Client Handout


AVMA members: Provide individual clients with needed information about the compounded medications you prescribe, including when to contact you after returning home.

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:

  • Mixing two injectable drugs
  • Creating an oral suspension from crushed tablets or an injectable solution
  • Adding flavoring to a commercially available drug

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.

Are You Playing by the Rules?

Make sure you understand all the dos and don’ts of compounding. View our recorded webinar.

AVMA Policies:


Compounding from Bulk in Non-Food Animals

Compounding from Bulk in Food Animals

What Are the Rules?

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.

What Is AVMA’s Role?

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.

  • AVMA communicates frequently with the FDA to safeguard veterinary access to compounded medications and ensure that the needs of veterinarians and our animal patients are protected.
  • AVMA educates Congress and regulatory agencies that compounding for animals is a complex issue, and that AVMA and our member veterinarians are available for consultation should other parties seek legislative changes.
  • AVMA educates veterinarians about the finer points of using compounded medications. An informed veterinarian prescribes medications conscientiously for patients and avoids inappropriate compounding practices. Learn more in our recorded webinar on compounding rules, regulations, and recommendations.
  • AVMA cultivates collaborative working relationships with pharmacy organizations, the animal drug manufacturing industry, and other affected stakeholders, building coalitions that advance and protect the interests of veterinarians and animals.
  • AVMA monitors the courts on issues of regulatory jurisdiction.

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 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.

The FDA published new draft guidance (PDF summary) 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 submitted formal comments on that proposal, drawing on input provided by more than 2,000 AVMA members, and making 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. The FDA later announced that it was withdrawing its draft guidance and would develop a new draft, which it said it would issue for public comment in 2018.

It is not yet known when the FDA will issue its final guidance on compounding animal drugs from bulk drug substances.

AVMA’s Advocacy Work Continues

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

About Compounding:

More on FDA's Draft Guidance for Industry:

FDA News and Resources:

AVMA's Work on Pharmaceutical Regulations

AVMA Advocacy: Federal Regulations on Pharmaceutical Issues

Click on image for larger version of U.S Compounding Laws