InBrief: FDA Again Says It Plans To Publish Track & Trace Guidance By Year End

FDA Guidance AgendaMany thanks to Alec Gaffney of Regulatory Focus for pointing out that the FDA just published their annual list of draft guidances that they anticipate will be published before the end of 2013.  Of course,  no guarantees come with it.  In fact, they included the anticipation of Track & Trace guidance in last year’s list as well but nothing was published (See “FDA To Publish Track & Trace Standard By Year End“).  That’s why it’s not surprising that it’s on the list again this year.

The FDA list seems to come out earlier each year.  Considering that the Track & Trace guidance was included on last year’s list, perhaps it will be published in the near future.  I’m not holding my breath, but it sure would be an interesting addition to the current situation in California where Continue reading InBrief: FDA Again Says It Plans To Publish Track & Trace Guidance By Year End

How Pedigrees Protect The Drug Supply: The Case Against Cumberland Distribution

Cumberland DistributionOn January 17, 2013 a federal grand jury indicted three individuals in 28 counts connected with Cumberland Distribution, a pharmaceutical distribution company licensed in Tennessee, on charges of conspiracy, mail fraud, money laundering and obstruction of justice.  Notably, some of the evidence used against the alleged co-conspirators are the pedigrees that they allegedly forged in an attempt to make their business look legitimate to their unsuspecting customers.

Now, as the press release about the indictment from the U.S. Department of Justice (DoJ), Middle District of Tennessee points out, “An indictment is merely an accusation and is not evidence of guilt.  All defendants are presumed innocent unless and until proven guilty in a court of law.”  So let’s just look at the evidence and how the DoJ is using it to build their case against the defendants in this case.  From that we can see what impact pedigrees might have in other cases like this.

The charges are for activities that Continue reading How Pedigrees Protect The Drug Supply: The Case Against Cumberland Distribution

How Should Inference Work?

5 Boxes
Drawing by Jasmaine Mathews

Important Notice To Readers of This Essay On November 27, 2013, President Barack Obama signed the Drug Quality and Security Act of 2013 into law. That act has many provisions, but one is to pre-empt all existing and future state serialization and pedigree laws like those that previously existed in California and Florida. Some or all of the information contained in this essay is about some aspect of one or more of those state laws and so that information is now obsolete. It is left here only for historical purposes for those wishing to understand those old laws and the industry’s response to them.The wide-scale use of “inference” in the pharmaceutical supply chain is essential to the successful operation of a track & track or ePedigree system.  Companies cannot be expected to open every case they plan to ship, or that they receive, so that they can figure out exactly which package-level serial numbers are involved.  The use of the serial number packaging hierarchy, or, “Aggregation information”, to “infer” which packages are being shipped or received is the only way to maintain a level of supply chain efficiency that is close to pre-serialization levels.  On the other hand, regulator acceptance of the use of inference in the supply chain has the potential to complicate their investigation of criminals.

In recognition of its importance in maintaining efficiencies, the California legislature instructed the Board of Pharmacy to draw up rules that would allow companies to optionally make use of it (see my essay “Inference in the Pharmaceutical Supply Chain” for the exact text of the inference provisions of the California Business and Professions Code).  It leaves the important question about who Continue reading How Should Inference Work?

Celebrating Martin Luther King Jr.

Martin_Luther_King_Jr_NYWTS
Martin Luther King Jr. Thinker of powerful thoughts, and with the skill to assert them as undeniable truths.

Don’t expect to reach me today.  For the first time in my career I work for a company that celebrates Reverend Dr. Martin Luther King Jr.’s birthday as a holiday.  I am particularly happy about that, because I rank Dr. King behind only George Washington, Thomas Jefferson, and Abraham Lincoln as the greatest American Founding Father.

Neither Lincoln nor King were present at the beginning of our country so most people don’t consider them to be “Founding Fathers”, but because they both caused major course corrections in our nation’s direction that actually straightened our path and lead us to achieve freedom for all Americans, I count them that way.

The United States is among only a few nations Continue reading Celebrating Martin Luther King Jr.

Walgreens, Automation, And Erasing Disabilities

Randy Lewis, Sr. VP, Walgreens, retired
Randy Lewis, Sr. VP, Walgreens

Amid news of our disfunctional Congress, more mass gun violence and negative economic news last week, I received the links to the following uplifting videos about Walgreen’s Anderson, South Carolina distribution center.  After watching them, I have determined that you must see them.

Click the link to watch what I think should have been called, “Walgreens, Automation, and Erasing Disabilities, Part 1” (but instead is called “The Coolest DC in the World…Part 1”):

http://www.moveitshow.com/clips/2057658540001/

and, “The Coolest DC in the World…Part 2”:

http://www.moveitshow.com/clips/2057658530001/

My original interest in watching these videos was to see all the automation they have added to this particular distribution center.  (“What?  They’re running pharmaceuticals down a tilt-tray sorter?  How unique!  I’ve got to see that.”)  but after the first minute or so Continue reading Walgreens, Automation, And Erasing Disabilities

Data Ownership In The Track & Trace Cloud

Cloud over IllinoisImportant Notice To Readers of This Essay On November 27, 2013, President Barack Obama signed the Drug Quality and Security Act of 2013 into law. That act has many provisions, but one is to pre-empt all existing and future state serialization and pedigree laws like those that previously existed in California and Florida. Some or all of the information contained in this essay is about some aspect of one or more of those state laws and so that information is now obsolete. It is left here only for historical purposes for those wishing to understand those old laws and the industry’s response to them.Who will own the data that supply chain trading partners store in some future cloud-based, semi-centralized Network Centric ePedigree (NCeP) data repository?  I met one potential future repository service provider who seemed to think that they would own that data.  Imagine their excitement.  All the data about where drugs go throughout the supply chain!  Think of the value they could mine from that.

Well, that’s never going to happen because companies in the supply chain won’t sign up for handing over all of their supply chain data to some third-party just so they can comply with regulations, especially when there exists an alternative approach that would allow them to avoid using a third-party and still comply (by using DPMS).  And regulatory agencies are Continue reading Data Ownership In The Track & Trace Cloud

“The Shadows Of Things That MAY BE, Only” : EPCIS and California Compliance

Magoo_christmas_futureImportant Notice To Readers of This Essay On November 27, 2013, President Barack Obama signed the Drug Quality and Security Act of 2013 into law. That act has many provisions, but one is to pre-empt all existing and future state serialization and pedigree laws like those that previously existed in California and Florida. Some or all of the information contained in this essay is about some aspect of one or more of those state laws and so that information is now obsolete. It is left here only for historical purposes for those wishing to understand those old laws and the industry’s response to them.Currently, we know that companies can use GS1’s Drug Pedigree Messaging Standard (DPMS) to comply with the California pedigree law.  That’s been known for a long time now.  But many companies have been hoping to use GS1’s more general purpose Electronic Product Code Information Services (EPCIS) standard instead for almost as long.  For just as long, it has been known that a number of problems arise when you try to figure out exactly how to apply EPCIS to California compliance.

The problem is, EPCIS was originally envisioned by its creators to share supply chain “visibility” data.  That is, event data that was to be collected automatically based on Radio Frequency IDentification (RFID) reads picked up by readers that were to be spread around the supply chain by each of its members.  The collection of RFID readers were to form a kind of “visibility” of each RFID tag applied to the products in the supply chain.  From this visibility would come benefits.  One of those benefits was to be Continue reading “The Shadows Of Things That MAY BE, Only” : EPCIS and California Compliance