Pharmaceutical Ingredient Importers: Are You Prepared for Shift to ACE?

December 14, 2015

In the first quarter of 2016, the FDA will require all importers of FDA-regulated products to submit data necessary for international trade through a new electronic portal.

What is ACE?

The Automated Commercial Environment (ACE) database system has been developed by US Customs and Border Protection (CBP) in collaboration with the FDA as well as 46 other government agencies. This software is integrated with the International Trade Data System (ACE/ITDS), and “is a single access point whereby industry can electronically submit all data required by government agencies for international trade.”

By creating one location for federal agencies to submit information, FDA feels that the implementation of ACE/ITDS will help to “modernize business processes” and expedite expansion and trade.

Implementing ACE

Starting February 28, 2016, the Agency will require all importers of FDA-regulated products to submit entry data and information through the ACE database. Additionally, according to RAPS, by the end of 2016 “ACE will be the primary system through which the trade industry will report imports and exports and the government will determine admissibility.”

In an interview with RAPS, Doug Stearn, director of FDA’s Office Regulatory AffairsOffice of Enforcement and Import Operations said that “brokers must be licensed by CBP to access ACE, and we estimate that there are approximately 4,300 licensed brokers that file import entries related to FDA commodities. While importers that do not act as brokers will not be accessing the system directly, importers will be affected and should be familiar with the system.”


The Automated Commercial System (ACS) was the comprehensive system previously used by Customs to “track, control, and process all commercial goods imported into the United States.” ACS has now been replaced by ACE.

What is different between the two? In his interview with RAPS, Stearn “explained that the new system ‘moves certain paper processes into an automated format where entries can be processed more quickly, reduces or eliminates redundant reporting, and provides unified messaging on behalf of the government.’”

Additionally, Stearn stated that the new process will have the ability to validate data immediately after submission, which will help to decrease processing delays, “which can slow things down when additional information must be submitted and reviewed. ACE also will provide more specific messaging at the line level for commodities admitted on this basis, streamlining the process by delinking each product line from other goods during the process.”

Do you import an FDA-regulated product into the US? Making sure you are compliant with all FDA regulations can be tricky. That is why we are here to help. For more information on how we can help you confirm compliance, please contact us


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