NORTHERN TERRITORY OF AUSTRALIA
MEDICINES, POISONS AND THERAPEUTIC GOODS REGULATIONS 2014
As in force at 10 February 2026
Table of provisions
Part 1 Preliminary matters
1 Citation ............................................................................................ 1
2 Commencement .............................................................................. 1
3 Definitions ........................................................................................ 1
3A Meaning of amphetamine ................................................................ 2
4 Australian/New Zealand Standard ................................................... 2
5 Corresponding law........................................................................... 3
6 Modification of medicines and poisons standard ............................. 3
Part 2 Dealing with Scheduled substances
Division 1 Requisitions, prescriptions and administration
and supply orders
7 Written requisition to pharmacist ..................................................... 3
7A Prescribed conditions ...................................................................... 4
7B Prohibited circumstance .................................................................. 4
8 Prescription issued by health practitioner ........................................ 4
9 Prescription issued by veterinarian .................................................. 6
10 Additional requirements for prescription for Schedule 8
substance ........................................................................................ 6
11 Prescription may be issued to agent................................................ 6
12 Conditions on which prescription may be issued to partner ............. 7
13 Administration order ........................................................................ 7
14 Supply order – person discharged from hospital ............................. 7
15 Supply order – nurse at residential facility ....................................... 8
16 Supply order – person in charge of declared place ......................... 9
17 Formal requirements for requisitions, prescriptions and
administration and supply orders ..................................................... 9
Division 1A Administering, supplying and possessing
Scheduled substances under SSTP
17A Prescribed health practitioners ...................................................... 10
17B Prescribed healthcare workers ...................................................... 10
17C Content of SSTP............................................................................ 11
Division 2 Dealings to be witnessed
18 Record of supply or administration of Schedule 8 substance ........ 11
Medicines, Poisons and Therapeutic Goods Regulations 2014 ii
19 Destruction of Schedule 8 substance ............................................ 11
20 Administration of Schedule 9 substance must be witnessed ......... 12
21 Destruction of Schedule 9 substance ............................................ 12
Division 3 Storage and transport
22 Storage of Schedule 2 substance by retailer ................................. 12
23 Storage of Schedule 3 substance by authority holder ................... 13
24 Storage of Schedule 2, 3 or 4 substance at pharmacy .................. 13
25 Storage of Schedule 4 substance by authority holder ................... 14
26 Storage of Schedule 4 substance at residential facility or
declared place ............................................................................... 14
27 Storage of methylated spirit ........................................................... 15
28 Storage of Schedule 7 substance by manufacturer or
wholesaler ..................................................................................... 15
29 Storage of Schedule 7 substance by retailer ................................. 16
30 Storage of Schedule 7 substance by authority holder ................... 16
31 Storage of Schedule 8 substance .................................................. 17
32 Delivery person must not leave certain Scheduled substances
unattended..................................................................................... 18
Division 4 Packaging and labelling
33 Packaging requirements ................................................................ 18
34 Labelling requirements .................................................................. 18
35 Container not to be used for human-use substance ...................... 19
Division 5 Manufacture, supply and use of paints
36 Paint applied to premises, structures and furniture........................ 19
37 Paint for toys.................................................................................. 19
38 Paint containing pesticide .............................................................. 19
Division 6 Advertising
39 Pharmacist pricelist advertising certain Scheduled substances..... 20
Part 3 Authorities to deal with Scheduled
substances
40 Additional conditions – certificate of registration ............................ 20
41 Duration of Schedule 8 authorisation for treating child's ADHD ..... 20
42 Contents of authority ..................................................................... 21
43 Authority holder to give notice of change of particulars ................. 21
Section 1 - MEDICINES, POISONS AND THERAPEUTIC GOODS REGULATIONS 2014 - MEDICINES, POISONS AND THERAPEUTIC GOODS REGULATIONS 2014 | Zoe
Medicines, Poisons and Therapeutic Goods Regulations 2014 iii
Part 4 Scheduled substance registers
Division 1 Maintaining Scheduled substance registers
Subdivision 1 Pseudoephedrine register
44 Keeping of register ........................................................................ 21
45 Details to be recorded ................................................................... 22
Subdivision 2 Schedule 4 register
46 Keeping of register ........................................................................ 22
47 Details to be recorded ................................................................... 22
Subdivision 3 Schedule 7 register
48 Keeping of register ........................................................................ 23
49 Details to be recorded ................................................................... 23
Subdivision 4 Schedule 8 register
50 Maintenance of register – persons in charge of premises ............. 23
51 Keeping of register – medical kit holder......................................... 26
52 Keeping of register – other persons............................................... 26
53 Form of Schedule 8 register .......................................................... 26
54 Details to be recorded ................................................................... 26
Subdivision 5 Schedule 9 register
55 Keeping of register ........................................................................ 28
56 Form of Schedule 9 register .......................................................... 28
57 Details to be recorded ................................................................... 28
Subdivision 6 Manufacturer/wholesaler/Schedule 4 supplier
58 Keeping of register ........................................................................ 29
59 Details to be recorded ................................................................... 29
Subdivision 7 General requirements
60 Form of register entries ................................................................. 29
61 Period of retention of registers....................................................... 30
Division 2 Offences relating to Scheduled substance
registers
62 Offence not to maintain register..................................................... 30
63 Offence not to sign entry................................................................ 30
64 Offence to make false or misleading entry .................................... 30
65 Offence to change entry ................................................................ 31
Medicines, Poisons and Therapeutic Goods Regulations 2014 iv
66 Offence not to record details of supply of pseudoephedrine .......... 31
67 Offence not to sign register after certain dealings with
Schedule 8 or 9 substance ............................................................ 31
68 Offence not to sign register after witnessing certain dealings
with Schedule 8 or 9 substance ..................................................... 32
69 Offence not to ensure witness signs register after certain
dealings with Schedule 8 or 9 substance ...................................... 32
70 Offence not to maintain register where substance kept ................. 33
71 Offence not to report possible loss etc. of Scheduled
substance ...................................................................................... 33
72 Offence not to report destruction, loss etc. of register ................... 33
Part 5 Other records and notices
Division 1 General requirements
73 Retention of documents relating to receipt or supply of
Scheduled substances .................................................................. 34
74 Retention of prescriptions .............................................................. 34
75 Record of supply or administration of Schedule 4 or 8
substance in clinical or other records ............................................ 34
76 Form and period of retention of records ........................................ 35
Division 2 Offences relating to records and notices
77 Offence not to make or keep record .............................................. 36
78 Offence not to give fraudulent prescription to police ...................... 36
79 Offence not to report supply or administration of Schedule 8
substance at declared place .......................................................... 36
80 Offence not to report administration of Schedule 8 substance
from medical kit ............................................................................. 37
Part 6 Legal proceedings
81 Declared provisions ....................................................................... 37
81A Declared provisions ....................................................................... 37
Part 6A Monitored medicines database
81B Definitions ...................................................................................... 37
81C Monitored medicine ....................................................................... 37
81D Database name ............................................................................. 38
81E Information to be given to CHO ..................................................... 38
81F Prescription issued by relevant prescriber in exempt
circumstances................................................................................ 39
81G Supply made by pharmacist in exempt circumstances .................. 39
Medicines, Poisons and Therapeutic Goods Regulations 2014 v
Part 7 Infringement notice offences
82 Infringement notice offence and prescribed amount payable ........ 40
83 When infringement notice may be given ........................................ 40
84 Contents of infringement notice ..................................................... 40
85 Payment by cheque ....................................................................... 41
86 Withdrawal of infringement notice.................................................. 41
87 Application of Part ......................................................................... 41
Part 8 Miscellaneous matters
89 Information in register of authorities .............................................. 42
90 Appointed Committee members .................................................... 43
91 Fees .............................................................................................. 43
Schedule 1 Infringement notice offences and
prescribed amounts
Schedule 2 Fees
ENDNOTES
NORTHERN TERRITORY OF AUSTRALIA
As in force at 10 February 2026
MEDICINES, POISONS AND THERAPEUTIC GOODS REGULATIONS 2014
Regulations under the Medicines, Poisons and Therapeutic Goods
Act 2012
Part 1 Preliminary matters
1 Citation
These Regulations may be cited as the Medicines, Poisons and
Therapeutic Goods Regulations 2014.
2 Commencement
These Regulations commence on the commencement of the
Medicines, Poisons and Therapeutic Goods Act 2012.
3 Definitions
In these Regulations:
amphetamine, see regulation 3A.
custodial correctional facility, for Part 6A, see regulation 81B.
infringement notice, see regulation 83.
infringement notice offence, see regulation 82(1).
key includes an electronic swipe card and electronic proximity
device.
maintain, in relation to a Scheduled substance register, means
keep the register or ensure the register is kept.
personal custody, of a key by a person, includes keeping the key
in a combination-operated key safe, the combination of which the
person keeps confidential.
Part 1 Preliminary matters
Medicines, Poisons and Therapeutic Goods Regulations 2014 2
pharmacist-in-charge:
(a) of a pharmacy – means the person appointed under
Schedule 7, clause 7(1) of the Health Practitioners Act 2004 to
be the pharmacist-in-charge of the pharmacy business carried
on in the pharmacy; or
(b) of a pharmacy department – means the person appointed
under Schedule 7, clause 7(3) of the Health Practitioners
Act 2004 to be the pharmacist-in-charge of the pharmacy
department.
pharmacy department, see Schedule 7, clause 1 of the Health
Practitioners Act 2004.
prescribed amount, see regulation 82(2).
prisoner, for Part 6A, see regulation 81B.
Scheduled substance register means a register required to be
maintained under Part 4, Division 1.
Schedule 8 register means a register in relation to Schedule 8
substances required to be kept under regulation 50, 51 or 52.
3A Meaning of amphetamine
(1) An amphetamine includes:
(a) beta-aminoisopropylbenzene; and
(b) a substance structurally derived from amphetamine or
beta-aminoisopropylbenzene by substitution in the side chain
or by ring closure (or both).
(2) Despite subregulation (1), a substance mentioned in
subregulation (1)(a) or (b) is not an amphetamine when contained
in a Schedule 2, 3 or 4 substance.
4 Australian/New Zealand Standard
In these Regulations, a reference consisting of the letters "AS/NZS"
followed by a number is a reference to the standard so numbered
published jointly by or for Standards Australia Limited ABN 85 087
326 690 and Standards New Zealand.
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Medicines, Poisons and Therapeutic Goods Regulations 2014 3
5 Corresponding law
For section 5 of the Act, definition corresponding law,
paragraph (a)(ii), each of the following laws is a corresponding law:
(a) Controlled Substances Act 1984 (SA);
(b) Drugs, Poisons and Controlled Substances Act 1981 (Vic);
(c) Medicines and Poisons Act 2019 (Qld);
(d) Medicines, Poisons and Therapeutic Goods Act 2008 (ACT);
(e) Medicines and Poisons Act 2014 (WA);
(f) Poisons Act 1971 (Tas);
(g) Poisons and Therapeutic Goods Act 1966 (NSW).
6 Modification of medicines and poisons standard
(1) This regulation modifies the medicines and poisons standard for
section 14(2) of the Act.
(2) Each substance listed in Appendix D, paragraph 1 of the medicines
and poisons standard is taken to be excluded from Appendix D of
the medicines and poisons standard.
Part 2 Dealing with Scheduled substances
Division 1 Requisitions, prescriptions and administration and
supply orders
Note for Division 1
A requisition, prescription, administration order or supply order may be issued
electronically in accordance with the Electronic Transactions (Northern Territory)
Act 2000.
7 Written requisition to pharmacist
For section 57(2) of the Act, a written requisition for the supply of a
Schedule 4 or 8 substance must contain the following information:
(a) the name of the health practitioner issuing it;
(b) the date of issue;
(c) the ward or department of the hospital for which the substance
is to be supplied;
Part 2 Dealing with Scheduled substances
Division 1 Requisitions, prescriptions and administration and supply orders
Medicines, Poisons and Therapeutic Goods Regulations 2014 4
(d) the name of the substance and the form, strength and quantity
to be supplied;
(e) the signature of the health practitioner.
7A Prescribed conditions
For section 58(2)(a) of the Act, the following conditions are
prescribed:
(a) for a Schedule 8 substance that is an unrestricted Schedule 8
substance – the pharmacist must verify:
(i) the identity of the person presenting the prescription; and
(ii) the validity of the prescription;
(b) for an amphetamine or methylphenidate prescribed by an
interstate prescriber who would otherwise ordinarily be
endorsed to initiate treatment in the Territory – the pharmacist
must verify:
(i) the identity of the person presenting the prescription; and
(ii) the validity of the prescription; and
(iii) the specialty of the interstate prescriber.
Example for paragraphs (a)(i) and (b)(i)
The pharmacist may request proof of the person's identity.
Example for paragraphs (a)(ii) and (b)(ii)
The pharmacist may contact the prescriber to ascertain the validity of the
prescription.
7B Prohibited circumstance
For section 84(2)(c) of the Act, issuing a prescription for the supply
of an unrestricted Schedule 8 substance to a person for therapeutic
use if the person's daily total oral morphine equivalent dose would
be equal to or exceed 100 mg daily is prohibited.
Note for regulation 7B
Section 139(1) of the Act provides that the CHO may, on application, authorise
the supply, administration or the issue of a prescription for the supply of an
unrestricted Schedule 8 substance in a prohibited circumstance.
8 Prescription issued by health practitioner
For section 87(1)(a) of the Act, a prescription issued by an
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Division 1 Requisitions, prescriptions and administration and supply orders
Medicines, Poisons and Therapeutic Goods Regulations 2014 5
authorised prescriber who is a health practitioner must:
(a) state the following particulars of the authorised prescriber:
(i) name;
(ii) business address and telephone number;
(iii) health profession; and
(b) state the date of issue; and
(c) state the name and address of the person for whom it is
issued; and
(d) state the name of the substance, and the dose, form and
strength, for which it is issued; and
(e) if it is for an unusual or dangerous dose – include the
authorised prescriber's initials beside an underlined reference
to the dose; and
(f) state the quantity of the substance to be supplied; and
(g) if it is a repeat prescription – state the number of repeats
permitted; and
(h) state the start date for supply, if different from the date the
prescription is issued; and
(i) include directions for the use of the substance that are
adequate to allow the substance to be taken or administered
safely; and
(j) be written in terms and symbols used in ordinary professional
practice; and
(k) if it is issued by:
(i) a dentist – state it is issued for dental purposes only; or
(ii) an optometrist – state it is issued for the treatment of a
condition of the eye only; or
(iii) a podiatrist – state it is issued for podiatry treatment
only; and
(l) if it is issued for a Schedule 8 substance – meet the
requirements specified in regulation 10; and
(m) be signed by the authorised prescriber.
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Division 1 Requisitions, prescriptions and administration and supply orders
Medicines, Poisons and Therapeutic Goods Regulations 2014 6
9 Prescription issued by veterinarian
For section 87(1)(a) of the Act, a prescription issued by an
authorised prescriber who is a veterinarian must:
(a) contain the information mentioned in section 32(2) of the
Agricultural and Veterinary Chemicals (Control of Use)
Act 2004; and
(b) state the date of issue; and
(c) state the name and address of the person who owns, or is in
charge of, the animal for which it is issued; and
(d) state it is issued for animal treatment only; and
(e) if it is issued for a Schedule 8 substance – meet the
requirements specified in regulation 10; and
(f) be signed by the authorised prescriber.
10 Additional requirements for prescription for Schedule 8
substance
(1) A prescription for a Schedule 8 substance must state:
(a) if it is issued for:
(i) a person – the date of birth of the person; or
(ii) an animal – sufficient information to identify the animal;
and
(b) the quantity of the substance to be supplied in words and
numerals; and
(c) if it is issued by an authorised health practitioner under a
Schedule 8 authorisation or Schedule 8 exemption – the
number or other identifier of the authorisation or exemption;
and
(d) if it is a repeat prescription – the minimum repeat interval.
(2) In addition, a prescription for a Schedule 8 substance of a particular
form and strength must not authorise the supply of any other
substance, including a Schedule 8 substance of a different form or
strength.
11 Prescription may be issued to agent
For section 89(1)(b)(iv) of the Act, a person who acts for the patient
Part 2 Dealing with Scheduled substances
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Medicines, Poisons and Therapeutic Goods Regulations 2014 7
is prescribed.
12 Conditions on which prescription may be issued to partner
For section 89(2)(c) of the Act, the conditions for the issue of a
prescription are:
(a) the recipient has been diagnosed with chlamydia that has
been confirmed microbiologically by nucleic acid amplification
test or related technologies; and
(b) the partner is at significant risk of contracting chlamydia; and
(c) the prescription is for a single dose of Azithromycin.
13 Administration order
For section 92(2) of the Act, an administration order for a
Scheduled substance must:
(a) state the name of the authorised prescriber issuing it; and
(b) if the order is written – state the date of issue and be signed
by the authorised prescriber; and
(c) state the name, address and, if applicable, hospital
registration number of the person to whom the substance is to
be administered; and
(d) state the name of the substance, and the dose, form and
strength, to be administered; and
(e) state the route, frequency and period of administration; and
(f) state the start date for administration, if different from the date
the order is issued.
14 Supply order – person discharged from hospital
For section 92(2) of the Act, a supply order authorising the supply
of a Scheduled substance to a person on the person's discharge as
a patient of a hospital must:
(a) state the following particulars of the authorised prescriber
issuing the order:
(i) name;
(ii) hospital pager number or telephone number;
(iii) name of the hospital and ward or department in which
Part 2 Dealing with Scheduled substances
Division 1 Requisitions, prescriptions and administration and supply orders
Medicines, Poisons and Therapeutic Goods Regulations 2014 8
the prescriber is working;
(iv) health profession; and
(b) state the date of issue; and
(c) state the name, address and hospital registration number of
the person to whom the substance is to be supplied; and
(d) state the name of the substance, and the dose, form and
strength, to be supplied; and
(e) state the quantity of the substance to be supplied; and
(f) include directions for the use of the substance that are
adequate to allow the substance to be taken or administered
safely; and
(g) be signed by the authorised prescriber.
15 Supply order – nurse at residential facility
(1) For section 92(2) of the Act, a supply order authorising the supply
of a Scheduled substance to a nurse employed at a residential
facility for administration to a resident at the facility must:
(a) state the following particulars of the authorised prescriber
issuing the order:
(i) name;
(ii) business address and telephone number;
(iii) health profession; and
(b) state the date of issue; and
(c) state the name, address and telephone number of the
residential facility; and
(d) state the resident's name and medical record number; and
(e) state the name of the substance, and the dose, form and
strength, to be supplied; and
(f) state instructions for the administration of the substance; and
(g) be signed by the authorised prescriber.
(2) In addition, a supply order for a Schedule 8 substance of a
particular form and strength must not authorise the supply of any
Part 2 Dealing with Scheduled substances
Division 1 Requisitions, prescriptions and administration and supply orders
Medicines, Poisons and Therapeutic Goods Regulations 2014 9
other substance, including a Schedule 8 substance of a different
form or strength.
(3) To avoid doubt, a medication chart for a resident may be used as a
supply order if it meets the requirements specified in
subregulations (1) and (2).
16 Supply order – person in charge of declared place
(1) For section 92(2) of the Act, a supply order authorising the supply
of a Scheduled substance to the person in charge of a declared
place must:
(a) state the following particulars of the authorised prescriber
issuing the order:
(i) name;
(ii) business address and telephone number;
(iii) health profession; and
(b) state the date of issue; and
(c) state the name, address and telephone number of the
declared place; and
(d) state the name and address of the person receiving medical
treatment at the declared place to whom the substance will be
administered; and
(e) state the name of the substance, and the dose, form and
strength, to be supplied; and
(f) state the quantity of the substance to be supplied; and
(g) state instructions for the administration of the substance; and
(h) be signed by the authorised prescriber.
(2) In addition, a supply order for a Schedule 8 substance of a
particular form and strength must not authorise the supply of any
other substance, including a Schedule 8 substance of a different
form or strength.
17 Formal requirements for requisitions, prescriptions and
administration and supply orders
(1) This regulation applies to each of the following (the document)
unless issued electronically:
Part 2 Dealing with Scheduled substances
Division 1A Administering, supplying and possessing Scheduled substances under SSTP
Medicines, Poisons and Therapeutic Goods Regulations 2014 10
(a) a requisition mentioned in regulation 7;
(b) a prescription;
(c) an administration order or supply order.
(2) The document must be written in ink.
(3) If there are changes to any of the details in the document, the
initials of the person who issued the document and the date the
change was made must appear beside each change.
Division 1A Administering, supplying and possessing
Scheduled substances under SSTP
17A Prescribed health practitioners
For section 70A(1) of the Act, the following types of health
practitioner are prescribed:
(a) Aboriginal and Torres Strait Islander health practitioner;
(b) dental hygienist;
(c) dental therapist;
(d) midwife;
(e) nurse;
(f) oral health therapist;
(g) paramedic;
(h) pharmacist.
17B Prescribed healthcare workers
(1) For section 70A(2) of the Act, an orthoptist is a prescribed class of
person.
(2) In this regulation:
orthoptist means a person whose name is recorded in the register
of orthoptists kept by the Australian Orthoptists Registration Body
Pty Ltd ACN 095 117 678.
Part 2 Dealing with Scheduled substances
Division 2 Dealings to be witnessed
Medicines, Poisons and Therapeutic Goods Regulations 2014 11
17C Content of SSTP
(1) For section 70B(2)(d) of the Act, the following matters are
prescribed:
(a) the indications for use of the Scheduled substance by a
person;
(b) any contraindications against use of the Scheduled substance
by a person;
(c) a description of any persons to whom the Scheduled
substance must not be administered or supplied.
(2) For section 70B(2)(e) of the Act, an SSTP must specify the
following matters:
(a) the form, strength, dose, route and frequency of administration
of the Scheduled substance;
(b) any monitoring requirements after administration of the
Scheduled substance to a person;
(c) any procedures or requirements in relation to documenting the
administration or supply of the Scheduled substance to a
person.
Division 2 Dealings to be witnessed
18 Record of supply or administration of Schedule 8 substance
For section 100(2) of the Act, the Schedule 8 register kept for the
ward or department of the hospital in which the patient is receiving
treatment, or the residential facility or declared place, is prescribed.
Note for regulation 18
Section 100 of the Act requires certain dealings with Schedule 8 substances to
be witnessed.
19 Destruction of Schedule 8 substance
(1) A person who is authorised under the Act to possess a Schedule 8
substance commits an offence if:
(a) the person destroys a substance; and
(b) the substance is a Schedule 8 substance; and
(c) the destruction is not witnessed by one of the following
persons:
Part 2 Dealing with Scheduled substances
Division 3 Storage and transport
Medicines, Poisons and Therapeutic Goods Regulations 2014 12
(i) an authorised officer;
(ii) a health practitioner;
(iii) a veterinarian.
Maximum penalty: 40 penalty units.
(2) Strict liability applies to subregulation (1)(c).
20 Administration of Schedule 9 substance must be witnessed
(1) A person who is authorised under the Act to possess a Schedule 9
substance commits an offence if:
(a) the person administers a substance to a person or animal; and
(b) the substance is a Schedule 9 substance; and
(c) the administration is not witnessed by another person.
Maximum penalty: 20 penalty units.
(2) Strict liability applies to subregulation (1)(c).
21 Destruction of Schedule 9 substance
(1) A person who is authorised under the Act to possess a Schedule 9
substance commits an offence if:
(a) the person destroys a substance; and
(b) the substance is a Schedule 9 substance; and
(c) the destruction is not witnessed by an authorised officer.
Maximum penalty: 40 penalty units.
(2) Strict liability applies to subregulation (1)(c).
Division 3 Storage and transport
Note for Division 3
There are no generally applicable storage requirements for prohibited
substances. However, a prohibited substance authorisation may contain
conditions regarding storage of the prohibited substance.
22 Storage of Schedule 2 substance by retailer
(1) The licensee under a retailer licence commits an offence if:
Part 2 Dealing with Scheduled substances
Division 3 Storage and transport
Medicines, Poisons and Therapeutic Goods Regulations 2014 13
(a) a Schedule 2 substance is stored at the place in relation to
which the licence was issued; and
(b) the licensee fails to ensure the substance is stored in a way
that restricts public access to it.
Maximum penalty: 30 penalty units.
(2) Strict liability applies to subregulation (1)(b).
23 Storage of Schedule 3 substance by authority holder
(1) The holder of a Schedule 3 authorisation, research authorisation or
medical kit authorisation commits an offence if:
(a) the holder possesses a substance; and
(b) the substance is a Schedule 3 substance that is in the holder's
possession under the authorisation; and
(c) the holder fails to ensure the substance is stored in a way that
prevents unauthorised access to it.
Maximum penalty: 30 penalty units.
(2) Strict liability applies to subregulation (1)(c).
24 Storage of Schedule 2, 3 or 4 substance at pharmacy
(1) The pharmacist-in-charge of a pharmacy commits an offence if:
(a) a Schedule 2 substance that is for retail sale is stored at the
pharmacy; and
(b) the pharmacist-in-charge fails to ensure the substance is
stored within 4 m of, or within sight of, the pharmacy's
dispensary.
Maximum penalty: 30 penalty units.
(2) The pharmacist-in-charge of a pharmacy commits an offence if:
(a) a Schedule 2 substance that is not for retail sale is stored at
the pharmacy; and
(b) the pharmacist-in-charge fails to ensure the substance is
stored in a way that restricts public access to it.
Maximum penalty: 30 penalty units.
(3) The pharmacist-in-charge of a pharmacy commits an offence if:
Part 2 Dealing with Scheduled substances
Division 3 Storage and transport
Medicines, Poisons and Therapeutic Goods Regulations 2014 14
(a) a Schedule 3 or 4 substance is stored at the pharmacy; and
(b) the pharmacist-in-charge fails to ensure the substance is
stored:
(i) in a part of the pharmacy to which the public does not
have access; or
(ii) in a way that prevents persons other than a pharmacist,
or a person under the direct supervision of a pharmacist,
from having access to the substance.
Maximum penalty: 30 penalty units.
(4) Strict liability applies to subregulations (1)(b), (2)(b) and (3)(b).
25 Storage of Schedule 4 substance by authority holder
(1) The holder of a Schedule 4 authorisation, research authorisation or
medical kit authorisation commits an offence if:
(a) the holder possesses a substance; and
(b) the substance is a Schedule 4 substance that is in the holder's
possession under the authorisation; and
(c) the holder fails to ensure the substance is stored in a way that
prevents unauthorised access to it.
Maximum penalty: 30 penalty units.
(2) Strict liability applies to subregulation (1)(c).
26 Storage of Schedule 4 substance at residential facility or
declared place
(1) The nurse in charge of a residential facility commits an offence if:
(a) a Schedule 4 substance is stored at the facility; and
(b) disposition of the substance is controlled by the nurse; and
(c) the nurse fails to ensure the substance is stored in a way that
prevents unauthorised access to it.
Maximum penalty: 30 penalty units.
(2) The person in charge of a declared place commits an offence if:
(a) a Schedule 4 substance is stored at the declared place; and
Part 2 Dealing with Scheduled substances
Division 3 Storage and transport
Medicines, Poisons and Therapeutic Goods Regulations 2014 15
(b) disposition of the substance is controlled by the person; and
(c) the person fails to ensure the substance is stored in a way that
prevents unauthorised access to it.
Maximum penalty: 30 penalty units.
(3) Strict liability applies to subregulations (1)(c) and (2)(c).
27 Storage of methylated spirit
(1) A person commits an offence if:
(a) the person owns a business that sells a substance; and
(b) the substance is methylated spirit; and
(c) the person fails to ensure the substance is stored in a part of
premises to which the public does not have access.
Maximum penalty: 20 penalty units.
(2) Strict liability applies to subregulation (1)(c).
28 Storage of Schedule 7 substance by manufacturer or
wholesaler
(1) The holder of a certificate of registration commits an offence if:
(a) the holder possesses a substance that is not for immediate
use; and
(b) the substance is a Schedule 7 substance that is in the holder's
possession under the certificate; and
(c) the holder fails to ensure that each of the following are
satisfied:
(i) the substance is stored in a locked container that
prevents ready access to the container's contents and is
securely attached to a building;
(ii) the container is kept securely locked when not in
immediate use;
(iii) if the container is unlocked by a combination lock – the
nominated person for the certificate of registration keeps
the combination confidential;
(iv) if the container is unlocked by a key – the nominated
person keeps personal custody of the key.
Part 2 Dealing with Scheduled substances
Division 3 Storage and transport
Medicines, Poisons and Therapeutic Goods Regulations 2014 16
Maximum penalty: 30 penalty units.
(2) Strict liability applies to subregulation (1)(c).
29 Storage of Schedule 7 substance by retailer
(1) The licensee under a retailer licence commits an offence if:
(a) the licensee possesses a substance; and
(b) the substance is a Schedule 7 substance that is in the
licensee's possession under the licence; and
(c) the licensee fails to ensure that:
(i) if the substance is for retail sale – the substance is
stored in a part of the place in relation to which the
licence was issued to which the public does not have
access; or
(ii) otherwise – each of the following are satisfied:
(A) the substance is stored in a locked container that
prevents ready access to the container's contents
and is securely attached to a building;
(B) the container is kept securely locked when not in
immediate use;
(C) if the container is unlocked by a combination lock –
the individual who has control of the business
activities under the retailer licence (the business
manager) keeps the combination confidential;
(D) if the container is unlocked by a key – the business
manager keeps personal custody of the key.
Maximum penalty: 30 penalty units.
(2) Strict liability applies to subregulation (1)(c).
30 Storage of Schedule 7 substance by authority holder
(1) The holder of a Schedule 7 authorisation or pest management
technician licence commits an offence if:
(a) the holder possesses a substance that is not for immediate
use; and
(b) the substance is a Schedule 7 substance that is in the holder's
possession under the authorisation or licence; and
Part 2 Dealing with Scheduled substances
Division 3 Storage and transport
Medicines, Poisons and Therapeutic Goods Regulations 2014 17
(c) the holder fails to ensure that each of the following are
satisfied:
(i) the substance is stored:
(A) if being transported – in a locked container that
prevents ready access to the container's contents;
or
(B) otherwise – in a locked container that prevents
ready access to the container's contents and is
securely attached to a building;
(ii) the container is kept securely locked when not in
immediate use;
(iii) if the container is unlocked by a combination lock – the
holder and other persons who hold an authority in
relation to the substance keep the combination
confidential;
(iv) if the container is unlocked by a key – the holder, or
another person who holds an authority in relation to the
substance, keeps personal custody of the key.
Maximum penalty: 30 penalty units.
(2) Strict liability applies to subregulation (1)(c).
31 Storage of Schedule 8 substance
(1) A person who is authorised under the Act to possess a Schedule 8
substance commits an offence if:
(a) the person possesses a substance; and
(b) the substance is a Schedule 8 substance; and
(c) the person fails to store the substance in accordance with the
storage requirements applicable to the person specified in the
Schedule 8 Code of Practice.
Maximum penalty: 60 penalty units.
(2) Strict liability applies to subregulation (1)(c).
(3) In this regulation:
Schedule 8 Code of Practice means the Code of Practice for
Schedule 8 substances made by the CHO under section 244 of the
Act, as in force from time to time.
Part 2 Dealing with Scheduled substances
Division 4 Packaging and labelling
Medicines, Poisons and Therapeutic Goods Regulations 2014 18
32 Delivery person must not leave certain Scheduled substances
unattended
(1) A delivery person commits an offence if:
(a) the person possesses a substance; and
(b) the substance is a Scheduled substance, other than a
Schedule 5, 6 or 7 substance, that the person has been
engaged by an authorised supplier to transport and deliver;
and
(c) the person leaves the substance unattended, other than in a
locked building or vehicle.
Maximum penalty: 40 penalty units.
(2) Strict liability applies to subregulation (1)(c).
(3) In this regulation:
authorised supplier, see section 79(3) of the Act.
delivery person, see section 79(1) of the Act.
Division 4 Packaging and labelling
33 Packaging requirements
(1) For section 101(1)(c) of the Act, a Scheduled substance must be
packaged in accordance with the container requirements set out in
Part 2 of the medicines and poisons standard (the packaging
requirements).
(2) However, the packaging requirements do not apply to the extent
that the holder of a manufacturer certificate of registration is exempt
from compliance with the requirements under a corresponding law.
34 Labelling requirements
(1) For section 102(1)(c) of the Act, a container of a Scheduled
substance must be labelled in accordance with the label
requirements set out in Part 2 of the medicines and poisons
standard (the labelling requirements).
Note for subregulation (1)
Part 2 of the medicines and poisons standard applies to health practitioners and
holders of a manufacturer certificate of registration.
(2) However, the labelling requirements do not apply to the extent that
Part 2 Dealing with Scheduled substances
Division 5 Manufacture, supply and use of paints
Medicines, Poisons and Therapeutic Goods Regulations 2014 19
the holder of a manufacturer certificate of registration is exempt
from compliance with the requirements under a corresponding law.
35 Container not to be used for human-use substance
For section 104(1)(b) of the Act, a container of a kind mentioned in
paragraph 42, 43 or 46 of the medicines and poisons standard is
prescribed.
Division 5 Manufacture, supply and use of paints
36 Paint applied to premises, structures and furniture
For section 110(1) of the Act, a first schedule paint must not be
manufactured, supplied or used for application to:
(a) a roof or other surface to be used for the collection or storage
of potable water; or
(b) furniture; or
(c) a fence, wall, post, gate or building (including the interior of a
building) other than a building that is used only for industrial
purposes or mining or as an oil terminal; or
(d) premises used for the manufacture, processing, preparation,
packing or serving of products intended for human or animal
consumption.
37 Paint for toys
For section 111(1)(b), (2)(c) and (3)(b) of the Act, a paint
manufactured, supplied or used for application to toys must comply
with the specification for coating materials in
AS/NZS ISO 8124.3:2012 (Safety of toys – Migration of certain
elements) as in force from time to time.
38 Paint containing pesticide
(1) For section 112(b) of the Act, the following pesticides are
prescribed:
(a) an algicide;
(b) an antifouling agent;
(c) a bactericide;
(d) a fungicide.
Part 3 Authorities to deal with Scheduled substances
Medicines, Poisons and Therapeutic Goods Regulations 2014 20
(2) However, subregulation (1) does not apply in relation to a paint for
human therapeutic use.
Division 6 Advertising
39 Pharmacist pricelist advertising certain Scheduled substances
(1) For section 113(3)(b) of the Act, a pharmacist pricelist is prescribed.
(2) In this regulation:
pharmacist pricelist means a pricelist published by or for a
pharmacist that:
(a) includes a prescribed substance (other than a Schedule 9
substance) as defined in section 113(4) of the Act; and
(b) complies with the Price Information Code of Practice,
published by the Therapeutic Goods Administration, as in
force from time to time.
Part 3 Authorities to deal with Scheduled substances
40 Additional conditions – certificate of registration
(1) For section 144(b) of the Act, the following are prescribed:
(a) for a certificate of registration – the "Australian Code of Good
Wholesaling Practice for Medicines in Schedules 2, 3, 4 and
8" (effective date 1 April 2011) published by the National
Coordinating Committee on Therapeutic Goods, as in force
from time to time;
(b) for a manufacturer certificate of registration – Part 7 of the
"Code of Conduct" published by Medicines Australia, as in
force from time to time.
41 Duration of Schedule 8 authorisation for treating child's ADHD
(1) For section 148(b) of the Act, a Schedule 8 authorisation for dealing
with an amphetamine for treating a child for ADHD remains in force
until the child becomes an adult.
(2) In this regulation:
ADHD means attention deficit hyperactivity disorder.
Part 4 Scheduled substance registers
Division 1 Maintaining Scheduled substance registers
Subdivision 1 Pseudoephedrine register
Medicines, Poisons and Therapeutic Goods Regulations 2014 21
42 Contents of authority
For section 149(b) of the Act, an authority must contain the
following information:
(a) the name of the holder of the authority;
(b) if the holder is a body corporate – the holder's ACN;
(c) if the holder will be conducting business under the authority
under a business name – the business name;
(e) the Scheduled substance to which the authority applies;
(f) the dealing with the substance authorised by the authority
and, if applicable, the address of the place where the holder is
authorised to deal with the substance;
(g) a unique identifying number;
(h) the date the authority is issued and the period it remains in
force;
(i) for a certificate of registration – the nominated person;
(j) for a pest management technician licence – the holder's date
of birth.
43 Authority holder to give notice of change of particulars
For section 173(1)(b) of the Act, the following particulars are
prescribed:
(a) the name of the holder of the authority;
(b) the holder's business name;
(c) the holder's postal address.
Part 4 Scheduled substance registers
Division 1 Maintaining Scheduled substance registers
Subdivision 1 Pseudoephedrine register
44 Keeping of register
The pharmacist-in-charge of a pharmacy or pharmacy department
must keep a register in relation to substances that:
Part 4 Scheduled substance registers
Division 1 Maintaining Scheduled substance registers
Subdivision 2 Schedule 4 register
Medicines, Poisons and Therapeutic Goods Regulations 2014 22
(a) contain pseudoephedrine; and
(b) are supplied by retail sale from the pharmacy or pharmacy
department.
45 Details to be recorded
The following details must be recorded in the register in relation to
each retail sale:
(a) the date of the sale;
(b) the name of the substance, and the form, strength and
quantity, sold;
(c) the name and address of the purchaser;
(d) the type and, if applicable, unique number of the photographic
identification of the purchaser produced at the time of sale.
Subdivision 2 Schedule 4 register
46 Keeping of register
Each of the following persons must keep a register in relation to
Schedule 4 substances that are supplied or administered under the
person's authorisation:
(a) the holder of a Schedule 4 authorisation;
(b) the holder of a research authorisation;
(c) the holder of a medical kit authorisation.
47 Details to be recorded
The following details must be recorded in the register in relation to
each supply or administration:
(a) the nature of the dealing;
(b) the date of the dealing;
(c) the name of the substance, and the form, strength and
quantity, dealt with;
(d) if the substance was supplied – the name and address of the
person to whom it was supplied;
(e) if the substance was administered:
Part 4 Scheduled substance registers
Division 1 Maintaining Scheduled substance registers
Subdivision 4 Schedule 8 register
Medicines, Poisons and Therapeutic Goods Regulations 2014 23
(i) to a person – the name and address of the person; or
(ii) to an animal – the name and address of the person who
owns, or is in charge of, the animal.
Subdivision 3 Schedule 7 register
48 Keeping of register
Each of the following persons must keep a register in relation to
Schedule 7 substances that are dealt with under the person's
authorisation or licence:
(a) the holder of a Schedule 7 authorisation;
(b) the holder of a pest management technician licence;
(c) the licensee under a retailer licence.
49 Details to be recorded
The following details must be recorded in the register in relation to
each dealing (other than possession):
(a) the nature of the dealing;
(b) the date of the dealing;
(c) the name of the substance, and the form, strength and
quantity, dealt with;
(d) if the dealing was receiving the substance – the name and
address of the supplier;
(e) if the dealing was supplying the substance – the name,
address and, if applicable, authorisation or licence number of
the recipient;
(f) the quantity of the substance held after the dealing.
Subdivision 4 Schedule 8 register
50 Maintenance of register – persons in charge of premises
(1) A person mentioned in the table below must maintain a register in
relation to Schedule 8 substances that are supplied to, or otherwise
dealt with, at the place mentioned opposite.
Person Place
Part 4 Scheduled substance registers
Division 1 Maintaining Scheduled substance registers
Subdivision 4 Schedule 8 register
Medicines, Poisons and Therapeutic Goods Regulations 2014 24
Person Place
The nurse in charge of a ward or
department of a hospital
The ward or department
The nurse in charge of a
residential facility
The residential facility
The person in charge of a declared
place
The declared place
A doctor Each premises from which the doctor
practises, other than a hospital
A dentist Each premises from which the dentist
practises
A podiatrist Each premises from which the
podiatrist practises
Part 4 Scheduled substance registers
Division 1 Maintaining Scheduled substance registers
Subdivision 4 Schedule 8 register
Medicines, Poisons and Therapeutic Goods Regulations 2014 25
Person Place
The pharmacist-in-charge of a
pharmacy or pharmacy department
The pharmacy or pharmacy
department
The person in charge of an
ambulance service
The premises from which the
ambulance service operates
A nurse Each premises from which the nurse
practises, other than:
(a) a hospital, residential facility or
declared place; or
(b) another place from which a
doctor, dentist or podiatrist
practices.
A midwife Each premises from which the
midwife practises, other than:
(a) a hospital or declared place; or
(b) another place from which a
doctor practices.
A veterinarian Each premises from which the
veterinarian practises
(2) However, subregulation (1) does not apply to the person in relation
to:
(a) a Schedule 8 substance in a medical kit; or
(b) if the person is the nurse in charge of a residential facility – a
Schedule 8 substance dispensed in a dose administration aid
for a resident of the facility; or
(c) if the person is the nurse in charge of a declared place – a
Schedule 8 substance dispensed in a dose administration aid
for a person receiving medical treatment at the place.
(3) Only 1 register is to be kept for each place mentioned in
subregulation (1).
Part 4 Scheduled substance registers
Division 1 Maintaining Scheduled substance registers
Subdivision 4 Schedule 8 register
Medicines, Poisons and Therapeutic Goods Regulations 2014 26
51 Keeping of register – medical kit holder
The holder of a medical kit authorisation must keep a register in
relation to Schedule 8 substances that are dealt with under the
authorisation.
52 Keeping of register – other persons
Each of the following persons must keep a register in relation to
Schedule 8 substances that are dealt with under the person's
certificate or authorisation:
(a) the holder of a manufacturer certificate of registration;
(b) the holder of a wholesaler certificate of registration;
(c) the holder of a Schedule 8 authorisation;
(d) the holder of a research authorisation.
53 Form of Schedule 8 register
(1) A Schedule 8 register must contain:
(a) a separate page for each form and strength of a Schedule 8
substance; or
(b) if the register is kept electronically – a separate record for
each form and strength of a Schedule 8 substance.
(2) However, the CHO may dispense with this requirement in relation
to a particular Schedule 8 register.
54 Details to be recorded
(1) The following details must be recorded in a Schedule 8 register in
relation to each dealing with a Schedule 8 substance (other than
possession):
(a) the nature of the dealing;
(b) the date of the dealing;
(c) the name of the substance, and the form, strength and
quantity, dealt with;
(d) if the dealing was receiving the substance – the name and
address of the supplier;
Part 4 Scheduled substance registers
Division 1 Maintaining Scheduled substance registers
Subdivision 4 Schedule 8 register
Medicines, Poisons and Therapeutic Goods Regulations 2014 27
(e) if the dealing was supplying the substance other than as
mentioned in subregulation (2) – the name and address of the
recipient;
(f) if the dealing was administering the substance other than as
mentioned in subregulation (2):
(i) the name of:
(A) the person to whom it was administered; or
(B) the person who owns, or is in charge of, the animal
to which it was administered; and
(ii) the name of the person who administered it;
(g) if the substance was supplied on a prescription – the name of
the person who issued the prescription;
(h) if the dealing was destroying the substance:
(i) the name of the person who destroyed the substance;
and
(ii) the name of the person who witnessed the destruction;
(i) the quantity of the substance held after the dealing.
(2) In addition, if the dealing was supplying or administering the
Schedule 8 substance to a patient of a hospital, a resident of a
residential facility or a person receiving medical treatment at a
declared place, the following details must be recorded:
(a) the name of the patient, resident or person;
(b) for a patient – the patient's hospital registration number;
(c) the time the substance was supplied or administered;
(d) the name of the person who authorised the supply or
administration;
(e) the name of the person who supplied or administered it;
(f) the name of the person who witnessed the supply or
administration.
Part 4 Scheduled substance registers
Division 1 Maintaining Scheduled substance registers
Subdivision 5 Schedule 9 register
Medicines, Poisons and Therapeutic Goods Regulations 2014 28
Subdivision 5 Schedule 9 register
55 Keeping of register
Each of the following persons must keep a register in relation to
Schedule 9 substances that are dealt with under the person's
certificate or authorisation:
(a) the holder of a manufacturer certificate of registration;
(b) the holder of a wholesaler certificate of registration;
(c) the holder of a prohibited substance authorisation;
(d) the holder of a research authorisation.
56 Form of Schedule 9 register
The register must contain:
(a) a separate page for each form and strength of a Schedule 9
substance; or
(b) if the register is kept electronically – a separate record for
each form and strength of a Schedule 9 substance.
57 Details to be recorded
The following details must be recorded in the register in relation to
each dealing (other than possession):
(a) the nature of the dealing;
(b) the date of the dealing;
(c) the name of the substance, and the form, strength and
quantity, dealt with;
(d) if the dealing was receiving the substance – the name and
address of the supplier;
(e) if the dealing was administering the substance:
(i) the name of the person to whom it was administered;
and
(ii) the name of the person who administered it; and
(iii) the name of the person who witnessed the
administration;
Part 4 Scheduled substance registers
Division 1 Maintaining Scheduled substance registers
Subdivision 7 General requirements
Medicines, Poisons and Therapeutic Goods Regulations 2014 29
(f) if the dealing was destroying the substance:
(i) the name of the person who destroyed the substance;
and
(ii) the name of the authorised officer who witnessed the
destruction;
(g) the quantity of the substance held after the dealing.
Subdivision 6 Manufacturer/wholesaler/Schedule 4 supplier
58 Keeping of register
The holder of a certificate of registration must keep a register in
relation to Schedule 2, 3, 4 and 7 substances that are dealt with
under the certificate.
59 Details to be recorded
The following details must be recorded in the register in relation to
each dealing (other than possession):
(a) the nature of the dealing;
(b) the date of the dealing;
(c) the name of the substance, and the form, strength and
quantity, dealt with;
(d) if the dealing was receiving the substance – the name and
address of the supplier;
(e) if the dealing was supplying the substance – the name and
address and, if applicable, authorisation or licence number of
the recipient;
(f) the quantity of the substance held after the dealing.
Subdivision 7 General requirements
60 Form of register entries
An entry in a Scheduled substance register must be:
(a) legible and expressed in the English language; and
(b) made as soon as practicable after the dealing to which the
entry relates happens.
Part 4 Scheduled substance registers
Division 2 Offences relating to Scheduled substance registers
Medicines, Poisons and Therapeutic Goods Regulations 2014 30
61 Period of retention of registers
(1) A Scheduled substance register, other than a register in relation to
Schedule 7 substances, must be kept for at least 2 years after the
day on which the last entry is made in the register.
(2) A register in relation to Schedule 7 substances must be kept for at
least 7 years after the day on which the last entry is made in the
register.
Division 2 Offences relating to Scheduled substance
registers
62 Offence not to maintain register
(1) A person who is required to maintain a Scheduled substance
register commits an offence if the person:
(a) fails to maintain the register; or
(b) fails to maintain the register in accordance with the
requirements of Division 1.
Maximum penalty: 50 penalty units.
(2) An offence against subregulation (1) is an offence of strict liability.
63 Offence not to sign entry
(1) A person commits an offence if the person:
(a) makes an entry in a Scheduled substance register; and
(b) fails to sign the entry as soon as practicable after it is made.
Maximum penalty: 20 penalty units.
(2) Strict liability applies to subregulation (1)(b).
64 Offence to make false or misleading entry
A person commits an offence if the person:
(a) makes an entry in a Scheduled substance register; and
(b) knows the entry contains information that is misleading in a
material particular or because of the omission of a material
particular.
Maximum penalty: 80 penalty units.
Part 4 Scheduled substance registers
Division 2 Offences relating to Scheduled substance registers
Medicines, Poisons and Therapeutic Goods Regulations 2014 31
65 Offence to change entry
(1) A person commits an offence if the person cancels, changes,
deletes or obliterates an entry in a Scheduled substance register.
Maximum penalty: 20 penalty units.
(2) However, subregulation (1) does not apply to a person if the
person:
(a) made the entry in the Scheduled substance register; and
(b) changes the entry as permitted under subregulation (3) or (4).
(3) An entry in a paper-based Scheduled substance register may be
changed by the person signing and dating a marginal note or
footnote that gives the correct details.
(4) An entry in an electronic Scheduled substance register may be
changed by the person attaching or linking, by electronic means, a
document that includes the person's signature, the date and the
correct details.
66 Offence not to record details of supply of pseudoephedrine
(1) A person commits an offence if the person:
(a) supplies, by retail sale from a pharmacy or pharmacy
department, a substance that contains pseudoephedrine; and
(b) fails to:
(i) sight photographic identification of the purchaser; or
(ii) record in the Scheduled substance register for the
substance each of the details specified in regulation 45.
Maximum penalty: 20 penalty units.
(2) Strict liability applies to subregulation (1)(b).
67 Offence not to sign register after certain dealings with
Schedule 8 or 9 substance
(1) A person commits an offence if:
(a) the person supplies, administers, otherwise uses or destroys a
Schedule 8 or 9 substance; and
(b) an entry about the dealing is made in the Scheduled
substance register for the substance by a third party; and
Part 4 Scheduled substance registers
Division 2 Offences relating to Scheduled substance registers
Medicines, Poisons and Therapeutic Goods Regulations 2014 32
(c) the person fails to sign the entry in the register as soon as
practicable after it is made.
Maximum penalty: 40 penalty units.
(2) Strict liability applies to subregulation (1)(c).
68 Offence not to sign register after witnessing certain dealings
with Schedule 8 or 9 substance
(1) A person commits an offence if:
(a) the person witnesses the supply, administration or destruction
of a Schedule 8 or 9 substance; and
(b) an entry about the dealing that names the person as the
witness to the dealing is made in the Scheduled substance
register for the substance by a third party; and
(c) the person fails to sign the entry in the register as witness as
soon as practicable after it is made.
Maximum penalty: 40 penalty units.
(2) Strict liability applies to subregulation (1)(c).
69 Offence not to ensure witness signs register after certain
dealings with Schedule 8 or 9 substance
(1) A person commits an offence if:
(a) the person:
(i) destroys a Schedule 8 substance; or
(ii) administers or destroys a Schedule 9 substance; and
(b) an entry about the dealing that names another person as the
witness to the dealing is made in the Scheduled substance
register for the substance; and
(c) the witness fails to sign the entry in the register as soon as
practicable after it is made.
Maximum penalty: 40 penalty units.
Note for regulation 69
Section 100 of the Act contains a similar offence in relation to the supply or
administration of Schedule 8 substances.
(2) Strict liability applies to subregulation (1)(c).
Part 4 Scheduled substance registers
Division 2 Offences relating to Scheduled substance registers
Medicines, Poisons and Therapeutic Goods Regulations 2014 33
70 Offence not to maintain register where substance kept
(1) A person who is required to maintain a Scheduled substance
register in relation to a Scheduled substance commits an offence if
the person fails to maintain the register:
(a) at the premises in which the Scheduled substance is kept; or
(b) for a Schedule 8 substance in a medical kit – with the medical
kit.
Maximum penalty: 20 penalty units.
(2) An offence against subregulation (1) is an offence of strict liability.
71 Offence not to report possible loss etc. of Scheduled
substance
(1) A person who is required to maintain a Scheduled substance
register commits an offence if the person:
(a) becomes aware of a substantial risk that a Scheduled
substance in relation to which the register is maintained has
been lost, misappropriated or stolen; and
(b) fails to give the CHO written notice about the risk as soon as
practicable (but not later than 7 days) after becoming aware of
it.
Maximum penalty: 20 penalty units.
(2) Strict liability applies to subregulation (1)(b).
72 Offence not to report destruction, loss etc. of register
(1) A person who is required to maintain a Scheduled substance
register commits an offence if:
(a) the register is damaged in a material respect, destroyed,
stolen or lost; and
(b) the person fails to give the CHO written notice about the
damage, destruction, theft or loss as soon as practicable (but
not later than 7 days) after the day it happens.
Maximum penalty: 20 penalty units.
(2) Strict liability applies to subregulation (1)(b).
Part 5 Other records and notices
Division 1 General requirements
Medicines, Poisons and Therapeutic Goods Regulations 2014 34
(3) This regulation does not apply in relation to a Scheduled substance
register if the most recent entry in the register is made more than
2 years before the day the register is damaged, stolen, lost or
destroyed.
(4) In this regulation, a Scheduled substance register is damaged in a
material respect if anything required to be entered in the register is
missing or cannot be easily read.
Part 5 Other records and notices
Division 1 General requirements
73 Retention of documents relating to receipt or supply of
Scheduled substances
(1) A health practitioner or veterinarian who, in the course of practising
in a health profession or providing veterinary services, receives or
supplies a Schedule 4 or 8 substance must keep the original or a
copy of each delivery docket or invoice relating to the receipt or
supply.
(2) The holder of an authority, other than a certificate of registration,
who receives a Scheduled substance to which the authority applies
must keep the original or a copy of each delivery docket or invoice
relating to the receipt.
(3) The holder of a certificate of registration who receives or supplies a
Schedule 2, 3, 4 or 7 substance to which the certificate applies
must keep the original or a copy of each delivery docket or invoice
relating to the receipt or supply.
74 Retention of prescriptions
The pharmacist-in-charge of a pharmacy or pharmacy department
must keep a copy of each prescription that is filled at the pharmacy
or pharmacy department.
75 Record of supply or administration of Schedule 4 or 8
substance in clinical or other records
(1) Subregulation (2) applies to a health practitioner or veterinarian
who supplies or administers a Schedule 4 or 8 substance to or for a
person or animal (the patient) in relation to whom the practitioner
or veterinarian keeps clinical records.
Part 5 Other records and notices
Division 1 General requirements
Medicines, Poisons and Therapeutic Goods Regulations 2014 35
(2) As soon as practicable after the dealing, the health practitioner or
veterinarian must record the following details in relation to the
dealing in the clinical records of the patient:
(a) the nature of the dealing;
(b) the date of the dealing;
(c) the name of the substance, and the form, strength and
quantity, dealt with;
(d) if the dealing was supplying the substance to someone other
than the patient – the name and address of the person to
whom it was supplied;
(e) if the dealing was supplying the substance on a prescription –
the name and address of the person who issued the
prescription.
(3) Subregulation (4) applies to a health practitioner who supplies a
Schedule 4 substance to a person in relation to whom the
practitioner does not keep clinical records.
(4) As soon as practicable after the dealing, the health practitioner
must record the following details in relation to the dealing in an
appropriate record:
(a) the date of the supply;
(b) the name of the substance, and the form, strength and
quantity, supplied;
(c) the name and address of the person to whom it was supplied;
(d) if the substance was supplied on a prescription:
(i) the name and address of the person for whom the
prescription was issued; and
(ii) the name and address of the person who issued the
prescription.
76 Form and period of retention of records
(1) A record that a person is required to make under this Division must
be legible and expressed in the English language.
(2) A record that a person is required under this Division to make or
keep must be kept for at least 2 years after the day on which it was
made or received.
Part 5 Other records and notices
Division 2 Offences relating to records and notices
Medicines, Poisons and Therapeutic Goods Regulations 2014 36
Division 2 Offences relating to records and notices
77 Offence not to make or keep record
(1) A person who, under Division 1, is required to make or keep a
record commits an offence if the person:
(a) fails to make or keep the record; or
(b) fails to make or keep the record in accordance with the
requirements of Division 1.
Maximum penalty: 50 penalty units.
(2) An offence against subregulation (1) is an offence of strict liability.
78 Offence not to give fraudulent prescription to police
(1) A pharmacist commits an offence if the pharmacist:
(a) receives a prescription; and
(b) becomes aware of a substantial risk that the prescription has
been forged or fraudulently altered; and
(c) fails to give a copy of the prescription to the Commissioner of
Police as soon as practicable (but not later than 7 days) after
becoming aware of the risk.
Maximum penalty: 80 penalty units.
(2) Strict liability applies to subregulation (1)(c).
79 Offence not to report supply or administration of Schedule 8
substance at declared place
(1) A person in charge of a declared place commits an offence if:
(a) a Schedule 8 substance is supplied or administered to a
person at the declared place; and
(b) the person in charge fails to give notice of the supply or
administration in the approved form to the CHO within 7 days
after the date of supply or administration.
Maximum penalty: 50 penalty units.
(2) Strict liability applies to subregulation (1)(b).
Part 6A Monitored medicines database
Medicines, Poisons and Therapeutic Goods Regulations 2014 37
80 Offence not to report administration of Schedule 8 substance
from medical kit
(1) The holder of a medical kit authorisation commits an offence if:
(a) the holder administers a substance to a person; and
(b) the substance is a Schedule 8 substance that is in the holder's
possession under the authorisation; and
(c) the holder fails to give notice of the administration in the
approved form to the CHO within 7 days after the date of
administration.
Maximum penalty: 50 penalty units.
(2) Strict liability applies to subregulation (1)(c).
Part 6 Legal proceedings
81 Declared provisions
For paragraph (b) of the definition declared provision in
section 212 of the Act, regulations 22, 23, 25, 27, 28, 29, 30, 62, 64
and 80 are declared provisions.
81A Declared provisions
For section 215(7) of the Act, definition declared EO liability
provision, paragraph (b), regulation 31 is prescribed.
Part 6A Monitored medicines database
81B Definitions
In this Part:
custodial correctional facility, see section 11(1)(a) of the
Correctional Services Act 2014.
prisoner, see section 6 of the Correctional Services Act 2014.
81C Monitored medicine
For section 243A of the Act, definition monitored medicine,
paragraph (b), the following Scheduled substances are prescribed:
(a) each benzodiazepine that is a Schedule 4 substance;
Part 6A Monitored medicines database
Medicines, Poisons and Therapeutic Goods Regulations 2014 38
(b) codeine;
(c) gabapentin;
(d) pregabalin;
(e) quetiapine;
(f) tramadol;
(g) zolpidem;
(h) zopiclone.
81D Database name
For section 243C(1) of the Act, the name NTScript is prescribed.
81E Information to be given to CHO
(1) For section 243E(1)(a) of the Act, the prescribed information in
relation to a recordable prescription is as follows:
(a) the date the prescription was issued;
(b) the name and address of the person to whom the prescription
was issued;
(c) the date of birth of the person to whom the prescription was
issued;
(d) the name, form, strength and quantity of the monitored
medicine prescribed;
(e) the number of repeats permitted under the prescription;
(f) the directions for use of the monitored medicine;
(g) the name, address and phone number of the person who
issued the prescription.
(2) For section 243E(1)(b) of the Act, the prescribed information in
relation to a recordable supply is as follows:
(a) the date of the supply;
(b) the name and address of the person to whom the supply was
made;
(c) the date of birth of the person to whom the supply was made;
Part 6A Monitored medicines database
Medicines, Poisons and Therapeutic Goods Regulations 2014 39
(d) the name, form, strength and quantity of the monitored
medicine supplied;
(e) the directions for use of the monitored medicine supplied;
(f) the name, address and phone number of the person who
authorised the supply;
(g) the name, address and phone number of the pharmacy or
pharmacy department from which the supply was made.
(3) For section 243E(1)(c) of the Act, the prescribed information:
(a) in relation to a recordable prescription – is the information
specified in subregulation (1); and
(b) in relation to a recordable supply – is the information specified
in subregulation (2).
81F Prescription issued by relevant prescriber in exempt
circumstances
For section 243J(1)(c) of the Act, the following circumstances are
exempt:
(a) a relevant prescriber issues a prescription for a monitored
medicine to a person who is being treated in an aged care
facility;
(b) a relevant prescriber issues a prescription for a monitored
medicine to a person who is a prisoner in a custodial
correctional facility;
(c) a relevant prescriber issues a prescription for a monitored
medicine to a person who is suffering a life threatening illness
and the supply of the monitored medicine is intended to
provide palliative treatment in an end of life situation.
81G Supply made by pharmacist in exempt circumstances
For section 243K(1)(c) of the Act, the following circumstances are
exempt:
(a) a pharmacist supplies a monitored medicine to a person who
is being treated in an aged care facility;
(b) a pharmacist supplies a monitored medicine to a person who
is a prisoner in a custodial correctional facility;
Part 7 Infringement notice offences
Medicines, Poisons and Therapeutic Goods Regulations 2014 40
(c) a pharmacist supplies a monitored medicine to a person who
is suffering a life threatening illness and the supply of the
monitored medicine is intended to provide palliative treatment
in an end of life situation.
Part 7 Infringement notice offences
82 Infringement notice offence and prescribed amount payable
(1) An infringement notice offence is an offence against a provision
specified in Schedule 1.
(2) The prescribed amount for an infringement notice offence is the
amount equal to the monetary value of the number of penalty units
specified for the offence in Schedule 1.
83 When infringement notice may be given
If an authorised officer reasonably believes a person has committed
an infringement notice offence, the officer may give a notice (an
infringement notice) to the person.
84 Contents of infringement notice
(1) The infringement notice must specify the following:
(a) the name and address of the person, if known;
(b) the date the infringement notice is given to the person;
(c) the date, time and place of the infringement notice offence;
(d) a description of the offence;
(e) the prescribed amount payable for the offence;
(f) the enforcement agency, as defined in the Fines and Penalties
(Recovery) Act 2001, to whom the prescribed amount is
payable.
(2) The infringement notice must include a statement to the effect of
the following:
(a) the person may expiate the infringement notice offence and
avoid any further action in relation to the offence by paying the
prescribed amount to the specified enforcement agency within
28 days after the notice is given;
Part 7 Infringement notice offences
Medicines, Poisons and Therapeutic Goods Regulations 2014 41
(b) the person may elect under section 21 of the Fines and
Penalties (Recovery) Act 2001 to have the matter dealt with by
a court instead of under that Act by completing a statement of
election and giving it to the specified enforcement agency;
(c) if the person does nothing in response to the notice,
enforcement action may be taken under the Fines and
Penalties (Recovery) Act 2001, including (but not limited to)
action for the following:
(i) suspending the person's licence to drive;
(ii) seizing personal property of the person;
(iii) deducting an amount from the person's wages or salary;
(iv) registering a statutory charge on land owned by the
person;
(v) making a community work order for the person and
imprisonment of the person if the person breaches the
order.
(3) Also, the infringement notice must include an appropriate form for
making the statement of election mentioned in subregulation (2)(b).
85 Payment by cheque
If the person tenders a cheque in payment of the prescribed
amount, the amount is not taken to have been paid unless the
cheque is cleared on first presentation.
86 Withdrawal of infringement notice
(1) The CHO may withdraw the infringement notice by written notice
given to the person.
(2) The notice must be given:
(a) within 28 days after the infringement notice is given to the
person; and
(b) before payment of the prescribed amount.
87 Application of Part
(1) This Part does not prejudice or affect the start or continuation of
proceedings for an infringement notice offence for which an
infringement notice has been given unless the offence is expiated.
Part 8 Miscellaneous matters
Medicines, Poisons and Therapeutic Goods Regulations 2014 42
(2) Also, this Part does not:
(a) require an infringement notice to be given; or
(b) affect the liability of a person to be prosecuted in a court for an
offence for which an infringement notice has not been given;
or
(c) prevent more than one infringement notice for the same
offence being given to a person.
(3) If more than one infringement notice for the same offence has been
given to a person, the person may expiate the offence by paying
the prescribed amount in accordance with any of the notices.
Part 8 Miscellaneous matters
89 Information in register of authorities
For section 255(3) of the Act, a register of authorities must contain
the following particulars for each authority to which it relates:
(a) the name of the holder of the authority;
(b) if the holder is a body corporate – the holder's ACN;
(c) if the holder of the authority will be conducting business under
the authority under a business name – the business name;
(d) the holder's postal address;
(e) the type of authority;
(f) the unique identifying number of the authority;
(g) each Scheduled substance to which the authority applies;
(h) the dealing with the substance authorised by the authority
and, if applicable, the address of the place where the holder is
authorised to deal with the substance;
(i) the date the authority was issued or renewed and the period it
is in force;
(j) any conditions of the authority imposed by the CHO;
(k) any suspension or cancellation of the authority and the
reasons for it;
(l) for a certification of registration – the nominated person.
Part 8 Miscellaneous matters
Medicines, Poisons and Therapeutic Goods Regulations 2014 43
90 Appointed Committee members
For section 265 of the Act, the following are the qualification
requirements for appointed members of the Committee:
(a) 2 members must be doctors with expertise in pain
management or rehabilitation;
(b) 2 members must be doctors with experience in general
practice;
(c) one member must be a doctor who is employed in the Agency
and working in the community drugs program managed by the
Agency;
(d) one member must be a person who is employed in the Agency
and working in the community drugs program managed by the
Agency but who is not a doctor;
(e) one member must be a pharmacist with experience in the
community pharmacy practice area;
(f) one member must be a pharmacist with experience in the
hospital or clinical pharmacy practice area;
(g) any other appointed member must be:
(i) a health practitioner; or
(ii) a veterinarian; or
(iii) a lawyer; or
(iv) a person who is employed in the Agency and working in
the community drugs program managed by the Agency
but who is not a doctor.
91 Fees
The fees specified in Schedule 2 are payable for the matter
specified opposite.
Schedule 1 Infringement notice offences and prescribed amounts
Medicines, Poisons and Therapeutic Goods Regulations 2014 44
Schedule 1 Infringement notice offences and prescribed
amounts
regulation 82
Provision Prescribed amount in penalty units
for individual for body corporate
Medicines, Poisons and Therapeutic Goods Act 2012
sections 97(2) and (3) and 107(1) 1
sections 112B(1) and 112C(2) 3
section 176(1) and (2) 1
section 243H(1) 2 10
sections 243J(1) and 243K(1) 2
Medicines, Poisons and Therapeutic Goods Regulations 2014
regulations 31(1), 62(1) and 77(1) 3
regulations 19(1), 28(1), 29(1),
30(1), 67(1), 68(1) and 69(1)
2
regulations 27(1), 63(1), 65(1),
66(1), 70(1), 71(1) and 72(1)
1
Schedule 2 Fees
Medicines, Poisons and Therapeutic Goods Regulations 2014 45
Schedule 2 Fees
regulation 91
Matter Fee
(revenue units)
1 Application for
(a) manufacturer certificate of registration 50 plus 100 for each
year the certificate will
be in force
(b) wholesaler certificate of registration 50 plus 100 for each
year the certificate will
be in force
(ba) Schedule 4 supplier certificate of
registration
50 plus 100 for each
year the certificate will
be in force
(c) retailer licence 50 plus 50 for each year
the licence will be in
force
(ca) Schedule 3 authorisation 50 for each year the
authorisation will be in
force
(d) Schedule 4 authorisation 50 for each year the
authorisation will be in
force
(e) Schedule 7 authorisation 50 for each year the
authorisation will be in
force
(f) pest management technician licence 50 for each year the
licence will be in force
(g) Schedule 8 authorisation other than
an authorisation for the issue of
prescriptions for therapeutic use
50 for each year the
authorisation will be in
force
(h) prohibited substance authorisation 50 for each year the
authorisation will be in
force
Schedule 2 Fees
Medicines, Poisons and Therapeutic Goods Regulations 2014 46
Matter Fee
(revenue units)
(i) research authorisation 50 for each year the
authorisation will be in
force
(j) medical kit authorisation 50 for each year the
authorisation will be in
force
2 Renewal of
(a) manufacturer certificate of registration 100 for each year the
certificate will be in force
after renewal
(b) wholesaler certificate of registration 100 for each year the
certificate will be in force
after renewal
(ba) Schedule 4 supplier certificate of
registration
100 for each year the
certificate will be in force
after renewal
(c) retailer licence 50 for each year the
licence will be in force
after renewal
3 Transfer of certificate of registration 50
4 Replacement of authority 50
ENDNOTES
Medicines, Poisons and Therapeutic Goods Regulations 2014 47
ENDNOTES
1 KEY Key to abbreviations
amd = amended od = order
app = appendix om = omitted
bl = by-law pt = Part
ch = Chapter r = regulation/rule
cl = clause rem = remainder
div = Division renum = renumbered
exp = expires/expired rep = repealed
f = forms s = section
Gaz = Gazette sch = Schedule
hdg = heading sdiv = Subdivision
ins = inserted SL = Subordinate Legislation
lt = long title sub = substituted
nc = not commenced
2 LIST OF LEGISLATION
Medicines, Poisons and Therapeutic Goods Regulations (SL No. 10, 2014)
Notified 19 April 2014
Commenced 1 May 2014 (r 2, s 2 Medicines, Poisons and Therapeutic
Goods Act 2012 (Act No. 13, 2012) and Gaz S22,
30 April 2014, p 12)
Statute Law Amendment (Directors' Liability) Act 2015 (Act No. 26, 2015)
Assent date 18 September 2015
Commenced 14 October 2015 (Gaz G41, 14 October 2015, p 3)
Statute Law Revision Act 2017 (Act No. 4, 2017)
Assent date 10 March 2017
Commenced 12 April 2017 (Gaz G15, 12 April 2017, p 3)
Medicines, Poisons and Therapeutic Goods Amendment Regulations 2020 (SL No. 3,
2020)
Notified 9 April 2020
Commenced 9 April 2020
Medicines, Poisons and Therapeutic Goods Legislation Amendment Act 2021 (Act
No. 27, 2021)
Assent date 15 December 2021
Commenced 16 December 2021 (s 2)
Medicines, Poisons and Therapeutic Goods Legislation Amendment Act 2022 (Act
No. 25, 2022)
Assent date 9 December 2022
Commenced 10 December 2022 (s 2)
Statute Law Revision and Repeals Act 2026 (Act No. 3, 2026)
Assent date 9 February 2026
Commenced 10 February 2026 (s 2)
ENDNOTES
Medicines, Poisons and Therapeutic Goods Regulations 2014 48
3 GENERAL AMENDMENTS
General amendments of a formal nature (which are not referred to in the table
of amendments to this reprint) are made by the Interpretation Legislation
Amendment Act 2018 (Act No. 22 of 2018) to: rr 1, 2, 3, 9, 84 and sch 1.
4 LIST OF AMENDMENTS
r 3 amd Act No. 4, 2017, s 34; Act No. 27, 2021, s 13; Act No. 25, 2022, s 56
r 3A ins Act No. 25, 2022, s 57
r 5 amd Act No. 27, 2021, s 14
pt 2 hdg amd Act No. 4, 2017, s 34
rr 7A – 7B ins Act No. 27, 2021, s 15
pt 2
div 1A ins Act No. 25, 2022, s 58
rr 17A – 17C ins Act No. 25, 2022, s 58
r 18 amd Act No. 25, 2022, s 59
r 23 amd Act No. 25, 2022, s 60
rr 32 – 34 amd Act No. 4, 2017, s 34
r 35 amd Act No. 3, 2026, s 47
pt 3 hdg amd Act No. 4, 2017, s 34
r 42 amd Act No. 4, 2017, s 34; Act No. 25, 2022, s 61
pt 4 hdg amd Act No. 4, 2017, s 34
pt 4
div 1 hdg amd Act No. 4, 2017, s 34
pt 4
div 1
sdiv 6 hdg amd Act No. 25, 2022, s 62
r 60 amd Act No. 4, 2017, s 34
r 61 amd Act No. 4, 2017, s 34
sub Act No. 25, 2022, s 63
pt 4
div 2 hdg amd Act No. 4, 2017, s 34
rr 62 – 73 amd Act No. 4, 2017, s 34
r 81A ins Act No. 26, 2015, s 78
pt 6A hdg ins Act No. 27, 2021, s 16
rr 81B – 81G ins Act No. 27, 2021, s 16
pt 8 hdg amd No. 3, 2020, r 4
r 87A ins No. 3, 2020, r 5
rep Act No. 25, 2022, s 64
r 88 rep Act No. 25, 2022, s 64
r 89 amd Act No. 4, 2017, s 34
r 90 sub Act No. 25, 2022, s 65
pt 9 hdg exp Act No. 13, 2012, s 294(5)
rr 92 – 93 exp Act No. 13, 2012, s 294(5)
sch 1 sub Act No. 27, 2021, s 17
amd Act No. 25, 2022, s 66
sch 2 amd Act No. 25, 2022, s 67