FDA issues draft guidance on insanitary conditions for compounding facilities
The Food and Drug Administration today issued draft guidance for pharmacies, physician offices and outsourcing facilities that compound or repackage drugs or mix, dilute or repackage biological products. The guidance provides examples of insanitary conditions under the Federal Food, Drug and Cosmetic Act, and recommended procedures to avoid or correct insanitary conditions in compounding facilities. FDA will accept comments on the guidance for 60 days after publication of a notice in tomorrow’s Federal Register.
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