BOSTON-- The commissioner of the 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.
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.
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.
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.
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."
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 Obama signed the bill into law in November.
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.
law attempts to sort out the legal gray area that allowed the
Massachusetts pharmacy and similar operations to skirt both state and