Peptide FDA Status Tracker
As of November 7, 2026, of the 25 names here, 1 has an FDA-approved product we read a label for, 6 are under an interim HHS enforcement discretion policy, 4 are in FDA's Category 1, 1 is named by FDA as not usable in compounding, 1 has a former approval and no stated category, and 12 have no federal policy in the sources we read.
Enforcement discretion is not approval: the HHS notice says compounded drugs "are not FDA-approved". Every status below comes with the source's own words. This page gives no doses and lists no research-use vendors.
The docket page for the HHS notice says the comment period ends 13 November 2026 at 11:59 PM EST (Regulations.gov: docket HHS-OASH-2026-0496, read ). Any change that follows goes in the change log by peptide.
By Julian Caraulani, reviewed by Dr. A. Goher, MBBS · sources last read · not legal or medical advice
Status at a glance
| Peptide | Federal status | Lowest listed price |
|---|---|---|
| Tesamorelin | FDA-approved product | $195/mo |
| BPC-157 | HHS interim enforcement discretion | $105/mo |
| TB-500 | HHS interim enforcement discretion | $149/mo |
| MOTS-c | HHS interim enforcement discretion | $105/mo |
| Semax | HHS interim enforcement discretion | $105/mo |
| Epitalon | HHS interim enforcement discretion | $134/mo |
| KPV | HHS interim enforcement discretion | None listed |
| GHK-Cu, not injected | FDA Category 1, under evaluation | $149/mo |
| NAD+ | FDA Category 1, under evaluation | $89/mo |
| Glutathione | FDA Category 1, under evaluation | $57/mo |
| Vasoactive intestinal peptide | FDA Category 1, under evaluation | None listed |
| Sermorelin | Former approval, no current category | $94/mo |
| Retatrutide | FDA says it cannot be compounded | None listed |
| Kisspeptin-10 | No federal policy found in these sources | None listed |
| Ipamorelin acetate | No federal policy found in these sources | None listed |
| GHK-Cu, injected | No federal policy found in these sources | None listed |
| Emideltide (DSIP) | No federal policy found in these sources | None listed |
| CJC-1295 | No federal policy found in these sources | None listed |
| AOD-9604 | No federal policy found in these sources | None listed |
| Cathelicidin LL-37 | No federal policy found in these sources | None listed |
| Selank acetate (TP-7) | No federal policy found in these sources | None listed |
| Melanotan II | No federal policy found in these sources | None listed |
| Dihexa acetate | No federal policy found in these sources | None listed |
| PEG-MGF | No federal policy found in these sources | None listed |
| Thymosin alpha-1 | No federal policy found in these sources | None listed |
Prices are each program's lowest published monthly plan on this site, often a prepaid long plan. A listed program is not a statement about a peptide's status. Every program and plan: price page.
FDA-approved product
One name here has an FDA-approved product on the market, for one labelled use.
Tesamorelin
FDA-approved as EGRIFTA WR for one labelled use. Compounded tesamorelin is not that approved product, and tesamorelin is not on FDA's 14 May 2026 category list or in HHS Appendix A.
"EGRIFTA WR is indicated for the reduction of excess abdominal fat in HIV-infected adult patients with lipodystrophy."
"EGRIFTA WR is not indicated for weight loss management as it has a weight neutral effect."
HHS interim enforcement discretion
Appendix A of the HHS policy lists six peptides. HHS says it does not intend to act against a 503A compounder if all ten conditions are met. None of the six is FDA-approved, and the policy is not binding on HHS.
BPC-157
Interim HHS enforcement discretion, acetate form, four routes. Not FDA-approved.
"enforcement discretion for BPC-157 acetate is appropriate for subcutaneous, intramuscular, oral, and topical dosage forms"
HHS Enforcement Discretion Policy with Appendices A and B, read
"Center for Drug Evaluation and Research (CDER) recommended against listing either form, and the Pharmacy Compounding Advisory Committee (PCAC) voted in favor of inclusion."
HHS Enforcement Discretion Policy with Appendices A and B, read
"FDA has identified no, or only limited, safety-related information for the proposed routes of administration. Therefore, the agency lacks sufficient information to know whether the drug would cause harm when administered to humans."
FDA: Certain bulk drug substances that may present significant safety risks, read
TB-500
Interim HHS enforcement discretion, acetate form, injection routes only. Not FDA-approved.
"enforcement discretion for TB-500 acetate appropriate for subcutaneous or intramuscular injectable dosage forms"
HHS Enforcement Discretion Policy with Appendices A and B, read
"CDER recommended against listing either form, and the PCAC voted in favor of both forms."
HHS Enforcement Discretion Policy with Appendices A and B, read
"FDA lacks important information regarding any safety issues raised by this drug, including whether it would cause harm if administered to humans."
FDA: Certain bulk drug substances that may present significant safety risks, read
MOTS-c
Interim HHS enforcement discretion, acetate form, injection routes only. Not FDA-approved.
"enforcement discretion for MOTS-c acetate is appropriate subcutaneous or intramuscular injectable dosage forms"
HHS Enforcement Discretion Policy with Appendices A and B, read
"CDER recommended against listing either form, and the PCAC voted in favor of both forms."
HHS Enforcement Discretion Policy with Appendices A and B, read
"FDA lacks important information regarding any safety issues raised by MOTs-C, including whether it would cause harm if administered to humans."
FDA: Certain bulk drug substances that may present significant safety risks, read
Semax
Interim HHS enforcement discretion, free base, intranasal use only. Not FDA-approved.
"enforcement discretion for semax free base is appropriate for intranasal use"
HHS Enforcement Discretion Policy with Appendices A and B, read
"CDER recommended against listing either form, and the PCAC voted in favor of both forms."
HHS Enforcement Discretion Policy with Appendices A and B, read
"FDA has no, or limited, safety-related information for proposed routes of administration. Therefore, the agency lacks sufficient information to know whether the drug would cause harm if administered to humans."
FDA: Certain bulk drug substances that may present significant safety risks, read
Epitalon
Interim HHS enforcement discretion, acetate form, injection routes, intermittent courses. Not FDA-approved.
"epitalon acetate is appropriate subcutaneous or intramuscular injectable dosage forms that are dispensed in intermittent courses"
HHS Enforcement Discretion Policy with Appendices A and B, read
"CDER recommended against listing either form, and the PCAC voted in favor of inclusion."
HHS Enforcement Discretion Policy with Appendices A and B, read
"FDA has not identified safety-related information regarding epitalon for the proposed route of administration. Therefore, the agency lacks sufficient information to know whether the drug would cause harm if administered to humans."
FDA: Certain bulk drug substances that may present significant safety risks, read
KPV
Interim HHS enforcement discretion, acetate form, topical and oral only. Not FDA-approved.
"enforcement discretion for KPV acetate is appropriate for topical and oral dosage forms"
HHS Enforcement Discretion Policy with Appendices A and B, read
"CDER recommended against listing either form, and the PCAC voted in favor of inclusion."
HHS Enforcement Discretion Policy with Appendices A and B, read
"FDA has not identified any human exposure data on drug products containing KPV administered via any route of administration."
FDA: Certain bulk drug substances that may present significant safety risks, read
FDA Category 1, under evaluation
For Category 1, FDA states it "does not intend to take action against a compounder for compounding drugs using bulk drug substances listed in category 1, provided that the conditions described in the guidance document are met." Compounded versions are not FDA-approved. NAD+ is not a peptide; it is tracked here because programs sell it beside peptides.
GHK-Cu, not injected
FDA Category 1, except injectable routes. FDA plans to consult its advisory committee before the end of February 2027. Not FDA-approved when compounded.
"GHK-Cu (except for injectable routes of administration)"
FDA: Bulk drug substances nominated under section 503A (category list), read
"before the end of February 2027"
FDA: Bulk drug substances nominated under section 503A (category list), read
NAD+
FDA Category 1. Not FDA-approved when compounded.
"Nicotinamide Adenine Dinucleotide (NAD)"
FDA: Bulk drug substances nominated under section 503A (category list), read
Glutathione
FDA Category 1. Not FDA-approved when compounded.
"Glutathione"
FDA: Bulk drug substances nominated under section 503A (category list), read
Vasoactive intestinal peptide
FDA Category 1. Not FDA-approved when compounded.
"Vasoactive Intestinal Peptide"
FDA: Bulk drug substances nominated under section 503A (category list), read
Former approval, no current category
The sources we read record the old approval but do not state a current compounding status.
Sermorelin
Former brand GEREF. FDA found it was not withdrawn from sale for safety or effectiveness reasons. Not on the 14 May 2026 category list, and no source here states its compounding status today.
"were not withdrawn from sale for reasons of safety or effectiveness"
Federal Register, 4 Mar 2013: GEREF (sermorelin acetate) determination, read
FDA says it cannot be compounded
FDA names this one directly.
Retatrutide
FDA says it cannot be used in compounding under federal law. This site lists no retatrutide offer.
"Retatrutide and cagrilintide cannot be used in compounding under federal law."
FDA: Concerns with unapproved GLP-1 drugs used for weight loss, read
No federal policy found in these sources
FDA lists these under "Bulk drug substances nominated but withdrawn" unless the row says otherwise. None is in HHS Appendix A or in Category 1 on the 14 May 2026 list. FDA's page says this list was "previously in category 2 of the interim policies" and "withdrawn by the nominators."
Kisspeptin-10
In FDA Category 2 for 503A (safety risks), added 29 Sep 2023. Not in the withdrawn list.
"the agency lacks sufficient information to know whether the drug would cause harm when administered to humans."
FDA: Certain bulk drug substances that may present significant safety risks, read
Ipamorelin acetate
503A nomination withdrawn. Also in Category 2 for 503B outsourcing facilities, added 29 Sep 2023.
"A study published in literature identified serious adverse events including death when ipamorelin was administered intravenously for improving gastric motility."
FDA: Certain bulk drug substances that may present significant safety risks, read
GHK-Cu, injected
Nomination withdrawn for injectable routes.
"There are limited data in humans to inform safety-related considerations."
FDA: Certain bulk drug substances that may present significant safety risks, read
Emideltide (DSIP)
Nomination withdrawn. On the July 2026 advisory committee agenda, not in HHS Appendix A.
"the agency lacks sufficient information to know whether the drug would cause harm if administered to humans."
FDA: Certain bulk drug substances that may present significant safety risks, read
CJC-1295
Nomination withdrawn.
"FDA has identified serious adverse events associated with CJC-1295 including increased heart rate and systemic vasodilatory reaction."
FDA: Certain bulk drug substances that may present significant safety risks, read
AOD-9604
Nomination withdrawn.
"FDA has identified no, or only limited, safety-related information."
FDA: Certain bulk drug substances that may present significant safety risks, read
Cathelicidin LL-37
Nomination withdrawn.
"FDA lacks sufficient safety-related information regarding cathelicidin LL-37 to know whether the drug would cause harm when administered to humans."
FDA: Certain bulk drug substances that may present significant safety risks, read
Selank acetate (TP-7)
Nomination withdrawn.
"FDA lacks important information regarding any safety issues raised by selank acetate administered to humans."
FDA: Certain bulk drug substances that may present significant safety risks, read
Melanotan II
Nomination withdrawn.
"Published case reports discuss serious adverse events including melanoma, posterior reversible encephalopathy syndrome, sympathomimetic toxidrome and priapism."
FDA: Certain bulk drug substances that may present significant safety risks, read
Dihexa acetate
Nomination withdrawn.
"FDA has not identified any human exposure data on drug products containing dihexa acetate administered via any route of administration."
FDA: Certain bulk drug substances that may present significant safety risks, read
PEG-MGF
Nomination withdrawn.
"FDA has not identified any human exposure data on drug products containing PEG-MGF administered via any route of administration."
FDA: Certain bulk drug substances that may present significant safety risks, read
Thymosin alpha-1
Nomination withdrawn.
"The safety-related information is inadequate for the agency to sufficiently understand the extent of any safety issues raised by the proposed compounded drug."
FDA: Certain bulk drug substances that may present significant safety risks, read
Sources and read dates
Change log by peptide
Every dated event we can source, under the peptide it touched. Last read with no status change: . A name with no event here has only the status above.
| Peptide | Dated changes, newest first |
|---|---|
| Tesamorelin |
|
| BPC-157 | |
| TB-500 | |
| MOTS-c | |
| Semax | |
| Epitalon | |
| KPV | |
| GHK-Cu, not injected |
|
| Sermorelin |
|
| Retatrutide |
|
| Emideltide (DSIP) |
|
Change log
- Re-read the Federal Register notice, FDA's category list, the EGRIFTA WR label and the docket. The docket page says the comment period ends 13 Nov 2026 at 11:59 PM EST, and shows 143 submissions received and 115 published. A Federal Register search for 503A peptide documents showed nothing newer than 2026-22192. No status changed. Source: Regulations.gov: docket HHS-OASH-2026-0496
- Tracker published. All nine sources read. A Federal Register search for 503A peptide documents showed nothing newer than 2026-22192. No status changed since 30 Oct 2026. Source: Federal Register 2026-22192 (91 FR 68526), HHS notice of availability
- HHS notice published, filed 28 Oct 2026. It says comments can be submitted until 2 weeks after publication, on docket HHS-OASH-2026-0496. Source: Federal Register 2026-22192 (91 FR 68526), HHS notice of availability
- FDA's page on unapproved GLP-1 drugs, content current as of this date, says retatrutide and cagrilintide cannot be used in compounding under federal law. Source: FDA: Concerns with unapproved GLP-1 drugs used for weight loss
- DailyMed shows the EGRIFTA WR label updated on this date. The label's indication is unchanged in our read: excess abdominal fat in HIV-infected adults with lipodystrophy. Source: DailyMed: EGRIFTA WR (tesamorelin) label
- Second day of the FDA advisory committee meeting: emideltide, Semax and epitalon. The first day, 23 July, covered BPC-157, KPV, TB-500 and MOTS-c. The meeting page lists briefing documents; we found no minutes or vote tally on it. The votes above are as HHS reports them. Source: FDA: Pharmacy Compounding Advisory Committee meeting, 23 and 24 July 2026
- FDA updated its category list: GHK-Cu, except injectable routes, back in Category 1, with an advisory committee consult planned before the end of February 2027. Source: FDA: Bulk drug substances nominated under section 503A (category list)
- HHS records that TB-500 "was in Category 2 from September 29, 2023, until April 22, 2026". The same date applies to the other five peptides in Appendix A. FDA's safety risks page carries this date as content current. Source: HHS Enforcement Discretion Policy with Appendices A and B
- FDA placed these peptides in Category 2. HHS gives this exact date for TB-500, epitalon, Semax and MOTS-c, and September 2023 for BPC-157 and KPV. Source: HHS Enforcement Discretion Policy with Appendices A and B
- Federal Register notice: FDA determined that GEREF was not withdrawn from sale for reasons of safety or effectiveness. Source: Federal Register, 4 Mar 2013: GEREF (sermorelin acetate) determination
Questions
Which peptides are FDA-approved?
Of the names on this page, tesamorelin is the one with an FDA-approved product we read a label for: EGRIFTA WR, for excess abdominal fat in HIV-infected adults with lipodystrophy. Its label says it is not indicated for weight loss management. A compounded peptide is not an FDA-approved product.
Does the HHS policy mean BPC-157 is FDA-approved?
No. HHS says it does not intend to take enforcement action against a compounder using the six peptides in its Appendix A when ten conditions are met. The notice says compounded drugs are not FDA-approved and that the policy does not establish any rights and is not binding on HHS or the public.
Which six peptides does the HHS interim policy list?
BPC-157, epitalon, KPV, MOTS-c, Semax and TB-500. Appendix B limits each to a named form and set routes, such as intranasal use for Semax and topical or oral forms for KPV. A route that is not named is outside the policy, and a product with more than one listed ingredient does not meet its conditions.
How long does the HHS policy last?
HHS applies it until a peptide is addressed in a final rule as being included or not included on the 503A bulks list. The notice also says HHS may revisit the policy, in whole or in part, if a safety signal or product quality issue arises.
Does this page cover research-use vendors?
No. This page and this site cover prescription programs only. The HHS policy addresses State-licensed pharmacies, Federal facilities and licensed physicians filling patient-specific prescriptions, and it says it is meant to discourage research-use-only peptides supplied by foreign manufacturers.
How often is this tracker re-read?
Every source has a re-read schedule of 7 to 30 days, and the Federal Register is searched for newer documents on the same run. Each source below shows the date we last read it. A date moves only after a real read, and any change goes in the change log.
How to cite this page
Rx Peptides Watchdog, "Peptide FDA Status Tracker", sources last read November 7, 2026, https://rxpeptideswatchdog.com/data/peptide-fda-status. Free to reuse under CC BY 4.0 with attribution. Check the source documents linked above before relying on a status, because the HHS policy is interim.
This page carries no paid links. More: the HHS policy explained, what each status means for a buyer, open data.