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.
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