Aug. 31, 2014 SIGN IN | REGISTER

Markey Bill Would Set Standards for FDA Oversight of Compounding Pharmacies

“Compounding pharmacies have been governed by fragmented regulations for too long, leading to the worst public health disaster in recent memory,” Markey said. He outlined his legislation Thursday at a press conference at the New England Compounding Center headquarters.

John Coster, senior vice president for government affairs at the National Community Pharmacists Association, said Markey’s bill could help address “anomalies” like the NECC.

“However, the proposed legislation also appears to create new overly broad requirements on traditional pharmacy compounding that could negatively impact both patients’ access to essential medications and the community pharmacists who provide them,” Coster said. He noted that his group will formally provide comments to Markey’s office after it finishes reviewing the legislation.

Earlier this week, Markey released a report that said the compounding industry has resisted increased regulation from the FDA and that state regulators have not had a consistent role in ensuring compounded drug safety.

Rep. Rosa DeLauro, D-Conn., has said she plans to introduce legislation when Congress returns from recess that would give the FDA more authority over compounding pharmacies. Other lawmakers also have sought information on the pharmacy and its oversight, and some have called for hearings.

As the number of people who have contracted meningitis from the NECC’s injectable steroid continues to grow, the Center for Medicaid and CHIP Services is advising states to prepare for treating patients. On Wednesday, the center told states to prepare for a rush of prescription requests for voriconazole, an anti-fungal drug the CDC recommends to treat infections caused by the contaminated product. It also told states to expedite all decisions about covering that drug and all other appropriate antifungal medications.

The center warned states that any delays could have “potentially life-threatening consequences” for patients with central nervous system or parameningeal infections and septic arthritis.

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