DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service
The regulations at 21 CFR 201.25 and 610.67 require bar codes on the labels of most prescription drugs, biologics, and OTC drug products that are dispensed pursuant to an order and are commonly used in hospitals. Under 21 CFR 201.25(d)(1), in response to a written request from a manufacturer, repacker, relabeler, or private label distributor, FDA may exempt a drug product from the barcode label requirements. A manufacturer, repacker, relabeler or private label distributor who requests an exemption under § 201.25(d)(1) must document why:
- Compliance with the bar code requirement would adversely affect the safety, effectiveness, purity or potency of the drug or would not be technologically feasible, and the concerns underlying the request could not reasonably be addressed by measures such as package redesign or use of overwraps, or
- an alternative regulatory program or method of product use renders the barcode unnecessary for patient safety.
As noted in the preamble to the final rule, we will not consider written requests that are based on other reasons such as financial reasons, a claimed low rate of medication errors, or a claim that the product is somehow unique such that medication errors do not occur or rarely occur (see 69 FR 9120, 9131 (February 26, 2004)). Additionally, we will not consider written requests that are based on small vials or containers, but firms may alternatively modify the drug’s immediate container to accommodate a label bearing a bar code (response to comment 27, 69 FR 9120 at 9131).
- a donation numbering system that ensures globally unique identification;
- the information to be transferred, using internationally agreed reference tables;
- an international product reference database;
- the data structures in which this information is placed;
- a bar coding system for transfer of the information on the product label;
- a standard layout for the product label;
- a standard reference for use in electronic messaging.