There was a particularly interesting public dialog that occurred during the March 14, 2013 meeting of the Enforcement Committee of the California Board of Pharmacy. I have been waiting for the official video recording of the meeting to be posted by the State of California but something seems to be holding it up. Fortunately, I recorded the audio myself.

UPDATE: Apparently the video has been out there for almost 3 weeks. I was looking for it in the wrong place. Find it here.

The dialog was between Joshua Room, Supervising Deputy Attorney General at California Department of Justice assigned to the California Board of Pharmacy, and Bob Celeste, Director, GS1 Healthcare US. Mr. Celeste had just finished presenting an update to the Committee on the recently published GS1 US Guideline (see “The New GS1 Healthcare US Track & Trace Guidance”) when Mr. Room asked him to remain at the front of the room to serve as a foil for an experiment he wanted to try. Mr. Room had
Continue reading The Board of Pharmacy Must Respond To Ideas For Making EPCIS Work →

InBrief: Can ePedigree Be Deferred Until Mid-2016?

April 4, 2013 Dirk Rodgers

It’s well known that the California pedigree law requires pharmaceutical manufacturers to serialize their drugs, 50% by January of 2015 and the remaining 50% by January of 2016. But the law also requires those manufacturers to start drug pedigrees for those drugs by those same dates. The only problem is, no one is required to be able to receive those pedigrees until July of 2016 when distributors and repackagers must have their systems ready, so why can’t we defer the selection of the ePedigree format and data exchange model until about that time at the latest?

Interestingly, Virginia Herold, the Executive Officer of the California State Board of Pharmacy gave some credibility to that idea Continue reading InBrief: Can ePedigree Be Deferred Until Mid-2016? →

California Board of Pharmacy

Q&A With Virginia Herold, Executive Officer, California Board Of Pharmacy

April 1, 2013 Dirk Rodgers

I finally had time to listen to the recording of the original webcast of the interview with Virginia Herold, the Executive Officer of the California Board of Pharmacy that occurred on March 20, 2013. Shabbir Dahod of TraceLink, a supplier of ePedigree solutions and other supply chain products and services, asked a series of very detailed and very interesting questions of Ms. Herold. The information conveyed through the questions and answers are very compelling and anyone interested in meeting the requirements of the law should listen to the whole recording. You can get access to it here on the TraceLink website. Continue reading Q&A With Virginia Herold, Executive Officer, California Board Of Pharmacy →

California Pedigree Law

Are Your Drugs Exempt From The California Pedigree Law?

March 25, 2013 Dirk Rodgers 6 Comments

Not all prescription drugs will need to comply with the California pedigree law on January 1, 2015 or 2016. In fact, there are a number of important exemptions that cover entire classes of certain drugs and certain types of transactions for all drugs. The volume of drug packages that could escape being serialized and pedigreed by those effective dates is not huge, but if you are a manufacturer or wholesaler, you should familiarize yourself with the list of exemptions. If you are lucky enough to make or handle any of the exempt drugs or transactions you might as well take advantage of your exemption.

The list of exemptions are covered in the California Business and Professions Code under section 4034 (g)(1) through (9) (see pages 20-21 of the “2013 Lawbook For Pharmacy”). Section 4034(g) simply states, “The following transactions are exempt from the pedigree requirement created by this section:” Continue reading Are Your Drugs Exempt From The California Pedigree Law? →

RxTrace

The Best Laid Plans…

March 18, 2013 Dirk Rodgers

I attended the California Board of Pharmacy Enforcement Committee meeting last week and several topics came up that I want to write about. Unfortunately I’ve been doing a lot of traveling since then and all of a sudden I started having computer problems a few days ago. My youngest daughter is getting married next month and so the family met up in Chicago this past weekend for several of the events leading up to the big one. There is more travel scheduled for this week.

Travel doesn’t normally interfere with my ability to write on a deadline, but Continue reading The Best Laid Plans… →

GS1 Healthcare US, track and trace, Uncategorized

The New GS1 Healthcare US Track & Trace Guidance

March 11, 2013 Dirk Rodgers

GS1 Healthcare US

GS1 Healthcare US, an arm of GS1 US the member organization (MO) of the global GS1 standards organization, has just published the “preliminary version” of a track & trace implementation guide. The full title is “Implementation Guideline, Applying GS1 Standards to U.S. Pharmaceutical Supply Chain Business Processes To Support Pedigree And Track & Trace, Release 1.0”.

This document contains the accumulation of thought and best practices generated over the last nine years within various working groups of GS1 Healthcare US and from pilots conducted by its members (including the Abbott Labs, McKesson, VA and GHX pilot that I wrote about in “The Significance of the Abbott, McKesson and VA Pilot”). Pulling it all together into a single coherent document turned out to Continue reading The New GS1 Healthcare US Track & Trace Guidance →

California Pedigree Law

The New Grandfathering Provisions Of The California Pedigree Law

March 4, 2013 Dirk Rodgers 1 Comment

At the February 5, 2013 meeting of the California Board of Pharmacy the Board took the final vote to proceed with filing a number of important clarifying regulations–the first since the Ridley-Thomas bill was enacted in 2008 that established the current staggered effective dates. These include the recognition of the FDA Standardized Numeric Identifier (SNI) as the “unique identifier” for use on each drug package, and definition around how supply chain companies can grandfather their existing non-serialized, non-pedigreed stock at the time the law goes into effect.

The official minutes of the meeting are not yet available but the video has been posted for a few weeks now. The pertinent action occurs in the first video of the two day meeting at approximately 2:24:00 (hours:minutes:seconds). (Don’t you just love government meetings on YouTube?) The source text of the pending regulation (which is Continue reading The New Grandfathering Provisions Of The California Pedigree Law →

pedigree software

E-Pedigree Vendor Selection

February 25, 2013 Dirk Rodgers 10 Comments

On Friday after 5pm I received a call from a potential consulting client. At least I thought that’s what they were. It turned out, it was a headhunter looking for warm bodies to work on serialization and pedigree projects to fill a quota he has from the consulting arm of one of the big-4 accounting firms. The people he’s looking for would probably work on projects under the direction of one of their long-term senior consultants. I’m not looking for that kind of opportunity.

My impression is that this is a sign that we are entering the “Y2K” phase of the California E-pedigree deadlines. That is, it is time for lots of “staff augmentation” companies to staff-up to offer “expertise” in droves. Continue reading E-Pedigree Vendor Selection →

…a comprehensive exploration of the intersection between healthcare supply chains, track and trace technology, standards and global regulatory compliance