Category Archives: DQSA of 2013

DQSA of 2013

DQSA: How Should Transaction Data Be Exchanged?

FDALogoThe U.S. FDA just published a docket asking for public input into standards for the interoperable exchange of information for tracing of human, finished, prescription drugs in paper or electronic format.  Ironically, they will accept responses to the docket in either paper or electronic format.  Comments should be submitted to the FDA within 60 days.  If my calculation is correct, you have until April 21st to submit your comments.

This docket was expected because the Drug Supply Chain Security Act (DSCSA), enacted last November, gives the FDA one year to publish a draft guidance document that establishes standards for the interoperable exchange of that type of information, and they are required to consult with the industry and other interested parties [see Section 582(a)(2)].  I have written about this requirement and the short time after the guidance is published before the members of the supply chain must make use of those standards (see “The Flaw That Must Be Addressed in H.R. 3204, The Drug Quality and Security Act” and “DQSA: Getting To Electronic Transaction Data Exchange“).  This docket fulfills the first of many mandates that the FDA is facing in

Continue reading DQSA: How Should Transaction Data Be Exchanged? →

DQSA of 2013

DQSA: Dancing Around The Returns Problem

Dancing.iStock.612379There is an interesting dialog going on in the Food and Drug Serialization Professionals group in LinkedIn that was kicked off by a recent RxTrace essay.  Click here to see the conversation.  It got real interesting when Marc Rosenblatt, Director of Sales at Veracity Network, related an experience his company had in a recent pilot.  He said:

“…An unsettling example occurred during one of our distributor pilot programs. Our system detected a number of counterfeit products (9% of the total sample to be exact) that were sent back as returns. This means that the molecular structure or product signature didn’t match up with the legitimate product standard. Upon further examination, it was discovered that the sealed bottles contained counterfeit replacements for the valid product. What makes this even a more difficult pill to swallow (pun intended) is the fact that these products would in most cases be restocked and sold again. The returns areas are the most overlooked link in the supply chain and from reading the DSCSA text, it continues to be (at least for the next 4 years).”

Marc’s reading of the Drug Supply Chain Security Act (DSCSA), which is Title II of the Drug Quality and Security Act (DQSA), gives him some comfort Continue reading DQSA: Dancing Around The Returns Problem →

California Pedigree Law, DQSA of 2013

The California Pedigree Law Is Now Officially Inoperative

bop_brandThe California Board of Pharmacy made it official late this afternoon.  As required by Section 4034.1 of the California Business and Professions Code (CB&PC), the Board posted a public notice late yesterday indicating that sections 4034, 4163, 4163.1, 4163.2, 4163.4, and 4163.5 of the CB&PC became inoperative due to the enactment of the Federal Drug Quality and Security Act (DQSA) on November 27, 2013 (see “It’s Official, President Obama Signs H.R. 3204, DQSA, Into Law“).  These specific sections of the CB&PC comprise what has been referred to in the industry as “the California Pedigree Law”.

The public notice was mandated by California law within 90 days of federal preemption because Continue reading The California Pedigree Law Is Now Officially Inoperative →

DQSA of 2013

How the DQSA Will–And Won’t–Protect The Supply Chain, Part 2

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Superhero right to leftLast week I published an overly long essay about how the supply chain provisions of the new U.S. Federal DQSA will and won’t protect the pharma supply chain.  Believe it or not, I had more to say on the subject, but because that essay was already too long, I withheld my additional thoughts until now.  Part 1 took another look at a number of supply chain crimes that have occurred over the last 5 to 6 years and attempted to determine how the new Drug Supply Chain Security Act (DSCSA) that is contained within the DQSA will add new protections that will or won’t help prevent crimes like them in the future.

In this Part 2 essay I want to look at the issue in a different way.  I’d like to compare the approach that Continue reading How the DQSA Will–And Won’t–Protect The Supply Chain, Part 2 →

DQSA of 2013

How the DQSA Will–And Won’t–Protect The Supply Chain, Part 1

SuperheroThe supply chain provisions contained within the Drug Quality and Security Act (DQSA)—themselves known as the Drug Supply Chain Security Act (DSCSA)—mark a significant achievement by Congress and the industry to protect the U.S. pharmaceutical supply chain from criminals.  It is the first completed attempt since 1987 when the Prescription Drug Marketing Act (PDMA) was enacted by Congress and signed by President Ronald Reagan.  In comparison, the provisions of the DSCSA are much more detailed and extensive than the PDMA and they read as if they were heavily influenced by people who solidly understand the scale and complexity of the legitimate supply chain.  Which, they were, based on the contribution of the Pharmaceutical Distribution Security Alliance (PDSA)—made up of key stakeholders in the supply chain—in their development.  That should ensure that the industry will be able to adopt the technology and process modifications necessary to meet the new law on time.

But will all this also lead to true protection of the supply chain from criminal activities?  Will the DSCSA portion of the DQSA end up presenting new and insurmountable barriers against criminals who game the supply chain to their advantage and thereby putting patients at risk?  These are the true measures of the success of this type of legislation.  How can we know if the DSCSA will have these positive affects? Continue reading How the DQSA Will–And Won’t–Protect The Supply Chain, Part 1 →

DQSA of 2013

Don’t Skip The DQSA Definition of Terms Section

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2014-01-10 16.02.25Lots of people across the U.S. pharma supply chain are spending their spare time these days trying to read and understand the U.S. Federal Drug Quality and Security Act (DQSA) that was enacted in November and begins to take effect in a significant way next January (see “It’s Official, President Obama Signs H.R. 3204, DQSA, Into Law”).  I am one of those people.

I have carried a printout of Title II (the Drug Supply Chain Security Act, or DSCSA) of the DQSA around with me ever since it was passed and it is now so dog-eared and marked up that I am about ready to print out another copy.  Only trouble is, I would need most of those markings in the new copy too, so I just keep using the same printout.

My understanding of the law and its implications rises every time I study it.  Sometimes Continue reading Don’t Skip The DQSA Definition of Terms Section →

DQSA of 2013

FDA: Ready, Set, Hike!

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FDALogoTuesday’s FDA stakeholder call with Dr. Ilisa Bernstein, deputy director in the FDA’s Center for Drug Evaluation and Research (CDER) Office of Compliance, was helpful if only to let us know that the FDA has begun to mobilize immediately after the Drug Quality and Security Act (DQSA) was signed into law by President Obama last week (see “It’s Official, President Obama Signs H.R. 3204, DQSA, Into Law” and “InBrief: Comments on H.R. 3204 by FDA’s Dr. Ilisa Bernstein at PSM Interchange 13”).  The call was very thin on what their plan is, but that was the point.  Dr. Bernstein wanted everyone to know Continue reading FDA: Ready, Set, Hike! →

DQSA of 2013

It’s Official, President Obama Signs H.R. 3204, DQSA, Into Law

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This is a stock photo of the President from the White House website, not the actual signing of H.R. 3204.

According to the White House website, President Barack Obama signed H.R. 3204, the Drug Quality and Security Act (DQSA), into law a short time ago, bringing to a successful conclusion efforts by the industry and consumer groups to create a national pharmaceutical serialization and track & trace regulation that eliminates the patchwork of state laws in addition to new regulations for compounding pharmacies.

Many people and organizations contributed to this successful effort and they all deserve congratulations, but I believe the organizations with the most responsibility for this conclusion is the California State legislature and the California Board of Pharmacy in Continue reading It’s Official, President Obama Signs H.R. 3204, DQSA, Into Law →