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
All posts by Dirk Rodgers
The Intrigue Contained In The New China Drug Code
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
Serializing Product Groupings Under Global Regulations
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
First Meeting of the HDA Verification Router Service Task Force
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
DSCSA: Saleable Returns Verification
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:
- Manufacturer sends to wholesale distributor product identifiers for only the units purchased by that wholesale distributor, and,
- Verification Router Service (VRS).
Brazil Gets Rational With Their New Pharma Traceability Law
Last week, Brazil President Michel Temer signed law number 13,410, which amends law number 11,903 from 2009, their original pharma serialization and tracing law. The effect of the new law on the old can be seen here. The problem for me is that I don’t read Portuguese, so I must rely on Google Translate to translate these texts. This results in an unofficial translation that has a few imperfections that are obvious, even to non-Portuguese readers, but it appears to be not bad. Continue reading Brazil Gets Rational With Their New Pharma Traceability Law
NDC Nearing Its End, Afflicted by ‘Identifier Failure’
Heart Failure is a human condition that is characterized by several easily identifiable symptoms, including fatigue, difficulty breathing and in its later stages, gurgled breathing. My mother and my mother-in-law both suffered from heart failure during their decline. Analogous to heart failure in humans is a condition of an identifier system that is near the end of its useful life that we can call “identifier failure”. At the end of November, a new FDA final guidance called “Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs That Are Regulated Under a Biologics License Application, and Animal Drugs” went into effect. Buried deep within this 200+ page document is the official announcement that signaled the National Drug Code (NDC) identifier system is now afflicted with this end-stage condition. The NDC won’t last long now, and there is no longer any excuse for inaction. The need for a replacement is now urgent. Continue reading NDC Nearing Its End, Afflicted by ‘Identifier Failure’
FDA Finalizes Guidance On Suspect Product
Here we are, waiting for the FDA to publish new draft guidance related to the Drug Supply Chain Security Act (DSCSA) after a deadline that passed more than a year ago, and what do we get? A final version of a guidance document that was originally published in draft form two and a half years ago: “Identification of Suspect Product and Notification”. Well, OK, thanks.
I have to say, this is important guidance. In fact, it is probably the most important DSCSA guidance that the FDA has published yet, whether in draft or final forms. And, unfortunately, Continue reading FDA Finalizes Guidance On Suspect Product
