We are commonly asked by veterinary professionals (not to mention concerned friends and family members) whether the United States Pharmacopeia (USP) standards apply to pharmacies and veterinary practices that prepare compounded medications for pets.
The short answer is: Yes! The same USP standards that govern compounding pharmacies serving humans also apply to those providing medications for our beloved non-human family members.
In this blog post, we break down what that means for veterinary compounding practices, clarify the relevant USP standards, and answer some of the common questions we hear from our veterinary customers.
What is the United States Pharmacopeia?
The United States Pharmacopeia (USP) is an independent, scientific organization that sets quality standards for both compounded and manufactured medications, as well as food ingredients and dietary supplements in the U.S. While these standards cover a broad range of pharmaceutical products, in this post, I will focus on compounded sterile preparations (CSPs). USP standards help ensure CSPs are safe, effective, and consistently prepared, providing critical guidance for pharmacists, healthcare professionals, and manufacturers who serve both human and animal patients.
USP Standards for Compounded Pharmaceuticals
The USP sets standards for four primary types of compounded pharmaceuticals. Each of these is referred to as a “chapter” of the larger United States Pharmacopeia–National Formulary (USP–NF), although the shorthand terms (e.g., USP <797> or USP 797) are more frequently used in informal communications.
USP <795> – Compounded Non-sterile Preparations: This chapter covers a variety of medications, such as topical creams and other formulations, that do not require sterility. The standard focuses on ensuring compounded medications are prepared in a safe, consistent, and high-quality manner. The fundamental standards for compounding quality and safety remain consistent across both human and animal applications.
USP Chapter <797> – Compounded Sterile Preparations: This chapter establishes the standards for compounding sterile medications, which include injectables, ophthalmic solutions, and other formulations that must remain free from contamination. USP 797 provides detailed requirements for proper facility design, environmental controls, personnel training, and aseptic techniques to ensure the safety and quality of compounded sterile preparations. These standards are vital for protecting both human and animal patients from potential infections or adverse events associated with improperly compounded sterile products.
USP Chapter <800> – Hazardous Compounded Preparations: USP 800 sets standards for handling and compounding hazardous drugs to protect both healthcare personnel and patients from exposure risks. This chapter outlines requirements for safe storage, proper use of personal protective equipment, engineering controls, and staff training to minimize contamination and ensure a safe working environment.
USP Chapter <825> – Radiopharmaceuticals: This chapter provides standards for the preparation, compounding, dispensing, and repackaging of radiopharmaceuticals—drugs containing radioactive isotopes used for diagnostic imaging and therapy. USP 825 outlines requirements for facility design, radiation safety, personnel training, and quality assurance to ensure both patient and handler safety. These regulations are essential for veterinary practices that prepare radiopharmaceuticals, such as technetium-99m-labeled compounds, which are commonly used in animal nuclear medicine for bone scans and organ imaging.
Q: Are USP Standards enforceable, and if so, by whom?
USP standards are indeed enforceable, but the responsibility for enforcement falls primarily to regulatory agencies, such as state boards of pharmacy, the U.S. Food and Drug Administration (FDA), and other federal or state authorities. These agencies may adopt USP chapters into their regulations, making compliance with the standards a legal requirement for pharmacies, compounding facilities, and healthcare provider practices, including veterinary clinics and hospitals. Enforcement can include inspections, audits, and penalties for non-compliance, all aimed at ensuring the safety and quality of compounded medications for both human and animal patients.
Veterinary practices may also seek accreditation by the Joint Commission, an organization that sets rigorous quality and safety standards for healthcare facilities. As part of the broader accreditation process, the Joint Commission may assess the facility’s adherence to the USP standards if the facility compounds pet medications on site.
Although professional organizations such as the American Veterinary Medical Association (AVMA) don’t have enforcement authority for the standards, they are strong advocates for their adoption. These groups frequently collaborate with the USP and state pharmacy boards to convey the unique needs of the veterinary field. The AVMA and similar organizations also reference USP standards in their guidelines and encourage members to follow them as best practices, which supports regulatory compliance and enhances patient safety.
Q: Are there clauses in these standards that are different for veterinary practices?
USP standards are often described as “standards of minimums,” meaning they establish the foundational requirements necessary to ensure the safety, quality, and consistency of compounded preparations. However, state regulatory agencies frequently build upon these minimums by introducing additional, more specific requirements and guidance tailored to their jurisdiction.
For instance, California’s Board of Pharmacy recently updated its standards, addressing industry concerns and adding clarity in instances where the USP standards left implementation up to the discretion of the pharmacy. Under these revisions, the requirements for veterinary medicines sometimes differ from those intended for human use.
Q: Do USP standards apply to compounded nutraceuticals or homeopathy compounds intended for us with animals?
USP standards generally do not apply to nutraceuticals or homeopathy compounds intended for use with animals. These products are considered dietary supplements or alternative therapies; therefore, fall under USP chapters above 2000, which function as guidance documents and are not themselves legally enforceable. However, individual state boards of pharmacy or other regulatory authorities may choose to implement specific requirements for these products, so it is important to consult local regulations to determine whether any standards apply in your jurisdiction.
Some nutraceutical and homeopathic manufacturers may use the USP logo or reference USP standards to signify quality benchmarks, but this does not mean their compounded products are subject to the compounding regulations applied to pharmaceuticals or enforced by state pharmacy boards, FDA, or other authorities.
Q: How can I get more information on USP compliance for my veterinary practice?
Our team provides expert guidance on interpreting and implementing USP standards, and we regularly host online webinars that cover the latest updates, best practices, and practical steps for maintaining compliance. Here are a couple of our most recent sessions:
The Complete Picture: A Contextual Bridge Between USP <797> & <800>
Personnel Competency & Environmental Monitoring
How to Demonstrate Your USP <797> Surface Sampling Competency
How can we help?
Whether you’re starting a new practice or just want to ensure your current protocols are up to date, Pace® is here to help. Visit us on the web to explore our testing services for USP compliance, or reach out to us to discuss your specific compliance requirements.