Tag Archives: SNI

PDUFA Will Not Include RxTEC

June 18, 2012 Dirk Rodgers 4 Comments

Politico.com reported today that the national track and trace addendum that many hoped would be made part of the Prescription Drug User Fee Act (PDUFA) of 2012 was rejected by the U.S. House and Senate Conference Committee. That committee is working on merging the differences between the versions adopted by the two Houses of Congress into a single bill. See “’Track And Trace’ On Ice For Now” in Politico PULSE.

According to Politico, “The word emerged late Sunday night from congressional staffers working on the package who said a last-minute compromise effort failed to win the support of stakeholders, and a decision had been made to drop it — for now.”

Assuming there isn’t a last minute reconsideration, this means that the odds are now slim that a national regulation will preempt the California pedigree law before its effective dates. The remaining chance comes from the fact that the industry is well organized and well represented by the Pharmaceutical Distribution Security Alliance (PDSA) and could decide to back the introduction of a stand-alone bill that contains the essence of the Pharmaceutical Traceability Enhancement Code (RxTEC) language that was part of the PDUFA negotiations, or some other proposal. The success of such an approach likely depends on Continue reading PDUFA Will Not Include RxTEC →

The Preemption Provisions Built Into The California Pedigree Law

June 4, 2012 Dirk Rodgers 10 Comments

In this time of potential Congressional legislative action on drug track and trace I think it is time to take a closer look at the specific provisions contained in the current California pedigree law regarding Federal preemption. As I recall, this language was added in the most recent update of the law, the same update that pushed it out to 2015 – 2017. It is an invitation to the federal government to create their own national pedigree regulation and, if that happens, would cause the California pedigree law to become “inoperative”, thus preempted.

Here is the full text of section 4034.1 from the California Business and Professions Code: Continue reading The Preemption Provisions Built Into The California Pedigree Law →

WMS

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

April 30, 2012 Dirk Rodgers 2 Comments

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 →

FDA, standards

Should FDA Cede All Standards Development To GS1?

April 16, 2012 Dirk Rodgers 1 Comment

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.

WHAT WE GOT WHEN THE FDA ALIGNED THEIR SNI STANDARD WITH GS1’S SGTIN TECHNICAL STANDARD

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? →

Pedigree models, standards, Uncategorized

GS1 Standards – Betcha Can’t Use Just One!

April 2, 2012 Dirk Rodgers 3 Comments

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! →

Federal Pedigree

InBrief: FDA To Publish Track & Trace Standard By Year End

March 28, 2012 Dirk Rodgers

I stumbled across the FDA’s recently published “Guidance Agenda: New & Revised Draft Guidances CDER is Planning to Publish During Calendar Year 2012” while surfing the PharmTech website late last week. The guide is published each year in the spring to provide a “heads-up” on which guidance documents the FDA thinks they will be able to complete and publish by the end of the calendar year.

I first learned about the significance of the annual document about 18 months ago when an FDA official explained it in a conference presentation. In response to a question from the audience about when she thought the FDA would publish the Track & Trace (T&T) standard for pharmaceuticals, she recommended that people watch for a notice of it in the “Guidance Agenda…” each year. She said Continue reading InBrief: FDA To Publish Track & Trace Standard By Year End →

Aggregation, Inference

Pharma Aggregation: How Companies Are Achieving Perfection Today

March 26, 2012 Dirk Rodgers 7 Comments

Bottle ID photo courtesy of Optel Vision

One of the biggest challenges for companies in the U.S. pharmaceutical supply chain when the California pedigree law becomes operational after December 31, 2014 will be the need to maximize the efficiency of dealing with serial numbers on each drug package. One way to do that is to maximize the use of “inference” where the case serial number is read and the unit package-level serial numbers are “inferred” from the unit-to-case aggregation information supplied by the upstream trading partner (See my essays “Inference in the Pharmaceutical Supply Chain” and “Will The Pharma Supply Chain Be Able To Use Inference? Maybe Not!”).

But the problem with the use of inference is that you need to be able to rely on the accuracy of the aggregation information that your supplier provides to you. There is an element of trust in that—not just that you trust your supplier to be truthful with you but that you trust that your supplier’s case packing processes and systems will always accurately capture and document the unit-to-case hierarchy—or “aggregation”. You must be able to trust that the aggregation information your supplier provides to you will be 100% accurate. That’s a lot of trust. Continue reading Pharma Aggregation: How Companies Are Achieving Perfection Today →

California Pedigree Law

California Enforcement Subcommittee Moves To Require FDA SNI

March 23, 2012 Dirk Rodgers 2 Comments

During the California Board of Pharmacy, Enforcement Subcommittee meeting on Wednesday the members voted unanimously to recommend to the full board the approval of a regulation that would require the use of the Food and Drug Administration’s (FDA) Standardized Numerical Identifier (SNI) as the unique identifier that is required on all drugs packages as part of their pedigree law. That law currently requires pharmaceutical manufacturers to apply unique identifiers to 50% of all their prescription drug packages by January 1, 2015 and the remainder by January 1, 2016.

The approved text reads as follows: Continue reading California Enforcement Subcommittee Moves To Require FDA SNI →

RxTrace