54
Sale or supply of Schedule 4 poison or Schedule 8 poison in accordance with hospital medication chart 100
54 Sale or supply of Schedule 4 poison or Schedule 8 poison in accordance with hospital medication chart 100
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54 Sale or supply of Schedule 4 poison or Schedule 8 poison in accordance with hospital medication chart 100
55 Sale or supply of Schedule 4 poison in accordance with residential medication chart 101
55A Sale or supply of Schedule 8 poison in accordance with residential medication chart that is an electronic medication chart 101
56 Sale or supply of Schedule 4 poison by pharmacist in emergency 102
57 Sale or supply of Schedule 4 poison by pharmacist for continuity of treatment 103
57A Sale or supply of Schedule 4 poison by pharmacist for treatment of a person under the pharmacist's care without prescription or other instruction or authorisation 103
58 Poison not to be sold or supplied unless supplementary labelling requirements complied with 104
Division 2—Duties of pharmacist relating to sale or supply 105
59 Division does not authorise supply on copy of prescription 105
60 Pharmacist must mark prescription 106
61 Pharmacist must mark hospital medication chart after supplying Schedule 4 or 8 poison on chart instruction 106
62 Pharmacist must mark residential medication chart after supplying Schedule 4 or 8 poison on chart instruction 107
63 Pharmacist must retain prescription for Schedule 8 poison when supplying without verifying the prescriber 107
64 Pharmacist must retain or further mark prescriptions for Schedule 8 poisons 108
65 Pharmacist must retain or further mark prescriptions for Schedule 9 poisons 108
66 Manner of retention of prescriptions retained after last supply is made 109
67 Pharmacist must produce prescriptions kept under Commonwealth Regulations 109
68 Pharmacist must notify prescriber if prescription departed from 110
69 Notification of fraudulent obtaining of poison 110
70 Pharmacist must notify different authorised prescribers of similar supply of certain Schedule 4 or 8 poisons 110
71 Pharmacist must notify different authorised prescribers of similar supply—Schedule 9 poisons 111
Part 7—Labelling and storage 113
Division 1—Labelling 113
72 Supplementary labelling requirements 113
Division 2—Storage 114
73 General security requirement—Schedule 4 poisons 114
74 Storage of Schedule 8 and 9 poisons and drugs of dependence 117
75 Storage requirements for aged care providers and other authorised persons 121
76 Additional security provisions required in certain circumstances 122
Part 8—Authorising administration 124
77 Persons who may authorise administration 124
78 Authorising administration of Schedule 4, 8 or 9 poison—registered medical practitioner 124
78A Authorising administration of Schedule 8 MDMA or Schedule 8 psilocybine—authorised psychedelic psychiatrist and certain registered medical practitioners 125
79 Authorising administration of Schedule 4, 8 or 9 poison—dentist 127
80 Authorising administration of Schedule 4 or 8 poison—nurse practitioner 128
81 Authorising administration of Schedule 4 or 8 poison—authorised midwife 129
82 Authorising administration of Schedule 4 poison—authorised optometrist 130
83 Authorising administration of Schedule 4 poison—authorised podiatrist 130
84 How registered medical practitioner or dentist must authorise administration of Schedule 4, 8 or 9 poison—written authorisation 131
84A How registered medical practitioner or dentist must authorise administration of Schedule 4, 8 or 9 poison—verbal authorisation in emergency 132
85 How nurse practitioner or authorised midwife must authorise administration of Schedule 4 or 8 poison—written authorisation 133
85A How nurse practitioner or authorised midwife must authorise administration of Schedule 4 or 8 poison—verbal instruction in emergency 133
86 How authorised optometrist or authorised podiatrist must authorise administration of Schedule 4 poison—written authorisation 134
86A How authorised optometrist or authorised podiatrist must authorise administration of Schedule 4 poison—verbal instruction in emergency 135
Part 9—Administration by practitioners other than pharmacists 136
87 Part not to apply to self-administration 136
88 Administration of Schedule 4, 8 or 9 poison—registered medical practitioner 136
89 Administration of Schedule 4, 8 or 9 poison—dentist 137
90 Administration of Schedule 4, 8 or 9 poison—veterinary practitioner 138
91 Administration of Schedule 4, 8 or 9 poison—nurse practitioner 139
92 Administration of Schedule 4, 8 or 9 poison—authorised registered nurse 141
92A Administration of Schedule 4, 8 or 9 poison—approved registered nurse 142
93 Administration of Schedule 4, 8 or 9 poison—authorised midwife 144
93A Administration of Schedule 4, 8 or 9 poison—approved registered midwife 145
94 Administration of Schedule 4 poison—authorised optometrist 147
95 Administration of Schedule 4 poison—authorised podiatrist 148
96 Administration of Schedule 4 poison—nurse or registered midwife 149
97 Administration of Schedule 8 poison—nurse or registered midwife 150
98 Administration of Schedule 9 poison—nurse or registered midwife 151
98A Administration of Schedule 8 MDMA or Schedule 8 psilocybine—authorised psychedelic psychiatrists and certain registered medical practitioners 153
98B Administration of Schedule 8 MDMA or Schedule 8 psilocybine—nurse or nurse practitioner 155
98C Administration of Schedule 4 poison—registered Aboriginal and Torres Strait Islander health practitioner 156
98D Administration of Schedule 8 poison—registered Aboriginal and Torres Strait Islander health practitioner 157
Part 10—Administration by pharmacists 158
99 Administration of Schedule 4 poison by pharmacist 158
99A Circumstances in which pharmacist may administer Schedule 4 poison to a person without instruction 159
99B Circumstances in which pharmacist may administer Schedule 4 poison for treatment of a person under the pharmacist's care without prescription or other instruction or authorisation 159
100 Administration of Schedule 8 poison by pharmacist 160
101 Administration of Schedule 9 poison by pharmacist 160
Part 11—Administration by persons other than pharmacists and other practitioners 162
102 Part not to apply to pharmacists and other practitioners 162
103 Person must not administer Schedule 4, 8 or 9 poison to another person except as specified 162
104 Person must not administer Schedule 4, 8 or 9 poison to an animal except as specified 164
Part 12—Self-administration 165
105 Person must not self-administer Schedule 4, 8 or 9 poison except as specified 165
Part 13—Records 169
106 Definition of transaction 169
107 Persons required to keep records 169
108 Details to be contained in records 170
109 Methods by which records are to be retained and retrieved 174
110 Exception for aged care services 175
111 Accurate records to be kept 176
112 Discrepancies in records to be investigated 176
113 Lost or stolen records to be reported 176
Part 14—Destruction of Schedule 8 poisons and Schedule 9 poisons 177
114 Wilful destruction prohibited 177
115 Exceptions 177
Part 15—Cultivation of narcotic plants 182
116 Authority to cultivate narcotic plants for non-therapeutic uses 182
117 Authority to possess narcotic plant 182
Part 16—Warrants for ovulatory stimulants, prostaglandins, retinoids and thalidomide 184
118 Application of Part 184
119 Certain practitioners not to deal with substance 184
120 Dealing with substance—registered medical practitioner 185
121 Dealing with substance—nurse practitioner 186
121A Dealing with substance—authorised registered nurse 187
121B Dealing with substance—approved registered nurse 187
122 Dealing with substance—authorised midwife 188
122A Dealing with substance—approved registered midwife 188
123 Effect of direction given to registered medical practitioner 189
124 Effect of direction given to nurse practitioner 189
125 Warrant number to be included in any prescription 190
Part 17—Use of premises—drugs of dependence 191
126 Authority to permit use of premises—owners and occupiers 191
Part 18—Forms 193
128 Form of application for Schedule 9 permit 193
129 Form of application for Schedule 8 permit 193
130 Form of Schedule 9 permit 193
131 Form of Schedule 8 permit 193
Part 19—Miscellaneous 194
132 Disclosure of drug use within previous 8 weeks required 194
Part 20—Monitored poisons database 196
132A Data source entity 196
132B Monitored poison 196
132C Monitored supply poison 196
132D Pharmacist to provide certain supply information to prescription exchange service 196
132E Records and information to be provided to the monitored poisons database 197
132F Circumstances where it is not mandatory for pharmacist to check monitored poisons database—certain classes of person 199
132G Circumstances where it is not mandatory to check monitored poisons database—certain classes of person 199
132H Circumstances where it is not mandatory to check monitored poisons database—incurable medical condition 200
132I Circumstances where it is not mandatory to check monitored poisons database—drug-checking services 201
Chapter 3—Schedule 2, 3 and 7 poisons 202
Part 1—Schedule 2 poisons 202
133 Boat captain authorised to obtain or possess Schedule 2 poison 202
133AA Holder of non-emergency patient transport service licence or first aid service licence authorised to obtain and possess Schedule 2 poison 202
133A Possession of a Schedule 2 poison by an approved registered nurse or approved registered midwife 202
133B Restrictions on dealing with Schedule 2 poison—approved registered nurse 203
133C Restrictions on dealing with Schedule 2 poison—approved registered midwife 203
133CA Possession of a Schedule 2 poison by a registered Aboriginal and Torres Strait Islander health practitioner 204
133CB Restrictions on dealing with Schedule 2 poison—registered Aboriginal and Torres Strait Islander health practitioner 205
133CC Possession of a Schedule 2 poison by an Aboriginal and Torres Strait Islander health worker 206
133CD Restrictions on dealing with Schedule 2 poison—Aboriginal and Torres Strait Islander health worker 207
Part 2—Schedule 3 poisons 208
133D Possession of a Schedule 3 poison by an approved registered nurse or approved registered midwife 208
133E Holder of non-emergency patient transport service licence or first aid service licence authorised to obtain and possess Schedule 3 poison 208
133F Possession and supply of Schedule 3 naloxone by approved naloxone provider 208
133G Possession and supply of Schedule 3 naloxone by approved naloxone worker 210
133H Possession and supply of Schedule 3 naloxone by person to whom it is supplied by approved naloxone worker 210
133I Possession of Schedule 3 poison by registered Aboriginal and Torres Strait Islander health practitioner 210
133J Possession of Schedule 3 poison by Aboriginal and Torres Strait Islander health worker 211
134 Restrictions on dealing with Schedule 3 poison—registered medical practitioner 212
135 Restrictions on dealing with Schedule 3 poison—veterinary practitioner 212
136 Restrictions on dealing with Schedule 3 poison—dentist 213
137 Restrictions on dealing with Schedule 3 poison—nurse practitioner 214
137A Sale, supply or administration of Schedule 3 poison—authorised registered nurse 214
137B Sale, supply or administration of Schedule 3 poison—approved registered nurse 215
138 Restrictions on dealing with Schedule 3 poison—authorised midwife 216
138A Sale, supply or administration of Schedule 3 poison—approved registered midwife 216
139 Restrictions on dealing with Schedule 3 poison—authorised optometrist 217
140 Restrictions on dealing with Schedule 3 poison—authorised podiatrist 218
141 Restrictions on dealing with Schedule 3 poison—pharmacist 218
141A Supply or administration of Schedule 3 poison—registered Aboriginal and Torres Strait Islander health practitioner 219
141B Administration of Schedule 3 poison—Aboriginal and Torres Strait Islander health worker 220
143 Restrictions on storage and display 221
144 Requirements to supply—delivery, supervision and directions for use 221
145 Requirements to supply—label identifying supplier 223
146 Administration, prescription, sale or supply prohibited if to support drug dependency 224
147 Notification of fraudulent obtaining of order or prescription 224
Part 3—Schedule 7 poisons 226
148 Controls concerning listed regulated poisons 226
149 Licences, permits or warrants required for special Schedule 7 substances 226
Chapter 3A—Medically supervised injecting centre 227
149A Prescribed injecting centre drugs 227
149B Permitted quantity of injecting centre drugs 227
149C Internal management protocols 227
Chapter 3B—Drug-checking services 229
149D Interpretation 229
149E Prescribed requirements for drug‑checking directors 229
149F Prescribed qualifications for special drug‑checking workers 229
149G Conditions of drug-checking permit—record-keeping 230
149H Storage of substances 232
149I Additional security provisions required in certain circumstances 234
149J Destruction of drug-checking substances 236
149K Fit and proper person consultation 236
149L Secretary must allow time for Chief Commissioner of Police to give advice 237
149M Matters the Secretary must consider before issuing drug-checking permit 237
149N Fit and proper person requirements 238
Chapter 4—Miscellaneous matters 240
Part 1—General requirements 240
150 Poisons to be sold by wholesale and retail in original unopened packs 240
151 Transfer of poisons to inappropriate containers prohibited 240
152 Lost or stolen substances to be notified—practitioners and certain workers 241
153 Lost or stolen poisons to be notified—other persons 242
154 Access to certain poisons restricted to a needs basis 243
155 Form of seizure notice under section 43(1) of the Act 243
156 Form of complaint notice against a seizure under section 43(2) of the Act 243
Part 2—Licences and permits issued under the Act 244
157 Licence to sell or supply Schedule 2 poisons by retail 244
158 Fees 244
Part 3—Other matters 245
Division 1—Approval of matters by Minister 245
159 Minister may approve Schedule 4 poison for supply by pharmacist without prescription 245
Division 2—Approval of matters by Secretary 245
159A Secretary may approve dental assisting qualifications and courses in the administration of Schedule 4 poisons 245
159B Approved registered midwives 245
159C Approved registered nurses 246
160 Secretary may approve Schedule 4 poisons for possession by certain persons 246
160A Secretary may approve an entity to be a public dental service 249
161 Secretary may approve Schedule 4, 8 or 9 poisons for possession by nurses or registered midwives 249
161A Secretary may approve Schedule 4 or Schedule 8 poisons for obtaining, possession, sale, supply or administration by approved registered nurses or approved registered midwives 251
161B Secretary may approve Schedule 2 poisons for obtaining, possession, sale, supply or administration by approved registered nurses or approved registered midwives 253
161C Secretary may approve Schedule 3 poisons for obtaining, possession, sale, supply or administration by approved registered nurses or approved registered midwives 255
161D Approved naloxone providers 257
161E Approved naloxone workers 257
161F Secretary may approve Schedule 4 or 8 poisons for obtaining, possession, supply or administration by registered Aboriginal and Torres Strait Islander health practitioners under instruction 259
161G Secretary may approve Schedule 2 poisons for obtaining, possession, supply or administration by registered Aboriginal and Torres Strait Islander health practitioners under instruction 260
161H Secretary may approve Schedule 3 poisons for obtaining, possession, supply or administration by registered Aboriginal and Torres Strait Islander health practitioners under instruction 261
161I Secretary may approve Schedule 2 poisons for obtaining, possession or administration by Aboriginal and Torres Strait Islander health workers 262
161J Secretary may approve Schedule 3 poisons for obtaining, possession or administration by Aboriginal and Torres Strait Islander health workers 263
162 Secretary may approve manner in which person may write a prescription 264
163 Secretary may approve Schedule 4 poison that pharmacist may administer to a person without instruction 265
163A Secretary may approve Schedule 4 poison that pharmacist may sell, supply or administer for treatment of a person under the pharmacist's care without prescription or other instruction or authorisation 267
163B Secretary may approve qualification of special drug-checking worker 268
Part 4—Transitional provisions 269
164 Definitions 269
165 Approval of poisons for possession by nurses and registered midwives 269
166 Approval of poisons for persons specified in table 269
167 Permit to deal with Schedule 9 poison 269
168 Approval of Schedule 4 poison as suitable for supply without prescription 269
169 Permits relating to special Schedule 8 poisons 270
170 Approval of manner of writing for prescription 270
171 Security directions and approvals 270
172 Approval of Schedule 4 poison for administration by pharmacist without instruction 270
173 Direction to comply with destruction requirements 271
174 Authority to cultivate narcotic plants for non‑therapeutic uses 271
Schedule 1––Revoked regulations 272
Schedule 2––Forms 274
Schedule 3––Fees 285
Schedule 4—Data source entities 291
Schedule 5—Monitored poisons 292
Schedule 6—Monitored supply poisons on and after 1 April 2020 293
═══════════════
Endnotes 294
1 General information 294
2 Table of Amendments 296
3 Explanatory details 298
Version No. 020
Drugs, Poisons and Controlled Substances Regulations 2017
S.R. No. 29/2017
Version incorporating amendments as at
Chapter 1—Preliminary
1 Objectives
The objectives of these Regulations are—
(a) to facilitate and enhance the safe and secure storage, sale, supply, prescribing, administration and use of drugs, poisons and controlled substances by registered practitioners, authorised persons, licensed or permitted persons and the public; and
Reg. 1(b) amended by S.R. No. 96/2022 reg. 5.
(b) to prescribe fees and other matters relating to the provision of licences and permits issued under the Drugs, Poisons and Controlled Substances Act 1981; and
(c) to prescribe forms and other matters necessary to be prescribed for the purposes of the Drugs, Poisons and Controlled Substances Act 1981.
2 Authorising provisions
These Regulations are made under sections 129, 131, 132, 132A and 132B of the Drugs, Poisons and Controlled Substances Act 1981.
3 Commencement
These Regulations come into operation on 23 May 2017.
4 Revocations
The Regulations set out in Schedule 1 are revoked.
5 Definitions
(1) In these Regulations—
Reg. 5(1) def. of Aboriginal and Torres Strait Islander health practitioner administration instruction inserted by S.R. No. 124/2025 reg. 4.
Aboriginal and Torres Strait Islander health practitioner administration instruction means an instruction that authorises a registered Aboriginal and Torres Strait Islander health practitioner to administer a Schedule 2 poison, Schedule 3 poison, Schedule 4 poison or Schedule 8 poison specified in the instruction to a person specified in the instruction;
Reg. 5(1) def. of Aboriginal and Torres Strait Islander health practitioner supply instruction inserted by S.R. No. 124/2025 reg. 4.
Aboriginal and Torres Strait Islander health practitioner supply instruction means an instruction that authorises a registered Aboriginal and Torres Strait Islander health practitioner to supply a Schedule 2 poison, Schedule 3 poison, Schedule 4 poison or Schedule 8 poison specified in the instruction to a person specified in the instruction;
Reg. 5(1) def. of Aboriginal and Torres Strait Islander health worker inserted by S.R. No. 124/2025 reg. 4.
Aboriginal and Torres Strait Islander health worker means a person who is not registered to practise in a health profession under the Health Practitioner Regulation National Law but who holds a VET qualification within the meaning of the National Vocational Education and Training Regulator Act 2011 of the Commonwealth for one of the following VET courses accredited under that Act—
(a) Certificate III in Aboriginal and/or Torres Strait Islander Primary Health Care;
(b) Certificate IV in Aboriginal and/or Torres Strait Islander Primary Health Care Practice;
(c) Certificate IV in Aboriginal and/or Torres Strait Islander Primary Health Care;
(d) a VET course that is equivalent to a course referred to in paragraph (a), (b) or (c);
Reg. 5(1) def. of Aboriginal and Torres Strait Islander health worker administration instruction inserted by S.R. No. 124/2025 reg. 4.
Aboriginal and Torres Strait Islander health worker administration instruction means an instruction that authorises an Aboriginal and Torres Strait Islander health worker to administer a Schedule 2 poison or Schedule 3 poison specified in the instruction to a person specified in the instruction;
Reg. 5(1) def. of advanced first aid service inserted by S.R. No. 174/2021 reg. 5(1).
advanced first aid service has the same meaning as in the Non-Emergency Patient Transport and First Aid Services (First Aid Services) Regulations 2021;
animal includes bird, fish or insect;
Reg. 5(1) def. of approved naloxone provider inserted by S.R. No. 113/2022 reg. 5.
approved naloxone provider means a person approved, or belonging to a class approved, by the Secretary in accordance with regulation 161D;
Reg. 5(1) def. of approved naloxone worker inserted by S.R. No. 113/2022 reg. 5.
approved naloxone worker means a person belonging to a class approved by the Secretary in accordance with regulation 161E;
Reg. 5(1) def. of approved registered midwife inserted by S.R. No. 13/2021 reg. 5(a).
approved registered midwife means a registered midwife belonging to a class approved by the Secretary in accordance with regulation 159B;
Reg. 5(1) def. of approved registered nurse inserted by S.R. No. 13/2021 reg. 5(a).
approved registered nurse means a registered nurse belonging to a class approved by the Secretary in accordance with regulation 159C;
Australian Sailing Limited means Australian Sailing Limited ACN 602 997 562;
authorised midwife means a registered midwife who is authorised by section 13(1)(bc) of the Act to obtain, possess, use, sell or supply a Schedule 2, 3, 4 or 8 poison in accordance with that provision;
authorised optometrist means a registered optometrist who is authorised by section 13(1)(c) of the Act to obtain, possess, use, sell or supply a Schedule 2, 3 or 4 poison in accordance with that provision;
authorised podiatrist means a registered podiatrist who is authorised by section 13(1)(ca) of the Act to obtain, possess, use, sell or supply a Schedule 2, 3 or 4 poison in accordance with that provision;
Reg. 5(1) def. of authorised psychedelic psychiatrist inserted by S.R. No. 61/2023 reg. 5.
authorised psychedelic psychiatrist means a registered medical practitioner—
(a) who is registered as a specialist psychiatrist under the Health Practitioner Regulation National Law; and
(b) for whom an authority under section 19(5) of the Therapeutic Goods Act 1989 of the Commonwealth that covers MDMA or psilocybine is in force;
authorised registered nurse means a registered nurse who is authorised by section 13(1)(bb) of the Act to obtain, possess, use, sell or supply a Schedule 2, 3, 4 or 8 poison in accordance with that provision;
Reg. 5(1) def. of calibration substance inserted by S.R. No. 126/2024 reg. 4.
calibration substance means a Schedule 4 poison, Schedule 8 poison or Schedule 9 poison that is supplied for the purposes of the calibration of the equipment or apparatus that is required for the provision of a drug‑checking service under a drug-checking permit;
chart instruction has the meaning given in regulation 6;
Commonwealth Regulations means the National Health (Pharmaceutical Benefits) Regulations 2017 of the Commonwealth;
Reg. 5(1) def. of Common-wealth Secretary inserted by S.R. No. 61/2023 reg. 5.
Commonwealth Secretary means the Secretary within the meaning of the Therapeutic Goods Act 1989 of the Commonwealth;
Reg. 5(1) def. of dental assistant inserted by S.R. No. 31/2018 reg. 5.
dental assistant means a person who—
(a) holds a qualification approved by the Secretary under regulation 159A; and
(b) has completed a course approved by the Secretary under regulation 159A;
Reg. 5(1) def. of drug-checking substance inserted by S.R. No. 126/2024 reg. 4.
drug-checking substance means a substance that has been received by the holder of a drug‑checking permit or a special drug‑checking worker as authorised by section 20AA(1)(a) of the Act;
Reg. 5(1) def. of electronic medication chart inserted by S.R. No. 73/2020 reg. 5.
electronic medication chart means a medication chart in an electronic form in accordance with the requirements of the Commonwealth Regulations;
enrolled nurse means a person registered under the Health Practitioner Regulation National Law—
(a) to practise in the nursing and midwifery profession as a nurse (other than as a student); and
(b) in the enrolled nurses division of the Register of Nurses;
Reg. 5(1) def. of first aid inserted by S.R. No. 174/2021 reg. 5(1).
first aid has the same meaning as in the Non‑Emergency Patient Transport and First Aid Services Act 2003;
Reg. 5(1) def. of first aid service inserted by S.R. No. 174/2021 reg. 5(1).
first aid service has the same meaning as in the Non-Emergency Patient Transport and First Aid Services Act 2003;
Reg. 5(1) def. of first aid service licence inserted by S.R. No. 174/2021 reg. 5(1).
first aid service licence has the same meaning as in the Non-Emergency Patient Transport and First Aid Services Act 2003;
general Schedule 9 permit means a permit issued under regulation 14(1);
hospital medication chart means a medication chart within the meaning of the Commonwealth Regulations that is kept in respect of a patient being treated in or at a hospital or day procedure centre;
Reg. 5(1) def. of human research ethics committee inserted by S.R. No. 96/2022 reg. 6.
human research ethics committee means a committee—
(a) that has notified its existence to the Australian Health Ethics Committee established under the National Health and Medical Research Council Act 1992 of the Commonwealth; and
(b) to which the NHMRC (within the meaning of that Act) has allocated a code to denote the NHMRC's registration of the committee as a human research ethics committee; and
(c) whose registration referred to in paragraph (b) is in force;
Reg. 5(1) def. of intermediate first aid service inserted by S.R. No. 174/2021 reg. 5(1).
intermediate first aid service has the same meaning as in the Non-Emergency Patient Transport and First Aid Services (First Aid Services) Regulations 2021;
listed regulated poison means a Schedule 7 poison that is included in Part 2 of Chapter 1 of the Poisons Code in the list of substances that are not for general sale by retail;
Reg. 5(1) def. of National Health (Continued Dispensing) Determination 2012 substituted as National Health (Continued Dispensing) Determination 2022 by S.R. No. 112/2022 reg. 5.
National Health (Continued Dispensing) Determination 2022 means the legislative instrument made under section 89A(3) of the National Health Act 1953 of the Commonwealth as formulated or published;
Reg. 5(1) def. of non-emergency patient transport service inserted by S.R. No. 178/2018 reg. 5, amended by S.R. No. 174/2021 reg. 5(2).
non-emergency patient transport service has the same meaning as it has in the Non‑Emergency Patient Transport and First Aid Services Act 2003;
Reg. 5(1) def. of non-emergency patient transport service licence inserted by S.R. No. 178/2018 reg. 5, amended by S.R. No. 174/2021 reg. 5(3).
non-emergency patient transport service licence has the same meaning as it has in the Non-Emergency Patient Transport and First Aid Services Act 2003;
nurse means—
(a) a registered nurse; or
(b) an enrolled nurse other than an enrolled nurse who has a notation on the nurse's registration indicating that the nurse is not qualified to administer medication;
orthoptist means a person who is registered as an orthoptist with the Australian Orthoptic Board, being a committee constituted by the directors of the Australian Orthoptists Registration Body Pty Ltd ACN 095 117 678;
ovulatory stimulant means a substance listed as an ovulatory stimulant in Part 2 of Chapter 1 of the Poisons Code;
palliative care service means a service which provides medical and nursing care to persons who are terminally ill;
pharmacy has the same meaning as it has in the Pharmacy Regulation Act 2010;
pharmacy business has the same meaning as it has in the Pharmacy Regulation Act 2010;
pharmacy department has the same meaning as it has in the Pharmacy Regulation Act 2010;
prescription does not include—
(a) a chart instruction; or
(b) an authorisation under Part 8 of Chapter 2;
Reg. 5(1) def. of prescription exchange service inserted by S.R. No. 72/2018 reg. 5.
prescription exchange service means a system that provides for the electronic transfer of prescription information between a person who issues a prescription and a pharmacist;
prostaglandin means a substance listed as a prostaglandin in Part 2 of Chapter 1 of the Poisons Code;
Reg. 5(1) def. of registered Aboriginal and Torres Strait Islander health practitioner inserted by S.R. No. 16/2022 reg. 4.
registered Aboriginal and Torres Strait Islander health practitioner means a person registered under the Health Practitioner Regulation National Law to practise in the Aboriginal and Torres Strait Islander health practice profession (other than as a student);
registered dental hygienist means a person registered under the Health Practitioner Regulation National Law—
(a) to practise in the dental profession as a dental hygienist (other than as a student); and
(b) in the dental hygienists division of the Register of Dental Practitioners;
Reg. 5(1) def. of registered dental practitioner inserted by S.R. No. 31/2018 reg. 5.
registered dental practitioner means—
(a) a dentist; or
(b) a registered dental hygienist; or
(c) a registered dental therapist; or
(d) a registered oral health therapist;
registered dental therapist means a person registered under the Health Practitioner Regulation National Law—
(a) to practise in the dental profession as a dental therapist (other than as a student); and
(b) in the dental therapists division of the Register of Dental Practitioners;
registered oral health therapist means a person registered under the Health Practitioner Regulation National Law—
(a) to practice in the dental profession as an oral health therapist (other than as a student); and
(b) in the oral health therapists division of the Register of Dental Practitioners;
resident means a person who receives residential care in a residential facility;
residential care service has the meaning given by Schedule 1 to the Aged Care Act 1997 of the Commonwealth;
residential medication chart means a medication chart within the meaning of the Commonwealth Regulations that is kept in respect of a person who is receiving treatment as a resident;
retinoid means a substance listed as a retinoid in Part 2 of Chapter 1 of the Poisons Code;
Reg. 5(1) def. of Schedule 3 naloxone inserted by S.R. No. 113/2022 reg. 5.
Schedule 3 naloxone means naloxone when prepared to be used for the treatment of opioid overdoses;
Reg. 5(1) def. of Schedule 8 cannabis revoked by S.R. No. 13/2022 reg. 5(a).
Reg. 5(1) def. of Schedule 8 MDMA inserted by S.R. No. 61/2023 reg. 5.
Schedule 8 MDMA means N, α ‑DIMETHYL‑3, 4‑(METHYLENEDIOXY)PHENYLETHY LAMINE in Schedule 8 of the Poisons Standard;
MDMA is included in Schedule 8 of the Poisons Standard only for the treatment of post-traumatic stress disorder.
Reg. 5(1) def. of Schedule 8 psilocybine inserted by S.R. No. 61/2023 reg. 5.
Schedule 8 psilocybine means psilocybine in Schedule 8 of the Poisons Standard;
Psilocybine is included in Schedule 8 of the Poisons Standard only for the treatment of treatment-resistant depression.
Reg. 5(1) def. of Schedule 8 tetrahydro-cannabinol revoked by S.R. No. 13/2022 reg. 5(b).
special Schedule 7 substance means a substance listed as a special Schedule 7 substance in Part 2 of Chapter 1 of the Poisons Code;
special Schedule 8 permit means a permit issued under regulation 12(1);
Reg. 5(1) def. of special Schedule 8 poison amended by S.R. No. 13/2022 reg. 5(c).
special Schedule 8 poison means—
(a) methadone;
(b) nabiximols;
(e) amphetamine;
(f) dexamphetamine;
(g) lisdexamfetamine;
(h) methylamphetamine;
(i) methylphenidate;
(j) sodium oxybate;
St John Ambulance means St. John Ambulance Australia (Victoria) Inc. ABN 69 061 844 380;
storage facility includes cabinet, receptacle, cupboard, refrigerator or room;
supplementary labelling requirements means the requirements set out in regulation 72;
thalidomide means—
(a) thalidomide for human use; or
(b) a substance listed as a thalidomide-like substance in Part 2 of Chapter 1 of the Poisons Code;
Reg. 5(1) def. of the Act amended by S.R. No. 13/2021 reg. 5(b).
the Act means the Drugs, Poisons and Controlled Substances Act 1981;
Reg. 5(1) def. of the Primary Clinical Care Manual inserted by S.R. No. 13/2021 reg. 5(a).
the Primary Clinical Care Manual means the document with that title, as published from time to time by the State of Queensland (Queensland Health) and the Royal Flying Doctor Service (Queensland Section).
(2) A reference in these Regulations to a drug of dependence includes a reference to a drug of dependence that is also a Schedule 4 poison, Schedule 8 poison or Schedule 9 poison.
Drug of dependence is defined in the Act.
6 Meaning of *chart instruction*
(1) A chart instruction is an order—
(a) that provides for a person to be supplied with a Schedule 3 poison, Schedule 4 poison or Schedule 8 poison; and
(b) that is given by complying with the procedure set out in the Commonwealth Regulations for writing a medication chart prescription within the meaning of those Regulations.
(2) An order may be a chart instruction—
(a) whether or not the Schedule 3 poison, Schedule 4 poison or Schedule 8 poison in respect of which the order is given is a pharmaceutical benefit within the meaning of the Commonwealth Regulations; and
(b) whether or not the person who writes the instruction is a PBS prescriber within the meaning of the Commonwealth Regulations.
1 Under the Commonwealth Regulations, a medication chart prescription must be for a pharmaceutical benefit and must be given by a PBS prescriber. Under subregulation (2), chart instruction includes medication chart prescriptions and also includes other orders that do not meet those requirements.
2 See regulations 28(3) and 29(2) in relation to the writing of other information on a hospital medication chart or residential medication chart.
Chapter 2—Schedule 4, 8 and 9 poisons
Part 1—Possession
7 Persons authorised to possess Schedule 4, 8 and 9 poisons
(1) A person or class of persons shown in an item in Column 1 of the following Table is authorised to obtain or possess a Schedule 4 poison, Schedule 8 poison or Schedule 9 poison to the extent and for the purpose shown in Column 2.
Reg. 7(1) (Table) amended by S.R. Nos 31/2018 reg. 6, 178/2018 reg. 6(1), 13/2021 reg. 6, 174/2021 reg. 6, 16/2022 reg. 5, 126/2024 reg. 5, 124/2025 reg. 5.
| Column 1 | Column 2 | ||
|---|---|---|---|
| authorised midwife, authorised optometrist, authorised podiatrist or pharmacist. | |||
| 3. | A person who is engaged, or employed by a person who is engaged, to transport a Schedule 8 poison at the request of a person holding a licence or permit issued under the Act or these Regulations, or a registered medical practitioner, veterinary practitioner, dentist, nurse practitioner, authorised midwife or pharmacist. | The Schedule 8 poison for the purposes of delivery to the person to whom the consignment is addressed. | |
| 4. | A person who is engaged, or employed by a person who is engaged, to transport a Schedule 9 poison at the request of a person holding a licence or permit issued under the Act or these Regulations. | The Schedule 9 poison for the purposes of delivery to the person to whom the consignment is addressed. | |
| 5. | A person for whom a Schedule 4 poison is supplied (other than as authorised by section 20AA(1)(b) or (2)(a) of the Act) by a registered medical practitioner, dentist, nurse practitioner, authorised registered nurse, approved registered nurse, authorised midwife, approved registered midwife, authorised optometrist, authorised podiatrist, pharmacist or registered Aboriginal and Torres Strait Islander health practitioner in accordance with the Act and these Regulations. | That Schedule 4 poison to the extent and for the purpose for which it is supplied. | |
| 6. | A person for whom a Schedule 8 poison is supplied (other than as authorised by section 20AA(1)(b) or (2)(a) of the Act) by a registered medical practitioner, dentist, nurse practitioner, authorised registered nurse, approved registered nurse, authorised midwife, approved registered midwife, pharmacist or registered Aboriginal and Torres Strait Islander health practitioner in accordance with the Act and these Regulations. | That Schedule 8 poison to the extent and for the purpose for which it is supplied. | |
| 7. | A person for whom a Schedule 9 poison is supplied (other than as authorised by section 20AA(1)(b) or (2)(a) of the Act) by a registered medical practitioner, dentist or pharmacist in accordance with the Act and these Regulations. | That Schedule 9 poison to the extent and for the purpose for which it is supplied. | |
| 8. | The agent of, or a person who has the care of, or who is assisting in the care of, a person referred to in item 5, 6 or 7. | That Schedule 4 poison, Schedule 8 poison or Schedule 9 poison to the extent and for the purpose for which it is supplied. | |
| 9. | An owner of, or a person having custody or care of, an animal for which a Schedule 4 poison, Schedule 8 poison or Schedule 9 poison is supplied by a veterinary practitioner or pharmacist in accordance with the Act and these Regulations. | That Schedule 4 poison, Schedule 8 poison or Schedule 9 poison to the extent and for the purpose for which it is supplied. | |
| 10. | An owner of, or person having custody or care of, animals for which a Schedule 4 poison is supplied by wholesale in a stock food on the order of a veterinary practitioner for the treatment of those animals in accordance with the Act or these Regulations. | That Schedule 4 poison to the extent and for the purpose for which it is supplied. | |
| 10A. | A person who holds a drug-checking permit or a special drug-checking worker engaged by the holder of the permit. | Those Schedule 4 poisons, Schedule 8 poisons or Schedule 9 poisons that are required for the purposes of the calibration of the equipment or apparatus that is required for the provision of a drug‑checking service under the permit. | |
| Part 2 | |||
| 11. | An operational staff member within the meaning of the Ambulance Services Act 1986. | Those Schedule 4 poisons or Schedule 8 poisons listed in the health services permit held by that ambulance service within the meaning of the Ambulance Services Act 1986 to the extent and for the purpose specified in the permit. | |
| * * * * * | |||
| 13. | A master or chief officer of a ship in port in Victoria. | Those Schedule 4 poisons or Schedule 8 poisons that are required by State, Commonwealth or international law for the purposes of completing the equipment of that ship. | |
| 14. | A yacht owner or crew member who is a member of Australian Sailing Limited and whose yacht is entered in a race conducted under the rules of Australian Sailing Limited. | Those Schedule 4 poisons or Schedule 8 poisons contained in the medical kit for the purposes of the Australian Sailing Limited race category in which the yacht is entered. | |
| 15. | A registered optometrist carrying on the lawful practice of the registered optometrist's profession who is not an authorised optometrist. | Those Schedule 4 poisons approved by the Secretary under regulation 160(1) that are required in the practice of the registered optometrist's profession for the purpose of the practice of optometry. | |
| 16. | A registered podiatrist carrying on the lawful practice of the registered podiatrist's profession who is not an authorised podiatrist. | Those Schedule 4 poisons approved by the Secretary under regulation 160(1) that are required in the practice of the registered podiatrist's profession for the purpose of the treatment of podiatric conditions. | |
| 17. | A person who holds a permit to use etorphine in accordance with the Act and these Regulations or a person assisting that permit holder. | Those morphine antagonists that are necessary for the purpose of administration as an antidote to etorphine. | |
| 18. | An Australian Ski Patrol Association Inc. ABN 26 369 760 601 qualified ski patroller. | Those Schedule 4 poisons approved by the Secretary under regulation 160(1) that are required in the performance of a ski patroller's duties for the purpose of treatment in emergencies. | |
| 19. | A Director within the meaning of the Victoria State Emergency Service Act 2005. | Those Schedule 4 poisons or Schedule 8 poisons that are required for the purpose of the performance of the state emergency services' duties in an emergency coming within the jurisdiction of a Director under the Victoria State Emergency Service Act 2005. | |
| 20. | A municipal council, an environmental health officer or a nurse or registered midwife employed or appointed by a municipal council. | Those Schedule 4 poisons that are necessary for the purpose of immunisation programs coordinated by a municipal council in accordance with its functions under the Public Health and Wellbeing Act 2008. | |
| 21 | A registered dental hygienist, registered dental therapist or registered oral health therapist. | Those Schedule 4 poisons approved by the Secretary under regulation 160(1) that are required for the purpose of the provision of dental care by the registered dental hygienist, registered dental therapist or registered oral health therapist. | |
| 21A. | A dental assistant employed or engaged by an entity declared to be a public dental service by the Secretary under regulation 160A. | Those Schedule 4 poisons approved by the Secretary under regulation 160(1) that are required for the treatment of a person whose name is specified in an instruction written by a registered dental practitioner and given to the dental assistant. | |
| 22. | An orthoptist practising under the direction of a registered medical practitioner or an authorised optometrist. | Those Schedule 4 poisons approved by the Secretary under regulation 160(1) in topical ophthalmic preparations for the purpose of use in the eyes of patients. | |
| 23. | On-site emergency response workers trained in Advanced First Aid at mine sites and power stations. | Those Schedule 4 poisons approved by the Secretary under regulation 160(1) that are required in the performance of an emergency response worker's duties for the purpose of treatment in emergencies. | |
| 24. | A person who holds a non-emergency patient transport service licence. | Those Schedule 4 poisons approved by the Secretary under regulation 160(1) that are required in the performance of the person's duties for the purpose of providing medical care to patients of the non-emergency patient transport service operated by the licence holder. | |
| 24A. | A person (including a nurse) employed or engaged by the holder of a non-emergency patient transport service licence to provide medical care to patients of the non-emergency patient transport service operated by the licence holder. | Those Schedule 4 poisons approved by the Secretary under regulation 160(1) that are required in the performance of the person's duties for the purpose of providing medical care to patients of the non-emergency patient transport service operated by the licence holder. | |
| 24B. | A person who holds a first aid service licence to operate an intermediate first aid service or an advanced first aid service. | Those Schedule 4 poisons approved by the Secretary under regulation 160(1) that are required in the performance of the person's duties for the purpose of providing first aid to patients of the intermediate first aid service or advanced first aid service operated by the licence holder. | |
| 24C. | A person (including a nurse) employed or engaged by a licence holder referred to in item 24B to provide first aid to patients of the intermediate first aid service or advanced first aid service operated by the licence holder. | Those Schedule 4 poisons approved by the Secretary under regulation 160(1) that are required in the performance of the person's duties for the purpose of providing first aid to patients of the intermediate first aid service or advanced first aid service operated by the licence holder. | |
| 25. | A person employed or engaged as a lifeguard (on a paid or unpaid basis) by Life Saving Victoria Limited ABN 21 102 927 364. | Those Schedule 4 poisons approved by the Secretary under regulation 160(1) that are required in the performance of the lifeguard's duties for the purpose of treatment in emergencies. | |
| * * * * * |
Reg. 7(2) amended by S.R. No. 178/2018 reg. 6(2).
(2) Nothing in this regulation limits any other authorisation of a person referred to in Column 1 of the preceding Table to obtain or possess a poison or controlled substance, whether in the capacity referred to in Column 1 or otherwise.
8 Possession of Schedule 4, 8 and 9 poisons by nurse or registered midwife
(1) A nurse or registered midwife is authorised to possess those Schedule 4 poisons that are necessary for administration to a patient under the care of that nurse or registered midwife in accordance with—
(2) A nurse or registered midwife is authorised to possess those Schedule 8 poisons that are necessary for administration to a patient under the care of that nurse or registered midwife in accordance with—
(3) A nurse or registered midwife is authorised to possess those Schedule 9 poisons that are necessary for administration to a patient under the care of that nurse or registered midwife in accordance with—
(4) Nothing in this regulation limits any other authorisation of a nurse or registered midwife to possess a poison or controlled substance, whether in the lawful practice of the nurse or midwife's profession or otherwise.
Reg. 8A inserted by S.R. No. 13/2021 reg. 7.
8A Possession of Schedule 4 and 8 poisons by an approved registered nurse or approved registered midwife
An approved registered nurse or approved registered midwife is authorised to obtain and possess a Schedule 4 poison or a Schedule 8 poison in accordance with an approval under regulation 161A for sale, supply or administration in accordance with that approval.
Reg. 8B inserted by S.R. No. 124/2025 reg. 6.
8B Possession of Schedule 4 and 8 poisons by a registered Aboriginal and Torres Strait Islander health practitioner
(1) A registered Aboriginal and Torres Strait Islander health practitioner is authorised to obtain and possess a Schedule 4 poison in accordance with an approval under regulation 161F for the purpose of—
(b) administration in accordance with an Aboriginal and Torres Strait Islander health practitioner administration instruction given by—
(2) A registered Aboriginal and Torres Strait Islander health practitioner is authorised to obtain and possess a Schedule 8 poison in accordance with an approval under regulation 161F for the purpose of—
(b) administration in accordance with an Aboriginal and Torres Strait Islander health practitioner administration instruction given by—
(iv) an authorised midwife.
9 Dentist must not possess methadone
A dentist must not possess methadone.
Reg. 9A inserted by S.R. No. 61/2023 reg. 6.
9A Person must not possess Schedule 8 MDMA or Schedule 8 psilocybine
A person must not possess Schedule 8 MDMA or Schedule 8 psilocybine unless—
(a) the person is an authorised psychedelic psychiatrist; or
(b) the person is a registered medical practitioner, nurse or nurse practitioner who is instructed by an authorised psychedelic psychiatrist to administer the Schedule 8 MDMA or Schedule 8 psilocybine to a person in the authorised psychedelic psychiatrist's care; or
(c) the person is a pharmacist carrying on the lawful practice of the pharmacist's profession; or
(d) the person holds or is the agent of a person who holds a licence or permit under the Act or Regulations that allows that person to possess Schedule 8 MDMA or Schedule 8 psilocybine; or
(e) the person is engaged, or employed by a person who is engaged, to transport Schedule 8 MDMA or Schedule 8 psilocybine at the request of a person referred to in paragraph (d); or
(f) the person is a registered medical practitioner and the Schedule 8 MDMA or Schedule 8 psilocybine is for another person who is a participant in a clinical trial that is—
(i) approved by or notified to the Commonwealth Secretary under the Therapeutic Goods Act 1989 of the Commonwealth; and
(ii) approved by a human research ethics committee; or
(g) the person is a nurse or nurse practitioner who is instructed by a registered medical practitioner to administer the Schedule 8 MDMA or Schedule 8 psilocybine to another person who is a participant in a clinical trial that is—
(A) approved by or notified to the Commonwealth Secretary under the Therapeutic Goods Act 1989 of the Commonwealth; and
(B) approved by a human research ethics committee.
Part 2—Permits and forms
Division 1—Special Schedule 8 permits
10 When special Schedule 8 permit required
(1) For the purposes of these Regulations, a special Schedule 8 permit is required if—
(a) a registered medical practitioner or a nurse practitioner considers it necessary to issue a prescription for, supply, authorise the administration of or administer a Schedule 8 poison to a patient of the practitioner; and
(b) the Schedule 8 poison is a special Schedule 8 poison; and
(c) the patient is not a drug-dependent person; and
(d) section 34 of the Act does not require the practitioner to apply to the Secretary for a Schedule 8 permit; and
(e) the prescription, supply, authorisation or administration is not authorised by section 34D, 34E or 34F of the Act.
Section 34 of the Act does not require a registered medical practitioner or nurse practitioner to apply to the Secretary for a Schedule 8 permit in respect of a person who is not a drug-dependent person unless the administration, supply or prescription is for a continuous period greater than 8 weeks, and the other circumstances set out in section 34(3)(a) apply.
(2) A special Schedule 8 permit is not required for a paediatrician or psychiatrist to issue a prescription, supply, authorise the administration of or administer any of the following poisons for the treatment of a person for attention deficit disorder—
(a) amphetamine;
(b) dexamphetamine;
(c) lisdexamfetamine;
(d) methylamphetamine;
(e) methylphenidate.
(3) A special Schedule 8 permit is not required for a registered medical practitioner or nurse practitioner to issue a prescription for, supply, authorise the administration of or administer methadone to a patient if—
(a) the practitioner is treating the patient at an oncology clinic in a hospital at which the patient is not an in-patient; or
(b) the practitioner is treating the patient at a pain clinic in a hospital at which the patient is not an in-patient; or
(c) the patient is under the care of a palliative care service.
11 Application for special Schedule 8 permit
(1) A registered medical practitioner or nurse practitioner may apply to the Secretary for a special Schedule 8 permit.
Regulations 17, 36, 78 and 88 make it an offence for a registered medical practitioner to issue a prescription for, sell, supply, authorise the administration of or administer a special Schedule 8 poison without a special Schedule 8 permit in certain circumstances. Regulations 20, 39, 80 and 91(3) impose the same prohibitions for nurse practitioners.
(2) An application under subregulation (1) must be in Form 3 in Schedule 2.
12 Special Schedule 8 permit
(1) On receiving an application under regulation 11, the Secretary may issue a permit to the applicant that authorises the applicant to do any of the following as specified in the permit—
(a) issue a prescription for a specified special Schedule 8 poison for a specified patient who is not a drug-dependent person;
(b) supply a specified special Schedule 8 poison to a specified patient who is not a drug-dependent person;
(c) authorise the administration of a specified special Schedule 8 poison to a specified patient who is not a drug-dependent person;
(d) administer a specified special Schedule 8 poison to a specified patient who is not a drug-dependent person.
Section 34C(1) and (2) of the Act are offences that apply to the prescribing, supplying or administering of a Schedule 8 poison to a person who is not a drug-dependent person. Those offences do not apply if the person who issues a prescription for, supplies or administers the poison is authorised by or under the Act to do so. Subregulation (2) provides that a special Schedule 8 permit may authorise those activities.
(2) A special Schedule 8 permit must be in Form 4 in Schedule 2.
(3) The Secretary, at any time, may amend, suspend or revoke a special Schedule 8 permit.
(4) A special Schedule 8 permit which is suspended or revoked under subregulation (3) ceases to have effect.
Reg. 12A inserted by S.R. No. 13/2022 reg. 6.
12A Permits relating to Schedule 8 cannabis and Schedule 8 tetrahydrocannabinol
Without limiting regulation 12(3), on the commencement of the Drugs, Poisons and Controlled Substances Amendment (Schedule 8 Cannabis and Schedule 8 Tetrahydrocannabinol) Regulations 2022, any special Schedule 8 permit issued for Schedule 8 cannabis or Schedule 8 tetrahydrocannabinol that is in force immediately before that commencement is revoked.
Division 2—General Schedule 9 permits
Reg. 13 substituted by S.R. No. 96/2022 reg. 7.
13 Application for general Schedule 9 permit
A veterinary practitioner or dentist may apply to the Secretary for a general Schedule 9 permit.
14 General Schedule 9 permit
(1) On receiving an application under regulation 13, the Secretary, subject to subregulation (2), may issue a permit to the applicant that authorises the applicant to do any of the following as specified in the permit—
(a) issue a prescription for a specified Schedule 9 poison;
(b) sell or supply a specified Schedule 9 poison;
(c) authorise the administration of a specified Schedule 9 poison;
(d) administer a specified Schedule 9 poison;
(e) manufacture a specified Schedule 9 poison;
(f) purchase or otherwise obtain a specified Schedule 9 poison;
(g) possess a specified Schedule 9 poison;
(h) use a specified Schedule 9 poison.
Reg. 14(2) substituted by S.R. No. 96/2022 reg. 8(1).
(2) The Secretary must not issue a general Schedule 9 permit to a dentist unless the Secretary is satisfied that—
(a) a human clinical trial has been approved by a human research ethics committee; and
(b) the activity to be authorised by the permit is to be undertaken for the purposes of that trial.
(3) A general Schedule 9 permit may be subject to any conditions specified in the permit.
Reg. 14(3A) inserted by S.R. No. 96/2022 reg. 8(2).
(3A) Without limiting subregulation (3), when issuing a general Schedule 9 permit to a dentist, the Secretary must include a condition that the activity is only authorised to be undertaken for the purposes of the human clinical trial specified in the condition.
(4) The Secretary, at any time, may amend, suspend or revoke a general Schedule 9 permit.
(5) A general Schedule 9 permit which is suspended or revoked under subregulation (4) ceases to have effect.
Reg. 15 substituted by S.R. No. 96/2022 reg. 9.
15 General Schedule 9 permit is not limited to specific animals
A general Schedule 9 permit granted to a veterinary practitioner is not restricted to the administration of a Schedule 9 poison to a specific animal.
Pt 2 Div. 3 (Heading and regs 15A, 15B) inserted by S.R. No. 96/2022 reg. 10.
Division 3—Schedule 9 permit
Reg. 15A inserted by S.R. No. 96/2022 reg. 10.
15A Documents to accompany application for Schedule 9 permit
(1) Subject to subregulation (2), an application under section 33A of the Act must be accompanied by the following—
(a) a copy of a document issued by a human research ethics committee approving the human clinical trial in relation to which the application is made; and
(b) a copy of the protocol for that trial; and
(c) for each patient in respect of whom the application is made, a copy of a consent form relating to that trial that is signed by the patient.
(2) An application under section 33A of the Act need not be accompanied by a document that has previously accompanied a different application made under that section.
Reg. 15B inserted by S.R. No. 96/2022 reg. 10.
15B Schedule 9 permits issued for clinical trials only
(1) The Secretary must not issue a Schedule 9 permit under section 33B of the Act authorising a medical practitioner to administer, supply or prescribe a Schedule 9 poison to a person unless the Secretary is satisfied that—
(a) a human clinical trial has been approved by a human research ethics committee; and
(b) the activity to be authorised by the permit is to be undertaken for the purposes of that trial.
(2) When issuing a Schedule 9 permit under section 33B of the Act, the Secretary must impose a condition under section 33B(2)(b) of the Act that the administration, supply or prescription of the Schedule 9 poison is only authorised to be undertaken for the purposes of the human clinical trial specified in the condition.
Part 3—Prescriptions
16 Persons authorised to issue prescriptions
(1) A person other than a registered medical practitioner, veterinary practitioner, dentist, nurse practitioner, authorised midwife, authorised optometrist or authorised podiatrist must not issue a prescription for a Schedule 4 poison.
(2) A person other than a registered medical practitioner, veterinary practitioner, dentist, nurse practitioner or authorised midwife must not issue a prescription for a Schedule 8 poison.
(3) A person other than a registered medical practitioner, veterinary practitioner or dentist must not issue a prescription for a Schedule 9 poison.
Reg. 16(4) inserted by S.R. No. 61/2023 reg. 7.
(4) A person must not issue a prescription for Schedule 8 MDMA or Schedule 8 psilocybine unless—
(a) the person is an authorised psychedelic psychiatrist; or
(b) the person is a registered medical practitioner and the prescription is for another person who is a participant in a clinical trial that is—
(i) approved by or notified to the Commonwealth Secretary under the Therapeutic Goods Act 1989 of the Commonwealth; and
(ii) approved by a human research ethics committee.
17 Issuing prescription for Schedule 4, 8 or 9 poison—registered medical practitioner
A registered medical practitioner must not issue a prescription for a Schedule 4 poison, Schedule 8 poison or Schedule 9 poison unless—
(a) the prescription is for the medical treatment of a person other than the practitioner; and
Reg. 17(da) inserted by S.R. No. 61/2023 reg. 8.
(da) if the poison is Schedule 8 MDMA or Schedule 8 psilocybine, the registered medical practitioner is—
(i) an authorised psychedelic psychiatrist; or
(ii) a registered medical practitioner and the prescription is for another person who is a participant in a clinical trial that is—
(A) approved by or notified to the Commonwealth Secretary under the Therapeutic Goods Act 1989 of the Commonwealth; and
(B) approved by a human research ethics committee; and
(e) if the poison is a drug of dependence, a Schedule 8 poison or a Schedule 9 poison, the practitioner has taken all reasonable steps to ascertain the identity of the person for whose treatment the prescription is issued; and
(f) in the case of a Schedule 8 poison, if, under regulation 10, a special Schedule 8 permit is required, the practitioner holds a special Schedule 8 permit that authorises the issuing of the prescription; and
Reg. 17(g) amended by S.R. No. 96/2022 reg. 11.
(g) in the case of a Schedule 9 poison, the practitioner holds a Schedule 9 permit, that authorises the issuing of the prescription.
1 In certain circumstances, sections 34B and 34C of the Act will also prohibit the registered medical practitioner from prescribing the Schedule 8 poison without a Schedule 8 permit.
2 If a registered medical practitioner holds a Schedule 9 permit, section 33C of the Act will also prohibit the practitioner from prescribing the Schedule 9 poison other than for the period specified in the permit and within the quantity specified in the permit.
Reg. 17A inserted by S.R. No. 61/2023 reg. 9.
17A Notice to Secretary of intention to prescribe, authorise administration, or administer Schedule 8 MDMA or Schedule 8 psilocybine
(1) An authorised psychedelic psychiatrist who intends to prescribe, authorise the administration of, or administer, Schedule 8 MDMA or Schedule 8 psilocybine to another person must notify the Secretary in the prescribed form of the psychiatrist's intention to do so not less than 7 days before prescribing, authorising the administration of, or administering, the Schedule 8 MDMA or Schedule 8 psilocybine.
(2) A registered medical practitioner who intends to prescribe, authorise the administration of, or administer, Schedule 8 MDMA or Schedule 8 psilocybine for or to another person who is a participant in a clinical trial must notify the Secretary in the prescribed form of the medical practitioner's intention to do so not less than 7 days before prescribing, authorising the administration of, or administering the Schedule 8 MDMA or Schedule 8 psilocybine.
(3) For the purposes of subregulations (1) and (2), the prescribed form is Form 7 in Schedule 2.
18 Issuing prescription for Schedule 4, 8 or 9 poison—dentist
(1) A dentist must not issue a prescription for methadone.
(2) A dentist must not issue a prescription for a Schedule 4 poison, Schedule 8 poison or Schedule 9 poison unless—
(a) the prescription is for the dental treatment of a person other than the dentist; and
(e) the prescription provides only for a single supply of the poison; and
(f) if the poison is a drug of dependence, a Schedule 8 poison or a Schedule 9 poison, the dentist has taken all reasonable steps to ascertain the identity of the person for whose treatment the prescription is issued; and
(g) in the case of a Schedule 9 poison, the dentist holds a general Schedule 9 permit that authorises the issuing of the prescription.
19 Issuing prescription for Schedule 4, 8 or 9 poison—veterinary practitioner
A veterinary practitioner must not issue a prescription for a Schedule 4 poison, Schedule 8 poison or Schedule 9 poison unless—
(a) that prescription is for the treatment of an animal—
(i) under the veterinary practitioner's care; and
(ii) described in the prescription; and
(b) the veterinary practitioner has taken all reasonable steps to ensure a therapeutic need exists for that poison; and
(c) if the poison is a drug of dependence, a Schedule 8 poison or a Schedule 9 poison, the veterinary practitioner has taken all reasonable steps to ascertain the identity of the person who owns or has custody or care of the animal for whose treatment the prescription is issued; and
(d) in the case of a Schedule 9 poison, the veterinary practitioner holds a general Schedule 9 permit that authorises the issuing of the prescription.
Regulation 27 separately provides for a veterinary practitioner who issues an order to a stock food manufacturer to supply a stock food containing a Schedule 4 poison.
20 Issuing prescription for Schedule 4 or 8 poison—nurse practitioner
A nurse practitioner must not issue a prescription for a Schedule 4 poison or Schedule 8 poison unless—
(a) the prescription is for the treatment of a person other than the nurse practitioner; and
(e) if the poison is a drug of dependence or a Schedule 8 poison, the nurse practitioner has taken all reasonable steps to ascertain the identity of the person for whose treatment the prescription is issued; and
(f) in the case of a Schedule 8 poison, if, under regulation 10, a special Schedule 8 permit is required, the nurse practitioner holds a special Schedule 8 permit that authorises the issuing of the prescription.
In certain circumstances, sections 34B and 34C of the Act will also prohibit the nurse practitioner from prescribing the Schedule 8 poison without a Schedule 8 permit.
21 Issuing prescription for Schedule 4 or 8 poison—authorised midwife
An authorised midwife must not issue a prescription for a Schedule 4 poison or Schedule 8 poison unless—
(a) the prescription is for the midwifery treatment of a person other than the midwife; and
(e) if the poison is a drug of dependence or a Schedule 8 poison, the midwife has taken all reasonable steps to ascertain the identity of the person for whose treatment the prescription is issued.
22 Issuing prescription for Schedule 4 poison—authorised optometrist
An authorised optometrist must not issue a prescription for a Schedule 4 poison unless—
(a) the prescription is for the ocular treatment of a person other than the optometrist; and
(e) if the poison is a drug of dependence, the optometrist has taken all reasonable steps to ascertain the identity of the person for whose treatment the prescription is issued.
23 Issuing prescription for Schedule 4 poison—authorised podiatrist
An authorised podiatrist must not issue a prescription for a Schedule 4 poison unless—
(a) the prescription is for the podiatric treatment of a person other than the podiatrist; and
(e) if the poison is a drug of dependence, the podiatrist has taken all reasonable steps to ascertain the identity of the person for whose treatment the prescription is issued.
24 Required form for issuing prescriptions
(1) A person who issues a prescription for a Schedule 4 poison, Schedule 8 poison or Schedule 9 poison must write the prescription either—
(a) in the person's own handwriting; or
(b) in a manner of writing approved by the Secretary under regulation 162(1).
Under regulation 16, only certain persons are permitted to issue a prescription for a Schedule 4 poison, Schedule 8 poison or Schedule 9 poison. Any other person who issues a prescription for one of those poisons commits an offence.
Reg. 24(1A) inserted by S.R. No. 31/2018 reg. 7.
(1A) A person who writes a prescription for a Schedule 4 poison, Schedule 8 poison or Schedule 9 poison must ensure that the prescription is written in a legible and durable form.
(2) A person who writes a prescription for a Schedule 4 poison, Schedule 8 poison or Schedule 9 poison must sign the prescription.
(3) A person who writes a prescription for a Schedule 4 poison, Schedule 8 poison or Schedule 9 poison must include in the prescription the following information—
(a) the name and address of, and a telephone number for, the person who wrote the prescription;
(b) the following information for the person or animal for whom the prescription is issued—
(i) in the case of a person, the person's name and address;
(ii) in the case of an animal, the species, age, breed and sex of the animal, and the name and address of a person who owns or has custody or care of the animal;
(c) the date on which the prescription was written;
(d) full particulars of the poison to be supplied;
(e) a statement of the quantity to be supplied;
(f) directions for the precise dose or use and frequency of administration except in cases where—
(i) because of the complexity of the dosage regimen or use it is impracticable to do so and the prescriber has separately supplied the patient with written instruction; or
(ii) a variable dosage regimen is directed and a statement specifying a maximum frequency of administration is included; or
(iii) the administration of the poison is to be carried out by a registered medical practitioner, veterinary practitioner, pharmacist, dentist, authorised optometrist, authorised podiatrist, nurse or registered midwife;
Reg. 24(3)(g) substituted by S.R. No. 72/2018 reg. 6.
(g) in the case of a Schedule 8 poison, a monitored poison or a Schedule 9 poison if the prescription is for a person and not an animal, that person's date of birth;
Reg. 24(3)(ga) inserted by S.R. No. 72/2018 reg. 6.
(ga) in the case of a Schedule 8 poison or a Schedule 9 poison—
(i) if the poison may be supplied only once, a statement, using words and not just figures, that there is to be no repeat supply; and
(ii) a statement of quantity to be supplied, written in both words and figures;
(h) subject to subregulations (4) and (5), the maximum number of times the poison may be supplied.
(4) If the prescription is for a Schedule 8 poison or a Schedule 9 poison, the maximum number of times that the poison may be supplied must be stated in both words and figures.
(5) If the prescription is for a Schedule 4 poison, the maximum number of times that the poison may be supplied need only be included if it is more than once.
(6) A person who writes a prescription for a Schedule 4 poison, Schedule 8 poison or Schedule 9 poison must not include any information that the person knows is false or misleading.
(7) A person who writes a prescription for a Schedule 4 poison, Schedule 8 poison or Schedule 9 poison must not write the prescription in a secret code or cipher.
Regulation 125 imposes special requirements in relation to a prescription for an ovulatory stimulant, a prostaglandin, a retinoid or thalidomide.
Reg. 25 (Heading) amended by S.R. No. 20/2023 reg. 5(1).
25 Emergency verbal instructions to pharmacists regarding supply
(1) A registered medical practitioner, veterinary practitioner or dentist may issue verbal instructions to a pharmacist to supply a Schedule 4 poison, Schedule 8 poison or Schedule 9 poison if, in the opinion of the registered medical practitioner, veterinary practitioner or dentist, an emergency exists.
(2) A nurse practitioner or an authorised midwife may issue verbal instructions to a pharmacist to supply a Schedule 4 poison or Schedule 8 poison if, in the opinion of the nurse practitioner or authorised midwife, an emergency exists.
(3) An authorised optometrist or an authorised podiatrist may issue verbal instructions to a pharmacist to supply a Schedule 4 poison if, in the opinion of the authorised optometrist or the authorised podiatrist, an emergency exists.
Reg. 25(4) amended by S.R. No. 20/2023 reg. 5(2).
(4) A registered medical practitioner, veterinary practitioner, dentist, nurse practitioner, an authorised midwife, an authorised optometrist or an authorised podiatrist who issues verbal instructions pursuant to subregulation (1), (2) or (3), as the case requires, must within 72 hours of issuing the verbal instruction—
(a) write an instruction that indicates that it is in confirmation of the verbal instructions previously given; and
Reg. 25(4)(b) amended by S.R. No. 20/2023 reg. 5(3).
(b) ensure that the instruction is sent to the pharmacist.
(5) For the purposes of subregulation (4), the written instruction may be a prescription, a chart instruction, or a written instruction of another kind.
Reg. 25A inserted by S.R. No. 20/2023 reg. 6.
25A Emergency transmission of digital image to pharmacists regarding supply
(1) A registered medical practitioner, veterinary practitioner or dentist may transmit a digital image of an original prescription to a pharmacist to supply a Schedule 4 poison, Schedule 8 poison or Schedule 9 poison if, in the opinion of the registered medical practitioner, veterinary practitioner or dentist, an emergency exists.
(2) A nurse practitioner or an authorised midwife may transmit a digital image of an original prescription to a pharmacist to supply a Schedule 4 poison or a Schedule 8 poison if, in the opinion of the nurse practitioner or authorised midwife, an emergency exists.
(3) An authorised optometrist or an authorised podiatrist may transmit a digital image of an original prescription to a pharmacist to supply a Schedule 4 poison if, in the opinion of the authorised optometrist or the authorised podiatrist, an emergency exists.
(4) A registered medical practitioner, a veterinary practitioner, a dentist, a nurse practitioner, an authorised midwife, an authorised optometrist or an authorised podiatrist who transmits a digital image of an original prescription pursuant to subregulation (1), (2) or (3) must—
(a) ensure that the original prescription complies with regulation 24; and
(b) ensure that the digital image of the original prescription is transmitted directly to the pharmacist or pharmacy of the patient's choice by electronic means; and
(c) not send the digital image of the original prescription to more than one pharmacy or to a person other than a pharmacist; and
(d) ensure that the original prescription is sent to the pharmacist or pharmacy within 72 hours of transmitting the digital image of the prescription.
26 Notification of fraudulent obtaining of order or prescription
(1) A registered medical practitioner, pharmacist, veterinary practitioner or dentist who suspects or has reason to believe that a person has obtained from the practitioner by means of a false pretence an order or prescription for a Schedule 9 poison, Schedule 8 poison or Schedule 4 poison must immediately inform the Secretary and a police officer of that suspicion or belief.
(2) A nurse practitioner or an authorised midwife who suspects or has reason to believe that a person has obtained from the practitioner or midwife by means of a false pretence an order or prescription for a Schedule 8 poison or Schedule 4 poison must immediately inform the Secretary and a police officer of that suspicion or belief.
(3) An authorised optometrist or authorised podiatrist who suspects or has reason to believe that a person has obtained from the optometrist or podiatrist by means of a false pretence an order or prescription for a Schedule 4 poison must immediately inform the Secretary and a police officer of that suspicion or belief.
Ch. 2 Pt 4 (Heading) amended by S.R. No. 124/2025 reg. 7.
Part 4—Stock food orders
Ch. 2 Pt 4 Div. 1 (Heading) revoked by S.R. No. 124/2025 reg. 8.
27 Veterinary practitioner order to supply stock food containing a Schedule 4 poison
(1) A veterinary practitioner who issues an order to a stock food manufacturer to supply a stock food containing a Schedule 4 poison must ensure that the order is in writing and is legible and durable and includes the following—
(a) the name, address and telephone number of the veterinary practitioner issuing the order;
(b) the name and address of the person who owns or has custody or care of the animals and, if different, the consignment address;
(c) the species, age, breed and sex of the animals;
(d) the date on which the order was written and a date not more than 3 months later, when the order expires;
(e) the signature (electronic or otherwise) of the veterinary practitioner issuing the order;
(f) the name and address of the stock food manufacturer;
(g) the name of the Schedule 4 poison that is to be used in the manufactured stock food;
(h) the final concentration of the Schedule 4 poison that is to be in the manufactured stock food;
(i) the quantity of the manufactured stock food required, to a maximum quantity for supply for 3 months;
(j) directions for use;
(k) the time at which the stock food manufacturer is to supply the manufactured stock food containing the Schedule 4 poison.
(2) A veterinary practitioner who issues a written order under subregulation (1) must keep a record of the order for a period of 3 years.
(3) A veterinary practitioner who issues a written order under subregulation (1) must produce it to an authorized officer on a demand made by that officer no more than 3 years after the order was issued.
Ch. 2 Pt 4A (Heading) inserted by S.R. No. 124/2025 reg. 9.
Part 4A—Chart instructions and Aboriginal and Torres Strait Islander health practitioner supply instructions
Ch. 2 Pt 4 Div. 2 (Heading) renumbered as Ch. 2 Pt 4A Div. 1 (Heading) by S.R. No. 124/2025 reg. 9.
Division 1—Chart instructions
28 Persons authorised to write chart instruction on hospital medication chart
(1) A person other than a registered medical practitioner, dentist, nurse practitioner, authorised midwife, authorised optometrist or authorised podiatrist must not write a chart instruction on a hospital medication chart for a Schedule 4 poison.
(2) A person other than a registered medical practitioner, dentist, nurse practitioner or authorised midwife must not write a chart instruction on a hospital medication chart for a Schedule 8 poison.
(3) Nothing in this regulation prohibits a person from writing on a hospital medication chart anything that is not a chart instruction.
29 Persons authorised to write chart instruction on residential medication chart
(1) A person other than a registered medical practitioner, dentist, nurse practitioner, an authorised optometrist or an authorised podiatrist must not write a chart instruction on a residential medication chart for a Schedule 4 poison.
Reg. 29(1A) inserted by S.R. No. 73/2020 reg. 6.
(1A) A person other than a registered medical practitioner, dentist or nurse practitioner must not write a chart instruction on a residential medication chart for a Schedule 8 poison.
(2) Nothing in this regulation prohibits a person from writing on a residential medication chart anything that is not a chart instruction.
Reg. 30 (Heading) amended by S.R. No. 73/2020 reg. 7(1).
30 When registered medical practitioner may write chart instruction on hospital medication chart
Reg. 30 amended by S.R. No. 73/2020 reg. 7(2).
A registered medical practitioner must not write a chart instruction for a Schedule 4 poison or Schedule 8 poison on a hospital medication chart unless—
(a) the instruction is for the medical treatment of a person other than the practitioner; and
(e) if the poison is a drug of dependence or a Schedule 8 poison, the practitioner has taken all reasonable steps to ascertain the identity of the person for whose treatment the instruction is given.
Reg. 30A inserted by S.R. No. 73/2020 reg. 8.
30A When registered medical practitioner may write chart instruction on residential medication chart
A registered medical practitioner must not write a chart instruction on a residential medication chart unless—
(i) the instruction is for the medical treatment of a person other than the practitioner; and
(A) under the practitioner's care; and
(iii) the practitioner has taken all reasonable steps to ensure a therapeutic need exists for that poison; and
(b) in the case of a Schedule 4 poison that is a drug of dependence, or a Schedule 8 poison, the practitioner has taken all reasonable steps to ascertain the identity of the person for whose treatment the instruction is given; and
This regulation prohibits a medical practitioner from writing a chart instruction on a residential medication chart for a Schedule 8 poison if the residential medication chart is in paper form.
Reg. 31 (Heading) amended by S.R. No. 73/2020 reg. 9(1).
31 When dentist may write chart instruction on hospital medication chart
Reg. 31(1) amended by S.R. No. 73/2020 reg. 9(2).
(1) A dentist must not write a chart instruction for methadone on a hospital medication chart.
Reg. 31(2) amended by S.R. No. 73/2020 reg. 9(3)(a).
(2) A dentist must not write a chart instruction for a Schedule 4 poison or Schedule 8 poison on a hospital medication chart unless—
(a) the instruction is for the dental treatment of a person other than the dentist; and
Reg. 31(2)(d) amended by S.R. No. 73/2020 reg. 9(3)(b).
(e) if the poison is a drug of dependence or a Schedule 8 poison, the dentist has taken all reasonable steps to ascertain the identity of the person for whose treatment the instruction is given.
Reg. 31A inserted by S.R. No. 73/2020 reg. 10.
31A When dentist may write chart instruction on residential medication chart
(1) A dentist must not write a chart instruction for methadone on a residential medication chart.
(2) A dentist must not write a chart instruction on a residential medication chart unless—
(i) the instruction is for the dental treatment of a person other than the dentist; and
(A) under the dentist's care; and
(iii) the dentist has taken all reasonable steps to ensure a therapeutic need exists for that poison; and
(b) in the case of a Schedule 4 poison that is a drug of dependence, or a Schedule 8 poison, the dentist has taken all reasonable steps to ascertain the identity of the person for whose treatment the instruction is given; and
This regulation prohibits a dentist from writing a chart instruction on a residential medication chart for a Schedule 8 poison if the residential medication chart is in paper form.
Reg. 32 (Heading) amended by S.R. No. 73/2020 reg. 11(1).
32 When nurse practitioner may write chart instruction on hospital medication chart
Reg. 32 amended by S.R. No. 73/2020 reg. 11(2).
A nurse practitioner must not write a chart instruction for a Schedule 4 poison or Schedule 8 poison on a hospital medication chart unless—
(a) the instruction is for the treatment of a person other than the nurse practitioner; and
(e) if the poison is a drug of dependence or a Schedule 8 poison, the nurse practitioner has taken all reasonable steps to ascertain the identity of the person for whose treatment the instruction is given.
Reg. 32A inserted by S.R. No. 73/2020 reg. 12.
32A When nurse practitioner may write chart instruction on residential medication chart
A nurse practitioner must not write a chart instruction on a residential medication chart unless—
(i) the instruction is for the treatment of a person other than the nurse practitioner; and
(A) under the nurse practitioner's care; and
(iii) the nurse practitioner has taken all reasonable steps to ensure a therapeutic need exists for that poison; and
(b) in the case of a Schedule 4 poison that is a drug of dependence, or a Schedule 8 poison, the nurse practitioner has taken all reasonable steps to ascertain the identity of the person for whose treatment the instruction is given; and
This regulation prohibits a nurse practitioner from writing a chart instruction on a residential medication chart for a Schedule 8 poison if the residential medication chart is in paper form.
33 When authorised midwife may write chart instruction
An authorised midwife must not write a chart instruction for a Schedule 4 poison or Schedule 8 poison on a hospital medication chart unless—
(a) the instruction is for the midwifery treatment of a person other than the midwife; and
(e) if the poison is a drug of dependence or a Schedule 8 poison, the midwife has taken all reasonable steps to ascertain the identity of the person for whose treatment the instruction is given.
34 When authorised optometrist may write chart instruction
An authorised optometrist must not write a chart instruction for a Schedule 4 poison on a hospital medication chart or residential medication chart unless—
(a) the instruction is for the ocular treatment of a person other than the optometrist; and
(e) if the poison is a drug of dependence, the optometrist has taken all reasonable steps to ascertain the identity of the person for whose treatment the instruction is given.
35 When authorised podiatrist may write chart instruction
An authorised podiatrist must not write a chart instruction for a Schedule 4 poison on a hospital medication chart or residential medication chart unless—
(a) the instruction is for the podiatric treatment of a person other than the podiatrist; and
(e) if the poison is a drug of dependence, the podiatrist has taken all reasonable steps to ascertain the identity of the person for whose treatment the instruction is given.
Ch. 2 Pt 4A Div, 2 (Heading and regs 35AA–35AI) inserted by S.R. No. 124/2025 reg. 10.
Division 2—Aboriginal and Torres Strait Islander health practitioner supply instructions
Reg. 35AA inserted by S.R. No. 124/2025 reg. 10.
35AA Persons authorised to give Aboriginal and Torres Strait Islander health practitioner supply instruction
(1) A person other than a registered medical practitioner, a dentist, a nurse practitioner, an authorised midwife, an authorised optometrist or an authorised podiatrist must not give an Aboriginal and Torres Strait Islander health practitioner supply instruction for a Schedule 4 poison.
(2) A person other than a registered medical practitioner, a dentist, a nurse practitioner or an authorised midwife must not give an Aboriginal and Torres Strait Islander health practitioner supply instruction for a Schedule 8 poison.
Reg. 35AB inserted by S.R. No. 124/2025 reg. 10.
35AB Aboriginal and Torres Strait Islander health practitioner supply instruction for Schedule 4 or 8 poison—registered medical practitioner
A registered medical practitioner must not give an Aboriginal and Torres Strait Islander health practitioner supply instruction for a Schedule 4 poison or Schedule 8 poison unless—
(a) the supply instruction is for the medical treatment of a person other than the practitioner; and
(e) if the poison is a drug of dependence or a Schedule 8 poison, the practitioner has taken all reasonable steps to ascertain the identity of the person for whose treatment the supply instruction is given; and
(f) in the case of a Schedule 8 poison, if, under regulation 10, a special Schedule 8 permit is required, the practitioner holds a special Schedule 8 permit that authorises the giving of the supply instruction; and
Reg. 35AC inserted by S.R. No. 124/2025 reg. 10.
35AC Aboriginal and Torres Strait Islander health practitioner supply instruction for Schedule 4 or 8 poison—dentist
A dentist must not give an Aboriginal and Torres Strait Islander health practitioner supply instruction for a Schedule 4 poison or Schedule 8 poison unless—
(a) the supply instruction is for the dental treatment of a person other than the dentist; and
(e) the supply instruction provides only for a single supply of the poison; and
(f) if the poison is a drug of dependence or a Schedule 8 poison, the dentist has taken all reasonable steps to ascertain the identity of the person for whose treatment the supply instruction is given; and
Reg. 35AD inserted by S.R. No. 124/2025 reg. 10.
35AD Aboriginal and Torres Strait Islander health practitioner supply instruction for Schedule 4 or 8 poison—nurse practitioner
A nurse practitioner must not give an Aboriginal and Torres Strait Islander health practitioner supply instruction for a Schedule 4 poison or Schedule 8 poison unless—
(a) the supply instruction is for the treatment of a person other than the nurse practitioner; and
(e) if the poison is a drug of dependence or a Schedule 8 poison, the nurse practitioner has taken all reasonable steps to ascertain the identity of the person for whose treatment the supply instruction is given; and
(f) in the case of a Schedule 8 poison, if, under regulation 10, a special Schedule 8 permit is required, the nurse practitioner holds a special Schedule 8 permit that authorises the giving of the supply instruction; and
Reg. 35AE inserted by S.R. No. 124/2025 reg. 10.
35AE Aboriginal and Torres Strait Islander health practitioner supply instruction for Schedule 4 or 8 poison—authorised midwife
An authorised midwife must not give an Aboriginal and Torres Strait Islander health practitioner supply instruction for a Schedule 4 poison or Schedule 8 poison unless—
(a) the supply instruction is for the midwifery treatment of a person other than the midwife; and
(e) if the poison is a drug of dependence or a Schedule 8 poison, the midwife has taken all reasonable steps to ascertain the identity of the person for whose treatment the supply instruction is given; and
Reg. 35AF inserted by S.R. No. 124/2025 reg. 10.
35AF Aboriginal and Torres Strait Islander health practitioner supply instruction for Schedule 4 poison—authorised optometrist
An authorised optometrist must not give an Aboriginal and Torres Strait Islander health practitioner supply instruction for a Schedule 4 poison unless—
(a) the supply instruction is for the ocular treatment of a person other than the optometrist; and
(e) if the poison is a drug of dependence, the optometrist has taken all reasonable steps to ascertain the identity of the person for whose treatment the supply instruction is given; and
Reg. 35AG inserted by S.R. No. 124/2025 reg. 10.
35AG Aboriginal and Torres Strait Islander health practitioner supply instruction for Schedule 4 poison—authorised podiatrist
An authorised podiatrist must not give an Aboriginal and Torres Strait Islander health practitioner supply instruction for a Schedule 4 poison unless—
(a) the supply instruction is for the podiatric treatment of a person other than the podiatrist; and
(e) if the poison is a drug of dependence, the podiatrist has taken all reasonable steps to ascertain the identity of the person for whose treatment the supply instruction is given; and
Reg. 35AH inserted by S.R. No. 124/2025 reg. 10.
35AH Giving a written Aboriginal and Torres Strait Islander health practitioner supply instruction
(1) An instructing practitioner who gives an Aboriginal and Torres Strait Islander health practitioner supply instruction for a Schedule 4 poison or Schedule 8 poison, other than in the circumstances described in regulation 35AI(1), must give that supply instruction in writing.
(2) An instructing practitioner who gives a written Aboriginal and Torres Strait Islander health practitioner supply instruction for a Schedule 4 poison or Schedule 8 poison must ensure that the supply instruction is in a legible and durable form.
(3) An instructing practitioner who gives a written Aboriginal and Torres Strait Islander health practitioner supply instruction for a Schedule 4 poison or Schedule 8 poison must sign the supply instruction.
(4) An instructing practitioner who gives a written Aboriginal and Torres Strait Islander health practitioner supply instruction for a Schedule 4 poison or Schedule 8 poison must ensure that the supply instruction specifies the following information—
(a) the instructing practitioner's name, address and telephone number;
(b) the name and address of the person to whom the poison is to be supplied;
(c) if the supply instruction is for a Schedule 8 poison, the date of birth of the person to whom the poison is to be supplied;
(d) the date on which the supply instruction is given;
(e) full particulars of the poison to be supplied;
(f) a statement of the quantity to be supplied, which must be written in both words and figures if the supply instruction is for a Schedule 8 poison;
(g) directions for the precise dose or use and frequency of administration except in cases where—
(i) because of the complexity of the dosage regimen or use, it is impracticable to do so and the instructing practitioner has separately supplied the patient with written instruction; or
(ii) a variable dosage regimen is directed and a statement specifying a maximum dose and frequency of administration is included; or
(iii) the administration of the poison is to be carried out by a registered medical practitioner, a pharmacist, a dentist, an authorised optometrist, an authorised podiatrist, a nurse or a registered midwife;
(h) if the supply instruction is for a Schedule 8 poison which may be supplied only once, a statement, using words and not just figures, that there is to be no repeat supply;
(i) if the poison may be supplied more than once, a statement in both words and figures of the maximum number of times the poison may be supplied.
(5) In this regulation—
Reg. 35AI inserted by S.R. No. 124/2025 reg. 10.
35AI Giving a verbal Aboriginal and Torres Strait Islander health practitioner supply instruction in an emergency
(1) An instructing practitioner who gives an Aboriginal and Torres Strait Islander health practitioner supply instruction for a Schedule 4 poison or Schedule 8 poison may give that supply instruction verbally if, in the opinion of the instructing practitioner, an emergency exists.
(2) Within 72 hours after an instructing practitioner gives a verbal Aboriginal and Torres Strait Islander health practitioner supply instruction for a Schedule 4 poison or Schedule 8 poison, the instructing practitioner must—
(a) give a written Aboriginal and Torres Strait Islander health practitioner supply instruction that confirms the verbal instruction; and
(b) include that written confirmation, or provide it for inclusion, in the treatment records of the person for whose treatment the supply instruction is given.
(3) In this regulation—
Part 5—Sale and supply by practitioners other than pharmacists
Reg. 35A inserted by S.R. No. 126/2024 reg. 6.
35A Part does not apply to drug-checking services
A reference in this Part to supply does not include supply authorised by section 20AA(1)(b) or (2)(a) or 22CD(1)(b) of the Act.
36 Sale or supply of Schedule 4, 8 or 9 poison—registered medical practitioner
Reg. 36 amended by S.R. No. 31/2018 reg. 8.
A registered medical practitioner must not sell or supply a Schedule 4 poison, Schedule 8 poison or Schedule 9 poison unless—
(a) that sale or supply is for medical treatment of a person—
(b) the practitioner has taken all reasonable steps to ensure a therapeutic need exists for that poison; and
(d) if the poison is a drug of dependence or a Schedule 8 poison or a Schedule 9 poison, the practitioner has taken all reasonable steps to ascertain the identity of the person for whose treatment the poison is sold or supplied; and
(e) in the case of a Schedule 8 poison, if, under regulation 10, a special Schedule 8 permit is required, the practitioner holds a special Schedule 8 permit that authorises that sale or supply; and
Reg. 36(f) amended by S.R. No. 96/2022 reg. 12.
(f) in the case of a Schedule 9 poison, the practitioner holds a Schedule 9 permit, that authorises that sale or supply.
1 In certain circumstances, sections 34B and 34C of the Act will also prohibit the registered medical practitioner from supplying the Schedule 8 poison without a Schedule 8 permit.
2 If a registered medical practitioner holds a Schedule 9 permit, section 33C of the Act will also prohibit the practitioner from supplying the Schedule 9 poison other than for the period specified in the permit and within the quantity specified in the permit.
Reg. 36A inserted by S.R. No. 61/2023 reg. 10.
36A Supply of Schedule 8 MDMA or Schedule 8 psilocybine—authorised psychedelic psychiatrist and certain registered medical practitioners
(1) An authorised psychedelic psychiatrist must not supply Schedule 8 MDMA or Schedule 8 psilocybine unless the supply is to—
(a) a nurse or nurse practitioner for the purpose of administering the Schedule 8 MDMA or Schedule 8 psilocybine under regulation 98B; or
(b) another registered medical practitioner for the purpose of administering Schedule 8 MDMA or Schedule 8 psilocybine to a person under regulation 98A.
(2) A registered medical practitioner must not supply Schedule 8 MDMA or Schedule 8 psilocybine for another person who is a participant in a clinical trial that is approved by or notified to the Commonwealth Secretary under the Therapeutic Goods Act 1989 of the Commonwealth and is approved by a human research ethics committee unless the supply is to—
(a) a nurse or nurse practitioner for the purpose of administering the Schedule 8 MDMA or Schedule 8 psilocybine under regulation 98B; or
(b) another registered medical practitioner for the purpose of authorising administration or administering Schedule 8 MDMA or Schedule 8 psilocybine to a person under regulation 78A or 98A.
37 Sale or supply of Schedule 4, 8 or 9 poison—dentist
(1) A dentist must not sell or supply—
(a) an ovulatory stimulant; or
(b) a prostaglandin; or
(c) a retinoid; or
(d) thalidomide; or
(e) methadone.
(2) A dentist must not sell or supply a Schedule 4 poison, Schedule 8 poison or Schedule 9 poison unless—
(a) that sale or supply is for dental treatment of a person—
(b) the dentist has taken all reasonable steps to ensure a therapeutic need exists for that poison; and
(d) if the poison is a drug of dependence, a Schedule 8 poison or a Schedule 9 poison the dentist has taken all reasonable steps to ascertain the identity of the person for whose treatment the poison is sold or supplied; and
(e) in the case of a Schedule 9 poison, the dentist holds a general Schedule 9 permit that authorises that sale or supply.
38 Sale or supply of Schedule 4, 8 or 9 poison—veterinary practitioner
A veterinary practitioner must not sell or supply a Schedule 4 poison, Schedule 8 poison or Schedule 9 poison unless—
(a) that sale or supply is for treatment of an animal under the veterinary practitioner's care; and
(b) the animal is owned by, or is in the custody or care of, the person to whom the poison is sold or supplied; and
(c) the veterinary practitioner has taken all reasonable steps to ensure a therapeutic need exists for that poison; and
(d) if the poison is a drug of dependence, Schedule 8 poison or Schedule 9 poison, the veterinary practitioner has taken all reasonable steps to ascertain the identity of the person who owns or has custody or care of the animal for whose treatment the poison is sold or supplied; and
(e) in the case of a Schedule 9 poison, the veterinary practitioner holds a general Schedule 9 permit that authorises that sale or supply.
39 Sale or supply of Schedule 4 or 8 poison—nurse practitioner or authorised registered nurse
A nurse practitioner or authorised registered nurse must not sell or supply a Schedule 4 poison or Schedule 8 poison unless—
(a) that sale or supply is for treatment that is—
(i) treatment of a person under the practitioner or nurse's care; and
(ii) treatment of the person to whom the poison is sold or supplied; and
(b) the practitioner or nurse has taken all reasonable steps to ensure a therapeutic need exists for that poison; and
(d) if the poison is a drug of dependence or a Schedule 8 poison, the practitioner or nurse has taken all reasonable steps to ascertain the identity of the person for whose treatment the poison is sold or supplied; and
(e) in the case of a Schedule 8 poison, if, under regulation 10, a special Schedule 8 permit is required, the nurse practitioner holds a special Schedule 8 permit that authorises the sale or supply.
In certain circumstances, sections 34B and 34C of the Act will also prohibit the nurse practitioner from supplying the Schedule 8 poison without a Schedule 8 permit.
Reg. 39A inserted by S.R. No. 13/2021 reg. 8.
39A Sale or supply of Schedule 4 or 8 poison—approved registered nurse
(1) An approved registered nurse is authorised to sell or supply a Schedule 4 poison or Schedule 8 poison if—
(a) that sale or supply is for treatment that is—
(i) treatment of a person under the nurse's care; and
(ii) treatment of the person to whom the poison is sold or supplied; and
(b) the nurse has taken all reasonable steps to ensure a therapeutic need exists for that poison; and
(d) if the poison is a drug of dependence or a Schedule 8 poison, the nurse has taken all reasonable steps to ascertain the identity of the person for whose treatment the poison is sold or supplied; and
(e) the sale or supply is in accordance with an approval under regulation 161A.
(2) An approved registered nurse must not sell or supply a Schedule 4 poison or Schedule 8 poison other than in accordance with subregulation (1).
40 Sale or supply of Schedule 4 or 8 poison—authorised midwife
An authorised midwife must not sell or supply a Schedule 4 poison or Schedule 8 poison unless—
(a) that sale or supply is for the midwifery treatment of a person under the midwife's care; and
(e) if the poison is a drug of dependence or a Schedule 8 poison, the midwife has taken all reasonable steps to ascertain the identity of the person for whose treatment the poison is sold or supplied.
Reg. 40A inserted by S.R. No. 13/2021 reg. 9.
40A Sale or supply of Schedule 4 or 8 poison—approved registered midwife
(1) An approved registered midwife is authorised to sell or supply a Schedule 4 poison or Schedule 8 poison if—
(a) that sale or supply is for the midwifery treatment of a person under the midwife's care; and
(e) if the poison is a drug of dependence or a Schedule 8 poison, the midwife has taken all reasonable steps to ascertain the identity of the person for whose treatment the poison is sold or supplied; and
(f) the sale or supply is in accordance with an approval under regulation 161A.
(2) An approved registered midwife must not sell or supply a Schedule 4 poison or Schedule 8 poison other than in accordance with subregulation (1).
41 Sale or supply of Schedule 4 poison—authorised optometrist
An authorised optometrist must not sell or supply a Schedule 4 poison unless—
(a) that sale or supply is for the ocular treatment of a person under the optometrist's care; and
(e) if the poison is a drug of dependence, the optometrist has taken all reasonable steps to ascertain the identity of the person for whose treatment the poison is sold or supplied.
42 Sale or supply of Schedule 4 poison—authorised podiatrist
An authorised podiatrist must not sell or supply a Schedule 4 poison unless—
(a) that sale or supply is for the podiatric treatment of a person under the podiatrist's care; and
(e) if the poison is a drug of dependence, the podiatrist has taken all reasonable steps to ascertain the identity of the person for whose treatment the poison is sold or supplied.
Reg. 42A inserted by S.R. No. 124/2025 reg. 11.
42A Supply of Schedule 4 poison—registered Aboriginal and Torres Strait Islander health practitioner
(1) A registered Aboriginal and Torres Strait Islander health practitioner must not sell or supply a Schedule 4 poison other than in accordance with subregulation (2).
(2) A registered Aboriginal and Torres Strait Islander health practitioner may supply a Schedule 4 poison to a person specified in an Aboriginal and Torres Strait Islander health practitioner supply instruction that is given by a registered medical practitioner, a dentist, a nurse practitioner, an authorised midwife, an authorised optometrist or an authorised podiatrist if—
(a) the supply is in accordance with—
(i) that supply instruction; and
(b) the supply is within 12 months after the supply instruction is given.
Reg. 42B inserted by S.R. No. 124/2025 reg. 11.
42B Supply of Schedule 8 poison—registered Aboriginal and Torres Strait Islander health practitioner
(1) A registered Aboriginal and Torres Strait Islander health practitioner must not sell or supply a Schedule 8 poison other than in accordance with subregulation (2).
(2) A registered Aboriginal and Torres Strait Islander health practitioner may supply a Schedule 8 poison to a person specified in an Aboriginal and Torres Strait Islander health practitioner supply instruction that is given by a registered medical practitioner, a dentist, a nurse practitioner or an authorised midwife if—
(a) the supply is in accordance with—
(i) that supply instruction; and
(b) the supply is within 6 months after the supply instruction is given.
Reg. 42C inserted by S.R. No. 124/2025 reg. 11.
42C Restrictions on registered Aboriginal and Torres Strait Islander health practitioner supplying Schedule 4 or 8 poison
(1) A registered Aboriginal and Torres Strait Islander health practitioner must not supply a Schedule 4 poison or Schedule 8 poison on an Aboriginal and Torres Strait Islander health practitioner supply instruction if the practitioner has reason to believe that the supply instruction—
(a) has been forged or is fraudulent in any way; or
(b) has been altered in any way other than by, or on the instruction of, the instructing practitioner who gave the supply instruction.
(2) A registered Aboriginal and Torres Strait Islander health practitioner must not supply a Schedule 4 poison or Schedule 8 poison on an Aboriginal and Torres Strait Islander health practitioner supply instruction if the supply instruction is—
(a) illegible or defaced; or
(b) not written in a durable form.
(3) A registered Aboriginal and Torres Strait Islander health practitioner who supplies a Schedule 4 poison or Schedule 8 poison on an Aboriginal and Torres Strait Islander health practitioner supply instruction must ensure that the supply instruction is marked durably in a way that indicates—
(4) In this regulation—
43 Poison not to be sold or supplied unless supplementary labelling requirements complied with
(1) A person must not sell or supply a Schedule 4 poison, Schedule 8 poison or Schedule 9 poison in accordance with this Part unless the container in which the poison is packed complies with the supplementary labelling requirements.
See also section 27A of the Act.
(2) Subregulation (1) does not apply to a veterinary practitioner selling or supplying a Schedule 4 poison in bulk transport for treatment of animals if the veterinary practitioner provides written instructions containing the information specified in the supplementary labelling requirements to the owner of, or the person having care or custody of, the animals.
44 Notification of fraudulent obtaining of poison
(1) A registered medical practitioner, veterinary practitioner or dentist who suspects or has reason to believe that a person has obtained from the practitioner by means of a false pretence a Schedule 9 poison, Schedule 8 poison or Schedule 4 poison must immediately inform the Secretary and a police officer of that suspicion or belief.
(2) A nurse practitioner or an authorised midwife who suspects or has reason to believe that a person has obtained from the practitioner or midwife by means of a false pretence a Schedule 8 poison or Schedule 4 poison must immediately inform the Secretary and a police officer of that suspicion or belief.
(3) An authorised optometrist or authorised podiatrist who suspects or has reason to believe that a person has obtained from the optometrist or podiatrist by means of a false pretence a Schedule 4 poison must immediately inform the Secretary and a police officer of that suspicion or belief.
(4) An authorised registered nurse who suspects or has reason to believe that a person has obtained from the nurse by means of a false pretence a Schedule 8 poison or Schedule 4 poison must immediately inform the Secretary and a police officer of that suspicion or belief.
Reg. 44(5) inserted by S.R. No. 13/2021 reg. 10.
(5) An approved registered nurse or approved registered midwife who suspects or has reason to believe that a person has obtained from the nurse or midwife by means of a false pretence a Schedule 8 poison or Schedule 4 poison must immediately inform the Secretary and a police officer of that suspicion or belief.
Reg. 44(6) inserted by S.R. No. 124/2025 reg. 12.
(6) A registered Aboriginal and Torres Strait Islander health practitioner who suspects or has reason to believe that a person has obtained from the practitioner by means of a false pretence a Schedule 8 poison or Schedule 4 poison must immediately inform the Secretary and a police officer of that suspicion or belief.
Part 6—Sale and supply by pharmacists
Division 1—Circumstances of sale or supply
Reg. 44A inserted by S.R. No. 126/2024 reg. 7.
44A Part does not apply to drug-checking services
A reference in this Part to supply does not include supply authorised by section 20AA(1)(b) or (2)(a) or 22CD(1)(b) of the Act.
45 Sale or supply of drug of dependence by pharmacist other than by wholesale or on prescription or chart instruction
(1) A pharmacist must not supply a drug of dependence (other than by wholesale or on a prescription or a chart instruction) unless—
(a) the pharmacist has taken all reasonable steps to—
(i) ascertain the identity of the person to or for whom it is proposed to supply the drug of dependence; and
(ii) ensure a therapeutic need for the drug of dependence exists; and
(b) the supply is only for the therapeutic use of the drug of dependence by the person to or for whom it is proposed to supply the drug of dependence.
(2) A pharmacist must not supply a drug of dependence for an animal (other than by wholesale or on a prescription) unless—
(a) the pharmacist has taken all reasonable steps to ensure a therapeutic need for the drug of dependence exists; and
(b) the supply is only for the therapeutic use of the drug of dependence for that animal.
Reg. 46 substituted by S.R. No. 96/2022 reg. 13.
46 Wholesale supply of Schedule 9 poison by pharmacist to another pharmacist
A pharmacist must not sell or supply a Schedule 9 poison to another pharmacist for use by the other pharmacist in the lawful practice of that pharmacist's profession unless the sale or supply is—
(a) sale or supply in accordance with an instruction from a registered medical practitioner who holds a Schedule 9 permit in which the Schedule 9 poison is specified; or
(b) sale or supply in accordance with an instruction from a dentist or veterinary practitioner who holds a general Schedule 9 permit in which the Schedule 9 poison is specified.
47 Sale or supply of Schedule 4 poison by pharmacist
(1) A pharmacist must not sell or supply a Schedule 4 poison unless that sale or supply is—
(a) subject to regulation 50, sale or supply—
(i) on an original prescription of a registered medical practitioner, veterinary practitioner, dentist, nurse practitioner, authorised midwife, authorised optometrist or authorised podiatrist; or
(ii) if the original prescription is required to be submitted to a public authority by any Act of a State or Territory or the Commonwealth, on a copy of a prescription referred to in subparagraph (i) certified by, or accompanied by a certification from, a pharmacist who has previously received the prescription; or
Reg. 47(1)(b) amended by S.R. No. 20/2023 reg. 7.
(b) sale or supply in accordance with a verbal instruction given under regulation 25(1), (2) or (3) or a digital image of an original prescription transmitted under regulation 25A(1), (2) or (3).; or
(c) subject to regulation 54, sale or supply to a patient in or at a hospital or day procedure centre in accordance with a chart instruction given on a hospital medication chart; or
(d) subject to regulation 55, sale or supply to a resident in accordance with a chart instruction given on a residential medication chart; or
(e) subject to regulation 56, sale or supply in an emergency in which the pharmacist considers it necessary to ensure continuity of treatment; or
(f) subject to regulation 57, sale or supply in circumstances where the pharmacist considers it necessary to ensure continuity of treatment; or
Reg. 47(1)(g) substituted by S.R. No. 13/2021 reg. 11.
(g) sale or supply in accordance with an order of—
(v) an authorised registered nurse; or
(vi) an approved registered nurse; or
(vii) an authorised midwife; or
(viii) an approved registered midwife; or
(ix) an authorised optometrist; or
(x) an authorised podiatrist; or
(h) sale or supply on the order of a person holding a permit for the poison; or
Reg. 47(1)(i) amended by S.R. No. 105/2023 reg. 4(1).
(i) sale or supply to a person referred to in Column 1 of Part 2 of the Table in regulation 7 to the extent and for the purpose referred to in Column 2 of that Part of that Table; or
Reg. 47(1)(j) inserted by S.R. No. 105/2023 reg. 4(2).
(j) sale or supply in accordance with regulation 57A.
(2) This regulation does not apply to the sale or supply of a Schedule 4 poison to another pharmacist for use by the other pharmacist in the lawful practice of that pharmacist's profession.
48 Sale or supply of Schedule 8 poison by pharmacist
(1) A pharmacist must not sell or supply a Schedule 8 poison unless that sale or supply is—
(a) subject to regulation 51, sale or supply—
(i) on an original prescription of a registered medical practitioner, veterinary practitioner, dentist, nurse practitioner or authorised midwife; or
(ii) if the original prescription is required to be submitted to a public authority by any Act of a State or Territory or the Commonwealth, on a copy of a prescription referred to in subparagraph (i) certified by, or accompanied by a certification from, a pharmacist who has previously received the prescription; or
Reg. 48(1)(b) amended by S.R. No. 20/2023 reg. 8.
(b) sale or supply in accordance with a verbal instruction given under regulation 25(1) or (2) or a digital image of an original prescription transmitted under regulation 25A(1) or (2).; or
(c) subject to regulation 54, sale or supply to a patient in or at a hospital or day procedure centre in accordance with a chart instruction given on a hospital medication chart; or
Reg. 48(1)(ca) inserted by S.R. No. 73/2020 reg. 13.
(ca) subject to regulation 55A, sale or supply to a resident in accordance with a chart instruction given on a residential medication chart that is an electronic medication chart; or
Reg. 48(1)(d) substituted by S.R. No. 13/2021 reg. 12.
(d) sale or supply in accordance with an order of—
(v) an authorised registered nurse; or
(vi) an approved registered nurse; or
(vii) an authorised midwife; or
(viii) an approved registered midwife; or
(e) sale or supply on the order of a person holding a permit for the poison; or
Reg. 48(1)(ea) inserted by S.R. No. 61/2023 reg. 11.
(ea) if the poison is Schedule 8 MDMA or Schedule 8 psilocybine, the sale or supply is to—
(i) an authorised psychedelic psychiatrist who has—
(A) issued a prescription for the Schedule 8 MDMA or Schedule 8 psilocybine and the sale or supply is on that original prescription; or
(B) issued a written instruction or given a verbal instruction in respect of the Schedule 8 MDMA or Schedule 8 psilocybine; or
(ii) a registered medical practitioner, nurse practitioner or nurse authorised by an authorised psychedelic psychiatrist referred to in subparagraph (i) to act on the psychiatrist's behalf; or
(iii) a registered medical practitioner who has—
(A) issued a prescription for the Schedule 8 MDMA or the Schedule 8 psilocybine for another person who is a participant in a clinical trial and the clinical trial is approved by or notified to the Commonwealth Secretary under the Therapeutic Goods Act 1989 of the Commonwealth and approved by a human research ethics committee and the sale or supply is on that original prescription; or
(B) issued a written instruction or given a verbal instruction in respect of the Schedule 8 MDMA or Schedule 8 psilocybine for another person who is a participant in a clinical trial that is approved by or notified to the Commonwealth Secretary under the Therapeutic Goods Act 1989 of the Commonwealth and approved by a human research ethics committee; or
(iv) a registered medical practitioner, nurse practitioner or nurse authorised by a registered medical practitioner referred to in subparagraph (iii) to act on the medical practitioner's behalf; or
(f) sale or supply to a person referred to in Column 1 of Part 2 of the Table in regulation 7 to the extent referred to in Column 2 of that Part of that Table.
(2) This regulation does not apply to the sale or supply of a Schedule 8 poison to another pharmacist for use by the other pharmacist in the lawful practice of that pharmacist's profession.
49 Sale or supply of Schedule 9 poison by pharmacist
Reg. 49(1) substituted by S.R. No. 96/2022 reg. 14.
(1) A pharmacist must not sell or supply a Schedule 9 poison unless—
(a) the sale or supply is in accordance with an instruction from a registered medical practitioner who holds a Schedule 9 permit in which the Schedule 9 poison is specified; or
(b) the sale or supply is in accordance with an instruction from a dentist or veterinary practitioner who holds a general Schedule 9 permit in which the Schedule 9 poison is specified; or
Reg. 49(1)(c) amended by S.R. No. 20/2023 reg. 9.
(c) subject to regulation 52, the sale or supply is in accordance with an original prescription or a digital image of an original prescription transmitted under regulation 25A(1) of—
(i) a registered medical practitioner who holds a Schedule 9 permit in which the Schedule 9 poison is specified; or
(ii) a veterinary practitioner or dentist who holds a general Schedule 9 permit in which the Schedule 9 poison is specified.
(2) This regulation does not apply to the sale or supply of a Schedule 9 poison to another pharmacist for use by the other pharmacist in the lawful practice of that pharmacist's profession.
50 Restrictions on pharmacist selling or supplying Schedule 4 poison on prescription
(1) This regulation applies in relation to a pharmacist selling or supplying a Schedule 4 poison on a prescription that is—
Reg. 50(1)(b) amended by S.R. No. 20/2023 reg. 10(1).
Reg. 50(2) amended by S.R. No. 20/2023 reg. 10(2).
(2) A pharmacist must not sell or supply a Schedule 4 poison on a prescription if it is more than 12 months since the date stated on the prescription as the day on which the prescription was written.
Reg. 50(3) amended by S.R. No. 20/2023 reg. 10(3).
(3) A pharmacist must not sell or supply a Schedule 4 poison on a prescription if—
Reg. 50(3)(ba) inserted by S.R. No. 31/2018 reg. 9.
(c) the Schedule 4 poison has already been sold or supplied on that prescription in the quantity that is permitted by the instructions written on the prescription.
Reg. 50(4) amended by S.R. No. 20/2023 reg. 10(4).
(4) Other than in the exceptional circumstances set out in regulation 53, a pharmacist must not sell or supply a Schedule 4 poison on a prescription contrary to the instructions written on the prescription, including by—
(c) if the prescription specifies that only a specific brand of the poison is to be supplied, supplying a different brand.
51 Restrictions on pharmacist selling or supplying Schedule 8 poison on prescription
(1) This regulation applies in relation to a pharmacist selling or supplying a Schedule 8 poison on a prescription that is—
Reg. 51(1)(b) amended by S.R. No. 20/2023 reg. 11(1).
Reg. 51(2) amended by S.R. No. 20/2023 reg. 11(2).
(2) A pharmacist must not sell or supply a Schedule 8 poison in a quantity that allows for more than 2 days' treatment unless—
(a) the prescription is handwritten and—
(i) the pharmacist is familiar with the purported prescriber's handwriting; and
(ii) the writing on the prescription is comparable to the usual writing of the purported prescriber; or
(b) the pharmacist has taken all reasonable steps to verify that the prescription was written by the purported prescriber.
Regulation 63 requires a pharmacist to retain a prescription for a Schedule 8 poison if the pharmacist cannot verify that the prescription was written by the purported prescriber and supplies a lesser quantity.
Reg. 51(3) amended by S.R. No. 20/2023 reg. 11(3).
(3) A pharmacist must not sell or supply a Schedule 8 poison on a prescription if it is more than 6 months since the date stated on the prescription as the day on which the prescription was written.
Reg. 51(4) amended by S.R. No. 20/2023 reg. 11(4).
(4) A pharmacist must not sell or supply a Schedule 8 poison on a prescription if—
Reg. 51(4)(ba) inserted by S.R. No. 31/2018 reg. 10.
(c) the Schedule 8 poison has already been sold or supplied on that prescription in the quantity that is permitted by the instructions written on the prescription.
Reg. 51(5) amended by S.R. No. 20/2023 reg. 11(5).
(5) Other than in the exceptional circumstances set out in regulation 53, a pharmacist must not sell or supply a Schedule 8 poison on a prescription contrary to the instructions written on the prescription, including by—
(c) if the prescription specifies that only a specific brand of the poison is to be supplied, supplying a different brand.
52 Restrictions on pharmacist selling or supplying Schedule 9 poison on prescription
Reg. 52(1) substituted by S.R. No. 20/2023 reg. 12(1).
(1) This regulation applies in relation to a pharmacist selling or supplying a Schedule 9 poison on a prescription that is—
Reg. 52(2) amended by S.R. No. 20/2023 reg. 12(2).
(2) A pharmacist must not sell or supply a Schedule 9 poison unless—
(a) the prescription is handwritten and—
(i) the pharmacist is familiar with the purported prescriber's handwriting; and
(ii) the writing on the prescription is comparable to the usual writing of the purported prescriber; or
(b) the pharmacist has taken all reasonable steps to verify that the prescription was written by the purported prescriber.
Reg. 52(3) amended by S.R. No. 20/2023 reg. 12(3).
(3) A pharmacist must not sell or supply a Schedule 9 poison on a prescription if it is more than 6 months since the date stated on the prescription as the day on which the prescription was written.
Reg. 52(4) amended by S.R. No. 20/2023 reg. 12(4).
(4) A pharmacist must not sell or supply a Schedule 9 poison on a prescription if—
Reg. 52(4)(ba) inserted by S.R. No. 31/2018 reg. 11.
(c) the Schedule 9 poison has already been sold or supplied on that prescription in the quantity that is permitted by the instructions written on the prescription.
Reg. 52(5) amended by S.R. No. 20/2023 reg. 12(5).
(5) A pharmacist must not sell or supply a
Schedule 9 poison on a prescription contrary to the instructions written on the prescription, including by—
(c) if the prescription specifies that only a specific brand of the poison is to be supplied, supplying a different brand.
53 Exceptional circumstances in which pharmacist may sell or supply Schedule 4 poison or Schedule 8 poison contrary to instructions on prescription
For the purposes of regulations 50(4) and 51(5), the exceptional circumstances in which a pharmacist may sell or supply a Schedule 4 poison or Schedule 8 poison on a prescription or a copy of a prescription but contrary to the instructions written on the prescription are the following—
(a) the supply is consistent with a further verbal or written instruction given by the prescriber;
(b) a departure from those instructions is requested by or on behalf of the person named on the prescription and—
(i) the pharmacist has taken reasonable steps to contact the prescriber but has been unable to do so; and
(ii) the pharmacist is satisfied that not to depart from the prescription as requested would impose an unreasonable difficulty or inconvenience on the patient; and
(iii) the pharmacist has taken all reasonable steps to ensure that supplying the poison as requested would not represent an unacceptable risk to the health and safety of the patient; and
(iv) the supply does not result in the poison being provided in a quantity that is greater than the quantity requested (if any) by or on behalf of the person named in the prescription;
(c) at the time that the prescription is presented, it is not reasonably practicable for the pharmacist to comply with the instructions written on the prescription and—
(i) the pharmacist has taken reasonable steps to contact the prescriber but has been unable to do so; and
(ii) the patient consents to the departure from the instructions; and
(iii) the pharmacist has taken all reasonable steps to ensure that supplying the poison in that manner would not represent an unacceptable risk to the health and safety of the patient.
1 Regulations 50(4) and 51(5) prohibit a pharmacist from selling or supplying a Schedule 4 poison or Schedule 8 poison on a prescription contrary to the instructions written on the prescription other than in the exceptional circumstances set out in this provision.
2 Regulation 68 requires that the pharmacist notify the prescriber and make a record of sale or supply in the circumstances set out in paragraphs (b) and (c).
54 Sale or supply of Schedule 4 poison or Schedule 8 poison in accordance with hospital medication chart
For the purposes of regulations 47(1)(c) and 48(1)(c), a pharmacist may supply a Schedule 4 poison or Schedule 8 poison to a patient in or at a hospital or day procedure centre in accordance with a chart instruction given on a hospital medication chart if—
(a) the pharmacist has seen the material that, under regulation 45(2) of the Commonwealth Regulations, an approved supplier must see before supplying a pharmaceutical benefit on the basis of a medication chart prescription; and
(b) the supply is to be undertaken by the pharmacist in the course of the pharmacist's practice at a pharmacy or pharmacy department connected to the hospital or day procedure centre.
Regulation 61 requires the pharmacist to mark the hospital medication chart on supplying the poison.
55 Sale or supply of Schedule 4 poison in accordance with residential medication chart
For the purposes of regulation 47(1)(d), a pharmacist may supply a Schedule 4 poison to a resident in accordance with a chart instruction given on a residential medication chart if the pharmacist has seen the material that, under regulation 45(2) of the Commonwealth Regulations, an approved supplier must see before supplying a pharmaceutical benefit on a medication chart prescription.
Regulation 62 requires the pharmacist to mark the residential medication chart on supplying the poison.
Reg. 55A inserted by S.R. No. 73/2020 reg. 14.
55A Sale or supply of Schedule 8 poison in accordance with residential medication chart that is an electronic medication chart
For the purposes of regulation 48(1)(ca), a pharmacist may supply a Schedule 8 poison to a resident in accordance with a chart instruction given on a residential medication chart that is an electronic medication chart, if the pharmacist has seen the material that, under regulation 45(2) of the Commonwealth Regulations, an approved supplier must see before supplying a pharmaceutical benefit on a medication chart prescription.
56 Sale or supply of Schedule 4 poison by pharmacist in emergency
For the purposes of regulation 47(1)(e), a pharmacist may sell or supply a Schedule 4 poison without a prescription in an emergency if—
(a) the pharmacist considers that the sale or supply is necessary to ensure continuity of treatment; and
(b) the pharmacist is satisfied that—
(i) there is an immediate need for the poison and it is impracticable for the patient to obtain a prescription in time to meet that need; and
Reg. 56(b)(ii) amended by S.R. No. 31/2018 reg. 12.
(ii) treatment with the poison has previously been provided for by a prescription issued, or a chart instruction written for the patient by a registered medical practitioner, dentist, nurse practitioner, authorised midwife, authorised optometrist or authorised podiatrist; and
(iii) the patient, or an agent of the patient, or a person who has the care of the patient, or a person who is assisting in the care of the patient, is aware of the appropriate dose of that poison for that patient; and
(c) the quantity supplied does not exceed—
(i) 3 days' supply; or
(ii) if it is not practical to supply a quantity required for 3 days, the smallest commercially available pack; and
(d) the sale or supply would not continue treatment that has already been continued by the pharmacist selling or supplying the poison to the patient under this regulation.
57 Sale or supply of Schedule 4 poison by pharmacist for continuity of treatment
For the purposes of regulation 47(1)(f), a pharmacist may sell or supply a Schedule 4 poison to a person without a prescription if—
(a) the pharmacist considers that the sale or supply is necessary to ensure continuity of treatment; and
Reg. 57(b) amended by S.R. No. 112/2022 reg. 6.
(b) the Schedule 4 poison is listed in the National Health (Continued Dispensing) Determination 2022; and
Reg. 57(c) amended by S.R. No. 112/2022 reg. 6.
(c) the sale or supply complies with the conditions in the National Health (Continued Dispensing) Determination 2022; and
(d) the Minister has approved under regulation 159 the sale or supply of that poison without a prescription; and
(e) the pharmacist has not previously sold or supplied the Schedule 4 poison to the patient in accordance with this regulation in the previous 12 months.
Reg. 57A inserted by S.R. No. 105/2023 reg. 5.
57A Sale or supply of Schedule 4 poison by pharmacist for treatment of a person under the pharmacist's care without prescription or other instruction or authorisation
For the purposes of regulation 47(1)(j), a pharmacist may sell or supply a Schedule 4 poison without a prescription or other instruction or authorisation referred to in regulation 47(1)(a) to (i) if—
(a) that sale or supply is for treatment of a person—
(i) under the pharmacist's care; and
(b) the pharmacist has taken all reasonable steps to ensure a therapeutic need exists for the poison; and
(c) the Secretary has approved the poison under regulation 163A(1); and
(d) the sale or supply complies with the conditions specified in the approval (if any).
58 Poison not to be sold or supplied unless supplementary labelling requirements complied with
(1) A pharmacist must not sell or supply a Schedule 4 poison, Schedule 8 poison or Schedule 9 poison in accordance with this Part unless the container in which the poison is packed complies with the supplementary labelling requirements.
See also section 27A of the Act.
(2) Subregulation (1) does not apply to sale or supply by wholesale.
(3) Subregulation (1) does not apply to sale or supply of a Schedule 4 poison—
(a) in accordance with an order of a registered medical practitioner, veterinary practitioner, dentist, nurse practitioner, authorised midwife, authorised optometrist or authorised podiatrist; or
(b) on the order of a person holding a permit for the poison; or
(c) to a person referred to in Column 1 of Part 2 of the Table in regulation 7 to the extent and for the purpose referred to in Column 2 of that Part of that Table.
(4) Subregulation (1) does not apply to sale or supply of a Schedule 8 poison—
(a) in accordance with an order of a registered medical practitioner, veterinary practitioner, dentist, nurse practitioner or authorised midwife; or
(b) on the order of a person holding a permit for the poison; or
(c) to a person referred to in Column 1 of Part 2 of the Table in regulation 7 to the extent referred to in Column 2 of that Part of that Table.
Division 2—Duties of pharmacist relating to sale or supply
59 Division does not authorise supply on copy of prescription
Nothing in this Division authorises a pharmacist to supply a Schedule 4 poison or Schedule 8 poison on a copy of a prescription.
Provisions in Division 1 of this Part authorise pharmacists to sell or supply Schedule 4 poisons and Schedule 8 poisons on copies of prescriptions in certain circumstances. See regulations 47(1)(a)(ii) and 48(1)(a)(ii).
60 Pharmacist must mark prescription
(1) A pharmacist who supplies a Schedule 4 poison or Schedule 8 poison on a prescription or a copy of a prescription must ensure that the prescription or copy is marked in a durable form in a way that indicates—
(2) A pharmacist who supplies a Schedule 9 poison on a prescription must ensure that the prescription is marked in a durable form in a way that indicates—
61 Pharmacist must mark hospital medication chart after supplying Schedule 4 or 8 poison on chart instruction
A pharmacist who supplies a Schedule 4 poison or Schedule 8 poison on a chart instruction given on a hospital medication chart must ensure that the chart is marked durably in a way that indicates—
Reg. 62 (Heading) amended by S.R. No. 73/2020 reg. 15(1).
62 Pharmacist must mark residential medication chart after supplying Schedule 4 or 8 poison on chart instruction
Reg. 62 amended by S.R. No. 73/2020 reg. 15(2).
A pharmacist who supplies a Schedule 4 poison or Schedule 8 poison on a chart instruction given on a residential medication chart must ensure that the chart is marked durably in a way that indicates—
63 Pharmacist must retain prescription for Schedule 8 poison when supplying without verifying the prescriber
A pharmacist who supplies a Schedule 8 poison in a quantity that allows for not more than 2 days' treatment must retain the prescription if the pharmacist—
(a) does not recognise the handwriting in which the prescription is written as being the purported prescriber's handwriting; and
(b) after taking reasonable steps, cannot verify that the prescription was written by the purported prescriber.
64 Pharmacist must retain or further mark prescriptions for Schedule 8 poisons
(1) This regulation applies if a pharmacist supplies a Schedule 8 poison in accordance with any of the following—
(a) a prescription;
(b) a copy of a prescription;
(c) an order of a registered medical practitioner, veterinary practitioner, dentist, nurse practitioner or an authorised midwife.
(2) If the prescription, copy or order does not authorise any further quantity of the Schedule 8 poison, the pharmacist must—
(a) retain, in a manner that maintains its integrity—
(i) the prescription, copy or order; or
(ii) if the pharmacist is required, by an Act of a State, a Territory or the Commonwealth, to submit the prescription, copy or order to a public authority, a legible copy of it; or
(b) if there are other poisons or controlled substances that may still be legally supplied on the prescription, copy or order, ensure that it is durably marked in such a way that it can be clearly seen that further supplies of the Schedule 8 poison are not allowed.
65 Pharmacist must retain or further mark prescriptions for Schedule 9 poisons
If a pharmacist supplies a Schedule 9 poison on a prescription or order of a registered medical practitioner, veterinary practitioner or dentist and the prescription or order does not authorise any further quantity of the Schedule 9 poison, the pharmacist must—
(a) retain the prescription or order in a manner that maintains its integrity; or
(b) if there are other poisons or controlled substances that may still be legally supplied on the prescription or order, ensure that it is durably marked in such a way that it can be clearly seen that further supplies of the Schedule 9 poison are not allowed.
66 Manner of retention of prescriptions retained after last supply is made
(1) A pharmacist who retains a prescription, a copy of a prescription, or an order under regulation 64(2)(a) or 65 must retain it—
(a) on a file kept solely for the purpose of retaining prescriptions, copies or orders; and
(b) for a period of 3 years from the date of the supply in respect of which it is required to be retained.
(2) A pharmacist must produce a prescription, a copy of a prescription, or an order referred to in subregulation (1) on demand to an authorized officer.
67 Pharmacist must produce prescriptions kept under Commonwealth Regulations
A pharmacist who is required by the Commonwealth Regulations to retain a prescription for a Schedule 4 poison must
produce the prescription on demand to an authorized officer.
68 Pharmacist must notify prescriber if prescription departed from
A pharmacist who sells or supplies a Schedule 4 poison or Schedule 8 poison on a prescription or a copy of a prescription but contrary to the instructions written on the prescription in the exceptional circumstances set out in regulation 53(b) or (c) must—
(a) inform the prescriber about the sale or supply as soon as practicable after the poison is sold or supplied; and
(b) make a record to confirm that the exceptional circumstances in regulation 53(b) or (c) existed in relation to that supply.
69 Notification of fraudulent obtaining of poison
A pharmacist who suspects or has reason to believe that a person has obtained or attempted to obtain from the pharmacist by means of a false pretence a Schedule 9 poison, Schedule 8 poison or Schedule 4 poison must immediately inform the Secretary and a police officer of that suspicion or belief.
70 Pharmacist must notify different authorised prescribers of similar supply of certain Schedule 4 or 8 poisons
(1) This regulation applies in relation to a prescription, or a copy of a prescription, for the treatment of a person (the patient) with a poison (the specified poison) that is—
(a) a Schedule 4 poison that is also a drug of dependence; or
(b) a Schedule 8 poison.
(2) If a pharmacist who is presented with the prescription or copy has reason to believe that the patient was supplied in the last 8 weeks with the same specified poison, or a similar poison or controlled substance, on a prescription or copy written by a different prescriber, the pharmacist must, as soon as practicable after being presented with the prescription or copy, take all reasonable steps to inform the person who wrote the current prescription of that previous supply unless the pharmacist has reason to believe that person is already aware.
(3) If a pharmacist who is presented with the prescription or copy is at that time also presented with another prescription or copy for the treatment of the patient with the same specified poison, or a similar poison or controlled substance, and that other prescription or copy is written by a different prescriber, the pharmacist must, as soon as practicable after being presented with the prescription, take all reasonable steps to inform the persons who wrote each prescription of the presentation of both prescriptions unless the pharmacist has reason to believe each of those persons is already aware.
71 Pharmacist must notify different authorised prescribers of similar supply—Schedule 9 poisons
(1) This regulation applies in relation to a prescription for the treatment of a person (the patient) with a Schedule 9 poison (the specified poison).
(2) If a pharmacist who is presented with the prescription has reason to believe that the patient was supplied in the last 8 weeks with the same specified poison, or a similar poison or controlled substance, on a prescription written by a different prescriber, the pharmacist must, as soon as practicable after being presented with the prescription, take all reasonable steps to inform the person who wrote the current prescription of that previous supply unless the pharmacist has reason to believe that person is already aware.
(3) If a pharmacist who is presented with the prescription is at that time also presented with another prescription for the treatment of the patient with the same specified poison, or a similar poison or controlled substance, and that other prescription is written by a different prescriber, the pharmacist must, as soon as practicable after being presented with the prescription, take all reasonable steps to inform the persons who wrote each prescription of the presentation of both prescriptions unless the pharmacist has reason to believe each of those persons is already aware.
Part 7—Labelling and storage
Division 1—Labelling
72 Supplementary labelling requirements
The supplementary labelling requirements for the sale or supply of a Schedule 4 poison, Schedule 8 poison or Schedule 9 poison are that the container in which the poison is packed must be labelled—
(a) if the poison is for the treatment of an animal—
(i) with the species, age, breed and sex of the animal; and
(ii) with the name of the person who owns or has custody or care of the animal; and
(b) with the date of the making of a record of the sale or supply as required by Part 13; and
(c) with the directions for use unless—
(i) the poison is being sold or supplied by a pharmacist on a prescription and directions for use have not been included on the prescription; or
(ii) the dosage regimen or directions for use are so complex that the person supplying the poison has also supplied the patient with separate written instructions; or
Reg. 72(c)(iii) amended by S.R. No. 124/2025 reg. 13.
(iii) the poison is being supplied for the purpose of it being administered by a registered medical practitioner, dentist, veterinary practitioner, nurse practitioner, authorised midwife, authorised optometrist, authorised podiatrist, nurse, registered midwife or registered Aboriginal and Torres Strait Islander health practitioner.
Division 2—Storage
73 General security requirement—Schedule 4 poisons
(a) a registered medical practitioner, pharmacist, veterinary practitioner, dentist, nurse practitioner, authorised midwife, authorised optometrist or authorised podiatrist; and
Reg. 73(1)(b) amended by S.R. No. 126/2024 reg. 8.
(b) a person holding a licence, permit (other than a drug-checking permit) or warrant to manufacture, sell, supply, purchase or otherwise obtain, possess, administer or use a Schedule 4 poison; and
Reg. 73(1)(c) amended by S.R. No. 13/2021 reg. 13(1).
(c) a nurse or registered midwife authorised under regulation 8 to be in possession of a Schedule 4 poison; and
Reg. 73(1)(d) inserted by S.R. No. 13/2021 reg. 13(2), amended by S.R. No. 124/2025 reg. 14(1).
(d) an approved registered nurse or approved registered midwife authorised under regulation 8A to be in possession of a Schedule 4 poison; and
Reg. 73(1)(e) inserted by S.R. No. 124/2025 reg. 14(2).
(e) a registered Aboriginal and Torres Strait Islander health practitioner authorised under regulation 8B(1) to be in possession of a Schedule 4 poison.
Reg. 73(2) substituted by S.R. No. 13/2021 reg. 13(3).
(2) A person to whom this regulation applies must store in a lockable storage facility any Schedule 4 poisons that the person possesses (other than in accordance with items 5, 8, 9 or 10 in Part 1 of the Table in regulation 7).
(3) A person to whom this regulation applies must take all reasonable steps to ensure that the storage facility referred to in subregulation (2) remains locked and secured to prevent access by a person not authorised by the Act or these Regulations at all times, except—
(a) when it is necessary to open it to carry out an essential operation in connection with the poisons stored in it; or
Reg. 73(3)(b) substituted by S.R. No. 13/2021 reg. 13(4).
(b) in the case of poisons stored in accordance with subregulation (4)(a) or (b), when any of the following is present—
(ii) a veterinary practitioner;
(iii) a dentist;
(iv) a nurse practitioner;
(v) a nurse who is authorised under regulation 8(1)(a);
(vi) an authorised registered nurse;
(vii) an approved registered nurse;
(viii) a midwife who is authorised under regulation 8(1)(a);
(ix) an authorised midwife;
(x) an approved registered midwife;
(xi) an authorised optometrist;
(xii) an authorised podiatrist;
Reg. 73 (3)(b)(xiii) amended by S.R. No. 124/2025 reg. 14(3).
(xiii) a pharmacist;
Reg. 73 (3)(b)(xiv) inserted by S.R. No. 124/2025 reg. 14(4).
(xiv) a registered Aboriginal and Torres Strait Islander health practitioner.
(4) Despite subregulations (2) and (3), a person to whom this regulation applies may store Schedule 4 poisons at the premises in which the person carries out the lawful practice of the person's profession in—
(a) the dispensing area or pharmacy department of the premises; or
(b) the treatment room of the premises; or
Reg. 73(4)(c) substituted by S.R. No. 13/2021 reg. 13(5).
(c) in an area separated from the remainder of the premises to which only the following persons have access—
(ii) a pharmacist;
(iii) a veterinary practitioner;
(iv) a dentist;
(v) a nurse practitioner;
(vi) an authorised registered nurse;
(vii) an approved registered nurse;
(viii) an authorised midwife;
(ix) an approved registered midwife;
(x) an authorised optometrist;
Reg. 73 (4)(c)(xi) amended by S.R. No. 124/2025 reg. 14(5).
(xi) an authorised podiatrist;
Reg. 73 (4)(c)(xii) inserted by S.R. No. 124/2025 reg. 14(6).
(xii) a registered Aboriginal and Torres Strait Islander health practitioner.
Sourced from Victorian Legislation (legislation.vic.gov.au), CC BY 4.0.
Version No. 020
Drugs, Poisons and Controlled Substances Regulations 2017
S.R. No. 29/2017
Version incorporating amendments as at
25 November 2025
TABLE OF PROVISIONS
Regulation Page
Chapter 1—Preliminary 1
1 Objectives 1
2 Authorising provisions 1
3 Commencement 1
4 Revocations 2
5 Definitions 2
6 Meaning of chart instruction 14
Chapter 2—Schedule 4, 8 and 9 poisons 15
Part 1—Possession 15
7 Persons authorised to possess Schedule 4, 8 and 9 poisons 15
8 Possession of Schedule 4, 8 and 9 poisons by nurse or registered midwife 23
8A Possession of Schedule 4 and 8 poisons by an approved registered nurse or approved registered midwife 25
8B Possession of Schedule 4 and 8 poisons by a registered Aboriginal and Torres Strait Islander health practitioner 25
9 Dentist must not possess methadone 27
9A Person must not possess Schedule 8 MDMA or Schedule 8 psilocybine 27
Part 2—Permits and forms 29
Division 1—Special Schedule 8 permits 29
10 When special Schedule 8 permit required 29
11 Application for special Schedule 8 permit 30
12 Special Schedule 8 permit 31
12A Permits relating to Schedule 8 cannabis and Schedule 8 tetrahydrocannabinol 32
Division 2—General Schedule 9 permits 32
13 Application for general Schedule 9 permit 32
14 General Schedule 9 permit 32
15 General Schedule 9 permit is not limited to specific animals 33
Division 3—Schedule 9 permit 34
15A Documents to accompany application for Schedule 9 permit 34
15B Schedule 9 permits issued for clinical trials only 34
Part 3—Prescriptions 36
16 Persons authorised to issue prescriptions 36
17 Issuing prescription for Schedule 4, 8 or 9 poison—registered medical practitioner 37
17A Notice to Secretary of intention to prescribe, authorise administration, or administer Schedule 8 MDMA or Schedule 8 psilocybine 38
18 Issuing prescription for Schedule 4, 8 or 9 poison—dentist 39
Who is affected (practically)
Why it matters (stated purpose and how that maps to effects)
The Regulations state their objectives are to facilitate and enhance safe and secure storage, sale, supply, prescribing, administration and use of drugs/poisons and to prescribe fees and forms for the parent Act (reg 1). The concrete mechanisms used to pursue that objective are: detailed role‑based authorisations and prohibitions (who may do what), permit and approval gates, mandatory recordkeeping and reporting, security standards, and criminal/penalty backstops.
Translating those mechanisms into practical effects:
Who pays, who decides, and what behaviour is changed
Trade‑offs, risks and implementation burdens (testing the stated purpose against costs and incentives)
Concentrated benefits and diffuse costs
Key specialised features to note (by section)
Bottom line
Mechanically the Regulations build a dense operational rule‑set that combines strict controls (who may do what, security, recordkeeping, penalties) with delegated flexibility (Secretary/Minister approvals, permit conditions) to broaden regulated practice in defined ways (task‑shifting, drug‑checking, monitored supply, restricted psychedelics pathways). That design trades administrative discretion and compliance costs for the ability to expand authorised practice and introduce harm‑reduction services without primary‑law change (see reg 1 and regs 159, 161, 149D–149N).
19 Issuing prescription for Schedule 4, 8 or 9 poison—veterinary practitioner 40
20 Issuing prescription for Schedule 4 or 8 poison—nurse practitioner 41
21 Issuing prescription for Schedule 4 or 8 poison—authorised midwife 42
22 Issuing prescription for Schedule 4 poison—authorised optometrist 43
23 Issuing prescription for Schedule 4 poison—authorised podiatrist 43
24 Required form for issuing prescriptions 44
25 Emergency verbal instructions to pharmacists regarding supply 47
25A Emergency transmission of digital image to pharmacists regarding supply 48
26 Notification of fraudulent obtaining of order or prescription 49
Part 4—Stock food orders 51
27 Veterinary practitioner order to supply stock food containing a Schedule 4 poison 51
Part 4A—Chart instructions and Aboriginal and Torres Strait Islander health practitioner supply instructions 53
Division 1—Chart instructions 53
28 Persons authorised to write chart instruction on hospital medication chart 53
29 Persons authorised to write chart instruction on residential medication chart 54
30 When registered medical practitioner may write chart instruction on hospital medication chart 54
30A When registered medical practitioner may write chart instruction on residential medication chart 55
31 When dentist may write chart instruction on hospital medication chart 56
31A When dentist may write chart instruction on residential medication chart 57
32 When nurse practitioner may write chart instruction on hospital medication chart 58
32A When nurse practitioner may write chart instruction on residential medication chart 59
33 When authorised midwife may write chart instruction 60
34 When authorised optometrist may write chart instruction 60
35 When authorised podiatrist may write chart instruction 61
Division 2—Aboriginal and Torres Strait Islander health practitioner supply instructions 62
35AA Persons authorised to give Aboriginal and Torres Strait Islander health practitioner supply instruction 62
35AB Aboriginal and Torres Strait Islander health practitioner supply instruction for Schedule 4 or 8 poison—registered medical practitioner 63
35AC Aboriginal and Torres Strait Islander health practitioner supply instruction for Schedule 4 or 8 poison—dentist 64
35AD Aboriginal and Torres Strait Islander health practitioner supply instruction for Schedule 4 or 8 poison—nurse practitioner 65
35AE Aboriginal and Torres Strait Islander health practitioner supply instruction for Schedule 4 or 8 poison—authorised midwife 66
35AF Aboriginal and Torres Strait Islander health practitioner supply instruction for Schedule 4 poison—authorised optometrist 66
35AG Aboriginal and Torres Strait Islander health practitioner supply instruction for Schedule 4 poison—authorised podiatrist 67
35AH Giving a written Aboriginal and Torres Strait Islander health practitioner supply instruction 68
35AI Giving a verbal Aboriginal and Torres Strait Islander health practitioner supply instruction in an emergency 70
Part 5—Sale and supply by practitioners other than pharmacists 72
35A Part does not apply to drug-checking services 72
36 Sale or supply of Schedule 4, 8 or 9 poison—registered medical practitioner 72
36A Supply of Schedule 8 MDMA or Schedule 8 psilocybine—authorised psychedelic psychiatrist and certain registered medical practitioners 73
37 Sale or supply of Schedule 4, 8 or 9 poison—dentist 74
38 Sale or supply of Schedule 4, 8 or 9 poison—veterinary practitioner 75
39 Sale or supply of Schedule 4 or 8 poison—nurse practitioner or authorised registered nurse 76
39A Sale or supply of Schedule 4 or 8 poison—approved registered nurse 77
40 Sale or supply of Schedule 4 or 8 poison—authorised midwife 78
40A Sale or supply of Schedule 4 or 8 poison—approved registered midwife 78
41 Sale or supply of Schedule 4 poison—authorised optometrist 79
42 Sale or supply of Schedule 4 poison—authorised podiatrist 80
42A Supply of Schedule 4 poison—registered Aboriginal and Torres Strait Islander health practitioner 81
42B Supply of Schedule 8 poison—registered Aboriginal and Torres Strait Islander health practitioner 81
42C Restrictions on registered Aboriginal and Torres Strait Islander health practitioner supplying Schedule 4 or 8 poison 82
43 Poison not to be sold or supplied unless supplementary labelling requirements complied with 83
44 Notification of fraudulent obtaining of poison 84
Part 6—Sale and supply by pharmacists 86
Division 1—Circumstances of sale or supply 86
44A Part does not apply to drug-checking services 86
45 Sale or supply of drug of dependence by pharmacist other than by wholesale or on prescription or chart instruction 86
46 Wholesale supply of Schedule 9 poison by pharmacist to another pharmacist 87
47 Sale or supply of Schedule 4 poison by pharmacist 87
48 Sale or supply of Schedule 8 poison by pharmacist 89
49 Sale or supply of Schedule 9 poison by pharmacist 92
50 Restrictions on pharmacist selling or supplying Schedule 4 poison on prescription 93
51 Restrictions on pharmacist selling or supplying Schedule 8 poison on prescription 95
52 Restrictions on pharmacist selling or supplying Schedule 9 poison on prescription 97
53 Exceptional circumstances in which pharmacist may sell or supply Schedule 4 poison or Schedule 8 poison contrary to instructions on prescription 99
54 Sale or supply of Schedule 4 poison or Schedule 8 poison in accordance with hospital medication chart 100
55 Sale or supply of Schedule 4 poison in accordance with residential medication chart 101
55A Sale or supply of Schedule 8 poison in accordance with residential medication chart that is an electronic medication chart 101
56 Sale or supply of Schedule 4 poison by pharmacist in emergency 102
57 Sale or supply of Schedule 4 poison by pharmacist for continuity of treatment 103
57A Sale or supply of Schedule 4 poison by pharmacist for treatment of a person under the pharmacist's care without prescription or other instruction or authorisation 103
58 Poison not to be sold or supplied unless supplementary labelling requirements complied with 104
Division 2—Duties of pharmacist relating to sale or supply 105
59 Division does not authorise supply on copy of prescription 105
60 Pharmacist must mark prescription 106
61 Pharmacist must mark hospital medication chart after supplying Schedule 4 or 8 poison on chart instruction 106
62 Pharmacist must mark residential medication chart after supplying Schedule 4 or 8 poison on chart instruction 107
63 Pharmacist must retain prescription for Schedule 8 poison when supplying without verifying the prescriber 107
64 Pharmacist must retain or further mark prescriptions for Schedule 8 poisons 108
65 Pharmacist must retain or further mark prescriptions for Schedule 9 poisons 108
66 Manner of retention of prescriptions retained after last supply is made 109
67 Pharmacist must produce prescriptions kept under Commonwealth Regulations 109
68 Pharmacist must notify prescriber if prescription departed from 110
69 Notification of fraudulent obtaining of poison 110
70 Pharmacist must notify different authorised prescribers of similar supply of certain Schedule 4 or 8 poisons 110
71 Pharmacist must notify different authorised prescribers of similar supply—Schedule 9 poisons 111
Part 7—Labelling and storage 113
Division 1—Labelling 113
72 Supplementary labelling requirements 113
Division 2—Storage 114
73 General security requirement—Schedule 4 poisons 114
74 Storage of Schedule 8 and 9 poisons and drugs of dependence 117
75 Storage requirements for aged care providers and other authorised persons 121
76 Additional security provisions required in certain circumstances 122
Part 8—Authorising administration 124
77 Persons who may authorise administration 124
78 Authorising administration of Schedule 4, 8 or 9 poison—registered medical practitioner 124
78A Authorising administration of Schedule 8 MDMA or Schedule 8 psilocybine—authorised psychedelic psychiatrist and certain registered medical practitioners 125
79 Authorising administration of Schedule 4, 8 or 9 poison—dentist 127
80 Authorising administration of Schedule 4 or 8 poison—nurse practitioner 128
81 Authorising administration of Schedule 4 or 8 poison—authorised midwife 129
82 Authorising administration of Schedule 4 poison—authorised optometrist 130
83 Authorising administration of Schedule 4 poison—authorised podiatrist 130
84 How registered medical practitioner or dentist must authorise administration of Schedule 4, 8 or 9 poison—written authorisation 131
84A How registered medical practitioner or dentist must authorise administration of Schedule 4, 8 or 9 poison—verbal authorisation in emergency 132
85 How nurse practitioner or authorised midwife must authorise administration of Schedule 4 or 8 poison—written authorisation 133
85A How nurse practitioner or authorised midwife must authorise administration of Schedule 4 or 8 poison—verbal instruction in emergency 133
86 How authorised optometrist or authorised podiatrist must authorise administration of Schedule 4 poison—written authorisation 134
86A How authorised optometrist or authorised podiatrist must authorise administration of Schedule 4 poison—verbal instruction in emergency 135
Part 9—Administration by practitioners other than pharmacists 136
87 Part not to apply to self-administration 136
88 Administration of Schedule 4, 8 or 9 poison—registered medical practitioner 136
89 Administration of Schedule 4, 8 or 9 poison—dentist 137
90 Administration of Schedule 4, 8 or 9 poison—veterinary practitioner 138
91 Administration of Schedule 4, 8 or 9 poison—nurse practitioner 139
92 Administration of Schedule 4, 8 or 9 poison—authorised registered nurse 141
92A Administration of Schedule 4, 8 or 9 poison—approved registered nurse 142
93 Administration of Schedule 4, 8 or 9 poison—authorised midwife 144
93A Administration of Schedule 4, 8 or 9 poison—approved registered midwife 145
94 Administration of Schedule 4 poison—authorised optometrist 147
95 Administration of Schedule 4 poison—authorised podiatrist 148
96 Administration of Schedule 4 poison—nurse or registered midwife 149
97 Administration of Schedule 8 poison—nurse or registered midwife 150
98 Administration of Schedule 9 poison—nurse or registered midwife 151
98A Administration of Schedule 8 MDMA or Schedule 8 psilocybine—authorised psychedelic psychiatrists and certain registered medical practitioners 153
98B Administration of Schedule 8 MDMA or Schedule 8 psilocybine—nurse or nurse practitioner 155
98C Administration of Schedule 4 poison—registered Aboriginal and Torres Strait Islander health practitioner 156
98D Administration of Schedule 8 poison—registered Aboriginal and Torres Strait Islander health practitioner 157
Part 10—Administration by pharmacists 158
99 Administration of Schedule 4 poison by pharmacist 158
99A Circumstances in which pharmacist may administer Schedule 4 poison to a person without instruction 159
99B Circumstances in which pharmacist may administer Schedule 4 poison for treatment of a person under the pharmacist's care without prescription or other instruction or authorisation 159
100 Administration of Schedule 8 poison by pharmacist 160
101 Administration of Schedule 9 poison by pharmacist 160
Part 11—Administration by persons other than pharmacists and other practitioners 162
102 Part not to apply to pharmacists and other practitioners 162
103 Person must not administer Schedule 4, 8 or 9 poison to another person except as specified 162
104 Person must not administer Schedule 4, 8 or 9 poison to an animal except as specified 164
Part 12—Self-administration 165
105 Person must not self-administer Schedule 4, 8 or 9 poison except as specified 165
Part 13—Records 169
106 Definition of transaction 169
107 Persons required to keep records 169
108 Details to be contained in records 170
109 Methods by which records are to be retained and retrieved 174
110 Exception for aged care services 175
111 Accurate records to be kept 176
112 Discrepancies in records to be investigated 176
113 Lost or stolen records to be reported 176
Part 14—Destruction of Schedule 8 poisons and Schedule 9 poisons 177
114 Wilful destruction prohibited 177
115 Exceptions 177
Part 15—Cultivation of narcotic plants 182
116 Authority to cultivate narcotic plants for non-therapeutic uses 182
117 Authority to possess narcotic plant 182
Part 16—Warrants for ovulatory stimulants, prostaglandins, retinoids and thalidomide 184
118 Application of Part 184
119 Certain practitioners not to deal with substance 184
120 Dealing with substance—registered medical practitioner 185
121 Dealing with substance—nurse practitioner 186
121A Dealing with substance—authorised registered nurse 187
121B Dealing with substance—approved registered nurse 187
122 Dealing with substance—authorised midwife 188
122A Dealing with substance—approved registered midwife 188
123 Effect of direction given to registered medical practitioner 189
124 Effect of direction given to nurse practitioner 189
125 Warrant number to be included in any prescription 190
Part 17—Use of premises—drugs of dependence 191
126 Authority to permit use of premises—owners and occupiers 191
Part 18—Forms 193
128 Form of application for Schedule 9 permit 193
129 Form of application for Schedule 8 permit 193
130 Form of Schedule 9 permit 193
131 Form of Schedule 8 permit 193
Part 19—Miscellaneous 194
132 Disclosure of drug use within previous 8 weeks required 194
Part 20—Monitored poisons database 196
132A Data source entity 196
132B Monitored poison 196
132C Monitored supply poison 196
132D Pharmacist to provide certain supply information to prescription exchange service 196
132E Records and information to be provided to the monitored poisons database 197
132F Circumstances where it is not mandatory for pharmacist to check monitored poisons database—cer
This is an opening excerpt, not the complete document.