Not all compounding pharmacies maintain the same quality standards. Providers should evaluate these key areas when selecting a compounding partner.
USP Compliance
The United States Pharmacopeia sets the compounding quality standards that 503A pharmacies follow:
- USP 795: Standards for non-sterile compounding — weighing, measuring, mixing, and labeling procedures
- USP 797: Standards for sterile compounding — cleanroom environment, gowning, testing, and beyond-use dating for injectable medications
- USP 800: Standards for handling hazardous drugs — containment, waste disposal, exposure monitoring
Third-Party Testing
The gold standard for compounding quality is independent third-party testing — not just in-house testing performed by the pharmacy itself. Look for:
- Potency testing: Verifies that the active ingredient concentration matches the label
- Sterility testing: Confirms absence of microbial contamination in sterile compounds
- Endotoxin testing: LAL testing for injectables to verify pyrogen-free status
- Identity testing: Confirms the correct active ingredient (e.g., HPLC for peptides)
Certificate of Analysis (COA)
A COA documents the testing results for each batch. Providers should have access to COAs showing:
- Compound identity and concentration
- Testing lab name and accreditation
- Test date and results
- Pass/fail determination against specifications
- Beyond-use dating
Promise Pharmacy Quality Standards
Promise Pharmacy maintains:
- Full USP 795, 797, and 800 compliance
- Third-party potency testing on every batch
- Sterility and endotoxin testing on all sterile compounds
- COA documentation accessible through the provider portal
- Ongoing state pharmacy board compliance and inspections