drug product
Defined in 3 places across 2 titles of the United States Code.
For purposes of sections 335a and 335b of this title, the term “drug product” means a drug subject to regulation under section 355, 357, 360b, or 382 of this title or under section 262 of title 42.
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- 1994–199721 U.S.C. § 321Food and Drugs · Definitions; generally · for the purposes of this chapter
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.
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- 1997–present21 U.S.C. § 321Food and Drugs · Definitions; generally · for the purposes of this chapter
The term “drug product” means an active ingredient in dosage form that has been approved or otherwise may be lawfully marketed under the Food, Drug, and Cosmetic Act 1 [21 U.S.C. 301 et seq.] for distribution in the United States.
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- 2007–present21 U.S.C. § 830Food and Drugs · Regulation of listed chemicals and certain machines · in this section
The term “drug product” means an active ingredient in dosage form that has been approved or otherwise may be lawfully marketed under the Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.] for distribution in the United States.
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- 2000–200721 U.S.C. § 830Food and Drugs · Regulation of listed chemicals and certain machines · in this section
The term “drug product” means the active ingredient of—
(A) a new drug, antibiotic drug, or human biological product (as those terms are used in the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act), or
(B) a new animal drug or veterinary biological product (as those terms are used in the Federal Food, Drug, and Cosmetic Act and the Virus-Serum-Toxin Act) which is not primarily manufactured using recombinant DNA, recombinant RNA, hybridoma technology, or other processes involving site specific genetic manipulation techniques,
including any salt or ester of the active ingredient, as a single entity or in combination with another active ingredient.
Source
- 1994–present35 U.S.C. § 156Patents · Extension of patent term · for purposes of this section