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# Certain Naloxone Products Could be OTC: FDA
- URL: https://www.fdaweb.com/certain-naloxone-products-could-be-otc-fda/
- Published: 2022-11-15T12:00:00.000Z
- Updated: 2026-09-14T18:06:29.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5153198

FDA has published in the *Federal Register* a preliminary assessment indicating that certain naloxone products have the potential to be safe and effective for over-the-counter use to counteract opiod overdose. The [notice](https://www.federalregister.gov/public-inspection/2022-24874/safety-and-effectiveness-of-certain-naloxone-hydrochloride-drug-products-for-nonprescription-use?ref=fdaweb.com) is intended to help facilitate the development and approval of certain nonprescription naloxone drug products, an FDA [announcement](https://www.fda.gov/news-events/press-announcements/fda-announces-preliminary-assessment-certain-naloxone-products-have-potential-be-safe-and-effective?ref=fdaweb.com) says, including through the switch of certain existing naloxone drug products from prescription to nonprescription status.

The *Federal Register* notice includes a preliminary assessment that naloxone nasal spray up to 4 mg and naloxone autoinjector for intramuscular or subcutaneous use up to 2 mg have the potential to be safe and effective for use as directed in nonprescription drug labeling without the supervision of a healthcare practitioner.

“We believe the prescription requirement for these naloxone products might not be necessary for the protection of the public health,” the agency says in the notice. “However, we need additional data such as product-specific data on the nonprescription user interface design, including packaging and labeling, to make a conclusive determination in this respect…. By issuing this notice, FDA is making application holders of certain prescription naloxone drug products aware of the preliminary assessment and the possibility that the agency may make a conclusive determination, through approval of a nonprescription naloxone drug product, that such products are safe and effective for use without a prescription.”

The notice says more data are needed on the safety and efficacy for nonprescription use of higher dose naloxone products and naloxone supplied in other presentations such as vials, ampules, or syringes without integrated needles, before a preliminary assessment for these products can be reached.

The *Federal Register* notice solicits comments from the public 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.