In recent months, the Food and Drug Administration has been cracking down on illegal drug compounding. The agency's efforts highlight the need for the veterinary profession to understand what the FDA requires for a drug to be compounded legally.
Compounding may be necessary if a veterinarian diagnoses a condition in an animal for which no FDA-approved animal or human drug, in its available dosage form and concentration, will appropriately treat the patient. For a drug to be compounded legally, however, a number of requirements must be met, and some veterinarians and pharmacists are receiving warning letters for failing to do so.
In January, for example, the FDA accused a pharmacy of, among other things, compounding a drug outside the context of a valid veterinarian-client-patient relationship. The agency stated that it appeared the pharmacy had sent compounded drugs to veterinarians for use as office stock in their professional practice and/or for subsequent general distribution. The agency based its claim on the fact that most of the prescription drug labeling did not identify the animal to receive the drug, or provide the dose, or indicate the duration of treatment.
Common violations include compounding from bulk drugs—raw chemical ingredients—and compounding for third parties who resell to individual clients for their animals.
In an effort to educate the veterinary profession, the AVMA, Animal Health Institute, and American Veterinary Distributors Association have developed a brochure called "Veterinary Compounding." The brochure clarifies compounding and regulations, and explains the distinction between drugs approved by the FDA and compounded drugs. It also provides a list of questions veterinarians can ask their compounding pharmacist. Individuals can obtain the free brochure by sending their mailing address to firstname.lastname@example.org or calling (800) 248-2862, Ext. 6636.
At press time, the Association had just launched an area on its Web site that will serve as a comprehensive educational resource on compounding. The site provides information on pharmacology basics, regulations, and issues on the horizon; answers to frequently asked questions; and definitions of compounding terms. It also provides links to the new compounding brochure, AVMA's position on compounding, and related news articles in the JAVMA. Individuals can access these pages by visiting here.
Dr. Elizabeth Curry-Galvin, assistant director of the AVMA Scientific Activities Division, points out that practitioners also need to be aware of state regulations. States require that prescriptions for compounded drugs be specific to a patient, but some states have a provision for in-office use of compounded products. These states allow pharmacists, under limited conditions, to fill a veterinarian's request for a drug that is not commercially available and must be compounded, if the product is to be administered by the veterinarian in their office. The same states often prohibit a veterinarian from dispensing such drugs or selling the product to other veterinarians. Other states, however, have no provision for in-office use, or ban the preparation of products entirely for office use.
Veterinarians should contact their state board of pharmacy and state board of veterinary medicine to determine state requirements.
Dr. Curry-Galvin stresses that it is important for the veterinary profession to seek resources that will help them understand the issues. The AVMA will continue to help with education.