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October 5, 2017

USP Issues New Timeline for Revisions to Compounding Rules, Aims to Publish Final Compounding Standards by December 2019


The United States Pharmacopeia (USP) has announced its intent to publish new draft standards for sterile compounding (Chapter 797) in the September-October 2018 issue of Pharmacopeial Forum. This announcement came on September 29 as USP stated that it would also postpone the official date of new standards on hazardous drug compounding (Chapter 800) to ensure that both chapters were aligned. This means stakeholders, including allergists, will have another opportunity, next fall, to weigh in on a revised set of compounding standards. USP states that it intends to issue final standards on sterile compounding by December 1, 2019.

The USP’s Expert Committee on Compounding met in Washington September 29 to discuss revisions to its sterile compounding proposal including the issue of physician compounding for administration to patients. AAAAI and ACAAI representatives were in attendance. At this point it is too early to say what changes will be made to the next draft set of standards, but we can tell you that the issue of physician compounding and allergy immunotherapy preparation definitely has the attention of USP. We are hopeful that the draft standards issued next fall will be substantially changed to address the concerns our organizations have been raising with USP.

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