Bar Codes Are Mandatory for Drugs

APRIL 01, 2004

The FDA is mandating that prescription drugs and biologic products have bar codes to reduce the risk of medication errors. The new ruling applies to a majority of companies that manufacture, repackage, or relabel drugs, FDA officials said. The agency regulation calls for manufacturers to put bar codes on labels of most prescription drugs, some OTC drugs, and blood products to improve the way they are tracked and dispensed. Although each bar code must contain the drug's National Drug Code, companies may include additional information about product expiration dates and lot numbers.

Once fully implemented, FDA officials predict that bar codes will help prevent almost 500,000 complications and transfusion errors over 20 years for an estimated savings of $93 billion in lowered health care costs, patient pain and suffering, and lost work time. Any new drugs covered by the rule will have to include bar codes within 60 days of their approval. Medicines that have already been approved, as well blood and blood products, must be in compliance within 2 years.


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