USP agrees to consider need for veterinary-specific compounding rules

The United States Pharmacopeia (USP), which sets pharmaceutical standards that apply to both human and veterinary medicine, will consider the AVMA’s resolution requesting the development of veterinary-specific standards for drug compounding.

The AVMA’s resolution has been combined with others received on compounding, and the compiled resolution will be reviewed by the USP Expert Committee on Compounding during the May 2020 USP Convention (see resolution 9 and associated white paper).The AVMA’s delegate, Dr. Michael Strobel, will be there to advocate in support of our request to develop veterinary-specific standards for compounding as the USP determines its activities for the next five years.

“The success of the process is largely dependent on the contributions of stakeholders like you,” the USP said in an email to the AVMA.

The AVMA has worked tirelessly to communicate to the USP that the veterinary profession is inherently different from human healthcare. In 2018, the USP published proposed revisions to USP General Chapters <795> and <797> on pharmaceutical compounding of nonsterile and sterile preparations, respectively. The AVMA gathered input and provided feedback on the proposed revisions, and did the same when updated revisions were posted in 2019. We requested, among other items, that the USP postpone application of the standards in <795> and <797> to veterinary practitioners and, instead, create a veterinary-specific compounding chapter.

This is partially because there are provisions of USP <795> or <797> that cannot currently be implemented in all veterinary practice settings, including:

• Use of containment ventilated enclosures
• Establishment of a clean room suite or segregated compounding area
• Maintenance of indicated air changes per hour to respective ISO classification levels, indicated room pressure differentials, and microbiological air and surface sampling

While USP did not postpone application of the standards to veterinary practitioners, the revisions originally scheduled to take effect on December 1, 2019, have been delayed pending further engagement with stakeholders on issues raised in appeals. In the meantime, we will focus on garnering support for our resolution.

Our message to the USP boils down to this: Veterinarians provide care for a broad array of species and compound drugs for our patients in a variety of settings, and veterinary professionals should have pharmaceutical standards appropriate to the practice of veterinary medicine.