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Tell your doctor immediately if any of these unlikely but serious side effects occur: muscle cramps, weakness, irregular heartbeat
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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With compounding pharmacies playing a key role in customized patient care, the outcome may shape supply chains, prescribing practices, and availability in the months ahead
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