Drug Operations Hub
Structured guidance for drug establishment registration, SPL lifecycle, and listing governance.
FDA Drug Quality Sampling and Testing Programs
Overview of FDA drug quality sampling and testing programs and what manufacturers should expect.
Drug Facts Label Review Workflow: Prevent OTC Labeling Defects
A structured workflow for Drug Facts content review, formatting checks, and controlled release governance.
Cosmetics Direct: How to Use FDA's New Submission Portal
Cosmetics Direct is FDA's new SPL-based portal for MoCRA facility registration and product listing. Learn account setup, submission steps, and how to avoid common errors.
What Is SPL Format and How to Submit Drug Listings to FDA
SPL (Structured Product Labeling) is the XML-based format FDA requires for all drug listing submissions under 21 CFR Part 207. Learn about SPL structure, WebSPL, DailyMed publication, and update cadence.
OTC Drug Monograph Registration: What Manufacturers Need to Know
OTC drugs marketed under an FDA monograph don't require NDA approval, but the establishment must still register and list products. Learn about the monograph system, MRA reform, and Drug Facts labeling.
How to Get an FDA Labeler Code for Drug Products
An FDA labeler code is the first segment of every NDC number. Learn the step-by-step process to obtain one, including DUNS requirements, SPL submission, and how it links to drug listing.
503B Outsourcing Facility Registration: FDA Requirements Explained
503B outsourcing facilities can compound drugs without individual prescriptions but must register with FDA, comply with cGMP, and report adverse events. Learn about DQSA requirements and the 503A vs 503B framework.
Drug cGMP Basics: 21 CFR Parts 210 and 211 for Foreign Manufacturers
Current Good Manufacturing Practice for drugs is codified in 21 CFR Parts 210 and 211. Learn about facility design, production controls, laboratory testing, and what foreign manufacturers need to know for FDA compliance.
Stabilize drug listing operations
Run SPL and listing workflows with clearer controls and fewer submission retries.