This regulation may be cited as the Health (Drugs and Poisons) Amendment Regulation (No. 3) 2016 .
This regulation amends the Health (Drugs and Poisons) Regulation 1996 .
3Amendment of s 45 (Offence to manufacture controlled drugs without licence)
(1)Section 45(b)—
omit.(2)Section 45(c) and (d)—
renumber as section 45(b) and (c).
4Replacement of s 49 (Offence to wholesale controlled drugs without licence)
Section 49—
omit, insert—49Offence to wholesale controlled drugs without licence
A person must not sell a controlled drug by wholesale unless the person holds a controlled drug manufacturer licence or controlled drug wholesaler licence for the drug.Maximum penalty—80 penalty units.
5Amendment of s 78B (Definitions for part)
(1)Section 78B—
insert—authorised person, at a hospital, means a person authorised under this part to administer or supply medicinal cannabis to an eligible hospital patient at the hospital.chief executive approval means an approval granted under section 78K.dosage condition, for a person, means a condition, relating to the dosage of medicinal cannabis that may be prescribed for or used by the person, imposed under—(a)a medicinal cannabis approval; or(b)section 78M; or(c)a chief executive approval.eligible hospital patient means a person who—(a)is a patient, other than an outpatient, being treated at a hospital; and(b)is—(i)a patient being treated by a patient-class prescriber under section 78F; or(ii)an approved patient under section 78G; or(iii)using medicinal cannabis under a chief executive approval.(2)Section 78B, definition medicinal cannabis, paragraphs (b) and (c)—
omit, insert—(b)used, or intended by the manufacturer of the product to be used, for human therapeutic purposes; and(c)a controlled drug, other than a regulated controlled drug.
6Amendment of s 78C (Purpose of part)
Section 78C(a)—
insert—(iii)the possession, supply, issue and administration of medicinal cannabis at hospitals; and(iv)approved clinical trials; and
7Amendment of s 78D (Application of part)
(1)Section 78D(2)(d), ‘(3) and (4)’—
omit.(2)Section 78D(2)(i) and (j)—
omit.(3)Section 78D(2)—
insert—(ea)section 59, except to the extent it authorises obtaining, possessing or issuing medicinal cannabis for treatment of an eligible hospital patient;(i)sections 66 to 69;(n)part 5;(o)section 119(4) and (5);(p)sections 120 and 122.(4)Section 78D(2)(ea) to (i)—
renumber as section 78D(2)(f) to (j).(5)Section 78D(3)—
omit, insert—(3)Nothing in part 2 is taken to authorise—(a)a person, other than a patient-class prescriber or a single-patient prescriber, to prescribe medicinal cannabis; or(b)a person, other than a doctor mentioned in section 78GA, to give an oral or written instruction to administer or supply medicinal cannabis to an eligible hospital patient at a hospital, hospice or medical centre at a prison; or(c)a person to supply or administer medicinal cannabis other than in accordance with—(i)a prescription written by a patient-class prescriber or a single-patient prescriber; or(ii)an oral or written instruction given by a doctor mentioned in section 78GA; or(iii) a chief executive approval.(4)Also, nothing in part 2 is taken to require medicinal cannabis to be obtained on a purchase order complying with part 5.
8Insertion of new ss 78GA–78GC
After section 78G—
insert—(1)This section applies if—(a)a doctor is employed or contracted to practise medicine at a hospital; and(b)an eligible hospital patient is being treated at the hospital.(2)To the extent necessary to practise medicine at the hospital, the doctor is authorised to do the following—(a)obtain medicinal cannabis when at the hospital for the purpose of treating the patient at the hospital;(b)possess medicinal cannabis when at the hospital for the purpose of treating the patient at the hospital;(c)if the doctor is reasonably satisfied the patient needs medicinal cannabis for a therapeutic use as part of the patient’s medical treatment at the hospital—(i)supply the medicinal cannabis to the patient at the hospital; or(ii)issue the medicinal cannabis to an authorised person at the hospital who is treating the patient; or(iii)administer the medicinal cannabis to the patient at the hospital;(d)give an authorised person at the hospital an oral or written instruction to administer or supply the medicinal cannabis to the patient at the hospital.(3)To remove any doubt, it is declared that—(a)a dosage condition for the patient does not apply in relation to an act of the doctor permitted under this section; and(b)subsection (2) no longer applies if the eligible hospital patient stops being treated at the hospital.(4)In this section—hospital includes—(a)a hospice; and(b)a medical centre at a prison.(1)This section applies if—(a)an enrolled nurse is employed or contracted to practise nursing at a hospital; and(b)an eligible hospital patient is being treated at the hospital.(2)To the extent necessary to practise nursing at the hospital, the enrolled nurse is authorised to do the following—(a)obtain medicinal cannabis when at the hospital for the purpose of treating the patient at the hospital;(b)possess medicinal cannabis when at the hospital for the purpose of treating the patient at the hospital;(c)administer medicinal cannabis to the patient at the hospital—(i)on the written instruction of a doctor employed or contracted to practise medicine at the hospital; and(ii)under the supervision of a doctor employed or contracted to practise medicine at the hospital.(3)Subsection (2) does not apply if the registration of the enrolled nurse under the Health Practitioner Regulation National Law is subject to a condition that the enrolled nurse is not qualified to administer controlled drugs.(4)To remove any doubt, it is declared that—(a)a dosage condition for the patient does not apply in relation to an act of the enrolled nurse permitted under this section; and(b)subsection (2) no longer applies if the patient stops being treated at the hospital.(5)In this section—hospital includes—(a)a hospice; and(b)a medical centre at a prison.(1)This section applies if—(a)a registered nurse is employed or contracted to practise nursing at a hospital; and(b)an eligible hospital patient is being treated at the hospital.(2)To the extent necessary to practise nursing at the hospital, the registered nurse is authorised to do the following—(a)obtain medicinal cannabis when at the hospital for the purpose of treating the patient at the hospital;(b)possess medicinal cannabis when at the hospital for the purpose of treating the patient at the hospital;(c)administer medicinal cannabis to the patient at the hospital on the oral or written instruction of a doctor employed or contracted to practise medicine at the hospital.(3)Subsection (2) does not apply if the registration of the registered nurse under the Health Practitioner Regulation National Law is subject to a condition that the registered nurse is not qualified to administer controlled drugs.(4)To remove any doubt, it is declared that—(a)a dosage condition for the patient does not apply in relation to an act of the registered nurse permitted under this section; and(b)subsection (2) no longer applies if the patient stops being treated at the hospital.(5)In this section—hospital includes—(a)a hospice; and(b)a medical centre at a prison.
9Amendment of section 78I (Pharmacists)
(1)Section 78I(1)—
insert—(c)for a pharmacist practising pharmacy at a hospital—issuing or supplying medicinal cannabis to an authorised person at the hospital.(2)Section 78I—
insert—(2A)If the pharmacist practises pharmacy at a hospital, the pharmacist, while practising pharmacy at the hospital, is authorised to issue or supply medicinal cannabis to an authorised person at the hospital—(a)on the oral or written instruction of a doctor employed or contracted to practise medicine at the hospital; and(b)for the purpose of treating an eligible hospital patient at the hospital.(2B)To remove any doubt, it is declared that—(a)a dosage condition for the patient does not apply in relation to an act of a pharmacist permitted under subsection (3); and(b)subsections (1)(c) and (3) no longer apply if the patient stops being treated at the hospital.(3)Section 78I(3)—
insert—hospital includes—(a)a hospice; and(b)a medical centre at a prison.(4)Section 78I(2A) to (3)—
renumber as section 78I(3) to (5).
After section 78I—
insert—78IA Hospital pharmaceutical assistants
To the extent necessary to perform the person’s pharmaceutical imprest duties in a hospital, a hospital pharmaceutical assistant, acting under the supervision of a pharmacist, is authorised to—(a)possess medicinal cannabis at the hospital; or(b)issue medicinal cannabis to an authorised person at the hospital—(i)on the oral or written instruction of a doctor employed or contracted to practise medicine at the hospital; and(ii)for the purpose of treating an eligible hospital patient at the hospital.
11Amendment of s 78P (Expiry of part)
(1)Section 78P(a), ‘or’—
omit.(2)Section 78P(b), ‘1 January’—
omit, insert—30 June
12Amendment of s 270B (Approval for cannabis)
Section 270B(b)(ii)—
omit, insert—(ii)research or analysis, including, for example, research into the potential benefits of cannabis for human therapeutic use or analysis for scientific or compliance purposes.
13Amendment of s 271 (Prohibition on dispensing etc. regulated poisons)
Section 271(2), ‘fluoroacetic acid or strychnine’—
omit, insert—fluoroacetic acid, para-aminopropiophenone or strychnine
14Amendment of appendix 7 (Regulated poisons)
Appendix 7, item 7, ‘para-amino propriophenone’—
omit, insert—para-aminopropiophenone