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HHS/FDA | RIN: 0910-AI45 | Publication ID: Spring 2020 |
Title: Importation of Prescription Drugs | |
Abstract:
This proposed rule, if finalized, would allow importation of certain prescription drugs from Canada under certain circumstances. States and certain other non-federal governmental entities would be able to submit importation program proposals to FDA for review and authorization. An importation program could be co-sponsored by a pharmacist, a wholesaler, or another State or non-federal governmental entity. The rule, when finalized, would contain requirements to demonstrate that an importation program will pose no additional risk to the public’s health and safety and would be expected to result in a significant reduction in the cost of covered products to the American consumer. |
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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: Final Rule Stage |
Major: No | Unfunded Mandates: No |
EO 13771 Designation: Deregulatory | |
CFR Citation: 21 CFR 1.74 21 CFR 251 | |
Legal Authority: 21 U.S.C. 351 21 U.S.C. 352 21 U.S.C. 353 21 U.S.C. 355 21 U.S.C. 371 21 U.S.C. 374 21 U.S.C. 381 21 U.S.C. 384 |
Legal Deadline:
None |
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Timetable:
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Regulatory Flexibility Analysis Required: No | Government Levels Affected: Federal, Local, State, Tribal |
Small Entities Affected: Businesses | Federalism: No |
Included in the Regulatory Plan: Yes | |
International Impacts: This regulatory action will be likely to have international trade and investment effects, or otherwise be of international interest. | |
RIN Data Printed in the FR: No | |
Agency Contact: Lyndsay Hennessey Department of Health and Human Services Food and Drug Administration 10903 New Hampshire Avenue, WO 51, Silver Spring, MD 20993 Phone:301 796-7605 Email: lyndsay.hennessey@fda.hhs.gov |