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Home » FDA Issues GMP and Enforcement Guidance for Compounding Pharmacies
FDA Issues GMP and Enforcement Guidance for Compounding Pharmacies
The FDA Tuesday released two major guidances for compounding pharmacies. One establishes for the first time an interim GMP framework for large compounders that register with the agency as outsourced facilities. The second finalizes draft enforcement guidance spelling out what enforcement smaller, traditional compounders can expect from the agency.