CSMS 63443664·Operational·December 18, 2024·View on csms.cbp.gov ↗

U.S. Food and Drug Administration (FDA) Supplemental Guide DRAFT Version 2.5.12 is Now Available

Plain-English explanation

CSMS 63443664 is a U.S. Customs and Border Protection (CBP) Cargo Systems Messaging Service bulletin (operational), published on December 18, 2024. It carries the official CBP guidance brokers and importers must follow for the topic — "U.S. Food and Drug Administration (FDA) Supplemental Guide DRAFT Version 2.5.12 is Now Available". 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 # 63443664 - U.S. Food and Drug Administration (FDA) Supplemental Guide DRAFT Version 2.5.12 is Now Available U.S. Customs and Border Protection sent this bulletin at 12/18/2024 11:51 AM EST Cargo Systems Messaging Service CSMS # 63443664 - U.S. Food and Drug Administration (FDA) Supplemental Guide DRAFT Version 2.5.12 is Now Available The U.S. Food and Drug Administration (FDA) Supplemental Guide (SG) (Draft Version 2.5.12) has been posted in the ‘ Draft Chapters: Future Capabilities ’ section of CBP.gov, found here: https://www.cbp.gov/trade/ace/catair . Review the Change Log in the draft document for the specific changes. These changes are expected in Customs and Border Protection’s Automated Commercial Environment (ACE) CERTIFICATION environment by December 16, 2024, and in PRODUCTION no earlier than February 1, 2025. A CSMS will be sent later, to confirm the production date. This draft version makes Intended Use Codes (IUC) mandatory for the following commodities in order 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 DRAFT 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. Finally, in order to improve data quality, a validation will be deployed to limit the optional IUCs that will be accepted for human and animal foods (Program Code FOO, excluding processing code CCW) to align with the FDA Supplemental Guide. For questions about these changes contact FDA ACE Support at ACE_Support@fda.hhs.gov . 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 63443664?

CSMS 63443664 is a U.S. Customs and Border Protection (CBP) Cargo Systems Messaging Service bulletin titled "U.S. Food and Drug Administration (FDA) Supplemental Guide DRAFT Version 2.5.12 is Now Available". 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 63443664 published?

CBP published CSMS 63443664 on December 18, 2024. 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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