Compounding

Compounding may include mixing, diluting, concentrating, flavoring, or changing a drug's dosage form to accommodate a specific patient's needs. The FDA also has indicated that some compounding is permissible for “office stock” or as therapy for toxicoses.

Discussion of compounding rules often centers on two issues: compounding from FDA-approved drug products and compounding from bulk drug substances.

View this compounding guide for veterinarians to learn about the regulatory parameters, quality control assurance, and practice considerations when using compounded products in veterinary medicine. 

FDA-approved products

Compounding from FDA-approved drug products is legal, as long as FDA's extralabel drug use rules and all state rules are followed.

Bulk drug substances

Compounding from bulk drug substances is more complex. The FDA says that it has jurisdiction to bar any compounding from bulk drug substances, but generally acknowledges that veterinarians sometimes need to use preparations compounded from these ingredients. Although the FDA has interpreted all compounding from bulk drug substances as being outside of the rules, the agency has recognized that there are circumstances where there is no drug available to treat a particular animal with a particular condition – because either no drug is approved for a specific animal species or none is available under the extralabel drug use provisions. In these limited circumstances, FDA acknowledges that an animal medication compounded from bulk drug substances may be an appropriate treatment option.

The AVMA believes compounding from bulk drug substances may be medically necessary in some scenarios for non-food animal patients:

• Prescribing the compounding of a drug that might have been approved previously by FDA but is no longer commercially available
• Prescribing a compounded preparation because the needed medication can't be prepared from an FDA-approved drug product

Learn about the FDA's guidance outlining situations in which it does not intend to take enforcement action related to compounding animal drugs from bulk drug substances.

Contact your liability insurance carrier, such as AVMA PLIT, with any questions you have about your liability coverage.

Get answers to some of the most commonly asked questions about veterinary compounding:

• Veterinary FAQ
• Pet owners FAQ

Because compounding is a critical tool for veterinarians, the AVMA ensures that veterinary concerns are heard and considered in regulatory rulemaking and in Congress. The association also keeps AVMA members informed of the rules and compounding best practices. This work takes many forms, including:

• Communicating regularly with the FDA to safeguard veterinary access to compounded medications and ensure that the needs of veterinarians and our patients are protected
• Educating lawmakers about the complexities of compounding for animals
• Providing resources that help veterinarians navigate the fine points of prescribing and using compounded medications.
• Collaborating with pharmacy organizations, animal drug manufacturers, and other stakeholders to build coalitions that advance and protect the interests of veterinarians and animals
• Monitoring the courts on issues of regulatory jurisdiction

The AVMA remains concerned that veterinarians' ability to create patient-specific prescriptions compounded from bulk drug substances needs greater protection. The association continues to work closely with stakeholders and the FDA to ensure access to these medications.

When the FDA published draft guidance in 2015 describing conditions under which it generally would not initiate enforcement action against state-licensed pharmacies, licensed veterinarians, and registered “outsourcing facilities,” the AVMA collected input from more than 2,000 AVMA members and provided a formal response to the FDA showing that veterinary compounding is absolutely necessary. The FDA withdrew the draft guidance and issued a new draft in 2019, which the AVMA reviewed and commented on. The FDA released final guidance in 2022 which reflected many of the changes advocated by the AVMA.