# Regulation Requiring an Approved New Drug Application for Drugs Sterilized by Irradiation
> **Food and Drug Administration** · Final rule. · Published 2019-12-16 · Effective 2020-01-15 · 84 FR 68331
## Document
- **Document number:** 2019-27046
- **Category:** fda-drug
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 84 FR 68331
- **CFR reference:** 21 CFR 310
- **Publication date:** 2019-12-16
- **Effective date:** 2020-01-15
- **HHS docket:** Docket No. FDA-2017-N-6924
## Abstract

The Food and Drug Administration (FDA, the Agency, or we) is issuing a final rule repealing a regulation that requires an FDA- approved new drug application (NDA) or abbreviated new drug application (ANDA) for any drug product that is sterilized by irradiation (the irradiation regulation). Repealing the irradiation regulation will mean that over-the-counter (OTC) drug products that are generally recognized as safe and effective, are not misbranded, and comply with all applicable regulatory requirements can be marketed legally without an NDA or ANDA, even if they are sterilized by irradiation. FDA is taking this action because the irradiation regulation is out of date and unnecessary.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2019/12/16/2019-27046/regulation-requiring-an-approved-new-drug-application-for-drugs-sterilized-by-irradiation)
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