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Compounding: How Do New Rules Affect You?

The U.S. Food and Drug Administration has announced that in April it will begin phasing in inspectional activities in relation to Guidance for Industry #256, Compounding Animal Drugs from Bulk Drug Substances.

Announcement: https://www.fda.gov/animal-veterinary/resources-you/letter-industry-phase-inspectional-activities-related-compounding-animal-drugs-bulk-drug-substances

GFI #256: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cvm-gfi-256-compounding-animal-drugs-bulk-drug-substances

In this guidance, the FDA specifies the circumstances in which it plans to exercise enforcement discretion for relevant violations of the federal Food, Drug, and Cosmetic Act for drug approval, labeling, and manufacturing. This means that although compounding from bulk substances for animal patients is still considered illegal, pharmacists and veterinarians may compound drugs in this way, without concern for enforcement action, provided they follow the guidance and adhere to certain criteria.

When it comes to enforcement, the FDA indicates it has no plans to inspect veterinary care facilities that do not compound animal drugs from bulk drug substances. Rather, it anticipates a limited number of inspections of state-licensed pharmacies. With regard to those inspections, the FDA indicates it will "afford individuals and firms an opportunity to voluntarily take appropriate and corrective action prior to the initiation of enforcement action."

The FDA also does not intend to conduct routine inspections of federally registered outsourcing facilities that compound drugs until it provides clarification on how GFI #256 applies to them.

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