U.S. regulatory status

AOD-9604

Also known as AOD9604, LAT-8881, AOD-9604 acetate

In limboWithdrawn from Category 2 in Sep 2024; PCAC voted 0-12 against the 503A list; not compoundable

Is AOD-9604 legal right now?

AOD-9604 is a synthetic fragment of human growth hormone (amino acids 177-191 plus an added tyrosine).

It is not FDA-approved, not on the 503A bulks list and in none of FDA’s interim compounding categories, so a U.S. pharmacy cannot lawfully compound it. FDA placed it in 503A Category 2 (significant safety risks) on September 29, 2023, and removed it on September 27, 2024 because the nominators withdrew their nominations.

Leaving Category 2 did not make it compoundable: only Category 1 substances get FDA’s interim enforcement discretion. FDA still put AOD-9604 before its Pharmacy Compounding Advisory Committee on December 4, 2024, where members voted 0-12 against placing it on the 503A bulks list, matching FDA’s own proposal.

It is not on the agenda of the next committee meeting, and FDA’s Category 2 page still lists it among withdrawn nominations with its stated safety concerns. It would become compoundable only if FDA added it to the 503A bulks list by rulemaking, which the committee advised against.

In limbo: Moved on paper - nominated, removed from a restricted list, or recommended by an FDA committee - but not added to the 503A list. The headline implies a change; the legal status has not moved.

Verified Oct 15, 2026 (ET) · status held since Sep 27, 2024

Primary source: FDA All 9 sources FDA category lists

The committee vote

December 4, 2024

The question put to the FDA Pharmacy Compounding Advisory Committee “Should AOD-9604 (free base) and AOD-9604 acetate be placed on the 503A Bulks List?”

Not recommended by the committee

0 in favour
12 against
0 abstained

12 votes recorded.

What this means: the vote is advice to the FDA, not a decision. AOD-9604 was not on the 503A Bulk Drug Substances List before the vote and is not on it now. Only a completed FDA rulemaking can change that.

Where it sits in the process

Nominated (stalled here - not advancing)
Under review (not reached)
Rulemaking (not reached)
Compounding-legal (not reached)

Not on a path to the 503A list right now. The process stalled or reversed at this stage - read the status above. Sitting at an earlier step is not a sign it will advance.

What changed last

No recorded changes yet - this entry has held one status since it was added.

Status elsewhere

AOD-9604: regulatory status by jurisdiction
Jurisdiction	Status	Note
United States (FDA)	In limbo	Removed from 503A Category 2 on Sep 27, 2024 after the nominations were withdrawn; PCAC voted 0-12 against the 503A list on Dec 4, 2024; in no category, not compoundable.
Australia (TGA)	Restricted	Named in Schedule 4 (prescription only) of the Poisons Standard and in Appendix D item 5 (possession without authority is illegal), entries made by a 2015 scheduling decision.
United Kingdom (MHRA)	Restricted	No UK marketing authorisation (not in the MHRA products substance index); supply as a medicine would be unlicensed.
European Union (EMA)	Restricted	No EU marketing authorisation or orphan designation (absent from the Union Register); sale as a medicine is unlawful EU-wide, with enforcement at member-state level.
Canada (Health Canada)	Restricted	Not in the Drug Product Database; Health Canada advisories in Aug and Dec 2025 list seized AOD-9604 among unauthorized injectable peptide drugs, which it regulates as prescription drugs.
Sport / anti-doping (WADA)	Restricted	Named in S2.2.3 of the 2027 Prohibited List as a growth hormone fragment (“e.g. AOD-9604 and hGH 176-191”); prohibited at all times.

The U.S. status is watched by automation every six hours. Statuses elsewhere change less often and are covered by a monthly wide-net sweep, then re-verified whenever a lead surfaces - this entry’s last-verified date covers every row above. How we track it

FDA warning letters

One FDA warning letter mentions AOD-9604, dated Jan 26, 2022.

Innoveix Pharmaceuticals Inc Jan 26, 2022 · Compounding Pharmacy / Adulterated Drug Products

A warning letter is the FDA telling one company it believes the company broke federal law. It does not change the status above. All warning letters, by compound

Sources & transparency

Sources for this entry

FDA - Certain bulk drug substances that may present significant safety risks (Category 2 page) FDA · primaryLists AOD-9604 under ‘Bulk drug substances nominated but withdrawn’ with FDA’s stated safety concerns (content current as of Apr 22, 2026).
FDA - Final summary minutes, Pharmacy Compounding Advisory Committee, Dec 4, 2024 FDA · primaryVote on placing AOD-9604 (free base) and AOD-9604 acetate on the 503A Bulks List: Yes 0, No 12, Abstain 0.
FDA - 503A categories list (updated May 14, 2026) FDA · primaryAOD-9604 does not appear in Category 1, 2 or 3.
Therapeutic Goods (Poisons Standard - October 2026) Instrument 2026 Government · primaryAOD-9604 (CAS No. 221231-10-3): Schedule 4; Appendix D, clause 5. Basis for the Australia (TGA) row.
Health Canada - Unauthorized injectable peptide drugs seized and sold by Canada Peptide (Aug 1, 2025) Health Canada · primaryLists AOD9604; ‘Injectable peptides are regulated as prescription drugs in Canada.’ Basis for the Canada row.
MHRA Products - substance index (A) UK gov · primaryNo AOD-9604 entry. Basis for the United Kingdom (MHRA) row.
EU Union Register of medicinal products (active substance index) EU · primaryNo AOD-9604 entry. Basis for the European Union (EMA) row.
WADA - 2027 Prohibited List (in force Jan 1, 2027) WADA · primaryS2.2.3 names AOD-9604 among growth hormone fragments; prohibited at all times. The 2026 List has the same wording.
FDA - 503A categories list, updated Sep 27, 2024 (Wayback Machine copy) Analysis’AOD-9604’ has been removed from Category 2 because the nominations were withdrawn by the nominators.

Last verified by a human: Oct 15, 2026 (ET) · how we verify
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