InBrief: ‘The Smallest Package Or Immediate Container’ In California

August 14, 2013 Dirk Rodgers 4 Comments

Drawing from the GS1 Healthcare GTIN Allocation Rules document showing how to assign GTINs in multi-pack scenarios. Click image to enlarge.

The California pedigree law requires manufacturers to serialize the smallest package of drugs that will be bought by a dispenser. For some manufacturers targeting the U.S. market, that may require serialization and e-pedigree at a lower unit of measure than they might have thought. For products that manufacturers package into multi-packs and sell to wholesalers packaged only that way, you might assume that your “smallest package or immediate container” is the multi-pack. Think again.

Continue reading InBrief: ‘The Smallest Package Or Immediate Container’ In California →

Vendor Managed Inventory Under California ePedigree

August 12, 2013 Dirk Rodgers 9 Comments

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 →

Uncategorized

InBrief: Estimated Rise in Serialized Drugs in The U.S. Supply Chain, 2013

August 7, 2013 Dirk Rodgers 1 Comment

In August 2010 I started an annual estimate of the rise in the percentage of drugs in the U.S. supply chain that will have serial numbers attached. Click here to read my first essay on the topic which explains the concept. Click here to read my 2011 essay and click here to read my 2012 essay. These are not estimates of the actual percentage today. Rather, it is a prediction of the rise from an immeasurably small percentage in early 2010 to 100% at some time in the future. My plan was to Continue reading InBrief: Estimated Rise in Serialized Drugs in The U.S. Supply Chain, 2013 →

Congress, Federal Pedigree

Federal Pedigree: Caught In A Web Of Politics

August 5, 2013 Dirk Rodgers 1 Comment

Seventeen 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

Senators Propose Amendments To S. 959

July 29, 2013 Dirk Rodgers

As many of you pointed out to me in private emails last Friday after I had claimed that things had been quiet, there had indeed been some significant activity on S. 959, “Pharmaceutical Quality, Security, and Accountability Act” (PQSA) that occurred last week. Even though the bill was awaiting action on the Senate floor, the bill managers in the Senate are apparently able to pull it back and amend it, and that’s what they did. The bill is a combination of the “Pharmaceutical Compounding Quality and Accountability Act” and the “Drug Supply Chain Security Act” and my interest is in the latter so I will limit my analysis to that part of the current bill.

The amendments are fairly light and sprinkled throughout. Most have little to no affect on the meaning or implementation of the bill–these include reformatting, corrections and minor logical adjustments–but there are a few things that are notable. Continue reading Senators Propose Amendments To S. 959 →

Congress, Federal Pedigree

Still Waiting For The Senate

July 26, 2013 Dirk Rodgers

A number of RxTrace subscribers asked me to provide an update on the current state of the federal pedigree legislation since things have been so quiet lately. As you may recall, the U.S. House of Representatives passed their H.R. 1919, “Safeguarding America’s Pharmaceuticals Act” about six weeks ago (see “InBrief: The Pharma Track & Trace Bill Has Passed the U.S. House Of Representatives“). The Senate Health Education Labor and Pensions Committee sent their S. 959 “Pharmaceutical Compounding Quality and Accountability Act” to the Senate floor two months ago (see. “InBrief: A Track & Trace bill Has Made It To The Senate Floor“).

So currently we are waiting for Continue reading Still Waiting For The Senate →

Summer Writing

Summer Writing: Steve Jobs, Bill Gates and Me

July 22, 2013 Dirk Rodgers

Portrait of American businessman and engineer Steve Jobs, co-founder of Apple Computer Inc, at the first West Coast Computer Faire, where the Apple II computer was debuted, in Brooks Hall, San Francisco, California, April 16th or 17th, 1977. (Photo by Tom Munnecke/Getty Images) — Three guys born in 1955

In his excellent 2008 book “Outliers: The Story of Success”, Malcolm Gladwell examined why the year 1955 seemed to spawn so many of the founders of the personal computer industry, including Steve Jobs, Bill Gates and others. In a nutshell, it is because being born in that year increased the odds that a person would be at a certain point in their lives in the month of January 1975. That was the month in which a critical event occurred that most people believe was the trigger for the personal computer revolution: The Continue reading Summer Writing: Steve Jobs, Bill Gates and Me →