FDA-TRACK: Center for Veterinary Medicine - Compounded Animal Drugs
Relevant Links:
FDA's Center for Veterinary Medicine (CVM) regulates animal drugs, animal devices and animal food under the Federal Food, Drug and Cosmetic Act. CVM protects and promotes the health of humans and animals by ensuring the safety of the American food supply, the safety of animal food and devices, and the safety and effectiveness of animal drugs.
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.
In April 2022, CVM issued final Guidance for Industry (GFI) #256, “Compounding Animal Drugs from Bulk Drug Substances,” to help protect animal health by recognizing the need for access to certain compounded animal drugs. This policy balances maintaining access to compounded drugs that veterinarians need to treat diverse animal populations and protecting human and animal health from poorly compounded products, or ones that copy existing FDA-approved drugs. CVM plans to focus on education and stakeholder engagement before shifting resources toward inspectional activities. CVM will take appropriate actions, as we currently do, when compounding practices threaten human or animal health.
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.