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 drugs, and compounding from bulk substances.

Compounding from FDA-approved drugs

 Compounding from FDA-approved drugs is legal, as long as FDA's Extralabel Drug Use Rules and all state rules (see AVMA's state legislative resources) are followed. Examples of compounding from FDA-approved drugs include:
   
  • Mixing two FDA-approved injectable drugs within one syringe;
  • Mixing an FDA-approved drug 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 substances

Compounding from bulk substances is more complex. We know that FDA contends that its Extralabel Drug Use Rules apply to compounded preparations, because FDA says its rules should not be construed somehow as permitting compounding from bulk substances. In other words, the federal government asserts that it has jurisdiction under the Federal Food, Drugs, and Cosmetics Act (FFDCA) to enforce against any compounding from bulk substances.
 
Veterinarians have the FDA's rules and state rules to follow, AVMA's policies, and particularly in the case of bulk substances, their own medical expertise to draw from as they develop appropriate therapeutic plans tailored to meet the specific needs of individual patients.
 
The AVMA believes compounding from bulk may be necessary in medically necessary scenarios for non-food animal patients:
 
  • Prescribing the compounding of a drug that might have been previously approached by FDA but is not commercially available anymore; and
  • Prescribing a compound because the needed drug preparation can't be prepared from the FDA-approved drug.

FDA's rules:

 

State rules: