> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Irradiation Regulation Repeal to Help OTC Drugs
- URL: https://www.fdaweb.com/irradiation-regulation-repeal-to-help-otc-drugs/
- Published: 2019-12-13T12:00:00.000Z
- Updated: 2026-09-14T15:56:35.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5145722

*Federal Register* notice: FDA has issued a final rule to repeal a regulation that required an FDA-approved NDA or ANDA for any drug product that is sterilized by irradiation. Repealing the irradiation regulation will mean that over-the-counter drug products that are generally recognized as safe and effective will not be misbranded, and will comply with all applicable regulatory requirements if marketed legally without an NDA or ANDA. The agency says the irradiation regulation is out of date and unnecessary. To view the notice, click [here](https://s3.amazonaws.com/public-inspection.federalregister.gov/2019-27046.pdf?ref=fdaweb.com).