In light of the memos released by Attorney General Jeff Sessions and Associate Attorney General Rachel Brand in recent months indicating that FDA guidance documents are non-binding and that noncompliance with guidance documents may not be used as a basis for proving violations of applicable law in Affirmative Civil Enforcement (ACE) cases, it is more important than ever for owners and pharmacists-in-charge of 503A pharmacies to understand the statutory limitations on the FDA’s inspection authority. They should be aware that, although FDA inspectors frequently cite guidance documents, federal statutes—not FDA guidance documents—govern the FDA’s inspection authority.
Posted in: Pharmacy Law & Regulation