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HHS/FDA RIN: 0910-AI45 Publication ID: Spring 2020 
Title: Importation of Prescription Drugs  

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.

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
Action Date FR Cite
NPRM  12/23/2019  84 FR 70796   
NPRM Comment Period End  03/09/2020 
Final Rule  12/00/2020 
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