Informational only. Not medical advice.INFORMATIONAL PLATFORM ONLY — NOT MEDICAL ADVICE, DIAGNOSIS, OR TREATMENT
Informational only. Not medical advice.INFORMATIONAL PLATFORM ONLY — NOT MEDICAL ADVICE, DIAGNOSIS, OR TREATMENT
FDA advisory meeting: July 23–24, 2026 — Epithalon is on the docket (July 24). PCAC makes recommendations; FDA issues any final rule later.
Epithalon (Longevity / Telomere): Removed from Category 2 on April 22, 2026; in no FDA category today. On the July 23–24, 2026 PCAC advisory docket for insomnia — not authorized for compounding.
The FDA removed it from Category 2 because the nomination was withdrawn, not because the agency cleared it. It now sits in no FDA category at all, so even the Category 1 enforcement-discretion policy no longer applies.
Epitalon is a synthetic tetrapeptide (Ala-Glu-Asp-Gly) developed by Khavinson as an analog of the bovine pineal extract Epithalamin. It is a research-only bioregulator — not FDA-approved — investigated for claimed telomerase activation and circadian/melatonin effects, with evidence limited primarily to Khavinson-group studies.
Category 1 — under evaluation
FDA does not intend to act against a compounder using these, if its guidance conditions are met — enforcement discretion during evaluation, not a finding of safety or efficacy. Epithalon is not on it.
Category 2 — significant safety risks
Substances the FDA flagged as raising significant safety risks. Epithalon left this list on April 22, 2026 when the nomination was withdrawn — which is not the same as being authorized.
Research-channel sources only — not compounding pharmacies. Best $/mg per vendor (single-vial or pack). Promos applied where active.
Compare all 16 Epithalon vendors →Disclosed Labs indexes publicly available Certificates of Analysis from research vendors. This data tracks which labs test Epithalon, purity distributions, and safety-panel coverage — useful for understanding what to expect from compounding-pharmacy batch testing.
Once Category 1 is finalized, Epithalon can only be dispensed by a registered pharmacy to patients with a valid prescription. Many providers now offer telehealth consultations and work with compounding pharmacies nationwide.
Regulatory information is for informational purposes only — not legal or medical advice. Verify current status with the FDA or a licensed pharmacist.
Removed from Category 2 on April 22, 2026; in no FDA category today. On the July 23–24, 2026 PCAC advisory docket for insomnia — not authorized for compounding. Removal from Category 2 is not promotion to Category 1 — the FDA's interim policy no longer covers a substance once it leaves the categories entirely. A substance may only be compounded under 503A when it appears on the final 503A bulks list, has a USP/NF monograph, or is a component of an FDA-approved drug. The FDA's Pharmacy Compounding Advisory Committee (PCAC) is advisory: it meets July 23–24, 2026 to review nominations and make recommendations, and the FDA issues any final rule later. Verify current status with the FDA or a licensed pharmacist.
Not today. Removed from Category 2 on April 22, 2026; in no FDA category today. On the July 23–24, 2026 PCAC advisory docket for insomnia — not authorized for compounding. If the FDA were to issue a final rule adding Epithalon to the 503A bulks list, registered 503A and 503B pharmacies could legally produce and dispense it — but only to patients holding a valid prescription from a licensed provider. Any such rule would come after the July 23–24, 2026 advisory meeting, typically 6–18 months later, and the FDA is not bound by the committee's recommendation.
Disclosed Labs maintains a directory of NPI-verified providers at disclosedlabs.com/prescribers, including providers offering telehealth consultations who work with compounded peptides. Many are licensed to prescribe nationwide.
Compounding pharmacies operating under USP <797> must conduct identity confirmation, potency/purity testing (HPLC), endotoxin testing (LAL), and sterility testing (USP <71>) on each batch. For injectable preparations, a full safety panel including heavy-metals testing is the standard. Disclosed Labs has indexed COA data from research vendors — the compounding pharmacy standard is set by federal USP requirements.
Disclosed Labs