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Pharmacopeia or National Formulary monograph and is not a component of an FDA-approved drug, it generally must appear on the 503A Bulks List for a compounded drug made from it to qualify for section 503A's exemptions.[4] A qualifying 503A compounded drug does not go through FDA premarket approval, does not need labeling with adequate directions for use, and is exempt from federal current good manufacturing practice requirements

Skldstam, L., Hagfors, L

The most common side effects in the antioxidant group were headache (n=10), gastrointestinal disturbances (n=10), itching (n=4), upper respiratory infection (n=4), insomnia (n=3), dry mouth (n=2), dizziness (n=2), hypertension (n=1), and an unspecified side effect (n=1)

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