Tuesday, June 4, 2013

Representative Morgan Griffith Plans to Intoduce Patient Specific Federal Legislation for Compounding


Meningitis Health Scare
Last fall’s fungal meningitis outbreak was a true public health crisis for our nation. In our region, there were 2 deaths and 50 confirmed cases of fungal meningitis associated with the sterile compounded injections from the New England Compounding Center (NECC).  Approximately 1,400 patients were notified that they could have been exposed through the tainted steroid injections.
I believe that the Food and Drug Administration (FDA) clearly had the authority they needed to prevent the fungal meningitis outbreak.
To be on the safe side, though, I plan to introduce legislation that further defines a compounding pharmacy.  These should continue to be regulated by the States.  Manufacturers, no matter what they call themselves, should continue to be regulated by the FDA.
In completing a thorough investigation of the fungal meningitis outbreak, the Energy and Commerce Committee obtained draft guidance for the oversight of compounding pharmacies that FDA had spent 3 years developing and were taking the steps necessary to finalize in the days before the public health crisis.  Instead of providing the agency with broad new authorities over our local community pharmacies, I believe this FDA draft guidance is the place to start.
The legislation being developed would clarify that to be a compounding pharmacy one must compound drugs based on patient-specific prescriptions.  The bill would also codify a guidance provision that FDA had proposed to allow hospitals, clinics, and doctors to administer some compounded medications in a healthcare setting that would then require a patient-specific prescription to be reported back to the pharmacy within 7 days.  The legislation would also require all compounding pharmacies meet a minimum federal standard for the safety, quality, and sterility of the drugs they produce.
Finally, the bill would provide for greater information sharing between FDA and the States.  With NECC, FDA received complaints from multiple states about NECC, but FDA never shared this information with other States or took action to investigate NECC for illegal manufacturing.

quoted from here

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