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Susan Haigney is managing editor of Pharmaceutical Technologyand Pharmaceutical Technology Europe, email@example.com.
The deadline for the implementation of California's prescription drug tracking system, ePedigree, has been delayed until January 2011.
Sacramento, CA (Mar. 30)-The deadline for the implementation of California’s prescription drug tracking system, ePedigree, has been delayed until January 2011. Stating that some industry manufacturers and distributors were having a difficult time coming up to speed on implementation requirements by the original January 2009 deadline, the California State Board of Pharmacy decided on March 25 to postpone the deadline for two years.
The delayed implementation comes after drug manufacturers expressed concerns about standardization issues as well as the complex regulation involved, changes to packaging, and the cost of implementation. The State Board of Pharmacy acknowledged in its ruling that while some companies have been moving forward with the program at a good pace, others have lagged behind. “This board recognizes that this sort of comprehensive model is not easily implemented and that it has required and will require significant efforts by industry participants. After consideration of all the evidence presented to the Board…the Board concurs that the additional two years to January 1, 2011 is [required…] in order to implement electronic technologies to track the distribution of dangerous drugs within the state,” stated William Powers, president of the California State Board of Pharmacy. The board also stated that the delay would give it time to work with FDA to develop standards consistent with Federal guidelines.
The ePedigree system is a part of California’s ongoing effort to combat counterfeit drugs and ensure drug safety. California legislation requires an electronic system be developed to track and trace prescription drugs from manufacture to pharmacy. This tracking system would follow a drug’s path along the distribution line including updates to records if and when a drug moved from one pharmacy chain to another. Information obtained would include prescription name, manufacturer name, dose, container size, lot or control number, purchaser names and addresses, sale dates, and shipping information.