An acronym for Structured Product Labeling, which is a document markup standard approved by Health Level Seven (HL7). It has been adopted by the U.S. Food and Drug Administration (FDA) as the required mechanism for manufacturers and distributors to exchange product and facility information.
Under this standard, companies must convert all new and existing narrative labeling content, along with drug listing information, into an XML format for submission to the FDA. This labeling contains a summary of the essential scientific information required for the safe and effective use of a drug, and it applies to both prescription and over-the-counter (OTC) products.
The primary goal of SPL is to ensure a uniform approach to labeling content by creating a standard format for details like ingredient names, package types, and dosage forms. This standardized XML format ensures that all labeling content is both human-readable and machine-processable, which allows for the timely and accurate review, storage, and distribution of product information.
The benefits of this system include improving patient safety with accurate and consistent information, providing readily available content for consumers, and reducing the manual effort associated with the review and approval of labeling content.
