Comment from Lazer Jessica

**RE: Docket No. FDA-2025-N-6895 — Patient Testimony Supporting Access to BPC-157 and TB-500** I am submitting this comment to support the inclusion of BPC-157 and TB-500 on the list of bulk drug substances that may be used in patient-specific compounding under section 503A. In February 2026, I experienced a collapsed lung. During my recovery, I dealt with severe and persistent inflammation that affected my comfort, mobility, breathing, and ability to return to normal daily activities. I used BPC-157 and TB-500 as part of a structured, time-limited recovery protocol rather than for indefinite or continuous use. After using these peptides, I experienced a significant reduction in inflammation and a meaningful improvement in my overall recovery and daily function. My experience is personal, and I understand that one patient’s testimony does not replace controlled clinical trials or establish that these substances are appropriate for every person. However, real-world patient outcomes should be considered when evaluating the potential clinical value of compounded medications. Before this experience, I did not understand how significantly prolonged inflammation could affect every aspect of recovery. Access to BPC-157 and TB-500 made a meaningful difference in my quality of life during an extremely difficult medical recovery. I support continued research, clear quality standards, accurate labeling, appropriate testing, patient-specific prescribing, and qualified medical and pharmacy oversight. I do not believe the limited amount of published human research should result in patients losing access entirely. Instead, it should lead to stronger research, better reporting, and responsible access through properly regulated compounding pharmacies. Patients recovering from serious medical events do not all respond to the same treatments or recover according to the same timeline. Qualified healthcare professionals should retain the ability to evaluate individual circumstances and determine whether a carefully scheduled, limited course of compounded BPC-157 or TB-500 may be appropriate. Based on my personal experience following a collapsed lung, I respectfully ask the FDA and the Pharmacy Compounding Advisory Committee to consider the meaningful reduction in inflammation and improvement in function that I experienced and to support the inclusion of properly characterized BPC-157 and TB-500 bulk drug substances on the 503A Bulks List.