Packaging Forum

Bar Coding Deadline Looms

Hallie Forcinio is Pharmaceutical Technology’s Packaging Forum editor, 4708 Morningside Drive, Cleveland, OH 44109, tel. 216.351.5824, fax 216.351.5684, editorhal@cs.com.

We are now less than a year away from the April 24, 2006, deadline that requires bar coded labels on approximately 153,500 packaging units of prescription and over-the-counter (OTC) drugs dispensed in hospitals. Drug products approved for use after the rule’s April 24, 2004, effective date must be bar coded within 60 days of approval. FDA’s final rule requires a linear bar code representing the product’s national drug code (NDC) to be placed on the immediate container label and the outer wrapper that appears on most prescription and certain OTC drugs commonly used in hospitals, or about 75% of OTC products. The lot number and expiration date do not have to be included, but drug makers may do so, if desired. The rule applies to most drug manufacturers, as well as repackers, relabelers, private label distributors, and blood establishments (www.fda.gov/OHRMS/DOCKETS/98fr/04-4249.htm). The goal is to reduce medication errors by providing an automated means to confirm the right dose is given to the right patient at the right time via the correct administration route. In use, the bar code on the unit dose pack is scanned at the time of administration. For a more complete record, bar codes on the patient’s wrist band and caregiver’s identification badge also could be scanned. Compliance with the unit-dose bar coding rule requires integration of bar code technology, printing, quality control, data collection and transmission, and recordkeeping. If widely divergent packaging formats are involved, more than one solution may be required. Narrowing the choices can be a bewildering, time-consuming endeavor. Further complicating the scenario, many technology providers, early adopters, and trade organizations recommend looking beyond simple compliance to use the information unit-dose coding makes available to gain internal benefits. This means encoding variable information such as the lot number and expiration date in addition to the NDC. “Many benefits can be gained through process changes that take advantage of information available on unit-of-use labels with little incremental labeling or equipment costs,” notes a white paper entitled, “Beyond Point of Care: Benefiting from Unit-of-Use Bar Code Traceability in the Life Sciences Supply Chain” (Zebra Technologies, Vernon Hills, IL, www.zebra.com). In fact, the report notes, “variable-information labeling can improve regulatory compliance, recall management, distribution and returns, production control, product authentication, customer service, and other operations for manufacturers and distributors.” Many of these benefits relate to the increased visibility unit-of-use bar codes can provide. The ability to track product at the batch level throughout the supply chain increases efficiency and improves customer service while ensuring returns are authorized. In recall situations, this level of traceability makes it possible to pinpoint affected quantities and shipments and minimize the amount of product returned. Unit-of-use data also can be valuable in production and inventory management. “Encoding lot numbers in the unit-of-use packaging and marrying that information with electronic production records can satisfy 21 CFR Part 11 [Electronic Records and Signatures Rule] reporting requirements and provide traceability by raw material batch, manufacturing equipment, time of production, equipment operator, and other variables,” the report says. (continued)