Comment from Harris Brian

Docket Item: [Insert FDA Docket Number, e.g., FDA-2023-N-XXXX] Subject: Public Comment regarding the Compounding and Scheduling of Peptide Compounds To Whom It May Concern, I am writing to submit my personal testimony regarding the therapeutic utility and life-changing impact of specific peptide compounds. As the FDA evaluates the regulatory status, scheduling, and compounding availability of these substances, I ask that patient access, quality of life, and clinical outcomes be heavily weighed. Over the course of my personal health journey, I have utilized the following peptides under appropriate guidance with significant success: •BPC-157 & TB-500: These compounds were utilized specifically for tissue repair, musculoskeletal recovery, and systemic inflammation management. Their availability as compounded options provided targeted healing where traditional interventions fell short. •MOTS-c: This mitochondrial-derived peptide was integrated to support metabolic function, cellular energy production, and physical endurance, directly addressing chronic fatigue and metabolic inefficiencies. •Semax: Utilized for its neuroprotective and nootropic properties, this compound provided documented support for cognitive clarity, memory retention, and executive function during periods of neurological strain. •KPV: This tripeptide was leveraged for its potent anti-inflammatory and antimicrobial properties, particularly in managing localized immune responses and gut-barrier health. •DSIP (Delta Sleep-Inducing Peptide): This compound was used to modulate disrupted sleep architecture, promoting deep, restorative sleep cycles and assisting with chronic sleep disturbances. Maintaining access to these specific compounds through regulated compounding pharmacies is vital for patients who do not respond adequately to mass-market pharmaceuticals. Restricting these substances through aggressive scheduling or compounding bans would severely disrupt my ongoing health maintenance and negatively impact my daily functionality. I strongly urge the FDA to establish a regulatory pathway that ensures safety and purity without entirely eliminating patient access to these critical therapies. Thank you for your time and consideration of this testimony. Sincerely,