Tag Archives: serialization

wholesaler

U.S. Drug Wholesale Distributors Provide Direction To Manufacturers

Providing "direction"Over the next few years, the U.S. drug wholesale distributors are going to start dictating their specific requirements related to the Drug Supply Chain Security Act (DSCSA) to their suppliers.  For the “Big 3” U.S. wholesale distributors, those suppliers happen to be nearly every drug manufacturer who markets drugs in the United States.  The “Big 3” include McKesson, AmerisourceBergen and Cardinal Health, which together distribute about 85% of all drugs that pass through the domestic supply chain.

Of course, each segment has Continue reading U.S. Drug Wholesale Distributors Provide Direction To Manufacturers →

DSCSA

Announcing: The Second Edition of The Drug Supply Chain Security Act Explained

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DSCSA2ndEditionAdImageThis past week I have been on a vacation with my family in the Caribbean so I do not have a topical essay for you this week, except to announce the availability of the second edition of The Drug Supply Chain Security Act Explained.  The full title is “The Drug Supply Chain Security Act Explained: Second Edition, Plus Explanations Of Key FDA DSCSA Guidances”.  This time the book is available as a paperback and at the much more affordable price of only US$59.99.

I am working on Continue reading Announcing: The Second Edition of The Drug Supply Chain Security Act Explained →

India

India Posts New Deadlines (Again) For Serialization Of Drug Exports


Right now we are waiting for major new announcements regarding serialization and tracing requirements in the United States (4 overdue FDA guidance documents), the European Union (final publication of the Delegate Act related to the Falsified Medicines Act), Brazil (major redesign of their regulation), and Russia (first official publication of their regulation).  But last week, the India Directorate General of Foreign Trade (DGFT) published a new public notice containing details of the “Implementation of the Track and Trace System for Export of Pharmaceuticals and Drug Consignments”.  These details are for drugs made in India but exported to other markets. Continue reading India Posts New Deadlines (Again) For Serialization Of Drug Exports →

Deadlines

‘An Open Letter To The FDA, EMA and ANVISA, RE: Who Are You Going To Punish?’, Again

Dear FriendI hope your holidays were filled with love and cheer.  Mine were.  It was great.  So great, in fact, that I did not have time to write a brand new essay for today.  Not much has happened lately since we are still awaiting publications from the FDA, the EC and ANVISA (and others),  Instead, here is one of my best essays from 2015, reposted as it appeared on August 31, 2015 without modification (see “An Open Letter To The FDA, EMA and ANVISA, RE: Who Are You Going To Punish?“).  I’m even leaving in the off-season references.  If you read this essay back then, you might enjoy it again.  If you did not read it back then, I recommend that you read it now.  Let me know what you think.

Before we begin, if you have not yet responded to the 2016 RxTrace U.S. Pharma Traceability Survey, sponsored by Frequentz, please to so now.  It is open to everyone and the survey will be closed soon.

And now Continue reading ‘An Open Letter To The FDA, EMA and ANVISA, RE: Who Are You Going To Punish?’, Again →

Predictions

RxTrace Preview of 2016

It’s time to think about what is likely to happen in 2016 with regard to pharma serialization and traceability.  As part of that, let me remind you right off the top to fill out the 2016 RxTrace U.S. Pharma Traceability Survey, sponsored by Frequentz.  You don’t have to be a subscriber  to respond and the results will also be open to everyone in the coming months.

So what about 2016?  I think Continue reading RxTrace Preview of 2016 →

EU FMD, EUDA

Insufficient Transitional Measures Doom The FMD-EUDA

EU Member States
EU Member States. Source

The pharmaceutical supply chain in most markets is complex, but in my view, the one in the European Union easily takes the prize for being the most complex of any other.  The addition of unit-level serialization and verification of authenticity to that supply chain over the next few years as required by the Falsified Medicines Directive (FMD) and the Delegated Act (EUDA) is going to be difficult (see “Breaking News: The EC Has Published The Delegated Act“).  It represents a huge change to the way drugs are packaged and how they are handled by each entity in the supply chain.  It is vital that the transition Continue reading Insufficient Transitional Measures Doom The FMD-EUDA →

ANVISA

Brazil Suspends Pharma Serialization And Tracing Requirements

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ANVISA logoLast week, Brazil’s pharma industry regulatory agency, the National Agency of Sanitary Surveillance (ANVISA), announced that they were “suspending” at least part of RDC-54/2013, the declaration that mandated drug serialization and tracing, until further notice.  Thank you to all who forwarded the link to the official announcement.  I was able to translate and read it on Thursday, and I submitted a comment on my own last essay, “Pharma Serialization Deadlines In Flux“, to include the link.  Apparently shortly after that essay was published, ANVISA  Continue reading Brazil Suspends Pharma Serialization And Tracing Requirements →

Deadlines

Sponsored: Pharma Serialization Deadlines In Flux

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iqpc.zoomThe industry is rife with rumors that Brazil’s ANVISA has made the decision to push out their serialization deadline for multiple years—and perhaps redefine the requirements.  I cannot confirm any of these rumors at this point and I do not recommend acting on rumors.  I suggest you continue down the path of meeting the existing, known regulation until—if ever—you get the official word from an official publication of ANVISA.  Who knows when that might occur.  If/when you see something official, let me know. Continue reading Sponsored: Pharma Serialization Deadlines In Flux →