ACT Medicines, Poisons and Therapeutic Goods Act 2008
The ACT Medicines, Poisons and Therapeutic Goods Act 2008 (Republication No 29): authorisation to supply, prescribe, possess and administer scheduled medicines and poisons, rules on invalid prescriptions and reporting to the chief health officer, monitored medicines, loss and theft reporting, controlled medicine registers and pharmacy handovers, packaging, labelling and storage, advertising and vending limits, therapeutic goods supply, licences and executive officer liability.
ACT Medicines, Poisons and Therapeutic Goods Act 2008 is a compliance framework from Australia (Australian Capital Territory) with 8 domains and 29 controls. The largest domains are Chapter 4 Part 4.1: dealings with regulated substances (supply, supply authorities, manufacture, possession, administration, prescribing, loss and theft) – ACT Medicines, Poisons and Therapeutic Goods Act 2008 (9 controls), Chapter 4 Part 4.3: packaging, labelling, storage, containers, representations, advertising, vending machines and paints – ACT Medicines, Poisons and Therapeutic Goods Act 2008 (7 controls), Chapter 4 Part 4.2: records and registers for regulated substances – ACT Medicines, Poisons and Therapeutic Goods Act 2008 (5 controls). Every control below carries what it requires and what an assessor expects to see.
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Framework Domains (8)
Chapter 4 Part 4.1: dealings with regulated substances (supply, supply authorities, manufacture, possession, administration, prescribing, loss and theft) – ACT Medicines, Poisons and Therapeutic Goods Act 2008
| Code | Title |
|---|---|
| act-medicines-poisons-and-therapeutic-goods-act-2008::s26 | Supply a declared substance to another person or to yourself only when authorised for that supply |
| act-medicines-poisons-and-therapeutic-goods-act-2008::s27-29 | Do not supply on a supply authority that is illegible, altered, cancelled, out of date, issued by an unauthorised person, obtained by deception or believed to be forged or changed |
| act-medicines-poisons-and-therapeutic-goods-act-2008::s30-32 | Cancel invalid supply authorities as prescribed, report specified cancellations and post-supply discoveries to the chief health officer and police immediately and in writing within 24 hours, and give required supply information for monitored medicines |
| act-medicines-poisons-and-therapeutic-goods-act-2008::s33-34 | Manufacture regulated substances only when authorised, and discard declared substances and poisons as prescribed or directed without risk to people, property or the environment |
| act-medicines-poisons-and-therapeutic-goods-act-2008::s35-37 | Obtain, possess and administer declared substances (and administer them to animals) only when authorised |
| act-medicines-poisons-and-therapeutic-goods-act-2008::s38-42 | Issue purchase orders, prescriptions, requisitions and standing orders only when authorised and in the form the regulation prescribes |
| act-medicines-poisons-and-therapeutic-goods-act-2008::s39 | Report loss of controlled medicines, schedule 7, 9 or 10 substances (or other prescribed substances) to the chief health officer in writing within 7 days, and theft to the chief health officer and police orally at once and in writing within 24 hours |
| act-medicines-poisons-and-therapeutic-goods-act-2008::s43 | Do not prescribe, supply or administer for human use a medicine made, packed, labelled or prepared for animal treatment unless authorised |
| act-medicines-poisons-and-therapeutic-goods-act-2008::s44-45 | Comply with every condition on an authorisation to deal with regulated substances, and never pretend to be authorised |
Chapter 4 Part 4.2: records and registers for regulated substances – ACT Medicines, Poisons and Therapeutic Goods Act 2008
| Code | Title |
|---|---|
| act-medicines-poisons-and-therapeutic-goods-act-2008::s46-47 | Record everything the Act requires in writing (electronic allowed), in English and retrievably, and keep cancelled invalid supply authorities for at least 2 years |
| act-medicines-poisons-and-therapeutic-goods-act-2008::s48-52 | Keep the prescribed register for controlled medicines (and other prescribed substances) at the prescribed place, enter each dealing within 24 hours and sign each entry within 24 hours |
| act-medicines-poisons-and-therapeutic-goods-act-2008::s53-55 | Prescribed witnesses sign register entries for administration and discarding within 24 hours, and no one cancels, changes, deletes or obliterates a register entry except the maker amending it as prescribed |
| act-medicines-poisons-and-therapeutic-goods-act-2008::s56-57 | Keep registers for at least 2 years after the last entry, and if a register is damaged, lost, stolen or destroyed tell the chief health officer in writing within 7 days and take a prescribed inventory |
| act-medicines-poisons-and-therapeutic-goods-act-2008::s58 | Community pharmacy handover: the departing responsible pharmacist takes and records a controlled medicines inventory, the incoming one checks and signs it, and discrepancies are resolved and reported to the chief health officer at once and in writing within 24 hours |
Chapter 4 Part 4.3: packaging, labelling, storage, containers, representations, advertising, vending machines and paints – ACT Medicines, Poisons and Therapeutic Goods Act 2008
| Code | Title |
|---|---|
| act-medicines-poisons-and-therapeutic-goods-act-2008::s59-60 | Package and label every regulated substance supplied to another person as the regulation prescribes or as approved under section 193 |
| act-medicines-poisons-and-therapeutic-goods-act-2008::s61 | Store declared substances as the regulation prescribes for the type of person holding them |
| act-medicines-poisons-and-therapeutic-goods-act-2008::s62-63 | Do not use a container permanently marked with another regulated substance's name, and do not supply food, drink or condiments in prescribed container types |
| act-medicines-poisons-and-therapeutic-goods-act-2008::s64-65 | Do not make false statements or give false names or addresses to obtain reportable substances, prescriptions or purchase orders, and do not supply something as a regulated substance it is not |
| act-medicines-poisons-and-therapeutic-goods-act-2008::s66 | Do not publish advertising that promotes controlled medicines or prohibited substances or offers to supply them, outside the professional publication and prescribed exceptions |
| act-medicines-poisons-and-therapeutic-goods-act-2008::s68-69 | As occupier, do not allow a vending machine on your premises to supply regulated substances, or unscheduled medicines other than small manufacturer's packs placed where children are unlikely to access them |
| act-medicines-poisons-and-therapeutic-goods-act-2008::s70-73 | Manufacture, supply and use paints containing white lead, first and second group paints, toy paints and paints with pesticides only as the regulation prescribes |
Chapter 5: regulated therapeutic goods – ACT Medicines, Poisons and Therapeutic Goods Act 2008
| Code | Title |
|---|---|
| act-medicines-poisons-and-therapeutic-goods-act-2008::s74-77 | Supply regulated therapeutic goods only when authorised, comply with authorisation conditions, and do not pretend to be authorised or misrepresent a thing as a regulated therapeutic good |
Chapter 6: licences – ACT Medicines, Poisons and Therapeutic Goods Act 2008
| Code | Title |
|---|---|
| act-medicines-poisons-and-therapeutic-goods-act-2008::s84-93 | As licence applicant or holder, give change statements during application, answer chief health officer information requests, meet statutory and imposed conditions, and give 7 days' written notice of anticipated changes and apply to amend the licence |
| act-medicines-poisons-and-therapeutic-goods-act-2008::s94-97 | Return an amended licence within 7 days, never contravene a licence condition (recklessly or otherwise), and surrender a licence by written notice with the licence or a statement of its loss |
Chapter 6A: monitored medicines database – ACT Medicines, Poisons and Therapeutic Goods Act 2008
| Code | Title |
|---|---|
| act-medicines-poisons-and-therapeutic-goods-act-2008::s97F-97H | Access, use and disclose monitored medicines database information only as authorised: relevant practitioners for the care of their own patients, others under a written access authority |
Chapters 1 to 3: objects, operation of the Act and important concepts – ACT Medicines, Poisons and Therapeutic Goods Act 2008
| Code | Title |
|---|---|
| act-medicines-poisons-and-therapeutic-goods-act-2008::s7 | Prescribe and supply medicines only in a quantity and for a purpose consistent with the recognised therapeutic standard |
Chapters 7 to 13: enforcement, liability, directions and other machinery – ACT Medicines, Poisons and Therapeutic Goods Act 2008
| Code | Title |
|---|---|
| act-medicines-poisons-and-therapeutic-goods-act-2008::s105 | Take all reasonable steps to comply with a medicines and poisons inspector's requirement to open containers or give information, answers, documents or other things |
| act-medicines-poisons-and-therapeutic-goods-act-2008::s171-172 | Prevent contraventions by employees and agents (whose conduct is attributed to the business unless it took all reasonable steps) and, as an executive officer, take reasonable steps including compliance assessments, implementing recommendations and staff training |
| act-medicines-poisons-and-therapeutic-goods-act-2008::s191-193 | Comply with chief health officer directions about discarding, safe dealing and compliance (within the stated period and storage terms), and with any approval conditions for non-standard packaging or labelling |
What is ACT Medicines, Poisons and Therapeutic Goods Act 2008 and who does it apply to?
ACT Medicines, Poisons and Therapeutic Goods Act 2008 is a compliance framework from Australia (Australian Capital Territory) with 8 domains and 29 controls. The ACT Medicines, Poisons and Therapeutic Goods Act 2008 (Republication No 29): authorisation to supply, prescribe, possess and administer scheduled medicines and poisons, rules on invalid prescriptions and reporting to the chief health officer, monitored medicines, loss and theft reporting, controlled medicine registers and pharmacy handovers, packaging, labelling and storage, advertising and vending limits, therapeutic goods supply, licences and executive officer liability. It is used by organisations to establish and maintain compliance with industry standards and regulatory requirements.
What does ACT Medicines, Poisons and Therapeutic Goods Act 2008 actually require?
ACT Medicines, Poisons and Therapeutic Goods Act 2008 has 29 controls organised across 8 domains. The largest domains are Chapter 4 Part 4.1: dealings with regulated substances (supply, supply authorities, manufacture, possession, administration, prescribing, loss and theft) – ACT Medicines, Poisons and Therapeutic Goods Act 2008 (9 controls), Chapter 4 Part 4.3: packaging, labelling, storage, containers, representations, advertising, vending machines and paints – ACT Medicines, Poisons and Therapeutic Goods Act 2008 (7 controls), Chapter 4 Part 4.2: records and registers for regulated substances – ACT Medicines, Poisons and Therapeutic Goods Act 2008 (5 controls). Each control defines specific requirements that organisations must implement to achieve compliance.
If I already comply with another framework, how much of ACT Medicines, Poisons and Therapeutic Goods Act 2008 do I already cover?
ACT Medicines, Poisons and Therapeutic Goods Act 2008 does not currently have cross-framework mappings in our system. Check back as we continuously expand our mapping database.
How do I implement ACT Medicines, Poisons and Therapeutic Goods Act 2008?
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