[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).
The Highlights of Prescribing Information includes a toll-free number and URL for reporting suspected adverse events and a Revision Date that identifies the month and year of the last change to the PI.
Starting June 1, 2009, the FDA required all OTC companies and Veterinary Medicines (Vet Med) manufacturers to submit their product labeling in compliance with the SPL standards.
These machine-readable tags in SPL format allow the information to be easily incorporated, based on assigned codes, into electronic health records, e-prescribing systems and clinical decision support systems for rapid searching, sorting and access of relevant product information needed to make critical health care decisions and enhance patient care.
In 2009 the FDA and National Institutes of Health (NIH) entered into an interagency agreement to develop an SPL Image standard called the SPLIMAGE.
SPLIMAGE is for image files of oral solid dosage forms that are submitted to the Food and Drug Administration (FDA) with SPL documents.
As part of an inter-agency collaboration with the FDA, the National Library of Medicine (NLM) studied the imaging of a broad range of oral solid dosage forms for pharmaceutical products.