Kala Shankle, JD, HDA’s vice president of regulatory affairs, shares that as DSCSA traceability requirements take full effect, distributors and trading partners are preparing for long-term gains in supply chain security, recall efficiency, and counterfeit prevention.
Kala Shankle, JD, HDA’s vice president of regulatory affairs, describes how FDA officials are signaling a balanced enforcement approach when it comes to DSCSA enforcement, expecting compliance efforts and documentation, but also recognizing that perfection will take time.
Kala Shankle, JD, HDA’s vice president of regulatory affairs, details that after a year of steady progress, manufacturers and distributors report over 97% data accuracy under DSCSA traceability requirements, marking a major milestone in supply chain interoperability and signaling confidence ahead of the November compliance deadline.
Kala Shankle, JD, HDA’s vice president of regulatory affairs, describes how at this year’s seminar, attendees emphasized pragmatic approaches to achieving full compliance while anticipating upcoming FDA rules that could reshape wholesale and 3PL licensure standards across the pharma supply chain.
Ullrich Mayeski, community engagement director of health with GS1 US, emphasizes the critical need to address interoperability challenges at the dispenser level, ranging from small independent pharmacies to large hospital systems.
Ullrich Mayeski, community engagement director of health with GS1 US, outlines how manufacturers, distributors, and dispensers can strengthen end-to-end traceability.
Ullrich Mayeski, community engagement director of health with GS1 US, describes the organization’s EPCIS standard for meeting DSCSA requirements while underscoring that true supply chain success depends on robust data quality practices, clear procedures, and cross-team accountability to ensure patients receive their medications without disruption.
Industry leaders—from manufacturers, distributors, and dispensers—reported increased preparedness for compliance, with discussions shifting toward exception management, governance, and enforcement readiness, note Ullrich Mayeski of GS1 US and Mark Karhoff of Ten Count Consulting.
In the final part of her interview with Pharma Commerce Editor Nicholas Saraceno, Elizabeth A. Gallenagh, General Counsel and Senior Vice President, Supply Chain Integrity, Healthcare Distribution Alliance, discusses the WEE request process itself, while also providing her thoughts on other sessions that have garnered her attention.
In an interview with Pharma Commerce Editor Nicholas Saraceno, Elizabeth A. Gallenagh, General Counsel and Senior Vice President, Supply Chain Integrity, Healthcare Distribution Alliance, highlights the hard-hitting points that she anticipated will be covered during her session at the 2024 HDA Traceability Seminar.
In the final part of her interview with Pharma Commerce Editor Nicholas Saraceno, Ilisa B.G. Bernstein, President of Bernstein Rx Solutions, LLC, comments on industry’s preparedness for DSCSA compliance and provides an update as to where pharma is in terms of RFID label adoption.
In the second part of her interview with Pharma Commerce Editor Nicholas Saraceno, Ilisa B.G. Bernstein, President of Bernstein Rx Solutions, LLC, discusses the best practices that compliance teams should consider as the end of the stabilization period approaches this November.
In an interview with Pharma Commerce Editor Nicholas Saraceno, Ilisa B.G. Bernstein, President of Bernstein Rx Solutions, LLC, highlights the hard-hitting points that she anticipated will be covered during her session at the 2024 HDA Traceability Seminar.
Panel offers suggestions on how compliance teams should be considering handling SOPs, stabilization, and much more.
In an interview with Pharma Commerce Editor Nicholas Saraceno, Jeb Hunter, Senior Regulatory Consultant, EAS Consulting Group, discusses the on “What to Expect When They’re Inspecting: FDA Inspections on DSCSA Compliance" breakout session at the 2024 HDA Traceability Seminar.
Session uncovers distributors’ experiences with the Waiver, Exception, or Exemption request process, and how these affect the overall supply chain.
The agency provides an update surrounding the Act’s implementation efforts.
Pharma Commerce provides a synopsis of the presentation.
Stakeholders uncover the obstacles surrounding the industry onboarding process.
Attendees meet to discuss operational issues related to traceability implementation.
Session offers information on industry readiness, plus an overview of a phase implementation recommendation.
In this breakout session, industry leaders discuss understanding and overcoming errors brought on by data challenges.
Pharma Commerce provides a summary of conference breakout session.
Event’s first session aims to analyze the legislation’s implementation, as FDA enforcement is delayed until November 2024.
