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.
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.
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.
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.
Yes.
Yes. LSPedia Professional Services and PDG can create the draft and gather affiliated supporting documents.
If you apply for a WEE after August 1, 2024, it is highly likely that the FDA will not review or approve your WEE application. Submitting your WEE application before August 1, 2024 will greatly improve your chance of getting your WEE reviewed by the FDA. However, the FDA does not guarantee the approval.
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.
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.
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.
If you have trading partners that are approved for a WEE, you will need ASN capability to exchange ASN data.
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