Category Archives: DSCSA

Dawn of HDA’s Origin, The Key to DSCSA Compliance

This week at the Healthcare Distribution Alliance (HDA) Distribution Management Conference and Expo (DMC) the HDA and ValueCentric will provide much more detail around the new master data sharing service they plan to make available in July.  The new service—named “Origin”—is intended to provide members of the pharma supply chain with a single directory of master data for all prescription drugs marketed in the United States (see Origin website).  That is, it is a database of master data wrapped within a cloud-based service. 

Origin master data is composed Continue reading Dawn of HDA’s Origin, The Key to DSCSA Compliance

Could Blockchain Technology Be Used For DSCSA Compliance?

c4scs-logoIf your email inbox is anything like mine it has recently been swamped with articles and webinar notices about the possible use of blockchain technology to solve multiple challenges in healthcare.  I recently attended a very interesting day-long workshop on that very topic. 

So is blockchain a real solution, or is it just the latest over-hyped buzzword that is being promoted by people who don’t understand the real needs of healthcare companies?  I’ll tell you what I think.  But first, a little background.

Blockchain technology is a way of encapsulating information within a layer of structured data that multiple parties can use as the basis for trust in the accuracy of the source of that information.  It’s all about adding trust to information that is shared between parties.  Trust is just one of the many Continue reading Could Blockchain Technology Be Used For DSCSA Compliance?

Will President Trump Eliminate The DSCSA?

screen_shot_2016-10-30_at_1-39-54_pm__previewPresident-elect Donald Trump has made no secret of his interest in eliminating regulations that burden businesses unnecessarily.  And he may take a particular interest in those that were newly imposed under President Obama.  He has vowed to use his first 100 days to repeal “Obamacare”, the Affordable Care Act (ACA) and his plans include “ cutting the red tape at the FDA: there are over 4,000 drugs awaiting approval, and we especially want to speed the approval of life-saving medications.”  Could the Drug Supply Chain Security Act (DSCSA) get caught up in that vow and also be repealed?  There are three obvious possibilities. Continue reading Will President Trump Eliminate The DSCSA?

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

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

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

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?

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

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?