There are about 3,000 compounding pharmacies in the U.S. that can whip up sterile injectable drugs. Fourteen of those have signed up to be regulated by the FDA. Four of those are part of the same company, PharMedium Services.
Congress in November passed the Drug Quality and Security Act, which broadens and defines the FDA authority over compounding pharmacies, a niche of drugmakers that has grown in recent years as doctors and hospitals looked for sources of drugs that were in short supply. The law came in response to the 2012 fungal meningitis outbreak, tied to a compounder, that sickened more than 750 people, 64 fatally. Rather than give the FDA the absolute authority over large compounders that it sought, Congress crafted a law creating a voluntary program with the idea that hospitals would want to buy from regulated companies with an FDA seal of approval.
"We're hopeful that market forces will drive more firms to register with FDA as outsourcers," agency spokesman Steven Immergut told Reuters, "but only time will tell."
FDA Commissioner Margaret Hamburg sent out hundreds of letters to hospitals on Wednesday urging them to buy only from those compounders who meet the stricter standards, Reuters reported. "As a purchaser of compounded drugs, you can play an important role in improving the quality of compounded drugs by requiring compounding pharmacies that supply drugs to your facility to register as outsourcing facilities," the missive says.
To be part of the program, the so-called outsourcing facilities must register with the FDA, agree to routine inspections, and report adverse events associated with their products. And they must pay a fee for the opportunity. The FDA is listing on its website those companies that have registered. It shows that two of the 14, Allergy Laboratories, of Oklahoma City, OK, and Medi-Fare Drug & Home Health Center of Blacksburg, SC, received warning letters from the FDA after the agency started a crash inspection program in response to the meningitis outbreak. Those that do not sign up will be regulated by their states, but the law also makes clear that in the case of questionable practices, the FDA can step in.
Allan Coukell of the The Pew Charitable Trusts told Reuters he considered 11 companies a good start for the new program. "Very few have gotten off to as fast a start as this one," Coukell said. Pew was a supporter of the new legislation.