- Anatomy Of The National Drug Code
- Will The FDA Delay The DSCSA?
- Just Released - The HDMA EDI ASN Guidance For DSCSA
- Pharma Serialization: Going Totally Global Soon
- Should You Off-Load Your DSCSA Obligations To Your Contract Partners?
- The Case Against RFID In Pharma
- DSCSA: Special Privileges For The “Big-3″ Wholesale Distributors, Part 2
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”
RxTrace offers unique context and focus on our industry.
Easy to understand summary and discussion of complex current topics.
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.
I rely heavily on RxTrace to understand what is changing with the DSCSA, the latest with the FDA and the industry in general.
Rx Trace is an excellent source of timely industry insight that take complex topics and makes them easier to digest and understand
The information provided is up-to-date and provides a pragmatic presentation and discussion of the pertinent issues as they unfold. It is an excellent and comprehensive summary.
RxTrace is my go-to source for information surrounding the implementation and implications of the Drug Quality and Security Act.
Look forward to RxTrace News-helps me to better manage key issues
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.
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.
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.
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November 1, 2014 (9:15)
The GS1 Healthcare US Guidance For DSCSA, Vsn 1.1The US law requires a verification based process when suspect product occurs....
Dirk A. Rodgers
October 31, 2014 (4:40)
The New Draft Guidance On The Effect of Section 585 of the FD&C Imposed By The DSCSARyan, It will be interesting to see if the FDA takes the view you propose. I...
October 31, 2014 (3:57)
The New Draft Guidance On The Effect of Section 585 of the FD&C Imposed By The DSCSAAgree on all parts there. I would agree that there is a requirement on temper...
Dirk A. Rodgers
October 30, 2014 (9:17)
Should You Off-Load Your DSCSA Obligations To Your Contract Partners?Julie, No, I don't think it really needs a specific template. I suggest you ...
October 30, 2014 (5:52)
Should You Off-Load Your DSCSA Obligations To Your Contract Partners?Question - in earlier articles you referenced that after a determination is m...