Drugs, Poisons and Controlled Substances Amendment (Pill Testing) Regulations 2024 (Vic)
Drugs, Poisons and Controlled Substances Amendment (Pill Testing) Regulations 2024
S.R. No. 126/2024
TABLE OF PROVISIONS
Regulation Page
1Objectives
2Authorising provisions
3Principal Regulations
4Definitions
5Persons authorised to possess Schedule 4, 8 and 9 poisons
6New regulation 35A inserted
7New regulation 44A inserted
8General security requirement—Schedule 4 poisons
9Storage of Schedule 8 and 9 poisons and drugs of dependence
10Definition of transaction
11Exceptions
12New regulation 132I inserted
13Possession and supply of Schedule 3 naloxone by approved naloxone provider
14Licences, permits or warrants required for special Schedule 7 substances
15New Chapter 3B inserted
16Transfer of poisons to inappropriate containers prohibited
17Regulation 152 amended
18Access to certain poisons restricted to a needs basis
19New regulation 163B inserted
20Schedule 3 amended
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Endnotes
STATUTORY RULES 2024
S.R. No. 126/2024
Drugs, Poisons and Controlled Substances Act 1981
Drugs, Poisons and Controlled Substances Amendment (Pill Testing) Regulations 2024
The Governor in Council makes the following Regulations:
Dated: 12 November 2024
Responsible Minister:
MARY-ANNE THOMAS
Minister for HealthSAMUAL WALLACE
Clerk of the Executive Council
1Objectives
The objectives of these Regulations are to amend the Drugs, Poisons and Controlled Substances Regulations 2017 to—
(a)prescribe matters related to drug-checking services; and
(b)provide for the supply of Schedule 3 naloxone for the treatment of opioid overdoses by an approved naloxone provider by means of an automatic machine.
2Authorising provisions
These Regulations are made under sections 22CJ, 129, 132 and 132B of the Drugs, Poisons and Controlled Substances Act 1981.
3Principal Regulations
In these Regulations, the Drugs, Poisons and Controlled Substances Regulations 2017[1] are called the Principal Regulations.
4Definitions
In regulation 5(1) of the Principal Regulations insert the following definitions—
"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;
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;".
5Persons authorised to possess Schedule 4, 8 and 9 poisons
(1)In Column 1 of item 1 of the Table to regulation 7(1) of the Principal Regulations, after "permit" insert "(other than a drug-checking permit)".
(2)In Column 1 of item 5 of the Table to regulation 7(1) of the Principal Regulations, after "supplied" insert "(other than as authorised by section 20AA(1)(b) or (2)(a) of the Act)".
(3)In Column 1 of item 6 of the Table to regulation 7(1) of the Principal Regulations, after "supplied" insert "(other than as authorised by section 20AA(1)(b) or (2)(a) of the Act)".
(4)In Column 1 of item 7 of the Table to regulation 7(1) of the Principal Regulations, after "supplied" insert "(other than as authorised by section 20AA(1)(b) or (2)(a) of the Act)".
(5)After item 10 of the Table to regulation 7(1) of the Principal Regulations insert—
"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.".
6New regulation 35A inserted
After the heading to Part 5 of Chapter 2 of the Principal Regulations insert—
"35A Part does not apply to drug-checking services
A reference in this Part to supply does not include supply authorised by section 20AA(1)(b) or (2)(a) or 22CD(1)(b) of the Act.".
7New regulation 44A inserted
After the heading to Division 1 of Part 6 of Chapter 2 of the Principal Regulations insert—
"44A Part does not apply to drug-checking services
A reference in this Part to supply does not include supply authorised by section 20AA(1)(b) or (2)(a) or 22CD(1)(b) of the Act.".
8General security requirement—Schedule 4 poisons
In regulation 73(1)(b) of the Principal Regulations, after "permit" insert "(other than a drug-checking permit)".
9Storage of Schedule 8 and 9 poisons and drugs of dependence
In regulation 74(1)(b) of the Principal Regulations, after "permit" insert "(other than a drug-checking permit)".
10Definition of transaction
At the end of regulation 106 of the Principal Regulations insert—
"(2)However, a reference in subregulation (1) to a Schedule 4 poison, Schedule 8 poison or Schedule 9 poison does not refer to a poison of any of those kinds that is, or that is contained in, a drug-checking substance.".
11Exceptions
(1)After regulation 115(3) of the Principal Regulations insert—
"(3A)Subject to subregulation (7), regulation 114 does not apply to a Schedule 8 poison or Schedule 9 poison if—
(a)it is destroyed by a special drug‑checking worker in the presence of another person who is a special drug‑checking worker or a registered medical practitioner, pharmacist, veterinary practitioner, dentist, nurse or registered midwife; and
(b)the details of the destruction are recorded in the records required to be kept under regulation 108, including—
(i)the name, strength and quantity of the poisons destroyed; and
(ii)the method and place of destruction; and
(iii)the names of the persons carrying out the destruction; and
(iv)the names of the witnesses.".
(2)In regulation 115(7) of the Principal Regulations, after "(3)," insert "(3A),".
12New regulation 132I inserted
After regulation 132H of the Principal Regulations insert—
"132I Circumstances where it is not mandatory to check monitored poisons database—drug-checking services
For the purposes of sections 30E, 30F, 30G and 30H of the Act, a pharmacist, a registered medical practitioner, a nurse practitioner or an authorised supplier (as the case requires) is not required to comply with the relevant section in relation to a person for whom a monitored supply poison may be supplied before supplying the monitored supply poison for that person if the supply is authorised by section 20AA(1)(b) or (2)(a) of the Act.".
13Possession and supply of Schedule 3 naloxone by approved naloxone provider
(1)In regulation 133F(2) of the Principal Regulations, for "subregulations (3) and (4)" substitute "subregulation (3)".
(2)After regulation 133F(3) of the Principal Regulations insert—
"(3A)Subject to subregulation (3B), an approved naloxone provider is authorised to supply Schedule 3 naloxone for the treatment of opioid overdose by means of an automatic machine if that supply is in accordance with the conditions (if any) specified in the provider's approval under regulation 161D.
(3B)An approved naloxone provider must not place Schedule 3 naloxone into an automatic machine by means of which the naloxone is to be supplied for the treatment of opioid overdose unless the naloxone is in a container on which there is a label that uniquely identifies the provider.
Penalty:50 penalty units.".
14Licences, permits or warrants required for special Schedule 7 substances
In regulation 149 of the Principal Regulations, for "unless the person holds a licence, permit or warrant issued under the Act" substitute "unless the person is authorised, licensed or permitted under the Act or these Regulations to do so".
15New Chapter 3B inserted
After Chapter 3A of the Principal Regulations insert—
"CHAPTER 3B—DRUG-CHECKING SERVICES
149DInterpretation
(1)Each of the following is a drug-checking transaction for the purposes of this Part—
(a)receiving a substance as authorised by section 20AA(1)(a) or (2)(b) of the Act;
(b)supplying a substance as authorised by section 20AA(1)(b) or (2)(a) of the Act;
(c)analysing a substance as authorised by section 20AA(1)(c) or (2)(b)(i) of the Act;
(d)destroying a substance as authorised by section 20AA(1)(d) or (2)(b)(ii) of the Act.
(2)A substance received, supplied, analysed or destroyed as referred to in subregulation (1) is a transacted substance for the purposes of this Part.
149EPrescribed requirements for drug‑checking directors
For the purposes of paragraph (b) of the definition of drug-checking director in section 4(1) of the Act, the prescribed requirement is at least 2 years of experience in operational management in the provision of alcohol and other drug treatment services or harm reduction services.
149FPrescribed qualifications for special drug‑checking workers
(1)For the purposes of the definition of special drug-checking worker in section 4(1) of the Act, the prescribed qualification is a bachelor degree in, or with a major in, any of the following areas, however described—
(a)chemistry;
(b)pharmacology;
(c)forensic science;
(d)forensic toxicology.
(2)A qualification approved by the Secretary under regulation 163B is also a prescribed qualification for the purposes of the definition of special drug-checking worker in section 4(1) of the Act.
149GConditions of drug-checking permit—record-keeping
(1)For the purposes of section 20AAB(1)(a) of the Act, the prescribed matters of which the holder of a drug-checking permit must keep records are the following matters in respect of each drug-checking transaction carried out by the holder of the permit or by a special drug-checking worker engaged by the holder of the permit—
(a)the date of the drug-checking transaction;
(b)the name of the person who carried out the drug-checking transaction;
(c)the quantity of the transacted substance;
(d)if the person carrying out the transaction knows which poisons, controlled substances or drugs of dependence are present in the transacted substance, the name of each poison, controlled substance or drug of dependence;
(e)if the person carrying out the transaction does not know which poisons, controlled substances or drugs of dependence the transacted substance contains, a description of the appearance of the substance;
Example
A description of the substance's colour, consistency and form.
(f)if the drug-checking transaction is the supply of a substance to the holder of another permit as authorised by section 20AA(2)(a) of the Act, the name and address of the holder of that other permit;
(g)if the drug-checking transaction is the receipt of a substance from the holder of another permit as authorised by section 20AA(2)(b) of the Act, the name and address of the holder of that other permit;
(h)if the drug-checking transaction is the destruction of a substance as authorised by section 20AA(1)(d) or (2)(b)(ii) of the Act—
(i)the method and place of destruction; and
(ii)the name of the person in whose presence the substance is destroyed as required by regulation 149J(1)(b).
(2)Additionally, for the purposes of section 20AAB(1)(a) of the Act, the prescribed matters of which the holder of a drug‑checking permit must keep records includes the transacted substances currently possessed under the permit.
(3)For the purposes of section 20AAB(1)(a) of the Act, the holder of a drug-checking permit must ensure that the records required to be kept under the condition set out in that provision—
(a)are able to be readily sorted by reference to the poison, controlled substance or drug of dependence contained in the transacted substances; and
(b)are readily retrievable in English; and
(c)are kept by the holder of the permit in a readily retrievable form for 3 years from the date of the drug-checking transaction; and
(d)are produced on demand to an authorized officer; and
(e)are maintained in a manner that ensures that the records cannot be altered, destroyed, deleted or removed without detection.
(4)For the purposes of section 20AAB(1)(a) of the Act, the holder of a drug-checking permit must not make, or cause to be made, a record referred to in that provision that the holder of the permit knows to be false or misleading.
(5)The holder of a drug-checking permit must notify the Secretary without delay of the circumstances of any loss, destruction or theft of records kept by the holder of the permit as required by the condition set out in section 20AAB(1)(a) of the Act.
149HStorage of substances
(1)The holder of a mobile drug-checking permit must store the drug-checking substances and calibration substances that the holder of the permit possesses in a lockable storage facility that, at all times during which a drug‑checking service is provided by the holder of the permit, remains secured to prevent unauthorised removal of the storage facility.
(2)Subregulation (1) does not apply to the holder of a mobile drug-checking permit to whom the Secretary has given a direction under regulation 149I(1).
(3)The holder of a fixed site drug-checking permit must store the drug-checking substances and calibration substances that the holder of the permit possesses in a lockable storage facility that provides security at least equivalent to a storage facility that is—
(a)constructed of mild steel plate of 10 mm thickness; and
(b)constructed with continuous welding of all edges; and
(c)fitted with a door constructed of mild steel plate of 10 mm thickness, swung on hinges welded to the door and body of the cabinet, the door being flush fitting with a clearance around the door of not more than 1·5 mm; and
(d)fitted with a fixed locking bar, welded to the inside face of the door near the hinge edge, which engages in a rebate when the door is closed; and
(e)fitted with a 6 lever lock securely affixed to the rear face of the door; and
(f)securely attached to a wall or floor in such a manner that it will resist attack by hand tools for 30 minutes or power tools for 5 minutes.
(4)Subregulation (3) does not apply to the holder of a fixed site drug-checking permit to whom the Secretary has given a direction under regulation 149I(1).
(5)A person who holds a drug-checking permit and to whom the Secretary has given a direction under regulation 149I(1) must store the drug-checking substances and calibration substances that the holder of the permit possesses in accordance with that direction.
(6)For the purpose of preventing unauthorised access to drug-checking substances and calibration substances, the holder of a drug‑checking permit must take all reasonable steps to ensure that a storage facility referred to in subregulation (1) or (3), or in which storage of substances is required under subregulation (5), remains locked and secured at all times, except when it is necessary to open it to carry out an essential operation in connection with the substances stored in it.
Penalty:100 penalty units.
(7)The holder of a drug-checking permit must take all reasonable steps to ensure that a storage facility referred to in subregulation (1) or (3), or in which storage of substances is required under subregulation (5), is used only for the storage of—
(a)drug-checking substances; and
(b)calibration substances; and
(c)the substances that are specified in, or that belong to a class specified in, an approval granted to the holder of the permit by the Secretary under regulation 149I(2).
Penalty:100 penalty units.
(8)The holder of a drug-checking permit must keep each drug-checking substance or calibration substance that—
(a)the holder of the permit possesses; and
(b)is being transported for use in another place—
in a locked storage facility which is secured to prevent unauthorised access to those poisons.
Penalty:100 penalty units.
149IAdditional security provisions required in certain circumstances
(1)Subject to subregulation (3), the Secretary may direct the holder of a drug-checking permit to provide more secure storage for drug-checking substances and calibration substances than that described in regulation 149H(1) or (3).
(2)Subject to subregulation (3), the Secretary may grant an approval in writing for the holder of a drug-checking permit to store, in the same storage facility as drug-checking substances and calibration substances, any other substance specified, or belonging to a class that is specified, in the approval.
(3)Before giving a direction under subregulation (1) or granting approval under subregulation (2), the Secretary—
(a)must have regard to—
(i)the nature and quantity of the drug-checking substances and calibration substances that are to be stored; and
(ii)the location, layout and construction of the storage facility and the premises; and
(iii)the warning devices and detectors with which the storage facility and premises are equipped; and
(iv)the previous or anticipated number and frequency of drug-checking transactions carried out under the drug-checking permit; and
(v)the number of persons requiring access; and
(b)may have regard to any other factors the Secretary considers relevant in the circumstances.
149JDestruction of drug-checking substances
(1)The holder of a drug-checking permit must ensure that any drug-checking substance that is required to be destroyed by a condition included in that permit under section 20AAB(2) of the Act is destroyed—
(a)by a special drug-checking worker engaged by the holder of the permit; and
(b)in the presence of—
(i)another special drug-checking worker engaged by the holder of the permit; or
(ii)a registered medical practitioner, pharmacist, veterinary practitioner, dentist, nurse or registered midwife; and
(c)in compliance with any requirements specified in a direction given to the holder of the permit by the Secretary under subregulation (2).
(2)The Secretary may direct the holder of a drug-checking permit, in writing, to comply with any requirements specified in the direction in relation to the destruction of a drug-checking substance.
149KFit and proper person consultation
(1)The Secretary must give a copy of an application for a drug-checking permit to the Chief Commissioner of Police within 7 days of receiving the application.
(2)The Chief Commissioner of Police may advise the Secretary of any matters that the Chief Commissioner of Police believes are relevant to whether the applicant is a fit and proper person.
(3)Advice under subregulation (2) may be given at any time within 21 days from the day on which the copy of the application is given under subregulation (1).
149LSecretary must allow time for Chief Commissioner of Police to give advice
The Secretary must not determine an application for a drug-checking permit until either of the following has occurred—
(a)the Chief Commissioner has advised the Secretary under regulation 149K(2); or
(b)the period provided by regulation 149K(3) for the giving of that advice has elapsed.
149MMatters the Secretary must consider before issuing drug-checking permit
(1)Before issuing a drug-checking permit to a person under section 19(3) of the Act the Secretary must consider whether the applicant is of good repute, having regard to—
(a)the applicant's character, honesty and integrity; and
(b)if the Chief Commissioner of Police advises the Secretary under regulation 149K(2), the contents of that advice.
(2)If the Chief Commissioner gives the Secretary advice referred to in regulation 149K(2) after the elapsing of the period provided by regulation 149K(3), the Secretary may have regard to that advice in determining the application but is not required to do so.
149NFit and proper person requirements
(1)Subject to subregulation (3), the requirements that a person must meet in order to be a fit and proper person in relation to the issue of a drug-checking permit are—
(a)that the person has not in the previous 10 years been found guilty of an indictable offence involving fraud, dishonesty or assault; and
(b)that the person has not in the previous 10 years been found guilty of an offence against the Act with a penalty of imprisonment of more than one year; and
(c)that the person has not in the previous 10 years been found guilty of an offence equivalent to an offence referred to in paragraph (a) or (b) under the law of another jurisdiction; and
(d)that the person has not in the previous 10 years had a licence, permit or warrant they held under the Act cancelled or suspended under section 22C(1)(a), (b), (ba) or (c) of the Act; and
(e)that, if the person is a body corporate, each officer of the body corporate also meets the requirements of the other paragraphs of this subregulation.
(2)A person is not to be taken, for the purposes of subregulation (1)(a), (b) and (c), to have been found guilty of an offence if the finding of guilt in respect of that offence is a spent conviction within the meaning of the Spent Convictions Act 2021.
(3)In determining whether a person is a fit and proper person in relation to the issue of a drug-checking permit, the Secretary may determine not to apply a requirement set out in subregulation (1)(a), (b) or (c) in relation to—
(a)that person; or
(b)if that person is a body corporate, either the body corporate or an officer of that body corporate—
if the Secretary is satisfied that the person is a fit and proper person despite that requirement not being met.
(4)In deciding whether to be satisfied as described in subregulation (3), the Secretary must have regard to—
(a)the seriousness of the conduct constituting the offence of which the person was found guilty; and
(b)the age of the person when the offence was committed; and
(c)the length of time since the conduct occurred; and
(d)the person's conduct since the offence occurred; and
(e)the public interest in enabling the provision of harm reduction information by a drug-checking service; and
(f)any other matter that the Secretary considers relevant.".
16Transfer of poisons to inappropriate containers prohibited
At the end of regulation 151 of the Principal Regulations insert—
"(2)This regulation does not apply in relation to a drug-checking substance.".
17Regulation 152 amended
(1)In the heading to regulation 152 of the Principal Regulations, for "poisons" substitute "substances".
(2)In regulation 152(2) of the Principal Regulations, for "poison or controlled substance" substitute "poison, controlled substance or drug-checking substance".
18Access to certain poisons restricted to a needs basis
In regulation 154 of the Principal Regulations—
(a)for "Schedule 8 poison or Schedule 9 poison" substitute "Schedule 8 poison, Schedule 9 poison or drug-checking substance";
(b)for "that poison or controlled substance" (wherever occurring) substitute "that poison or substance".
19New regulation 163B inserted
After regulation 163A of the Principal Regulations insert—
"163B Secretary may approve qualification of special drug-checking worker
The Secretary, by notice published in the Government Gazette, may approve a specified qualification, or all qualifications of a specified class, for the purposes of regulation 149F(2).".
20Schedule 3 amended
After item 13 in the table in Schedule 3 to the Principal Regulations insert—
"14 A drug-checking permit 94·5 fee units 94·5 fee units 20·3 fee units".
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ENDNOTES
[1] Reg. 3: S.R. No. 29/2017 as amended by S.R. Nos 31/2018, 45/2018, 72/2018, 178/2018, 15/2020, 73/2020, 13/2021, 174/2021, 13/2022, 16/2022, 96/2022, 112/2022, 113/2022, 20/2023, 46/2023, 61/2023 and 105/2023.
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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 2024 is $16.33. 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 2024 is $197.59. 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.
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