FDA Delays UDI and FSMA: What About DSCSA?

June 7, 2017 Dirk Rodgers

Image of November 27, 2017 calendar A few weeks ago I predicted that the FDA would soon announce a delay in enforcement of the Drug Supply Chain Security Act (DSCSA) November 27, 2017 deadline for serialization of drug packages (see “FDA Tea Leaves: Are They About To Delay The November Deadline?”, see also “Breaking: FDA Official Offers Advice In Absence Of DSCSA Waiver Guidance”). As I said, I don’t have any “inside information”, I’m just looking at the evidence that we can all see. I provided links to the public information I used for evidence so you can decide for yourself. Don’t just take my word for it. It is entirely speculation.

Now there is new evidence that the FDA is in a “delay” mood these days. In the last 4 business days the FDA has Continue reading FDA Delays UDI and FSMA: What About DSCSA? →

GS1 U.S.

New Must-Read DSCSA Resource

June 5, 2017 Dirk Rodgers

Last week, GS1 US published a free DSCSA resource that every RxTrace reader must have. It’s called “Frequently Asked Questions (FAQs) by the Pharmaceutical Industry in Preparing for the U.S. DSCSA” and it can be downloaded free after registration. Do it now, then come back and finish reading this essay.

The document is 42 pages in PDF form and it Continue reading New Must-Read DSCSA Resource →

ANVISA

Brazil Publishes RDC-157 To Regulate 2017 3-Lot Pilot

May 22, 2017 Dirk Rodgers

ANVISA logo On May 11, 2017, ANVISA formally published RDC-157/2017 that will serve as the regulations for their 3-Lot Pilot that is to take place in 2017. We’ve been expecting this new RDC around this time because they were required by the recent Law Number 13.410 of December 28, 2016 (see “Brazil Gets Rational With Their New Pharma Traceability Law”). ANVISA also held a “public consultation” to allow the public to review and comment on an earlier draft of what is now RDC-157/2016 (see “ANVISA Reveals Draft Serialization Regulation and Asks For Comments”). The newly adopted RDC-157 is clearly intended to guide the pilot and then ANVISA intends to update it as part of their analysis of the pilot results. They will likely go through another public consultation before they make it a final regulation that all companies will need to follow. Bottom line, if you are not part of the 3-Lot Pilot, don’t start implementing a solution until Continue reading Brazil Publishes RDC-157 To Regulate 2017 3-Lot Pilot →

Thank You!

Thank You Peggy Staver!

May 15, 2017 Dirk Rodgers 7 Comments

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! →

DSCSA

Breaking: FDA Official Offers Advice In Absence Of DSCSA Waiver Guidance

May 10, 2017 Dirk Rodgers

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 →

Deadlines, DSCSA

FDA Tea Leaves: Are They About To Delay The November Deadline?

May 8, 2017 Dirk Rodgers

Drawing of tea leaves to be read — Can you read these?

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? →

Labels

Is Your Drug Too Small For The Mandated 2D Barcode?

May 1, 2017 Dirk Rodgers

Is your Drug Too Small? Sample vial and syringe with barcode attached. — As an experiment, I taped the smallest DSCSA-compliant 2D barcode I could define to these sample vial and syringe from CCL Label. Notice that neither sample includes the required human readable text of the data encoded in the barcode, which means that these examples may not comply in some markets. The barcode on the vial is readable, but the one on the syringe is not readable because of the short radius of the barrel (about 5mm).

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? →

DSCSA

Will Manufacturers Have Trouble Verifying Some Drugs Next Year?

April 24, 2017 Dirk Rodgers

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? →

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