A compounded animal drug is made by combining, mixing or altering ingredients to create a medication tailored to the needs of an individual animal or a small group of animals. These drugs, which can play a critical role in veterinary medicine, are typically made by pharmacists or veterinarians.

Compounded animal drugs are not FDA-approved drugs. When FDA approves an animal drug, the approval covers a finished drug product, ready for use by a veterinarian or patient without further manufacturing. The FDA review encompasses the specific active and inactive ingredients to be used; manufacturing methods; and labeling, including the drug’s indications, intended species, warnings, safety information, and other conditions of use. FDA approval means that FDA has determined that the data demonstrates the approved animal drug is safe, effective, quality manufactured, and truthfully labeled. Further, the approved animal drug becomes part of our post-approval pharmacovigilance program, where we monitor adverse events, product defects, advertising, and changes in the manufacturing and labeling of the approved animal drug. Because they are not FDA-approved, compounded animal drugs don’t have the same assurances of safety, effectiveness, and quality manufacturing, and truthful labeling as approved animal drugs.

The Federal Food, Drug, and Cosmetic Act (the “Act”) permits compounding of animal drugs when the source of the active ingredient is a finished, FDA-approved drug. In contrast, nothing in the Act authorizes the compounding of animal drugs from bulk drug substances (BDS). Nevertheless, there are situations in which a needed compounded animal drug can only be made using a BDS.

Accomplishments: CVM has taken regulatory and enforcement actions to ensure that unsafe compounded animal drugs are removed from the market. These actions include Warning Letters, which seek voluntary compliance, and more formal actions such as injunctions, which seeks a court order to require a firm to stop or prevent violations of the law.

Next Steps: On November 19, 2019, CVM issued draft Guidance for Industry #256, entitled “Compounding Animal Drugs from Bulk Drug Substances.” The new draft guidance, if finalized, would describe our animal drug compounding enforcement priorities and advise veterinarians, pharmacists, and the public on circumstances under which FDA does not intend to take action for certain violations of the Act when pharmacists and veterinarians compound or oversee the compounding of animal drugs from a BDS. CVM has received over 1,400 comments on the draft GFI, and is currently reviewing those comments.

 

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Note:  The data provided on this website is produced on an ongoing basis for performance management purposes and is subject to change due to updates of preliminary estimates, corrections, or other reasons. In addition, FDA may change the type or amount of data provided on this website at any time.