Compounding: What Are the Rules?


Are You Playing by the Rules?

Make sure you understand all the do’s and don’ts of compounding. View our recorded webinar. (AVMA members only.)

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

Compounding from FDA-approved drug products is legal, as long as FDA's Extralabel Drug Use Rules and all state rules are followed. Examples of compounding from FDA-approved drug products include:
  • Mixing two FDA-approved injectable drug products within one syringe;
  • Mixing an FDA-approved drug product with a tuna flavor in order to effectively treat a cat's medical condition; and
  • Mixing an FDA-approved antimicrobial injectable with saline to instill into a dog's ears.

Compounding from bulk drug substances

Compounding from bulk drug substances is more complex. FDA contends that its Extralabel Drug Use Rules apply to compounded preparations, and that  its rules should not be construed as permitting compounding from bulk drug substances. In other words, the federal government asserts that it has jurisdiction under the Federal Food, Drug, and Cosmetics Act to enforce against any compounding from bulk drug substances.
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 previously approved by FDA but is no longer commercially available; and
  • Prescribing a compounded preparation because the needed medication can't be prepared from the FDA-approved drug product.

FDA's rules:

State rules: