The implementation of California’s ePedigree system has been knocked back yet again, with 1 January 2015 now the proposed date.
ePedigree has now been delayed twice, with the date moved back from the initial proposal of 2009 to give companies more time to prepare.
The delays will have been noted by companies and regulators around the world, who have been monitoring California’s pioneering implementation of an ePedigree system.
Universal adoption now seems many years away, with the Californian system suffering delays as interested parties try to ensure the regulatory and technological challenges are overcome. The concern is that if ePedigree is implemented in a rush it could lead to a disruption in the supply of medicines.
By delaying implementation until 2011 legislators had intended to give adequate preparation time but not all parties were convinced it would. In a statement following the previous delay the Pharmaceutical Research and Manufacturers of America (PhRMA) said: “it is possible that even by 2011, some of the key challenges will remain and still need to be resolved."
This has proven to be true resulting in revised legislation that states any manufacturer selling drugs in California must have an ePedigree for 50 per cent of its products by the start of 2015. The remaining 50 per cent must be designated an ePedigree before 1 January 2016.
Another wave of legislation comes into affect on 1 July 2016 prohibiting wholesalers or repackagers from selling, trading, or transferring a dangerous drug without a pedigree. Also they cannot acquire a dangerous drug without receiving a pedigree.
The complete legislation will finally be implemented on 1 July 2017, when the measures affecting pharmacies come into force. These will apply the wholesaler and repackager regulations implemented in 2016 to pharmacies.
Industry responds to delay
The Generic Pharmaceutical Association (GPhA) has signaled its support for the delay and for ePedigree as a system.
Responding to the news, Kathleen Jaeger, President and CEO of the GPhA, said the delay: "will help manufacturers to determine the most cost-effective and efficient approach to establishing an electronic track and trace system."
Support for the delay has also been shown by the National Community Pharmacists Association (NCPA), which described the 2011 deadline as: "a logistical and financial nightmare for all of the affected parties."