Safe and effective medicines are important tools for veterinarians. While approval by the Food and Drug Administration provides these guarantees of safety and effectiveness, an approved drug is not always available to treat an animal condition. In these instances, veterinarians need access to compounded medicines. But current lack of regulation of compounding can put animals at risk.
Consider the challenges faced by a veterinarian. Whereas a human doctor treats a single species, a veterinarian can be confronted with several species from dogs and horses to birds and iguanas.
Yet the human doctor has over 12 times more drugs approved by the Food and Drug Administration (FDA) than does the veterinarian.
One way a veterinarian meets this challenge is through the use of compounding. Certain compounding is legal, while others is not. In 1994 Congress passed a law called the Animal Medicinal Drug Use Clarification Act (AMDUCA) allowing for the extra-label drug use, under certain conditions, of animal drugs. Under this law, a veterinarian or pharmacist can manipulate an approved drug upon the prescription of a veterinarian to meet the medical needs of a specific patient.
Examples of legal compounding include:
- Mixing two injectable drugs in the same syringe
- Creating an oral suspension from crushed tablets or an injectable solution
- Adding flavoring to a commercially available drug
- Creating a transdermal gel for a drug typically taken through other routes
- Mixing two solutions for instilling into the ear
It is illegal under federal law for pharmacies to make their own compounded drugs from bulk drug substances (or raw active ingredients). These are considered new animal drugs, which are required by law to undergo a rigorous evaluation to make sure they are safe and effective and that the company meets high manufacturing standards. But FDA, using enforcement discretion, does allow some animal compounds to be made from bulk drug substances for one reason: There simply aren’t enough active ingredients in the approved drugs to meet all the medical needs of animal patients. When a veterinarian needs a medicine with an active ingredient that is not contained in an approved drug, compounding from bulk drug substances is necessary for patient health.
Unfortunately, this “enforcement discretion” has become a large loophole used by some large compounding pharmacies to become de facto drug manufacturers. They import bulk drug substances from overseas and compound large quantities of products that are copies or near copies of FDA-approved products, and then market them to veterinarians as cheap alternatives to approved drugs. This practice has two serious problems:
First, it endangers animal health.
- In 2009, 21 polo ponies in Florida were killed as a result of receiving a compounded product that had been made in error.
- In 2014, four horses in Kentucky and Florida died after receiving a compounded product that had been made in error.
- In 2019, three horses in Maine and Ohio died or were euthanized after receiving a compounded product that had been made in error.
Studies have shown differences in the potencies of the active ingredients in products from compounding pharmacies. This can have serious consequences on the efficacy or toxicity of a product if it has too much or too little of the needed active ingredient.
Second, this practice of compounders acting like manufacturers undermines the FDA drug approval process.
FDA approval means the drug has been proven to be safe and effective. Veterinarians can administer these approved products to their patients with the confidence they will have the desired therapeutic effect and not harm the patient. Compounded products do not carry these guarantees, increasing the risk. When compounders are making and marketing thousands of doses, the number of potentially harmed animals increases.
The drug approval process at FDA is data-driven and resource intensive. When a compounding pharmacy can make a copy of an FDA-approved product without spending the resources and providing the data the company did to get the product approved, they remove the incentive for a company to spend the time and money to provide veterinarians with high-quality, approved products. Given the challenges faced by veterinarians, they need more approved products, not fewer.
New FDA Guidance clearly defines the difference
New guidance issued by FDA, Guidance for Industry #256, defines the scope of enforcement discretion. It creates a mechanism for defining the bulk substances that can be used to compounding animal preparations and he circumstances under which that can be done. This clarity is desperately needed.
The new guidance does not eliminate compounding. In fact, the new guidance does not deal at all with compounding from an approved product with a veterinary prescription, as defined by AMDUCA. It specifically allows for some compounding from bulk drug substances, when that compounding is needed to address medical needs in patients.
The new guidance helps veterinarians. It will help them, and their customers identify and know when they are using an approved product or a compounded product. It will also assure they are not using products that are illegal and subject to FDA enforcement action.
The animal health industry supports the use of compounding to address the medical needs of animal patients. We do not support the ability of compounders to act like manufacturers and put patient health at risk. This guidance document from FDA defines the difference between the two and we believe it should be finalized.