Drugs, Poisons and Controlled Substances Regulations 2017 (Vic)

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

1Objectives

2Authorising provisions

3Commencement

4Revocations

5Definitions

6Meaning of chart instruction

Chapter 2—Schedule 4, 8 and 9 poisons

Part 1—Possession

7Persons authorised to possess Schedule 4, 8 and 9 poisons

8Possession of Schedule 4, 8 and 9 poisons by nurse or registered midwife

8APossession of Schedule 4 and 8 poisons by an approved registered nurse or approved registered midwife

8BPossession of Schedule 4 and 8 poisons by a registered Aboriginal and Torres Strait Islander health practitioner

9Dentist must not possess methadone

9APerson must not possess Schedule 8 MDMA or Schedule 8 psilocybine

Part 2—Permits and forms

Division 1—Special Schedule 8 permits

10When special Schedule 8 permit required

11Application for special Schedule 8 permit

12Special Schedule 8 permit

12APermits relating to Schedule 8 cannabis and Schedule 8 tetrahydrocannabinol

Division 2—General Schedule 9 permits

13Application for general Schedule 9 permit

14General Schedule 9 permit

15General Schedule 9 permit is not limited to specific animals

Division 3—Schedule 9 permit

15ADocuments to accompany application for Schedule 9 permit

15BSchedule 9 permits issued for clinical trials only

Part 3—Prescriptions

16Persons authorised to issue prescriptions

17Issuing prescription for Schedule 4, 8 or 9 poison—registered medical practitioner

17ANotice to Secretary of intention to prescribe, authorise administration, or administer Schedule 8 MDMA or Schedule 8 psilocybine

18Issuing prescription for Schedule 4, 8 or 9 poison—dentist

19Issuing prescription for Schedule 4, 8 or 9 poison—veterinary practitioner

20Issuing prescription for Schedule 4 or 8 poison—nurse practitioner

21Issuing prescription for Schedule 4 or 8 poison—authorised midwife

22Issuing prescription for Schedule 4 poison—authorised optometrist

23Issuing prescription for Schedule 4 poison—authorised podiatrist

24Required form for issuing prescriptions

25Emergency verbal instructions to pharmacists regarding supply

25AEmergency transmission of digital image to pharmacists regarding supply

26Notification of fraudulent obtaining of order or prescription

Part 4—Stock food orders

27Veterinary practitioner order to supply stock food containing a Schedule 4 poison

Part 4A—Chart instructions and Aboriginal and Torres Strait Islander health practitioner supply instructions

Division 1—Chart instructions

28Persons authorised to write chart instruction on hospital medication chart

29Persons authorised to write chart instruction on residential medication chart

30When registered medical practitioner may write chart instruction on hospital medication chart

30AWhen registered medical practitioner may write chart instruction on residential medication chart

31When dentist may write chart instruction on hospital medication chart

31AWhen dentist may write chart instruction on residential medication chart

32When nurse practitioner may write chart instruction on hospital medication chart

32AWhen nurse practitioner may write chart instruction on residential medication chart

33When authorised midwife may write chart instruction

34When authorised optometrist may write chart instruction

35When authorised podiatrist may write chart instruction

Division 2—Aboriginal and Torres Strait Islander health practitioner supply instructions

35AAPersons authorised to give Aboriginal and Torres Strait Islander health practitioner supply instruction

35ABAboriginal and Torres Strait Islander health practitioner supply instruction for Schedule 4 or 8 poison—registered medical practitioner

35ACAboriginal and Torres Strait Islander health practitioner supply instruction for Schedule 4 or 8 poison—dentist

35ADAboriginal and Torres Strait Islander health practitioner supply instruction for Schedule 4 or 8 poison—nurse practitioner

35AEAboriginal and Torres Strait Islander health practitioner supply instruction for Schedule 4 or 8 poison—authorised midwife

35AFAboriginal and Torres Strait Islander health practitioner supply instruction for Schedule 4 poison—authorised optometrist

35AGAboriginal and Torres Strait Islander health practitioner supply instruction for Schedule 4 poison—authorised podiatrist

35AHGiving a written Aboriginal and Torres Strait Islander health practitioner supply instruction

35AIGiving a verbal Aboriginal and Torres Strait Islander health practitioner supply instruction in an emergency

Part 5—Sale and supply by practitioners other than pharmacists

35APart does not apply to drug-checking services

36Sale or supply of Schedule 4, 8 or 9 poison—registered medical practitioner

36ASupply of Schedule 8 MDMA or Schedule 8 psilocybine—authorised psychedelic psychiatrist and certain registered medical practitioners

37Sale or supply of Schedule 4, 8 or 9 poison—dentist

38Sale or supply of Schedule 4, 8 or 9 poison—veterinary practitioner

39Sale or supply of Schedule 4 or 8 poison—nurse practitioner or authorised registered nurse

39ASale or supply of Schedule 4 or 8 poison—approved registered nurse

40Sale or supply of Schedule 4 or 8 poison—authorised midwife

40ASale or supply of Schedule 4 or 8 poison—approved registered midwife

41Sale or supply of Schedule 4 poison—authorised optometrist

42Sale or supply of Schedule 4 poison—authorised podiatrist

42ASupply of Schedule 4 poison—registered Aboriginal and Torres Strait Islander health practitioner

42BSupply of Schedule 8 poison—registered Aboriginal and Torres Strait Islander health practitioner

42CRestrictions on registered Aboriginal and Torres Strait Islander health practitioner supplying Schedule 4 or 8 poison

43Poison not to be sold or supplied unless supplementary labelling requirements complied with

44Notification of fraudulent obtaining of poison

Part 6—Sale and supply by pharmacists

Division 1—Circumstances of sale or supply

44APart does not apply to drug-checking services

45Sale or supply of drug of dependence by pharmacist other than by wholesale or on prescription or chart instruction

46Wholesale supply of Schedule 9 poison by pharmacist to another pharmacist

47Sale or supply of Schedule 4 poison by pharmacist

48Sale or supply of Schedule 8 poison by pharmacist

49Sale or supply of Schedule 9 poison by pharmacist

50Restrictions on pharmacist selling or supplying Schedule 4 poison on prescription

51Restrictions on pharmacist selling or supplying Schedule 8 poison on prescription

52Restrictions on pharmacist selling or supplying Schedule 9 poison on prescription

53Exceptional circumstances in which pharmacist may sell or supply Schedule 4 poison or Schedule 8 poison contrary to instructions on prescription

54Sale or supply of Schedule 4 poison or Schedule 8 poison in accordance with hospital medication chart

55Sale or supply of Schedule 4 poison in accordance with residential medication chart

55ASale or supply of Schedule 8 poison in accordance with residential medication chart that is an electronic medication chart

56Sale or supply of Schedule 4 poison by pharmacist in emergency

57Sale or supply of Schedule 4 poison by pharmacist for continuity of treatment

57ASale 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

58Poison not to be sold or supplied unless supplementary labelling requirements complied with

Division 2—Duties of pharmacist relating to sale or supply

59Division does not authorise supply on copy of prescription

60Pharmacist must mark prescription

61Pharmacist must mark hospital medication chart after supplying Schedule 4 or 8 poison on chart instruction

62Pharmacist must mark residential medication chart after supplying Schedule 4 or 8 poison on chart instruction

63Pharmacist must retain prescription for Schedule 8 poison when supplying without verifying the prescriber

64Pharmacist must retain or further mark prescriptions for Schedule 8 poisons

65Pharmacist must retain or further mark prescriptions for Schedule 9 poisons

66Manner of retention of prescriptions retained after last supply is made

67Pharmacist must produce prescriptions kept under Commonwealth Regulations

68Pharmacist must notify prescriber if prescription departed from

69Notification of fraudulent obtaining of poison

70Pharmacist must notify different authorised prescribers of similar supply of certain Schedule 4 or 8 poisons

71Pharmacist must notify different authorised prescribers of similar supply—Schedule 9 poisons

Part 7—Labelling and storage

Division 1—Labelling

72Supplementary labelling requirements

Division 2—Storage

73General security requirement—Schedule 4 poisons

74Storage of Schedule 8 and 9 poisons and drugs of dependence

75Storage requirements for aged care providers and other authorised persons

76Additional security provisions required in certain circumstances

Part 8—Authorising administration

77Persons who may authorise administration

78Authorising administration of Schedule 4, 8 or 9 poison—registered medical practitioner

78AAuthorising administration of Schedule 8 MDMA or Schedule 8 psilocybine—authorised psychedelic psychiatrist and certain registered medical practitioners

79Authorising administration of Schedule 4, 8 or 9 poison—dentist

80Authorising administration of Schedule 4 or 8 poison—nurse practitioner

81Authorising administration of Schedule 4 or 8 poison—authorised midwife

82Authorising administration of Schedule 4 poison—authorised optometrist

83Authorising administration of Schedule 4 poison—authorised podiatrist

84How registered medical practitioner or dentist must authorise administration of Schedule 4, 8 or 9 poison—written authorisation

84AHow registered medical practitioner or dentist must authorise administration of Schedule 4, 8 or 9 poison—verbal authorisation in emergency

85How nurse practitioner or authorised midwife must authorise administration of Schedule 4 or 8 poison—written authorisation

85AHow nurse practitioner or authorised midwife must authorise administration of Schedule 4 or 8 poison—verbal instruction in emergency

86How authorised optometrist or authorised podiatrist must authorise administration of Schedule 4 poison—written authorisation

86AHow authorised optometrist or authorised podiatrist must authorise administration of Schedule 4 poison—verbal instruction in emergency

Part 9—Administration by practitioners other than pharmacists

87Part not to apply to self-administration

88Administration of Schedule 4, 8 or 9 poison—registered medical practitioner

89Administration of Schedule 4, 8 or 9 poison—dentist

90Administration of Schedule 4, 8 or 9 poison—veterinary practitioner

91Administration of Schedule 4, 8 or 9 poison—nurse practitioner

92Administration of Schedule 4, 8 or 9 poison—authorised registered nurse

92AAdministration of Schedule 4, 8 or 9 poison—approved registered nurse

93Administration of Schedule 4, 8 or 9 poison—authorised midwife

93AAdministration of Schedule 4, 8 or 9 poison—approved registered midwife

94Administration of Schedule 4 poison—authorised optometrist

95Administration of Schedule 4 poison—authorised podiatrist

96Administration of Schedule 4 poison—nurse or registered midwife

97Administration of Schedule 8 poison—nurse or registered midwife

98Administration of Schedule 9 poison—nurse or registered midwife

98AAdministration of Schedule 8 MDMA or Schedule 8 psilocybine—authorised psychedelic psychiatrists and certain registered medical practitioners

98BAdministration of Schedule 8 MDMA or Schedule 8 psilocybine—nurse or nurse practitioner

98CAdministration of Schedule 4 poison—registered Aboriginal and Torres Strait Islander health practitioner

98DAdministration of Schedule 8 poison—registered Aboriginal and Torres Strait Islander health practitioner

Part 10—Administration by pharmacists

99Administration of Schedule 4 poison by pharmacist

99ACircumstances in which pharmacist may administer Schedule 4 poison to a person without instruction

99BCircumstances 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

100Administration of Schedule 8 poison by pharmacist

101Administration of Schedule 9 poison by pharmacist

Part 11—Administration by persons other than pharmacists and other practitioners

102Part not to apply to pharmacists and other practitioners

103Person must not administer Schedule 4, 8 or 9 poison to another person except as specified

104Person must not administer Schedule 4, 8 or 9 poison to an animal except as specified

Part 12—Self-administration

105Person must not self-administer Schedule 4, 8 or 9 poison except as specified

Part 13—Records

106Definition of transaction

107Persons required to keep records

108Details to be contained in records

109Methods by which records are to be retained and retrieved

110Exception for aged care services

111Accurate records to be kept

112Discrepancies in records to be investigated

113Lost or stolen records to be reported

Part 14—Destruction of Schedule 8 poisons and Schedule 9 poisons

114Wilful destruction prohibited

115Exceptions

Part 15—Cultivation of narcotic plants

116Authority to cultivate narcotic plants for non-therapeutic uses

117Authority to possess narcotic plant

Part 16—Warrants for ovulatory stimulants, prostaglandins, retinoids and thalidomide

118Application of Part

119Certain practitioners not to deal with substance

120Dealing with substance—registered medical practitioner

121Dealing with substance—nurse practitioner

121ADealing with substance—authorised registered nurse

121BDealing with substance—approved registered nurse

122Dealing with substance—authorised midwife

122ADealing with substance—approved registered midwife

123Effect of direction given to registered medical practitioner

124Effect of direction given to nurse practitioner

125Warrant number to be included in any prescription

Part 17—Use of premises—drugs of dependence

126Authority to permit use of premises—owners and occupiers

Part 18—Forms

128Form of application for Schedule 9 permit

129Form of application for Schedule 8 permit

130Form of Schedule 9 permit

131Form of Schedule 8 permit

Part 19—Miscellaneous

132Disclosure of drug use within previous 8 weeks required

Part 20—Monitored poisons database

132AData source entity

132BMonitored poison

132CMonitored supply poison

132DPharmacist to provide certain supply information to prescription exchange service

132ERecords and information to be provided to the monitored poisons database

132FCircumstances where it is not mandatory for pharmacist to check monitored poisons database—certain classes of person

132GCircumstances where it is not mandatory to check monitored poisons database—certain classes of person

132HCircumstances where it is not mandatory to check monitored poisons database—incurable medical condition

132ICircumstances where it is not mandatory to check monitored poisons database—drug-checking services

Chapter 3—Schedule 2, 3 and 7 poisons

Part 1—Schedule 2 poisons

133Boat captain authorised to obtain or possess Schedule 2 poison

133AAHolder of non-emergency patient transport service licence or first aid service licence authorised to obtain and possess Schedule 2 poison

133APossession of a Schedule 2 poison by an approved registered nurse or approved registered midwife

133BRestrictions on dealing with Schedule 2 poison—approved registered nurse

133CRestrictions on dealing with Schedule 2 poison—approved registered midwife

133CAPossession of a Schedule 2 poison by a registered Aboriginal and Torres Strait Islander health practitioner

133CBRestrictions on dealing with Schedule 2 poison—registered Aboriginal and Torres Strait Islander health practitioner

133CCPossession of a Schedule 2 poison by an Aboriginal and Torres Strait Islander health worker

133CDRestrictions on dealing with Schedule 2 poison—Aboriginal and Torres Strait Islander health worker

Part 2—Schedule 3 poisons

133DPossession of a Schedule 3 poison by an approved registered nurse or approved registered midwife

133EHolder of non-emergency patient transport service licence or first aid service licence authorised to obtain and possess Schedule 3 poison

133FPossession and supply of Schedule 3 naloxone by approved naloxone provider

133GPossession and supply of Schedule 3 naloxone by approved naloxone worker

133HPossession and supply of Schedule 3 naloxone by person to whom it is supplied by approved naloxone worker

133IPossession of Schedule 3 poison by registered Aboriginal and Torres Strait Islander health practitioner

133JPossession of Schedule 3 poison by Aboriginal and Torres Strait Islander health worker

134Restrictions on dealing with Schedule 3 poison—registered medical practitioner

135Restrictions on dealing with Schedule 3 poison—veterinary practitioner

136Restrictions on dealing with Schedule 3 poison—dentist

137Restrictions on dealing with Schedule 3 poison—nurse practitioner

137ASale, supply or administration of Schedule 3 poison—authorised registered nurse

137BSale, supply or administration of Schedule 3 poison—approved registered nurse

138Restrictions on dealing with Schedule 3 poison—authorised midwife

138ASale, supply or administration of Schedule 3 poison—approved registered midwife

139Restrictions on dealing with Schedule 3 poison—authorised optometrist

140Restrictions on dealing with Schedule 3 poison—authorised podiatrist

141Restrictions on dealing with Schedule 3 poison—pharmacist

141ASupply or administration of Schedule 3 poison—registered Aboriginal and Torres Strait Islander health practitioner

141BAdministration of Schedule 3 poison—Aboriginal and Torres Strait Islander health worker

143Restrictions on storage and display

144Requirements to supply—delivery, supervision and directions for use

145Requirements to supply—label identifying supplier

146Administration, prescription, sale or supply prohibited if to support drug dependency

147Notification of fraudulent obtaining of order or prescription

Part 3—Schedule 7 poisons

148Controls concerning listed regulated poisons

149Licences, permits or warrants required for special Schedule 7 substances

Chapter 3A—Medically supervised injecting centre

149APrescribed injecting centre drugs

149BPermitted quantity of injecting centre drugs

149CInternal management protocols

Chapter 3B—Drug-checking services

149DInterpretation

149EPrescribed requirements for drug‑checking directors

149FPrescribed qualifications for special drug‑checking workers

149GConditions of drug-checking permit—record-keeping

149HStorage of substances

149IAdditional security provisions required in certain circumstances

149JDestruction of drug-checking substances

149KFit and proper person consultation

149LSecretary must allow time for Chief Commissioner of Police to give advice

149MMatters the Secretary must consider before issuing drug-checking permit

149NFit and proper person requirements

Chapter 4—Miscellaneous matters

Part 1—General requirements

150Poisons to be sold by wholesale and retail in original unopened packs

151Transfer of poisons to inappropriate containers prohibited

152Lost or stolen substances to be notified—practitioners and certain workers

153Lost or stolen poisons to be notified—other persons

154Access to certain poisons restricted to a needs basis

155Form of seizure notice under section 43(1) of the Act

156Form of complaint notice against a seizure under section 43(2) of the Act

Part 2—Licences and permits issued under the Act

157Licence to sell or supply Schedule 2 poisons by retail

158Fees

Part 3—Other matters

Division 1—Approval of matters by Minister

159Minister may approve Schedule 4 poison for supply by pharmacist without prescription

Division 2—Approval of matters by Secretary

159ASecretary may approve dental assisting qualifications and courses in the administration of Schedule 4 poisons

159BApproved registered midwives

159CApproved registered nurses

160Secretary may approve Schedule 4 poisons for possession by certain persons

160ASecretary may approve an entity to be a public dental service

161Secretary may approve Schedule 4, 8 or 9 poisons for possession by nurses or registered midwives

161ASecretary may approve Schedule 4 or Schedule 8 poisons for obtaining, possession, sale, supply or administration by approved registered nurses or approved registered midwives

161BSecretary may approve Schedule 2 poisons for obtaining, possession, sale, supply or administration by approved registered nurses or approved registered midwives

161CSecretary may approve Schedule 3 poisons for obtaining, possession, sale, supply or administration by approved registered nurses or approved registered midwives

161DApproved naloxone providers

161EApproved naloxone workers

161FSecretary may approve Schedule 4 or 8 poisons for obtaining, possession, supply or administration by registered Aboriginal and Torres Strait Islander health practitioners under instruction

161GSecretary may approve Schedule 2 poisons for obtaining, possession, supply or administration by registered Aboriginal and Torres Strait Islander health practitioners under instruction

161HSecretary may approve Schedule 3 poisons for obtaining, possession, supply or administration by registered Aboriginal and Torres Strait Islander health practitioners under instruction

161ISecretary may approve Schedule 2 poisons for obtaining, possession or administration by Aboriginal and Torres Strait Islander health workers

161JSecretary may approve Schedule 3 poisons for obtaining, possession or administration by Aboriginal and Torres Strait Islander health workers

162Secretary may approve manner in which person may write a prescription

163Secretary may approve Schedule 4 poison that pharmacist may administer to a person without instruction

163ASecretary 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

163BSecretary may approve qualification of special drug-checking worker

Part 4—Transitional provisions

164Definitions

165Approval of poisons for possession by nurses and registered midwives

166Approval of poisons for persons specified in table

167Permit to deal with Schedule 9 poison

168Approval of Schedule 4 poison as suitable for supply without prescription

169Permits relating to special Schedule 8 poisons

170Approval of manner of writing for prescription

171Security directions and approvals

172Approval of Schedule 4 poison for administration by pharmacist without instruction

173Direction to comply with destruction requirements

174Authority to cultivate narcotic plants for non‑therapeutic uses

Schedule 1––Revoked regulations

Schedule 2––Forms

Schedule 3––Fees

Schedule 4—Data source entities

Schedule 5—Monitored poisons

Schedule 6—Monitored supply poisons on and after 1 April 2020

═══════════════

Endnotes

1     General information

2     Table of Amendments

3     Explanatory details

Version No. 020

Drugs, Poisons and Controlled Substances Regulations 2017

S.R. No. 29/2017

Version incorporating amendments as at

25 November 2025

CHAPTER 1—PRELIMINARY

1Objectives

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

(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.

2Authorising provisions

These Regulations are made under sections 129, 131, 132, 132A and 132B of the Drugs, Poisons and Controlled Substances Act 1981.

3Commencement

These Regulations come into operation on 23 May 2017.

4Revocations

The Regulations set out in Schedule 1 are revoked.

5Definitions

(1)In these Regulations—

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;

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;

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);

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;

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;

approved naloxone provider means a person approved, or belonging to a class approved, by the Secretary in accordance with regulation 161D;

approved naloxone worker means a person belonging to a class approved by the Secretary in accordance with regulation 161E;

approved registered midwife means a registered midwife belonging to a class approved by the Secretary in accordance with regulation 159B;

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;

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;

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;

Commonwealth Secretary means the Secretary within the meaning of the Therapeutic Goods Act 1989 of the Commonwealth;

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;

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;

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;

first aidhas the same meaning as in the Non‑Emergency Patient Transport and First Aid Services Act 2003;

first aid service has the same meaning as in the Non-Emergency Patient Transport and First Aid Services Act 2003;

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;

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;

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;

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;

non-emergency patient transport service has the same meaning as it has in the Non‑Emergency Patient Transport and First Aid ServicesAct 2003;

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;

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;

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;

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;

Schedule 3 naloxone means naloxone when prepared to be used for the treatment of opioid overdoses;

*                *                *                *                *

Schedule 8 MDMA means N, α ‑DIMETHYL‑3, 4‑(METHYLENEDIOXY)PHENYLETHY LAMINE in Schedule 8 of the Poisons Standard;

Note

MDMA is included in Schedule 8 of the Poisons Standard only for the treatment of post-traumatic stress disorder.

Schedule 8 psilocybine means psilocybine in Schedule 8 of the Poisons Standard;

Note

Psilocybine is included in Schedule 8 of the Poisons Standard only for the treatment of treatment-resistant depression.

*                *                *                *                *

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);

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;

the Act means the Drugs, Poisons and Controlled Substances Act 1981;

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.

Note

Drug of dependence is defined in the Act.

6Meaning 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.

Notes

1Under 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.

2See 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

7Persons 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.

Table
Column 1		Column 2
Part 1
1.	A person who holds or who is the agent of a person who holds a licence, permit (other than a drug-checking permit) or warrant issued under the Act or these Regulations.	Those Schedule 4 poisons, Schedule 8 poisons or Schedule 9 poisons named on the licence, permit or warrant to the extent and for the purpose specified in the licence, permit or warrant.
2.	A person who is engaged, or employed by a person who is engaged, to transport a Schedule 4 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,	The Schedule 4 poison for the purposes of delivery to the person to whom the consignment is addressed.

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.
*                *                *                *     *

(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.

8Possession 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—

(a)the instructions of and on the authorisation for that patient by—

(i)a registered medical practitioner; or

(ii)a dentist; or

(iii)a nurse practitioner; or

(iv)an authorised midwife; or

(v)an authorised optometrist; or

(vi)an authorised podiatrist; or

(b)the conditions of a permit to purchase or obtain and use a poison for the provision of health services; or

(c)the approval of the Secretary under regulation 161(1).

(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—

(a)the instructions of and on the authorisation for that patient by—

(i)a registered medical practitioner; or

(ii)a dentist; or

(iii)a nurse practitioner; or

(iv)an authorised midwife; or

(b)the conditions of a permit to purchase or obtain and use a poison for the provision of health services; or

(c)the approval of the Secretary under regulation 161(1).

(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—

(a)the instructions of and on the authorisation for that patient by—

(i)a registered medical practitioner; or

(ii)a dentist; or

(b)the conditions of a permit to purchase or obtain and use a poison for the provision of health services; or

(c)the approval of the Secretary under regulation 161(1).

(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.

8APossession 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.

8BPossession 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—

(a)supply in accordance with an Aboriginal and Torres Strait Islander health practitioner supply instruction given by—

(i)a registered medical practitioner; or

(ii)a dentist; or

(iii)a nurse practitioner; or

(iv)an authorised midwife; or

(v)an authorised optometrist; or

(vi)an authorised podiatrist; or

(b)administration in accordance with an Aboriginal and Torres Strait Islander health practitioner administration instruction given by—

(i)a registered medical practitioner; or

(ii)a dentist; or

(iii)a nurse practitioner; or

(iv)an authorised midwife; or

(v)an authorised optometrist; or

(vi)an authorised podiatrist.

(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—

(a)supply in accordance with an Aboriginal and Torres Strait Islander health practitioner supply instruction given by—

(i)a registered medical practitioner; or

(ii)a dentist; or

(iii)a nurse practitioner; or

(iv)an authorised midwife; or

(b)administration in accordance with an Aboriginal and Torres Strait Islander health practitioner administration instruction given by—

(i)a registered medical practitioner; or

(ii)a dentist; or

(iii)a nurse practitioner; or

(iv)an authorised midwife.

9Dentist must not possess methadone

A dentist must not possess methadone.

Penalty:100 penalty units.

9APerson 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.

Penalty:100 penalty units.

PART 2—PERMITS AND FORMS

Division 1—Special Schedule 8 permits

10When 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.

Note

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.

11Application for special Schedule 8 permit

(1)A registered medical practitioner or nurse practitioner may apply to the Secretary for a special Schedule 8 permit.

Note

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.

12Special 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.

Note

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.

12APermits 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

13Application for general Schedule 9 permit

A veterinary practitioner or dentist may apply to the Secretary for a general Schedule 9 permit.

14General 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.

(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.

(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.

15General 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.

Division 3—Schedule 9 permit

15ADocuments 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.

15BSchedule 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

16Persons 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.

Penalty:100 penalty units.

(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.

Penalty:100 penalty units.

(3)A person other than a registered medical practitioner, veterinary practitioner or dentist must not issue a prescription for a Schedule 9 poison.

Penalty:100 penalty units.

(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.

Penalty:100 penalty units.

17Issuing 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

(b)that person is—

(i)under the practitioner's care; and

(ii)named in the prescription; and

(c)the practitioner has taken all reasonable steps to ensure a therapeutic need exists for that poison; and

(d)the prescription is issued not merely for the purpose of supporting the drug dependence of a person; and

(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

(g)in the case of a Schedule 9 poison, the practitioner holds a Schedule 9 permit, that authorises the issuing of the prescription.

Penalty:100 penalty units.

Notes

1In 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.

2If 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.

17ANotice 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.

Penalty:100 penalty units.

(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.

Penalty:100 penalty units.

(3)For the purposes of subregulations (1) and (2), the prescribed form is Form 7 in Schedule 2.

18Issuing prescription for Schedule 4, 8 or 9 poison—dentist

(1)A dentist must not issue a prescription for methadone.

Penalty:100 penalty units.

(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

(b)that person is—

(i)under the dentist's care; and

(ii)named in the prescription; and

(c)the dentist has taken all reasonable steps to ensure a therapeutic need exists for that poison; and

(d)the prescription is issued not merely for the purpose of supporting the drug dependence of a person; 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.

Penalty:100 penalty units.

19Issuing 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.

Penalty:100 penalty units.

Note

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.

20Issuing 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

(b)that person is—

(i)under the nurse practitioner's care; and

(ii)named in the prescription; and

(c)the nurse practitioner has taken all reasonable steps to ensure a therapeutic need exists for that poison; and

(d)the prescription is issued not merely for the purpose of supporting the drug dependence of a person; 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.

Penalty:100 penalty units.

Note

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.

21Issuing 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

(b)that person is—

(i)under the midwife's care; and

(ii)named in the prescription; and

(c)the midwife has taken all reasonable steps to ensure a therapeutic need exists for that poison; and

(d)the prescription is issued not merely for the purpose of supporting the drug dependence of a person; 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.

Penalty:100 penalty units.

22Issuing 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

(b)that person is—

(i)under the optometrist's care; and

(ii)named in the prescription; and

(c)the optometrist has taken all reasonable steps to ensure a therapeutic need exists for that poison; and

(d)the prescription is issued not merely for the purpose of supporting the drug dependence of a person; 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.

Penalty:100 penalty units.

23Issuing 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

(b)that person is—

(i)under the podiatrist's care; and

(ii)named in the prescription; and

(c)the podiatrist has taken all reasonable steps to ensure a therapeutic need exists for that poison; and

(d)the prescription is issued not merely for the purpose of supporting the drug dependence of a person; 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.

Penalty:100 penalty units.

24Required 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).

Penalty:50 penalty units.

Note

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.

(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.

Penalty:50 penalty units.

(2)A person who writes a prescription for a Schedule 4 poison, Schedule 8 poison or Schedule 9 poison must sign the prescription.

Penalty:50 penalty units.

(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;

(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;

(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;

174Authority to cultivate narcotic plants for non‑therapeutic uses

An authority issued under regulation 52(1) of the old Regulations and in effect immediately before 23 May 2017 is, on and after that date, taken to be an authority under regulation 116(1) of these Regulations.

SCHEDULE 1––REVOKED REGULATIONS

1Drugs, Poisons and Controlled Substances Regulations 2006[1]

2Drugs, Poisons and Controlled Substances (Health Professions Amendment) Regulations 2007[2]

3Drugs, Poisons and Controlled Substances Amendment Regulations 2009[3]

4Drugs, Poisons and Controlled Substances Amendment Regulations 2010[4]

5Drugs, Poisons and Controlled Substances Amendment Regulations 2012[5]

6Drugs, Poisons and Controlled Substances Amendment (Continued Dispensing) Regulations 2013[6]

7Drugs, Poisons and Controlled Substances Amendment (Cultivation of a Narcotic Plant) Regulations 2013[7]

8Drugs, Poisons and Controlled Substances Amendment (Schedule 8 Permit) Regulations 2013[8]

9Drugs, Poisons and Controlled Substances Amendment (Residential Medication Chart) Regulations 2014[9]

10Drugs, Poisons and Controlled Substances Amendment (Sodium Oxybate) Regulations 2015[10]

11Drugs, Poisons and Controlled Substances Amendment (Administration of Schedule 3 and 4 Poisons by Pharmacists) Regulations 2016[11]

12Drugs, Poisons and Controlled Substances Amendment (Cannabis and Tetrahydrocannabinols) Regulations 2016[12]

13Drugs, Poisons and Controlled Substances Amendment Regulations 2016[13]

14Drugs, Poisons and Controlled Substances Amendment Regulations 2017[14]

SCHEDULE 2––FORMS

*                *                *                *                *

FORM 2

Regulation 128

Drugs, Poisons and Controlled Substances Regulations 2017

APPLICATION FOR PERMIT TO ADMINISTER, SUPPLY OR PRESCRIBE SCHEDULE 9 POISONS BY A REGISTERED MEDICAL PRACTITIONER FOR A CLINICAL TRIAL

Section 1:

Full name of patient participating in trial	Date of birth	Sex
Private address of patient	Postcode

Full name and qualifications of applying registered medical practitioner

Address of applying registered medical practitioner Postcode

Telephone and fax no. of applying registered medical practitioner

Name and address of site where patient is participating in the clinical trial

Section 2:

Schedule 9 poison(s) for which permit is requested:

POISON NAME PROPRIETARY NAME (if available) DOSE FORM DOSE PER UNIT EXPECTED MAXIMUM DAILY DOSE

Name and address of supplier

Is this product registered for therapeutic use? If Yes, in which countries?

Details of other treatment (if applicable)

Section 3: Details of clinical trial and human research ethics committee

Name and registration number of the clinical trial

Purpose of the clinical trial

Name of principal investigators of the clinical trial

Registry that the clinical trial is registered on

Date that clinical trial was registered on the registry

Sites for which the clinical trial approval has been granted in Victoria

Has the clinical trial received approval from a human research ethics committee?

Ethics approval number

Date ethics approval was granted

Date ethics approval expires

Name and registration number of the human research ethics committee that granted the ethics approval

Institution responsible for the human research ethics committee, if applicable

Signature of applying registered medical practitioner

Date

FORM 3

Regulations 11(2), 129

Drugs, Poisons and Controlled Substances Regulations 2017

TREATMENT WITH SCHEDULE 8 POISONS BY A REGISTERED MEDICAL PRACTITIONER OR A NURSE PRACTITIONER

(Application for permit to administer, prescribe or supply)

This is an application for a permit under [regulation 11(1) of the Drugs, Poisons and Controlled Substances Regulations 2017/section 34A of the Drugs, Poisons and Controlled Substances Act 1981].

PART A: FOR TREATMENT WITH SCHEDULE 8 POISONS OTHER THAN TREATMENT OF AN OPIOID DEPENDENT PERSON WITH METHADONE OR BUPRENORPHINE

Section 1: (To be completed in all cases)

Full name of patient  Date of birth         Sex

Private address of patient  Postcode

Full name and qualifications of registered medical practitioner/nurse practitioner

Address of registered medical practitioner/nurse practitioner

Postcode

Telephone and fax no. of registered medical practitioner/nurse practitioner

Name and address of hospital where patient is undergoing treatment (if applicable)

Clinical diagnosis

Section 2:

Schedule 8 poison(s) for which permit is requested:

NAME OF POISON(S) EXPECTED MAXIMUM DAILY DOSE

Details of other treatment (if applicable)

I have/have not previously applied for a permit to administer, prescribe or supply a Schedule 8 poison to this patient.

Please note that evidence-based practice guidelines recommend that specialist advice should be sought for patients requiring opioid doses exceeding oral morphine [quantity] mg daily, oxycodone [quantity] mg daily or equivalent, for the treatment of chronic non-cancer pain, or when prescribing opioids to a patient with a history of drug dependency or aberrant drug-related behaviours. Opioids should only be prescribed as part of a comprehensive pain management plan. When applying for a permit to treat a patient with an opioid, applicants may be requested by the Secretary to provide the Secretary with evidence of a pain management plan or specialist review.

The morbidity and mortality risks associated with long-term opioid therapy should be discussed with the patient, in particular the increased mortality risks correlated with the prolonged use of opioids at doses exceeding [quantity] mg daily in morphine equivalents.

Signature of registered medical practitioner/nurse practitioner

Date

PART B: FOR TREATMENT OF AN OPIOID DEPENDENT PERSON WITH METHADONE OR BUPRENORPHINE

I, [full name of registered medical practitioner/nurse practitioner] of [address of registered medical practitioner/nurse practitioner, including postcode, phone and fax numbers] certify that this patient shows evidence of dependence on an opioid drug and that, in my opinion, methadone/buprenorphine is required in support of treatment.

Personal Details:

Full name of patient

Address of patient

Date of birth

DPU client number (if known)

Sex

Aliases (if any)

Mother's full maiden name

Aboriginal or Torres Strait Islander origin

Yes, Aboriginal

Yes, Torres Strait Islander

Yes, Aboriginal and Torres Strait Islander

No

Not stated

Medical Details of Patient:

Starting drug

Starting methadone/buprenorphine dose

Anticipated date of first dose

Period for which permit sought (if short-term)

Has the patient been treated previously with methadone or buprenorphine for opioid dependency?   Yes/No

Is the patient transferring from another prescriber?   Yes/No

If yes, what was the last drug prescribed?

When was the last dose administered?

Has the previous prescriber been advised of the transfer?   Yes/No

Name of previous prescriber

Name, address and telephone number of person dispensing methadone/buprenorphine

Signature of registered medical practitioner/nurse practitioner

Date

FORM 4

Regulations 12(2), 130 and 131

Drugs, Poisons and Controlled Substances Regulations 2017

SCHEDULE 8 PERMIT/SCHEDULE 9 PERMIT

This permit is granted to [full name and address of registered medical practitioner/nurse practitioner]

and authorises that registered medical practitioner/nurse practitioner to administer, prescribe or supply the following poison(s) in accordance with the following details and conditions. The poison(s) must not be administered, prescribed or supplied in excess of the quantities specified, or for a period greater than that specified in this permit.

Name of patient

Address of patient

NAME OF POISON                 MAXIMUM DOSE

Special conditions (if any):

This permit is valid from [date] to [date] (if applicable) unless sooner revoked or suspended.

Date  Secretary

FORM 5

Regulation 155

Drugs, Poisons and Controlled Substances Regulations 2017

NOTICE OF SEIZURE

To

of

I,  an authorized officer under the Drugs, Poisons and Controlled Substances Act 1981 give notice that I have at         a.m./p.m. on [date] seized on the following grounds:

at [address]

the poisons or controlled substances, other substances or documents described below:

of which you are

Unless you, or a person claiming the poisons or controlled substances, other substances or documents complain to a registrar of the Magistrates' Court within 96 hours of seizure by giving notice of complaint in Form 6 to the Drugs, Poisons and Controlled Substances Regulations 2017, and a copy of that notice to the authorized officer who made the seizure, the poisons or controlled substances, other substances or documents will be destroyed or disposed of in accordance with section 43(4) of the Drugs, Poisons and Controlled Substances Act 1981.

Dated [insert date]

at [place]

at [time]

Authorized Officer

The authorized officer's address for service of any notice of complaint verified by an accompanying statutory declaration is [address].

FORM 6

Regulation 156

Drugs, Poisons and Controlled Substances Regulations 2017

NOTICE OF COMPLAINT IN RESPECT OF A SEIZURE

To the registrar of the Magistrates' Court at [venue]
I,				of
[Full name]						[Address]
claiming the poisons or controlled substances, other substances or documents described below— which were seized by
on		[date]			at			[time], in accordance
with section 43(2) of the Drugs, Poisons and Controlled Substances Act 1981, complain about that seizure.
[Signature of complainant] [Date]
Note:
Section 43(2) of the Drugs, Poisons and Controlled Substances Act 1981 requires that in lodging a notice of complaint to the registrar of the Magistrates' Court—
(a)			the notice must be verified by an accompanying statutory declaration; and
(b)			a copy of the notice and statutory declaration must be given to the authorized officer who made the seizure.

FORM 7

Regulation 17A

Drugs, Poisons and Controlled Substances Regulations 2017

NOTICE OF INTENTION TO PRESCRIBE, AUTHORISE TO ADMINISTER, OR ADMINISTER SCHEDULE 8 MDMA OR SCHEDULE 8 PSILOCYBINE

Section 1: Psychiatrist or medical practitioner's details

First name and surname

Practice address

Qualifications

Health Practitioner Regulation National Law registration number 

TGA Authorised Prescriber approval number (if applicable)

Phone number

Email address

Section 2: Person's details

First name and surname 

Address

Date of birth 

Sex

Name and address of site where the person is receiving treatment 

Substance details

Name of substance 

Proprietary name (if available)

Dose form and strength

Maximum dose and frequency

Anticipated date(s) of administration

Local Australian supplier details

Name and address of local Australian supplier (e.g. pharmacy or wholesaler)

Details of other treatment (if applicable)

Name of Clinical Trial (if applicable)

Clinical Trial Notification ID/Clinical Trial Approval ID (if applicable)

Ethics approval number (if applicable)

Name of Human Research Ethics Committee that granted the ethics approval (if applicable)

SCHEDULE 3––FEES

Column 1 Description of licence or permit

Column 2 Application fee for licence or permit

Column 3 Fee for amendment of licence or permit if amendment requires inspection of premises by an authorized officer

Column 4 Fee for renewal of licence or permit

1     A licence to manufacture and sell or supply by wholesale any Schedule 8 poison or Schedule 9 poison other than heroin.

94·5 fee units

94·5 fee units

20·3 fee units

2     A licence to manufacture and sell or supply by wholesale any Schedule 2 poison, Schedule 3 poison, Schedule 4 poison or Schedule 7 poison or any combination of those poisons.

83·6 fee units

83·6 fee units

18·4 fee units

3     A licence to manufacture and sell or supply by retail a Schedule 7 poison (other than a listed regulated poison).

83·6 fee units

83·6 fee units

18·4 fee units

Column 1 Description of licence or permit

Column 2 Application fee for licence or permit

Column 3 Fee for amendment of licence or permit if amendment requires inspection of premises by an authorized officer

Column 4 Fee for renewal of licence or permit

4     Subject to item 5, a licence to sell or supply by wholesale any Schedule 8 poison or Schedule 9 poison other than heroin.

94·5 fee units

94·5 fee units

20·3 fee units

5     A licence to sell or supply by wholesale by Indent any Schedule 8 poison or Schedule 9 poison other than heroin.

72·8 fee units

72·8 fee units

16·6 fee units

6     Subject to item 7, a licence to sell or supply by wholesale any Schedule 4 poison (alone or together with any Schedule 2 poison, Schedule 3 poison or Schedule 7 poison or any combination of those poisons).

83·6 fee units

83·6 fee units

18·4 fee units

Column 1 Description of licence or permit

Column 2 Application fee for licence or permit

Column 3 Fee for amendment of licence or permit if amendment requires inspection of premises by an authorized officer

Column 4 Fee for renewal of licence or permit

7     A licence to sell or supply by wholesale by Indent any Schedule 4 poison (alone or together with any Schedule 2 poison, Schedule 3 poison or Schedule 7 poison or any combination of those poisons).

72·8 fee units

72·8 fee units

16·6 fee units

8     Subject to item 9, a licence to sell or supply by wholesale any Schedule 2 poison, Schedule 3 poison or Schedule 7 poison or any combination of those poisons.

83·6 fee units

83·6 fee units

18·4 fee units

9     A licence to sell or supply by wholesale by Indent any Schedule 2 poison, Schedule 3 poison or Schedule 7 poison or any combination of those poisons.

72·8 fee units

72·8 fee units

16·6 fee units

Column 1 Description of licence or permit

Column 2 Application fee for licence or permit

Column 3 Fee for amendment of licence or permit if amendment requires inspection of premises by an authorized officer

Column 4 Fee for renewal of licence or permit

10  A licence to sell or supply by retail any Schedule 2 poison.

72·8 fee units

72·8 fee units

16·6 fee units

11  A permit to purchase or obtain and use for industrial, educational, advisory or research purposes any Schedule 8 poison or Schedule 9 poison (alone or together with any Schedule 2 poison, Schedule 3 poison, Schedule 4 poison or Schedule 7 poison or any combination of those poisons).

94·5 fee units

94·5 fee units

20·3 fee units

12  A permit to purchase or obtain and use for industrial, educational, advisory or research purposes any Schedule 2

83·6 fee units

83·6 fee units

18·4 fee units

Column 1 Description of licence or permit

Column 2 Application fee for licence or permit

Column 3 Fee for amendment of licence or permit if amendment requires inspection of premises by an authorized officer

Column 4 Fee for renewal of licence or permit

poison, Schedule 3 poison, Schedule 4 poison or Schedule 7 poison or any combination of those poisons.

13  A permit to purchase or obtain and use any poison or controlled substance for the provision of health services by the following types of health service provider—

Type A (single site with no beds);

72·8 fee units

72·8 fee units

16·6 fee units

Type B (residential aged care with single storage facility (no bed limit) or single site with 1 to 30 beds);

72·8 fee units

72·8 fee units

16·6 fee units

Column 1 Description of licence or permit

Column 2 Application fee for licence or permit

Column 3 Fee for amendment of licence or permit if amendment requires inspection of premises by an authorized officer

Column 4 Fee for renewal of licence or permit

Type C (multiple sites with no beds or single site with 31 to 100 beds);

94·5 fee units

94·5 fee units

20·3 fee units

Type D (multiple sites or single site with more than 100 beds).

94·5 fee units

94·5 fee units

20·3 fee units

14  A drug-checking permit

94·5 fee units

94·5 fee units

20·3 fee units

SCHEDULE 4—DATA SOURCE ENTITIES

Regulation 132A

1eRx Script Exchange Pty Ltd

2MediSecure Pty Ltd

3Any prescription exchange service operating in the Commonwealth, another State or a Territory

4Medication Knowledge Pty Ltd

SCHEDULE 5—MONITORED POISONS

Regulation 132B

1All benzodiazepines that are Schedule 4 poisons

2Codeine when it is a Schedule 4 poison

2AGabapentin

2BPregabalin

3Quetiapine

3ATramadol

4Zolpidem

5Zopiclone

SCHEDULE 6—MONITORED SUPPLY POISONS ON AND AFTER 1 APRIL 2020

Regulation 132C

1All Schedule 8 poisons

2All benzodiazepines that are Schedule 4 poisons

3Codeine when it is a Schedule 4 poison

3AGabapentin

3BPregabalin

4Quetiapine

4ATramadol

5Zolpidem

6Zopiclone

═══════════════

ENDNOTES

1   General information

See for Victorian Bills, Acts and current Versions of legislation and up-to-date legislative information.

The Drugs, Poisons and Controlled Substances Regulations 2017, S.R. No. 29/2017 were made on 16 May 2017 by the Governor in Council under sections 129, 131, 132, 132A and 132B of the Drugs, Poisons and Controlled Substances Act 1981, No. 9719/1981 and came into operation on 23 May 2017: regulation 3.

The Drugs, Poisons and Controlled Substances Regulations 2017 will sunset 10 years after the day of making on 16 May 2027 (see section 5 of the Subordinate Legislation Act 1994).

INTERPRETATION OF LEGISLATION ACT 1984 (ILA)

Style changes

Section 54A of the ILA authorises the making of the style changes set out in Schedule 1 to that Act.

References to ILA s. 39B

Sidenotes which cite ILA s. 39B refer to section 39B of the ILA which provides that where an undivided regulation, rule or clause of a Schedule is amended by the insertion of one or more subregulations, subrules or subclauses the original regulation, rule or clause becomes subregulation, subrule or subclause (1) and is amended by the insertion of the expression "(1)" at the beginning of the original regulation, rule or clause.

Interpretation

As from 1 January 2001, amendments to section 36 of the ILA have the following effects:

•     Headings

All headings included in a Statutory Rule which is made on or after
1 January 2001 form part of that Statutory Rule.  Any heading inserted in a Statutory Rule which was made before 1 January 2001, by a Statutory Rule made on or after 1 January 2001, forms part of that Statutory Rule.
This includes headings to Parts, Divisions or Subdivisions in a Schedule; Orders; Parts into which an Order is divided; clauses; regulations; rules; items; tables; columns; examples; diagrams; notes or forms. 
See section 36(1A)(2A)(2B).

•     Examples, diagrams or notes

All examples, diagrams or notes included in a Statutory Rule which is made on or after 1 January 2001 form part of that Statutory Rule.  Any examples, diagrams or notes inserted in a Statutory Rule which was made before 1 January 2001, by a Statutory Rule made on or after 1 January 2001, form part of that Statutory Rule.  See section 36(3A).

•     Punctuation

All punctuation included in a Statutory Rule which is made on or after
1 January 2001 forms part of that Statutory Rule.  Any punctuation inserted in a Statutory Rule which was made before 1 January 2001, by a Statutory Rule made on or after 1 January 2001, forms part of that Statutory Rule.

See section 36(3B).

•     Provision numbers

All provision numbers included in a Statutory Rule form part of that Statutory Rule, whether inserted in the Statutory Rule before, on or after
1 January 2001.  Provision numbers include regulation numbers, rule numbers, subregulation numbers, subrule numbers, paragraphs and subparagraphs.  See section 36(3C).

•     Location of "legislative items"

A "legislative item" is a penalty, an example or a note.  As from 13 October 2004, a legislative item relating to a provision of a Statutory Rule is taken to be at the foot of that provision even if it is preceded or followed by another legislative item that relates to that provision.  For example, if a penalty at the foot of a provision is followed by a note, both of these legislative items will be regarded as being at the foot of that provision.  See section 36B.

•     Other material

Any explanatory memorandum, table of provisions, endnotes, index and other material printed after the Endnotes does not form part of a Statutory Rule.  See section 36(3)(3D)(3E).

2   Table of Amendments

This publication incorporates amendments made to the Drugs, Poisons and Controlled Substances Regulations 2017 by statutory rules, subordinate instruments and Acts.

–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––

Drugs, Poisons and Controlled Substances Amendment (Dental Assistants) Regulations 2018, S.R. No. 31/2018

Date of Making:	20.3.18
Date of Commencement:	26.3.18: reg. 3

Drugs, Poisons and Controlled Substances Amendment (Medically Supervised Injecting Centre) Regulations 2018, S.R. No. 45/2018

Date of Making:	10.4.18
Date of Commencement:	10.4.18

Drugs, Poisons and Controlled Substances Amendment (Real-time Prescription Monitoring) Regulations 2018, S.R. No. 72/2018

Date of Making:	5.6.18
Date of Commencement:	2.7.18: reg. 3

Drugs, Poisons and Controlled Substances Further Amendment Regulations 2018, S.R. No. 178/2018

Date of Making:	23.10.18
Date of Commencement:	24.10.18: reg. 3

Drugs, Poisons and Controlled Substances Amendment (Monitored Poisons Database) Regulations 2020, S.R. No. 15/2020

Date of Making:	3.3.20
Date of Commencement:	3.3.20

Drugs, Poisons and Controlled Substances Amendment (Residential Medication Chart) Regulations 2020, S.R. No. 73/2020

Date of Making:	21.7.20
Date of Commencement:	23.7.20: reg. 3

Drugs, Poisons and Controlled Substances Amendment (Nurses and Midwives) Regulations 2021, S.R. No. 13/2021

Date of Making:	10.3.21
Date of Commencement:	1.7.21: reg. 3

Drugs, Poisons and Controlled Substances Amendment (Non-Emergency Patient Transport and First Aid Services) Regulations 2021, S.R. No. 174/2021

Date of Making:	21.12.21
Date of Commencement:	21.12.21: reg. 3

Drugs, Poisons and Controlled Substances Amendment (Schedule 8 Cannabis and Schedule 8 Tetrahydrocannabinol) Regulations 2022, S.R. No. 13/2022

Date of Making:	15.2.22
Date of Commencement:	28.2.22: reg. 3

Drugs, Poisons and Controlled Substances Amendment (Registered Aboriginal and Torres Strait Islander Health Practitioners) Regulations 2022, S.R. No. 16/2022

Date of Making:	22.2.22
Date of Commencement:	22.2.22

Drugs, Poisons and Controlled Substances Amendment (Schedule 9 Poisons) Regulations 2022, S.R. No. 96/2022

Date of Making:	27.9.22
Date of Commencement:	27.9.22: reg. 3

Drugs, Poisons and Controlled Substances Amendment (Continued Dispensing) Regulations 2022, S.R. No. 112/2022

Date of Making:	11.10.22
Date of Commencement:	18.10.22: reg. 3

Drugs, Poisons and Controlled Substances Amendment (Naloxone) Regulations 2022, S.R. No. 113/2022

Date of Making:	11.10.22
Date of Commencement:	12.10.22: reg. 3

Drugs, Poisons and Controlled Substances Amendment (Image-Based Prescribing) Regulations 2023, S.R. No. 20/2023

Date of Making:	28.3.23
Date of Commencement:	31.3.23: reg. 3

Drugs, Poisons and Controlled Substances Amendment Regulations 2023, S.R. No. 46/2023

Date of Making:	6.6.23
Date of Commencement:	3.7.23: reg. 3

Drugs, Poisons and Controlled Substances Amendment (MDMA and Psilocybine) Regulations 2023, S.R. No. 61/2023

Date of Making:	27.6.23
Date of Commencement:	1.7.23: reg. 3

Drugs, Poisons and Controlled Substances Amendment (Authorising Pharmacists) Regulations 2023, S.R. No. 105/2023

Date of Making:	3.10.23
Date of Commencement:	3.10.23

Drugs, Poisons and Controlled Substances Amendment (Pill Testing) Regulations 2024, S.R. No. 126/2024

Date of Making:	12.11.24
Date of Commencement:	12.11.24

Drugs, Poisons and Controlled Substances Amendment (Aboriginal and Torres Strait Islander Health Practitioner and Worker) Regulations 2025, S.R. No. 124/2025

Date of Making:	25.11.25
Date of Commencement:	25.11.25

–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––

3   Explanatory details

[1] Sch. 1 item 1: S.R. No. 57/2006. Reprint No. 2 as at 21 October 2016. Reprinted to S.R. No. 132/2016. Extended in operation by S.R. No. 42/2016 and subsequently amended by S.R. Nos 134/2016 and 13/2017.

[2] Sch. 1 item 2: S.R. No. 63/2007.

[3] Sch. 1 item 3: S.R. No. 16/2009.

[4] Sch. 1 item 4: S.R. No. 131/2010.

[5] Sch. 1 item 5: S.R. No. 136/2012.

[6] Sch. 1 item 6: S.R. No. 107/2013.

[7] Sch. 1 item 7: S.R. No. 50/2013.

[8] Sch. 1 item 8: S.R. No. 108/2013.

[9] Sch. 1 item 9: S.R. No. 194/2014.

[10] Sch. 1 item 10: S.R. No. 14/2015.

[11] Sch. 1 item 11: S.R. No. 20/2016.

[12] Sch. 1 item 12: S.R. No. 134/2016.

[13] Sch. 1 item 13: S.R. No. 132/2016.

[14] Sch. 1 item 14: S.R. No. 13/2017.

——

Fee Units

These Regulations provide for fees by reference to fee units within the meaning of the Monetary Units Act 2004. The amount of the fee is to be calculated, in accordance with section 7 of that Act, by multiplying the number of fee units applicable by the value of a fee unit.

The value of a fee unit for the financial year commencing 1 July 2025 is $16.81. The amount of the calculated fee may be rounded to the nearest 10 cents.

The value of a fee unit for future financial years is to be fixed by the Treasurer under section 5 of the Monetary Units Act 2004. The value of a fee unit for a financial year must be published in the Government Gazette and a Victorian newspaper before 1 June in the preceding financial year.

Penalty Units

These Regulations provide for penalties by reference to penalty units within the meaning of section 110 of the Sentencing Act 1991. The amount of the penalty is to be calculated, in accordance with section 7 of the Monetary Units Act 2004, by multiplying the number of penalty units applicable by the value of a penalty unit.

The value of a penalty unit for the financial year commencing 1 July 2025 is $203.51. The amount of the calculated penalty may be rounded to the nearest dollar.

The value of a penalty unit for future financial years is to be fixed by the Treasurer under section 5 of the Monetary Units Act 2004. The value of a penalty unit for a financial year must be published in the Government Gazette and a Victorian newspaper before 1 June in the preceding financial year.

——

Table of Applied, Adopted or Incorporated Matter

The following table of applied, adopted or incorporated matter was included in S.R. No. 29/2017 in accordance with the requirements of regulation 5 of the Subordinate Legislation Regulations 2014.

Statutory Rule Provision	Title of applied, adopted or incorporated document	Matter in applied, adopted or incorporated document
Regulation 5(1) (definition of National Health (Continued Dispensing) Determination 2012	National Health (Continued Dispensing) Determination 2012, made under the National Health Act 1953 of the Commonwealth	The whole
Regulation 5(1) (definition of Schedule 8 cannabis)	Poisons Standard	Schedule 8
Regulation 5(1) (definition of Schedule 8 tetrahydrocannabinol)	Poisons Standard	Schedule 8

——

Table of Applied, Adopted or Incorporated Matter

The following table of applied, adopted or incorporated matter was included in S.R. No. 13/2021 in accordance with the requirements of regulation 5 of the Subordinate Legislation Regulations 2014.

In this table, Principal Regulations means the Drugs, Poisons and Controlled Substances Regulations 2017.

Statutory rule provision	Title of applied, adopted or incorporated document	Matter in applied, adopted or incorporated document
Regulation 5 which inserts the definition of the Primary Clinical Care Manual in regulation 5(1) of the Principal Regulations	The Primary Clinical Care Manual as published from time to time by the State of Queensland (Queensland Health) and the Royal Flying Doctor Service (Queensland Section).	The whole

——

Table of Applied, Adopted or Incorporated Matter

The following table of applied, adopted or incorporated matter was included in S.R. No. 112/2022 in accordance with the requirements of regulation 5 of the Subordinate Legislation Regulations 2014.

Statutory rule provision	Title of applied, adopted or incorporated document	Matter in applied, adopted or incorporated document
Regulation 5 which substitutes the definition of National Health (Continued Dispensing) Determination 2012 with the definition of National Health (Continued Dispensing) Determination 2022 in regulation 5 of the Drugs, Poisons and Controlled Substances Regulations 2017	National Health (Continued Dispensing) Determination 2022 made under the National Health Act 1953 of the Commonwealth	The whole
Regulation 6 which amends regulation 57(b) and (c) of the Drugs, Poisons and Controlled Substances Regulations 2017	National Health (Continued Dispensing) Determination 2022 made under the National Health Act 1953 of the Commonwealth	The whole