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!
Monthly Archives: June 2013
The California ePedigree Timeline Vs. The Senate Bill Timeline
The U.S. House of Representatives passed their H.R. 1919, Safeguarding America’s Pharmaceuticals Act a few weeks ago (see, “InBrief: The Pharma Track & Trace Bill Has Passed the U.S. House Of Representatives” and also don’t miss “An Industry Protection Bill Concealed Under The Veil Of Patient Protection”). The Senate is next up with S. 957 Drug Supply Chain Security Act (or S. 959 depending on if they really did combine it with the compounding act as they passed it out of committee).
We still don’t know exactly when this bill will be debated or considered in a vote on the Senate floor but indications are that Continue reading The California ePedigree Timeline Vs. The Senate Bill Timeline
Summer News
When I was in sixth grade at Lincoln Elementary School in Galva, Illinois, the town built a swimming pool at a new park that was within sight of the school. My friends and I could not believe our luck. In the entire history of the town, nothing as big had ever happened (well, for sixth graders anyway). When the grand opening was scheduled for the day school was let out for the summer, we laid our plans to be the first in line. That’s just what we did. We checked in on the first day and did not leave until the day it closed at the end of the summer. We had so much fun!
That was a long time ago in the days before Continue reading Summer News
Falling Between The Cracks Of The California Pedigree Law
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
Should Pharmacies Decommission EPCs Upon Dispense?
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?
InBrief: The Pharma Track & Trace Bill Has Passed the U.S. House Of Representatives
Late yesterday The Hill, a political news website, began reporting that the U.S. House of Representatives has passed H.R. 1919, Safeguarding America’s Pharmaceuticals Act in a voice vote that required a two-thirds majority vote. I was watching the House floor streaming feed live as it happened and I must admit that the parliamentary proceedings were slightly confusing to me regarding the vote, so now that The Hill is reporting passage I feel more comfortable saying the same thing. 😉
The text of the bill as it was before the vote appears here.
During the debate leading up to the vote, Continue reading InBrief: The Pharma Track & Trace Bill Has Passed the U.S. House Of Representatives
InBrief: CBO Estimates H.R. 1919 Would Exceed Unfunded Mandate Threshold For Private Entities
Just one business day before the U.S. House of Representatives is scheduled to vote on H.R. 1919, Safeguarding America’s Pharmaceuticals Act of 2013, the Congressional Budget Office (CBO) published their estimates for the public and private costs to implement it relative to the Federal Unfunded Mandates Reform Act (UMRA).
CBO has determined that the costs to State, local, and tribal governments would be “…small and below the intergovernmental threshold established by UMRA…”. However, they also estimate that the costs to private entities “…would exceed the threshold established in UMRA ($150 million in 2013, adjusted annually for inflation)”.
Interestingly, the CBO used Continue reading InBrief: CBO Estimates H.R. 1919 Would Exceed Unfunded Mandate Threshold For Private Entities
The Federal Lot-Based Pedigree Before Congress
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