AANEM News Express

AANEM News Express

FDA Granted More Power Over Drug Compounding Pharmacies

12/4/2013
 
FDA Granted More PowerLast week, a bill was signed into law that grants the Food and Drug Administration (FDA) more regulatory power over drug compounding pharmacies. This law was created in response to a meningitis outbreak that was a traced back to tainted steroid injections produced at the New England Compounding Center (NECC). In the last year, 31 compounding pharmacies have been inspected, with conditions that could create a contamination risk found in all but one.
 
The new law gives the FDA the authority to develop a database of facilities that voluntarily register their business as a compounding pharmacy. Registered companies will provide information about their products and comply with quality standards similar to those that apply to drug manufactures.
 
Unfortunately, the law does not go so far as to make it mandatory for all compounding pharmacies to register. As such, the FDA encourages physicians to make sure the compounded drugs they purchase are mixed in facilities that are included in the registry.
 
The FDA investigation continues to investigate the NECC, with charges expected to be filed after the first of the year.


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