Announcing The 2014 RxTrace U.S. Pharma Traceability Survey

December 3, 2013 Dirk Rodgers

With the enactment of the Drug Supply Chain Security Act of 2013 (DSCSA) last week (see “It’s Official, President Obama Signs H.R. 3204, DQSA, Into Law“) I have decided to conduct an annual survey of U.S. pharma traceability preparedness. You can fill out the survey by clicking on this link: Take the 2014 RxTrace U.S. Pharma Traceability Survey Now.

The answers you provide anonymously will be aggregated to provide a view of the thinking of the industry, solution providers, regulators, academics and more, in addition to a view of the preparedness of the industry to meet the new federal pharmaceutical traceability law. Please make sure your company is represented in the data that is collected. The survey is Continue reading Announcing The 2014 RxTrace U.S. Pharma Traceability Survey →

Florida Pedigree

Preemption: What Does It Mean?

December 2, 2013 Dirk Rodgers 3 Comments

On November 27, 2013 President Barack Obama signed the Drug Quality and Security Act of 2013 (DQSA) into law (see “It’s Official, President Obama Signs H.R. 3204, DQSA, Into Law“). That act has many provisions, but one is to preempt all existing and future state pharmaceutical serialization and pedigree laws like those that previously existed in California and Florida. Because of the preemption language contained within the DQSA, the information contained within many previous RxTrace essays is now obsolete. Some essays are entirely obsolete and some are only partially obsolete. This is because many of these essays contain ideas and discussion about topics that will also apply to the new federal law in almost the same way that they applied to the California and/or other state laws that are now inoperative. In those cases, the ideas and discussion are not obsolete, only their application to the state law(s) is now obsolete.

To address this issue I have Continue reading Preemption: What Does It Mean? →

DQSA of 2013

It’s Official, President Obama Signs H.R. 3204, DQSA, Into Law

November 27, 2013 Dirk Rodgers 1 Comment

p101813ps-0012.1_0 — This is a stock photo of the President from the White House website, not the actual signing of H.R. 3204.

According to the White House website, President Barack Obama signed H.R. 3204, the Drug Quality and Security Act (DQSA), into law a short time ago, bringing to a successful conclusion efforts by the industry and consumer groups to create a national pharmaceutical serialization and track & trace regulation that eliminates the patchwork of state laws in addition to new regulations for compounding pharmacies.

Many people and organizations contributed to this successful effort and they all deserve congratulations, but I believe the organizations with the most responsibility for this conclusion is the California State legislature and the California Board of Pharmacy in Continue reading It’s Official, President Obama Signs H.R. 3204, DQSA, Into Law →

DQSA of 2013

DQSA: The U.S. Pharma Supply Chain Must Organize, Or Risk Failure

November 25, 2013 Dirk Rodgers 4 Comments

If there is one overriding lesson exposed by my essays last week it is that the companies in the U.S. pharmaceutical supply chain must quickly organize to work out technology and process issues that stand in the way of an efficient implementation of phase 1 of Title II of the Drug Quality and Security Act of 2013 (see “DQSA: Getting To Electronic Transaction Data Exchange” and “DQSA: Will U.S. Pharma Distributors Mandate Aggregation Data In Phase 1?”). Title II of the DQSA is the Drug Supply Chain Security Act (DSCSA).

The law gives the FDA one year to publish guidance containing standards for use by companies in the supply chain for the exchange of Continue reading DQSA: The U.S. Pharma Supply Chain Must Organize, Or Risk Failure →

DQSA of 2013

DQSA: Will U.S. Pharma Distributors Mandate Aggregation Data In Phase 1?

November 22, 2013 Dirk Rodgers 13 Comments

I attended the Healthcare Distribution Management Association (HDMA) Track and Trace Seminar held in Crystal City, VA on November 11-13, 2013. I was particularly interested in the session called “Distributor Case Studies and Updates”, as were a lot of other people. The speakers were:

Chris J. Anderson, Director, Quality Systems, Cardinal Health, Inc.
Steve Tadevich, Director, Product Serialization Technologies, McKesson Corporation
Heather Zenk, PharmD, Vice President, Business Integration, AmerisourceBergen Corporation

Each speaker gave a brief presentation about their current serialization and pedigree programs before taking questions as a panel. As you would expect, all of the preparation these companies have done up to this point has been aimed squarely at the California pedigree law which would have gone into effect for wholesalers in California in mid-2016. But, Continue reading DQSA: Will U.S. Pharma Distributors Mandate Aggregation Data In Phase 1? →

DQSA of 2013

DQSA: Getting To Electronic Transaction Data Exchange

November 21, 2013 Dirk Rodgers 6 Comments

While we wait for President Obama to sign the Drug Quality and Security Act of 2013 (DQSA, a.k.a. H.R. 3204) we can be confident it will become law in the next week or so. This President has been presented with over 740 bills so far in his Presidency and he has signed all but two. He has 10 days to sign the bill or it becomes law anyway but there might be some delay in the process between passage by the Senate and when the President is presented with the bill.

My interest in the DQSA of 2013 is only the Drug Supply Chain Security Act (DSCS) which is Title II within the overall bill. I’m going to keep referring to it as the DQSA of 2013 but be aware that I probably won’t ever write about the compounding part, Title I. If that is what brought you here, sorry, look elsewhere.

It is not law yet, but we can now be 100% sure it will be very soon. Even before the bill was Continue reading DQSA: Getting To Electronic Transaction Data Exchange →

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 →

Federal Pedigree

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 →

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