Senators propose legislation to carve out 'compounding manufacturers' subject to FDA regulation

Draft legislation introduced in Senate HELP Committee

WASHINGTON — One of the difficulties that federal regulators ran into during the nationwide scandal surrounding the New England Compounding Center — the Massachusetts-based pharmacy blamed for a nationwide fungal meningitis epidemic that has sickened hundreds and killed dozens — was the issue of when such pharmacies cross the line from compounding to manufacturing.

New draft legislation — proposed in the Senate Health, Education, Labor and Pensions Committee by Sens. Tom Harkin, D-Iowa, and Lamar Alexander, R-Tenn., and others — would seek to resolve the issue by creating a new category of drug compounders called "compounding manufacturers" that would be subject to Food and Drug Administration regulation.

In the wake of the NECC scandal, FDA commissioner Margaret Hamburg called for giving the FDA the authority to regulate sterile compounding — compounding of medications, usually for injection, that differs from traditional compounding in its complexity and need for attention to sterile practices. Currently, compounding pharmacies are regulated by state boards of pharmacy.

The new legislation would require compounding manufacturers to register with the FDA and pay a fee intended to help cover inspections.

Trade group the National Association of Chain Drug Stores cautioned on what it called potential unintended consequences of the draft legislation, saying it was important to distinguish between traditional compounding - medication orders based on individual prescriptions for products not commercially available - and manufacturing.

“NACDS supports the mission and work of FDA in ensuring that Americans receive only safe and effective prescription medications. Safeguarding the health and welfare of our patients remains our highest priority,” the group said in a statement. “Pharmacist compounding services are the only source of critical medications for millions of patients who each have their own unique health care needs. For these patients, there are no commercially-manufactured preparations available. Accordingly, we agree with FDA that pharmacist compounding services are a valuable and important part of our nation’s healthcare system.”

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