Cargo Systems Messaging Service

CSMS #44436055 - FDA Supplemental Guide Updates Including Technical Changes for Section 804 Drug Importation Program

FDA’s ACE Supplemental Guide (SG), version 2.5.2 has been posted. This version of the SG consists mostly of formatting and language changes to improve clarity and standardize language throughout the document. The associated version 2.5.2 FDA example PGA message sets was also posted.

Programming changes in v. 2.5.2 are changes associated with the following:

• Final rule for FDA’s Section 804 Drug Importation Program which was announced in a press release (https://www.fda.gov/news-events/press-announcements/fda-takes-actions-help-lower-us-prescription-drug-prices) on September 24, 2020
• New Industry Code 58 in the Drug Program which is for future use.

Changes have been made to the Drug Program Code of the SG for FDA’s Section 804 Drug Importation Program. The following new codes have been added to the SG and Appendix PGA:

• Government Agency Processing Code: 804
• Affirmations of Compliance Codes: FSR and PRN

Please see the change logs to identify all PG records which have changed for this program.

All updates for FDA’s section 804 requirements are expected to be deployed to CBP’s CERTIFICATION environment between October 28, 2020 and November 5, 2020. They are expected to be deployed to the PRODUCTION environment on December 5, 2020. 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.

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.