Resources ## Breadcrumb 1. [Home](/) 2. [Resources](/resources/resource-center) 3. [Resource Center](/resources/resource-center) # FDA Reiterates November 2023 Deadline for DSCSA-Compliant Systems with 12-Month Stabilization Period ![banner-image](https://www.tracelink.com/sites/default/files/2024-03/healthcare-provider-stat-component-background.png) - [Download PDF](/node/25211/pdf) - [Share](#) - [ LinkedIn ](https://www.linkedin.com/shareArticle?mini=true&url=https://www.tracelink.com/resources/resource-center/fda-reiterates-november-2023-deadline-with-stabilization-period&title=FDA Reiterates November 2023 Deadline for DSCSA-Compliant Systems with 12-Month Stabilization Period&summary=The FDA has announced a 12-month stabilization period for the final set of DSCSA compliance requirements. Find out what that means for the industry in this strategy brief. &source=TraceLink "LinkedIn") - [ Facebook ](https://www.facebook.com/share.php?u=https://www.tracelink.com/resources/resource-center/fda-reiterates-november-2023-deadline-with-stabilization-period&t=FDA Reiterates November 2023 Deadline for DSCSA-Compliant Systems with 12-Month Stabilization Period "Facebook") - [ Mail ](mailto:?subject=FDA Reiterates November 2023 Deadline for DSCSA-Compliant Systems with 12-Month Stabilization Period+|+TraceLink&body=https://www.tracelink.com/resources/resource-center/fda-reiterates-november-2023-deadline-with-stabilization-period "Mail") - [ Twitter ](https://twitter.com/intent/tweet?text=FDA Reiterates November 2023 Deadline for DSCSA-Compliant Systems with 12-Month Stabilization Period https://www.tracelink.com/resources/resource-center/fda-reiterates-november-2023-deadline-with-stabilization-period&via=TraceLink "Twitter") #### Table of contents [![](https://www.tracelink.com/sites/default/files/2023-09/FDA-One-Pager-Thumbnail.PNG)](/sites/default/files/2023-09/FDA-Reiterates-November-2023-Deadline-for-DSCSA-Compliant-Systems-with-12-Month-Stabilization-Period.pdf)In new guidance from the U.S. Food and Drug Administration (FDA), the organization announced a 12-month stabilization period to give trading partners more time to finalize the implementation of DSCSA-compliant systems and processes. The FDA states that companies should “use the additional time to implement, troubleshoot, and mature their systems and processes while supporting the continued availability of products to patients.” The FDA strongly reiterated that the law has not changed and this guidance “should not be viewed as providing a justification for delaying efforts… to implement EDDS requirements.” So, what are the implications of the FDA’s guidance and what should pharmaceutical supply chain trading partners do next? [**Download our new strategy brief**](/sites/default/files/2023-09/FDA-Reiterates-November-2023-Deadline-for-DSCSA-Compliant-Systems-with-12-Month-Stabilization-Period.pdf) to find out. You’ll get actionable insight into the FDA’s latest guidance, covering topics like: - What the FDA’s new guidance means for stakeholders across the drug supply chain. - What actions trading partners need to take over the 12-month stabilization period. - What the timeline for deploying and stabilizing DSCSA-compliant systems looks like. - How TraceLink solutions offer the fastest and lowest-cost path to [**DSCSA compliance**](/products/regulatory-compliance/us-dscsa-compliance). The clock is ticking and most pharmaceutical supply chain trading partners still have a lot of work to do. [**Download this strategy brief today**](/sites/default/files/2023-09/FDA-Reiterates-November-2023-Deadline-for-DSCSA-Compliant-Systems-with-12-Month-Stabilization-Period.pdf) to inform your next steps. [Contact TraceLink to schedule your free DSCSA-Readiness Assessment](/contact-us) [Solution Brief](/category/solution-brief)[DSCSA for Dispensers](/category/dscsa-dispensers), [DSCSA for Manufacturers](/category/dscsa-manufacturers) #### Table of contents Contact us to learn more about DSCSA compliance! Fill out the form for a DSCSA consultation. document.addEventListener("DOMContentLoaded", function() { // Delay the execution by 2 seconds (2000 milliseconds) setTimeout(function() { (function() { 'use strict'; // Load Marketo form MktoForms2.loadForm("//go.tracelink.com", "776-BAW-230", 2259); })(); // Wait until the Marketo form is loaded MktoForms2.whenReady(function(form) { var formElement = document.getElementById('mktoForm_2259'); if (!formElement) { console.error("Form with id 'mktoForm_2259' not found."); return; } var formLocation = formElement.querySelector("input[name=formLocation]"); // Get the current URL and set the formLocation field if (formLocation) { var currentURL = window.location.href; formLocation.value = currentURL; } // Add onSuccess handler form.onSuccess(function(values, followUpUrl) { var formElem = form.getFormElem()[0]; if (formElem) { formElem.style.display = 'none'; } else { console.warn("Form element could not be found to hide it."); } var confirmMessage = document.getElementById('confirmform'); if (confirmMessage) { confirmMessage.style.display = 'block'; } else { console.warn("Confirmation message with id 'confirmform' not found."); } return false; // Prevent the form from submitting normally }); }); }, 2000); // Delay for 2 seconds }); **Thank you for contacting us; we’ll be in touch shortly.** ##### Related Content [ ![DSCSA](https://www.tracelink.com/sites/default/files/styles/resize_image_style_640_480/public/2024-04/For%20Internal%208.png.webp?itok=iaEyYXqW) ](/resources/resource-center/enforcement-update-everything-you-need-to-know) ##### FDA DSCSA Enforcement Update: Everything You Need to Know The FDA has announced a 12-month stabilization period for the final set DSCSA compliance requirements. Find out what that means for the industry in this webinar. [View More](/resources/resource-center/enforcement-update-everything-you-need-to-know) [ ![Pharmacy](https://www.tracelink.com/sites/default/files/styles/resize_image_style_640_480/public/2022-08/dispenser.png.webp?itok=mKbaC97y) ](/resources/resource-center/how-ensure-drug-supply-and-create-business-value-dscsa-compliance) ##### How To Ensure Drug Supply and Create Business Value with DSCSA Compliance How to Ensure Drug Supply and Create Business Value with DSCSA Compliance: The Definitive Guide for Health Systems and Pharmacies [View More](/resources/resource-center/how-ensure-drug-supply-and-create-business-value-dscsa-compliance) [ ![DSCSA](https://www.tracelink.com/sites/default/files/styles/resize_image_style_640_480/public/2024-04/For%20Internal%2029.png.webp?itok=8YdrgEGx) ](/resources/resource-center/dscsa-compliance-need-to-know-essentials-wholesale-distributors) ##### DSCSA Compliance Need-to-Know Essentials for Wholesale Distributors Get a complete overview of DSCSA requirements for wholesale distributors. Download the brief today. [View More](/resources/resource-center/dscsa-compliance-need-to-know-essentials-wholesale-distributors)