Spotlight: California Pedigree
"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.
Meeting materials published by the board for the March 21, 2007 Enforcement Committee meeting indicate:
- California Board of Pharmacy representatives met with EPCglobal representatives on March 8, 2007, to review how the ratified standard addresses the California pedigree requirements.
- The California Board of Pharmacy published on March 14, 2007, that "the board believes the standard meets California's electronic pedigree requirements."
- The board indicated that these discussions with EPCglobal representatives helped to identify areas where "additional work and amplification need to be done by industry and by the board. In some cases regulations may be necessary to provide the necessary specification."
- The board called ratification of the pedigree standard "a significant milestone" toward industry readiness for California's January 2009 electronic pedigree requirement.
To read the CA Board of Pharmacy Enforcement Committee full report, see the 11-page summary starting on page 26.
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 20 months. To ensure success, manufacturers of brand, bio and generic drugs, as well as medical devices packaged with drugs, and their trading partners, work 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
Learn what your business needs to do now
To make rapid progress for California, SupplyScape experts in drug security approaches, 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.