CSMS # 56036654 - FDA Supplemental Guide Version 2.5.8 Now Available

U.S. Customs and Border Protection sent this bulletin at 04/25/2023 03:11 PM EDT

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CSMS # 56036654 - FDA Supplemental Guide Version 2.5.8 Now Available

FDA’s ACE Supplemental Guide (SG), version 2.5.8 has been posted on CBP.gov. These changes are strictly changes to the Supplemental Guide. No programming changes were made by FDA or CBP.

This version of the SG consists of the following updates in Programming Code DRU (Drugs):

PG02: Clarified language for the Product Code Subclasses applicable to the various Industry Codes
PG23, Table 7-20: Changed Affirmation of Compliance Code DLS for Intended Use Code 080.012 to conditional.
PG23, Table 7-18: Added clarifying information to indicate REG is optional for Government Agency Processing Code 804

For ACE technical inquiries, contact FDA ACE Support, ACE_Support@fda.hhs.gov. ACE Support Hours: Monday - Friday, 8AM-8PM ET, excluding federal holidays.

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