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HIMS and others simply ignored those deadlines and kept selling, betting correctly, as it turned out that the FDA wouldnt actually enforce

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The maximum recommended dose is 3,000 mg per day for over-the-counter use (up to 4,000 mg per day only with healthcare provider supervision)

As of September 2023 it is on the FDA's Category 2 list of bulk drug substances that may not be compounded due to significant safety risks, and the agency has scheduled a Pharmacy Compounding Advisory Committee (PCAC) review for July 2026 covering proposed uses in opioid withdrawal, chronic insomnia, and narcolepsy

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