Veterinary Compounding: Recent State Legislation Updates

State boards of pharmacy continue to have primary responsibility of the day-to-day oversight of state-licensed pharmacies that compound drugs in accordance with Section 503A of the Food and Drug Cosmetic Act (FDCA) while the FDA regulates and inspects registered outsourcing facilities licensed under Section 503B of the FDCA.

While the exact definition of compounding may vary slightly state by state, in general terms, compounding is a practice in which a licensed pharmacist, a licensed practitioner, or in the case of an outsourcing facility, a person under the supervision of a licensed pharmacist combines two or more drugs to create a tailored medication to address the needs of an individual patient.

Currently, Section 503B only applies to human compounding and the veterinary medicine community continues to explore pharmacy related legislation changes that would specifically address the unique needs of their animal patients.

According to the American Veterinary Medical Association (AVMA), nine states have laws or regulations that permit licensed veterinarians to administer and dispense compounded products, in some cases under specified conditions. In the past few months, at least four more states have introduced bills or regulations that would permit or place limitations on compounding for animal patients in specified situations.

Maryland recently introduced SB 614 which provides an exception to state pharmacy law, specifying that it does not prohibit a licensed veterinarian from dispensing a sterile or non sterile compounded preparations, provided by certain pharmacies, for use in a companion animal, under specified circumstances. Additionally, under SB 614, a pharmacy would be authorized to provide certain compounded preparations without a patient-specific prescription to a certain licensed veterinarian under certain circumstances.

Massachusetts introduced HB 3989 which would authorize a veterinarian to dispense a compounded drug, distributed from a pharmacy, when the animal is his own patient within the valid veterinarian-client-patient relationship (VCPR), as defined by the Principles of Veterinary Medical Ethics of the AVMA provided that:

  • The animal is a companion animal;
  • 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 Massachusetts bill would also allow a veterinarian to compound for individual patients within a valid VCPR provided that the veterinarian (1) does not compound from bulk substances, (2) does not duplicate proprietary products, (3) does not wholesale compounded medications and (4) does not compound from federally controlled substances for dispensing.

New York is considering a bill that would allow pharmacists to compound strictly limited amounts of substances for veterinary facilities which in turn could then dispense, under certain limited circumstances, to animals with which the veterinarians have a valid VCPR. Interestingly, the New York bill addressed the uniqueness of veterinary medicine:

  • “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 had 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.”

The New York bill provides additional safeguards by strictly limiting the quantities of compounded pharmaceuticals that a veterinary practice may have on hand to a short term supply of 100 doses or twelve ounces of liquid medications, twelve ophthalmic, topical or inhaled preparations and 100ml of sterile injectable solutions.

Last week in Colorado, HB 16-1324 was introduced to the  House Health, Insurance, & Environment committee. 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 
  • Allow 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 compounded pharmacy. 

Patient safety remains paramount while states continue to address veterinary compounding, office use and office stock in an effort to protect the health, safety and welfare of the animal population.

Baer Law will continue to keep you updated on veterinary compounding issues.