The Food and Drug Administration outlined plans Monday to encourage large-scale compounding pharmacies to register with the agency and agree to increased federal regulations.
The oversight effort is in response to a fungal meningitis outbreak last year that killed 64 people and sickened more than 750 others across the country. The source of the outbreak was traced to tainted steroid injections mixed by the Framingham, Mass.-based New England Compounding Center.
A section of the new Drug Quality and Security Act, passed by Congress and signed into law last week by President Obama, allows large drug-compounding plants, which mix ingredients to make a custom blend of medicine, to register as “outsourcing facilities” and be subject to FDA oversight, including inspections and compliance with “current good manufacturing practices.”
“We will be encouraging health care providers and health networks to consider strongly purchasing compounded products from FDA-registered and regulated facilities,” FDA Commissioner Margaret Hamburg says. “This will be a critical step they can take to better assure the health and safety of their patients.”
Outsourcing facilities will also be required to report specific information about the products they compound, including a list of all the products compounded during the previous six months, and details about the source of the active ingredient, as well a report known as adverse effects.
“We do appreciate having greater clarity. There are, of course, other authorities we would like to have seen,” Hamburg says, citing as an example the authority to inspect company records.
She notes that the measure also eliminates a section in the old law limiting advertising. That provision was declared unconstitutional in a court case, which in turn led to confusion over the FDA’s regulatory authority.
Jane Axelrad, associate director for policy at the FDA’s drug evaluation center, says the agency won’t be able to track compounding pharmacies that don’t choose to register.
“We can say that it will be difficult for us to identify a compounding pharmacy that chose not to register as outsourcers and that try to hide out in the category of traditional compounders,” she says. “In those cases, we won’t be able to do proactive inspections of them. We’ll have to wait until we hear about them through either an adverse quality or report complaint.”
The FDA doesn’t know for certain how many compounding pharmacies exist in the U.S., says Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research. She adds that the number could range from 700 to 1,000 such businesses.
Hamburg says the agency will have to rely on state regulators to help spot companies that should be registered or that deserve closer scrutiny. The law does call for increased communication between state pharmacy boards and the FDA.
FDA spokeswoman Erica Jefferson says the law also provides that the added revenue generated by the companies registering as compounders will be available to fund the program.
In addition to revised regulations for compounding pharmacies, the new act authorizes the FDA to develop a national track-and-trace system “to help protect the public from counterfeit, stolen or otherwise harmful drugs … as they move through the U.S. drug supply chain,” Hamburg says.