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HHS/FDA RIN: 0910-AI87 Publication ID: Fall 2023 
Title: Registration of Commercial Importers of Drugs; Good Importing Practice 

This proposed rulemaking meets the mandate of section 714 of the Food and Drug Administration Safety and Innovation Act and will establish registration and good importing practice requirements for commercial importers of drugs. Although manufacturers are subject to regulatory requirements to ensure such quality standards are met, there are few clear responsibilities for commercial importers of drugs to do the same.

Cost estimates of the rule include reading and understanding the rule, registering as a commercial importer through the Food and Drug Administration’s (FDA) electronic importer registration system, annual updating of registration, establishing a quality management system, conducting risk evaluations of drugs and suppliers, shipment verifications, investigations, corrective actions, and records maintenance.

The unquantified benefits of the proposed rule include improvement in the safety of finished drugs allowed to enter the United States from the commercial drug importer’s requirement to register with FDA and for increased due diligence required by the importer regarding the safety of the drugs. There would also be cost savings to both FDA and industry from facilitating the review of documentation that ensures compliance with our regulations prior to being allowed to enter the United States. This proposed rulemaking will also enhance FDA’s ability to collect and analyze data to enable risk-informed decision-making while focusing on protecting the integrity of the global drug supply chain and ensuring safety, effectiveness, and quality of imported drugs.

Agency: Department of Health and Human Services(HHS)  Priority: Section 3(f)(1) Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: Yes  Unfunded Mandates: Private Sector 
CFR Citation: 21 CFR 217   
Legal Authority: sec. 714 of the Food and Drug Administrative Safety and Innovation Act (FDASIA) of July 2012   
Legal Deadline:
Action Source Description Date
NPRM  Statutory    07/09/2015 
Final  Statutory    07/09/2015 

Overall Description of Deadline: Section 714 of FDASIA required FDA to issue regulations to establish good importer practices by July 2015.

Action Date FR Cite
NPRM  01/00/2024 
Regulatory Flexibility Analysis Required: Yes  Government Levels Affected: Federal 
Small Entities Affected: Businesses  Federalism: No 
Included in the Regulatory Plan: No 
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: Yes 
Agency Contact:
James Hanratty
Regulatory Counsel
Department of Health and Human Services
Food and Drug Administration
WO 75, Rm. 1607A, 10903 New Hampshire Avenue,
Silver Spring, MD 20993
Phone:240 402-4718