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Yet despite high-speed oxygen ventilation, inflammation of the respiratory tract and exudation of viscous mucus in bronchioles and alveoli make oxygenation of blood inefficient in severe COVID-19 as O 2 cannot easily penetrate mucus plugs

What This Means Practically According to FDA guidance and legal analysis, the regulatory framework has shifted: What May Still Be Permitted: According to FDA published guidance, compounding under Section 503A may continue when a prescriber determines that a compounded product provides a clinical difference for a specific patient that cannot be met by commercially available FDA-approved products