In plain English
Australia has a national rulebook called the Poisons Standard. It puts medicines and chemicals into groups called “Schedules” [1, 2]. The Schedule decides how tightly a substance is controlled: whether it can sit on a supermarket shelf, must be sold in a pharmacy, needs a prescription, or carries even stricter controls [1].
For medicines, four Schedules matter most [1]:
- Schedule 2: pharmacy medicines.
- Schedule 3: pharmacist only medicines (sold by a pharmacist, no prescription).
- Schedule 4: prescription only medicines.
- Schedule 8: controlled drugs, with extra rules on supply and possession.
An extra section, Appendix D, adds more rules for some Schedule 4 and 8 substances. Clause 5 of Appendix D lists poisons that are illegal to possess without authority (for example, without a prescription) [1].
Being in a Schedule does not mean a product is approved. Several peptides promoted online are in Schedule 4 and Appendix D, clause 5, but are not approved medicines in Australia [1, 4].
What is the Poisons Standard?
The Poisons Standard records decisions about classifying medicines and poisons into Schedules, for inclusion in state and territory legislation. It also contains model rules on containers and labels, lists of exemptions, and recommendations on other controls [2]. It is a legislative instrument, and may also be cited as the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP) [2].
The current edition is the Therapeutic Goods (Poisons Standard—October 2026) Instrument 2026 (F2026L01327), which superseded the June 2026 instrument. Editions are named by month and year rather than by edition number [1, 2].
Who makes the decisions?
Scheduling decisions are made under the Therapeutic Goods Act 1989. In practice they are usually made by a delegate of the Secretary of the Department of Health [3]. Two expert committees, the Advisory Committee on Medicines Scheduling (ACMS) and the Advisory Committee on Chemicals Scheduling (ACCS), make recommendations to the Secretary; the Commonwealth and each state and territory may nominate members [3]. The TGA publishes interim and final decisions, and lists decisions due to take effect in future editions [2, 3].
Who enforces it?
The Commonwealth makes the Poisons Standard, but states and territories put it into effect through their own laws. The instrument itself notes that, for the legal definitions of each Schedule, it is necessary to check with each state or territory authority [1].
The Schedules at a glance
The instrument gives a general description of each Schedule [1]:
| Schedule | Title | General description (summarised from the instrument) |
|---|---|---|
| 1 | Blank | Intentionally blank |
| 2 | Pharmacy medicines | Safe use may require advice from a pharmacist; available from a pharmacy or, where there is no pharmacy service, a licensed person |
| 3 | Pharmacist only medicines | Safe use requires professional advice; available from a pharmacist without a prescription |
| 4 | Prescription only medicines and prescription animal remedies | Use or supply should be by or on the order of a person permitted by state or territory law to prescribe; available from a pharmacist on prescription |
| 5 | Caution | Low potential for harm; simple warnings on the label |
| 6 | Poisons | Moderate potential for harm; distinctive packaging and strong warnings |
| 7 | Dangerous poisons | High potential for harm at low exposure; available only to specialised or authorised users |
| 8 | Controlled drugs | Should be available for use, but manufacture, supply, distribution, possession and use are restricted to reduce abuse, misuse and dependence |
| 9 | Prohibited substances | Prohibited except for approved medical or scientific research, analysis, teaching or training |
| 10 | Prohibited for specified purposes | Supply and use prohibited for the purposes listed for each poison |
The instrument explains that medicines are mostly in Schedules 2, 3, 4 and 8, “with progression through these Schedules signifying increasingly restrictive regulatory controls”. Schedules 5, 6 and 7 apply mainly to agricultural, domestic and industrial poisons [1].
Schedules 2, 3, 4 and 8 in more detail
Schedule 2: Pharmacy medicines
Substances whose safe use may require a pharmacist’s advice. They are sold from pharmacies, or from a licensed person where no pharmacy service is available [1].
Schedule 3: Pharmacist only medicines
Substances whose safe use requires professional advice, but which can be supplied by a pharmacist without a prescription [1]. The TGA states that advertising most pharmacist-only medicines to the public is prohibited [4]; Appendix H of the instrument lists the Schedule 3 medicines that are permitted to be advertised [1].
Schedule 4: Prescription only medicines
Substances whose use or supply should be by, or on the order of, a person permitted by state or territory law to prescribe, and which are available from a pharmacist on prescription [1]. The TGA states that advertising prescription-only medicines to the public is prohibited unless authorised or required by an Australian government authority [4].
Schedule 8: Controlled drugs
Substances that should be available for use, but whose manufacture, supply, distribution, possession and use are restricted to reduce abuse, misuse and physical or psychological dependence [1].
What is Appendix D?
Appendix D lists poisons in Schedule 4 or 8 that carry additional controls on possession or supply [1]. It has nine clauses:
| Clause | Additional control [1] |
|---|---|
| 1 | Available for human use only from or on the prescription or order of an authorised medical practitioner |
| 2 | Available for human use only on the prescription or order of a specialist physician or a dermatologist |
| 3 | Available only on the prescription or order of a medical practitioner approved or authorised under section 19 of the Act |
| 4 | Available only on the order of a specialist physician |
| 5 | Poisons for which possession without authority is illegal |
| 6 | Available for human use only on the prescription or order of a specialist physician |
| 7 | Available for human use only on the prescription or order of a dermatologist |
| 8 | Must be stored in a locked container to prevent unauthorised access |
| 9 | Available only when prescribed or authorised in certain circumstances |
Clause 5 is the one most relevant to peptides. For a substance in clause 5, possession without authority (for example, other than in accordance with a lawful prescription) is illegal [1].
How peptides are scheduled
Scheduling is substance by substance. The table below shows what the October 2026 instrument says about some peptides discussed in this library [1].
| Peptide | Entry in the October 2026 Poisons Standard |
|---|---|
| BPC-157 | Named: Schedule 4 and Appendix D, clause 5 |
| TB-500 and thymosin beta-4 | Named: Schedule 4 and Appendix D, clause 5 |
| CJC-1295 | Named: Schedule 4 and Appendix D, clause 5; also within the class “growth hormone releasing hormones (GHRHs)” |
| Ipamorelin | Named: Schedule 4 and Appendix D, clause 5; also within the class “growth hormone secretagogues (GHSs)” |
| GHRP-6 | Named: Schedule 4 and Appendix D, clause 5; also within the class “growth hormone releasing peptides (GHRPs)” |
| Pralmorelin (GHRP-2) | Named: Schedule 4 and Appendix D, clause 5 |
| Sermorelin | Named: Schedule 4. The GHRH class entry is Schedule 4 and Appendix D, clause 5 |
| Oxytocin | Named: Schedule 4 (also Appendix G) |
| Human chorionic gonadotrophin | Named: Schedule 4, except in pregnancy test kits |
| Glutathione | Named: Schedule 4 for certain preparations only (check the entry wording) |
| GHK-Cu, KPV, MOTS-c, NAD+, Epitalon, Semax, Selank, DSIP | Not named |
Class entries and derivatives
Two features of the instrument make scheduling broader than the list of named substances [1]:
- Group or class entries. Some entries cover a whole group, such as “growth hormone releasing peptides”. The instrument explains that group terms are retained to catch members of a class that might otherwise escape attention. Whether a class entry captures a specific compound is a legal question.
- Salts and derivatives. A Schedule entry includes preparations containing the poison in any concentration, and its salts and derivatives, unless the entry says otherwise. Whether a substance is a derivative depends on a balanced consideration of factors, including structural, pharmacological and toxicological similarity.
Not named does not mean unregulated
If a peptide is not named in the current Poisons Standard, that does not mean it is unregulated. If it is not entered on the ARTG, it is still an unapproved therapeutic good, and the TGA regards unapproved peptide products as therapeutic goods subject to import, supply and advertising controls [4, 5]. See What Is the ARTG?.
Three things the Poisons Standard does not do
The instrument is explicit that inclusion in a Schedule does not [1]:
- indicate that the poison is available
- indicate that it has been approved, or is efficacious, for any use
- remove any obligation to register a therapeutic good.
It also states that poisons packed and sold solely for industrial, manufacturing, laboratory or dispensary use are exempt from its labelling requirements, but that “this exemption does not extend to controls on supply” [1].
What this means in Australia
- ARTG. Scheduling and approval are separate. A substance can be in Schedule 4 without any product containing it being on the ARTG. Products not on the ARTG have not been assessed by the TGA for safety, quality or effectiveness [1, 5].
- Poisons Standard. Schedule 4 means prescription-only. Appendix D, clause 5 means possessing the substance without authority is illegal. BPC-157, TB-500, thymosin beta-4, CJC-1295, ipamorelin, GHRP-6 and pralmorelin (GHRP-2) are each named in both [1]. States and territories implement the Schedules through their own laws [1].
- TGA position. In April 2026 the TGA stated that “research use only” disclaimers do not make supply lawful, and do not change a product’s regulatory status, permit importation, or remove advertising or supply obligations. It named BPC-157, GHK-Cu, TB-500 and CJC-1295 as examples of unapproved peptide products [4]. In June 2026 it added unapproved peptide products to its compliance priorities [6].
- Sport. Anti-doping lists are a separate system from the Poisons Standard.
This is general information, not legal advice. Laws change; check the current Poisons Standard and TGA guidance.
Frequently asked questions
What is the Poisons Standard?
It is a Commonwealth legislative instrument, also called the SUSMP, that classifies medicines and poisons into Schedules for adoption into state and territory law. The current edition is the October 2026 instrument [1, 2].
What does Schedule 4 mean?
Schedule 4 is “prescription only medicines”. Use or supply should be by or on the order of an authorised prescriber, and the medicine is available from a pharmacist on prescription [1].
What is the difference between Schedule 4 and Schedule 8?
Schedule 8 (controlled drugs) adds restrictions on manufacture, supply, distribution, possession and use to reduce abuse, misuse and dependence. It is the most restrictive of the main medicine Schedules [1].
What does Appendix D, clause 5 mean?
It lists poisons for which possession without authority is illegal, such as possession other than in accordance with a lawful prescription [1].
Is BPC-157 a Schedule 4 substance?
Yes. BPC-157 is named in Schedule 4 and in Appendix D, clause 5 of the October 2026 Poisons Standard. It is not on the ARTG [1, 4].
Does being in a Schedule mean a medicine is approved?
No. The instrument states that scheduling does not indicate that a substance is available, approved or efficacious, and does not remove the need for registration [1].
References
- Commonwealth of Australia. Therapeutic Goods (Poisons Standard—October 2026) Instrument 2026 (F2026L01327). Federal Register of Legislation. legislation.gov.au/F2026L01327/latest/text. Accessed 11 October 2026.
- Therapeutic Goods Administration. The Poisons Standard (the SUSMP). tga.gov.au. Accessed 11 October 2026.
- Therapeutic Goods Administration. Scheduling handbook: guidance for amending the Poisons Standard. Version 1.1, July 2019. tga.gov.au. Accessed 11 October 2026.
- Therapeutic Goods Administration. Understanding your responsibilities when importing, compounding and supplying unapproved peptide products. Safety advisory, 13 April 2026. tga.gov.au. Accessed 11 October 2026.
- Therapeutic Goods Administration. Unapproved therapeutic goods. tga.gov.au/products/unapproved-therapeutic-goods. Accessed 11 October 2026.
- Therapeutic Goods Administration. TGA strengthens compliance focus on unapproved peptide products as part of evolving risk response. Media release, 10 June 2026. tga.gov.au. Accessed 11 October 2026.
Important information and disclaimer
General information only. This article is published for general educational and informational purposes. It summarises published scientific literature and public regulatory information as at the “last reviewed” date shown above. It is not medical, health, pharmaceutical, veterinary or legal advice, and it must not be relied on as a substitute for advice from a qualified professional about your circumstances.
Not for human or animal use. Nothing in this article recommends, endorses or describes the use of any substance in humans or animals. Findings from cell, animal or early human studies cannot be assumed to apply to people. The compounds discussed have not been evaluated by the Therapeutic Goods Administration (TGA) for safety, quality or efficacy unless the article expressly states otherwise. Any research materials offered by Iconic Peptides are supplied solely for in vitro and laboratory research.
No therapeutic claims. Iconic Peptides makes no claim that any product treats, cures, prevents, alleviates or diagnoses any disease, condition or symptom. References to published studies, clinical trials or medicines approved by regulators are factual descriptions of the scientific and regulatory record. They are not representations about any product we supply.
Regulatory status. Many peptides are scheduled substances under the Poisons Standard. Some are prescription-only (Schedule 4), and some may not be possessed without authority (Appendix D). The TGA has stated that a “research use only” label does not make supply lawful, change a product’s regulatory status, or remove advertising or supply obligations. State and territory laws may also apply. You are responsible for knowing and complying with all laws that apply to you. Regulatory information in this article may change after the review date.
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