• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

  • Print
  • Share
  • E-mail

FDA Product Codes For Importing CBER-Regulated Products

Product Codes For Importing CBER-Regulated Products

 

 

What is an FDA Product Code?
The FDA Product Code, composed of a seven-character set of letters and numbers, helps FDA classify and review imports. An FDA Product Code has five parts:
  • The first part is the “Industry Code.” The Industry Code for all CBER-regulated products is the number “57,” so the FDA Product Codes for all CBER-regulated products begin with “57”.
  • The second part of the FDA Product Code is the “Class Code.” For CBER-regulated products, the Class Code is a letter that describes, generally, what grouping the product falls into, for example, is it a viral vaccine, blood derivative, or human musculoskeletal (tissue) product.
  • The third part of the FDA Product Code is the “Subclass Code”. For CBER-regulated products the Subclass Code is a letter that describes how the product will be used in the United States, for example, for further manufacturing, in final dosage form for patient use, or sample for product testing/assessment or FDA/CBER lot release.
  • The fourth part of the FDA product Code is the “Process Indicator Code.” CBER-regulated products do not have a Process Indicator Code so in a FDA Product Code for a CBER-regulated product, this part is filled in with a hyphen (-).
  • The fifth part of the FDA Product Code is the “Specific Product Code.” The Specific Product Code for CBER-regulated products is two numbers that specifically describes the particular kind of product, e.g., rabies vaccine.
How do I use this page to find the FDA Product Code to use when importing a CBER-regulated product?
To assist those importing CBER-regulated products, CBER has created two searchable tables in PDF format that match most CBER-regulated products to their FDA Product Codes:  one table is organized by Product Class (product categories) and the other table is organized alphabetically by manufacturer name (if one is listed).  Please note that these two tables are intended as a resource, but are not intended to be a complete list of every CBER-regulated product.  If you are the import filer, you should review the information printed on product labeling, invoice papers, or entry documents that are provided by the manufacturer, exporter, and/or importer to identify possible search terms. Such information will help you select the best possible search term(s) to use to find the correct FDA Product Code. The bullets below summarize the most commonly used product codes for CBER-regulated products. If you still have questions about what the product is, contact the manufacturer, exporter, and/or importer for more information.
  • For most biological drugs and devices that are licensed, approved, or cleared by CBER, the tables identify the Industry Code, (57), the Product Class (e.g., C [Viral Vaccines]), the Specific Product Code (e.g., 02), the product  (e.g., influenza virus vaccine), trade name (e.g., Flumist), and the sponsor’s (usually the manufacturer’s) name, (e.g., Medimmune). 

 

  • For blood and blood component (human) products that are licensed by CBER, we have not provided any trade names or manufacturers.  The tables identify the Industry Code (57), the Product Class (D [Blood and Blood Components]), the Specific Product Code (e.g., 44), and the product description (e.g., Source Plasma (Human)).

 

  • For certain CBER regulated drugs used in conjunction with blood banking and/or transfusions, we have not provided any trade names or manufacturer. The tables identify the Industry Code, (57), the Product Class (e.g., Y), and the Specific Product Code (e.g. , 03) for the product description  [e.g., Plasma Volume Expander (Dextran, Hetastarch, Pentastarch)].

 

  • For medical devices approved or cleared by CBER, the tables identify the Industry Code, ( 73, 75, 80, 81, 82, or 83), the Product Class (e.g., M), and the Specific Product Code (e.g., VZ) for the product description [e.g., System, Test, Home, HIV-1]. 

 

  • For human cells, tissue, and cellular or tissue-based products (HCT/Ps), we have not provided any trade names or manufacturers unless the product is licensed by CBER.  For most HCT/Ps, the tables identify the Industry Code (57), the Product Class (J through T), the Specific Product Code, and the product description.
 
What should I do if I can’t find a FDA Product Code for the product?
First, make sure you have enough specific information about the product.  If you have enough specific information and searched using each applicable search term (e.g., product description, trade name, and/or manufacturer), and still cannot find the exact product you are searching for listed, there are two possible reasons:  the product may have been licensed by CBER since the table was last updated or the product may be investigational. 
If you found another product with the same product description as yours, just not the one manufactured by your manufacturer, then you should use that Specific Product Code for your product as FDA Product Codes are not specific to a particular manufacturer.  For example, all rabies vaccines have the same Specific Product Code, so if you are importing a newly licensed, finished dosage form rabies vaccine, your vaccine would have the same Specific Product Code as an already licensed rabies vaccine, 57CH-15. 
If you did not find any other product with a similar or identical product description to your product, then the product is likely the first of its kind and has not yet been assigned a Specific Product Code.  If that is the case, you should determine what class of product it is and then use the “Not Elsewhere Classified” Specific Product Code, which is always “99”.  For example, if you were importing a finished dosage form of new kind of bacterial vaccine that has not yet been assigned a Specific Product Code, the FDA product Code would be 57HH-99.  For new kinds of products, FDA will assigned a Specific Product Code the next time it updates the table, so you should check the list each time you file an import entry for the product.   
How do I find the FDA Product Code for importing an investigational (IND or IDE) product?
These tables do not include any investigational products by trade name or manufacturer so you will need to search by product description.  First, make sure you have specific information about what the product is and what product class it falls into.  If your search finds another product with the same product description as yours, but not manufactured by your manufacturer, then you should use that Specific Product Code for your product as FDA Product Codes are not specific to a particular manufacturer.  For example, all rabies vaccines, even a rabies vaccine under investigation, should use the same Specific Product Code, so if you are importing an investigational rabies vaccine in finished dosage form, your vaccine would have the same Specific Product Code as an already licensed rabies vaccine (57CH-15). 
If  you did not find any other product with a similar or identical product description to your product, then product is likely be the first of its kind and has not yet been assigned a Specific Product Code.  If that is the case, then you should determine what class of product it is and, then use the “Not Elsewhere Classified” Specific Product Code, which is always “99”.  For example, if you were importing a new kind of bacterial vaccine in finished dosage form that has not yet been assigned a Specific Product Code, the FDA product Code would be 57HH-99. 
Are FDA Product Codes different from CBER Biological Product Deviation (BPD) codes?
Yes, FDA Product Codes are different from CBER BPD product codes.  When importing a CBER-regulated product, you should use the FDA Product Codes provided in the searchable tables. Do not use CBER BPD product codes to import your CBER-regulated products because this may cause a delay in FDA’s processing of your import.