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HHS/FDA RIN: 0910-AH11 Publication ID: Fall 2022 
Title: National Standards for the Licensure of Wholesale Drug Distributors and Third-Party Logistics Providers 
Abstract:

The final rule establishes national standards for State licensing of prescription drug wholesale distributors and third-party logistics providers. The rulemaking also establishes 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: Other Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Long-Term Actions 
Major: No  Unfunded Mandates: No 
CFR Citation: 21 CFR 205   
Legal Authority: Secs. 583 and 584 of the FD&C Act, as added by the DSCSA under Pub. L. 113-54, together with related FD&C Act authority added by the DSCSA.   
Legal Deadline:
Action Source Description Date
Final  Statutory  The Drug Supply Chain Security Act requires FDA to issue licensure regulations no later than two years after the date of enactment.  11/27/2015 
Timetable:
Action Date FR Cite
NPRM  02/04/2022  87 FR 6708   
NPRM Comment Period End  06/06/2022 
NPRM Comment Period Extended  05/24/2022  87 FR 31439   
NPRM Comment Period Extended End  09/06/2022 
Final Rule  04/00/2025 
Regulatory Flexibility Analysis Required: Yes  Government Levels Affected: Federal, State 
Small Entities Affected: Businesses  Federalism: No 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: Yes 
Agency Contact:
Aaron Weisbuch
Regulatory Counsel
Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research, Building 51, Room 4261, 10903 New Hampshire Avenue,
Silver Spring, MD 20993
Phone:301 796-9362
Email: aaron.weisbuch@fda.hhs.gov