FDA chips away at illegal compounders

Apr 01, 2002

Rockville, Md.-A recent Food and Drug Administration update warning that prescribing, purchasing, or distributing "compounded" clenbuterol violates federal law, is a first step to reform, indicate several DVMs.

Dr. Cynthia Kollias-Baker, associate professor, University of California, Davis, says she was "somewhat surprised" by the update. "The problem with compounders is certainly nothing new and certainly not unique to clenbuterol."

The update targets use of Ventipulmin® syrup, which contains clenbuterol. It is approved for use in horses as a prescriptive drug to treat airway obstruction. Recently, use of illegal compounded clenbuterol formulations has spiked, according to the update.

Kollias-Baker, who spoke on clenbuterol use in racehorses at an American Association of Equine Practitioners symposium, says FDA may have issued a notice because compounders were creating an injectable clenbuterol form.

"I don't think it's feasible for compounders to take the oral formulation and make it into an injectable formulation," she says. "The tone of the letter indicates the compounders were using bulk chemicals. That is not legal."

The Animal Medical Drug Use Clarification Act states compounding from bulk drugs is strictly prohibited. Legally, bulk clenbuterol, according to FDA, is only available from Boehringer Ingelheim Vetmedica, while limited compounding of Ventipulmin is allowed.

Ventipulmin has been the center of controversy since 1998, when FDA first issued rules to ensure the beta-agonist drug would not be abused to enhance production of food-producing animals.

Underlying intent

A driver for the latest update may involve lost money, says Kollias-Baker. "Drug companies are starting to put a lot of pressure on the FDA to crack down on illegal compounding because it really is cutting into their profits. They have gone to an incredible amount of money and effort to get a product approved. Then a compounder can - without having to prove safety, efficacy - sell it over the counter to (any) veterinarian."

Dr. Joe Bertone, MS, DACVIM, formerly an FDA veterinary medical officer who now practices at Alpine Animal Hospital in Carbondale, Colo., agrees. "The money being made in compouding is astronomical because costs are so low. They can buy an oil drum filled with clenbuterol for pennies on the dollar," and sell it for much more.

Why compounding works

Because many drugs are not labeled for equine use, veterinarians may resort to human medications that become extraordinarily costly, says Dr. Rick Mitchell co-owner of Fairfield Equine Hospital, Fairfield, Conn.

Yet raw materials are available to pharmaceutical compounders to produce the drugs and do so in dosage delivery systems appropriate for horse use.

"Having the compounding pharmacies that can make more concentrated or specialized delivery systems such as a syrup that is palatable is really helpful to us immensely," he says.

To compound or not

Whether to compound is "a judgement call" on the part of a doctor, says Mitchell.

"When it's a situation of absolute needs and we can't get a product in a veterinary label that we need for the horse for health-preserving and life-saving measures, the compounding pharmacies have proven to be quite useful. On the other hand, when it gets down to economics, and veterinary products are already available, it may not always be the right choice from a quality standpoint," he says.

In the case of clenbuterol, Mitchell says he'll only buy from Boehringer, because in his practice people don't object to paying for brand names. "We feel our clientele will bear the expense of it without complaining."

Check out your compounder

Some compounders are known to stretch the law.

Bertone cites an analysis of an unnamed product, in which 10 compounders were evaluated. The average of what was indicated on the label, when the compound was tested, was only 60 percent of what it said it contained.

"You could assume that they knew they're gypping the practitioner," says Bertone. "But on the other hand, they may think they are making the product according to the label, but they have no verification. When they buy these products, almost invariably, they buy them from overseas, from India and China. The product they're getting - who knows what it is," he says.

Illegal compounders, i.e. those who know they're selling a raw deal, have survived thus far due to FDA cutbacks, says Kollias-Baker. "FDA says they don't have enough money to go to the individual pharmacies to close them down. I think they chose clenbuterol because they were probably given evidence that it was a blatant violation of the compounding laws."

Future monitoring

The future for black market clenbuterol is in the hands of the FDA and knowledgeable veterinarians. In short, Bertone says the reality is FDA has no way to track it.

"You can't depend on the FDA to regulate this," he says. "It's got a low priority because (horses are) non-food animals."

Adds Bertone, "The FDA is slow to move. They have reasons for being slow to move. They have to take into account the law.

"What you don't want to do is press the FDA into a situation where they have to stop and go after every compounder, because we need that process in practice."

Meanwhile, he says the onus is on veterinarians to remain vigilant about illegitimate compounders.

"A lot of practitioners don't know that some of these non-reputable companies were doing something illegal," says Bertone. "It was the assumption that if you buy it, it must be legal."

He concludes, "It's my basic feeling that if a compounder is willing to compound things like clenbuterol, knowing it's illegal, that should give you some indication of the quality of their product. Maybe they don't care about the law, and maybe they don't care about what kind of quality product they're giving you as well."

The FDA would not respond to numerous attempts to obtain comment.