Happy Martin Luther King Day!
Congress set the calendar for many different kinds of requirements when it adopted the Drug Supply Chain Security Act, signed by the President back on November 27, 2013. One of those dates was last November 27, 2015, two years after enactment, when the FDA was required to publish four new draft guidances. So far, none of them have appeared (see “FDA DSCSA Deadline Passes Quietly”). Continue reading Who Is Being Harmed By Four Overdue FDA DSCSA Guidances?
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
One 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
Another type of business affected by the U.S. Drug Supply Chain Security Act (DSCSA) is the third party logistics provider (3PL) business.
I wrote an RxTrace essay about the impact of the California pedigree law on 3PLs back in 2013 (see “3PL Operation Under California ePedigree“). This is an update of that essay to address the impacts of the new DSCSA on 3PLs since the California pedigree law is now obsolete.
There are a number of important differences between wholesale distributors and 3PLs as defined in the DSCSA. Continue reading 3PL Operation Under The DSCSA
I wrote this essay on Vendor Managed Inventory (VMI) back in 2013 which was aimed at what would likely happen to VMI under the California pedigree law (see “Vendor Managed Inventory Under California ePedigree”). But even though that law is now obsolete (see “The California Pedigree Law Is Now Officially Inoperative“), surprise, some of the same issues crop up when VMI is performed under the DSCSA. So I converted the original essay to speak to VMI under the DSCSA. I think you will agree, it is still pertinent…
One of the complexities of the modern pharmaceutical supply chain occurs when a pharmaceutical dispensing organization “outsources” the management of their on-premises inventory to their supplier, or “vendor”. This is known as Vendor Managed Inventory, or VMI. There are several Continue reading Vendor Managed Inventory Under the DSCSA
Last week I discussed controversy over the use of GS1’s Serial Shipping Container Code (SSCC) in the Brazil pharma supply chain to meet regulatory requirements imposed by ANVISA. But there are different controversies, or at least potential confusion, in the U.S. pharma supply chain surrounding case labels, and some of those are relate to the SSCC and its use.
A case product identification label is the label a manufacturer usually places on each homogeneous case at case-packing time to identify what is inside the corrugated box. A “homogenous case” is a case that Continue reading Identification Of Pharma Cases In The U.S.
The FDA posted new draft guidance for pharma wholesale distributors and third-party logistics providers to follow to meet their obligation to register their licensing information annually. The new requirement is from the Drug Supply Chain Security Act (DSCSA) that was enacted last year (see “It’s Official, President Obama Signs H.R. 3204, DQSA, Into Law“). The draft guidance explains who, what, when and how companies must report. The FDA will make the data reported available to the public through a web site at some point in the future.
The information the FDA will collect as part of the report from both wholesale distributors and 3PLs include facility location and contact information, a unique facility identifier, license information for each State–including expiration dates–and any significant disciplinary action Continue reading FDA Posts Guidance For Wholesale Distributor and 3PL Annual Reporting
Back in the middle of the summer the Healthcare Distribution Management Association (HDMA), the industry association for the primary healthcare distributors in the United States, published on their website a very valuable resource for companies that must meet the U.S. Drug Supply Chain Security Act (DSCSA) beginning in January. This new resource is tucked away in the HDMA’s “Issues in Distribution”, “Pharmaceutical Traceability” page under the “Technical/Standards” heading [look for “Supply Chain Product Transaction Scenarios: Drug Supply Chain Security Act Implementation (2014)”]. It is free for anyone to download and I highly recommend that you do. (And while you’re at it, check out some of the other resources available on that page.)
HDMA has been a leader in developing high quality guidance documents that aim to help Continue reading The HDMA Supply Chain Product Transaction Scenarios For DSCSA
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