Executive Summary
The ("") released five regulatory and guidance documents pertaining to compounding in an effort to provide clarity to pharmaceutical stakeholders. The documents, issued pursuant to the Drug Quality and Security Act ("Act"), describe expectations regarding compliance with current good manufacturing practices ("cGMPs") for compounding outsourcing facilities and standards for compounding pharmacies, request nominations to the lists of bulk drug substances that can be used in compounding in those facilities and propose to update the list of drugs withdrawn from the market for safety or efficacy reasons.
Background
The recently released five documents related to compounding pharmacies and outsourcing facilities pursuant to the Act. The documents focus on Sections 503A and 503B of the Food, Drug, and Cosmetic Act, which was amended by the Act. Section 503A places restrictions on compounding pharmacies that generally sell their products to specific patients within a single state. The Act adds Section 503B that creates "outsourcing facilities," which do not face the same geographic restrictions as 503A compounding pharmacies but must register with the FDA and meet strict operational requirements.
continue to read here
The ("") released five regulatory and guidance documents pertaining to compounding in an effort to provide clarity to pharmaceutical stakeholders. The documents, issued pursuant to the Drug Quality and Security Act ("Act"), describe expectations regarding compliance with current good manufacturing practices ("cGMPs") for compounding outsourcing facilities and standards for compounding pharmacies, request nominations to the lists of bulk drug substances that can be used in compounding in those facilities and propose to update the list of drugs withdrawn from the market for safety or efficacy reasons.
Background
The recently released five documents related to compounding pharmacies and outsourcing facilities pursuant to the Act. The documents focus on Sections 503A and 503B of the Food, Drug, and Cosmetic Act, which was amended by the Act. Section 503A places restrictions on compounding pharmacies that generally sell their products to specific patients within a single state. The Act adds Section 503B that creates "outsourcing facilities," which do not face the same geographic restrictions as 503A compounding pharmacies but must register with the FDA and meet strict operational requirements.
continue to read here
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