The FDA is granting exemptions to small dispensers (pharmacies) and their trading partners until November 27, 2026. A small dispenser is defined as having 25 or fewer full-time employees licensed as pharmacists or qualified as pharmacy technicians as of November 27, 2024.

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.  

Yes, trading partners that do not qualify for small dispenser exemptions and cannot meet the enhanced drug distribution security requirements by November 27, 2024 may request a waiver or exemption. The FDA recommends submitting requests by August 1, 2024, although requests can be submitted at any time.  

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

Useful information has included:
- Steps taken to implement section 582 requirements
- Explanation of why additional time is necessary
- Planned steps to achieve full compliance
- Number of full-time employees of the trading partner
- Identity of the product manufacturer if a co-licensed partner or affiliate submits the request

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.

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

No. WEE Application and Approvals will not be published by the FDA.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.  

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.  

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.

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.

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.

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.

Without receiving DSCSA compliant EPCIS data, generating product trace information becomes challenging, potentially effecting your status as a preferred supplier.

Without receiving DSCSA compliant EPCIS data, utilizing inbound data for automated processes and meeting BPMs' product trace requirements may become increasingly difficult.

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.  

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

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

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

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.  

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

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.

The three types of requests that can be submitted are:
‍Waivers: Temporary relief from specific DSCSA requirements due to unique circumstances. Exceptions: Permanent relief from specific DSCSA requirements for certain products or trading partners.
‍Exemptions: Relief from DSCSA requirements for products or circumstances that may not pose a significant risk to public health.

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.

WEE requests must be submitted electronically via the FDA's online portal. The submission should include detailed information about the request, the justification for the waiver, exception, or exemption, and any supporting documentation.

A WEE submission requires:
- Identification of the specific DSCSA requirement(s) for which the request is being made.
- A detailed explanation of the circumstances or conditions justifying the request.
- Supporting documentation, such as risk assessments, scientific evidence, or other relevant data.
- Contact information for the individual or entity submitting the request.

No, there are currently no fees for submitting a WEE request to the FDA.

Yes, a WEE request can be submitted for products already in distribution if compliance with specific DSCSA requirements is infeasible or poses significant challenges.

Yes, multiple waivers, exceptions, or exemptions can be requested in a single submission, provided each request is clearly justified and documented.

Companies can apply to join the Beta Program for LSPedia’s WEE Management Module by clicking this link. Early adopters will have their license fees waived for 2024.

The review time for WEE requests can vary depending on the complexity of the request and the volume of submissions. The FDA aims to review and respond to requests as efficiently as possible, but there is no guaranteed timeframe.

Expedited review may be requested if there is an urgent need, such as an imminent risk to public health. However, the decision to expedite is at the FDA's discretion.

If a WEE request is denied, the FDA will provide a written explanation for the denial. The trading partner may submit additional information or a revised request if appropriate.

The FDA has received nearly 400 WEERs, which are currently under review. Companies can expect responses soon, with approximately 150 WEERs anticipated to receive feedback in the coming weeks.

LSPedia is introducing a WEE Management Module as part of the Beta launch of OneScan 7.3 on October 6, 2024. This module helps trading partners efficiently manage WEE approvals, ensuring smooth operations and compliance. LSPedia is currently accepting 10 early adopters for the Beta Program, with waived license fees for 2024.

More information about WEEs, including guidance documents and submission instructions, can be found on the FDA's official website under the Drug Supply Chain Security Act (DSCSA) section.

The FDA does not maintain a publicly accessible database of approved WEEs. However, trading partners may contact the FDA for information on specific requests.

No, the FDA has confirmed that the DSCSA compliance deadline is firm, and there will be no additional stabilization period. Companies must take immediate action to ensure they meet compliance requirements by the set deadline.

DSCSA provisions can be enforced at both the federal and state levels. While the FDA may not have immediate resources for enforcement, local boards of pharmacy may take independent action. However, WEER approvals from the FDA preempt state-level requirements, providing protection against state non-compliance.

Ilisa Bernstein, founder of Bernstein Rx Solutions LLC and a former FDA lead on DSCSA, emphasized the importance of proactively filing WEERs if companies have concerns about DSCSA compliance. These requests can address both product-related and transaction-related non-compliance issues.

The validity of a waiver, exception, or exemption varies depending on the specific terms set by the FDA in their approval. Some may be temporary with specific expiration dates, while others may be permanent.