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Reviewing the Main Changes to USP <797> in 2024

- Posted by: msi-admin
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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 and animal patients resulting from microbial contamination, the presence of
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Navigating the New USP <797> Media Fill Testing Requirements for Sterile Compounding

- Posted by: msi-admin
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Navigating the 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> is important because it establishes the minimum requirements for preparing sterile
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