Heart Failure is a human condition that is characterized by several easily identifiable symptoms, including fatigue, difficulty breathing and in its later stages, gurgled breathing. My mother and my mother-in-law both suffered from heart failure during their decline. Analogous to heart failure in humans is a condition of an identifier system that is near the end of its useful life that we can call “identifier failure”. At the end of November, a new FDA final guidance called “Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs That Are Regulated Under a Biologics License Application, and Animal Drugs” went into effect. Buried deep within this 200+ page document is the official announcement that signaled the National Drug Code (NDC) identifier system is now afflicted with this end-stage condition. The NDC won’t last long now, and there is no longer any excuse for inaction. The need for a replacement is now urgent. Continue reading NDC Nearing Its End, Afflicted by ‘Identifier Failure’
Yearly Archives: 2016
FDA Finalizes Guidance On Suspect Product
Here we are, waiting for the FDA to publish new draft guidance related to the Drug Supply Chain Security Act (DSCSA) after a deadline that passed more than a year ago, and what do we get?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
Sponsored: Will Global Serialization Mandates Result In Less Counterfeiting?
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?
Could Blockchain Technology Be Used For DSCSA Compliance?
If your email inbox is anything like mine it has recently been swamped with articles and webinar notices about the possible use of blockchain technology to solve multiple challenges in healthcare. I recently attended a very interesting day-long workshop on that very topic.
So is blockchain a real solution, or is it just the latest over-hyped buzzword that is being promoted by people who don’t understand the real needs of healthcare companies? I’ll tell you what I think. But first, a little background.
Blockchain technology is a way of encapsulating information within a layer of structured data that multiple parties can use as the basis for trust in the accuracy of the source of that information. It’s all about adding trust to information that is shared between parties. Trust is just one of the many Continue reading Could Blockchain Technology Be Used For DSCSA Compliance?
Drug Samples Under Global Serialization and Tracing Regulations
Some pharma manufacturers make special packages of certain drugs that they give away to certain medical practitioners as a way of promoting the product and introducing the practitioner and their patients to it. The method of distribution is usually through field sales people employed directly by the drug manufacturer, and the drug samples are delivered by them directly to the practitioner.
What could go wrong with that? Probably diversion of the product contained within the “free sample” packaging back into the supply chain, but without the “free sample” indicator on the package. Should these special packages be tracked? Should they be serialized? Continue reading Drug Samples Under Global Serialization and Tracing Regulations
The New GS1 US DSCSA Implementation Guidance Suite
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
HDA Delivers Home Run To Record-Breaking Audience
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
Will President Trump Eliminate The DSCSA?
President-elect Donald Trump has made no secret of his interest in eliminating regulations that burden businesses unnecessarily. And he may take a particular interest in those that were newly imposed under President Obama. He has vowed to use his first 100 days to repeal “Obamacare”, the Affordable Care Act (ACA) and his plans include “… cutting the red tape at the FDA: there are over 4,000 drugs awaiting approval, and we especially want to speed the approval of life-saving medications.” Could the Drug Supply Chain Security Act (DSCSA) get caught up in that vow and also be repealed? There are three obvious possibilities. Continue reading Will President Trump Eliminate The DSCSA?