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

What specific information has been useful in past waiver/exemption requests?

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

WEE

What entities are exempt from the Drug Supply Chain Security Act (DSCSA) requirements?

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.

WEE

Can trading partners request a waiver or exemption beyond the stabilization period?

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.

WEE

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VA Pharmacy Benefits Management Clinical Informatics

U.S. Department of Veterans Affairs

"The VA has awarded the DSCSA Solution Provider national contract to LSPedia, and will be utilizing OneScan to streamline and optimize our supply chain processes."

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Chet D. Mrha

Executive VP

Pharmaceutical Buyers, Inc.

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Cheryl Krueger

Supply Chain Director

Specialty Care Distribution

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Brad King

Business Operations

Kowa Pharmaceuticals

“We consider LSPediA to be experts when it comes to the DSCSA and serialization. They know and understand the ever-changing regulations, and are proactive on putting things in place to get us ready to go live with serialization.”

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