Brand Institute's Jerry Phillips on the Impact of the FDA's Proposed Rule to Modify the NDC and Barcode Regulations

Jerry Phillips, R.Ph., applies his first-hand knowledge of the FDA's Labeling and Bar Code regulations to assist in preventing medication errors by safely designing and evaluating labels for the pharmaceutical industry.

MIAMI, July 27, 2022 /PRNewswire/ -- Brand Institute (BI) is pleased to share President of Regulatory Strategy Jerry Phillips' 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."

Prior to joining BI as the President of Regulatory Strategy, Mr. Phillips worked at the FDA for 16 years where he became the spokesman for the FDA in preventing medication errors related to naming and labeling issues. He also became a Division Director approving generic drug products and became the first Division Director of what is known today as DMEPA, establishing the FDA's original brand name testing methodology. He was the lead FDA official in proposing a uniform bar code for pharmaceutical products to reduce medication errors.

Brand Institute is the global leader in brand name and identity development, providing a broad portfolio of branding and naming related services, including brand strategy, name development, trademark searches, market research, regulatory services, and visual identity solutions.

Drug Safety Institute (DSI) is a wholly owned subsidiary of Brand Institute that provides Brand Institute's healthcare clients with industry-leading guidance pertaining to drug name safety, packaging, and labeling. DSI is comprised of former naming regulatory officials from global government health agencies, including FDA, EMA, Health Canada, AMA, and the WHO.

Contact:
James Dettore
Chairman & C.E.O.
[email protected]
www.brandinstitute.com

SOURCE Brand Institute, Inc.

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