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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