WEDNESDAY, Nov. 2 (HealthDay News) -- Under regulations effective Wednesday, the U.S. Food and Drug Administration will require drug manufacturers to submit package insert or labels to the federal agency in a new electronic format known as the structured product labeling (SPL).
Intended for use by physicians and patients, the SPL information will be available for free through DailyMed, a new interagency health information clearinghouse. The FDA says that labels for most approved prescription medications will be posted on DailyMed within a year .
Embedded computer tags allow users to electronically manage prescribing and product information, and search for specific drug-label sections such as indications, dosage and administration, and warnings.
Because the format enables physicians to quickly search and access specific information prior to prescribing medication, the FDA says it will lead to better informed decision making and help prevent medication errors.