Compounding – any manipulation of an FDA-approved drug product beyond that stipulated on the product's label – is needed in veterinary medicine to provide individualized medication for specific patients with special needs not met by FDA-approved drug products. Manipulation might include mixing, diluting, concentrating, flavoring, or changing a drug's dosage form to accommodate a specific patient's needs.
Examples of compounding include:
Compounded preparations can sometimes provide effective therapies for treating painful or life-threatening medical conditions in animal patients. Compounding is a needed tool and provides much-needed therapeutic flexibility for veterinarians, especially considering the wide range of species and breeds veterinarians treat.
However, if done incorrectly or inappropriately, the use of compounded preparations can lead to prolonged treatment needs; adverse events, including treatment failure; liability; or even enforcement action by federal or state authorities.
Compounding should be implemented based on a licensed practitioner's prescription, and only to meet the medical needs of a specific patient.
Make sure you understand all the dos and don’ts of compounding. View our recorded webinar.
Compounding from Bulk in Non-Food Animals
Compounding from Bulk in Food Animals
Discussion of compounding rules often centers on two issues: compounding from FDA-approved drug products, and compounding from bulk drug substances. Compounding from FDA-approved drug products is legal, as long as FDA's Extralabel Drug Use Rules and all state rules are followed.
Compounding from bulk drug substances is more complex. The FDA asserts 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. Compounding: What Are the Rules? provides a deep dive into the rules that you need to follow, whether working with FDA-approved drug products or bulk drug substances. To make certain you understand the rules fully, you might also want to view our recorded webinar, Compounding: Are You Playing By the Rules (available to AVMA members only).
Contact your liability insurance carrier, such as AVMA PLIT, for any questions you have regarding specifics of your liability coverage.
Because compounding is a critical tool for veterinarians, the AVMA works hard to ensure that veterinary concerns are heard and considered in regulatory rule-making and in Congress, and to keep our member veterinarians informed of the rules and compounding best practices.
Although the FDA has interpreted all compounding from bulk drug substances as being outside of the rules, the agency has recognizes 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 no drug is available under the extralabel drug use provisions.
In those limited circumstances, FDA acknowledges that an animal medication
compounded from bulk drug substances may be an appropriate treatment option.
In May 2015, FDA officials published new draft guidance (PDF summary) describing conditions under which it generally does not intend to initiate enforcement action against state-licensed pharmacies, licensed veterinarians, and registered “outsourcing facilities.” The AVMA submitted formal comments on that proposal, drawing on input provided to the association by more than 2,000 members, thus ensuring that the voices of America’s veterinarians would be heard in the rule-making process.
The AVMA’s response made clear that compounding is absolutely necessary for veterinary medicine because of the limited number of FDA-approved drug products for the many species and conditions that veterinarians treat.
It is not yet known when the FDA will issue its final guidance on compounding animal drugs from bulk drug substances.
The AVMA remains concerned that veterinarians’ ability to create patient-specific prescriptions compounded from bulk drug substances needs greater protection. Even with its new draft guidance, the FDA has not changed its position that compounding from bulk drug substances is illegal; the draft guidance would simply allow compounding from bulk drug substances when certain criteria are met.
That’s why we’re working toward passage of meaningful legislation that would legalize veterinary compounding from bulk drug substances. Our Task Force on Veterinary Compounding Legislation was charged with developing a legislative proposal consistent with the AVMA’s policies on compounding; this proposal was approved by the AVMA Board of Directors during their June 2016 meeting. AVMA members with any concerns or comments should email us at email@example.com.
AVMA Advocacy: Federal Regulations on Pharmaceutical Issues
2016 American Veterinary Medical Association