Tag Archives: GS1

GS1 Publishes Version 16 Of Their General Specifications …And Why You Should Care

GS1_logoMedical device manufacturers have a choice of standards to use when identifying their products for the U.S. market.  The FDA’s Unique Device Identification (UDI) rule allows them to select from any identification standards organization (referred to as a “number issuing” agency) that is accredited by the Agency for that purpose.  So far, three organizations have been FDA-accredited:  HIBCC, ICCBBA and GS1.

ICCBBA has a lock on the identification of Continue reading GS1 Publishes Version 16 Of Their General Specifications …And Why You Should Care

The Next Markets To Impose Pharma Serialization and Tracing?

Digital WorldThe pharmaceutical markets that currently have a serialization and/or tracing regulation on the books include the United States, the European Union, China, Brazil, India, Italy, Turkey, South Korea, Argentina, Saudi Arabia and Jordan.  Not all are fully operational yet, but they are official.  This list may be about to grow by two. Continue reading The Next Markets To Impose Pharma Serialization and Tracing?

The Official Suspension of the Three-Lot Pilot in Brazil

395px-Coat_of_arms_of_Brazil.svgOn October 23, 2015, a very brief resolution was published in the Official Diary of the Union (Diário Oficial da União) (Brazil’s equivalent to the U.S. Federal Register) which formally suspends the 3-lot track and trace pilot that drug registration-holders were formerly required to complete by December 10 of this year (see “Brazil Suspends Pharma Serialization And Tracing Requirements”).  Apparently, that makes it official.  The new resolution is numbered RDC-45 and it is dated October 22, 2015.  Of course, this new resolution is only available officially in Portuguese, but here is an unofficial translation of its core contents in English: Continue reading The Official Suspension of the Three-Lot Pilot in Brazil

I’ve Changed My Mind, Follow GS1’s HRI Specification

HRI zoomThat’s right, I now recommend that you follow GS1’s Human Readable Interpretation (HRI) specification for drug labeling, even when under a serialization regulation.  Previously I recommended against it (see “The DSCSA Product Identifier On Drug Packages”, and “The ANVISA Unique Medicine Identifier (IUM) on Drug Packages”).  Why have I changed my mind?  GS1 modified their specification to accommodate most of the objections I had over it.  Let me explain.

The new specification for HRI is in the latest version of Continue reading I’ve Changed My Mind, Follow GS1’s HRI Specification

The ANVISA Unique Medicine Identifier (IUM) on Drug Packages

Idea for a barcode that might meet ANVISA requirements
Idea for a barcode that might meet ANVISA requirements

Last week I wrote about the DSCSA Product Identifier on Drug Packages in the United States.  Last month I wrote about shipping container/transport package identification under the Brazil National Medicine Control System (SNCM) (see “ANVISA And The SSCC Controversy”).  Today I will take a look at drug package identifiers under the SNCM as regulated there by the National Agency of Sanitary Surveillance (ANVISA).  Most of the factual information included here is based on Continue reading The ANVISA Unique Medicine Identifier (IUM) on Drug Packages

ANVISA And The SSCC Controversy

ANVISA logoGS1’s Serial Shipping Container Code, or SSCC, has been around a long time, but the logistics identifier has recently taken center-stage in a number of controversies related to meeting several country-specific pharma traceability regulations.  I’ll cover these controversies in multiple essays—in this one, Brazil.

This controversy started when ANVISA, the pharma regulator in Brazil, indicated in their regulations that they expected companies to mark every “transport package” entering their supply chain with a unique identification code so that each serialized unit inside can be associated with it (the aggregation requirement).

The problem is, a homogeneous case of product can Continue reading ANVISA And The SSCC Controversy

Thank You Ron Bone!

Bone Ron Prototype 1
Ron Bone

Well over 18 months ago I learned that Ron Bone was stepping down as SVP of Distribution Support at McKesson.  He immediately became a solo consultant and was engaged directly with McKesson again, but this time he filled a part-time role.  This was Ron’s way of staying connected with the activities at McKesson related to meeting the federal Drug Supply Chain Security Act (DSCSA) which was on its journey toward enactment, and it was McKesson’s way of maintaining continuity in those efforts.  Win-win.

Ron originally intended to fully retire last July…then December…and now, someday.  Does anyone think it will happen this time?  Frankly, I hope not.  I think Ron is having too much fun, and everyone in the industry who knows him enjoys having Ron engaged as much as he is willing.  So take your time Ron.  No need to rush.

Like Bob Celeste, who departed GS1 US last month after serving as the lead traceability facilitator and motivator for the U.S. pharma supply chain (see “Thank You Bob Celeste!”), Ron was Continue reading Thank You Ron Bone!

DQSA: Will U.S. Pharma Distributors Mandate Aggregation Data In Phase 1?

worker with stacker at warehouseI attended the Healthcare Distribution Management Association (HDMA) Track and Trace Seminar held in Crystal City, VA on November 11-13, 2013.  I was particularly interested in the session called “Distributor Case Studies and Updates”, as were a lot of other people.  The speakers were:

Each speaker gave a brief presentation about their current serialization and pedigree programs before taking questions as a panel.  As you would expect, all of the preparation these companies have done up to this point has been aimed squarely at the California pedigree law which would have gone into effect for wholesalers in California in mid-2016.  But, Continue reading DQSA: Will U.S. Pharma Distributors Mandate Aggregation Data In Phase 1?