1. Purpose

This policy ensures the safe and lawful ordering, storage, prescribing, administration, documentation and disposal of Schedule 4 (S4) medicines used in cosmetic practice, including Letybo®, Dysport®, dermal fillers, and lignocaine. It complies with the Medicines, Poisons and Therapeutic Goods Act 2022 (NSW) and NSW Health Medication Handling standards.^{1 2}

2. Scope

This policy applies to all medical practitioners, registered nurses and authorised administrative staff at Newcastle Cosmetic Doctor who are involved in the handling of S4 medicines. All staff must also comply with privacy requirements under the Privacy Act 1988 (Cth) and HRIP Act 2002 (NSW).^{3 4}

3. Ordering & Supply

Only authorised prescribers (medical practitioners) may order S4 medicines from TGA-approved wholesalers or manufacturers. Each order must be documented with date, supplier, medicine name, strength, quantity, batch number and prescriber signature in compliance with NSW legislation and TGA requirements.^{1 5}

4. Storage Requirements

All medicines must be stored securely in a locked cupboard or refrigerator accessible only to authorised staff. Botulinum toxins (Letybo®, Dysport®) must be stored at 2–8 °C in accordance with product information and the national Strive for 5 cold-chain standards.^{3 6 7 8}

5. Prescribing & Administration

S4 medicines may only be prescribed by a medical practitioner. Registered nurses may administer under a valid prescription. Each administration must record patient identifiers, prescriber name, medicine, batch, expiry, site and date in line with NSW Health and TGA requirements.^{3 4 9}

6. Documentation & Record-Keeping

Records must be retained for a minimum of 7 years and comply with the Australian Privacy Principles (APPs) and the HRIP Act 2002 (NSW). All entries must ensure full traceability from ordering to administration and disposal.^{6 10}

7. Inventory & Stock Rotation

A drug register must be maintained to record receipts, administration, and disposals. Stock rotation must follow FEFO (first-expiry, first-out) principles. Weekly stock checks and quarterly audits must be performed in compliance with NSW Health PD2022_032.³

8. Expired, Damaged & Disposal

Expired or damaged medicines must be quarantined, clearly labelled 'Do Not Use', and disposed of using licensed pharmaceutical waste services in compliance with NSW Health directives.³

9. Recalls & Adverse Events

In the event of a TGA recall, affected batches must be quarantined, prescribers notified, and actions documented. Adverse events must be reported to the TGA Database of Adverse Event Notifications (DAEN).^{4 10}

10. Complaints & Reporting

Patients may lodge complaints internally or escalate to the NSW Health Care Complaints Commission (HCCC). Serious safety breaches may also be reportable to AHPRA.^{8 11}

Sources

1. NSW Government (2022), Medicines, Poisons and Therapeutic Goods Act 2022 No 73, viewed 7 October 2025, https://legislation.nsw.gov.au/view/html/inforce/current/act-2022-073 ↩︎
2. NSW Health (2022), Medication Handling (Policy Directive PD2022_032), viewed 7 October 2025, https://www1.health.nsw.gov.au/pds/ActivePDSDocuments/PD2022_032.pdf ↩︎
3. Therapeutic Goods Administration (TGA), Report an adverse event or safety problem, viewed 7 October 2025, https://www.tga.gov.au/safety/reporting-problems/reporting-adverse-events ↩︎
4. Office of the Australian Information Commissioner (OAIC), Australian Privacy Principles guidelines, viewed 7 October 2025, https://www.oaic.gov.au/privacy/australian-privacy-principles/australian-privacy-principles-guidelines ↩︎
5. Therapeutic Goods Administration (TGA), Product Information: Letybo (botulinum toxin type A), viewed 7 October 2025, https://www.tga.gov.au/sites/default/files/2023-11/auspar-letybo-231114-pi.pdf ↩︎
6. NSW Government (2002), Health Records and Information Privacy Act 2002 No 71, viewed 7 October 2025, https://legislation.nsw.gov.au/view/whole/html/inforce/current/act-2002-071 ↩︎
7. Galderma (2020), Australian Product Information – DYSPORT (botulinum type A toxin), viewed 7 October 2025, https://www.galderma.com/au/sites/default/files/inline-files/DYSPORT%20PI_V6_final_21JUL20_final.pdf ↩︎
8. Medical Board of Australia, Guidelines for registered medical practitioners who advertise cosmetic surgery, viewed 7 October 2025, https://www.medicalboard.gov.au/Codes-Guidelines-Policies/Guidelines-for-registered-medical-practitioners-who-advertise-cosmetic-surgery.aspx ↩︎
9. Australian Government Department of Health, National Vaccine Storage Guidelines ‘Strive for 5’, viewed 7 October 2025, https://www.health.gov.au/resources/publications/national-vaccine-storage-guidelines-strive-for-5 ↩︎
10. Therapeutic Goods Administration (TGA), Database of Adverse Event Notifications (DAEN), viewed 7 October 2025, https://www.tga.gov.au/safety/database-adverse-event-notifications-daen ↩︎
11. NSW Health Care Complaints Commission (HCCC), Understanding Complaints, viewed 7 October 2025, https://www.hccc.nsw.gov.au/Complaints/default.aspx ↩︎