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Senate Bill Would Give FDA Greater Authority Over Some Compounding Pharmacies
Chairman of the Senate Health, Education, Labor, and Pensions (HELP) Committee U.S. Senator Tom Harkin (D-Iowa) and Ranking Member Lamar Alexander (R-Tenn.), with other members of the HELP Committee, have released draft legislation aimed at improving the safety of compounded human and animal drugs by making clear the compounding oversight responsibilities of state and federal authorities.
The draft legislation makes a clear distinction between traditional compounding — which will continue to be regulated primarily by state pharmacy boards — and compounding manufacturers that make sterile products without, or in advance of, a prescription and sell those products across state lines. The compounding manufacturers would be regulated by the FDA.
“This legislation is a significant step forward in protecting the public from unsafe compounded products,” Harkin said. “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.”
Alexander added: “Last year’s meningitis outbreak was a nightmare for Tennesseans, and this legislation will help ensure that it never happens again. Our goal with this bill is to put an end to FDA inaction and make it clear who is on the flagpole — who is in charge and accountable for oversight of these pharmacies and manufacturers.”
The draft legislation clarifies a national, uniform set of rules for compounding manufacturers while preserving the states’ primary role in traditional pharmacy regulation.
In addition to distinguishing between pharmacies and manufacturers, and clarifying proper oversight of each, the legislation sets forth requirements on compounding manufacturers. They must register with the FDA and tell the agency what products they have made, make products under a pharmacist’s oversight and in compliance with good manufacturing practices, and investigate and report adverse events.
The draft legislation allows the FDA to identify categories of drugs that currently cannot be safely compounded, preserves and enhances current protections regarding the ingredients from which drugs are compounded, and preserves the line between compounding manufacturers and traditional manufacturers by placing prohibitions on wholesale distribution of compounded products.
The draft bill also would encourage communication among states and increase communication between states and the FDA. If the FDA receives a complaint from a state regulatory agency about a traditional pharmacy in another state, the FDA must relay that information to the relevant state pharmacy board within 15 days.