CSMS 52003620·Operational·May 27, 2022·View on csms.cbp.gov ↗

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

Plain-English explanation

CSMS 52003620 is a U.S. Customs and Border Protection (CBP) Cargo Systems Messaging Service bulletin (operational), published on May 27, 2022. It carries the official CBP guidance brokers and importers must follow for the topic — "Food and Drug Administration (FDA) New Product Code Industry 58 for Human and Animal Therapeutic Biologic and Biosimilar Drugs". CSMS messages are the operational layer between Commerce determinations and at-the-border collections: when Commerce publishes a new rate, scope ruling, or instruction, CBP turns it into a CSMS that ACE/ACS systems and brokers act on.

Message body

Full text as published by U.S. Customs and Border Protection

CSMS #52003620 - Food and Drug Administration (FDA) New Product Code Industry 58 for Human and Animal Therapeutic Biologic and Biosimilar Drugs U.S. Customs and Border Protection sent this bulletin at 05/27/2022 09:00 AM EDT Cargo Systems Messaging Service 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 . CSMS template Industry 58 attachment 3-9-2022.xlsx Update your subscriptions, modify your password or e-mail address, or stop subscriptions at any time on your Subscriber Preferences Page . You will need to use your e-mail address to log in. If you have questions or problems with the subscription service, please contact subscriberhelp.govdelivery.com . This service is provided to you at no charge by U.S. Customs and Border Protection . Privacy Policy | GovDelivery is providing this information on behalf of U.S. Department of Homeland Security, and may not use the information for any other purposes. Powered by Privacy Policy | Cookie Statement | Help

Frequently asked questions

What is CSMS 52003620?

CSMS 52003620 is a U.S. Customs and Border Protection (CBP) Cargo Systems Messaging Service bulletin titled "Food and Drug Administration (FDA) New Product Code Industry 58 for Human and Animal Therapeutic Biologic and Biosimilar Drugs". CSMS bulletins are the operational instructions CBP issues to brokers, importers, and ACE filers covering rate changes, system updates, scope guidance, and other day-to-day customs-operations changes.

When was CSMS 52003620 published?

CBP published CSMS 52003620 on May 27, 2022. The bulletin's instructions are typically operative as of the publication date unless the body specifies a different effective date.

Is the CBP CSMS the legally binding instruction?

Yes — for at-the-border filing and entry collection. CSMS messages translate Commerce's Federal Register determinations into operational CBP instructions that ACE/ACS systems and brokers execute. The Federal Register notice is the underlying legal authority; the CSMS is the operational implementation. Both should be read together when reconciling a rate or scope change.

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