{ "name": "Peptide Compounding Status Index", "description": "A sourced reference of the seven peptides the FDA Pharmacy Compounding Advisory Committee (PCAC) evaluated on July 23-24, 2026 for possible inclusion on the Section 503A bulk drug substances list, with each peptide's regulatory status, evaluated uses, available human clinical data, and citations. The committee recommended six and rejected one; none of these peptides is FDA-approved and none is legal to compound today. CC-BY-4.0.", "version": "1.4.3", "datePublished": "2026-07-23", "dateModified": "2026-07-26", "license": "https://creativecommons.org/licenses/by/4.0/", "publisher": { "name": "Cora Health", "url": "https://www.trycora.io", "contact": "help@trycora.io" }, "scope": "The seven peptides the FDA Pharmacy Compounding Advisory Committee (PCAC) evaluated at its July 23-24, 2026 meeting for possible addition to the Section 503A bulk drug substances list: BPC-157, KPV, TB-500, and MOTS-c (July 23), and Emideltide (DSIP), Semax, and Epitalon (July 24).", "methodology": "Row facts trace only to the sources named on that row — the FDA PCAC meeting notice (the authoritative agenda and evaluated uses), FDA pages on the Section 503A bulks list, and contemporaneous reporting from Reuters and RAPS. The FDA staff position is cited as reported by Reuters and RAPS; no FDA staff briefing document is among the named sources. The timeline and claim checks carry their own sources, including FDA — Compounding Laws and Policies. One statement there — that FDA rulemakings of this kind have historically run 12 to 24 months — is Cora Health's own characterization of past rulemakings, is attributable to no cited source, and is not a forecast for this rulemaking; no date is attached to the pending FDA decision. A PCAC recommendation is non-binding and is not FDA approval. A substance being recommended for, or added to, the 503A bulks list would permit compounding under a patient-specific prescription — it does not make the substance an FDA-approved drug, and it is not the same as the substance being legal to compound today, which requires a completed FDA rulemaking (proposed rule, public comment, final rule) that has not occurred.", "unverifiedNote": "All seven vote outcomes are confirmed in the sources reviewed as of the last-verified date. The committee recommended six peptides for the 503A bulks list (BPC-157, KPV, TB-500, MOTS-c, Semax, Epitalon) and rejected one — Emideltide (DSIP). FDA career staff recommended against listing all seven; the committee voted against that advice on the six it recommended, and agreed with staff only in rejecting Emideltide (DSIP). A recommendation is a non-binding advisory step and is not FDA approval; the FDA has not made a final decision on any of them.", "disclaimer": "None of the peptides in this index is FDA-approved, and none is legal to compound today. They are not therapeutically equivalent to any FDA-approved product. The evidence base for these peptides is thinner than for the compounded GLP-1 medications that licensed providers at Wasef Health, PC prescribe — several have no located human clinical data. Cora Health does not sell, prescribe, or compound these peptides. Cora Health does not prescribe medication; licensed providers at Wasef Health, PC make all prescribing decisions. Compounded medications, where offered, are prepared by Hallandale Pharmacy (a PCAB-accredited 503A compounding pharmacy) or VialsRx (a US-licensed 503A compounding pharmacy). Individual results vary. This dataset is for general informational reference and is not medical or legal advice.", "corrections": "See an error or an update? Email help@trycora.io — corrections ship with a dataset version bump.", "changelog": "v1.4.3 (2026-07-26): the \"It is not legal to compound today.\" sentence added in v1.4.1 had reached only the MOTS-c note, because the other five recommended notes carried the advisory clause inline rather than by reference; all six recommended notes now share that clause and carry the sentence. Narrowed the methodology statement, which said facts trace only to the sources named on each row — true of the rows, but the timeline and claim checks carry their own sources, and the 12-to-24-month rulemaking duration is Cora Health's own characterization attributable to no source. Replaced \"the compounded medications Cora does offer\" with wording that does not imply Cora is the source of the medication. No row, outcome, vote count or date changed. v1.4.2 (2026-07-26): corrected the methodology statement, which listed \"FDA staff materials\" among the sources — no FDA staff briefing document is cited on any row; the FDA staff position traces to the Reuters and RAPS reporting named on each row. No row, outcome, vote count or date changed. v1.4.1 (2026-07-26): added `slug` and `context` fields to every row and a `url` column to the CSV endpoint (13 to 14 columns) — naive consumers pinned to the old column count should re-read the header. Replaced the shared recommended-peptide note with a per-peptide note carrying that peptide's own vote margin, indication and the FDA staff position; the MOTS-c note now carries the same patient-specific-prescription clause as the other recommended rows, states inline that MOTS-c is not an alternative to a prescribed GLP-1 medication, and replaces the loose descriptor \"the only weight-loss-adjacent peptide in the set\" with the sourced \"the only peptide in the set whose FDA-evaluated use includes obesity\". Removed a duplicated \"only rejection\" label and vote count from the Emideltide note, and corrected number agreement in the MOTS-c and KPV evaluated-use fields. Each row now also has its own page at /peptides//, generated from this dataset, and the shared advisory clause now ends \"It is not legal to compound today.\" Also retracted the unsourced descriptor \"The only weight-loss-adjacent peptide in the set\" from the MOTS-c note, published since v1.0.0 (where it read \"the only weight-loss-adjacent peptide in this evaluation set\"). No outcome, vote count or date changed. v1.3.0 (2026-07-26): added a sourced regulatory timeline of the 503A sequence (April 22 nomination-list update, June 30 FDA staff review, both PCAC meeting days, and the pending FDA decision, which carries no date) and a set of sourced straight answers on approval, legality, timing and scope. No dataset row or field changed; separately, an on-page note that some outcomes still read \"UNVERIFIED\" was corrected to state that all seven outcomes are confirmed. v1.2.1 (2026-07-25): corrected the staff-agreement statement — FDA staff recommended against listing all seven, the committee overrode that on the six it recommended, and the Emideltide (DSIP) rejection agreed with staff; a prior version said every vote went against staff. Also removed a comparative characterization of the MOTS-c 7-5 vote as a narrower margin than the 8-6-1 votes: the two-vote gap was the same, only the panel tally differed. v1.2.0 (2026-07-25): added the confirmed July 24 vote outcomes (Semax 8-5, Epitalon 7-5-1, Emideltide/DSIP rejected 6-7-1). v1.1.0 (2026-07-24): removed five peptides (LL-37, GHK-Cu, Dihexa, Melanotan-II, PEG-MGF) and the associated 'approximately February 2027' evaluation track — they were not on the FDA meeting notice and not supported by any source, and the dataset went from 12 rows to the 7 peptides the FDA actually evaluated; anyone holding a v1.0.0 copy should discard those five rows. The same release resolved the July 23 outcomes: KPV and TB-500 from an unconfirmed 'narrow split' to 8-6-1, and MOTS-c from UNVERIFIED to 7-5. It also dropped an unsourced comparative characterization of MOTS-c as \"the weakest case cited\", which had been published in v1.0.0 without a changelog entry at the time. v1.0.0 (2026-07-23): first publication.", "timeline": [ { "date": "2026-04-22", "dateLabel": "April 22, 2026", "title": "FDA updates the 503A bulk-substances nomination list", "detail": "Among other changes, the update removed 12 research peptides — including BPC-157, Semax, and TB-500 — from Category 2 of the nomination list. It is a step inside the same unfinished 503A nomination process, not a ban and not an approval.", "sources": [ { "title": "FDA — Bulk Drug Substances Nominated for Use in Compounding Under Section 503A", "url": "https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-nominated-use-compounding-under-section-503a-fdca", "fetched": "2026-07-25" } ], "status": "past" }, { "date": "2026-06-30", "dateLabel": "June 30, 2026", "title": "FDA staff review reported — recommends against listing all seven", "detail": "As reported on June 30, 2026, FDA career scientists highlighted safety risks and what they described as little evidence of benefit, and recommended against adding any of the seven peptides to the 503A bulks list.", "sources": [ { "title": "Reuters — FDA staff highlights peptide risks, says little evidence of benefits, 2026-06-30", "url": "https://www.reuters.com/business/healthcare-pharmaceuticals/us-fda-staff-highlights-peptide-risks-says-little-evidence-benefits-2026-06-30/", "fetched": "2026-06-30" } ], "status": "past" }, { "date": "2026-07-23", "dateLabel": "July 23, 2026", "title": "PCAC day one — four peptides evaluated, four recommended", "detail": "The advisory committee voted to recommend BPC-157 (8-6-1), KPV (8-6-1), TB-500 (8-6-1), and MOTS-c (7-5) for the 503A bulks list, against the recommendation of FDA staff. These are non-binding advisory votes, not FDA approval.", "sources": [ { "title": "FDA — July 23-24, 2026 Meeting of the Pharmacy Compounding Advisory Committee (agenda and uses evaluated)", "url": "https://www.fda.gov/advisory-committees/advisory-committee-calendar/july-23-24-2026-meeting-pharmacy-compounding-advisory-committee-07232026", "fetched": "2026-07-25" }, { "title": "Reuters — FDA advisers back first four of seven unapproved peptides under review for looser rules, 2026-07-23", "url": "https://www.reuters.com/legal/litigation/us-fda-advisers-weigh-restrictions-seven-peptides-industry-presses-expansion-2026-07-23/", "fetched": "2026-07-25" }, { "title": "RAPS — FDA advisory committee backs two controversial peptides, 2026-07-23", "url": "https://www.raps.org/resource/fda-advisory-committee-backs-two-controversial-peptides.html", "fetched": "2026-07-25" } ], "status": "past" }, { "date": "2026-07-24", "dateLabel": "July 24, 2026", "title": "PCAC day two — three peptides evaluated, one rejected", "detail": "The committee recommended Semax (8-5) and Epitalon (7-5-1), and voted against Emideltide, also called DSIP (6-7-1) — the meeting's only rejection, and its only vote that agreed with FDA staff. Six of seven recommended across the two days.", "sources": [ { "title": "FDA — July 23-24, 2026 Meeting of the Pharmacy Compounding Advisory Committee (agenda and uses evaluated)", "url": "https://www.fda.gov/advisory-committees/advisory-committee-calendar/july-23-24-2026-meeting-pharmacy-compounding-advisory-committee-07232026", "fetched": "2026-07-25" }, { "title": "RAPS — FDA advisory committee backs two more peptides, rejects one for compounding list, 2026-07-24", "url": "https://www.raps.org/resource/fda-advisory-committee-backs-two-more-peptides-rejects-one-for-compounding-list.html", "fetched": "2026-07-25" } ], "status": "past" }, { "date": "", "dateLabel": "Next step — no date", "title": "An FDA decision on the recommendations", "detail": "The FDA has not acted on the committee's recommendations. Adding any substance to the 503A bulks list requires a full rulemaking — a proposed rule, a public comment period, and a final rule the agency can decline to issue. Rulemaking of this kind has historically run on the order of 12 to 24 months; that duration is our characterization of past FDA rulemakings, not a figure the FDA has published for this one. We are not attaching a date to this, and no one credibly can. This entry updates when the FDA moves.", "sources": [ { "title": "FDA — Compounding Laws and Policies", "url": "https://www.fda.gov/drugs/human-drug-compounding/compounding-laws-and-policies", "fetched": "2026-07-25" }, { "title": "FDA — Pharmacy Compounding Advisory Committee (PCAC)", "url": "https://www.fda.gov/advisory-committees/human-drug-advisory-committees/pharmacy-compounding-advisory-committee", "fetched": "2026-07-25" } ], "status": "pending" } ], "claimChecks": [ { "question": "Did the FDA approve BPC-157, or any of these peptides, in July 2026?", "shortAnswer": "No.", "detail": "An FDA advisory committee (PCAC) voted to recommend six of them for the list of bulk substances pharmacies may compound under Section 503A. A recommendation from that committee is non-binding, it is not FDA approval, and on all six recommendations it went against the FDA's own staff scientists. None of these peptides is an FDA-approved drug.", "sources": [ { "title": "FDA — Pharmacy Compounding Advisory Committee (PCAC)", "url": "https://www.fda.gov/advisory-committees/human-drug-advisory-committees/pharmacy-compounding-advisory-committee", "fetched": "2026-07-25" }, { "title": "FDA — July 23-24, 2026 Meeting of the Pharmacy Compounding Advisory Committee (agenda and uses evaluated)", "url": "https://www.fda.gov/advisory-committees/advisory-committee-calendar/july-23-24-2026-meeting-pharmacy-compounding-advisory-committee-07232026", "fetched": "2026-07-25" }, { "title": "Reuters — FDA advisers back first four of seven unapproved peptides under review for looser rules, 2026-07-23", "url": "https://www.reuters.com/legal/litigation/us-fda-advisers-weigh-restrictions-seven-peptides-industry-presses-expansion-2026-07-23/", "fetched": "2026-07-25" } ] }, { "question": "Is it legal to compound or buy these peptides right now?", "shortAnswer": "No.", "detail": "None of the seven is on the FDA's 503A bulks list, and the rulemaking that could add any of them has not been completed. Anyone describing these peptides as legal to order today is describing something that has not happened.", "sources": [ { "title": "FDA — Bulk Drug Substances Nominated for Use in Compounding Under Section 503A", "url": "https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-nominated-use-compounding-under-section-503a-fdca", "fetched": "2026-07-25" }, { "title": "FDA — Compounding Laws and Policies", "url": "https://www.fda.gov/drugs/human-drug-compounding/compounding-laws-and-policies", "fetched": "2026-07-25" } ] }, { "question": "Did the committee recommend all seven peptides?", "shortAnswer": "No — six of seven.", "detail": "Emideltide, also called DSIP, was rejected 6-7-1 on July 24, 2026. It was the committee's only rejection and the only vote that agreed with FDA staff, who cited a lack of safety and efficacy data, inadequate characterization of the substance, and existing approved therapies for the proposed uses. A rejection is not an FDA final decision either.", "sources": [ { "title": "FDA — July 23-24, 2026 Meeting of the Pharmacy Compounding Advisory Committee (agenda and uses evaluated)", "url": "https://www.fda.gov/advisory-committees/advisory-committee-calendar/july-23-24-2026-meeting-pharmacy-compounding-advisory-committee-07232026", "fetched": "2026-07-25" }, { "title": "RAPS — FDA advisory committee backs two more peptides, rejects one for compounding list, 2026-07-24", "url": "https://www.raps.org/resource/fda-advisory-committee-backs-two-more-peptides-rejects-one-for-compounding-list.html", "fetched": "2026-07-25" } ] }, { "question": "When will these peptides become available?", "shortAnswer": "There is no reliable date.", "detail": "Adding a substance to the 503A bulks list requires a full FDA rulemaking — proposed rule, public comment, final rule — that the agency can decline to complete. Rulemaking of this kind has historically run on the order of 12 to 24 months; that duration is our characterization of past FDA rulemakings, not a figure the FDA has published for this one. We will not promise a timeline, and a specific launch date from any seller is a signal to be skeptical.", "sources": [ { "title": "FDA — Compounding Laws and Policies", "url": "https://www.fda.gov/drugs/human-drug-compounding/compounding-laws-and-policies", "fetched": "2026-07-25" } ] }, { "question": "Does a PCAC recommendation mean the FDA will add these to the list?", "shortAnswer": "No — it is advice the FDA can decline.", "detail": "PCAC advises the FDA; it does not set policy. The FDA's own career scientists recommended against listing all seven peptides, and the agency has made no final decision on any of them.", "sources": [ { "title": "FDA — Pharmacy Compounding Advisory Committee (PCAC)", "url": "https://www.fda.gov/advisory-committees/human-drug-advisory-committees/pharmacy-compounding-advisory-committee", "fetched": "2026-07-25" }, { "title": "Reuters — FDA staff highlights peptide risks, says little evidence of benefits, 2026-06-30", "url": "https://www.reuters.com/business/healthcare-pharmaceuticals/us-fda-staff-highlights-peptide-risks-says-little-evidence-benefits-2026-06-30/", "fetched": "2026-06-30" } ] }, { "question": "Does Cora Health sell peptides?", "shortAnswer": "No.", "detail": "Cora Health does not sell, prescribe, or compound peptides. Cora does not prescribe medication at all — licensed providers at Wasef Health, PC make every prescribing decision, and the compounded medications available through Cora Health are prescribed by licensed providers and prepared by Hallandale Pharmacy or VialsRx, both US-licensed 503A compounding pharmacies. Compounded medications are not FDA-approved.", "sources": [] } ], "rows": [ { "peptide": "BPC-157", "slug": "bpc-157", "context": "BPC-157 is one of the seven peptides the FDA's Pharmacy Compounding Advisory Committee evaluated in July 2026. The use the FDA evaluated was ulcerative colitis. The human evidence is thin: FDA staff cited insufficient human data, and the only human evidence located in the sources reviewed is a single small, decades-old abstract. On July 23, 2026 the committee voted 8-6-1 to recommend adding it to the Section 503A bulks list, against the recommendation of FDA staff scientists.", "pcac_status": "Recommended for the 503A bulks list, 8-6-1, 2026-07-23 (advisory recommendation, against FDA staff)", "legal_to_compound_today": "No — not on the FDA 503A bulks list; no final rule", "fda_approved_drug": "No", "evaluated_use": "Studied for tissue and gut repair; the use FDA evaluated was ulcerative colitis", "human_clinical_data": "Limited — a single small, decades-old abstract; FDA staff cited insufficient human data", "wada_status": "Not addressed in the sources reviewed", "evaluation_track": "PCAC evaluated 2026-07-23", "notes": "Recommended 8-6-1 on July 23, 2026 for ulcerative colitis, over FDA staff's position that the human data is insufficient — the only human evidence located in the sources reviewed is a single small, decades-old abstract. Advisory recommendation only; being recommended for the 503A bulks list would permit compounding under a patient-specific prescription and is not the same as being an FDA-approved, FDA-reviewed drug. FDA career scientists recommended against listing, and the FDA has not made a final decision. It is not legal to compound today.", "sources": [ { "title": "FDA — Pharmacy Compounding Advisory Committee (PCAC)", "url": "https://www.fda.gov/advisory-committees/human-drug-advisory-committees/pharmacy-compounding-advisory-committee", "fetched": "2026-07-25" }, { "title": "FDA — Bulk Drug Substances Nominated for Use in Compounding Under Section 503A", "url": "https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-nominated-use-compounding-under-section-503a-fdca", "fetched": "2026-07-25" }, { "title": "FDA — July 23-24, 2026 Meeting of the Pharmacy Compounding Advisory Committee (agenda and uses evaluated)", "url": "https://www.fda.gov/advisory-committees/advisory-committee-calendar/july-23-24-2026-meeting-pharmacy-compounding-advisory-committee-07232026", "fetched": "2026-07-25" }, { "title": "RAPS — FDA advisory committee backs two controversial peptides, 2026-07-23", "url": "https://www.raps.org/resource/fda-advisory-committee-backs-two-controversial-peptides.html", "fetched": "2026-07-25" }, { "title": "Reuters — FDA staff highlights peptide risks, says little evidence of benefits, 2026-06-30", "url": "https://www.reuters.com/business/healthcare-pharmaceuticals/us-fda-staff-highlights-peptide-risks-says-little-evidence-benefits-2026-06-30/", "fetched": "2026-06-30" }, { "title": "Reuters — FDA advisers back first four of seven unapproved peptides under review for looser rules, 2026-07-23", "url": "https://www.reuters.com/legal/litigation/us-fda-advisers-weigh-restrictions-seven-peptides-industry-presses-expansion-2026-07-23/", "fetched": "2026-07-25" } ], "last_verified": "2026-07-25" }, { "peptide": "KPV", "slug": "kpv", "context": "KPV is a fragment of the hormone alpha-MSH and one of the seven peptides the FDA's Pharmacy Compounding Advisory Committee evaluated in July 2026. The uses the FDA evaluated were wound healing and inflammatory conditions. No human clinical trials of KPV were located in the sources reviewed, and FDA staff cited that absence of human data. On July 23, 2026 the committee voted 8-6-1 to recommend adding it to the Section 503A bulks list, against FDA staff.", "pcac_status": "Recommended for the 503A bulks list, 8-6-1, 2026-07-23 (advisory recommendation, against FDA staff)", "legal_to_compound_today": "No — not on the FDA 503A bulks list; no final rule", "fda_approved_drug": "No", "evaluated_use": "Fragment of alpha-MSH; the uses FDA evaluated were wound healing and inflammatory conditions", "human_clinical_data": "None found — no human clinical trials located; FDA staff cited absence of human data", "wada_status": "Not addressed in the sources reviewed", "evaluation_track": "PCAC evaluated 2026-07-23", "notes": "Recommended 8-6-1 on July 23, 2026 for wound healing and inflammatory conditions, over FDA staff's position that no human clinical trials of KPV could be located. Advisory recommendation only; being recommended for the 503A bulks list would permit compounding under a patient-specific prescription and is not the same as being an FDA-approved, FDA-reviewed drug. FDA career scientists recommended against listing, and the FDA has not made a final decision. It is not legal to compound today.", "sources": [ { "title": "FDA — Pharmacy Compounding Advisory Committee (PCAC)", "url": "https://www.fda.gov/advisory-committees/human-drug-advisory-committees/pharmacy-compounding-advisory-committee", "fetched": "2026-07-25" }, { "title": "FDA — Bulk Drug Substances Nominated for Use in Compounding Under Section 503A", "url": "https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-nominated-use-compounding-under-section-503a-fdca", "fetched": "2026-07-25" }, { "title": "FDA — July 23-24, 2026 Meeting of the Pharmacy Compounding Advisory Committee (agenda and uses evaluated)", "url": "https://www.fda.gov/advisory-committees/advisory-committee-calendar/july-23-24-2026-meeting-pharmacy-compounding-advisory-committee-07232026", "fetched": "2026-07-25" }, { "title": "RAPS — FDA advisory committee backs two controversial peptides, 2026-07-23", "url": "https://www.raps.org/resource/fda-advisory-committee-backs-two-controversial-peptides.html", "fetched": "2026-07-25" }, { "title": "Reuters — FDA staff highlights peptide risks, says little evidence of benefits, 2026-06-30", "url": "https://www.reuters.com/business/healthcare-pharmaceuticals/us-fda-staff-highlights-peptide-risks-says-little-evidence-benefits-2026-06-30/", "fetched": "2026-06-30" }, { "title": "Reuters — FDA advisers back first four of seven unapproved peptides under review for looser rules, 2026-07-23", "url": "https://www.reuters.com/legal/litigation/us-fda-advisers-weigh-restrictions-seven-peptides-industry-presses-expansion-2026-07-23/", "fetched": "2026-07-25" } ], "last_verified": "2026-07-25" }, { "peptide": "TB-500", "slug": "tb-500", "context": "TB-500 is a thymosin beta-4 fragment and one of the seven peptides the FDA's Pharmacy Compounding Advisory Committee evaluated in July 2026. The use the FDA evaluated was wound healing. No human clinical studies were located in the sources reviewed, and FDA staff cited that absence of human data. It is prohibited by the World Anti-Doping Agency. On July 23, 2026 the committee voted 8-6-1 to recommend adding it to the Section 503A bulks list, against FDA staff.", "pcac_status": "Recommended for the 503A bulks list, 8-6-1, 2026-07-23 (advisory recommendation, against FDA staff)", "legal_to_compound_today": "No — not on the FDA 503A bulks list; no final rule", "fda_approved_drug": "No", "evaluated_use": "Thymosin beta-4 fragment; the use FDA evaluated was wound healing", "human_clinical_data": "None found — no human clinical studies located; FDA staff cited absence of human data", "wada_status": "Prohibited (WADA)", "evaluation_track": "PCAC evaluated 2026-07-23", "notes": "Recommended 8-6-1 on July 23, 2026 for wound healing, over FDA staff's position that no human clinical studies could be located; TB-500 is also prohibited by the World Anti-Doping Agency. Advisory recommendation only; being recommended for the 503A bulks list would permit compounding under a patient-specific prescription and is not the same as being an FDA-approved, FDA-reviewed drug. FDA career scientists recommended against listing, and the FDA has not made a final decision. It is not legal to compound today.", "sources": [ { "title": "FDA — Pharmacy Compounding Advisory Committee (PCAC)", "url": "https://www.fda.gov/advisory-committees/human-drug-advisory-committees/pharmacy-compounding-advisory-committee", "fetched": "2026-07-25" }, { "title": "FDA — Bulk Drug Substances Nominated for Use in Compounding Under Section 503A", "url": "https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-nominated-use-compounding-under-section-503a-fdca", "fetched": "2026-07-25" }, { "title": "FDA — July 23-24, 2026 Meeting of the Pharmacy Compounding Advisory Committee (agenda and uses evaluated)", "url": "https://www.fda.gov/advisory-committees/advisory-committee-calendar/july-23-24-2026-meeting-pharmacy-compounding-advisory-committee-07232026", "fetched": "2026-07-25" }, { "title": "RAPS — FDA advisory committee backs two controversial peptides, 2026-07-23", "url": "https://www.raps.org/resource/fda-advisory-committee-backs-two-controversial-peptides.html", "fetched": "2026-07-25" }, { "title": "Reuters — FDA staff highlights peptide risks, says little evidence of benefits, 2026-06-30", "url": "https://www.reuters.com/business/healthcare-pharmaceuticals/us-fda-staff-highlights-peptide-risks-says-little-evidence-benefits-2026-06-30/", "fetched": "2026-06-30" }, { "title": "Reuters — FDA advisers back first four of seven unapproved peptides under review for looser rules, 2026-07-23", "url": "https://www.reuters.com/legal/litigation/us-fda-advisers-weigh-restrictions-seven-peptides-industry-presses-expansion-2026-07-23/", "fetched": "2026-07-25" } ], "last_verified": "2026-07-25" }, { "peptide": "MOTS-c", "slug": "mots-c", "context": "MOTS-c is a mitochondrial-derived peptide and the only peptide in the set whose FDA-evaluated use includes obesity — the uses the FDA evaluated were obesity and osteoporosis. Because obesity was among the uses the FDA evaluated, it is worth being precise: no human clinical data for MOTS-c was located in the sources reviewed, it is prohibited by the World Anti-Doping Agency, and it is not an alternative to a prescribed GLP-1 medication. On July 23, 2026 the committee voted 7-5 to recommend adding it to the Section 503A bulks list, against FDA staff.", "pcac_status": "Recommended for the 503A bulks list, 7-5, 2026-07-23 (advisory recommendation, against FDA staff)", "legal_to_compound_today": "No — not on the FDA 503A bulks list; no final rule", "fda_approved_drug": "No", "evaluated_use": "Mitochondrial-derived peptide; the uses FDA evaluated were obesity and osteoporosis", "human_clinical_data": "None found — no human clinical data located", "wada_status": "Prohibited (WADA)", "evaluation_track": "PCAC evaluated 2026-07-23", "notes": "The only peptide in the set whose FDA-evaluated use includes obesity; it is not an alternative to a prescribed GLP-1 medication. Recommended 7-5 on July 23, 2026 for obesity and osteoporosis, on a smaller panel tally than the 8-6-1 recorded for BPC-157/KPV/TB-500 — the margin was two votes in both cases. Advisory recommendation only; being recommended for the 503A bulks list would permit compounding under a patient-specific prescription and is not the same as being an FDA-approved, FDA-reviewed drug. FDA career scientists recommended against listing, and the FDA has not made a final decision. It is not legal to compound today.", "sources": [ { "title": "FDA — Pharmacy Compounding Advisory Committee (PCAC)", "url": "https://www.fda.gov/advisory-committees/human-drug-advisory-committees/pharmacy-compounding-advisory-committee", "fetched": "2026-07-25" }, { "title": "FDA — Bulk Drug Substances Nominated for Use in Compounding Under Section 503A", "url": "https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-nominated-use-compounding-under-section-503a-fdca", "fetched": "2026-07-25" }, { "title": "FDA — July 23-24, 2026 Meeting of the Pharmacy Compounding Advisory Committee (agenda and uses evaluated)", "url": "https://www.fda.gov/advisory-committees/advisory-committee-calendar/july-23-24-2026-meeting-pharmacy-compounding-advisory-committee-07232026", "fetched": "2026-07-25" }, { "title": "Reuters — FDA staff highlights peptide risks, says little evidence of benefits, 2026-06-30", "url": "https://www.reuters.com/business/healthcare-pharmaceuticals/us-fda-staff-highlights-peptide-risks-says-little-evidence-benefits-2026-06-30/", "fetched": "2026-06-30" }, { "title": "Reuters — FDA advisers back first four of seven unapproved peptides under review for looser rules, 2026-07-23", "url": "https://www.reuters.com/legal/litigation/us-fda-advisers-weigh-restrictions-seven-peptides-industry-presses-expansion-2026-07-23/", "fetched": "2026-07-25" } ], "last_verified": "2026-07-25" }, { "peptide": "Emideltide", "aka": "DSIP", "slug": "emideltide-dsip", "context": "Emideltide, also called delta sleep-inducing peptide (DSIP), is the one peptide of the seven that the FDA's Pharmacy Compounding Advisory Committee voted AGAINST in July 2026. The uses the FDA evaluated were opioid withdrawal, chronic insomnia, and narcolepsy. No human clinical data was located in the sources reviewed; FDA cited a lack of safety and efficacy data, inadequate characterization of the substance, and existing approved therapies for the proposed uses, and a witness noted the last study was roughly 30 years old. On July 24, 2026 the committee voted 6-7-1 against adding it to the Section 503A bulks list.", "pcac_status": "Rejected by PCAC — voted against inclusion on the 503A bulks list, 6-7-1, 2026-07-24 (the committee's only rejection)", "legal_to_compound_today": "No — not on the FDA 503A bulks list; no final rule", "fda_approved_drug": "No", "evaluated_use": "Delta sleep-inducing peptide (DSIP); the uses FDA evaluated were opioid withdrawal, chronic insomnia, and narcolepsy", "human_clinical_data": "None found — FDA cited a lack of safety and efficacy data and inadequate characterization; a witness noted the last study was roughly 30 years old", "wada_status": "Not addressed in the sources reviewed", "evaluation_track": "PCAC evaluated 2026-07-24", "notes": "PCAC voted against adding Emideltide to the 503A bulks list, aligning with FDA staff, who cited a lack of safety and efficacy data, inadequate characterization, and existing FDA-approved therapies for the proposed uses. Not an FDA final decision either way.", "sources": [ { "title": "FDA — Pharmacy Compounding Advisory Committee (PCAC)", "url": "https://www.fda.gov/advisory-committees/human-drug-advisory-committees/pharmacy-compounding-advisory-committee", "fetched": "2026-07-25" }, { "title": "FDA — Bulk Drug Substances Nominated for Use in Compounding Under Section 503A", "url": "https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-nominated-use-compounding-under-section-503a-fdca", "fetched": "2026-07-25" }, { "title": "FDA — July 23-24, 2026 Meeting of the Pharmacy Compounding Advisory Committee (agenda and uses evaluated)", "url": "https://www.fda.gov/advisory-committees/advisory-committee-calendar/july-23-24-2026-meeting-pharmacy-compounding-advisory-committee-07232026", "fetched": "2026-07-25" }, { "title": "Reuters — FDA staff highlights peptide risks, says little evidence of benefits, 2026-06-30", "url": "https://www.reuters.com/business/healthcare-pharmaceuticals/us-fda-staff-highlights-peptide-risks-says-little-evidence-benefits-2026-06-30/", "fetched": "2026-06-30" }, { "title": "RAPS — FDA advisory committee backs two more peptides, rejects one for compounding list, 2026-07-24", "url": "https://www.raps.org/resource/fda-advisory-committee-backs-two-more-peptides-rejects-one-for-compounding-list.html", "fetched": "2026-07-25" } ], "last_verified": "2026-07-25" }, { "peptide": "Semax", "slug": "semax", "context": "Semax is one of the seven peptides the FDA's Pharmacy Compounding Advisory Committee evaluated in July 2026. The uses the FDA evaluated were cerebral ischemia, migraine, and trigeminal neuralgia. Human clinical data for Semax was not detailed in the sources reviewed, so this entry asserts none. On July 24, 2026 the committee voted 8-5 to recommend adding it to the Section 503A bulks list, against the recommendation of FDA staff scientists, who recommended against listing all seven peptides under review.", "pcac_status": "Recommended for the 503A bulks list, 8-5, 2026-07-24 (advisory recommendation, against FDA staff)", "legal_to_compound_today": "No — not on the FDA 503A bulks list; no final rule", "fda_approved_drug": "No", "evaluated_use": "The uses FDA evaluated were cerebral ischemia, migraine, and trigeminal neuralgia", "human_clinical_data": "Not detailed in the sources reviewed", "wada_status": "Not addressed in the sources reviewed", "evaluation_track": "PCAC evaluated 2026-07-24", "notes": "Recommended 8-5 on July 24, 2026 for cerebral ischemia, migraine and trigeminal neuralgia. Human clinical data for Semax was not detailed in the sources reviewed, so this entry asserts none. Advisory recommendation only; being recommended for the 503A bulks list would permit compounding under a patient-specific prescription and is not the same as being an FDA-approved, FDA-reviewed drug. FDA career scientists recommended against listing, and the FDA has not made a final decision. It is not legal to compound today.", "sources": [ { "title": "FDA — Pharmacy Compounding Advisory Committee (PCAC)", "url": "https://www.fda.gov/advisory-committees/human-drug-advisory-committees/pharmacy-compounding-advisory-committee", "fetched": "2026-07-25" }, { "title": "FDA — Bulk Drug Substances Nominated for Use in Compounding Under Section 503A", "url": "https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-nominated-use-compounding-under-section-503a-fdca", "fetched": "2026-07-25" }, { "title": "FDA — July 23-24, 2026 Meeting of the Pharmacy Compounding Advisory Committee (agenda and uses evaluated)", "url": "https://www.fda.gov/advisory-committees/advisory-committee-calendar/july-23-24-2026-meeting-pharmacy-compounding-advisory-committee-07232026", "fetched": "2026-07-25" }, { "title": "Reuters — FDA staff highlights peptide risks, says little evidence of benefits, 2026-06-30", "url": "https://www.reuters.com/business/healthcare-pharmaceuticals/us-fda-staff-highlights-peptide-risks-says-little-evidence-benefits-2026-06-30/", "fetched": "2026-06-30" }, { "title": "RAPS — FDA advisory committee backs two more peptides, rejects one for compounding list, 2026-07-24", "url": "https://www.raps.org/resource/fda-advisory-committee-backs-two-more-peptides-rejects-one-for-compounding-list.html", "fetched": "2026-07-25" } ], "last_verified": "2026-07-25" }, { "peptide": "Epitalon", "slug": "epitalon", "context": "Epitalon is one of the seven peptides the FDA's Pharmacy Compounding Advisory Committee evaluated in July 2026. The use the FDA evaluated was insomnia. No human clinical data was located in the sources reviewed: FDA staff cited no published efficacy data for the proposed insomnia use, plus immunogenicity and impurity risks. On July 24, 2026 the committee voted 7-5-1 to recommend adding it to the Section 503A bulks list, against FDA staff.", "pcac_status": "Recommended for the 503A bulks list, 7-5-1, 2026-07-24 (advisory recommendation, against FDA staff)", "legal_to_compound_today": "No — not on the FDA 503A bulks list; no final rule", "fda_approved_drug": "No", "evaluated_use": "The use FDA evaluated was insomnia", "human_clinical_data": "None found — FDA cited no published efficacy data for the proposed insomnia use, plus immunogenicity and impurity risks", "wada_status": "Not addressed in the sources reviewed", "evaluation_track": "PCAC evaluated 2026-07-24", "notes": "Recommended 7-5-1 on July 24, 2026 for insomnia, over FDA staff's position that there is no published efficacy data for the proposed insomnia use, alongside immunogenicity and impurity risks. Advisory recommendation only; being recommended for the 503A bulks list would permit compounding under a patient-specific prescription and is not the same as being an FDA-approved, FDA-reviewed drug. FDA career scientists recommended against listing, and the FDA has not made a final decision. It is not legal to compound today.", "sources": [ { "title": "FDA — Pharmacy Compounding Advisory Committee (PCAC)", "url": "https://www.fda.gov/advisory-committees/human-drug-advisory-committees/pharmacy-compounding-advisory-committee", "fetched": "2026-07-25" }, { "title": "FDA — Bulk Drug Substances Nominated for Use in Compounding Under Section 503A", "url": "https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-nominated-use-compounding-under-section-503a-fdca", "fetched": "2026-07-25" }, { "title": "FDA — July 23-24, 2026 Meeting of the Pharmacy Compounding Advisory Committee (agenda and uses evaluated)", "url": "https://www.fda.gov/advisory-committees/advisory-committee-calendar/july-23-24-2026-meeting-pharmacy-compounding-advisory-committee-07232026", "fetched": "2026-07-25" }, { "title": "Reuters — FDA staff highlights peptide risks, says little evidence of benefits, 2026-06-30", "url": "https://www.reuters.com/business/healthcare-pharmaceuticals/us-fda-staff-highlights-peptide-risks-says-little-evidence-benefits-2026-06-30/", "fetched": "2026-06-30" }, { "title": "RAPS — FDA advisory committee backs two more peptides, rejects one for compounding list, 2026-07-24", "url": "https://www.raps.org/resource/fda-advisory-committee-backs-two-more-peptides-rejects-one-for-compounding-list.html", "fetched": "2026-07-25" } ], "last_verified": "2026-07-25" } ] }