USP 800 Compouding Pharmacies Identification: 503(a) and 503(b)

Compounding pharmacies are regulated by State Boards of Pharmacy and are subject to inspection by federal and state jurisdiction. They can be a traditional compounding pharmacy, identified as a 503(a) or a outsourcing facility, a 503(b). US Pharmacopeia Convention (USP) created standards to help ensure a quality environment and protect pharmacists and technicians that work with compounding. This regulations apply to USP 795, for non-sterile compounding; USP 797, for all sterile compounding; and USP 800 for all compounding that uses hazardous drugs.

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