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Drug & Device News

By ALM Staff | Law Journal Newsletters |
May 29, 2008

California's Drug Pedigree Program Delayed

The California State Board of Pharmacy has agreed to delay for two years enforcement of a new law intended to cut down on the marketing of counterfeit drugs within the State. The regulation, which was to have gone into effect on Jan. 1, 2009, calls for electronic tracking of drug products. Manufacturers and sellers of pharmaceuticals complained, however, that they would be unable to put adequate tracking systems in place in time to meet the deadline, particularly as they would not be able to segregate products meant for California from those that would go to other states and would thus have to implement the pedigree program for all production lots. Rather than break the law, some asserted that they would simply stop selling their products in California. Once the law goes into effect, possible penalties for disobedience will include criminal prosecution and fines of up to $5,000 per noncompliant unit of product.

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