- Anatomy Of The National Drug Code
- FDA Postpones Enforcement of DSCSA Transaction Data Exchange Until May 1
- DSCSA: Transaction Statement
- Just Released - The HDMA EDI ASN Guidance For DSCSA
- Will The FDA Delay The DSCSA?
- Will The DSCSA Cause Drug Shortages After January 1?
- Global Traceability Data Exchange: Troubled Waters Ahead
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 spearheaded industry efforts to preempt multiple and conflicting state laws related to pedigree and the traceability of drugs. …”
See the related press release here.
I also expect President Obama to sign the bill into law. As I said in my essay earlier today (see “All Eyes On The U.S. Senate Tonight”), I will begin work on adding a banner to the top of all obsolete RxTrace essays and I will begin writing about the implications of the new prospective law. Clients of Dirk Rodgers Consulting, LLC are welcome to contact me to schedule conference calls to discuss the implications to your projects and your businesses going forward. All projects should be re-evaluated in light of this major action.
2 Responses to “U.S. Senate Passes H.R. 3204 With A Voice Vote”
The first website I visit on Monday mornings is RxTrace
Easy to understand summary and discussion of complex current topics.
Been following RxTrace ever since some of the very first postings, and it’s one of my absolutely best sources of serious and thorough analyses, on an otherwise very delicate and complicated topic. Dirk’s writings and articles comes highly recommended, and I’m always looking forward to the next posting. Many thanks from Denmark for sharing your thoughts with us all.
RxTrace is informative and well-written. It’s my ‘go to’ source for information on serialization and DSCSA.
ROC IT Solutions uses RxTrace to help keep abreast with the industry view(s) on the DQSA legislation and how companies are dealing with meeting the mandates. The views and insights are valuable to our assessment of how our product roadmap reacts to best serve our clients.
Government and industry between them have made the issues surrounding traceablity and pedigree of medicines confused and fluid – RxTrace is my first choice when I want to untangle the history of these issues and to understand new developments.
Rx Trace is an excellent source of timely industry insight that take complex topics and makes them easier to digest and understand
RxTrace is the most informative and most current source for information on tracking pharma using AIDC. Their integration of information on UDI is also rather unique. RxTrace serves the pharma stakeholders as the pharma business model evolves to include services enabled by AIDC.
The knowledge presented in RxTrace, not simply the more common focus of the manufacturing, packaging, and regulatory requirements, but Dirk’s wholesale experience provides him with a complex view on the impacts to the end-to-end supply chain.
RxTrace distills the complexities of pharmaceutical supply chain issues to simple concepts and also accurately projects issues on the horizon that industry leaders and legislators should heed.
Dirk is an independent consultant and founder of RxTrace. He has contributed to many of the industry groups that have been formed over the last 10 years to investigate solutions to the problem of counterfeit and other illegitimate drugs in the legitimate supply chain. He served as co-chair of a number of key technical work groups in GS1 and GS1 US. These include the original GS1 EPCglobal Drug Pedigree Messaging work group that created the DPMS pedigree standard, the Network Centric ePedigree (NCeP) work group and the RFID Barcode Interoperability Guideline work group. Dirk holds a BS in Electrical and Computer Engineering from the University of Wisconsin-Madison.
View the Dirk Rodgers Consulting, LLC website
View Dirk's LinkedIn Profile
Follow Dirk on Twitter
The Pharmaceutical Traceability Forum offers best practices and strategies for a 2015 secure serialization program bit.ly/1wjsiDl
Preparing yr serialization program for coming deadlines? Join the Pharmaceutical Traceability Forum for info you need www.rxtrace.com/2015/01/pharma…
Make sure your products will be accepted throughout the supply chain with the upcoming compliance deadlines www.rxtrace.com/2015/01/pharma…
Dirk A. Rodgers
January 22, 2015 (12:16)
The Coming Battle Over Decommissioning At The PharmacyRyan, Thanks for your comment. The points you have raised with your question...
January 22, 2015 (11:11)
The Coming Battle Over Decommissioning At The PharmacyBy large distribution companies, I presume you mean ABC, Cardinal, and McKess...
January 12, 2015 (3:18)
The Coming Battle Over Decommissioning At The PharmacyIf the death certificate is issued at receiving at the pharmacy, IMO, that wo...
December 31, 2014 (5:50)
A Closer Look At Web Portals for DSCSA Transaction Data ExchangeI wonder who will be reconciling TI/TH with what physically showed up? My gue...
Dirk A. Rodgers
December 29, 2014 (10:20)
A Closer Look At Web Portals for DSCSA Transaction Data ExchangeBoris, That's a good question. My current thinking is that companies offerin...