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Pharmaceutical & Medical Packaging News, November/December 2014

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Editorial pmpnews.com • Pharmaceutical & Medical Packaging News November/December 2014 8 ® PMP News is on Follow Daphne username: @daphneallen Brand Director–Packaging Steve Everly 610/705-8705 E-mail: steve.everly@ubm.com Co-Executive Editor Daphne Allen 310/445-4263 • Fax: 310/445-4269 E-mail: daphne.allen@ubm.com Co-Executive Editor Lisa McTigue Pierce 630/481-1422 E-mail: lisa.pierce@ubm.com Technical Editor Rick Lingle 630/481-1426 E-mail: rick.lingle@ubm.com Account Director Doris Luftglass 310/740-9073 E-mail: doris.luftglass@ubm.com Reprints Wright's Media 877/652-5295 sales@wrightsmedia.com List Rentals Statlistics • 203/778-8700 Postal lists Jennifer Felling, j.felling@statlistics.com E-lists Turk Hassan, t.hassan@statlistics.com Circulation Management Knowledge Marketing Corey McMahon, corey.mcmahon@teamkm.com UBM Canon 310/445-4200 • Fax: 310/445-4299 DEPARTMENTAL STAFF Creative Director Marco Aguilera Art Director Prakash Barnabas Publications Production Director Jeff Tade Production Manager Anbarasan Mannar Production Coordinator Rajan Muthu Marketing Manager Mary Williams Group Director, Audience Data & Segmentation Sandra Martin EXECUTIVE OFFICERS CEO Tim Cobbold Executive Vice President, Managing Director Josh Dome Vice President/Design & Manufacturing Portfolio Director Roger Burg Senior Vice President/Medical Portfolio Director Steve Corrick Senior Vice President/Content & Strategy Pam Moore Senior Vice President/Integrated Media Amy Sklar Senior Vice President/Event Sales Ruthann Fisher Data Exchange per FDA I n an era of smart phones and the Internet of Things, it may be a little surprising to some that FDA's November 2014 draft guidance on exchanging pre- scription drug product information allows the exchange of both paper- and electronic-based methods. Others may be breathing a sigh of relief. Allowing both paper and electronic methods "will allow the sup- ply chain to mature," observes Bob Celeste, senior direc- tor, pharmaceutical sector, for GS1 US. "To get such a big industry to make a change will take time. The supply chain will be in transition for a few years." Written to satisfy provisions of the Drug Supply Chain Security Act (DSCSA), "Standards for the Interoperable Exchange of Information for Tracing of Certain Human, Finished, Prescription Drugs" explains that "trading partners can utilize current paper-based or electronic-based methods for the interoperable exchange of data to provide product tracing information to subsequent purchasers," reads FDA's announcement. Specific methods include (but are not limited to) paper or electronic versions of invoices, paper versions of packing slips, Electronic Data Interchange (EDI) standards, and EPCIS (Electronic Product Code Information Services). Celeste believes that most partners "likely will not pass paper along, but they will interpret and transcribe what is on that paper into EDI or EPCIS systems and move the information along in transaction statements. These statements must rep- resent the truth and may not change or manipulate any facts." While the November 2014 draft doesn't directly address packaging issues, it could help reassure manufacturers "making large investments in infrastructure that it is not all for naught," says Celeste. It allows them to "visualize how all of it—the software, data, codes, and what goes on the package—connects together." Celeste believes the guidance "gives manufacturers enough to start with, but there are still a lot of questions." Many such questions surround packaging, labeling, and coding issues, so coupled with DSCSA's 2017 deadline for serializing saleable items, FDA's acceptance of paper may give industry—and the agency—the time they need. For instance, even though FDA spelled out its expectations for item-level serializa- tion in its 2010 guidance on "Standardized Numerical Identification for Prescription Drug Packages," the agency still needs to reconcile them with its 2004 Bar Code Rule requiring linear bar codes for hospital-distributed drugs. Otherwise, packages will be carrying two bar codes—one linear and another one (most likely a 2-D code) to carry the serial number. The challenges go beyond space issues, says Celeste. "If the codes are too close together on the label, a typical bar code scanner could pick up the linear code first, and the scan may miss the serial number, expiration date, or lot code," says Celeste. He is optimistic that FDA will clarify such challenges by 2017. But other questions remain. "How do you actually exchange the transaction state- ment? Is it the actual data, or just an indicator?" he asks. FDA "intends to issue additional guidance," Celeste notes. He believes "FDA is being very careful about how it issues guidance—and it will come in phases." He advises manufacturers to read the DSCSA law and all FDA's related guidances very carefully. Comments on the draft guidance will be accepted through January 27, 2015. Daphne Allen, Editor

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