Pharmacy Compounding

Drug compounding (or pharmacy compounding) is the act of mixing certain drug components to make a new drug. According to the PCCA (Professional Compounding Centers of America), pharmacy compounding “is the art and science of preparing personalized medications for patients. Compounded medications are 'made from scratch' — individual ingredients are mixed together in the exact strength and dosage form required by the patient. This method allows the compounding pharmacist to work with the patient and the prescriber to customize a medication to meet the patient’s specific needs.”

Generic animal drugs are not compounded drugs. Generic animal drugs:

  • must undergo rigorous testing to meet certain quality criteria
  • are manufactured under strict controls established by government regulation, and
  • are reviewed and approved by FDA before being permitted on the market for administration to animals.

Compounded drugs are not pre-approved by FDA, and are only permitted by FDA under limited circumstances when needed for a particular animal patient. Veterinarians and animal owners must be prudent if utilizing compounded drugs to know the pharmacy compounding the drug is meeting FDA requirements and the drug can be used safely and effectively in their animal patient.

In 2013, draft legislation was introduced in both the Senate and the House of Representatives to provide clarity on authority over pharmacy compounding between the FDA and states.

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