According to the Animal Health Institute (AHI), veterinarians recently have received communications from compounding pharmacies regarding Congressional consideration of legislation on drug compounding. These communications, according to AHI, have mischaracterized the issue and AHI’s policy positions.
In response, AHI has issued a letter explaining current policy and efforts to modify government policies on drug compounding.
Key points include:
- Animal drug compounding is the customized manipulation of an approved drug or drugs by a veterinarian or pharmacist upon the prescription of a veterinarian to meet the needs of a particular patient.
- AHI supports legitimate animal drug compounding.
- Animal-drug compounding from bulk active ingredients is not legal. FDA has stated it is illegal and three federal appeals courts have reached the same conclusion.
- However, FDA uses “enforcement discretion” to allow some animal-drug compounding from bulk substances. This is generally necessary when there is a need for a specific active ingredient and there is no approved human or animal drug with that active ingredient.
- In recent years, some compounding pharmacists have undercut the FDA approval process by performing drug manufacturing under the guise of compounding, selling large quantities of compounded products as cheap alternatives to approved drugs.
- AHI has asked Congress to consider a proposal that would legalize a certain amount of needed compounding from bulk active ingredients. It would not restrict current legal compounding, but would provide a mechanism for medically necessary compounding where there are no approved products that will meet a medical need.
- AHI has asked Congress to create and maintain a list of products or substances that can be compounded from bulk while making it clear that all other, non-listed compounding from bulk remains illegal.
- Recognizing the scarcity of approved drugs for minor species, AHI favors exemptions for drugs compounded for those species.
- Compounding for food animals should be more restrictive than for companion animals due to food safety implications.
Read the full letter from AHI, including a link to AHI’s legal analysis of the compounding issue.
Click here for a full explanation of AHI’s legal analysis of the compounding issue.