The DSCSA exemption for large dispensers expires on November 27, 2025. If your organization is not going to meet the deadline, this is what you need to do.
Information Gathering
In order to complete an FDA WEE application (waiver, exemption, and exception application) you must provide detailed justification for your application. The FDA does not provide a standardized template for these applications, so to give your organization the best opportunity to receive WEE approval, you are best to err on the side of the more detailed the better.
Contact Information
- Contact Person: Legal name of the primary contact individual, direct telephone number, email address
- Organization/Trading Partner: Legal name of the organization/trading partner (including DBA if applicable), full physical address(es) of the trading partners covered in the application
Justification
- Waiver: Explain in detail why compliance with the DSCSA requirement would result in undue economic hardship or is necessary for emergency medical reasons, such as a public health emergency declaration.
- Exception: This application only applies to manufacturers and repackagers (whose exemption deadline expired on May 27, 2025 and must clearly explain why a specific product’s container is unable to accommodate a label with all required product identifier information, such as an individual container being too small for the details required.
- Exemption: Explain in detail why the exemption is required to maintain public health or otherwise appropriate.
Product and Activity Specifications
- Describe all activities and/or products for which the application is being submitted.
- Include the NDC numbers for all applicable prescription drugs involved in the application.
- If the application is being submitted for mandated activities under Section 582 of the FD&C Act, clearly define the extent of those activities. Core activities include – Product Tracing, Product Identification/Serialization, Product Verification, Authorized Trading Partner Status.
Detailed Implementation Efforts & Challenges
- Steps Completed: Describe the specific steps that your organization has already taken to implement Section 582 requirements (system changes, data connections, trading partner onboarding, etc.)
- Explanation of Need: Provide a fact-based and detailed explanation for why your organization is requesting additional time to meet the Section 582 requirements, or why you are requesting an exclusion for specific products.
- Planned Steps: Provide an outline what your organization has planned as next steps for each item that you are requesting a waiver or exemption in order to achieve full compliance.
Supply Chain Security & Safety
- Explain what measures your organization is taking and/or what controls have or will be implemented to ensure the safety and security of the drug supply chain while you operating under the approval of a WEE. You must demonstrate your organizations commitment to public health and safety while operating under an approved WEE.
Administrative & Supporting Information
- Effective Period: Identify the start and end dates for the WEE you are requesting. For example, if you are requesting an exemption to complete system changes required to meet Section 582 requirements, identify when you expect to have all changes completed and implemented within your organization.
- Statutory Provision: Identify the specific statutory provision(s) of Section 582 to which the WEE would apply, if approved.
- Unique/Special Circumstances: Include an explanation of unique/special circumstances of the product/activity that apply to the WEE application.
- Employee Information (Undue Economic Hardship): If you are submitting a waiver for undue economic hardship, include the number of qualifying full-time employees of the organization as relevant supporting data.
Attestation
- Include the required affirmation statement concerning the veracity of the information. This information can be located under “Attestation” in the FDA document, Waivers, Exemptions, and Exemptions From the Requirements of Section 582 of the Federal Food, Drug, and Cosmetic Act
Keep in mind when drafting your WEE application, you must include concrete data, specific dates, and examples. Vague or generalized statements are often insufficient and increase your risk of having your application denied. Ensure that your criteria is well aligned with the official FDA guidance document linked above (Waiver, Exceptions, and Exemptions). Always include documentation to support each item in your WEE application request, such as financial statements if applying for economic hardship, technical specifications for packaging exemptions, or project plans for system challenges.
Submitting Your Application
Most WEE applications must be submitted through the FDA’s CDER NextGen Portal. You can upload your application and supporting documents through the online portal in DOCX, PDF, or XML format.
If your WEE application request is for a product that is regulated by the Center for Biologics Evaluation and Research (CBER) and is not associated with a Biologics License Application (BLA), New Drug Application (NDA), or Abbreviated New Drug Application (ANDA), you must email your application the CBER WEE mailbox: DS*************@*****hs.gov
Wait for Application Approval
The FDA has stated that it cannot guarantee specific response times for WEE requests, especially if the application is submitted close to the exemption deadline. Trading partner’s requirements are not paused or extended once a completed application has been submitted. Because there is no guarantee of approval and compliance obligations are not paused during the waiting period, trading partners must continue to make every effort toward meeting the full DSCSA requirements. The primary goal during the waiting period is to demonstrate that your organization is acting in good faith and making measurable progress toward meeting your obligations. During this waiting period, focus on the following areas:
Implementation Efforts
- Continue moving forward with your project plan and timeline to meet full DSCSA compliance.
- Keep meticulous records for all steps taken, milestones achieved, systems tested, and continued engagement with solution providers and trading partners.
Maintain Contact & Be Prepared with Updates
- Be fully prepared to provide the FDA with regular updates on your progress, keeping in mind the requested timeline for compliance included in your WEE request.
- Ensure team members are prepared to respond to any clarifying requests received by the FDA regarding your application, data, and proposed path to compliance.
Managing Supply Chain Risk
- Implement all measures outlined in your WEE application in regard to patient access and supply chain safety and security, as this is a top priority to the FDA.
- Be prepared for enforcement action if your application is denied or a decision is delayed. FDA actions are typically phased, starting with advisory measures and escalating to legal actions, depending on the severity of the violation and your organization’s responsiveness. These actions can include:
- Advisory/Administrative: Warning Letters, Untitled Letters, Inspections & Audits
- Operational and Product Specific: Product Seizures/Quarantine, Shipping Delays/Held Orders, Return Rejections
- Judicial/Monetary: Injunctions, Civil Monetary Penalties, Criminal Prosecution