Trading partners, including manufacturers, repackages, wholesale distributors, and dispensers (pharmacies), who are required to comply with DSCSA regulations, can submit a WEERS request to the FDA.

WEERs are requests submitted by companies to the FDA to seek waivers, exemptions, or exceptions from certain requirements under the Drug Supply Chain Security Act (DSCSA). These requests are essential for companies that may face challenges in aligning with DSCSA compliance.

If you have trading partners that are approved for a WEE, you will need ASN capability to exchange ASN data.

Your trading partner that has received a WEE approval is responsible for communication of their status including provision of documentation to validate the WEE. Without such notification and documented approval, you must follow standard DSCSA process under the standard DSCSA requirements.

Continuing to receive ASN data for compliance and making informed business decisions regarding supplier relationships are essential steps forward.

Implementing ASN receipts and pseudo-commissioning events for inventory received and outbound TI/TS generation can help navigate challenges with exempt suppliers.

Continuing ASN exchanges to meet product trace requirements at the lot level can help maintain business relationships.

If you are approved for a WEE, you must have ASN capabilities to exchange electronic lot level data with TI, TH, TS. If you are not yet connected with trading partners for ASN, you need to take that step to communicate with your trading partners and request ASN connections.

The waiver exempts you from receiving and sending EPCIS data, potentially effecting your distributor customers' compliance and ability to sell products that require product trace information for future reimbursement.

The waiver exempts you from the requirement to send EPCIS data, affecting your customers' ability to generate outbound Transaction Information (TI) and Transaction Statements (TS), which may impact their ability to sell your products.