Yearly Archives: 2016

China

China Adds Traceability Requirement To CFDA Drug Quality Management Specification

CFDA.logoEveryone who markets drugs in China has been watching for the publication of revised requirements for tracing drugs there since the government apparently suspended their previous requirements earlier this year.  Interpreting Chinese government announcements is very hard to do.  Even knowing for sure exactly what has been suspended about the previous regulation is very difficult.  Google Translate does a poor job of making Chinese understandable enough to provide me with confidence.

With all that said, a few weeks ago a notice appeared Continue reading China Adds Traceability Requirement To CFDA Drug Quality Management Specification →

Decommissioning, EUDR

Decommissioning Under the FMD/EUDR

1 Comment

iStock_83566139_smallerIt is a little surprising that the European Union Delegated Regulation (EUDR) uses a form of the word “decommission” 67 times, but not even once uses the opposite term, “commission”.  Article 3.2(c) of the EUDR defines the term ‘decommissioning of a unique identifier’ as:

“… the operation changing the active status of a unique identifier stored in the repositories system referred to in Article 31 of this Regulation to a status impeding any further successful verification of the authenticity of that unique identifier;”

It is a striking omission to define how to change the active status of a drug to impede successful verification, but to fail to define the opposite operation that sets the active status to enable successful verification in the first place. Continue reading Decommissioning Under the FMD/EUDR →

DSCSA, Grandfathering

Will Manufacturers Be Able To Grandfather Products In Their DC And 3PL? Again

Grandfather clockThis week I am posting one of my favorite essays from last fall because at this moment, I am in the middle of moving my home and office from one side of the Chicago metro area to the other to be closer to our kids.  Also at this moment, the FDA is almost eight months late in publishing the grandfathering guidance that was mandated by the DSCSA.  Here it is again.

Regulations often make use of a concept known as “grandfathering” to soften a given deadline so that it is easier for companies to meet.  When allowed, grandfathering allows Continue reading Will Manufacturers Be Able To Grandfather Products In Their DC And 3PL? Again →

#BlackLivesMatter

#BlackLivesMatter Explained By A White Guy

17 Comments

iStock_5179418_SmallerDon’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 →

RxTrace

Seven

Presence (Led Zeppelin 7)
Presence (Led Zeppelin 7)

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 →

Brexit

How Brexit Might Impact The Pharma Supply Chain

1 Comment

iStock_94550925_smallerA 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 →

DSCSA

How Will The DSCSA Serialization Mandate Be Enforced After 2017?

iStock_38947550_smallerDrug 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

DSCSA: Label Artwork Heartaches

iStock_93803221_barcode.artOne 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 →