Tag Archives: H.R. 3204

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: 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? →

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 →

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 →

California Pedigree Law, Federal Pedigree

California, Congress and The Choices We Are Forced To Face

October 7, 2013 Dirk Rodgers 11 Comments

Another week has gone by with no official movement in the Senate on the compromise pharmaceutical compounding and track & trace bill, H.R. 3204, the Drug Quality and Security Act (DQSA) (see “Waiting For The Senate To Act On A Track & Trace Bill, Again”). With the focus of the Congress rightly on reopening the government I think we should expect to wait a little longer. You can bet that the supporters and the opposition are both developing their strategy as time goes by.

I attended the GS1 Global Healthcare Conference in San Francisco last week and it was a great opportunity to reconnect with a lot of people I have worked with over the years on defining workable standards for healthcare supply chain data exchange. Some of us are Continue reading California, Congress and The Choices We Are Forced To Face →

RxTrace