FDA protects public health by promoting supply chain integrity working to ensure medicines imported to the U.S. comply with applicable legal and regulatory requirements. Imported drugs must meet FDA’s standards for quality, safety and effectiveness. For example, medicines from outside the legitimate U.S. drug supply chain do not have the same assurance of safety, effectiveness and quality as drugs subject to FDA oversight.
FDA reviews shipments of imported drugs to determine whether they are admissible into the U.S. An imported drug may be refused entry if, for example, it appears to be:
- Adulterated – Federal law requires manufacturers to comply with quality manufacturing regulations. A drug may be adulterated if, for example, it was not manufactured in compliance with these quality manufacturing requirements.
- Misbranded – Appropriate label information is an important aspect of marketing a drug because it gives patients the information they need to take medications correctly. A drug label must comply with FDA regulations. A drug may be misbranded if, for example, its label is false or misleading, it lacks FDA-required information, or otherwise does not follow FDA’s label rules. Manufacturers also must register and list their drugs with FDA. A drug may be misbranded if a manufacturer has not complied with these requirements. A drug may also be misbranded if it is a prescription drug offered for sale without a prescription.
- Unapproved – Drugs must be proven to be safe and effective for use before companies can market them in the U.S. A drug that lacks the required FDA-approval is considered to be unapproved.
FDA examines and analyzes samples of imported drugs to ensure they comply with applicable standards and/or label requirements. See the human drug imports flyer for more information.
- Regulatory procedures manual (RPM) Chapter 9: Import operations and actions
- Investigations operations manual (IOM) Chapter 6: Imports
- Predictive risk-based evaluation for dynamic import compliance targeting (PREDICT)
- Automated commercial environment/international trade data system (ACE/ITDS)
- Import Basics
- Human Drugs
- Federal Food, Drug, and Cosmetic Act (FD&C Act)
- FD&C Act chapter VIII: Imports and exports
- Code of Federal Regulations (CFR)
Safe Importation Action Plan
The safe importation action plan describes steps HHS and FDA will take to allow the safe importation of certain prescription drugs originally intended for foreign markets. The action plan describes two pathways to provide safe, lower cost drugs to consumers. FDA has published a guidance and a rule outlining two pathways to allow importation of certain prescription drugs to the U.S. Please send Section 804 Importation Programs (SIP) proposals for agency review to SIPDrugImportsandRFP@fda.hhs.gov.
Personal importation policy (PIP)
In most circumstances, it is illegal for individuals to import drugs into the U.S. for personal use because the medicine has often not been approved by FDA for use in the U.S. FDA’s personal importation policy provides guidance regarding situations where patients might be able, in limited circumstances, to import an unapproved drug for personal use.
Pre-launch activities importation requests (PLAIR)
FDA grants pre-launch activities importation requests (PLAIR) in certain circumstances to allow product sponsors anticipating approval of a drug application to import unapproved finished drug products in order to prepare for market launch. See the following documents for additional information on PLAIR.
- PLAIR request instructions (PDF – 51 KB)
- PLAIR frequently asked questions (FAQ)
- Draft guidance for industry: Pre-launch activities importation requests (PLAIR)
Other specific import requirements
Contact CDERImportsExports@fda.hhs.gov with questions about human drug importation.