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HHS/FDA | RIN: 0910-AH47 | Publication ID: Spring 2018 |
Title: Repeal of Regulation Requiring an Approved New Drug Application for Drugs Sterilized by Irradiation | |
Abstract:
This would repeal a requirement that any drug sterilized by irradiation is considered a new drug” and subject to the approval requirements of a new drug and not to be produced under an OTC monograph. This would mean that FDA pre-approval would no longer be required for over-the-counter drugs sterilized by irradiation that otherwise could be marketed legally without an approved new drug application or abbreviated new drug application. FDA is taking this action because the irradiation regulation is out of date and unnecessary. The technology of controlled nuclear radiation is better understood. Other FDA regulations require drugs marketed pursuant to an OTC drug monograph be manufactured in compliance with current good manufacturing practices (CGMPs). Appropriate and effective sterilization, including irradiation, is adequately addressed by the CGMP requirements. |
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Agency: Department of Health and Human Services(HHS) | Priority: Substantive, Nonsignificant |
RIN Status: Previously published in the Unified Agenda | Agenda Stage of Rulemaking: Final Rule Stage |
Major: Undetermined | Unfunded Mandates: No |
EO 13771 Designation: Deregulatory | |
CFR Citation: Not Yet Determined (To search for a specific CFR, visit the Code of Federal Regulations.) | |
Legal Authority: 21 U.S.C. 321 21 U.S.C. 331 21 U.S.C. 351 to 353 21 U.S.C. 355 21 U.S.C. 360 21 U.S.C. 371 21 U.S.C. 374 42 U.S.C. 264 |
Legal Deadline:
None |
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Timetable:
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Regulatory Flexibility Analysis Required: No | Government Levels Affected: None |
Small Entities Affected: No | Federalism: No |
Included in the Regulatory Plan: No | |
RIN Data Printed in the FR: No | |
Agency Contact: Sudha Shukla Health Science Project Manager Department of Health and Human Services Food and Drug Administration 10903 New Hampshire Avenue, Building 51, Room 5198, Silver Spring, MD 20993 Phone:301 796-3345 Email: sudha.shukla@fda.hhs.gov |