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Contents (2008 - 392)
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Poisons and Therapeutic Goods Regulation 2008
Current version for 1 July 2017 to date (accessed 23 September 2017 at 04:45)
Part 2
Part 2 Poisons (S1, S2, S3, S5, S6, S7)
Division 1 Packaging and labelling
7   Packaging and labelling generally
(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. 80 applies, in accordance with that Order.
(2)  This clause does not apply to the labelling of a substance that is supplied by an authorised practitioner or pharmacist so long as the substance is supplied in a package that is labelled in accordance with the requirements of Appendix A.
(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).
(4)  Despite subclause (1), an authorised practitioner or pharmacist who supplies a poison to a person who, in the opinion of the authorised practitioner or pharmacist, would suffer undue hardship through difficulty in opening a container that is packaged in accordance with Therapeutic Goods Order No. 80, is not required to package the poison in accordance with that Order.
Maximum penalty: 10 penalty units.
8   Misleading labelling of substances as poisons
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.
9   Schedule 3 substances supplied by dealers
(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.
10   Exemptions
(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 a 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 2 Storage
11   Storage generally
A dealer who has possession of any poison must keep the poison:
(a)  apart from food intended for consumption by humans or animals, and
(b)  in such a way that, if its container breaks or leaks, the poison cannot mix with or contaminate any food intended for consumption by humans or animals.
Maximum penalty: 10 penalty units.
12   Schedule 3 or 7 substances
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.
13   Schedule 6 substances
(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.
Maximum penalty: 10 penalty units.
(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 complex welded plastic structure.
(3)  In this clause, child-resistant closure means:
(a)  a child-resistant closure within the meaning of the current Poisons Standard, or
(b)  a closure of a design approved for the time being by the Director-General.
Division 3 Prescriptions
14   Unauthorised persons not to prescribe Schedule 2 or 3 substances
(1)  An authorised practitioner may issue a prescription for a Schedule 2 or 3 substance.
(2)  A person must not issue a prescription for a Schedule 2 or 3 substance unless authorised to do so by this clause.
Maximum penalty: 10 penalty units.
15   Prescription for pseudoephedrine
(1)  A person who issues a prescription for pseudoephedrine must ensure that the prescription complies with Division 3 of Part 3 as if pseudoephedrine were a restricted substance.
Maximum penalty: 10 penalty units.
(2)  Subclause (1) applies to pseudoephedrine only in so far as it is a Schedule 3 substance.
16   Quantity and purpose of prescriptions to be appropriate
An authorised practitioner must not issue a prescription for a Schedule 2 or 3 substance in a quantity, or for a purpose, that does not accord with the recognised therapeutic standard of what is appropriate in the circumstances.
Maximum penalty: 10 penalty units.
Division 4 Supply
17   Schedule 2 and 3 substances may be supplied by authorised persons
A person who is not an authorised practitioner or a pharmacist may supply a Schedule 2 or 3 substance to another person if the supplier holds a licence or authority under Part 8 to supply the substance.
18   Schedule 3 substances to be supplied personally by pharmacists
(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 an authorised practitioner, or
(b)  to any other person on the prescription of an authorised 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 director of nursing of a nursing home of any substance in the manufacturer’s original pack, in accordance with a written order signed by the director of nursing, 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, podiatrist, 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.
19   Prescriptions for Schedule 2 or 3 substances to be endorsed
(1)  A pharmacist who supplies a Schedule 2 or 3 substance on prescription must endorse the prescription for the substance in accordance with clause 41 as if the substance were a restricted substance.
Maximum penalty: 10 penalty units.
(2)  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.
(3)  Such an exemption may be given unconditionally or subject to conditions.
20   Certain Schedule 7 substances to be supplied and used only under an authority
(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.
Maximum penalty: 10 penalty units.
(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.
Maximum penalty: 10 penalty units.
(3)  A person being supplied with a Schedule 7 substance must surrender to the dealer the person’s authority to obtain the substance.
Maximum penalty: 10 penalty units.
(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 170 (4)),
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.
(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
21   “Particular use” poisons may only be supplied in original containers
(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 an authorised practitioner or pharmacist) who supplies a substance to which this clause applies must supply the substance, unopened, in the container in which it was received by the dealer.
Maximum penalty: 10 penalty units.
22   Supply of art materials, toys, furniture and the like containing poisons
(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.
23   Quantity and purpose of supply to be appropriate
An authorised practitioner, pharmacist or retail dealer must not supply any poison:
(a)  in the case of a therapeutic substance, in a quantity, or for a purpose, that does not accord with the recognised therapeutic standard of what is appropriate in the circumstances, or
(b)  in any other case, for a purpose other than that stated on its container or for a purpose other than that for which it is normally used.
Maximum penalty: 20 penalty units or imprisonment for 3 months, or both.
Division 5 Records of supply
24   Supply of certain Schedule 2 or 3 substances to be recorded
(1)  A pharmacist who supplies pseudoephedrine on prescription must record details of the supply in accordance with clause 55 as if pseudoephedrine were a restricted substance.
Maximum penalty: 20 penalty units or imprisonment for 3 months, or both.
(1A)  A pharmacist who supplies pseudoephedrine to a person without a prescription must, at the time of the supply, record the following details in an electronic form approved by the Secretary:
(a)  a unique reference number for the supply,
(b)  the name of the person by whom the pseudoephedrine is supplied,
(c)  the name and address of the person to whom the pseudoephedrine is supplied,
(d)  the name, strength (if not readily apparent) and quantity of the pseudoephedrine supplied and the date on which it is supplied,
(e)  if the pharmacist does not know the identity of the person to whom the pseudoephedrine is supplied, the unique reference number of a photo identification of the person and the type of that identification.
Maximum penalty: 20 penalty units or imprisonment for 3 months, or both.
(2)  Subclauses (1) and (1A) apply to pseudoephedrine only in so far as it is a Schedule 3 substance.
(2A)  The operator of a residential care facility in which medication charts are used must ensure that an employee of the facility makes a record in the medication chart of a resident of the facility of the administration of any Schedule 2 or 3 substance to the resident.
Maximum penalty: 10 penalty units.
(3)  The Secretary may, by order in writing, exempt any person or any class of persons from the requirements of this clause.
(4)  Such an exemption may be given unconditionally or subject to conditions.
(5)  In this clause:
photo identification means any of the following types of identification held by the person being supplied:
(a)  an Australian driver licence that displays a photograph of the person, or
(b)  a passport, or
(c)  a NSW Photo Card issued under the Photo Card Act 2005, or
(d)  a card issued under a law of the Commonwealth or another State or Territory for the purpose of proving the person’s age which contains a photograph of the person in whose name the card is issued.
Secretary means the Secretary of the Ministry of Health.
Division 6 Miscellaneous
25   Poisons to be used or disposed of safely
A person must not use or dispose of a poison in any place or in any manner likely to constitute a risk to the public.
Maximum penalty: 20 penalty units or imprisonment for 3 months, or both.