Maintain controlled drugs register (Schedule 8 / 9)
Pharmacies + medical practices must keep contemporaneous register of S8/S9 medicines.
Who must comply
Pharmacies, hospitals, medical practices, veterinary practices handling S8/S9 medicines.
What triggers it
Acquiring or supplying S8/S9 medicines.
When due
Per-event recording; annual reconciliation.
Evidence required
Controlled drugs register; stocktake reports; police notification of theft/loss.
Max penalty
State Poisons Act penalties + AHPRA notification + criminal liability for diversion
Summary
State Poisons Acts + Regulations require controlled drugs registers for Schedule 8 (controlled drugs — e.g. morphine, methadone, oxycodone) and Schedule 9 (prohibited substances) medicines. Each acquisition + supply must be recorded with date, quantity, patient + prescriber. Annual stocktake + reconciliation.
Enforced by
Topics
Related obligations
- CWLTHMaintain PBS approval + claim accurately for PBS-listed medicinesPharmacy approval-to-supply under s 90 National Health Act; PBS claiming subject to compliance review.
- CWLTHConduct post-market surveillance of therapeutic goodsARTG-included goods must be monitored post-market for safety + performance.
- CWLTHIn-vitro diagnostic medical device classification + ARTGIVDs classified by risk (Class 1-4); ARTG inclusion required for supply.
Frequently asked questions
- Who must comply with controlled drugs register (Schedule 8 / 9)?
- Pharmacies, hospitals, medical practices, veterinary practices handling S8/S9 medicines.
- What triggers controlled drugs register (Schedule 8 / 9)?
- Acquiring or supplying S8/S9 medicines.
- When is controlled drugs register (Schedule 8 / 9) due?
- Per-event recording; annual reconciliation.
- What is the maximum penalty for controlled drugs register (Schedule 8 / 9)?
- State Poisons Act penalties + AHPRA notification + criminal liability for diversion
- What evidence is required for controlled drugs register (Schedule 8 / 9)?
- Controlled drugs register; stocktake reports; police notification of theft/loss.
Source: https://tga.gov.au/products/medicines/medicines-scheduling/poisons-standard-susmp. Rules Mate is not a law firm. Always verify against the live regulator source before acting.