FDA compounding status
AOD-9604
AOD-9604 is not FDA-approved, and there is no pathway for a US pharmacy to compound it today. FDA removed it from its 503A Category 2 on September 27, 2024, after the nominations were withdrawn, and FDA's Pharmacy Compounding Advisory Committee voted against it on December 4, 2024. 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
- Voted against, Dec 4, 2024
- Sport (WADA 2026)
- Prohibited at all times under WADA class S2.2.3 (growth hormone, its analogues and fragments).
- Offered by PEPLUX
- Yes, as AOD-9604
- Checked on
Offered by PEPLUX
AOD-9604
PEPLUX offers AOD-9604. The product page covers what it is, its risks, and how prescribing and pricing work.
Basis
What this status traces to.
FDA's 503A categories document of September 27, 2024 removed AOD-9604 from Category 2 after its nominations were withdrawn. At its December 4, 2024 meeting, FDA's Pharmacy Compounding Advisory Committee voted 12 to 0 against it, in one vote covering the free base and the acetate, according to the final minutes. It has no entry in FDA's current 503A or 503B category documents, it is not on the 503A bulks list (21 CFR 216.23) or the 503B bulks list, and it is not a component of an FDA-approved drug. FDA's safety page says compounded AOD-9604 may pose a significant risk of immunogenicity, that FDA has identified no, or only limited, safety-related information, and that FDA has identified serious adverse events that may be associated with it, though causality is not clear.
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 503A categoriesBulk drug substances nominated for use in compounding under section 503A (categories), updated September 27, 2024Document dated . Checked .
- FDACertain Bulk Drug Substances for Use in Compounding that May Present Significant Safety RisksDocument dated . Checked .
- FDA advisory committee minutesPharmacy Compounding Advisory Committee, December 4, 2024: final minutesDocument 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 voted against it at its meeting of December 4, 2024, according to the final minutes.
Pharmacy Compounding Advisory Committee, December 4, 2024: final minutes (dated )
If you are subject to anti-doping rules
Prohibited at all times under WADA class S2.2.3 (growth hormone, its analogues and fragments).
Pending or unconfirmed
FDA's inventory of food-ingredient notices has not yet been checked for AOD-9604.
Common questions
AOD-9604, answered plainly.
- What is the FDA compounding status of AOD-9604?
- AOD-9604 is not FDA-approved, and there is no pathway for a US pharmacy to compound it today. FDA removed it from its 503A Category 2 on September 27, 2024, after the nominations were withdrawn, and FDA's Pharmacy Compounding Advisory Committee voted against it on December 4, 2024. Nothing favorable is pending.
- What does the status of AOD-9604 trace to?
- FDA's 503A categories document of September 27, 2024 removed AOD-9604 from Category 2 after its nominations were withdrawn. At its December 4, 2024 meeting, FDA's Pharmacy Compounding Advisory Committee voted 12 to 0 against it, in one vote covering the free base and the acetate, according to the final minutes. It has no entry in FDA's current 503A or 503B category documents, it is not on the 503A bulks list (21 CFR 216.23) or the 503B bulks list, and it is not a component of an FDA-approved drug. FDA's safety page says compounded AOD-9604 may pose a significant risk of immunogenicity, that FDA has identified no, or only limited, safety-related information, and that FDA has identified serious adverse events that may be associated with it, though causality is not clear. Checked against the primary sources on October 13, 2026.
- Does a Category 2 removal or an advisory committee recommendation change the status of AOD-9604?
- 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 AOD-9604?
- PEPLUX offers AOD-9604. Compounded medications are not approved by the FDA and have not been reviewed for safety, effectiveness, or quality. AOD-9604 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.
- Is AOD-9604 prohibited in sport?
- Prohibited at all times under WADA class S2.2.3 (growth hormone, its analogues and fragments).
- Is anything about the status of AOD-9604 pending or unconfirmed?
- FDA's inventory of food-ingredient notices has not yet been checked for AOD-9604.