FDA TO HOLD PUBLIC MEETING ON ELECTRONIC DRUG REGISTRATION RULE

The FDA will hold a public meeting Dec. 11 to discuss its proposed electronic identification system for drugs and other changes to the National Drug Code (NDC) Directory. The agency also extended the period to make comments on the proposals to Jan. 26, 2007.

The meeting will be from 9 a.m. to 4 p.m. in Rockville, Md., the FDA said in a notice in the Oct. 31 Federal Register. Attendees must register for the meeting by Nov. 24, the same day that written or electronic comments submitted for consideration at the meeting are due.

The proposed rule, published in the Aug. 29 Federal Register, would require manufacturers to electronically register all their products in the FDA's Electronic Drug Registration and Listing System. The proposal came soon after an HHS Office of Inspector General report blasting the agency's NDC Directory as incomplete and inaccurate.

The Federal Register announcement can be viewed at www.fda.gov/OHRMS/DOCKETS/98fr/05n-0403-nec0001.pdf (http://www.fda.gov/OHRMS/DOCKETS/98fr/05n-0403-nec0001.pdf).