Denial, revocation, or suspension of registration

21 U.S.C. § 824

• Title: 21 — Food and Drugs
• Chapter: SUBCHAPTER I—CONTROL AND ENFORCEMENT
• Part: C

Text

(a) Grounds
A registration pursuant to section 823 of this title 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 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.
A registration pursuant to section 823(h) of this title 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.
(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, 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 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.
(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, 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. 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.

History

(Pub. L. 91–513, title II, §304, Oct. 27, 1970, 84 Stat. 1255; Pub. L. 93–281, §4, May 14, 1974, 88 Stat. 125; Pub. L. 98–473, title II, §§304, 512, 513, Oct. 12, 1984, 98 Stat. 2050, 2073; Pub. L. 100–93, §8(j), Aug. 18, 1987, 101 Stat. 695; Pub. L. 103–200, §3(d), Dec. 17, 1993, 107 Stat. 2337; Pub. L. 103–322, title XXXIII, §330024(e), Sept. 13, 1994, 108 Stat. 2151; Pub. L. 106–310, div. B, title XXXV, §3502(b), Oct. 17, 2000, 114 Stat. 1227; Pub. L. 114–145, §2(a)(2), (b), Apr. 19, 2016, 130 Stat. 354; Pub. L. 117–36, §2, Aug. 6, 2021, 135 Stat. 328; Pub. L. 117–215, title I, §103(b)(1)(C), Dec. 2, 2022, 136 Stat. 2263; Pub. L. 117–328, div. FF, title I, §1262(b)(1), Dec. 29, 2022, 136 Stat. 5682; Pub. L. 119–26, §4(2)(B)(i), (ii), July 16, 2025, 139 Stat. 416.)

Editorial Notes

Editorial Notes

References in Text
This subchapter, referred to in subsecs. (a)(1), (2), (c)(4), (d)(2), and (h), was in the original "this title", meaning title II of Pub. L. 91–513, Oct. 27, 1970, 84 Stat. 1242, and is popularly known as the "Controlled Substances Act". For complete classification of title II to the Code, see second paragraph of Short Title note set out under section 801 of this title and Tables.
Subchapter II, referred to in subsecs. (a)(1), (2) and (d)(2), was in the original "title III", meaning title III of Pub. L. 91–513, Oct. 27, 1970, 84 Stat. 1285. Part A of title III comprises subchapter II of this chapter. For classification of Part B, consisting of sections 1101 to 1105 of title III, see Tables.

Amendments
2025—Subsecs. (a), (d)(1). Pub. L. 119–26, §4(2)(B)(i), (ii), amended Pub. L. 117–328, §1262(b)(1). See 2022 Amendment notes below.
2022—Subsec. (a). Pub. L. 117–328, §1262(b)(1), as amended by Pub. L. 119–26, §4(2)(B)(i), (ii), in concluding provisions, substituted "823(h)" for "823(h)(1)" in two places.
Pub. L. 117–215, in concluding provisions, substituted "823(h)(1)" for "823(g)(1)" in two places.
Subsec. (d)(1). Pub. L. 117–328, §1262(b)(1), as amended by Pub. L. 119–26, §4(2)(B)(i), (ii), substituted "823(h)" for "823(h)(1)".
Pub. L. 117–215 substituted "823(h)(1)" for "823(g)(1)".
2021—Subsec. (h). Pub. L. 117–36 added subsec. (h).
2016—Subsec. (c). Pub. L. 114–145, §2(b), struck out "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 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 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." after "denied, revoked, or suspended.", designated existing provisions as par. (1), and added pars. (2) to (5).
Subsec. (d). Pub. L. 114–145, §2(a)(2), designated existing provisions as par. (1) and added par. (2).
2000—Subsec. (a). Pub. L. 106–310, §3502(b)(1), substituted "section 823(g)(1) of this title" for "section 823(g) of this title" in two places in concluding provisions.
Subsec. (d). Pub. L. 106–310, §3502(b)(2), substituted "section 823(g)(1) of this title" for "section 823(g) of this title".
1994—Subsec. (g). Pub. L. 103–322 inserted "or chemical" after "such substance" in last sentence.
1993—Subsec. (a). Pub. L. 103–200, §3(d)(1), inserted "or a list I chemical" after "controlled substance" in introductory provisions and par. (2) and inserted "or list I chemicals" after "controlled substances" in par. (3).
Subsec. (b). Pub. L. 103–200, §3(d)(2), inserted "or list I chemical" after "controlled substance".
Subsec. (f). Pub. L. 103–200, §3(d)(3), inserted "or list I chemicals" after "controlled substances" wherever appearing.
Subsec. (g). Pub. L. 103–200, §3(d)(4), inserted "or list I chemicals" after "controlled substances" in two places and "or list I chemical" after "controlled substance" wherever appearing.
1987—Subsec. (a)(5). Pub. L. 100–93 added par. (5).
1984—Subsec. (a)(3). Pub. L. 98–473, §512(1), inserted provisions relating to suspension, etc., recommended by competent State authority.
Subsec. (a)(4). Pub. L. 98–473, §512(2), added par. (4).
Subsec. (f). Pub. L. 98–473, §304, inserted provisions relating to vesting of right, title, and interest in the United States.
Subsec. (g). Pub. L. 98–473, §513, added subsec. (g).
1974—Subsec. (a). Pub. L. 93–281, §4(a), provided for revocation or suspension of a registration pursuant to section 823(g) of this title for failure of a registrant to comply with standards referred to in such section 823(g).
Subsec. (d). Pub. L. 93–281, §4(b), substituted "A suspension under this subsection" for "Such suspension" in third sentence.

Statutory Notes and Related Subsidiaries

Effective Date of 2025 Amendment
Pub. L. 119–26, §4, July 16, 2025, 139 Stat. 416, provided that the amendment made by section 4(2)(B)(i), (ii) is effective as if included in the enactment of Pub. L. 117–328.

Effective Date of 1994 Amendment
Amendment by Pub. L. 103–322 effective 120 days after Dec. 17, 1993, see section 330024(f) of Pub. L. 103–322, set out as a note under section 802 of this title.

Effective Date of 1993 Amendment
Amendment by Pub. L. 103–200 effective on date that is 120 days after Dec. 17, 1993, see section 11 of Pub. L. 103–200, set out as a note under section 802 of this title.

Effective Date of 1987 Amendment
Amendment by Pub. L. 100–93 effective at end of fourteen-day period beginning Aug. 18, 1987, and inapplicable to administrative proceedings commenced before end of such period, see section 15(a) of Pub. L. 100–93, set out as a note under section 1320a–7 of Title 42, The Public Health and Welfare.

Effective Date
Section effective on first day of seventh calendar month that begins after Oct. 26, 1970, see section 704 of Pub. L. 91–513, set out as a note under section 801 of this title.

Provisional Registration
Applicability of this section to provisional registrations, see section 703 of Pub. L. 91–513, set out as a note under section 822 of this title.