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Negócios · 25/01/20231 min de leitura
Compounding Certain Ibuprofen Oral Suspension Products Under Section 503B of the Federal Food, Drug, and Cosmetic Act; Guidance for Industry; Availability
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Resumo
The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a final guidance for industry entitled "Compounding Certain Ibuprofen Oral Suspension Products Under Section 503B of the Federal Food, Drug, and Cosmetic Act." This guidance describes FDA's regulatory and enforcement priorities regarding compounding certain ibuprofen oral suspension products in outsourcing facilities for administration in hospitals and health systems.
Idioma original da fonte: Federal Register — Food and Drug AdministrationAbrir o comunicado original →