CSMS 63839331·System update·January 22, 2025·View on csms.cbp.gov ↗

Deployment of Changes in FDA ACE Supplemental Guide 2.5.12

Plain-English explanation

CSMS 63839331 is a U.S. Customs and Border Protection (CBP) Cargo Systems Messaging Service bulletin (system update), published on January 22, 2025. It carries the official CBP guidance brokers and importers must follow for the topic — "Deployment of Changes in FDA ACE Supplemental Guide 2.5.12". 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 # 63839331 - Deployment of Changes in FDA ACE Supplemental Guide 2.5.12 U.S. Customs and Border Protection sent this bulletin at 01/22/2025 11:58 AM EST Cargo Systems Messaging Service CSMS # 63839331 - Deployment of Changes in FDA ACE Supplemental Guide 2.5.12 This CSMS message provides an update related to the changes referenced in CSMS messages 63443664, 63566274, 63658882 and 63824491 in the U.S. Food and Drug Administration (FDA) Supplemental Guide (SG) (Draft Version 2.5.12 updated January 15, 2025). To support the import community’s request for a transition period, the severity (warning or reject) of the validations associated with these changes and their respective deployment dates will vary as indicated below. In order to facilitate efficient review by FDA, filers are encouraged to transmit accurate data during the transition period . Refer to the FDA Supplemental Guide (Draft Version 2.5.12 updated 01/15/2025) in the Draft Chapters section of CBP.gov for valid Intended Use Codes (IUC) for each commodity. The validations associated with the following changes will result in a warning on February 22, 2025: An IUC that is valid for cosmetics (program code COS) is not transmitted. An IUC that is valid for ceramicware and other food contact substances (program/processing code FOO/CCW) is not transmitted. An IUC that is not valid for animal devices (program/processing Code VME/ADE) is transmitted. An IUC that is not valid for food (program code FOO) is transmitted. NOTE: these warnings will occur during the transition period starting February 22, 2025. On March 22, 2025, the above validations will result in a reject. Validations associated with the following changes will deploy on February 22, 2025: IUC 110.000 will be added for human drugs (program code DRU and processing codes PRE (prescription) and OTC (over the counter)). Medical devices FDA import scenario for IUC 170.000, will no longer require Affirmation of Compliance IFE. NOTE: There is no transition period for these changes. March 22, 2025, will be the final deployment for all changes in FDA SG Version 2.5.12. On this date, the changes resulting in warnings above and the additional changes below will result in a reject. Not transmitting a valid IUC for pharmaceutical necessities, containers, inactive pharmaceutical ingredients, and excipients (program/processing code DRU/ PHN) (transmitting an IUC prior to March 22, 2025, will result in a reject). Not transmitting a valid IUC for animal devices (program/processing Code VME/ADE). For questions, contact FDA ACE Support ACE_Support@fda.hhs.gov . Related messages: CSMS # 63443664, 63566274, 63658882 and 63824491 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 63839331?

CSMS 63839331 is a U.S. Customs and Border Protection (CBP) Cargo Systems Messaging Service bulletin titled "Deployment of Changes in FDA ACE Supplemental Guide 2.5.12". 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 63839331 published?

CBP published CSMS 63839331 on January 22, 2025. 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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