Now that the US Customs Automated Commercial Environment (ACE) is in full use, Customs brokers have new reporting responsibilities. While ACE does not create new import requirements for FDA-regulated products, it does require brokers to provide additional data elements in their import entries.  For example, brokers must now report an FDA intended use code for each import shipment. 

The new, FDA intended use codes designate both the general and specific use intended for an imported product. The mandatory use of intended use codes combined with FDA product codes and other required Affirmation of Compliance codes is designed to streamline FDA’s entry review process.

Brokers are required to use the Customs and Trade Automated Interface Requirements (CATAIR) technical manual, Appendix R[i] to determine the correct intended use code to report. For many years, Brokers have asked importers to provide an FDA Intended Use Letter (EUL) for each import shipment. Recently, brokers have begun asking importers to provide more product details in the EUL so they can determine which intended use code to declare in ACE.

The list of intended use codes is wide-ranging so Importers of FDA-regulated products must provide their brokers with enough details about imported products so the broker can find the correct FDA intended use code. The EUL should specify whether the product is a drug, a chemical or device and clearly describe its use (e.g., commercial use, clinical trial use, R&D, etc.).

Importers may also consider determining the intended use code for their products and listing it in their EUL.  Below are a few examples of intended use codes currently available.

 

Intended Use Code

Description

Examples of products include

080.000

A product or material distributed, with or without repackaging, by authorized medical or public health officials and intended for use in the medical treatment of humans.

Medical devices, prescription drugs and biological products such as vaccines.

Does not include: chemicals for non-medicinal use, and “over-the-counter” drugs

180.000

A product or material intended for private, educational, or government use to advance scientific knowledge for public benefit or to improve commercial products or services and create competitive advantage.

Examples include products for commercial research and development, plant or animal specimens for scientific study, and human and animal drugs used in investigational stages of drug development.             

180.009

Chemical for research and development in a pharmaceutical product

Placebos intended for use in a controlled clinical trial under an Investigational New Drug application (IND)

 

Providing FDA with the correct intended use will help improve FDA clearance times and overall compliance with import requirements. 


Questions about FDA intended use codes and ACE can be emailed to info@marken.com

[i] https://www.cbp.gov/document/guidance/appendix-r-intended-use-codes-ace