Tag Archives: DSCSA

DSCSA

DSCSA Cascading Delays

Last week I covered the likely impact of the recent draft compliance policy currently under a 60-day public comment period (see “DSCSA and RxTrace: The Song Remains The Same“).  This week, I will take a look at its likely impact on downstream trading partners, including repackagers, wholesale distributors and dispensers.

Under the Drug Supply Chain Security Act (DSCSA), these organizations have specific obligations to only engage in transactions with product that has the DSCSA-mandated product identifier (serial number) on it (see “The DSCSA Product Identifier On Drug Packages“).  And when investigating suspect product or receiving saleable returns, they must Continue reading DSCSA Cascading Delays →

DSCSA, RxTrace

DSCSA and RxTrace: The Song Remains The Same

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Led Zeppelin: The Song Remains The Same album coverDrug manufacturers facing the November 27, 2017 deadline for applying unique identifiers to their products should take care when interpreting the FDA’s recent draft compliance policy.  All the headlines scream (including last week’s RxTrace essay:  “FDA Delays Enforcement of DSCSA November Deadline: What It Means”) that the Drug Supply Chain Security Act (DSCSA) serialization deadline is delayed, but there are important nuances to the delay.  Don’t just read the headlines, read the whole articles.  Officially, the deadline remains the same.  Yes, the FDA will look the other way for some drugs, but for others, the deadline still appears to apply.  How do you know if your drugs are those where the deadline still applies?  Read on. Continue reading DSCSA and RxTrace: The Song Remains The Same →

Deadlines, DSCSA

FDA Delays Enforcement of DSCSA November Deadline: What It Means

Business man trying to stop the clockAs you have read, the FDA has let it slip, with a draft guidance document, that they have decided not to enforce the DSCSA’s November 27, 2017 deadline for manufacturers to apply the new serialized product identifier on drug packages and verification requirements for one year, but it also contains cascading enforcement delays (see “FDA Tea Leaves: Are They About To Delay The November Deadline?”).  This is a major move by the FDA and it will have important consequences for the industry.  Let’s break it down. Continue reading FDA Delays Enforcement of DSCSA November Deadline: What It Means →

Blockchain, DSCSA

Blockchain Reigns At GS1 Connect 2017

Maybe I’m just hyper sensitive to all things blockchain right now, but it sure seemed like the topic of blockchain permeated the sessions and the halls at last week’s GS1 Connect conference, GS1 US’s annual membership event.  Oddly, all of the official blockchain content was outside the Healthcare track.  The technology is certainly applicable in all industries and apparently there is interest in it outside of the healthcare vertical within GS1 US.  But what I observed there leads me to think we are very close to an important tipping point. Continue reading Blockchain Reigns At GS1 Connect 2017 →

Deadlines

FDA Delays UDI and FSMA: What About DSCSA?

Image of November 27, 2017 calendarA 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

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

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 →

DSCSA

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 →