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U.S. Department of Health and Human Services

Drugs

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Certificate of a Pharmaceutical Product (CPP) Information

 

The Food and Drug Administration has historically issued various types of certificates to firms exporting products to foreign countries. The Center for Drug Evaluation and Research (CDER) has revised its procedures for the issuance of Certificates of a Pharmaceutical Product for the following types of requests:
  • Drug products that are legally marketable in the U.S.
    • A Red ribbon will be affixed to all (regular) Certificates of Pharmaceutical Product. (See example).
  • Products not authorized for sale in the U.S. and manufactured for export only that may be legally exported to foreign governments (Certificate of Pharmaceutical Product for Export of an Unapproved Product under Sections 801(e) or 802 of the FDA&C Act)
    • A Blue ribbon will be affixed to Certificates for Export of an Unapproved Product. (See example).
  • Foreign Manufacturer (products manufactured outside of the U.S.).
    • A Yellow ribbon will be affixed to Certificates with Foreign Manufacturing sites. (See example).
       
Examples of Completed Form 3613b
 
Example of API Manufacturer Completed Form 3613b (PDF - 592KB)  1
Example of Foreign Manufacturer Completed Form 3613b (PDF - 593KB) 1,2
Example of OTC Drugs Manufacturer Completed Form 3613b (PDF - 593KB) 1
Example of Unapproved Non-Marketed Drugs Completed Form 3613b (PDF - 592KB) 1,3
 
Note:
  1. Must include statement – “Is the product currently marketed in the United States? Yes or No.
  2. Must include statement- “We certify that (Product Name) is manufactured and/or packaged in (Name of Country) and is exported from the United States.”
  3. Must include statement – “We certify that the product to be exported is in compliance with the applicable provisions of § 801(e) and 802 of the Act as amended by the FDA Reform and Enhancement Act of 1996.”

 

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