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HHS/FDA RIN: 0910-AH11 Publication ID: Spring 2014 
Title: ●National Standards for Licensing of Prescription Drug Wholesale Distributor and Third-Party Logistics Providers  
Abstract: The rule will establish national standards for the 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 system that meets federal standards. 
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 
CFR Citation: Not Yet Determined (To search for a specific CFR, visit the Code of Federal Regulations.
Legal Authority: PL 113-54 
Legal Deadline:
Action Source Description Date
Final  Statutory  Issue final regulations no later than 2 years after the enactment of the Drug Supply Chain Security Act.  11/27/2015 

Overall Description of Deadline: The Drug Supply Chain Security Act (DSCSA) (Pub. L. 113-54) requires FDA to issue final regulations for the licensing of prescription drug wholesale distributors and third-party logistics providers no later than two years after the date of the law's enactment. As the DSCSA was enacted on November 27, 2013, FDA must issue final regulations no later than November 27, 2015.

Timetable:
Action Date FR Cite
NPRM  11/00/2014   
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:
Karen Rothschild
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 4282,
Silver Spring, MD 20993
Phone:301 796-3689
Fax:301 847-8722
Email: karen.rothschild@fda.hhs.gov

 
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