- Anatomy Of The National Drug Code
- Will The FDA Delay The DSCSA?
- Pharma Serialization: Going Totally Global Soon
- Just Released - The HDMA EDI ASN Guidance For DSCSA
- DSCSA: Special Privileges For The "Big-3" Wholesale Distributors, Part 1
- 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”
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.
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.
Rx Trace is an excellent source of timely industry insight that take complex topics and makes them easier to digest and understand
RxTrace offers unique context and focus on our industry.
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.
RxTrace is informative and well-written. It’s my ‘go to’ source for information on serialization and DSCSA.
The first website I visit on Monday mornings is RxTrace
Easy to understand summary and discussion of complex current topics.
Look forward to RxTrace News-helps me to better manage key issues
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
Counterfeiting as a Form of Free Advertising - Harvard Business Review lnkd.in/bs9Bptv
FDA Announces Major Agency Reorganization, With Focus on Drug Quality | RAPS lnkd.in/b24wN28
Dirk A. Rodgers
October 24, 2014 (10:30)
The New Draft Guidance On The Effect of Section 585 of the FD&C Imposed By The DSCSARyan, No, I don't agree that wholesale distributors and 3PLs should be expect...
October 24, 2014 (9:35)
The New Draft Guidance On The Effect of Section 585 of the FD&C Imposed By The DSCSANot directly tied, but related. Many of the wholesalers and third party provi...
October 18, 2014 (4:37)
Will GS1's EPCIS Be Used Widely For DSCSA Data Exchange?Thanks Dirk, great outlook. My humble vision is that EPCIS is gaining moment...
September 23, 2014 (6:19)
Is Your Drug Exempt From The Federal Drug Supply Chain Security Act? RevisitedThanks, Dirk. Take it from someone who has lived and (almost) died with Flor...
Dirk A. Rodgers
September 23, 2014 (2:34)
Is Your Drug Exempt From The Federal Drug Supply Chain Security Act? RevisitedRobert, Thanks. I agree that the DSCSA clearly only applies to finished dosa...