Tag Archives: FDA

DSCSA

Human Readable Text Controversy

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This example shows a compromise alternative to print both the NDC and the GS1 GTIN in the DSCSA Product Code human readable, following the GS1 General Specifications healthcare human readable guidelines in section 4.14.1

I was a little surprised at how heated the discussion was at the breakfast table back during last year’s Healthcare Distribution Alliance (HDA) Traceability Seminar.  I chose an open seat at a table with people from multiple drug manufacturers and someone from GS1 US.  Our conversation at the table started out typically—the weather, the previous day’s speakers—the usual.  I had recently been thinking about the human readable portion of the Product Identifier mandated by the Drug Supply Chain Security Act (DSCSA) (see “The DSCSA Product Identifier On Drug Packages”), so I asked everyone what their company was planning to do? Continue reading Human Readable Text Controversy →

UDI

Sponsored: Unique Device Identification Questions Answered Here

If you have anything to do with Unique Device Identification (UDI) in your company and you’ve never been to one of the UDI Conferences put on by the Clarion Group, then you don’t know what you are missing. Those who have been to one know that these are the best possible events to attend for UDI.

Why? Easy. I’ve never been to a conference where the experts from the regulatory body itself—the FDA in this case—dominate the speaker list as they do here. If you have Continue reading Sponsored: Unique Device Identification Questions Answered Here →

DSCSA

Wholesalers Find Troubling Results In DSCSA Barcode Assessment

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Last month GS1 US published the results of an assessment of the implementation progress by drug manufacturers of the Drug Supply Chain Security Act (DSCSA) serialization requirements.  It contains troubling indications of the next problem the industry will face in its quest for DSCSA compliance:  too many unusable barcodes.

Big deal, you say?  That kind of complacency could come back to haunt you later this year.  Now is the time to look at your own packages and address any deficiencies.  Here is a look at what GS1 US found in their assessment. Continue reading Wholesalers Find Troubling Results In DSCSA Barcode Assessment →

DSCSA

Blockchain Will Not Be Used For DSCSA Data Exchange

That’s right.  I have now concluded that Blockchain will never be used in the US supply chain to fulfill the DSCSA requirement for sellers to provide buyers with Transaction Information (TI) and Transaction Statements (TS) (see also “Could Blockchain Technology Be Used For DSCSA Compliance?”).  So if you are currently planning to do a pilot to test a proposed architecture to do that, I recommend that you adjust it to test something else (see also “What Should FDA Pilot?”).

In fact, the thing to test is whether or not it can be used to facilitate gathering the TIs for a given Standardized Numerical Identifier (SNI) going back to the original manufacturer, as needed after November 27, 2023 during a suspect product investigation or recall.  Those are rare events compared with the number of drug sales and shipments where the TI and TS will need to be exchanged.

How and why did I come to this conclusion?  Let me explain. Continue reading Blockchain Will Not Be Used For DSCSA Data Exchange →

DSCSA

HDA Questions FDA’s Authority To Mandate A Centralized System For the EDDS

Man in camelhair business suit wearing Question Authority button on left lapelOnce again, the Healthcare Distribution Alliance (HDA) has submitted written comments to the FDA as a follow-up to the FDA’s most recent DSCSA Public Meeting held on December 5-6 (see “HDA Schools FDA On DSCSA”, and “FDA DSCSA Public Meeting #2, Still A Gulf”).  The comments cover seven “issues” HDA wanted to provide further comments on, beyond those already expressed in the public meeting itself and earlier written comments.  The seven issues include:

  1. “HDA urges greater appreciation for and recognition of the ‘distributed model’…”
  2. “HDA recommends topics to address at the February 28 public meeting”
  3. “We expand upon certain data standard and exchange issues from the December public meeting”
  4. “…we offer suggestions for where ‘guardrails’ may be useful [to the industry]”
  5. “We summarize our understanding of the aggregation and inference discussion at the public meeting…”
  6. “HDA urges FDA to begin undertaking the small business assessment mandated by the DSCSA”
  7. “…various other issues raised during the public meeting…”

Continue reading HDA Questions FDA’s Authority To Mandate A Centralized System For the EDDS →

Data Exchange, DSCSA

EDDS: The New Data Exchange Requirements

The Enhanced Drug Distribution Security (EDDS) phase of the Drug Supply Chain Security Act (DSCSA) is due to begin on November 27, 2023.  That’s the first day that the US pharma supply chain is supposed to fully operate with serial numbers.  Yes, serial numbers in human readable and encoded into 2D barcodes will be on every drug packaged after November of this year, but there is only limited use of those serial numbers in the supply chain until 2023.  But when the EDDS starts, everything changes.  From that point on, every Transaction Information (TI) document must include the full DSCSA Unique Identifiers—including the serial numbers for the first time—that are physically included in the shipment, the Transaction History (TH) no longer needs to be exchanged, and the data exchange requirements change.  Let’s focus in on those data exchange changes. Continue reading EDDS: The New Data Exchange Requirements →

DSCSA, FDA

2018: The Year of FDA DSCSA Public Meetings

Happy New Year, 2018 is here!  Last year, the FDA announced a series of three Drug Supply Chain Security Act (DSCSA) Public Meetings (see “FDA Announces New DSCSA Pilot Program and Public Meeting Series”).  So far they have held two (see “FDA DSCSA Public Meeting #1 Exposes Gulf In Goals” and “FDA DSCSA Public Meeting #2, Still A Gulf”).  One more is left in that series, to be held on February 28, 2018. Continue reading 2018: The Year of FDA DSCSA Public Meetings →

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 →