Tag Archives: TS

DSCSA

Will The FDA Delay The DSCSA?

Dirty Harry.Do you Feel Lucky
Do you feel lucky?

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? →

Dispensers, 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? →

Data Exchange

The HDMA Supply Chain Product Transaction Scenarios For DSCSA

HDMA DSCSA ScenariosBack 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 →

Conferences

2014 Fall Conference Season Preview

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ConferenceIt 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 →

DSCSA

DSCSA: Special Privileges For The “Big-3″ Wholesale Distributors, Part 3

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AB ZoomIn Part 2 of this series I explained exactly what the “special privileges” are in the Drug Supply Chain Security Act (DSCSA) for wholesale distributors who purchase directly from the manufacturer, the exclusive distributor of the manufacturer, or a repackager who buys directly from the manufacturer (see “DSCSA: Special Privileges For The “Big-3″ Wholesale Distributors, Part 1”, and “DSCSA: Special Privileges For The “Big-3″ Wholesale Distributors, Part 2”).  In this third part, I will explain why all of this matters to drug manufacturers and how, in some situations, the “Big-3” wholesale distributors may not want to handle your product after the end of this year. Continue reading DSCSA: Special Privileges For The “Big-3″ Wholesale Distributors, Part 3 →

DSCSA

DSCSA: Special Privileges For The “Big-3″ Wholesale Distributors, Part 2

iStock_000001015002SmallerIn Part 1 of this series I explained how the “Big-3” wholesale distributors in the U.S. changed their buying practices back in the mid-2000s so now they only buy their inventory directly from each drug manufacturer.  But in a small number of cases, that isn’t possible.  In those cases, they are forced to buy from an exclusive distributor, or from a company who buys pre-packaged drugs from the NDA- or ANDA-holder.  (See “DSCSA: Special Privileges For The “Big-3″ Wholesale Distributors, Part 1”.)  And I pointed out that the DSCSA contains “special privileges” for any wholesale distributor who can buy direct from the manufacturer.  In this second part, I will explain exactly what these “special privileges” are in the Drug Supply Chain Security Act (DSCSA). Continue reading DSCSA: Special Privileges For The “Big-3″ Wholesale Distributors, Part 2 →

Record-keeping

DSCSA: A Closer Look At The Six-Year Record-Keeping Requirement

??????????The Drug Supply Chain Security Act (DSCSA) contains record-keeping requirements for drug manufacturers, wholesale distributors, repackagers and dispensers that begin on January 1st.  All companies must keep a copy of the Transaction Information (TI), Transaction History (TH), and Transaction Statements (TS) they receive and those they send for at least six years.  In addition, manufacturers and repackagers must also retain knowledge about the “product identifier” on each unit they sell into the supply chain for a period of six years after the date it was sold.  Companies who perform investigations into suspect product must also keep records of their process and the outcome for six years.

There are a few implications of these record-keeping requirements.  Let’s take a look at some of them.  Continue reading DSCSA: A Closer Look At The Six-Year Record-Keeping Requirement →

DSCSA

U.S. Pharma Supply Chain Complexity–Revisited

© Copyright 2011 Duncan Champney. used with Permission. This image was created with FractalWorks, a high performance fractal renderer for Macintosh computers. FractalWorks is available on the Mac App Store.
© Copyright 2011 Duncan Champney. used with Permission. This image was created with FractalWorks, a high performance fractal renderer for Macintosh computers. FractalWorks is available on the Mac App Store.

About 3 years ago I published an essay called “U.S. Pharma Supply Chain Complexity” where I attempted to provide a more realistic understanding of the U.S. pharma supply chain than the typical supply chain drawing offers.  That essay was aimed at helping the industry select an approach to meeting U.S. state pedigree laws, which are now preempted by the Drug Supply Chain Security Act (DSCSA).  But, as with many of my older essays, the underlying ideas still have value despite preemption.

In this case, the ideas also provide a clear explanation for why pharma manufacturers should expect to meet the electronic data exchange requirements that are dictated by the large U.S. wholesale distributors, rather than attempting to get them to accept some alternate approach.

So I have copied and pasted that essay below and then edited to serve this new purpose. Continue reading U.S. Pharma Supply Chain Complexity–Revisited →