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Compounding pharmacies operate under different regulations than traditional manufacturers: Section 503A pharmacies: State-licensed facilities that compound medications for individual patients with prescriptions Section 503B outsourcing facilities : Larger operations that can compound medications in bulk and must register with the FDA Both types can legally compound medications during FDA-declared drug shortages They may also compound when patients have allergies to inactive ingredients in commercial products However, its crucial to understand that compounded medications dont undergo the same rigorous FDA review for safety, effectiveness, and quality as FDA-approved drugs