GUIDANCE

Waivers and Exemptions

FDA Guidance on Waivers and Exemptions Beyond the Stabilization Period

Guidance on applying for WEEs

If you're a small dispenser considering requesting a waiver for more time to become DSCSA compliant, it's important to consider the potential outcomes. For example, distributors may still require complete DSCSA data, like EPCIS, affecting revenue and customer relations. LSPedia offers expert support to help you achieve compliance with our OneScan suite software. Contact LSPedia for guidance on submitting a WEE today.

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WAIVERS AND EXEMPTIONS

Frequently Asked Questions

As a dispenser, if FDA approves my waiver submission, how does the waiver effect my business?

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

How long is a waiver, exception, or exemption valid?

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.

What insights were shared during the HDA’s Legal Perspectives Panel about WEEs?

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.

Who enforces DSCSA provisions, and how does this relate to WEER approvals?

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.

Is there a public database of approved WEEs?

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

Is there an extension or stabilization period for DSCSA compliance?

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.

Where can I find more information about WEEs?

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.

What is LSPedia’s WEE Management Module, and how can it help companies?

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.

What are the types of requests that can be submitted through WEEs?

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.

How many WEERs has the FDA received, and when can companies expect responses?

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.

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Related Resources

LSPedia's Response to the FDA’s DSCSA Compliance Extension
FDA Grants Exemptions to Trading Partners Facing DSCSA Compliance Challenges
FDA's DSCSA Enforcement Updates: Key Takeaways from HDA Traceability Seminar and LSPedia’s New WEE Management Solution
Pharmacy DSCSA Compliance: Why Acting Now is Critical Ft. Dr. Faast, DiversifyRx
Waivers and Exemptions Beyond the Stabilization Period - FDA, July 17, 2024 update
CDER Application Form
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