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CSMS #52003620 - Food and Drug Administration (FDA) New Product Code Industry 58 for Human and Animal Therapeutic Biologic and Biosimilar Drugs

The Food and Drug Administration (FDA) has added a new Industry Code
58: Human and Animal Therapeutic Biologic and Biosimilar Drugs, along with the associated Class Codes, Process Indicator Codes (PIC) and Product Codes. Refer to the attachment for the new codes. The new codes are available immediately.

Please note that the Subclass Codes used for Industries 60 to 66 are the same Subclass Codes used in the new Industry Code 58.

An updated version of FDA’s Supplemental Guide will be posted in the near future to include the new Industry Code.

Additional Industry 58 product codes will be added to address other human and animal therapeutic biologic and biosimilar drugs at a later date. A CSMS message will be issued when this occurs. Until then, filers may continue to use existing industry 60-66 product codes for specific therapeutic biologic and biosimilar drugs when no appropriate industry 58 product code is found.

Please send any questions or concerns to the email address for the Product Code Builder Feedback: PCBFeedback@fda.hhs.gov

For assistance with product code identification, the public may also refer to the FDA Product Code Builder.