Is Methylene Blue Legal in Australia?

In Australia, the use of methylene blue for medicinal purposes is only legal with a prescription from an authorised healthcare provider, as required by regulatory controls. In Australia, methylene blue is classified as a Schedule 4 substance, meaning it is only legal for medicinal use with a prescription from a registered medical practitioner and is not available over the counter for therapeutic purposes.

Methylene blue is all over social media, with influencers highlighting its potential for cognitive enhancement, anti-aging, antimicrobial properties and neuroprotective effects. However, its legal status in Australia is complex, and the unauthorised import and sale of methylene blue may constitute a criminal offence.

Our drug lawyers Sydney team outline and examine the legal framework surrounding methylene blue in Australia, including its classification under various regulatory bodies and potential penalties for its unauthorised import and sale.

What is Methylene Blue?

Methylene blue is a synthetic compound originally developed as a dye, but has found various industrial and clinical uses including as a staining agent in biological research and histology, as a drug within aquaculture and veterinary medicine, as well as a reagent for milk freshness testing.

Currently, the mainstream medical use of methylene blue is limited to treating methemoglobinemia by restoring haemoglobin’s oxygen-carrying ability. However, excessive doses can paradoxically worsen the condition. It is also currently being researched as an antidote for cyanide and carbon monoxide poisoning, aiding cellular respiration and counteracting toxicity, with applications in emergency rooms.

Nevertheless, recent years have seen a resurgence of interest in methylene blue online, with various alternative health practitioners and social media influencers claiming the chemical is a “miracle drug” capable of anti-aging and cognitive enhancement benefits, as well as a potential treatment for conditions such as Alzheimer’s disease and long COVID. These claims are not well substantiated by scientific evidence, and experts have warned that consumption of methylene blue outside of regulated therapeutic applications could lead to adverse side effects, including hypertension, dizziness, nausea, haemolytic anaemia, serotonin toxicity and severe drug interactions.

Benefits and Side Effects of Methylene Blue

Methylene blue being a laboratory made dye with many uses for medicinal purposes, it is an FDA approved substance to treat health conditions such as methemoglobinemia (a blood disorder). Methylene Blue assists in converting red blood cells into a form that will efficiently carry and release oxygen.

Here are some of the benefits of Methylene Blue:

• Can assist healthcare providers identify abnormal cells in your body. It can find gastrointestinal cancers, overactive parathyroid glands, and cancer inside of lymph nodes.
• Can be effective to treat malaria.
• May treat nail fungus (onychomycosis).
• May assist raise blood pressure when typical treatment won’t work.
• Can assist in treating ifosfamide-induced encephalopathy.

Methylene Blue research is ongoing for looking into any other health benefits it may cause, including to help cure Alzheimer’s disease, anti-aging, Lyme disease, and chemotherapy and radiation-induced mouth sores.

Methylene blue is normally safe if used properly. But it does have some known risks if you take serotonin-raising medications or have a glucose-6-phosphate dehydrogenase (G6PD) deficiency. The below are some of the risks concerns of Methylene blue:

• There is a risk of serotonin syndrome if Methylene blue is used with other medications that raise serotonin levels. Illicit drugs such as amphetamines, MDMA, cocaine increase the risks for serotonin syndrome
• People with a glucose-6-phosphate dehydrogenase (G6PD) deficiency blood disorder should not take methylene blue. It can cause a significant break down of red blood cells and cause anemia.
• Can cause harm to a developing baby in the womb of a pregnant female. It can also cause the methylene blue to be transferred into breast mild which can be harmful to a baby.

How to Use Methylene Blue?

Methylene Blue can be administered in several ways, depending on its intended use. Medically, it is most commonly given as an intravenous infusion over a short period of time. In some cases, it may also be taken orally or applied topically. As a diagnostic dye, its distinctive blue colour helps healthcare professionals highlight abnormal or suspicious cells during certain medical procedures, and it may be injected directly into lymph nodes for this purpose.

Is Methylene Blue Legal in Australia?

Individuals seeking to use methylene blue for medicinal purposes in Australia must obtain it through a legally authorised prescription, ensuring compliance with regulatory controls. It is otherwise illegal in Australia. Methylene blue is not legally available over the counter for therapeutic use in Australia. Due to its Schedule 4 classification, it requires a prescription from a registered medical practitioner for medicinal purposes to be lawfully possessed and used. Here is more on drug possession and supply charges and penalties.

In Australia, methylene blue is classified as a controlled therapeutic good and is therefore subject to the Therapeutic Goods Act 1989 (Cth) and regulation by the Therapeutic Goods Administration (TGA).

The availability and legal status of methylene blue depends on what Schedule of the Poisons Standard the chemical falls into. The schedules under the Standard include:

• Schedule 1: which is no longer used.
• Schedule 2 (Pharmacy Medicine): meaning the chemical is available over the counter in pharmacies and is considered low risk.
• Schedule 3 (Pharmacist-Only Medicine): which requires pharmacist advice before supply, but no prescription needed.
• Schedule 4 (Prescription-Only Medicine): which is available only with a doctor’s prescription.
• Schedule 5 (Caution): which involves a non-therapeutic product with low toxicity, but requires safety labelling.
• Schedule 6 (Poison): which refers to chemicals of moderate to high toxicity with strong warnings required.
• Schedule 7 (Dangerous Poison): which refers to highly toxic substances requiring strict controls on use.
• Schedule 8 (Controlled Drug): which refers to prohibited drugs with a high abuse potential but accepted medical use, requiring stricter regulation.
• Schedule 9 (Prohibited Substance): which refers to prohibited drugs that are restricted only to research use.
• Schedule 10 (Prohibited for Sale and Use): which refers to drugs too dangerous for consumer use.

Which schedule methylene blue falls under, depends on the purposes for its use and its preparation. Methylene blue will be scheduled under the Poison Standard as a:

• Schedule 4 (prescription only) medication when in preparations for injection.
• Schedule 5 (caution) substance when in preparations for veterinary use with less than 50% of methylene blue per preparation.
• Schedule 7 (dangerous poison) when in preparations for veterinary use with more that 50% of methylene blue per preparation.

Can I Buy Methylene Blue In Australia?

Generally, no, methylene blue is not legally available over the counter for therapeutic use in Australia. Due to its Schedule 4 classification, it requires a prescription from a registered medical practitioner for medicinal purposes to be lawfully possessed and used.

Some online vendors may sell methylene blue without explicitly stating its intended use or by marketing it as a veterinary or research chemical. However, purchasing methylene blue for personal medicinal use without a prescription would likely violate Australian therapeutic goods laws.

As well as being against the law, purchasing methylene blue without a prescription from an online seller also carries significant risks of contamination, incorrect dosing and lack of quality control. Products sold online may not meet Australian safety standards, potentially containing impurities or incorrect concentrations that could be harmful. Additionally, self-medicating with methylene blue without medical supervision may lead to serious adverse effects, interactions with other medications or inappropriate use for conditions where it is not clinically recommended.

Where to Buy Methylene Blue in Australia?

Methylene blue can be purchased online from places like Amazon, chem-supply, Westlab Australia, Australia chemical suppliers, Blootropic and Blueprint vitality. However, a valid prescription by a doctor is required to acquire this product. It is illegal to sell and buy without valid authorisation.

Is it Legal to Import Methylene Blue into Australia?

You can only import methylene blue into Australia if you have a valid prescription from a medical doctor. The importation of methylene blue without a prescription would likely contravenes sections of the Customs Act 1901 (Cth). Under section 233 of the Customs Act it is a criminal offence to smuggle goods, import prohibited imports, export prohibited exports, or possess smuggled goods or prohibited imports or exports unlawfully. The offence is a strict liability offence for importing or exporting prohibited goods or possessing them unlawfully, meaning no intent is required for prosecution.

For a detailed overview of drug importation offences and penalties, you can refer to this guide.

Penalties for Importing Methylene Blue in Australia

Penalties for unauthorised importing of methylene blue in Australia vary depending on the nature of the offence, as follows:

• The maximum penalty for importing or handling a prohibited import under this section is a fine of up to three times the value of the goods, or up to $275,000, whichever is greater.
• Additionally, methylene blue may be classified as a ‘tier 1 good’ under section 233BAA of the Act, which applies to non-narcotic drugs intentionally imported in violation of the Customs Act. This offence carries a maximum penalty of 5 years’ imprisonment, a fine of $275,000, or both.

Preparations of methylene blue for medicinal purposes not currently available in Australia, may also be able to be imported if the doctor has applied to have the drug imported via a special access scheme under the TGA. The special access scheme allows medical practitioners to prescribe unapproved therapeutic goods for individual patients under specific circumstances.

The scheme provides three pathways: firstly, for patients who are seriously ill and require immediate access; secondly, for therapeutic goods with an established history of use, allowing for immediate access with notification to the TGA within 28 days; and lastly following application and approval from the TGA. Methylene blue, given its current limited application medically, would likely require a formal application and approval by the TGA to be accessed under the special access scheme.

Is it Illegal to Possess and Supply Methylene Blue in Australia?

Each State and Territory in Australia has specific offences relating to the unauthorised possession and supply of medicinal goods, including methylene blue. The below is an outline of the penalties based on State and Territory.

Possession and Supply of Methylene Blue in New South Wales

In NSW, under section 10 of the Poisons and Therapeutic Goods Act 1966 (NSW), it is an offence to supply a restricted substance (including methylene blue) otherwise than by authorised wholesale. This offence carries a maximum penalty of a fine up to 15 penalty units or 6 months imprisonment. Exceptions apply allowing supply by medical practitioners, dentists, veterinarians, nurse practitioners, optometrists, midwife practitioners, podiatrists, and pharmacists acting within their professional scope. Supply is also permitted to patients in designated hospitals or institutions, and individuals assisting in care, provided they administer the substance in accordance with a prescription.

Further, section 16 of the Act outlines offences related to the unauthorised possession and fraudulent acquisition of prescribed restricted substances, which include Schedule 4 poisons. The maximum penalties for these offences are 6 months’ imprisonment or a fine of 20 penalty units or both.

Possession and Supply Offences of Methylene Blue in Victoria

In Victoria, section 13 of the Drugs, Poisons and Controlled Substances Act 1981 (Vic), it is an offence to possess, use, sell or supply a poison, restricted substance, or controlled substance without authorisation.

The maximum penalty of this violation depends on the classification of the substance involved and whether the contravention was deliberate or inadvertent. This can range from terms of imprisonment to a small civil fine of 5 penalty units.

Possession and Supply Offences of Methylene Blue in Queensland

In Queensland, section 34 of the Medicines and Poisons Act 2019 (Qld), outlines an offence if a person buys or possesses a Schedule 4 (S4) or Schedule 8 (S8) medicine, or hazardous poison, without authorisation. This offence carries a maximum penalty of a fine of 200 penalty units.

Further, under section 35 of the Act it is an offence to supply a medicine or poison without authorisation. This offence carries a maximum penalty a fine of 500 penalty units.

Possession and Supply of Methylene Blue in Western Australian

In Western Australia, under section 14 of the Medicines and Poisons Act 2014 (WA), establishes offences related to the manufacture, supply, prescribing, and possession of Schedule 4 and Schedule 8 substances. A person commits an offence if they manufacture or supply such poisons unless they hold an appropriate licence or professional authority and comply with the regulations.

Possession of these poisons is also restricted, with exemptions granted for licensed manufacturers, authorised suppliers, permit holders and individuals with a valid prescription for personal use.

The maximum penalties for these offences are a fine of $45,000 and/or imprisonment for 3 years.

Possession and Supply of Methylene Blue in South Australian

In South Australia, under section 18 of the Controlled Substances Act 1984 (SA),  outlines offences related to the prescribing, selling, supplying, administering, manufacturing, packing, or possessing prescription drugs (excluding drugs of dependence) without authorisation.

These offences carry a maximum penalty of $10,000 or imprisonment for 2 years. This penalty applies to unauthorised actions involving prescription drugs unless carried out by authorised health practitioners (such as dentists, medical practitioners, nurse practitioners, pharmacists, and veterinary surgeons) acting within the scope of their professional duties, or by individuals licensed by the Minister.

Supply or Sell Methylene Blue in Tasmanian

In Tasmania, under section 26 of the Poisons Act 1971 (Tas), it is an offence to sell or supply medicinal substances without authorisation.

The offence carries a maximum penalty of a fine of 10 penalty units. Medical practitioners, pharmacists, licensed chemists, dentists, authorised health professionals, veterinary surgeons, and authorised nurse practitioners acting within their lawful practice are permitted to sell or supply these substances.

Possession and Supply of Methylene Blue in The Australian Capital Territory (ACT)

In ACT, under section 26 of the Medicines, Poisons and Therapeutic Goods Act 2008 (ACT), it is an offence to supply a declared substance without authorisation. A person commits an offence if they supply a declared substance to another person (s 26(1)) or to themselves (s 26(2)) without the necessary authorisation. The term “supply” includes selling or offering to sell a substance (see s 24). The maximum penalty for this offence is 500 penalty units, 5 years imprisonment, or both.

Further, under section 36 of the Act it is an offence to possess certain declared substances without authorisation. A person commits an offence if they possess a declared substance that is classified as a pharmacy medicine, pharmacist-only medicine, prescription-only medicine, controlled medicine, dangerous poison, or prohibited substance, and they are not authorised to possess it. The maximum penalty for this offence is 200 penalty units, 2 years imprisonment, or both.

Possession and Supply of Methylene Blue in Northern Territory

In NT, under section 40 of the Medicines, Poisons and Therapeutic Goods Act 2012 (NT), it is an offence to supply a Schedule 4 substance without authorisation. The maximum penalty is a fine of 200 penalty units or two years months’ imprisonment.

Under section 39 of the Act a person must not possess a Schedule 4 substance unless the possession is authorised. A breach of this section carries a maximum penalty of 100 penalty units or imprisonment for 12 months.

Finally, under section 41 of the Act a person must not use a Schedule 4 substance unless the use is authorised. This offence carries a maximum penalty of 100 penalty units or imprisonment for 12 months.

Potential Changes to the Legal Status of Methylene Blue

Regulatory authorities continue to monitor and review the classification and risks associated with methylene blue, ensuring that its use remains aligned with public health and safety standards.

In some jurisdictions, there have been calls for greater access of methylene blue for alternative treatments, particularly for neurodegenerative conditions and treatment-resistant infections. The TGA periodically reviews substances based on emerging scientific evidence, and if new clinical trials demonstrate the safety and efficacy of methylene blue for broader medical applications, its classification under the Poisons Standard may be reconsidered.

By Jarryd Bartle and Jimmy Singh.

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