I’ve Changed My Mind, Follow GS1’s HRI Specification

HRI zoomThat’s right, I now recommend that you follow GS1’s Human Readable Interpretation (HRI) specification for drug labeling, even when under a serialization regulation.  Previously I recommended against it (see “The DSCSA Product Identifier On Drug Packages”, and “The ANVISA Unique Medicine Identifier (IUM) on Drug Packages”).  Why have I changed my mind?  GS1 modified their specification to accommodate most of the objections I had over it.  Let me explain.

The new specification for HRI is in the latest version of Continue reading I’ve Changed My Mind, Follow GS1’s HRI Specification

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

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

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India Proposes Serialization of Domestic Drug Supply

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

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Six Years of RxTrace

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

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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

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Dispensers Make Last Minute Appeal for Delay in DSCSA Deadline

NCPA logoLess 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

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India’s Pharma Export Serialization Deadlines: April Fools!

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!

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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

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DISCLAIMER: RxTrace contains some of the personal thoughts, ideas and opinions of Dirk Rodgers. The material contained in RxTrace is not legal advice. Dirk Rodgers is not a lawyer.
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