STRUCTURED PRODUCT LABELING (SPL R4)

Drug establishment registration and drug listing information have, until now, been submitted using a paper-based format, i.e., Form FDA 2656 (Registration of Drug Establishment/Labeler Code Assignment), Form FDA 2657 (Drug Product Listing), and Form FDA 2658 (Registered Establishments' Report of Private Label Distributors).

Beginning June 1, 2009, FDA no longer accepts paper submissions for drug establishment registration and listing unless a waiver is granted. The Structured Product Labeling (SPL) is a document mark up standard approved by Health Level Seven (HL7) and adopted by FDA for Electronic Drug Registration and Listing System (eDRLS).

DocentPharma offer following SPL R4 services where it ensures accurate transfer of the Labeler, Establishment Registration and Product Information into FDA compliant and validated SPL XML structure.

• Registration of Drug Establishment
• NDC (National Drug Code) Labeler Code Request
• Product Listing/Labeling
• Consultancy for eDRLS

For DocentPharma SPL services or information, please write email to us: - docent@docentpharma.com