Tag Archives: free

Sponsored: Extracting Value Beyond Compliance From Serialization

Companies are spending hundreds of millions of dollars, euros, rupees and rubles getting ready to comply with serialization regulatory mandates around the world.  Deadlines are fast approaching in the US and the EU and they are already passed in India, South Korea, Argentina and Turkey.  What companies are looking for next is how to extract some value beyond just complying with government mandates.  Just about every solution provider offering serialization components and solutions out there has at least one product or service that is aimed squarely at this type of need.  What we need to do is get these people together:  those who are looking, and those who have the solutions.

Cognizant, a management consulting company, has written a very nice 11-page white paper exploring value beyond compliance. Continue reading Sponsored: Extracting Value Beyond Compliance From Serialization

DSCSA: OIG Report Exposes Likely Enforcement Approach

Last week the US Department of Health and Human Services (HHS) Office of Inspector General (OIG) published their second report on the experience of selected members of the pharma supply chain with the exchange of drug product tracing information as required by the DSCSA.  This one was aimed at dispensers.  The one published last fall was aimed at wholesale distributors.  As you know, starting in January 1, 2015 (delayed until May 1, 2015), pharmaceutical wholesale distributors have been required to pass to their customers for non-exempt prescription drug shipments, and retain for six years, transaction documents (TI, TH and TS).  Since July 1, 2015 (delayed until March 1, 2016), dispensers have been required to receive and store these Continue reading DSCSA: OIG Report Exposes Likely Enforcement Approach

Sponsored: Newly Updated Global Serialization Regulation Map

I just helped IQPC update their printable global pharma serialization regulation map.  Get a copy here.  Things change around the world pretty often so it’s important to update resources like this frequently.  The information for most of the existing countries was updated and I added a few new countries.  It’s a great resource to print and pin up on your office wall, or the company bulletin board to keep everyone focused on the approaching deadlines around the world.  And it looks great too! Continue reading Sponsored: Newly Updated Global Serialization Regulation Map

Sponsored: Interview With Four Pharma Supply Chain Thought Leaders

The IQPC PharmaTrace Summit will be held on June 4-6 in Princeton, NJ.  In preparation for the event, IQPC asked four industry veterans to respond to a set of forward-looking questions to get a glimpse of the future of serialization and track & trace in the US pharma supply chain.  The four include: Continue reading Sponsored: Interview With Four Pharma Supply Chain Thought Leaders

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?

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

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

Wholesalers Find Troubling Results In DSCSA Barcode Assessment

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