Poisons and Therapeutic Goods Regulation 2002 (NSW)

Case
No judgment structure available for this case.

Part 1Preliminary1Name of Regulation(cf cl 1 of PTG Reg 1994)

This Regulation is the Poisons and Therapeutic Goods Regulation 2002.

2Commencement(cf cl 2 of P&G Reg 1994)

This Regulation commences on 1 September 2002.

Note—

This Regulation replaces the Poisons and Therapeutic Goods Regulation 1994 which is repealed on 1 September 2002 by section 10 (2) of the Subordinate Legislation Act 1989.

3Definitions(cf cll 3 and 3A of P&G Reg 1994)(1)

In this Regulation:

charitable organisation means an organisation or association that holds an authority under Part 2 of the Charitable Fundraising Act 1991 or that is referred to in section 7 of that Act as an organisation or association to which that Act does not apply.

child-resistant closure means:

  • (a)

    in the case of a can fitted with a press-on lid, a lid of the design known as “double tight” or “triple tight”, or

  • (b)

    in any other case, a closure that is resistant to opening by children and that complies with:

    • (i)

      section 2 (Requirements for Reclosable Packages) of Australian Standard AS 1928—2001, Child-resistant packages, or

    • (ii)

      a design approved by any order made under section 10 of the Therapeutic Goods Act 1989 of the Commonwealth, or

    • (iii)

      a design approved for the time being by the Director-General.

Commonwealth Department of Health means the Commonwealth Department of Health and Ageing.

current Poisons Standard has the same meaning as it has in the Therapeutic Goods Act 1989 of the Commonwealth.

day procedure centre means premises licensed as a day procedure centre under the Private Hospitals and Day Procedure Centres Act 1988.

dealer, in relation to a substance, means a person who supplies the substance as a manufacturer, as an importer or exporter or as a wholesale or retail dealer, and includes a medical practitioner, nurse practitioner, midwife practitioner, dentist, optometrist, veterinary practitioner or pharmacist in his or her capacity as a supplier of the substance.

Director-General means the Director-General of the Department of Health.

function includes a power, authority and duty, exercise a function includes perform a duty, confer a function includes impose a duty.

hallucinogen means any of the following drugs of addiction:

  • (a)

    etorphine,

  • (b)

    tetrahydrocannabinol and its alkyl homologues where Schedule 8 of the Poisons List applies.

hospital means a public hospital, public institution, private hospital, nursing home, day procedure centre or residential centre for persons with disabilities.

inspector means a person authorised by the Director-General to exercise the powers conferred by section 43 of the Act.

midwife means a person who is a registered midwife within the meaning of the Nurses and Midwives Act 1991.

nurse means a person who is a registered nurse within the meaning of the Nurses and Midwives Act 1991.

nursing home has the same meaning as in the Public Health Act 1991.

practitioner of alternative medicine means a herbalist, nutritionist, naturopath, practitioner of Chinese medicine or homoeopathic practitioner.

prescribed restricted substance means a substance listed in Appendix D.

prescription reference number means the unique reference number for the prescription recorded under clause 54 or 113.

private hospital means premises licensed as a private hospital under the Private Hospitals and Day Procedure Centres Act 1988.

public hospital means a public hospital within the meaning of the Health Services Act 1997.

residential centre for persons with disabilities means an institution that is declared by clause 178 to be a residential centre for persons with disabilities for the purposes of this Regulation.

retail dealer, in relation to a substance, means a person who supplies the substance as a retailer, and not as a manufacturer, importer, exporter or wholesaler, and not as a medical practitioner, nurse practitioner, midwife practitioner, dentist, optometrist, veterinary practitioner or pharmacist in his or her capacity as a supplier of the substance.

retail pharmacist means a pharmacist who is employed in premises approved under clause 1 of Schedule 2 to the Pharmacy Practice Act 2006 as suitable for carrying on the business of a pharmacist.

retail pharmacy means premises approved under clause 1 of Schedule 2 to the Pharmacy Practice Act 2006.

scientifically qualified person means:

  • (a)

    a medical practitioner, dentist or veterinary practitioner or pharmacist, or

  • (b)

    a person who is the holder of a degree or diploma approved for the time being by the Director-General, or

  • (c)

    a person approved for the time being by the Director-General.

seized goods means regulated goods that have been seized under section 43 of the Act.

the Act means the Poisons and Therapeutic Goods Act 1966.

Therapeutic Goods Order No 20 means the order of that name, as in force from time to time under Part 2 of the Therapeutic Goods Act 1989 of the Commonwealth.

therapeutic substance means a substance that is manufactured for therapeutic use within the meaning of the current Poisons Standard.

ward of a hospital includes any theatre, laboratory or department of the hospital, other than the pharmacy department.

(2)

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 or 8 substance is a reference to a substance included in the correspondingly numbered Schedule of the Poisons List, and

  • (d)

    a reference to an Appendix B substance is a reference to a substance included in Appendix B to this Regulation.

(3)

Notes in the text of this Regulation do not form part of the Regulation.

4Authorisation of nurse practitioner or midwife practitioner under section 17A of the Act(cf cl 3B of PTG Reg 1994)

Nothing in this Regulation authorises a nurse practitioner or midwife practitioner to possess, use, supply or prescribe any poison or restricted substance otherwise than in accordance with an authorisation in force under section 17A of the Act in respect of the nurse practitioner or midwife practitioner.

4AAuthorisation of nurse practitioner or midwife practitioner to possess, use, supply or prescribe drugs of addiction(1)

Nothing in this Regulation authorises a nurse practitioner or midwife practitioner to possess, use, supply or prescribe a drug of addiction otherwise than in accordance with an authorisation of the Director-General under this clause.

(2)

The Director-General may, by means of a written authorisation, authorise a nurse practitioner or midwife practitioner, or a class of nurse practitioners or midwife practitioners, to possess, use, supply or prescribe any drug of addiction for the purposes of the practice of a nurse practitioner’s or midwife practitioner’s profession.

(3)

Such an authority is to be given only if the Director-General approves guidelines, under section 78A of the Nurses and Midwives Act 1991, that provide for the possession, use, supply or prescription of drugs of addiction by nurse practitioners or midwife practitioners and is to be given in accordance with those guidelines.

(4)

The Director-General may amend or revoke any authorisation given under this section.

4BAuthorisation of optometrist under section 17B of the Act

Nothing in this Regulation authorises an optometrist to possess, use, supply or prescribe any poison or restricted substance unless:

  • (a)

    the use of the poison or restricted substance in the practice of optometry has been approved under section 17B of the Act, and

  • (b)

    the optometrist holds a drug authority issued by the Optometrists Registration Board allowing the optometrist to possess, use, supply or prescribe that poison or restricted substance.

Note—

Section 21 (5) of the Optometrists Act 2002 provides for a registered optometrist to possess and use certain drugs in the practice of optometry. That section is unaffected by this clause.

Part 2Poisons (S1, S2, S3, S5, S6, S7)Division 1Packaging and labelling5Packaging and labelling generally(cf cl 4 of P&G Reg 1994)(1)

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 20 applies, in accordance with that Order.

(2)

This clause does not apply to the labelling of a substance that is supplied by a medical practitioner, nurse practitioner, midwife practitioner, dentist, optometrist, veterinary practitioner or pharmacist so long as the substance is supplied in a package that is labelled in accordance with the requirements of Appendix A.

(3)

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).

Maximum penalty: 10 penalty units.

6Misleading labelling of substances as poisons(cf cl 5 of PTG Reg 1994)

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.

7Packaging of camphor and naphthalene(cf cl 6 of PTG Reg 1994)

A dealer must ensure that any camphor or naphthalene supplied by the dealer (being camphor or naphthalene packaged in block, disc, ball or pellet form suitable for domestic use) is packaged so that, in normal use, the contents of the package cannot be ingested or touched while the package remains unbroken.

Maximum penalty: 10 penalty units.

8Schedule 3 substances supplied by dealers(cf cl 7 of PTG Reg 1994)(1)

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.

(2)

Subclause (1) does not apply to the supply of any Schedule 3 substance by wholesale.

9Exemptions(cf cl 8 of PTG Reg 1994)(1)

The Director-General may, by order in writing, exempt any person or substance, or any class of persons or substances, from the requirements of this Division.

(2)

Such an exemption may be given unconditionally or subject to conditions.

(3)

Subject to subclause (4), any exemption in force under a law of the Commonwealth, or of another State or Territory, corresponding to this clause has the same effect as an exemption under this clause.

(4)

The Director-General may, by order published in the Gazette, declare that subclause (3) does not have effect with respect to an exemption specified in the order.

Division 2Storage10Storage generally(cf cl 9 of PTG Reg 1994)

A dealer who has possession of any poison must keep the poison:

  • (a)

    apart from human or animal food, and

  • (b)

    in such a way that, if its container breaks or leaks, the poison cannot mix with or contaminate any human or animal food.

Maximum penalty: 10 penalty units.

11Schedule 3 or 7 substances(cf cl 10 of PTG Reg 1994)

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.

12Schedule 6 substances(cf cl 11 of PTG Reg 1994)(1)

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.

(2)

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 welded plastic labyrinth.

Maximum penalty: 10 penalty units.

Division 3Prescriptions13Unauthorised persons not to prescribe Schedule 2 or 3 substances(cf cl 12 of PTG Reg 1994)(1)

A person must not issue a prescription for a Schedule 2 or 3 substance unless authorised to do so by this clause.

(2)

A medical practitioner, nurse practitioner, midwife practitioner, dentist, optometrist or veterinary practitioner may issue a prescription for a Schedule 2 or 3 substance.

Maximum penalty: 10 penalty units.

14Certain Schedule 3 substances(cf cl 13 of PTG Reg 1994)(1)

This clause applies to the following substances, but only in so far as they are Schedule 3 substances:

  • pseudoephedrine

(2)

A person who issues a prescription for a substance to which this clause applies must ensure that the prescription complies with Division 3 of Part 3 as if the substance were a restricted substance.

Maximum penalty: 10 penalty units.

15Quantity and purpose of prescriptions to be appropriate(cf cl 14 of P&G Reg 1994)

A medical practitioner, nurse practitioner, midwife practitioner, dentist, optometrist or veterinary 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.

Division 4Supply16Schedule 2 and 3 substances may be supplied by authorised persons(cf cl 16 of P&G Reg 1994)

A person who is not a medical practitioner, nurse practitioner, midwife practitioner, dentist, optometrist, veterinary practitioner or 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.

17Schedule 3 substances to be supplied personally by pharmacists(cf cl 17 of P&G Reg 1994)(1)

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.

(2)

This clause does not apply to the supply of any substance:

  • (a)

    to a medical practitioner, nurse practitioner, midwife practitioner, dentist, optometrist or veterinary practitioner, or

  • (b)

    to any other person on the prescription of a medical practitioner, nurse practitioner, midwife practitioner, dentist, optometrist or veterinary practitioner.

(3)

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 Director-General for the purposes of this subclause.

(4)

This clause does not apply to the supply to the chief nurse of a nursing home of any substance in the manufacturer’s original pack, in accordance with a written order signed by the chief nurse, if the Director-General has determined that the substance may be supplied for emergency use at the nursing home in accordance with the authorisation of a medical practitioner, nurse practitioner, dentist or optometrist who prescribes substances to the nursing home’s residents.

(5)

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 Director-General for the purposes of this paragraph.

Maximum penalty: 10 penalty units.

18Prescriptions for Schedule 2 or 3 substances to be endorsed(cf cl 19 of PTG Reg 1994)

A pharmacist who supplies a Schedule 2 or 3 substance on prescription must endorse the prescription for the substance in accordance with clause 40 as if the substance were a restricted substance.

Maximum penalty: 10 penalty units.

19Certain Schedule 7 substances to be supplied and used only under an authority(cf cl 20 of P&G Reg 1994)(1)

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.

(2)

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.

(3)

A person being supplied with a Schedule 7 substance must surrender to the dealer the person’s authority to obtain the substance.

(4)

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 166 (3)),

it is sufficient compliance with subclause (3) if the person being supplied surrenders a copy of the authority to the dealer.

(5)

The functions of the Director-General under Part 8 with respect to an authority under this clause may be exercised by the Permanent Head of the Commonwealth Department of Health.

Maximum penalty: 10 penalty units.

(6)

The Director-General 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.

(7)

Such an exemption may be given unconditionally or subject to conditions.

(8)

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.

(9)

In subclause (8) (d), highly dangerous substance means any of the following substances:

  • arsenic

  • cyanides

  • fluoroacetamide

  • fluoroacetic acid

  • hydrocyanic acid

  • strychnine

  • thallium

  • any Schedule 7 substance that is listed in Appendix C of the current Poisons Standard

20“Particular use” poisons may only be supplied in original containers(cf cl 21 of PTG Reg 1994)(1)

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.

(2)

A dealer (other than a medical practitioner, nurse practitioner, midwife practitioner, dentist, optometrist, veterinary 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.

21Supply of art materials, toys, furniture etc containing poisons(cf cl 22 of PTG Reg 1994)(1)

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.

(2)

Subclause (1) does not apply to the supply of artists’ oil colours.

(3)

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.

22Quantity and purpose of supply to be appropriate(cf cl 23 of PTG Reg 1994)

A medical practitioner, nurse practitioner, midwife practitioner, dentist, optometrist, veterinary 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: 10 penalty units.

Division 5Records of supply23Supply of certain Schedule 3 substances to be recorded(cf cl 25 of PTG Reg 1994)(1)

This clause applies to the following substances, but only in so far as they are Schedule 3 substances:

  • pseudoephedrine

(2)

A pharmacist who supplies a substance to which this clause applies, whether on prescription or otherwise, must record details of the supply in accordance with clause 54 as if the substance were a restricted substance.

Maximum penalty: 10 penalty units.

Division 6Miscellaneous24Poisons to be used or disposed of safely(cf cl 26 of P&G Reg 1994)

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: 10 penalty units.

Part 3Restricted substances (S4)Division 1Packaging and labelling25Packaging and labelling generally(cf cl 27 of P&G Reg 1994)(1)

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 20 applies, in accordance with that Order.

(2)

Despite subclause (1), a medical practitioner, nurse practitioner, midwife practitioner, dentist, optometrist or veterinary practitioner who supplies a restricted substance must ensure that the substance is packaged in accordance with the requirements of that subclause but labelled in accordance with the requirements of Appendix A.

(3)

A pharmacist who supplies any quantity of a restricted substance on prescription, or in the circumstances referred to in clause 44 or 47, 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).

Maximum penalty: 10 penalty units.

26Misleading labelling of substances as restricted substances(cf cl 28 of PTG Reg 1994)

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.

27Exemptions(cf cl 29 of P&G Reg 1994)(1)

The Director-General may, by order in writing, exempt any person or substance, or any class of persons or substances, from the requirements of this Division.

(2)

Such an exemption may be given unconditionally or subject to conditions.

(3)

Subject to subclause (4), any exemption in force under a law of the Commonwealth, or of another State or Territory, corresponding to this clause has the same effect as an exemption under this clause.

(4)

The Director-General may, by order published in the Gazette, declare that subclause (3) does not have effect with respect to an exemption specified in the order.

Division 2Storage28Storage generally(cf cl 30 of P&G Reg 1994)

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 human or animal food, and

  • (c)

    in such a way that, if its container breaks or leaks, the substance cannot mix with or contaminate any human or animal food.

Maximum penalty: 15 penalty units.

29Storage of prescribed restricted substances in hospital wards(cf cl 32 of P&G Reg 1994)(1)

Prescribed restricted substances that are kept in a hospital ward must be stored apart from all other goods (other than drugs of addiction) 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.

(2)

This clause does not apply to the storage of prescribed restricted substances on an emergency trolley, anaesthetic trolley or operating theatre trolley.

Maximum penalty: 20 penalty units.

30Responsibility for storage in hospitals(cf cl 33 of P&G Reg 1994)(1)

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.

(2)

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 chief nurse of the hospital, or

  • (b)

    the medical superintendent of the hospital,

as the chief executive officer of the hospital may determine.

(3)

The nurse or midwife in charge of a hospital ward is responsible for the storage of all restricted substances in the ward.

Division 3Prescriptions31Unauthorised persons not to prescribe restricted substances(cf cl 34 of P&G Reg 1994)(1)

A person must not issue a prescription for a restricted substance unless authorised to do so by this clause.

(2)

A medical practitioner, nurse practitioner, midwife practitioner, dentist, optometrist or veterinary practitioner may issue a prescription for a restricted substance.

Maximum penalty: 15 penalty units.

32Prescriptions may only be issued for certain purposes(cf cl 35 of PTG Reg 1994)(1)

A medical practitioner must not issue a prescription for a restricted substance otherwise than for medical treatment.

(2)

A nurse practitioner must not issue a prescription for a restricted substance otherwise than in the course of practising as a nurse practitioner.

(2A)

A midwife practitioner must not issue a prescription for a restricted substance otherwise than in the course of practising as a midwife practitioner.

(3)

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”.

(3A)

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”.

(4)

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”.

Maximum penalty: 15 penalty units.

33Quantity and purpose of prescriptions to be appropriate(cf cl 36 of PTG Reg 1994)

A medical practitioner, nurse practitioner, midwife practitioner, dentist, optometrist or veterinary 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: 15 penalty units.

34Form of prescription(cf cl 37 of PTG Reg 1994)(1)

A prescription for a restricted substance must include the following details:

  • (a)

    the date on which it is issued,

  • (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 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 an Appendix B 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.

(2)

The details referred to in subclause (1) (a)–(f) 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 Director-General,

and the prescription must be signed by the person by whom it is issued.

(3)

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.

(4)

A person who issues a prescription for a restricted substance must ensure that the prescription complies with the requirements of this clause.

(5)

The Director-General 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.

(6)

Such an exemption may be given unconditionally or subject to conditions.

Maximum penalty: 15 penalty units.

35Emergency prescriptions may be given by telephone or otherwise(cf cl 38 of P&G Reg 1994)(1)

In an emergency, a medical practitioner, nurse practitioner, midwife practitioner, dentist, optometrist or veterinary practitioner may direct the supply of a restricted substance orally, by telephone, by electronic mail or by facsimile.

(2)

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.

(3)

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.

(4)

This clause does not apply to a direction given under clause 57.

Maximum penalty: 15 penalty units.

36Authority required to prescribe certain restricted substances(cf cl 39 of PTG Reg 1994)(1)

This clause applies to the following restricted substances:

  • acitretin

  • clomiphene

  • cyclofenil

  • dinoprost

  • dinoprostone

  • etretinate

  • follitropin beta

  • isotretinoin for oral use

  • luteinising hormone

  • tretinoin for oral use

  • urofollitrophin (human follicle stimulating hormone)

(2)

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.

(3)

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.

(4)

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 the words “ISSUED UNDER CLAUSE 36 OF THE POISONS AND THERAPEUTIC GOODS REGULATION 2002” or with other words that indicate that the prescription has been issued under this clause.

Maximum penalty: 15 penalty units.

37Records to be kept of certain prescriptions(cf cl 40 of P&G Reg 1994)(1)

A medical practitioner, nurse practitioner, midwife practitioner, dentist, optometrist or veterinary 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 an Appendix B substance, the intervals at which the substance may be supplied on the prescription,

  • (f)

    the directions for use, as shown on the prescription.

(2)

The record must be kept at the surgery, hospital or office of the person prescribing the substance.

Maximum penalty: 15 penalty units.

Division 4SupplySubdivision 1Supply on prescription38Prescriptions may be filled only if in proper form(cf cl 41 of PTG Reg 1994)(1)

A pharmacist must not supply a restricted substance on prescription unless the prescription is in the form required by Division 3.

(2)

This clause does not prevent a pharmacist from supplying a restricted substance on prescription merely because:

  • (a)

    the prescription fails to specify the maximum number of times the substance may be supplied, or

  • (b)

    in the case of a prescription for an Appendix B 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 medical practitioner, nurse practitioner, midwife practitioner, dentist, optometrist or veterinary practitioner from some other State or Territory.

(3)

A pharmacist must not supply a restricted substance more than once on a prescription referred to in subclause (2) (a) or (b), regardless of how many times the prescription purports to authorise the supply of the substance.

Maximum penalty: 15 penalty units.

39Certain prescriptions not to be filled(cf cl 42 of PTG Reg 1994)(1)

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 medical practitioner, nurse practitioner, midwife practitioner, dentist, optometrist or veterinary practitioner by whom it was issued, or

  • (g)

    if the prescription is dated more than 12 months (or, in the case of a prescription for a prescribed restricted substance, 6 months) before the date on which the supply is requested.

(2)

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.

40Prescriptions to be endorsed(cf cl 43 of PTG Reg 1994)(1)

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.

(2)

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 an Appendix B 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.

41Prescriptions for certain substances to be kept(cf cl 44 of P&G Reg 1994)(1)

A pharmacist who supplies an Appendix B substance on prescription must keep the prescription, whether or not the prescription authorises more than one supply of the substance.

(2)

Prescriptions for Appendix B substances must be kept apart from other prescriptions (other than prescriptions for drugs of addiction).

Maximum penalty: 20 penalty units.

Subdivision 2Supply without prescription42Supply by medical practitioners, nurse practitioners, midwife practitioners, dentists, optometrists and veterinary practitioners(cf cl 45 of P&G Reg 1994)(1)

A medical practitioner must not supply a restricted substance to any person otherwise than for medical treatment.

(2)

A nurse practitioner must not supply a restricted substance to any person otherwise than in the course of practising as a nurse practitioner.

(2A)

A midwife practitioner must not supply a restricted substance to any person otherwise than in the course of practising as a midwife practitioner.

(3)

A dentist must not supply a restricted substance to any person otherwise than for dental treatment.

(3A)

An optometrist must not supply a restricted substance to any person otherwise than in the course of practising as an optometrist.

(4)

A veterinary practitioner must not supply a restricted substance to any person otherwise than for veterinary treatment.

Maximum penalty: 15 penalty units.

43Emergency supply by pharmacists on direction of medical practitioners, nurse practitioners, midwife practitioners, dentists, optometrists or veterinary practitioners(cf cl 46 of PTG Reg 1994)(1)

A pharmacist may supply a person with a restricted substance (including a prescribed restricted substance) in accordance with a direction given under clause 35.

(2)

A prescription that is subsequently sent in confirmation of the direction must be dealt with in accordance with clauses 40 and 41, and details of the supply must be recorded in accordance with clause 54, in the same way as if the restricted substance had been supplied on prescription.

(3)

If such a prescription is not received within 7 days after the substance is supplied, the pharmacist must report that fact to the Director-General.

Maximum penalty: 15 penalty units.

44Emergency supply by pharmacists otherwise than on direction of medical practitioners, nurse practitioners, midwife practitioners, dentists or optometrists(cf cl 47 of P&G Reg 1994)(1)

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 a medical practitioner, nurse practitioner, midwife practitioner, dentist or optometrist.

(2)

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 3 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.

45Supply by pharmacists to medical practitioner, nurse practitioner, midwife practitioner, dentist, optometrist or veterinary practitioner for emergency use(cf cl 48 of P&G Reg 1994)

A pharmacist may supply a medical practitioner, nurse practitioner, midwife practitioner, dentist, optometrist or veterinary practitioner with a restricted substance (including a prescribed restricted substance) for emergency use, but only on a written order signed and dated by the medical practitioner, nurse practitioner, midwife practitioner, dentist, optometrist or veterinary practitioner.

46Supply by pharmacists to nursing homes of stock for emergency use(cf cl 47A of PTG Reg 1994)(1)

A retail pharmacist may supply the chief nurse of a nursing home with a manufacturer’s original pack of a restricted substance approved by the Director-General for the purposes of this clause for emergency use at the nursing home in accordance with an authorisation by a medical practitioner, nurse practitioner, dentist or optometrist who prescribes substances to the nursing home’s residents.

(2)

A restricted substance may not be supplied under subclause (1) unless it is supplied in accordance with a written order signed by the chief nurse.

Maximum penalty: 15 penalty units.

(3)

The Director-General may, by order in writing, either generally or in the case of a particular nursing home or class of nursing homes, approve the supply of a restricted substance (including a prescribed restricted substance) for emergency use in the nursing home or nursing homes.

(4)

An approval under subclause (3) may be given unconditionally or subject to conditions.

47Supply by pharmacists of benzylpenicillin for use in animals(cf cl 67 of PTG Reg 1994)(1)

This clause applies to benzylpenicillin, including procaine penicillin, in preparations for use by intramuscular injection in animals.

(2)

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.

(3)

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.

(4)

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.

Subdivision 3Supply in hospitals48Supply by pharmacists(cf cl 49 of P&G Reg 1994)

A pharmacist 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 Director-General) of a medical practitioner, nurse practitioner, midwife practitioner, dentist or optometrist, 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 Director-General) of a medical practitioner, nurse practitioner, midwife practitioner, dentist, optometrist or the nurse or midwife in charge of the ward in which the substance is to be used or stored.

49Supply in original containers: section 10(cf cl 50 of PTG Reg 1994)(1)

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.

(2)

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.

Subdivision 4Supply generally50Research drugs(cf cl 54 of P&G Reg 1994)(1)

This clause applies to thalidomide other than as registered goods.

(2)

A dealer must not supply thalidomide unless the person being supplied holds an authority under Part 8 to be supplied with thalidomide.

(3)

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.

(4)

A person being supplied with thalidomide other than as registered goods (otherwise than as referred to in subclause (3) (c)) must surrender his or her authority to the dealer.

(5)

A dealer must keep any authority surrendered to the dealer under this clause.

Maximum penalty: 15 penalty units.

51Authority required to supply certain restricted substances(cf cl 55 of PTG Reg 1994)(1)

This clause applies to the following substances:

  • acitretin

  • clomiphene

  • cyclofenil

  • dinoprost

  • dinoprostone

  • etretinate

  • follitropin beta

  • isotretinoin for oral use

  • luteinising hormone

  • tretinoin for oral use

  • urofollitrophin (human follicle stimulating hormone)

(2)

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.

(3)

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.

52Restricted substances may be supplied by authorised persons(cf cl 56 of P&G Reg 1994)

A person who is not a medical practitioner, nurse practitioner, midwife practitioner, dentist, optometrist or veterinary 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.

53Quantity and purpose of supply to be appropriate(cf cl 57 of PTG Reg 1994)

A medical practitioner, nurse practitioner, midwife practitioner, dentist, optometrist, veterinary 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: 15 penalty units.

Division 5Records of supply54Supply on prescription to be recorded(cf cl 58 of PTG Reg 1994)(1)

A pharmacist who supplies a restricted substance on prescription must record the following details in a manner approved by the Director-General:

  • (a)

    the details required by clause 34 (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.

(2)

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.

Maximum penalty: 15 penalty units.

55Records to be kept of supply of restricted substances by medical practitioners, nurse practitioners, midwife practitioners, dentists, optometrists and veterinary practitioners(cf cl 59 of P&G Reg 1994)

A medical practitioner, nurse practitioner, midwife practitioner, dentist, optometrist or veterinary 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 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, 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: 15 penalty units.

56Certain supplies of restricted substances to be separately recorded(cf cl 60 of PTG Reg 1994)(1)

A pharmacist who supplies a restricted substance as referred to in clause 44, or who supplies the restricted substance benzylpenicillin as referred to in clause 47, must record the following details of the supply in a manner approved by the Director-General:

  • (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 44, the name and address of the medical practitioner, nurse practitioner, midwife practitioner, dentist or optometrist 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.

(2)

A pharmacist who supplies a restricted substance as referred to in clause 45, or a relevant prescribed substance as referred to in clause 46, must record the following details of the supply in a manner approved by the Director-General:

  • (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.

Division 6Administration57Administration by persons employed at a hospital(cf cl 51 of PTG Reg 1994)(1)

A person employed at a hospital must not administer a restricted substance to a patient in the hospital otherwise than on the direction of a medical practitioner, nurse practitioner, midwife practitioner, dentist or optometrist.

(2)

Such a direction:

  • (a)

    must be given in writing (otherwise than by electronic mail or facsimile) or in any other manner approved by the Director-General for the purposes of this paragraph, or

  • (b)

    in an emergency, may be given:

    • (i)

      by electronic mail or by facsimile, or

    • (ii)

      orally, by telephone or in any other manner approved by the Director-General for the purposes of this subparagraph.

(3)

A medical practitioner, nurse practitioner, midwife practitioner, dentist or optometrist who gives a direction under subclause (2) (b) (ii) must:

  • (a)

    as soon as is practicable (and in any case within the next 24 hours) either:

    • (i)

      sign an entry in the patient’s medical history confirming that he or she has given the direction, or

    • (ii)

      confirm the direction by electronic mail or by facsimile, and

  • (b)

    attend to review the patient as soon as he or she considers it appropriate in the circumstances of the case.

(4)

If confirmation is not received within 7 days after the restricted substance is administered, the person by whom the substance was administered must report that fact to the Director-General.

(5)

A medical practitioner, nurse practitioner, midwife practitioner, dentist or optometrist who, by electronic mail or by facsimile, gives or confirms a direction for the administration of a restricted substance to a patient must attend to review the patient as soon as he or she considers it appropriate in the circumstances of the case.

(6)

Subclauses (3), (4) and (5) do not apply to the administration of a restricted substance to an inmate of a correctional centre (within the meaning of the Crimes (Administration of Sentences) Act 1999) if confirmation of the direction for the administration of the substance has been given in accordance with the requirements of a protocol approved by the Director-General.

Maximum penalty: 15 penalty units.

58Administration of prescribed restricted substances(cf cl 52 of P&G Reg 1994)(1)

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 a nurse practitioner in the course of practising as a nurse practitioner, or

  • (d)

    for the purposes of treatment prescribed by a midwife practitioner in the course of practising as a midwife practitioner, or

  • (e)

    for the purposes of treatment prescribed by an optometrist in the course of practising as an optometrist.

Maximum penalty: 20 penalty units.

(2)

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.

(3)

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.

59Authority required to administer certain restricted substances(cf cl 53 of P&G Reg 1994)(1)

This clause applies to the following restricted substances:

  • acitretin

  • clomiphene

  • cyclofenil

  • dinoprost

  • dinoprostone

  • etretinate

  • follitropin beta

  • isotretinoin for oral use

  • luteinising hormone

  • tretinoin for oral use

  • urofollitrophin (human follicle stimulating hormone)

(2)

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.

(3)

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.

Division 7Miscellaneous60Prescribed restricted substances: sections 9, 10, 11, 16, 18 and 18A(cf cl 62 of P&G Reg 1994)(1)

For the purposes of section 16 of the Act, the substances specified in Appendix D are prescribed restricted substances.

(2)

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.

(3)

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.

61Authorised persons: section 16 (1) (e)(cf cl 63 of P&G Reg 1994)

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 chief nurse of a hospital that does not employ a chief pharmacist,

  • (b)

    the master of a ship, in respect of a therapeutic substance that is required by law to be carried on the ship,

  • (c)

    the holder of a licence under Part 8 to manufacture or supply drugs of addiction,

  • (d)

    an analyst,

  • (e)

    a scientifically qualified person in charge of a laboratory or department, being a person who is engaged in medical or scientific research or instruction, or in quality control or analysis,

  • (f)

    a person acting under the direct personal supervision of a person referred to in paragraph (d) or (e).

62Disclosure of other prescribed restricted substances obtained or prescribed(cf cl 64 of P&G Reg 1994)(1)

A person who asks a medical practitioner, nurse practitioner, midwife practitioner, dentist or optometrist:

  • (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 medical practitioner, nurse practitioner, midwife practitioner, dentist or optometrist 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.

(2)

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.

63Delivery by carrier(cf cl 65 of P&G Reg 1994)

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.

64Pentobarbitone sodium(cf cl 66 of P&G Reg 1994)(1)

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.

(2)

An authorised person who uses pentobarbitone sodium for the destruction of animals must ensure that the requirements of this clause are complied with.

(3)

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.

(4)

An authorised person must keep a separate register of all pentobarbitone sodium that is obtained or used by the authorised person.

(5)

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.

(6)

Each entry must be dated and signed by the authorised person.

(7)

In this clause, authorised person means:

  • (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.

65Restricted substances to be used or disposed of safely(cf cl 68 of P&G Reg 1994)

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.

66Loss or theft of prescribed restricted substances(cf cl 70 of P&G Reg 1994)(1)

A person must immediately notify the Director-General if the person loses a prescribed restricted substance or if a prescribed restricted substance is stolen from the person.

(2)

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, a medical practitioner, nurse practitioner, midwife practitioner, dentist, optometrist or veterinary practitioner.

Maximum penalty: 20 penalty units.

67Forfeiture of prescribed restricted substances(cf cl 71 of PTG Reg 1994)

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.

Part 4Drugs of addiction (S8)Division 1Packaging and labelling68Packaging and labelling generally(cf cl 72 of P&G Reg 1994)(1)

A dealer who supplies a drug of addiction must ensure that the drug is packaged and labelled:

  • (a)

    in accordance with the relevant provisions of the current Poisons Standard, and

  • (b)

    in the case of a drug of addiction to which Therapeutic Goods Order No 20 applies, in accordance with that Order.

(2)

Despite subclause (1), a medical practitioner, nurse practitioner, midwife practitioner, dentist or veterinary practitioner who supplies a drug of addiction must ensure that the drug is packaged in accordance with the requirements of that subclause but labelled in accordance with the requirements of Appendix A.

(3)

A pharmacist who supplies any quantity of a drug of addiction on prescription must ensure that the drug 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).

Maximum penalty: 10 penalty units.

69Misleading labelling of substances as drugs of addiction(cf cl 73 of PTG Reg 1994)

A dealer must not supply any substance in a container that has a label that states or implies that the substance is a drug of addiction, unless the substance is such a drug.

Maximum penalty: 10 penalty units.

70Packages to be sealed so that broken seal is readily distinguishable(cf cl 74 of P&G Reg 1994)(1)

A dealer who supplies any drug of addiction must ensure that the drug is packaged in such a way that:

  • (a)

    its container is so sealed that, when the seal is broken, it is readily distinguishable from sealed containers, and

  • (b)

    if several containers are enclosed in a single primary pack, the primary pack is so sealed that, when the seal is broken, it is readily distinguishable from sealed primary packs.

(2)

This clause does not apply to the supply of a drug of addiction:

  • (a)

    by a medical practitioner, nurse practitioner, midwife practitioner, dentist or veterinary practitioner in the practice of his or her profession, or

  • (b)

    by a pharmacist on the prescription of a medical practitioner, nurse practitioner, midwife practitioner, dentist or veterinary practitioner, or

  • (c)

    by a pharmacist employed at a hospital, on the written requisition of a medical practitioner, nurse practitioner, midwife practitioner, dentist or the nurse or midwife in charge of the ward in which the drug is to be used or stored, or

  • (d)

    by a nurse or midwife on the direction in writing of a medical practitioner, nurse practitioner, midwife practitioner or dentist.

Maximum penalty: 20 penalty units.

71Exemptions(cf cl 75 of PTG Reg 1994)(1)

The Director-General may, by order in writing, exempt any person or substance, or any class of persons or substances, from the requirements of this Division.

(2)

Such an exemption may be given unconditionally or subject to conditions.

(3)

Subject to subclause (4), any exemption in force under a law of the Commonwealth, or of another State or Territory, corresponding to this clause has the same effect as an exemption under this clause.

(4)

The Director-General may, by order published in the Gazette, declare that subclause (3) does not have effect with respect to an exemption specified in the order.

Division 2Storage72Storage generally(1)

A person who is in possession of any drug of addiction must keep the drug:

  • (a)

    in his or her possession stored apart from all other goods (other than cash or documents) 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, or

  • (b)

    stored in any other manner approved by the Director-General for the particular person or class of persons to which the person belongs.

(2)

A person who is a medical practitioner, nurse practitioner, midwife practitioner, dentist, veterinary practitioner or a person referred to in clause 101 (1) (g) is taken to comply with subclause (1) (a) if he or she keeps any drug of addiction (for use in an emergency only) in a bag that is in a room, or in a vehicle, kept locked when not occupied by the person.

Maximum penalty: 20 penalty units.

73Responsibility for storage in hospitals(cf cl 77 of PTG Reg 1994)(1)

The chief pharmacist of a hospital is responsible for the storage of all drugs of addiction at a hospital other than those that have been supplied to a ward.

(2)

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 chief nurse of the hospital, or

  • (b)

    the medical superintendent of the hospital,

as the chief executive officer of the hospital may determine.

(3)

The nurse or midwife in charge of a hospital ward is responsible for the storage of all drugs of addiction in the ward.

74Storage in hospital wards(cf cl 77A of P&G Reg 1994)(1)

Drugs of addiction that are kept in a hospital ward must be stored apart from all other goods (other than prescribed restricted substances) in a separate room, safe, cupboard or other receptacle securely attached to a part of the ward and kept securely locked when not in immediate use.

(2)

The nurse or midwife in charge of a hospital ward must ensure that:

  • (a)

    the room, safe, cupboard or receptacle is kept securely locked when not in immediate use, and

  • (b)

    any key or other device by means of which the room, safe, cupboard or receptacle may be unlocked:

    • (i)

      is kept on the person of a nurse or midwife whenever it is in the ward, and is removed from the ward whenever there is no nurse or midwife in the ward, or

    • (ii)

      is kept in a separately locked safe to which only a nurse or midwife has access, and

  • (c)

    any code or combination that is required to unlock the room, safe, cupboard or receptacle is not divulged to any unauthorised person.

Maximum penalty: 20 penalty units.

75Storage in pharmacies(cf cl 78 of P&G Reg 1994)(1)

The pharmacist for the time being in charge of a pharmacy must keep any drug of addiction stored apart from other substances or goods (other than cash or documents) in a separate safe.

(2)

Unless otherwise approved for the time being by the Director-General, such a safe must comply with the following requirements:

  • (a)

    it must be made of black mild steel plate at least 9 millimetres thick with continuous welding along all edges,

  • (b)

    it must be fitted with a door made of mild steel plate at least 9 millimetres thick, the door being flush fitting with a clearance around the door of not more than 1.5 millimetres,

  • (c)

    it must have a fixed locking bar, welded to the inside face of the door near the hinged edge, that engages in a rebate in the safe body when the door is closed,

  • (d)

    it must be fitted with a five lever key lock (or a locking mechanism providing at least equivalent security) securely fixed to the rear face of the door,

  • (e)

    if mounted on a brick or concrete wall or floor, it must be attached to the wall or floor by means of suitably sized expanding bolts through holes 9 millimetres in diameter drilled in the rear or bottom of the safe,

  • (f)

    if mounted on a timber framed wall or floor, it must be attached to the wall or floor frame by means of suitably sized coachscrews through holes 9 millimetres in diameter drilled in the rear or bottom of the safe,

  • (g)

    if mounted on any other kind of wall or floor, it must be attached to the wall or floor in a manner approved for the time being by the Director-General.

(3)

The pharmacist must ensure that:

  • (a)

    the safe is kept securely locked when not in immediate use, and

  • (b)

    any key or other device by means of which the safe may be unlocked:

    • (i)

      is kept on the person of a pharmacist whenever it is on the same premises as the safe, and is removed from the premises whenever there is no pharmacist at those premises, or

    • (ii)

      is kept in a separately locked safe to which only a pharmacist has access, and

  • (c)

    any code or combination that is required to unlock the safe is not divulged to any unauthorised person.

(4)

This clause applies to a hospital pharmacy as well as to a retail pharmacy.

Maximum penalty: 20 penalty units.

Division 3Prescriptions76Unauthorised persons not to prescribe drugs of addiction(cf cl 79 of P&G Reg 1994)(1)

A person must not issue a prescription for a drug of addiction unless authorised to do so by this clause.

(2)

A medical practitioner, nurse practitioner, midwife practitioner, dentist or veterinary practitioner may issue a prescription for a drug of addiction.

Maximum penalty: 20 penalty units.

77Form of prescription(cf cl 82 of PTG Reg 1994)(1)

A person who issues a prescription for a drug of addiction must ensure that the prescription includes the following details:

  • (a)

    the date on which it is issued,

  • (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 (expressed in both words and figures) of the drug to be supplied,

  • (d)

    adequate directions for use,

  • (e)

    the maximum number of times the drug may be supplied on the prescription,

  • (f)

    the intervals at which the drug 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.

(2)

The details referred to in subclause (1) (a)–(f) 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 Director-General,

and the prescription must be signed by the person by whom it is issued.

(3)

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.

(4)

A person must not issue a prescription that includes:

  • (a)

    more than one preparation containing a drug of addiction, or

  • (b)

    both a preparation containing a drug of addiction and another preparation.

(5)

The Director-General may, by order in writing, exempt any person or drug of addiction, or any class of persons or drugs of addiction, from any or all of the requirements of this clause.

(6)

Such an exemption may be given unconditionally or subject to conditions.

Maximum penalty: 20 penalty units.

78Prescriptions may only be issued for certain purposes(cf cl 80 of P&G Reg 1994)(1)

A medical practitioner must not issue a prescription for a drug of addiction otherwise than for medical treatment.

(1A)

A nurse practitioner must not issue a prescription for a drug of addiction otherwise than in the course of practising as a nurse practitioner.

(1B)

A midwife practitioner must not issue a prescription for a drug of addiction otherwise than in the course of practising as a midwife practitioner.

(2)

A dentist must not issue a prescription for a drug of addiction otherwise than for the dental treatment (for a period not exceeding one month’s continuous treatment) of a patient and must endorse any such prescription with the words “FOR DENTAL TREATMENT ONLY”.

(3)

If the patient is in a hospital, the dentist may issue a prescription for any drug of addiction.

(4)

If the patient is not in a hospital, the dentist may issue a prescription only:

  • (a)

    for pentazocine, or

  • (b)

    for any drug of addiction included in the list of preparations that may be prescribed by participating dental practitioners for dental treatment only set out in the Schedule of Pharmaceutical Benefits issued by the Commonwealth Department of Health, as that Schedule is in force from time to time.

(5)

A veterinary practitioner must not issue a prescription for a drug of addiction otherwise than for veterinary treatment, and must endorse any such prescription with the words “FOR ANIMAL TREATMENT ONLY”.

Maximum penalty: 20 penalty units.

79Quantity and purpose of prescriptions to be appropriate(cf cl 81 of PTG Reg 1994)

A medical practitioner, nurse practitioner, midwife practitioner, dentist or veterinary practitioner must not issue a prescription for a drug of addiction 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.

80Emergency prescriptions may be given by telephone or otherwise(cf cl 83 of PTG Reg 1994)(1)

In an emergency, a medical practitioner, nurse practitioner, midwife practitioner, dentist or veterinary practitioner may direct the supply of a drug of addiction orally, by telephone, by electronic mail or by facsimile.

(2)

A person who so directs the supply of a drug of addiction:

  • (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.

(3)

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.

(4)

This clause does not apply to a direction given under clause 119.

Maximum penalty: 20 penalty units.

81Records of prescriptions(cf cl 84 of PTG Reg 1994)(1)

A medical practitioner, nurse practitioner, midwife practitioner, dentist or veterinary practitioner who prescribes a drug of addiction must make a record of the following particulars:

  • (a)

    the name, strength and quantity of the drug prescribed and the date on which it was prescribed,

  • (b)

    if the drug is intended for the treatment of a person, the name and address of the person to be treated,

  • (c)

    if the drug 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 drug may be supplied on the prescription,

  • (e)

    the intervals at which the substance may be supplied on the prescription,

  • (f)

    the directions for use, as shown on the prescription.

(2)

The record must be kept at the surgery, hospital or office of the person prescribing the substance.

Maximum penalty: 20 penalty units.

82Exceptions to section 28: prescriptions generally(cf cl 86 of PTG Reg 1994)(1)

A medical practitioner or nurse practitioner is authorised to issue a prescription for a drug of addiction for a person without an authority under section 29 of the Act if:

  • (a)

    the medical practitioner or nurse practitioner is of the opinion that the person requires the use of the drug in the course of treatment as an in-patient in a public or private hospital, and

  • (b)

    the prescription is for a course of treatment for a period of not more than 14 days following the person’s admission as an in-patient.

(2), (3)

(Repealed)

(4)

A medical practitioner or nurse practitioner is authorised to prescribe methadone or buprenorphine for the treatment of a person without an authority under section 29 of the Act if:

  • (a)

    in the case of a medical practitioner, the medical practitioner is approved as a prescriber of drugs of addiction under section 28A of the Act and, in the case of a nurse practitioner, the nurse practitioner is authorised by the Director-General for the purposes of this clause, and

  • (b)

    at the time the prescription is issued the person is, or at some time during the preceding 21 days was, an inmate in a correctional centre (within the meaning of the Crimes (Administration of Sentences) Act 1999), and

  • (c)

    the prescription is for methadone or buprenorphine in oral dosage form for use by the person as a course of treatment:

    • (i)

      while an inmate, or

    • (ii)

      during a period of not more than 21 days after release, and

  • (d)

    immediately before the person became an inmate, a medical practitioner or nurse practitioner had an authority under section 29 of the Act to prescribe methadone or buprenorphine for the person, or supply methadone or buprenorphine to the person, and

  • (e)

    the prescription is issued for the purpose of continuing the treatment that the person was receiving or was about to receive immediately before the person became an inmate.

(5)

A medical practitioner or nurse practitioner is authorised to issue a prescription for a drug of addiction for a person without an authority under section 29 of the Act if:

  • (a)

    the person is the subject of such an authority, and

  • (b)

    the medical practitioner or nurse practitioner is practising at the same premises that the holder of the authority was practising at when the authority was issued, and

  • (c)

    the prescription is issued in accordance with any conditions to which that authority is subject.

83Exceptions to section 28: prescriptions for amphetamines(cf cl 85 of PTG Reg 1994)(1)

This clause applies to the following substances:

  • amphetamine

  • dexamphetamine

  • methylamphetamine

  • methylphenidate

  • phendimetrazine

  • phenmetrazine

(2)

A medical practitioner is authorised to issue a prescription for dexamphetamine or methylphenidate for a person without an authority under section 29 of the Act:

  • (a)

    for the purpose of testing the suitability of the person to undergo a course of medical treatment involving the use of such a substance, or

  • (b)

    for the purpose of treating the person for attention deficit disorder (ADD) or attention deficit hyperactivity disorder (ADHD),

so long as the medical practitioner holds an authority under Part 8 to prescribe such a substance.

(3)

A nurse practitioner, midwife practitioner, dentist or veterinary practitioner must not issue a prescription for a substance to which this clause applies.

Maximum penalty: 20 penalty units.

Division 4SupplySubdivision 1Supply on prescription84Pharmacists may supply drugs of addiction on prescription(cf cl 87 of PTG Reg 1994)

A pharmacist may supply a drug of addiction on prescription.

Maximum penalty: 20 penalty units.

85Prescriptions may be filled only if in proper form(cf cl 88 of P&G Reg 1994)(1)

A pharmacist must not supply a drug of addiction on prescription unless the prescription is in the form required by Division 3.

(2)

This clause does not prevent a pharmacist from supplying a drug of addiction on prescription merely because the prescription fails to specify the maximum number of times, or the intervals at which, the drug may be supplied.

(3)

A pharmacist must not supply a drug of addiction more than once on a prescription referred to in subclause (2), regardless of how many times the prescription purports to authorise the supply of the drug.

Maximum penalty: 20 penalty units.

86Certain prescriptions not to be filled(cf cl 89 of P&G Reg 1994)(1)

A pharmacist must not supply a drug of addiction on prescription:

  • (a)

    if the prescription is marked “CANCELLED”, or

  • (b)

    if the drug 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 drug 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 drug, or

  • (d)

    if the prescription is illegible or defaced, or

  • (e)

    if the prescription is dated more than 6 months before the date on which the supply is being requested, or

  • (f)

    if the prescription appears to have been forged or fraudulently obtained, or

  • (g)

    if the prescription appears to have been altered otherwise than by the medical practitioner, nurse practitioner, midwife practitioner, dentist or veterinary practitioner by whom it was issued, or

  • (h)

    if notice of an order prohibiting the person by whom the prescription was issued from issuing such a prescription has been published in the Gazette, unless the prescription contains a direction for the supply of the drug more than once and it appears that the drug has been supplied on the basis of the prescription at least once before the notice was published.

(2)

Immediately on being requested to supply a drug of addiction in any of the circumstances referred to in subclause (1) (f), (g) or (h), a pharmacist must retain the prescription and cause notice of the request to be given to a police officer.

Maximum penalty: 15 penalty units.

(3)

A pharmacist must not supply a drug of addiction on a prescription that includes:

  • (a)

    more than one preparation containing a drug of addiction, or

  • (b)

    both a preparation containing a drug of addiction and another preparation.

Maximum penalty: 20 penalty units.

87Prescriptions require verification(cf cl 90 of PTG Reg 1994)(1)

A pharmacist must not supply a drug of addiction on prescription unless he or she:

  • (a)

    is familiar with the handwriting of the person who issued the prescription, or

  • (b)

    knows the person for whom the drug is prescribed, or

  • (c)

    has verified that the person who is purported to have issued the prescription has actually issued the prescription.

(2)

This clause does not prevent a pharmacist who is otherwise authorised to supply drugs of addiction from supplying a drug of addiction on prescription in a quantity sufficient for no more than 2 days’ treatment.

(2)

A licence to manufacture drugs of addiction authorises the manufacturer to supply drugs that are manufactured under the licence, subject to the conditions of the licence.

(3)

A licence remains in force until suspended, cancelled or surrendered.

(4)

A licence is not transferable.

164Conditions of licences(cf cl 145 of P&G Reg 1994)(1)

A licence is subject to such conditions as the Director-General may endorse on the licence and to such further conditions as the Director-General may from time to time impose by order in writing served on the holder of the licence.

(2)

The Director-General may from time to time vary or revoke any condition of a licence by means of a further order in writing served on the holder of the licence.

(3)

A licence is ineffective unless its conditions are complied with.

165Annual licence fees(cf cl 146 of P&G Reg 1994)(1)

The holder of a licence to manufacture drugs of addiction must, on or before 30 September in each year following that in which the licence was issued, pay to the Director-General an annual licence fee of:

  • (a)

    $55, if the holder is a public institution, or

  • (b)

    $510, in any other case.

(2)

The holder of a licence to supply drugs of addiction must, on or before 30 September in each year following that in which the licence was issued, pay to the Director-General an annual licence fee of:

  • (a)

    $15, if the holder is a charitable organisation, or

  • (b)

    $55, if the holder is a public institution (other than a charitable organisation), or

  • (c)

    $255, in any other case.

Division 4Authorities166Authorities(cf cl 147 of PTG Reg 1994)(1)

The Director-General may issue authorities for the purposes of the Act and this Regulation.

(2)

The Director-General may require a person seeking an authority to furnish such information as is necessary to enable the Director-General to determine the issuing of the authority.

(3)

An authority may be issued to a particular person (by means of an instrument in writing given to the person) or to a specified class of persons (by means of an instrument published in a manner approved by the Director-General).

(4)

In particular, the Director-General may refuse to issue an authority to a person if of the opinion that the person is not a fit and proper person to hold the authority.

(5)

An authority that is issued to a particular person remains in force until it is suspended, cancelled or surrendered.

(6)

An authority that is issued to a particular person is not transferable.

(7)

In this Regulation, a reference to a person who holds an authority under this Part includes a reference to a person who belongs to a class of persons specified in an instrument referred to in subclause (3).

167Conditions of authorities(cf cl 148 of P&G Reg 1994)(1)

The exercise of the functions conferred on a person by an authority is subject to such conditions as the Director-General may specify in the instrument by which the authority is issued and to such further conditions as the Director-General may from time to time impose by order in writing served on that person.

(2)

The Director-General may from time to time vary or revoke any condition of an authority by means of a further order in writing served on the holder of the authority.

(3)

An authority is ineffective unless its conditions are complied with.

Division 5Suspension and cancellation of licences and authorities168Grounds for suspension or cancellation(cf cl 149 of P&G Reg 1994)(1)

The Director-General must suspend or cancel a licence or authority in the event of one or more of the following:

  • (a)

    the holder of the licence or authority requests or agrees in writing to the suspension or cancellation of the licence or authority,

  • (b)

    the holder of the licence or authority is convicted of a serious offence against the Drug Misuse and Trafficking Act 1985 or any regulation in force under that Act,

  • (c)

    the Director-General forms the opinion that the holder of the licence or authority is no longer a fit and proper person to hold the licence or authority,

  • (d)

    in the case of a licence or authority to supply methadone or buprenorphine, the Director-General forms the opinion that the supply of methadone or buprenorphine has a significant adverse effect on the amenity of the area in which the premises from which it is being supplied are situated.

(2)

The Director-General may, at the Director-General’s discretion, suspend or cancel a licence or authority on any one or more of the following grounds:

  • (a)

    the holder of the licence or authority contravenes any condition of the licence or authority,

  • (b)

    the holder of the licence or authority is convicted of an offence against the Act or this Regulation, or of an offence (not being a serious offence) against the Drug Misuse and Trafficking Act 1985 or any regulation in force under that Act,

  • (c)

    an order is made under section 10 (1) of the Crimes (Sentencing Procedure) Act 1999 relating to the holder of the licence or authority in respect of an offence against the Act or this Regulation, or an offence against the Drug Misuse and Trafficking Act 1985 or any regulation in force under that Act,

  • (d)

    the annual fee for the licence is not duly paid.

(3)

In this clause, serious offence means an offence that is punishable by imprisonment for life or for a term of 5 years or more.

169Suspension or cancellation(cf cl 150 of P&G Reg 1994)(1)

Before suspending or cancelling a licence or authority (otherwise than at the request of its holder), the Director-General:

  • (a)

    must cause written notice of the proposed suspension or cancellation, and of the grounds for the proposed suspension or cancellation, to be served on the holder of the licence or authority, and

  • (b)

    must give the holder of the licence or authority a reasonable opportunity to make representations with respect to the proposed suspension or cancellation, and

  • (c)

    must take any such representations into consideration.

(2)

Suspension or cancellation of a licence or authority takes effect on the date on which written notice of the suspension or cancellation is served on its holder or on such later date as is specified in the notice.

(3)

The Director-General may, by a further notice in writing served on the holder of a licence or authority that is suspended, revoke the suspension or vary the period of the suspension.

Division 6Modification of applied provisions of Commonwealth therapeutic goods laws170Modification of applied provisions of Commonwealth therapeutic goods laws with respect to advertising: section 31 (3)(cf cl 150B of P&G Reg 1994)(1)

This clause applies to circumstances to which the Therapeutic Goods Act 1989 of the Commonwealth applies by reason of section 31 of the Poisons and Therapeutic Goods Act 1966.

(2)

Part 2 of the Therapeutic Goods Regulations of the Commonwealth is modified in its application to circumstances to which this clause applies to the extent that the Director-General may, by order in writing, exempt any person or substance, or any class of persons or substances, from the requirements of that Part.

(3)

Such an exemption may be given unconditionally or subject to conditions.

Part 9Miscellaneous171Director-General may restrict authorisations conferred by this Regulation(cf cl 151 of P&G Reg 1994)(1)

The Director-General may, by order in writing served on any person, prohibit or restrict the person from doing anything authorised by this Regulation.

(2)

Such an order may be made on any one or more of the following grounds:

  • (a)

    the person requests or agrees in writing to the making of the order,

  • (b)

    the person is convicted of an offence against the Act or this Regulation, or of an offence against the Drug Misuse and Trafficking Act 1985 or any regulation in force under that Act, or an order is made against the person under section 10 (1) of the Crimes (Sentencing Procedure) Act 1999 in respect of such an offence,

  • (c)

    the person has, in the opinion of the Director-General, failed to comply with any restriction imposed on the person by an order under this clause,

  • (d)

    the person is, in the opinion of the Director-General, a person whose authorisation to do that thing should be withdrawn for the purpose of protecting the life, or the physical or mental health, of that or any other person (whether or not any other such person is identifiable).

(3)

An order that restricts a person as referred to in subclause (1):

  • (a)

    may be made unconditionally or subject to conditions, and

  • (b)

    may apply generally or be limited in its application by reference to specified exceptions or factors, and

  • (c)

    may apply differently according to different factors of a specified kind.

(4)

An order under this clause must specify the grounds on which it is made including, if it is made on the grounds referred to in subclause (2) (c), the reasons for its withdrawal on those grounds.

(5)

An order under this clause takes effect:

  • (a)

    in the case of an order made on the grounds referred to in subclause (2) (d), when the order is served on the person against whom it is made, or

  • (b)

    in any other case, the date specified in the order in that regard.

(6)

Except in the case of an order that is made on the ground referred to in subclause (2) (a), the date referred to in subclause (5) (b) must be a date occurring not less than 14 days after the date on which the order is served on the person against whom it is made.

(7)

On making an order that prohibits a person from doing all of the things authorised by Part 2, 3, 4 or 5 of this Regulation, or by any two or more of those Parts, the Director-General is to cause notice of:

  • (a)

    the name of the person, and

  • (b)

    the terms of the order, and

  • (c)

    the date on which the order took effect,

to be published in the Gazette.

(8)

A person must not contravene any order in force under this clause.

172Records generally(cf cl 153 of P&G Reg 1994)(1)

Except to the extent to which this Regulation otherwise provides, all documents required to be kept under this Regulation:

  • (a)

    must be kept in the form of legible instruments written indelibly in English, or

  • (b)

    must be kept in some other manner from which a legible instrument written indelibly in English is readily reproducible.

(2)

A record required to be made of the manufacture, receipt, supply, administration or use of any substance at or from any premises must be kept at those premises.

(3)

A person who is required by this Regulation to keep any document or make any record must keep it for at least 2 years, running from the latest date on which:

  • (a)

    any entry was made in the document or record, or

  • (b)

    any substance was manufactured, received, supplied, administered or used in accordance with, or on the authority of, the document or record,

and must make it available for inspection on demand by a police officer or an inspector.

Maximum penalty: 20 penalty units.

173False or misleading entries in records and registers(cf cl 154 of P&G Reg 1994)(1)

A person who is required by this Regulation to keep any record or register must not make any entry in the record or register that the person knows to be false or misleading in a material particular.

(2)

A person must not make any alterations, obliterations or cancellations in a register required by this Regulation, but may correct any mistake in any entry by making a marginal note or footnote and by initialling and dating it.

Maximum penalty: 20 penalty units.

174False or misleading applications(cf cl 155 of P&G Reg 1994)

A person must not, in or in connection with an application under this Regulation, make any statement that the person knows to be false or misleading in a material particular.

Maximum penalty: 20 penalty units.

175Service of notices(cf cl 156 of P&G Reg 1994)

A notice referred to in this Regulation may be served on a person:

  • (a)

    by delivering it to the person personally, or

  • (b)

    by leaving it at the person’s place of residence last known to the Director-General with someone who apparently resides there, or

  • (c)

    by leaving it at the person’s place of business or employment last known to the Director-General with someone who is apparently employed there, or

  • (d)

    by posting it to the person in an envelope addressed to the person at the place of his or her residence, business or employment last known to the Director-General.

176Applications for authorities under section 29(cf cl 157 of P&G Reg 1994)

Before determining an application referred to in section 29 (1) of the Act, the Director-General may require the applicant to furnish such further information as the Director-General may require in relation to the application.

177Quorum for Poisons Advisory Committee(cf cl 158 of P&G Reg 1994)

The quorum for a meeting of the Advisory Committee referred to in clause 2 of Schedule 2 to the Act is 9.

178Residential centres for persons with disabilities

The following institutions are declared to be residential centres for persons with disabilities for the purposes of this Regulation:

  • The Stockton Centre, Stockton

179Saving(cf cl 159 of P&G Reg 1994)

Any act, matter or thing that, immediately before the repeal of the Poisons and Therapeutic Goods Regulation 1994, had effect under that Regulation is taken to have effect under this Regulation.

Appendix ALabelling of therapeutic substances

(Clauses 5, 25, 68 and 142)

Note—

Although this Appendix refers to labels “on” a container, the information required by this Appendix may be shown by tags, brands, marks or statements in writing on the container itself (rather than on something affixed or attached to the container). See the definition of Label in section 4 (1) of the Act.

1General(1)

All details, words and other information that a label on a container of a therapeutic substance must carry must be in the English language (although it may also be in another language).

(2)

All symbols, numbers and words on a label must be in durable characters.

(3)

The label on a container of a therapeutic substance must contain the following details:

  • (a)

    the name and address of the dealer supplying the substance,

  • (b)

    the substance’s approved name,

  • (b1)

    the substance’s proprietary name (unless the substance is a preparation compounded in accordance with the dealer’s own formula),

  • (c)

    adequate directions for use,

  • (d)

    the words “KEEP OUT OF REACH OF CHILDREN” in red on a white background,

  • (e)

    if the substance is intended for external use only, the word “POISON”, or the words “FOR EXTERNAL USE ONLY”, in red on a white background,

  • (f)

    if the substance is intended for the treatment of a person, the name of the person,

  • (g)

    if the substance is intended for the treatment of an animal, the species of animal and the name of the animal’s owner,

  • (h)

    if the substance is supplied in the circumstances referred to in clause 44 or 47, the words “EMERGENCY SUPPLY”.

2Additional labelling requirements for certain substances(1)

The label on a container of a therapeutic substance that is supplied on prescription must also bear:

  • (a)

    the prescription reference number, and

  • (b)

    the date on which the prescription was supplied (unless that date is clear from the prescription reference number), and

  • (c)

    the directions for use set out in the prescription.

(2)

The label on a container of a restricted substance that is supplied in the circumstances referred to in clause 44 or 47 must also bear:

  • (a)

    the unique reference number recorded under clause 56 with respect to the supply, and

  • (b)

    the date on which the substance was supplied, and

  • (c)

    the directions given by the pharmacist for the use of the substance.

3Warning: therapeutic substances for internal use

The label on a container of a therapeutic substance specified in Appendix F to the current Poisons Standard (being a therapeutic substance that is intended for internal use) must bear the warning specified in that Appendix in respect of that substance.

The label on a container of a therapeutic substance specified in Appendix K to the current Poisons Standard (being a therapeutic substance that is supplied on prescription and is intended for internal use in humans) must bear Warning Statement 39, 40 or 90 specified in Part 1 of Appendix F to that Standard. The warning must be immediately preceded by a symbol in the form of an open equilateral triangle at least 4.5 millimetres high in bold print, coloured red.

4Warning: quinine

The label on a container of quinine must bear the words “WARNING—MAY BE FATAL TO CHILDREN”.

5Warning: other substances(1)

This clause applies to the following substances:

  • amphetamine

  • chlorphentermine

  • dexamphetamine

  • diethylpropion

  • ephedrine

  • methylphenidate

  • phentermine

  • propylhexedrine

(2)

The label on a container of such a substance (being a substance that is represented as being for oral use by a person other than a child under 16) must bear the words “THIS MEDICATION (MEDICINE) MAY AFFECT MENTAL ALERTNESS OR CO-ORDINATION OR BOTH. IF AFFECTED, DO NOT DRIVE A MOTOR VEHICLE OR OPERATE MACHINERY”.

(3)

The warning must be immediately preceded by a symbol in the form of an open equilateral triangle at least 4.5 millimetres high in bold print, coloured red.

Appendix BSpecial restricted substances

(Clauses 3, 34, 37, 38, 40, 41, 89)

Amylobarbitone when included in Schedule 4 of the Poisons List

Anabolic and androgenic steroidal agents included in Schedule 4 of the Poisons List, except when referred to elsewhere in this Appendix

Drostanolone

Ethyloestrenol

Fluoxymesterone

Mesterolone

Methandienone

Methandriol

Methenolone

Methylandrostanolone

Methyltestosterone

Mibolerone

Nandrolone

Norethandrolone

Oxandrolone

Oxymesterone

Oxymetholone in preparations for therapeutic use

Pentobarbitone when included in Schedule 4 of the Poisons List

Stanolone

Stanozolol

Testosterone except when included in Schedule 6 of the Poisons List

Appendix CSupply by wholesale

(Clause 126)

1Medical superintendents of hospitals

The medical superintendent of a hospital is authorised to be in possession of any Schedule 2, 3 or 4 substance.

2Persons licensed to manufacture or supply drugs of addiction

The holder of a licence under Part 8 to manufacture or supply drugs of addiction is authorised to be in possession of any Schedule 2, 3 or 4 substance.

3Scientifically qualified persons

A scientifically qualified person in charge of a laboratory or department is authorised to be in possession of any Schedule 2, 3 or 4 substance for use in the conduct of medical or scientific research or instruction or the conduct of quality control or analysis.

4Masters of ships

The master of a ship is authorised to be in possession of any Schedule 2, 3 or 4 substance that is required by law to be carried on the ship.

5Miscellaneous trades and industries

A person who is engaged in any of the following activities is authorised to be in possession of any Schedule 2 or 3 substance 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.

6Optometrists

An optometrist is authorised to be in possession of any Schedule 2, 3 or 4 substance prescribed under the Optometrists Act 2002 for the purposes of section 21 (5) of that Act.

7Podiatrists

A registered podiatrist (within the meaning of the Podiatrists Act 1989) is authorised to be in possession of synthetic cocaine substitutes (prepared for parenteral use) for use in connection with podiatry.

8Dental therapists or oral health therapists(1)

A dental therapist or oral health therapist is authorised to be in possession of the following substances 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)

(2)

In this clause:

dental therapist means a person who is registered under the Dental Practice Act 2001 as a dental auxiliary in the class of dental therapist.

oral health therapist means a person who is registered under the Dental Practice Act 2001 as a dental auxiliary in the class of oral health therapist.

8ADental hygienists(1)

A dental hygienist is authorised to be in possession of the following substances for use in connection with an activity prescribed in clause 6 of the Dental Practice Regulation 2004:

  • benzocaine

  • lignocaine

  • mepivacaine

  • prilocaine

  • procaine

(2)

In this clause:

dental hygienist means a person who is registered under the Dental Practice Act 2001 as a dental auxiliary in the class of dental hygienist.

9Emergency medical treatment by ambulance officers

A person:

  • (a)

    who is employed by the Ambulance Service of New South Wales as an ambulance officer or as an air ambulance flight nurse, and

  • (b)

    who is approved for the time being by the Ambulance Service of New South Wales for the purposes of this clause,

is authorised to be in possession of such Schedule 2, 3 or 4 substances as are approved by the Ambulance Service of New South Wales for use by such persons in the carrying out of emergency medical treatment.

10Emergency medical treatment of divers

A person:

  • (a)

    who is a dive medical technician within the Police Service, 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 be in possession of any substance referred to in the Table to this clause so long as 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)

11Industrial first aid

A person who is in control of an industrial first aid post is authorised to be in possession of any Schedule 2 substance in connection with the carrying out of industrial first aid.

12Registered nurses involved in vaccination programs

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 be in possession of vaccines for use in humans.

13Ski rescue

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 be in possession of methoxyflurane, nitrous oxide and trichloroethylene for use in connection with the carrying out of ski rescues.

14Bee keeping

A person:

  • (a)

    who is registered as a beekeeper under the Apiaries Act 1985, and

  • (b)

    who holds a written authority (issued by the Director-General of the Department of Agriculture) recommending the use, by that person, of that substance for that purpose,

is authorised to be in possession of oxytetracycline in the form of a stock medicine registered under the Stock Medicines Act 1989 for use in the treatment or prevention of European Foulbrood disease in bees.

15Animal feedstuff production(1)

A person who is authorised under this Regulation to obtain a Schedule 2, 3 or 4 substance is authorised to be in possession of the substance for use in connection with the commercial production of animal feedstuffs or feedstuff premixes.

(2)

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 6 to the Poisons List applies to the substance, or

  • (b)

    that the substance is not a poison.

16First aid in mines

A person is authorised to be in possession of nitrous oxide for use in connection with the carrying out of first aid at a mine if:

  • (a)

    in the case of a coal or shale mine, the person is appointed in accordance with the regulations under the Coal Mines Regulation Act 1982 to be in charge of a first aid room at the mine or as a first aid attendant at the mine, or

  • (b)

    in the case of any other mine, the person is employed in accordance with the rules under the Mines Inspection Act 1901 to provide first aid treatment at the mine.

17General first aid

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 be in possession of methoxyflurane and nitrous oxide in connection with the carrying out of first aid.

18Asthma first aid

A person who holds a current emergency asthma management certificate issued by an organisation approved by the Director-General for the purposes of clause 17 (3) of this Regulation is authorised to be in possession of salbutamol or terbutaline in metered aerosols in connection with the carrying out of first aid.

19Anaphylaxis first aid

A person is authorised to be in possession of adrenaline in connection with the carrying out of anaphylaxis first aid 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 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 Director-General for the purposes of clause 17 (5) (b).

Appendix DPrescribed restricted substances

(Clause 60)

Substance

Prescribed quantity

Alprazolam

0.25 gram

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

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

Clobazam

2.5 grams

Clonazepam

0.5 gram

Clorazepate

3.0 grams

Clostebol

2.0 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

Ephedrine

5.0 grams

Ethchlorvynol

50.0 grams

Ethinamate

50.0 grams

Ethyldienolone

5.0 grams

Ethyloestrenol

1.0 gram

Fencamfamin

1.0 gram

Fenproporex

1.0 gram

Fluoxymesterone

2.0 grams

Flurazepam

10.0 grams

Formebolone

1.0 gram

Formyldienolone

1.0 gram

Furazabol

0.5 gram

Glutethimide

50.0 grams

Hydroxystenozol

5.0 grams

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

Phenobarbitone

50.0 grams

Phentermine

10.0 grams

Pipradrol except in compounded preparations containing 0.01 per cent or less of pipradrol

1.0 gram

Prasterone

1.0 gram

Prazepam

2.5 grams

Propylhexedrine

5.0 grams

Pseudoephedrine when included in Schedule 4 of the Poisons List

20.0 grams

Pyrovalerone

1.0 gram

Quinbolone

3.0 grams

Silandrone

5.0 grams

Stanolone

10.0 grams

Stanozolol

2.0 grams

Stenbolone

5.0 grams

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

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

Actions
Download as PDF Download as Word Document


Cases Citing This Decision

0

Cases Cited

0

Statutory Material Cited

0