Compounding Pharmacy

Compounding pharmacy is under increased regulatory focus after high-profile incidents and the GLP-1 era. The session covers USP 797 (sterile compounding) and USP 800 (hazardous drugs), FDA 503A vs 503B distinction, GLP-1 compounding controversies and 2024-2025 enforcement actions, sterile compounding errors and prevention, drug-shortage compounding role, and emerging quality-assurance frameworks. Discussion addresses HIPAA in compounding, the comparison of US vs Canadian compounding regulation, hospital compounding practice, the FDA Memorandum of Understanding programme with states, pediatric and palliative-care compounding, and personalised medicine compounding.