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21 U.S.C. § 336 — Report of minor violations
Federal law — U.S. Code and appendices · legal_authorities
Nothing in this chapter shall be construed as requiring the Secretary to report for prosecution, or for the institution of libel or injunction proceedings, minor violations of this chapter whenever he believes that the public interest will be adequately served by a suitable written notice or warning.
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Source location: Title 21, Chapter 9, § 336; chapter-009-federal-food-drug-and-cosmetic-act.md
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Nothing in this chapter shall be construed as requiring the Secretary to report for prosecution, or for the institution of libel or injunction proceedings, minor violations of this chapter whenever he believes that the public interest will be adequately served by a suitable written notice or warning.
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Federal law — U.S. Code and appendices · legal_authorities
For the purposes of this chapter—
**(a)**
(1) The term “State”, except as used in the last sentence of [section 372(a) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section372/a&num=0&edition=prelim), means any State or Territory of the United States, the District of Columbia, and the Commonwealth of Puerto Rico.
(2) The term “Territory” means any Territory or possession of the United States, including the District of Columbia, and excluding the Commonwealth of Puerto Rico and the Canal Zone.
**(b)** The term “interstate commerce” means (1) commerce between any State or Territory and any place outside thereof, and (2) commerce within the District of Columbia or within any other Territory not organized with a legislative body.
**(c)** The term “Department” means Department of Health and Human Services.
**(d)** The term “Secretary” means the Secretary of Health and Human Services.
**(e)** The term “person” includes individual, partnership, corporation, and association.
**(f)** The term “food” means (1) articles used for food or drink for man or other animals, (2) chewing gum, and (3) articles used for components of any such article.
**(g)**
(1) The term “drug” means (A) articles recognized in the official United States Pharmacopoeia,11 So in original. Probably should be “Pharmacopeia,”. official Homoeopathic Pharmacopoeia of the United States, or official National Formulary, or any supplement to any of them; and (B) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and (C) articles (other than food) intended to affect the structure or any function of the body of man or other animals; and (D) articles intended for use as a component of any article specif
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Federal law — U.S. Code and appendices · legal_authorities
**(a) Mandatory debarment; certain drug applications**
(1) **Corporations, partnerships, and associations** — If the Secretary finds that a person other than an individual has been convicted, after May 13, 1992, of a felony under Federal law for conduct relating to the development or approval, including the process for development or approval, of any abbreviated drug application, the Secretary shall debar such person from submitting, or assisting in the submission of, any such application.
(2) **Individuals** — If the Secretary finds that an individual has been convicted of a felony under Federal law for conduct—
(A) relating to the development or approval, including the process for development or approval, of any drug product, or
(B) otherwise relating to the regulation of any drug product under this chapter,
the Secretary shall debar such individual from providing services in any capacity to a person that has an approved or pending drug product application.
**(b) Permissive debarment; certain drug applications; food imports**
(1) **In general** — The Secretary, on the Secretary’s own initiative or in response to a petition, may, in accordance with paragraph (2) or (3), debar—
(A) a person other than an individual from submitting or assisting in the submission of any abbreviated drug application;
(B) an individual from providing services in any capacity to a person that has an approved or pending drug product application;
(C) a person from importing an article of food or offering such an article for import into the United States; or
(D) a person from importing or offering for import into the United States a drug.
(2) **Persons subject to permissive debarment; certain drug applications** — The following persons are subject to debarment under sub
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 335a
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Federal law — U.S. Code and appendices · legal_authorities
Page 76
TITLE 21—FOOD AND DRUGS
§ 335c
(1) $250,000, or
(2) one-half of the penalty so imposed and
collected,
whichever is less. The decision of the Secretary
on such award shall not be reviewable.
(June 25, 1938, ch. 675, § 307, as added Pub. L.
102–282, § 3, May 13, 1992, 106 Stat. 159; amended
Pub. L. 103–80, § 3(g), Aug. 13, 1993, 107 Stat. 776.)
Editorial Notes
PRIOR PROVISIONS
A prior section 307 of act June 25, 1938, was renum-
bered section 310 and is classified to section 337 of this
title.
AMENDMENTS
1993—Subsec. (b)(3)(A). Pub. L. 103–80 made technical
amendment to reference to May 13, 1992, to reflect cor-
rection of corresponding provision of original act.
Statutory Notes and Related Subsidiaries
CONSTRUCTION
This section not to preclude any other civil, criminal,
or administrative remedy provided under Federal or
State law, including any private right of action against
any person for the same action subject to any action or
civil penalty under an amendment made by Pub. L.
102–282, see section 7 of Pub. L. 102–282, set out as a note
under section 335a of this title.
§ 335c. Authority to withdraw approval of abbre-
viated drug applications
(a) In general
The Secretary—
(1) shall withdraw approval of an abbre-
viated drug application if the Secretary finds
that the approval was obtained, expedited, or
otherwise facilitated through bribery, pay-
ment of an illegal gratuity, or fraud or mate-
rial false statement, and
(2) may withdraw approval of an abbreviated
drug application if the Secretary finds that
the applicant has repeatedly demonstrated a
lack of ability to produce the drug for which
the application was submitted in accordance
with the formulations or manufacturing prac-
tice set forth in the abbreviated drug applica-
t
Source: Supplied 2024 U.S. Code historical extraction · 21 U.S.C. § 336
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