- Anatomy Of The National Drug Code
- Just Released - The HDMA EDI ASN Guidance For DSCSA
- Will The FDA Delay The DSCSA?
- Global Traceability Data Exchange: Troubled Waters Ahead
- Pharma Serialization: Going Totally Global Soon
- Will The DSCSA Cause Drug Shortages After January 1?
- Should You Off-Load Your DSCSA Obligations To Your Contract Partners?
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 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.
Easy to understand summary and discussion of complex current topics.
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.
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.
RxTrace is my go-to source for information surrounding the implementation and implications of the Drug Quality and Security Act.
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.
RxTrace offers unique context and focus on our industry.
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.
Rx Trace is an excellent source of timely industry insight that take complex topics and makes them easier to digest and understand
The first website I visit on Monday mornings is RxTrace
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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December 5, 2014 (6:00)
Will The DSCSA Cause Drug Shortages After January 1?I wonder how a manufacturer could develop a single data exchange system for a...
December 1, 2014 (8:37)
The Coming Transition To Serialized DataVERY good and constructive analysis. In a timely manner, once more.... Thx......
November 26, 2014 (11:02)
The DSCSA, the NDC, Inventory Management, GS1 GTINs...and TurkeysGreat news! Obama was looking for a legacy. HR 3204 can be it!
November 17, 2014 (3:30)
Will The DSCSA Cause Drug Shortages After January 1?Dirk, You have stated well the conundrum that Wholesaler Distributors face i...
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....