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Abstract:  Recent articles by individuals associated with the Controlled Environmental Testing Association (CETA) offer recommendations for barrier isolators used in pharmacy compounding. These recommendations are based, however, on misinterpretations of US Food and Drug Administration (FDA) policy, confusing guidelines for manufacturing with guidelines for compounding. United States Pharmacopeia (USP) Chapter <797> is an enforceable standard for compounding sterile preparations, while FDA regulations govern drug manufacturing processes. Great care has been taken in the construction of USP Chapter <797> to separate the requirements of manufacturing from the pharmacist’s right to compound. Compounding under the definitions and requirements outlined in USP Chapter <797> provide a safe environment without adding the more stringent requirements of the manufacturing environment. Confusing the requirements, as in the CETA documents, not only creates confusion but also endangers the intended separation of manufacturing and compounding.

Related Keywords: Hank Rahe, BSIM, MSE, barrier isolators, cleanroom, United States Pharmacopeia, USP Chapter <797>, US Food and Drug Administration, FDA, airflow, sterile preparation

Related Categories: LEGAL, STERILE PREPARATIONS, UNITED STATES PHARMACOPEIA CONVENTIONS

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