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

ANVISA logoOn 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

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?

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 see 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?

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?