The agency estimates that implementing the rule will help prevent nearly 500,000 adverse events and transfusion errors - a reduction of around 50 per cent - while saving $93 billion (€75bn) in health costs over 20 years.
Widespread use of bar coding was first put forward by the FDA in March last year, and has been met with enthusiasm by doctors, the drug industry and patent groups. At present, US hospitals are not required to install bar code scanning systems, but the agency hopes that the new rule will encourage more to embrace the technology not only for inventory control but also at the patient's bedside.
"The rule is designed to support and encourage widespread adoption of advanced information systems that, in some hospitals, have reduced medication error rates by as much as 85 per cent," said Health and Human Services Secretary Tommy Thompson.
In these institutions, patients are provided with identification bracelets that bear a bar code. The health care professional then scans the patient's bar code and that present on the drug. The information system then compares the patients drug regimen information to the drug to verify that the right patient is getting the right drug, at the right time, with the right dose and route of administration.
In a study conducted at a Veterans Affairs Medical Centre employing such a bar-code scanning system, 5.7 million doses of medication were administered to patients with no medication errors.
As a minimum, each bar code for a drug will have to contain its National Drug Code number, although companies may also include information about lot number and product expiration dates.
Machine-readable information is also mandated on container labels of blood and blood components intended for transfusion. These labels, which are already used by most blood establishments, contain symbols identifying the collecting facility, the lot number relating to the donor, the product code, and the donor's blood group and type.
It will come into effect on 26 April. Drugs that are cleared for marketing after that must comply with the bar code requirement within 60 days of the approval date. Those that received approval before that date have two years to come into compliance.