Category Archives: DSCSA

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 →

DSCSA

3 DSCSA Requirements You Can Totally Ignore

The Drug Quality and Security Act (DQSA) was constructed back in 2013 by Congressional staff, with input from the FDA, members of the industry and who knows who else.  There was one bill in the House of Representatives and a different bill in the Senate.  Once these bills passed their respective houses, they formed a conference committee who merged the two bills into the final text that we know today as the DQSA (see “It’s Official, President Obama Signs H.R. 3204, DQSA, Into Law”).  Chapter 2 of that act is the Drug Supply Chain Security Act (DSCSA).  Most readers of RxTrace haven’t forgotten that history but it is important to look back at that history to explain why most companies can ignore certain requirements in the law.  That’s right.  There are requirements in the law that you can ignore because they will not be enforced by anyone.  They are the result of the disjoint way the DQSA was written.  Let me explain. Continue reading 3 DSCSA Requirements You Can Totally Ignore →

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 →

DSCSA, FDA

FDA DSCSA Public Meeting #2, Still A Gulf

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The gulf in expectations and goals exposed in the first FDA Drug Supply Chain Security Act (DSCSA) Public Meeting back in August (see “FDA DSCSA Public Meeting #1 Exposes Gulf In Goals” and “HDA Schools FDA On DSCSA”) was still visible in the second meeting last week.  There is still one more announced meeting scheduled for February 28, 2018 for the FDA and the industry to align (see “FDA Announces New DSCSA Pilot Program and Public Meeting Series”).  Based on my observations at these first two meetings, I’m not going to hold my breath.  The FDA is likely to announce more meetings in 2018.

The FDA did adjust their position on at least one thing after the August meeting. Continue reading FDA DSCSA Public Meeting #2, Still A Gulf →