Tag Archives: California Pedigree Law

Will Generic Drug Manufacturers Serialize Their Drugs In Time?

July 9, 2013 Dirk Rodgers 2 Comments

The one thing all pharmaceutical manufacturers can count on, regardless of whether or not the U.S. Congress passes a new track and trace regulation in this or future sessions, is that unit-level serialization will be a necessity on drug packages sold into the U.S. market within the next few years. We have all been paying close attention to the draft legislation that has been moving through the two houses of Congress for several months now, but there is no doubt that unit-level serialization will be required whether something passes at the federal level or not. The only questions are, exactly which year will it be required and what else will be required?

We know that Continue reading Will Generic Drug Manufacturers Serialize Their Drugs In Time? →

California Board of Pharmacy

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

June 26, 2013 Dirk Rodgers 2 Comments

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 Pedigree Law, Federal Pedigree

The California ePedigree Timeline Vs. The Senate Bill Timeline

June 24, 2013 Dirk Rodgers 1 Comment

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 →

California Pedigree Law

Falling Between The Cracks Of The California Pedigree Law

June 17, 2013 Dirk Rodgers 2 Comments

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 →

California Pedigree Law

Should Pharmacies Decommission EPCs Upon Dispense?

June 10, 2013 Dirk Rodgers 4 Comments

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? →

Federal Pedigree

Would A U.S. Federal Pedigree Law Require A New UFA?

May 28, 2013 Dirk Rodgers 4 Comments

One of the questions that must be answered is, “how will an ePedigree and track & trace system be funded?”. Who pays, who gets paid, and how much? The answer to these questions are partly determined by which technology model is in use. One reason a distributed model is usually the first model people think of is that the funding is so obvious: it is localized. In that model each company would arrange for their own services. No pooling is needed. That’s simple to understand and quantify because everyone is in control of the services they need.

But because distributed models have so many points of failure—any one of which would Continue reading Would A U.S. Federal Pedigree Law Require A New UFA? →

Congress, Federal Pedigree

InBrief: A Track & Trace bill Has Made It To The Senate Floor

May 22, 2013 Dirk Rodgers 2 Comments

The Senate Health Education Labor and Pensions Committee has just voted unanimously to combine their current draft of “S. 957, Drug Supply Chain Security Act” with their current draft of “S. 959, Pharmaceutical Compounding Quality and Accountability Act” and pass the result onto the Senate floor for consideration. No amendments were offered in today’s session on either bill before the action. All committee members who spoke on behalf of both bills spoke very favorably about them. Now that the bills have been combined they will retain the number S. 959 if I understood the wording of the vote correctly.

This action, combined with the action in the House of Representatives last week (see “InBrief: A Track And Trace Bill Has Made It To The House Floor”), indicates that Continue reading InBrief: A Track & Trace bill Has Made It To The Senate Floor →

Congress, Federal Pedigree

An Industry Protection Bill Concealed Under The Veil Of Patient Protection

May 13, 2013 Dirk Rodgers 1 Comment

There are two pharmaceutical track & trace bills making their way through committees of Congress, one in the U.S. House of Representatives and one in the Senate. In both houses, these drafts are touted as bills to protect patients from the ill effects of illegitimate drugs in the legitimate supply chain, but, after reviewing the two drafts at length, I have concluded that the House draft is something else entirely. Rather than focusing on protection of patients, the House draft is primarily intended to protect the industry from the California pedigree law. “Patient protection” is little more than a veil to provide cover while the debate is kept on grounds more acceptable to the industry.

Here is my justification for such an assertion. First, Continue reading An Industry Protection Bill Concealed Under The Veil Of Patient Protection →

RxTrace