On June 1, 2019, the United States Pharmacopeia (“USP”) published the final revisions to its pharmaceutical sterile compounding standards (“chapter <797>”). Chapter <797> sets forth standards for the preparation of compounded sterile medications to help ensure products are safe and effective and reduce risks such as contamination or incorrect dosing. The most recent revisions implement new standards and revise existing ones based on recent scientific and technological developments. The chapter <797> revisions also incorporate stakeholder input raised during the July 2018 to November 2018 public comment period, much of which concerned allergens, beyond-use dating, and the general ambiguity throughout the chapter.
The USP’s most recent revisions to chapter <797> are extensive and those who prepare compounded sterile products (“CSPs”) are advised to familiarize themselves with the new standards. Significant changes include: