Information on E-Pedigree

California’s e-pedigree requirements for prescription drugs will take effect on a staggered basis from January 1, 2015 through July 1, 2017. Changes enacted by SB 1307 (Ridley-Thomas, Chapter 713, Statutes of 2008) instituted the following schedule.

The implementation compliance dates are:

• 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 forward products with the e-pedigree by July 1, 2016; and
• Pharmacy and pharmacy warehouses must accept and pass e-pedigrees by July 1, 2017.

Read more in the February 2009 issue of The Script on page 6.

 

• Schwarzenegger Administration released a legislative proposal that would repeal portions of California's e-pedgree law and replace it with new and different requirements
• Board Comments to the FDA on Docket No. 0120 Standards for Standardized Numerical Identifier, Validation, Track and Trace, and Authentication for Prescription Drugs; Request for Comments
• Board Comments to the FDA on Docket No. 0121 Technologies for Prescription Drug Identification, Validation, Track and Trace, or Authentication; Request for Information

Implementation Date Moved to January 1, 2011

• Board Policy March 25, 2008
• FDA Statement March 25, 2008
• California E-Pedigree Law
• Questions and Answers
• Minutes of Meetings Holding E-Pedigree Discussion
• Power Point Presentations Made to the Board of Pharmacy
• Implementation Submission Statement Template to Submit a Problem/Solution Statement to the Board
• Template for Submission Statements Regarding Readiness to Implement California ePedigree Laws by 1/1/2009
• Future Meetings Scheduled

Meeting Minutes

Meeting Minutes and Materials
Enforcement Committee Meetings	Board Meetings Holding Discussion of E-Pedigree Issues
September 20, 2007	October 24, 2007
June 20, 2007	July 24, 2007
March 21, 2007	April 18, 2007
December 12, 2006	January 31, 2007
September 28, 2006	October 25, 2006
June 20, 2006	July 27, 2006
March 16, 2006	April 26, 2006
December 7, 2005	February 1, 2006

Power Point Presentations

October 24, 2007 (Board Meeting with Discussion of E-Pedigree Issues)

• Rite Aid
• Walgreens
• HDMA
• Bracco Diagnostics Inc.
• GlaxoSmithKline
• CVS Caremark
• rfXcel
• EPCglobal
• California Board of Pharmacy - Enforcement Committee
• EPCglobal

September 20, 2007 (Enforcement Committee Meeting)

• California Board of Pharmacy - Enforcement Committee

July 24, 2007 (Board Meeting with Discussion of E-Pedigree Issues)

• EPCglobal
• Pfizer
• Walgreens

April 18, 2007 (Board Meeting with Discussion of E-Pedigree Issues)

• EPCglobal
• AmerisourceBergen
• SupplyScape
• EPCglobal

January 31, 2007 (Board Meeting with Discussion of E-Pedigree Issues)

• EPCglobal
• AmerisourceBergen
• Cardinal Health
• EPCglobal
• AmerisourceBergen
• Cardinal Health

October 25, 2006 (Board Meeting with Discussion of E-Pedigree Issues)

• California State Board of Pharmacy
• EPCglobal
• McKesson

July 27, 2006 (Board Meeting with Discussion of E-Pedigree Issues)

• US Food and Drug Administration
• Bio, GPhA, HDMA, NACDS and PhRMA

April 26, 2006 (Board Meeting with Discussion of E-Pedigree Issues)

• EPCglobal

March 16, 2006 (Enforcement Committee Meeting)

• California State Board of Pharmacy

Future Enforcement Committee and Work Group on E-Pedigree Meetings

• March 26, 2008 - Southern California - Rescheduled to March 25, 2008 as a Board Meeting
• June 24, 2008 - Sacramento
• September 9, 2008 - Southern California
• December 9, 2008 - Sacramento