Structured Product Labeling – Establishment Registration and Product Listings (SPL)

The SPL is a document markup standard approved by Health Level Seven (HL7) and adopted by FDA as a way to exchange product and facility information for the pharmaceutical establishment and product registration. 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 are considered to be misbranded. FDA requires that the establishment registration is renewed every year between October 1 and December 31st. Also, FDA requires that foreign establishments have an appointed US Agent for which EAS can serve.

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.