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21 U.S.C. § 957 — Persons required to register

Federal law — U.S. Code and appendices · legal_authorities

21 U.S.C. § 957 — Persons required to register

**(a) Coverage** No person may— (1) import into the customs territory of the United States from any place outside thereof (but within the United States), or import into the United States from any place outside thereof, any controlled substance or list I chemical, or (2) export from the United States any controlled substance or list I chemical, unless there is in effect with respect to such person a registration issued by the Attorney General under [section 958 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section958&num=0&edition=prelim), or unless such person is exempt from registration under subsection (b). **(b) Exemptions** (1) The following persons shall not be required to register under the provisions of this section and may lawfully possess a controlled substance or list I chemical: (A) An agent or an employee of any importer or exporter registered under [section 958 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section958&num=0&edition=prelim) if such agent or employee is acting in the usual course of his business or employment. (B) A common or contract carrier or warehouseman, or an employee thereof, whose possession of any controlled substance or list I chemical is in the usual course of his business or employment. (C) An ultimate user who possesses such substance for a purpose specified in section 802(25) 11 See References in Text note below. of this title and in conformity with an exemption granted under [section 956(a) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section956/a&num=0&edition=prelim). (2) The Attorney General may, by regulation, waive the requirement for registration of certain importers and exporters if he finds it

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Source location: Title 21, Chapter 13, § 957; chapter-013-drug-abuse-prevention-and-control.md

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Federal law — U.S. Code and appendices · legal_authorities

21 U.S.C. § 958 — Registration requirements

**(a) Applicants to import or export controlled substances in schedule I or II** The Attorney General shall register an applicant to import or export a controlled substance 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 factors enumerated in paragraph (1) through (6) of [section 823(a) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section823/a&num=0&edition=prelim) shall be considered. **(b) Activity limited to specified substances** Registration granted under this section shall not entitle a registrant to import or export controlled substances other than specified in the registration. **(c) Applicants to import controlled substances in schedule III, IV, or V or to export controlled substances in schedule III or IV; applicants to import or export list I chemicals** (1) The Attorney General shall register an applicant to import a controlled substance in schedule III, IV, or V or to export a controlled substance in schedule III or IV, unless he determines that the issuance of such registration is inconsistent with the public interest. In determining the public interest, the factors enumerated in paragraphs (1) through (6) of [section 823(e) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section823/e&num=0&edition=prelim) shall be considered. (2) (A) The Attorney General shall register an applicant to import or export a list I chemical unless the Attorney General determines that registration of the applicant is inconsistent with the public interest. Registration under this subsection sha

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Federal law — U.S. Code and appendices · legal_authorities

21 U.S.C. § 824 — Denial, revocation, or suspension of registration

**(a) Grounds** A registration pursuant to [section 823 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section823&num=0&edition=prelim) to manufacture, distribute, or dispense a controlled substance or a list I chemical may be suspended or revoked by the Attorney General upon a finding that the registrant— (1) has materially falsified any application filed pursuant to or required by this subchapter or subchapter II; (2) has been convicted of a felony under this subchapter or subchapter II or any other law of the United States, or of any State, relating to any substance defined in this subchapter as a controlled substance or a list I chemical; (3) has had his State license or registration suspended, revoked, or denied by competent State authority and is no longer authorized by State law to engage in the manufacturing, distribution, or dispensing of controlled substances or list I chemicals or has had the suspension, revocation, or denial of his registration recommended by competent State authority; (4) has committed such acts as would render his registration under [section 823 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section823&num=0&edition=prelim) inconsistent with the public interest as determined under such section; or (5) has been excluded (or directed to be excluded) from participation in a program pursuant to [section 1320a–7(a) of title 42](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section1320a–7/a&num=0&edition=prelim). A registration pursuant to [section 823(h) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section823/h&num=0&edition=prelim) to dispense a narcotic drug for maintenance treatment or detoxification tr

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Federal law — U.S. Code and appendices · legal_authorities

21 U.S.C. § 951 — Definitions

**(a)** For purposes of this subchapter— (1) The term “import” means, with respect to any article, any bringing in or introduction of such article into any area (whether or not such bringing in or introduction constitutes an importation within the meaning of the tariff laws of the United States). (2) The term “customs territory of the United States” has the meaning assigned to such term by general note 2 of the Harmonized Tariff Schedule of the United States. **(b)** Each term defined in [section 802 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section802&num=0&edition=prelim) shall have the same meaning for purposes of this subchapter as such term has for purposes of subchapter I.

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Federal law — U.S. Code and appendices · legal_authorities

21 U.S.C. § 360 — Registration of producers of drugs or devices

**(a) Definitions** As used in this section— (1) the term “manufacture, preparation, propagation, compounding, or processing” shall include repackaging or otherwise changing the container, wrapper, or labeling of any drug package or device package in furtherance of the distribution of the drug or device from the original place of manufacture to the person who makes final delivery or sale to the ultimate consumer or user; and (2) the term “name” shall include in the case of a partnership the name of each partner and, in the case of a corporation, the name of each corporate officer and director, and the State of incorporation. **(b) Annual registration** (1) During the period beginning on October 1 and ending on December 31 of each year, every person who owns or operates any establishment in any State engaged in the manufacture, preparation, propagation, compounding, or processing of a drug or drugs shall register with the Secretary the name of such person, places of business of such person, all such establishments, the unique facility identifier of each such establishment, and a point of contact e-mail address. (2) During the period beginning on October 1 and ending on December 31 of each year, every person who owns or operates any establishment in any State engaged in the manufacture, preparation, propagation, compounding, or processing of a device or devices shall register with the Secretary his name, places of business, and all such establishments. (3) The Secretary shall specify the unique facility identifier system that shall be used by registrants under paragraph (1). The requirement to include a unique facility identifier in a registration under paragraph (1) shall not apply until the date that the identifier system is specified by the Secretary under the pr

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Federal law — U.S. Code and appendices · legal_authorities

21 U.S.C. § 802 — Definitions

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

21 U.S.C. § 957 — Persons required to register

Page 897 TITLE 21—FOOD AND DRUGS § 957 territory of the United States, a controlled sub- stance in schedule I or II or a narcotic drug in schedule III or IV, unless such substance or drug is a part of the cargo entered in the manifest or part of the official supplies of the vessel, air- craft, or vehicle. (Pub. L. 91–513, title III, § 1005, Oct. 27, 1970, 84 Stat. 1287.) Editorial Notes REFERENCES IN TEXT Schedules I, II, III, and IV, referred to in text, are set out in section 812(c) of this title. Statutory Notes and Related Subsidiaries EFFECTIVE DATE Section effective on first day of seventh calendar month that begins after Oct. 26, 1970, see 1105(a) of Pub. L. 91–513, set out as a under section 951 of this title. §§ 955a to 955d. Transferred Editorial Notes CODIFICATION Sections, Pub. L. 96–350, §§ 1–4, Sept. 15, 1980, 94 Stat. 1159, 1160, relating to maritime drug law enforcement, were transferred to sections 1901 to 1904 of the former Appendix to Title 46, Shipping. Sections 1901 to 1904 of the former Appendix to Title 46 were repealed and re- stated in chapter 705 of Title 46, Shipping, by Pub. L. 109–304, §§ 10(2), 19, Oct. 6, 2006, 120 Stat. 1683, 1710. For disposition of sections of the former Appendix to Title 46, see Disposition Table preceding section 101 of Title 46. § 956. Exemption authority (a) Individual possessing controlled substance (1) Subject to paragraph (2), the Attorney Gen- eral may by regulation exempt from sections 952(a) and (b), 953, 954, and 955 of this title any individual who has a controlled substance (ex- cept a substance in schedule I) in his possession for his personal medical use, or for administra- tion to an animal accompanying him, if he law- fully obtained such substance and he makes such declarat

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