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Imprese · 28/06/20231 min di lettura
Prohibition on Wholesaling Under Section 503B of the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry; Availability
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Riepilogo
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Prohibition on Wholesaling Under Section 503B of the Federal Food, Drug, and Cosmetic Act." This draft guidance describes FDA's interpretation of, and policies concerning, the statutory prohibition on wholesaling for certain compounded drugs. This draft guidance also describes examples of how FDA intends to apply the statutory wholesaling provision.
Lingua originale della fonte: Federal Register — Food and Drug AdministrationApri il comunicato originale →