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* **Monitoring for Paradoxical Excitation:** Some children may develop hyperactivity, irritability, or insomnia rather than sedation

FOR LABORATORY RESEARCH USE ONLY

Agenda On July 23, 2026, the Committee will discuss the following bulk drug substances being considered for inclusion on the 503A Bulks List: BPC-157-related bulk drug substances (BPC-157 (free base)/ BPC-157 acetate), KPV-related bulk drug substances (KPV (free base)/ KPV acetate), TB-500-related bulk drug substances (TB-500 (free base)/ TB-500 acetate), and MOTs-C-related bulk drug substances (MOTs-C (free base)/ MOTs-C acetate)

Here is the honest evidence status up front: the individual compounds have real human data Tesamorelin is an FDA-approved prescription drug (EGRIFTA) for HIV-associated lipodystrophy, and Ipamorelin has been characterized in human GH-release studies but the fixed Tesamorelin + Ipamorelin blend as sold for research has no completed human randomized controlled trial of its own