Dr. Connie T. Jung, Acting Associate Director for Policy & Communications, Office of Drug Security, Integrity and Recalls, Office of Compliance, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, spoke last week at the 2014 Healthcare Distribution Management Association (HDMA) Traceability Seminar in Arlington, VA.
The presentation was similar to those given in the past except she provided an update on the progress of the next draft guidance the Agency is expected to publish on standards for data exchange (see “
DSCSA: Many Questions, Few Answers”). The deadline imposed on the FDA by the Drug Supply Chain Security Act (DSCSA) is November 27, 2014 for that draft, but during the FDA DSCSA Workshop last spring (see “ The 2014 FDA DSCSA Workshop”), Dr. Jung said that the Agency recognized the need to publish earlier than that. Last week she indicated that they will Continue reading Will The DSCSA Cause Drug Shortages After January 1?
The California Board of Pharmacy made it official late this afternoon. As required by Section 4034.1 of the California Business and Professions Code (CB&PC), the Board posted a public notice late yesterday indicating that sections 4034, 4163, 4163.1, 4163.2, 4163.4, and 4163.5 of the CB&PC became inoperative due to the enactment of the Federal Drug Quality and Security Act (DQSA) on November 27, 2013 (see “ It’s Official, President Obama Signs H.R. 3204, DQSA, Into Law“). These specific sections of the CB&PC comprise what has been referred to in the industry as “the California Pedigree Law”.
The public notice was mandated by California law within 90 days of federal preemption because
Continue reading The California Pedigree Law Is Now Officially Inoperative
This is a stock photo of the President from the White House website, not the actual signing of H.R. 3204.
the White House website, President Barack Obama signed H.R. 3204, the Drug Quality and Security Act (DQSA), into law a short time ago, bringing to a successful conclusion efforts by the industry and consumer groups to create a national pharmaceutical serialization and track & trace regulation that eliminates the patchwork of state laws in addition to new regulations for compounding pharmacies.
Many people and organizations contributed to this successful effort and they all deserve congratulations, but I believe the organizations with the most responsibility for this conclusion is the California State legislature and the California Board of Pharmacy in
Continue reading It’s Official, President Obama Signs H.R. 3204, DQSA, Into Law
Rumors abound that the Drug Quality and Security Act (DQSA), H.R. 3204 will be debated and voted on in the Senate any day now (see “ Waiting For The Senate To Act On A Track & Trace Bill, Again”). It already passed the House of Representatives back in September and the text is a compromise between the bill managers in both the House and the Senate, so everyone expects it to pass and be signed into law by President Obama. No one (except maybe some folks who don’t like the compounding part) wants to see its progress slowed, but there is a problem with the track and trace part that must be addressed before it is adopted or its implementation will quickly run into difficulties. Continue reading The Flaw That Must Be Addressed in H.R. 3204, The Drug Quality and Security Act
Another week has gone by with no official movement in the Senate on the compromise pharmaceutical compounding and track & trace bill, H.R. 3204, the Drug Quality and Security Act (DQSA) (see “ Waiting For The Senate To Act On A Track & Trace Bill, Again”). With the focus of the Congress rightly on reopening the government I think we should expect to wait a little longer. You can bet that the supporters and the opposition are both developing their strategy as time goes by.
I attended the
GS1 Global Healthcare Conference in San Francisco last week and it was a great opportunity to reconnect with a lot of people I have worked with over the years on defining workable standards for healthcare supply chain data exchange. Some of us are Continue reading California, Congress and The Choices We Are Forced To Face
The U.S. House of Representatives made quick work of the new bipartisan, bicameral compounding and track & trace bill draft that was circulated only last Wednesday evening (see “ InBrief: Important New Bicameral Draft Of A Pharma Supply Chain Security Bill”). They interrupted their debate over defunding “ObamaCare”, the Patient Protection and Affordable Care Act (PPACA), for a quick voice vote on the newly numbered H.R. 3204, Drug Quality and Security Act (DQSA) and it passed ( see the draft bill here).
So now we are waiting for the Senate to take action, just as we have for the last 3 months since the House of Representatives voted to pass their earlier bill with drug supply chain track & trace provisions, H.R. 1919, Safeguarding America’s Pharmaceuticals Act, back in June (see “
InBrief: The Pharma Track & Trace Bill Has Passed the U.S. House Of Representatives“ and “ Still Waiting For The Senate”). The Senate had their own Continue reading Waiting For The Senate To Act On A Track & Trace Bill, Again
I just arrived in California a couple hours ago to attend the next California Board of Pharmacy ePedigree Committee meeting later this morning. I was expecting to check into my hotel and go to bed, but as soon as I turned my phone back on I received multiple notices that a new bipartisan, bicameral draft of a pharma supply chain security bill was being circulated for review and comment. The email from the Senate HELP Committee was timestamped at 9:54pm EDT on Wednesday and they want people to comment on it by noon on Thursday. Wow. I still hope to get some sleep tonight, but I wanted to Continue reading InBrief: Important New Bicameral Draft Of A Pharma Supply Chain Security Bill
Late last Friday the California Board of Pharmacy published a proposed regulation for pharmaceutical drop shipments under their ePedigree law that is scheduled to go into effect in 2015 through 2017. See the text of the proposed regulation for “Electronic Pedigree Requirements for Drop Shipments” here, the notice of its proposed action here, and their “Initial Statement of Reasons” here. The Board is now seeking public comments on the proposed text through October 28, 2013.
The Board had asked for public input into the operation of drop shipments in the past to assist it with drawing up the regulation, which was mandated by
Continue reading InBrief: California Proposes Breakthrough ePedigree Regulation On Drop Shipments