Tag Archives: California Board of Pharmacy

California Board of Pharmacy, Federal Pedigree

California Responds To The Senate Pharma Track & Trace Discussion Draft

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BoP Not QuiteImportant 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.On April 26, 2013, Stanley C. Weisser, R.Ph. and President of the California Board of Pharmacy, replied to the Senate Health Education Labor and Pensions (HELP) Committee regarding their discussion draft of a potential federal pharmaceutical track & trace law that had been published one week before.  Writing on behalf of the California Board, the letter is eight pages long and includes some very detailed expressions of concern over a few specific sections of the draft.  It is well worth reading carefully.  You can ask the Board of Pharmacy for a copy, or you can see the copy I obtained here.

This is a significant document because it provides the best clues we have into how Continue reading California Responds To The Senate Pharma Track & Trace Discussion Draft →

California Pedigree Law

California’s Draft Regulation on Inspections

InspectorImportant 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.Tomorrow I’m going to write about last week’s hearing on “Securing Our Nation’s Prescription Drug Supply Chain” held by the U.S. House of Representatives Energy & Commerce Committee.  In the meantime, in the last few weeks I have written about the new draft regulation on certifications in California e-pedigrees and California’s Draft Regulation on Inference.  In the same document—distributed by Joshua Room, Supervising Deputy Attorney General, California Department of Justice assigned to the California Board of Pharmacy, at the March 14, 2013 Enforcement Committee meeting (and converted to MS Word document form by me)—on page 6, you will find the short draft regulation on inspections.

The draft regulation on pedigree inspections is so short that I didn’t bother doing a markup with my suggestions.  Besides, I’ve written about inspecting drug pedigrees before (see “Inspecting An Electronic Pedigree“).  That essay is still valid, even though Continue reading California’s Draft Regulation on Inspections →

Inference

California’s Draft Inference Regulation

Thinking cardboard boxImportant 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.Yesterday I published an essay about the new discussion draft of a Federal track and trace regulation bill from the Senate HELP Committee.  It is definitely worth watching closely, but don’t let it take your eye off of the California regulations.  Those are real today and will move forward unless Congress and the President complete the enactment of a bill that preempts the California law.  That’s a long and uncertain road and the discussion draft released last week is only the first unofficial step.

Last week I wrote about the new draft regulation on certifications in California e-pedigrees.  In the same document—distributed by Joshua Room, Supervising Deputy Attorney General, California Department of Justice assigned to the California Board of Pharmacy, at the March 14, 2013 Enforcement Committee meeting (and converted to MS Word document form by me)—on page 3, you will find the draft regulation for the use of inference.  This draft regulation is Continue reading California’s Draft Inference Regulation →

pedigree certification

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 →

California Pedigree Law

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 →

RxTrace

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… →

Inference

How Should Inference Work?

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Drawing by Jasmaine Mathews

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.The wide-scale use of “inference” in the pharmaceutical supply chain is essential to the successful operation of a track & track or ePedigree system.  Companies cannot be expected to open every case they plan to ship, or that they receive, so that they can figure out exactly which package-level serial numbers are involved.  The use of the serial number packaging hierarchy, or, “Aggregation information”, to “infer” which packages are being shipped or received is the only way to maintain a level of supply chain efficiency that is close to pre-serialization levels.  On the other hand, regulator acceptance of the use of inference in the supply chain has the potential to complicate their investigation of criminals.

In recognition of its importance in maintaining efficiencies, the California legislature instructed the Board of Pharmacy to draw up rules that would allow companies to optionally make use of it (see my essay “Inference in the Pharmaceutical Supply Chain” for the exact text of the inference provisions of the California Business and Professions Code).  It leaves the important question about who Continue reading How Should Inference Work? →

data ownership

Data Ownership In The Track & Trace Cloud

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Cloud over IllinoisImportant 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.Who will own the data that supply chain trading partners store in some future cloud-based, semi-centralized Network Centric ePedigree (NCeP) data repository?  I met one potential future repository service provider who seemed to think that they would own that data.  Imagine their excitement.  All the data about where drugs go throughout the supply chain!  Think of the value they could mine from that.

Well, that’s never going to happen because companies in the supply chain won’t sign up for handing over all of their supply chain data to some third-party just so they can comply with regulations, especially when there exists an alternative approach that would allow them to avoid using a third-party and still comply (by using DPMS).  And regulatory agencies are Continue reading Data Ownership In The Track & Trace Cloud →