DSCSA: Transaction Information

TI.iStock_000020581807SmallerIn the new U.S. Drug Supply Chain Security Act (DSCSA) enacted last November as part of the Drug Quality and Security Act (DQSA), “Transaction Information” (TI) is one of three primary sets of data that supply chain sellers of drugs must provide to the buyers beginning January 1 of next year.  I will discuss “Transaction History” (TH) and “Transaction Statements” (TS) in future essays.

On first look, TI can seem pretty simple.  Here is how the DSCSA defines it:

“(26) TRANSACTION INFORMATION.—

The term ‘transaction information’ means—

“(A) the proprietary or established name or names of the product;
“(B) the strength and dosage form of the product;
“(C) the National Drug Code (NDC) number of the product;
“(D) the container size;
“(E) the number of containers;
“(F) the lot number of the product;
“(G) the date of the transaction;
“(H) the date of the shipment, if more than 24 hours after the date of the transaction;
“(I) the business name and address of the person from whom ownership is being transferred; and
“(J) the business name and address of the person to whom ownership is being transferred.”

Sounds kind of like a delivery manifest or packing list. Continue reading DSCSA: Transaction Information

The Drug Supply Chain Security Act Explained

OLYMPUS DIGITAL CAMERAEven before the Drug Quality and Security Act (DQSA) was passed last November I began to study Title II, the Drug Supply Chain Security Act (DSCSA).  But as soon as it was passed, I began to devote all of my spare time to that study.  The DSCSA text is much more complicated than any previous U.S. drug pedigree law and so, to really understand it, I’ve read it through many times, concentrating on different parts at different times.  I wanted to understand the law as well as I had come to understand the California pedigree law, the one that previously was the most complex.

It has taken this long, but I can now say that I have cracked it.  Continue reading The Drug Supply Chain Security Act Explained

The Future of Healthcare Supply Chain Security

Businessman looking through binocularsLet’s take a brief pause from our in-the-moment work on meeting today’s healthcare supply chain security needs and consider what the supply chain will look like in the future.  Because of regulations and laws enacted in 2012 and 2013 in the U.S., and expected in 2014 in the E.U., we know more today about how healthcare supply chain security will work In 2024 than looking forward in any previous 10 year period.  In the last two years the U.S. and the E.U. have enacted legislation and introduced regulations that will have a profound impact on the security of these major supply chains in ten years.  These include:

Continue reading The Future of Healthcare Supply Chain Security

Decoding The FDA’s DSCSA Timeline

FDA DSCSA Implementation Plan.shrunkMany RxTrace readers probably saw the FDA press release last week that included the timeline chart called “Summary of Planned Implementation Timeframes for the Drug Supply Chain Security Act”.  If you did not see it, here is the link.  I found the text to be too small so I reproduced the chart using a larger font size.  See that version below.  Click on it to enlarge the image.  You might find this version better for inclusion in Powerpoint slides.

This is the FDA’s interpretation of their obligations under the Drug Supply Chain Security Act (DSCSA), which is Title II of the Drug Quality and Security Act (DQSA) that was signed into law last November (see “It’s Official, President Obama Signs H.R. 3204, DQSA, Into Law”).  There really are not any surprises in their interpretation, but there are a few interesting things to notice in this timeline and the associated table of target dates that accompanied it.  I have also reproduced the FDA’s deliverable table, but my version is sorted by the estimated target date column to make it easier to see what they plan to do in time sequence.

The first thing to notice about the timeline is Continue reading Decoding The FDA’s DSCSA Timeline

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: 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 essayClick 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

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

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

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…

…a comprehensive exploration of the intersection between healthcare supply chains, track and trace technology, standards and global regulatory compliance

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