Cosmetic injectables and the law

3.1 Risk

Medical risk

The TGA calls cosmetic injections serious medical procedures. If they are done incorrectly, the harm can be serious: skin damage, blindness or even death. An injection into the wrong area of the face may cause blindness or death, which is why the TGA says the person giving it must have the right knowledge and training.

Ahpra describes the products as potentially dangerous medicines, which must be approved for supply in Australia by the TGA.

3.2 Prescribing

Prescribers

The products need a valid prescription from an authorised prescriber, such as a medical doctor, a dentist or a nurse practitioner, and the prescriber must consult with you and explain the procedure fully before it goes ahead. Ahpra adds that before the procedure the prescriber must take your full history, make sure the procedure is safe for you, explain the possible risks and seek your informed consent. You can confirm that a nurse is a nurse practitioner on the national register.

Prescription rules

Ahpra and the National Boards’ current guidelines for non-surgical procedures, which cover prescribers other than doctors, add three rules:

• A consultation, in person or by video, every time they prescribe a cosmetic injectable.
• An individual prescription for every person; one prescription for several people (“bulk” or “batch” prescribing) is not acceptable.
• A refusal to prescribe if, after assessing the person, the practitioner believes it is not appropriate for them.

The Medical Board’s guidelines, in force since 1 July 2023, set the same consultation rule for doctors who prescribe these injectables.

3.3 Administering

The person giving the injection

The person who gives the injection is not always the prescriber. Ahpra says the prescriber must make sure that person is authorised to give it under the drugs and poisons laws of the state or territory, and has the right qualifications, skills and experience; usually it is a registered nurse, or an enrolled nurse supervised by a registered nurse.

New South Wales

NSW Health’s cosmetic procedures page, current as at 13 July 2021, says that from 1 September 2021 NSW strengthened its regulation of how these medicines are administered. In NSW Health’s words, “only an authorised practitioner, or a nurse acting on the direction of a medical practitioner or nurse practitioner, may administer Cosmetic Medicines”, and an authorised practitioner includes a medical practitioner, nurse practitioner or dentist. Before directing a nurse, the medical practitioner or nurse practitioner must review you, in person or by audio-visual link.

3.4 Advertising

Product names in advertising

Because most cosmetic injectables contain prescription-only substances, the ban on advertising prescription medicines applies to them, and an advertisement for a cosmetic service must not refer to those medicines or substances, even indirectly. The TGA’s questions and answers show how far that reaches:

• Acronyms, nicknames, abbreviations and hashtags count, if a consumer could take them as a reference to a specific prescription-only medicine or substance.
• A price for a prescription-only cosmetic injectable, whether for the whole treatment or per unit, is generally likely to be an advertisement for it.
• A “before and after” photo is likely to break the law where the “after” is plainly the result of a prescription-only injectable.

The ban does not apply to cosmetic injectables that contain no prescription-only substance. For the rest, the TGA’s view is that whether one suits a particular person is a conversation for a consultation with a suitably trained health practitioner. Section 4 covers the wider advertising rules.

3.5 Checks

Product checks

• Ask the prescriber for the brand and the substance, since neither can be advertised.
• Search the Australian Register of Therapeutic Goods (ARTG), which lists the products that can be legally supplied in Australia, to check that the product is registered.
• Expect any medication to be supplied under Australian law with English labelling.

Counterfeit products imported from overseas are illegal and dangerous, and the TGA reports that some clinics have imported and used them. NSW Health’s advice is to compare prices: “If the prices quoted are far less than competitors, this can indicate the products may be counterfeit or not Australian registered medicines.”

3.6 Patients under 18

Younger patients

Ahpra and the National Boards’ guidelines, which cover practitioners other than doctors, add these rules for a person under 18. Among nurses, only registered nurses and nurse practitioners may carry out the assessment these rules describe. Practitioners must know and follow the laws of their state or territory that restrict non-surgical cosmetic procedures for this age group. They must consider whether any cosmetic procedure is appropriate for a person under 18, and the National Boards name two kinds of cosmetic injectable that they consider should not be prescribed for cosmetic purposes to anyone under 18 (section 4.2 of the guidelines). Practitioners must assess the person’s capacity to consent to the procedure and be satisfied that they have it. They should, as far as practicable, consider the views of a parent or guardian, including whether they support the procedure. At least seven days must pass between obtaining informed consent and a non-surgical cosmetic procedure, and no money should be payable until after that cooling-off period, other than for initial consultations. During the cooling-off period, the person should be encouraged to talk about why they want the procedure with an appropriate independent registered health practitioner. The guidelines describe this as a practitioner who already has a relationship with the person, such as, though not only, a GP, psychologist, psychiatrist or nurse practitioner, who should be independent of the practitioner performing the procedure and should not work in the cosmetic procedure industry.

3.7 Follow-up

Aftercare

The person responsible for the procedure is also responsible for aftercare. The TGA says you should receive written instructions, and advice on what follow-up there will be and what to do about unexpected side effects. Problems after a cosmetic injection can be reported directly to the TGA. Section 5 covers what to do if something goes wrong.