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HHS/FDA | RIN: 0910-AH35 | Publication ID: Spring 2018 |
Title: Amendments to the Regulation Regarding the List of Drug Products That Have Been Withdrawn or Removed From the Market for Reasons of Safety or Effectiveness | |
Abstract:
This rule would amend the regulation regarding the list of drug products that may not be compounded under sections 503A or 503B of the Federal Food, Drug, and Cosmetic Act, because the drug products have been withdrawn or removed from the market because such drug products or components of such drug products have been found to be unsafe or not effective.
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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: Long-Term Actions |
Major: No | Unfunded Mandates: No |
EO 13771 Designation: Regulatory | |
CFR Citation: 21 CFR 216.24 | |
Legal Authority: 21 U.S.C. 351 21 U.S.C. 352 21 U.S.C. 353a Pub. L. 113-54, 127 Stat. 587 21 U.S.C. 355 21 U.S.C. 371 |
Legal Deadline:
None |
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Timetable:
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Regulatory Flexibility Analysis Required: No | Government Levels Affected: None |
Federalism: No | |
Included in the Regulatory Plan: No | |
RIN Data Printed in the FR: No | |
Agency Contact: Alexandria Fujisaki Regulatory Counsel Department of Health and Human Services Food and Drug Administration 10903 New Hampshire Avenue, Building 51, Room 5169, Silver Spring, MD 20993 Phone:240 402-4078 Email: alexandria.fujisaki@fda.hhs.gov |