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NCPA endorses Compounding Clarity Act
September 13th, 2013
ALEXANDRIA, Va. – The National Community Pharmacists Association is throwing its support behind House legislation aimed at preventing a recurrence of the 2012 meningitis outbreak at the New England Compounding Center (NECC).
NCPA said Thursday that in a letter to House lawmakers it endorsed the Compounding Clarity Act (H.R. 3089), which would better enable regulators to protect the public from entities like the NECC without impacting patients or burdening community pharmacies with new red tape.
The bill is sponsored by Reps. Morgan Griffith (R., Va.), Gene Green (D., Texas) and Diana DeGette (D., Colo.).
"Our independent pharmacies provide a needed service in compounding medications and have a long history of protecting patient safety while preserving patient access to vital medications," NCPA chief executive officer B. Douglas Hoey wrote in the letter. "The House legislation appropriately addresses the issues that led to the NECC tragedy and prevents another tragedy from occurring while also not interfering with the physician-patient-pharmacist relationship and maintaining critical patient access to compounded medications."
H.R. 3089 would preserve state board of pharmacy oversight of the vast majority of independent community pharmacies that compound medications, NCPA noted.
If a pharmacy prepares sterile medications for office use (such as by a doctor or hospital), ships those medications across state lines, and those medications account for more than 5% of drugs it produces, then the compounding provider would fall under the legislation's new category of "outsourcing facilities" subject to Food and Drug Administration regulation.
The bill also would help ensure more effective coordination and communication between FDA and state boards of pharmacy, which NCPA said addresses one of the key breakdowns that helped facilitate and prolong the meningitis outbreak.
Earlier this month, NCPA indicated that it doesn't support a Senate proposal, S. 959, for bolstering regulation of pharmacy compounding. The association said that as currently written, the bill would subject community pharmacists to broadly expanded FDA authority that could impede patient access to medications. For example, the measure would require community pharmacists to notify the FDA every time they compound a medication that is in shortage, and the FDA would be given blanket authority over what a community pharmacist can compound in response to a doctor's prescription.
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