A bipartisan committee on Capitol Hill has crafted a bill intended to prevent a public health crisis like the fatal meningitis outbreak last year that was linked to a Bay State compounding pharmacy.
The Drug Quality and Security Act would give the Food and Drug Administration greater authority over compounding pharmacies, which currently are regulated by states, by putting some in a separate category that would require them to register with the FDA, submit to inspections by the agency and notify authorities in the event of a problem.
"Compounding pharmacies have been governed by fragmented regulations for too long, leading to one of the worst public health disasters in recent memory," U.S. Sen. Edward J. Markey said, referring to the New England Compounding Center debacle, which led to the deaths of more than 60 people and the sickening of another 700 nationwide. "We need to end this regulatory black hole by giving the FDA new, clear authority to protect patients and oversee these companies, and this bill is an important step."
However, the bill leaves it up to compounders "who wish" to register with the FDA as outsourcing facilities, while others would continue to be regulated by state boards of pharmacy.
"It'll be incumbent on physicians and hospitals to purchase drugs made under a higher quality standard from FDA-registered facilities," said Allan Coukell, a drug policy expert at the Pew Charitable Trusts.
The bill also would replace the current patchwork of state prescription drug tracing laws by creating a uniform framework for tracking drugs from the manufacturer to the pharmacy.
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