Tag Archives: free

Ken Traub (1963 – 2017)

Photo of Ken Traub
Ken Traub

Like all of you, I was incredibly shocked and sad to hear that my friend and occasional collaborator Ken Traub passed away on Sunday.  My heart and prayers go out to his wife and son.  Ken will be remembered for a long time by people all over the world because of  the depth of his technical knowledge, the clarity of his writing, the impact of his succinct speaking, the creativity of his thinking, the passion he had for solving complex problems, and the love in his heart. 

According to Brezniak-Rodman Funeral Directors, the memorial service will be held at Temple Isaiah, 55 Lincoln Rd., Lexington, on Wednesday, April 5, 2017 at 11:00 am.  Memorial contributions may be made to any cancer charity.

I’ve known Ken for a few Continue reading Ken Traub (1963 – 2017)

Can Anyone Buy Non-Serialized Drugs After 11-27-2019?

Image of a package of non-serialized drugsWell over a year ago, my good friend Kevan MacKenzie, Director, Serialization Technology with McKesson, pointed out a really interesting discrepancy contained in the Drug Supply Chain Security Act (DSCSA) regarding the sale of non-serialized drugs.  I’ve been meaning to write about it since then.  The topic finally bubbled up to the top on my list.

What Kevan pointed out is that there are two sections of the DSCSA that contain slightly conflicting requirements.  This leaves companies Continue reading Can Anyone Buy Non-Serialized Drugs After 11-27-2019?

Sponsored: How To Properly Define GTINs For Your NDCs

Image showing relationships of define GTINs
Packaging Hierarchy. Drawing by Omega Design

RxTrace readers are well aware that the deadline is this November 27 for applying unique serial numbers within GS1 DataMatrix 2D barcodes to prescription drugs distributed in the United States under the Drug Supply Chain Security Act (DSCSA).  Once that happens, most prescription drugs entering the U.S. supply chain will be identified by 14-digit GS1 Global Trade Item Numbers (GTIN-14) for the first time (see “Anatomy of a GTIN”).  That’s because, you can’t fit the drug’s National Drug Code (NDC) along with the serial number, lot number and expiration date into a data matrix barcode, as required by the law, without first encoding it into a GTIN-14 (see “Anatomy Of The National Drug Code”, and “Depicting An NDC Within A GTIN”).  This fact forces companies to encode their NDCs into GTIN-14s, many for the first time. Continue reading Sponsored: How To Properly Define GTINs For Your NDCs

My Handshake With Germany

image of my handshake offer to GermanyOur industry is international by nature.  Protecting patients from counterfeit drugs is partly a humanitarian mission and partly a business.  Consequently, I don’t worry much about who is looking for information on RxTrace.  I have happily fielded queries from Russia, China and even Iran, countries who are not always political “friends” of my beloved country. 

But what if a counterfeiter is seeking information Continue reading My Handshake With Germany

Sponsored: Pharma Traceability

May 22-24, Hotel Del Coronado, Coronado, CA

Pharmaceutical serialization and traceability laws continue to be developed all over the world.  In any one market, it takes several years to progress from the initial stirrings to the publication of full, workable regulations.  As we have seen, several countries have had to take a few steps back, make adjustments and then move forward again (see “Brazil Gets Rational With Their New Pharma Traceability Law” and “China’s Retreat From Pharma Serialization: Will This Become A Global Trend?”).  In fact, I think those countries that do, will end up with a much better approach.

What that means to you is Continue reading Sponsored: Pharma Traceability

Sponsored: The Season For Label Redesign

With the approach of pharma serialization deadlines all around the world, this is the season for label redesign.  The addition of new unique identifiers in 2D barcodes and human readable forms—often without removing existing linear barcodes—requires knowledge of the pharma labeling regulations in the target markets as well as artwork skills (see “DSCSA: Label Artwork Heartaches”).  The problem is, serialization doesn’t apply to just one product, it applies to all prescription drugs marketed in the target market.  That threatens to cause Continue reading Sponsored: The Season For Label Redesign

Dawn of HDA’s Origin, The Key to DSCSA Compliance

This week at the Healthcare Distribution Alliance (HDA) Distribution Management Conference and Expo (DMC) the HDA and ValueCentric will provide much more detail around the new master data sharing service they plan to make available in July.  The new service—named “Origin”—is intended to provide members of the pharma supply chain with a single directory of master data for all prescription drugs marketed in the United States (see Origin website).  That is, it is a database of master data wrapped within a cloud-based service. 

Origin master data is composed Continue reading Dawn of HDA’s Origin, The Key to DSCSA Compliance

Sponsored: Brand Protection: The ‘No Brainer’ Value, Beyond Compliance

Pharma companies are spending a boat-load of money to put serial numbers on their drug packages and homogeneous cases, and collecting aggregation data for the wholesale distributors.  And in every one of those companies, their leadership is asking, “What can we do to get some value, beyond compliance, from our investments?  Can we sell someone some data?  Can we get some new business advantage?  Can we get some new insight into our processes or into the operation of the supply chain?” Continue reading Sponsored: Brand Protection: The ‘No Brainer’ Value, Beyond Compliance