Medicines for Your Pet: What's The Difference Between FDA-approved & Pharmacy-compounded Drugs?

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If you’ve ever had to give your pet a dose of medicine, you know it might turn into a battle. While many animals will gladly take any pill hidden in cheese, peanut butter or other treat, some do not enjoy the process and will refuse to take a pill. Additionally, some species are unable to take pills at all.

If necessary, your veterinarian can ask a compounding pharmacist to change that FDA-approved pill into a liquid for your pet who cannot, or will not, take the pill. This is one example of animal drug compounding.

What is animal drug compounding?

Animal drug compounding is the process of a combining, mixing, or altering ingredients, in a pharmacy setting, to create a medication tailored to the needs of an animal species or individual animal. 

Compounded drugs are not FDA-approved and therefore, FDA does not verify their safety, effectiveness, or quality before they are marketed.  Consumers should not confuse compounded drugs with FDA-approved generic or brand-name drugs. 

Some examples where veterinarians might prescribe a compounded drug for a difficult patient, a patient with an allergy, or for use in a different species:

• Creating a liquid medication from tablets 
• Adding flavoring 
• Making a medication in a different strength (i.e., for a different species)
• Reformulating a medication to remove a harmful ingredient, such as an allergen

Though compounded medications may be helpful in examples like those above, they aren’t always the best option. For example, compounded drugs can be poorly absorbed or ineffective. By comparison, FDA-approved drugs have been tested for efficacy and are manufactured under strict quality standards.

FDA’s Role in Animal Drugs

The FDA is responsible for evaluating animal drugs to make sure they are safe and do what they claim to do - for example, treating a particular type of infection, relieving pain, or removing worms. 

Approved Drugs 

FDA approval requires substantial evidence, typically gathered over the course of many years, that shows a drug is safe and effective. 

When evaluating this evidence to determine if the animal drug can be FDA-approved, teams of scientists, including veterinarians, assess the active and inactive ingredients, dose, effectiveness, safety for the animal being treated and the people administering the drug, as well as the impact on the environment. If the medicine is used in animals that produce food, like meat, milk or eggs, the FDA also ensures the food is safe for people to eat. Only after all this testing and review can the drug be FDA-approved.

Approved drugs, commonly referred to as brand-name, pioneer or generic drugs, must be properly labeled and manufactured to ensure quality. The FDA ensures the directions for how to use the drug are clearly and completely printed on the labeling, and the FDA conducts routine inspections of the production facility. 

Additionally, after approval, the FDA monitors the drug and addresses any problems that come to light after it’s used in the general animal population. Drug companies are required to report any complaints they receive about the drug to the FDA, including expected and unexpected side effects, or defective products. 

Just like for people, there are brand-name and generic drugs for animals. Generic animal drugs are also FDA-approved, meaning they have been demonstrated to be safe and effective, manufactured to high quality standards, and labeled properly. They also have the same reporting requirements post approval as a brand-name animal drug. Simply stated: a generic medicine works the same way in the animal’s body as the brand name drug. 

Compounded Animal Drugs 

Unlike brand-name and generic animal drugs, compounded animal drugs are not FDA-approved. Compounded animal drugs haven’t been well-researched, don’t go through FDA-approval and oversight processes, and typically aren’t made to the same quality standards as FDA-approved drugs. Additionally, compounders are not required to report problems to the FDA. This makes it hard for the FDA to track the safety record of compounded animal drugs.

So, with fewer safeguards and higher risks, why might you use a compounded animal drug?

Your Pet and Compounded Animal Drugs

The FDA recognizes that there isn’t an FDA-approved animal drug for every disease or condition in every animal species. For example, there aren’t many approved animal drugs for animals like chinchillas nor for wildlife or zoo animals—and remember our example from before about the pets who refuse to or cannot take pills. 

In situations where there are no FDA-approved drugs that are appropriate for your pet’s treatment, your veterinarian may decide to prescribe a compounded animal drug. 

Considerations Before Using a Compounded Animal Drug

Here’s some information on what you can do to help advocate for your pet. Although there’s not always an FDA-approved option, pets always deserve high quality medicine that is proven safe and effective when it is available:

• First, always ask if the prescription is for an FDA-approved brand-name or generic drug, or if it is for a compounded drug that is not FDA-approved. 
• If your veterinarian recommends a compounded drug, ask them to consider if there is an FDA-approved animal (or human) drug containing the same active ingredient that can be used extralabel. For example, extralabel use may be at a different dosage, in a different species, or to treat a different disease.
• Remember, a compounded drug is not the same as a generic drug. Generic drugs are FDA-approved and are safe and effective, just like the brand-name products. There are many generic animal drugs available for pets. Veterinarians can also prescribe FDA-approved human drugs for your pet, if appropriate. Just like approved animal drugs, these approved human drugs give your pet the benefit of strict quality standards. 

Remember, compounded drugs don’t come with the same assurances as an FDA-approved drug. They haven’t been well-researched, don’t go through FDA-approval and oversight processes, and typically aren’t made to the same quality standards as FDA-approved drugs.  

What Can I Do if my Pet Experiences an Adverse Event While Taking a Compounded Drug?

First contact your veterinarian and seek appropriate treatment for the adverse event.  

The FDA encourages veterinarians and animal owners to report adverse drug events associated with any drugs used in animals. 

• Download the fillable 1932a electronic form to your computer and email the completed form to CVM1932a@fda.hhs.gov. 
• You should also report the problem to the compounder who made the product.

For questions or to request a hard copy of the form, please contact us at AskCVM@fda.hhs.gov, 1-888-FDA-VETS (1-888-332-8387), or by mail:  

Center for Veterinary Medicine
Food and Drug Administration
HFV-1
7500 Standish Place
Rockville, MD 20855