Drugs

Import Operations Branch

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:

CDERImportsExports@fda.hhs.gov

For Export Certificate and Compliance questions, Contact:

CDERExportCertificateProgram@fda.hhs.gov

 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.

Presentations

Other Resources
 

 

                              

 

Page Last Updated: 12/07/2014
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.