Animal Health Solutions

8 Covetrus | ph: 855.724.3461 | fx: 888.329.3861 | northamerica.covetrus.com State Boards of Pharmacy Individual SBOP are the main compounding regulators, with each state having their own rules and standards. Per state pharmacy practice acts, each state has authority to govern all pharmacy practices, including veterinary compounding, when performed by a pharmacy. 4 Although not veterinary-specific, SBOP do many things that help keep veterinary drugs safe. SBOP regulate pharmacists, in- and out-of-state prescription drug wholesalers, pharmacies, and those who compound. Acting to protect patient safety and public health, SBOP grant licensure of qualified personnel and have authority to inspect facilities, enforce regulations, and investigate complaints. Subpar compounding procedures and drug products can lead to disciplinary action, including fines and/or revoked licenses of pharmacies, pharmacists, and pharmacy technicians. State boards of veterinary medicine can get involved if a veterinarian is found to be using compounded drug products inappropriately. The US Pharmacopeia The USP is a nonprofit, nongovernmental public health organization that sets national chemical purity standards for all medicines and healthcare products sold in the United States. The USP sets compounding quality standards but does not have enforcement authority. It also lacks guidance specific to veterinary compounding. Regardless, veterinarians should be familiar with the USP, as it sets the quality standards that all veterinary compounders must follow. Each section of the USP is called a chapter; most SBOP require compounding pharmacies to be compliant with USP chapters <795> and <797> for nonsterile and sterile compounding, respectively. 5 USP standards are in the process of being updated, as they are reviewed periodically as science and technology evolve. Most clinicians are familiar with chapter <800>, which provides guidance on the handling, storage, and use of hazardous materials. Who is actually doing the compounding? When a veterinarian in a busy general practice needs a compounded drug, they often refer to a list of pharmacies, in- or out-of-state, that are used frequently in the practice and generally seen by the team as trusted sources of the medications they need. But who are these compounding pharmacies? Why are different pharmacies used for different drugs or formulations? 503A facilities are traditional compounding pharmacies that make custom, patient-specific formulations pursuant to a prescription and in response to an immediate medical need. 6 Most 503A facilities specialize in either nonsterile (ie, general) or sterile compounding, but some facilities perform both. Compounding at a 503A pharmacy is not subject to manufacturing standards such as GMPs. 503B facilities, also known as outsourcing facilities, allow for compounding drugs for office use and resale to practitioners. 7,8 The larger scale and scope of practice of these facilities require additional oversight, similar to manufacturers. 503Bs must register with the FDA, current GMPs must be followed, and the facility must maintain their own quality-assurance department. 6,9,10 For 503B facilities, office-use sale is allowed and is not subject to the same limits that a 503A pharmacy would have imposed on these types of sales. Many states have restrictions on the total volume of compounded products that a 503A can sell to practitioners for office use. 6 Because laws vary among states, it is the responsibility of the compounding entity—whether a 503A pharmacy or a 503B outsourcing facility—to gain appropriate licensure and lawfully sell products for office stock use. It is the responsibility of the prescribing veterinarian to also follow these laws as it relates to their use (ie, administration in clinic or dispensing for pets). Because office-use laws can be confusing, it is highly recommended that veterinarians meticulously document patient-specific use of any compounded products they may purchase. This is a fundamental way to achieve compounding compliance. The compounding pharmacies used by practicing veterinarians, ranging from small local businesses to large facilities shipping drugs nationwide, fall into one of the two above categories, and their classification and location will partially dictate what products they are able to produce, sell, and ship. Veterinarians should confirm that any pharmacies offering compounded drugs are licensed to do so. Veterinarians should also be familiar with the regulations in their state regarding keeping compounded products for office use and/or resale. Veterinarians should be familiar with the USP, as it sets the quality standards that all veterinary compounders must follow.

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