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HHS/FDA RIN: 0910-AI45 Publication ID: Fall 2019 
Title: ●Importation of Prescription Drugs  

This proposed rule, if finalized, would allow importation of certain drugs under certain circumstances. Pharmacists and wholesalers would be allowed to import prescription drugs from Canada into the United States if they meet conditions designed to ensure that the importation poses no additional risk to safety and will achieve cost savings.  


Agency: Department of Health and Human Services(HHS)  Priority: Other Significant 
RIN Status: First time published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: Undetermined  Unfunded Mandates: Undetermined 
EO 13771 Designation: Deregulatory 
CFR Citation: Not Yet Determined     (To search for a specific CFR, visit the Code of Federal Regulations.)
Legal Authority: Not Yet Determined   
Legal Deadline:  None

Statement of Need:

Currently, prescription drugs can cost more in the United States than they do in Canada. This proposed rulemaking would rely on the authority in Federal Food, Drug, and Cosmetic Act (FD&C Act) section 804 to authorize importation of drugs from Canada under conditions that meet statutory criteria for safety and cost considerations. The proposed rule would include conditions and other elements to ensure the importation poses no additional risk to the public’s health and safety and that it will achieve significant cost savings to the American consumer.

Summary of the Legal Basis:

The legal basis for this proposed rule is FD&C Act section 804. 


Section 804 provides the statutory framework for allowing importation of prescription drugs from Canada, and it sets forth specific conditions to which HHS must certify in order to use this authority. Based on careful evaluation, FDA and HHS have not identified any alternative approaches to implementing section 804 that would meet the statutory certification criteria.

Anticipated Costs and Benefits:

The proposed rule would create costs associated with the conditions and elements required or authorized by statute to ensure that implementation poses no additional safety risks and generates cost savings, including costs to government associated with the implementation and monitoring of any activities authorized under these regulations. Benefits from the proposed rule would be in the form of cost savings to consumers, which depend on the scope and scale of activities authorized under these regulations.


Action Date FR Cite
NPRM  01/00/2020 
Regulatory Flexibility Analysis Required: Undetermined  Government Levels Affected: Undetermined 
Small Entities Affected: Businesses  Federalism: Undetermined 
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:
Kate Greenwood
Regulatory Counsel
Department of Health and Human Services
Food and Drug Administration
10903 New Hampshire Avenue, Building 51, Room 6286,
Silver Spring, MD 20993
Phone:204 402-1748