That’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 →
When 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 →
Last 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 →
This 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 →