The New Pharma Track & Trace Discussion Draft In The Senate

A discussion draftImportant 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.The U.S. Senate Health, Education, Labor and Pensions (HELP) Committee released a new discussion draft last Friday of a bill that would preempt all state pharmaceutical ePedigree laws and establish a pathway toward a nationwide track & trace regulation.  Take careful note of this one.  It could be the one that finally makes it.  Let me explain. Continue reading The New Pharma Track & Trace Discussion Draft In The Senate

Draft Regulations On Certifications Within California ePedigrees

Edited by DirkImportant 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.During the March 14, 2013 meeting of the Enforcement Committee of the California Board of Pharmacy, Joshua Room, Supervising Deputy Attorney General at California Department of Justice assigned to the California Board of Pharmacy distributed copies of draft text that he is looking for public comments on.  The draft is for regulations covering pedigree “certification”, the use of “inference” and “inspection” of electronic pedigrees.  Unfortunately the text is Continue reading Draft Regulations On Certifications Within California ePedigrees

The Board of Pharmacy Must Respond To Ideas For Making EPCIS Work

cross-examinationImportant 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.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?

Unlabeled Time Line 9Important 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.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?

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