Tag Archives: DSCSA

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expected because the Drug Supply Chain Security Act (DSCSA), enacted last November, gives the FDA one year to publish a draft guidance document that establishes standards for the interoperable exchange of that type of information, and they are required to consult with the industry and other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 →

RxTrace Traceability Survey

Does The DQSA Require Manufacturers To Provide Aggregation Data? Survey Says…

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AggregationDataSurveyResultsZoomOne of the most intense questions about any serialization mandate is whether or not manufacturers would be required to pass “aggregation data” to their customers.  “Aggregation data” is the serial number-based packaging hierarchy of the shipment.  That is, a list of the package-level serial numbers that are contained in each serialized bundle, and then which bundles are contained within which serialized cases and then which cases are contained on which serialized pallet, etc.

You can’t expect to give a couple of workers a handheld barcode reader and expect them to produce six sigma aggregation data.  It is possible to collected highly accurate aggregation data (see “Pharma Aggregation: How Companies Are Achieving Perfection Today”), but it requires systems specifically designed to do so.  The now obsolete California pedigree law did not Continue reading Does The DQSA Require Manufacturers To Provide Aggregation Data? Survey Says… →

RxTrace Traceability Survey

DQSA: Did The Authors Get The Timeline Right?

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2014 enough time graph.zoomIn the last update by the California Legislature, the timeline for the rollout of the California pedigree law was spread out so that it was to take 2 ½ years from the first manufacturer deadline for serialization of 50% of their product until everything was serialized, pedigreed and wholesalers and pharmacies were making use of the serial numbers and pedigrees.  Of course, everyone should be aware by now that the U.S. Drug Quality and Security Act (DQSA) preempted that law and all State and Federal pharma serialization and pedigree laws, and replaced them with new Federal requirements that have a different rollout timeline.

The track and trace provisions of the DQSA are defined within Title II of that act, known as the Drug Supply Chain Security Act (DSCSA).  Some of its provisions begin next January.  Some start in November of 2017 and some start in 2023.  Continue reading DQSA: Did The Authors Get The Timeline Right? →

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 →

RxTrace, RxTrace Traceability Survey

Announcing The 2014 RxTrace U.S. Pharma Traceability Survey

iStock_000028920134XSmallWith the enactment of the Drug Supply Chain Security Act of 2013 (DSCSA) last week (see “It’s Official, President Obama Signs H.R. 3204, DQSA, Into Law“) I have decided to conduct an annual survey of U.S. pharma traceability preparedness.  You can fill out the survey by clicking on this link:  Take the 2014 RxTrace U.S. Pharma Traceability Survey Now.

The answers you provide anonymously will be aggregated to provide a view of the thinking of the industry, solution providers, regulators, academics and more, in addition to a view of the preparedness of the industry to meet the new federal pharmaceutical traceability law.  Please make sure your company is represented in the data that is collected.  The survey is Continue reading Announcing The 2014 RxTrace U.S. Pharma Traceability Survey →