FDA Supplemental Guide Updates Including Technical Changes for Section 804 Drug Importation Program

CSMS #44436055 - FDA Supplemental Guide Updates Including Technical Changes for Section 804 Drug Importation Program U.S. Customs and Border Protection sent this bulletin at 10/15/2020 01:56 PM EDT   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.   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.govdelivery.com . This service is provided to you at no charge by U.S. Customs and Border Protection . Privacy Policy | GovDelivery is providing this information on behalf of U.S. Department of Homeland Security, and may not use the information for any other purposes. Powered by Privacy Policy | Cookie Statement | Help