The U.S. Food and Drug Administration and a trade group that represents large compound pharmacies have resolved a long-running dispute over the use of bulk ingredients, clearing the way for some compounded medicines to become available more quickly.
At issue has been the approach taken by the agency to approve the use of certain bulk substances, or active ingredients, which could be used to make compounded medicines. A federal law that went into effect in 2013 requires the FDA to identify ingredients needed to satisfy an unmet “clinical need” and to include those on a list for use by large compounding pharmacies.
The requirement was part of an effort to improve oversight of compounding pharmacies following a scandal the previous year in which a fungal meningitis outbreak caused 64 deaths. The episode was traced to a large compounding pharmacy that sold large quantities of injectable drugs and, at the time, was considered to be the worst public health crisis of its sort in the U.S. in decades.
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