CSMS 52003620PGAinformational

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

Published May 27, 2022

Summary

FDA has added a new Industry Code 58 for Human and Animal Therapeutic Biologic and Biosimilar Drugs, along with associated Class Codes, Process Indicator Codes, and Product Codes, effective immediately. Filers may continue using existing Industry 60-66 product codes until additional Industry 58 codes are issued.

Summary is machine-generated at the linking layer for discovery only. Refer to the source bulletin for authoritative guidance.

CSMS 52003620 · full bulletin