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Aggregation: The Achilles’ Heel of Pharma Supply Chain Operation Under A Serialization Regulation

View of a layer of drug cartons inside a case. Photo courtesy of Omega Design. Click image to enlarge.

Neither the Drug Supply Chain Security Act (DSCSA) in the United States, nor the Falsified Medicines Directive (FMD) in the European Union explicitly mandates the capture or use of aggregation data (see “Aggregation –> Chargeback Accuracy –> ROI” and “EU FMD: Aggregation Is Not Mandated, But It Will Be Necessary“).   In this instance, “aggregation data” is data that documents the serialized packaging containment hierarchy of drug products—also known as “parent-child relationships”.  It is well established that companies are not required by law to capture it, but for the smooth operation of pharma supply chains under a serialization, tracing and/or verification regulation, high quality aggregation data will be necessary.  But there are warning signs that a significant percentage of drug manufacturers are not going to meet that bar by the deadlines. Continue reading Aggregation: The Achilles’ Heel of Pharma Supply Chain Operation Under A Serialization Regulation

Newly Published Material From HDA and C4SCS

I was on vacation last week and only arrived home Sunday evening so I didn’t have time to write an essay for Monday, but this is Tuesday!  Near the end of last month there was a spike in the number of things that need to be covered in RxTrace.  Two of them are important things from HDA and the Center For Supply Chain Studies.  I’ve been waiting for both for months, and here they are. Continue reading Newly Published Material From HDA and C4SCS

Important New Blockchain Study Launched

Today, the Center For Supply Chain Studies (C4SCS) announced that they are launching a new study called “Blockchain & Metadata”.  C4SCS has been studying blockchain applications in the US pharma supply chain for nearly two years—including its potential use to help the industry meet future requirements of the Drug Supply Chain Security Act (DSCSA) (see “Could Blockchain Technology Be Used For DSCSA Compliance?”).  This newly announced study marks the first time the organization plans to explore applications of blockchain technology without specifically attaching them to pharma, although the subject definitely applies in pharma.  Target participants of this study include Continue reading Important New Blockchain Study Launched

FDA To Publish Key Draft Guidance Tomorrow

This morning the FDA announced their intention to publish the long overdue draft guidance on Drug Supply Chain Security Act waivers, exceptions and exemptions tomorrow.  The timing of the publication of this particular draft guidance is critical to the FDA holding their current enforcement deadline for serialization and verification for manufacturers and repackagers.  In fact, if they had failed to meet their late May deadline for publication of this particular draft guidance Continue reading FDA To Publish Key Draft Guidance Tomorrow

An Open Letter To Blockchain Vendors: Please Pay More Attention

Dear Blockchain Vendors,

It was good to see all of you at last week’s Drug Supply Chain Security Act (DSCSA) and Blockchain proof of concepts pilots review held by the Center For Supply Chain Studies (C4SCS) in Rockville, MD.  I hope your travel home was uneventful.  Let me say right at the top, I was in the audience representing Systech International.  My co-worker, Joe Lipari partnered with Dwight deVere of RxTransparent as the Green Team.  RxTrace is independent of Systech International.  That said, as the author of RxTrace, I have some helpful advice for you. Continue reading An Open Letter To Blockchain Vendors: Please Pay More Attention

Sponsored: Extracting Value Beyond Compliance From Serialization

Companies are spending hundreds of millions of dollars, euros, rupees and rubles getting ready to comply with serialization regulatory mandates around the world.  Deadlines are fast approaching in the US and the EU and they are already passed in India, South Korea, Argentina and Turkey.  What companies are looking for next is how to extract some value beyond just complying with government mandates.  Just about every solution provider offering serialization components and solutions out there has at least one product or service that is aimed squarely at this type of need.  What we need to do is get these people together:  those who are looking, and those who have the solutions.

Cognizant, a management consulting company, has written a very nice 11-page white paper exploring value beyond compliance. Continue reading Sponsored: Extracting Value Beyond Compliance From Serialization

DSCSA: OIG Report Exposes Likely Enforcement Approach

Last week the US Department of Health and Human Services (HHS) Office of Inspector General (OIG) published their second report on the experience of selected members of the pharma supply chain with the exchange of drug product tracing information as required by the DSCSA.  This one was aimed at dispensers.  The one published last fall was aimed at wholesale distributors.  As you know, starting in January 1, 2015 (delayed until May 1, 2015), pharmaceutical wholesale distributors have been required to pass to their customers for non-exempt prescription drug shipments, and retain for six years, transaction documents (TI, TH and TS).  Since July 1, 2015 (delayed until March 1, 2016), dispensers have been required to receive and store these Continue reading DSCSA: OIG Report Exposes Likely Enforcement Approach