Cargo Systems Messaging Service

CSMS #46970234 - FDA Entries: Submission of Product Codes in PG02

Attention software vendors and filers: The Food and Drug Administration (FDA) message set includes the PG02 record, which is used to submit product information, such as the FDA Product Code.

As indicated in the FDA Supplemental Guide, the PG02 is a mandatory record, and is not repeatable, i.e., ONLY ONE PG02 record is allowed for a given FDA line. In addition, only one Product Code Qualifier and Product Code Number are allowed in the PG02 record per FDA line.

Recently, the FDA has seen an increase in submissions with multiple Product Code Number data elements transmitted on a single FDA line, resulting in issues processing these entries. Software vendors are encouraged to prevent transmission of multiple Product Code Numbers on a single FDA line. Filers who have been contacted regarding multiple Product Code Numbers are encouraged to review FDA data prior to transmission.

For further assistance or ACE inquiries, contact FDA ACE Support, 877-345-1101, ACE_Support@fda.hhs.gov. ACE Support Hours: Monday - Friday, 8AM-8PM ET.