Amendments to the Poisons and Therapeutic Goods Regulation 2008 will come into effect from 1 September 2021 to improve the safety of the use of cosmetic medicines in NSW.
The regulation will set additional requirements relating to the administration, storage, and record keeping of medicines commonly used for cosmetic purposes, such as anti-wrinkle injections and dermal fillers (cosmetic medicines).
New requirements under the regulation
The new regulation will:
- prohibit a person other than an authorised practitioner, or a nurse acting under the direction of a medical practitioner or nurse practitioner, from administering cosmetic medicines (An authorised practitioner includes a medical practitioner, nurse practitioner or dentist)
- require a medical practitioner or nurse practitioner to personally review the patient (including via audio-visual link) before authorising administration of the cosmetic medicines
- if the cosmetic medicine is administered by a nurse, require records of the direction to be made and kept by the medical practitioner or other authorised practitioner
- if the cosmetic medicine is administered by a nurse, require records of the administration to be made and kept by the nurse administering on the direction of a medical practitioner or nurse practitioner
- set storage requirements on the occupier of the premises where cosmetic medicines are stored
- require businesses that provide services using cosmetic medicines to keep records made by the medical practitioner or other authorised practitioner, and by the nurse administering on the direction of a medical practitioner or nurse practitioner
- require businesses that provide services using cosmetic medicines to have appropriate risk management policies and procedures in place to protect the health and safety of patients; appropriate equipment for use in a patient medical emergency; and to ensure that nurses are adequately trained for patient medical emergencies
- require businesses that provide services using cosmetic medicines to ensure that the regulations are complied with.
Penalties for breaching the regulation
A breach of the regulation is an offence with a maximum penalty of between $5,500 to $22,000 and/or imprisonment for 6 months for an individual, and between $27,500 and $110,000 for a body corporate.
These restrictions do not apply where the administration is undertaken by an authorised practitioner themselves or by an employee in a hospital acting on an authorised practitioner’s direction.
What are cosmetic medicines?
Cosmetic medicines include:
- botulinum toxins
- calcium hydroxylapatite
- deoxycholic acid
- hyaluronic acid and its polymers
- polylactic acid.