A live source-check view of which tracked peptides are FDA-approved, Category 1, Category 2, under PCAC review, investigational, or not currently compoundable.
Statuses overlap. FDA approval, Category 1 compounding posture, and PCAC review are different legal concepts. This page is educational context, not medical or legal advice.
Source check
Last checked May 16, 2026
Anchored to FDA category lists, safety-risk pages, PCAC meeting notices, GLP-1 compounding safety updates, and Drugs@FDA records.
Category 1
FDA's current interim 503A posture for nominated bulk drug substances that may be used in compounding if all legal conditions are met. This is not FDA drug approval.
Category 2
FDA has identified significant safety risks or demonstrable difficulties for compounding. These entries should be treated as not currently compoundable.
PCAC review
The Pharmacy Compounding Advisory Committee has reviewed, or is scheduled to review, the substance for possible 503A bulk-list inclusion. Recommendations are advisory, not final FDA approval.
FDA-approved
At least one FDA-approved drug product exists for the active ingredient. This does not authorize non-approved uses or unrestricted copy compounding.
Investigational
The peptide is in clinical development or limited research use and is not FDA-approved for routine prescribing.
Not compoundable
No current federal bulk-substance path is identified for routine compounding, or FDA has explicitly stated the substance cannot be used in compounding.
These lanes are tag-based, so a peptide can appear in more than one lane. For example, a PCAC-reviewed peptide may also be not currently compoundable.
FDA's current interim 503A posture for nominated bulk drug substances that may be used in compounding if all legal conditions are met. This is not FDA drug approval.
Glycyl-L-histidyl-L-lysine copper
Category 1 for non-injectable routes in the current FDA 503A list. Injectable GHK-Cu remains carved out and is still under FDA safety-risk review.
PCAC discussion for injectable routes before end of February 2027.
Nicotinamide adenine dinucleotide
Category 1 in the current FDA 503A list. It is a coenzyme, not a peptide, and Category 1 is not FDA drug approval.
VIP
Category 1 in the current FDA 503A list if all compounding conditions are met.
FDA has identified significant safety risks or demonstrable difficulties for compounding. These entries should be treated as not currently compoundable.
Kisspeptin fragment
Category 2 in the current FDA 503A list. Treat as not currently compoundable.
Growth hormone secretagogue
Category 2 for 503B outsourcing facilities and not listed as a Category 1 503A bulk substance.
Growth hormone releasing peptide-2
Category 2 for injectable and nasal routes in FDA's safety-risk materials. Treat as not currently compoundable.
Growth hormone releasing peptide-6
Category 2 in FDA's safety-risk materials. Treat as not currently compoundable.
MK-677
Category 2 in the current FDA 503A list. Included because it is frequently grouped with growth hormone peptides in consumer searches.
The Pharmacy Compounding Advisory Committee has reviewed, or is scheduled to review, the substance for possible 503A bulk-list inclusion. Recommendations are advisory, not final FDA approval.
Glycyl-L-histidyl-L-lysine copper
Category 1 for non-injectable routes in the current FDA 503A list. Injectable GHK-Cu remains carved out and is still under FDA safety-risk review.
PCAC discussion for injectable routes before end of February 2027.
Growth hormone secretagogue
Category 2 for 503B outsourcing facilities and not listed as a Category 1 503A bulk substance.
Not currently Category 1. FDA lists it on the safety-risk page and scheduled it for July 2026 PCAC review.
PCAC review scheduled for July 23, 2026.
Not currently Category 1. Scheduled for FDA PCAC review for possible 503A bulk-list inclusion.
PCAC review scheduled for July 23, 2026.
Not currently Category 1. Scheduled for FDA PCAC review for possible 503A bulk-list inclusion.
PCAC review scheduled for July 23, 2026.
Not currently Category 1. Scheduled for FDA PCAC review for possible 503A bulk-list inclusion.
PCAC review scheduled for July 23, 2026.
Not currently Category 1. Scheduled for FDA PCAC review for possible 503A bulk-list inclusion.
PCAC review scheduled for July 24, 2026.
Delta sleep-inducing peptide
Not currently Category 1. Scheduled for FDA PCAC review for possible 503A bulk-list inclusion.
PCAC review scheduled for July 24, 2026.
Epitalon free base and acetate salt
Not currently Category 1. Scheduled for FDA PCAC review for possible 503A bulk-list inclusion.
PCAC review scheduled for July 24, 2026.
hGH fragment 176-191
Not currently Category 1. FDA PCAC reviewed AOD-9604-related bulk substances in December 2024; no current Category 1 listing identified.
CJC-1295 related bulk drug substances
Not currently Category 1. FDA PCAC reviewed CJC-1295-related bulk substances in December 2024; no current Category 1 listing identified.
Thymosin alpha-1 free base and acetate
Not currently Category 1. FDA PCAC reviewed thymosin alpha-1-related bulk substances in December 2024; no current Category 1 listing identified.
At least one FDA-approved drug product exists for the active ingredient. This does not authorize non-approved uses or unrestricted copy compounding.
GLP-1 receptor agonist
FDA-approved products exist. Broad copy compounding is not a Category 1 peptide-bulk pathway, and FDA flags unapproved GLP-1 products and salt forms as safety risks.
Dual GIP/GLP-1 receptor agonist
FDA-approved products exist. Copy compounding is constrained by approved-drug and shortage rules, not Category 1 peptide-bulk status.
GLP-1 receptor agonist
FDA-approved products exist. This is an approved-drug pathway, not a Category 1 peptide-bulk listing.
GHRH analog
FDA-approved product exists. Any compounding analysis starts from approved-drug rules rather than Category 1 bulk status.
Melanocortin receptor agonist
FDA-approved product exists for a specific indication. That approval does not validate non-approved indications.
Neuropeptide hormone
FDA-approved drug products exist. This is not a consumer peptide-bulk compounding status.
Mitochondria-targeted peptide
FDA-approved product exists under an approved-drug pathway. It is not a Category 1 compounded bulk peptide.
The peptide is in clinical development or limited research use and is not FDA-approved for routine prescribing.
Kisspeptin fragment
Category 2 in the current FDA 503A list. Treat as not currently compoundable.
Triple GIP/GLP-1/glucagon receptor agonist
Investigational. FDA explicitly states retatrutide cannot be used in compounding under federal law.
Amylin analog
Investigational. FDA explicitly states cagrilintide cannot be used in compounding under federal law.
No current federal bulk-substance path is identified for routine compounding, or FDA has explicitly stated the substance cannot be used in compounding.
Kisspeptin fragment
Category 2 in the current FDA 503A list. Treat as not currently compoundable.
Growth hormone secretagogue
Category 2 for 503B outsourcing facilities and not listed as a Category 1 503A bulk substance.
Growth hormone releasing peptide-2
Category 2 for injectable and nasal routes in FDA's safety-risk materials. Treat as not currently compoundable.
Growth hormone releasing peptide-6
Category 2 in FDA's safety-risk materials. Treat as not currently compoundable.
MK-677
Category 2 in the current FDA 503A list. Included because it is frequently grouped with growth hormone peptides in consumer searches.
Not currently Category 1. FDA lists it on the safety-risk page and scheduled it for July 2026 PCAC review.
PCAC review scheduled for July 23, 2026.
Not currently Category 1. Scheduled for FDA PCAC review for possible 503A bulk-list inclusion.
PCAC review scheduled for July 23, 2026.
Not currently Category 1. Scheduled for FDA PCAC review for possible 503A bulk-list inclusion.
PCAC review scheduled for July 23, 2026.
Not currently Category 1. Scheduled for FDA PCAC review for possible 503A bulk-list inclusion.
PCAC review scheduled for July 23, 2026.
Not currently Category 1. Scheduled for FDA PCAC review for possible 503A bulk-list inclusion.
PCAC review scheduled for July 24, 2026.
Delta sleep-inducing peptide
Not currently Category 1. Scheduled for FDA PCAC review for possible 503A bulk-list inclusion.
PCAC review scheduled for July 24, 2026.
Epitalon free base and acetate salt
Not currently Category 1. Scheduled for FDA PCAC review for possible 503A bulk-list inclusion.
PCAC review scheduled for July 24, 2026.
hGH fragment 176-191
Not currently Category 1. FDA PCAC reviewed AOD-9604-related bulk substances in December 2024; no current Category 1 listing identified.
CJC-1295 related bulk drug substances
Not currently Category 1. FDA PCAC reviewed CJC-1295-related bulk substances in December 2024; no current Category 1 listing identified.
Thymosin alpha-1 free base and acetate
Not currently Category 1. FDA PCAC reviewed thymosin alpha-1-related bulk substances in December 2024; no current Category 1 listing identified.
Selank acetate / TP-7
Not currently Category 1. FDA's safety-risk page continues to flag the substance even though nomination-status changes affected Category 2 placement.
Triple GIP/GLP-1/glucagon receptor agonist
Investigational. FDA explicitly states retatrutide cannot be used in compounding under federal law.
Amylin analog
Investigational. FDA explicitly states cagrilintide cannot be used in compounding under federal law.
The list focuses on Peptide Garden profiles and high-interest FDA compounding substances. It is not a complete reproduction of every FDA bulk drug substance table.
| Peptide | Status | Practical posture | Source basis |
|---|---|---|---|
| Semaglutide GLP-1 receptor agonist | FDA-approved | FDA-approved products exist. Broad copy compounding is not a Category 1 peptide-bulk pathway, and FDA flags unapproved GLP-1 products and salt forms as safety risks. | FDA-approved products and FDA GLP-1 compounding safety communications. |
| Tirzepatide Dual GIP/GLP-1 receptor agonist | FDA-approved | FDA-approved products exist. Copy compounding is constrained by approved-drug and shortage rules, not Category 1 peptide-bulk status. | FDA-approved products and FDA GLP-1 compounding safety communications. |
| Liraglutide GLP-1 receptor agonist | FDA-approved | FDA-approved products exist. This is an approved-drug pathway, not a Category 1 peptide-bulk listing. | FDA-approved product records. |
| Tesamorelin GHRH analog | FDA-approved | FDA-approved product exists. Any compounding analysis starts from approved-drug rules rather than Category 1 bulk status. | FDA-approved product records. |
| PT-141 / Bremelanotide Melanocortin receptor agonist | FDA-approved | FDA-approved product exists for a specific indication. That approval does not validate non-approved indications. | FDA-approved product records. |
| Oxytocin Neuropeptide hormone | FDA-approved | FDA-approved drug products exist. This is not a consumer peptide-bulk compounding status. | FDA-approved product records. |
| Elamipretide Mitochondria-targeted peptide | FDA-approved | FDA-approved product exists under an approved-drug pathway. It is not a Category 1 compounded bulk peptide. | FDA-approved product records. |
| GHK-Cu Glycyl-L-histidyl-L-lysine copper | Category 1PCAC review | Category 1 for non-injectable routes in the current FDA 503A list. Injectable GHK-Cu remains carved out and is still under FDA safety-risk review. PCAC discussion for injectable routes before end of February 2027. | Current FDA 503A category PDF lists GHK-Cu except injectable routes; FDA safety-risk page says GHK-Cu injection will be discussed with PCAC before the end of February 2027. |
| NAD+ Nicotinamide adenine dinucleotide | Category 1Not a peptide | Category 1 in the current FDA 503A list. It is a coenzyme, not a peptide, and Category 1 is not FDA drug approval. | Current FDA 503A category PDF. |
| Vasoactive intestinal peptide VIP | Category 1 | Category 1 in the current FDA 503A list if all compounding conditions are met. | Current FDA 503A category PDF. |
| Sermorelin GHRH (1-29) | Other compoundable path | Not shown as a May 2026 Category 1 peptide-bulk entry. Peptide Garden tracks it separately because its profile cites a prior FDA approval, withdrawal not for safety or effectiveness, and an established compounding pathway. | Secondary Peptide Garden profile context; not counted as a Category 1 tracker entry. |
| Kisspeptin-10 Kisspeptin fragment | Category 2InvestigationalNot compoundable | Category 2 in the current FDA 503A list. Treat as not currently compoundable. | Current FDA 503A category PDF and profile clinical-trial context. |
| Ipamorelin acetate Growth hormone secretagogue | Category 2PCAC reviewNot compoundable | Category 2 for 503B outsourcing facilities and not listed as a Category 1 503A bulk substance. | FDA safety-risk page and prior PCAC review context; no current Category 1 listing identified. |
| GHRP-2 Growth hormone releasing peptide-2 | Category 2Not compoundable | Category 2 for injectable and nasal routes in FDA's safety-risk materials. Treat as not currently compoundable. | FDA safety-risk page. |
| GHRP-6 Growth hormone releasing peptide-6 | Category 2Not compoundable | Category 2 in FDA's safety-risk materials. Treat as not currently compoundable. | FDA safety-risk page. |
| Ibutamoren MK-677 | Category 2Not compoundableNon-peptide secretagogue | Category 2 in the current FDA 503A list. Included because it is frequently grouped with growth hormone peptides in consumer searches. | Current FDA 503A category PDF. |
| BPC-157 BPC-157 free base and acetate salt PCAC hub | PCAC reviewNot compoundable | Not currently Category 1. FDA lists it on the safety-risk page and scheduled it for July 2026 PCAC review. PCAC review scheduled for July 23, 2026. | FDA July 2026 PCAC meeting notice and FDA safety-risk page. |
| KPV KPV free base and acetate salt PCAC hub | PCAC reviewNot compoundable | Not currently Category 1. Scheduled for FDA PCAC review for possible 503A bulk-list inclusion. PCAC review scheduled for July 23, 2026. | FDA July 2026 PCAC meeting notice. |
| TB-500 Thymosin beta-4 fragment (17-23) acetate PCAC hub | PCAC reviewNot compoundable | Not currently Category 1. Scheduled for FDA PCAC review for possible 503A bulk-list inclusion. PCAC review scheduled for July 23, 2026. | FDA July 2026 PCAC meeting notice. |
| MOTS-c MOTS-c free base and acetate salt PCAC hub | PCAC reviewNot compoundable | Not currently Category 1. Scheduled for FDA PCAC review for possible 503A bulk-list inclusion. PCAC review scheduled for July 23, 2026. | FDA July 2026 PCAC meeting notice. |
| Semax Semax free base and acetate salt PCAC hub | PCAC reviewNot compoundable | Not currently Category 1. Scheduled for FDA PCAC review for possible 503A bulk-list inclusion. PCAC review scheduled for July 24, 2026. | FDA July 2026 PCAC meeting notice. |
| Emideltide / DSIP Delta sleep-inducing peptide PCAC hub | PCAC reviewNot compoundable | Not currently Category 1. Scheduled for FDA PCAC review for possible 503A bulk-list inclusion. PCAC review scheduled for July 24, 2026. | FDA July 2026 PCAC meeting notice. |
| Epitalon Epitalon free base and acetate salt PCAC hub | PCAC reviewNot compoundable | Not currently Category 1. Scheduled for FDA PCAC review for possible 503A bulk-list inclusion. PCAC review scheduled for July 24, 2026. | FDA July 2026 PCAC meeting notice. |
| AOD-9604 hGH fragment 176-191 | PCAC reviewNot compoundable | Not currently Category 1. FDA PCAC reviewed AOD-9604-related bulk substances in December 2024; no current Category 1 listing identified. | FDA December 2024 PCAC notice and current 503A category PDF. |
| CJC-1295 CJC-1295 related bulk drug substances | PCAC reviewNot compoundable | Not currently Category 1. FDA PCAC reviewed CJC-1295-related bulk substances in December 2024; no current Category 1 listing identified. | FDA December 2024 PCAC notice and current 503A category PDF. |
| Thymosin alpha-1 Thymosin alpha-1 free base and acetate | PCAC reviewNot compoundable | Not currently Category 1. FDA PCAC reviewed thymosin alpha-1-related bulk substances in December 2024; no current Category 1 listing identified. | FDA December 2024 PCAC notice and current 503A category PDF. |
| Selank Selank acetate / TP-7 | Not compoundable | Not currently Category 1. FDA's safety-risk page continues to flag the substance even though nomination-status changes affected Category 2 placement. | FDA safety-risk page and current 503A category PDF. |
| Retatrutide Triple GIP/GLP-1/glucagon receptor agonist | InvestigationalNot compoundable | Investigational. FDA explicitly states retatrutide cannot be used in compounding under federal law. | FDA GLP-1 compounding safety page. |
| Cagrilintide Amylin analog | InvestigationalNot compoundable | Investigational. FDA explicitly states cagrilintide cannot be used in compounding under federal law. | FDA GLP-1 compounding safety page. |
Regulatory pages can change without much notice. These are the specific source surfaces this tracker currently uses.
Checked May 16, 2026
Current FDA category list for 503A nominated bulk drug substances, including Category 1, Category 2, and Category 3 entries.
Open sourceChecked May 16, 2026
FDA's safety-risk page for nominated bulk drug substances, including entries that may not currently appear on Category 2 because nominations were withdrawn.
Open sourceChecked May 16, 2026
Official FDA advisory committee notice for the July 2026 peptide bulk-substance agenda.
Open sourceChecked May 16, 2026
Official FDA advisory committee notice for AOD-9604, CJC-1295, and thymosin alpha-1 related bulk-substance review.
Open sourceChecked May 16, 2026
FDA safety page for unapproved GLP-1 drugs, including explicit statements about semaglutide, tirzepatide, retatrutide, and cagrilintide compounding.
Open sourceChecked May 16, 2026
FDA plain-language compounding FAQ explaining that compounded drugs are not FDA-approved.
Open sourceChecked May 16, 2026
FDA database for approved drug products, labels, approval letters, and regulatory history.
Open sourceDisclaimer
This tracker is educational and reflects source checks performed on May 16, 2026. It is not legal advice, medical advice, prescribing guidance, or a sourcing recommendation. Consult qualified counsel or a licensed healthcare professional for decisions that depend on current law or patient-specific care.