Regulatory Information

On May 22, 2025, the U.S. Food and Drug Administration (FDA) granted A-S Medication Solutions LLC an exemption from the enhanced drug distribution security requirements under Section 582(g)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

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This exemption was granted pursuant to Section 582(a)(3) of the FD&C Act, which authorizes the FDA to issue waivers, exceptions, and exemptions from the requirements outlined in Section 582.

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The purpose of this exemption is to provide additional time for trading partners to align their systems, mitigate operational disruptions, and ensure continued stability across the supply chain.

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A-S Medication Solutions LLC remains steadfast in its commitment to the safety and security of the pharmaceutical supply chain during this exemption period. We are actively collaborating with our DSCSA service provider and are dedicated to achieving full compliance with the enhanced drug distribution security requirements. We expect all upstream and downstream trading partners to work collaboratively to communicate and validate system compliance with FDA regulations

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We appreciate your continued partnership. Should you have any questions or require further information, please contact your designated account representative, who will be happy to assist you.