Tag Archives: free

DSCSA

FDA DSCSA Public Meeting #3: A Difference?

Last Wednesday the FDA held the third in a series of three Drug Supply Chain Security Act (DSCSA) public meetings (see “FDA Announces New DSCSA Pilot Program and Public Meeting Series”).  I noticed a few important differences at this meeting compared with the two previous meetings (see “FDA DSCSA Public Meeting #1 Exposes Gulf In Goals”, and “FDA DSCSA Public Meeting #2, Still A Gulf”).

Overall, these differences indicate that the FDA may be beginning to recognize how much ground they and the industry must cover between now and November of 2023, and it appears that has led them to get a little more rational.  One meeting is not enough to establish a change in pattern, but if it eventually proves true, then this meeting would be the beginning of that change.  A big injection of rationality is what happened in Brazil back in late 2016 (see “Brazil Gets Rational With Their New Pharma Traceability Law”) and that seems to have put them on a course for success.  Could something similar be happening here? Continue reading FDA DSCSA Public Meeting #3: A Difference? →

EU FMD

The Most Head-Scratching Section Of The FMD

I found this sealed OTC product in my own closet. Note the round clear adhesive seal between the four yellow arrows. Would this anti-tamper seal render this product illegal in the EU after next February?

Just after I posted my last FMD essay on RxTrace (see “FMD, One Year Out”) I found out that the European Commission had published version 9 of their “Safety Features for Medicinal Products for Human Use, Questions and Answers”.  This is must reading for anyone with questions about how to interpret the most confusing provisions of the Falsified Medicines Directive (FMD) (also known as EU Directive 2011/62 and which amends Directive 2001/83) and the Delegated Regulation (EUDR) (also known as EU Regulation No 2016/161) (see “The E.C. Officially Published The Pharma Safety Feature Delegated Act This Morning“).

With each major revision this Q&A document grows.  This time it grew substantially with the addition of 21 new questions and answers and updates to four previously posted answers.

But there is one provision of the FMD that defies explanation, even though the Q&A document burns two Q&As to attempt it.  That provision in the FMD is Section 1 of Article 45a, which basically says, in part, that you cannot put an anti-tamper device on non-prescription drugs unless the EC or a Member State specifically says you can.  What’s going on here? Continue reading The Most Head-Scratching Section Of The FMD →

UDI

Sponsored: Unique Device Identification Questions Answered Here

If you have anything to do with Unique Device Identification (UDI) in your company and you’ve never been to one of the UDI Conferences put on by the Clarion Group, then you don’t know what you are missing. Those who have been to one know that these are the best possible events to attend for UDI.

Why? Easy. I’ve never been to a conference where the experts from the regulatory body itself—the FDA in this case—dominate the speaker list as they do here. If you have Continue reading Sponsored: Unique Device Identification Questions Answered Here →

Anti-counterfeiting, Brand Protection, DSCSA

Sponsored: Dispenser Perspectives On The DSCSA: An IQPC Interview

Many RxTrace readers have a fairly good understanding of the perspective of drug manufacturers and wholesale distributors regarding the Drug Supply Chain Security Act (DSCSA) and its implementation, but dispenser perspectives are not so well understood.  Enter IQPC who interviewed Brian Files, Principal Consultant with Healthcare Strategies Consulting Group and former Director, Inventory and Compliance with CVS Health, one of the largest chain pharmacies in the US, to find out his perspectives on the DSCSA.

Continue reading Sponsored: Dispenser Perspectives On The DSCSA: An IQPC Interview →

DSCSA

Wholesalers Find Troubling Results In DSCSA Barcode Assessment

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Last month GS1 US published the results of an assessment of the implementation progress by drug manufacturers of the Drug Supply Chain Security Act (DSCSA) serialization requirements.  It contains troubling indications of the next problem the industry will face in its quest for DSCSA compliance:  too many unusable barcodes.

Big deal, you say?  That kind of complacency could come back to haunt you later this year.  Now is the time to look at your own packages and address any deficiencies.  Here is a look at what GS1 US found in their assessment. Continue reading Wholesalers Find Troubling Results In DSCSA Barcode Assessment →

Anti-counterfeiting, Brand Protection

Sponsored: Anti-counterfeiting Successes and Failures Around the World

Governments around the world recognize the problem that the World Health Organization (WHO) once called Substandard/Spurious/ Falsely-labelled/Falsified/ Counterfeit medical products, or SSFFC, but more recently calls Substandard and Falsified medical products.  These governments recognize the problem, and their citizens suffer from it, but some of them don’t seem to know what to do about it.  Nigeria, Kenya and other countries in Africa have been very assertive in attacking the problems, but other poorer countries without strong central governments can’t afford or don’t have the will necessary to take strong action.

Rich countries impose serialization and tracing requirements, but that only helps to keep the legitimate supply chain clean.  Many countries Continue reading Sponsored: Anti-counterfeiting Successes and Failures Around the World →

DSCSA, FDA

2018: The Year of FDA DSCSA Public Meetings

Happy New Year, 2018 is here!  Last year, the FDA announced a series of three Drug Supply Chain Security Act (DSCSA) Public Meetings (see “FDA Announces New DSCSA Pilot Program and Public Meeting Series”).  So far they have held two (see “FDA DSCSA Public Meeting #1 Exposes Gulf In Goals” and “FDA DSCSA Public Meeting #2, Still A Gulf”).  One more is left in that series, to be held on February 28, 2018. Continue reading 2018: The Year of FDA DSCSA Public Meetings →

DSCSA

A US Medicines Verification Organization (USMVO)? Again

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If you’re like me, you are doing at least some work this week.  I usually do some work work during this quiet time when I am not interrupted.  It’s usually things I need to do to wrap up the year, but also includes planning for the new year.  In case you are working this week but you need a little diversion, here is something to think about for 2018.

It has become increasingly clear that what the US pharma supply chain needs is for some organization to step up and take responsibility for the decisions and actions that are needed to ensure successful development and operation of the Enhanced Drug Distribution Security phase of the Drug Supply Chain Security Act (DSCSA).  There are less than six years before that phase is supposed to begin.  But with no one clearly specified as the organization responsible, odds are, it isn’t going to happen.  This was the topic I covered two months ago when I originally published “A US Medicines Verification Organization (USMVO)?”.  With the end of the year and the holidays coming up, I’ve been too busy to write a new essay this week, so take another look at this idea. Continue reading A US Medicines Verification Organization (USMVO)? Again →