FDA Clarifies Limits on Compounding Pharmacies

The U.S. Food and Drug Administration has released draft guidance to clarify its regulations involving compounded drugs, rules that were developed to prevent situations similar to a 2012 meningitis outbreak, when tainted drugs killed more than 60 people. The draft guidance sheds more light on the FDA’s limitations for compounding pharmacies, which aren’t subject to manufacturing regulations. Under the draft guidance, pharmacies are restricted to compounding drugs when they’ve received a prescription for an identified individual patient. The pharmacy may produce a 30-da...