Tag Archives: VMI

Vendor Managed Inventory Under the DSCSA

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

DSCSA: Transaction Information

TI.iStock_000020581807SmallerIn the new U.S. Drug Supply Chain Security Act (DSCSA) enacted last November as part of the Drug Quality and Security Act (DQSA), “Transaction Information” (TI) is one of three primary sets of data that supply chain sellers of drugs must provide to the buyers beginning January 1 of next year.  I will discuss “Transaction History” (TH) and “Transaction Statements” (TS) in future essays.

On first look, TI can seem pretty simple.  Here is how the DSCSA defines it:

“(26) TRANSACTION INFORMATION.—

The term ‘transaction information’ means—

“(A) the proprietary or established name or names of the product;
“(B) the strength and dosage form of the product;
“(C) the National Drug Code (NDC) number of the product;
“(D) the container size;
“(E) the number of containers;
“(F) the lot number of the product;
“(G) the date of the transaction;
“(H) the date of the shipment, if more than 24 hours after the date of the transaction;
“(I) the business name and address of the person from whom ownership is being transferred; and
“(J) the business name and address of the person to whom ownership is being transferred.”

Sounds kind of like a delivery manifest or packing list. Continue reading DSCSA: Transaction Information

Vendor Managed Inventory Under California ePedigree

At the counterImportant Notice To Readers of This Essay On November 27, 2013, President Barack Obama signed the Drug Quality and Security Act of 2013 into law. That act has many provisions, but one is to pre-empt all existing and future state serialization and pedigree laws like those that previously existed in California and Florida. Some or all of the information contained in this essay is about some aspect of one or more of those state laws and so that information is now obsolete. It is left here only for historical purposes for those wishing to understand those old laws and the industry’s response to them.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 good reasons this might be done, including eliminating the need to deal with issues that have more to do with supply chain execution mechanics and fluctuating supply and demand than they do with the core competency of dispensing drugs.

When VMI is used in the pharma supply chain the supplier is typically a wholesaler whose core competency is in dealing with those exact issues.  That’s just what they do.  The wholesaler benefits from the VMI relationship because they become the exclusive supplier to the VMI customer.  VMI can be a “win-win” proposition as long as costs are kept in-check.

But what will happen to VMI relationships in California after the California pedigree law goes into effect? 

Continue reading Vendor Managed Inventory Under California ePedigree