Compounding Pharmacy Quality Standards

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 active ingredient identity)

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