§335a. Debarment, temporary denial of approval, and suspension — Inbound Citations

Code of Federal Regulations Citations

Cited by 2 regulations in the Code of Federal Regulations.

• 21 C.F.R. § 1.241(a) — What are the consequences of failing to register, update, renew, or cancel your registration?

  Go to regulation →

  (a) Section 301 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331) prohibits the doing of certain acts or causing such acts to be done. Under section 302 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 332), the United States can bring a civil action in Federal court to enjoin a person who commits a prohibited act. Under section 303 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 333), the United States can bring a criminal action in Federal court to prosecute a person who is responsible for the commission of a prohibited act. Under section 306 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 335a), FDA can seek debarment of any person who has been convicted of a felony relating to importation of food into the United States. Failure of an owner, operator, or agent in charge of a domestic or foreign facility to register its facility, renew the registration of its facility, update required elements of its facility's registration, or cancel its registration in accordance with the requirements of this subpart is a prohibited act under section 301(dd) of the Federal Food, Drug, and Cosmetic Act.

• 21 C.F.R. § 1.284(c) — What are the other consequences of failing to submit adequate prior notice or otherwise failing to comply with this subpart?

  Go to regulation →

  (c) Under section 306 of the act (21 U.S.C. 335a), FDA can seek debarment of any person who has been convicted of a felony relating to importation of food into the United States or any person who has engaged in a pattern of importing or offering for import adulterated food that presents a threat of serious adverse health consequences or death to humans or animals.

Citations to 21 U.S.C. § 335a as a whole

• 21 U.S.C. § 321(aa)(1)

  Go to provision →

  (1) in the case of section 335a of this title, includes a supplement to such an application for a different or additional use of the drug but does not include a supplement to such an application for other than a different or additional use of the drug, and

• 21 U.S.C. § 321(cc)

  Go to provision →

  (cc) For purposes of section 335a of this title, the term “high managerial agent”—

  (1) means—

  (A) an officer or director of a corporation or an association,

  (B) a partner of a partnership, or

  (C) any employee or other agent of a corporation, association, or partnership,

  having duties such that the conduct of such officer, director, partner, employee, or agent may fairly be assumed to represent the policy of the corporation, association, or partnership, and

  (2) includes persons having management responsibility for—

  (A) submissions to the Food and Drug Administration regarding the development or approval of any drug product,

  (B) production, quality assurance, or quality control of any drug product, or

  (C) research and development of any drug product.

• 21 U.S.C. § 321(dd)

  Go to provision →

  (dd) For purposes of sections 335a and 335b of this title, the term “drug product” means a drug subject to regulation under section 355, 360b, or 382 of this title or under section 262 of title 42.

• 21 U.S.C. § 335b(a)(6)

  Go to provision →

  (6) is a person that has an approved or pending drug product application and has knowingly—

  (A) employed or retained as a consultant or contractor, or

  (B) otherwise used in any capacity the services of,

  a person who was debarred under section 335a of this title, or

• 21 U.S.C. § 335b(a)(7)

  Go to provision →

  (7) is an individual debarred under section 335a of this title and, during the period of debarment, provided services in any capacity to a person that had an approved or pending drug product application,

Citations to §335a(b)(3)

• 21 U.S.C. § 331(cc)

  Go to provision →

  (cc) The importing or offering for import into the United States of an article of food or a drug by, with the assistance of, or at the direction of, a person debarred from such activity under section 335a(b)(3) of this title.

• 21 U.S.C. § 381(k)(1)

  Go to provision →

  (1) If an article of food is being imported or offered for import into the United States, and the importer, owner, or consignee of the article is a person who has been debarred under section 335a(b)(3) of this title, such article shall be held at the port of entry for the article, and may not be delivered to such person. Subsection (b) does not authorize the delivery of the article pursuant to the execution of a bond while the article is so held. The article shall be removed to a secure facility, as appropriate. During the period of time that such article is so held, the article shall not be transferred by any person from the port of entry into the United States for the article, or from the secure facility to which the article has been removed, as the case may be.

• 21 U.S.C. § 381(k)(2)

  Go to provision →

  (2) An article of food held under paragraph (1) may be delivered to a person who is not a debarred person under section 335a(b)(3) of this title if such person affirmatively establishes, at the expense of the person, that the article complies with the requirements of this chapter, as determined by the Secretary.

Citations to §335a(b)(3)(D)

• 21 U.S.C. § 381(t)

  Go to provision →

  (t) If the Secretary determines that a person subject to debarment as a result of engaging in a pattern of importing or offering for import controlled substances or drugs as described in section 335a(b)(3)(D) of this title, and such pattern is identified by the Secretary as being offered for import from the same manufacturer, distributor, or importer, the Secretary may by order determine all drugs being offered for import from such person as adulterated or misbranded, unless such person can provide evidence otherwise.