How to obtain the document
Apply online: CDRH devices via CECATS (electronic PDF delivery since Jan. 2, 2024; one-time download within 45 days; valid 2 years; QR-verifiable); CDER drugs via CDEReCATS (eCPP downloadable PDF, fee up to $175 for issuance within 20 days, valid 24 months, invoiced quarterly); CBER biologics via BECATS. Certificates carry an FDA official's signature and an embossed HHS seal (cosmetic certificates have no seal).
Why it goes to the U.S. Department of State
Signed by a federal (HHS/FDA) official; travel.state.gov lists 'HHS certificates of foreign governments and certificates of pharmaceutical product or export' as federal documents. FDA stopped notarizing export certificates on March 1, 2014 and directs anyone needing authentication or apostille to the Office of Authentications.
Format the Office of Authentications accepts
FDA's CDRH letter states that apostilles and authentications of electronic certificates 'must be printed in color to be valid'. Submit the printed certificate (original signature/seal where paper-issued) with DS-4194.
Filing the request
- Keep the document unaltered
Do not notarize it, write on it or remove staples. Originals or agency-certified copies only.
- Complete Form DS-4194
Name the destination country for each document. Download DS-4194.
- Pay $20 per document
Check or money order payable to ‘U.S. Department of State’ by mail; card at the counter.
- Mail or hand-deliver
Mail: U.S. Department of State, Office of Authentications, 44132 Mercure Cir., PO Box 1206, Sterling, VA 20166-1206. Walk-in: Office of Authentications, 600 19th Street NW, Washington, DC 20006, Drop-off and pick-up 7:30-9:00 a.m., Monday-Thursday, no appointment needed; processing about 7 business days. Max 15…
- Allow for processing
Mail-in: up to 5 weeks from receipt (tracking 'delivered' at the Sterling PO box does not mean processing has started; package takes several days to reach DC). Walk-in: about 7 business days.
Common reasons for rejection
- Black-and-white printout of an electronic FDA certificate.
- Notarized FDA certificate.
- Expired certificate (2-year validity).
Practical notes
- Foreign governments can verify CDRH certificates via the FURLS Export Certificate Validator; some accept that in lieu of apostille.
- eCPPs cannot be reissued; apply again if a fresh original is needed.
Non-Hague destinations
For countries outside the Hague Convention the office issues an authentication certificate rather than an apostille, and the document must then be legalized at the destination's embassy or consulate in Washington. See embassy legalization.
Frequently asked questions
Can my state apostille a FDA Export Certificates?
No. Only the U.S. Department of State authenticates federal signatures. A state can apostille a notarized copy, but many destinations will not accept that in place of the federal apostille on the original.
How much is the federal apostille fee?
$20 per document, payable to the U.S. Department of State. The fee is charged even if the request is returned unprocessed.
How long does it take?
Mail-in: up to 5 weeks from receipt (tracking 'delivered' at the Sterling PO box does not mean processing has started; package takes several days to reach DC). Walk-in: about 7 business days.
Should I notarize it first?
No. Notarizing a federal document makes it invalid for authentication at the Office of Authentications.
