FDA requires electronic format for prescription drug label data

December 1, 2005

Currently, health-care providers could be accessing information that is as much as1 year out-of-date.

Washington, DC-In an effort to meet President George W. Bush's Management Agenda goal of expanded electronic government, FDA is requiring drug manufacturers to submit prescription drug label information to the agency in a new electronic format. This electronic format will allow health-care providers and consumers to access the product information in package inserts more easily for all approved medications in the United States.

Structured Product Labeling (SPL) is an XML format that allows the electronic management of medication information, resulting in more accurate and complete data that can be provided directly to the health-care community and the public in a timely manner. A standardized, electronic format allows for efficient dissemination of risk information to a broad audience, according to the FDA.

Using embedded computer tags, the content of prescribing information in SPL format can be electronically managed, allowing a user to search for specific information. These tags can instruct computers to read specific sections of a drug label, including product names, indications, dosage and administration, warnings, descriptions of a drug product, active and inactive ingredients, and how the drug is supplied.

The SPL format will result in improvement in the quality of health care by:

These new electronic product labels will be the key element and primary source of medication information for "DailyMed," a new interagency online health information clearinghouse provided by the National Library of Medicine (NLM). The information can be accessed through NLM at http://dailymed.nlm.nih.gov/. In the future, this new product information will also be provided through FACTS@FDA, an FDA Internet resource designed to give one-stop access for information about all FDA-regulated products.

Within 1 year, product labels for most approved prescription medications will be posted on DailyMed. The SPL project, led by FDA's Center for Drug Evaluation and Research (CDER), is the first in an agency-wide initiative regarding the public provision of electronic information. In the future, DailyMed will also include labels for biologics, medical devices, veterinary drugs, and some food products. The goal is for updated product labels to be posted on the site within 1 business day of an approval action by FDA or submission to FDA of a product label change that does not require prior approval.

The DailyMed system was developed in collaboration with federal agencies including: FDA, NLM, Agency for Healthcare Research and Quality (AHRQ), and the National Cancer Institute (NCI) in HHS, and the Veterans Health Administration in the Department of Veteran Affairs.