On April 23, 2026, the FDA removed twelve clinically meaningful peptides — including BPC-157, TB-500, CJC-1295, and Ipamorelin — from Category 2. The PCAC's formal review on July 23–24 is the next decision point. This page documents how Limitless prescribes, sources, and monitors peptides through that transition window.
Compounded peptides are not the same as approved pharmaceutical drugs. They are prescription therapeutics — prepared by licensed compounding pharmacies, prescribed by a physician for a specific patient, and monitored on a defined schedule. At Limitless, that is the only way a peptide ever reaches a patient.
We do not stock, sell, resell, or refer patients to retail or online peptide vendors. Every peptide a Limitless patient receives originates from a state-licensed 503A or FDA-registered 503B pharmacy under a valid prescription written by Dr. Joshua Hare, DO.
Every peptide originates from a 503A pharmacy with a current state board license, valid PIC (pharmacist-in-charge), and clean inspection record — or from an FDA-registered 503B outsourcing facility for higher-volume preparations. We maintain primary and secondary supplier relationships to prevent inventory gaps.
A peptide is prescribed only after a clinical evaluation, lab review, and identification of an indication consistent with current evidence. Each prescription is patient-specific. Standing orders, "office stock" peptides, and direct-to-consumer sales are not part of the Limitless model.
Before initiating therapy, each patient signs a written informed consent acknowledging that compounded peptides are not FDA-approved drugs, that supporting evidence varies by molecule, that on- and off-target effects are possible, and that monitoring is required. Consent forms are stored in the patient portal and refreshed annually.
Each protocol carries a written monitoring plan: baseline labs, follow-up labs at defined intervals, symptom check-ins, and stop criteria. NAD+ patients have hepatic and energy-marker review. Tesamorelin patients have IGF-1, glucose, and DEXA review. GH-secretagogue patients have IGF-1 and HbA1c review. Recovery-stack (BPC-157 + TB-500) patients receive structured progress checks.
For the past several years, the FDA's Pharmacy Compounding Advisory Committee (PCAC) had placed a number of clinically meaningful peptides on Category 2 — a status that meaningfully restricted compounding access. Following the February 2026 HHS announcement, twelve peptides were removed from Category 2 effective April 23, 2026.
It is important to be precise about what that change does and does not do. Removal from Category 2 cleared one regulatory barrier. It did not, by itself, place these peptides on the 503A bulk drug substances list — the list that authoritatively governs what 503A pharmacies may compound from bulks. That decision rests with the PCAC's formal review on July 23–24, 2026, and the FDA's subsequent determination. In the meantime, licensed 503A and 503B pharmacies are operating in a transition status: most are filling patient-specific prescriptions written by physicians for indicated uses, while exercising heightened documentation and patient-counseling standards in anticipation of the July decision.
This is the regulatory posture Limitless has chosen to operate inside. We do not assume the July decision is a foregone conclusion. We document accordingly.
Reclassification does not make these peptides FDA-approved drugs. They remain prescription therapeutics with a still-evolving evidence base. They should be used with the same physician oversight and documentation that any specialty therapeutic warrants — and that is the standard we hold ourselves to, regardless of how the July decision lands.
A 30-minute consultation, a full lab panel, and a physician-built protocol — sourced, prescribed, and monitored to a documented standard.
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