FDA issues new temporary policy regarding state license pharmacies

by TLM


Today the FDA issued a new guidance explaining a temporary policy for the

Compounding of certain drugs. Click here to read the press release and guidance. We urge you to stay informed and read this document.

What this means for you:

FDA does not intend to take action against a pharmacy for compounding a drug that is essentially a copy of a commercially available drug, or for providing a drug to a hospital without obtaining a patient-specific prescription if all of the circumstances are present and other conditions of section 503A of the FD&C Act are met.

The FDA Process is ever-changing. We invite you to read more about how we have helped guide our clients with solutions that make sense to navigate the FDA’s regulatory process.

The Team at Compliance Insight