Purpose & Scope

This SOP defines the governance, safety and quality requirements for the handling, storage, reconstitution, and disposal of all injectable products used at Newcastle Cosmetic Doctor (NCD). It includes botulinum toxin, dermal fillers, hyaluronidase, lidocaine, and other therapeutic injectables. The purpose is to ensure compliance with Australian medication-safety standards, mitigate risks of contamination or misadministration, and ensure defensible traceability from procurement to patient delivery. ¹

Governance & Regulation

This protocol aligns with AHPRA’s 2025 cosmetic procedure guidelines, TGA’s Good Wholesaling Practice (GWP), PBS dispensing regulations, NSW Health cold-chain storage directives, and RACGP standards for safe prescribing and medicine management. It also references NHMRC infection control guidelines and ACSQHC’s NSQHS Standard 4: Medication Safety. ^{2 3 4 5 6}

Procurement & Verification

Injectable medicines and devices must be procured only from TGA-licensed suppliers. ARTG listings should be verified for every product prior to purchase. Staff must check supplier authenticity, packaging integrity, batch/lot numbers, and expiry. Counterfeit detection procedures are mandatory for all toxin and filler products. Documentation must include supplier details, ARTG number, and verification log. ^{2 4 7}

Cold-Chain & Temperature Logs

All temperature-sensitive injectables must be stored between 2–8°C in monitored pharmaceutical-grade refrigerators. Continuous temperature logging is required with daily manual verification. Any excursion triggers immediate quarantine, supervisor notification, and a corrective action record. Fridge validation mapping is performed annually. Power outages or mechanical failures must be documented and reviewed. ^{3 8 9}

Reconstitution & Labelling

Botulinum toxin reconstitution must be performed using aseptic technique with preservative-free saline. Each vial must be clearly labelled with product name, dilution, reconstitution date/time, expiry time, and clinician initials. Fillers and reconstituted products should never be stored beyond manufacturer guidance. Any leftover product is discarded in accordance with biohazard policy. ^{5 9 10}

Traceability & Batch Logging

Every injectable product administered must be recorded in the patient’s EMR, including product name, batch/lot number, expiry date, site of injection, dose, and operator. Images of vials or packaging should be captured for verification. All documentation must permit immediate product recall if required. Traceability logs are retained for a minimum of 10 years, consistent with NSW Health recordkeeping standards. ^{3 11}

Incident Response

Any cold-chain breach, expired product discovery, or administration error must be immediately reported to the Medical Director. The affected product is quarantined and investigated per NCD’s Incident Management SOP. Reportable incidents are submitted to the TGA via the DAEN system, and corrective actions are logged. Patient notification follows AHPRA and NSW Health privacy and duty-of-disclosure standards. ^{1 2 4 12}

Audit & Continuous Improvement

Quarterly internal audits evaluate storage temperatures, reconstitution logs, labelling accuracy, and traceability completeness. Deviations are reviewed at clinical governance meetings and linked to CAPA outcomes. Staff retraining occurs after significant noncompliance or procedural change. The policy is reviewed annually or upon regulatory update. ^{4 5 13}

Sources

1. Ahpra, Guidelines for practitioners who perform cosmetic medical and surgical procedures (2025)., viewed 27 October 2025, https://www.medicalboard.gov.au/Codes-Guidelines-Policies/Cosmetic-medical-and-surgical-procedures-guidelines.aspx ↩
2. Therapeutic Goods Administration (TGA), Good Wholesaling Practice for medicines., viewed 27 October 2025, https://www.tga.gov.au/wholesaling-medicines ↩
3. NSW Health, Cold Chain Management Guidelines for Vaccines and Medicines., viewed 27 October 2025, https://www.health.nsw.gov.au/Infectious/controlguideline/Pages/cold-chain.aspx ↩
4. ACSQHC, National Safety and Quality Health Service Standards (NSQHS), Standard 4: Medication Safety., viewed 27 October 2025, https://www.safetyandquality.gov.au/standards/nsqhs-standards/medication-safety-standard ↩
5. RACGP, Prescribing and Medicines Management Guidelines., viewed 27 October 2025, https://www.racgp.org.au/clinical-resources/clinical-guidelines ↩
6. NHMRC, Infection Prevention and Control Guidelines (2019)., viewed 27 October 2025, https://www.nhmrc.gov.au/about-us/publications/australian-guidelines-prevention-and-control-infection-healthcare-2019 ↩
7. ARTG, Australian Register of Therapeutic Goods Database., viewed 27 October 2025, https://www.tga.gov.au/products/artg ↩
8. PBS, Pharmaceutical Benefits Scheme Storage Requirements., viewed 27 October 2025, https://www.pbs.gov.au/ ↩
9. WHO, Good Storage and Distribution Practices for Health Products., viewed 27 October 2025, https://www.who.int/publications ↩
10. NSW Health, Safe Handling of Cytotoxic and Hazardous Drugs Policy., viewed 27 October 2025, https://www.health.nsw.gov.au/policies/ ↩
11. OAIC, Australian Privacy Principles for Health Records., viewed 27 October 2025, https://www.oaic.gov.au/privacy/australian-privacy-principles ↩
12. TGA, Database of Adverse Event Notifications (DAEN)., viewed 27 October 2025, https://www.tga.gov.au/reporting-adverse-events ↩
13. SafeWork NSW, Work Health and Safety Regulation (NSW)., viewed 27 October 2025, https://www.safework.nsw.gov.au/law-and-policy/work-health-and-safety-legislation ↩