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Suicidal ideation corresponding to type 4 or 5 on the Columbia-Suicide Severity Rating Scale within the past 30 days before screening

In September 2023, FDA placed "Thymosin Beta-4, Fragment (LKKTETQ)," the substance sold as TB-500, on Category 2 of its interim 503A bulk drug substances list, meaning FDA identified significant safety concerns and would not permit licensed compounding pharmacies to use it

doi:10.1016/j.psyneuen.2013.11.004

And budget for ongoing monitoring, because most clinics do not include labs in the headline fee

If users saw no change in the first 14 days, they routinely bumped up their dose, switched injection sites, or questioned if their peptide was real