FDA regulations require that certain human drug and biological product labels contain a bar code consisting of, at a minimum, the National Drug Code (NDC) number (21 CFR 201.25). This guidance provides questions and answers relating to how the bar code label requirements apply to specific products or circumstances. The questions are based on those posed to the Agency since the final rule published in February 2004. This guidance, which is a revision of the April 2006 version, contains input from the Center for Biologics Evaluation and Research.
FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.
In the Federal Register of February 26, 2004 (69 FR 9120), we published a final rule requiring certain human drug and biological products to have on their labels a linear bar code that contains, at a minimum, the drug's NDC number (21 CFR 201.25). The rule also requires the use of machine-readable information on blood and blood component labels (21 CFR 606.121(c)(13)).
Bar codes will allow health care professionals to use bar code scanning equipment to verify that the right drug (in the right dose and right route of administration) is being given to the right patient at the right time. This new system is intended to help reduce the number of medication errors that occur in hospitals and health care settings