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21 CFR 207.69

FDA US Agent for Foreign Drug Establishments

A foreign establishment that manufactures, repacks, relabels or salvages a drug imported or offered for import into the United States must register with FDA electronically, list its drugs, and identify a U.S. Agent who lives or has a place of business in the U.S. Registration is renewed each year between October 1 and December 31.

Who needs a U.S. Agent

  • Foreign manufacturers of finished human and animal drugs, including OTC products and hand sanitizers
  • Foreign API manufacturers, repackers and relabelers whose products are imported into the U.S.

Deadlines

  • Register within 5 calendar days after beginning operations (21 CFR 207.21)
  • Renew annually between October 1 and December 31 (21 CFR 207.29)
  • Update drug listings each June and December, or certify no changes

Steps to register

  1. Get a DUNS number for the establishment
  2. Request a labeler code if you will list products under your own name
  3. Prepare Structured Product Labeling (SPL) files for registration and listing
  4. Submit through FDA's Electronic Submissions Gateway or CDER Direct
  5. The U.S. Agent is named in the registration and FDA contacts them to confirm

US Agent Desk prepares this data for your officer and serves as your U.S. Agent. Your company's own officer submits the registration in FDA's system.

Common mistakes

  • Submitting SPL with a DUNS whose address does not match
  • Missing the year-end listing certification
  • Assuming registration or an NDC number means FDA approved the drug. It does not

By country

Drug establishment U.S. Agent for China · Drug establishment U.S. Agent for India · Drug establishment U.S. Agent for South Korea · Drug establishment U.S. Agent for Japan · Drug establishment U.S. Agent for Vietnam · Drug establishment U.S. Agent for Taiwan · Drug establishment U.S. Agent for Mexico · Drug establishment U.S. Agent for Italy · Drug establishment U.S. Agent for Germany · Drug establishment U.S. Agent for France · Drug establishment U.S. Agent for Spain · Drug establishment U.S. Agent for Turkey · Drug establishment U.S. Agent for Thailand · Drug establishment U.S. Agent for Indonesia · Drug establishment U.S. Agent for Brazil · Drug establishment U.S. Agent for Canada · Drug establishment U.S. Agent for United Kingdom · Drug establishment U.S. Agent for Israel · Drug establishment U.S. Agent for Malaysia · Drug establishment U.S. Agent for Pakistan

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