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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:
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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. |
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Timetable:
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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 |