December 01, 2004


 FDA's stance on compounding from bulk drugs challenged

Posted Nov. 15, 2004

Compounding pharmacies are pursuing legal challenges to the Food and Drug Administration's stance on compounding drugs from bulk ingredients for nonfood animals, despite the agency's stated intention to revise its Compliance Policy Guide on veterinary drug compounding to address some concerns raised by pharmacists, veterinarians, and other groups.

The CPG was published in 2002 to clarify the FDA's position on veterinary drug compounding. The CPG states that veterinary compounding from bulk drugs is illegal, but that regulatory discretion would be applied in certain cases. Following the publication of the CPG, the FDA stepped up its enforcement efforts to stop illegal drug compounding. As part of that renewed effort, the FDA has inspected several compounding pharmacies this year.

As a result of inspections at BET Pharm LLC, a Kentucky compounding pharmacy, the FDA filed a complaint against the pharmacy in the U.S. District Court for the Eastern District of Kentucky. In the complaint, the agency recommended that U.S. marshals seize several boxes of drugs that the agency alleges were illegally compounded by the pharmacy. In response to the seizure, the pharmacy has filed a motion to dismiss the FDA's complaint. The FDA has filed a countermotion. The International Academy of Compounding Pharmacists has filed a friend of the court brief in support of BET Pharm.

Additionally, 10 compounding pharmacies have filed a lawsuit against the FDA in the U.S. District Court for the Western District of Texas. The crux of the pharmacies' complaint is that the FDA does not have jurisdiction to regulate compounding pharmacies, and that it is not illegal to compound drugs from bulk ingredients for nonfood animals on a veterinarian's prescription when there is not an FDA-approved drug available to fill the medical need.

When contacted for comment about the lawsuits, a spokesman for the FDA referred to the FDA Center for Veterinary Medicine's Sept. 1 announcement that the agency would revise its CPG on veterinary compounding. The announcement said the FDA deemed a revision appropriate because the agency had received numerous letters from veterinarians, pet owners, compounding pharmacists, and associations—including the AVMA—expressing concern that the CPG is unclear. In particular, many letters stated that the CPG does not specify circumstances in which veterinary compounding from bulk drugs would be allowed. Many letters also disagreed with the policy and challenged the FDA's legal authority, according to the FDA.

The FDA's complete statement is available online at