The purpose of the bar coding rule is to reduce transfusion errors and increase patient safety. CBER will carefully review any request for exception or alternative. The bar code regulation for drug products recognizes that exemptions may be warranted when compliance would adversely affect the drug's safety, effectiveness, purity or potency or not be technologically feasible. In the preamble to the rule discussing exemptions for drug products, FDA noted that almost all drug products are capable of bearing a bar code. FDA noted that we would not consider written requests based on reasons such as financial reasons, a claimed low rate of medication errors, or a claim that the product is unique such that medication errors do not occur or rarely occur. In assessing requests for exemptions for blood and blood components, FDA would follow the same approach as that described in the drug regulations (21 CFR 201.25(d)). | 
