The Pharmaceutical Distribution Security Alliance (PDSA) is a coalition of companies and organizations dedicated to the safety and integrity of the U.S. pharmaceutical supply chain. When the Drug Supply Chain Security Act (DSCSA) went into effect on November 27, 2013 the PDSA began to serve as a voice for its members in communications with the U.S. FDA. Their preferred way of communication is through formal letters signed by their legal advisor, Vince Ventimiglia. PDSA letters to the FDA are really interesting because they do an excellent job of providing recommendations for the FDA to consider as they prepared to publish the four guidance documents that were due back on November 27, 2015. The FDA has still not published those documents. Continue reading In Absence Of FDA Guidance, Follow PDSA Recommendations
Category Archives: DSCSA
Can Anyone Buy Non-Serialized Drugs After 11-27-2019?
Well over a year ago, my good friend Kevan MacKenzie, Director, Serialization Technology with McKesson, pointed out a really interesting discrepancy contained in the Drug Supply Chain Security Act (DSCSA) regarding the sale of non-serialized drugs. I’ve been meaning to write about it since then. The topic finally bubbled up to the top on my list.
What Kevan pointed out is that there are two sections of the DSCSA that contain slightly conflicting requirements. This leaves companies Continue reading Can Anyone Buy Non-Serialized Drugs After 11-27-2019?
Sponsored: How To Properly Define GTINs For Your NDCs
RxTrace readers are well aware that the deadline is this November 27 for applying unique serial numbers within GS1 DataMatrix 2D barcodes to prescription drugs distributed in the United States under the Drug Supply Chain Security Act (DSCSA). Once that happens, most prescription drugs entering the U.S. supply chain will be identified by 14-digit GS1 Global Trade Item Numbers (GTIN-14) for the first time (see “Anatomy of a GTIN”). That’s because, you can’t fit the drug’s National Drug Code (NDC) along with the serial number, lot number and expiration date into a data matrix barcode, as required by the law, without first encoding it into a GTIN-14 (see “Anatomy Of The National Drug Code”, and “Depicting An NDC Within A GTIN”). This fact forces companies to encode their NDCs into GTIN-14s, many for the first time. Continue reading Sponsored: How To Properly Define GTINs For Your NDCs
DSCSA Serialization: What Wholesalers Expect
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
Dawn of HDA’s Origin, The Key to DSCSA Compliance
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
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?
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?
FDA Posts DSCSA-Specific Information Sharing Agreement Template For State Agencies
While I was preparing a DSCSA resource list to be handed out at the Systech Uniquity event in Mumbai next week I stumbled across a document that the FDA recently posted on their website. It is a template for a DSCSA-specific information sharing agreement that is aimed at state agencies, like state boards of pharmacy and probably state’s attorneys’ offices and state bureaus of investigation, etc. The DSCSA contains several clauses that imply data sharing between the FDA and “…appropriate Federal or State official[s]”.
The problem is, the data that would likely need to be shared Continue reading FDA Posts DSCSA-Specific Information Sharing Agreement Template For State Agencies
