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TB-500 is under FDA advisory review in July 2026, and FDA staff documents recommend caution because human safety and effectiveness data are limited

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In summary, this compounded injection is contraindicated in anyone with allergies to its components, in neonates, and in patients in whom even moderate doses of B/B might pose unacceptable risks (e.g

Published FDA enforcement data shows that marketing violations, product adulteration, and inadequate quality documentation were the three most commonly cited factors in enforcement actions targeting research chemical vendors between 2023 and 2026

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Reconstitution with bacteriostatic water or appropriate laboratory solvent is required prior to research use