The Serial Number Handling In Your WMS Probably Isn’t Sufficient For Pharma Serialization

Important Notice To Readers of This Essay On November 27, 2013, President Barack Obama signed the Drug Quality and Security Act of 2013 into law. That act has many provisions, but one is to pre-empt all existing and future state serialization and pedigree laws like those that previously existed in California and Florida. Some or all of the information contained in this essay is about some aspect of one or more of those state laws and so that information is now obsolete. It is left here only for historical purposes for those wishing to understand those old laws and the industry’s response to them.Most Warehouse Management Systems (WMS) available on the market today do a fine job of allowing their users to manage inventories in the warehouses of drug manufacturers, distributors and chain drug stores.  A WMS is a software system that may be a part of a larger Enterprise Resource Planning (ERP) system, or it may be a third-party application that is interfaced with the owner’s ERP system.

All WMS systems that I am aware of are intended to be sold into multiple industries, not just in pharma.  That’s so that the WMS vendor can maximize their sales.  The more industries, the more sales and the more profitable it is.  Because some industries have long had serial numbers on some of their products (computers and peripheral equipment, cell phones, electronics, medical equipment, appliances, etc.) WMS vendors have included serial number handling in their software for decades.  In fact, I would bet that a serial number handling feature was included in WMS systems since the very beginning of that category of software.

However, buyers of WMS systems in the pharma supply chain should be very careful not to confuse a “serial number handling” or even “serialization” checkbox on the WMS vendor’s spec sheets with the kind of “serialization” they will need for compliance with modern pharma serialization regulations.  I include Continue reading The Serial Number Handling In Your WMS Probably Isn’t Sufficient For Pharma Serialization

Your GS1 Company Prefix: An Enterprise Resource

Any company wishing to make use of GS1 standards—including their barcodes, identifiers and data exchange standards—must first obtain a GS1 Company Prefix, or “GCP”.  Normally you would obtain a GCP by applying to the GS1 Member Organization (M.O.) in the country where your company headquarters resides, but if you are a pharmaceutical company that makes drugs for the U.S. market, regardless of where you are located, you will need to obtain a special GCP from GS1 US, the GS1 M.O. in the United States.

That’s because currently, drugs sold into the U.S. market must contain a linear barcode that encodes your U.S. Food and Drug Administration (FDA) National Drug Code (NDC).  To properly encode that NDC into a GS1 barcode symbol, you must register with GS1 US the GS1 GCP that matches the FDA-assigned Labeler Code that is a part of every NDC.  Only GS1 US can assign/register a GCP that matches your FDA-assigned Labeler Code.  I explain all of this in more detail in my essay “Anatomy Of The National Drug Code”.

Companies may end up with more than one GCP over time for several reasons.  For example, if a drug company is based in Switzerland, merged with another pharmaceutical company in France a few years ago and sells pharmaceuticals globally, they may end up Continue reading Your GS1 Company Prefix: An Enterprise Resource

Should FDA Cede All Standards Development To GS1?

Back in 2007 the U.S. Congress passed the Food and Drug Administration Amendments Act (FDAAA) and it was signed into law by President Bush.  One of the provisions of that law was an instruction to the FDA to “…develop standards and identify and validate effective technologies for the purpose of securing the drug supply chain against counterfeit, diverted, subpotent, substandard, adulterated, misbranded, or expired drugs”, and “…develop standards for the identification, validation, authentication, and tracking and tracing of prescription drugs.”

The FDA fulfilled these instructions for one of the specific standards that the law identified when the agency published their Standardized Numerical Identifier (SNI) standard back in 2010.  That standard was fairly high level and for the vast majority of drugs, use of GS1’s Serialized Global Trade Item Number (SGTIN) (or “GTIN plus serial number”) for drug package identification would comply with it.  The text of the FDA’s standard says as much.

By defining the SNI in this way did the FDA surrender the development of the real SNI standard to GS1 (at least the sNDC portion of it)?  I don’t think so.  In my essay about the SNI standard I described it as the FDA “aligning” with GS1’s SGTIN (see my essay “FDA Aligns with GS1 SGTIN For SNDC”).  Alignment shouldn’t be confused with surrender.  The choice of alignment with SGTIN was good for the FDA, good for patients and good for the industry.


In the case of the SNI aligning with GS1’s SGTIN we got the following things: Continue reading Should FDA Cede All Standards Development To GS1?

InBrief: ePedigree Models and Points of Failure

Over the last year in GS1, in many of the members of the U.S. pharma supply chain and even in the FDA, the focus has turned to the analysis and discussion of three classes of electronic pedigree models:

  • Fully Centralized,
  • Semi-Centralized, and
  • Fully Distributed.

I’ve discussed some of the pros and cons of these models here in RxTrace too (see “The Viability of Global Track & Trace Models”, “Should Regulations Dictate Technology?”, and “Could This Be Your Future Track & Trace/ePedigree Exchange Solution?”).

One of the characteristics included in many of these discussions is the “points of failure” of each model.  For example, I’ve heard it said several times that the Fully Centralized model suffers from a “single point of failure”, with the implication being that Fully Distributed models do not have this problem.  In fact, this is incorrect and in reality, both the Fully and Semi-Centralized models are much less likely to fail than models that fall within the Fully Distributed category when “failure” is defined as not being able to provide an ePedigree on demand in any given instance.


Wikipedia has a pretty good article on Reliability Engineering so I’ll spare you the background of the discipline that studies points of failure.  The mistake people sometimes make Continue reading InBrief: ePedigree Models and Points of Failure

GS1 Standards – Betcha Can’t Use Just One!

The title is a paraphrase of a TV commercial from the 1960’s, ’70’s and ’80’s for Lay’s Potato Chips but the sentiment is the same.  You really can’t get away with using only a single GS1 standard.  That’s why they are sometimes referred to as “The GS1 System of Standards“.  It’s a “system” of standards.  Multiple standards that are designed to work for you together in concert; as a whole; not independently.

So when your customer demands that you make use of Global Location Numbers (GLN) and/or Global Trade Item Number (GTIN), they are starting you down the path of adoption of much more than just those two “entry-level” standards (see my essay “So a customer demands that you use GLN’s and GTIN’s. What next?”).  Here is a partial list of other GS1 standards that you may benefit from adopting once you fully embrace GLN and GTIN: Continue reading GS1 Standards – Betcha Can’t Use Just One!