This is the third of a five part interview with Ken Traub, GS1 standards expert and independent consultant, on GS1 serial number randomization. The full series includes essays covering:
This week Ken introduces the concept of threat analysis. – Dirk. Continue reading Randomization—An Interview with Ken Traub—Part 3: Threat Analysis
This is the second of a five part interview with Ken Traub, GS1 standards expert and independent consultant, on GS1 serial number randomization. The full series includes essays covering:
This week Ken introduces three properties of randomization. — Dirk.
Continue reading Randomization—An Interview with Ken Traub—Part 2: Properties of Randomization
Over the next two weeks I have a very special treat for RxTrace readers. It is an interview with Ken Traub, GS1 standards expert and independent consultant. The subject is GS1 serial number randomization, something so important that I think pharma companies ought to give deep thought to it before they turn on their serial number applications.
Pharma manufacturer who sell into the E.U. and/or Brazil markets will be forced to randomize their serial numbers because of regulatory requirements, but even those who only sell into the U.S. market should strongly consider randomization. I’ll have more to say about why in a follow-up essay after this series is over.
Because the interview with Ken covers the topic so thoroughly, it is long. That’s good, because it provides readers with an easy to understand explanation of everything they need to know about randomizing. But it also makes for a very long essay, so I have broken the interview down into five RxTrace essays. Read sequentially, they contain the complete interview. The subtopics covered by those essays include: Continue reading Randomization—An Interview with Ken Traub—Part 1: GS1 Serial Number Considerations
RxTrace is proud to sponsor the 2014 UDI Implementation Workshop to be held in Baltimore on May 20-22. The UDI Implementation Workshop is specifically for Class III medical device manufacturers who are in immediate need of information and guidance from the UDI experts at the FDA to meet their September 24, 2014 compliance deadline, and for those Class I and II Device manufacturers that need to jumpstart their UDI adoption efforts.
The FDA UDI Team will conduct a roll-up-your sleeves / deep-dive workshop covering all components of the UDI regulation and the Global UDI Database (GUDID) guidance. This workshop is strictly focused on critical information exchange, expanded interaction, and heightened networking designed to deliver immediate and actual results in your UDI implementation initiative. If you need to meet the September deadline, don’t miss this workshop. It is perfectly timed to give you the boost you need to be ready on time. Continue reading Bringing UDI and the Global UDI Database to Life
Connie T. Jung, RPh, PhD, Acting Associate Director of Policy and Communications, Office of Drug Security, Integrity and Recalls, in the Office of Compliance within the U.S. FDA Center for Drug Evaluation and Research (CDER) delivered an overview of the new Drug Supply Chain Security Act (DSCSA) during a webinar last Monday. The title of the webinar was “FDA Perspectives on Implementation of the Drug Supply Chain Security Act”. The webinar is one of a series that the Healthcare Distribution Management Association (HDMA) plans to offer on related topics through the remainder of the year. If you missed it, don’t worry, they will post the recording and the slides on the HDMA event web page.
I have to give credit to Dr. Jung and the FDA in general for being willing to make presentations like this at this time. The material they cover is a good overview of the new law at a high level. The tough part for the speaker comes at the end when the floor is opened up for Q&A. There were a number of very good questions asked by participants on this one, but most were answered with simple reference to future guidance. Here is Dr. Jung’s answer to Continue reading DSCSA: Many Questions, Few Answers
Ever since the Drug Quality and Security Act (DQSA) was signed into law last November (see “It’s Official, President Obama Signs H.R. 3204, DQSA, Into Law”), more and more people are asking the question, “Does my drug have to follow the DQSA?”. Recently I was on a monthly industry call put on by one of the Big 3 wholesale distributors to discuss the Drug Supply Chain Security Act (DSCSA), which is Title II of the DQSA.
I was surprised how many people asked the wholesaler if their specific product was covered or exempt. Of course, asking a wholesale distributor if your own product must follow a particular Federal law is not likely to get a usable response and that was true in this case, but it did not stop the next person from asking the same kind of question.
In fact, no one can answer that question for you. Even the FDA can’t answer that question for you. I can’t answer that question for you. Only YOU can answer that question based on your knowledge of your product’s characteristics and a careful reading of certain provisions of the DSCSA. I can help you with that part. Continue reading Is Your Drug Exempt From The Federal Drug Supply Chain Security Act?
This is the third in a series of essays about data exchange components required by the Drug Supply Chain Security Act (DSCSA) beginning next January. The previous essays in this series include DSCSA Transaction Information (TI) and DSCSA Transaction History (TH). The DSCSA, which is Title II of the Drug Quality and Security Act (DQSA), defines Transaction Statement (TS) this way:
“(27) TRANSACTION STATEMENT.—
The ‘transaction statement’ is a statement, in paper or electronic form, that the entity transferring ownership in a transaction—
This is the second in a series of essays about data exchange components required by the Drug Supply Chain Security Act (DSCSA) beginning next January. Last week’s essay was about DSCSA Transaction Information (TI). On the surface, Transaction History (TH) looks simple. The DSCSA, which is Title II of the Drug Quality and Security Act (DQSA), defines TH this way:
“(25) TRANSACTION HISTORY.—
The term ‘transaction history’ means a statement in paper or electronic form, including the transaction information for each prior transaction going back to the manufacturer of the product.”
According to this simple definition, Continue reading DSCSA: Transaction History
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