UDI

Everything You Need To Know About UDI In One Neat Package

September 25, 2014 Dirk Rodgers

Manufacturers of class III medical devices are (hopefully) breathing a sigh of relief today after the recent scurry of activity leading up to yesterday’s deadline for meeting the FDA’s Unique Device Identifier (UDI) regulation. Now they can relax, right? Well, odds are, most of them also make class II devices, and maybe even some that are “life supporting and/or life sustaining” devices as well, which means the march toward the next UDI deadlines has to start all over again.

Fortunately, the experience gained by those who faced this first deadline can help guide those who need to meet the next one(s). Device distributors and hospitals will Continue reading Everything You Need To Know About UDI In One Neat Package →

Global Alignment

Pharma Serialization: Going Totally Global Soon

September 22, 2014 Dirk Rodgers 3 Comments

One of the best sessions during last week’s LogiPharma conference held in Princeton, NJ was called “Staging Your Implementation To Meet The 2017 Deadline”. The “deadline” refers to the November 27, 2017 deadline for drug manufacturers to apply unique serial numbers to all drug packages and cases shipped into the U.S. market as required in the Drug Supply Chain Security Act (DSCSA), but it can also refer to similar deadlines with similar requirements in a number of other regions of the world. The panel included knowledgeable representatives from two of the largest global pharma manufacturers selling into the U.S. market. Both manufacturers are facing serialization mandates in the E.U., Brazil, Turkey, South Korea, China, India, Argentina and a few countries in Africa as well as the U.S.

As they spoke about their respective programs for meeting the requirements, one of the speakers mentioned that roughly 90% Continue reading Pharma Serialization: Going Totally Global Soon →

GS1 Healthcare US

GS1 Healthcare US Publishes Updated Guidance For DSCSA

September 17, 2014 Dirk Rodgers

I happened to be chatting with Bob Celeste of GS1 Healthcare US yesterday at the LogiPharma conference in Princeton, NJ where he was about to speak, when he found out that version 1.1 of their guideline had just been published on their website. The full title of the 137 page document is “IMPLEMENTATION GUIDELINE, Applying GS1 Standards to U.S. Pharmaceutical Supply Chain Business Processes FOR THE DRUG SUPPLY CHAIN SECURITY ACT AND TRACEABILITY R1.1 — SEP 12, 2014”. You can download a free copy from their web page.

I will have more to say about this document in a few weeks when I have time to review it more fully, but this is the long awaited update that brings the earlier version up-to-date with the Drug Supply Chain Security Act (DSCSA). The 1.0 version of the guideline, published in March of last year, was Continue reading GS1 Healthcare US Publishes Updated Guidance For DSCSA →

Dispensers, DSCSA

Who Is A DSCSA Dispenser?

September 15, 2014 Dirk Rodgers

When the U.S. Drug Supply Chain Security Act (DSCSA) was signed into law last November, it introduced a new term into the supply chain lexicon: “Dispenser”. It is unfortunate that the authors chose not to use a more recognizable word—like “pharmacies”, or “hospitals”, or “physicians”—because, if they had, more organizations in the dispensing sector might have taken more notice of the requirements they are facing. But, of course, they could not do that because they wanted to refer to all of those organizations using a single term. All of those types of organizations fall into the DSCSA definition of “dispensers” and the use of that word appears to have led to some confusion, and therefore some amount of complacency.

“Dispenser” is one of the terms the DSCSA defines so that the rest of the text does not need to repeat the full list of organizations the authors are referring to (see “Don’t Skip The DQSA Definition of Terms Section”). Its definition is only applicable Continue reading Who Is A DSCSA Dispenser? →

Data Exchange

The HDMA Supply Chain Product Transaction Scenarios For DSCSA

September 8, 2014 Dirk Rodgers

Back in the middle of the summer the Healthcare Distribution Management Association (HDMA), the industry association for the primary healthcare distributors in the United States, published on their website a very valuable resource for companies that must meet the U.S. Drug Supply Chain Security Act (DSCSA) beginning in January. This new resource is tucked away in the HDMA’s “Issues in Distribution”, “Pharmaceutical Traceability” page under the “Technical/Standards” heading [look for “Supply Chain Product Transaction Scenarios: Drug Supply Chain Security Act Implementation (2014)”]. It is free for anyone to download and I highly recommend that you do. (And while you’re at it, check out some of the other resources available on that page.)

HDMA has been a leader in developing high quality guidance documents that aim to help Continue reading The HDMA Supply Chain Product Transaction Scenarios For DSCSA →

DSCSA, exemptions

Is Your Drug Exempt From The Federal Drug Supply Chain Security Act? Revisited

September 2, 2014 Dirk Rodgers 5 Comments

I am working this week, but I know this is a popular time for vacations, especially for those who do not have children in school. I typically write my Monday essays over the weekend, but because it was a holiday weekend and my wife and I did some leisure traveling, I decided to re-post a popular essay from earlier this year: “Is Your Drug Exempt From The Federal Drug Supply Chain Security Act?“.

I wrote this essay to help companies, large and small, figure out whether or not their products might be exempt from the DSCSA. In it, I provide a kind of a formula that you can use to determine if a given product is exempt or not. At least it’s a series of questions or statements that you can ask yourself about your product. So without further ado,

IS YOUR DRUG EXEMPT FROM THE FEDERAL DRUG SUPPLY CHAIN SECURITY ACT?

Ever since the Drug Quality and Security Act (DQSA) was signed into law last November Continue reading Is Your Drug Exempt From The Federal Drug Supply Chain Security Act? Revisited →

Traceability models

Pharma Supply Chain Companies Organize To Establish Global Traceability Data Exchange Architecture

August 25, 2014 Dirk Rodgers 1 Comment

Last Friday a new committee formed by Rx-360 held their first meeting of parties interested in identifying architectures—or at least “conceptual models”—useful for efficiently meeting the full diversity of pharmaceutical track and trace regulations around the globe. Rx-360 is a non-profit organization “…formed in 2009 to support an industry-wide commitment to ensure patient safety by enhancing quality and authenticity throughout the pharmaceutical supply chain”, according to their press releases.

The new committee is called the “Traceability Data Exchange Architecture Work Group” and it seeks Continue reading Pharma Supply Chain Companies Organize To Establish Global Traceability Data Exchange Architecture →

Conferences

2014 Fall Conference Season Preview

August 18, 2014 Dirk Rodgers 1 Comment

It is time to look at the better healthcare supply chain conferences coming up this fall. This year the focus will be on the Drug Supply Chain Security Act (DSCSA) and the Unique Device Identification (UDI) final rule implementations. For the DSCSA I think we will see presentations aimed at both the immediate 2015 data exchange requirements and those aimed at the 2017 serialization requirements, but I also expect to see presentations aimed at “second generation” data exchange—those based on GS1’s recently updated Electronic Product Code Information Services (EPCIS) standard. After meeting the initial data exchange requirements for Transaction Information (TI), Transaction History (TH) and Transaction Statements (TS) in January, companies will need to begin preparing for the second generation using EPCIS (see “DQSA: Getting To Electronic Transaction Data Exchange”). That transition will likely occur over the next three years. Continue reading 2014 Fall Conference Season Preview →

RxTrace