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HHS/FDA

RIN: 0910-AH11

Publication ID: Fall 2019

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: Other Significant
RIN Status: Previously published in the Unified Agenda	Agenda Stage of Rulemaking: Proposed Rule Stage
Major: No	Unfunded Mandates: No
EO 13771 Designation: Regulatory
CFR Citation: 21 CFR 205
Legal Authority: Pub. L. 113-54

Legal Deadline:

Action	Source	Description	Date
Final	Statutory	The Drug Supply Chain Security Act of 2013 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	01/00/2020

Regulatory Flexibility Analysis Required: Undetermined	Government Levels Affected: Federal, State
Small Entities Affected: Businesses	Federalism: Undetermined
Included in the Regulatory Plan: No
RIN Data Printed in the FR: No
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