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

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

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

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**(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 shall not be required for the import or export of a drug product that is exempted under [section 802(39)(A)(iv) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section802/39/A/iv&num=0&edition=prelim). (B) In determining the public interest for the purposes of subparagraph (A), the Attorney General shall consider the factors specified in [section 823(i) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section823/i&num=0&edition=prelim). **(d) Denial of application** (1) The Attorney General may deny an application for registration under subsection (a) if he is unable to determine that such registration is consistent with the public interest (as defined in subsection (a)) and with the United States obligations under international treaties, conventions, or protocols in effect on May 1, 1971. (2) The Attorney General may deny an application for registration under subsection (c), or revoke or suspend a registration under subsection (a) or (c), if he determines that such registration is inconsistent with the public interest (as defined in subsection (a) or (c)) or with the United States obligations under international treaties, conventions, or protocols in effect on May 1, 1971. (3) The Attorney General may limit the revocation or suspension of a registration to the particular controlled substance, or substances, or list I chemical or chemicals, with respect to which grounds for revocation or suspension exist. (4) Before taking action pursuant to this subsection, the Attorney General shall serve upon the applicant or registrant an order to show cause as to why the registration should not be denied, revoked, or suspended. The order to show cause shall contain a statement of the basis thereof and shall call upon the applicant or registrant to appear before the Attorney General, or his designee, at a time and place stated in the order, but in no event less than thirty days after the date of receipt of the order. Proceedings to deny, revoke, or suspend shall be conducted pursuant to this subsection in accordance with subchapter II of chapter 5 of title 5. Such proceedings shall be independent of, and not in lieu of, criminal prosecutions or other proceedings under this subchapter or any other law of the United States. (5) The Attorney General may, in his discretion, suspend any registration simultaneously with the institution of proceedings under this subsection, in cases where he finds that there is an imminent danger to the public health and safety. Such suspension shall continue in effect until the conclusion of such proceedings, including judicial review thereof, unless sooner withdrawn by the Attorney General or dissolved by a court of competent jurisdiction. (6) In the event that the Attorney General suspends or revokes a registration granted under this section, all controlled substances or list I chemicals owned or possessed by the registrant pursuant to such registration at the time of suspension or the effective date of the revocation order, as the case may be, may, in the discretion of the Attorney General, be seized or placed under seal. No disposition may be made of any controlled substances or list I chemicals under seal until the time for taking an appeal has elapsed or until all appeals have been concluded, except that a court, upon application therefor, may at any time order the sale of perishable controlled substances or list I chemicals. Any such order shall require the deposit of the proceeds of the sale with the court. Upon a revocation order becoming final, all such controlled substances or list I chemicals (or proceeds of the sale thereof which have been deposited with the court) shall be forfeited to the United States; and the Attorney General shall dispose of such controlled substances or list I chemicals in accordance with [section 881(e) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section881/e&num=0&edition=prelim). **(e) Registration period** No registration shall be issued under this subchapter for a period in excess of one year. Unless the regulations of the Attorney General otherwise provide, sections 822(f), 825, 827, and 830 of this title shall apply to persons registered under this section to the same extent such sections apply to persons registered under [section 823 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section823&num=0&edition=prelim). **(f) Rules and regulations** The Attorney General is authorized to promulgate rules and regulations and to charge reasonable fees relating to the registration and control of importers and exporters of controlled substances or listed chemicals. **(g) Scope of authorized activity** Persons registered by the Attorney General under this section to import or export controlled substances or list I chemicals may import or export (and for the purpose of so importing or exporting, may possess) such substances to the extent authorized by their registration and in conformity with the other provisions of this subchapter and subchapter I. **(h) Separate registrations for each principal place of business** A separate registration shall be required at each principal place of business where the applicant imports or exports controlled substances or list I chemicals. **(i) Emergency situations** Except in emergency situations as described in [section 952(a)(2)(A) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section952/a/2/A&num=0&edition=prelim), prior to issuing a registration under this section to a bulk manufacturer of a controlled substance in schedule I or II, and prior to issuing a regulation under [section 952(a) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section952/a&num=0&edition=prelim) authorizing the importation of such a substance, the Attorney General shall give manufacturers holding registrations for the bulk manufacture of the substance an opportunity for a hearing.

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

21 U.S.C. § 830 — Regulation of listed chemicals and certain machines

**(a) Record of regulated transactions** (1) Each regulated person who engages in a regulated transaction involving a listed chemical, a tableting machine, or an encapsulating machine shall keep a record of the transaction for two years after the date of the transaction. (2) A record under this subsection shall be retrievable and shall include the date of the regulated transaction, the identity of each party to the regulated transaction, a statement of the quantity and form of the listed chemical, a description of the tableting machine or encapsulating machine, and a description of the method of transfer. Such record shall be available for inspection and copying by the Attorney General. (3) It is the duty of each regulated person who engages in a regulated transaction to identify each other party to the transaction. It is the duty of such other party to present proof of identity to the regulated person. The Attorney General shall specify by regulation the types of documents and other evidence that constitute proof of identity for purposes of this paragraph. **(b) Reports to Attorney General** (1) Each regulated person shall report to the Attorney General, in such form and manner as the Attorney General shall prescribe by regulation— (A) any regulated transaction involving an extraordinary quantity of a listed chemical, an uncommon method of payment or delivery, or any other circumstance that the regulated person believes may indicate that the listed chemical will be used in violation of this subchapter; (B) any proposed regulated transaction with a person whose description or other identifying characteristic the Attorney General furnishes in advance to the regulated person; (C) any unusual or excessive loss or disappearance of a listed chemical under the c

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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. § 823 — Registration requirements

**(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

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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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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21 U.S.C. § 844 — Penalties for simple possession

**(a) Unlawful acts; penalties** It shall be unlawful for any person knowingly or intentionally to possess a controlled substance unless such substance was obtained directly, or pursuant to a valid prescription or order, from a practitioner, while acting in the course of his professional practice, or except as otherwise authorized by this subchapter or subchapter II. It shall be unlawful for any person knowingly or intentionally to possess any list I chemical obtained pursuant to or under authority of a registration issued to that person under [section 823 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section823&num=0&edition=prelim) or [section 958 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section958&num=0&edition=prelim) if that registration has been revoked or suspended, if that registration has expired, or if the registrant has ceased to do business in the manner contemplated by his registration. It shall be unlawful for any person to knowingly or intentionally purchase at retail during a 30 day period more than 9 grams of ephedrine base, pseudoephedrine base, or phenylpropanolamine base in a scheduled listed chemical product, except that, of such 9 grams, not more than 7.5 grams may be imported by means of shipping through any private or commercial carrier or the Postal Service. Any person who violates this subsection may be sentenced to a term of imprisonment of not more than 1 year, and shall be fined a minimum of $1,000, or both, except that if he commits such offense after a prior conviction under this subchapter or subchapter II, or a prior conviction for any drug, narcotic, or chemical offense chargeable under the law of any State, has become final, he shall be sentenced to a term

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21 U.S.C. § 952 — Importation of controlled substances

**(a) Controlled substances in schedule I or II and narcotic drugs in schedule III, IV, or V; exceptions** It shall be unlawful to import into the customs territory of the United States from any place outside thereof (but within the United States), or to import into the United States from any place outside thereof, any controlled substance in schedule I or II of subchapter I, or any narcotic drug in schedule III, IV, or V of subchapter I, or ephedrine, pseudoephedrine, or phenylpropanolamine, except that— (1) such amounts of crude opium, poppy straw, concentrate of poppy straw, and coca leaves, and of ephedrine, pseudoephedrine, and phenylpropanolamine, as the Attorney General finds to be necessary to provide for medical, scientific, or other legitimate purposes, and (2) such amounts of any controlled substance in schedule I or II or any narcotic drug in schedule III, IV, or V that the Attorney General finds to be necessary to provide for the medical, scientific, or other legitimate needs of the United States— (A) during an emergency in which domestic supplies of such substance or drug are found by the Attorney General to be inadequate, (B) in any case in which the Attorney General finds that competition among domestic manufacturers of the controlled substance is inadequate and will not be rendered adequate by the registration of additional manufacturers under [section 823 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section823&num=0&edition=prelim), or (C) in any case in which the Attorney General finds that such controlled substance is in limited quantities exclusively for scientific, analytical, or research uses, may be so imported under such regulations as the Attorney General shall prescribe. No crude opium may be s

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

21 U.S.C. § 965 — Applicability of part E of subchapter I

Part E of subchapter I shall apply with respect to functions of the Attorney General (and of officers and employees of the Bureau of Narcotics and Dangerous Drugs) under this subchapter, to administrative and judicial proceedings under this subchapter, and to violations of this subchapter, to the same extent that such part applies to functions of the Attorney General (and such officers and employees) under subchapter I, to such proceedings under subchapter I, and to violations of subchapter I. For purposes of the application of this section to section 880 or 881 of this title, any reference in such section 880 or 881 of this title to “this subchapter” shall be deemed to be a reference to this subchapter, any reference to [section 823 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section823&num=0&edition=prelim) shall be deemed to be a reference to [section 958 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section958&num=0&edition=prelim), and any reference to [section 822(d) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section822/d&num=0&edition=prelim) shall be deemed to be a reference to [section 957(b)(2) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section957/b/2&num=0&edition=prelim).

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

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

Page 898 TITLE 21—FOOD AND DRUGS § 958 1 See References in Text note below. (A) An agent or an employee of any importer or exporter registered under section 958 of this title if such agent or employee is acting in the usual course of his business or employment. (B) A common or contract carrier or ware- houseman, or an employee thereof, whose pos- session 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 sub- stance for a purpose specified in section 802(25) 1 of this title and in conformity with an exemption granted under section 956(a) of this title. (2) The Attorney General may, by regulation, waive the requirement for registration of cer- tain importers and exporters if he finds it con- sistent with the public health and safety; and may authorize any such importer or exporter to possess controlled substances or list I chemicals for purposes of importation and exportation. (Pub. L. 91–513, title III, § 1007, Oct. 27, 1970, 84 Stat. 1288; Pub. L. 98–473, title II, § 523, Oct. 12, 1984, 98 Stat. 2076; Pub. L. 103–200, § 3(e), Dec. 17, 1993, 107 Stat. 2337.) Editorial Notes REFERENCES IN TEXT Section 802(25) of this title, referred to in subsec. (b)(1)(C), was redesignated section 802(26) of this title by Pub. L. 98–473, title II, § 507(a), Oct. 12, 1984, 98 Stat. 2071, and was further redesignated section 802(27) of this title by Pub. L. 99–570, title I, § 1003(b)(2), Oct. 27, 1986, 100 Stat. 3207–6. AMENDMENTS 1993—Subsec. (a)(1). Pub. L. 103–200, § 3(e)(1)(A), in- serted ‘‘or list I chemical’’ after ‘‘controlled sub- stance’’. Subsec. (a)(2). Pub. L. 103–200, § 3(e)(1)(B), substituted ‘‘or list I chemical,’’ for ‘‘in schedule I, II, III, IV, or V,’

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