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

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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Stable record: federal_law:legal_authorities:record_usc_72dbdafbf5b52b56e03a6984
Source file: Laws/federal/codes/united-states-code/title-21/section-824-denial-revocation-or-suspension-of-registration--130058f0e8.md
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Source location: Title 21, Chapter 13, § 824; chapter-013-drug-abuse-prevention-and-control.md

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**(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 treatment may be suspended or revoked by the Attorney General upon a finding that the registrant has failed to comply with any standard referred to in [section 823(h) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section823/h&num=0&edition=prelim). **(b) Limits of revocation or suspension** The Attorney General may limit revocation or suspension of a registration to the particular controlled substance or list I chemical with respect to which grounds for revocation or suspension exist. **(c) Service of show cause order; proceedings** (1) Before taking action pursuant to this section, or pursuant to a denial of registration under [section 823 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section823&num=0&edition=prelim), the Attorney General shall serve upon the applicant or registrant an order to show cause why registration should not be denied, revoked, or suspended. (2) An order to show cause under paragraph (1) shall— (A) contain a statement of the basis for the denial, revocation, or suspension, including specific citations to any laws or regulations alleged to be violated by the applicant or registrant; (B) direct the applicant or registrant to appear before the Attorney General at a time and place stated in the order, but not less than 30 days after the date of receipt of the order; and (C) notify the applicant or registrant of the opportunity to submit a corrective action plan on or before the date of appearance. (3) Upon review of any corrective action plan submitted by an applicant or registrant pursuant to paragraph (2), the Attorney General shall determine whether denial, revocation, or suspension proceedings should be discontinued, or deferred for the purposes of modification, amendment, or clarification to such plan. (4) Proceedings to deny, revoke, or suspend shall be conducted pursuant to this section 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 requirements of this subsection shall not apply to the issuance of an immediate suspension order under subsection (d). **(d) Suspension of registration in cases of imminent danger** (1) The Attorney General may, in his discretion, suspend any registration simultaneously with the institution of proceedings under this section, in cases where he finds that there is an imminent danger to the public health or safety. A failure to comply with a standard referred to in [section 823(h) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section823/h&num=0&edition=prelim) may be treated under this subsection as grounds for immediate suspension of a registration granted under such section. A suspension under this subsection 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. (2) In this subsection, the phrase “imminent danger to the public health or safety” means that, due to the failure of the registrant to maintain effective controls against diversion or otherwise comply with the obligations of a registrant under this subchapter or subchapter II, there is a substantial likelihood of an immediate threat that death, serious bodily harm, or abuse of a controlled substance will occur in the absence of an immediate suspension of the registration. **(e) Suspension and revocation of quotas** The suspension or revocation of a registration under this section shall operate to suspend or revoke any quota applicable under [section 826 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section826&num=0&edition=prelim). **(f) Disposition of controlled substances or list I chemicals** In the event the Attorney General suspends or revokes a registration granted under [section 823 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section823&num=0&edition=prelim), 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 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 sale deposited in 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). All right, title, and interest in such controlled substances or list I chemicals shall vest in the United States upon a revocation order becoming final. **(g) Seizure or placement under seal of controlled substances or list I chemicals** The Attorney General may, in his discretion, seize or place under seal any controlled substances or list I chemicals owned or possessed by a registrant whose registration has expired or who has ceased to practice or do business in the manner contemplated by his registration. Such controlled substances or list I chemicals shall be held for the benefit of the registrant, or his successor in interest. The Attorney General shall notify a registrant, or his successor in interest, who has any controlled substance or list I chemical seized or placed under seal of the procedures to be followed to secure the return of the controlled substance or list I chemical and the conditions under which it will be returned. The Attorney General may not dispose of any controlled substance or list I chemical seized or placed under seal under this subsection until the expiration of one hundred and eighty days from the date such substance or chemical was seized or placed under seal. **(h) Order to prohibit registration based on prior history** The Attorney General may issue an order to prohibit, conditionally or unconditionally, and permanently or for such period as the Attorney General may determine, any person from being registered under this subchapter to manufacture, distribute, or dispense a controlled substance or a list I chemical, if the Attorney General finds that— (1) such person meets or has met any of the conditions for suspension or revocation of registration under subsection (a); and (2) such person has a history of prior suspensions or revocations of registration.

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

21 U.S.C. § 822 — Persons required to register

**(a) Period of registration** (1) Every person who manufactures or distributes any controlled substance or list I chemical, or who proposes to engage in the manufacture or distribution of any controlled substance or list I chemical, shall obtain annually a registration issued by the Attorney General in accordance with the rules and regulations promulgated by him. (2) Every person who dispenses, or who proposes to dispense, any controlled substance, shall obtain from the Attorney General a registration issued in accordance with the rules and regulations promulgated by him. The Attorney General shall, by regulation, determine the period of such registrations. In no event, however, shall such registrations be issued for less than one year nor for more than three years. (3) (A) Except as provided in subparagraph (C), the registration of any registrant under this subchapter to manufacture, distribute, or dispense controlled substances or list I chemicals terminates if and when such registrant— (i) dies; (ii) ceases legal existence; (iii) discontinues business or professional practice; or (iv) surrenders such registration. (B) In the case of such a registrant who ceases legal existence or discontinues business or professional practice, such registrant shall promptly notify the Attorney General in writing of such fact. (C) No registration under this subchapter to manufacture, distribute, or dispense controlled substances or list I chemicals, and no authority conferred thereby, may be assigned or otherwise transferred except upon such conditions as the Attorney General may specify and then only pursuant to written consent. A registrant to whom a registration is assigned or transferred pursuant to the preceding sentence may not manufacture, distr

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

42 U.S.C. § 1320a–7 — Exclusion of certain individuals and entities from participation in Medicare and State health care programs

**(a) Mandatory exclusion** The Secretary shall exclude the following individuals and entities from participation in any Federal health care program (as defined in [section 1320a–7b(f) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section1320a–7b/f&num=0&edition=prelim)): (1) **Conviction of program-related crimes** — Any individual or entity that has been convicted of a criminal offense related to the delivery of an item or service under subchapter XVIII or under any State health care program. (2) **Conviction relating to patient abuse** — Any individual or entity that has been convicted, under Federal or State law, of a criminal offense relating to neglect or abuse of patients in connection with the delivery of a health care item or service. (3) **Felony conviction relating to health care fraud** — Any individual or entity that has been convicted for an offense which occurred after August 21, 1996, under Federal or State law, in connection with the delivery of a health care item or service or with respect to any act or omission in a health care program (other than those specifically described in paragraph (1)) operated by or financed in whole or in part by any Federal, State, or local government agency, of a criminal offense consisting of a felony relating to fraud, theft, embezzlement, breach of fiduciary responsibility, or other financial misconduct. (4) **Felony conviction relating to controlled substance** — Any individual or entity that has been convicted for an offense which occurred after August 21, 1996, under Federal or State law, of a criminal offense consisting of a felony relating to the unlawful manufacture, distribution, prescription, or dispensing of a controlled substance. **(b) Permissive exclusion** The Secr

Source: Supplied U.S. Code snapshot — release unconfirmed · 42 U.S.C. § 1320a–7

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

21 U.S.C. § 801 — Congressional findings and declarations: controlled substances

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

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. § 826 — Production quotas for controlled substances

**(a) Establishment of total annual needs** (1) The Attorney General shall determine the total quantity and establish production quotas for each basic class of controlled substance in schedules I and II and for ephedrine, pseudoephedrine, and phenylpropanolamine to be manufactured each calendar year to provide for the estimated medical, scientific, research, and industrial needs of the United States, for lawful export requirements, and for the establishment and maintenance of reserve stocks. Except as provided in paragraph (2), production quotas shall be established in terms of quantities of each basic class of controlled substance and not in terms of individual pharmaceutical dosage forms prepared from or containing such a controlled substance. (2) The Attorney General may, if the Attorney General determines it will assist in avoiding the overproduction, shortages, or diversion of a controlled substance, establish an aggregate or individual production quota under this subsection, or a procurement quota established by the Attorney General by regulation, in terms of pharmaceutical dosage forms prepared from or containing the controlled substance. **(b) Individual manufacturing quotas; revised quotas** The Attorney General shall limit or reduce individual manufacturing quotas to the extent necessary to prevent the aggregate of individual quotas from exceeding the amount determined necessary each year by the Attorney General under subsection (a). The quota of each registered manufacturer for each basic class of controlled substance in schedule I or II or for ephedrine, pseudoephedrine, or phenylpropanolamine shall be revised in the same proportion as the limitation or reduction of the aggregate of the quotas. However, if any registrant, before the issuance of a limitati

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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

**(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. § 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

Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 958

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

42 U.S.C. § 11101 — Reports and memoranda of understanding

**(a) Annual reports to Congress** The Secretary shall report to Congress, annually during the three years after November 14, 1986, on the implementation of this chapter. **(b) Memoranda of understanding** The Secretary of Health and Human Services shall seek to enter into memoranda of understanding with the Secretary of Defense and the Administrator of Veterans’ Affairs to apply the provisions of subchapter II of this chapter to hospitals and other facilities and health care providers under the jurisdiction of the Secretary or Administrator, respectively. The Secretary shall report to Congress, not later than two years after November 14, 1986, on any such memoranda and on the cooperation among such officials in establishing such memoranda. **(c) Memorandum of understanding with Drug Enforcement Administration** The Secretary of Health and Human Services shall seek to enter into a memorandum of understanding with the Administrator of Drug Enforcement relating to providing for the reporting by the Administrator to the Secretary of information respecting physicians and other practitioners whose registration to dispense controlled substances has been suspended or revoked under [section 824 of title 21](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section824&num=0&edition=prelim). The Secretary shall report to Congress, not later than two years after November 14, 1986, on any such memorandum and on the cooperation between the Secretary and the Administrator in establishing such a memorandum.

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

42 U.S.C. § 1305 — Short title of chapter

This chapter may be cited as the “Social Security Act”.

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