November 20, 2013— The U.S. Senate has passed legislation clarifying Food and Drug Administration (FDA) oversight of compounding pharmacies, clearing it for President Obama’s signature. The House passed the bill in July. [ms-protect-content id=”2799″]
Compounded medicines are those made by hand by pharmacists. Many providers turned to large-scale compounding pharmacies recently for supplies of hard-to-obtain generic sterile injectable drugs. The bill awaiting enactment comes about a year after New England Compounding Center, a Boston-based compounding pharmacy, shipped contaminated medication that killed dozens and sickened hundreds around the country.
The bill encourages compounding pharmacies to register for FDA regulation. Those that do are expected to gain an advantage in the prescription drug marketplace over non-registrants. The bill also creates a tracking system for prescription drugs.
Congress passed a drug user-fee bill in 2012 requiring manufacturers to give the FDA early notification of possible shortages. [/ms-protect-content]