It has been almost two years since I published “RFID is DEAD…at Unit-Level in Pharma” and we are approaching a pivotal decision by the Food and Drug Administration (FDA) that will determine whether or not RFID will be acceptable for identifying drugs in the U.S. supply chain. Last Thursday was the scheduled final closing of the recent request for comment issued by the FDA formally known as “Bar Code Technologies for Drugs and Biological Products; Retrospective Review Under Executive Order 13563; Request for Comments, 76 Fed. Reg. 66,235” (Oct. 26, 2011) [Docket No. FDA-2011-N-0719].
The closing of this request for comment (RFC) means that it is now time for the FDA to figure out what they might do with the original questions. That is, should they change the requirement for all packages of prescription drugs and many over-the-counter (OTC) drugs in the U.S. to contain the National Drug Code (NDC) encoded into a linear barcode? And if so, what should they replace it with? The RFC doesn’t give any hints about how far they might go and simply asks a series of questions of the industry and interested parties, letting the respondents propose whatever they think the agency should do.
I have spent my Sunday afternoon reading (OK, in some instances, skimming) through all of the responses. They are available for anyone to read (or skim) at http://www.regulations.gov (search for FDA-2011-N-0719). Considering that the input received from this RFC may influence the FDA’s decision about what to replace the linear barcode requirement with, I think Continue reading Will the FDA Accept RFID for Drug Identification?
That’s right. And it comes from an economic reality that was evident even six years ago. That was when a small group of people with various pharmaceutical supply chain backgrounds had an informal discussion of the relative costs and impacts that each of the three primary business segments in the supply chain would face in a full deployment of Radio Frequency IDentification (RFID). As I recall, this conversation may not have even been part of the official proceedings of the project we were assembled to work on at the time. It may have actually occurred during one of the social hours after a day of meetings, but it stuck with me. Ever since that time I kept meaning to get around to creating the graphs that we envisioned at that time but have never gotten around to it, until now. Continue reading RFID is DEAD…at Unit-Level in Pharma
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