Recently, several of the larger U.S. wholesale distributors have sent letters to their suppliers to review what they expect from them relative to the Drug Supply Chain Security Act (DSCSA). You may recall that these companies have provided requirements in advance of earlier DSCSA deadlines (see “U.S. Drug Wholesale Distributors Provide Direction To Manufacturers“). These expectations are aimed at the November 27, 2017 serialization requirements and beyond. Continue reading DSCSA Serialization: What Wholesalers Expect
Drug companies who serve markets within the European Union (EU) have until February 9, 2019 to add serial numbers within a Data Matrix barcode to their drug packages, among many other specific requirements (see “The ‘Unique Identifier’ in the EU Delegated Act”). The specific requirements are outlined in the EU Delegated Regulation (EUDR). I’ve written a lot about the EUDR over the last few years (see RxTrace: Delegated Regulation). Today I want to highlight and explain a problem that may be brewing in the implementation of the system of repositories as established by the non-profit European Medicines Verification Organization (EMVO). The potential problem is related to the way the EMVO Continue reading Pharma Serial Number Randomization Under The Falsified Medicines Directive
This week at the Healthcare Distribution Alliance (HDA) Distribution Management Conference and Expo (DMC) the HDA and ValueCentric will provide much more detail around the new master data sharing service they plan to make available in July. The new service—named “Origin”—is intended to provide members of the pharma supply chain with a single directory of master data for all prescription drugs marketed in the United States (see Origin website). That is, it is a database of master data wrapped within a cloud-based service.
Origin master data is composed Continue reading Dawn of HDA’s Origin, The Key to DSCSA Compliance
The Healthcare Distribution Alliance (HDA) Traceability Seminar that was held back in early November was so packed with valuable information that I still have a number of topics queued up from that event for RxTrace essays in the future. Today I want to take a closer look at the results of the Saleable Returns Pilots conducted by the HDA last year to figure out the most efficient way to verify saleable returns. I discussed the overall project in my report of the Traceability Seminar (see “HDA Delivers Home Run To Record-Breaking Audience”) but today I want to focus in on just two of the approaches piloted. These are:
- Manufacturer sends to wholesale distributor product identifiers for only the units purchased by that wholesale distributor, and,
- Verification Router Service (VRS).
Here we are, waiting for the FDA to publish new draft guidance related to the Drug Supply Chain Security Act (DSCSA) after a deadline that passed more than a year ago, and what do we get? A final version of a guidance document that was originally published in draft form two and a half years ago: “Identification of Suspect Product and Notification”. Well, OK, thanks.
I have to say, this is important guidance. In fact, it is probably the most important DSCSA guidance that the FDA has published yet, whether in draft or final forms. And, unfortunately, Continue reading FDA Finalizes Guidance On Suspect Product
One of the focuses of RxTrace is to explore global pharma serialization and tracing regulations in an attempt to discover some of their implications. Some implications turn out to be obvious, but some turn out to be surprising. Identifying the implications early provides us with a better understanding of what to expect from our investments in time to fine-tune those investments. If company leaders have a realistic understanding of what to expect from different investments, they will make better decisions for their stakeholders. Can they expect to be fully compliant? Only partly compliant, thus needing to spend more down the road? Will they be fully compliant with the law, but disappoint their primary customers and thus find that their business takes a hit? If they have a good idea of what to expect before they Continue reading Sponsored: Will Global Serialization Mandates Result In Less Counterfeiting?
A few weeks ago, GS1 US published version 1.2 of the DSCSA implementation guidance that documents how to apply GS1 standards when meeting the U.S. Drug Supply Chain Security Act (DSCSA). GS1 US is the GS1 Member Organization (MO) in the United States, of GS1, the global supply chain standards organization. Companies who market drugs in the U.S. pharma supply chain and their solution providers will find this new version to be an indispensable resource that will Continue reading The New GS1 US DSCSA Implementation Guidance Suite
Last week the Healthcare Distribution Alliance (HDA) (formerly the HDMA) held their annual Traceability Seminar in Washington DC. More than 450 people registered, shattering the previous record set just last year (see “Aggregation –> Chargeback Accuracy –> ROI”) and nearly equaling the record set in March for their 2016 Distribution Management Conference and Expo (see “HDMA DMC Serves Sizzling Steak With A Small Side Of Snake Oil”). This year’s event was executed nearly flawlessly with presentations by the FDA and wholesale distributors, and various panel discussions with thought-leaders from drug manufacturers, 3PLs, contract manufacturers, wholesale distributors, repackages, hospitals and chain pharmacies. Here are some of my notes from the event. Continue reading HDA Delivers Home Run To Record-Breaking Audience