Next Upcoming Seminar: Implementing SQF 8.0 Systems – May 17-18, 2017

Specializing in FDA Regulatory Matters

Structured Product Labeling

The Structured Product Labeling (SPL) is a document markup standard approved by Health Level Seven (HL7) a standards development organization accredited by the American National Standards Institute (ANSI), and adopted by FDA as a mechanism for exchanging product and facility information.

Drug establishments are required to register via their D-U-N-S number, and maintain current drug listing information which is to be submitted electronically unless a waiver is granted, otherwise they will are considered to be misbranded. FDA requires that the establishment registration be renewed every year between October 1 and December 31st. Also, FDA requires that foreign establishments have an appointed U.S. Agent for which EAS can serve.

The information in SPL is used to support health information technology initiatives allowing for a fully automated health information system which is intended to improve patient care while allowing for efficiency for both FDA and manufacturers to expedite changes to specific label data elements versus the entire label.

EAS Consulting Group provides a number of services related to SPL registrations including preparation and submission of the SPL establishment registration, product listing (Rx, OTC, Homeopathic drug products), Labeler Code Requests and GDUFA Self-Identification files. EAS can submit these files to the FDA via their secure Electronic Submissions Gateway Account.