Animal Health Solutions

7 Q2 2021 | Animal Health Solutions The need for customizable medicines is clear and apparent in veterinary medicine—from zoo animals and exotic species to avian species and, of course, pets. Unique formulations, ingredients, strengths, and dose forms are needed on a regular basis. For many veterinarians, compounding is an indispensable part of practicing veterinary medicine, but understanding how the compounding industry works has become increasingly complex. Compounding for veterinary use is an important therapeutic tool that meets needs that are not being met by manufacturers. The need for customizable medicines is clear and apparent in veterinary medicine, as there are a variety of species, sizes, and weights within species, and situations that arise—from zoo animals and exotic species to avian species and, of course, pets. Unique formulations, ingredients, strengths, and dose forms are needed on a regular basis. This article, which is the second in a series of four, intends to give the practicing veterinarian a deeper understanding of veterinary compounding regulations, including the legal framework and relevant authorities. Understanding the regulations governing veterinary compounding can be complicated, as there are a multitude of regulations both at the federal and state level that touch veterinary compounding. These laws affect all veterinarians and clinics that use compounded products, whether through their own compounding in-house or a third-party pharmacy. Who makes the decisions when it comes to veterinary compounding? There are three main bodies that have some oversight of compounded veterinary medications: the Food and Drug Administration (FDA), state boards of pharmacy (SBOP), and the US Pharmacopeia (USP). The FDA Historically, control over the practice of compounding has mainly been exerted at the state level, with the FDA focused more on regulation of manufacturing or compounding for veterinarian use in office. However, the FDA has recently issued draft guidance specific to compounding for veterinary purposes (GFI #256), which seeks to clarify the federal policy in this space. 1 At the time of this publication, comments on the draft are being reviewed by the FDA. 1 Compounds are not required to pass through FDA approval processes for use (eg, new drug applications [NDAs], new animal drug applications [NADAs]). 2 Compounding is considered a different legal entity from drug manufacturing, so the same requirements do not apply. Manufacturers must adhere to current good manufacturing practices (GMPs) and are regulated by FDA rules and powers as compared with compounders. 2,3

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