Drug manufacturers, contract manufacturers (CMOs) and contract packagers (CPOs) are all working hard right now preparing to meet the November 27, 2017 deadline when all prescription drugs entering the U.S. market must contain the new machine- and human-readable product identifier defined in the Drug Supply Chain Security Act (DSCSA) (see “The DSCSA Product Identifier On Drug Packages“). The date for repackagers is one year later (see “Who Is A DSCSA Repackager?”). From what I hear around the industry, some companies are going to make that date, but some will not. What will happen next for those how are not ready? I discussed this from a regulator perspective last year in one of my personal favorite essays, “An Open Letter To The FDA, EMA and ANVISA, RE: Who Are You Going To Punish?”, but what about from the perspective of those who will be late? Continue reading How Will The DSCSA Serialization Mandate Be Enforced After 2017?
Category Archives: DSCSA
DSCSA: Label Artwork Heartaches
One of the surprising things about industry preparations for the Drug Supply Chain Security Act (DSCSA) is how hard it is to make label changes to add the new DSCSA product identifier barcode (see “The DSCSA Product Identifier On Drug Packages”). The artwork changes necessary take a lot longer than everyone originally expected. Companies with hundreds of different drug packages to redesign may have trouble getting all the work done by the November 27, 2017 deadline (2018 for repackagers). If you have thousands of different packages, you had better have a large team working on the artwork changes right now.
What’s the problem? All you need to do is Continue reading DSCSA: Label Artwork Heartaches
Important HDMA Webinar On Barcoding for DSCSA
RxTrace followers will want to register and listen in on the Healthcare Distribution Management Association’s (HDMA) upcoming important webinar on May 19, 2016 from 1:00 to 2:00pm EDT. The webinar will cover the new changes to their “Bar Coding Quick Start Guide” for compliance with the U.S. Drug Supply Chain Security Act. HDMA originally published this document back in 2014 (see the HDMA’s website) but they are expected to publish an updated version of it any day now. I checked the HDMA website last night and did not see the new version, but with the scheduling of this webinar, odds are it will be made available to the public between now and May 19.
When that document becomes available Continue reading Important HDMA Webinar On Barcoding for DSCSA
HDMA DMC Serves Sizzling Steak With A Small Side Of Snake Oil
According to the HDMA, their Distribution Management Conference and Expo in San Antonio last week broke the attendance record at more than 500 attendees, but for the life of me, I can’t figure out why the number wasn’t double that amount. When you compare the value you receive by attending this (or any) HDMA event with what you receive from any third-party event, well, there isn’t any comparison. HDMA serves sizzling steak to their soggy puffed rice. The reason is not just the quality of the speakers. In fact, as “speakers”, they really aren’t any better at speaking than any other group of people, but it is who they are and what they know that makes the difference. And just as important, who else is in the audience that makes these events so special. It’s not just what is going on in the sessions, but it is who you meet and what you learn in the hallways and networking breaks between sessions. I’ve said this before (see “Terminology: Track and Trace, and Pedigree”). Continue reading HDMA DMC Serves Sizzling Steak With A Small Side Of Snake Oil
Drug Verification: EU Vs US
Drug verification is at the heart of most pharma serialization regulations. It is the point at which someone in the supply chain or a patient uses the unique identifier on the drug package to determine that the drug is probably authentic, or definitely is not. We can tell a lot about the intent of a given serialization regulation by looking at the specific language that determines by whom and when a unique identifier must be verified. Continue reading Drug Verification: EU Vs US
FDA Limits Ongoing Dispenser Enforcement Discretion To First Responders
Back in October the FDA announced the extended use of enforcement discretion to temporarily set aside the data exchange provisions of the Drug Supply Chain Security Act (DSCSA) for dispensers until March 1, 2016 (see “FDA Extends Dispenser Delay in DSCSA Enforcement“). That was itself an additional four month extension to the four month enforcement discretion they originally announced on June 30 (see “FDA Publishes New Guidance Delaying Dispenser 3T Requirements Until November 1, 2015“). Many dispensers were hoping for another extension in these last few days of February. It turns out, the enforcement discretion will be extended until further notice, but apparently mostly just for first responders. Continue reading FDA Limits Ongoing Dispenser Enforcement Discretion To First Responders
Sponsored: The Many Faces Of The FDA
Why is there such a wide gap between the actions of the UDI face of the FDA and the DSCSA face?
The U.S. Food and Drug Administration (FDA) is an agency of the U.S. government that falls under the Department of Health and Human Services, which is under the leadership of the current Presidential Administration through a cabinet seat. But it is also a concept, and the concept has been conceived, modified, adjusted, influenced and expanded—especially expanded—by many thousands of members of Congress that have served from 1906 to 2016. It started as a nearly powerless monitoring agency in 1906 with the passage of the Federal Food and Drugs Act. But in the aftermath of a number of widely-reported incidents of harm and deaths caused by cosmetics and medicines, the Congress passed the original Food, Drug and Cosmetics Act (FD&C) in 1938 and President Franklin D. Roosevelt signed it into law.
Right from the beginning you had an agency with at least three faces: foods, drugs and cosmetics. Continue reading Sponsored: The Many Faces Of The FDA
Meeting U.S. and E.U. Drug Serialization Requirements With A Single Solution
As serialization mandates sweep the world you would think that drug manufacturers and repackagers would just deploy one generic “serialization application” and simply turn it on for any drugs that requires it, and turn it off for any that do not. That’s probably what the legislatures and regulators who create the requirements think. RxTrace readers know it’s not nearly that easy.
The problem is that every regulation requires something different. The only common thread is that there is always a “serial number” requirement in there somewhere (thus the name). But the serial number itself is usually defined differently and everything else that surrounds the serial number is often not the same. It’s not a matter of just turning it on and off, it’s a matter of changing a bunch of parameters, which result in significantly more complexity in the setup, testing and validation of the system for each market. Continue reading Meeting U.S. and E.U. Drug Serialization Requirements With A Single Solution
