Tag Archives: free

China: NMPA Drug Traceability Guidance

Most RxTrace readers will recall that China was an early adopter of drug traceability.  Back in 2007, companies were required to begin printing unique identifiers in linear barcodes on certain drug packages.  The unique identifiers had to be purchased from a government contractor.  The list of drugs grew each year to the point where all drugs were effectively covered by early 2016.  But shortly after that, the whole requirement was suspended (see “China’s Retreat From Pharma Serialization: Will This Become A Global Trend?” and “China Adds Traceability Requirement To CFDA Drug Quality Management Specification”).  Then last summer, a new government agency, the National Medical Products Administration (NMPA), posted three draft guidance documents for review and comments (see “China Posts New Draft Pharma Serialization Guidelines”).  Finally, last month, the NMPA published two of those documents in final form, “Implemented on April 19, 2019”. 

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PDSA Brainstorms Vision For DSCSA Governance Organization With Stakeholders

Last week the Pharmaceutical Distribution Security Alliance (PDSA) held a workshop for interested stakeholders to brainstorm just how their proposed independent, balanced and sector-neutral organization might meet their vision.  This was the follow-on meeting tied to the publication of two documents last month that provided their “vision” and the actual proposal for the organization (see “PDSA’s Proposal for Governance of DSCSA Phase II Interoperability”). 

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PDSA’s Proposal for Governance of DSCSA Phase II Interoperability

Independent, balanced, sector-neutral

Last week, the Pharmaceutical Distribution Security Alliance (PDSA) published two papers aimed at kickstarting the creation of a new non-profit organization that would accept the responsibility for setting up and executing governance over Drug Supply Chain Security Act (DSCSA) phase II interoperability (see “A Serious DSCSA Governance Organizational Proposal Emerges From PDSA”).  PDSA defines “DSCSA phase II” to be the same as what the DSCSA text calls the “Enhanced Drug Distribution Security” (EDDS) phase (see “EDDS: The New Data Exchange Requirements”).  The EDDS phase (err, Phase II of the DSCSA) starts on November 27, 2023.  In most informal conversations this phase is usually just referred to as “2023”. 

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DSCSA: What Wholesalers Want

Last November pharma manufacturers selling into the U.S. market had to meet a big serialization and verification deadline under the Drug Supply Chain Security Act (DSCSA).  Now, pharma wholesale distributors in the United States are facing their own important deadline this coming November.  Remember how manufacturers had to scramble and go through a lot of pain to achieve compliance in time?  Your friendly neighborhood wholesale distributors—big and small—are going through that now.  And the problem is…they can’t do what they need on their own.  They need all drug manufacturers to do something so that they can be compliant with the DSCSA in November.

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DSCSA: Interoperable Data Exchange In 2023

Lots of people have been talking lately about what interoperable data exchange in the US pharma supply chain will look like after the Enhance Drug Distribution Security (EDDS) phase of the Drug Supply Chain Security Act (DSCSA) takes effect in November 2023 (see “Does Interoperability Change In 2023?”, “5 Myths About The DSCSA In 2023” and “Interoperability And The DSCSA”). 

Increasingly, I’ve heard the opinion expressed that there will surely be multiple approaches adopted for exchanging data, and so it will be necessary for all of those approaches to be made interoperable with each other.  Proponents of this idea claim it is unrealistic to expect a single approach to be accepted by all companies in the supply chain and therefore, having to deal with multiple approaches is inevitable.  This kind of talk makes me nervous.  Here’s why.

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Most Companies Will Do DSCSA Verification Wrong

A lot has been written about the concept of “verification”, here in RxTrace and elsewhere.  It’s all good, but I still don’t think the critical point has been made yet by anyone—including me (see “What’s So Hard About Unique Identifier Verification?”)—and until it is, companies are going to do it wrong.  Less than an hour after I posted my essay last Wednesday (see “GS1’s Messaging Standard For Verification Of Product Identifiers”) I received an email from a subscriber who had questions about it, the essay was referenced in a post on LinkedIn by a reader in Europe, and I found a great link to a brand new essay about verification by Scott Pugh that had just been posted about the same time.  So here is my new take on why most companies are going to get it wrong.

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GS1’s Messaging Standard For Verification Of Product Identifiers

Verification%20messaging.png

For companies in the US pharma supply chain, 2019 is going to be the year of an important milestone of the Drug Supply Chain Security Act (DSCSA).   In November, wholesale distributors will be required to begin issuing verification requests to manufacturers, at the Standardized Numerical Identifier (SNI) level, for any returned drug that is still saleable, before they resell it.  I’ve written a lot about this change in the past.  

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My Comments Regarding The New NDC Format

Happy New Year!

A few hours before the end of the comment period, I submitted my comments to FDA’s docket on Regulations.gov for the new NDC format. By the time your read this, the docket will be closed. The agency that operates that web site often takes a few days to post submissions, but because of the government shutdown, I doubt if anyone will be working on it until after the government re-opens (assuming the furloughed workers haven’t gotten a better job by then…In that case, it could be even longer).

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