FDA Proposes Changes to National Directory
FDA on Wednesday proposed new regulations intended to improve the accuracy of information in the National Drug Code Directory, a federal database of prescription and over-the-counter drugs, the Wall Street Journal reports (Corbett Dooren, Wall Street Journal, 8/23).
The directory currently does not include about 9,200 medications and includes 34,200 treatments no longer on the market or listed in error, according to a report released earlier this month by the HHS Office of Inspector General. The report finds that the problems limit the usefulness of the directory, which FDA and other federal agencies use to handle recalls, identify medication errors and manage imports.
As of February 2005, the directory included 123,856 prescription drug products, compared with about 39,000 in 1990. Most of the problems with the directory resulted because pharmaceutical companies did not comply with a federal law that requires them to list their medications with FDA, the report finds.
FDA has not taken criminal or regulatory action against pharmaceutical companies for failure to comply with the law, according to the report (California Healthline, 8/15).
Under the FDA proposal, companies would be required to provide electronic updates every six months on where their prescription and OTC drugs are made and whether they are still on the market. Currently, companies file paper registrations to FDA when they start or stop selling a drug (Washington Post, 8/24).
The proposal also would change the system FDA uses for assigning drug listing numbers, known as the National Drug Code, and would require drugs to display the NDC on their label.
The proposal is subject to a 90-day comment period (Wall Street Journal, 8/23).