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Memorandum of Understanding

FDA Issues New Draft MOU for 503A Compounders Governing Cross-Border Dispensing and Comments Related to CGMP Compliance for Outsourcing Facilities

[11/02/18]

Posted on November 2, 2018 in Health Law News

Published by: Hall Render

On September 7, 2018, the United States Food and Drug Administration (“FDA”) issued a revised draft Memorandum of Understanding (“MOU”) that would govern interstate dispensing and distribution of “inordinate amounts” of compounded prescription drugs by certain compounding physicians and pharmacies. The concept of this MOU first appeared in the Compliance Policy Guidance issued by... READ MORE

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