Advocates Warn of Drug Compounding Loophole

By Walter F. Roche Jr.

Warning that it leaves the public subject to harmful exposure to dangerous drugs, an advocacy group is calling on the U.S. Food and Drug Administration to close a loophole that allows drug compounders to produce drugs deemed harmful or ineffective.
In a petition filed with the FDA, Public Citizen said closing the loophole was crucial to minimizing the risk to patients of harmful exposure.
Specifically the petition asks the agency to add two drugs,the weight loss drug locaserin, formerly known BELVIQ, and injectable forms of bacitracin, to the list of drugs removed from the market because they were deemed unsafe or ineffective.
Placing the drugs on that list would make it illegal for drug compounders to produce snd msrket this drug, said Michael Carome of Public Citizen.
Carome noted that the FDA already had removed those drugs from the market due to safety or effectiveness concerns.
Carome said that in the past the FDA has sometimes taken several years to place banned drugs on the official list.
"Such foot-dragging poses unacceptable and avoidable risks to patients and public health," Carome said.
Earlier this month the FDA issued notices that the two drugs were being withdrawn for sale for safety reasons. Carome noted that the FDA had asked the two manufactuers of the drugs to withdraw them from the market.
In addition to asking the FDA to act on locaserin and bacitracin, Carome asked the agency to institute a new policy requiring that when drugs are withdrawn from the market for safety and efficacy concerns, that they simultaneously be placed on the banned drug list.
Contact:wfrochejr999@gmail.com