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Simply put, compounding is any manipulation of a drug beyond that described on the drug label.

Manipulation might include mixing, diluting, concentrating, flavoring, or changing a drug’s dosage form.

Veterinary drugs should only be compounded based on a licensed veterinarian’s prescription, and to meet the medical needs of a specific patient. Examples of 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 skin-penetrating gel for a drug typically taken through other routes;
  • mixing two solutions for instilling into the ear.

Compounding is usually necessary when an animal is suffering from a medical condition and there is no FDA-approved human or veterinary product available and medically appropriate to treat the patient. The decision to use a compounded preparation must be medically necessary and made within the confines of a veterinarian-client-patient-relationship.

For example, a cat needs a medication that is only available in a pill form. If the cat’s owner is unable to administer the pill at home, the veterinarian might have the drug compounded into a flavored liquid that the cat will take.

Realize that although compounds might be necessary in some medical situations in pets, there are benefits and risks to their use. Because compounded preparations are not approved by the FDA, there is no assurance of how well they can be expected to work (e.g., safety, potency, stability, efficacy). That’s why it’s best to use an approved drug, but that is not always possible and compounded medications play an important role in animal health.

According to the U.S. Food and Drug Administration (FDA), federal rules currently require that compounded medications only be modified versions of FDA-approved medications. In other words, compounded medications should only be prepared using FDA-approved drugs that have been crushed, had a flavor added or otherwise changed from the original form. If they are made from ingredients that are not already approved by FDA for humans or animals, then FDA considers these preparations to be “new animal drugs,” which are required to have FDA approval in order to be legally sold.

For example, let’s say your animal has a unique condition that needs to be treated with eardrops, but the FDA-approved drug your pet needs is only available as a tablet. Your veterinarian can ask a compounding pharmacy to create an eardrop version of that tablet so your animal can get the treatment it needs.

In some situations veterinarians may find it necessary to compound from a source that has not been approved by the FDA to relieve the animal’s suffering. In these cases, veterinarians and pharmacists must carefully assess whether the use is consistent with state and federal law and FDA policy.

The federal government is currently assessing how compounding rules should be clarified further. We will update these FAQs as new information becomes available.

Common examples of appropriate compounding in veterinary practice are mixing two injectable drugs, preparing an oral paste or suspension from crushed tablets or adding flavoring to a drug. One of the most common examples of compounding for animals is modifying an FDA-approved tablet or capsule into an oral suspension; for example, crushing a tablet and adding a tuna fish flavor to make it a palatable liquid.

Other frequently compounded preparations include cisapride (a drug that enhances gut movement), metronidazole benzoate (an antibiotic) and apomorphine (a drug used to induce vomiting). While often compounded and medically necessary for successful treatment of certain conditions, these four preparations are actually not examples of legal compounding as defined by the FDA. Federal regulations require that compounded preparations be created using an FDA-approved drug as the starting ingredient. Since there is no FDA-approved product to start with in preparing these compounded medications, an active pharmaceutical ingredient (i.e. raw chemical) must be used to prepare the medication.

In addition to these four examples, some other medically necessary drugs, such as poison antidotes, are only available as compounded preparations made from active pharmaceutical ingredients (API).

Yes, and those rules are much more strict because of the need to prevent potentially harmful residues in the meat, milk or eggs that come from the treated animals. FDA-approved products have a determined withdrawal time, which is the time from when the animal was last treated with the drug to when the animal can be slaughtered for food or the animal’s milk can go to market. The withdrawal time of a compounded product is unknown because it hasn’t been studied. The FDA’s Extralabel Drug Use Rules and Compliance Policy Guide must be followed.

No, you shouldn’t, unless your veterinarian has specifically directed you to do so. Prescriptions for compounded medications are specifically written for individual animals; using one pet’s compounded medication for another pet could harm your pet. Only a veterinarian can prescribe for a medication to be compounded for an animal, so giving the compounded medication to another animal is essentially practicing veterinary medicine without a license.

There is no assurance, like there is with an FDA-approved drug, that a compounded medication will be safe or effective for an animal’s medical condition. Therefore, the use of compounded medications is only recommended when an FDA-approved medication is not available in the appropriate formulation. When using compounded preparations, the best way to ensure your pet’s safety is to discuss with your veterinarian signs and symptoms of an adverse reaction. Also, if the appearance of the compounded medication changes (color change, odor change, consistency change) while you are using it, you should stop using it and call your veterinarian immediately.

Compounded medications have not been tested for safety and efficacy like FDA-approved drugs. During research and development of a medication, drug manufacturers conduct FDA-required tests to demonstrate to the satisfaction of the FDA that their product is effective and safe. FDA evaluates the data before approving the drug and allowing it to be put on the market. This is not the case with compounded medications since they have not undergone FDA’s rigorous approval process.

No. Only a veterinarian can prescribe a compounded medication for an animal. Any unlawful practices, such as providing compounded medications without a valid prescription, should be reported to the state board of pharmacy.