DSCSA Schedule Assessment, July 2019

It’s time to assess the progress of the industry and the FDA in their quest toward the November 27, 2023 Drug Supply Chain Security Act (DSCSA) goal known as the Enhanced Drug Distribution (EDDS) phase…otherwise known as just ‘2023’ (see “EDDS: The New Data Exchange Requirements”).  Let’s step back and look at where we have come and where we need to go.

Continue reading DSCSA Schedule Assessment, July 2019

EMVO Calls For Enforcement Of FMD/DR

Wait.  I thought the Falsified Medicines Directive and its companion Delegated Regulation (FMD/DR)—which has been in effect since February 9, 2019—was a mandate that would be enforced.  Turns out, it was apparently just a suggestion.  No actual government enforcement.  In fact, according to new estimates by the European Medicines Verification Organization (EMVO) and the National Medicines Verification Organizations (NMVOs),  only 60% of drug manufacturers and 75% of “other” supply chain actors (pharmacies, hospitals, wholesalers, dispensing doctors etc.) have connected to the medicines verification systems (the “system of repositories” mandated in the FMD/DR).  A partial result is that one out of every 33 verification attempts at pharmacies and hospitals who are connected result in a ‘false alert’.  That is, an alert that the drug being verified is not in the repository or the scan is not being interpreted correctly. 

Continue reading EMVO Calls For Enforcement Of FMD/DR

China Commits To The Digital Future In Healthcare, Including Pharma Traceability

Tesla Gigafactory 3 near Shanghai, China, June 22, 2019. Screengrab from YouTube video posted by Jason Yang.

I finally had time to finish applying Google Translate to the document issued on May 23, 2019 by the Comprehensive and Planning Finance Department of the China National Drug Administration (CNDA), called “State Drug Administration:  Action Plan to Accelerate the Promotion of Smart Drug Supervision”.  I originally thought “Smart Drug Supervision” was solely related to supply chain supervision, serialization and traceability, but that’s only a part of their plan.

Continue reading China Commits To The Digital Future In Healthcare, Including Pharma Traceability

Barcodes 45, RxTrace 10

The commercial use of barcodes began 45 years ago last week, and RxTrace began 10 years ago this week.  These are pretty incredible milestones and it is worth stepping back and thinking about what it all means.  GS1 issued a press release about the barcode’s 45th anniversary last week, providing links to several videos.  These include some old-timey videos of what grocery checkout was like before barcodes, and when the UPC barcode was first introduced in Troy, Ohio in 1973.  It made me feel old. 

Continue reading Barcodes 45, RxTrace 10