Regulatory tracker

Peptide Legal Status Tracker

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 June 27, 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.

Status lanes

Current categories at a glance

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.

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.

3 tracked

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 Injectable GHK-Cu was removed from Category 2 in April 2026 (its nomination was withdrawn) effective on or about April 22, 2026 — that removal does not place it on Category 1 and does not authorize compounding. Injectable GHK-Cu is slated for a separate FDA PCAC consultation before the end of February 2027.

PCAC consultation for injectable routes before 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.

Vasoactive intestinal peptide

VIP

Category 1

Category 1 in the current FDA 503A list if all compounding conditions are met.

Category 2

FDA has identified significant safety risks or demonstrable difficulties for compounding. These entries should be treated as not currently compoundable.

5 tracked

Kisspeptin-10

Kisspeptin fragment

Category 2InvestigationalNot compoundable

Category 2 in the current FDA 503A list. Treat as not currently compoundable.

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.

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.

GHRP-6

Growth hormone releasing peptide-6

Category 2Not compoundable

Category 2 in FDA's safety-risk materials. Treat as not currently compoundable.

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.

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.

12 tracked

GHK-Cu

Glycyl-L-histidyl-L-lysine copper

Category 1PCAC review

PCAC consultation for injectable routes before end of February 2027.

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.

BPC-157

BPC-157 free base and acetate salt

PCAC hub

PCAC reviewNot compoundable

Not currently Category 1. Removed from Category 2 in April 2026 (nomination withdrawn) and scheduled for July 2026 PCAC review for possible 503A bulk-list inclusion. Removal from Category 2 does not authorize compounding.

PCAC review scheduled for July 23, 2026.

KPV

KPV free base and acetate salt

PCAC hub

PCAC reviewNot compoundable

Not currently Category 1. Removed from Category 2 in April 2026 (nomination withdrawn) and scheduled for FDA PCAC review for possible 503A bulk-list inclusion. Removal from Category 2 does not authorize compounding.

PCAC review scheduled for July 23, 2026.

TB-500

Thymosin beta-4 fragment (17-23) acetate

PCAC hub

PCAC reviewNot compoundable

PCAC review scheduled for July 23, 2026.

MOTS-c

MOTS-c free base and acetate salt

PCAC hub

PCAC reviewNot compoundable

PCAC review scheduled for July 23, 2026.

Semax

Semax free base and acetate salt

PCAC hub

PCAC reviewNot compoundable

PCAC review scheduled for July 24, 2026.

Emideltide / DSIP

Delta sleep-inducing peptide

PCAC hub

PCAC reviewNot compoundable

PCAC review scheduled for July 24, 2026.

Epitalon

Epitalon free base and acetate salt

PCAC hub

PCAC reviewNot compoundable

PCAC review scheduled for July 24, 2026.

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.

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.

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-approved

At least one FDA-approved drug product exists for the active ingredient. This does not authorize non-approved uses or unrestricted copy compounding.

7 tracked

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. On May 1, 2026, FDA separately proposed to exclude semaglutide from the 503B outsourcing-facility bulks list on a 'no clinical need' finding; if finalized, this would permanently bar large-scale 503B bulk compounding. This is a 503B action, not a 503A category change, and does not alter the drug's FDA-approved status.

Public comment on the proposed 503B bulks-list exclusion due July 30, 2026 (FDA extended the deadline 30 days on June 26, 2026; docket FDA-2018-N-3240).

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. On May 1, 2026, FDA proposed to exclude tirzepatide from the 503B outsourcing-facility bulks list on a 'no clinical need' finding; if finalized, this would permanently bar large-scale 503B bulk compounding. This is a 503B action, not a 503A category change, and does not alter the drug's FDA-approved status.

Public comment on the proposed 503B bulks-list exclusion due July 30, 2026 (FDA extended the deadline 30 days on June 26, 2026; docket FDA-2018-N-3240).

Liraglutide

GLP-1 receptor agonist

FDA-approved

FDA-approved products exist. This is an approved-drug pathway, not a Category 1 peptide-bulk listing. On May 1, 2026, FDA proposed to exclude liraglutide from the 503B outsourcing-facility bulks list on a 'no clinical need' finding; if finalized, this would permanently bar large-scale 503B bulk compounding. This is a 503B action, not a 503A category change, and does not alter the drug's FDA-approved status.

Public comment on the proposed 503B bulks-list exclusion due July 30, 2026 (FDA extended the deadline 30 days on June 26, 2026; docket FDA-2018-N-3240).

Tesamorelin

GHRH analog

FDA-approved

FDA-approved product exists. Any compounding analysis starts from approved-drug rules rather than Category 1 bulk status.

PT-141 / Bremelanotide

Melanocortin receptor agonist

FDA-approved

FDA-approved product exists for a specific indication. That approval does not validate non-approved indications.

Oxytocin

Neuropeptide hormone

FDA-approved

FDA-approved drug products exist. This is not a consumer peptide-bulk compounding status.

Elamipretide

Mitochondria-targeted peptide

FDA-approved

FDA-approved product exists under an approved-drug pathway. It is not a Category 1 compounded bulk peptide.

Investigational

The peptide is in clinical development or limited research use and is not FDA-approved for routine prescribing.

3 tracked

Kisspeptin-10

Kisspeptin fragment

Category 2InvestigationalNot compoundable

Category 2 in the current FDA 503A list. Treat as not currently compoundable.

Retatrutide

Triple GIP/GLP-1/glucagon receptor agonist

InvestigationalNot compoundable

Investigational. FDA explicitly states retatrutide cannot be used in compounding under federal law.

Cagrilintide

Amylin analog

InvestigationalNot compoundable

Investigational. FDA explicitly states cagrilintide cannot be used in compounding under federal law.

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.

18 tracked

Kisspeptin-10

Kisspeptin fragment

Category 2InvestigationalNot compoundable

Category 2 in the current FDA 503A list. Treat as not currently compoundable.

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.

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.

GHRP-6

Growth hormone releasing peptide-6

Category 2Not compoundable

Category 2 in FDA's safety-risk materials. Treat as not currently compoundable.

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.

BPC-157

BPC-157 free base and acetate salt

PCAC hub

PCAC reviewNot compoundable

PCAC review scheduled for July 23, 2026.

KPV

KPV free base and acetate salt

PCAC hub

PCAC reviewNot compoundable

PCAC review scheduled for July 23, 2026.

TB-500

Thymosin beta-4 fragment (17-23) acetate

PCAC hub

PCAC reviewNot compoundable

PCAC review scheduled for July 23, 2026.

MOTS-c

MOTS-c free base and acetate salt

PCAC hub

PCAC reviewNot compoundable

PCAC review scheduled for July 23, 2026.

Semax

Semax free base and acetate salt

PCAC hub

PCAC reviewNot compoundable

PCAC review scheduled for July 24, 2026.

Emideltide / DSIP

Delta sleep-inducing peptide

PCAC hub

PCAC reviewNot compoundable

PCAC review scheduled for July 24, 2026.

Epitalon

Epitalon free base and acetate salt

PCAC hub

PCAC reviewNot compoundable

PCAC review scheduled for July 24, 2026.

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.

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.

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.

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.

Retatrutide

Triple GIP/GLP-1/glucagon receptor agonist

InvestigationalNot compoundable

Investigational. FDA explicitly states retatrutide cannot be used in compounding under federal law.

Cagrilintide

Amylin analog

InvestigationalNot compoundable

Investigational. FDA explicitly states cagrilintide cannot be used in compounding under federal law.

Full tracker

Deduplicated peptide-by-peptide table

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. On May 1, 2026, FDA separately proposed to exclude semaglutide from the 503B outsourcing-facility bulks list on a 'no clinical need' finding; if finalized, this would permanently bar large-scale 503B bulk compounding. This is a 503B action, not a 503A category change, and does not alter the drug's FDA-approved status. Public comment on the proposed 503B bulks-list exclusion due July 30, 2026 (FDA extended the deadline 30 days on June 26, 2026; docket FDA-2018-N-3240).	FDA-approved products, FDA GLP-1 compounding safety communications, and the May 2026 proposed 503B bulks-list exclusion. FDA GLP-1 compounding safety page FDA proposed 503B bulks-list exclusion for GLP-1s Drugs@FDA approved drug records FDA compounding questions and answers
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. On May 1, 2026, FDA proposed to exclude tirzepatide from the 503B outsourcing-facility bulks list on a 'no clinical need' finding; if finalized, this would permanently bar large-scale 503B bulk compounding. This is a 503B action, not a 503A category change, and does not alter the drug's FDA-approved status. Public comment on the proposed 503B bulks-list exclusion due July 30, 2026 (FDA extended the deadline 30 days on June 26, 2026; docket FDA-2018-N-3240).	FDA-approved products, FDA GLP-1 compounding safety communications, and the May 2026 proposed 503B bulks-list exclusion. FDA GLP-1 compounding safety page FDA proposed 503B bulks-list exclusion for GLP-1s Drugs@FDA approved drug records FDA compounding questions and answers
Liraglutide GLP-1 receptor agonist	FDA-approved	FDA-approved products exist. This is an approved-drug pathway, not a Category 1 peptide-bulk listing. On May 1, 2026, FDA proposed to exclude liraglutide from the 503B outsourcing-facility bulks list on a 'no clinical need' finding; if finalized, this would permanently bar large-scale 503B bulk compounding. This is a 503B action, not a 503A category change, and does not alter the drug's FDA-approved status. Public comment on the proposed 503B bulks-list exclusion due July 30, 2026 (FDA extended the deadline 30 days on June 26, 2026; docket FDA-2018-N-3240).	FDA-approved product records and the May 2026 proposed 503B bulks-list exclusion. Drugs@FDA approved drug records FDA proposed 503B bulks-list exclusion for GLP-1s FDA compounding questions and answers
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. Drugs@FDA approved drug records FDA compounding questions and answers
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. Drugs@FDA approved drug records FDA compounding questions and answers
Oxytocin Neuropeptide hormone	FDA-approved	FDA-approved drug products exist. This is not a consumer peptide-bulk compounding status.	FDA-approved product records. Drugs@FDA approved drug records FDA compounding questions and answers
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. Drugs@FDA approved drug records FDA compounding questions and answers
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 was removed from Category 2 in April 2026 (its nomination was withdrawn) effective on or about April 22, 2026 — that removal does not place it on Category 1 and does not authorize compounding. Injectable GHK-Cu is slated for a separate FDA PCAC consultation before the end of February 2027. PCAC consultation for injectable routes before end of February 2027.	Current FDA 503A category PDF lists GHK-Cu except injectable routes; injectable GHK-Cu was among 12 peptides removed from Category 2 in April 2026 (nominations withdrawn) and is slated for a PCAC consultation before the end of February 2027. FDA 503A bulk drug substances category PDF FDA safety-risk bulk drug substances page FDA April 2026 Category 2 removal of 12 peptides
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. FDA 503A bulk drug substances category PDF FDA compounding questions and answers
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. FDA 503A bulk drug substances category PDF FDA compounding questions and answers
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. Drugs@FDA approved drug records FDA compounding questions and answers
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. FDA 503A bulk drug substances category PDF
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. FDA safety-risk bulk drug substances page FDA December 4, 2024 PCAC meeting notice FDA 503A bulk drug substances category PDF
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. FDA safety-risk bulk drug substances 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. FDA safety-risk bulk drug substances 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. FDA 503A bulk drug substances category PDF
BPC-157 BPC-157 free base and acetate salt PCAC hub	PCAC reviewNot compoundable	Not currently Category 1. Removed from Category 2 in April 2026 (nomination withdrawn) and scheduled for July 2026 PCAC review for possible 503A bulk-list inclusion. Removal from Category 2 does not authorize compounding. PCAC review scheduled for July 23, 2026.	FDA July 2026 PCAC meeting notice and the April 2026 Category 2 removal. FDA July 23-24, 2026 PCAC meeting notice FDA April 2026 Category 2 removal of 12 peptides FDA safety-risk bulk drug substances page
KPV KPV free base and acetate salt PCAC hub	PCAC reviewNot compoundable	Not currently Category 1. Removed from Category 2 in April 2026 (nomination withdrawn) and scheduled for FDA PCAC review for possible 503A bulk-list inclusion. Removal from Category 2 does not authorize compounding. PCAC review scheduled for July 23, 2026.	FDA July 2026 PCAC meeting notice. FDA July 23-24, 2026 PCAC meeting notice FDA April 2026 Category 2 removal of 12 peptides FDA 503A bulk drug substances category PDF
TB-500 Thymosin beta-4 fragment (17-23) acetate PCAC hub	PCAC reviewNot compoundable	Not currently Category 1. Removed from Category 2 in April 2026 (nomination withdrawn) and scheduled for FDA PCAC review for possible 503A bulk-list inclusion. Removal from Category 2 does not authorize compounding. PCAC review scheduled for July 23, 2026.	FDA July 2026 PCAC meeting notice. FDA July 23-24, 2026 PCAC meeting notice FDA April 2026 Category 2 removal of 12 peptides FDA 503A bulk drug substances category PDF
MOTS-c MOTS-c free base and acetate salt PCAC hub	PCAC reviewNot compoundable	Not currently Category 1. Removed from Category 2 in April 2026 (nomination withdrawn) and scheduled for FDA PCAC review for possible 503A bulk-list inclusion. Removal from Category 2 does not authorize compounding. PCAC review scheduled for July 23, 2026.	FDA July 2026 PCAC meeting notice. FDA July 23-24, 2026 PCAC meeting notice FDA April 2026 Category 2 removal of 12 peptides FDA 503A bulk drug substances category PDF
Semax Semax free base and acetate salt PCAC hub	PCAC reviewNot compoundable	Not currently Category 1. Removed from Category 2 in April 2026 (nomination withdrawn) and scheduled for FDA PCAC review for possible 503A bulk-list inclusion. Removal from Category 2 does not authorize compounding. PCAC review scheduled for July 24, 2026.	FDA July 2026 PCAC meeting notice. FDA July 23-24, 2026 PCAC meeting notice FDA April 2026 Category 2 removal of 12 peptides FDA 503A bulk drug substances category PDF
Emideltide / DSIP Delta sleep-inducing peptide PCAC hub	PCAC reviewNot compoundable	Not currently Category 1. Removed from Category 2 in April 2026 (nomination withdrawn) and scheduled for FDA PCAC review for possible 503A bulk-list inclusion. Removal from Category 2 does not authorize compounding. PCAC review scheduled for July 24, 2026.	FDA July 2026 PCAC meeting notice. FDA July 23-24, 2026 PCAC meeting notice FDA April 2026 Category 2 removal of 12 peptides FDA 503A bulk drug substances category PDF
Epitalon Epitalon free base and acetate salt PCAC hub	PCAC reviewNot compoundable	Not currently Category 1. Removed from Category 2 in April 2026 (nomination withdrawn) and scheduled for FDA PCAC review for possible 503A bulk-list inclusion. Removal from Category 2 does not authorize compounding. PCAC review scheduled for July 24, 2026.	FDA July 2026 PCAC meeting notice. FDA July 23-24, 2026 PCAC meeting notice FDA April 2026 Category 2 removal of 12 peptides FDA 503A bulk drug substances category PDF
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. FDA December 4, 2024 PCAC meeting notice FDA 503A bulk drug substances category PDF FDA safety-risk bulk drug substances page
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. FDA December 4, 2024 PCAC meeting notice FDA 503A bulk drug substances category PDF FDA safety-risk bulk drug substances page
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. FDA December 4, 2024 PCAC meeting notice FDA 503A bulk drug substances category PDF FDA safety-risk bulk drug substances page
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. FDA safety-risk bulk drug substances page FDA 503A bulk drug substances 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. FDA GLP-1 compounding safety page FDA compounding questions and answers
Cagrilintide Amylin analog	InvestigationalNot compoundable	Investigational. FDA explicitly states cagrilintide cannot be used in compounding under federal law.	FDA GLP-1 compounding safety page. FDA GLP-1 compounding safety page FDA compounding questions and answers

Source monitor

Official sources checked for this page

Regulatory pages can change without much notice. These are the specific source surfaces this tracker currently uses.

Checked June 14, 2026

FDA 503A bulk drug substances category PDF

Current FDA category list for 503A nominated bulk drug substances, including Category 1, Category 2, and Category 3 entries.

Open source

Checked June 14, 2026

FDA safety-risk bulk drug substances page

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 source

Checked June 14, 2026

FDA July 23-24, 2026 PCAC meeting notice

Official FDA advisory committee notice for the July 2026 peptide bulk-substance agenda.

Open source

Checked May 16, 2026

FDA December 4, 2024 PCAC meeting notice

Official FDA advisory committee notice for AOD-9604, CJC-1295, and thymosin alpha-1 related bulk-substance review.

Open source

Checked May 16, 2026

FDA GLP-1 compounding safety page

FDA safety page for unapproved GLP-1 drugs, including explicit statements about semaglutide, tirzepatide, retatrutide, and cagrilintide compounding.

Open source

Checked June 27, 2026

FDA proposed 503B bulks-list exclusion for GLP-1s

FDA Federal Register notice (published May 1, 2026; FR doc 2026-08552) proposing to exclude semaglutide, tirzepatide, and liraglutide from the 503B outsourcing-facility bulks list on a finding of no clinical need. The comment period (originally closing June 30, 2026) was extended 30 days to July 30, 2026 (FR Doc 2026-12937; docket FDA-2018-N-3240). This is a 503B action, not a 503A category change, and does not alter the drugs' FDA-approved status.

Open source

Checked June 27, 2026

FDA April 2026 Category 2 removal of 12 peptides

FDA removed 12 peptide bulk substances (including BPC-157, KPV, TB-500, MOTS-c, Semax, DSIP, Epitalon, and injectable GHK-Cu) from Category 2 of the interim 503A list in April 2026 after the nominations were withdrawn. Removal does not authorize compounding; it does not place the substances on Category 1. Seven go to the July 2026 PCAC meeting; injectable GHK-Cu and four others are slated for a separate PCAC consultation before the end of February 2027. The linked Federal Register notice (FR 2026-07361) is the FDA notice establishing the July 2026 PCAC meeting and its public docket.

Open source

Checked May 16, 2026

FDA compounding questions and answers

FDA plain-language compounding FAQ explaining that compounded drugs are not FDA-approved.

Open source

Checked May 16, 2026

Drugs@FDA approved drug records

FDA database for approved drug products, labels, approval letters, and regulatory history.

Open source

Disclaimer

This tracker is educational and reflects source checks performed on June 27, 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.