Manufacturing facility credentials.

Evaluate the actual supplying facility before purchasing. This page explains what to verify; it does not establish a credentialed manufacturing partnership or a product supply pathway.

Reviewing a proposed 503B source

For a proposed outsourcing-facility transaction, verify the actual facility registration, applicable quality requirements and inspection history. Registration does not approve a compounded drug or establish eligibility for every preparation. Request evidence of:

• FDA registration as a 503B outsourcing facility
• cGMP-compliant operations with documented SOPs
• Inspection-ready batch records and quality systems
• USP <85> endotoxin and USP sterility testing

503A bulk API supply chain

For a pharmacy bulk-substance inquiry, verify the manufacturer and applicable compounding conditions for the exact substance. Before accepting material, request and assess evidence concerning:

• cGMP-aligned API manufacturing
• Per-lot identity, HPLC purity, and endotoxin testing
• Documented chain of custody from manufacturer to pharmacy

Separate contact details from facility credentials

A business address is not evidence of manufacturing, distribution or cold-chain qualifications. Confirm the entity performing each activity and the documentation for the exact proposed transaction.