Update on USP compounding activities

By: Ashley S. Morgan, DVM, CAE, Director | Division of State Advocacy, American Veterinary Medical Association

In 2018, the United States Pharmacopeia (USP)—the organization that develops and disseminates public compendial quality standards for medicines and other articles—published proposed revisions to General Chapters <795> and <797> of Pharmaceutical Compounding regarding nonsterile and sterile preparations, respectively. The AVMA received input from our councils and committees, various species-specific veterinary organizations and members, then met with USP staff to provide feedback on the revisions. On June 1, 2019, the USP posted updated revisions, and AVMA again provided feedback. AVMA sent an appeal, shared supporting information at the USP Compounding Expert Committee’s meeting on August 8, and also submitted a resolution related to the creation of a veterinary specific-compounding chapter that was considered by the USP at their annual meeting earlier this month.

At this May meeting, USP passed Resolution # 9 at the request of AVMA and additional stakeholders that states: “New and revised standards for compounding, including beyond-use dates, will be developed based on data, scientific evidence, and input from recognized healthcare professionals and state and federal regulators.” The white paper accompanying the resolution specifically identifies veterinary medicine as an area needing practical, focused standards, indicating that: “…through stakeholder engagement, USP has learned of the request for standards specific to veterinary practitioners, who treat a range of species and practice in varied settings and environments…”

The Chairs of the Expert Committees have also been appointed and Brenda Jensen, CPhT, CNMT, MBA has been selected to Chair the Expert Committee on Compounding. The AVMA’s liaison to the USP and member of the Council on Biologic and Therapeutic Agents, Dr. Michael Strobel has applied for membership on the Committee and will learn whether he has been appointed late in June.

This is a “win” for the AVMA and the veterinary profession and we are excited that USP pharmaceutical standards applicable to veterinary medicine will be developed with engagement from the veterinary community. We look forward to collaborating with the USP during development and will continue to update you as additional information becomes available.

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