Tag Archives: Illegitimate Product

DSCSA Guidance: Definitions of Suspect and Illegitimate Product for Verification Obligations

As I mentioned last week, the FDA published two new draft DSCSA guidance documents on the day of the recent FDA DSCSA Public Meeting (see “FDA DSCSA Public Meeting #3: A Difference?”).  Let’s take a closer look at what’s in them and their significance to companies facing the Drug Supply Chain Security Act (DSCSA).  I’ll cover one of the two in this essay and cover the other document in the next essay. Continue reading DSCSA Guidance: Definitions of Suspect and Illegitimate Product for Verification Obligations

FDA Finalizes Guidance On Suspect Product

suspect-product-final-guidanceHere we are, waiting for the FDA to publish new draft guidance related to the Drug Supply Chain Security Act (DSCSA) after a deadline that passed more than a year ago, and what do we get?  A final version of a guidance document that was originally published in draft form two and a half years ago:  “Identification of Suspect Product and Notification”.  Well, OK, thanks. 

I have to say, this is important guidance.  In fact, it is probably the most important DSCSA guidance that the FDA has published yet, whether in draft or final forms.  And, unfortunately, Continue reading FDA Finalizes Guidance On Suspect Product

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The FDA’s Draft Guidance on Suspect Product, and Farewell Columbus

Suspect Product Draft GuidanceThe FDA published the draft guidance on the identification of suspect product and notification of suspect and illegitimate product on June 11 as mandated by Congress in the Drug Supply Chain Security Act (DSCSA).  The document provides helpful suggestions for those who wish to reduce the risk that they will unknowingly acquire illegitimate product through increased vigilance.  The suggestions are based on the experience the FDA has gained in their investigations over the years of many situations where companies have been duped by criminals into purchasing drugs that turned out to be counterfeit, diverted, stolen, adulterated, or otherwise unfit for consumption.  No legitimate company wants to be a party to buying, selling or dispensing to patients that kind of product, so Continue reading The FDA’s Draft Guidance on Suspect Product, and Farewell Columbus