Category Archives: DSCSA

DSCSA

Again, Should You Off-Load Your DSCSA Obligations To Your Contract Partners?

??????????????????????I spent my holiday weekend having fun with my family and I hope you did the same.  Instead of spending my holiday writing a new RxTrace essay I am re-running one of my better essays, originally posted on October 6, 2014.  If you missed it then, or even if you read it then, it is worth another read.  See if you agree:

Manufacturers who make use of third-party contract manufacturers, contract packagers and/or third-party logistics providers (3PLs) may wish to off-load their 2015 and 2017 obligations under the U.S. Drug Supply Chain Security Act (DSCSA) to those contract organizations.  These obligations include Continue reading Again, Should You Off-Load Your DSCSA Obligations To Your Contract Partners? →

Aggregation, DSCSA, wholesaler

Wholesaler Confusion Over DSCSA Aggregation Explained

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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 →

DSCSA, FDA

FDA Looking For Consulting Org To Run DSCSA Pilots

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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 →

Dispensers, DSCSA

FDA Publishes New Guidance Delaying Dispenser 3T Requirements Until November 1, 2015

FDALogoThe FDA updated their website this morning with new guidance that indicates they intend to use enforcement discretion by not enforcing the dispenser requirements to accept and capture Transaction Information (TI),Transaction History (TH) and a Transaction Statement (TS) until November 1, 2015, a four month delay in enforcement.  The document indicates that the FDA’s decision to take this action was based on the fact that “…some dispensers have expressed concern that electronic systems used to exchange, capture, and maintain product tracing information will not be operational by this effective date.” Continue reading FDA Publishes New Guidance Delaying Dispenser 3T Requirements Until November 1, 2015 →

Dispensers, DSCSA

Dispensers Make Last Minute Appeal for Delay in DSCSA Deadline

Less than a week before the July 1, 2015 Drug Supply Chain Security Act (DSCSA) deadline for dispensers to begin receiving, storing a being able to retrieve Transaction Information (TI),Transaction History (TH) and a Transaction Statement (TS) for every incoming shipment of prescription drugs, a group of pharmacy associations have asked the FDA for enforcement discretion for an unspecified time to avoid “…the possible outcome of disruptions to the supply chain”.  Continue reading Dispensers Make Last Minute Appeal for Delay in DSCSA Deadline →

DSCSA, FDA Guidance

FDA DSCSA Deliverables Are Bunching Up In Second Half of 2015

SNI Guidance Document coverI was poking around on the FDA website yesterday to find out if any new DSCSA documents had been released recently.  I just returned from a near three-week trip to Western Europe and wanted to see if perhaps I missed something.  No.  Nothing released recently.  You can find a list of DSCSA documents released by the FDA on their website and the most recent one was published on December 31, 2014.

Back in January of this year the FDA published their annual list of guidance titles that they think they will publish in the coming year (updated in April).  That list included six titles of guidance documents related to the DSCSA that they expect to either publish in draft form, or finalize.  These include: Continue reading FDA DSCSA Deliverables Are Bunching Up In Second Half of 2015 →

DSCSA

3PL Operation Under The DSCSA

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Photo from Wikipedia

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 →

DSCSA

Vendor Managed Inventory Under the DSCSA

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At the counterI 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 →