Tag Archives: free

DSCSA Red Light Green Light: Verification Responses

Yellow stoplight
Even a stoplight has three lights

There is an important debate going on over the last 9 months regarding exactly how many different answers companies should prepare to provide in response to a DSCSA verification request.  Some say two:  “Red light” or “Green light”.  And others say three:  “Yes”, “No”, or “It’s Complicated”.  This might seem like a minor question, but people on each side are surprisingly passionate about their positions.  Let me explain. Continue reading DSCSA Red Light Green Light: Verification Responses

DSCSA and RxTrace: The Song Remains The Same

Led Zeppelin:  The Song Remains The Same album coverDrug manufacturers facing the November 27, 2017 deadline for applying unique identifiers to their products should take care when interpreting the FDA’s recent draft compliance policy.  All the headlines scream (including last week’s RxTrace essay:  “FDA Delays Enforcement of DSCSA November Deadline: What It Means”) that the Drug Supply Chain Security Act (DSCSA) serialization deadline is delayed, but there are important nuances to the delay.  Don’t just read the headlines, read the whole articles.  Officially, the deadline remains the same.  Yes, the FDA will look the other way for some drugs, but for others, the deadline still appears to apply.  How do you know if your drugs are those where the deadline still applies?  Read on. Continue reading DSCSA and RxTrace: The Song Remains The Same

FDA Delays Enforcement of DSCSA November Deadline: What It Means

Business man trying to stop the clockAs you have read, the FDA has let it slip, with a draft guidance document, that they have decided not to enforce the DSCSA’s November 27, 2017 deadline for manufacturers to apply the new serialized product identifier on drug packages and verification requirements for one year, but it also contains cascading enforcement delays (see “FDA Tea Leaves: Are They About To Delay The November Deadline?”).  This is a major move by the FDA and it will have important consequences for the industry.  Let’s break it down. Continue reading FDA Delays Enforcement of DSCSA November Deadline: What It Means

New Must-Read DSCSA Resource

Last week, GS1 US published a free DSCSA resource that every RxTrace reader must have.  It’s called “Frequently Asked Questions (FAQs) by the Pharmaceutical Industry in Preparing for the U.S. DSCSA” and it can be downloaded free after registration.  Do it now, then come back and finish reading this essay.

The document is 42 pages in PDF form and it Continue reading New Must-Read DSCSA Resource

Is Your Drug Too Small For The Mandated 2D Barcode?

Is your Drug Too Small?  Sample vial and syringe with barcode attached.
As an experiment, I taped the smallest DSCSA-compliant 2D barcode I could define to these sample vial and syringe from CCL Label. Notice that neither sample includes the required human readable text of the data encoded in the barcode, which means that these examples may not comply in some markets. The barcode on the vial is readable, but the one on the syringe is not readable because of the short radius of the barrel (about 5mm).

RxTrace readers are already well aware that multiple new laws around the world will require prescription drug manufacturers to put a new 2D barcode on their products in the next few years.  But what if your drug package is too small to fit the new mandated 2D barcode and human readable information on the label?  Let’s take a look at what the regulations say in the E.U., Brazil and the United States.  From that, we can come up with some strategies. Continue reading Is Your Drug Too Small For The Mandated 2D Barcode?

Ken Traub (1963 – 2017)

Photo of Ken Traub
Ken Traub

Like all of you, I was incredibly shocked and sad to hear that my friend and occasional collaborator Ken Traub passed away on Sunday.  My heart and prayers go out to his wife and son.  Ken will be remembered for a long time by people all over the world because of  the depth of his technical knowledge, the clarity of his writing, the impact of his succinct speaking, the creativity of his thinking, the passion he had for solving complex problems, and the love in his heart. 

According to Brezniak-Rodman Funeral Directors, the memorial service will be held at Temple Isaiah, 55 Lincoln Rd., Lexington, on Wednesday, April 5, 2017 at 11:00 am.  Memorial contributions may be made to any cancer charity.

I’ve known Ken for a few Continue reading Ken Traub (1963 – 2017)

Can Anyone Buy Non-Serialized Drugs After 11-27-2019?

Image of a package of non-serialized drugsWell over a year ago, my good friend Kevan MacKenzie, Director, Serialization Technology with McKesson, pointed out a really interesting discrepancy contained in the Drug Supply Chain Security Act (DSCSA) regarding the sale of non-serialized drugs.  I’ve been meaning to write about it since then.  The topic finally bubbled up to the top on my list.

What Kevan pointed out is that there are two sections of the DSCSA that contain slightly conflicting requirements.  This leaves companies Continue reading Can Anyone Buy Non-Serialized Drugs After 11-27-2019?