Barcode Label Requirements

Barcoding involves encoding information into a series of parallel lines or concentric circles readable by an optical machine. Encoded information details characteristics about a particular product. Federal regulations in the United States stipulate what information must be encoded for specified products. These measures contribute to product consistency and consumer protection.

Federal Food, Drug and Cosmetic Act

• The Federal Food, Drug and Cosmetic Act applies to manufacturers, repackers, relabelers and private label distributors of a human prescription drug product or an over-the-counter (OTC) drug product, according to the U.S. "Code of Federal Regulations." While some products receive exemption from barcode requirements under the act, major product categories which must be barcoded include prescription drugs, biological products and OTC drug items.

Information and Placement

• Beyond requiring that certain drugs must be barcoded, the barcode itself must contain required information. For example, the National Drug Code number must be in linear code, conforming to European Article Number/Uniform Code Council or Health Industry Business Communications Council (HIBCC) standards. Additionally, the bar code must have enough blank space surrounding it providing ideal reading capability.

Exemptions

• For exemption from barcoding requirements a manufacturer or packer must prove that barcoding would somehow adversely affect the product, or would not be "technologically feasible" after unsuccessfully finding an alternative package design. Products used in a hospital setting or given directly to patients in the form of samples may not require barcoding. Requests for exemption should be sent to the Food and Drug Administration's (FDA's) Center for Drug Evaluation and Research in Rockville, Maryland.

Technological Requirements

• With the advent of new identification technologies, such as radio frequency identification (RFID) chips, questions have arisen about the use of such technologies in lieu of barcoding. The FDA has rule that liner bar codes must be used on all applicable products, but additional information may be encoded using different technologies, such as RFID.