§335a. Debarment, temporary denial of approval, and suspension — Inbound Citations
21 U.S.C. § 335a
Cited by 9 provisions in release 119-102.
Citations to 21 U.S.C. § 335a as a whole
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(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
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(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.
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(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
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(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)
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(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.
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(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.
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(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)
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(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.