Tag Archives: EDDS

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, 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, 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 →

DSCSA

HDA Schools FDA On DSCSA

Last week the Healthcare Distribution Alliance (HDA) submitted nine pages of comments in response to the FDA’s Request For Comments in docket number FDA-2017-N-3857 (find their submission here).  It is worthwhile for you to read because the HDA generally sets the gold standard for detailed analysis of the Drug Supply Chain Security Act (DSCSA), and because this one is particularly pertinent to discussions going on at the FDA and around the industry right now. Continue reading HDA Schools FDA On DSCSA →

DSCSA

FDA DSCSA Public Meeting #1 Exposes Gulf In Goals

The FDA held the first of three scheduled DSCSA public meetings last week.  This one focused on:

  • The vision for 2023; and,
  • The enhanced drug distribution security (EDDS) needs related to tracing prescription drugs at the package level.

The meeting started off with short presentations by representatives from:

In the short time they were each given, these speakers Continue reading FDA DSCSA Public Meeting #1 Exposes Gulf In Goals →

DSCSA

What Should FDA Pilot?

Last week the FDA announced it will coordinate one or more pilot(s) to assist in the development of the electronic, interoperable system that will identify and trace drugs in the U.S. under the Drug Supply Chain Security Act (DSCSA) in its Enhanced Drug Distribution Security (EDDS) phase starting in 2023.  Once they start work on pilot planning, they will call for proposals from stakeholders and others.  But they can’t start until they get permission from the Office of Management and Budget (OMB), and they won’t even ask OMB for permission until they collect comments on the proposed collection of information associated with establishing the pilot program.  Believe it or not, that was the Continue reading What Should FDA Pilot? →

DSCSA, HDA

Dawn of HDA’s Origin, The Key to DSCSA Compliance

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This week at the Healthcare Distribution Alliance (HDA) Distribution Management Conference and Expo (DMC) the HDA and ValueCentric will provide much more detail around the new master data sharing service they plan to make available in July.  The new service—named “Origin”—is intended to provide members of the pharma supply chain with a single directory of master data for all prescription drugs marketed in the United States (see Origin website).  That is, it is a database of master data wrapped within a cloud-based service. 

Origin master data is composed Continue reading Dawn of HDA’s Origin, The Key to DSCSA Compliance →