- FDA Postpones Enforcement of DSCSA Transaction Data Exchange Until May 1
- Anatomy Of The National Drug Code
- DSCSA Exception Handling: A Preview of Your Next Surprise Headache
- Is An ASN Really The Best Way to Pass Lot-Based DSCSA Transaction Data?
- The Coming Battle Over Decommissioning At The Pharmacy
- DSCSA "Serial Numbers"
- Interoperability And The DSCSA
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.
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 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.
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.
The first website I visit on Monday mornings is RxTrace
I rely heavily on RxTrace to understand what is changing with the DSCSA, the latest with the FDA and the industry in general.
RxTrace is informative and well-written. It’s my ‘go to’ source for information on serialization and DSCSA.
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.
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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Dirk A. Rodgers
March 9, 2015 (4:29)
DSCSA "Serial Numbers"Stephen, The DSCSA mandates serial numbers on Rx product only, and I do not t...
March 9, 2015 (4:18)
DSCSA "Serial Numbers"Will these DSCSA "Serial Numbers" be applied to OTC products as well as Rx?
Dirk A. Rodgers
February 27, 2015 (10:11)
Is An ASN Really The Best Way to Pass Lot-Based DSCSA Transaction Data?Marsha, Thanks for providing us with your company's real-world experience wit...
Dirk A. Rodgers
February 27, 2015 (10:02)
When Will The DSCSA Ever Require Investments In Aggregation?Sunil, Thanks for commenting. I share your concern about how the industry gr...
Marsha Flores Harris
February 26, 2015 (10:08)
Is An ASN Really The Best Way to Pass Lot-Based DSCSA Transaction Data?Dirk - Thanks for the discussion. What I've found from our customers, parti...