The Ultimate Guide to Structured Product Labeling (SPL)

What is Structured Product Labeling?

Structured product labeling is a standardized format used by the U.S. Food and Drug Administration (FDA) to submit prescription drug labeling information electronically. It’s a comprehensive reference for healthcare providers, pharmacists, and regulators to ensure consistency and accuracy in drug information.

Its foundation is XML (Extensible Markup Language), which enables the efficient and reliable communication of detailed product information, such as drug names, dosage forms, indications, contraindications, administration routes, and other critical usage data.

Importance

SPL plays a key role in maintaining manufacturing compliance and ensuring patient safety. Let’s take a closer look at some of its key benefits:

• Ensures Accuracy and Consistency: SPL uses a standardized format to reduce errors and inconsistencies in drug and product labeling. It helps improve patient safety by providing reliable, up-to-date information.

• Enables Efficient Regulatory Compliance: The FDA requires SPL for electronic submissions, essential for approval and avoiding penalties. Proper SPL submissions speed up reviews and approvals.

• Improves Data Interoperability and Accessibility: SPL’s XML format makes drug data readable and machine-processable, enabling easier access and integration with systems like DailyMed.

• Supports Supply Chain and Regulatory Reporting: SPL includes manufacturer, packaging, and dosage details. It enables smooth data sharing across the supply chain and product lifecycle.

• Advances Patient Safety and Usability: Timely and accurate labeling ensures healthcare providers and patients get trustworthy drug information, reducing medication errors and improving outcomes.

• Facilitates Digital Health Integration and Future Readiness: SPL supports health standards like IDMP and UDI. It enables seamless updates and integration with digital health platforms.

Roles of SPL in the Pharma Industry

SPL plays a vital role in the healthcare and pharmaceutical industries, fulfilling several essential functions. This includes:

• Facilitates Seamless Information Sharing: SPL enables efficient communication of product and facility data between manufacturers, regulators, healthcare providers, and patients. It helps maintain consistency and accuracy across all touchpoints.

• Enables Accurate Drug Registration: SPL is used to submit drug listings and establish registrations with the FDA. It ensures every approved drug is listed correctly and accounted for.

• Strengthens Drug Safety Oversight: SPL supports standardized reporting of adverse events and quality issues, which can help regulatory bodies monitor drug performance and safety more effectively.

Different Structured Product Labeling Data Elements

FDA Structured Product Labeling uses standardized data elements to organize drug information in a clear, accessible format. These elements, structured in HL7-compliant XML, allow the FDA and other stakeholders to process, validate, and review submissions efficiently.

The essential elements of SPL data include:

• Product and Manufacturer Identifiers: National Drug Codes (NDC) and company names, uniquely identifying the product and its manufacturer.

• Labeling Version History: Used to track updates and changes to the labeling over time.

• Product Name: Proprietary (brand) and nonproprietary (generic) names.

• Dosage Form: Use of controlled terminology to specify the form in which the drug is administered (e.g., tablet, injection).

• Route of Administration: How the drug will be delivered (oral, intravenous, etc.).

• Ingredients: Active, inactive, and adjuvant ingredients, including their strengths.

• Contraindications, Warnings, and Drug Interactions: Safety-related information critical to proper drug use.

• Dosage and Administration Instructions: How the drug should be dosed and administered.

• Packaging Information: Details on packaging types, quantities, and representative labels or images.

• Product Characteristics: Color, shape, size, and imprint codes for identification.

• Marketing and Regulatory Status: Marketing category, start and end dates, and application or citation numbers.

• DEA Schedule: If the drug is a controlled substance, its schedule classification.

• Registrant, Labeler, and Establishment Information: Who registers and labels the drug, and identifiers like DUNS numbers.

Challenges in Compiling Structured Product Labeling

Despite being a well-defined format, SPLs can still present some challenges to manufacturers and regulators. Compiling an SPL can present several common challenges, including:

• Inaccurate Label Content Sources: Ensuring label content is correct from the start can be difficult. Errors may lead to misinformation, recalls, and regulatory issues.

• Limited Regulatory Knowledge: SPL rules often change, and staying updated is challenging. The lack of regulatory know-how can cause delays or FDA rejections.

• Outdated Tools and Systems: Legacy software may not meet current SPL and FDA standards, slowing submissions and increasing the risk of non-compliance.

• Difficulty Aligning Label Formats: Label formats often differ across products and regions. Harmonizing them without templates takes time and adds manual work.

• Lack of Technical Skills: SPL requires XML and HL7 expertise, which many teams lack. It can lead to formatting errors and failed submissions.

• High Resource and Time Demand: SPL prep needs input from multiple teams and is time-consuming. Late-stage errors can delay approvals and product launches.

• Security and Compliance Concerns: Integrating SPL tools with cloud systems raises data security risks. Companies must protect sensitive information and stay compliant.

Best Practices for Managing SPL Workflows

To effectively manage SPL workflows, pharma companies must implement best practices that ensure compliance, efficiency, and accuracy. These practices include:

• Establish Strong Validation Protocols: Running SPL files through rigorous validation checks is essential to meet FDA submission standards. Automated validation tools can help flag errors early, reducing rework and speeding up approvals.

• Enable Real-Time Team Collaboration: Cross-functional coordination is key to accurate label development. Cloud-based platforms make it easier for teams to co-author, review, and update files in sync.

• Manage Labeling Through Its Entire Lifecycle: Label content evolves as products change over time. Tracking updates through structured version control ensures consistency and ongoing compliance.

• Prioritize Clean, Centralized Data: Accurate labeling depends on well-organized product data. A centralized system helps maintain consistency across ingredients, warnings, and dosage information.

• Monitor Regulatory Shifts Proactively: Regulatory agencies frequently update SPL requirements. Having a process to track and implement these changes helps avoid compliance risks.

• Automate Repetitive Labeling Tasks: Technology can simplify routine SPL functions like XML generation and formatting. Automating these steps saves time and reduces manual errors.

• Invest in Team Knowledge and Skills: Train labeling teams regularly on SPL standards, tools, and workflows. Ongoing learning builds confidence and ensures better quality control across submissions.