Recent news and more

With less than 240 days until the final and most challenging parts of the federal DSCSA law take effect, it is easy to see many are still not grasping the importance or level of effort required to ensure compliance. It can feel a bit like the scene in a comic when everyone is waiting for a superhero to swoop in an make things better. The reality is, a DSCSA superhero isn't coming, you need to make sure you organization has the tools and partners to save itself.

With the final months of that timeline winding down, we felt it was important to share a few updated thoughts. We realize there is a significant amount of DSCSA groups and events going and we welcome any comments or additional points that peers feel are important to highlight. We appreciate the work that the FDA and other regulatory groups do on a daily basis to help keep the supply chain and patients safe and hope help provide some insights as we work with clients across the supply chain on DSCSA implementation.

Don't forget the last critical stepin your journey to DSCSA compliance of ensuring that your organizationspolicies, procedures and training are updated appropriately to clearly documentyour compliance. The FDA increased mentions of DSCSA in warning letters andother activities in 2022 and we expect this to continue to increase as theimportant DSCSA requirement of November 27th, 2023 approach. State Boards ofPharmacies are now becoming more aware of the law and are expected toincorporate more aspects in their inspections and activities as well.

FDA to hold DSCSA Public Meetings Dec 7 & 8 2022

How do I know my company is "DSCSA 2023" ready?

Special Guest speaker Mark Karhoff of Ten Count Consulting will present at the LSPediA Customer Advisory Board Meeting June 28, 2022

For pharmacies (dispensers) storing and sharing your DSCSA related data as you prepare to ensure system and processes to comply with DSCSA 2023. It is important to remember that DSCSA is primarily an "ownership change" law and generally does not include the dispensing of medicine to patients. Here is an overview of considerations for storing and sharing DSCSA related transaction data.

With the interoperability requirements of DSCSA just around the corner on November 27,2023, continue to share thoughts for the diverse and dedicated pharmacists of the United States around this important federal law. A key part of DSCSA is ensuring your organization understands the Products and Barcoding is Key to Stopping Potentially Harmful Medicine

With the interoperability requirements of DSCSA just around the corner on November 27,2023, continue to share thoughts anr the diverse and dedicated pharmacists of the United States around this important federal law. A key part of DSCSA is ensuring your organization understands the term used throughout the law known as ATP (Authorized Trading Partners).

JnJ Joins Gilead in Filing Suit Against Distribution/Dispense of Counterfeit Product. These cases further highlight the importance of the ongoing industry work to define DSCSA 2023 requirements in a way that will more effectively protect patients. The US Rx Supply Chain is only as strong as it's weakest links and clearly more preventative and proactive approaches are needed.

In an effort to help share insights, we are starting this DSCSA 2023 for Pharmacist blog series to help provide areas you should be working on and understand why it is important your organziation.

T-minus 21 months until DSCSA Nov 27, 2023...... It's not an unreasonable reaction to feel the panic kick in as many big questions remain but there are already things that all this work is making clear, interoperability does not work without alignment and eventual adoption. This is very easily said but much work is involved in answering:‍What is the industry aligning on to enable a secure, electronic and interoperable manner?How fast minimally is "promptly" facilitating the gathering of information in the event of potentially harmful product?How does adoption happen across an incredibly diverse ecosystem of systems?‍

We appreciate advancing open dialogue on the use of unfolding technologies such as Blockchain. Here are some recent resources along with some past information we shared on the topic.

Several Industry Organizations Collaborate to Create a DSCSA Dispenser Resource Page

The Healthcare Distribution Alliance recently released their annual survey to share "the current readiness of manufacturers and distributors to meet the Drug Supply Chain Security Act (DSCSA) requirements." The survey contains useful insights on how the industry is doing in the path towards DSCSA2023 including the challenging interoperable requirements.

The FDA has announced a public meeting to allow stakeholders to provide further feedback on the Enhanced Drug Distribution Security provisions of DSCSA.

Are you ready for DSCSA Audits?5 Steps To Ensure The Answer Is "Yes"

With the overwhelming number of events and things happening in the US Rx Supply Chain, many manufacturers to Rx dispensers are asking if the time is now to rethink RFID?

Summary of FDA DSCSA 2023 Draft Guidance Comments These notes are provided for free use without copyright and meant to summarize the comments in the documents to the best of our ability but are not a complete representation of the documents and are not intended to be legal or business advice.

FDA CDER announces a planned webinar "Enhanced Drug Distribution Security in 2023 Under the DSCSA"

Ten Count Consulting announces new website to help US Rx Supply Chain clients stay informed.

Finding the Right Partners is Key to Making Beneficial Short and Long Term Decisions

What software do you need to be DSCSA compliant? With the fast approaching DSCSA 2023 requirments now 16 months away, many pharmacuetical stakeholders from manufacturers to dispensers are asking this question. DSCSA has been especially challenging to predict what is needed for the more complex requirements related to interoperability

What Is the True Impact of the FDA Proposed NDC Format Expansion? It is critical for the industry to fully understand the impacts of this proposed change. While cost in some areas may be less, this change impact is significantly wider than those caused by DSCSA due to the areas impacted from regulatory establishment of product through distribution/dispensing and into payment impacts.