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 it was written before this new draft was published by the Board.

The current draft says that inspectors would use equipment supplied by the company under inspection to inspect their electronic pedigrees.  That’s about as foolproof as asking them to provide a printed pedigree–an idea I shoot down in my earlier essay–because if the company is a criminal organization, they could just as easily twist the pedigrees to cover their tracks when the inspector uses their computer and software to view the “pedigrees”.  The company under inspection would be in control of the software that the inspector would use, so if they were criminals (and if they were as diabolical as comic book criminals), they could make the software generate valid-looking pedigrees on the screen when none actually exists.

For routine inspections, use of that inspection technique would probably be fine.  But whenever it would important to be totally sure that the pedigrees and their certifications are valid, the Board of Pharmacy representative should get a copy of the electronic pedigree and check its integrity using their own software.  This would be true whenever there is suspicion and for use in prosecutions.  This would require the Board of Pharmacy and the California Department of Justice to invest in electronic pedigree checking software, as I pointed out in my earlier essay.

This concludes my analysis and recommendations for the three latest draft regulations.  The Enforcement Committee will probably discuss the comments they receive from stakeholders and the public in their June meeting.

See you there.