FDA Drafts Drug Compounding Guidance for Health-System Pharmacies
The FDA has issued 3 draft guidance documents that clarify how it intends to enforce the prescription requirement for drugs compounded by health-system pharmacies. Currently, under Section 503A of the Federal Food, Drug, and Cosmetic Act (FDCA), compounding pharmacies that aren’t registered outsourcing facilities must obtain a valid prescription order prior to compounding any drug products. If the …
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