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Department of Health and Human Services, Food and Drug Administration, Pharmacy Compounding of Human Drug Products Under Section 503A of the Federal Food, Drug, and Cosmetic Act, June 2016, Revision 2

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Safety is ensured through comprehensive initial screening and ongoing monitoring

Serious adverse effects are uncommon in healthy adults but can include elevated homocysteine levels if methionine metabolism is impaired, which is why patients with MTHFR gene variants should use methylated B-vitamin formulations instead of standard Lipo C