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21 U.S.C. § 827 — Records and reports of registrants
Federal law — U.S. Code and appendices · legal_authorities
**(a) Inventory** Except as provided in subsection (c)—
(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 nonnarcoti
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Source location: Title 21, Chapter 13, § 827; chapter-013-drug-abuse-prevention-and-control.md
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**(a) Inventory** Except as provided in subsection (c)—
(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**
(1) Every manufacturer registered under [section 823 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section823&num=0&edition=prelim) 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](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section822/d&num=0&edition=prelim)) to whom such sale, delivery, or other disposal was made.
(2) Each pharmacy with a modified registration under [section 823(g) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section823/g&num=0&edition=prelim) 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.
**(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](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section823&num=0&edition=prelim) 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) Records and reports of registrants**
(1) The Attorney General shall, not less frequently than quarterly, make the following information available to manufacturer and distributor registrants through the Automated Reports and Consolidated Orders System, or any subsequent automated system developed by the Drug Enforcement Administration to monitor selected controlled substances:
(A) The total number of distributor registrants that distribute controlled substances to a pharmacy or practitioner registrant, aggregated by the name and address of each pharmacy and practitioner registrant.
(B) The total quantity and type of opioids distributed, listed by Administration Controlled Substances Code Number, to each pharmacy and practitioner registrant described in subparagraph (A).
(2) The information required to be made available under paragraph (1) shall be made available not later than the 30th day of the first month following the quarter to which the information relates.
(3)
(A) All registered manufacturers and distributors shall be responsible for reviewing the information made available by the Attorney General under this subsection.
(B) In determining whether to initiate proceedings under this subchapter against a registered manufacturer or distributor based on the failure of the registrant to maintain effective controls against diversion or otherwise comply with the requirements of this subchapter or the regulations issued thereunder, the Attorney General may take into account that the information made available under this subsection was available to the registrant.
**(g) 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.
**(h) 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.
**(i) 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](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355&num=0&edition=prelim), 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](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section830/b/3&num=0&edition=prelim) (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.
**(j) Electronic reporting format** All of the reports required under this section shall be provided in an electronic format.
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Federal law — U.S. Code and appendices · legal_authorities
**(a) Necessity of effective approval of application** No person shall introduce or deliver for introduction into interstate commerce any new drug, unless an approval of an application filed pursuant to subsection (b) or (j) is effective with respect to such drug.
**(b) Filing application; contents**
(1)
(A) Any person may file with the Secretary an application with respect to any drug subject to the provisions of subsection (a). Such persons shall submit to the Secretary as part of the application—
(i) full reports of investigations which have been made to show whether such drug is safe for use and whether such drug is effective in use;
(ii) a full list of the articles used as components of such drug;
(iii) a full statement of the composition of such drug;
(iv) a full description of the methods used in, and the facilities and controls used for, the manufacture, processing, and packing of such drug;
(v) such samples of such drug and of the articles used as components thereof as the Secretary may require;
(vi) specimens of the labeling proposed to be used for such drug;
(vii) any assessments required under [section 355c of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355c&num=0&edition=prelim); and
(viii) the patent number and expiration date of each patent for which a claim of patent infringement could reasonably be asserted if a person not licensed by the owner of the patent engaged in the manufacture, use, or sale of the drug, and that—
(I) claims the drug for which the applicant submitted the application and is a drug substance (active ingredient) patent or a drug product (formulation or composition) patent; or
(II) claims a method of using such drug for which approv
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Federal law — U.S. Code and appendices · legal_authorities
The Congress makes the following findings and declarations:
(1) Many of the drugs included within this subchapter have a useful and legitimate medical purpose and are necessary to maintain the health and general welfare of the American people.
(2) The illegal importation, manufacture, distribution, and possession and improper use of controlled substances have a substantial and detrimental effect on the health and general welfare of the American people.
(3) A major portion of the traffic in controlled substances flows through interstate and foreign commerce. Incidents of the traffic which are not an integral part of the interstate or foreign flow, such as manufacture, local distribution, and possession, nonetheless have a substantial and direct effect upon interstate commerce because—
(A) after manufacture, many controlled substances are transported in interstate commerce,
(B) controlled substances distributed locally usually have been transported in interstate commerce immediately before their distribution, and
(C) controlled substances possessed commonly flow through interstate commerce immediately prior to such possession.
(4) Local distribution and possession of controlled substances contribute to swelling the interstate traffic in such substances.
(5) Controlled substances manufactured and distributed intrastate cannot be differentiated from controlled substances manufactured and distributed interstate. Thus, it is not feasible to distinguish, in terms of controls, between controlled substances manufactured and distributed interstate and controlled substances manufactured and distributed intrastate.
(6) Federal control of the intrastate incidents of the traffic in controlled substances is essential to the effective control of the interstate incidents
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Federal law — U.S. Code and appendices · legal_authorities
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 Prev
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Federal law — U.S. Code and appendices · legal_authorities
**(a) Manufacturers of controlled substances in schedule I or II** The Attorney General shall register an applicant to manufacture controlled substances in schedule I or II if he determines that such registration is consistent with the public interest and with United States obligations under international treaties, conventions, or protocols in effect on May 1, 1971. In determining the public interest, the following factors shall be considered:
(1) maintenance of effective controls against diversion of particular controlled substances and any controlled substance in schedule I or II compounded therefrom into other than legitimate medical, scientific, research, or industrial channels, by limiting the importation and bulk manufacture of such controlled substances to a number of establishments which can produce an adequate and uninterrupted supply of these substances under adequately competitive conditions for legitimate medical, scientific, research, and industrial purposes;
(2) compliance with applicable State and local law;
(3) promotion of technical advances in the art of manufacturing these substances and the development of new substances;
(4) prior conviction record of applicant under Federal and State laws relating to the manufacture, distribution, or dispensing of such substances;
(5) past experience in the manufacture of controlled substances, and the existence in the establishment of effective control against diversion; and
(6) such other factors as may be relevant to and consistent with the public health and safety.
**(b) Distributors of controlled substances in schedule I or II** The Attorney General shall register an applicant to distribute a controlled substance in schedule I or II unless he determines that the issuance of such registration is inconsist
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Federal law — U.S. Code and appendices · legal_authorities
As used in this subchapter:
(1) The term “addict” means any individual who habitually uses any narcotic drug so as to endanger the public morals, health, safety, or welfare, or who is so far addicted to the use of narcotic drugs as to have lost the power of self-control with reference to his addiction.
(2) The term “administer” refers to the direct application of a controlled substance to the body of a patient or research subject by—
(A) a practitioner (or, in his presence, by his authorized agent), or
(B) the patient or research subject at the direction and in the presence of the practitioner,
whether such application be by injection, inhalation, ingestion, or any other means.
(3) The term “agent” means an authorized person who acts on behalf of or at the direction of a manufacturer, distributor, or dispenser; except that such term does not include a common or contract carrier, public warehouseman, or employee of the carrier or warehouseman, when acting in the usual and lawful course of the carrier’s or warehouseman’s business.
(4) The term “Drug Enforcement Administration” means the Drug Enforcement Administration in the Department of Justice.
(5) The term “control” means to add a drug or other substance, or immediate precursor, to a schedule under part B of this subchapter, whether by transfer from another schedule or otherwise.
(6) The term “controlled substance” means a drug or other substance, or immediate precursor, included in schedule I, II, III, IV, or V of part B of this subchapter. The term does not include distilled spirits, wine, malt beverages, or tobacco, as those terms are defined or used in subtitle E of the Internal Revenue Code of 1986.
(7) The term “counterfeit substance” means a controlled substance which, or the container or labelin
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Federal law — U.S. Code and appendices · legal_authorities
**(a) Schedule II substances** Except when dispensed directly by a practitioner, other than a pharmacist, to an ultimate user, no controlled substance in schedule II, which is a prescription drug as determined under the Federal Food, Drug, and Cosmetic Act [[21 U.S.C. 301](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section301&num=0&edition=prelim) et seq.], may be dispensed without the written prescription of a practitioner, except that in emergency situations, as prescribed by the Secretary by regulation after consultation with the Attorney General, such drug may be dispensed upon oral prescription in accordance with section 503(b) of that Act [[21 U.S.C. 353(b)](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section353/b&num=0&edition=prelim)]. Prescriptions shall be retained in conformity with the requirements of [section 827 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section827&num=0&edition=prelim). No prescription for a controlled substance in schedule II may be refilled.
**(b) Schedule III and IV substances** Except when dispensed directly by a practitioner, other than a pharmacist, to an ultimate user, no controlled substance in schedule III or IV, which is a prescription drug as determined under the Federal Food, Drug, and Cosmetic Act [[21 U.S.C. 301](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section301&num=0&edition=prelim) et seq.], may be dispensed without a written or oral prescription in conformity with section 503(b) of that Act [[21 U.S.C. 353(b)](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section353/b&num=0&edition=prelim)]. Such prescriptions may not be filled or refilled more than six months after the date the
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Federal law — U.S. Code and appendices · legal_authorities
**(a) In general** Notwithstanding [section 802(10) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section802/10&num=0&edition=prelim), a pharmacy may deliver a controlled substance to a practitioner in accordance with a prescription that meets the requirements of this subchapter and the regulations issued by the Attorney General under this subchapter, for the purpose of administering the controlled substance by the practitioner if—
(1) the controlled substance is delivered by the pharmacy to the prescribing practitioner or the practitioner administering the controlled substance, as applicable, at the location listed on the practitioner’s certificate of registration issued under this subchapter;
(2) the controlled substance is a drug in schedule III, IV, or V to be administered—
(A) by injection or implantation for the purpose of maintenance or detoxification treatment; or
(B) subject to a risk evaluation and mitigation strategy pursuant to [section 355–1 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355-1&num=0&edition=prelim) that includes elements to assure safe use of the drug described in subsection (f)(3)(E) of such section, including a requirement for post-administration monitoring by a health care provider;
(3) the pharmacy and the practitioner are authorized to conduct the activities specified in this section under the law of the State in which such activities take place;
(4) the prescription is not issued to supply any practitioner with a stock of controlled substances for the purpose of general dispensing to patients;
(5) except as provided in subsection (b), the controlled substance is to be administered only to the patient named on the prescription not later than 45
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Federal law — U.S. Code and appendices · legal_authorities
**(a) Cooperation of Attorney General with local, State, tribal, and Federal agencies** The Attorney General shall cooperate with local, State, tribal, and Federal agencies concerning traffic in controlled substances and in suppressing the abuse of controlled substances. To this end, he is authorized to—
(1) arrange for the exchange of information between governmental officials concerning the use and abuse of controlled substances;
(2) cooperate in the institution and prosecution of cases in the courts of the United States and before the licensing boards and courts of the several States;
(3) conduct training programs on controlled substance law enforcement for local, State, tribal, and Federal personnel;
(4) maintain in the Department of Justice a unit which will accept, catalog, file, and otherwise utilize all information and statistics, including records of controlled substance abusers and other controlled substance law offenders, which may be received from Federal, State, tribal, and local agencies, and make such information available for Federal, State, tribal, and local law enforcement purposes;
(5) conduct programs of eradication aimed at destroying wild or illicit growth of plant species from which controlled substances may be extracted;
(6) assist State, tribal, and local governments in suppressing the diversion of controlled substances from legitimate medical, scientific, and commercial channels by—
(A) making periodic assessments of the capabilities of State, tribal, and local governments to adequately control the diversion of controlled substances;
(B) providing advice and counsel to State, tribal, and local governments on the methods by which such governments may strengthen their controls against diversion; and
(C) establishing cooperative inv
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 873
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Federal law — U.S. Code and appendices · legal_authorities
Page 826
TITLE 21—FOOD AND DRUGS
§ 827
(Pub. L. 112–144, title X, § 1006, July 9, 2012, 126
Stat. 1105.)
Editorial Notes
REFERENCES IN TEXT
Section 1005 of this Act, referred to in par. (1), means
section 1005 of Pub. L. 112–144, which amended section
826 of this title.
CODIFICATION
Section was enacted as part of the Food and Drug Ad-
ministration Safety and Innovation Act, and not as
part of the Controlled Substances Act which comprises
this subchapter.
Statutory Notes and Related Subsidiaries
DEFINITION OF ‘‘SECRETARY’’
The term ‘‘Secretary’’ as meaning the Secretary of
Health and Human Services, see section 1001(b) of Pub.
L. 112–144, set out as an Effect of Notification note
under section 356c of this title.
§ 827. Records and reports of registrants
(a) Inventory
Except as provided in subsection (c)—
(1) every registrant under this subchapter
shall, on May 1, 1971, or as soon thereafter as
such registrant first engages in the manufac-
ture, 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 regula-
tions prescribed under this section shall per-
mit each such biennial inventory (following
the initial inventory required by this para-
graph) to be prepared on such registrant’s reg-
ular 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 accu
Source: Supplied 2024 U.S. Code historical extraction · 21 U.S.C. § 827
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