One of my favorite conferences each year is the annual Unique Device Identification (UDI) Conference put on by the Clarion Group on behalf of the Food and Drug Administration (FDA). I am happy to sponsor the event each year, and I try to attend when I can.
As an educational authority on UDI, the 9th annual UDI Conference will Continue reading Sponsored: RxTrace to Sponsor the 2017 UDI Conference – June 7 & 8 in Baltimore, MD!
Because of all the major news and developments over the last six months, it has taken me way too long to fully cover the Healthcare Distribution Alliance’s (HDA’s) 2016 Serialization Readiness Survey of drug manufacturers. In my defense, I did cover it partially in my report of the HDA 2016 Traceability Seminar (see “HDA Delivers Home Run To Record-Breaking Audience”), but the other news from that event seemed to overshadow the survey results. The HDA survey executive summary was so well done, and the results so important that it deserves closer scrutiny. So here is my coverage, better late than never. Continue reading HDA’s 2016 Serialization Readiness Survey
Last week, GS1 Healthcare raised the awareness of new documents available on the Russian Federation government website. Actually, the news was contributed to that group by Brian Daleiden of TraceLink, who has been very generous with contributions of news and documents from multiple markets. These Russian documents explain the basis for a voluntary pharma supply chain pilot that the government is beginning this quarter. Of course, these documents are only provided officially in the native Russian language. Continue reading Russia Begins Its Pharma Supply Chain Pilot
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Key Highlights for 2017 include: Continue reading Sponsored: Monitor Your Product. Manage Your Brand.
Over the last few weeks, the pharma serialization and tracing landscape has begun to shift in China. The China Food and Drug Administration (CFDA) announced a new use for an existing “National Drug Code” in Public Notice 2017-1 that, according to Google Translate (a helpful but very imperfect translator), will be referred to as the “Bit Code”. In addition, a new notice has appeared on the AliHealth-hosted web portal that drug companies have been using for the last seven years or so to obtain serial numbers for their drug packages. Automated translation tools leave too much to speculation so companies should not use them for compliance purposes. However, here are my thoughts/speculation on what is happening. Continue reading The Intrigue Contained In The New China Drug Code
A “product grouping” is any collection of saleable units of products that are bound together in some way. They can be “bundles”, homogeneous or non-homogeneous cases, totes, pallets or something like these. The pharma serialization regulations in some markets call out some of these groupings for special treatment, and some do not. I’ll try to catalog what we know about product groupings in each of the current, known regulations. Continue reading Serializing Product Groupings Under Global Regulations
Happy Martin Luther King Jr. Day!
As someone who often attempts to explain truth and reality through writing, I can really appreciate the writing skill of Rev. Dr. Martin Luther King Jr. (see “Celebrating Martin Luther King Jr.”). I’ve learned that the best writing has to come from your heart just as much as it does from your head, but I still make mistakes that I don’t expect to see in Dr. King’s writing. Last week is an example. By attending the Healthcare Distribution Alliance’s (HDA’s) Verification Router Services (VRS) Task Force meeting in Crystal City, Virginia, I learned more about HDA’s intentions for the design of the VRS. Continue reading First Meeting of the HDA Verification Router Service Task Force
The Healthcare Distribution Alliance (HDA) Traceability Seminar that was held back in early November was so packed with valuable information that I still have a number of topics queued up from that event for RxTrace essays in the future. Today I want to take a closer look at the results of the Saleable Returns Pilots conducted by the HDA last year to figure out the most efficient way to verify saleable returns. I discussed the overall project in my report of the Traceability Seminar (see “HDA Delivers Home Run To Record-Breaking Audience”) but today I want to focus in on just two of the approaches piloted. These are:
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