FDA plans more restrictive policy for bulk drug compounding


(Reuters) – The head of the U.S. Food and Drug Administration on Thursday said it is preparing a new, more restrictive policy targeting what drugs compounding pharmacies can produce that do not go through the agency’s approval process.


FDA Commissioner Scott Gottlieb said the agency in March will issue draft guidance with new criteria for determining what substances can be used to produce drugs in bulk for hospitals and doctors’ offices without individual patient prescriptions.


“Ultimately, there’s no question that the framework we will be laying out will place more restrictions on what they can do,” Gottlieb told Reuters.


The announcement was one of several by the FDA on Thursday regarding its priorities in 2018 for drug compounding, which involves pharmacists making drugs to meet patients’ specific needs.


Photo of FDA Commissioner Scott Gottlieb
Scott Gottlieb; Foto: Reuters


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