Structured Product Labeling (SPL) is an essential component of the healthcare industry that provides a standardized format for drug information exchange among various healthcare systems. Labeling content must be presented in an electronic format for marketing applications. It must be submitted in a format that the United States Food and Drug Administration (USFDA) can process, review, and archive. SPL is a standardized way of presenting essential drug information, such as indications, dosage, administration, and contraindications, in a structured format so that healthcare professionals and patients can easily access and understand it. The SPL format is based on the Health Level Seven (HL7) international standard, which uses the Extensible Markup Language (XML) to create SPLs.
Creating accurate and compliant SPL files is crucial for ensuring patient safety and effective communication among healthcare providers. The USFDA requires drug manufacturers to submit SPLs for all prescription and Over-the-Counter (OTC) drugs, veterinary medicinal products, biologics, and medical devices marketed in the US. The USFDA uses the information in SPLs to evaluate the safety and efficacy of drugs and to communicate essential drug information to healthcare providers and patients.
In this article, we shall discuss the key steps involved in creating SPLs. By following these steps, drug manufacturers can create accurate and compliant SPL files that meet the US FDA’s requirements and provide essential drug information to healthcare providers and patients.
The Steps Involved in Creating SPLs
The following are five (05) main steps required for creating SPLs:
- Use the Correct SPL Format: As discussed earlier, SPLs follow the HL7 international standard and use the XML format. The latest version of the SPL schema can be found on the USFDA’s website. To create SPL files, you need to use the correct, updated SPL format that adheres to the current schema.
- Use Standardized Terminology: It is important to use standardized terminology for creating accurate and consistent SPL files. The Unified Medical Language System (UMLS) of the National Library of Medicine (NLM) is a good corpus of standardized terminology for healthcare. By using standardized terminology, you can ensure that the drug information is consistent across different sources and that healthcare professionals and patients can easily comprehend it.
- Use the USFDA’s SPL Implementation Guide: The USFDA has an SPL implementation guide that helps create the files. The guide provides information on how to use correct terminology, format the label, and use correct codes. By following the guide, you can ensure that your files are consistent with the USFDA’s requirements and contain all the necessary information.
- Use the SPL Authoring Tool: The FDA provides you with an SPL authoring tool called Xforms. The Center for Drug Evaluation and Research (CDER) Direct allows you to create SPLs in the XML format using this tool. It is free for download and use. The tool provides a user-friendly interface for creating SPL files and ensures that your labels are compliant with the US FDA’s requirements. It also allows you to preview your files before submitting them.
- Validate Your SPLs: Before submitting your SPL files, it is important that you validate them to ensure that they are accurate and compliant with the US FDA’s requirements. The USFDA provides a tool that allows you to validate your SPLs. The validation tool checks for errors and provides you with feedback on how to correct any issues that may arise. By validating your SPLs, you can ensure that they meet the US FDA’s requirements and contain all the necessary information.
In conclusion, creating SPL files is an important part of the drug approval process. Using SPL ensures that the drug information is consistent across different sources and is easily accessible to the target consumers. To create SPLs, you need to use the correct SPL format, standardized terminology, the USFDA’s SPL implementation guide, and the SPL authoring tool, and validate your labels. Having a reliable and experienced partner who can help you save costs and time during the SPL submission process can be valuable. Click here to partner with Freyr experts for your SPLs!