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HHS/FDA RIN: 0910-AH11 Publication ID: Fall 2017 
Title: National Standards for the Licensure of Wholesale Drug Distributors and Third-Party Logistics Providers 
Abstract:

The rulemaking will establish standards for State licensing of prescription drug wholesale distributors and third-party logistics providers. The rulemaking will also establish a Federal system for wholesale drug distributor and third-party logistics provider licensing for use in the absence of a State licensure program.

 
Agency: Department of Health and Human Services(HHS)  Priority: Substantive, Nonsignificant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: Undetermined  Unfunded Mandates: Undetermined 
EO 13771 Designation: Regulatory 
CFR Citation: 21 CFR 204 and 205   
Legal Authority: Pub. L. 113-54   
Legal Deadline:
Action Source Description Date
Final  Statutory  Issue licensure regulations no later than two years after the enactment of the Drug Supply Chain Security Act.  11/27/2015 
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