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Zhang S, Li B, Liu L, et al
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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