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FDA Gains Authority Over Drug Compounders in Senate Plan

Compounding pharmacies would have to register with the Food and Drug Administration and list the products they’ve made under legislation being considered by U.S. senators in response to last year’s meningitis outbreak.

The draft legislation sets federal, uniform rules for drug compounders while preserving the states’ role in traditional pharmacy regulation, Tom Harkin, the Iowa Democrat who leads the Senate health committee, said in a statement today. The proposal, which has yet to be formally submitted, would help improve safety by making clear the oversight responsibilities of state and federal authorities, the senator said.

The FDA has cited conflicting legal decisions on its authority over compounders to deflect criticism that the agency didn’t act quickly to close New England Compounding Pharmacy Inc., the company at the center of the meningitis outbreak that killed more than 50 people. FDA Commissioner Margaret A. Hamburg has called for legislation to clarify the agency’s role.

“This legislation is a significant step forward in protecting the public from unsafe compounded products,” Harkin said in the statement. “By clarifying FDA authority over high-risk compounding practices, this bill will enhance protections for patients taking compounded drugs and help prevent crises like last year’s tragic meningitis outbreak.”

Compounding pharmacies traditionally prepare personalized prescriptions and are regulated by state health authorities. The meningitis outbreak revealed some companies go beyond that task to produce larger amounts of medicines without or in advance of a prescription, acting more like a drug manufacturer that would be overseen by the FDA.

The draft legislative proposal distinguishes between traditional compounders and compounding manufacturers. Other senators that helped to craft the proposal include: Lamar Alexander, a Tennessee Republican; Pat Roberts, a Kansas Republican, and Al Franken, a Minnesota Democrat.

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