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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

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However, the steroid injection requires just one session that combines diagnosis and treatment, where the RFA procedure typically requires 3-4 sessions initially