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HHS/FDA

RIN: 0910-AH08

Publication ID: Spring 2014

Title: ●Additions and Modifications to the List of Drug Products That Have Been Withdrawn or Removed From the Market for Reasons of Safety or Effectiveness
Abstract: This rule would update and amend the list of drug products to add to or modify the list of drug products that may not be compounded because the drug products have been withdrawn or removed from the market because such drug products or components of such drug products have been found to be unsafe or not effective.
Agency: Department of Health and Human Services(HHS)	Priority: Other Significant
RIN Status: First time published in the Unified Agenda	Agenda Stage of Rulemaking: Proposed Rule Stage
Major: No	Unfunded Mandates: No
CFR Citation: 21 CFR 216.24
Legal Authority: 21 USC 351 21 USC 352 21 USC 353a PL 113-54, 127 Stat 587 21 USC 355 21 USC 371

Legal Deadline:

Action	Source	Description	Date
Final	Statutory	Not more than 18 months following publication of the proposed rule.

Overall Description of Deadline: Section 104 of the Drug Quality and Security Act (DQSA) requires that in promulgating any regulations to implement the DQSA (e.g., section 503B of the FD&C Act), at least 60 days be provided for comments on a proposed regulation and the final regulation be published not more than 18 months following publication of the proposed rule and not less than 30 calendar days before the effective date of such final regulation.

Timetable:

Action	Date	FR Cite
NPRM	05/00/2014

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: Olivia Ziolkowski Regulatory Counsel Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research, 10903 New Hampshire Avenue, Building 51, Room 6210, Silver Spring, MD 20993 Phone:301 796-2888 Fax:301 847-8440 Email: olivia.ziolkowski@fda.hhs.gov