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Structured Product Labeling (SPL) is a Health Level Seven International (HL7) standard which defines the content of human prescription drug labeling in an XML format.[1] The "drug labeling" includes all published material accompanying a drug, such as the Prescribing Information which contains a great deal of detailed information about the drug.[2][3] As of Release 4 of the SPL standard, 22,000 FDA informational product inserts have been encoded according to the standard.[3]
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 (proprietary and nonproprietary names, ingredients, ingredient strengths, dosage forms, routes of administration, appearance, DEA schedule) and the packaging (package quantity and type).
- ^ Office of the Commissioner (May 2009). Guidance for Industry: Providing Regulatory Submissions in Electronic Format – Drug Establishment Registration and Drug Listing (PDF) (Report). Food and Drug Administration. Retrieved 2015-07-18.
- ^ Kass-Hout, Taha A. (18 August 2014). "Providing Easy Public Access to Prescription Drug, Over-the-Counter Drug, and Biological Product Labeling". FDA Voice (blog). Retrieved 2015-07-19.
- ^ a b "HL7 Standards Product Brief - HL7 Version 3 Standard: Structured Product Labeling, Release 4". Health Level Seven International. Retrieved 2015-07-19.
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