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Prevent release into water systems

(Explains that compounded medications under Section 503A are exempt from FDA pre-market approval requirements, meaning their safety and efficacy are not evaluated by FDA prior to use)

Several stakeholders commented on the draft guidance

These may include: Fatigue Brain fog Memory loss Neurological problems Heart palpitations Pale skin Muscle weakness Mood changes Appetite loss Constipation Infertility Side Effects of Vitamin B12 While the recommended daily amount of vitamin B12 for adults is 2.4 micrograms, higher doses have been found to be safe

Schrade et al., 2022)

Chemical Characteristics: Bacteriostatic water with 0.9% benzyl alcohol