Tag Archives: serialization

No Surprise: DSCSA Verification Delay

Dr. Ilisa Bernstein leaves FDA for APhA

It was fairly easy to predict the FDA would invoke enforcement discretion for the wholesale distributor’s saleable returns requirement of the Drug Supply Chain Security Act (DSCSA), as they announced last Tuesday (see “Is The FDA About To Delay Enforcement Of The Wholesaler’s 2019 Mandate?”).  The deadline for the mandate was originally this November 27, but with the announcement, will not be enforced until November 27, 2020.

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Pharma Counterfeiter Strategies In a Track & Trace World

What is a counterfeiter to do today?  Governments around the world are moving toward standardized serialization and track & trace requirements aimed directly at their bottom line.  It’s getting harder to fake your way past supply chain workers who are increasingly educated on what to look for and how to raise their suspicions to the authorities.  Or is it?  Let’s take a closer look.

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DSCSA Uniqueness: SNI vs SGTIN…Again

Ahh, summer.  Some years it seems like everyone is on vacation except me.  I usually only take a few days off here and there in the summer, preferring to do longer vacations in other parts of the year.  So next weekend I’m going to take an extra day off, and so there will be no RxTrace essay published next Monday (the Labor Day holiday here in the US), and I’m going to link to one of my favorite essays from the last year this week as the summer winds down.  This essay was posted on October 7, 2018 under the “A Monthly Slice of RxTrace” on the Center For Supply Chain Studies (C4SCS) website.  Unfortunately I haven’t been able to keep up with the “Monthly” part of that title due to time pressures, but there is some great content out there from the last 12 months (see “A Monthly Slice of RxTrace”).  Other than my diverted attention, nothing has changed so I may post more new content on the C4SCS site in the future if I can make some time.

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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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Russia: CRPT Posts Test Methodology For Crypto Code

CRPT, the company authorized to conduct the development, piloting and operation of the Russian government pharmaceutical serialization and tracing system, posted an important document last week.  The document is intended “…to unify the process of testing printing on the packaging of medicinal products of identification features using the verification code and electronic signature with the content in it of a different number of characters and the aggregation process of drug manufacturers to obtain comparable test results and their applicability in the framework of industrial implementation.”  Will it help you? 

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HDA Makes A Strong Case For ‘Reframing’ Of FDA’s Draft Guidance On DSCSA Verification Systems

Last October the FDA published a draft guidance called “Verification Systems Under the Drug Supply Chain Security Act (DSCSA) for Certain Prescription Drugs” (see “DSCSA: Verification Systems Draft Guidance”).  Near the end of the comment period in December, the Healthcare Distribution Alliance (HDA) submitted comments containing proposed changes.  Like other comments submitted by the HDA for other FDA DSCSA guidance, these are well worth reading.  Once again, the HDA demonstrates their thorough understanding of the DSCSA and their ability to clearly and crisply explain where the FDA’s draft language fails to reflect the language in the original law. 

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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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Mixed Signals From Russia

I’m not talking about the mixed signals from Russia in your daily political newsfeed, I’m talking about the mixed signals we see between the Russian Federation decrees for their pharma serialization and traceability mandate, and the announcements of the government’s designated technology contractor to develop that system:  CRPT, LLC.  Considering how short the deadlines are, these mixed signals are counterproductive because they cause companies to pause while they figure out what they should do.  Let me explain.

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