--- title: "Regulatory status, line by line" url: https://humanpeptides.fyi/knowledge-base/regulatory-status site: humanpeptides.fyi last_reviewed: 2026-10-12 --- # Regulatory status, line by line These are the regulatory statements this index records for each compound, quoted as recorded, with the source for each. They are not legal conclusions, and statements can change: the linked source is the authority. Terms are defined in the [glossary](https://humanpeptides.fyi/glossary): [FDA-approved](https://humanpeptides.fyi/glossary#fda-approved), [accelerated approval](https://humanpeptides.fyi/glossary#accelerated-approval), [off-label](https://humanpeptides.fyi/glossary#off-label), [compounding](https://humanpeptides.fyi/glossary#compounding), [503A and 503B](https://humanpeptides.fyi/glossary#503a), [FDA Category 1 and Category 2](https://humanpeptides.fyi/glossary#category-2), [PCAC](https://humanpeptides.fyi/glossary#pcac), [research use only](https://humanpeptides.fyi/glossary#ruo), [WADA Prohibited List](https://humanpeptides.fyi/glossary#wada). - [HCG](https://humanpeptides.fyi/peptides/hcg) (Approved (specific use)): FDA has approved HCG as a prescription drug for female infertility and other medical conditions; it is not approved for weight loss or for use without a prescription, and FDA advises consumers to avoid HCG weight-loss products sold as oral drops, pellets and sprays. Source: https://www.fda.gov/consumers/consumer-updates/avoid-dangerous-hcg-diet-products - [HGH (Somatropin)](https://humanpeptides.fyi/peptides/hgh) (Approved (specific use)): FDA-approved only for specific conditions such as childhood growth failure and adult GH deficiency; US federal law (21 U.S.C. 333(e)) makes it a crime to distribute HGH for unapproved uses, and FDA states no anti-aging, bodybuilding or athletic use has been authorized. Source: https://www.accessdata.fda.gov/cms_ia/importalert_204.html - [L-carnitine](https://humanpeptides.fyi/peptides/l-carnitine) (Approved (specific use)): FDA-approved as Carnitor (levocarnitine) for primary systemic carnitine deficiency and for inborn errors of metabolism that cause secondary carnitine deficiency. Source: https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/018948s028,019257s014lbl.pdf - [PT-141](https://humanpeptides.fyi/peptides/pt-141) (Approved (specific use)): FDA-approved in 2019 as Vyleesi for premenopausal women with acquired, generalized hypoactive sexual desire disorder; the label states it is not indicated for this condition in postmenopausal women or in men. Source: https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210557s000lbl.pdf - [Semaglutide](https://humanpeptides.fyi/peptides/semaglutide) (Approved (specific use)): FDA warns that compounded and other unapproved versions of semaglutide do not undergo FDA review for safety, effectiveness or quality before they are marketed, and that counterfeit Ozempic has been marketed in the US. Source: https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/fdas-concerns-unapproved-glp-1-drugs-used-weight-loss - [SS-31](https://humanpeptides.fyi/peptides/ss-31) (Approved (specific use)): FDA granted accelerated approval on September 19, 2025 to elamipretide (Forzinity) as the first treatment for Barth syndrome in patients weighing at least 30 kg; continued approval depends on a confirmatory trial. Source: https://www.fda.gov/news-events/press-announcements/fda-grants-accelerated-approval-first-treatment-barth-syndrome - [Tesamorelin](https://humanpeptides.fyi/peptides/tesamorelin) (Approved (specific use)): FDA-approved since 2010 and available in two formulations, Egrifta SV and Egrifta WR, for the reduction of excess abdominal fat in HIV-infected adults with lipodystrophy; the label states it is not indicated for weight loss management. Source: https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/022505s020lbl.pdf - [Tirzepatide](https://humanpeptides.fyi/peptides/tirzepatide) (Approved (specific use)): Tirzepatide was first approved in the US in 2022, and Zepbound is FDA-approved, with a reduced-calorie diet and increased physical activity, to reduce excess body weight and maintain weight reduction long term in adults with obesity, or with overweight and a weight-related condition, and to treat moderate to severe obstructive sleep apnea in adults with obesity. Source: https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/217806s042lbl.pdf - [Vitamin B12](https://humanpeptides.fyi/peptides/vitamin-b12) (Approved (specific use)): Cyanocobalamin injection is a prescription drug whose US label covers vitamin B12 deficiency due to malabsorption, such as pernicious anemia; energy and weight-loss uses are not labeled indications. Source: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a66eb3c4-3e1d-4d49-b963-4fa2334cc9b6 - [AOD9604](https://humanpeptides.fyi/peptides/aod9604) (Trial-backed): FDA listed AOD-9604 among nominated compounding substances that may present significant safety risks, citing immunogenicity and serious adverse events of unclear causality, and the nomination was later withdrawn. Source: https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks - [Cagrilintide](https://humanpeptides.fyi/peptides/cagrilintide) (Trial-backed): CagriSema (cagrilintide plus semaglutide) is not FDA-approved; Novo Nordisk submitted its application in December 2025, and the company expects an FDA decision in the fourth quarter of 2026. Source: https://www.medicaldaily.com/cagrisema-brain-scan-food-noise-fda-decision-479416 - [Glutathione](https://humanpeptides.fyi/peptides/glutathione) (Trial-backed): Glutathione is in FDA's 503A Category 1, bulk substances under evaluation for compounding, as of the May 14, 2026 list. Source: https://www.fda.gov/media/94155/download - [Retatrutide](https://humanpeptides.fyi/peptides/retatrutide) (Trial-backed): Not a component of any FDA-approved drug; FDA states retatrutide cannot be used in compounding under federal law and has not been found safe and effective for any condition, and has warned companies marketing or selling unapproved versions. Source: https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/fdas-concerns-unapproved-glp-1-drugs-used-weight-loss - [Thymosin Alpha-1](https://humanpeptides.fyi/peptides/thymosin-alpha-1) (Trial-backed): Not FDA-approved; in a December 2024 briefing, FDA staff concluded the criteria weigh against adding it to the 503A compounding list, though thymalfasin (Zadaxin) is approved abroad, including in Italy, India and Hong Kong. Source: https://www.fda.gov/media/183820/download - [ARA-290](https://humanpeptides.fyi/peptides/ara-290) (Early human): FDA granted ARA 290, then a clinical-stage product candidate, orphan drug designation for sarcoidosis in 2016, a designation that brings development incentives rather than an approval. Source: https://www.biospace.com/araim-pharmaeuticals-receives-orphan-drug-designation-from-the-us-fda-for-ara-290-for-the-treatment-of-sarcoidosis - [CJC-1295 with DAC](https://humanpeptides.fyi/peptides/cjc-1295-dac) (Early human): FDA listed CJC-1295 among nominated compounding substances that may present significant safety risks, citing serious adverse events including increased heart rate and a systemic vasodilatory reaction, and the nomination was later withdrawn. Source: https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks - [DSIP](https://humanpeptides.fyi/peptides/dsip) (Early human): On July 24, 2026, FDA's Pharmacy Compounding Advisory Committee voted 6 to 7 against adding emideltide (DSIP) to the 503A bulks list after FDA reviewed it for opioid withdrawal, chronic insomnia and narcolepsy. Source: https://www.mcdermottlaw.com/insights/bulk-list-bound-pcac-backs-majority-of-peptides-in-two-day-public-meeting/ - [Epithalon](https://humanpeptides.fyi/peptides/epithalon) (Early human): On July 24, 2026, FDA's Pharmacy Compounding Advisory Committee voted 7 to 4 to recommend adding epitalon to the 503A bulks list after FDA reviewed it for insomnia, against FDA scientists' advice, a non-binding step that still requires rulemaking. Source: https://www.mcdermottlaw.com/insights/bulk-list-bound-pcac-backs-majority-of-peptides-in-two-day-public-meeting/ - [GHK-Cu](https://humanpeptides.fyi/peptides/ghk-cu) (Early human): GHK-Cu for non-injectable routes was returned to FDA's 503A Category 1 (under evaluation for compounding) on May 14, 2026, with an advisory committee consult planned before the end of February 2027, while nominations for injectable use were withdrawn. Source: https://www.fda.gov/media/94155/download - [Kisspeptin](https://humanpeptides.fyi/peptides/kisspeptin) (Early human): Since September 2023 kisspeptin-10 has been on FDA's 503A Category 2 list of bulk substances that may present significant safety risks in compounding, with FDA citing possible immunogenicity and too little safety information to know whether it would harm people. Source: https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks - [Melanotan II](https://humanpeptides.fyi/peptides/melanotan-ii) (Early human): Australia's TGA lists Melanotan II as a prescription-only medicine that is not approved as a tanning agent, with no approved products, and in August 2026 warned consumers after seized tanning nasal sprays proved inconsistently dosed. Source: https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts/melanotan-ii-tanning-peptide-products-found-be-inconsistently-dosed - [NAD+](https://humanpeptides.fyi/peptides/nad-plus) (Early human): In October 2024 FDA reminded compounders that food-grade NAD+ is not suitable for making sterile intravenous products without appropriate processing, and noted adverse event reports after NAD+ injections, including severe chills, shaking, vomiting and fatigue, consistent with excessive endotoxin levels. Source: https://www.fda.gov/drugs/human-drug-compounding/fda-reminds-compounders-use-ingredients-suitable-sterile-compounding - [Selank](https://humanpeptides.fyi/peptides/selank) (Early human): FDA lists selank acetate (TP-7) among compounding nominations withdrawn by their nominators after being placed in its safety-risk category, noting possible immunogenicity and that the agency lacks important information on its safety in humans. Source: https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks - [Semax](https://humanpeptides.fyi/peptides/semax) (Early human): Not FDA-approved; FDA told its July 2026 compounding advisory committee it proposed keeping Semax off the 503A bulks list, while noting Semax is a registered drug in Russia as nasal drops. Source: https://www.fda.gov/media/193774/download - [Sermorelin](https://humanpeptides.fyi/peptides/sermorelin) (Early human): Formerly FDA-approved as Geref for growth hormone deficiency in children and for diagnostic testing; the maker discontinued it in 2008, approval was withdrawn in 2009, and FDA later determined this was not for safety or effectiveness reasons. Source: https://www.govinfo.gov/content/pkg/FR-2013-03-04/html/2013-04827.htm - [Snap-8](https://humanpeptides.fyi/peptides/snap-8) (Early human): Snap-8 (acetyl octapeptide-3) is listed as a cosmetic ingredient in the EU and is not an approved drug; in the US, cosmetic ingredients need no FDA premarket approval, but a product intended to affect the body's structure or function is a drug, and no FDA drug approval for Snap-8 was found. Source: https://wikipep.org/wiki/Snap-8 - [Thymalin](https://humanpeptides.fyi/peptides/thymalin) (Early human): Approved for medical use in the Soviet Union by 1982 and still approved and widely used in Russia, Ukraine and other Eastern European countries, thymalin is not approved for human therapeutic use by the FDA or EMA. Source: https://www.seekpeptides.com/blog/articles/thymalin-peptide-benefits - [VIP](https://humanpeptides.fyi/peptides/vip) (Early human): In 2022 FDA declined emergency use authorization for aviptadil (Zyesami), a synthetic form of VIP, for COVID-19 respiratory failure. Source: https://www.managedhealthcareexecutive.com/view/fda-declines-eua-request-for-zyesami-for-covid-19 - [5-Amino-1MQ](https://humanpeptides.fyi/peptides/5-amino-1mq) (Preclinical): A March 2026 report on FDA warning letters says FDA inspectors found that compounder GenoGenix made 5-Amino-1MQ, which is ineligible for the section 503B compounding exemptions. Source: https://www.biospace.com/fda/fda-sends-30-warning-letters-to-continue-clampdown-on-compounded-glp-1s - [AHK-Cu](https://humanpeptides.fyi/peptides/ahk-cu) (Preclinical): FDA states that products claiming to restore hair growth are drugs even if marketed as cosmetics, and drugs generally need FDA approval or must conform to an over-the-counter monograph. Source: https://www.fda.gov/cosmetics/cosmetics-laws-regulations/it-cosmetic-drug-or-both-or-it-soap - [BPC-157](https://humanpeptides.fyi/peptides/bpc-157) (Preclinical): Not FDA-approved for any use; an FDA advisory committee voted 8-6 in July 2026 to recommend allowing pharmacy compounding, a nonbinding step that is not drug approval, and WADA prohibits it at all times under S0. Source: https://pepedhub.com/peptides/bpc-157 - [CJC-1295 without DAC](https://humanpeptides.fyi/peptides/cjc-1295-no-dac) (Preclinical): FDA's compounding safety listing for CJC-1295 (form not specified) cited serious adverse events including increased heart rate and a systemic vasodilatory reaction, and the nomination was later withdrawn. Source: https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks - [FOXO4-DRI](https://humanpeptides.fyi/peptides/foxo4-dri) (Preclinical): Not FDA-approved for any indication and never tested in a registered human trial; in the US it is classified as unregulated and is available as a research chemical. Source: https://www.peptideprotocolwiki.com/peptides/foxo4-dri - [IGF-1 LR3](https://humanpeptides.fyi/peptides/igf-1-lr3) (Preclinical): Not FDA-approved for human use and sold as a research chemical; the World Anti-Doping Agency bans IGF-1 variants in competitive sport. Source: https://www.seekpeptides.com/blog/articles/igf-1-lr3-peptide - [Ipamorelin](https://humanpeptides.fyi/peptides/ipamorelin) (Preclinical): Ipamorelin acetate has been in FDA's 503B compounding Category 2 (significant safety risks) since September 29, 2023, and FDA also lists a withdrawn ipamorelin acetate nomination that was previously in Category 2. Source: https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks - [KPV](https://humanpeptides.fyi/peptides/kpv) (Preclinical): Not FDA-approved; in July 2026 an FDA advisory committee voted 8-6-1 to recommend adding KPV to the 503A compounding bulks list, against FDA staff advice, but the vote is advisory and FDA's next step is notice-and-comment rulemaking. Source: https://www.sheppard.com/insights/blogs/compounded-peptides-on-the-loose-what-the-recent-pcac-meeting-means-for-industry - [MOTS-c](https://humanpeptides.fyi/peptides/mots-c) (Preclinical): Not approved by the US FDA for use in humans or in compounded medications, and an FDA briefing for its compounding advisory committee highlighted the lack of clinical data on efficacy or safety; it is prohibited at all times in sport under WADA's AMPK activator class. Source: https://www.usada.org/spirit-of-sport/what-is-mots-c-peptide/ - [TB-500](https://humanpeptides.fyi/peptides/tb-500) (Preclinical): Not FDA-approved; in July 2026 an FDA advisory panel voted 8-6 to recommend letting pharmacies compound TB-500, reviewed for wound healing, a nonbinding recommendation that still requires formal FDA rulemaking and is not approval. Source: https://www.pharmexec.com/view/fda-votes-loosen-restrictions-four-peptides - [Adamax](https://humanpeptides.fyi/peptides/adamax) (Unstudied): Not approved by the US FDA or any other regulator, with no registered clinical trials, and it does not appear on FDA's 503A compounding nomination lists. Source: https://wikipep.org/wiki/Adamax - [BPC-157 + TB-500](https://humanpeptides.fyi/peptides/bpc-157-tb-500) (Unstudied): FDA placed both BPC-157 and TB-500 on its high-risk compounding list in 2023, their removal was announced in 2026, and an FDA advisory panel then voted 8-6, nonbinding, to ease compounding. Source: https://www.pbs.org/newshour/health/watch-live-fda-advisory-panel-considers-use-of-peptides - [CJC-1295 + Ipamorelin](https://humanpeptides.fyi/peptides/cjc-1295-ipamorelin) (Unstudied): FDA lists CJC-1295 among compounding nominations that were withdrawn from Category 2, while ipamorelin acetate remains in 503B Category 2 for significant safety risks. Source: https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks - [GLOW](https://humanpeptides.fyi/peptides/glow) (Unstudied): FDA's 503A compounding listing for GHK-Cu, as of May 14, 2026, covers only non-injectable routes because the nomination for injectable use was withdrawn. Source: https://www.fda.gov/media/94155/download - [KLOW](https://humanpeptides.fyi/peptides/klow) (Unstudied): As of the July 2026 advisory vote, an FDA panel narrowly recommended BPC-157, KPV and TB-500 for the 503A compounding list against FDA staff advice, but none had been added to the list and none is an FDA-approved drug. Source: https://www.ajmc.com/view/fda-panel-backs-6-peptides-for-compounding - [Lemon Bottle](https://humanpeptides.fyi/peptides/lemon-bottle) (Unstudied): FDA warns that unapproved fat-dissolving injections have caused permanent scars, serious infections and skin deformities, and that Kybella (for under-chin fat) is the only approved fat-dissolving injection. Source: https://www.fda.gov/drugs/buying-using-medicine-safely/using-fat-dissolving-injections-are-not-fda-approved-can-be-harmful - [Lipo-C](https://humanpeptides.fyi/peptides/lipo-c) (Unstudied): Lipo-C is a pharmacy-compounded blend of amino acids, B vitamins and other nutrients, and the formulation as a whole has not been FDA-approved for weight loss. Source: https://www.seekpeptides.com/blog/articles/lipo-c-peptide - [MIC](https://humanpeptides.fyi/peptides/mic) (Unstudied): Lipo-C, a pharmacy-compounded injection that typically includes the MIC (methionine, inositol, choline) combination, is not FDA-approved, and the complete formulation has not undergone FDA approval for weight loss. Source: https://www.seekpeptides.com/blog/articles/lipo-c-peptide - [Semax + Selank](https://humanpeptides.fyi/peptides/semax-selank) (Unstudied): Neither Semax nor Selank is FDA-approved; Dr. Axe's A-Z guide lists both as research only. Source: https://draxe.com/peptides/ - [Tesamorelin + Ipamorelin](https://humanpeptides.fyi/peptides/tesamorelin-ipamorelin) (Unstudied): Dr. Axe's A-Z guide lists tesamorelin as FDA-approved for a specific HIV-related belly fat condition, while it lists ipamorelin, paired with CJC-1295, as research only and not FDA-approved. Source: https://draxe.com/peptides/ > humanpeptides.fyi makes no claims of its own. Every benefit, side effect, nickname and quote reports what a cited source says, with its link. Not medical advice.