November 19, 2013 — Congress has approved a new law that will expand authority of the U.S. Food and Drug Administration (FDA) to oversee compounding pharmacies that mass-produce drugs, according to the New York Times.
Compounding pharmacies originally filled the role of a modern-day apothecary, custom-mixing drugs for individual patients based on a doctor’s prescription.
Today, 80% of hospitals outsource the mixing of drugs to compounding pharmacies. Some pharmacies have moved beyond custom-made drugs and have started mass-producing drugs like mini pharmaceutical companies.
However, unlike a pharmaceutical company, compounding pharmacies operate in a regulatory “gray area” between state laws, local pharmacy boards, and the FDA. Until now, the FDA had little authority to inspect facilities or records, even when outbreaks of infection occurred.
These shortcomings were exposed last year, when a multi-state outbreak of fungal meningitis was traced to New England Compounding Center (NECC), a Massachusetts-based compounding pharmacy. The company shipped over 17,000 vials of a moldy spinal injection all over the United States. Over 751 people who were received the injections developed meningitis, including 64 people who died.
The Drug Quality Security Act will require high-volume compounding pharmacies to register as “outsourcing facilities,” with stricter requirements on quality control. Small-scale compounding pharmacies that do not mass-produce drugs will not need to register with the FDA or open their records for FDA inspection.
Do I have a Compounding Pharmacy Lawsuit?
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