Spotlight: California Pedigree Update
CA Board of Pharmacy extended the deadline for electronic pedigree, serialization and interoperability to January 1, 2011 at the March 25, 2008 meeting in San Diego. This decision turns what was a nearly impossible date into an extremely aggressive deadline. The Board discussion underscored that commitments by companies across the industry to fully comply on 1/1/11 enabled the Board's decision, as explained in the statement Decision of the California State Board of Pharmacy Pursuant to Business & Professions Code Section 4163.5 published March 25, 2008.
Additionally, the Board discussed proposed changes to the law in California bills SB 1307 (Ridley-Thomas) and SB 1207 (Cedillo).
Understand the implications of the California Board's decision, as it relates to pending state legislation and Federal initiatives on standards for serialization and track and trace, in the recap webinar.
Industry discussion with the Board on January 23 in San Diego focused on readiness and the letters that industry submitted to the Board. For more information on this meeting of the Full Board meeting, see the CA BoP meetings webpage.
ePedigree Workgroup Topics, and Questions and Answers
45 trading partners and their industry associations submitted letters to the Board about their readiness and recommendations regarding the 1/1/09 date. To view these submissions, refer to the Board's website, January 23, 2008 Full Board meeting.
The Board of Pharmacy is gathering insight on key topics raised by industry, including Grandfathering of inventory already in the supply chain, and Inference for drugs serialized with 2D to avoid opening sealed cases. To submit information for the Board's consideration, use the Implementation Submission Template.
The Board of Pharmacy published a Questions and Answers document on January 22, 2008. To submit a question, send an email to californiapedigree@dca.ca.gov, or contact Virginia Herold, the Board's Executive Officer.
California Board of Pharmacy affirms the EPCglobal Drug Pedigree Standard meets CA pedigree requirements
"The board believes the standard meets California's electronic pedigree requirements."California Board of Pharmacy, March 14, 2007
On March 14, 2007, the California Board of Pharmacy stated that the GS1 EPCglobal Drug Pedigree Standard meets the requirements of the California pedigree law. Read more...
California Board of Pharmacy meeting Recaps
A number of industry presentations were shared during the Workgroup on E- Pedigree, held with the Board's Enforcement Committee. SupplyScape participated in the meetings.
For a recap of each meeting's discussions and presentations, click below.
- Recaps of previous Board of Pharmacy meetings:
For more information on the public meetings, click here.
SupplyScape Leadership in California Compliance Readiness
The California electronic pedigree introduces new requirements for pharmaceutical companies, medical device manufacturers and trading partners across the supply chain:
- Pedigrees must be electronic
- Manufacturers initiate the pedigrees
- Serialization
Companies urgently need to develop a pedigree and serialization strategy, implement a solution and begin filling the distribution channel with pedigreed products. Time grows short as the California deadline falls below 13 months (January 1, 2009), and earlier trading partner deadlines fall below 7 months (June 1, 2008).
To ensure success, companies across the pharmaceutical value chain are working closely with SupplyScape to develop a cohesive product and process roadmap.
These firms consider five imperatives in their business blueprints for California readiness:
- Improve patient safety and product security
- Achieve pedigree compliance
- Plan and implement serialization cost-effectively
- Test interoperability with trading partners
- Derive business value from pedigree data
Manufacturers of brand, bio and generic drugs, as well as medical devices packaged with drugs, and their 3PL, wholesaler, distributor and pharmacy trading partners, are adopting solutions and preparing to test interoperability with their trading partners.
At their request, SupplyScape is enabling these efforts and providing deeper understanding of the requirements and impacts through the SupplyScape Customer Council.
Learn what your business needs to do now
To make rapid progress for California, SupplyScape experts in drug security approaches, pedigree compliance, serialization strategies and supply chain operations are working with Pharma companies, wholesale distributors, repackagers, 3PLs and pharmacies.
SupplyScape's electronic pedigree data management system, along with our RFID (and barcode) EPC authentication service, provides rapid compliance and operational improvement for companies of all sizes.
Discover how we can deliver these benefits for your business by registering for a Webinar on California Pedigree Readiness.
