Legislation is pending in congress to give the Food and Drug Administration more authority in regulating compounding pharmacies like the one that was linked to an outbreak that caused the deaths of more than 50 people last year, the Augusta Chronicle reported.
Since the outbreak, the FDA has cracked down on about 40 compounding pharmacies across the nation.
A group that represents compounding pharmacies complained that the FDA has imposed much more rigid expectations on sterility than pharmacies have ever had to deal with before.
Under the new standards, most of the said compounding pharmacies are being cited for violations. The new standard "is almost akin to fear-mongering," said a spokesman for the group.
A compounding pharmacy is one that repackages drugs that have already been made into different doses or combines drugs for physicians who may not be able to find exact drug that they need somewhere else.
Over 23,000 members of the National Community Pharmacists Association were surveyed, it was announced in front of a House subcommittee that 86 percent of them do compounding.
"The agency recently took a critical look at our surveillance and enforcement approach to pharmacies that produce sterile drug products," FDA spokesman Curtis Allen said in an e-mail. "Using a risk-based model, FDA identified 29 firms for priority inspections that focused on their sterile drug production practices."
The pending legislation in the U.S Senate would clarify the FDA's ability to inspect compounding pharmacies on a "risk-based schedule."
The pharmacies that have been inspected are in various states of operation, some have even been completely shut down.
"It's kind of like you showed up with your colleagues for your local softball team. And you're all ready to play softball and the FDA team shows up wearing helmets, shoulder pads and carrying a football," said David Miller, the executive vice president and CEO of the International Academy of Compounding Pharmacists.
