Tag Archives: DPMS

DQSA of 2013

DQSA: How Should Transaction Data Be Exchanged?

February 20, 2014 Dirk Rodgers

The U.S. FDA just published a docket asking for public input into standards for the interoperable exchange of information for tracing of human, finished, prescription drugs in paper or electronic format. Ironically, they will accept responses to the docket in either paper or electronic format. Comments should be submitted to the FDA within 60 days. If my calculation is correct, you have until April 21^st to submit your comments.

This docket was expected because the Drug Supply Chain Security Act (DSCSA), enacted last November, gives the FDA one year to publish a draft guidance document that establishes standards for the interoperable exchange of that type of information, and they are required to consult with the industry and other interested parties [see Section 582(a)(2)]. I have written about this requirement and the short time after the guidance is published before the members of the supply chain must make use of those standards (see “The Flaw That Must Be Addressed in H.R. 3204, The Drug Quality and Security Act” and “DQSA: Getting To Electronic Transaction Data Exchange“). This docket fulfills the first of many mandates that the FDA is facing in

Continue reading DQSA: How Should Transaction Data Be Exchanged? →

DQSA of 2013

DQSA: Will U.S. Pharma Distributors Mandate Aggregation Data In Phase 1?

November 22, 2013 Dirk Rodgers 13 Comments

I attended the Healthcare Distribution Management Association (HDMA) Track and Trace Seminar held in Crystal City, VA on November 11-13, 2013. I was particularly interested in the session called “Distributor Case Studies and Updates”, as were a lot of other people. The speakers were:

Chris J. Anderson, Director, Quality Systems, Cardinal Health, Inc.
Steve Tadevich, Director, Product Serialization Technologies, McKesson Corporation
Heather Zenk, PharmD, Vice President, Business Integration, AmerisourceBergen Corporation

Each speaker gave a brief presentation about their current serialization and pedigree programs before taking questions as a panel. As you would expect, all of the preparation these companies have done up to this point has been aimed squarely at the California pedigree law which would have gone into effect for wholesalers in California in mid-2016. But, Continue reading DQSA: Will U.S. Pharma Distributors Mandate Aggregation Data In Phase 1? →

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

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 →

Inference

California’s Draft Inference Regulation

April 23, 2013 Dirk Rodgers

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 →

pedigree certification

Draft Regulations On Certifications Within California ePedigrees

April 15, 2013 Dirk Rodgers

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 →

California Pedigree Law

InBrief: Can ePedigree Be Deferred Until Mid-2016?

April 4, 2013 Dirk Rodgers

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? →

pedigree software

E-Pedigree Vendor Selection

February 25, 2013 Dirk Rodgers 10 Comments

On Friday after 5pm I received a call from a potential consulting client. At least I thought that’s what they were. It turned out, it was a headhunter looking for warm bodies to work on serialization and pedigree projects to fill a quota he has from the consulting arm of one of the big-4 accounting firms. The people he’s looking for would probably work on projects under the direction of one of their long-term senior consultants. I’m not looking for that kind of opportunity.

My impression is that this is a sign that we are entering the “Y2K” phase of the California E-pedigree deadlines. That is, it is time for lots of “staff augmentation” companies to staff-up to offer “expertise” in droves. Continue reading E-Pedigree Vendor Selection →

RxTrace