Tips for ACE: Importing Drugs Through U.S. Customs

U.S. Customs and Border Protection created the ACE system to provide a single window to interact, manage and oversee import and export data. Aiming to transition to the system by the end of 2016, the organization has already observed a 25% faster processing time among ACE submitted entries.

U.S. Customs and Border Protection (CBP) has taken on the task of streamlining electronic data submission for international trade with ACE/ITDS (Automated Commercial Environment/International Trade Data System), creating one portal for 47 agencies. At IQPC’s 14th Cold Chain - GDP & Temperature Management Logistics Global Forum, Ted Poplawski, Director, Division of Import Operations, FDA, discussed how ACE will become the “single window” through which industry will report imports and exports, and how the government will determine admissibility.

With recommendations from trade industry and support from presidential task forces, CBP is aiming to transition to the new system by the end of 2016. Poplawski said that ACE will change the current business process by allowing entry information for all Partner Government Agencies to be submitted in ACE and providing messaging capability from each agency to the filer. Additionally, the FDA will require complete data when the product is offered for entry, more than the four pieces of data required by the existing Automated Commercial System (ACS).

Poplawski noted that the FDA is still developing regulations on those data requirements, and is on track to do so by the end of year. Benefits of the system include:

  • Data prompts will help filers to ensure the proper information is submitted. These prompts will also help the FDA speed entry decisions, as reviewers will not have to verify information manually in a separate database.

  • Fewer requests for paper documents will result in eliminating unnecessary paper use in the process.

  • Built-in edits allow filers to seek exemption in a more streamlined way.

  • The trade community will be able to comply with U.S. laws and regulations more easily and efficiently.

Poplawski noted that the ACE has already brought an increase in efficiency in processing shipments to those using the system, and that the CBP will continue to monitor the process closely. According to the CBP’s site, they have seen “…an overall decrease in entry processing times for ACE submitted entries compared with entries submitted via other means.Specifically, the average processing time for manual review of ACE submitted entries is 25% faster than the average processing time was for manual review of ACS submitted entries.”

In order to avoid delays in processing, Poplawski advised companies follow these tips for importing drug products in ACE:

  • Be sure to use the correct product code and intended use code, as well as brand name, active ingredient and dosage.

  • Include the name and address for the following entities, but whenever possible, submit the DUNS number. The system can accept the name and address, but the DUNS number is the fastest option as it is an easier electronic match.

    • Manufacturer, shipper, importer, deliver to party and API producer.

  • Submit an Affirmation of Compliance, a mechanism for providing additional information such as Drug Listing Number, Drug Application Number, Investigational New Drug Number and Drug Registration Number.

Poplawski said that delays can result from submitting incomplete information, or information that does not match what is currently in the system. Be sure to update data, including a change in supplier or address as soon as possible. If data is not updated in the drug database, it will not match the entry information resulting in increased potential for detention and delays in shipment.

During a Q&A session at the end of his presentation, Poplawski also mentioned that the FDA has an emphasis in courier and mail coverage because a lot of counterfeit products enter the country that way. The FDA works with couriers (not just the larger ones) to get electronic information. There is interest in the U.S. Government developing an electronic submission system for the postal system as well.

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