All posts by Dirk Rodgers

Dirk is the founder of RxTrace where he writes regularly on the intersection between the pharmaceutical supply chain, track and trace technology, standards and regulatory compliance. He has written hundreds of essays on those specific topics. A logical thinker, Dirk is skilled at making complex technical topics understandable to non-technical readers and listeners. An Electrical and Computer Engineer by education, Dirk has worked as a consultant, software architect and automation engineer during a career spanning 30 years. Overall, Dirk's thought leadership has helped to expose hidden complexities and reveal surprising consequences and implications of drug serialization and pedigree laws around the world. Dirk is the author of "The Drug Supply Chain Security Act Explained". View Dirk's LinkedIn Profile Follow Dirk on Twitter
FDA Guidance

Is The FDA Intentionally Delaying Publication Of The Overdue DSCSA Guidance?

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Last week I wrote about the recent FDA DSCSA Public Meeting where the FDA asked for reports on the progress of the industry toward meeting the November 27, 2017 serialization requirements contained in the Drug Supply Chain Security Act (DSCSA) (see “FDA Forfeits Opportunity To Guide Industry”).  In that essay I expressed a view that the FDA has squandered too much of the time necessary for the industry to meet whatever guidance they might offer about grandfathering and exceptions for products that are too small to accommodate a DSCSA product identifier.  These guidance documents are now 11 months late.

What if the delay in publishing these guidance documents is intentional? Continue reading Is The FDA Intentionally Delaying Publication Of The Overdue DSCSA Guidance? →

FDA

FDA Forfeits Opportunity To Guide Industry

fda-building-2016-10-14-16-38-20I hope you were able to attend last Friday’s FDA DSCSA Public Meeting at FDA’s White Oak, Maryland campus (see “FDA To Hold DSCSA Public Meeting”).  If you missed it, make sure you listen in on the recording that the FDA will provide on the event webpage.  You can also submit written comments through that page as well.  The event was called “Progress Toward Implementing the Product Identification Requirements of the Drug Supply Chain Security Act (DSCSA)” and it consisted of very brief introductory comments by the FDA followed by presentations made by attendees who applied for a speaking slot.  Presentations covering progress toward the November 27, 2017 DSCSA serialization requirements were made by: Continue reading FDA Forfeits Opportunity To Guide Industry →

Kits

DSCSA: Kit, Repack, Combo Product, or Just A ‘Collection’?…Again

iStock_000069076997_smallerI am writing this from Mumbai India where I am scheduled to speak at the Systech Uniquity Conference, but I will be home by the time you read this.  I just won’t have time to publish a new essay this week due to the incredibly long flights I need to get home.  So, here is a re-posting of a great essay from May 9, 2016.

 

DSCSA: Kit, Repack, Combo Product, or Just A ‘Collection’?

Medical convenience kits are exempt from the Drug Supply Chain Security Act (DSCSA).  But be careful.  Continue reading DSCSA: Kit, Repack, Combo Product, or Just A ‘Collection’?…Again →

standards

The Open Serialization Communication Standard (Open-SCS)

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open-scs-logo2-300x289Most RxTrace readers are at least aware of GS1 standards.  GS1 is an international non-profit membership organization that facilitates the development and maintenance of technical standards that are intended for use within supply chain operations and interactions.  GS1 standards are used in many supply chains including pharma.  GS1 standards are playing an indispensable role in the implementation of pharma serialization, including their GTIN, GLN, SSCC, Datamatrix, application identifier and EPCIS standards.  I have written frequently about GS1 and these specific standards (see “GS1”).

But today I want to draw your attention to a different standards development organization Continue reading The Open Serialization Communication Standard (Open-SCS) →

ANVISA

Sponsored: Brazil Officially Suspends All Remaining Serialization Deadlines Of RDC-54

iqpc-serial-labeling-playbook-2016Apparently, the National Agency of Sanitary Surveillance (ANVISA), Brazil’s pharma regulatory body, has passed a resolution that finally suspends all remaining serialization deadlines that were left over in their old RDC-54 regulation.  Remember that they suspended the deadline for the 3-lot pilot from RDC-54 last year (see “The Official Suspension of the Three-Lot Pilot in Brazil“).  I consider this news to be a “rumor” only because I have not yet seen the official word, despite having heard it from a very reliable source.

This is not Continue reading Sponsored: Brazil Officially Suspends All Remaining Serialization Deadlines Of RDC-54 →

DSCSA

FDA Posts DSCSA-Specific Information Sharing Agreement Template For State Agencies

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istock_19522725_smallerWhile I was preparing a DSCSA resource list to be handed out at the Systech Uniquity event in Mumbai next week I stumbled across a document that the FDA recently posted on their website.  It is a template for a DSCSA-specific information sharing agreement that is aimed at state agencies, like state boards of pharmacy and probably state’s attorneys’ offices and state bureaus of investigation, etc.  The DSCSA contains several clauses that imply data sharing between the FDA and “…appropriate Federal or State official[s]”. 

The problem is, the data that would likely need to be shared Continue reading FDA Posts DSCSA-Specific Information Sharing Agreement Template For State Agencies →

FDA

FDA To Hold DSCSA Public Meeting

2016-04-05 14.11.09.reducedThe FDA is almost 10 months behind in the release of guidance documents for the Drug Supply Chain Security Act (DSCSA) as scheduled by Congress (see “FDA DSCSA Deadline Passes Quietly”, “Who Is Being Harmed By Four Overdue FDA DSCSA Guidances?”, “FDA Speaks At GS1 Connect”, and “FDA Plans Busy Second Half of 2016 With Six DSCSA Draft Guidances Expected”).  So far this year the FDA has held one public meeting to collect public and stakeholder input on the pilot that the law mandates (see “FDA To Hold DSCSA Pilots Workshop”, and “The 2016 FDA Pilots Workshop”).  The DSCSA requires the FDA to hold at least five public meetings “…to enhance the safety and security of the pharmaceutical distribution supply chain and provide for comment.”

This morning, the FDA announced Continue reading FDA To Hold DSCSA Public Meeting →

serialization

Serialization Mistake #1: Printing On Your Outsert

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istock_83993805_smallerThere are lots of mistakes a company can make when designing their solution to comply with pharma serialization and tracing regulations.  One of these is to print the unique identifier on the outsert attached to their packaging.  An “outsert” is a tightly folded piece of paper that contains very detailed prescribing information intended to inform medical professionals who prescribe, dispense and/or administer the drug.  It contains Continue reading Serialization Mistake #1: Printing On Your Outsert →