Tag Archives: FDA

The Partnership for DSCSA Governance Is Up and Running

Early rejected Logo for the PDG

The most exciting thing happening lately with the Drug Supply Chain Security Act (DSCSA) is the setting up of a new non-profit organization aimed at coordinating the development of “…a comprehensive shared vision for interoperable drug tracing...” so all companies can comply in 2023 and beyond (See “PDSA’s Proposal for Governance of DSCSA Phase II Interoperability” and “PDSA Brainstorms Vision For DSCSA Governance Organization With Stakeholders“).  The Pharmaceutical Distribution Security Alliance (PDSA) initiated the development of that new organization last year and we now have its name:  The Partnership for DSCSA Governance, Inc., or PDG.  I am told their website will be set up in the next few weeks, so until then, I have posted several of their public documents for RxTrace readers.  Let’s take a look at them.

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DSCSA: Industry Moves Forward

Some members of the US pharmaceutical supply chain are not waiting for the FDA to make the next move (see “DSCSA: Will 2020 Be FDA’s Year To Leap Forward?”).  Instead, they are proactively organizing and setting the standards that will most likely be used to meet the requirements of the Enhanced Drug Distribution Security (EDDS) phase of the Drug Supply Chain Security Act (DSCSA), which goes into effect on November 27, 2023.  Forward motion has been made over the last month on two fronts:  The DSCSA governance organization and the Verification Router Service (VRS).

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DSCSA: Will 2020 Be FDA’s Year To Leap Forward?

When it comes to the Drug Supply Chain Security Act (DSCSA), the FDA seems to alternate between hibernating, and leaping forward.  2017 through mid-2018 was a leap forward period with the publication of 8 draft or final guidance documents and 3 public meetings.  Then in 2019, hibernation.  Yes, FDA’s list of DSCSA guidance and policy documents has two entries for 2019 so far, but one is simply a notice reopening the comment period on the DSCSA Pilots request for information that was originally opened in 2016 and 2017.  The other is the compliance policy that provides one year of enforcement discretion for the 2019 wholesaler saleable returns requirement (see “No Surprise: DSCSA Verification Delay”).  Neither were very taxing on the FDA to prepare.  What should the FDA do next?  What should they be doing right now?

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Next Week’s HDA Traceability Seminar

Every year I look forward to the Healthcare Distribution Alliance (HDA) Traceability Seminar.  It’s the one event in the US that is attended by everyone connected with pharma serialization and traceability, including those from manufacturers, 3PLs, repackagers, wholesale distributors, dispensers and solution providers.  In that one time and place I can get answers to burning questions about what is going on in the industry and a sense for what people are thinking about a wide range of issues that appear here in RxTrace.  The sessions are helpful, but the real goldmine are the hallway conversations.  Of course, I’ve written about this before (see “2014 Fall Conference Season Preview” and “Terminology: Track and Trace, and Pedigree”).

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FDA Inaction On Fixing The NDC Indicates Why They Should Get Out Of The Numbering Business

It’s been eleven months since the FDA held their public hearing to collect ideas for fixing the National Drug Code (NDC) system (see “FDA Seeks Input On The Future Format of the National Drug Code” and “FDA New NDC Format Public Meeting”).  The FDA, themselves, estimated that they may have as little as 10 years before they run out of Labeler Codes, and that was over a year ago.  So now we have less than nine years?  My friends, it’s almost time to panic because the FDA seems to have dropped the ball after hearing from the industry that they would need at least ten years to prepare for any changes that the FDA may make (see “FDA New NDC Format Public Meeting”).

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GS1 US Publishes New DSCSA VRS Implementation Guide

Last week GS1 US announced that they have published a new implementation guideline to help companies in the US pharma supply chain make use of the new GS1 lightweight messaging standard for verification of product identifiers to meet the saleable returned drug verification requirement of the Drug Supply Chain Security Act (DSCSA).  The messaging standard itself was ratified by GS1 in January and it can be used to implement a wide range of product verification schemes in any industry.  The new GS1 US guideline is a valuable resource for companies wanting to apply that standard to the problem of verifying drugs that fall under the DSCSA, so it contains a wealth of information needed to ensure interoperability of Verification Router Service (VRS) solutions.

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DSCSA Schedule Assessment, July 2019

It’s time to assess the progress of the industry and the FDA in their quest toward the November 27, 2023 Drug Supply Chain Security Act (DSCSA) goal known as the Enhanced Drug Distribution (EDDS) phase…otherwise known as just ‘2023’ (see “EDDS: The New Data Exchange Requirements”).  Let’s step back and look at where we have come and where we need to go.

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Barcodes 45, RxTrace 10

The commercial use of barcodes began 45 years ago last week, and RxTrace began 10 years ago this week.  These are pretty incredible milestones and it is worth stepping back and thinking about what it all means.  GS1 issued a press release about the barcode’s 45th anniversary last week, providing links to several videos.  These include some old-timey videos of what grocery checkout was like before barcodes, and when the UPC barcode was first introduced in Troy, Ohio in 1973.  It made me feel old. 

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