USP revised compounding standards go into effect

Revised compounding standards from the United States Pharmacopeia (USP) became effective November 1, 2023, after 12 years of work. According to the USP, the revised standards reflect the latest scientific advancements, stakeholder input, and a more practical and risk-based approach to assigning beyond-use dates. They also intended to provide clearer guidelines for facilities, equipment, and cleaning.

The USP Compounding Compendium is provided as a resource for pharmacists and health care practitioners, including veterinarians, that offers quality assurance for compounding methods, preparations, and overall practices among its 40 chapters. The compendium provides access to not only USP standards, but also the National Formulary (USP–NF), which is the official compendia of standards for drugs marketed in the United States.

Recent revisions were made to the following sections:

• Chapter 795: Pharmaceutical Compounding—Nonsterile Preparations
• Chapter 797: Pharmaceutical Compounding—Sterile Preparations
• Chapter 800: Hazardous Drugs—Handling in Healthcare Settings

Chapters 795 and 797 describe requirements for the compounding process, which helps to ensure patients receive quality preparations that are free from contaminants and consistent in intended identity, strength, and potency. Chapter 800 provides standards for safe handling of hazardous drugs to minimize the risk of exposure to health care personnel, patients, and the environment.

To help veterinarians understand the revised compounding standards, the AVMA is making a two-part series on the topic available to veterinarians through AVMA Axon, the Association’s digital education platform.  

Each webinar offers one hour of continuing education credit and is free for AVMA and Student AVMA (SAVMA) members. The cost is $25 for nonmembers. The first webinar, “The USP and Immediate-Use Sterile Compounding,” is presented by Dr. Dharati Szymanski, an assistant director in the AVMA’s Division of Animal and Public Health who  serves as a staff consultant to the Council on Biologic and Therapeutic Agents. The second webinar, “Sterile Compounding within USP Categories 1, 2 & 3,” is delivered by Dr. Gigi Davidson, former director of clinical pharmacy at North Carolina State University College of Veterinary Medicine.

USP Chapters 795 and 797 contain provisions that are intended to apply and be relevant and useful for veterinary practitioners, but USP defers to the Food and Drug Administration (FDA) and state boards of pharmacy or veterinary medicine to interpret and enforce the applicability of these chapters.

“Veterinarians should contact their state board of veterinary medicine to understand how the USP compounding standards might apply to them,” Dr. Szymanski explained.

For the most part, sterile compounded preparations that involve no more than three different sterile products and that are administered within four hours of preparation are exempt from compliance with the standards of USP Chapter 797 as long as certain conditions are met. Additional details regarding those conditions are provided in the webinar.

Veterinarians who compound using products found on the Centers for Disease Control and Prevention’s (CDC) National Institute for Occupational Safety and Health (NIOSH) List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings need to be aware of the standards provided in USP Chapter 800.

“It’s important for veterinarians to look at the NIOSH List of Antineoplastic and Other Hazardous drugs and look at the drugs that they use themselves in their own practice, and then make sure that they are following USP 800 appropriately when it comes to the handling of those drugs,” Dr. Szymanski said.

The AVMA will continue to work with USP and FDA as well as state 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 with a reasonable shelf life obtained from compounding pharmacists, she added.