FDA urges states, others to register compounding pharmacies under law passed after outbreak

BOSTON – The commissioner of the U.S. Food and Drug Administration has sent letters to state agencies and other stakeholders across the country calling on them to encourage compounding pharmacies to register as producers of sterile drugs in an effort to protect the public.

The letter from Commissioner Dr. Margaret Hamburg, dated Wednesday, reminds stakeholders of a law passed last year in response to a meningitis outbreak from contaminated steroid pain injections that killed 64 people and sickened more than 750. The outbreak was traced to the now-closed New England Compounding Center pharmacy in Framingham.

Under the new law, large-volume compounding pharmacies that send medicine all over the country can voluntarily register with the FDA and submit to federal inspections and quality standards, much like drug manufacturers.

“If compounders register with the FDA as outsourcing facilities, hospitals and other health care providers that purchase compounded drugs necessary to meet the medical needs of their patients can provide their patients with drugs that were compounded in outsourcing facilities,” which are subject to manufacturing standards and increased oversight, said the letter to governors, state boards of pharmacy and health departments.

U.S. Sen. Tom Harkin, an Iowa Democrat who heads the Senate Health, Education, Labor, and Pensions Committee, said Friday that the law and the FDA’s letter help “ensure the safety of compounded drugs and is aimed at helping to prevent a future public health crisis.”

“We’re already seeing progress with 14 outsourcing facilities registered with the FDA,” Harkin said in a statement. “I urge state leaders in Iowa and around the country to continue this progress by working with the FDA and other health officials to move forward with the smooth and timely implementation of the law so that patients will have access to safe, high-quality compounded drugs.”

President Barack Obama signed the bill into law in November.

Jurisdiction over such large-volume compounding pharmacies has long been murky. Pharmacies are typically regulated through state boards, but the Food and Drug Administration regulates manufacturers of medicines.

The law attempts to sort out the legal grey area that allowed the Massachusetts pharmacy and similar operations to skirt both state and federal regulations.