Compounded GLP-1 legality in Ohio

Semaglutide left the FDA shortage list (Feb 2025). Routine 503A compounding of an essentially-a-copy product is no longer permitted; FDA applies enforcement discretion only for pharmacies filling 4 or fewer such prescriptions per calendar month, plus narrow documented-clinical-need exceptions (e.g., a strength not commercially available).

Semaglutide is on neither the FDA shortage list nor the 503B bulks list, so outsourcing facilities may not compound it from bulk. FDA proposed (Apr 30, 2026) to formally exclude semaglutide from the 503B bulks list.

Tirzepatide left the FDA shortage list (Dec 2024). Routine 503A compounding of an essentially-a-copy product is no longer permitted; FDA applies enforcement discretion only for pharmacies filling 4 or fewer such prescriptions per calendar month, plus narrow documented-clinical-need exceptions.

Tirzepatide is on neither the FDA shortage list nor the 503B bulks list, so outsourcing facilities may not compound it from bulk. FDA proposed (Apr 30, 2026) to formally exclude tirzepatide from the 503B bulks list.