Drug information will be managed more efficiently under a Food and Drug Administration proposal to automate the process used by drug companies to register themselves and list their products with the US agency. Issued on August 23, 2006, the proposed electronic drug registration and listing system would make the complete list of drug products marketed in the US readily accessible electronically.
Currently, part of the National Drug Code Directory of over 120,000 drug products is kept on paper. “Having drug makers submit drug information electronically will help us to keep an accurate, up-to-date inventory of drugs on the market,” said Health and Human Services Secretary Mike Leavitt. “This will help us maintain more accurate information and make it easier for us to respond to drug emergencies such as recalls and drug shortages.”
And, announcing this initiative in the Federal Register, the FDA stated: “We rely on establishment registration and drug listing information for administering many of our programmes, such as post-marketing surveillance (including FDA inspections), bioterrorism, drug shortages and availability, and user fee assessments.” The current Directory is used not only by the FDA but also by other government agencies, healthcare providers and healthcare payers and contains information on more than 120,000 drug products, including ingredients, dosage forms, strengths, labelling and manufacturer data.
The proposed revisions to the current regulations would re-organise and clarify current regulations concerning which drug establishments must register and list their drugs with the FDA and what information they must submit. The system for assigning a drug listing number (the National Drug Code) would be changed and drugs would be required to display the NDC code on their label.
The proposed rule is part of a broader federal initiative to modernise management of health information and provide accessible electronic drug product information to healthcare providers, consumers and the public. It would support the full implementation of the electronic prescription provisions of the Medicare Modernisation Act: e-prescribing is mandated by the Act for plans offering the new Medicare drug benefit by 2009. The proposal would also support the FDA’s recent requirement for bar codes on certain drug product labels.
“The conversion to an electronic system will make the registration and listing process more efficient and effective for industry and the agency,” said Janet Woodcock, FDA Deputy Commissioner for Operations. By Jeanette Marchant and Lynne Taylor
