What is animal drug compounding?

When your pet is sick, the medications your veterinarian prescribes must meet stringent development and production guidelines. Just like drugs prescribed by human physicians, your pet’s medications are approved by the Food and Drug Administration.

When there is no appropriate drug available to treat a sick animal, pharmacists sometimes prescribe drugs formulated through a process called compounding.

Pharmacists rely on two basic methods for compounding an animal drug.

  • Extra-Label Drugs: A pharmacist “manipulates” an FDA-approved veterinary drug. She might mix it with other ingredients, combine it, crush the tablets, or change it in ways that better meet an animal’s needs.
  • Bulk Ingredients: Pharmacists also compound new drugs by mixing bulk ingredients with suspension solutions, flavors, fillers, and other ingredients.

Why drug compounding is necessary.

The “Pharmaceutics” article, “Veterinary Compounding: Regulation, Challenges, and Resources,” explains how the availability of veterinary medication is limited compared to what’s needed. Pharmacists compound drugs for animals because there aren’t enough available pharmaceutical choices.

  • While considering the industry’s guidance for compounded drugs, the FDA estimated that, annually, 75,000 pharmacies compounded 6,350,000 prescriptions for animals in the US. The FDA guidelines outlined in its “Resource for Veterinarians” article explains these and other general conditions where it considers extra-label drug use an acceptable alternative.
  • The approved drug doesn’t have the necessary active ingredient.
  • If there is no approved animal drug available for the proposed use.
  • The approved drug isn’t in the appropriate dosage or form. (ex, liquid vs tablet)
  • The approved drug doesn’t work as prescribed.

What the FDA doesn’t approve

Compounded drugs are often the only economically viable option for pet owners without insurance. Unfortunately, FDA guidelines do not approve the use of compounded/off-label drugs when cost is the only factor.

The FDA guidelines acknowledge compounding as a process involving off-label use of approved drugs. When discussing compounding with bulk ingredients, the agency has issued ambiguous statements.

While the FDA states that prior laws disapprove of compounding with bulk ingredients, they further explain that the agency ”… would not intend to take action against the compounding of animal drugs from bulk drug substances…” They have further explained that compounding with bulk ingredients “…may be an appropriate treatment option…”

Considering its widespread use, the FDA plans to issue further drug compounding guidance in the future.

Contact Hebron Veterinary Hospital

Give us a call if you want to know more about animal drug compounding or if you need to schedule a pet checkup. You can reach us at (860) 228-4324.