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
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).
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’
Here we are, waiting for the FDA to publish new draft guidance related to the Drug Supply Chain Security Act (DSCSA) after a deadline that passed more than a year ago, and what do we get?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
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
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
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?
There are a number of misconceptions floating around the industry right now about what will happen in November of 2023, when the Enhanced Drug Distribution Security (EDDS) phase mandated by the Drug Supply Chain Security Act (DSCSA) begins. It is surprising where you hear some of these, but they are all based on mis-reads of the DSCSA law itself. I’ll explain the myths, and then I will try to provide extracts from the DSCSA that expose them as myths. Continue reading 5 Myths About The DSCSA In 2023