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Web Sightings
Informative and interesting industry news and views from web sites around the globe.
Guidance for Industry, Bar Code Label Requirements, Questions and Answers
FDA regulations require that certain human drug and biological product labels contain a bar code consisting of, at a minimum, the National Drug Code (NDC) number (21 CFR 201.25). This guidance provides questions and answers relating to how the bar code label requirements apply to specific products or circumstances. The questions are based on those posed to the Agency since the final rule published in February 2004.
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Manufacturer Unit-of-Use Bar Coding
With the intention to reduce the number of medication errors that occur in hospitals, the Food and Drug Administration (FDA) published (February, 2004) a final rule requiring bar codes on the labels of certain drugs and biological products. At a minimum, the bar code requires the drug’s National Drug Code (NDC) number. With the clinical use of bar code scanning technology, health care professionals can determine that the correct drug and dose are administered to the patient.
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Implementing a Successful Modular Design – PTC’s Approach
In recent years, companies have made significant investments in optimizing product development and manufacturing operating processes in pursuit of economic value. Unfortunately, many of those same companies have missed the opportunity to tune their product’s architecture to align to their business objectives. In many cases, their product’s architecture has inhibited their ability to execute. In fact, most companies have not made the realization that product’s architecture can determine the fundamental economics of the product as well as company results.
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Bar Code Quality
The first published document concerning the quality of printed bar codes was the Universal Product Code (U.P.C.) Symbol Specification and U.P.C. Verification manuals of the Uniform Code Council (UCC). These “traditional” metrics were based on linear measurements of bar/space widths as seen by the human eye, reflectance values of background vs. bar color when measured through a red filter, and the correct data encodation. However, visual measurement results do not necessarily correlate with bar code scanning systems. In fact, bar codes had been printed that met the existing standards, but would not scan, while bar codes printed outside the standard specifications would scan successfully.
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