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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. |
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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:
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Timetable:
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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 |