Tag Archives: drug supply chain

DSCSA

A US Medicines Verification Organization (USMVO)? Again

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If you’re like me, you are doing at least some work this week.  I usually do some work work during this quiet time when I am not interrupted.  It’s usually things I need to do to wrap up the year, but also includes planning for the new year.  In case you are working this week but you need a little diversion, here is something to think about for 2018.

It has become increasingly clear that what the US pharma supply chain needs is for some organization to step up and take responsibility for the decisions and actions that are needed to ensure successful development and operation of the Enhanced Drug Distribution Security phase of the Drug Supply Chain Security Act (DSCSA).  There are less than six years before that phase is supposed to begin.  But with no one clearly specified as the organization responsible, odds are, it isn’t going to happen.  This was the topic I covered two months ago when I originally published “A US Medicines Verification Organization (USMVO)?”.  With the end of the year and the holidays coming up, I’ve been too busy to write a new essay this week, so take another look at this idea. Continue reading A US Medicines Verification Organization (USMVO)? Again →

supply chain master data

What The TraceLink v HDA Lawsuit Teaches Us About The Value of Supply Chain Master Data

Buried deep inside the complaint filed in federal court last month by TraceLink against the Healthcare Distribution Alliance (HDA) is the heart of the issue (see “Tracelink vs. HDA”).  It’s about the sharing of product master data throughout the supply chain—that is, “Supply Chain Master Data” (SCMD) (see “Supply Chain Data Synchronization and Patient Safety”).  According to TraceLink’s complaint, the closed nature of HDA’s Origin master data sharing service (see “Dawn of HDA’s Origin, The Key to DSCSA Compliance”) is causing problems for vendors of DSCSA compliance solutions, and that will cause end-user companies in the supply chain to pay more for their overall solution. Continue reading What The TraceLink v HDA Lawsuit Teaches Us About The Value of Supply Chain Master Data →

Opioid epidemic

Opioid Epidemic: Root Cause Exposed

Screen-grab of Joe Rannazzisi on 60 Minutes.

The root cause of the US opioid epidemic was made visible on television two Sundays ago.  Did you see it?  I’m referring to the 60 Minutes/Washington Post expose called “The Whistleblower” that aired on Sunday, October 15.  But if you watched that episode with the volume up, odds are you missed the root cause.  Let me explain. Continue reading Opioid Epidemic: Root Cause Exposed →

DSCSA

A US Medicines Verification Organization (USMVO)?

The Drug Supply Chain Security Act (DSCSA) makes it clear that the FDA must work with industry stakeholders to figure out exactly how the US pharma supply chain should meet its requirements after November 27, 2023–see DSCSA Section 582(g).  That section specifies “The transaction information and the transaction statements shall be exchanged in a secure, interoperable, electronic manner…”.  There is no mention of the creation of an independent third-party to design or coordinate that exchange, and Continue reading A US Medicines Verification Organization (USMVO)? →

Kits

DSCSA: Kit, Repack, Combo Product, or Just A ‘Collection’?…Again

iStock_000069076997_smallerI am writing this from Mumbai India where I am scheduled to speak at the Systech Uniquity Conference, but I will be home by the time you read this.  I just won’t have time to publish a new essay this week due to the incredibly long flights I need to get home.  So, here is a re-posting of a great essay from May 9, 2016.

 

DSCSA: Kit, Repack, Combo Product, or Just A ‘Collection’?

Medical convenience kits are exempt from the Drug Supply Chain Security Act (DSCSA).  But be careful.  Continue reading DSCSA: Kit, Repack, Combo Product, or Just A ‘Collection’?…Again →

DSCSA

How Will The DSCSA Serialization Mandate Be Enforced After 2017?

iStock_38947550_smallerDrug manufacturers, contract manufacturers (CMOs) and contract packagers (CPOs) are all working hard right now preparing to meet the November 27, 2017 deadline when all prescription drugs entering the U.S. market must contain the new machine- and human-readable product identifier defined in the Drug Supply Chain Security Act (DSCSA) (see “The DSCSA Product Identifier On Drug Packages“).  The date for repackagers is one year later (see “Who Is A DSCSA Repackager?”).  From what I hear around the industry, some companies are going to make that date, but some will not.  What will happen next for those how are not ready?  I discussed this from a regulator perspective last year in one of my personal favorite essays, “An Open Letter To The FDA, EMA and ANVISA, RE: Who Are You Going To Punish?”, but what about from the perspective of those who will be late? Continue reading How Will The DSCSA Serialization Mandate Be Enforced After 2017? →

Kits

DSCSA: Kit, Repack, Combo Product, or Just A ‘Collection’?

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iStock_000069076997_smallerMedical convenience kits are exempt from the Drug Supply Chain Security Act (DSCSA).  But be careful.  Just because you and your customers have called your product “a kit” for years doesn’t mean that Congress and the FDA call it that under the DSCSA.  In fact, many products that have historically been referred to as “medical convenience kits” will be treated under the DSCSA as a repackaged drug, a combination product, or worse, just a collection of device(s) and drug(s).  Let’s take a closer look. Continue reading DSCSA: Kit, Repack, Combo Product, or Just A ‘Collection’? →

GTIN, NDC

Is A GS1 GTIN Really Usable As An NDC For DSCSA Compliance? Part 2

QuestionBottle.Part 2Part 1 of this essay provided a wealth of hyperlinks into the Code of Federal Regulations (CFR) and FDA guidance documents with content related to placing the National Drug Code in human- and machine-readable form onto drug packages prior to November 27, 2017 (see “Is A GS1 GTIN Really Usable As An NDC For DSCSA Compliance?  Part 1”).  In Part 2, we will look at how the Drug Supply Chain Security Act (DSCSA) will change, or add-to, the requirements found in those earlier specifications.  And finally, we will be able to answer the question in the essay title.

HOW THE DSCSA CHANGES THE NDC AND BARCODE REQUIREMENTS FOR DRUG PACKAGES

First of all, the DSCSA does not change anything Continue reading Is A GS1 GTIN Really Usable As An NDC For DSCSA Compliance? Part 2 →