Today, Peggy Staver will officially retire from Pfizer, after a career of 35 years. Those of us who have worked on figuring out how to implement anti-counterfeiting solutions that work in the U.S. pharma supply chain over the last 15 years or so will miss her friendly, inquisitive and steady voice very much. Continue reading Thank You Peggy Staver!
Yearly Archives: 2017
Breaking: FDA Official Offers Advice In Absence Of DSCSA Waiver Guidance
FDA official, Connie Jung PhD, Senior Advisor for Policy, spoke at the International Society of Pharmaceutical Engineering (ISPE) Serialization Workshops event yesterday to provide background on the Drug Supply Chain Security Act (DSCSA). I used the opportunity to ask her a number of questions regarding some of the things I based my prediction in Monday’s essay that the FDA will announce a delay in the DSCSA in the next three weeks (see “FDA Tea Leaves: Are They About To Delay The November Deadline?”). The timing was perfect, and when I registered for the event, I didn’t even know the FDA was on the agenda.
Here’s the backstory. Continue reading Breaking: FDA Official Offers Advice In Absence Of DSCSA Waiver Guidance
FDA Tea Leaves: Are They About To Delay The November Deadline?
I don’t have any hard evidence, but there are some interesting things out there that just might point to a coming delay in the Drug Supply Chain Security Act (DSCSA) November 27, 2017 deadline for drug manufacturer serialization and electronic transaction data exchange. Let’s call them “tea leaves”, and let me attempt to “read” them. They might turn out to be meaningless, so don’t take any action based on such speculation. And if you know something more, or interpret something differently, leave a message.
During the Cold War the U.S. government and the press attempted to figure out what was going on in the Soviet Union by paying attention to who was standing next to whom during military parades. Our exercise might seem a little like that. Continue reading FDA Tea Leaves: Are They About To Delay The November Deadline?
Is Your Drug Too Small For The Mandated 2D Barcode?
RxTrace readers are already well aware that multiple new laws around the world will require prescription drug manufacturers to put a new 2D barcode on their products in the next few years. But what if your drug package is too small to fit the new mandated 2D barcode and human readable information on the label? Let’s take a look at what the regulations say in the E.U., Brazil and the United States. From that, we can come up with some strategies. Continue reading Is Your Drug Too Small For The Mandated 2D Barcode?
Will Manufacturers Have Trouble Verifying Some Drugs Next Year?
I recently wrote about several letters sent to the FDA by the Pharmaceutical Distribution Security Alliance (PDSA) regarding the overdue guidance documents (see “In Absence Of FDA Guidance, Follow PDSA Recommendations”). I highly recommend that you read those letters. But there was one letter from the PDSA to the FDA that I did not reference in that essay because it is not related to missing guidance. Instead, it’s about PDSA’s fear about the potential inability of some manufacturers to verify, in the DSCSA sense, certain drugs between now and November of 2019. To be exact, the type of verification they are worried about is the kind that will be based on a drug’s Standardized Numerical Identifier (SNI). Continue reading Will Manufacturers Have Trouble Verifying Some Drugs Next Year?
InBrief: Why The DSCSA Will Be Enforced Even Without FDA Guidance
As you are already well aware, the FDA is long overdue to publish four different guidance documents covering various aspects of the Drug Supply Chain Security Act (DSCSA), as mandated by Congress (see “Who Is Being Harmed By Four Overdue FDA DSCSA Guidances?”). At least two of those guidance documents would affect how companies should expect to comply with the serialization deadline on November 27, 2017.
If the FDA doesn’t publish on or before that date, does that mean you don’t need to comply on time? Can you just sit back and wait for the FDA to post those guidance documents someday? I don’t think so. Here’s why. Continue reading InBrief: Why The DSCSA Will Be Enforced Even Without FDA Guidance
In Absence Of FDA Guidance, Follow PDSA Recommendations
The Pharmaceutical Distribution Security Alliance (PDSA) is a coalition of companies and organizations dedicated to the safety and integrity of the U.S. pharmaceutical supply chain. When the Drug Supply Chain Security Act (DSCSA) went into effect on November 27, 2013 the PDSA began to serve as a voice for its members in communications with the U.S. FDA. Their preferred way of communication is through formal letters signed by their legal advisor, Vince Ventimiglia. PDSA letters to the FDA are really interesting because they do an excellent job of providing recommendations for the FDA to consider as they prepared to publish the four guidance documents that were due back on November 27, 2015. The FDA has still not published those documents. Continue reading In Absence Of FDA Guidance, Follow PDSA Recommendations
Ken Traub (1963 – 2017)
Like all of you, I was incredibly shocked and sad to hear that my friend and occasional collaborator Ken Traub passed away on Sunday. My heart and prayers go out to his wife and son. Ken will be remembered for a long time by people all over the world because of the depth of his technical knowledge, the clarity of his writing, the impact of his succinct speaking, the creativity of his thinking, the passion he had for solving complex problems, and the love in his heart.
According to Brezniak-Rodman Funeral Directors, the memorial service will be held at Temple Isaiah, 55 Lincoln Rd., Lexington, on Wednesday, April 5, 2017 at 11:00 am. Memorial contributions may be made to any cancer charity.
I’ve known Ken for a few Continue reading Ken Traub (1963 – 2017)
