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Summary: Repeal of Regulation Requiring an Approved New Drug Application for Drugs Sterilized by Irradiation (Proposed Rule)

Summary: Repeal of Regulation Requiring an Approved New Drug Application for Drugs Sterilized by Irradiation (Proposed Rule)

The proposed rule, if finalized, will repeal 21 CFR § 310.502(a)(11), a regulation that provides that any drug sterilized by irradiation is a new drug. Repealing this regulatory provision will mean that over-the-counter (OTC) drugs marketed pursuant to the OTC Drug Review that are generally recognized as safe and effective (GRASE), that are not misbranded, and that comply with all applicable regulatory requirements may be legally marketed without an FDA-approved new drug application (NDA) or abbreviated new drug application (ANDtinA), even if the drugs are sterilized by irradiation. We consider this regulation as outdated and unnecessary because we no longer conclude that drugs sterilized by irradiation are necessarily new drugs. Appropriate and effective sterilization of drugs, including sterilization by irradiation, is adequately addressed by the CGMP requirements.

Regulatory Impact Analysis

Repeal of Regulation Requiring an Approved New Drug Application for Drugs Sterilized by Irradiation (Proposed Rule) RIA (PDF-225KB)

Federal Register: 83 FR 46121, September 12, 2018

Docket: FDA-2017-N-6924