All products regulated by the Food and Drug Administration must meet the same requirements, whether imported from abroad or produced domestically. The FDA’s Office of Regulatory Affairs ORA) is the lead office for all FDA field activities, as well as providing FDA leadership on imports, inspections, and enforcement policy. Use the map below to locate the applicable port of entry for your shipment and contact the corresponding Import Division.
The Nationalized Drug Entry Review Pilot concluded on 6/11/2022. All contact information established for this pilot has been shut down, including the email and phone numbers. For drug import questions, please see below to contact the appropriate OEIO division.
Division of Northeast Imports (DNEI)
Division of Northern Border Imports (DNBI)
Division of Southeast Imports (DSEI)
Division of Southwest Imports (DSWI)
Division of West Coast Imports (DWCI)
For ALL international courier packages (e.g., FED-EX, UPS) click HERE
***Effective March 6, 2022, all employees, contractors and visitors (regardless of their vaccination status) will be required to wear masks at FDA facilities located in counties designated as a “High COVID-19 Community Level”. Masks will be optional at FDA facilities located in counties experiencing a “Medium COVID-19 Community Level” or “Low COVID-19 Community Level” regardless of vaccination status. Visit CDC.GOV to find community levels and prevention steps to take: https://www.cdc.gov/coronavirus/2019-ncov/science/community-levels.html