FDA to Make Drug API Data Elements Optional in ACE

The Food and Drug Administration’s recent move to relax certain ACE data element requirements includes a more permanent change that will make filing of certain active pharmaceutical ingredient data optional, said FDA officials during a March 23 webinar. While the agency will only temporarily allow filing of a “UNK” code, indicating unknown, for intended use, brand name and device listing number data elements beginning April 5 (see 1603210028), the shift of the active ingredient producer data element from mandatory to optional will remain in place “for the foreseeable future,” said Sandra Abbott, director of FDA’s Division of Compliance Systems.

Joining that data element as optional will be active ingredient name and dosage, a change that will appear in the next version of FDA’s supplemental guide, said Jessica Aranda, who leads development of the document at FDA. Release of the updated guide is imminent, said Aranda, with FDA hoping to finish up work on the document and send it to CBP on March 23.

FDA’s relaxation of its data element requirements is intended to “facilitate the transition” away from the legacy Automated Commercial System by enhancing the ability of the trade to file ACE entries, said Abbott. Filers who don’t know the information required in these data elements will still be able to submit their entries and avoid getting stopped by CBP’s initial data validation. However, once the entry gets to FDA there is a “high likelihood” that the agency will request documents to get the required information, which is still necessary to make an admissibility decision. FDA is just “relaxing on the front end” to make sure the trade community is able to get their data into FDA’s databases, said Abbott.

FDA still “highly encourages” the submission of entries with “complete and correct” information, including the data elements that are set for relaxation, said Abbott. Entries that include all the information will be prioritized, while entries that don’t may face manual review. Filers that don’t include certain data elements will also lack the benefit of data validation, which could further increase the likelihood of errors and cause FDA to manually review an entry, said Aranda. For example, submitting “UNK” for intended use on an entry of medical devices would mean ACE would not be able to validate affirmation of compliance codes, which are tied to the intended use filed, said Aranda. Failure to provide an affirmation of compliance code would cause an entry to fail FDA’s system validation, moving the entry to manual review and a request for documentation.