FDA Requiring Bar Codes on Drugs

According to an article by Diane Romza-Kutz and Debra Bogo-Ernst, the U.S. Food and Drug Administration (FDA) is now requiring "bar codes" on most prescription drugs and certain over-the-counter drugs. The FDA hopes that the ne rule (69 Fed. Reg. 9120, 9120 on Feb. 26, 2004) will reduce 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 in the right dose and right route of administration is being given to the right patient at the right time.

Although the Final Rule became effective on April 26, 2004, drug products that receive approval on or after that effective date must comply with the bar code requirement within 60 days after the drug’s approval date. Drug products that received approval before April 26, 2004 must comply with the bar code requirement within 2 years of that date.