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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.