Don’t worry. It is not my intention to change this pharma/regulatory/technology blog into a political platform, but after the events of last week, I think it is appropriate for all of us to step back and examine how we can make our country better. I believe I can make a positive contribution by explaining my sincere interpretation of #BlackLivesMatter. I first heard the phrase “Black Lives Matter” back in 2012 when Travon Martin was killed by George Zimmerman in Sanford, Florida. Like most people, when I first heard the phrase, I thought it was clearly wrong. I thought, what they should say, is “all lives matter”. Continue reading #BlackLivesMatter Explained By A White Guy
All posts by Dirk Rodgers
Seven
I started writing RxTrace seven years ago on July 4, 2009 (see “Welcome to rxTrace”). Not much has changed in my goals since then. My interests still revolve around the intersection between the healthcare supply chains, track and trace technology, standards and global regulatory compliance. I still like exploring ideas, including those that might not be mainstream yet. My only regret is Continue reading Seven
How Brexit Might Impact The Pharma Supply Chain
A revolution occurred last week. Not by guns—by referendum. Like most revolutions, it caught a lot of people by surprise. The most laughable surprise comes from those who voted for the UK to leave the European Union as a kind of protest vote, but immediately became sorry they voted that way after learning that they had “won”, because they really didn’t mean it! It’s also laughable to hear the cries of the people who didn’t bother to vote because they felt confident that the referendum would go their way. Now they would like to go back in time so they can cast their vote. Whoops, too late.
What these people didn’t realize is that revolutions are serious business, whether executed with guns or with votes. One of the reasons Continue reading How Brexit Might Impact The Pharma Supply Chain
How Will The DSCSA Serialization Mandate Be Enforced After 2017?
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?
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
FDA Speaks At GS1 Connect
Last week, Connie Jung, RPh, PhD, Acting Associate Director for Policy and Communications, Office of Drug Security, Integrity, & Recalls, U.S. Food and Drug Administration, spoke about the Drug Supply Chain Security Act (DSCSA) at the GS1 US Connect event in Washington DC. This was our latest opportunity to get a glimpse of what the FDA is thinking and what they are doing. Dr. Jung spoke for about 50 minutes and then answered questions from the audience. Continue reading FDA Speaks At GS1 Connect
How RxTrace Became The Target Of A Counterfeiter
The term “counterfeit” is usually defined as an unauthorized copy of a physical thing. Here is how Dictionary.com defines it:
“[koun-ter-fit]
…
noun
3. an imitation intended to be passed off fraudulently or deceptively as genuine; forgery.”
Counterfeiters seek to expropriate the good reputation, good will and trust in a recognized brand by deceit to carve out undeserved profit or other gain. Their goal is to Continue reading How RxTrace Became The Target Of A Counterfeiter
HDMA Responds To FDA Pilots RFC
A few months ago the FDA opened two “dockets”, or Requests for Comments (RFC) to collect ideas and experiences about technology pilots related to the Drug Supply Chain Security Act (DSCSA). The first docket was associated with the FDA Public Meeting held on April 5 and 6 (see “The 2016 FDA Pilots Workshop”). The second docket was opened shortly after the Public Meeting to continue collecting the same kind of information from anyone who had already conducted their own pilots or was planning future pilots. Both dockets are now closed so here is a look at the responses. Continue reading HDMA Responds To FDA Pilots RFC
