FDA's Proposed Rule to Modify the NDC and Barcode Regulations

Regulatory Strategy Jerry Phillips of Brand Institute (BI) recently summarized plans of rhe FDA to modify regulations to establish a uniform, 12-digit format for the National Drug Code (NDC) (21 CFR 207.33) that can accommodate longer NDCs once the FDA begins issuing 6-digit labeler codes.

The FDA estimates that it will exhaust its inventory of available 5-digit labeler codes and begin assigning 6-digit labeler codes in 10-15 years. summary on the recent FDA proposal to modify its regulations to establish a uniform, 12-digit format for the National Drug Code (NDC) (21 CFR 207.33) that can accommodate longer NDCs once the FDA begins issuing 6-digit labeler codes. The FDA estimates that it will exhaust its inventory of available 5-digit labeler codes and begin assigning 6-digit labeler codes in 10-15 years.

The FDA is also proposing to revise the drug barcode label requirements to allow the use of either linear or nonlinear barcodes, so long as the barcode meets the prescribed standards, said Mr. Phillips. "This will affect all manufacturers of pharmaceutical drug products in designing compliant and safe labels and assuring that patients receive their correctly prescribed medication."