Australia has no single national rule for Schedule 8 (S8) registers. Each state and territory regulates S8 medicines (controlled drugs, or "drugs of addiction" in NSW law) under its own poisons law. For a wholesaler, NSW and Queensland are the two clearest published examples of what an electronic register must do. Both expect a system that identifies every user and keeps a running balance. Neither allows a finalised entry to be edited or deleted.
Who sets Schedule 8 register rules in Australia?
The TGA's Poisons Standard decides which medicines are in Schedule 8. The states and territories license the wholesalers that store and supply them, and set the rules for their registers. The Australian Code of Good Wholesaling Practice for Medicines in Schedules 2, 3, 4 and 8 adds good-practice expectations on top.
If you hold S8 stock in more than one state, your register has to meet each state's rules. Where they differ, design to the strictest one.
What does NSW require of a wholesaler's electronic drug register?
NSW Health publishes a separate standard for licensed wholesalers: the Framework for Use of an Electronic Drug Register Requiring Single Signature by a Licensed Wholesaler (TG217/1, May 2021). An electronic register is valid only if it meets these standards. The main system requirements are:
| Standard | Requirement (summarised) |
|---|---|
| 1.1–1.3 | Authenticate and uniquely identify every user on each login. Multi-factor authentication is preferred. |
| 1.4 | Role-based access with least privilege |
| 1.6–1.7 | Keep audit logs for at least 2 years, covering access, failed logins, account changes and security setting changes |
| 1.13–1.14 | Lock accounts after at most 5 failed logins. Require re-authentication after at most 15 minutes of inactivity. |
| 1.16 | Record the user's unique identifier against every entry added or modified |
| 1.19–1.20 | Show the balance on hand after each transaction, and record a reason for any adjustment |
| 1.21 | Record the witness to any destruction |
| 1.22–1.23 | Give each finalised entry a unique reference and date-time. Never allow a finalised entry to be altered or deleted. |
| 1.24 | Allow invoicing or warehouse systems to create "pending entries" that an authorised person then finalises |
| 1.25 | Keep finalised entries available for 2 years |
| 1.26 | Produce reports immediately, on screen and printed: current balances; entries by drug, date, customer, supplier or authorised person |
| 1.30 | Back up and restore in line with industry and government standards |
The framework also requires the business to meet three conditions. Access is removed on the same day a user leaves. An inspector can see and print entries immediately. Every exportable record can be retrieved even if the software is discontinued.
NSW Health's S8 guidance also requires an inventory of each S8 drug, with the balance recorded, every March and September.
Change coming: NSW Health states that from 5 November 2026, the Medicines, Poisons and Therapeutic Goods Act 2022 and its Regulation replace the 1966 Act and 2008 Regulation. The wholesaler framework refers to the old law. Check with NSW Health's Pharmaceutical Services how it applies after commencement.
What does Queensland require?
Queensland's Medicines and Poisons Act 2019 and Medicines and Poisons (Medicines) Regulation 2021 (MPMR) commenced on 27 September 2021. Queensland Health's guidance on storage and record-keeping for S8 medicines (current as at 30 May 2022) summarises the register rules:
- Keep a separate register for each S8 safe, showing each movement in or out and the amount in the safe at any time.
- Electronic registers must meet MPMR section 208. Entries can be made only with the person's secure system identifier, and that identifier is recorded automatically with each entry.
- Record each dealing as soon as practicable, and no later than 24 hours after it. The authorised user signs the entry, and an electronic signature is allowed.
- No one may cancel, delete or obscure an entry. A correction records the date, the name and position of the person correcting it, and the reason.
- Every entry shows the actual balance remaining, so the register should never show a negative balance.
- Keep electronic records for 2 years from the date each record is made.
- The safe manager reconciles the register against physical stock at least monthly, records the reconciliation, and reports unresolved discrepancies to Queensland Health.
The guidance notes that manufacturers and wholesalers should also follow the Code of Good Wholesaling Practice, as well as the relevant MPMR sections.
What about Victoria and the other states?
Victoria licenses wholesalers of scheduled substances under the Drugs, Poisons and Controlled Substances Act 1981 and its Regulations. See the Department of Health licence page. We have not summarised Victoria's electronic register conditions here. Confirm the current rules for Victoria and every other state or territory where you hold S8 stock directly with its medicines and poisons regulator, and check your licence conditions.
What should your software do? A checklist
- Unique, strong logins. No shared accounts. Lockout and inactivity timeouts at least as strict as NSW's (5 attempts, 15 minutes).
- Automatic user stamp. Record the user ID and date-time on every entry without relying on the user to type it.
- Immutable entries. Once finalised, an entry cannot be edited or deleted. Corrections are new entries with a reason.
- Running balance per drug, form and strength, shown after every transaction. The balance can never go negative.
- Full transaction types: receipt, supply, return or credit, transfer, adjustment, stock check, loss, damage and destruction with a witness.
- Links to source documents. Draft entries can come from purchase receipts and invoices, but a person must finalise them.
- Inspector reports on demand, by drug, date, customer, supplier and user, on screen and printed.
- Retention and export. Keep entries for at least the longest period any of your states requires, and be able to export everything.
- A reconciliation workflow that records counted stock against the register balance, the variance and the investigation.
- Backups that are tested by restoring them.
How Asli Pharma ERP helps
Asli Pharma ERP already provides several parts of this checklist:
- Named user logins, with account lockout
- An audit trail that records who did what and when
- Approvals on stock adjustments
- Batch-level stock ledgers with a running balance
- Tested backups
A dedicated Schedule 8 register is on our roadmap and is not available yet. That means immutable finalised entries, pending entries finalised by an authorised person, witness capture and state-specific inspector reports. Until it ships, keep your approved S8 register alongside the ERP.
Frequently asked questions
Can a wholesaler keep its Schedule 8 register electronically?
In the states covered here, yes, under conditions. In NSW a licensed wholesaler may use an electronic drug register if it meets NSW Health's 'Framework for Use of an Electronic Drug Register Requiring Single Signature by a Licensed Wholesaler' (TG217/1, May 2021). Queensland's Medicines and Poisons (Medicines) Regulation 2021 permits electronic registers that meet its section 208 conditions. Check the rules in each state where you hold stock.
How long must S8 register entries be kept?
The NSW wholesaler framework requires finalised entries and audit logs to be kept for at least two years. Queensland Health guidance says a record in an electronic medicine register must be kept for 2 years from the date it is made. Other states may set different periods, and your own policies or tax records may require longer.
Can an S8 register entry be corrected?
Yes, but it cannot be erased. The NSW framework says a finalised entry must not be altered or deleted under any circumstances, so a correction is made as a new entry with a reason. Queensland guidance says no one may cancel, delete or obscure an entry, and a correction must record the date, the corrector's name and position, and the reason.
How often must S8 stock be reconciled?
It varies. NSW guidance requires an inventory of each S8 drug, with the balance recorded, every March and September and more often where required. Queensland's safe manager must reconcile at least monthly. Wholesalers should also follow any conditions on their licence.
Is NSW law changing?
Yes. NSW Health states that from 5 November 2026 the Poisons and Therapeutic Goods Act 1966 and Regulation 2008 are replaced by the Medicines, Poisons and Therapeutic Goods Act 2022 and its Regulation. Check NSW Health guidance for how existing electronic register approvals carry over.
Sources
- NSW Health: Electronic drug registers
- NSW Health: Framework for use of an electronic drug register requiring single signature by a licensed wholesaler (TG217/1, May 2021)
- NSW Health: Medicines, poisons and therapeutic goods legislation overview
- NSW Health: Management of Schedule 8 medicines
- Queensland Health: Storage and record-keeping requirements for S8 medicines (current as at 30 May 2022)
- Queensland Health: Medicines and poisons legislation, standards and extended practice authorities
- Victorian Department of Health: Licences and permits for scheduled substances
- TGA: Australian Code of Good Wholesaling Practice for Medicines in Schedules 2, 3, 4 and 8