FDA compounding status
Retatrutide
Retatrutide is not FDA-approved, there is no approved drug it could be a component of, it is in no FDA compounding category and it is on neither bulks list, so there is no pathway for a US pharmacy to compound it today. Nothing favorable is pending.
Checked against the primary sources on .
The record
- FDA status
- No compounding pathway today.
- Compounding basis
- No compounding pathwayNo facility type may compound this substance today.
- FDA advisory committee
- Not reviewed
- Sport (WADA 2026)
- Prohibited at all times under WADA class S0 (non-approved substances).
- Offered by PEPLUX
- No
- Checked on
Basis
What this status traces to.
Retatrutide has no entry in FDA's 503A or 503B category documents, and it is not on the 503A bulks list (21 CFR 216.23) or the 503B bulks list. FDA's Pharmacy Compounding Advisory Committee has not reviewed it. FDA's warning letters of August 24, 2026 to two online peptide sellers named retatrutide products as unapproved new drugs.
Primary sources
- FDA 503A categoriesBulk drug substances nominated for use in compounding under section 503A (categories), updated May 14, 2026Document dated . Checked .
- FDA 503B categoriesBulk drug substances nominated for use in compounding under section 503B (categories), updated March 21, 2025Document dated . Checked .
- FDA503B Bulk Drug Substances ListDocument dated . Checked .
- eCFR21 CFR 216.23, Bulk drug substances that can be used to compound drug productsDocument dated . Checked .
- FDA warning letterWarning letter 734884, Royal Peptides LLCDocument dated . Checked .
- FDA warning letterWarning letter 735063, Peptide Partners LLCDocument dated . Checked .
- WADAWorld Anti-Doping Code, 2026 Prohibited ListDocument dated . Checked .
Context
A removal or a committee vote is not a listing.
Removal from FDA's Category 2 is not FDA approval and not a listing. FDA removed several peptides from its 503A Category 2 after their nominators withdrew the nominations, not because the substances were found safe: BPC-157, TB-500, MOTS-c, semax and epitalon among others (removal noticed April 15, 2026, effective after 7 days), and CJC-1295 and ipamorelin earlier (removal notice dated September 27, 2024). None was added to the 503A bulks list, so none has a compounding pathway today. A favorable vote by FDA's Pharmacy Compounding Advisory Committee is a recommendation, not a listing: nothing changes unless FDA publishes a final rule.
FDA advisory committee
FDA's Pharmacy Compounding Advisory Committee has not reviewed it.
If you are subject to anti-doping rules
Prohibited at all times under WADA class S0 (non-approved substances).
Not named on the 2026 list. S0 covers drugs under clinical development that no government health authority has approved for human therapeutic use.
Common questions
Retatrutide, answered plainly.
- What is the FDA compounding status of Retatrutide?
- Retatrutide is not FDA-approved, there is no approved drug it could be a component of, it is in no FDA compounding category and it is on neither bulks list, so there is no pathway for a US pharmacy to compound it today. Nothing favorable is pending.
- What does the status of retatrutide trace to?
- Retatrutide has no entry in FDA's 503A or 503B category documents, and it is not on the 503A bulks list (21 CFR 216.23) or the 503B bulks list. FDA's Pharmacy Compounding Advisory Committee has not reviewed it. FDA's warning letters of August 24, 2026 to two online peptide sellers named retatrutide products as unapproved new drugs. Checked against the primary sources on October 13, 2026.
- Does a Category 2 removal or an advisory committee recommendation change the status of retatrutide?
- Removal from FDA's Category 2 is not FDA approval and not a listing. FDA removed several peptides from its 503A Category 2 after their nominators withdrew the nominations, not because the substances were found safe: BPC-157, TB-500, MOTS-c, semax and epitalon among others (removal noticed April 15, 2026, effective after 7 days), and CJC-1295 and ipamorelin earlier (removal notice dated September 27, 2024). None was added to the 503A bulks list, so none has a compounding pathway today. A favorable vote by FDA's Pharmacy Compounding Advisory Committee is a recommendation, not a listing: nothing changes unless FDA publishes a final rule.
- Does PEPLUX offer retatrutide?
- Retatrutide is not FDA-approved, and there is no lawful pathway for a US pharmacy to compound it today. Its safety and effectiveness in people have not been established. PEPLUX does not offer, prescribe or sell it. This page explains its regulatory status and is not a recommendation to use it.
- Is retatrutide prohibited in sport?
- Prohibited at all times under WADA class S0 (non-approved substances). Not named on the 2026 list. S0 covers drugs under clinical development that no government health authority has approved for human therapeutic use.