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# FDA Pushing Naloxone OTC Switch: Attorney
- URL: https://www.fdaweb.com/fda-pushing-naloxone-otc-switch-attorney/
- Published: 2023-01-03T12:00:00.000Z
- Updated: 2026-09-14T18:10:11.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5153437

Attorney **Heidi Gertner** (Hogan Lovells) says an FDA *Federal Register* notice aiming to help facilitate the development of nonprescription naloxone drug products, including the switch of certain naloxone drug products from prescription to nonprescription status, “demonstrates the agency’s trend toward promoting prescription to over-the-counter switches.” Writing in an online [post](https://www.lexology.com/library/detail.aspx?g=3feb34ab-31b6-473a-b09a-9b327e547344&utm%5Fsource=Lexology+Daily+Newsfeed&utm%5Fmedium=HTML+email+-+Body+-+General+section&utm%5Fcampaign=Lexology+subscriber+daily+feed&utm%5Fcontent=Lexology+Daily+Newsfeed+2022-12-19&utm%5Fterm=), Gertner says FDA is receiving comments on the proposal until 1/17.

She says the notice “represents FDA’s first public discussion of Rx-to-OTC switches in recent memory and is further novel in that the agency is very strongly encouraging, but stops short of forcing, an OTC switch. It’s clever of the agency to attempt to accomplish its goals of making naloxone drug products more readily accessible in light of the widespread opioid epidemic via *Federal Register* notice.”

She says the law is explicit that FDA may, “by regulation,” remove drugs subject to the prescription dispensing requirements when the requirements are no longer necessary for the protection of the public health. “So,” she says, “the *Federal Register* notice encourages a switch in a way that’s about as far as possible for the agency to go without actually forcing a switch via a proposed rule, which has never happened and which could be challenging for FDA.”

The notice requests comments, Gertner says, on whether there are data to support safe and effective nonprescription use of higher-dose naloxone products and on potential consequences of a switch from prescription to nonprescription status. It says more data are needed on the safety and efficacy of nonprescription use of higher-dose naloxone products and naloxone supplied in other presentations, including vials, ampules, or syringes without integrated needles, before a preliminary assessment concerning those products can be reached.