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FDA workshop talks Turkey about item-level pharmaceutical packaging

Turkey and France are out in front requiring serialization of drug packages, while the U.S. is in a catch-up position.

Pw 1957 Bar Code Meds

The packaging executives who gathered at the U.S. Food and Drug Administration track-and-trace workshop in mid-February didn’t mean the bird when they talked Turkey between sessions at the FDA White Oak Complex in Silver Spring, MD. They were referring to the country—more particularly—its drug package serialization requirements, which have gone into effect, and whose requirements and standards may or may not jibe with the standards the FDA is developing for the U.S. market.

The workshop was held so that the FDA could get industry input into standards it is developing for track-and-trace of item-level pharmaceutical packaging. The FDA Amendments Act (FDAAA) passed in 2007 requires the FDA to establish standards on authentication, interoperability, and data management. Pharmaceutical manufacturers, who swarmed the two-day workshop, voiced concern that standards the FDA might develop could conflict with those underlying the pharmaceutical packaging security programs already instituted by Turkey, whose program will probably be mimicked by countries in the EU.

Turkey has been out in front, internationally, in requiring serialization of drug packages, with France a close second. The U.S. is in a catch-up position. The 2007 FDAAA doesn’t actually require manufacturers to serialize packages or to track-and-trace them; it just tells the FDA to develop standards manufacturers can use. However, the state of California does require manufacturers to serialize packages starting in 2015, and to pass an electronic pedigree. Nearly everyone in the U.S. pharmaceutical industry expects the FDA, with a congressional grant of authority or without, to require e-Pedigrees nationally—or even a more robust track-and-trace system—as to avert a patchwork of 50 state laws kicked off by California’s action.

Even Virginia Herold, executive officer at the California Board of Pharmacy, appearing at the FDA workshop via video conference from California, said, “We need a federal solution, although I’m not sure when that will start.”

The problem is, from the standpoint of pharmaceutical manufacturers, that the U.S. seems headed down the track-and-trace road, while Turkey and France have stopped well short of that, complicating matters for companies such as GE Healthcare, which manufactures off one packaging line for multiple countries.

Gordon Glass is director of manufacturing project management at the medical diagnostics unit at GE Healthcare, which has finished serializing the packaging line at its Cork, Ireland, manufacturing plant. The plant produces contrast media products used in conjunction with x-ray and MRI devices. Turkish requirements have been a big motivator for GE Healthcare, since its Cork plant produces product for Turkey (and the U.S. for that matter). GE Healthcare will be serializing 12 other packaging lines at Cork, and in Norway and Shanghai, between now and 2014 as countries around the world, including the U.S., impose anti-counterfeiting packaging requirements on item-level drug packages arriving at their borders.

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