FDA Starts Regulating Compounding Pharmacies
New process designed to make specialty drugs safer for patients
TUESDAY, Dec. 3, 2013 (HealthDay News) -- The U.S. Food and Drug Administration on Monday began the process of regulating compounding pharmacies. Under the Drug Quality and Security Act, signed into law Nov. 27 by President Barack Obama, these pharmacies are being encouraged to register with the FDA. The agency will then classify them as outsourcing pharmacies, enabling them to sell bulk drugs to hospitals and other health care facilities.
"The part of the law related to compounding is a step forward by creating a new pathway in which compounders register with FDA as an outsourcing facility," FDA commissioner Margaret Hamburg, M.D., said during a Monday afternoon press briefing.
If a compounding pharmacy registers with the agency, hospitals and other health care providers will be able to buy products compounded by companies that are subject to FDA oversight, she said. The oversight includes inspections and adherence to "good manufacturing practices," she added. To get compounding pharmacies to register, the FDA will encourage hospitals and other health care providers to buy their compounded products only from FDA-registered companies. For compounders that don't register, the new law removes the uncertainty of FDA's authority to regulate them. This will allow the agency to treat them as any other drug maker, subject to the same scrutiny and drug approvals.
"One of the loopholes in the new law: Since pharmacy registration is voluntary, unregistered compounding companies that ship products will only be caught if a problem like contamination arises and is reported," Hamburg said. "We will need to work closely with the states. They will have to provide us with ongoing information about the facilities they are overseeing."