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Legal Basis for Compounding FDA Regulations: 503A Compounding Pharmacies: Traditional compounding under state law Can compound when patient-specific prescription exists Must be licensed pharmacy Subject to state board oversight 503B Outsourcing Facilities: Federally registered with FDA Can produce larger batches Subject to FDA inspection Can distribute across state lines more easily Drug Shortage List: Tirzepatide on FDA shortage list periodically Allows compounding of commercially available drugs Permits legitimate compounding when supply limited Legal basis for current compounding market Compounding is legal, regulated, and appropriate for addressing drug shortages and patient access

Outcomes from branded clinical trials cannot be directly attributed to compounded preparations