In a significant move towards streamlining cosmetic product registrations and listings, the U.S. Food and Drug Administration (FDA) rolled out a comprehensive Structured Product Labeling (SPL) Implementation Guide with Validation Procedures (the Implementation Guide) on October 13, 2023. This development comes on the heels of the recent unveiling of Cosmetics Direct, the electronic submission portal through a draft guidance, which requires cosmetic registration and listing data to be electronically submitted in the SPL format, aligning with the submission format for drug products.
The Implementation Guide consists of 36 chapters and an Appendix, as shown below.
Introduction
SPL Documents in General
Product Data Elements
Drug and Biologics Labeling, Listing, and other Product Submissions
NDC/NHRIC Labeler Code Request
Establishment registration
Out of Business Notification
Pharmacologic Class Indexing
Dietary Supplement Labeling
Medical Food Labeling
Medical Device Labeling
Billing Unit Indexing
Generic User Fee Facility Self-Identification
[RESERVED]
Indexing - Product Concept
Lot Distribution Report
[RESERVED]
Wholesale Drug Distributor/Third-Party Logistics Facility Report
40 CFR 180 TOLERANCE
Indexing - Biologic or Drug Substance
Indexing - Warning Letter Alert
[RESERVED]
Risk Evaluation and Mitigation Strategy (REMS)
REMS Shared System Indexing
[RESERVED]
[RESERVED]
[RESERVED]
Blanket No Changes Certification of Product Listing Data
Human and Animal Salvaged Drug Products
FDA-Initiated Compliance Action – Drug Listing Inactivation
FDA-Initiated Compliance Action – Establishment Registration Inactivation
Drug Interactions Indexing
[RESERVED]
[RESERVED]
Cosmetic Facility Registration
Cosmetic Product Listing
Appendix: List of Tables
Original regulatory document
