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Make Your Mark in Item Identification Standards

With a two-year extension in meeting California’s electronic pedigree rules, you may be tempted to postpone your serialization efforts for a while. You do have more time now to revisit your options, but start planning your programs as soon as you can.

In the meantime, you have two more-pressing deadlines to meet next month. FDA has asked for your comments on standards and technology for drug identification. At issue are standards for numerical identifiers as well as track and trace or authentication technologies. You have until May 19 to weigh in on both.

Health and Human Services Secretary Michael O. Leavitt is charged with developing a “standardized numerical identifier to be applied to a prescription drug at the point of manufacturing and repackaging (in which case the numerical identifier shall be linked to the numerical identifier applied at the point of manufacturing) at the package or pallet level, sufficient to facilitate the identification, validation, authentication, and tracking and tracing of the prescription drug.” He also has to develop standards addressing “radio-frequency identification, nanotechnology, encryption technologies, and other track and trace or authentication technologies.” All by March 2010. Ideally, the numerical identifier standard would be harmonized with international consensus standards.

Do not miss your chance to comment. At every California State Board of Pharmacy (BoP) Pedigree Enforcement Committee meeting I’ve attended, drug companies have decried the lack of standards and scant FDA guidance. You now have your chance to share your concerns.

Some stakeholders may be reluctant to speak up. It may almost feel like asking for more regulations and responsibilities. But FDA needs answers to some pretty important questions. For instance, “Should the standardized numerical identifier contain recognizable characteristics (e.g., National Drug Code number) or be random codes?” the agency asks. There is interest in using the global trade item number (GTIN), specifically the serialized global trade item number (SGTIN) without an embedded NDC in the GTIN. Would that work for your company? 

Also, asks FDA, “Should the numerical identifier be machine readable, human readable, or both?” Answers to this question may also include discussions of technology feasibility as well as the need for redundancy and fail-safe systems. For instance, some companies are looking at backing up RFID with 2-D Data Matrix. But is this needed?

FDA asks whether certain standards should be developed and implemented before others and perhaps even concurrently. These questions bring to mind the potential for aligning drug identification with medical device identification. (After soliciting industry comments on what FDA calls unique device identification in 2006, the agency is currently preparing regulations for identifying medical devices.) A common system could ease product recalls, reduce medical errors, and facilitate billing, which could help Secretary Leavitt meet a number of his goals. FDA may be interested in a common system—but are you?

FDA is also looking at how track-and-trace systems would operate in the U.S. supply chain. It wants to consider feasibility, costs, timeline, interoperability, information technology, and data storage. Answering this question is vital for smooth operations with your supply chain partners. At the CA BoP meetings, for instance, retail pharmacy chains expressed reluctance to invest in hardware and software to read  2-D bar codes or RFID, because they were waiting to learn what the pharmaceutical industry would do. 

Data handling is also a concern. “How [should] the data generated from track and trace be held, [and] where?” What “means for access to ensure interoperability for data sharing” is needed? FDA asks. And, “What elements should be included in such a standard for data exchange, storage, and interoperability?” While I have heard some people ask whether there would be a “great database in the sky” for every product, on-demand data sharing seems more feasible—but will that satisfy everyone along the supply chain?

These are exciting times for both the pharmaceutical and medical device industries. Unique item identification can play powerful roles in fighting counterfeiting and medical errors as well as reducing waste up and down the supply chain. These threats are converging and taxing the healthcare system. By sending comments to FDA, you can help drive standards and play important roles in increasing product safety and supply chain efficiency.

Daphne Allen
Editor

Drug Pedigrees*?
As pedigree builders know, the bar code’s one sticking point is that to read it, you always need line of sight for every bar code. Or do you?

Single Source Solution
New software brings one-stop serialization to pharma packaging. 

Pharma Serialization and Data Carrier Choices
A provider of UHF Gen2 RFID addresses the RFID versus 2-D Data Matrix debate.

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