Tag Archives: pharmaceutical supply chain

California Pedigree Law

Vendor Managed Inventory Under California ePedigree

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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 →

Congress, Federal Pedigree

Federal Pedigree: Caught In A Web Of Politics

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spiderwebSeventeen months ago, the goal of the Pharmaceutical Distribution Security Alliance (PDSA) was to get a nationwide track & trace bill introduced into Congress and then get it attached to some “must-pass” legislation which would pull it through to certain passage.  They found sympathetic members of both houses of Congress and they worked together to produce a single bill.  Last summer the “must-pass” legislation was the Prescription Drug User Fee Act (PDUFA) which was combined with other bills and was enacted as the FDA Security and Innovation Act (FDASIA).  See “What If RxTEC Isn’t Adopted?”, “PDUFA Will Not Include RxTEC” and “The Supply Chain Provisions Of The FDA Safety & Innovation Act”.)

Unfortunately the track & trace Continue reading Federal Pedigree: Caught In A Web Of Politics →

Congress, Federal Pedigree

InBrief: CBO Estimates S. 959 Would Exceed Unfunded Mandate Threshold For Private Entities In At Least One Year

CBO LogoJust as they did just prior to the U.S. House of Representatives vote on H.R. 1919 “Safeguarding America’s Pharmaceuticals Act of 2013” (see “InBrief: CBO Estimates H.R. 1919 Would Exceed Unfunded Mandate Threshold For Private Entities“), the Congressional Budget Office (CBO) just published their estimates of the public and private costs to implement S. 959 “Pharmaceutical Quality, Security, and Accountability Act” relative to the Federal Unfunded Mandates Reform Act (UMRA), paving the way for a vote in the Senate. Continue reading InBrief: CBO Estimates S. 959 Would Exceed Unfunded Mandate Threshold For Private Entities In At Least One Year →

California Board of Pharmacy

Hey California Board of Pharmacy: Your Time Is Running Out!

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wicked witch hourglassImportant 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.The California Board of Pharmacy has begun to hold ePedigree-specific meetings with staff and a subset of the Board present.  The first of these occurred on Monday of this week.  The agenda was fairly long and promised action on a number of important topics, including the possibility that the Board would consider the use of EPCIS as a pedigree platform, inference, pedigree certifications and drop shipments.  I came away disappointed that the only thing that happened was a brief discussion of each topic but seemingly no real action.  It was almost as if the Board members and staff had made no progress on any of these topics since the March Enforcement Committee meeting.  All that seemed to happen since that meeting Continue reading Hey California Board of Pharmacy: Your Time Is Running Out! →

California Pedigree Law, Federal Pedigree

The California ePedigree Timeline Vs. The Senate Bill Timeline

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CA Vs S. 957 Timeline.ZoomImportant 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.The U.S. House of Representatives passed their H.R. 1919, Safeguarding America’s Pharmaceuticals Act a few weeks ago (see, “InBrief: The Pharma Track & Trace Bill Has Passed the U.S. House Of Representatives” and also don’t miss “An Industry Protection Bill Concealed Under The Veil Of Patient Protection”).  The Senate is next up with S. 957 Drug Supply Chain Security Act (or S. 959 depending on if they really did combine it with the compounding act as they passed it out of committee).

We still don’t know exactly when this bill will be debated or considered in a vote on the Senate floor but indications are that Continue reading The California ePedigree Timeline Vs. The Senate Bill Timeline →

California Pedigree Law

Falling Between The Cracks Of The California Pedigree Law

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Photo by Jose Mora
Photo by Jose Mora

Important 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.Most prescription pharmaceuticals distributed in California pass from manufacturer to pharmacy through wholesale distributors, but a small percentage are sold by the manufacturer directly to doctors and clinics.  An even smaller percentage are sold through small companies licensed as kit manufacturers or distributors to dental offices, fire departments, ambulance companies and other carriers of emergency medical kits.  These transactions are just as open to the introduction of illegitimate products as the larger transactions that we normally think of when we talk about the use of drug pedigrees, but because they are outside of the ordinary, they are at risk of falling between the cracks.  That is, they might be a lot more complex, or not even possible, under the California pedigree law. Continue reading Falling Between The Cracks Of The California Pedigree Law →

Congress, Federal Pedigree

InBrief: CBO Estimates H.R. 1919 Would Exceed Unfunded Mandate Threshold For Private Entities

WASHINGTON - JANUARY 26: The Congressional Budget Office made copies of its Budget and Economic Outlook for FY 2010 to 2020 available to reporters and the public January 26, 2010 in Washington, DC. The CBO's latest estimates see a $1.35 trillion deficit for the current budget year, dropping to $980 billion next year only if a host of tax cuts enacted under President George W. Bush are allowed to expire at the end of the year. (Photo by Chip Somodevilla/Getty Images)Just one business day before the U.S. House of Representatives is scheduled to vote on H.R. 1919, Safeguarding America’s Pharmaceuticals Act of 2013, the Congressional Budget Office (CBO) published their estimates for the public and private costs to implement it relative to the Federal Unfunded Mandates Reform Act (UMRA).

CBO has determined that the costs to State, local, and tribal governments would be “…small and below the intergovernmental threshold established by UMRA…”.  However, they also estimate that the costs to private entities “…would exceed the threshold established in UMRA ($150 million in 2013, adjusted annually for inflation)”.

Interestingly, the CBO used Continue reading InBrief: CBO Estimates H.R. 1919 Would Exceed Unfunded Mandate Threshold For Private Entities →

Congress, Federal Pedigree

The Federal Lot-Based Pedigree Before Congress

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SANYO DIGITAL CAMERAImportant 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.The current drafts of the nationwide pharmaceutical track and trace (Pedigree) bills on the floors of the U.S. Senate and House of Representatives both include an initial lot-based pedigree requirement that may be based on paper or electronic documentation (see “The Politics Of Federal Track & Trace Legislation”).  What is a lot-based pedigree and how is it different from one based on package-level serial numbers?  Let’s take a closer look at the kind of system that these bills would require.  Keep in mind that the Senate bill would mandate this kind of pedigree system for the next 10 years and the House bill would make it permanent.

First of all, according to both bills, pharma manufacturers would be required to Continue reading The Federal Lot-Based Pedigree Before Congress →