What's a "compounded" drug vs. an FDA approved drug?

The FDA (Food and Drug Administration) regulates drug or medication use in the U.S., both for human use and veterinary use. Its role is to protect the public/consumer and help ensure that drugs available in the U.S. are safe and effective. Compounding a medication is allowed when there is no FDA-approved product or formulation available, but the medication is needed to help the health of a patient. The following are some definitions to help clarify the differences.

FDA-approved drug- must meet rigorous testing to demonstrate safety and effectiveness before the drug is approved and available for use in the U.S.  The quality of FDA-approved drugs available on the market is monitored by the FDA, including monitoring manufacturers- their facilities and their production processes.  The FDA can stop production, impose fines and recall medications. Veterinarians and physicians can also report any "adverse affects" or problems with drugs that they use to the FDA.  Some drugs have been taken off of the market after initial approval because significant new adverse affects have shown up after more wide-spread use of the drug.  FDA-approved drugs are labeled for a specific use and dosage and a specific species: some drugs are labeled for human use; other drugs are labeled for veterinary use in a specific animal and indication.

Compounding or a compounded medication-  is made up & formulated by a licensed "compounding pharmacy".  A prescription is needed by a veterinarian.  Using a compounded medication is only allowed for a specific individual patient and must be special ordered when needed. Sometimes a special formulation, dosage or flavoring is needed to be able to administer a medication to a patient.  As your veterinarians, we select compounding pharmacies that we believe are reliable and provide a good quality product. Compounded medications however do not go through the rigorous testing and monitoring as FDA-approved products. Testing of some compounded products has found that they don't always contain the amount of medication as on the label.  FDA-approved drugs should be used and are preferred if available. However, in some cases a compounded medication is all that's available for a particular use.

See our longer article on Compounded & FDA Drugs with more on this as well as brand name & generic drugs, OTC (over the counter) medications and "extra-label" use of medications. Click on More Equine Topics- Cmpd vs FDA and select file name "Compounded vs FDA-approved Drug".