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OCTOBER 21, 2024

No more enforcement delays

FDA Inspections, Waivers Amid Top Concerns as DSCSA Looms


Click here for the latest DSCSA updates, including the FDA's decision to delay enforcement and set several new 2025 deadlines.

 
By Heidi Splete

Any stakeholders, including pharmacies, distributors and manufacturers, who are not ready to comply with the Drug Supply Chain Security Act (DSCSA) need to start preparing their requests for waivers, exceptions and exemptions (WEEs). Facilities that execute these documents poorly will be at risk for being held noncompliant by the FDA, state