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On October 13, 2023, the U.S. Food and Drug Administration (FDA) rolled out a comprehensive Structured Product Labeling (SPL) Implementation Guide with Validation Procedures (the Implementation Guide) for cosmetic product facility registrations and product listings. On November 11, 2023, the FDA released an updated version of the Implementation Guide. This guide encompasses modifications to both cosmetic product facility registrations and product listings that are included within the SPL framework.
The updated 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)
[RESERVED]
[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
National Clinical Trials Number Indexing
[RESERVED]
Cosmetic Facility Registration
Cosmetic Product Listing
Appendix: List of Tables
Original regulatory document
