FDA to drug makers: Submit labels electronically

07.11.2005
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.