On March 12, USP announced that the USP Appeals Panel had issued final decisions on the appeals to revisions to General Chapters <795> Pharmaceutical Compounding – Nonsterile Preparation, and <797> Pharmaceutical Compounding – Sterile Preparations originally published on June 1, 2019.
The Appeals Panel granted the appeals to both General Chapters <795> and <797> and is remanding the chapters back to the Compounding Expert Committee (CMP EC) with the recommendation for “further engagement on the issues raised in the appeals.”
As we outlined in the USP Insider article a few weeks ago, Chapter 795 does not apply to allergen extracts so does not affect allergy. The appeals to Chapter <797> were initiated by several compounding pharmacies and professional associations related to Beyond Use Dates. Since the appeal does not include any provisions related to USP Chapter <797> Section 21, Compounding Allergenic Extracts, we do not expect any changes to be made, even if other sections are revised.
The appeal will likely extend the implementation date of USP <797> into sometime late in 2020 or even 2021. We are still recommending proceeding with implementing procedures to follow USP Chapter <797> Section 21.
The Advocacy Council – we have you covered.