A small number of U.S. compounding pharmacies have begun registering with the Food and Drug Administration under new legislation designed to tighten control of the custom medication makers following a deadly outbreak of fungal meningitis linked to a pharmacy in Massachusetts.
So far, 11 compounding pharmacies have taken up the option under the Drug Quality and Security Act of registering with the FDA, a move they hope will give them a marketing edge.
The law signed in November aims to clarify the FDA's authority to regulate compounding pharmacies after federal regulators were blamed for not acting soon enough to shut down the pharmacy at the center of the meningitis outbreak.
Names of the registered facilities were posted on the FDA's website on Thursday. They range from big players such as Pharmedium Services LLC to smaller outfits such as Marlborough Hospital in Massachusetts and Medi-Fare Drug and Home Health Center in Blacksburg, South Carolina. Some of the firms have already been inspected, and even received warning letters from the FDA, while others have yet to be inspected.
According to the International Academy of Compounding Pharmacists, which represents pharmacists who make custom medications, there are about 3,000 pharmacies which compound sterile products - those that are at the greatest risk for contamination.
Centers that choose to register with the FDA must pay a fee, adhere to good manufacturing standards, subject themselves to routine inspections by the agency and report adverse events associated with their products. In return, they join a new class of compounding firm known as outsourcing facilities. These are allowed to sell products in bulk to hospitals and physician practices in the absence of individual prescriptions.
Pharmedium was one of the first to sign up. Its chief executive, David Jonas, said in a statement in December that going forward, "there will be more consistent regulations and consistent oversight, which should raise the level of confidence among hospital leaders, providers and their patients."
Pharmacists have long mixed tailored medications for patients based on individual prescriptions; but over the past two decades the practice has mushroomed, with some pharmacies selling thousands of doses of regularly used mixtures for physicians to keep on hand for future use.
In 2012, the New England Compounding Center in Framingham, Massachusetts, distributed a contaminated steroid often used to treat back pain. The product has been associated with more than 750 cases of fungal meningitis, including 64 deaths. The scandal prompted Congress to pass a law clarifying the FDA's regulatory authority over drug compounding.
The rules governing outsourcing facilities under the new law are not as strict as those governing pharmaceutical companies such as Pfizer Inc, whose products must be reviewed and approved by the FDA before they can be sold. But they are stricter than those governing a compounding pharmacy that chooses not to register.
Pharmacies that do not register with the FDA will be regulated by state boards of pharmacy. They will be allowed to compound a certain amount of product in advance of receiving a prescription but will not be allowed to sell without a prescription. The FDA can inspect them in response to a complaint, but the agency would require a court order to access records.
The FDA's hope is that healthcare organizations will choose to buy from an FDA-regulated facility, and that customers will press their suppliers to register with the agency. FDA Commissioner Margaret Hamburg sent out hundreds of letters to hospitals on Wednesday encouraging them to purchase compound medication only from FDA-registered suppliers.
"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," she wrote.
The FDA said it is too soon to tell how many will ultimately sign up.
"We're hopeful that market forces will drive more firms to register with FDA as outsourcers," agency spokesman Steven Immergut said, "but only time will tell."
Allan Coukell, who oversees medical programs at The Pew Charitable Trusts, said he is encouraged by the number of firms that have registered since the law was passed on November 27th.
"Very few have gotten off to as fast a start as this one," he said.