In a significant decision for pharmaceutical supply chain stakeholders, on March 25, 2008 the California State Board of Pharmacy voted to extend the date for compliance with the state’s pharmaceutical pedigree law from January 1, 2009 to January 1, 2011. The vote came following extensive public meetings of the Board, which had solicited written comments and considerable input from the pharmaceutical industry over the past several months.

Pedigrees are intended to protect the drug supply from counterfeits, adulterated or misbranded products, and drug diversion by providing a record of each transfer of a given drug from the initial sale by the manufacturer until the final sale to a pharmacy or practitioner. The California law does not allow pharmacies or wholesalers to buy or sell packages of drugs unless the package has a unique serial number and an electronic pedigree documenting each change in ownership.

The Board of Pharmacy’s decision to delay the effective date of the California law comes after it concluded that “more time is necessary for technology development and adoption and that in the absence of such additional time there is a significant risk of disruption of the drug supply.” Moreover, the Board found that the additional time would allow for a “more measured scale-up” to implement the drug pedigree system. The Board expressed clear concern, however, that parties affected by the pedigree law may now slow their efforts to achieve compliance and warned that it would take a dim view of further discussions to delay pedigree compliance which may surface as the January 1, 2011 date nears. The Board did not go so far as to speak of increasing enforcement measures or setting milestones between now and 2011. The Board’s policy statement upon which it based its decision can be found at : http://www.pharmacy.ca.gov/laws_regs/delay_implementation.pdf.

No other state law currently imposes an electronic pedigree requirement, although many recently enacted state pedigree laws require an administrative study of the feasibility of electronic pedigrees, with the goal of switching from a paper to an electronic system in 2010 or 2011. California’s decision and its effect on infrastructure development may affect other state pedigree programs and could facilitate the enactment of federal legislation to bring some measure of uniformity as states continue to push for and industry accepts the ultimate move to electronic pedigrees.

The recent Food and Drug Administration Amendments Act of 2007 requires FDA to prioritize and develop standards for the identification validation, authentication, and tracking and tracing of prescription drugs. To this end, the FDA recently published two Federal Register Notices seeking information and comments on existing standards and information technologies in order to assess the current state of development of track and trace technologies, their relative usefulness and interoperability potential. Comments may be submitted electronically at http://www.regulations.gov.

If you have any questions about the California law or other state pedigree requirements, please feel free to contact any of the following Arent Fox attorneys:

Brian P. Waldman
waldman.brian@arentfox.com
202.857.8971

Joanne S. Hawana*
hawana.joanne@arentfox.com
202.715.8591

James Conolly
conolly.james@arentfox.com
213.443.7517