CHPA issues statement on FDA’s proposed rule for additional conditions for nonprescription use

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WASHINGTON — CHPA’s president and CEO, Scott Melville, today released the following statement in response to the FDA releasing a proposed rule on “Nonprescription Drug Product with an Additional Condition for Nonprescription Use” (ACNU):

Scott Melville

“CHPA is pleased the FDA has issued this long-awaited proposed rule. Prescription to over-the-counter switches for certain pharmaceutical ingredients (“Rx-to-OTC switch”) have positively impacted U.S. healthcare over many decades by increasing consumer access to safe, effective, and affordable treatments and driving down healthcare costs for individuals and systems.

“Creating a modernized framework that allows more prescription medicines to be safely switched using innovative approaches has the potential to reduce healthcare costs even further, provide greater efficiency, and encourage more consumer self-care by increasing the availability of certain products that would otherwise be available only by prescription.

“CHPA looks forward to reviewing the proposed rule and submitting comments to FDA.”


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