Compounding Clarity Act Seeks To Expand FDA Oversight

Posted on September 13, 2013

If you follow recalls, you will have noticed a recent surge in the last few months in the number of announcements related to compounding pharmacies.  That’s because the Food and Drug Administration appears to have taken a renewed interest in compounded medication on the heels of a fungal meningitis outbreak that reportedly killed 64 people.

Now, lawmakers have introduced a bill in the House that seeks to expand the authority of the FDA to oversee compounders.  Previously, the companies existed in a regulatory gray area due to their nature.  Compounders alter drugs to suit unique prescriptions written by doctors in order to treat certain patients who may not be able to handle a non-customized portion of a given drug.  But because some larger entities ship these drugs around the country, there was some question as to whether state or federal agencies were responsible for regulation.

The Compounding Clarity Act now placed in front of the House would give the FDA purview over these compounding entities.  Pharmacy boards at the state level would still be involved in regulation, however, as they would be responsible for fielding complaints, which would then be shuttled along to the FDA.  The measure seeks to boost communication and prevent a situation like the aforementioned meningitis outbreak from taking place.  Basically, the hope is that all confusion would be removed from regulation.

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