Applies to: All NCD clinical, administrative and dispensing staff

1. Purpose

To define standardised, evidence-based requirements for safe storage, cold chain maintenance, security, documentation and disposal of medicines at Newcastle Cosmetic Doctor (NCD), including Schedule 4 (S4) and other regulated products. This SOP mitigates risk of degradation, diversion and error; supports product traceability; and meets Australian regulatory and accreditation standards. ^{1 2 3}

2. Scope & Applicability

Applies to all medicines held, supplied or administered at NCD (in-clinic rooms, storerooms and refrigerators), including prescription injectables, topical S4 items, compounded preparations and emergency drugs. It covers reception, storage, temperature monitoring, handling, transport within the facility, stock control, recall and disposal. Non-prescription retail cosmetics are excluded and governed by the Product Classification and Retail Skincare Policy. ^{1 2 3 4}

3. Legislative & Regulatory Framework

NCD complies with NSW Poisons and Therapeutic Goods legislation (storage, access control, records), TGA requirements (GMP context, Poisons Standard scheduling), and NSQHS Medication Safety standards. Professional duties are guided by AHPRA/Medical Board prescribing and supervision expectations; documentation and retention meet OAIC privacy requirements. Cold-chain principles reference ATAGI and PSA guidance; where appropriate, WHO/CDC best-practice documents inform methodology. ^{2 3 1 5 6 7 8 9 10 11}

4. Responsibilities

Responsible Medical Practitioner (RMP): overall governance; approves formulary; authorises access; reviews cold-chain deviations and incident reports; signs disposal/destruction records. Delegated Clinicians/Nurses: day-to-day handling; checking deliveries; logging temperatures; segregating quarantined stock; escalating breaches. Admin/Dispensing Support: inventory reconciliation; batch/lot tracking; filing temperature logs and maintenance certificates; recall coordination; privacy-compliant record storage. ^{1 2 5 6}

5. Storage Requirements (Room Temperature & Security)

Store medicines in clean, dry, lockable cupboards or rooms with restricted, role-based access; maintain ambient conditions per product information or AMH/Therapeutic Guidelines. Separate medicines from chemicals/consumables; keep original packaging with batch/expiry visible; apply FEFO (first-expire-first-out). Record daily room temperature if stability requires; maintain keys/access logs for S4 storage per NSW requirements. ^{2 12 1 10}

6. Cold Chain Management

Use purpose-built pharmaceutical or vaccine-grade refrigerators; do not store food/biological samples with medicines. Continuously monitor temperatures (preferred data logger with 30‑day memory); target +2°C to +8°C unless product specifies otherwise; place max–min thermometer inside. Record at least twice daily readings and download logger reports monthly; investigate any breach immediately, quarantine stock, and seek manufacturer stability advice before use. ^{8 7 12 13 1}

7. Receipt of Goods & Chain of Custody

On receipt, verify supplier, integrity of packaging, correct item/strength, quantity, batch number and expiry; cross-check cold-chain indicators for refrigerated deliveries. Record delivery time and reconcile against purchase order; promptly place stock into appropriate storage; maintain a signed handover or electronic custody log for S4 medicines. ^{1 2 7 3}

8. Temperature Excursions & Incident Management

If temperatures fall outside specified ranges, immediately quarantine affected stock, label “Do Not Use,” document min–max and duration, and notify the RMP. Check logger data and fridge power status; arrange service if needed; consult product PI/manufacturer for stability decisions; document outcome. Report significant quality or safety concerns via TGA post-market channels where indicated. ^{8 12 3 1}

9. Inventory, Batch/Lot Tracking & Recall

Maintain an inventory system that records product, strength, quantity, batch/lot, ARTG number (if applicable), receipt date, and expiry. Run monthly stocktakes; isolate expired or damaged items; generate FEFO pick lists. For manufacturer or TGA recalls, immediately identify affected batches, quarantine stock, contact patients if already supplied, and complete recall response documentation. ^{3 1 13 2}

10. Controlled Substances & Schedules (S4 focus)

Schedule 4 (Prescription Only) medicines require secure, restricted storage with key or digital access control; maintain usage logs as applicable and reconcile balances. Follow the Poisons Standard (SUSMP) and NSW storage/record-keeping directions. Limit quantities held on site to operational needs; separate and clearly label compounded S4 preparations with beyond-use dates. ^{10 2 3}

11. Labelling, Expiry, Quarantine & Disposal

Ensure labels remain legible with product name, strength, batch and expiry visible; do not overlabel to obscure critical information. Remove from active stock any item that is expired, damaged, or subject to temperature breach; segregate in a quarantined area pending decision. Dispose of unusable medicines via approved pharmaceutical waste streams; destruction of S4 stock is authorised and documented by the RMP per NSW requirements. ^{2 1 3}

12. Documentation, Privacy & Record Retention

Retain temperature logs, service records, delivery dockets, inventory/stocktake reports, excursion investigations, disposal forms and recall responses for ≥7 years. Restrict access to records to authorised roles; store electronic records with audit trails; manage any patient-identifiable data under the Australian Privacy Principles. ^{6 1 2}

13. Training & Competency

All staff handling medicines complete induction and annual refresher training on storage, cold-chain, schedule controls, documentation and incident response. Competency is verified via observed practice and periodic quizzes; training records are retained with staff files. ^{1 7 8}

14. Audit, Review & Continuous Improvement

The Medical Director conducts quarterly spot-checks of temperature logs, access controls, stock rotation and documentation; corrective actions are tracked to closure. This SOP is reviewed annually or earlier following legislative or guidance updates, equipment changes, or incident learnings. ^{1 2 3}

Sources

1. ACSQHC — National Safety and Quality Health Service (NSQHS) Standards – Medication Safety (Std, 4)., viewed 24 October 2025, https://www.safetyandquality.gov.au/standards/nsqhs-standards/medication-safety-standard ↩
2. NSW Health — Pharmaceutical Services: Poisons and Therapeutic Goods (storage, records, authorities)., NSW Health — Pharmaceutical Services: Poisons and Therapeutic Goods (storage, records, authorities)., viewed 24 October 2025, https://www.health.nsw.gov.au/pharmaceutical/Pages/default.aspx ↩
3. Therapeutic Goods Administration (TGA) — Good Manufacturing Practice (GMP) and Therapeutic Goods Act framework., Therapeutic Goods Administration (TGA) — Good Manufacturing Practice (GMP) and Therapeutic Goods Act framework., viewed 24 October 2025, https://www.tga.gov.au ↩
4. AHPRA/Medical Board of Australia — Cosmetic procedures & prescribing responsibilities; Advertising Guidelines., AHPRA/Medical Board of Australia — Cosmetic procedures & prescribing responsibilities; Advertising Guidelines., viewed 24 October 2025, https://www.medicalboard.gov.au/ ↩
5. RACGP — Prescribing and quality use of medicines in general practice., RACGP — Prescribing and quality use of medicines in general practice., viewed 24 October 2025, https://www.racgp.org.au/ ↩
6. OAIC — Guide to health privacy for health service providers (Australian Privacy Principles)., OAIC — Guide to health privacy for health service providers (Australian Privacy Principles)., viewed 24 October 2025, https://www.oaic.gov.au/privacy/your-privacy-rights/health-and-medical-research/guide-to-health-privacy ↩
7. PSA — Australian Pharmaceutical Society: Practice Guidelines (cold chain, handling, documentation)., PSA — Australian Pharmaceutical Society: Practice Guidelines (cold chain, handling, documentation)., viewed 24 October 2025, https://www.psa.org.au/practice-support-industry/standards/ ↩
8. ATAGI/Department of Health — National vaccine storage guidelines: Strive for 5 (for cold-chain methodology & data loggers)., ATAGI/Department of Health — National vaccine storage guidelines: Strive for 5 (for cold-chain methodology & data loggers)., viewed 24 October 2025, https://www.health.gov.au/resources/publications/national-vaccine-storage-guidelines-strive-for-5 ↩
9. NSW Health — Medication handling in NSW public health facilities (procedures applicable to handling principles)., NSW Health — Medication handling in NSW public health facilities (procedures applicable to handling principles)., viewed 24 October 2025, https://www1.health.nsw.gov.au/pds/ActivePDSDocuments/PD2013_043.pdf ↩
10. TGA — Uniform Scheduling of Medicines and Poisons (SUSMP) / Poisons Standard (for S4/S8 definitions)., TGA — Uniform Scheduling of Medicines and Poisons (SUSMP) / Poisons Standard (for S4/S8 definitions)., viewed 24 October 2025, https://www.tga.gov.au/resources/publication/poisons-standard ↩
11. Standards Australia — AS 85000: Quality management systems for pharmacy services (context)., Standards Australia — AS 85000: Quality management systems for pharmacy services (context)., viewed 24 October 2025, https://www.standards.org.au/ ↩
12. WHO — Model guidance for storage and transport of time- and temperature-sensitive pharmaceutical products., WHO — Model guidance for storage and transport of time- and temperature-sensitive pharmaceutical products., viewed 24 October 2025, https://www.who.int/publications ↩
13. U.S, CDC — Vaccine Storage and Handling Toolkit (good practice reference for refrigerators/data loggers)., viewed 24 October 2025, https://www.cdc.gov/vaccines/hcp/downloads/storage-handling-toolkit.pdf ↩
14. Therapeutic Guidelines / AMH — Australian Medicines Handbook (stability and storage references)., Therapeutic Guidelines / AMH — Australian Medicines Handbook (stability and storage references)., viewed 24 October 2025, https://amhonline-amh-net-au/ ↩
15. ACCC — Australian Consumer Law (product safety, recall obligations for consumer goods)., ACCC — Australian Consumer Law (product safety, recall obligations for consumer goods)., viewed 24 October 2025, https://www.accc.gov.au/consumers/consumer-rights-guarantees/repair-replace-refund ↩