Primary regulatory
FDA: Human Drug Compounding: State and Federal Roles
FDA overview of the compounding regulatory framework describing the division of authority between federal and state regulators: the FDA regulates 503B outsourcing facilities while state boards of pharmacy primarily regulate 503A traditional compounding pharmacies.
Registry record
Source metadata
- Publisher
- U.S. Food and Drug Administration
- Source type
- Primary regulatory
- Registry ID
fda-compounding-state-oversight
Interpretation boundary
What this record can and cannot establish
Inclusion in the registry is not endorsement. The record supports only the claims that fit its design, population, date, and scope. Company, media, and community records can document that a claim was made without proving the claim itself.