Poisons and Therapeutic Goods Regulation 2008 (NSW)
This Regulation remains in force until the Poisons and Therapeutic Goods Act 1966 No 31 is repealed by the Medicines, Poisons and Therapeutic Goods Act 2022 No 73— see the Subordinate Legislation Act 1989 No 146, Sch 5, cl 1.
This Regulation is the Poisons and Therapeutic Goods Regulation 2008.
This Regulation commences on 1 September 2008.
This Regulation replaces the Poisons and Therapeutic Goods Regulation 2002 which is repealed on 1 September 2008 by section 10(2) of the Subordinate Legislation Act 1989.
In this Regulation—
(a) in Part 4 (Drugs of addiction), a medical practitioner, nurse or midwife authorised under section 17A of the Act, dentist or veterinary practitioner, and
(b) in a Part other than Part 4, a medical practitioner, nurse or midwife authorised under section 17A of the Act, podiatrist, dentist, optometrist or veterinary practitioner.
A managed correctional centre is a kind of correctional centre.
(a) that includes the following cannabinoids—
(i) tetrahydrocannabinol,
(ii) cannabidiol,
(iii) cannabinol,
(iv) cannabigerol,
(v) cannabichromene,
(vi) cannabidiolic acid,
(vii) tetrahydrocannabinolic acid,
(viii) tetrahydrocannabivarol,
(ix) cannabidivarol, and
(b) in which tetrahydrocannabinol and cannabidiol (in approximately equal proportions) comprise not less than 90 per cent of the total cannabinoid content.
(a) the director of nursing of the residential care facility, or
(b) in the case of a residential care facility for which there is no director of nursing—the residential care facility manager.
(a) a medical practitioner, dentist, veterinary practitioner or pharmacist, or
(b) a person who holds a degree or diploma approved for the time being by the Secretary, or
(c) a person approved for the time being by the Secretary.
(a) a registered good, or
(b) a substance or good that has been excluded from this definition by an order made by the Secretary and published in the Gazette.
See the Voluntary Assisted Dying Act 2022, section 7, which provides for the approval of a Schedule 4 or 8 substance as a voluntary assisted dying substance.
The Act and the Interpretation Act 1987 contain definitions and other provisions that affect the interpretation and application of this Regulation.
In this Regulation—
(a) expressions that are defined in the current Poisons Standard have the meanings given to them by that Standard, and
(b) expressions that are defined in the current Poisons Standard and that are also defined in the Act or in this Regulation have the meanings given to them by the Act or this Regulation, respectively, and
(c) a reference to a Schedule 1, 2, 3, 4, 5, 6, 7, 8 or 9 substance is a reference to a substance included in the correspondingly numbered Schedule of the Poisons List.
Notes included in this Regulation do not form part of this Regulation.
(Repealed)
A dealer who supplies a poison must ensure that the poison is packaged and labelled—
(a) in accordance with the relevant provisions of the current Poisons Standard, and
(b) in the case of a poison to which Therapeutic Goods Order No. 95 applies, in accordance with that Order.
This clause does not apply to the labelling of a substance that is supplied by an authorised practitioner or pharmacist so long as the substance is supplied in a package that is labelled in accordance with the requirements of Appendix A.
A pharmacist who supplies any quantity of a Schedule 2 or 3 substance on prescription must ensure that the substance is supplied in a package that is labelled in accordance with the requirements of Appendix A instead of in accordance with the requirements of subclause (1).
Despite subclause (1), an authorised practitioner or pharmacist who supplies a poison to a person who, in the opinion of the authorised practitioner or pharmacist, would suffer undue hardship through difficulty in opening a container that is packaged in accordance with Therapeutic Goods Order No. 95, is not required to package the poison in accordance with that Order.
Maximum penalty—10 penalty units.
A dealer must not supply any substance in a container that has a label that states or implies that the substance is a poison, unless the substance is a poison.
Maximum penalty—10 penalty units.
A dealer must ensure that any Schedule 3 substance supplied by the dealer is labelled with the dealer’s name and address.
Maximum penalty—2 penalty units.
Subclause (1) does not apply to the supply of any Schedule 3 substance by wholesale.
The Secretary may, by order in writing, exempt any person or substance, or any class of persons or substances, from the requirements of this Division.
Such an exemption may be given unconditionally or subject to conditions.
Subject to subclause (4), any exemption in force under a law of the Commonwealth, or of another State or a Territory, corresponding to this clause has the same effect as an exemption under this clause.
The Secretary may, by order published in the Gazette, declare that subclause (3) does not have effect with respect to an exemption specified in the order.
A dealer who has possession of any poison must keep the poison—
(a) apart from food intended for consumption by humans or animals, and
(b) in such a way that, if its container breaks or leaks, the poison cannot mix with or contaminate any food intended for consumption by humans or animals.
Maximum penalty—10 penalty units.
A dealer who has possession of any Schedule 3 or 7 substance must keep the substance in a room or enclosure to which the public does not have access.
Maximum penalty—10 penalty units.
A dealer who has possession of any Schedule 6 substance must keep that substance—
(a) in a place to which the public does not have access, or
(b) in a place that is at least 1.2 metres above the floor and at least 1.2 metres away from any step, stairway, ramp or escalator to which the public has access.
Maximum penalty—10 penalty units.
This clause does not apply to any of the following—
(a) any therapeutic substance for internal use in animals,
(b) any substance in a container that is fitted with a child-resistant closure,
(c) any substance in a pressurised spray dispenser that is fitted with a cap that can be removed only by using a levering instrument applied through a slot in the cap,
(d) any substance in a container that has a capacity of 5 litres or more or a weight (inclusive of its contents) of 5 kilograms or more,
(e) any hair dye in a container that has a capacity of 50 millilitres or less,
(f) any cockroach bait that is enclosed in a complex welded plastic structure.
In this clause,
(a) a child-resistant closure within the meaning of the current Poisons Standard, or
(b) a closure of a design approved for the time being by the Secretary.
An authorised practitioner may issue a prescription for a Schedule 2 or 3 substance.
A person must not issue a prescription for a Schedule 2 or 3 substance unless authorised to do so by this clause.
Maximum penalty—10 penalty units.
A person who issues a prescription for pseudoephedrine must ensure that the prescription complies with Division 3 of Part 3 as if pseudoephedrine were a restricted substance.
Maximum penalty—10 penalty units.
Subclause (1) applies to pseudoephedrine only in so far as it is a Schedule 3 substance.
An authorised practitioner must not issue a prescription for a Schedule 2 or 3 substance in a quantity, or for a purpose, that does not accord with the recognised therapeutic standard of what is appropriate in the circumstances.
Maximum penalty—10 penalty units.
A person who is not an authorised practitioner or a pharmacist may supply a Schedule 2 or 3 substance to another person if the supplier holds a licence or authority under Part 8 to supply the substance.
A pharmacist must not supply a Schedule 3 substance to any person unless the pharmacist—
(a) personally hands the substance to the person, and
(b) gives the person an opportunity to seek advice as to the use of the substance, including advice that the person may require in respect of the dosage, frequency of administration and general toxicity of the substance.
This clause does not apply to the supply of any substance—
(a) to an authorised practitioner, or
(b) to any other person on the prescription of an authorised practitioner.
This clause does not apply to the supply of salbutamol or terbutaline in metered aerosols for first aid purposes to a person who holds a current emergency asthma management certificate issued by an organisation approved by the Secretary for the purposes of this subclause.
This clause does not apply to the supply to the responsible person for a residential care facility of any substance that is—
(a) in the manufacturer’s original pack, and
(b) approved by the Secretary for urgent use in a residential care facility, and
(c) supplied in accordance with—
(i) any conditions of the approval, and
(ii) a written order signed by the responsible person.
This clause does not apply to the supply of adrenaline for anaphylaxis first aid purposes if—
(a) the adrenaline is contained in single use automatic injectors that have been filled by the manufacturer and that deliver no more than 0.3 milligrams of adrenaline each, and
(b) the supply is to a person who holds a current first aid certificate issued after completion of a first aid course approved by the WorkCover Authority as referred to in regulations made under the Occupational Health and Safety Act 2000, and the person has received training on the symptoms and first aid management of anaphylaxis from—
(i) a first aid training organisation approved by the WorkCover Authority, or
(ii) any other organisation approved by the Secretary for the purposes of this paragraph.
Maximum penalty—10 penalty units.
A pharmacist who supplies a Schedule 2 or 3 substance on prescription must endorse the prescription for the substance in accordance with clause 41 as if the substance were a restricted substance.
Maximum penalty—10 penalty units.
The Secretary may, by order in writing, exempt any person or substance, or any class of persons or substances, from any or all of the requirements of this clause.
Such an exemption may be given unconditionally or subject to conditions.
A person must not obtain or use a Schedule 7 substance unless the person holds an authority under Part 8 to obtain or use the substance.
Maximum penalty—10 penalty units.
A dealer must not supply a Schedule 7 substance to any other person unless—
(a) the dealer holds an authority under Part 8 to supply the substance, and
(b) the person being supplied holds an authority under Part 8 to obtain the substance.
Maximum penalty—10 penalty units.
A person being supplied with a Schedule 7 substance must surrender to the dealer the person’s authority to obtain the substance.
Maximum penalty—10 penalty units.
In the case of an authority—
(a) that authorises multiple supplies of a Schedule 7 substance, or
(b) that has been issued to a class of persons (as referred to in clause 170(4)),
it is sufficient compliance with subclause (3) if the person being supplied surrenders a copy of the authority to the dealer.
The functions of the Secretary under Part 8 with respect to an authority under this clause may be exercised by the Permanent Head of the Commonwealth Department of Health.
The Secretary may, by order in writing, exempt any person or substance, or any class of persons or substances, from any or all of the requirements of this clause.
Such an exemption may be given unconditionally or subject to conditions.
This clause does not apply to—
(a) the supply by wholesale of any Schedule 7 substance, or
(b) the use by a person of any Schedule 7 substance that is—
(i) a pesticide (within the meaning of the Pesticides Act 1999), or
(ii) a stock medicine (within the meaning of the Stock Medicines Act 1989),
or the supply to, or obtaining by, such a person of any such substance, or
(c) the use by a person in charge of an institution or facility for scientific research, instruction, analysis or study of any Schedule 7 substance for use in that institution or facility, or the supply to, or obtaining by, such a person of any such substance for use in that institution or facility, or
(d) the use by a person of any Schedule 7 substance (other than a highly dangerous substance) for non-domestic purposes, or the supply to, or obtaining by, a person of any such substance for use for non-domestic purposes.
In subclause (8)(d),
• arsenic
• cyanides
• fluoroacetamide
• fluoroacetic acid
• hydrocyanic acid
• strychnine
• thallium
This clause applies to any Schedule 5, 6 or 7 substance that is specified in the Poisons List as being a substance that is manufactured or supplied for a particular use.
A dealer (other than an authorised practitioner or pharmacist) who supplies a substance to which this clause applies must supply the substance, unopened, in the container in which it was received by the dealer.
Maximum penalty—10 penalty units.
A person must not supply any pencil, crayon, finger colour, poster paint, school pastel or show card colour or other such article or substance if the article or substance contains a Schedule 2, 3, 5, 6 or 7 substance.
Subclause (1) does not apply to the supply of artists’ oil colours.
A person must not supply any painted toy, furniture or other item of household goods if the paint contains a Schedule 6 or 7 substance.
Maximum penalty—10 penalty units.
An authorised practitioner, pharmacist or retail dealer must not supply any poison—
(a) in the case of a therapeutic substance, in a quantity, or for a purpose, that does not accord with the recognised therapeutic standard of what is appropriate in the circumstances, or
(b) in any other case, for a purpose other than that stated on its container or for a purpose other than that for which it is normally used.
Maximum penalty—20 penalty units or imprisonment for 3 months, or both.
A pharmacist who supplies pseudoephedrine on prescription must record details of the supply in accordance with clause 55 as if pseudoephedrine were a restricted substance.
Maximum penalty—20 penalty units or imprisonment for 3 months, or both.
A pharmacist who supplies pseudoephedrine to a person without a prescription must, at the time of the supply, record the following details in an electronic form approved by the Secretary—
(a) a unique reference number for the supply,
(b) the name of the person by whom the pseudoephedrine is supplied,
(c) the name and address of the person to whom the pseudoephedrine is supplied,
(d) the name, strength (if not readily apparent) and quantity of the pseudoephedrine supplied and the date on which it is supplied,
(e) if the pharmacist does not know the identity of the person to whom the pseudoephedrine is supplied, the unique reference number of a photo identification of the person and the type of that identification.
Maximum penalty—20 penalty units or imprisonment for 3 months, or both.
Subclauses (1) and (1A) apply to pseudoephedrine only in so far as it is a Schedule 3 substance.
The operator of a residential care facility in which medication charts are used must ensure that an employee of the facility makes a record in the medication chart of a resident of the facility of the administration of any Schedule 2 or 3 substance to the resident.
Maximum penalty—10 penalty units.
The Secretary may, by order in writing, exempt any person or any class of persons from the requirements of this clause.
Such an exemption may be given unconditionally or subject to conditions.
In this clause—
(a) an Australian driver licence that displays a photograph of the person, or
(b) a passport, or
(c) a NSW Photo Card issued under the Photo Card Act 2005, or
(d) a card issued under a law of the Commonwealth or another State or Territory for the purpose of proving the person’s age which contains a photograph of the person in whose name the card is issued.
A person must not use or dispose of a poison in any place or in any manner likely to constitute a risk to the public.
Maximum penalty—20 penalty units or imprisonment for 3 months, or both.
This part, other than clauses 61 and 67, does not apply to—
(a) a prescription for a voluntary assisted dying substance for use under the Voluntary Assisted Dying Act 2022, or
(b) a voluntary assisted dying substance prescribed in accordance with the Voluntary Assisted Dying Act 2022.
A dealer who supplies a restricted substance must ensure that the substance is packaged and labelled—
(a) in accordance with the relevant provisions of the current Poisons Standard, and
(b) in the case of a substance to which Therapeutic Goods Order No. 95 applies, in accordance with that Order.
Despite subclause (1), an authorised practitioner who supplies a restricted substance must ensure that the substance is packaged in accordance with the requirements of subclause (1) but labelled in accordance with the requirements of Appendix A.
Despite subclause (1), a pharmacist who supplies a restricted substance on prescription, or as referred to in clause 45, or who supplies the restricted substance benzylpenicillin as referred to in clause 48, must ensure that the substance is packaged and labelled in accordance with the requirements of Appendix A.
Despite subclause (1), an authorised practitioner or pharmacist who supplies a restricted substance to a person who, in the opinion of the authorised practitioner or pharmacist, would suffer undue hardship through difficulty in opening a container that is packaged in accordance with Therapeutic Goods Order No. 95, is not required to package the substance in accordance with that Order.
Maximum penalty—10 penalty units.
A dealer must not supply any substance in a container that has a label that states or implies that the substance is a restricted substance, unless the substance is such a substance.
Maximum penalty—10 penalty units.
The Secretary may, by order in writing, exempt any person or substance, or any class of persons or substances, from the requirements of this Division.
Such an exemption may be given unconditionally or subject to conditions.
Subject to subclause (4), any exemption in force under a law of the Commonwealth, or of another State or a Territory, corresponding to this clause has the same effect as an exemption under this clause.
The Secretary may, by order published in the Gazette, declare that subclause (3) does not have effect with respect to an exemption specified in the order.
A dealer who has possession of any restricted substance must keep the substance—
(a) in a room or enclosure to which the public does not have access, and
(b) apart from food intended for consumption by humans or animals, and
(c) in such a way that, if its container breaks or leaks, the substance cannot mix with or contaminate any food intended for consumption by humans or animals.
Maximum penalty—15 penalty units.
Prescribed restricted substances that are kept in a hospital ward must be stored apart from all other goods (other than drugs of addiction or propofol) in a separate room, safe, cupboard or other receptacle securely attached to a part of the premises and kept securely locked when not in immediate use.
This clause does not apply to the storage of prescribed restricted substances on an emergency trolley, anaesthetic trolley or operating theatre trolley.
(Repealed)
Maximum penalty—20 penalty units.
The chief pharmacist of a hospital is responsible for the storage of all restricted substances at the hospital other than those that have been supplied to a ward.
In the case of a hospital for which there is no pharmacist, the responsibilities of a chief pharmacist under this clause are instead the responsibilities of—
(a) the director of nursing of the hospital, or
(b) the medical superintendent of the hospital,
as the chief executive officer of the hospital may determine.
The nurse or midwife in charge of a hospital ward is responsible for the storage of all restricted substances in the ward.
The management company for a managed correctional centre must ensure that restricted substances at the managed correctional centre are stored—
(a) in a room or enclosure to which the public does not have access, and
(b) apart from food intended for consumption by humans or animals, and
(c) in a way that, if the container breaks or leaks, the restricted substance cannot mix with or contaminate any food intended for consumption by humans or animals.
The management company for a managed correctional centre must ensure that prescribed restricted substances at the managed correctional centre are stored—
(a) apart from all other goods and substances, and
(b) in a separate room, safe, cupboard or other receptacle that is securely attached to a part of the premises and kept securely locked when not in immediate use.
The management company for a managed correctional centre must appoint, by written instrument, a pharmacist employed at the managed correctional centre as the person responsible for the storage of restricted substances at the managed correctional centre.
If there is no pharmacist employed at the managed correctional centre, an authorised practitioner or nurse in charge may be appointed.
This clause does not apply to a restricted substance at a retail pharmacy located at a managed correctional centre.
This clause does not prevent prescribed restricted substances from being stored with drugs of addiction.
In this clause—
Maximum penalty—20 penalty units.
A medical practitioner, dentist or veterinary practitioner may issue a prescription for a restricted substance.
A person must not issue a prescription for a restricted substance unless authorised to do so by or under the Act (including by an authority under Part 8).
Maximum penalty—15 penalty units.
A medical practitioner must not issue a prescription for a restricted substance otherwise than for medical treatment.
A nurse practitioner must not issue a prescription for a restricted substance otherwise than in the course of practising as a nurse practitioner.
A midwife practitioner must not issue a prescription for a restricted substance otherwise than in the course of practising as a midwife practitioner.
A dentist must not issue a prescription for a restricted substance otherwise than for dental treatment, and must endorse any such prescription with the words “FOR DENTAL TREATMENT ONLY”.
An optometrist must not issue a prescription for a restricted substance otherwise than in the course of practising as an optometrist, and must endorse any such prescription with the words “FOR OPTOMETRICAL TREATMENT ONLY”.
A veterinary practitioner must not issue a prescription for a restricted substance otherwise than for veterinary treatment, and must endorse any such prescription with the words “FOR ANIMAL TREATMENT ONLY”.
A podiatrist must not issue a prescription for a restricted substance otherwise than in the course of practising as a podiatrist, and must endorse any such prescription with the words “FOR PODIATRY TREATMENT ONLY”.
Maximum penalty—15 penalty units.
An authorised practitioner must not issue a prescription for a restricted substance in a quantity, or for a purpose, that does not accord with the recognised therapeutic standard of what is appropriate in the circumstances.
Maximum penalty—20 penalty units or imprisonment for 6 months, or both.
The authority of a pharmacist to supply a restricted substance on prescription (other than for a special restricted substance or a substance listed in clause 37) extends, in the case of a medication chart prescription, to supply on a duplicate copy of the medication chart prescription.
Accordingly, a reference in this Regulation to a prescription (in the context of the supply on prescription of a restricted substance by a pharmacist) is a reference, in the case of supply on a medication chart prescription, to a duplicate copy of the prescription.
A prescription for a restricted substance must include the following details—
(a) the date on which it is issued,
(b) if the treatment is for—
(i) a patient—the name, date of birth and address of the patient, or
(ii) an animal—the species of animal and the name and address of the animal’s owner, or
(iii) a patient’s partner and the prescription is for azithromycin for the treatment of chlamydia—the name and email address or mobile phone number of the partner,
(c) the name, strength (if not readily apparent) and quantity of the substance to be supplied,
(c1) the route of administration (if not readily apparent) of the substance to be supplied,
(d) adequate directions for use,
(e) the maximum number of times the substance may be supplied on the prescription,
(f) in the case of a prescription for a special restricted substance, the intervals at which the substance may be supplied on the prescription,
(g) if the prescription is issued at a hospital, the name and designation of the person by whom it is issued and the name, address and telephone number of the hospital,
(h) if the prescription is issued elsewhere than at a hospital, the name and designation of the person by whom it is issued and the address and telephone number of the premises at which it is issued.
As an alternative to complying with subclause (1), a medication chart prescription authorising the supply of a substance that is not a special restricted substance or a substance listed in clause 37 must include the following details—
(a) the date on which it is issued,
(b) the name, date of birth and address of the patient,
(c) the name and form (if not readily apparent) of the substance to be supplied,
(d) the strength (if not readily apparent) of the substance to be supplied,
(e) the route of administration (if not readily apparent) of the substance to be supplied,
(f) adequate directions for use,
(g) the frequency or times at which the substance is to be administered or used,
(h) the period during which the substance is to be used or administered (being a period that ends on a date that is no more than 4 months from the date of first use of the relevant chart for the resident),
(i) the name and designation of the person by whom it is issued,
(j) the name, address and telephone number of the relevant residential care facility.
The details referred to in subclause (1A)(b) and (j) can be made out by any person.
The details referred to in subclause (1)(a)–(f) and (1A)(a) and (c)–(i) must be made out—
(a) in the handwriting of the person by whom the prescription is issued, or
(b) in such other manner as may be approved for the time being by the Secretary.
A prescription must be signed by the person by whom it is issued (whether it complies with subclause (1) or (1A)).
The person by whom the prescription is issued must confirm any dose that could be regarded as being dangerous or unusual by underlining the part of the prescription that specifies the intended dose and by initialling the prescription in the margin.
A person who issues a prescription for a restricted substance must ensure that the prescription complies with the requirements of this clause.
The Secretary may, by order in writing, exempt any person or restricted substance, or any class of persons or restricted substances, from any or all of the requirements of this clause.
Such an exemption may be given unconditionally or subject to conditions.
In this clause—
(a) the patient’s spouse,
(b) the patient’s de facto partner,
(c) a person with whom the patient is or was in a sexual relationship.
(Repealed)
Maximum penalty—15 penalty units.
In an emergency or other urgent circumstances, an authorised practitioner may direct the supply of a restricted substance orally, including by telephone, by electronic mail or by facsimile.
A person who so directs the supply of a restricted substance—
(a) must immediately make out a prescription, and
(b) must send the prescription without delay (and in any case within 24 hours) to the person to whom the direction was given.
A person who issues a prescription under this clause must ensure that the prescription is endorsed with words that indicate the prescription has been issued in confirmation of a direction under this clause.
This clause does not apply to a direction given under clause 58.
Maximum penalty—15 penalty units.
A medical practitioner or nurse practitioner may issue a prescription for a restricted substance by sending a prescription to a pharmacist employed in or engaged by a public health organisation in relation to carrying out functions in the course of that employment or engagement by email or facsimile.
A medical practitioner or nurse practitioner who issues a prescription for a restricted substance in accordance with this clause must keep the prescription.
A pharmacist to whom a prescription is sent under this clause must—
(a) print a copy of the prescription, and
(b) keep a printed copy.
The copy of the prescription printed by the pharmacist is taken to be a prescription for the purposes of Division 4 of this Part.
This clause does not apply to a medication chart prescription.
In this clause—
This clause applies to a medical practitioner or nurse practitioner and a pharmacist—
(a) employed in or engaged by the same private health facility, and
(b) in relation to carrying out functions in the course of that employment or engagement.
During the prescribed period, a medical practitioner or nurse practitioner may issue a prescription for a restricted substance by sending a prescription to a pharmacist by email or facsimile.
A medical practitioner or nurse practitioner who issues a prescription for a restricted substance in accordance with this clause must keep the prescription.
A pharmacist to whom a prescription is sent under this clause must—
(a) print a copy of the prescription, and
(b) keep a printed copy.
The copy of the prescription printed by the pharmacist is taken to be a prescription for the purposes of Division 4 of this Part.
This clause does not apply to a medication chart prescription.
In this clause—
This clause applies to the following restricted substances—
• acitretin
• clomiphene
• cyclofenil
• dinoprost
• dinoprostone
• etretinate
• follitropin beta
• hydroxychloroquine
• isotretinoin for oral use
• luteinising hormone
• tretinoin for oral use
• urofollitrophin (human follicle stimulating hormone)
A person must not prescribe a restricted substance to which this clause applies unless the person holds an authority under Part 8 to prescribe the substance.
This clause does not apply to the prescription of a substance—
(a) by a veterinary practitioner, or
(b) by a person who is authorised by the Permanent Head of the Commonwealth Department of Health to issue a prescription for the substance.
A person who issues a prescription that authorises the supply of a substance to which this clause applies must ensure—
(a) in the case of a prescription that is issued in accordance with an authority under Part 8 that was granted to a particular person (by means of an instrument in writing given to the person), that the prescription is endorsed with the reference number shown on the authority, or
(b) in any other case, that the prescription is endorsed with words that clearly indicate that the prescription has been issued under this clause.
Maximum penalty—15 penalty units.
An authorised practitioner who prescribes a prescribed restricted substance must make a record of the following particulars—
(a) the name, strength and quantity of the substance prescribed and the date on which it was prescribed,
(b) if the substance is intended for the treatment of a person, the name and address of the person to be treated,
(c) if the substance is intended for the treatment of an animal, the species of animal and the name and address of the animal’s owner,
(d) the maximum number of times the substance may be supplied on the prescription,
(e) in the case of a prescription for a special restricted substance, the intervals at which the substance may be supplied on the prescription,
(f) the directions for use, as shown on the prescription.
The record must be kept at the surgery, hospital or office of the person prescribing the substance.
Maximum penalty—15 penalty units.
A pharmacist must not supply a restricted substance on prescription unless the prescription is in the form required by Division 3.
This clause does not prevent a pharmacist from supplying a restricted substance on a prescription that otherwise complies with clause 35(1) merely because—
(a) the prescription fails to specify the maximum number of times the substance may be supplied, or
(a1) the prescription fails to specify the patient’s date of birth, or
(b) in the case of a prescription for a special restricted substance, the prescription fails to specify the intervals at which the substance may be supplied, or
(c) the address shown on the prescription indicates that it has been issued by a veterinary practitioner from some other State or a Territory.
This clause does not prevent a pharmacist from supplying a substance on a medication chart prescription that otherwise complies with clause 35(1A) merely because—
(a) the prescription fails to specify the maximum number of times the substance may be supplied, or
(b) the prescription fails to specify the patient’s date of birth.
A pharmacist must not supply a restricted substance on a prescription referred to in subclause (2)(a), (a1) or (b) if it appears to the pharmacist that the substance has previously been supplied on the prescription, regardless of how many times the prescription purports to authorise the supply of the substance.
The Secretary may, by order in writing, exempt any person or restricted substance, or any class of persons or restricted substances, from any or all of the requirements of this clause.
Such an exemption may be given unconditionally or subject to conditions.
Maximum penalty—15 penalty units.
A pharmacist must not supply a restricted substance on prescription—
(a) if the prescription is marked “CANCELLED”, or
(b) if the substance has already been supplied on the prescription the maximum number of times indicated by the prescription, or
(c) if the interval of time that has elapsed since the substance was last supplied on the prescription is less than that indicated by the prescription as the minimum interval that must elapse between successive supplies of the substance, or
(d) if the prescription is illegible or defaced, or
(e) if the prescription appears to have been forged or fraudulently obtained, or
(f) if the prescription appears to have been altered otherwise than by the authorised practitioner by whom it was issued, or
(g) if the prescription is dated—
(i) in the case of a medication chart prescription—more than 4 months before the date on which the supply is requested, or
(ii) in the case of a prescription, other than a medication chart prescription, for a prescribed restricted substance—more than 6 months before the date on which the supply is requested, or
(iii) in any other case—more than 12 months before the date on which the supply is requested, or
(h) in the case of a medication chart prescription—where it appears to the pharmacist that a sufficient quantity of the substance has already been supplied to the resident for the period indicated on the prescription.
Immediately on being requested to supply a prescribed restricted substance in either of the circumstances referred to in subclause (1)(e) or (f), a pharmacist must retain the prescription and cause notice of the request to be given to a police officer.
Maximum penalty—15 penalty units.
A pharmacist who supplies a restricted substance on prescription must (on each occasion the substance is supplied) endorse the following particulars (in ink) on the prescription—
(a) the date on which the substance was supplied,
(b) the address of the place at which the substance was supplied,
(c) the prescription reference number.
Maximum penalty—15 penalty units.
A person who supplies a substance on prescription must endorse (in ink) across the prescription the word “CANCELLED”—
(a) if the maximum number of times the prescription is to be dispensed is not clearly specified, or
(b) if (in the case of a prescription for a special restricted substance) the intervals at which the substance may be supplied are not clearly specified, or
(c) if the prescription has reached the last occasion on which it can be supplied according to the maximum number of times specified on it.
Maximum penalty—15 penalty units.
The Secretary may, by order in writing, exempt any person or substance, or any class of persons or substances, from any or all of the requirements of this clause.
Such an exemption may be given unconditionally or subject to conditions.
This clause does not apply to a medication chart prescription.
A pharmacist who supplies a special restricted substance on prescription must keep the prescription, whether or not the prescription authorises more than one supply of the substance.
Maximum penalty—20 penalty units.
A pharmacist must keep prescriptions for special restricted substances separate from other prescriptions (other than prescriptions for drugs of addiction).
Maximum penalty—20 penalty units.
The Secretary may, by order in writing, exempt any person or substance, or any class of persons or substances, from any or all of the requirements of this clause.
Such an exemption may be given unconditionally or subject to conditions.
(Repealed)
A medical practitioner must not supply a restricted substance to any person otherwise than for medical treatment.
A nurse practitioner must not supply a restricted substance to any person otherwise than in the course of practising as a nurse practitioner.
A midwife practitioner must not supply a restricted substance to any person otherwise than in the course of practising as a midwife practitioner.
A dentist must not supply a restricted substance to any person otherwise than for dental treatment.
An optometrist must not supply a restricted substance to any person otherwise than in the course of practising as an optometrist.
A veterinary practitioner must not supply a restricted substance to any person otherwise than for veterinary treatment.
A podiatrist must not supply a restricted substance to any person otherwise than in the course of practising as a podiatrist.
Maximum penalty—15 penalty units.
A pharmacist may supply a person with a restricted substance (including a prescribed restricted substance) in accordance with a direction given under clause 36.
A prescription that is subsequently sent in confirmation of the direction must be dealt with in accordance with clauses 41 and 42, and details of the supply must be recorded in accordance with clause 55, in the same way as if the restricted substance had been supplied on prescription.
If such a prescription is not received within 7 days after the substance is supplied, the pharmacist must report that fact to the Secretary.
Maximum penalty—15 penalty units.
A pharmacist may supply a person with a restricted substance (other than a prescribed restricted substance) if the pharmacist is satisfied—
(a) that the person is undergoing treatment essential to the person’s well-being, and
(b) that the substance has previously been prescribed for the treatment, and
(c) that the person is in immediate need of the substance for continuation of the treatment, and
(d) that, in the circumstances, it is not practicable for the person to obtain a prescription for the substance from an authorised practitioner.
A restricted substance may not be supplied to any person under this clause unless—
(a) the quantity supplied is no more than that required for 7 days’ treatment, or
(b) in the case of a liquid, aerosol, cream, ointment or anovulant tablet that is contained in a standard pack, the standard pack is the smallest standard pack in which that kind of liquid, aerosol, cream, ointment or anovulant tablet is generally available.
Maximum penalty—15 penalty units.
A pharmacist may supply a person with a restricted substance that is covered by the Continued Dispensing Determination under this clause if—
(a) the supply is made in accordance with conditions that are specified in that determination, and
(b) the supply is made in accordance with the document entitled Guidelines for the Continued Dispensing of eligible prescribed medicines by pharmacists, published by the Pharmaceutical Society of Australia in 2018 and as in force from time to time, and
(c) the pharmacist is an approved pharmacist within the meaning of the National Health Act 1953 of the Commonwealth, and
(d) the person is in immediate need of the substance for continuation of treatment.
In this clause,
A pharmacist may supply an authorised practitioner with a restricted substance (including a prescribed restricted substance) for emergency use, but only on a written order signed and dated by the authorised practitioner.
The responsible person for a residential care facility is authorised to have possession of a restricted substance (including a prescribed restricted substance) that is approved by the Secretary for urgent use in a residential care facility.
A retail pharmacist is authorised to supply a restricted substance (including a prescribed restricted substance) in the manufacturer’s original pack to the responsible person for a residential care facility, but only if the substance is supplied—
(a) at the premises of, and in the course of carrying on the business of, the pharmacy, and
(b) in accordance with a written order signed by the responsible person.
The responsible person for a residential care facility must not—
(a) sign an order under this clause for a restricted substance unless the substance is approved by the Secretary for urgent use in that residential care facility, or
(b) allow any restricted substance in his or her possession to be used otherwise than for administration to a resident of the residential care facility by a registered nurse in accordance with the direction of an authorised practitioner (other than a veterinary practitioner) or by an authorised practitioner (other than a veterinary practitioner).
Maximum penalty—15 penalty units.
An approval under this clause—
(a) is to be by order in writing, and
(b) may apply generally or may be limited to a particular residential care facility or class of residential care facilities, and
(c) may apply generally or may be limited to a particular substance or class of substance, and
(d) may be given unconditionally or subject to conditions.
This clause applies to benzylpenicillin, including procaine penicillin, in preparations for use by intramuscular injection in animals.
A pharmacist may supply benzylpenicillin otherwise than on prescription to a person who satisfies the pharmacist that it is needed for the urgent treatment of an animal and that, under the circumstances, it is not practicable to obtain a prescription authorising its supply.
A pharmacist must not supply benzylpenicillin—
(a) to any person who is under 18 years of age, or
(b) to any person who is unknown to the pharmacist.
Subclause (3)(b) does not prevent a pharmacist from supplying benzylpenicillin to a person who is unknown to the pharmacist if it is supplied in the presence of a person who is known to the pharmacist and who satisfies the pharmacist that he or she knows the person being supplied.
(Repealed)
A pharmacist who has authority to supply and administer a vaccine otherwise than on prescription must—
(a) before supplying and administering a vaccine, have completed a training course conducted by an education provider accredited by the Australian Pharmacy Council to provide the course, being a course that complies with standards for the accreditation of programs to support the administration of vaccines published by the Australian Pharmacy Council from time to time, and
(b) comply with standards approved by the Secretary.
(Repealed)
A pharmacist who, under an authority, supplies and administers a vaccine to a person in accordance with this clause must record the following details—
(a) the person’s name, address, date of birth and contact details,
(b) the name and contact details of the person’s primary medical practitioner,
(c) the brand, batch number and expiry date of the vaccine,
(d) the part of the body to which the vaccine was administered,
(e) the date on which the vaccine was administered,
(f) the pharmacist’s name, contact details and certificate of accreditation number,
(g) the address of the place at which the vaccination was administered,
(h) a unique reference number for the supply and administration.
Maximum penalty—15 penalty units.
A pharmacist employed at a hospital may supply a restricted substance—
(a) on a prescription issued in accordance with Division 3, or
(b) on the authorisation (whether in writing, by electronic mail, by facsimile or by any other form of electronic communication approved by the Secretary) of an authorised practitioner (other than a veterinary practitioner), where that authorisation is entered on a patient’s medication chart, or
(c) on the requisition (whether in writing, by electronic mail, by facsimile or by any other form of electronic communication approved by the Secretary) of an authorised practitioner (other than a veterinary practitioner) or the nurse or midwife in charge of the ward in which the substance is to be used or stored.
A pharmacist employed at a managed correctional centre may supply a restricted substance for the purposes of treating an inmate at the managed correctional centre—
(a) on the written authorisation of an authorised practitioner, if the authorisation is entered on the inmate’s medication chart, or
(b) on the written requisition of an appropriate person.
Maximum penalty—20 penalty units.
This clause does not limit the power of a pharmacist employed in a retail pharmacy located at a managed correctional centre to supply a restricted substance on prescription in accordance with the Act or this Regulation.
In this clause—
A person who supplies a restricted substance to a patient in a hospital, or to an inmate in an institution, in accordance with section 10(4)(c) of the Act must supply the substance, unopened, in the container in which it was received by the person.
This clause does not prevent the person from supplying an individual dose of the substance to the patient or inmate.
Maximum penalty—15 penalty units.
This clause applies to thalidomide other than as registered goods.
A dealer must not supply thalidomide unless the person being supplied holds an authority under Part 8 to be supplied with thalidomide.
This clause—
(a) does not prohibit a dealer from supplying thalidomide to a person who has the approval in writing of the Permanent Head of the Commonwealth Department of Health to import, buy, obtain or otherwise be supplied with thalidomide, and
(b) does not prohibit a person holding an authority under Part 8 to be supplied with thalidomide from supplying thalidomide to a person under his or her general supervision, for the purpose of enabling that other person to carry out medical diagnosis, or medical or scientific research or analysis (including the conduct of clinical trials), and
(c) does not prohibit a medical practitioner holding an authority under Part 8 to be supplied with thalidomide from supplying thalidomide to another person for the purpose of treating that other person in accordance with the authority.
A person being supplied with thalidomide (otherwise than as referred to in subclause (3)(c)) must surrender his or her authority to the dealer.
A dealer must keep any authority surrendered to the dealer under this clause.
Maximum penalty—15 penalty units.
This clause applies to the following substances—
• acitretin
• clomiphene
• cyclofenil
• dinoprost
• dinoprostone
• etretinate
• follitropin beta
• hydroxychloroquine
• isotretinoin for oral use
• luteinising hormone
• tretinoin for oral use
• urofollitropin (human follicle stimulating hormone)
A person must not supply a substance to which this clause applies unless the person holds an authority under Part 8 to supply the substance.
This clause does not apply to the supply of a substance—
(a) by wholesale, or
(b) by a veterinary practitioner, or
(c) by a pharmacist on the prescription of—
(i) a medical practitioner holding an authority under Part 8 to prescribe the substance, or
(ii) a veterinary practitioner, or
(d) by a person who is authorised by the Permanent Head of the Commonwealth Department of Health to supply the substance.
Maximum penalty—15 penalty units.
A person who is not an authorised practitioner may supply a restricted substance to another person if the person by whom the substance is supplied holds an authority under Part 8 to supply the substance.
An authorised practitioner or pharmacist must not supply any restricted substance in a quantity, or for a purpose, that does not accord with the recognised therapeutic standard of what is appropriate in the circumstances.
Maximum penalty—20 penalty units or imprisonment for 6 months, or both.
A pharmacist who supplies a restricted substance on prescription must record the following details in a manner approved by the Secretary—
(a) the details required by clause 35(1) to be included in the prescription,
(b) a unique reference number for the prescription,
(c) the date on which the substance was supplied,
(d) the name of the person by whom the substance was supplied.
Maximum penalty—15 penalty units.
A prescription for the supply of a restricted substance in a hospital need not be recorded so long as the chief pharmacist of the hospital keeps the prescription or a copy of the prescription.
The Secretary may, by order in writing, exempt any person or restricted substance, or any class of persons or restricted substances, from the requirements of this clause.
Such an exemption may be given unconditionally or subject to conditions.
A pharmacist who supplies any substance to a person on a medication chart prescription must keep the prescription.
Maximum penalty—15 penalty units.
A pharmacist who supplies any substance to a person on a medication chart prescription must endorse the following particulars (in ink) on the prescription on each occasion on which the substance is dispensed—
(a) the date on which the substance was supplied,
(b) the address of, or number identifying, the pharmacy from which the substance was supplied,
(c) the prescription reference number,
(d) the quantity supplied.
Maximum penalty—15 penalty units.
The operator of a residential care facility in which medication charts are used must ensure that an employee of the facility makes a record in the medication chart of a resident of the facility of the administration of any restricted substance to the resident.
Maximum penalty—15 penalty units.
An authorised practitioner who supplies a restricted substance—
(a) must record the name, strength and quantity of the substance supplied and the date on which it was supplied, and
(b) must record—
(i) if the supply of the restricted substance is for a patient—the name and address of the patient, or
(ii) if the supply of the restricted substance is for an animal—the species of the animal and the name and address of the animal’s owner, or
(iii) if the restricted substance is azithromycin and the supply is for a patient’s partner for the treatment of chlamydia—the name and email address or mobile phone number of the partner, and
(c) must keep the record of the supply of the substance at the hospital, surgery or office of the person supplying the substance.
Maximum penalty—20 penalty units or imprisonment for 6 months, or both.
In this clause—
(a) the patient’s spouse,
(b) the patient’s de facto partner,
(c) a person with whom the patient is or was in a sexual relationship.
(Repealed)
A pharmacist who supplies a restricted substance as referred to in clause 45, or who supplies the restricted substance benzylpenicillin as referred to in clause 48, must record the following details of the supply in a manner approved by the Secretary—
(a) a unique reference number for the supply,
(b) the name and address of the patient or (if the treatment is for an animal) the species of animal and the name and address of the animal’s owner,
(c) the name, strength and quantity of the substance,
(d) the directions given by the pharmacist for the use of the substance,
(e) in the case of a restricted substance supplied as referred to in clause 45, the name and address of the authorised practitioner by whom it appears to the pharmacist that the substance was last prescribed,
(f) the date on which the substance was supplied,
(g) the name of the person by whom the substance was supplied.
Maximum penalty—15 penalty units.
A pharmacist who supplies a restricted substance as referred to in clause 46 or clause 47 must record the following details of the supply in a manner approved by the Secretary—
(a) a unique reference number for the supply,
(b) the name and address of the person supplied,
(c) the name, strength and quantity of the substance,
(d) the date on which the substance was supplied,
(e) the name of the person by whom the substance was supplied.
Maximum penalty—15 penalty units.
A person employed at a hospital or managed correctional centre must not administer a restricted substance to a patient without a direction from an authorised practitioner.
A direction must be—
(a) written and given in person, or
(b) given in another manner approved by the Secretary.
However, a direction may be given in an emergency—
(a) by email or facsimile, or
(b) orally, including by telephone, or
(c) in another way approved by the Secretary.
An authorised practitioner who gives a direction under subclause (3) must attend to review the patient as soon after giving the direction as the authorised practitioner considers appropriate in the circumstances.
As soon as practicable and no later than 24 hours after giving a direction under subclause (3)(b), the authorised practitioner must confirm the direction by—
(a) signing an entry in the patient’s medical history, or
(b) email or facsimile.
If the authorised practitioner does not confirm the direction under subclause (5) within 7 days after the restricted substance is administered, the person who administered the substance must notify the Secretary.
Subclause (1) does not apply to a person employed at a hospital or managed correctional centre who holds an authority under Part 8 to administer the substance.
Subclauses (4)–(6) do not apply to the administration of a restricted substance to a patient who is an inmate in a correctional centre if confirmation of the direction for the administration of the substance is given in accordance with the requirements of a protocol approved by the Secretary.
In this clause—
(a) a patient in a hospital, or
(b) an inmate in a managed correctional centre.
Maximum penalty—15 penalty units.
A person must not self-administer a prescribed restricted substance, or administer a prescribed restricted substance to any other person, otherwise than—
(a) for the purposes of medical treatment prescribed by a medical practitioner, or
(b) for the purposes of dental treatment prescribed by a dentist, or
(c) for the purposes of treatment prescribed by—
(i) a nurse practitioner in the course of practising as a nurse practitioner, or
(ii) a midwife practitioner in the course of practising as a midwife practitioner, or
(iii) an optometrist in the course of practising as an optometrist, or
(iv) a podiatrist in the course of practising as a podiatrist.
Maximum penalty—20 penalty units.
For the purposes of subclause (1), it is sufficient if the treatment referred to in subclause (1)(a) or (b) in relation to the self-administration of a prescribed restricted substance has been prescribed by the person by whom the substance is being self-administered.
This clause has effect for the purposes of Division 1 of Part 2 of the Drug Misuse and Trafficking Act 1985 in relation to any prescribed restricted substance that is included in Schedule 1 to that Act.
This clause applies to the following restricted substances—
• acitretin
• clomiphene
• cyclofenil
• dinoprost
• dinoprostone
• etretinate
• follitropin beta
• hydroxychloroquine
• isotretinoin for oral use
• luteinising hormone
• tretinoin for oral use
• urofollitropin (human follicle stimulating hormone)
A person must not administer a restricted substance to which this clause applies unless the person holds an authority under Part 8 to administer the substance.
This clause does not apply to—
(a) the administration to a patient of a substance whose administration has been prescribed or directed by a medical practitioner holding an authority under Part 8 to prescribe the substance, or
(b) the administration of a substance to an animal by a veterinary practitioner or by a person acting under the general supervision of a veterinary practitioner.
Maximum penalty—15 penalty units.
For the purposes of section 16 of the Act, the substances specified in Appendix D are prescribed restricted substances.
The substances specified in Appendix D are also restricted substances for the purposes of sections 9, 10, 11 and 18 of the Act, as referred to in paragraph (a) of the matter specified at the end of sections 9(1), 10(3), 11(1) and 18 of the Act with respect to penalties.
For the purposes of section 18A(1) of the Act, the quantities specified in Appendix D are the prescribed quantities for the corresponding restricted substances specified in that Appendix.
For the purposes of section 16(1)(e) of the Act, the following persons are authorised to obtain possession of prescribed restricted substances for the purposes of their profession or employment—
(a) the director of nursing of a hospital that does not employ a chief pharmacist,
(b) the nurse or midwife in charge of a ward in a public hospital,
(b1) the responsible person for a residential care facility,
(b2) a registered nurse at a residential care facility that is not a nursing home, but for the purpose only of administering doses of such substances to individual residents of the residential care facility,
(c) a nurse or midwife who is approved for the time being by the Secretary for the purposes of this clause, or who belongs to a class of nurses or a class of midwives so approved,
(d) any other nurse or midwife, but for the purpose only of administering doses of such substances to individual patients in a hospital,
(e) an analyst, or a person acting under the direct personal supervision of an analyst.
A person who asks an authorised practitioner (other than a veterinary practitioner)—
(a) to supply the person with a prescribed restricted substance, or
(b) to give the person a prescription for a prescribed restricted substance,
must disclose to the authorised practitioner the quantity of that and any other prescribed restricted substance with which the person has been supplied, or for which the person has been given prescriptions, within the last 2 months.
If the request is made on behalf of some other person, the person making the request is obliged only to furnish such information as is within that person’s knowledge.
Maximum penalty—20 penalty units.
A carrier is authorised to be in possession of a package containing a prescribed restricted substance, but for the purpose only of delivering it to the person to whom it is addressed.
This clause applies to pentobarbitone sodium to the extent only to which it is a restricted substance, and not to the extent to which it is a drug of addiction.
An authorised person who uses pentobarbitone sodium for the destruction of animals must ensure that the requirements of this clause are complied with.
Pentobarbitone sodium must be kept separately from all other goods in a safe, cupboard or other receptacle—
(a) that is securely attached to a part of the premises, and
(b) that is kept securely locked except when in immediate use.
An authorised person must keep a separate register of all pentobarbitone sodium that is obtained or used by the authorised person.
On the day on which an authorised person obtains or uses any pentobarbitone sodium, the authorised person must enter in the register such of the following details as are relevant to the transaction—
(a) the quantity that was obtained or used,
(b) the name and address of the person from whom it was obtained,
(c) the number and species of animals for which it was used,
(d) the total quantity held by the authorised person after the entry is made.
Each entry must be dated and signed by the authorised person.
In this clause,
(a) a person nominated by the council of a local government area, or
(b) an officer of an animal welfare organisation nominated by the organisation,
being in either case a person who is authorised under section 16(1)(d) of the Act to obtain possession of pentobarbitone sodium for the humane destruction of animals.
Maximum penalty—20 penalty units.
A person must not use or dispose of a restricted substance in any place or in any manner likely to constitute a risk to the public.
Maximum penalty—15 penalty units.
A person must immediately notify the Secretary if the person loses a prescribed restricted substance or if a prescribed restricted substance is stolen from the person.
This clause does not apply to the loss of any substance by, or the theft of any substance from, a person who has been supplied with the substance by, or on the prescription of, an authorised practitioner.
Maximum penalty—20 penalty units.
The court before which a person is convicted of the illegal possession of a prescribed restricted substance may order that the substance be forfeited to the Crown, and may further order the forfeited substance to be destroyed or otherwise disposed of as the court thinks fit.
In this Part—
This Part applies to the administration of the following substances (
(a) a substance specified in the Act, section 18C(a) or (b),
(b) the following substances specified in Schedule 4 of the Poisons List that are prescribed for the purposes of the Act, section 18C(c)—
(i) calcium hydroxylapatite in preparations for injection or implantation for tissue augmentation or cosmetic use,
(ii) collagen in preparations for injection or implantation for tissue augmentation or cosmetic use,
(iii) deoxycholic acid,
(iv) polyacrylamide in preparations for injection or implantation for tissue augmentation or cosmetic use,
(v) polycaprolactone in preparations for injection or implantation for tissue augmentation or cosmetic use,
(vi) polylactic acid in preparations for injection or implantation for tissue augmentation or cosmetic use.
This Part does not apply to the administration of a relevant substance to a patient by—
(a) an authorised practitioner administering the relevant substance in the lawful practice of the practitioner’s profession, or
(b) a person employed at the hospital administering the relevant substance to a patient in a hospital on the direction of an authorised practitioner, other than a veterinary practitioner.
This Part does not apply to the administration of a relevant substance to an animal by—
(a) a veterinary practitioner in the lawful practice of the practitioner’s profession, or
(b) another person on the direction of a veterinary practitioner.
A person must not administer a relevant substance to a patient unless the person—
(a) is a nurse, and
(b) is acting in accordance with a direction of a medical practitioner or nurse practitioner.
A nurse must not administer a relevant substance unless satisfied there is appropriate equipment available for use in a patient medical emergency.
A nurse who administers a relevant substance in accordance with a direction must record the following information for each administration—
(a) the nurse’s name,
(b) the date on which the relevant substance was administered,
(c) the batch number of the relevant substance,
(d) the information specified in clause 68E(1)(a)–(e) and (i).
A nurse must give a copy of the record to the responsible provider.
A medical practitioner or nurse practitioner may give a direction to a nurse only if the practitioner has personally reviewed the patient in person or by audiovisual link.
A direction must be written, signed by the medical practitioner or nurse practitioner and given to the nurse in person or by facsimile, email or other electronic means.
However, if the medical practitioner or nurse practitioner is present when the relevant substance is administered by the nurse to whom the direction is given, the direction may be given orally.
A direction has effect—
(a) for a written direction—for the period specified in the direction, not exceeding 6 months from the date on which the medical practitioner or nurse practitioner personally reviewed the patient under subclause (1), and
(b) for an oral direction—for the particular administration of the relevant substance to which the direction applies.
A direction must include the following information—
(a) the patient’s name,
(b)
The medical superintendent of a hospital is authorised to possess and, if the medical superintendent is an authorised practitioner, use any Schedule 2, 3 or 4 substance that is required for use in connection with the medical treatment of persons at the hospital.
(Repealed)
A registered podiatrist is authorised to possess and use a Schedule 2, 3 or 4 substance that is a synthetic local anaesthetic if required for use in connection with the practice podiatry.
A dental therapist or oral health therapist is authorised to possess and use the following substances if required for use in connection with dental therapy or oral health therapy—
• benzocaine
• lignocaine
• mepivacaine
• prilocaine
• procaine
• tetracycline (in preparations for treatment of dental pulp)
• triamcinolone (in preparations for treatment of dental pulp)
(Repealed)
A dental hygienist is authorised to possess and use the following substances if required for use in connection with his or her practice as a dental hygienist—
(a) benzocaine,
(b) lignocaine,
(c) mepivacaine,
(d) prilocaine,
(e) procaine,
(f) a Schedule 2, 3 or 4 substance that is a synthetic local anaesthetic.
(Repealed)
A person who is a registered nurse and who is employed in connection with a vaccination program carried out in a public institution or place of work is authorised to possess and use vaccines if required for use in vaccinating humans.
A person—
(a) who is employed in the Ambulance Service of NSW as an ambulance officer or as an air ambulance flight nurse, and
(b) who is approved for the time being by the Secretary for the purposes of this clause,
is authorised to possess and use any Schedule 2, 3 or 4 substance that is approved by the Secretary for use by such persons in the carrying out of emergency medical treatment.
A person—
(a) who is a dive medical technician within the NSW Police Force, and
(b) whose duties include the carrying out (under the supervision of a medical practitioner who is qualified in underwater medicine) of emergency medical treatment on divers,
is authorised to possess and use any substance referred to in the Table to this clause if the substance is required for the emergency medical treatment of divers and the substance complies with the requirements as to form and strength set out in that Table opposite that substance.
Table
Substance | Form | Strength |
adrenaline | ampoule | not more than 0.01 per cent |
amoxycillin with clavulanic acid | tablet | not more than 500 milligrams (amoxycillin) and 125 milligrams (clavulanic acid) |
atropine | ampoule | not more then 600 micrograms per ampoule |
dexamethasone with framycetin and gramicidin | ear drops | not more than 500 micrograms (dexamethasone), 5 milligrams (framycetin) and 50 micrograms (gramicidin) |
diazepam | ampoule | not more than 10 milligrams per ampoule |
diclofenac | tablet | not more than 50 milligrams |
frusemide | ampoule | not more than 20 milligrams per ampoule |
heparin | ampoule | not more than 25,000 units per 5 millilitres |
lignocaine | ampoule | not more than 1 per cent |
lignocaine with chlorhexidine | ampoule | not more than 2 per cent |
metronidazole | tablet | not more than 200 milligrams |
naloxone | ampoule | not more than 400 micrograms per ampoule |
piroxicam | gel | not more than 0.5 per cent |
prochlorperazine | ampoule | not more than 12.5 milligrams per ampoule |
prochlorperazine | tablet | not more than 5 milligrams |
trimethoprim with sulfamethoxazole | tablet | not more than 160 milligrams (trimethoprim) and 800 milligrams (sulfamethaxozone) |
A person who holds a current occupational first-aid certificate approved by the WorkCover Authority in accordance with the regulations under the Occupational Health and Safety Act 2000 is authorised to possess and use methoxyflurane and nitrous oxide if required in connection with the carrying out of first aid.
A person who is in control of an industrial first aid post is authorised to possess and use any Schedule 2 substance that is required in connection with the carrying out of industrial first aid.
A person who is trained and authorised to administer first aid at a mine (within the meaning of the Work Health and Safety (Mines) Act 2013) is authorised to possess and use methoxyflurane and nitrous oxide if required for use in connection with the carrying out of first aid at a mine.
A person who holds a current emergency asthma management certificate issued by an organisation approved by the Secretary for the purposes of clause 18(3) of this Regulation is authorised to possess and use salbutamol or terbutaline in metered aerosols if required in connection with the carrying out of first aid.
A person is authorised to possess and use adrenaline if—
(a) if the person requires the adrenaline for use in connection with the carrying out of anaphylaxis first aid, and
(b) the adrenaline is contained in single use automatic injectors that have been filled by the manufacturer and that deliver no more than 0.3 milligrams of adrenaline each, and
(c) the person holds a current first aid certificate issued after completion of a first aid course approved by the WorkCover Authority as referred to in regulations made under the Occupational Health and Safety Act 2000, and the person has received training on the symptoms and first aid management of anaphylaxis from—
(i) a first aid training organisation approved by the WorkCover Authority, or
(ii) any other organisation approved by the Secretary for the purposes of clause 18(5)(b)(ii) of this Regulation.
A ski patroller who holds a valid first aid certificate issued by the Australian Ski Patrol Association for use in ski patrol duties is authorised to possess and use methoxyflurane, nitrous oxide and trichloroethylene if required for use in connection with the carrying out of ski rescues.
A person who is authorised under this Regulation to obtain a Schedule 2, 3 or 4 substance is authorised to possess and use the substance if the substance is required for use in connection with the commercial production of animal feedstuff or feedstuff premixes.
In this clause, a reference to an animal feedstuff or feedstuff premix is a reference to a feedstuff or feedstuff premix containing a Schedule 2, 3 or 4 substance at such a level, or in such a form—
(a) that Schedule 5 or 6 to the Poisons List applies to the substance, or
(b) that the substance is not a poison.
A registered beekeeper is authorised to possess and use oxytetracycline in the form of a stock medicine (within the meaning of the Stock Medicines Act 1989) if—
(a) required by the registered beekeeper for use in the treatment or prevention of European Foulbrood disease in bees, and
(b) the registered beekeeper holds a written authority (issued by the Secretary of the Department of Industry, Skills and Regional Development) recommending the use, by that person, of that substance for that purpose.
In this clause—
The holder of a licence under Part 8 to manufacture or supply drugs of addiction is authorised to possess and use any Schedule 2, 3 or 4 substance that the holder of the licence requires for use in accordance with that licence.
A person who is engaged in any of the following activities is authorised to possess and use any Schedule 2 or 3 substance that is required for use in connection with that activity—
(a) jewellery manufacture,
(b) electroplating,
(c) paint manufacture,
(d) ferrous hardening,
(e) commercial pest control,
(f) mining gold or other precious metals,
(g) refining non-ferrous metals.
A scientifically qualified person in charge of a laboratory or department, or a person acting under the direct personal supervision of such a person, is authorised to possess and use any Schedule 2, 3 or 4 substance that is required for the conduct of medical or scientific research or instruction or the conduct of quality control or analysis.
The master of a ship is authorised to possess and use any Schedule 2, 3 or 4 substance that is required by law to be carried on the ship for use in connection with the medical treatment of persons on the ship.
A responsible person for a managed correctional centre is authorised to possess and, if the responsible person is an authorised practitioner, use a Schedule 2, 3 or 4 substance that is required in connection with the medical treatment of inmates at the managed correctional centre.
A management company for a managed correctional centre must appoint, by written instrument, a pharmacist employed at the managed correctional centre as the responsible person for the purposes of this clause.
If there is no pharmacist employed at the managed correctional centre, an authorised practitioner or nurse in charge may be appointed.
In this clause—
(Clause 61)
Substance | Prescribed quantity |
Amylobarbitone when included in Schedule 4 of the Poisons List | 50.0 grams |
Anabolic and androgenic steroidal agents included in Schedule 4 of the Poisons List, except when referred to elsewhere in this Appendix | 5.0 grams |
Androisoxazole | 5.0 grams |
AOD-9604 (CAS No. 221231-10-3) | 0.10 gram |
Barbiturates included in Schedule 4 of the Poisons List, except when referred to elsewhere in this Appendix | 50.0 grams |
Benzodiazepine derivatives included in Schedule 4 of the Poisons List, except when referred to elsewhere in this Appendix | 0.5 gram |
Benzphetamine | 5.0 grams |
Bolandiol | 5.0 grams |
Bolasterone | 5.0 grams |
Boldenone | 2.5 grams |
Bolmantalate | 5.0 grams |
Bromazepam | 5.0 grams |
Calusterone | 30.0 grams |
Cathine | 5.0 grams |
Chlorandrostenolone | 5.0 grams |
Chlordiazepoxide | 5.0 grams |
Chloroxydienone | 5.0 grams |
Chloroxymesterone | 5.0 grams |
CJC-1295 (CAS No. 863288-34-0) | 0.50 gram |
Clobazam | 2.5 grams |
Clonazepam | 0.5 gram |
Clorazepate | 3.0 grams |
Clostebol | 2.0 grams |
Darbepoetin | 0.015 grams |
Dextropropoxyphene when included in Schedule 4 of the Poisons List | 15.0 grams |
Diazepam | 2.5 grams |
Diethylpropion | 5.0 grams |
Dihydrolone | 5.0 grams |
Dimethandrostanolone | 5.0 grams |
Dimethazine | 5.0 grams |
Doxapram | 2.0 grams |
Drostanolone | 2.0 grams |
Enobosarm | 0.3 grams |
Ephedrine | 5.0 grams |
Epoetins | 0.01 grams or 1,000,000 International Units |
Erythropoietins (except when referred to elsewhere in this Appendix) | 1,000,000 International Units |
Ethchlorvynol | 50.0 grams |
Ethinamate | 50.0 grams |
Ethyldienolone | 5.0 grams |
Ethyloestrenol | 1.0 gram |
Fencamfamin | 1.0 gram |
Fenproporex | 1.0 gram |
Fibroblast Growth Factors | 0.10 gram |
Fluoxymesterone | 2.0 grams |
Flurazepam | 10.0 grams |
Follistatin | 0.1 grams |
Formebolone | 1.0 gram |
Formyldienolone | 1.0 gram |
Furazabol | 0.5 gram |
Glutethimide | 50.0 grams |
Growth Hormone Releasing Hormones (GHRHs) including those separately specified in Schedule 4 of the Poisons List | 0.50 gram |
Growth Hormone Releasing Peptide-6 (GHRP-6) | 0.50 gram |
Growth Hormone Releasing Peptides (GHRPs) including those separately specified in Schedule 4 of the Poisons List | 0.50 gram |
Growth Hormone Secretagogues including those separately specified in Schedule 4 of the Poisons List | 0.50 gram |
Hexarelin | 0.50 gram |
Hydroxystenozol | 5.0 grams |
Ibutamoren | 0.50 gram |
Insulin-like growth factors | 0.005 grams |
Ipamorelin | 0.50 gram |
Lorazepam | 1.0 gram |
Mazindol | 0.5 gram |
Medazepam | 2.5 grams |
Mefenorex | 5.0 grams |
Meprobamate | 100.0 grams |
Mesabolone | 5.0 grams |
Mestanolone | 5.0 grams |
Mesterolone | 10.0 grams |
Methandienone | 1.0 gram |
Methandriol | 20.0 grams |
Methenolone | 2.0 grams |
Methylandrostanolone | 5.0 grams |
Methylclostebol | 5.0 grams |
Methylphenobarbitone | 50.0 grams |
Methyltestosterone | 20.0 grams |
Methyltrienolone | 5.0 grams |
Methyprylone | 40.0 grams |
Mibolerone | 0.01 gram |
Midazolam | 0.5 gram |
Nalbuphine | 0.5 gram |
Nandrolone | 1.0 gram |
Nitrazepam | 1.0 gram |
Norandrostenolone | 1.0 gram |
Norbolethone | 5.0 grams |
Norethandrolone | 4.0 grams |
Normethandrone | 0.5 gram |
Oxabolone | 0.5 gram |
Oxandrolone | 1.0 gram |
Oxazepam | 10.0 grams |
Oxymesterone | 4.0 grams |
Oxymetholone | 40.0 grams |
Paraldehyde | 250 millilitres |
Pentobarbitone when included in Schedule 4 of the Poisons List | 50.0 grams |
Perampanel for human use | 0.80 gram |
Phenobarbitone | 50.0 grams |
Phentermine | 10.0 grams |
Pipradrol | 1.0 gram |
Pralmorelin ((Growth Hormone Releasing Peptide-2) (GHRP-2)) | 0.50 gram |
Prasterone | 1.0 gram |
Prazepam | 2.5 grams |
Pregabalin | 30.0 grams |
Propylhexedrine | 5.0 grams |
Pseudoephedrine when included in Schedule 4 of the Poisons List | 20.0 grams |
Pyrovalerone | 1.0 gram |
Quetiapine | 40.0 grams |
Quinbolone | 3.0 grams |
Selective androgen receptor modulators | 0.3 grams |
Silandrone | 5.0 grams |
Somatropin (human growth hormone) | 0.25 grams |
Stanolone | 10.0 grams |
Stanozolol | 2.0 grams |
Stenabolic (SR9009) and other synthetic REV-ERB agonists | 2.0 grams |
Stenbolone | 5.0 grams |
TB-500 | 0.30 gram |
Temazepam | 5.0 grams |
Testolactone | 100.0 grams |
Testosterone except when included in Schedule 6 of the Poisons List | 20.0 grams |
Thiomesterone | 5.0 grams |
Thymosin Beta 4 (THYMOSIN β4) | 0.30 gram |
Tianeptine | 3.75 grams |
Tramadol | 30.0 grams |
Trenbolone except when included in Schedule 6 of the Poisons List | 5.0 grams |
Trestolone | 5.0 grams |
Triazolam | 0.05 gram |
Zolazepam | 2.5 grams |
Zolpidem | 1.0 gram |
Zopiclone | 0.75 gram |
Clause 174A
Substance |
All substances included in Schedule 8 of the Poisons List |
Any benzodiazepine derivative included in Schedule 4 of the Poisons List |
Bromazepam |
Chlordiazepoxide |
Clobazam |
Clonazepam |
Clorazepate |
Codeine when included in Schedule 4 of the Poisons List |
Diazepam |
Flurazepam |
Lorazepam |
Medazepam |
Midazolam |
Nitrazepam |
Oxazepam |
Prazepam |
Pregabalin |
Quetiapine |
Temazepam |
Tramadol |
Triazolam |
Zolazepam |
Zolpidem |
Zopiclone |
Poisons and Therapeutic Goods Regulation 2008 (392). GG No 106 of 29.8.2008, p 8508. Date of commencement, 1.9.2008, cl 2. This Regulation has been amended by this Regulation, cl 42A(7) and as follows—
(330) | Poisons and Therapeutic Goods Amendment (First Aid in Mines) Regulation 2009. LW 17.7.2009. Date of commencement, on publication on LW, cl 2. | |
(490) | Poisons and Therapeutic Goods Amendment (Fees) Regulation 2009. LW 30.9.2009. Date of commencement, on publication on LW, cl 2. | |
No 34 | Health Practitioner Regulation Amendment Act 2010. Assented to 15.6.2010. Date of commencement of Sch 2, 1.7.2010, sec 2 (2). | |
(485) | Poisons and Therapeutic Goods Amendment (Fees) Regulation 2010. LW 27.8.2010. Date of commencement, on publication on LW, cl 2. | |
(394) | Poisons and Therapeutic Goods Amendment (Fees) Regulation 2011. LW 5.8.2011. Date of commencement, on publication on LW, cl 2. | |
(480) | Poisons and Therapeutic Goods Amendment (Miscellaneous) Regulation 2011. LW 9.9.2011. Date of commencement, on publication on LW, cl 2. | |
(537) | Poisons and Therapeutic Goods Amendment (Licences) Regulation 2011. LW 7.10.2011. Date of commencement, on publication on LW, cl 2. | |
(450) | Poisons and Therapeutic Goods Amendment (Fees) Regulation 2012. LW 7.9.2012. Date of commencement, on publication on LW, cl 2. | |
(176) | Poisons and Therapeutic Goods Amendment (Supply by Pharmacists) Regulation 2013. LW 3.5.2013. Date of commencement, on publication on LW, cl 2. | |
(485) | Poisons and Therapeutic Goods Amendment (Fees) Regulation 2013. LW 30.8.2013. Date of commencement, on publication on LW, cl 2. | |
(551) | Poisons and Therapeutic Goods Amendment (Continued Dispensing) Regulation 2013. LW 20.9.2013. Date of commencement, on publication on LW, cl 2. | |
(648) | Poisons and Therapeutic Goods Amendment (Supply by Pharmacists) Regulation (No 2) 2013. LW 15.11.2013. Date of commencement, on publication on LW, cl 2. | |
No 111 | Statute Law (Miscellaneous Provisions) Act (No 2) 2013. Assented to 3.12.2013. Date of commencement of Sch 3.20, 3.1.2014, sec 2 (1). | |
(82) | Poisons and Therapeutic Goods Amendment Regulation 2014. LW 28.2.2014. Date of commencement, on publication on LW, cl 2. | |
(534) | Poisons and Therapeutic Goods Amendment (Fees) Regulation 2014. LW 22.8.2014. Date of commencement, on publication on LW, cl 2. | |
No 71 | Work Health and Safety (Mines) Amendment Act 2014. Assented to 11.11.2014. Date of commencement of Sch 2, 1.2.2015, sec 2 and 2014 (787) LW 12.12.2014. | |
(138) | Poisons and Therapeutic Goods Amendment (National Residential Medication Chart and Influenza Vaccination) Regulation 2015. LW 5.3.2015. Date of commencement, on publication on LW, cl 2. | |
(305) | Poisons and Therapeutic Goods Amendment (Fees) Regulation 2015. LW 19.6.2015. Date of commencement, on publication on LW, cl 2. | |
No 24 | Biosecurity Act 2015. Assented to 22.9.2015. Date of commencement of Sch 8.31, 1.7.2017, sec 2 and 2017 (227) LW 2.6.2017. Amended by Statute Law (Miscellaneous Provisions) Act 2016. Assented to 7.6.2016. Date of commencement of Sch 1.3, 8.7.2016, sec 2 (1). | |
(814) | Poisons and Therapeutic Goods Amendment (Electronic Record of Information) Regulation 2015. LW 18.12.2015. Date of commencement, 23.3.2016, cl 2. | |
(286) | Poisons and Therapeutic Goods Amendment (Fees) Regulation 2016. LW 3.6.2016. Date of commencement, on publication on LW, cl 2. | |
(287) | Poisons and Therapeutic Goods Amendment (Partner Treatment—Chlamydia) Regulation 2016. LW 3.6.2016. Date of commencement, on publication on LW, cl 2. | |
(409) | Poisons and Therapeutic Goods Amendment (Designated Non-ARTG Products) Regulation 2016. LW 1.7.2016. Date of commencement, 1.8.2016, cl 2. | |
(265) | Poisons and Therapeutic Goods Amendment (Fees) Regulation 2017. LW 16.6.2017. Date of commencement, on publication on LW, cl 2. | |
No 50 | Health Practitioner Regulation Amendment Act 2017. Assented to 24.10.2017. Date of commencement of Sch 5.25, 8.1.2018, sec 2 and 2017 (666) LW 1.12.2017. | |
(689) | Poisons and Therapeutic Goods Amendment (Records of Partners) Regulation 2017. LW 8.12.2017. Date of commencement, 15.12.2017, cl 2. | |
(232) | Poisons and Therapeutic Goods Amendment (Fees) Regulation 2018. LW 1.6.2018. Date of commencement, on publication on LW, cl 2. | |
(655) | Poisons and Therapeutic Goods Amendment (Cannabis and Unregistered Drugs of Addiction) Regulation 2018. LW 23.11.2018. Date of commencement, on publication on LW, cl 2. | |
(656) | Poisons and Therapeutic Goods Amendment (Supply by Pharmacists of Vaccines) Regulation 2018. LW 23.11.2018. Date of commencement, 1.1.2019, cl 2. | |
(689) | Poisons and Therapeutic Goods Amendment (Supply by Pharmacists) Regulation 2018. LW 30.11.2018. Date of commencement, on publication on LW, cl 2. | |
(703) | Poisons and Therapeutic Goods Amendment (Residential Care Facilities) Regulation 2018. LW 7.12.2018. Date of commencement, on publication on LW, cl 2. | |
(206) | Poisons and Therapeutic Goods Amendment (Fees) Regulation 2019. LW 24.5.2019. Date of commencement, on publication on LW, cl 2. | |
(477) | Poisons and Therapeutic Goods Amendment (Cannabis Medicines) Regulation 2019. LW 27.9.2019. Date of commencement, 30.9.2019, cl 2. | |
(79) | Poisons and Therapeutic Goods Amendment (Supply and Administration by Pharmacists) Regulation 2020. LW 6.3.2020. Date of commencement, on publication on LW, cl 2. | |
(111) | Poisons and Therapeutic Goods Amendment (Drugs of Addiction) Regulation 2020. LW 27.3.2020. Date of commencement, on publication on LW, cl 2. | |
(128) | Poisons and Therapeutic Goods Amendment (Restricted Substances) Regulation 2020. LW 3.4.2020. Date of commencement, on publication on LW, cl 2. | |
(153) | Poisons and Therapeutic Goods Amendment (Prescriptions) Regulation 2020. LW 17.4.2020. Date of commencement, on publication on LW, cl 2. | |
(183) | Poisons and Therapeutic Goods Amendment (Supply of Vaccines by Pharmacists) Regulation 2020. LW 8.5.2020. Date of commencement, on publication on LW, cl 2. | |
(412) | Poisons and Therapeutic Goods Amendment (Fees) Regulation 2020. LW 17.7.2020. Date of commencement, on publication on LW, cl 2. | |
(118) | Poisons and Therapeutic Goods Amendment (COVID-19 Vaccine) Regulation 2021. LW 19.3.2021. Date of commencement, on publication on LW, cl 2. | |
(134) | Poisons and Therapeutic Goods Amendment (Real Time Prescription Monitoring) Regulation 2021. LW 26.3.2021. |
Date of commencement, on publication on LW, cl 2. | ||
(162) | Poisons and Therapeutic Goods Amendment (Restricted Substances) Regulation 2021. LW 1.4.2021. Date of commencement, on publication on LW, cl 2. | |
(372) | Poisons and Therapeutic Goods Amendment (Cosmetic Use) Regulation 2021. LW 9.7.2021. Date of commencement, 1.9.2021, cl 2. | |
(385) | Health Legislation Amendment (Fees) Regulation 2021. LW 16.7.2021. Date of commencement, on publication on LW, cl 2. | |
(386) | Poisons and Therapeutic Goods Amendment (Correctional Centres) Regulation 2021. LW 16.7.2021. Date of commencement, 1.8.2021, cl 2. | |
(561) | Poisons and Therapeutic Goods Amendment (Restricted Substances) Regulation (No 2) 2021. LW 24.9.2021. Date of commencement, on publication on LW, sec 2. | |
(194) | Poisons and Therapeutic Goods Amendment (Prescription Requirements) Regulation 2022. LW 6.5.2022. Date of commencement of Sch 1.1, on publication on LW, sec 2(1); date of commencement of Sch 1.2, 1.11.2022, sec 2(2). | |
(247) | Poisons and Therapeutic Goods Amendment (Vaccines) Regulation 2022. LW 27.5.2022. Date of commencement, on publication on LW, sec 2. | |
(445) | Health Legislation Amendment (Fees) Regulation 2022. LW 10.8.2022. Date of commencement, on publication on LW, sec 2. | |
(581) | Poisons and Therapeutic Goods Amendment Regulation 2022. LW 30.9.2022. Date of commencement, 30.9.2022, sec 2. | |
(302) | Poisons and Therapeutic Goods Amendment (Authority Management) Regulation 2023. LW 16.6.2023. Date of commencement of Sch 1[1]–[5] and[8]–[18], on publication on LW, sec 2(b); date of commencement of Sch 1[6] and [7], 1.7.2023, sec 2(a). | |
(499) | Health Legislation Amendment (Fees) Regulation 2023. LW 1.9.2023. Date of commencement, on publication on LW, sec 2. | |
(548) | Poisons and Therapeutic Goods Amendment (Voluntary Assisted Dying Substances) Regulation 2023. LW 29.9.2023. Date of commencement of Sch 1[1]–[3] and [6], 28.11.2023, sec 2(a); date of commencement of Sch 1[4] [5] and [7], on publication on LW, sec 2(b). | |
(257) | Poisons and Therapeutic Goods Amendment (Prescription Database) Regulation 2024. LW 28.6.2024. Date of commencement, on publication on LW, sec 2. | |
(605) | Poisons and Therapeutic Goods Amendment (Fees) Regulation 2025. LW 7.11.2025. Date of commencement, 17.11.2025, sec 2. |
Cl 3 | Am 2010 No 34, Sch 2.38 [1] [2]; 2011 (480), Sch 1 [1]–[3]; 2014 (82), Sch 1 [1] [2]; 2015 (138), Sch 1 [1]; 2016 (409), Sch 1 [1] [2]; 2018 (655), Sch 1 [1]; 2018 (703), Sch 1 [1]; 2019 (477), Sch 1 [1]; 2021 (372), Sch 1[2]–[4]; 2021 (386), Sch 1[1]; 2022 (581), Sch 1[1]; 2023 (548), Sch 1[1]. |
Cll 4–6 | Rep 2010 No 34, Sch 2.38 [3]. |
Cl 7 | Am 2011 (480), Sch 1 [4] [5]; 2021 (372), Sch 1[5]. |
Cl 18 | Am 2011 (480), Sch 1 [6]; 2018 (703), Sch 1 [2]. |
Cl 20 | Am 2016 (409), Sch 1 [3]. |
Cl 24 | Am 2015 (138), Sch 1 [2]; 2015 (814), Sch 1 [1]–[4]; 2021 (372), Sch 1[6]. |
Part 3, heading | Am 2021 (386), Sch 1[2]. |
Part 3, Div 1A | Ins 2023 (548), Sch 1[2]. |
Cl 25A | Ins 2023 (548), Sch 1[2]. |
Cl 26 | Am 2011 (480), Sch 1 [4] [7]; 2021 (372), Sch 1[5]. |
Cl 30 | Am 2020 (153), Sch 1[1]; 2022 (194), Sch 1.1[1] [2]. |
Cl 31A | Ins 2021 (386), Sch 1[3]. |
Cl 32 | Am 2010 No 34, Sch 2.38 [4]. |
Cl 33 | Am 2011 (480), Sch 1 [8]. |
Cl 34A | Ins 2015 (138), Sch 1 [3]. |
Cl 35 | Am 2015 (138), Sch 1 [4] [5]; 2016 (287), Sch 1 [1] [2]; 2017 (689), cl 3 (1); 2022 (194), Sch 1.2[1]; 2022 (581), Sch 1[2]. |
Cl 36 | Am 2022 (581), Sch 1[3] [4]. |
Cl 36A | Ins 2020 (153), Sch 1[2]. Am 2021 (162), cl 3(1); 2021 (561), sec 3(1); 2022 (581), Sch 1[5]–[8]. |
Cl 36B | Ins 2022 (581), Sch 1[9]. |
Cl 37 | Am 2020 (128), Sch 1[1]; 2021 (561), sec 3(2); 2023 (302), Sch 1[1]. |
Cl 39 | Am 2011 (480), Sch 1 [9]; 2015 (138), Sch 1 [6] [7]; 2022 (194), Sch 1.2[2] [3]; 2023 (302), Sch 1[2]. |
Cl 40 | Am 2015 (138), Sch 1 [8]. |
Cl 41 | Am 2015 (138), Sch 1 [9]. |
Cl 42A | Ins 2020 (128), Sch 1[2]. Am 2021 (162), cl 3(2). Rep 2008 (392), cl 42A. |
Cl 43 | Am 2011 (480), Sch 1 [10]. |
Cl 45 | Am 2022 (581), Sch 1[10]. |
Cl 45A | Ins 2013 (551), cl 3. Am 2022 (581), Sch 1[11]–[13] |
Cl 47 | Am 2011 (480), Sch 1 [11]. Subst 2018 (703), Sch 1 [3]. |
Cl 48A | Ins 2015 (138), Sch 1 [10]. Am 2018 (656), cl 3 (1)–(5); 2020 (79), cl 3(1) (2); 2020 (183), cl 3(1) (2); 2021 (118), Sch 1[1]; 2022 (194), Sch 1.1[3]–[5]; 2022 (247), sec 3(1)–(4). |
Part 3, Div 4, Subdiv 3, heading | Am 2021 (386), Sch 1[4]. |
Cl 49A | Ins 2021 (386), Sch 1[5]. |
Cl 52 | Am 2020 (128), Sch 1[1]; 2021 (561), sec 3(2); 2023 (302), Sch 1[1]. |
Cl 55A | Ins 2015 (138), Sch 1 [11]. |
Cl 56 | Am 2016 (287), Sch 1 [3] [4]; 2017 (689), cl 3 (2). |
Cl 58 | Subst 2021 (386), Sch 1[6]. Am 2022 (194), Sch 1.1[6]; 2022 (581), Sch 1[14]; 2023 (302), Sch 1[3]. |
Cl 59 | Am 2011 (480), Sch 1 [12]. |
Cl 60 | Am 2020 (128), Sch 1[1]. |
Cl 62 | Am 2018 (703), Sch 1 [4]. |
Part 3A, Divs 1–3 (cll 68A–68I) | Ins 2021 (372), Sch 1[7]. |
Part 4, heading | Am 2021 (386), Sch 1[7]. |
Part 4, Div 1A | Ins 2023 (548), Sch 1[3]. |
Cl 68J | Ins 2023 (548), Sch 1[3]. |
Cl 69 | Am 2011 (480), Sch 1 [4] [13]; 2021 (372), Sch 1[5]. |
Cl 75 | Am 2022 (194), Sch 1.1[7]. |
Cl 76 | Am 2018 (655), Sch 1 [2]. |
Cl 76A | Ins 2021 (386), Sch 1[8]. |
Cl 78 | Am 2018 (655), Sch 1 [3]. |
Cl 80 | Am 2018 (655), Sch 1 [4]; 2022 (194), Sch 1.2[4]. |
Cl 81 | Am 2018 (655), Sch 1 [5]; 2022 (581), Sch 1[15] [16]. |
Cl 81A | Ins 2022 (581), Sch 1[17]. |
Cl 83 | Am 2018 (655), Sch 1 [6] [7]; 2020 (111), Sch 1[1]; 2021 (386), Sch 1[9]. |
Cl 84 | Am 2014 (82), Sch 1 [3] [4]; 2018 (655), Sch 1 [8] [9]. |
Cl 84A | Ins 2019 (477), Sch 1 [2]. Am 2020 (111), Sch 1[2]; 2022 (581), Sch 1[18] [19]. |
Cl 84B | Ins 2019 (477), Sch 1 [2]. |
Cl 85 | Am 2022 (194), Sch 1.2[5]; 2023 (302), Sch 1[4]. |
Cl 90 | Am 2014 (82), Sch 1 [5]. Subst 2018 (655), Sch 1 [10]. |
Cl 91 | Am 2013 (176), Sch 1 [1]. |
Cl 92 | Am 2013 (176), Sch 1 [2] [3]; 2013 No 111, Sch 3.20; 2018 (689), cl 3. |
Cl 93 | Am 2013 (648), cl 3 (1) (2). |
Cl 94 | Am 2018 (655), Sch 1 [11] [12]; 2020 (111), Sch 1[3]; 2021 (386), Sch 1[9]. |
Cl 94AA | Ins 2019 (477), Sch 1 [3]. Am 2020 (111), Sch 1[4]. |
Cl 94AB | Ins 2019 (477), Sch 1 [3]. |
Cl 94A | Ins 2013 (176), Sch 1 [4]. Am 2013 (648), cl 3 (3). |
Cl 96 | Am 2018 (655), Sch 1 [13]. |
Cl 97 | Am 2018 (655), Sch 1 [14]. |
Cl 98 | Am 2014 (82), Sch 1 [6] [7]; 2018 (655), Sch 1 [15] [16]. |
Part 4, Div 3, Subdiv 3, heading | Am 2021 (386), Sch 1[10]. |
Cl 99A | Ins 2021 (386), Sch 1[11]. |
Cl 101 | Am 2014 (82), Sch 1 [8] [9]; 2016 (409), Sch 1 [4]; 2019 (477), Sch 1 [4]; 2021 (386), Sch 1[12]–[14]. |
Cl 102 | Am 2016 (409), Sch 1 [5]. |
Cl 103 | Am 2011 (480), Sch 1 [14] [15]. Subst 2018 (703), Sch 1 [5]. |
Cl 104 | Am 2016 (409), Sch 1 [6]. |
Cl 105 | Rep 2016 (409), Sch 1 [7]. |
Cl 110 | Subst 2018 (703), Sch 1 [6]. Am 2021 (386), Sch 1[15]. |
Cl 114 | Am 2018 (703), Sch 1 [7]. |
Part 4, Div 5, Subdiv 2, heading | Am 2018 (703), Sch 1 [8]; 2021 (386), Sch 1[16]. |
Cl 115 | Subst 2018 (703), Sch 1 [9]. Am 2021 (386), Sch 1[17]. |
Cl 116 | Subst 2018 (703), Sch 1 [10]; 2021 (386), Sch 1[18]. |
Cl 117 | Am 2018 (703), Sch 1 [11]–[13]; 2021 (386), Sch 1[19]–[22]. |
Cll 118, 119 | Am 2018 (703), Sch 1 [14]. |
Cl 119A | Ins 2015 (138), Sch 1 [12]. |
Cl 120 | Subst 2021 (386), Sch 1[23]. Am 2022 (194), Sch 1.1[8]; 2022 (581), Sch 1[20]; 2023 (302), Sch 1[5]. |
Cl 121 | Am 2018 (655), Sch 1 [17]. |
Cl 122 | Am 2014 (82), Sch 1 [10] [11]; 2018 (655), Sch 1 [18] [19]; 2019 (477), Sch 1 [5] [6]; 2023 (302), Sch 1[6] [7]. |
Cl 123 | Am 2014 (82), Sch 1 [12]; 2020 (111), Sch 1[5]. |
Cl 125 | Am 2021 (386), Sch 1[24]; 2023 (548), Sch 1[4]. |
Cl 125A | Ins 2023 (548), Sch 1[5]. |
Cl 126A | Am 2011 (480), Sch 1 [16]. |
Cl 128 | Am 2011 (480), Sch 1 [17]. Subst 2018 (703), Sch 1 [15]. |
Cl 128A | Ins 2016 (409), Sch 1 [8]. Rep 2018 (655), Sch 1 [20]. Ins 2021 (386), Sch 1[25]. |
Part 4A | Ins 2016 (409), Sch 1 [9]. Rep 2018 (655), Sch 1 [21]. Ins 2023 (548), Sch 1[6]. |
Part 4A, Div 1 | Ins 2023 (548), Sch 1[6]. |
Cl 128B | Ins 2016 (409), Sch 1 [9]. Rep 2018 (655), Sch 1 [21]. Ins 2023 (548), Sch 1[6]. |
Cl 128C | Ins 2016 (409), Sch 1 [9]. Rep 2018 (655), Sch 1 [21]. Ins 2023 (548), Sch 1[6]. |
Part 4A, Div 2 | Ins 2023 (548), Sch 1[6]. |
Cl 128D | Ins 2016 (409), Sch 1 [9]. Rep 2018 (655), Sch 1 [21]. Ins 2023 (548), Sch 1[6]. |
Cl 128E | Ins 2016 (409), Sch 1 [9]. Rep 2018 (655), Sch 1 [21]. Ins 2023 (548), Sch 1[6]. |
Cl 128F | Ins 2016 (409), Sch 1 [9]. Rep 2018 (655), Sch 1 [21]. Ins 2023 (548), Sch 1[6]. |
Part 4A, Div 3 | Ins 2023 (548), Sch 1[6]. |
Cl 128G | Ins 2016 (409), Sch 1 [9]. Rep 2018 (655), Sch 1 [21]. Ins 2023 (548), Sch 1[6]. |
Cl 1285H | Ins 2016 (409), Sch 1 [9]. Rep 2018 (655), Sch 1 [21]. Ins 2023 (548), Sch 1[6]. |
Cl 128I | Ins 2016 (409), Sch 1 [9]. Rep 2018 (655), Sch 1 [21]. Ins 2023 (548), Sch 1[6]. |
Cl 128J | Ins 2016 (409), Sch 1 [9]. Rep 2018 (655), Sch 1 [21]. Ins 2023 (548), Sch 1[6]. |
Cl 128K | Ins 2016 (409), Sch 1 [9]. Rep 2018 (655), Sch 1 [21]. Ins 2023 (548), Sch 1[6]. |
Part 4A, Div 4 | Ins 2023 (548), Sch 1[6]. |
Cl 128L | Ins 2016 (409), Sch 1 [9]. Rep 2018 (655), Sch 1 [21]. Ins 2023 (548), Sch 1[6]. |
Cl 128LA | Ins 2023 (548), Sch 1[6]. |
Cl 128LB | Ins 2023 (548), Sch 1[6]. |
Cl 128LC | Ins 2023 (548), Sch 1[6]. |
Cl 128LD | Ins 2023 (548), Sch 1[6]. |
Parts 4B, 4C (cll 128M–128P) | Ins 2016 (409), Sch 1 [9]. |
Cl 129 | Am 2021 (386), Sch 1[26]. |
Cl 131 | Am 2011 (480), Sch 1 [18]. |
Cl 134 | Am 2021 (118), Sch 1[2]. |
Cl 155 | Am 2009 (490), cl 3 (1); 2012 (450), cl 3 (1); 2014 (534), cl 3 (1); 2015 (305), cl 3 (1); 2016 (286), cl 3 (1); 2017 (265), cl 3 (1); 2018 (232), cl 3 (1); 2019 (206), cl 3 (1); 2020 (412), cl 3(1); 2021 (385), Sch 3[1]; 2022 (445), Sch 3[1]; 2023 (499), Sch 3[1]; 2025 (605), Sch 1[1]. |
Cl 159 | Am 2009 (490), cl 3 (1); 2012 (450), cl 3 (1); 2014 (534), cl 3 (1); 2015 (305), cl 3 (1); 2016 (286), cl 3 (1); 2017 (265), cl 3 (1); 2018 (232), cl 3 (1); 2019 (206), cl 3 (1); 2020 (412), cl 3(1); 2021 (385), Sch 3[2]; 2022 (445), Sch 3[2]; 2023 (499), Sch 3[1]; 2025 (605), Sch 1[1]. |
Cl 160 | Am 2009 (490), cl 3 (2); 2010 (485), cl 3 (1); 2011 (394), cl 3 (1) (2); 2012 (450), cl 3 (2); 2013 (485) cl 3 (1); 2014 (534), cl 3 (2) (3); 2015 (305), cl 3 (2) (3); 2016 (286), cl 3 (2) (3); 2017 (265), cl 3 (2) (3); 2018 (232), cl 3 (2) (3); 2019 (206), cl 3 (2) (3); 2020 (412), cl 3(2)(3); 2021 (385), Sch 3[3]; 2022 (445), Sch 3[3] [4]; 2023 (499), Sch 3[2] [3]; 2025 (605), Sch 1[2] [3]. |
Cl 164 | Am 2009 (490), cl 3 (2); 2010 (485), cl 3 (1); 2011 (394), cl 3 (1) (2); 2012 (450), cl 3 (2); 2013 (485) cl 3 (1); 2014 (534), cl 3 (2) (3); 2015 (305), cl 3 (2) (3); 2016 (286), cl 3 (2) (3); 2017 (265), cl 3 (2) (3); 2018 (232), cl 3 (2) (3); 2019 (206), cl 3 (2) (3); 2020 (412), cl 3(2)(3); 2021 (385), Sch 3[4]; 2022 (445), Sch 3[5] [6]; 2023 (499), Sch 3[2] [3]; 2025 (605), Sch 1[2] [3]. |
Cl 165 | Am 2009 (490), cl 3 (3) (4); 2010 (485), cl 3 (2) (3); 2011 (394), cl 3 (1) (3) (4); 2012 (45), cl 3 (3) (4); 2013 (485) cl 3 (2) (3); 2014 (534), cl 3 (2) (4) (5); 2015 (305), cl 3 (2) (4)–(6); 2016 (286), cl 3 (2) (4) (5); 2017 (265), cl 3 (2) (4) (5); 2018 (232), cl 3 (2) (4)–(6); 2019 (206), cl 3 (2) (4) (5); 2020 (412), cl 3(2)(4)(5); 2021 (385), Sch 3[5] [6]; 2022 (445), Sch 3[7]–[10]; 2023 (499), Sch 3[2] [4]–[6]; 2025 (605), Sch 1[2] [4]–[6]. |
Cl 166 | Am 2011 (537), cl 3. |
Cl 169 | Am 2009 (490), cl 3 (3) (4); 2010 (485), cl 3 (2) (3); 2011 (394), cl 3 (1) (3) (4); 2012 (450), cl 3 (3) (4); 2013 (485) cl 3 (2) (3); 2014 (534), cl 3 (2) (4) (5); 2015 (305), cl 3 (2) (4)–(6); 2016 (286), cl 3 (2) (4) (5); 2017 (265), cl 3 (2) (4) (5); 2018 (232), cl 3 (2) (4)–(6); 2019 (206), cl 3 (2) (4) (5); 2020 (412), cl 3(2)(4)(5); 2021 (385), Sch 3[7] [8]; 2022 (445), Sch 3[11]–[14]; 2023 (499), Sch 3[2] [4]–[6]; 2025 (605), Sch 1[2] [4]–[6]. |
Part 8A, heading | Ins 2021 (134), Sch 1[1]. Am 2023 (302), Sch 1[8]. |
Part 8A | Ins 2021 (134), Sch 1[1]. |
Cl 174A | Ins 2021 (134), Sch 1[1]. Am 2023 (302), Sch 1[9]. |
Cl 174B | Ins 2021 (134), Sch 1[1]. Am 2023 (302), Sch 1[10]. |
Cl 174C | Ins 2021 (134), Sch 1[1]. Am 2023 (302), Sch 1[11]; 2024 (257), Sch 1[1] [2]. |
Cl 174D | Ins 2021 (134), Sch 1[1]. Am 2022 (194), Sch 1.1[9] [10]. |
Cl 174E | Ins 2021 (134), Sch 1[1]. Am 2022 (194), Sch 1.1[11]–[14], Sch 1.2[6] [7]. |
Cl 174EA | Ins 2023 (302), Sch 1[12]. |
Cl 174EB | Ins 2023 (302), Sch 1[12]. |
Cl 174F | Ins 2021 (134), Sch 1[1]. Am 2023 (302), Sch 1[13]. |
Cl 174G | Ins 2021 (134), Sch 1[1]. Am 2023 (302), Sch 1[14]–[16]. |
Cl 174H | Ins 2021 (134), Sch 1[1]. Am 2023 (302), Sch 1[17]. |
Cl 174I | Ins 2021 (134), Sch 1[1]. Am 2023 (302), Sch 1[18]; 2023 (548), Sch 1[7]. |
Cl 174J | Ins 2021 (134), Sch 1[1]. |
Cl 175A | Ins 2016 (409), Sch 1 [10]. |
Cl 182 | Ins 2018 (655), Sch 1 [22]. |
Cl 183 | Ins 2021 (386), Sch 1[27]. |
Appendix A | Am 2014 (82), Sch 1 [13]. |
Appendix C | Am 2009 (330), cl 3; 2010 No 34, Sch 2.38 [5]–[7]; 2014 No 71, Sch 2.2; 2015 No 24, Sch 8.31; 2017 No 50, Sch 5.25; 2021 (386), Sch 1[28]; 2022 (581), Sch 1[21] [22]. |
Appendix D | Am 2014 (82), Sch 1 [14] [15]; 2020 (153), Sch 1[3]. |
Appendix E | Ins 2021 (134), Sch 1[2]. |
The whole Regulation | Am 2021 (372), Sch 1[1] (“Director-General” and “Director-General’s” omitted wherever occurring, “Secretary” and “Secretary’s” inserted instead). |
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