More and more people are asking if the FDA will delay the January 1, 2015 requirements of the Drug Supply Chain Security Act (DSCSA). On that day, drug manufacturers, repackagers and wholesale distributors must begin exchanging Transaction Information (TI), Transaction History (TH) and Transaction Statements (TS), (dispensers join them next July) and the FDA is not even due to publish guidance on how to do that until November 27 (see “The Flaw That Must Be Addressed in H.R. 3204, The Drug Quality and Security Act“). While they have said they hope to publish that guidance earlier than that date, it still won’t give companies much time to prepare. So, will they delay it? Continue reading Will The FDA Delay The DSCSA?
Monthly Archives: September 2014
Everything You Need To Know About UDI In One Neat Package
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
Pharma Serialization: Going Totally Global Soon
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 Publishes Updated Guidance For DSCSA
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
Who Is A DSCSA Dispenser?
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?
The HDMA Supply Chain Product Transaction Scenarios For DSCSA
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
Is Your Drug Exempt From The Federal Drug Supply Chain Security Act? Revisited
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