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# FDA Proposed Rule Nixes Irradiation Regulation
- URL: https://www.fdaweb.com/fda-proposed-rule-nixes-irradiation-regulation/
- Published: 2018-09-12T12:00:00.000Z
- Updated: 2026-09-15T00:31:31.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5142333

*Federal Register* proposed rule: FDA has proposed to repeal a regulation that requires an FDA-approved NDA or ANDA for any drug product that is sterilized by irradiation. Repealing the irradiation regulation would mean that over-the-counter drug products that are generally recognized as safe and effective, that are not misbranded, and that comply with all applicable regulatory requirements can be marketed legally without an NDA or ANDA, even if they are sterilized by irradiation. FDA is intending to take this action because the irradiation regulation is out of date and unnecessary. To view the proposed rule, click [here](https://www.gpo.gov/fdsys/pkg/FR-2018-09-12/pdf/2018-19845.pdf?ref=fdaweb.com).