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HHS/FDA RIN: 0910-AH56 Publication ID: Fall 2017 
Title: ●Amendment of Certain Requirements Under 21 CFR 203 
Abstract:

The Food and Drug Administration (FDA) is revising the regulations at 21 CFR 203 to remove parts no longer in effect and incorporate changes following enactment of the Drug Supply Chain Security Act (DSCSA).  In this proposed rulemaking, the Agency is amending the regulations to clarify provisions and avoid causing confusion with the new standards for wholesale distribution established by DSCSA.

 
Agency: Department of Health and Human Services(HHS)  Priority: Substantive, Nonsignificant 
RIN Status: First time published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: Undetermined  Unfunded Mandates: Undetermined 
EO 13771 Designation: Deregulatory 
CFR Citation: 21 CFR 203   
Legal Authority: Pub. L. 113-54   
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM  06/00/2018 
Regulatory Flexibility Analysis Required: Undetermined  Government Levels Affected: State 
Small Entities Affected: Businesses  Federalism: Undetermined 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: No 
Agency Contact:
Melissa Mannion
Regulatory Counsel
Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research, Building 51, Room 4259, 10903 New Hampshire Avenue,
Silver Spring, MD 20993
Phone:301 796-2747
Email: melissa.mannion@fda.hhs.gov