Sec. 6503. Definitions
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/bill/119/hr/5371/eas/section-6503·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
Section 744L(9)(A) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379j–71(9)(A) ) is amended— in clause (v), by striking ; or and inserting a semicolon; in clause (vi)— by striking addition and inserting the addition ; and by striking the period and inserting ; or ; and by adding at the end the following: the addition or modification of a testing procedure applicable to one or more OTC monograph drugs, provided that such additional or modified testing procedure reflects a voluntary consensus standard with respect to pharmaceutical quality that is— established by a national or international standards development organization; and recognized by the Secretary through a process described in guidance for industry, initially published in July 2023, or any successor guidance, publicly available on the website of the Food and Drug Administration, which addresses voluntary consensus standards for pharmaceutical quality. .
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- 21 USC 379j–71(9)(A)
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Sec. 6503
Definitions
Cite21 USC 379j–71(9)(A)
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