Category 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Business man trying to stop the clockAs you have read, the FDA has let it slip, with a draft guidance document, that they have decided not to enforce the DSCSA’s November 27, 2017 deadline for manufacturers to apply the new serialized product identifier on drug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 →

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 →

Deadlines, DSCSA

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 seem a little like that. Continue reading FDA Tea Leaves: Are They About To Delay The November Deadline? →

DSCSA

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? →

DSCSA, FDA Guidance

InBrief: Why The DSCSA Will Be Enforced Even Without FDA Guidance

New Regulations comic
(click image to enlarge)

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 →