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February 16, 2026
Approximately 5 minutes
U.S. FDA Human Drug Import Requirements and Procedures
U.S. FDA Human Drug Import Requirements and Procedures
1. Import Basics
The FDA protects public health by ensuring imported drugs comply with legal and regulatory requirements for quality, safety, and effectiveness. Drugs from outside the legitimate U.S. supply chain lack assurance of safety, effectiveness, and quality under FDA oversight. Imported drugs may be refused entry if they are adulterated (e.g., not manufactured in compliance with quality requirements), misbranded (e.g., false or misleading labels, lacking required information, not registered/listed with FDA, or prescription drugs offered without prescription), or unapproved (lacking FDA approval, except in certain cases). FDA examines and analyzes samples to ensure compliance with standards and labeling. Source: https://www.fda.gov/drugs/guidance-compliance-regulatory-information/human-drug-imports
2. Import Procedures
FDA reviews shipments of imported drugs to determine admissibility. Procedures include regulatory operations and actions, investigations, predictive risk-based evaluation (PREDICT), and Automated Commercial Environment/International Trade Data System (ACE/ITDS). For drugs originally intended for foreign markets, there are two pathways: a final guidance for industry on procedures for FDA-approved drugs manufactured abroad and authorized for foreign sale, and the Section 804 Importation Program (SIP), which includes a final rule implementing section 804 of the FD&C Act. FDA works with states and tribes on SIP proposals to reduce costs without additional public health risks. Pre-launch activities importation requests (PLAIR) allow importation of unapproved finished drug products by sponsors anticipating approval, with a final guidance describing the process, including detention for control and tracking, and submissions via CDER NextGen Portal. Personal importation policy (PIP) states it is illegal for individuals to import drugs for personal use in most cases, as they are often unapproved; guidance applies where FDA does not intend to prevent such importation. Source: https://www.fda.gov/drugs/guidance-compliance-regulatory-information/human-drug-imports
3. Compliance and Enforcement
Imported drugs must meet FDA standards; non-compliance leads to refusal of entry for adulteration, misbranding, or lack of approval. FDA ensures supply chain integrity through reviews, sample analysis, and enforcement under FD&C Act Chapter VIII: Imports and Exports. Compliance involves adhering to quality requirements, proper labeling, registration/listing, and approvals. Source: https://www.fda.gov/drugs/guidance-compliance-regulatory-information/human-drug-imports
4. Resources and Guidance Documents
Key resources include the Regulatory Procedures Manual Chapter 9: Import Operations and Actions, Investigations Operations Manual Chapter 6: Imports, PREDICT, ACE/ITDS, Import Basics, Human Drugs, FD&C Act Chapter VIII: Imports and Exports, Guidance for industry on importation of drugs originally intended for foreign markets, Section 804 Importation Program (SIP) policies and authorizations, Pre-Launch Activities Importation Requests (PLAIR) guidance, Information on importing liquid cough and cold medicine from India, Heparin importation, and Personal importation policy. Source: https://www.fda.gov/drugs/guidance-compliance-regulatory-information/human-drug-imports
5. Contact Information
For questions about human drug importation, email CDERImports@fda.hhs.gov. For SIP proposals, contact FDA’s Intergovernmental Affairs Staff at IGA@fda.hhs.gov or submit proposals/questions to SIPDrugImportsandRFP@fda.hhs.gov. Source: https://www.fda.gov/drugs/guidance-compliance-regulatory-information/human-drug-imports
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