FDA's Bar Code Rule
FDA's proposed bar code rule for prescription and OTC drugs used in hospitals aims to prevent medication errors.
FDA’s long-awaited proposed rule on bar coding requires all prescription drugs and some other healthcare products to be bar coded. But it does not specify a symbology or require lot numbers and expiration dates.
The proposal, published in the March 14, 2003, Federal Register [68 FR: 12499–12534], would cover all prescription drug products (including biologics and vaccines but excluding physician samples) and over-the-counter (OTC) drugs dispensed pursuant to an order and commonly used in hospitals. For blood and blood components, “the use of machine-readable information” is all that is required. Medical devices (and biologics regulated as devices) are not covered because “different issues arise for devices than for drugs,” the agency says. It will continue to study whether it should develop a separate rule for devices.
For OTC products, the term commonly used in hospitals means “sold to hospitals; packaged for institutional use; labeled for institutional use; or marketed, promoted, or sold to hospitals through drug purchasing contracts or catalogues.” OTC products such as toothpaste and mouthwash that are dispensed without a physician’s order are not covered.
The rule would require the bar code to contain the drug’s National Drug Code (NDC) number. In concert with that, FDA intends to “redefine the NDC and to make the NDC number unique and more useful to informational databases,” and propose a separate rule on that issue. Use of a Universal Product Code (UPC) number, an International Article Number (the EAN system), or a Global Trade Item Number (GTIN) is acceptable as long as the NDC is present within.
The reason for using the NDC number, the agency says, is that “if we allowed distributors to assign unique identifying numbers and did not coordinate the assignment of such numbers to drugs, the result could be extremely confusing as distributors could use different identification schemes.” It will also be easier for medication-error tracking if information came from a single source.
Lot numbers and expiration dates will not be required. While they would “make it easier to identify drugs that had been recalled or were expired, we neither found nor received data to show that the benefits of bar coding lot number and expiration date information would exceed the costs of putting that information in the bar code,” the agency says. The purpose of the rule is to prevent medication errors, and considerations such as tracking products and identifying counterfeits are secondary. The agency will not object if such information is included.
In lieu of requiring a certain symbology, the proposed rule calls for the bar code to be “any linear bar code in the UCC (Uniform Code Council)/EAN standard.” That, the agency says, “should give firms some flexibility in selecting the bar code symbology that best fits their needs and should also give the rule some flexibility as linear bar code symbologies change, are added, or are phased out. However, FDA acknowledged that some firms may prefer to use Health Industry Business Communications Council (HIBCC) bar codes and invites comment as to whether the rule should refer to “linear bar codes” without reference to any standard.
The proposal does not specify the use of Datamatrix, radio-frequency identification (RFID), or other non-linear formats because hospitals that already have linear scanners would not want to pay to upgrade them or purchase new ones. In addition, the agency believes linear bar codes are sufficient for encoding NDC numbers.
The bar code would have to be surrounded by sufficient blank space so it can be scanned correctly and remain intact under normal conditions of use. The agency does not plan to audit bar code quality or develop guidances on that topic, instead relying on a firm’s use of CGMPs to ensure its quality and verification.
The rule would require the bar code to appear on the label—both on the immediate container label as well as the outside container or wrapper. There will not be a requirement for the specific location on the label.
There are no plans for an exemption process for small packages or other product or package classes because the agency believes that almost all products are capable of bearing a bar code, especially with the advent of Reduced Space Symbology (RSS) linear bar codes.
Implementation would occur within three years after FDA publishes a final rule.
Written or electronic comments on the proposed rule must be submitted by June 12, 2003. Written comments can be sent to the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Electronic comments can be submitted at www.fda.gov/dockets/ecomments.