Category Archives: DSCSA

DSCSA

Does Interoperability Change In 2023?

There are many terms specifically defined within the Drug Supply Chain Security Act (DSCSA) text (see “Don’t Skip The DQSA Definition of Terms Section”).  One of the words you should expect to be defined there is “interoperability”, because it plays such a big role in the system(s) that must be used by everyone in the supply chain after November 27, 2023.  That is, the “…interoperable, electronic tracing of product at the package level…” that is at the core of the Enhanced Drug Distribution Security (EDDS) phase that is defined in Section 582(g).  But surprisingly, the term is not defined in the text.

In fact, it appears to be left up to Continue reading Does Interoperability Change In 2023? →

DSCSA

DSCSA: The U.S. Pharma Supply Chain Must Organize, Or Risk Failure, Again

iStock_000021010135XSmallA couple of days before President Obama signed the DQSA legislation back in 2013 I published an RxTrace essay that looked at what was going to be necessary in the next year from the FDA and the industry (see “DQSA: The U.S. Pharma Supply Chain Must Organize, Or Risk Failure“).  The initial standards necessary at that time were for data exchange, and the FDA had one year to come up with them.  My essay was about the need for the industry to work with the FDA to come up with the standards that would work.  The FDA didn’t have the expertise or the knowledge of how the supply chain operated and so I felt it was imperative for the industry to help them out.

Fast forward to today.  Rather than data exchange standards, the FDA is facing Continue reading DSCSA: The U.S. Pharma Supply Chain Must Organize, Or Risk Failure, Again →

DSCSA

FDA DSCSA Public Meeting #1 Exposes Gulf In Goals

The FDA held the first of three scheduled DSCSA public meetings last week.  This one focused on:

  • The vision for 2023; and,
  • The enhanced drug distribution security (EDDS) needs related to tracing prescription drugs at the package level.

The meeting started off with short presentations by representatives from:

In the short time they were each given, these speakers Continue reading FDA DSCSA Public Meeting #1 Exposes Gulf In Goals →

DSCSA

Identifying Trading Partners Under the DSCSA

The FDA published a new draft guidance yesterday with explanations intended to dispel various kinds of confusion over the five kinds of trading partners defined in the Drug Supply Chain Security Act (DSCSA) text.  They are clearly on a roll, with the combination of the recent draft compliance policy, pilot and public meeting announcements, and now this draft guidance exceeding all of the DSCSA-specific communications they produced last year.  We’ll know for sure that the logjam has been cleared when we finally see one of the four mandated guidance documents that were originally due on November 27, 2015 (see “Who Is Being Harmed By Four Overdue FDA DSCSA Guidances?“).  But what about this new one? Continue reading Identifying Trading Partners Under the DSCSA →

DSCSA

DSCSA Verification and Suspect Product

Last week I wrote about the debate over the number of possible responses to verification requests in any potential solution the industry might adopt to meet the Drug Supply Chain Security Act (DSCSA) (see “DSCSA Red Light Green Light: Verification Responses”).  Today I want to take a closer look at a related issue:  the relationship between verification and suspect product.  Most specifically, does a failed verification automatically force a product into the suspect product category?  The answer might surprise you. Continue reading DSCSA Verification and Suspect Product →

DSCSA

DSCSA Red Light Green Light: Verification Responses

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Yellow stoplight
Even a stoplight has three lights

There is an important debate going on over the last 9 months regarding exactly how many different answers companies should prepare to provide in response to a DSCSA verification request.  Some say two:  “Red light” or “Green light”.  And others say three:  “Yes”, “No”, or “It’s Complicated”.  This might seem like a minor question, but people on each side are surprisingly passionate about their positions.  Let me explain. Continue reading DSCSA Red Light Green Light: Verification Responses →

DSCSA

DSCSA Serialization Delay Eclipses Grandfathering

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On August 21st, large portions of the United States and other places will experience a total eclipse of the sun by the moon.  On November 27th, the serialization and verification delay of the Drug Supply Chain Security Act (DSCSA) contained within the FDA’s recent draft compliance policy (see “FDA Delays Enforcement of DSCSA November Deadline: What It Means”) will eclipse the grandfathering guidance that hasn’t even been published yet.  In fact, the overdue grandfathering guidance should be easy for the FDA to write now (see “Who Is Being Harmed By Four Overdue FDA DSCSA Guidances?”).  Grandfathering probably just won’t exist.  Here’s why. Continue reading DSCSA Serialization Delay Eclipses Grandfathering →

DSCSA

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? →