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Drug Firms Granted Two More Years to Comply With Tracking

Drug companies will have another two years to put in place electronic drug-tracking technologies aimed at combating counterfeit medicines under a state Board of Pharmacy decision made March 25 in San Diego.

Under pressure by drug makers and suppliers to push back a Jan. 1, 2009, deadline requiring electronic pedigrees on all prescription drugs in California, the pharmacy board unanimously voted to give companies until Jan. 1, 2011, to come up with solutions.

“We believe this will give the supply chain adequate time to get it right,” said Liz Gallenagh, senior director of government affairs for the Healthcare Distribution Management Association.

California could become the first state in the country to require electronic drug tracking by all segments of the health care supply chain, including manufacturers, distributors and pharmacies. Each bottle or small drug container would include electronic information such as name of the prescription medicine, the dates of all previous sales and shipping information.

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California originally required the tracking in 2004, following a recall of fake bottles of the cholesterol drug Lipitor.

Allow More Time

Industry executives implored the board to allow them more time at a meeting held at the Town and Country Resort and Convention Center in Mission Valley March 25.

“My concern is we don’t want to be the gate that stops consumers from getting their product because our manufacturing partner does not have an e-pedigree,” Ronald Bone, senior vice president of distribution support for San Francisco-based McKesson Pharmaceutical, told board members prior to their vote.

Lara Simmons, corporate vice president of quality assurance and regulatory affairs for wholesale hospital supply company Medline Industries Inc., said the implementation of e-pedigrees would disrupt the way surgical kits are manufactured. Because each kit contains multiple drugs and surgical supplies tagged with a single bar code, Simmons said complications would arise if each unit had to be tagged separately.

“Current e-pedigree formats were not designed for medical kits,” she said.

Some members grew frustrated at presenters asking for additional time to comply.

“We’ve been hammering on this thing since 2004,” said D. Timothy Daz & #233;. “My god, they built an atomic bomb with slide rules in seven years.”

Despite his sharp comments, Daz & #233; voted alongside the rest of the board to extend the deadline.


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