October 2008               return to newsletter contents page

California Pedigree Extension Law Signed

Governor Schwarzenegger signed SB 1307 (Ridley-Thomas) on September 30 as the 2008 year of legislative session drew to a close.

A copy of this bill can be obtained here. 

This law now replaces the 2011 implementation date for e-pedigree requirements to a series of staggered implementation dates requiring:

• 50 percent of a manufacturer’s products by 2015

• the remaining 50 percent of the manufacturer’s products by 2016

• Wholesalers and repackagers must accept and pass e-pedigrees by July 1, 2016, and

• Pharmacies and pharmacy distribution centers must accept e-pedigrees by July 1, 2017.

There is preemption language that would repeal California’s provisions if federal law regarding e-pedigrees is enacted, or if federal standards are enacted, they would take effect in CA.

There are provisions that define drop shipments, 3PLs, repackagers and manufacturers. Grandfathering provisions for drugs already in the supply chain are included. The board will ultimately have to develop regulations for various components, including inference.

Senator Ridley-Thomas added a letter to the Senate Journal, reflecting the agreement of those who worked on amendments to California’s e-pedigree law. A copy of this letter can be obtained from http://www.pharmacy.ca.gov/about/e_pedigree.shtml.