The U.S. Food and Drug Administration on Monday began the process of regulating compounding pharmacies, which create new drug combinations or alter drugs to suit individual patient needs.
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.
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 law was prompted by the deaths last year of 64 people who received fungus-contaminated steroid medications that were given in injections to treat back and joint pain. An additional 750 people in 20 states were sickened by the contaminated drug. The medication was made by the now-shuttered New England Compounding Center, in Framingham, Mass., according to federal health officials.
"The part of the law related to compounding is a step forward by creating a new pathway in which compoundersregister with FDA as an outsourcing facility," FDA commissioner Dr. Margaret Hamburg said during a Monday afternoon press briefing.
with FDA as an outsourcing facility," FDA commissioner Dr. Margaret Hamburg said during a Monday afternoon press briefing.
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