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
Brand Protection

Your Plain Old Package: Unlock Its Built-in Brand Protection Capability

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iStock_000042072924_SmallerWhen serialization of drugs was first being considered for pharmaceuticals back in the mid-2000s, I recall that it seemed to rattle the traditional brand protection vendors who offered package-level authentication technologies.  They were more than a little worried that drug companies would end up using serial numbers in place of their more traditional offerings, like holograms, specialty inks, micro-printing and other technologies.  Back then, some drug companies were looking at using Radio Frequency IDentification (RFID) tags to carry the serial numbers on their drug packaging, and perhaps these vendors feared that they would be left out.

I never understood what all the angst was about.  Continue reading Your Plain Old Package: Unlock Its Built-in Brand Protection Capability →

India

India Proposes Serialization of Domestic Drug Supply

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India Ministry of Health and Family WelfareLast month India’s Central Government published a proposal for comment that, if enacted, would cause all drugs entering the Indian domestic supply to contain unique serial numbers encoded within 2D barcodes, and including aggregation and data reporting–all 180 days after publication of the final rule.

If you download the PDF, don’t be disappointed when you find that the first couple of pages are in Hindi.  The full text is also included in English, starting on page 3.

RxTrace readers will recall that India Continue reading India Proposes Serialization of Domestic Drug Supply →

RxTrace

Six Years of RxTrace

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Physcial GraffitiThis is the sixth anniversary of the beginning of RxTrace and over that time I have published 325 essays.  Pageviews and subscribers to RxTrace have continued to rise the entire time.  I thank you all for that because I enjoy writing (and thinking), and without you as readers, I would not be able to do it.

Many people have asked what led me to start RxTrace in the first place?  In fact, there were three people who contributed to that decision. Continue reading Six Years of RxTrace →

Dispensers, DSCSA

FDA Publishes New Guidance Delaying Dispenser 3T Requirements Until November 1, 2015

FDALogoThe FDA updated their website this morning with new guidance that indicates they intend to use enforcement discretion by not enforcing the dispenser requirements to accept and capture Transaction Information (TI),Transaction History (TH) and a Transaction Statement (TS) until November 1, 2015, a four month delay in enforcement.  The document indicates that the FDA’s decision to take this action was based on the fact that “…some dispensers have expressed concern that electronic systems used to exchange, capture, and maintain product tracing information will not be operational by this effective date.” Continue reading FDA Publishes New Guidance Delaying Dispenser 3T Requirements Until November 1, 2015 →

Dispensers, DSCSA

Dispensers Make Last Minute Appeal for Delay in DSCSA Deadline

Less than a week before the July 1, 2015 Drug Supply Chain Security Act (DSCSA) deadline for dispensers to begin receiving, storing a being able to retrieve Transaction Information (TI),Transaction History (TH) and a Transaction Statement (TS) for every incoming shipment of prescription drugs, a group of pharmacy associations have asked the FDA for enforcement discretion for an unspecified time to avoid “…the possible outcome of disruptions to the supply chain”.  Continue reading Dispensers Make Last Minute Appeal for Delay in DSCSA Deadline →

India

India’s Pharma Export Serialization Deadlines: April Fools!

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animated ashok chakraOn May 22nd, 2015, India’s Directorate General of Foreign Trade (DGFT) quietly published Public Notice #13 with the subject “Implementation of the Track and Trace system export of drug formulations”.  It was an amended version of Public Notice #4, dated April 1, 2015 with a similar subject.   Get it?  April Fools!

I have to admit, I fell for it.  Did you? Continue reading India’s Pharma Export Serialization Deadlines: April Fools! →

DSCSA, FDA Guidance

FDA DSCSA Deliverables Are Bunching Up In Second Half of 2015

SNI Guidance Document coverI was poking around on the FDA website yesterday to find out if any new DSCSA documents had been released recently.  I just returned from a near three-week trip to Western Europe and wanted to see if perhaps I missed something.  No.  Nothing released recently.  You can find a list of DSCSA documents released by the FDA on their website and the most recent one was published on December 31, 2014.

Back in January of this year the FDA published their annual list of guidance titles that they think they will publish in the coming year (updated in April).  That list included six titles of guidance documents related to the DSCSA that they expect to either publish in draft form, or finalize.  These include: Continue reading FDA DSCSA Deliverables Are Bunching Up In Second Half of 2015 →

DSCSA Product Identifier, serialization

InBrief: ‘The Smallest Individual Saleable Unit’ In The DSCSA

Drawing from the GS1 Healthcare GTIN Allocation Rules document showing how to assign GTINs in multi-pack scenarios. Click image to enlarge.
Drawing from the GS1 Healthcare GTIN Allocation Rules document showing how to assign GTINs in multi-pack scenarios. Click image to enlarge.

The U.S. Drug Supply Chain Security Act (DSCSA) requires manufacturers and repackagers to place DSCSA-specific “product identifiers” on all drug packages and homogeneous cases by November 27, 2017 (2018 for repackagers).  These product identifiers must include a Standardized Numeric Identifier (SNI), which is composed of the drugs National Drug Code (NDC) and a unique serial number (for more on DSCSA “product identifiers”, see “The DSCSA Product Identifier On Drug Packages“, for more on the SNI, see “FDA Aligns with GS1 SGTIN For SNDC“, and for more on the NDC, see “Anatomy Of The National Drug Code“).

A common question is, what is the smallest level of packaging that must be serialized?.  The DSCSA text provides the answer. Continue reading InBrief: ‘The Smallest Individual Saleable Unit’ In The DSCSA →