Draft legislation preserves the states’ primary role in traditional pharmacy regulation and clarifies FDA authority over those making sterile products without prescriptions and shipping across state borders
Apr 26 2013
Washington, D.C., April 26 – Chairman of the Senate Health, Education, Labor and Pensions Committee U.S. Senator Tom Harkin (D-Iowa) and Ranking Member Lamar Alexander (R-Tenn.), with Senators Al Franken (D-Minn.) and Pat Roberts (R-Kan.) and other members of the HELP Committee, today released draft legislation that would improve 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 Food and Drug Administration.
Harkin said: “This legislation is a significant step forward in protecting the public from unsafe compounded products. 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 said: “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.”
Franken said: "When drugs are prescribed to make a patient healthier – and in many cases, save a life – that patient should know their prescription is exactly what the doctor ordered. We've seen far too many deaths in this country because some pharmacies have acted more like drug manufacturers – without following rigorous safety rules. This legislation will keep Minnesotans safe by ensuring that drug manufacturers have appropriate oversight, and that responsible pharmacies don't see any unnecessary restrictions."
Roberts said: “This legislation was very carefully crafted as an attempt to address concerns from stakeholders and patients. It represents a thorough and bipartisan effort to clear up any question about who is accountable for ensuring compounded drugs are safe for the patients who receive them. We owe it to victims and the American people to get this right.”
This 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 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 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.
Senators Harkin, Alexander, Franken and Roberts and other members of the HELP Committee are requesting that stakeholders provide feedback on the policy merits, potential unintended consequences, and opportunities to improve the legislative language.
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