Firms exporting FDA-regulated articles are often asked by foreign customers or foreign governments to supply a certification relating to articles subject to the Federal Food, Drug, and Cosmetic Act (FD&C Act) and other laws FDA administers. Section 801(e)(4)(A) of the FD&C Act, as amended by the FDA Export Reform and Enhancement Act of 1996 (Public Law 104-134) provides that FDA may issue certificates for food, drugs, animal drugs, and devices within 20 days of receipt of a request for such a certificate. FDA issues export certificates for approved or licensed drugs and for unapproved drugs that meet the requirements of Sections 801(e)(1) or 802 of the FD&C Act. Certificates of Pharmaceutical Product (CPPs), the only export certificate issued by CDER, are issued for drugs typically exported from the U.S. directly to the requesting country. CPPs conform to the format established by the World Health Organization (WHO) and are intended for use by importing countries when considering whether to license the product in question for sale in that country. CDER only issues CPPs for human drugs that it regulates. Certificates expire 24 months from the date of issuance, after which a new application must be submitted. Certificates cannot be reissued.
CPPs issued for drugs exported from the U.S. are printed on security paper and contain the signature of the authorized CDER Official, embossed federal seal, and ribbon. Different ribbon colors are used to designate the type of CPP issued, as follows:
- Red designates FDA-approved products, over-the-counter (OTC) products that follow an FDA monograph [example]
- Blue designates unapproved products [example]
- Yellow designates drugs manufactured in foreign facilities [example]
- Orange designates Active Pharmaceutical Ingredients (APIs) [example]
Under Section 801(e)(4)(B) of the FD&C Act, FDA is authorized to charge a fee for CPPs issued within 20 days of receipt of an application, not to exceed $175.00. The fees are as follows:
- First certificate for the same country in the same application ........................................... $175.00
- Second certificate for the same country in the same application .......................................... 90.00
- Third and subsequent certificates for the same country in the same application .................. 40.00
PLEASE DO NOT send payment with the application; invoices are issued quarterly.
For inquiries about CPPs, please e-mail: CDERExportCertificateProgram@fda.hhs.gov or call 301-796-4950.
Return to Page: Import Export Compliance Branch (IECB)