USP publishes final compounding chapters

The United States Pharmacopeia (USP), which sets pharmaceutical standards that apply to both human and veterinary medicine, has released final standards for compounding.

On November 1, it was announced that final revisions to USP General Chapters <795> and <797> on pharmaceutical compounding of nonsterile and sterile preparations, respectively, had been completed. These chapters become official on November 1, 2023, to allow flexibility for engagement and adoption. See USP’s summary of the major changes.

Implications for veterinarians

Though USP is not a regulatory body and does not enforce its standards, these chapters might impact veterinarians if USP standards are incorporated or referenced in laws affecting the locale in which they practice.

While USP guidance may contain provisions that are intended to be relevant and useful for veterinary practitioners, USP defers to the FDA and state boards of pharmacy to interpret and enforce the applicability of these chapters. For example, in April, the FDA released Final Guidance for Industry (GFI) #256—Compounding Animal Drugs from Bulk Drug Substances—from which they removed reference to USP <795> and <797>.

AVMA’s response to the final chapters

Unfortunately, the complete USP <795> and <797> chapters were not available for review at the time USP announced they had been finalized. The AVMA will provide more information after seeing the chapters in their entirety. In the meantime, interested veterinary professionals can attend USP-hosted virtual open forum sessions for both <795> and <797> on November 8, 2022.

While AVMA supports some revisions shared via USP’s summary, there are still concerns:

• USP has not developed a risk-based veterinary chapter.
• Changes to beyond use dates for critical medications may require veterinarians to dispose of medications more frequently.
• Several provisions of USP <795> or <797> cannot currently be implemented in all veterinary practice settings, especially requirements for facility design as described in USP <797>, but also those pertaining to personnel qualifications, environmental monitoring, handwashing and garbing, water source, and cleanliness and disinfection.
• In USP <795>, an immediate use exemption does not exist to allow preparation of multiple doses of immediate-use compounded non-sterile preparations intended for use in one or more patients in a single batch. The exemption for administration occurring within 4 hours of compounding that is included in <795> only applies to a single dose for a single patient.  

AVMA’s influence on USP compounding chapters

The AVMA has worked tirelessly for several years to communicate to the USP that the veterinary profession is inherently different from human healthcare, and veterinary professionals need pharmaceutical standards appropriate to the practice of veterinary medicine. 

In the summer of 2018, USP released proposed revisions to Chapters <795> and <797>. At that time, AVMA requested that USP develop a veterinary-specific chapter with greater and more direct involvement of veterinary practitioners. See more about AVMA’s response to these revisions.

After receiving appeals from multiple stakeholders, USP postponed implementation of those revisions and convened a veterinary roundtable comprising representatives from multiple areas of the veterinary and pharmacy community, including the AVMA. In August 2021, USP released another set of proposed revisions intended to address the concerns identified during those stakeholder discussions as well as in the appeals. The AVMA also provided comments to USP on these revisions to <795> and <797>.

The AVMA will continue to work with USP and FDA as well as boards of pharmacy and veterinary medicine, to ensure that veterinarians can continue to compound preparations in their clinics and have access to vital, cost-effective medications.

Advancing the profession with compounding resources

The AVMA provides a range of resources that help veterinarians understand the fine points of prescribing and using compounded medications. Understand the rules that apply to compounding, get answers to common questions, and find definitions and AVMA policies related to compounding at avma.org/Compounding.