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For outsourcing facilities under section 503B of the FD&C Act: compounding, distributing or dispensing semaglutide injection products that are essentially a copy of an FDA-approved drug product within 90 calendar days from todays announcement, until May 22, 2025

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As a result of COVID-19-related travel restrictions and lockdowns, the worldwide supply chain for GLP-1 receptor agonists was disrupted

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