FDA Proposes New Rule to Automate Drug Registration and Listing

Electronic Submission of Detailed Drug Information to Help Build Searchable Database for Drugs

August 23, 2006 - The U.S. Food and Drug Administration (FDA) today issued a proposed rule to make managing drug information more efficient and effective by automating the process by which drug firms register themselves and list their products with FDA. The proposed rule is part of a broader federal effort to modernize the management of health information.

The Electronic Drug Registration and Listing System would make the complete list of drug products marketed in the United States readily accessible electronically. Currently, part of the list is kept on paper. The new proposal would improve the quality and completeness of the drug product information that FDA receives and manages.

Users of the list also include other government agencies, healthcare providers and healthcare payers. The list, which currently has more than 120,000 drug products, contains up-to-date information about specific drug formulations and manufacturers. The data includes ingredients, dosage forms, strengths, labeling and manufacturer information. Drug developers and manufacturers would be required to submit establishment registration and drug listing information electronically, rather than on paper.

“Having drug makers submit drug information electronically will help to keep an accurate, up-to-date inventory of drugs on the market,” said HHS 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.”

The National Drug Code Directory relies primarily on drug listing information to provide details on marketed drug products. Drug establishment registration provides FDA with drug manufacturing, repacking, and relabeling locations and contact information. FDA uses this information to identify sites for inspection and for other regulatory and drug-safety purposes. These data are used, among other things, to identify alternate product sources during drug shortages and to facilitate drug recalls.

“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 providing FDA better-organized and more reliable information about drugs in the marketplace, this initiative also supports the agency’s continuing efforts to ensure the safety and quality of drugs in the United States.”

The proposed revisions would also reorganize and clarify current regulations concerning which drug establishments must register and list their drugs with FDA and what information they must submit. The proposal would change the system FDA uses for assigning a drug listing number (the National Drug Code, or NDC), to marketed drugs, and would require drugs to display the NDC code on their label. FDA maintains the repository of NDC numbers in its Drug Registration and Listing System (DRLS) and publishes an extract of this information in its NDC Directory.

The proposed rule supports the implementation of broader initiatives within HHS which provide accessible electronic drug product information to healthcare providers, consumers, and the public. These include the electronic prescribing provisions of the Medicare Prescription Drug Improvement and Modernization Act, FDA’s recent rulemaking requiring bar codes on certain drug product labels, and the DailyMed/FACTS@FDA programs.

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Laura Alvey

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U.S. Food and Drug Administration (FDA)

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