Ingredient importers: Get ACE in place by February, says US FDA

By Dan Stanton

- Last updated on GMT

Photo - Grzegorz Petrykowski/iStock
Photo - Grzegorz Petrykowski/iStock

Related tags International trade

A new system will simplify and speed-up US imports of pharma ingredients the FDA says, but industry needs to be on board by the end of February.

The Automated Commercial Environment database system was developed by US Customs and Border Protection (CBP) in collaboration with the US Food and Drug Administration (FDA) and other federal agencies to replace the current automated commercial system used when importing FDA-controlled products.

The software incorporates the International Trade Data System (ACE/ITDS) which provides a single window for submitting trade information across a number of federal agencies which will, according to the FDA, streamline business processes and facilitate growth and trade.

“Like other FDA regulated products, the entry process for the importation of pharmaceutical ingredient and finished formulation drugs will take place through ACE,” ​Douglas Stearn, Director of the Office of Enforcement and Import Operations for the Office of Regulatory Affairs at the FDA, told

February deadline

But the new software system will also help protect drug ingredient importers and brokers from counterfeit or adulterated goods, according to Stearn.

“Because the single window allows federal agencies to coordinate and have greater communication, it makes efforts to detect breaches in supply chain security more likely to be effective​,” he said.

Since the Security and Accountability For Every Port Act of 2006​, it has been mandatory for importers to use the ACS (Automated Commercial System) to control products coming into the US, but as of February 28th​ companies will have to use the new system.

The industry trade group Society of Chemical Manufacturers and Affiliates (SOCMA) was unable to comment when asked whether its members were ready for the new system, but Stearn said FDA believes that importers and brokers still have time to adapt to the new system.

“The ACE pilot has been proceeding for many months now, and a good deal of work preceded the launch with industry and other stakeholders,”​ he told us. However, “if importers and brokers have not begun that work, they should do so immediately.”

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