Happy DSCSA Day Manufacturers & Repackagers!
DSCSA Interoperable Requirements Now in Effect for Manufacturers and Repackagers
The final broad DSCSA (Drug Supply Chain Security Act) exemption for manufacturers and repackagers of applicable U.S. prescription drugs has officially ended—marking a major milestone in pharmaceutical supply chain security and patient safety. Congratulations to all our clients, peers, and friends who have worked hard to make this date happen! We hope that this spirit of collaboration and innovation will carry over and equip the next date of readiness for wholesale distributors on August 27, 2025.
What does this mean for manufacturers and repackagers? The following Enhanced Drug Distribution Security (Sec. 582(g)) requirements are now included with all other requirements. ALL requirements are in effect and enforceable.
Transaction Information (TI) and Transaction Statement (TS) must be exchanged electronically and securely at the package level, using interoperable systems.
TI must include the Product Identifier (PI) on each package (NDC (GTIN), serial number, lot, and expiration date), enabling product tracing, and verification when required.
Manufacturers and repackagers must have systems to verify products at the package level and promptly respond to State or Federal agents with TI and TS upon request for a recall or investigating a suspect or illegitimate product.
Saleable returns can only be accepted if they can be associated with the TI and TS, ensuring authenticity and traceability.
What are all the DSCSA Compliance Requirements as a Manufacturer or Repackager?
While a comprehensive analysis is necessary to outline all requirements, we have created a framework that allows for a quick overview of these requirements. Developing, conducting, and documenting training for all systems, processes, policies, and procedures is essential for ensuring and maintaining compliance, as illustrated below.
How Can Manufacturers/Repackagers Ensure They Are Fully Compliant?
Ten Count is proud to be a leader in offering flexible DSCSA compliance assessment and readiness services. We offer services ranging from guided checklists to comprehensive on-site mock audits to assess your organization’s DSCSA compliance.. We are always glad to offer a free consultation to discuss your journey, challenges, and understand how we might be able to serve your organization.
Email us at: info@tencountconsulting.com
For further thoughts on readiness, check out our past news threads and some of these past articles.
Ten Count-Is My Organization Ready for the End of the FDA Stabilization Period?
Ten Count- Our Ten Count: PDG-FDA Town Hall Takeaways
