Human Drug Importation Resources for Industry
Human Drug Imports
Import resources for industry
The following is a list of resources to help industry understand and comply with the applicable regulatory requirements to import human drugs into the U.S.
Information on importing specific drugs:
General Resources
| Resource | Description |
|---|---|
| Email CDER imports | With regulatory or product-specific questions |
| CDERNexGen Portal | Submit inquiries and pre-launch activities importation requests (PLAIRs) |
| RegulatoryProcedures Manual (RPM) Chapter 9: Import Operations and Actions | Comprehensive guidance on FDA's import operations, procedures and enforcement actions |
| InvestigationsOperations Manual (IOM) Chapter 6: Imports | Detailed instructions for FDA field staff conducting import inspections and examinations |
| Importing Human Drugs Guide | General overview of requirements for importing human drugs into the U.S. |
Regulatory guidance and legal framework
| Resource | Description |
|---|---|
| FDA Supplemental Guide for Automated Commercial Environment (ACE) | Information on intended use codes and affirmations of compliance for drug commodities |
| Pre-Launch Activities Importation Requests (PLAIR) Guidance | Final guidance describing the agency’s policy for importing unapproved drugs in preparation for market launch |
| Federal Food, Drug and Cosmetic Act (FD&C Act) | Primary legislation governing drug imports (sections 801, 804, 505, 510, etc.) |
| 21 USC 381: Imports and exports | Statutory provisions governing the importation and exportation of FDA-regulated products |
| Title 21 Code of Federal Regulations (CFR) | Implementing regulations (Parts 201, 207, 210-211, 312, 314, etc.) |
Application databases
| Resource | Description |
|---|---|
| Drugs@FDA | Information about FDA-approved finished drugs (prescription and over-the-counter/non-prescription drugs) for human use |
| Orange Book | Approved drugs with therapeutic equivalence evaluations |
| Product code builder | Interactive tool to help build FDA product codes for pharmaceutical products |
| OTC Monographs@FDA | Resource to view OTC Drug Monographs and Administrative Orders |
| Import alerts | Listing of current import alerts |
Registration and listing
| Resource | Description |
|---|---|
| Electronic drug registration and listing (eDRLS) | System for registration and listing of drug establishments and products |
| Drug establishments current registration site | Database for current Registration |
| Drug registration and listing guidance | Guidance on providing regulatory submissions in electronic format |
Special programs and authorities
| Resource | Description |
|---|---|
| Section 804 importation program | Pathway for states or tribes to import certain prescription drugs from Canada |
| Personal importation | Guidelines for personal importation of unapproved drugs |
| Emergency use authorization (EUA) | Information on medical countermeasures during public health emergencies |
Federal partners
| Resource | Description |
|---|---|
| U.S. Customs and Border Protection (CBP) | Inspects FDA-regulated products at ports, international mail facilities, courier facilities and all ports of entry |
| Drug Enforcement Administration (DEA) | Enforces compliance of controlled substances imported into the U.S. |
| Department of Agriculture Veterinary Services | Has requirements for importing certain animal-derived products, such as biological products |
| Transportation Security Administration | Screens for security threats during transportation including when individuals travel with FDA-regulated products through TSA-secured transportation systems. |