FDA Apostille

Do you need an FDA Apostille?

At USA Apostille, Inc., we take the guesswork out of authenticating issued from the Food and Drug Administration (FDA) and the U.S. Department of Health and Human Services. Our trained and knowledgeable staff are available Monday – Saturday from 8am to 7pm to answer your questions and provide you easy to follow step by step instructions.

Firms exporting products from the United States are often asked by foreign customers or foreign governments to supply a certification relating to products regulated by the Federal Food, Drug, and Cosmetic Act (FD&C Act).

Common documents we can apostille from the FDA and the U.S. Department of Health and Human Services are:

U.S. Food and Drug Administration – FDA
– Certificate of Free Sale (Can also be issued by the local Chamber of Commerce or State office)
– Certificate of Origin (Can also be issued by the local Chamber of Commerce or State office)
– Certificate of Pharmaceutical Product – FDA

US Department of Health and Human Services – HHS
– Certificate to Foreign Governments
– Certificate of Pharmaceutical Product
– Certificate of Free Sale
– Certificate of Export

A food may be exported if it meets the specification of section 801(e) of the FD&C Act [21 U.S.C. 381(e)].  In accordance with the provisions of this section, a food intended for export shall not be deemed to be adulterated or misbranded under the FD&C Act if it:
(a) accords to the specifications of the foreign purchaser
(b) is not in conflict with the laws of the country to which it is intended for export,
(c) is labeled on the outside of the shipping package that it is intended for export, and
(d) is not sold or offered for sale in domestic commerce.

Document issued by the Department of Health and Human Services FDA division can be apostilled through our Washington, D.C. apostille office.  Documents received at our offices are submitted directly to the U.S. Department of State – Office of Authentications the following business morning.  The current processing time is four business days.  We also provide FedEx/UPS overnight return shipping at no additional cost.

Below is an example of a Certificate of Free Sale issued by the Food and Drug Administration (FDA).

Apostilles can be complicated. Don’t leave this process to untrained employees or non-professionals who do not fully understand the Apostille process and the unique requirements of certain countries. Your paperwork could be rejected costing you time and money. Don’t let this happen to you!

International Apostille Order Form PDFClick to download our International Apostille Order Form. Our Apostille service is fast, convenient, and saves you time and money.

Certificate to Pharmaceutical Product FDA Apostille

FDA ApostilleDo you need an apostille on a Certificate to Pharmaceutical Product?

The United States Food and drug Administration (FDA) issues Certificate of Pharmaceutical Product certificates that can be used in other countries (apostille).  This certificate conforms to the format recommended by the World Health Organization.

Firms exporting products from the U.S. are often asked by foreign customers or foreign governments to supply a  certification relating to products subject to the Federal Food, Drug, and Cosmetic Act and other acts the Food and Drug Administration (FDA) administers. Under the FDA Export Reform and Enhancement Act of 1996 (the Act), FDA is  authorized to issue certificates for drugs, animal drugs, and devices within 20 days of receipt of a request for such a certificate. A fee of up to $175 may be charged for each certificate issued. In addition to issuing export certificates for approved or licensed products, the FDA will also issue export certificates for unapproved products that meet the requirements of Sections 801(e) or 802 of the Act.

The “Certificate of a Pharmaceutical Product” conforms to the format established by the World Health Organization (WHO) and is intended for use by the importing country when the product in question is under consideration for a product license that will authorize its importation and sale or for renewal, extension, amending or reviewing a license.

The U.S. Food and Drug Administration (U.S. FDA) of the United States of America (USA), attach different colored Ribbons to the CPP, which mark the content details. They differentiate between three different types of CPPs for:

Finished medicinal products that are legally marketable in the US authorized by the U.S FDA; A Red Ribbon will be affixed to all (regular) CPPs issued for authorized medicinal products;

Finished medicinal products which are not authorized by U.S. FDA but which may be legally exported; A Blue Ribbon will be affixed to CPPs issued only for export of an unapproved medicinal products; and a CPP for Foreign Manufacturer (products manufactured outside of the U.S.).

A Yellow Ribbon will be affixed to CPPs with foreign manufacturing sites outside of the USA. (Famulare & U.S. FDA, 2003)

Documents issued from the FDA can be processed through our Washington, D.C. office.  For immediate answers to your questions, please call us at 1-888-810-4054.

We can also apostille the following documents issued by the FDA:

Certificate to Foreign Government
Certificate of Exportability

International Apostille Order Form PDF SmallClick to download our International Apostille Order Form. Our Apostille service is fast, convenient, and saves you time and money.