Tag Archives: DSCSA

Aggregation –> Chargeback Accuracy –> ROI

Last week I attended my favorite annual conference on pharma serialization and tracing in the U.S.:  The Healthcare Distribution Management Association’s (HDMA) Traceability Seminar.  They call it a “seminar” because the subject of the sessions are generally the same every year, but it is better than any other third-party conference, primarily because the right people attend it:  lots of people from drug manufacturers, wholesale distributors and some dispensers.  With this ideal spectrum of attendees, it is very easy to get your questions answered, in the hallway between sessions if not in the sessions themselves.

Of course, every year the folks from the FDA who are directly responsible for writing regulations related to the Drug Supply Chain Security Act (DSCSA) provide Continue reading Aggregation –> Chargeback Accuracy –> ROI

More Thoughts On FDA and ANVISA

More ThoughtsOne of the problems with trying to respond overnight to big announcements made by regulators is that it’s easy to leave something significant out.  And in the ensuing days you find out what you should have included in those original essays.  That’s what happened with my two essays from last week:  “Brazil Suspends Pharma Serialization And Tracing Requirements” and “FDA Posts Wholesale Distributor and 3PL License Database“.

So let me add a few more thoughts and observations regarding Continue reading More Thoughts On FDA and ANVISA

FDA Posts Wholesale Distributor and 3PL License Database

FDALogoYesterday the U.S. FDA posted the first issue of the wholesale distributor and third-party logistics provider (3PL) database as mandated by the Drug Supply Chain Security Act (DSCSA).  Through this webpage, you can either download the entire database (in .XLS form), or enter a specific query and then download that result set if desired.  I couldn’t get the result set download to work, so there are obviously some bugs that need to get worked out, but this is still an important step in the implementation of the DSCSA.

With this posting, anyone who buys drugs Continue reading FDA Posts Wholesale Distributor and 3PL License Database

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

Grandfather clockRegulations 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 a company to continue doing something after a regulatory deadline that mandates a change, as long as one or more pre-conditions apply.  For example, Section 582(a)(5)(B) of the Drug Supply Chain Security Act (DSCSA) allows wholesale distributors, and repackagers to sell drugs that were already within the supply chain on January 1, 2015 without passing the necessary transaction data.  This makes sense because companies were not obligated to supply that data before that date and so some of the assertions required in the Transaction Statement would not be true (among other problems that grandfathering eliminates).  [Of course, Continue reading Will Manufacturers Be Able To Grandfather Products In Their DC And 3PL?

SAP Makes Bold Move Into Pharma Traceability

sap-erp-graphicLast week SAP announced the availability of their brand new software module they are calling “SAP Advanced Track and Trace for Pharmaceuticals”, or ATTP.  Pharmaceutical Commerce magazine published an article about it recently that provides the details of what is contained in this new module.  The same issue contained a sponsored article from SAP about the module.  As long-term readers of RxTrace know, I do not endorse specific products and I rarely even write about specific products.  This essay is not an endorsement— Continue reading SAP Makes Bold Move Into Pharma Traceability

Again, A Closer Look At The Six-Year Record-Keeping Requirement

I sat on my back porch gazing at this amazing sky all afternoon Sunday.
I sat on my back porch gazing at this amazing sky all afternoon Sunday.

It was a very beautiful weekend here in the Chicago area, and consequently I could not bring myself to spend any part of it sitting in front of a computer hammering out a new essay, so for the second week in a row (sorry), here is a re-run of a popular essay from July 14, 2014.  I promise to return next week with a brand new essay.

??????????The Drug Supply Chain Security Act (DSCSA) contains record-keeping requirements for drug manufacturers, wholesale distributors, repackagers and dispensers that begin on January 1st, 2015,  All companies must keep a copy of the Transaction Information (TI), Transaction History (TH), and Transaction Statements (TS) they receive and those they send for at least six years.  In addition, manufacturers and repackagers must also retain Continue reading Again, A Closer Look At The Six-Year Record-Keeping Requirement

Wholesaler Confusion Over DSCSA Aggregation Explained

iStock_000028920134XSmallWhile listening to a monthly Drug Supply Chain Security Act (DSCSA) call hosted by one of the Big-3 wholesale distributors I heard a comment that snapped me out of my conference call-induced stupor.  Unfortunately I was in a location where I could not take notes so I don’t remember the exact comments that were made, but I remember what it was that brought me back to full consciousness.

The comment made me realize in a jolt why the Big-3—or at least the one running this monthly call—may be unwilling to give up on their claims that they will need aggregation data to accompany shipments of prescription drugs from manufacturers as early as November 2019.  It may have to do with a mis-interpretation of their handling of saleable returned product within the DSCSA.  Let me explain. Continue reading Wholesaler Confusion Over DSCSA Aggregation Explained

FDA Looking For Consulting Org To Run DSCSA Pilots

FDALogoLast week the FDA quietly posted a Request For Proposal (RFP) on the FedBizOpps.gov government bidding site for a consulting organization to design and implement a program of pilot projects that explore and evaluate methods to enhance the safety and security of the pharma supply chain.  The scope of work is: Continue reading FDA Looking For Consulting Org To Run DSCSA Pilots