1. FDA status (USA)
The FDA classifies substances in several ways relevant to peptides:
| Status | Meaning |
|---|---|
| FDA-approved drug | Full clinical trial programme completed; approved for specific indication(s). E.g., Ozempic (semaglutide), Mounjaro (tirzepatide). |
| IND (Investigational New Drug) | In clinical trials under FDA oversight. Not yet approved. |
| Bulk active pharmaceutical ingredient (API) | Can be used by compounding pharmacies under specific conditions. FDA has tightened rules on which peptides can be compounded. |
| Nominated to Category 1 (503A/503B restriction) | FDA has restricted certain peptides from compounding — e.g., BPC-157, TB-500 were added to Category 1 in 2024, though this has faced legal challenges. |
| Not scheduled / unregulated API | No FDA approval and not subject to specific restrictions — technically unregulated for research purposes. |
FDA status directly affects US compounding pharmacies and may indicate regulatory trajectory globally, but doesn't directly govern Australian research use.
2. TGA status (Australia)
The Therapeutic Goods Administration (TGA) regulates therapeutic goods in Australia:
| Status | Meaning for Australian researchers |
|---|---|
| ARTG-listed prescription medicine | Approved drug — available via prescription. Semaglutide (Ozempic) is TGA-registered. |
| Schedule 4 (Prescription Only) | Requires a doctor's prescription. Most pharmaceutically approved peptides fall here. |
| Schedule 8 (Controlled Drug) | Strict prescribing and dispensing controls. Some compounds may fall here depending on pharmacological classification. |
| Unscheduled / unapproved | Not scheduled, but not TGA-approved for therapeutic use. Many research peptides fall here. Selling as therapeutic goods without TGA approval is prohibited; possession for personal research is generally not targeted for enforcement. |
3. WADA prohibited list
The World Anti-Doping Agency maintains the Prohibited List (updated annually). WADA status is relevant only for competitive athletes subject to anti-doping rules.
| Category | Examples | What it means |
|---|---|---|
| S2 — Peptide hormones, growth factors | GH, IGF-1, GH-releasing peptides (CJC, ipamorelin, GHRP-2/6) | Banned in and out of competition |
| S4 — Hormone and metabolic modulators | GLP-1 receptor agonists (as of 2024 WADA updates) | Banned in and out of competition |
| Not currently listed | BPC-157, TB-500 (though under review) | Not prohibited — but WADA evolves annually |
Always check the current WADA Prohibited List at wada-ama.org rather than relying on secondhand information — the list changes annually and mid-year updates occur.
4. Compounding status
Compounding pharmacies prepare customised pharmaceutical-grade preparations for individual patients under doctor supervision. The compounding landscape for peptides has shifted significantly:
- In Australia, compounding pharmacies can prepare unapproved peptides for individual patients under a doctor's prescription (s70 TGA authority).
- In the USA, the FDA's 503A/503B nominations have progressively restricted which peptides compounding pharmacies can use — creating significant regulatory uncertainty for US compounders.
- Compounded peptides are pharmaceutical-grade with GMP manufacturing standards — a different quality tier from research-grade peptides.
5. Research use designation
The “Research Use Only — Not for Human Consumption” label is a regulatory disclaimer, not a safety statement. See the full research-only label guide for detailed explanation.
In summary: the designation indicates the vendor is not selling a therapeutic good (which would require TGA registration). It doesn't mean the compound is untested, dangerous, or that anyone using it is acting illegally — in most jurisdictions including Australia, personal possession of research chemicals is not a criminal matter.