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

Federal Pedigree

U.S. Senate Passes H.R. 3204 With A Voice Vote

November 18, 2013 Dirk Rodgers 2 Comments

The U.S. Senate has passed H.R. 3204, the Drug Quality and Security Act (DQSA) with a voice vote, sending the important legislation to the desk of President Barack Obama. The President is expected to sign it happily. In an email to members, John M. Gray, President and CEO of the Healthcare Distribution Management Association (HDMA) stated:

“Today the U.S. Senate passed the Drug Quality and Security Act (H.R. 3204). We expect it will be quickly signed into law by the President. This is the culmination of nearly 10 years of effort by HDMA members to preempt all state laws relating to drug pedigrees and track-and-trace systems, to further enhance the security and safety of our nation’s drug supply chain. Since 2004, HDMA has Continue reading U.S. Senate Passes H.R. 3204 With A Voice Vote →

All Eyes On The U.S. Senate Tonight

November 18, 2013 Dirk Rodgers 2 Comments

U.S. Capitol building, Senate wing. The flag above the wing indicates that the Senate is in session. Photo by Dirk. Click to enlarge.

The effort to enact a nationwide pharmaceutical serialization law that would preempt all state laws has been going on for four or five years now, and this evening could be the culmination of all of those efforts. The U.S. Senate calendar for today makes the passage of H.R. 3204, the Drug Quality and Security Act a top priority. It finally looks like it is going to happen.

The official Senate calendar for today includes the following as the first order of business:

“ CALENDAR OF BUSINESS

Monday, November 18, 2013

SENATE CONVENES AT 2:00 P.M.

PENDING BUSINESS

H.R. 3204 (ORDER NO. 236)

An act to amend the Federal Food, Drug, and Cosmetic Act with respect to human drug compounding and drug supply chain security, and for other purposes. Continue reading All Eyes On The U.S. Senate Tonight →

exemptions

Drug-Device Combo Products Under State And Federal Pedigree Laws

November 11, 2013 Dirk Rodgers

Metered dose inhaler drug-device combination product

Both the California ePedigree law and the potential federal pedigree law that currently exists within the womb that is H.R. 3204 contain an exemption for drug-device combination products. This is an expanding category of products so this exemption is worthy of a closer look.

The drug-device combo product exemption language included in the California Business and Professions Code, 4034(g)(9), is almost identical to the language in H.R. 3204, 581(24)(B)(xii). There is a reason for that. They are both based on part of the FDA’s definition for a drug-device combination product, found in 21 CFR 3.2 (e). Continue reading Drug-Device Combo Products Under State And Federal Pedigree Laws →

Federal Pedigree

The Flaw That Must Be Addressed in H.R. 3204, The Drug Quality and Security Act

November 4, 2013 Dirk Rodgers 5 Comments

Rumors abound that the Drug Quality and Security Act (DQSA), H.R. 3204 will be debated and voted on in the Senate any day now (see “Waiting For The Senate To Act On A Track & Trace Bill, Again”). It already passed the House of Representatives back in September and the text is a compromise between the bill managers in both the House and the Senate, so everyone expects it to pass and be signed into law by President Obama. No one (except maybe some folks who don’t like the compounding part) wants to see its progress slowed, but there is a problem with the track and trace part that must be addressed before it is adopted or its implementation will quickly run into difficulties. Continue reading The Flaw That Must Be Addressed in H.R. 3204, The Drug Quality and Security Act →

California Pedigree Law

How Smooth Will Industry Deployment of the ePedigree Laws Be? Take a Good Look At Healthcare.gov

October 28, 2013 Dirk Rodgers 1 Comment

When either the California ePedigree law or the federal law go into full effect, how smooth will that rollout be? While there are big differences between those implementations and the deployment of Healthcare.gov, the U.S. federal government’s new health insurance exchange website that is part of the Patient Protection and Healthcare Affordable Care Act (often referred to as the ACA, or “Obamacare”), I think the troubles it is experiencing may be an example of how the ePedigree system will work on initial rollout. That’s right, I’m predicting a nightmare, especially if it’s the California law that rolls out. Continue reading How Smooth Will Industry Deployment of the ePedigree Laws Be? Take a Good Look At Healthcare.gov →

FDA

InBrief: Comments on H.R. 3204 by FDA’s Dr. Ilisa Bernstein at PSM Interchange 13

October 25, 2013 Dirk Rodgers 1 Comment

Dr. Ilisa Bernstein, Pharm.D, JD, Deputy Director of the U.S. FDA Office of Compliance in the Center for Drug Evaluation and Research (CDER), delivered the keynote address at yesterday’s Partnership for Safe Medicines (PSM) Interchange 2013 event (see “Dr Ilisa Bernstein of FDA CDER Office of Compliance To Keynote PSM Interchange”).

Her presentation covered the full range of activities that the FDA is currently pursuing to improve the security of the U.S. pharmaceutical supply chain, including their efforts to implement the new powers they were given by Congress in last year’s FDA Safety and Innovation Act (FDASIA). Continue reading InBrief: Comments on H.R. 3204 by FDA’s Dr. Ilisa Bernstein at PSM Interchange 13 →

serialization

Eli Lilly: “Serialization Needs Standardization”

October 21, 2013 Dirk Rodgers 3 Comments

Last month, Eli Lilly posted a video about their serialization initiative on YouTube. It features Grant Lindman, Manager of Lilly’s Global Anti-Counterfeiting Operations, and David Colombo, Commercial Implementation Leader of Lilly’s Global Serialization Program talking about their global serialization program. It is worth a listen. Continue reading Eli Lilly: “Serialization Needs Standardization” →

Partnership For Safe Medicines

Dr Ilisa Bernstein of FDA CDER Office of Compliance To Keynote PSM Interchange

October 16, 2013 Dirk Rodgers

The Partnership for Safe Medicines (PSM) announced recently that Ilisa Bernstein, Pharm.D, JD, Deputy Director of the U.S. FDA Office of Compliance in the Center for Drug Evaluation and Research (CDER), will be the keynote speaker at their annual Interchange event next Thursday, October 24, 2013 at the Newseum in Washington DC. RxTrace is a media partner for the event again this year and I plan to attend.

According to the PSM website:

“The annual Interchange brings together policymakers, pharmaceutical manufacturers, patient advocates, law enforcement, healthcare professionals, and anti-counterfeiting companies to discuss the problem and solutions to the global scourge of pharmaceutical counterfeiting.”

Dr. Bernstein Continue reading Dr Ilisa Bernstein of FDA CDER Office of Compliance To Keynote PSM Interchange →

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