Yearly Archives: 2017

China

The Intrigue Contained In The New China Drug Code

The CFDA “Bit 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 →

SSCC

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 →

HDA

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 →

Product Identifier Authentication, Saleable Returns Verification

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).

Continue reading DSCSA: Saleable Returns Verification →

ANVISA

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 →