of this subsection in such a manner as to avoid the unnecessary imposition of duplicative requirements under this title on manufacturers subject to the requirements of this subsection.”. Sec. 105. Section 1002(b) of the Controlled Substances Import and Export Act (21 U.S.C. 952(b)) is amended by inserting immediately before the period at the end of paragraph (2) the following: “, except that if a nonnarcotic controlled substance in schedule III, IV, or V is also listed in schedule I or II of the Convention on Psychotropic Substances it shall be imported pursuant to such import permit requirements, prescribed by regulation of the Attorney General, as are required by the Convention”. Sec. 106. Subsection (e) of section 1003 of the Controlled Substances Import and Export Act (21 U.S.C. 953(e)) is amended— (1) by striking out “, and” at the end of paragraph (2) and inserting in lieu thereof a semicolon; (2) by striking out the period at the end of paragraph (3) and inserting in lieu thereof “; and”: and (3) by adding after paragraph (3) the following new paragraph: “(4) in any case when a nonnarcotic controlled substance in schedule III, IV, or V is also listed in schedule I or II of the Convention on Psychotropic Substances, it is exported pursuant to such export permit requirements, prescribed by regulation of the Attorney General, as are required by the Convention, instead of the invoice required by paragraphs (2) and (3) of this subsection.”. Sec. 107 (a) Part D of the Controlled Substances Act (21 U.S.C. 841 et seq.) is amended by adding at the end thereof the following new section: “Sec. 412. “application of treaties and other international agreements Nothing in the Single Convention on Narcotic Drugs, the 21 USC 852. Convention on Psychotropic Substances, or other treaties or international agreements shall be construed to limit the provision of treatment, education, or rehabilitation as alternatives to conviction or criminal penalty for offenses involving any drug or other substance subject to control under any such treaty or agreement.”. (b) The table of contents of the Comprehensive Drug Abuse Prevention and Control Act of 1970 is amended by inserting— 21 USC 801 note. “Sec. 412. Application of treaties and other international agreements.” immediately after “Sec. 411. Proceedings to establish previous convictions.”. Sec. 108. (a) Section 502 of the Controlled Substances Act (21 U.S.C. 872) is amended by redesignating subsection (d) as subsection (e), and by adding after subsection (c) the following new subsection: “(d) Nothing in the Single Convention on Narcotic Drugs, the Convention on Psychotropic Substances, or other treaties or international agreements shall be construed to limit, modify, or prevent the protection of the confidentiality of patient records or of the names and other identifying characteristics of research subjects as provided by any Federal. State, or local law or regulation.”. (b) Section 303 of the Public Health Service Act (42 U.S.C. 242a) is amended by redesignating subsection (b) as subsection (c), and by adding after subsection (a) the following new subsection: “(b) Nothing in the Single Convention on Narcotic Drugs, the Convention on Psychotropic Substances, or other treaties or international agreements shall lie construed to limit, modify, or prevent the protection of the confidentiality of patient records or of the names and other identifying characteristics of research subjects as provided by any Federal. State, or local law or regulation.”. Sec. 109. Subsection (f) of section 303 of the Controlled Substances Act (21 U.S.C. 823(f)) is amended by adding at the end the following sentence: “Article 7 of the Convention on Psychotropic Substances shall not be construed to prohibit, or impose additional restrictions upon, research involving drugs or other substances scheduled under the Convention which is conducted in conformity with this subsection and other applicable provisions of this title.”. Sec. 110. Subsection (c) of section 307 of the Controlled Substances Act (21 U.S.C. 827(c)) is amended by adding the following after and below paragraph (3): “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.”. Sec. 111. Subsection (n) of section 502 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 352(n)) is amended by adding the fol-lowing new sentence at the end thereof: “Nothing in the Convention on Psychotropic Substances, signed at Vienna, Austria, on February 21, 1971, shall be construed to prevent drug price communications to consumers.”. Sec. 112. This title and the amendments made by this title shall take effect on the date the Convention on Psychotropic Substances, signed at Vienna, Austria on February 21, 1971, enters into force in respect to the United States.

5. 1984

   Pub. L. 98–473 § 514(a) · 98 Stat. 1837

   Substituted · 21 U.S.C. § 827(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”

   Source evidence

   Code amendment note
   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”.

   Enacted provision · exact public law section
   Sec. 514. None of the funds made available by this Act may be obligated under an appropriation account to which they were not appropriated without the written approval of the Appropriations Committees of both Houses of the Congress.

6. 1984

   Pub. L. 98–473 § 514(b) · 98 Stat. 1837

   Substituted · 21 U.S.C. § 827(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”

   Source evidence

   Code amendment note
   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”.

   Enacted provision · exact public law section
   Sec. 514. None of the funds made available by this Act may be obligated under an appropriation account to which they were not appropriated without the written approval of the Appropriations Committees of both Houses of the Congress.

7. 1984

   Pub. L. 98–473 § 515 · 98 Stat. 1837

   Added · 21 U.S.C. § 827(g)

   Pub. L. 98–473, § 515, added subsec. (g)

   Source evidence

   Code amendment note
   Subsec. (g). Pub. L. 98–473, § 515, added subsec. (g).

   Enacted provision · exact public law section
   Sec. 515. Amounts certified pursuant to section 1311 of the Supplemental 31 USC 1501, 1108, 1502. Appropriations Act, 1955, as having been obligated against appropriations heretofore made under the authority of the Foreign Assistance Act of 1961 for the same general purpose as any of the paragraphs under “Agency for International Development” are, if deobligated, hereby continued available for the same period as the respective appropriations in such paragraphs for the same general purpose and for the same country as originally obligated, or for activities in the Andean region: Provided, That the Appropriations Committees of both Houses of the Congress are notified fifteen days in advance of the deobligation or reobligation of such funds.

8. 2000

   Hillory J. Farias and Samantha Reid Date-Rape Drug Prohibition Act of 2000

   Pub. L. 106–172 § 4 · 114 Stat. 7

   Added · 21 U.S.C. § 827(h)

   Pub. L. 106–172 added subsec. (h)

   Source evidence

   Code amendment note
   Subsec. (h). Pub. L. 106–172 added subsec. (h).

   Enacted provision · exact public law section
   SEC. 4. AUTHORITY FOR ADDITIONAL REPORTING REQUIREMENTS FOR GAMMA HYDROXYBUTYRIC PRODUCTS IN SCHEDULE III. Section 307 of the Controlled Substances Act (21 U.S.C. 827) is amended by adding at the end the following: “(h) In the case of a drug product containing gamma Records. hydroxybutyric acid for which an application has been approved under section 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 Deadline. 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 310(b)(3) (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.”.

9. 2008

   Ryan Haight Online Pharmacy Consumer Protection Act of 2008

   Pub. L. 110–425 § 3(c) · 122 Stat. 4820

   1. Amended · 21 U.S.C. § 827(d)

      Pub. L. 110–425 designated existing provisions as par. (1)

   2. Added · 21 U.S.C. § 827(d)

      Pub. L. 110–425 added par. (2)

   Source evidence

   Code amendment note
   Subsec. (d). Pub. L. 110–425 designated existing provisions as par. (1) and added par. (2).

   Enacted provision · exact public law section
   (c) Reporting Requirements.— Section 307(d) of the Controlled Substances Act (21 U.S.C. 827(d)) is amended by— (1) striking “(d) Every” and inserting “(d)(1) Every”; and (2) adding at the end the following: “(2) Regulations. 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 controlled 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 pharmacy 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 required: “(A) 100 or more prescriptions dispensed. “(B) 5,000 or more dosage units of all controlled substances combined.” .

   Effective date note
   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.

10. 2018

    Using Data To Prevent Opioid Diversion Act of 2018

    Pub. L. 115–271 § 3273(a)(1) · 132 Stat. 3894

    1. Added · 21 U.S.C. § 827(f)(i)

       Pub. L. 115–271, § 3273(a)(1), (2), added subsec. (f)

    2. Redesignated · 21 U.S.C. § 827(f)(i)

       Pub. L. 115–271, § 3273(a)(1), (2), redesignated former subsecs. (f) to (h) as (g) to (i), respectively

    Source evidence

    Code amendment note
    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.

    Enacted provision · exact public law section
    (1) by redesignating subsections (f), (g), and (h) as subsections (g), (h), and (i), respectively;

11. 2018

    Using Data To Prevent Opioid Diversion Act of 2018

    Pub. L. 115–271 § 3273(a)(3) · 132 Stat. 3894

    Added · 21 U.S.C. § 827(j)

    Pub. L. 115–271, § 3273(a)(3), added subsec. (j)

    Source evidence

    Code amendment note
    Subsec. (j). Pub. L. 115–271, § 3273(a)(3), added subsec. (j).

    Enacted provision · exact public law section
    (3) by inserting after subsection (i), as so redesignated, the following: “(j) All of the reports required under this section shall be provided in an electronic format.” .

12. 2022

    Medical Marijuana and Cannabidiol Research Expansion Act

    Pub. L. 117–215 title I § 103(b)(1)(D) · 136 Stat. 2257

    Substituted · 21 U.S.C. § 827(d)(2)

    Pub. L. 117–215 substituted “823(g)” for “823(f)” in introductory provisions

    Source evidence

    Code amendment note
    Subsec. (d)(2). Pub. L. 117–215 substituted “823(g)” for “823(f)” in introductory provisions.

    Enacted provision · exact public law section
    (D) in section 307(d)(2) (21 U.S.C. 827(d)(2)), by striking “303(f)” and inserting “303(g)”;

13 of 15 references resolved to an enrolled provision · 2 partial