Tag Archives: inspections

Hey California Board of Pharmacy: Your Time Is Running Out!

wicked witch hourglassImportant 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 California Board of Pharmacy has begun to hold ePedigree-specific meetings with staff and a subset of the Board present.  The first of these occurred on Monday of this week.  The agenda was fairly long and promised action on a number of important topics, including the possibility that the Board would consider the use of EPCIS as a pedigree platform, inference, pedigree certifications and drop shipments.  I came away disappointed that the only thing that happened was a brief discussion of each topic but seemingly no real action.  It was almost as if the Board members and staff had made no progress on any of these topics since the March Enforcement Committee meeting.  All that seemed to happen since that meeting Continue reading Hey California Board of Pharmacy: Your Time Is Running Out!

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

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…