Reference table

The 2026 record

What happened to United States peptide compounding law in 2026, in order?

The answer

Twelve peptides left a prohibition category in April and an advisory committee recommended six of them for listing in July; no peptide reviewed in 2026 became lawful to compound, because the FDA has issued no final rule.

By Peptide America · Publisher · Reviewed October 2026

The ground moved twice in 2026, in opposite-seeming directions, and the two events are routinely collapsed into one another. In April the FDA removed twelve peptides from Category 2 of its interim 503A bulks list without adding them to Category 1. In July an advisory committee recommended six of the seven it reviewed for the section 503A list. Neither action authorized a pharmacy to compound anything.

The chronology below is every dated entry this index holds, newest first, across every molecule it tracks. It is not a summary of the year; it is the ledger itself, and it extends back to the approvals and listings that set the positions 2026 moved.

Denominator

Every dated entry in this index's regulatory ledger is listed, for all molecules it tracks. The list is not a record of every FDA action on every peptide; it is the record this index has verified, molecule by molecule, on the dates its monographs carry.

Rows are read from MOLECULES[].record[].date, MOLECULES[].record[].text, MOLECULES[].name — the same dated ledger the molecule index renders. No cell on this page is typed by hand.

DateMoleculeWhat the record states
September 2026AfamelanotideNeither afamelanotide nor the name melanotan appears in any of the three categories of the 503A bulks list published May 14, 2026; that list files substances nominated for compounding, and a marketed product supplies this one.
September 2026ARA-290Drugs@FDA holds no approved product with cibinetide as an active ingredient, and the substance was not among the seven peptides the advisory committee reviewed in July 2026.
September 2026CerebrolysinCerebrolysin appears in no category of the section 503A bulks list published May 14, 2026, in none of the tables on FDA's Category 2 safety-risk page, and nowhere on the section 503B nominations list. Drugs@FDA holds no application for it under any name.
September 2026DulaglutideDulaglutide appears in none of the three categories of the 503A bulks list published May 14, 2026; that list files substances nominated for compounding, and a licensed biologic is supplied by its own manufacturer. FDA's drug shortage database holds no entry for it, in a query whose control on liraglutide returned eleven records with the status Current.
September 2026ElamipretideElamipretide appears in none of the three categories of the 503A bulks list published May 14, 2026; that list files substances nominated for compounding, and a marketed product supplies this one. FDA's drug shortage database holds no entry for it.
September 2026GHRP-2Drugs@FDA holds no approved product with GHRP-2 or pralmorelin as an active ingredient, and the substance was not among the seven peptides the advisory committee reviewed in July 2026. Its position is therefore unchanged by the 2026 meeting.
September 2026GHRP-6Drugs@FDA holds no approved product with GHRP-6 as an active ingredient, and the substance was not among the seven peptides the advisory committee reviewed in July 2026.
September 2026IpamorelinFDA's Category 2 page, content current April 22, 2026, still lists ipamorelin acetate under the 503B policy, and the 503A list updated May 14, 2026 names it in no category. Neither a 503A pharmacy nor a 503B outsourcing facility has a lawful route to compound it.
September 2026L-carnosineDrugs@FDA holds no approved product with carnosine as an active ingredient, and the substance was not among the seven peptides the advisory committee reviewed in July 2026. It is lawfully sold as a dietary supplement, which is a separate regulatory regime carrying its own and much lower evidentiary threshold.
September 2026Mechano growth factorDrugs@FDA holds no approved product with mechano growth factor as an active ingredient, and neither form was among the seven peptides the advisory committee reviewed in July 2026. Two forms of one molecule therefore hold two different dispositions and the same absence of a lawful route.
September 2026SetmelanotideSetmelanotide sits in no category of the 503A bulks list published May 14, 2026 and on no 503B list. An approved product exists, so the question the bulks list answers does not arise for it.
September 2026ThymulinDrugs@FDA holds no approved product with thymulin as an active ingredient, and the substance was not among the seven peptides the advisory committee reviewed in July 2026.
September 2026Vasoactive intestinal peptideDrugs@FDA holds no approved product with vasoactive intestinal peptide or aviptadil as an active ingredient. The lawful route to a patient is therefore a pharmacy preparation under section 503A, not a manufactured product, and the difference decides what quality obligations attach.
August 2026AOD-9604AOD-9604 appears in FDA's table of substances nominated but withdrawn and in no category of the 503A list published May 14, 2026. FDA's published finding notes serious adverse events that may be associated with the substance, though causality is not clear.
August 2026DihexaFDA continues to publish its finding for the substance: it has not identified any human exposure data on drug products containing dihexa acetate administered via any route of administration, and it lacks important information regarding any safety issues raised by the substance, including whether it would cause harm if administered to humans.
August 2026GlutathioneListed in Category 1 of the interim 503A bulks list; pharmacies may compound while FDA review continues.
August 2026Kisspeptin-10Kisspeptin-10 remains in Category 2 of the 503A list published May 14, 2026, and is the only peptide among the six substances in that category. Placement in Category 2 bars a licensed pharmacy from compounding the substance.
August 2026LiraglutideThe shortage entry still reads currently in shortage. Two generic manufacturers report both presentations available; the brand manufacturer reports limited availability, with Saxenda 6 mg/mL available until discontinuation in January 2027 and Victoza 6 mg/mL delayed in shipping with no estimated duration.
August 2026LL-37FDA continues to publish the safety finding: it lacks sufficient safety-related information to know whether the drug would cause harm when administered to humans, and nonclinical research findings suggest detrimental effects on male reproduction and that the drug can be pro-tumorigenic in some tissues.
August 2026Melanotan IIFDA still publishes its Category 2 safety finding for the substance among those nominated but withdrawn: compounded drugs containing Melanotan II may pose a risk for immunogenicity, and published case reports discuss melanoma, posterior reversible encephalopathy syndrome, sympathomimetic toxidrome, and priapism. The withdrawal removed the substance from the category; it did not retract the finding.
August 2026NAD+Listed in Category 1 of the interim 503A bulks list; pharmacies may compound while FDA review continues.
August 2026PEG-MGFOn the list FDA published May 14, 2026, PEG-MGF appears in no category, while the unpegylated substance — mechano growth factor (MGF) — appears in Category 3, the category for substances nominated without adequate support. FDA's published finding for PEG-MGF is that it has identified no human exposure data on drug products containing it by any route.
August 2026PT-141The product remains marketed under a new labeler and is recorded as prescription-only in Drugs@FDA. Bremelanotide sits in no category of the 503A bulks list published May 14, 2026 and on no 503B list.
August 2026RetatrutideDrugs@FDA holds no record of retatrutide as the active ingredient of any drug product, and the substance sits in no category of the 503A bulks list published May 14, 2026 and on no 503B list. It has never been nominated for one.
August 2026SelankSelank acetate (TP-7) appears in FDA's table of substances nominated but withdrawn and in no category of the 503A list published May 14, 2026. FDA's published finding is that it lacks important information regarding any safety issues raised by selank acetate administered to humans.
August 2026SermorelinCompounded by 503A pharmacies with a valid prescription; the discontinued approval was withdrawn for commercial, not safety, reasons.
August 2026Thymosin alpha-1Thymosin alpha-1 appears in FDA's table of substances nominated but withdrawn, in no category of the 503A list published May 14, 2026, and in Category 3 of the 503B list — nominated without adequate support. No FDA-approved product containing it exists.
July 2026BPC-157The Pharmacy Compounding Advisory Committee votes 8–6 (one abstention) to recommend adding BPC-157 to the section 503A bulks list. The vote is advisory; FDA rulemaking is required before any pharmacy may compound it. FDA has published no minutes, transcript or vote summary for this meeting; the tally is as reported by McDermott Will & Schulte and LumaLex Law.
July 2026DSIPPCAC votes 6–7 (one abstention) against recommending 503A listing — the panel's only rejection. FDA has published no minutes, transcript or vote summary for this meeting; the tally is as reported by McDermott Will & Schulte and LumaLex Law.
July 2026EpitalonPCAC votes 7–4 (one abstention) to recommend 503A listing; advisory only. FDA has published no minutes, transcript or vote summary for this meeting; the tally is as reported by McDermott Will & Schulte and LumaLex Law.
July 2026KPVPCAC votes 8–6 (one abstention) to recommend 503A listing; advisory only. FDA has published no minutes, transcript or vote summary for this meeting; the tally is as reported by McDermott Will & Schulte and LumaLex Law.
July 2026MOTS-cPCAC votes 7–5 (two abstentions) to recommend 503A listing; advisory only. FDA has published no minutes, transcript or vote summary for this meeting; the tally is as reported by McDermott Will & Schulte and LumaLex Law.
July 2026SemaxPCAC votes 8–5 (one abstention) to recommend 503A listing; advisory only. FDA has published no minutes, transcript or vote summary for this meeting; the tally is as reported by McDermott Will & Schulte and LumaLex Law.
July 2026TB-500PCAC votes 8–6 (one abstention) to recommend 503A listing; advisory only. FDA has published no minutes, transcript or vote summary for this meeting; the tally is as reported by McDermott Will & Schulte and LumaLex Law.
June 2026DulaglutideThe label in effect June 16, 2026 indicates the product as an adjunct to diet and exercise to improve glycemic control in adults and in pediatric patients ten years of age and older with type 2 diabetes mellitus, and to reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes who have established cardiovascular disease or multiple cardiovascular risk factors. No weight-management indication appears in that section.
June 2026RetatrutideFDA states that retatrutide and cagrilintide cannot be used in compounding under federal law, that they are not components of FDA-approved drugs, and that they have not been found safe and effective for any condition.
May 2026AfamelanotideThe label in effect May 11, 2026 indicates the product to increase pain free light exposure in adult patients with a history of phototoxic reactions from erythropoietic protoporphyria, and names no other use. It describes the active ingredient as a synthetic peptide containing 13 amino acids.
May 2026ARA-290The section 503A bulks list FDA published May 14, 2026 lists Cibinetide (ARA-290) in Category 3, the file for substances nominated without adequate support to evaluate. The category speaks to what the nomination contained, not to what the published literature contains.
May 2026GHK-CuAfter a nominator clarified on May 5, 2026 that it had intended to withdraw only its nomination of the injectable route, FDA's list document updated May 14, 2026 states that GHK-Cu (except for injectable routes of administration) will be added back to category 1, and lists it there. The injectable route was not restored and sits on no list. FDA states it intends to consult the Pharmacy Compounding Advisory Committee before the end of February 2027.
May 2026GHRP-2The section 503A bulks list FDA published May 14, 2026 lists GHRP-2 in Category 3, the file for substances nominated without adequate support to evaluate. It sits in neither of the other two 503A categories, and Category 3 carries no authorization to compound.
May 2026GHRP-6The section 503A bulks list FDA published May 14, 2026 lists GHRP-6 in Category 3, the file for substances nominated without adequate support to evaluate. It sits in neither of the other two 503A categories, and Category 3 carries no authorization to compound.
May 2026L-carnosineThe section 503A bulks list FDA published May 14, 2026 lists L-Carnosine in Category 3, the file for substances nominated without adequate support to evaluate. It sits in neither of the other two 503A categories.
May 2026Mechano growth factorThe section 503A bulks list FDA published May 14, 2026 lists mechano growth factor (MGF) in Category 3, the file for substances nominated without adequate support to evaluate. The pegylated form appears in no category of the same document; that separate disposition is recorded on the PEG-MGF row.
May 2026SecretinThe section 503A bulks list published May 14, 2026 lists Secretin, human 99% in Category 3, the file for substances nominated without adequate support to evaluate. A bulk nomination for a substance that is already the active ingredient of an approved product raises the essentially-a-copy question that section 503A exists to control.
May 2026ThymulinThe section 503A bulks list FDA published May 14, 2026 lists Thymulin acetate in Category 3, the file for substances nominated without adequate support to evaluate. It sits in neither of the other two 503A categories, and Category 3 carries no authorization to compound.
May 2026Vasoactive intestinal peptideListed in Category 1 of the interim 503A bulks list published May 14, 2026; pharmacies may compound while FDA review continues. It is one of a small number of peptides anywhere in Category 1, and the only one this index added in 2026.
April 2026BPC-157FDA removes BPC-157 and eleven other peptides from Category 2 without adding them to Category 1; the removal ends the explicit prohibition but confers no authorization.
April 2026DihexaThe nomination is withdrawn by its nominators and dihexa acetate leaves Category 2 of the interim 503A bulks list without being added to Category 1; it appears in no category of the list FDA published on May 14, 2026.
April 2026DSIPRemoved from Category 2 without Category 1 listing.
April 2026EpitalonRemoved from Category 2 without Category 1 listing.
April 2026GHK-CuFDA removes GHK-Cu from Category 1 of the interim 503A bulks list on April 22, 2026, the nominations withdrawn by the nominators. GHK-Cu was not among the seven peptides reviewed at the July 2026 PCAC meeting.
April 2026KPVRemoved from Category 2 without Category 1 listing.
April 2026LL-37The nomination is withdrawn by its nominators and cathelicidin LL-37 leaves Category 2 of the interim 503A bulks list without being added to Category 1; it appears in no category of the list FDA published on May 14, 2026.
April 2026Melanotan IIThe nomination is withdrawn by its nominators and Melanotan II leaves Category 2 of the interim 503A bulks list. It is not added to Category 1, and it appears in no category of the list FDA published on May 14, 2026.
April 2026MOTS-cRemoved from Category 2 without Category 1 listing.
April 2026PEG-MGFThe nomination is withdrawn by its nominators and mechano growth factor pegylated leaves Category 2 of the interim 503A bulks list without being added to Category 1.
April 2026SemaglutideFDA proposes excluding semaglutide from the 503B bulks list, closing the outsourcing-facility route; patient-specific 503A compounding requires a documented clinical need an approved product cannot meet.
April 2026SemaxRemoved from Category 2 without Category 1 listing.
April 2026TB-500Removed from Category 2 without Category 1 listing.
April 2026TirzepatideFDA proposes excluding tirzepatide from the 503B bulks list; the lawful remainder is patient-specific 503A compounding with documented clinical need.
March 2026RetatrutideFDA issues warning letters to two firms whose websites offered retatrutide for sale, finding the products to be unapproved new drugs; both letters state that despite labeling the products for research use only and not for human consumption, evidence from the firms' own websites establishes that the products are intended to be drugs for human use.
March 2026SetmelanotideDrugs@FDA records three approved efficacy supplements to the application after the original approval, dated June 16, 2022, December 20, 2024 and March 19, 2026, alongside two labeling supplements. The label in effect on April 1, 2026 indicates the product to reduce excess body weight and maintain weight reduction long term in patients aged four years and older with acquired hypothalamic obesity, and aged two years and older with obesity due to Bardet-Biedl syndrome or to confirmed proopiomelanocortin, proprotein convertase subtilisin/kexin type 1 or leptin receptor deficiency.
December 2025ElamipretideThe label in effect December 10, 2025 indicates the product to improve muscle strength in adult and pediatric patients with Barth syndrome weighing at least 30 kg. The same section states that the indication is approved under accelerated approval on an improvement in knee extensor muscle strength, an intermediate clinical endpoint, and that continued approval may be contingent upon verification of clinical benefit in a confirmatory trial.
September 2025ElamipretideFDA approves elamipretide injection under new drug application 215244, approval dated September 19, 2025, as a Type 1 new molecular entity. Drugs@FDA records the product as Forzinity, a subcutaneous solution of elamipretide hydrochloride at 280 mg base per 3.5 mL, sponsored by Stealth BioTherapeutics and marketed as prescription-only.
March 2025TesamorelinFDA approves EGRIFTA WR, an eight-fold concentrated formulation reconstituted weekly rather than daily; it replaces EGRIFTA SV.
December 2024AOD-9604The Pharmacy Compounding Advisory Committee votes 0 in favor, 12 against, and 0 abstaining on whether AOD-9604 (free base) and AOD-9604 acetate should be placed on the 503A bulks list. FDA had proposed that neither be included; the committee took a single grouped vote by 12 to 0. The use evaluated was obesity.
December 2024LiraglutideFDA approves the first generic liraglutide injection referencing Victoza, under abbreviated new drug application 215503, effective December 23, 2024. The agency's announcement notes that liraglutide injection and certain other GLP-1 medicines are in shortage.
December 2024Thymosin alpha-1The Pharmacy Compounding Advisory Committee votes 4 in favor and 17 against placing Thymosin alpha-1 (free base) on the 503A bulks list, and 4 to 17 again on Thymosin alpha-1 acetate. The minutes record that members voting against found no compelling evidence demonstrating clinical effectiveness and safety in the uses under review, which included hepatitis B, hepatitis C, HIV, COVID-19, malignant melanoma, hepatocellular carcinoma, non-small cell lung cancer, and sepsis.
October 2024IpamorelinFDA presents its evaluation to the Pharmacy Compounding Advisory Committee anyway, proposing that neither form be placed on the 503A bulks list. The committee votes 0–12, with one abstention, against listing each form.
October 2024Kisspeptin-10The Pharmacy Compounding Advisory Committee votes 0 in favor, 11 against, and 0 abstaining on whether Kisspeptin-10 should be placed on the 503A bulks list. The minutes record that the committee unanimously agreed it should not be included, for lack of convincing safety and efficacy data. The use evaluated was treatment of secondary hypogonadism in men.
September 2024CJC-1295Removed from Category 2 after nominator withdrawal; not added to Category 1.
September 2024IpamorelinThe nominators withdraw their nominations of ipamorelin acetate and ipamorelin free base for the section 503A bulks list on September 19, 2024. FDA later files ipamorelin acetate among the substances previously in 503A Category 2 whose nominations were withdrawn.
September 2023BPC-157FDA places BPC-157 in Category 2 of the interim 503A bulks list, citing immunogenicity risk and impurity concerns; Category 2 placement bars pharmacy compounding.
September 2023GHRP-2FDA places growth hormone releasing peptide-2, for injectable and nasal routes of administration, in Category 2 under the section 503B interim policy, with a date added of September 29, 2023. The agency states that compounded drugs containing GHRP-2 may pose a risk for immunogenicity from aggregation and peptide-related impurities, that the substance contains an unnatural amino acid which adds to the complexity of peptide characterization, and that it is aware of reports of serious adverse events in patients who received GHRP-2 — increased insulin requirement, death of critically ill study subjects, infection and pancreatitis — though causality has not been established.
September 2023GHRP-6FDA places growth hormone releasing peptide-6 in Category 2 under the section 503B interim policy, with a date added of September 29, 2023. The agency states that compounded drugs containing GHRP-6 may pose a risk for immunogenicity for certain routes of administration due to the potential for aggregation and peptide-related impurities, and that it has identified limited safety-related information, with the available data revealing concerns including a potential effect on cortisol and an increase in blood glucose from decreased insulin sensitivity.
September 2023IpamorelinFDA places ipamorelin acetate in Category 2 under the section 503B interim policy for outsourcing facilities, date added September 29, 2023. The agency cites a risk of immunogenicity from aggregation or peptide-related impurities, unnatural amino acids that complicate characterization, and a published report of serious adverse events including death when ipamorelin was given intravenously for gastric motility.
September 2023Kisspeptin-10FDA places Kisspeptin-10 in Category 2 of the interim 503A bulks list, with a date added of September 29, 2023. The stated concern is a risk of immunogenicity for certain routes of administration, complexities of peptide-related impurities and characterization of the active ingredient, and no or only limited safety information for the proposed routes.
July 2023LiraglutideLiraglutide injection is entered in FDA's drug shortage database, with a date first posted of July 18, 2023.
November 2021CerebrolysinA second FDA warning letter, to an Indianapolis firm, states that Cerebrolysin was not nominated for inclusion on the 503A bulks list.
November 2020SetmelanotideFDA approves setmelanotide injection under new drug application 213793, approval dated November 25, 2020, as a Type 1 new molecular entity. Drugs@FDA records the product as Imcivree, a subcutaneous solution containing setmelanotide acetate at a strength of 10 mg base per mL, sponsored by Rhythm and marketed as prescription-only.
October 2020CerebrolysinThe same pharmacy pleads guilty in federal court to distributing unapproved new drugs; the Justice Department's account of the plea agreement names Cerebrolysin among them.
April 2020AOD-9604FDA warns a Kentucky compounding pharmacy that drug products it compounded using AOD 9604 and twenty-one other substances are not eligible for the exemptions in section 503A(a).
April 2020CerebrolysinFDA warns a Kentucky compounding pharmacy that drug products it compounded using Cerebrolysin and twenty-one other substances are not eligible for the exemptions in section 503A(a); the letter states that Cerebrolysin had not been nominated for inclusion on the 503A bulks list.
April 2020LL-37FDA warns a Kentucky compounding pharmacy that drug products it compounded using LL-37 and twenty-one other substances are not eligible for the exemptions in section 503A(a); the letter states that the substances had not been nominated for inclusion on the 503A bulks list.
April 2020Melanotan IIFDA warns a Kentucky compounding pharmacy that drug products it compounded using Melanotan II and twenty-one other substances are not eligible for the exemptions in section 503A(a), because the substances are not the subject of an applicable USP or NF monograph, are not a component of an FDA-approved human drug, and do not appear on the 503A bulks list.
April 2020PEG-MGFFDA warns a Kentucky compounding pharmacy that drug products it compounded using PEG-MGF and twenty-one other substances are not eligible for the exemptions in section 503A(a).
April 2020PT-141FDA warns a Kentucky compounding pharmacy that drug products it compounded using bremelanotide (PT-141) and twenty-one other substances are not eligible for the exemptions in section 503A(a).
April 2020SelankFDA warns a Kentucky compounding pharmacy that drug products it compounded using Selank and twenty-one other substances are not eligible for the exemptions in section 503A(a).
October 2019AfamelanotideFDA approves afamelanotide implant under new drug application 210797, approval dated October 8, 2019, as a Type 1 new molecular entity. Drugs@FDA records the product as Scenesse, a 16 mg subcutaneous implant marketed as prescription-only, with one labeling supplement approved August 12, 2024.
June 2019PT-141FDA approves bremelanotide injection under new drug application 210557, effective June 21, 2019, for the treatment of premenopausal women with acquired, generalized hypoactive sexual desire disorder. The label's limitations of use state that the product is not indicated for hypoactive sexual desire disorder in postmenopausal women or in men, and is not indicated to enhance sexual performance.
April 2016CerebrolysinFDA grants an orphan designation to the peptide fraction derived from porcine brain protein for the treatment of frontotemporal dementia. The agency's database now shows the designation as no longer in effect, and no approved product followed.
December 2014LiraglutideFDA approves a second liraglutide product, Saxenda, under new drug application 206321, effective December 23, 2014, for chronic weight management alongside a reduced-calorie diet and increased physical activity.
September 2014DulaglutideFDA licenses dulaglutide injection under biologics license application 125469, approval dated September 18, 2014, as a Type 1 new molecular entity. Drugs@FDA records the product as Trulicity, a prescription injection in four strengths of 0.75 mg, 1.5 mg, 3 mg and 4.5 mg per 0.5 mL, sponsored by Eli Lilly and Company.
November 2010TesamorelinFDA approves tesamorelin (EGRIFTA) for the reduction of excess abdominal fat in adults with HIV and lipodystrophy.
January 2010LiraglutideFDA approves liraglutide injection as Victoza under new drug application 022341, effective January 25, 2010; the indication is now an adjunct to diet and exercise for glycemic control in type 2 diabetes and reduction of major adverse cardiovascular events in adults with established cardiovascular disease.
April 2004SecretinFDA approves ChiRhoStim, synthetic human secretin, under new drug application 021256, in 16 microgram and 40 microgram vials for intravenous use. Two earlier secretin products, SecreFlo and Secretin-Ferring, are recorded in Drugs@FDA as discontinued.
April 2002SecretinFDA approves Porcine Secretin under new drug application 021209; the product remains prescription-only.

The final slot is deliberately empty. Each monograph for a molecule awaiting rulemaking renders an FDA final-action line that reads as unfilled until an action lands; nothing in this ledger fills it. The pending page carries the six recommendations, and the vote ledger carries the arithmetic that produced them.

Elsewhere in this index

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Monographs in this table