Depending on the outcome of the waiver request, trading partners may need to quickly adjust their operations if the waiver is denied or delayed, potentially leading to operational disruptions, additional costs, and impacts on supply chain logistics.

Submitting a waiver request does not pause or extend the compliance deadline of November 27, 2024. Trading partners must continue their efforts to meet the requirements until FDA approves or denies the request. Non-compliance may result in enforcement actions by the FDA and state pharmacy boards, including warnings, fines, or other penalties.

No. Your WEE application includes your plan to become fully compliant to DSCSA. The WEE approval grants 2 more years to get to 100% product trace and product verification at the package level.

No. WEE Application and Approvals will not be published by the FDA. It is the WEE holder's responsibility to share the WEE information with their trading partners.

For CDER-regulated products, all requests should be submitted through CDER NextGen portal. For further details, please refer to the FDA guidance document on waivers, exceptions, and exemptions from the requirements of section 582 of the FD&C Act.

Yes. LSPedia Professional Services and PRG can create the draft and gather affiliated supporting documents.

Yes.

The FDA cannot guarantee a response by the deadline but will make every effort to review requests promptly. The trading partner’s obligation to comply by November 27, 2024, remains in effect regardless of the status of their waiver or exemption request.

Requests should include:- A detailed statement justifying the request- Pertinent supporting documentation- Any special circumstances related to the product or transaction

The DSCSA interoperability requirement requiring trading partners to exchange Transaction Information at the package level and Transaction Statements. In other words, companies that receive the FDA's approval for the waiver do not need to exchange EPCIS data.