What Should FDA Pilot?

Last week the FDA announced it will coordinate one or more pilot(s) to assist in the development of the electronic, interoperable system that will identify and trace drugs in the U.S. under the Drug Supply Chain Security Act (DSCSA) in its Enhanced Drug Distribution Security (EDDS) phase starting in 2023.  Once they start work on pilot planning, they will call for proposals from stakeholders and others.  But they can’t start until they get permission from the Office of Management and Budget (OMB), and they won’t even ask OMB for permission until they collect comments on the proposed collection of information associated with establishing the pilot program.  Believe it or not, that was the Continue reading What Should FDA Pilot?

FDA Announces New DSCSA Pilot Program and Public Meeting Series

Yesterday the FDA published a preview of two announcements related to the Drug Supply Chain Security Act (DSCSA).  One was announcing a new pilot program, “…to assist in development of the electronic, interoperable system that will identify and trace certain prescription drugs as these are distributed within the United States.”  That is, the system that will comprise the “Enhanced Drug Distribution Security” (EDDS) system in 2023.  The other announcement was for a series of DSCSA public meetings—also intended to work on the system in 2023.  Both announcements include a docket for use by stakeholders and the public to submit written comments to the FDA. Continue reading FDA Announces New DSCSA Pilot Program and Public Meeting Series

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 and RxTrace: The Song Remains The Same

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

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 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

Two-For-One FDA Guidance Docs

Back in February I noted the steep drop in public inspection documents posted by the FDA immediately after President Trump took office (see “One Immediate Impact of President Trump On The FDA”).  For that essay I created a graph that clearly showed the steep drop.  But that was only one month after the new President took office.  What has happened since then?  This week I updated my graph so we can see how things are progressing.  Continue reading Two-For-One FDA Guidance Docs

Serial Number Bonding

There are some discontinuities between the needs of the industry for meeting serialization regulations around the world and certain GS1 standards, including their Electronic Product Code Information Services (EPCIS) and Core Business Vocabulary (CBV) standards.  I’ve already pointed out the issue of EPCIS expecting everyone who uses it to possess, by default, a GS1 Global Location Number (GLN) (see “GLN: The Lowly Identifier That Could Kill The Use Of EPCIS For Pharma Regulatory Compliance”).  Here is one more. Continue reading Serial Number Bonding