On November 27, 2019 the Drug Supply Chain Security Act (DSCSA) requires wholesale distributors to step up their supply chain security activities another notch. They are required to:Continue reading Is The FDA About To Delay Enforcement Of The Wholesaler’s 2019 Mandate?
There is a reason so many RxTrace essays have something to do with the Healthcare Distribution Alliance (HDA) (I won’t list them all, but here are two recent ones: “HDA Traceability Seminar: RxTrace Future Topic List Explodes” and “HDA Schools FDA On DSCSA”). It’s because they have their fingers in just about everything related to the US pharma supply chain’s preparation for compliance with the Drug Supply Chain Security Act (DSCSA). HDA members are literally in the “center” of the supply chain, and the organization is at the center of many of the most important initiatives related to meeting the DSCSA, including their Origin master data sharing service (see “Dawn of HDA’s Origin, The Key to DSCSA Compliance”), their future Verification Router Service (VRS) (see “First Meeting of the HDA Verification Router Service Task Force”), and they hold the most important DSCSA conference every year (see “FDA Speaks About DSCSA At HDA”). And their HDA Research Foundation now conducts the most important manufacturer DSCSA serialization readiness survey. They just published the latest one. Let’s take a look at it. Continue reading HDA’s 2017 Manufacturer Serialization Readiness Survey Results
The root cause of the US opioid epidemic was made visible on television two Sundays ago. Did you see it? I’m referring to the 60 Minutes/Washington Post expose called “The Whistleblower” that aired on Sunday, October 15. But if you watched that episode with the volume up, odds are you missed the root cause. Let me explain. Continue reading Opioid Epidemic: Root Cause Exposed
Last week I covered the likely impact of the recent draft compliance policy currently under a 60-day public comment period (see “DSCSA and RxTrace: The Song Remains The Same“). This week, I will take a look at its likely impact on downstream trading partners, including repackagers, wholesale distributors and dispensers.
Under the Drug Supply Chain Security Act (DSCSA), these organizations have specific obligations to only engage in transactions with product that has the DSCSA-mandated product identifier (serial number) on it (see “The DSCSA Product Identifier On Drug Packages“). And when investigating suspect product or receiving saleable returns, they must Continue reading DSCSA Cascading Delays
Last week I listened in on a Drug Supply Chain Security Act (DSCSA) call hosted by one of the Big-3 U.S. wholesale distributors. It was a well-run call that included several presentations and a Q&A session. Several times the question was discussed about whether or not the wholesale distributor would accept non-serialized product in the time between November 27, 2017 and November 27, 2019. Continue reading Who Will Enforce The DSCSA 2017 Serialization Mandate?
Over the next few years, the U.S. drug wholesale distributors are going to start dictating their specific requirements related to the Drug Supply Chain Security Act (DSCSA) to their suppliers. For the “Big 3” U.S. wholesale distributors, those suppliers happen to be nearly every drug manufacturer who markets drugs in the United States. The “Big 3” include McKesson, AmerisourceBergen and Cardinal Health, which together distribute about 85% of all drugs that pass through the domestic supply chain.
Of course, each segment has Continue reading U.S. Drug Wholesale Distributors Provide Direction To Manufacturers
As I reported last Thursday, the FDA published new revised guidance that extends their enforcement delay of the Drug Supply Chain Security Act (DSCSA) data exchange requirements for dispensers by an additional 4 months (see “FDA Extends Dispenser Delay in DSCSA Enforcement“). What does this mean for drug manufacturers, wholesale distributors and repackagers? Continue reading Pay No Attention To The Enforcement Delay Unless You Are A Dispenser
Yesterday the U.S. FDA posted the first issue of the wholesale distributor and third-party logistics provider (3PL) database as mandated by the Drug Supply Chain Security Act (DSCSA). Through this webpage, you can either download the entire database (in .XLS form), or enter a specific query and then download that result set if desired. I couldn’t get the result set download to work, so there are obviously some bugs that need to get worked out, but this is still an important step in the implementation of the DSCSA.
With this posting, anyone who buys drugs Continue reading FDA Posts Wholesale Distributor and 3PL License Database