FDA requires drug makers to submit drug labels electronically

The U.S. Food and Drug Administration is now requiring drug manufacturers to submit prescription drug labels electronically. The change, which went into effect last week, will keep the public better informed and improve patient safety, according to a statement from the FDA.

The new regulation will allow health care providers and the public to more easily access product and prescribing information found in FDA-approved packet inserts or labels for all approved prescription medicines in the U.S., the agency said.

Providing health care providers and patients with clear, concise information about their prescriptions will help ensure safe use of drugs and better health outcomes, Health and Human Services Secretary Mike Leavitt said in the statement. Now medication information will be easy to access on a publicly available Web site, and this will lead to future innovations with health information technology.

Drug manufacturers are now required to submit the prescribing and product information in a structured product labeling (SPL) format that provides accurate, up-to-date drug information using standardized medical terminology in a readable, accessible format, the FDA said.

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

As the FDA receives the SPL-formatted labeling information, it will become available, free of charge, via the Web. Drug manufacturers, technologists and the FDA worked together to develop the SPL standard, according to FDA spokeswoman Karen Mahoney.

Industry has been having minor problems coding more complicated labeling situations, Mahoney said. However, we are expecting that these will be sorted out quickly. The FDA has been advising industry in these situations.

The new electronic product labels will be the primary source of medication information for DailyMed, a new, free, interagency online health information clearinghouse for consumers, health care providers and health care information providers, the FDA said. Within one year, product labels for most approved prescription medications will be posted on DailyMed, according to the FDA.

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