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

Long Beach Airport FlagsImportant Notice To Readers of This Essay On November 27, 2013, President Barack Obama signed the Drug Quality and Security Act of 2013 into law. That act has many provisions, but one is to pre-empt all existing and future state serialization and pedigree laws like those that previously existed in California and Florida. Some or all of the information contained in this essay is about some aspect of one or more of those state laws and so that information is now obsolete. It is left here only for historical purposes for those wishing to understand those old laws and the industry’s response to them.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

Are Your Drugs Exempt From The California Pedigree Law?

Exempt signImportant Notice To Readers of This Essay On November 27, 2013, President Barack Obama signed the Drug Quality and Security Act of 2013 into law. That act has many provisions, but one is to pre-empt all existing and future state serialization and pedigree laws like those that previously existed in California and Florida. Some or all of the information contained in this essay is about some aspect of one or more of those state laws and so that information is now obsolete. It is left here only for historical purposes for those wishing to understand those old laws and the industry’s response to them.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?

The Best Laid Plans…

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…

The New GS1 Healthcare US Track & Trace Guidance

 

GS1 Healthcare US
GS1 Healthcare US

Important Notice To Readers of This Essay On November 27, 2013, President Barack Obama signed the Drug Quality and Security Act of 2013 into law. That act has many provisions, but one is to pre-empt all existing and future state serialization and pedigree laws like those that previously existed in California and Florida. Some or all of the information contained in this essay is about some aspect of one or more of those state laws and so that information is now obsolete. It is left here only for historical purposes for those wishing to understand those old laws and the industry’s response to them.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

The New Grandfathering Provisions Of The California Pedigree Law

Grandfather clockImportant Notice To Readers of This Essay On November 27, 2013, President Barack Obama signed the Drug Quality and Security Act of 2013 into law. That act has many provisions, but one is to pre-empt all existing and future state serialization and pedigree laws like those that previously existed in California and Florida. Some or all of the information contained in this essay is about some aspect of one or more of those state laws and so that information is now obsolete. It is left here only for historical purposes for those wishing to understand those old laws and the industry’s response to them.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

E-Pedigree Vendor Selection

davidvsgoliathOn 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

New RxTrace Column in Healthcare Packaging Magazine

HCP mag Feb13The February issue of Healthcare Packaging Magazine is out today in digital form and it contains my first contribution as Contributing Editor in my regular column called…wait for it…RxTrace!  Check it out here and let me know what you think.  Subscribers of the print magazine should receive their copy in the mail soon.  This will expose my ideas to an even wider audience and to more traditional readers.

I’d like to thank the great folks at Summit Media Group for extending the invitation and working it out.  Particular thanks go to Editor-In-Chief Jim Butschli and Publisher Jim Chrzan.  Great work guys.  It looks fabulous. Continue reading New RxTrace Column in Healthcare Packaging Magazine

Well-Intended Report Calls For Global Track & Trace Of Pharmaceuticals

Studying the IOM reportI’ve been reading the Institute of Medicine (IOM) report called “Countering the Problem of Falsified and Substandard Drugs” that was published last week.  At 360 pages, it is quite literally a book, and you can buy it that way.  But they also allow you to download the “Pre-publication Copy:  Uncorrected Proofs” version in a 300 page PDF for free.  I’m not sure why they would post uncorrected proofs rather than the final document on their site but I assume the text is in its final edited form and only the formatting might be different between the book and the PDF.  I hope so anyway.

I have not yet read the whole thing so this isn’t intended to be a proper review (see the Regulatory Focus article about it).  The document offers Continue reading Well-Intended Report Calls For Global Track & Trace Of Pharmaceuticals