Our PCAC public comment.

Re: Bulk Drug Substances Nominated for Inclusion on the 503A Bulks List — BPC-157, TB-500, MOTS-c, KPV

Dear Committee Members,

I write as the founding physician of Limitless Performance Medicine, a regenerative medicine clinic in Dalton, Georgia. I am a Doctor of Osteopathic Medicine in active clinical practice. My patients are adult men and women, many of them post-injury, peri- and post-menopausal, hypogonadal, or pursuing structured longevity care. Peptide therapy is one component of a comprehensive clinical program that includes hormone optimization, NAD+ therapy, supplementation, and individualized training and nutrition. I am not a manufacturer or distributor. I have no financial relationship with any compounding pharmacy on the bulk substance nomination side. My interest in this docket is clinical.

I respectfully urge the Committee to recommend the inclusion of BPC-157, TB-500, and MOTS-c on the 503A bulk drug substances list, with the patient-safety conditions outlined below. I take no position on KPV at this time — the preclinical record is consistent, but the published human data has not yet reached a threshold I would set for prescribing inside my practice.

1. The clinical context the Committee should weigh.

For BPC-157, TB-500, and MOTS-c, the preclinical mechanism is well-characterized and the safety record across animal and small human pilot exposures is benign. The human Phase II/III efficacy literature is small. This is the gap the Committee is being asked to vote on.

I would respectfully observe that this gap is the standard reason compounding pathways exist. Compounded medications, by definition, address clinical needs where the New Drug Application pathway has not delivered a commercial product. The trial economics for a 16-amino-acid mitochondrial-derived peptide, or a 15-amino-acid gastric pentadecapeptide, will not in the foreseeable future support a sponsor-funded Phase III program. The choice in front of the Committee is therefore not between "well-studied compounded peptides" and "less-studied compounded peptides." The choice is between regulated 503A prescribing by licensed pharmacists and physicians who carry insurance, malpractice exposure, and state-board accountability — versus an existing, growing, and demonstrably unsafe parallel market in unaccredited overseas sourcing, "research chemicals," and influencer-driven self-administration.

I see the consequences of that parallel market in my exam room every week. Patients arrive with substances of unknown identity, unknown purity, unknown stability, no certificate of analysis, no informed consent, and no follow-up labs. A workable 503A pathway is the only configuration that puts the FDA, the State Board of Pharmacy, the prescribing physician, and the dispensing pharmacist in the same regulatory frame as the patient.

2. The case for BPC-157.

BPC-157 has a substantial peer-reviewed preclinical record across tendon, ligament, gastrointestinal mucosa, and vascular injury models. The published human safety data is small but consistent — no serious adverse events reported in completed trials and case series. The clinical use case in my practice is specific and narrow: tendinopathy or joint injury with documented failure of conservative rehab, or inflammatory bowel disease with stalled response to first-line therapy. Cycle duration is 4–8 weeks with reassessment. I do not present BPC-157 as a "longevity drug" or a "performance enhancement drug." I present it as a tissue-repair adjunct with a clean mechanism, a benign safety record, and a thin but credible human signal — and I document that framing in every patient consent.

3. The case for TB-500.

TB-500, the synthetic Thymosin Beta-4 fragment, has a related but distinct preclinical record — angiogenesis, actin sequestration, cardioprotection in ischemic injury models. The Phase II cardiac data published a decade ago did not progress to commercial development, which I take as informative about trial economics, not about safety. The clinical use in my practice is paired with BPC-157 for soft-tissue and vascular recovery contexts. I do not believe TB-500 should be included on the bulks list independently of BPC-157; the literature supports them as a stack, and including one without the other would create an irrational asymmetry in the compounding pharmacy formulary.

4. The case for MOTS-c.

MOTS-c is in a separate category. The mechanism — AICAR accumulation, AMPK activation, PGC-1α–driven mitochondrial biogenesis — is among the cleanest in the entire compounded-peptide literature. The 2026 PGC-1α / AMPK muscle paper (PubMed 41520850) demonstrated load-bearing dependency on the canonical pathway in vivo. The endogenous-peptide biology is unusual and informative: MOTS-c is encoded in mitochondrial DNA, declines with age, is lower in people with type 2 diabetes, and is detectable in human plasma. The human efficacy data, as the Committee knows, is limited. I prescribe MOTS-c in selected metabolically active patients, at modest doses (5–10 mg SubQ, 3–5x weekly), in 8–12 week blocks, with baseline and 12-week metabolic monitoring and informed consent that explicitly states the absence of completed human RCTs. An "include" vote would let me continue that prescribing inside the federal compounding framework; an "exclude" vote would push the same prescribing into the grey market.

5. The conditions I respectfully urge the Committee to require.

If the Committee votes to include any of these substances, I urge the following conditions be made part of the inclusion record so that downstream FDA rulemaking and state-board guidance have a clear path:

1. Per-lot certificate of analysis as a condition of bulk-substance receipt. Every lot received by a 503A compounding pharmacy should carry a written CoA documenting identity, purity (HPLC), residual solvents, endotoxin levels, and where applicable peptide sequence confirmation. The pharmacy should retain the CoA per state-board record retention.
2. Per-lot stability data appropriate to the dosage form. Reconstituted and lyophilized peptides have distinct stability profiles. Compounding pharmacies should not assign beyond-use dates that exceed published stability data for the specific formulation.
3. Written, signed informed consent that explicitly addresses the absence of completed human Phase III efficacy trials for any included peptide whose dossier does not contain such trials. The consent should be patient-specific, not a generic clinic disclosure, and should be retained as part of the medical record.

These conditions are already part of standard practice at well-run 503A pharmacies and physician practices. Codifying them in the inclusion record would close a known gap between best-in-class operators and operators who, in 2026, are still cutting corners. The FDA's own 2024–2026 inspection record across the broader compounding space supports the need for that codification.

6. A note on what is not on this docket.

I note for the record that CJC-1295 (mod GRF 1-29) is not on the July 23–24 docket and, as far as I can determine, is not currently legal for human compounding under the 503A framework in 2026. Patients in my practice receive tesamorelin (FDA-approved GHRH analog) as the lead growth-hormone-axis option, with sermorelin as an alternative where indicated. We restructured our standing protocol in May 2026 to reflect that reality. I mention this only to note that the Limitless prescribing posture is already aligned with what the existing rules permit, and we have publicly committed to updating that posture within 48 hours of any FDA final rule.

7. Closing.

The Committee's task is difficult. The literature is uneven, the public attention is intense, and the regulatory architecture has shifted twice in the last 24 months. I would offer that the cleanest principle the Committee can apply is the principle compounding has always rested on: where a real clinical need exists, where the safety record is acceptable, and where the alternative is an unregulated grey market, the 503A pathway should remain available — with the safeguards above attached to it.

I am grateful for the Committee's work, and I appreciate the opportunity to comment.