§384. Importation of prescription drugs — Inbound Citations
21 U.S.C. § 384
Cited by 5 provisions in release 119-102.
Citations to 21 U.S.C. § 384 as a whole
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(aa) The importation of a prescription drug in violation of section 384 of this title, the falsification of any record required to be maintained or provided to the Secretary under such section, or any other violation of regulations under such section.
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(A) Except as provided in paragraph (2) and section 384 of this title, no drug subject to section 353(b) of this title or composed wholly or partly of insulin which is manufactured in a State and exported may be imported into the United States unless the drug is imported by the manufacturer of the drug.
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(B) Except as authorized by the Secretary in the case of a drug that appears on the drug shortage list under section 356e of this title or in the case of importation pursuant to section 384 of this title, no drug that is subject to section 353(b)(1) of this title may be imported into the United States for commercial use if such drug is manufactured outside the United States, unless the manufacturer has authorized the drug to be marketed in the United States and has caused the drug to be labeled to be marketed in the United States.
Citations to §384(b)
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(6) Notwithstanding subsection (a), any person who is a manufacturer or importer of a prescription drug under section 384(b) of this title and knowingly fails to comply with a requirement of section 384(e) of this title that is applicable to such manufacturer or importer, respectively, shall be imprisoned for not more than 10 years or fined not more than $250,000, or both.
Citations to §384(e)
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(6) Notwithstanding subsection (a), any person who is a manufacturer or importer of a prescription drug under section 384(b) of this title and knowingly fails to comply with a requirement of section 384(e) of this title that is applicable to such manufacturer or importer, respectively, shall be imprisoned for not more than 10 years or fined not more than $250,000, or both.