Category Archives: DSCSA

DSCSA

FDA Posts DSCSA-Specific Information Sharing Agreement Template For State Agencies

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istock_19522725_smallerWhile I was preparing a DSCSA resource list to be handed out at the Systech Uniquity event in Mumbai next week I stumbled across a document that the FDA recently posted on their website.  It is a template for a DSCSA-specific information sharing agreement that is aimed at state agencies, like state boards of pharmacy and probably state’s attorneys’ offices and state bureaus of investigation, etc.  The DSCSA contains several clauses that imply data sharing between the FDA and “…appropriate Federal or State official[s]”. 

The problem is, the data that would likely need to be shared Continue reading FDA Posts DSCSA-Specific Information Sharing Agreement Template For State Agencies →

DSCSA, FDA Guidance

FDA Plans Busy Second Half of 2016 With Six DSCSA Draft Guidances Expected

FDALogoLast week the US FDA Center for Drug Evaluation and Research (CDER) published an update to their guidance agenda for calendar 2016.  Originally published in January, this is the mid-year update, when the CDER has a shorter window to think about and, presumably, can be more accurate.  What has changed since January?  The number of Drug Supply Chain Security Act (DSCSA)-related draft guidance they expect to publish by year end remains the same, as reported by our friends at the Regulatory Affairs Professionals Society (RAPS).

In fact, according to RAPS, those same six draft guidances were Continue reading FDA Plans Busy Second Half of 2016 With Six DSCSA Draft Guidances Expected →

DSCSA

Who Will Enforce The DSCSA 2017 Serialization Mandate?

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? →

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 →

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 →

Barcodes, DSCSA, HDMA

Important HDMA Webinar On Barcoding for DSCSA

HDMA LogoRxTrace 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 →

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 →