The U.S. FDA is poised to publish their final Unique Device Identification (UDI) rule any day now. The publication was due earlier in the summer but has apparently been held up in the review by the Office of Management and Budget (OMB) without any kind of accurate timeline. The organizers of this year’s UDI Conference are hoping the FDA will be able to announce its publication at their event this Thursday and Friday in Baltimore. I understand that not everyone is looking forward to its publication, but some are kind of tired of waiting for it. I’ll bet Jay Crowley and his team Continue reading What The UDI Date Format Says About FDA’s Direction
Most prescription pharmaceuticals distributed in California pass from manufacturer to pharmacy through wholesale distributors, but a small percentage are sold by the manufacturer directly to doctors and clinics. An even smaller percentage are sold through small companies licensed as kit manufacturers or distributors to dental offices, fire departments, ambulance companies and other carriers of emergency medical kits. These transactions are just as open to the introduction of illegitimate products as the larger transactions that we normally think of when we talk about the use of drug pedigrees, but because they are outside of the ordinary, they are at risk of falling between the cracks. That is, they might be a lot more complex, or not even possible, under the California pedigree law. Continue reading Falling Between The Cracks Of The California Pedigree Law
I finally had a chance to listen to the recording of the rfXcel webinar with Virginia Herold, Executive Officer of the California Board of Pharmacy, and Joshua Room, Deputy Attorney General, California Department of Justice assigned to the Board of Pharmacy. The webinar was recorded on May 29, 2013. Ms. Herold and Mr. Room have done these kind of webinars before (see “Q&A With Virginia Herold, Executive Officer, California Board Of Pharmacy”). But don’t worry, while there is a fair amount of repetition as you might expect, the Q&A is different enough that I always learn something new. I found this one to be entertaining as well as informative.
One of the questions they addressed was Continue reading Should Pharmacies Decommission EPCs Upon Dispense?
The current drafts of the nationwide pharmaceutical track and trace (Pedigree) bills on the floors of the U.S. Senate and House of Representatives both include an initial lot-based pedigree requirement that may be based on paper or electronic documentation (see “The Politics Of Federal Track & Trace Legislation”). What is a lot-based pedigree and how is it different from one based on package-level serial numbers? Let’s take a closer look at the kind of system that these bills would require. Keep in mind that the Senate bill would mandate this kind of pedigree system for the next 10 years and the House bill would make it permanent.
First of all, according to both bills, pharma manufacturers would be required to Continue reading The Federal Lot-Based Pedigree Before Congress
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
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
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
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?