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California gives industry a two-year reprieve on ePedigree


Pharmaceutical manufacturers, distributors and retailers have also received a unanimous vote of the California State Board of Pharmacy, the deadline by two years the implementation of electronic pedigree required for the pursuit of drugs from manufacturers at the pharmacy.
All major players in the chain, be sure to support the principle of the system ePedigree California. Similarly, if it takes place, all elders of the closing date of the 1st January 2009 to meet the requirements tree was simply impossible to implement in practice because the rest of the unanswered questions surrounding the Track and Trace Technology the lack of standardization in the field, and that the costs and challenges of implementation.

These arguments prevailed in the medicine chest of the meeting, on March 25. The deadline for implementation is now back on the 1st January 2011 will mark the second time that the effective date of ePedigree program was expanded in California.

The proposed legislation also has the power to monitor compliance of delay, by January 2011, when the State captain stated that “the producers or wholesalers of the time needed for the implementation of electronic technologies for disseminating Drug dangerous to the state. ”

The medicine chest had, “he said reluctantly to postpone the agreed timeframe, given that most major pharmaceutical companies, manufacturers, distributors and retailers have been unable, for the purposes until ePedigree 1st January 2009.

According to a report published in The New York Times, Pfizer - which makes it something of a pioneering role in the adoption of radio frequency identification (RFID), technology (albeit selectively), followed by the alignment of treatment of erectile dysfunction, Viagra (sildenafil citrate), forgers - Had said, the board would be five to seven years for the serial number on all its products.

Without the grace of two years, it was a risk that the “California supply of drugs, and perhaps the entire United States supply of medicines May welfare with negative consequences on the” shortage Essential Medicines, pharmacy captain warned.

“The board of directors to the conclusion that its primary mission of protecting the public is best served, with a lag allow for a less embarrassing that the implementation of a rush on respect for the industry in the world”, at he explained. The board said there had received “assurances” from representatives of the pharmaceutical industry, that “it can and should be ready for full implementation” not later than 1 January 2009. ”

The reaction to the decision last Tuesday, the Pharmaceutical Research and Manufacturers of America (PhRMA), was less reassuring. The vote to delay implementation is “a confirmation of the complexity of legal and technological issues that must still be overcome,” comments PhRMA. “And it is even possible that, over 2011, some of the most important challenges remain and are yet to be resolved.”

The most important thing is that the association adds that the decision “shows aboard recognition of the importance of the protection of patients in the state during the transition to the new e-tree requirements.”

Pharmaceutical Manufacturers reached agreement on the costs and expenses associated with the introduction of changes in the packing lines, which must implement more effectively in Germany, such as the producers do not know that their products are likely to get in Routed by the distribution system in California. Accordingly, they would have preferred a single national system rather than potential state-to-state variations.

Some companies, to see how the requirements in California ePedigree done gradually, starting with the products most susceptible to counterfeiting. The national law does not expressly provide that kind of flexibility, even if the Board of Pharmacy said that it was ready to talk about “grandfathering” requirements for drugs that are in the electronic system without root trees prior to the deadline for compliance.



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