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  1. Guidance, Compliance, & Regulatory Information

Import Export Compliance Branch (IECB)

Our mission is to promote and protect the public health by ensuring human drug importation and exportation adhere to FDA's standards of compliance. More specifically to:

  • Serve as FDA focal point at CDER for all human drug import and export compliance issues.
  • Promote goodwill and cooperation between the United States and foreign governments through the Export Certificate Program.
  • Assure the integrity of imported and exported drugs by monitoring investigational and unapproved new drugs.  

For General Imports Compliance questions, Contact:


For Export Certificate and Compliance questions, Contact:


 On this page:

Drug Imports

Import Guidance and Policy

Compliance Communications

Import Requirements for Specific Drugs

Pre-Launch Activities Importation Requests (PLAIR)

Imports for Human Drug Pharmacy Compounding

Personal Importation Policy (PIP)

Drug Exports

The FDA CDER Export Certificate Program is responsible for the issuance of Certificates of Pharmaceutical Product (CPP). In connection with the issuance of CPPs, we review the regulatory status of the manufacturing establishments, compliance with cGMPs, labeling, listings/registrations, and marketing authority.

Export Guidance and Policy

Export Compliance and CDER Export Certificate Program Communications

CDER Certificate of Pharmaceutical Product (CPP) Information

CDEReCATS (CDER Electronic Certificate Application and Tracking System)


Other Resources