Because compounding is a critical tool for veterinarians, the AVMA works hard to ensure that veterinary concerns are heard and considered in regulatory rule-making. Along with frequent communication with the FDA and Congress, we also engage with pharmacy organizations and other affected stakeholders, like the United States Pharmacopeia (USP)—the organization that develops and disseminates public compendial quality standards for medicines and other articles. Here’s the latest update.
In 2018, the USP published proposed revisions to General Chapters <795> and <797> of Pharmaceutical Compounding regarding nonsterile and sterile preparations, respectively. There were also 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 we hope will be considered by the USP in May 2020.
AVMA’s position on the USP proposal
The AVMA made these requests:
- Asked that the USP postpone application of the standards in <795> and <797> to veterinary practitioners and, instead, create a veterinary-specific compounding chapter.
- Requested that the USP establish an expert panel of veterinarians with varied professional backgrounds to assist in developing the new veterinary-specific compounding chapter.
- Suggested the USP host a stakeholder roundtable to ensure a full understanding of the particular challenges faced by veterinarians and our patients.
- Advocated for an alternative mechanism for compounding pharmacies to extend beyond-use-dates (BUDs) for compounded sterile preparations. Without such a change, we believe veterinarians will be forced to unnecessarily dispose of large quantities of medications and purchase new inventory more frequently.
The USP declined to postpone the applicability of the chapters to veterinarians. However, after other appeals were filed, the USP decided to postpone the official date of implementation of <795> and <797>, which originally was scheduled for December 1, 2019, until after those appeals are addressed. Chapter <800> regarding handling of hazardous drugs in healthcare settings, which applies to veterinary personnel, was also scheduled to be implemented December 1, 2019. However, it will be considered “informational only” until appeals related to <795> and <797> are resolved.
The USP agreed to consider developing a veterinary-specific chapter and said it welcomes AVMA’s input to define appropriate standards specific for compounding for animal patients. The requests to establish an expert panel and convene a roundtable were taken under advisement. The USP’s Compounding Expert Committee also voted to maintain the BUD provisions for compounded sterile preparations but committed to develop resources for extending BUDs.
The USP also stated that “while it encourages widespread use and adoption of <795> and <797> by veterinary practitioners, the federal legal applicability of these chapters to the compounding of drugs for animal patients is not clear.” Their view is that Chapters <795> and <797> contain provisions that are intended to be relevant and useful for veterinary practitioners, but they defer to the FDA and state boards of pharmacy to interpret and enforce the applicability of these chapters.
As the USP continues its internal review process, the AVMA Council on Biologic and Therapeutic Agents and Clinical Practitioners Advisory Committee have been leading recent efforts to review the AVMA’s compounding policies and ensure that they continue to reflect and support veterinary practitioners’ and patients’ needs.
AVMA will remain engaged with the USP as we continue to advocate for appropriate standards for preparations compounded for animal patients.