Structured Product Labeling

Structured Product Labeling (SPL) defines the content of human prescription drug labeling in an XML format. This format is defined within the SPL schema and is displayed in a web browser using the SPL stylesheet. It is approved by Health Level Seven (HL7) and has been adopted by FDA as a mechanism for exchanging medication information.

SPL documents contain both the content of labeling (all text, tables and figures) for a product along with additional machine readable information (drug listing data elements). Drug listing data elements include information about the product (product and generic names, ingredients, ingredient strengths, dosage forms, routes of administration, appearance, DEA schedule) and the packaging (package quantity and type).

Background

Since October 31, 2005, labeling submissions to the FDA's Center for Drug Evaluation and Research (CDER) must be in SPL format. In addition, annual report submissions must contain content of labeling in SPL format.

In January 2006, the FDA unveiled a major change to the format of prescription drug information, commonly referred to as the Physician Labeling Rule (PLR). The new format requires that the content of labeling be organized in a specific manner. Other changes include the addition of a Highlights section that contains key benefit and risk information, a table of contents, the date of initial product approval, and a toll-free number and URL for reporting suspected adverse events.

Starting June 1, 2009, the FDA will require all OTC companies and Veterinary Medicines (Vet Med) manufacturers to submit their product labeling in compliance with the SPL standards. Additionally, all companies that produce Pharmaceutical (Rx), Over-the-Counter (OTC), Biologics products, Veterinary medicines, and distributors must provide FDA with all registration listing and drug listings in the SPL electronic format.

FDA-approved SPLs can be viewed and downloaded from "DailyMed" on the National Library of Medicine web site. DailyMed provides free access to consumers and health information providers to comprehensive, up-to-date labeling as found in medication package inserts.

SPL Working Group

The SPL Standard was initially developed by a small group within the HL7 Regulated Clinical Research Information Management Technical Committee. HL7 is an independent and international provider of healthcare standards. PhRMA HL7 Task Group formed the SPL Working Group in January 2004 to further the work of the initial development team.

Composition of the SPL Working Group

The group has grown significantly since its inception in 2004. Participants come from:

• Industry sponsors of human and veterinary (pharmaceuticals, generic pharmaceuticals, biologics, devices, over-the-counter) products submitted to the FDA.
• FDA representatives
• Vendors
• HL7

The SPL Working Group has a Technical Team and a Process Communications Forum. Additionally, a variety of subteams address specific topical and subject issues. Current subteams include: Biologics, VetMeds, Devices, Generics, Establishment Registration Lifecycle, Labeling Content Lifecycle. An Over-the-Counter (OTC) Products subteam is in the early planning stages.

Current Objectives of the SPL Working Group

• Raise industry awareness concerning SPL (on-going)
• Sponsor industry webcasts and meetings, as appropriate
• Provide forum for discussion of issues, best practices, and FDA documentation of SPL
• Review changes to HL7 SPL model
• Review changes to XSL Stylesheet
• Produce revisions to Implementation Guide in line with schema releases
• Determine future direction of SPL Standard

SPL Solutions

Various approaches exist for creating and managing content and data in SPL format. Solutions fall under three basic categories.

• Installed Software
• Software-as-a-Service (SaaS)
• Outsourcing

Installed Software

This approach is associated with solutions that are installed on a desktop or server and hosted and the customers location. Vendors of solutions include:

• i4i - software vendor (A4L) and conversion services
• First Consulting Group - consulting and software vendor (FirstDoc)
• Glemser - software vendor (xmLabeling)
• Intrasphere - consulting
• In.vision - software vendor (SPL Accelerator)
• PTC - consulting and conversion services
• Thinspring - software vendor (splServer) and conversion services (RTIS)
• Virtify - software, consulting, conversion and submission services.

Software-as-a-Service (SaaS)

The SaaS approach is a software deployment model in which an enterprise application is delivered and managed as a service by the vendor to meet the needs of multiple customers simultaneously. A widely used example is the service model used by ADP to provide payroll and other business services to multiple organizations.

SaaS solutions are delivered via a network, most often the Web. They are priced on a subscription service basis.

The SaaS model shifts the burden of getting and keeping an enterprise application up and running from the customer to the vendor. It permits users to leverage the software functionality without the burden of deploying and managing the software themselves. It also eliminates the added costs and complexities of deploying additional hardware and software, or dedicating additional staff resources to support the enterprise application on an ongoing basis.

The SaaS model also enables every customer to benefit from the vendor’s latest technological features without the disruptions and costs associated with software updates and upgrades.

SPL SaaS Applications

• SPL Portal

Outsourcing

Outsourcing involves the transfer of the creation of SPL to external service provider. The client organization and the supplier enter into a contractual agreement that defines the transferred services. The client agrees to procure the services from the supplier for the term of the contract.

SPL Outsourcing Providers

• Data Conversion Laboratory (DCL)
• Intagras
• i4i

References

• U.S. FDA resource page
• DailyMed
• Guidance for Industry: Providing Regulatory Submissions in Electronic Format – Drug Establishment Registration and Drug Listing (Draft)

Other Links

• HL7 website
• FDA SPL Resources
• PhRMA
• CHPA
• GPHA
• AHI
• GADA
• Comments on Federal Proposed Regulations, Guidances, et al.