Now that the final interoperability requirements of the DSCSA (Drug Supply Chain Security Act) are in effect, the focus shifts to ensuring your organization is taking advantage of the FDA-announced stabilization period through November 27^th, 2024.   We would like to share our learnings from the past 10 years helping clients achieve full compliance in all sectors of the supply chain from manufacturer, to repackager, to distributor, to dispenser, to 3PL organizations.  We have also conducted orientation training and provided support for service firms of all types from business consulting, to law firms, to software solution providers and regulatory agencies.  All of these experiences have led us to develop a tiered DSCSA assessment offering that incorporates a broader understanding of the law and related guidance than others can offer.  We considered system, process, operational, regulatory, quality, federal and state factors as we developed and updated our flexible offering.  

We have developed what we consider to be the 4 main pillars to understanding and complying with DSCSA.  

1.      Obtaining or Establishing Ownership- This includes all activities related to preparing for and receiving title of DSCSA applicable product.  Some key activities in this pillar include: ensuring the authorization of trading partners, establishing foundational business data, ensuring receipt of required transactional data, and handling exceptions.

2.      Providing Ownership-  Similar to the tasks in the previous pillar but in a downstream fashion, this includes activities related to sharing title of DSCSA product.  Rather than focusing on suppliers of product, the focus is on establishing connections, sharing data, checking authorization and handling exceptions of customers and others receiving title from your organization.

3.      Handling Product- For any organization physically handling product prior to dispensing, this pilar is critical for ensuring compliant movement of product. It is important to note that this pillar may apply, even if your organization is not obtaining ownership but does have associates handling product.  Some key activities in this area include: monitoring for suspicious product, fully dispositioning suspect or illegitimate product, quarantine with investigations, and FDA 3911 filing.

4.      Communication- There are several important requirements for all roles outlined in DSCSA related to communication both internally and externally.  These include ensuring all stakeholders are informed and prepared to act in a timely manner when any DSCSA-related event occurs.  

We help clients review and ensure coverage for all requirements for the DSCSA roles within which they are performing business activities.  We also help clients ensure they are external audit-ready through well-established procedures, policies and training.  Understanding these pillars of DSCSA is a starting point for beginning the journey of full compliance.  For each pillar and all related requirements, it is important to understand that alignment with not only standards but with general practices of your peers and partners is critical.  Many organizations have learned the painful financial, scope and timing lessons related to taking actions that do not align with practices being done across the industry.

We humbly suggest your organization consider one of our fixed-price DSCSA assessments at any phase of your journey to ensure you are on the right path to compliance and ready as state and federal regulators move from stabilization to full enforcement including applicable fines and penalties.  

It is important to remember, DSCSA provides significant power to federal and state agents to secure the US supply chain.  We encourage your organization to avoid being among the unfortunate stakeholders who will learn through enforcement as we move beyond 2024.

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Take a Free Next Step:

We enjoy connecting and discussing how our assessment tools or project management offerings may be able to expedite your compliance journey.

Follow this link to schedule a meeting to discuss your DSCSA needs or email us at info@tencountconsulting.com

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