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ASHP Expresses Major Concerns with Proposed Revisions to Chapter <797> Standards, Offers Recommendations


A number of proposed changes to the U.S. Pharmacopeial Convention (USP) General Chapter <797> Pharmaceutical Compounding — Sterile Preparations standards are incompatible with the medication-use process in patient care environments, ASHP stated in comments submitted to a USP expert panel earlier this month.

In its comment letter, ASHP points out that many of the new requirements are more appropriate for making drugs from bulk chemicals in compounding pharmacies or outsourcing facilities than for preparing medications for administration in patient care settings. The letter urges the expert panel to revise the proposals to better meet the urgent and unpredictable demands of the typical acute patient care setting.

In addition, ASHP’s letter encourages USP to reorganize the standards into separate sections covering basic and advanced compounding as well as the preparation of special compounded sterile products (CSPs) such as radiopharmaceuticals and allergenic extracts.

ASHP’s comments are available at here. Members can send their feedback on the proposed revisions to


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