An official website of the United States government Here’s how you know

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.

In this section: Guidance, Compliance, & Regulatory Information

Human Drug Exports

The agency works to protect patients around the world by assuring drugs exported from the U.S. are compliant with FDA requirements.

Visit Export Requirements for Human Drugs for more information.

Sub-Topic Paragraphs

Person sitting at laptop with stylized screen display

Electronic Certificates of Pharmaceutical Product: General Information

Access information on electronic certificate of pharmaceutical products

metal gears with word compliance

CGMP Declarations

Access information on current good manufacturing practice declarations

Map of the World with lights marking various cities

Human Drug Export Resources for Foreign Governments

Find export resources for foreign governments

guy on laptop with checklist

Export Requirements for Unapproved Drugs

Find information on export notifications for unapproved drugs

compliance check mark abstract

Online Verification of Electronic Certificates of Pharmaceutical Product

Verify your electronic certificate of pharmaceutical product online

exporting investigational new drugs

Exporting Investigational New Drugs

Exporting investigational new drugs

Top