Animal Health Solutions

9 Q1 2021 | Animal Health Solutions A practice traditionally performed by pharmacists, compounding allows prescribers to formulate and customize medications tailored to unique patient needs. Compounding medications for animals is crucial to the practice of veterinary medicine, which requires flexible medications for a pharmacologically and physiologically diverse patient base. Governing U.S. bodies provide conflicting guidance and legislation on compounding, and controversy remains in how to best regulate its scope. This article series will look at how this is addressed and what clinicians should be aware of, including compounding do's and don'ts, regulatory requirements, quality control, clinical resources, and upcoming guidance. What is considered compounding? Two major authorities, the U.S. Food and Drug Administration (FDA) and the United States Pharmacopeia (USP), define compounding slightly differently. The USP is a nonprofit organization that sets national chemical purity standards, which are federally enforceable when compounding. 1 The USP sets a broad definition of compounding as "combining, mixing, and/or altering, packaging, and labeling medicinal products to create a custom drug formulation in accordance with a licensed practitioner's prescription." 1 Almost any manipulation of a finished drug product may fall under this definition. The FDA, the primary overseer of U.S. drugs, defines compounding as a service performed by or under the direct supervision of a licensed pharmacist in a state-licensed pharmacy. 2 The FDA further narrows the definition, stating that compounding is any change to a commercially available drug, including any preparation outside its approved product labeling. 2 Based on these definitions, mixing, reconstituting, and/or preparing a drug product according to the manufacturer's labeling are not considered compounding by the FDA but are considered compounding by the USP. 1,2 Tablet-splitting can be considered compounding by both entities, as it is a change to a finished product, 2 but the FDA has yet to provide a clear answer. Compounding offers near-endless creativity to find patient-specific options and continues to hold a crucial role in veterinary care. Compounding's utility in veterinary medicine can significantly impact patient care. Improving compliance can save an animal's life and enhance the pet and pet owner's quality of life. Compounding a rare medication or unique route of administration may be the only way an animal can be treated. However, understanding compounding, what it is, and the ways it can—and cannot—be used can be daunting. This article aims to introduce compounding for veterinary use.

• Cover