Department of Health and Human Services, Food and Drug Administration: Bar Code Label Requirement for Human Drug Products and Biological Products, GAO-04-532R, B-293752, March 12, 2004
B-293752, Mar 12, 2004
This is our report on a major rule promulgated by the Department of Health and Human Services. It was published in the Federal Register as a final rule on February 26. The final rule requires certain human drug and biological product labels to have bar codes that must contain the National Drug Code number in a linear bar code. FDA states that the rule 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. Whichever is later. 5 U.S.C. 801 (a)(3)(A). The rule was published in the Federal Register on February 26.