CSMS 64637319·Operational·April 3, 2025·View on csms.cbp.gov ↗

U.S. Food and Drug Administration (FDA) Supplemental Guide

Plain-English explanation

CSMS 64637319 is a U.S. Customs and Border Protection (CBP) Cargo Systems Messaging Service bulletin (operational), published on April 3, 2025. It carries the official CBP guidance brokers and importers must follow for the topic — "U.S. Food and Drug Administration (FDA) Supplemental Guide". 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 # 64637319 - U.S. Food and Drug Administration (FDA) Supplemental Guide - Version 2.5.12 is Now Available U.S. Customs and Border Protection sent this bulletin at 04/03/2025 04:59 PM EDT Cargo Systems Messaging Service CSMS # 64637319 - U.S. Food and Drug Administration (FDA) Supplemental Guide - Version 2.5.12 is Now Available U.S. Food and Drug Administration (FDA) Supplemental Guide (SG), version 2.5.12, has been posted on CBP.gov. The changes associated with this version have been deployed in production. Review the Change Log in the document for the specific changes. This version makes Intended Use Codes (IUC) mandatory for the following commodities to be in compliance with 21 CFR 1.72: Cosmetics (Program Code COS) Ceramicware and other food contact substances (Program/Processing Code FOO/CCW) Pharmaceutical Necessities, Containers, Inactive Pharmaceutical Ingredients and Excipients (Program/Processing Code DRU/ PHN) Veterinary medical devices (Program/Processing Code VME/ADE) In addition, the following changes are included in the SG: IUC 110.000 has been added for Human Drugs (Program Code DRU and Processing Code PRE (prescription) and OTC (over the counter)). Medical Devices IUC 170.000; Affirmation of Compliance IFE is no longer required. Removed indication to mandatory TST affirmation for tobacco products in footnote. Finally, the following documents will be updated to align with the changes associated with SG version 2.5.12: PGA Message Set Samples-Food and Drug Administration Automated Commercial Environment/International Trade Data System (ACE/ITDS) | FDA Industry Quick Reference Guide to the FDA ACE Supplemental Guide FDA ACE Affirmations of Compliance For questions about these changes contact FDA ACE Support ACE_Support@fda.hhs.gov . Related messages: CSMS 63443664, 63566274, 63658882, 63824491 and 63839331 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 64637319?

CSMS 64637319 is a U.S. Customs and Border Protection (CBP) Cargo Systems Messaging Service bulletin titled "U.S. Food and Drug Administration (FDA) Supplemental Guide". 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 64637319 published?

CBP published CSMS 64637319 on April 3, 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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