On April 26, 2013, Stanley C. Weisser, R.Ph. and President of the California Board of Pharmacy, replied to the Senate Health Education Labor and Pensions (HELP) Committee regarding their discussion draft of a potential federal pharmaceutical track & trace law that had been published one week before. Writing on behalf of the California Board, the letter is eight pages long and includes some very detailed expressions of concern over a few specific sections of the draft. It is well worth reading carefully. You can ask the Board of Pharmacy for a copy, or you can see the copy I obtained here.
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.
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.
I attended the California Board of Pharmacy Enforcement Committee meeting last week and several topics came up that I want to write about. Unfortunately I’ve been doing a lot of traveling since then and all of a sudden I started having computer problems a few days ago. My youngest daughter is getting married next month and so the family met up in Chicago this past weekend for several of the events leading up to the big one. There is more travel scheduled for this week.
The wide-scale use of “inference” in the pharmaceutical supply chain is essential to the successful operation of a track & track or ePedigree system. Companies cannot be expected to open every case they plan to ship, or that they receive, so that they can figure out exactly which package-level serial numbers are involved. The use of the serial number packaging hierarchy, or, “Aggregation information”, to “infer” which packages are being shipped or received is the only way to maintain a level of supply chain efficiency that is close to pre-serialization levels. On the other hand, regulator acceptance of the use of inference in the supply chain has the potential to complicate their investigation of criminals.
In recognition of its importance in maintaining efficiencies, the California legislature instructed the Board of Pharmacy to draw up rules that would allow companies to optionally make use of it (see my essay “Inference in the Pharmaceutical Supply Chain” for the exact text of the inference provisions of the California Business and Professions Code). It leaves the important question about who Continue reading How Should Inference Work?→
Who will own the data that supply chain trading partners store in some future cloud-based, semi-centralized Network Centric ePedigree (NCeP) data repository? I met one potential future repository service provider who seemed to think that they would own that data. Imagine their excitement. All the data about where drugs go throughout the supply chain! Think of the value they could mine from that.
Well, that’s never going to happen because companies in the supply chain won’t sign up for handing over all of their supply chain data to some third-party just so they can comply with regulations, especially when there exists an alternative approach that would allow them to avoid using a third-party and still comply (by using DPMS). And regulatory agencies are Continue reading Data Ownership In The Track & Trace Cloud→
…a comprehensive exploration of the intersection between healthcare supply chains, track and trace technology, standards and global regulatory compliance
DISCLAIMER: RxTrace contains some of the personal thoughts, ideas and opinions of Dirk Rodgers. The material contained in RxTrace is not legal advice. Dirk Rodgers is not a lawyer. The reader must make their own decisions about the accuracy of the opinions expressed in RxTrace. Readers are encouraged to consult their own legal counsel and trading partners before taking any actions based on information found in RxTrace. RxTrace is not a vehicle for communicating the positions of any company, organization or individual other than Dirk Rodgers.