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Description

Why This Matters: A Quick Primer on Section 503A Under Section 503A of the Federal Food, Drug, and Cosmetic Act (FD&C Act), human drug products compounded by a licensed pharmacist in a state-licensed pharmacy or by a licensed physician can be exempt from three major FDA requirements: current Good Manufacturing Practice (cGMP) standards, certain labeling requirements, and the standard new drug approval process (NDAs/ANDAs)

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S2CID 47006345

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Rhonda Patrick has a more measured approach

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nonetheless, subgroup analysis based on different diagnostic methods indicated a correlation between PPI use and SIBO when assessed using small intestine aspirate culture or the glucose hydrogen breath test but not when using the lactulose hydrogen breath test (Su et al., 2018)

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