Regulation Requiring an Approved New Drug Application for Drugs Sterilized by Irradiation
fda-drug · Food and Drug Administration · Rule · Published 2019-12-16 · Effective 2020-01-15 · 84 FR 68331
Document
Document number
2019-27046
Federal Register citation
84 FR 68331
CFR reference
21 CFR 310
Type
Rule
Action
Final rule.
Category
fda-drug
Sub-agency
Food and Drug Administration
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 FDA is taking this action because the irradiation regulation is out of date and unnecessary.