0910-AI45 202010 The Regulatory Plan and the Unified Agenda of Federal Regulatory and Deregulatory Actions 0910 Food and Drug Administration FDA 0900 Department of Health and Human Services HHS Importation of Prescription Drugs

This final rule will 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 will contain requirements to demonstrate that an importation program will pose no additional risk to the public’s health and safety and will be expected to result in a significant reduction in the cost of covered products to the American consumer.

]]> Other Significant Previously Published in The Unified Agenda Completed Actions No No Deregulatory 21 CFR 1.74 21 CFR 251 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 No NPRM 12/23/2019 84 FR 70796 NPRM Comment Period End 03/09/2020 Final Rule 10/01/2020 85 FR 62094 Final Action Effective 11/30/2020 No Businesses Federal Local State Tribal No No Yes Lyndsay Hennessey 0910 Food and Drug Administration FDA 301 796-7605 lyndsay.hennessey@fda.hhs.gov 10903 New Hampshire Avenue, WO 51, Silver Spring MD 20993