CSMS # 63839331 - Deployment of Changes in FDA ACE Supplemental Guide 2.5.12

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
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.