FDA takes steps to authorize some naloxone products for over-the-counter sale

FDA takes steps to authorize some overdose-reversing medicines for over-the-counter sale

Nov 15, 2022 by CBS News

Key Facts

  • Food and Drug Administration has issued a notice that could help increase access to overdose-reversing naloxone drug products without the need for a prescription, paving the way to make more of them available for over-the-counter use.
  • The notice issued by the FDA, known as a Federal Register notice, aims to change some naloxone drug products from prescription status to nonprescription status, in addition to developing and approving new products.
  • The final decision will be made by the FDA, based on additional data that would usually be submitted to the agency in an application for a proposed nonprescription naloxone product.
  • In addition to the FDA's push to make naloxone more accessible nationwide, the CDC has spoken in support of testing strips, a harm reduction tool that lets people who use drugs check for the presence of fentanyl in their substances.

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