While there is a dispute amongst attorneys about FDA’s authority to govern compounding in veterinary medicine in the absence of amendments to the Federal Food Drug and Cosmetic Act, there is no doubt that states may legislate or regulate this area of practice.
Compounding, defined by AVMA as “any manipulation of a drug beyond that stipulated on the drug label – is needed in veterinary medicine to provide individually mixed drugs for specific patients with special needs not met by FDA-approved drugs” remains an important tool for veterinarians, who must be vigilant in remaining in compliance with all relevant state and federal laws.
At least five states have recently introduced bills or regulations that limit or permit compounding by veterinarians for their patients in specified situations. “According to the American Veterinary Medical Association (AVMA), as of August 2015, nine states (including Virginia) have laws or regulations that permit licensed veterinarians to administer and dispense compounded products, in some cases under specified conditions.”
Maryland bill SB 614 “would provide an exception to state pharmacy law, specifying that it does not prohibit a licensed veterinarian from dispensing compounded preparations, provided by a pharmacy, for use in a companion animal, under specified circumstances. A pharmacy would be authorized to provide certain compounded preparations without a patient-specific prescription to a licensed veterinarian.”
Maryland defines “companion animal” as “a rabbit, bird, rodent, fish, reptile, amphibian, nonhuman primate, or any species of animal kept for pleasure rather than utility and accustomed to living in or about human habitation, or a cat or dog regardless of any utilitarian purpose. Companion animal does not include cattle, sheep, goats, swine, poultry, or any other animals kept for bona fide research or agricultural issues.”
Massachusetts HB 3989 would authorize a veterinarian to dispense a compounded drug, that is not prepared from bulk supplies, to the veterinarian’s patient under the following limited circumstances:
the animal is an animal companion; the quantity dispensed is no more than a 120 hour supply; the compounded drug is for the treatment of an emergency condition; and timely access to a compounding pharmacy is not available, as determined by the prescribing veterinarian.
The bill would also prohibit a veterinarian from selling or administering a compounded drug if it duplicated proprietary products or was a federally controlled substance.
In Colorado, HB 1324 would:
authorize a compounding pharmacy to compound and distribute a drug to a veterinarian without a specific patient indicated to receive the compounded drug; and a veterinarian to dispense a compounded drug, maintained as part of the veterinarian’s office stock, in an amount not to exceed 5 days’ worth of doses, if a patient has an emergency condition that the compounded drug is necessary to treat and the veterinarian cannot access, in a timely manner, the compounded drug through a compounding pharmacy.
Similar to the proposed Colorado bill, New York legislators are considering a bill that would permit veterinarians to inventory certain compounded drugs for use during emergencies and times that drugs would be available. Despite concerns about the safety of compounded drugs, the official justification for the bill stated:
Unlike human medicine, veterinary medicine has a unique service model. In many cases there is no ready alternative to a veterinarian having compounded medicines on hand at all times. This is especially true in emergency situations and at night and on weekends and holidays where there is no practical alternative but the animal hospital and its staff veterinarians for the purposes of filling a prescription for an animal with which a veterinary client patient relationship exists. The alternative to the safe and proper use of these safe substances would in many cases be suffering and possible death for the animal in need of them.
In Delaware, a proposed amendment to the Board of Pharmacy regulations would prohibit a pharmacist from selling “non-patient specific compounded products to a practitioner for office use unless covered under federal authority.” Unfortunately, this language does not provide much guidance to the regulated community.
“AVMA reports that compounding is critical for veterinary medicine because of the limited number of U.S. Food and Drug Administration-approved drug products for the many species and conditions that veterinarians treat.
Hopefully more states will permit the use of compounded drugs in veterinary practices so that practitioners can provide for the health of their patients.