Protect your pharmacy — and your registration — in an evolving national regulatory environment.
Pharmacy proprietors are legally accountable for ensuring medicines, poisons and therapeutic goods are stored, supplied and documented correctly — even when day-to-day tasks are delegated.
Across Australia, regulators have strengthened audit and enforcement powers, increasing scrutiny on areas such as:
These expectations are reflected in updated legislation, policy reforms and enforcement approaches across multiple jurisdictions.
Non-compliance may expose pharmacies to tiered penalties, infringement notices and significant financial or professional consequences. Serious breaches can lead to substantial fines, regulatory action affecting registration, and in extreme cases criminal prosecution.
Proprietors often have limited time and specialised expertise to manage evolving compliance obligations. Independent audits led by practising pharmacists provide practical assurance — supporting operational excellence while protecting licence, reputation and business continuity.

Even moderate breaches (Tier 3 – 5) can lead to regulator action, fines, and reputational harm.
Typical risks include:


NSW MP&TG Act 2022
Common breach:
S8 register not maintained or supplier not verified
Example:
Ordering narcotics from an unlicensed vendor or incomplete S8 records
Potential fine:
$4,400 – $8,800
Mitigation:
Supplier validation log, daily reconciliation, restricted access
Common breach:
Missing prescriber authority or discarded scripts
Example:
Dispensing S4D without authority or missing digital records
Potential fine:
$2,200 – $4,400
Mitigation:
Authority verification checklist, monthly S4D audits
Common breach:
Expired or improperly stored medicines
Example:
Dispensing expired eye drops or failing to record fridge temperature deviations
Potential fine:
$550 – $1,650
Mitigation:
Automated expiry alerts, temperature monitoring, disposal logs
Start by completing the Expression of Interest (EOI) form and receive the free pharmacy coach Proprietor Self-Audit Checklist, designed to highlight common Tier 3 – 5 risks before regulators do.
Our independent audits are led by pharmacist auditors with proprietor experience – just like you. Our independent auditors understand both clinical practice and legislative compliance.
Each audit provides a confidential, practical assessment and report aligned with NSW Health expectations.
Example pricing: $2,500 – $3,500
Model: One-off comprehensive compliance audit
Includes:
• End-to-end compliance review
• Staff interviews and environment checks
• Full corrective action plan
Example pricing: By scope
Model: Targeted audit for specific regulatory risk areas
Specialty areas may include:
• S8 management
• Vaccinations by injection audit
• Medicinal cannabis (MC)
• SOP review
Example pricing:
$500 – $800 per month
Model: Ongoing compliance support and monitoring
Includes:
• SOP maintenance
• Remote compliance support
• Staff updates
• Ongoing compliance monitoring
Example pricing: $150 – $500 per person
Model: Staff CPD workshops
Topics include:
• S8 handling
• Dispensing compliance
• Record management
Example pricing: $500
Model: Tailored proprietor-led self-audit
Purpose: Robust periodic auditing and reporting to meet regulatory requirements, including aligned SOPs
Example pricing: By negotiation
Model: SOP and record review with corrective actions and practical tools
Pricing: By requirement
Model: Supplementary compliance or oversight solutions
May include:
• Camera installation setup
• Ongoing remote monitoring tools
We combine pharmacy practice insight with compliance expertise to protect your business and your pharmacy’s licence and possible pain points proactively.
Our pharmacist auditors understand your workflow — not just the legislation.
We combine clinical insight with compliance rigour to help you:
Compliance is no longer optional — it’s part of safe, modern pharmacy practice.
empowerment + compliance intelligence + leading quality pharmacy practice +
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