Trying to protect their ability to compound veterinary drugs, 10 pharmacy owners in six states have filed a federal lawsuit against the Food & Drug Administration for banning the use of bulk ingredients.

The suit filed in U.S. District Court for the Western District of Texas alleges that the FDA overstepped its authority when it decreed that it's illegal to use bulk ingredients in the compounding of medications for nonfood companion animals. The current legal battle involves family pets, but the pharmacist plaintiffs are concerned that going after Fido and Fluffy is only the opening gambit in an FDA campaign that would ultimately try to put their human owners off-limits to compounded drugs as well.

The seeds of the plaintiffs' legal tussle with the FDA were planted last year when the agency issued the compliance policy guideline (CPG 7125.40 Section 608.400) that outlawed compounding veterinary medicines from bulk ingredients.

The plaintiffs also petitioned federal Judge Robert Junell for an injunction to allow them to continue to fill prescriptions from doctors and veterinarians using bulk ingredients manufactured in FDA-registered, inspected, and approved facilities. "We're hoping the injunction would be honored throughout the country," Petersen added.

The FDA cannot comment on pending litigation, according to a spokeswoman. However, she added that on Sept. 1, the agency issued a notice that it plans to revise the CPG. When it's available later this fall, the draft will be posted on the Center for Veterinary Medicine Web site and a notice will be published in the Federal Register.

"FDA has received numerous letters from veterinarians, pet owners, compounding pharmacists, and associations expressing concern that the CPG lacks sufficient clarity on the circumstances in which veterinary compounding, particularly from bulk drugs, would be permitted," said the FDA announcement. "After meeting with several groups and considering the comments ... it has received, FDA concluded that issuing a revised CPG is appropriate."

The pharmacists' lawsuit was triggered by the FDA's aggressive stance on inspection of vet compounding pharmacies, said Petersen, who added, "Enforcement is a big issue because it's very costly if the FDA comes to your door. You have to have an attorney. If the state people are there too, they can take your records and cause all kinds of disruption of your business. We've heard that over a two-week period, they were in three pharmacies. It's a hard thing to have to worry about every day."

The plaintiffs see themselves as defenders of the pharmacy tradition of compounding. "We're talking about a lot of small pharmacies trying to provide a patient service," said Petersen. "The essence of our whole profession is to have the ability to make sure the individual patient gets served. It's a critical question we are asking for everybody, even if you don't compound."

The compounding pharmacists have hired as their lead national attorney Howard M. Hoffman of the Chicago firm of Duane Morris, LLP. Hoffman successfully represented another group of compounding pharmacy owners who beat the FDA. In that case, Thompson v. Western States, the U.S. Supreme Court ruled that the portion of the 1997 Food & Drug Administration Modernization Act dealing with compounding pharmacies was unconstitutional.

Hiring a legal heavyweight to challenge Uncle Sam in federal court is an expensive proposition, so the plaintiffs set up a legal defense fund, which by late last month had raised more than half the estimated $1.5 million that it's going to take. To donate, send a check or money order to: Compounding Pharmacy Legal Defense Fund, c/o Connie Hegerfeld, 2 Marsh Court, Madison, WI 53718.