# FDA Inspection Authority Over Compounding Pharmacies

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FDA · 2026-03-06


    FDA inspection authority over compounding pharmacies differs by type. Outsourcing facilities registered under 503B are subject to routine FDA inspection on a risk-based schedule similar to traditional drug manufacturers. 503A pharmacies are primarily inspected by state boards of pharmacy, though FDA retains concurrent inspection authority and can inspect when it has cause to believe federal law is being violated. In practice, FDA has become more active in 503A inspections over the past several years, particularly in the compounded GLP-1 context. The 2026 enforcement record includes multiple high-profile FDA-led inspections of large 503A pharmacies.


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