The Updates to FDA Section 804 Drug Importation Program have been deployed to CBP’s Certification region. Software programming changes were announced in the FDA’s ACE Supplemental Guide (SG), version 2.5.2 (see CSMS #44436055). FDA will contact software vendors to request testing assistance.

Refer to the Guidance for Industry (https://www.hhs.gov/sites/default/files/importation-guidance.pdf) for additional information. Regulatory and operational information about this program will be announced by FDA as it becomes available.

In addition, the following FDA bug fixes were deployed into the Certification region.

·       FDA/FOO - fixed bug in PN rule to reject in conditions when mandatory PG19 entity is missing

·       FDA/FOO/CCW - Entry should not be accepted when FDA product code is not valid for the program/processing codes

·       FDA/FOO - implemented fix related to valid source type codes

·       FDA/BIO - Entry should not be accepted when mandatory PG20 country is missing

·       FDA/FOO -  fixed bug in PN rule to reject in conditions when mandatory PG23 AofC 'VFT' is missing

The 804 updates, and the additional FDA bug fixes, are expected to be deployed to the PRODUCTION environment on December 5, 2020.

For technical changes related to v. 2.5.2 of FDA’s SG, contact ACE Support, 877-345-1101, ACE_Support@fda.hhs.gov. ACE Support Hours: Monday - Friday, 6AM-8PM ET, Saturdays, 8AM-4PM ET.