Cosmetic use substances

​​​​​​ ​​On this page​

1. ​List of cosmetic use substances
2. Requirements for medical practitioners and nurse practitioners​
3. Administration of cosmetic use substances
4. ​ Storage requirements
5. Responsibilities of cosmetic businesses​
6. New offences and increased penalties
7. More information​​

​​​List of cosmetic use substances

Cosmetic use substances are Schedule 4 (prescription only) medicines that are used for cosmetic procedures and include: 

• Botulinum toxins (commonly used as anti-wrinkle injections)
• Dermal fillers and similar products, including:
• calcium hydroxylapatite,
• collagen,
  
• hyaluronic acid and its polymers,
• polyacrylamide,
• polycaprolactone,
• polylactic acid.​
  
• Deoxycholic acid​
  

​​Requirements for medical practitioners and nurse practitioners

A medical practitioner or nurse practitioner can only prescribe or give a direction for the administration of a cosmetic substance if the substance:

• ​​is included on theAustralian Register ​of Therapeutic Goods (ARTG)​, or
• is approved for supply under section 19 or 19A of the Therapeutic Goods Act 1989​, or
• is supplied by a manufacturer that has a manufacturer's licence under the Therapeutic Goods Act 1989​​

Before prescribing or giving a written direction for the use of these substances, the prescriber must ​personally review the patient in person or via video consultation.

A verbal direction is only allowed if the prescriber is physically present at the time of administration.

Written directions

Written directions are valid for 6 months and must be signed by the medical practitioner or nurse practitioner. The direction must include:

• the ​patient details (name and address)
• the prescriber details and contact information
• the address where the substance will be administered
• name of the responsible provider (clinic or business name)
• the date of patient review
• how long the direction applies for, and
  
• how often the substance may be administered.

For each cosmetic use substance used for treatment the direction must include the following:

• ​name and form of the substance
• administration area of the face or body
  
• route of administration (if not obvious)
• quantity to be administered​.

​Record keeping

Medical practitioners and nurse practitioners must keep a record of all written or verbal directions.

• Records of verbal directions must include the patient's street address.
• A copy of these records must be provided to the responsible provider (business owners or operators).

[back to top]

​Administration of cosmetic use substances

Cosmetic use substances may only be administered by the following authorised health practitioners:

• Medical practitioners and nurse practitioners - as part of their lawful practice.
• Nurses if they:
• are acting in the course of their nursing practice, and
• are directed by a medical practitioner or nurse practitioner to administer the substance, or
• administer a cosmetic use substance that has been lawfully prescribed and dispensed for the patient.
• In a hospital, administration may occur by a person acting under the direction of a medical or nurse practitioner.
• For animals, administration is limited to veterinary practitioners or a person acting under their direction.

No other person is permitted to administer cosmetic use substances.

[back to top]

Responsibilities of nurses administering cosmetic use substances

A nurse administering a cosmetic use substance must:

• ​ensure emergency equipment is available
• confirm the substance to be administered is approved or lawfully supplied (ARTG listed, approved or supplied under the Therapeutic Goods Act as outlined above)
• make a written record for each administration, and include the:
• nurse’s name
• date of administration
• batch number of the substance administered
• patient name and address
• treatment details, including:
• ​prescriber name, principal place of practice and telephone number,
• address of premises that substance is being administered
• name of the responsible provider
• date that patient was reviewed by the prescriber
• the period of time the direction for administration is valid for and the number of times and intervals between the administration
• for each substance administered, the name, form, quantity and route (if not apparent) of administration, and the part the patient's face or body to which administration will occur
  

A copy of the administration ​record must be provided to:

• ​the medical practitioner or nurse practitioner who gave the direction to administer the cosmetic use substance
• the responsible provider of the business.

​ [back to top]

Storage requirements

​Cosmetic use substances must be stored:

• in a non‑public area
• separate from food
• in a way that prevents contamination if containers break or leak
• in line with the label’s storage instructions.

​These requirements apply both to clinics generally and to practitioners who obtain substances for administration.

[back to top]

​Responsibilities of cosmetic businesses

Busine​sses​ providing cosmetic procedures must ensure:

• all cosmetic procedures comply with the legislation​
• appropriate risk management policies and procedures are in place
• appropriate emergency equipm​ent is available at all times
• nurses who administer cosmetic substances are trained to respond to medical emergencies
• prescriber directions and records of administration are made and kept​ for 2 years.

Record keeping

​Responsible providers (business owners and operators) must keep copies of all: 

• ​written or verbal directions for administering a cosmetic use substance, as provided by medical practitioners or nurse practitioners
• records of administration by nurses.​

​[back to top]

New offences and increased penalties

The Act and Regulation outline penalties for offences​ associated with unauthorised activities.

Penalties are classified in 5 tiers​​​​ and differ for individuals and corporations. They range from 20 to 400 penalty units for individuals and 100 to 2000 penalty units for corporations.