EU FMD

EU FMD: Aggregation Is Not Mandated, But It Will Be Necessary

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iStock_000016455220_SmallerEver since the E.U. Falsified Medicines Directive (FMD) was passed in 2011 my European friends have touted the fact that their government mandated solution would take a “bookend” approach.  The implication was always that it would be much less complex than the ePedigree approaches that were being planned by various U.S. states, and then by the U.S. federal government with the passage in 2013 of the Drug Supply Chain Security Act (DSCSA).

My friends always liked to point out how simple Continue reading EU FMD: Aggregation Is Not Mandated, But It Will Be Necessary →

RxTrace Traceability Survey

Sponsored: The 2016 RxTrace U.S. Pharma Traceability Survey, Sponsored by Frequentz, Final Report

Cover thumbnailThe final report of the 2016 RxTrace U.S. Pharma Traceability Survey, sponsored by Frequentz is now available.  Download the full free report here.  With this year’s survey we attempted to get a glimpse of the progress toward the next deadlines of the Drug Supply Chain Security Act (DSCSA) from drug manufacturers, repackagers, wholesale distributors, 3PLs and dispensers.  Each of those different types of respondents were asked a different set of questions that were pertinent to their segment and their regulatory requirements under the DSCSA.

Frequentz.logoTake a close look at the results.  They reveal that Continue reading Sponsored: The 2016 RxTrace U.S. Pharma Traceability Survey, Sponsored by Frequentz, Final Report →

DSCSA, HDMA

HDMA DMC Serves Sizzling Steak With A Small Side Of Snake Oil

iStock_000043324250_SmallerAccording 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 →

DSCSA, EUDR

Drug Verification: EU Vs US

USvsEU flagsDrug 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 →

Dispensers, DSCSA

FDA Limits Ongoing Dispenser Enforcement Discretion To First Responders

iStock_000022846474_smallerBack 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 →

DSCSA, FDA, UDI

Sponsored: The Many Faces Of The FDA

MultiFacesWhy 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 →

DSCSA, EUDR

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 →

FDA Workshop

FDA To Hold DSCSA Pilots Workshop

FDALogoAs we saw last fall, the FDA is planning to conduct at least one pilot project in 2016 to fulfill its DSCSA mandate to do so.  The pilot should focus on the 2023 DSCSA technologies and processes (see “FDA Looking For Consulting Org To Run DSCSA Pilots“).  Today we learned that a pilot will indeed occur this year, and the FDA wants your input into its design and goals.  To accomplish that quickly, the FDA will establish a docket next Tuesday for collecting written comments, and a public workshop for collecting verbal comments.

The last DSCSA public workshop Continue reading FDA To Hold DSCSA Pilots Workshop →

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