CSMS 44710394·Operational·November 5, 2020·View on csms.cbp.gov ↗

Updates related to FDA’s Section 804 Drug Importation Program have been deployed to CBP’s Certification Region

Plain-English explanation

CSMS 44710394 is a U.S. Customs and Border Protection (CBP) Cargo Systems Messaging Service bulletin (operational), published on November 5, 2020. It carries the official CBP guidance brokers and importers must follow for the topic — "Updates related to FDA’s Section 804 Drug Importation Program have been deployed to CBP’s Certification Region". CSMS messages are the operational layer between Commerce determinations and at-the-border collections: when Commerce publishes a new rate, scope ruling, or instruction, CBP turns it into a CSMS that ACE/ACS systems and brokers act on.

Message body

Full text as published by U.S. Customs and Border Protection

CSMS #44710394 - Updates related to FDA’s Section 804 Drug Importation Program have been deployed to CBP’s Certification Region U.S. Customs and Border Protection sent this bulletin at 11/05/2020 10:56 AM EST Cargo Systems Messaging Service CSMS #44710394 - Updates related to FDA’s Section 804 Drug Importation Program have been deployed to CBP’s Certification Region 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. 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

Frequently asked questions

What is CSMS 44710394?

CSMS 44710394 is a U.S. Customs and Border Protection (CBP) Cargo Systems Messaging Service bulletin titled "Updates related to FDA’s Section 804 Drug Importation Program have been deployed to CBP’s Certification Region". CSMS bulletins are the operational instructions CBP issues to brokers, importers, and ACE filers covering rate changes, system updates, scope guidance, and other day-to-day customs-operations changes.

When was CSMS 44710394 published?

CBP published CSMS 44710394 on November 5, 2020. The bulletin's instructions are typically operative as of the publication date unless the body specifies a different effective date.

Is the CBP CSMS the legally binding instruction?

Yes — for at-the-border filing and entry collection. CSMS messages translate Commerce's Federal Register determinations into operational CBP instructions that ACE/ACS systems and brokers execute. The Federal Register notice is the underlying legal authority; the CSMS is the operational implementation. Both should be read together when reconciling a rate or scope change.

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