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SPL – Information Flow
SPL (Structured Product Labeling) Overview
The U.S. Food and Drug Administration issued the “Electronic Labeling” Rule on December 11th, 2003 with an effective date of June 8, 2004. This rule required the submission of content of labeling in electronic format for all marketing applications. In April 2005, the agency released a corresponding guidance document titled, “ Guidance for Industry: Providing Regulatory Submissions in Electronic Format – Content of Labeling”. As of October 31, 2005, SPL is the required format for submission of “content of labeling” for prescription drugs.
The SPL program has evolved under the umbrella of the DailyMed Initiative, which is a partnership between the FDA, National Library of Medicine, and healthcare information suppliers. The goal of this initiative is to enhance patient safety through accessible medication information. The SPL information will pass through multiple systems as it is dispersed. A sponsor produces and submits SPL to the agency. The SPL is stored in the Electronic Labeling Information Processing System (ELIPS) at the FDA. The information then goes to the DailyMed database at the National Library of Medicine where current prescribing information is made available to healthcare information providers.
SPL is based on the Clinical Document Architecture (CDA) developed by Health Level Seven (HL7), an ANSI accredited standards organization. It is an XML (extensible Markup Language) based standard that facilitates the submission of product labeling in both a human readable and machine processable format.
SPL has three basic components:
- Header: The header offers general information about the label and product
- Sections: The Label is divided into sections or “semantic units” that are defined in the specification and based on regulations and needs.
- Data Elements: These elements provide specific information about the product and capture a subset of the data elements that are currently submitted via the FDA Form 2657.
It is expected that SPL will be expanded to FDA CBER (Vaccines) as early as Janaury 2006. Phase 2 of the project begins in August 2006 and will include expansion of SPL to cover OTC and non-application prescription drug products. Eventually, it is expected to be implemented for veterinary medicines and medical devices.
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