Drug information is important in highly regulated world of pharmaceuticals because use of incorrect information may result in an injurious outcome. The Structured Product Labeling (SPL) is one of the basic instruments that the U.S. Food and Drug Administration (FDA) employs in this undertaking. As a stakeholder in the drug manufacturing, distribution or labeling industry, it is important to learn about USFDA SPL as it will help you meet regulatory compliance and transparency in the promotion of health in the population.
What Is Structured Product Labeling (SPL) and Why Does the FDA Use It?
Structured Product Labeling (SPL) is an XML labeling format to electronically submit labeling material to the FDA. Developed in collaboration with Health Level Seven (HL7), SPL allows the FDA to receive, manage, and share drug product information in a consistent and machine-readable way.
Unlike the PDF or paper label formats, SPL comes with a consistent, hierarchical structure, which is easy to be processed and published through digital mediums like DailyMed or FDA NDC Directory. This ensures that healthcare providers, patients, and regulators always have access to the most accurate and up-to-date drug information.
The SPL format is critical towards enhancing data accuracy, minimizing submission mistakes, and improving-public safety.
Who Is Required to Submit SPL to the FDA?
PL submission is required by a broad scope of parties engaged in the U.S drug supply chain, including:- Prescription drug manufacturers
- Over-the-counter (OTC) product marketers
- Biologic and veterinary drug companies
- Private label distributors
- Repackagers and relabelers
Whether you’re introducing a new product or updating an existing one, you must submit an SPL file to the FDA to stay compliant. Additionally, an Annual Report SPL is required every year, even if no changes have been made to the product.
What Information Must Be Included in an SPL Submission?
An SPL file is not just a copy of your drug label—it contains detailed, structured data that enables proper classification and digital publishing. A typical SPL includes:- Product name (proprietary and non-proprietary)
- Dosage form and route of administration
- Active and inactive ingredients
- Indications and usage instructions
- Contraindications and warnings
- Package details, such as NDC codes and sizes
- Manufacturer and labeler contact information
This comprehensive format ensures that the FDA and the public have access to the most critical product information in a uniform way.
How to Create and Submit an SPL File to the USFDA
Building an SPL means creating an XML file that aligns with the specifications of the FDA as well as validation rules. The process can be managed through:- FDA’s XForms tool (free XML editor)
- Commercial SPL authoring software
- Third-party vendors who specialize in SPL preparation
Once your SPL file is complete, it must be submitted via the FDA Electronic Submissions Gateway (ESG). Before submission, the file should be validated using FDA’s provided tools to ensure compliance.
The USFDA SPL system is not just a regulatory requirement but a vital system that ensures drug safety, label accuracy, and health transparency of the people. Creating and submitting SPL files is a crucial aspect of launching a new pharmaceutical product or when maintaining compliance with pharmaceutical products.
For hassle-free and accurate SPL submissions, Masuu Global provides expert support tailored to FDA requirements. Let us help you stay compliant and focus on what matters most—growing your business with confidence.