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Pharm Micro Assurance

Reviewing the Main Changes to USP <797> in 2024

Reviewing the Main Changes to USP <797> in 2024   By Roberto Juarez Jr. BS, M(ASCP)CM On November 1st, 2023, the United State Pharmacopeia (USP) made several changes to general chapter <797> which describes the minimum requirements for the preparation of compounded sterile preparations (CSP’s) for human and animal drugs. The purpose of these guidelines is to reduce the chance of harm and/or death to human
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Navigating the New USP <797> Media Fill Testing Requirements for Sterile Compounding

New USP <797> Media Fill Testing Requirements for Sterile Compounding   By Roberto Juarez Jr. BS, M(ASCP)CM USP <797> Revamps Media Fill Testing Requirements The United States Pharmacopeia has been setting the standards for compounding pharmacies for a long time. On 11/1/23, several new updates were made to USP<797> which significantly changed the compounded sterile products (CSPs) test requirements for sterile compounding pharmacies. USP<797>
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