FDA Compounding Pharmacy Guidance

The FDA regulates compounding pharmacies through Section 503A and 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Drug Quality and Security Act (DQSA) of 2013. This guide covers the key regulatory frameworks providers should understand.

Drug Quality and Security Act (2013)

The DQSA created the two-tier compounding system that exists today:

• Section 503A: Traditional compounding pharmacies preparing individual patient prescriptions
• Section 503B: Outsourcing facilities registered with the FDA that can compound without prescriptions

For a detailed comparison: 503A vs 503B Guide

Drug Shortage Compounding

When a drug is on the FDA Drug Shortage List, compounding pharmacies have expanded ability to compound versions of that drug. This is the regulatory pathway that enables compounding of medications like semaglutide and tirzepatide during shortage periods.

USP Compounding Standards

503A pharmacies follow United States Pharmacopeia (USP) standards:

• USP 795: Non-sterile compounding standards
• USP 797: Sterile compounding standards — applicable to injectables
• USP 800: Hazardous drug handling standards

What This Means for Providers

When selecting a compounding pharmacy partner, verify:

1. State licensure and inspection history
2. USP compliance documentation
3. Third-party testing practices (not just self-testing)
4. Proper handling of shortage-listed compounds
5. Certificate of Analysis availability for every batch