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At 10 active days per cycle, the total annual injection commitment at maximum frequency is only 30 days, making it one of the lowest-burden protocols in terms of active treatment time

Section 503A Traditional Compounding FDA describes Category 2 substances (for 503A) as those with identified safety risks pending evaluation, and the agency does not intend to apply the same enforcement discretion it uses for Category 1

Clinical services, including medical consultations and prescribing decisions, are provided by independent, licensed healthcare providers who exercise their own professional judgment

Subcutaneous Protocol (4 mL = 12.5 mg/mL) Frequency: Inject once or twice daily subcutaneously