Who must maintain controlled drugs register (Schedule 8 / 9)?

Pharmacies + medical practices must keep contemporaneous register of S8/S9 medicines.

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.

Applies when the business has a pharmacy. Where the business has industry: Health practitioners or approved aged care provider status or a health service, check whether you hold Schedule 8 medicines.

How the regulator frames it: Pharmacies, hospitals, medical practices, veterinary practices handling S8/S9 medicines.

What triggers it: Acquiring or supplying S8/S9 medicines.

Jurisdiction: Commonwealth law, so the test is the same in every state and territory.

Outcome across the 35 industries Rules Mate maps (3 of 35: only if a further fact applies; 32 of 35: no).

Structure does not change the answer in the 3 industries it can reach: for every structure the answer is "only if a further fact applies".

Size does not change the answer in the 3 industries it can reach: at every size band the answer is "only if a further fact applies".

Each line is one run of the Rules Mate applicability engine for a single business profile, with the reason the engine gives:

• Pty Ltd company in real estate agents with 6–19 employees, turnover $1M–$3M: does not apply. Requires a pharmacy.
• Pty Ltd company in aged care providers with 6–19 employees, turnover $1M–$3M: check whether it applies. applies only if you hold Schedule 8 medicines.

Starting from a small or large professional services company that does not otherwise meet the test, each of these single facts changes the engine's answer:

• The business is a registered NDIS provider: it becomes worth checking, because it applies only if you hold Schedule 8 medicines.
• The business is an approved aged care provider: it becomes worth checking, because it applies only if you hold Schedule 8 medicines.

The engine shows this obligation as "check whether this applies" when a business has industry: Health practitioners or approved aged care provider status or a health service. It then applies only if you hold Schedule 8 medicines. That fact is not something Rules Mate can infer from industry, structure or size.

When due

Per-event recording; annual reconciliation.

Frequency

Ongoing

Evidence to keep

Controlled drugs register; stocktake reports; police notification of theft/loss.

Status

Current

Priority

Critical

Maximum penalty: State Poisons Act penalties + AHPRA notification + criminal liability for diversion.

Rules Mate has not yet classified the audit or assurance level for this obligation. Any audit, review or certification requirement is set by the regulator source listed below.

• Maintain PBS approval + claim accurately for PBS-listed medicines: Pharmacy approval-to-supply under s 90 National Health Act; PBS claiming subject to compliance review.

Rules Mate tracks 2 published obligations tagged "pharmacy", 2 of them rated critical. For a professional services Pty Ltd company with 6–19 employees operating in every state, 0 of those apply outright. This obligation is rated critical priority and carries criminal liability, and is an ongoing duty.

Regulated by Australian Health Practitioner Regulation Agency and Therapeutic Goods Administration.

AHPRA: Single national registration and accreditation scheme for 16 regulated health professions under the National Law.

TGA: Regulator of therapeutic goods — medicines, medical devices, biologicals, and blood products. Administers the Therapeutic Goods Act and ARTG.

• Australian Health Practitioner Regulation Agency
• Therapeutic Goods Administration

Free tools that help with this obligation:

• Compliance calendar builder