All posts by Dirk Rodgers

Dirk is the founder of RxTrace where he writes regularly on the intersection between the pharmaceutical supply chain, track and trace technology, standards and regulatory compliance. He has written hundreds of essays on those specific topics. A logical thinker, Dirk is skilled at making complex technical topics understandable to non-technical readers and listeners. An Electrical and Computer Engineer by education, Dirk has worked as a consultant, software architect and automation engineer during a career spanning 30 years. Overall, Dirk's thought leadership has helped to expose hidden complexities and reveal surprising consequences and implications of drug serialization and pedigree laws around the world. Dirk is the author of "The Drug Supply Chain Security Act Explained". View Dirk's LinkedIn Profile Follow Dirk on Twitter

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 →

Congress, Federal Pedigree

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

July 18, 2013 Dirk Rodgers

Just 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 →

Conferences

Fall Conference Season Preview

July 15, 2013 Dirk Rodgers

I am a fan of attending conferences because, in addition to hearing thought-provoking presentations by knowledgeable speakers, you get to connect with the other attendees to learn what they are doing and thinking. That’s why it is so important to select the right conferences. Your goal should be to find the conferences that attract the best attendees so that you have the opportunity to make new connections and get updates from your existing ones. Of course, the speakers Continue reading Fall Conference Season Preview →

serialization

Will Generic Drug Manufacturers Serialize Their Drugs In Time?

July 9, 2013 Dirk Rodgers 2 Comments

The one thing all pharmaceutical manufacturers can count on, regardless of whether or not the U.S. Congress passes a new track and trace regulation in this or future sessions, is that unit-level serialization will be a necessity on drug packages sold into the U.S. market within the next few years. We have all been paying close attention to the draft legislation that has been moving through the two houses of Congress for several months now, but there is no doubt that unit-level serialization will be required whether something passes at the federal level or not. The only questions are, exactly which year will it be required and what else will be required?

We know that Continue reading Will Generic Drug Manufacturers Serialize Their Drugs In Time? →

RxTrace

Four Years Of RxTrace

July 1, 2013 Dirk Rodgers 9 Comments

This week marks the four year anniversary of RxTrace. The first essay, published on July 4, 2009, said it all, “Welcome to rxTrace“. And almost four years later I found myself yelling at the California Board of Pharmacy with my most recent essay, “Hey California Board of Pharmacy: Your Time Is Running Out!“. In between there have been 177 other essays of varying topics and varying quality. Thanks for sticking with me.

Readership has grown significantly over the last 1 1/2 years. I don’t make readership numbers public because they probably aren’t as big as one might imagine, but the growth has been incredible. RxTrace readers are people who are looking for information about pharma and medical device regulations and the technology solutions necessary to meet them. I call it, “a comprehensive exploration of the intersection between the pharmaceutical (and medical devices) supply chains, track & trace technology, standards and regulatory compliance”. That about sums it up, I think.

Here is a graph of Continue reading Four Years Of RxTrace →

California Board of Pharmacy

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

June 26, 2013 Dirk Rodgers 2 Comments

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

June 24, 2013 Dirk Rodgers 1 Comment

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 →

…a comprehensive exploration of the intersection between healthcare supply chains, track and trace technology, standards and global regulatory compliance