Advocacy & Practice Updates — Advocacy & Practice

USP Reaches Out to Medicine  For Input

In September 2017, ASRS attended a meeting convened by USP with the AMA and national medical specialties as part of a mandate to expand its stakeholder community and improve physician engagement. USP is undertaking a revision of its current standards, including those for sterile compounding in its General Chapter. After receiving an unprecedented number of comments on its initial draft revision proposed for comment in 2015 and listening to feedback from physicians, it is now reaching out to physicians for input.

General Chapter first published in 2004 was revised in USP31–NF26 2nd Supplement, which became official on June 1, 2008 and that remains the current official version. Based on the nature and significance of the public comments received in 2016 on the current revision, the chapter is being revised and is anticipated to be published again in the Pharmacopeial Forum 44(5) Sept./Oct. 2018 for a second round of public comment.

Due to the lack of involvement by the physician community on USP committees in recent years and general USP organizational constraints, the revised chapter will be drafted without any practicing physicians on the USP Compounding Expert Committee. In summer 2018, as part of its regular process, USP will undertake a call for candidates for the next expert committee which will begin its work in 2020, for its next 5 year cycle.

ASRS submitted comments on the first revised in 2015 and cosigned a letter to USP with the AMA and numerous medical specialties in 2017 as part of its commitment to remain engaged on this issue to ensure USP receives critical physician input.