Topical Product Compounding & Pharmacy Collaboration SOP

Published:

October 22, 2025

1. Purpose

This SOP establishes the standards and procedures for safe, compliant collaboration between Newcastle Cosmetic Doctor (NCD) and compounding pharmacies for the preparation of prescription-only topical medicines. It ensures patient safety, traceability, and adherence to Australian regulatory, ethical, and quality frameworks governing extemporaneous compounding and dispensing. ¹ ² ³ ⁴ ⁵ ⁶ ⁷ ⁸ ⁹ ¹⁰ ¹¹ ¹²

2. Scope & Applicability

Applies to all compounded topical medicines prescribed, prepared, dispensed, or supplied under NCD, including retinoids, hydroquinone, peptide complexes, enzyme creams, and other prescription-grade formulations. It includes interactions with external compounding pharmacies and the associated governance of documentation, labelling, and delivery. ¹ ² ³ ⁴ ⁵ ⁶ ⁷ ⁸ ⁹ ¹⁰ ¹¹ ¹²

3. Regulatory & Quality Framework

NCD operates within the Therapeutic Goods Act, Pharmacy Board compounding standards, NSW Poisons and Therapeutic Goods Regulation, and NSQHS Medication Safety requirements. International benchmarks from WHO, PIC/S, and USP provide guidance on good compounding and manufacturing practices for non-sterile topical preparations. ¹ ² ³ ⁴ ⁵ ⁶ ⁷ ⁸ ⁹ ¹⁰ ¹¹ ¹²

4. Prescribing Responsibilities

All compounded topical prescriptions must be initiated by an AHPRA-registered prescriber following patient consultation, diagnosis, and consent. Prescriptions must clearly specify active ingredients, strengths, vehicle, dosage form, quantity, beyond-use date, and any compounding notes. Prescribers must ensure indication justification and absence of contraindications. ¹ ² ³ ⁴ ⁵ ⁶ ⁷ ⁸ ⁹ ¹⁰ ¹¹ ¹²

5. Pharmacy Selection & Accreditation

Only compounding pharmacies licensed under the Pharmacy Board and compliant with TGA and state pharmaceutical regulations may be engaged. The Responsible Medical Practitioner verifies registration, compounding scope, and quality assurance certifications before collaboration. Ongoing compliance audits are conducted biennially. ¹ ² ³ ⁴ ⁵ ⁶ ⁷ ⁸ ⁹ ¹⁰ ¹¹ ¹²

6. Communication & Documentation Exchange

Prescriptions are transmitted securely to the pharmacy with complete patient identifiers, indications, and safety notes. Any formulation adjustment requires prescriber approval. Both NCD and the pharmacy maintain mirrored documentation for seven years, ensuring audit readiness and traceability. ¹ ² ³ ⁴ ⁵ ⁶ ⁷ ⁸ ⁹ ¹⁰ ¹¹ ¹²

7. Quality Assurance & Batch Verification

Upon receipt, compounded items are checked for packaging integrity, labelling accuracy, batch/lot identification, and beyond-use date. Pharmacies provide Certificates of Analysis or equivalent documentation confirming formulation accuracy and microbial safety for each batch. ¹ ² ³ ⁴ ⁵ ⁶ ⁷ ⁸ ⁹ ¹⁰ ¹¹ ¹²

8. Labelling & Patient Instructions

Labels must comply with Pharmacy Board and NSW Health requirements, displaying patient name, ingredients, strength, directions for use, beyond-use date, and compounding pharmacy details. Patient information sheets accompany all compounded items to reinforce safe use and monitoring. ¹ ² ³ ⁴ ⁵ ⁶ ⁷ ⁸ ⁹ ¹⁰ ¹¹ ¹²

9. Delivery, Storage & Chain of Custody

Pharmacies dispatch compounded items using temperature-controlled packaging where required. NCD staff verify delivery integrity and log date/time, receiver, and storage location. Cold-chain items are stored at recommended ranges and monitored per Medication Storage SOP. ¹ ² ³ ⁴ ⁵ ⁶ ⁷ ⁸ ⁹ ¹⁰ ¹¹ ¹²

10. Handling Deviations & Complaints

Any suspected error in composition, labelling, or packaging is reported immediately to the compounding pharmacy and documented in the Nonconformance Register. Investigations are completed collaboratively, and corrective actions are reviewed by the Responsible Medical Practitioner before product release. ¹ ² ³ ⁴ ⁵ ⁶ ⁷ ⁸ ⁹ ¹⁰ ¹¹ ¹²

11. Patient Safety & Adverse Reaction Reporting

Adverse events or quality complaints involving compounded topicals are investigated promptly. Events are documented, reviewed clinically, and reported to the TGA or Pharmacy Board where indicated. Patient follow-up ensures safety and confidence in care continuity. ¹ ² ³ ⁴ ⁵ ⁶ ⁷ ⁸ ⁹ ¹⁰ ¹¹ ¹²

12. Privacy & Data Protection

All prescription and compounding data are managed in compliance with the Australian Privacy Principles. Electronic communication between NCD and pharmacies uses encrypted channels. Only authorised staff may access prescription or patient data, with audit trails enabled. ¹ ² ³ ⁴ ⁵ ⁶ ⁷ ⁸ ⁹ ¹⁰ ¹¹ ¹²

13. Training & Competency

All staff involved in prescribing, receiving, or handling compounded medicines undergo annual competency-based training on compounding standards, communication protocols, and quality assurance requirements. Competency is documented and reviewed annually. ¹ ² ³ ⁴ ⁵ ⁶ ⁷ ⁸ ⁹ ¹⁰ ¹¹ ¹²

14. Review & Continuous Improvement

This SOP is reviewed annually or upon regulatory change. Feedback from audits, adverse events, and pharmacy collaborations informs revisions to strengthen compliance, patient safety, and professional collaboration standards. ¹ ² ³ ⁴ ⁵ ⁶ ⁷ ⁸ ⁹ ¹⁰ ¹¹ ¹²

Sources

Therapeutic Goods Administration (TGA), Guidance on compounding and extemporaneous dispensing., viewed 22 October 2025, https://www.tga.gov.au/ ↩
Pharmacy Board of Australia, Guidelines on compounding of medicines., viewed 22 October 2025, https://www.pharmacyboard.gov.au/ ↩
AHPRA, Professional standards for prescribing and medicine management., viewed 22 October 2025, https://www.ahpra.gov.au/ ↩
NSW Health, Pharmaceutical Services – Poisons and Therapeutic Goods Regulation., viewed 22 October 2025, https://www.health.nsw.gov.au/pharmaceutical/Pages/default.aspx ↩
ACSQHC, NSQHS Standards – Medication Safety (Standard 4)., viewed 22 October 2025, https://www.safetyandquality.gov.au/standards/nsqhs-standards/medication-safety-standard ↩
OAIC, Australian Privacy Principles – handling of health information., viewed 22 October 2025, https://www.oaic.gov.au/privacy/your-privacy-rights/health-and-medical-research/guide-to-health-privacy ↩
RACGP, Prescribing and medicine safety in general practice., viewed 22 October 2025, https://www.racgp.org.au/ ↩
WHO, Good Compounding Practices and Quality Assurance in Pharmacy., viewed 22 October 2025, https://www.who.int/publications ↩
USP <795>, Pharmaceutical Compounding – Nonsterile Preparations., viewed 22 October 2025, https://www.usp.org/ ↩
PIC/S, Guide to Good Manufacturing Practice for Medicinal Products., viewed 22 October 2025, https://picscheme.org/en/publications ↩
ISO 22716, Cosmetics – Good Manufacturing Practices (GMP) – Guidelines on Good Manufacturing Practices., viewed 22 October 2025, https://www.iso.org/ ↩
NHMRC, Clinical governance and ethical prescribing in healthcare., viewed 22 October 2025, https://www.nhmrc.gov.au/ ↩

Disclaimer for Newcastle Cosmetic Doctor Policies & Procedures

The policies and procedures contained within this document are the exclusive property of Newcastle Cosmetic Doctor and are provided for internal clinical governance and educational purposes only. These materials represent the internal operational framework, safety standards, and evidence-based protocols developed and implemented by Dr. Bart John Scanlon and the Newcastle Cosmetic Doctor team. They are designed specifically for use within Newcastle Cosmetic Doctor and reflect our clinic’s own professional standards, risk assessments, and compliance obligations under Australian law and regulatory authorities. External individuals, practitioners, or organisations must not copy, reproduce, distribute, or rely upon these materials, in whole or in part, for their own clinical, commercial, or educational use without prior written consent from Newcastle Cosmetic Doctor. These materials do not constitute medical, legal, or professional advice and are not intended to be adopted as official protocols or procedures by any other entity. Any external use or adaptation must be independently reviewed and modified to meet the relevant laws, guidelines, and standards applicable to the user’s own jurisdiction, scope of practice, and facility operations. Newcastle Cosmetic Doctor and Dr. Bart Scanlon accept no liability for any loss, injury, or damage arising from the unauthorised use, reliance upon, or misinterpretation of this material.