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# FDA Preliminary Assessment on OTC Naloxone
- URL: https://www.fdaweb.com/fda-preliminary-assessment-on-otc-naloxone/
- Published: 2022-11-16T12:00:00.000Z
- Updated: 2026-09-14T18:06:44.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5153208

*Federal Register* notice: FDA has announced its preliminary assessment that certain types of naloxone hydrochloride drug products may be approvable as safe and effective for nonprescription use to counteract opiod overdose. It found that naloxone nasal spray up to 4 milligrams (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. It noted, however, that additional data is needed, such as product-specific data on the nonprescription user interface design, including packaging and labeling, to make a conclusive determination. Therefore, if and when FDA has sufficient data to support approval of a nonprescription naloxone product (e.g., through submission and approval of an application for a nonprescription naloxone product or a supplemental application to switch an FDA-approved naloxone product from prescription to nonprescription status), currently marketed naloxone products labeled as ‘‘Rx only’’ with no clinically meaningful difference from the approved nonprescription products would be considered misbranded. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2022-11-16/pdf/2022-24874.pdf?ref=fdaweb.com).