Department of Health and Human Services, Food and Drug Administration: Bar Code Label Requirement for Human Drug Products and Biological Products
GAO-04-532R: Mar 12, 2004
- Full Report:
GAO reviewed the Food and Drug Administration's (FDA) new rule on Bar Code Label Requirement for Human Drug Products and Biological Products. GAO found that (1) the rule would require certain human drug and biological product labels to have bar codes that must contain the National Drug Code number in a linear bar code, which FDA states will help reduce the number of medication errors in hospitals and other health care settings by allowing health care professionals to use bar code scanning equipment to verify that the right drug is being given to the right patient at the right time; and (2) the FDA, with the exception of the delay in effective date, complied with applicable requirements in promulgating the rule.