Poisons and Therapeutic Goods Regulation 2008

Part 1 Preliminary

1 Name of Regulation

This Regulation is the Poisons and Therapeutic Goods Regulation 2008.

2 Commencement

This Regulation commences on 1 September 2008.

Note—

This Regulation replaces the Poisons and Therapeutic Goods Regulation 2002 which is repealed on 1 September 2008 by section 10(2) of the Subordinate Legislation Act 1989.

3 Definitions

(1)  In this Regulation—

Ambulance Service of NSW has the same meaning as it has in the Health Services Act 1997.

authorised practitioner means—

(a)  in Part 4 (Drugs of addiction), a medical practitioner, nurse or midwife authorised under section 17A of the Act, dentist or veterinary practitioner, and

(b)  in a Part other than Part 4, a medical practitioner, nurse or midwife authorised under section 17A of the Act, podiatrist, dentist, optometrist or veterinary practitioner.

charitable organisation means an organisation or association that holds an authority under 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 (section 48 excepted) does not apply.

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

confer a function includes impose a duty.

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

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

director of nursing means, in relation to a residential care facility, a registered nurse who is responsible for the care of the residents of the residential care facility.

exercise a function includes perform a duty.

function includes a power, authority and duty.

hospital means a public hospital, public institution, private health facility or nursing home.

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

medication chart means a document, in a form that complies with the National Health (Residential Medication Chart) Determination 2012 of the Commonwealth, that contains detailed information about an individual patient and the medication orders, administration record and other health care information related to that patient’s care.

medication chart prescription means a prescription included in a medication chart kept at a residential care facility in relation to a resident of that facility.

nabiximols means a botanical extract of Cannabis sativa in a buccal spray for human therapeutic use—

(a)  that includes the following cannabinoids—

(i)  tetrahydrocannabinol,

(ii)  cannabidiol,

(iii)  cannabinol,

(iv)  cannabigerol,

(v)  cannabichromene,

(vi)  cannabidiolic acid,

(vii)  tetrahydrocannabinolic acid,

(viii)  tetrahydrocannabivarol,

(ix)  cannabidivarol, and

(b)  in which tetrahydrocannabinol and cannabidiol (in approximately equal proportions) comprise not less than 90 per cent of the total cannabinoid content.

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—see clause 61.

prescription reference number means the unique reference number for the prescription recorded under clause 55 or 114.

private health facility means a private health facility licensed under the Private Health Facilities Act 2007.

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

residential care facility means a residential facility at which a person is provided with residential care, within the meaning of the Aged Care Act 1997 of the Commonwealth, and includes a nursing home.

residential care facility manager means the person (not being the director of nursing) employed at the residential care facility who is responsible for the management of that facility.

responsible person, in relation to a residential care facility, means—

(a)  the director of nursing of the residential care facility, or

(b)  in the case of a residential care facility for which there is no director of nursing—the residential care facility manager.

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 an authorised practitioner or pharmacist in his or her capacity as a supplier of the substance.

retail pharmacist means a pharmacist who is employed in a retail pharmacy.

retail pharmacy means premises included in the Register of Pharmacies kept under Schedule 5F of the Health Practitioner Regulation National Law (NSW).

scientifically qualified person means—

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

(b)  a person who holds a degree or diploma approved for the time being by the 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.

special restricted substance means a substance included in Appendix B to this Regulation.

the Act means the Poisons and Therapeutic Goods Act 1966.

Therapeutic Goods Order No. 80 means the order of that number called Child-Resistant Packaging Requirements for Medicines, as in force from time to time under section 10 of the Therapeutic Goods Act 1989 of the Commonwealth.

therapeutic substances means substances that are therapeutic goods.

type A drug of addiction means a drug of addiction prescribed by clause 122.

type C drug of addiction has the meaning given by section 28(6) of the Act.

type C unregistered drug of addiction means an unregistered drug of addiction other than an unregistered drug of addiction that is a type A drug of addiction.

unregistered drug of addiction means any therapeutic good that consists of a Schedule 8 substance and that is not—

(a)  a registered good, or

(b)  a substance or good that has been excluded from this definition by an order made by the Secretary and published in the Gazette.

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

Note—

The Act and the Interpretation Act 1987 contain definitions and other provisions that affect the interpretation and application of this Regulation.

(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, 8 or 9 substance is a reference to a substance included in the correspondingly numbered Schedule of the Poisons List.

(3)  Notes included in this Regulation do not form part of this Regulation.

cl 3: Am 2010 No 34, Sch 2.38 [1] [2]; 2011 (480), Sch 1 [1]–[3]; 2014 (82), Sch 1 [1] [2]; 2015 (138), Sch 1 [1]; 2016 (409), Sch 1 [1] [2]; 2018 (655), Sch 1 [1]; 2018 (703), Sch 1 [1]; 2019 (477), Sch 1 [1].

4–6 (Repealed)

cll 4–6: Rep 2010 No 34, Sch 2.38 [3].

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.

cl 7: Am 2011 (480), Sch 1 [4] [5].

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 responsible person for a residential care facility of any substance that is—

(a)  in the manufacturer’s original pack, and

(b)  approved by the Secretary for urgent use in a residential care facility, and

(c)  supplied in accordance with—

(i)  any conditions of the approval, and

(ii)  a written order signed by the responsible person.

(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.

cl 18: Am 2011 (480), Sch 1 [6]; 2018 (703), Sch 1 [2].

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

cl 20: Am 2016 (409), Sch 1 [3].

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.

cl 24: Am 2015 (138), Sch 1 [2]; 2015 (814), Sch 1 [1]–[4].

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.

Part 3 Restricted substances (S4)

Division 1 Packaging and labelling

26 Packaging and labelling generally

(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. 80 applies, in accordance with that Order.

(2)  Despite subclause (1), an authorised practitioner who supplies a restricted substance must ensure that the substance is packaged in accordance with the requirements of subclause (1) but labelled in accordance with the requirements of Appendix A.

(3)  Despite subclause (1), a pharmacist who supplies a restricted substance on prescription, or as referred to in clause 45, or who supplies the restricted substance benzylpenicillin as referred to in clause 48, must ensure that the substance is packaged and labelled in accordance with the requirements of Appendix A.

(4)  Despite subclause (1), an authorised practitioner or pharmacist who supplies a restricted substance to a person who, in the opinion of the authorised practitioner or pharmacist, would suffer undue hardship through difficulty in opening a container that is packaged in accordance with Therapeutic Goods Order No. 80, is not required to package the substance in accordance with that Order.

Maximum penalty—10 penalty units.

cl 26: Am 2011 (480), Sch 1 [4] [7].

27 Misleading labelling of substances as restricted substances

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.

28 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

29 Storage generally

A dealer who has possession of any restricted substance must keep the substance—

(a)  in a room or enclosure to which the public does not have access, and

(b)  apart from food intended for consumption by humans or animals, and

(c)  in such a way that, if its container breaks or leaks, the substance cannot mix with or contaminate any food intended for consumption by humans or animals.

Maximum penalty—15 penalty units.

30 Storage of prescribed restricted substances in hospital wards

(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.

31 Responsibility for storage in hospitals

(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 director of nursing 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 3 Prescriptions

32 Prescriptions for restricted substances

(1)  A medical practitioner, dentist or veterinary practitioner may issue a prescription for a restricted substance.

(2)  A person must not issue a prescription for a restricted substance unless authorised to do so by or under the Act (including by an authority under Part 8).

Maximum penalty—15 penalty units.

cl 32: Am 2010 No 34, Sch 2.38 [4].

33 Prescriptions may be issued only for certain purposes

(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.

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

(4)  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”.

(5)  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”.

(6)  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”.

(7)  A podiatrist must not issue a prescription for a restricted substance otherwise than in the course of practising as a podiatrist, and must endorse any such prescription with the words “FOR PODIATRY TREATMENT ONLY”.

Maximum penalty—15 penalty units.

cl 33: Am 2011 (480), Sch 1 [8].

34 Quantity and purpose of prescriptions to be appropriate

An authorised practitioner must not issue a prescription for a restricted substance in a quantity, or for a purpose, that does not accord with the recognised therapeutic standard of what is appropriate in the circumstances.

Maximum penalty—20 penalty units or imprisonment for 6 months, or both.

34A Medication chart prescriptions

(1)  The authority of a pharmacist to supply a restricted substance on prescription (other than for a special restricted substance or a substance listed in clause 37) extends, in the case of a medication chart prescription, to supply on a duplicate copy of the medication chart prescription.

(2)  Accordingly, a reference in this Regulation to a prescription (in the context of the supply on prescription of a restricted substance by a pharmacist) is a reference, in the case of supply on a medication chart prescription, to a duplicate copy of the prescription.

cl 34A: Ins 2015 (138), Sch 1 [3].

35 Form of prescription

(1)  A prescription for a restricted substance must include the following details—

(a)  the date on which it is issued,

(b)  if the treatment is for—

(i)  a patient—the name and address of the patient, or

(ii)  an animal—the species of animal and the name and address of the animal’s owner, or

(iii)  a patient’s partner and the prescription is for azithromycin for the treatment of chlamydia—the name and email address or mobile phone number of the partner,

(c)  the name, strength (if not readily apparent) and quantity of the substance to be supplied,

(c1)  the route of administration (if not readily apparent) of the substance to be supplied,

(d)  adequate directions for use,

(e)  the maximum number of times the substance may be supplied on the prescription,

(f)  in the case of a prescription for a special restricted substance, the intervals at which the substance may be supplied on the prescription,

(g)  if the prescription is issued at a hospital, the name and designation of the person by whom it is issued and the name, address and telephone number of the hospital,

(h)  if the prescription is issued elsewhere than at a hospital, the name and designation of the person by whom it is issued and the address and telephone number of the premises at which it is issued.

(1A)  As an alternative to complying with subclause (1), a medication chart prescription authorising the supply of a substance that is not a special restricted substance or a substance listed in clause 37 must include the following details—

(a)  the date on which it is issued,

(b)  the name and address of the patient,

(c)  the name and form (if not readily apparent) of the substance to be supplied,

(d)  the strength (if not readily apparent) of the substance to be supplied,

(e)  the route of administration (if not readily apparent) of the substance to be supplied,

(f)  adequate directions for use,

(g)  the frequency or times at which the substance is to be administered or used,

(h)  the period during which the substance is to be used or administered (being a period that ends on a date that is no more than 4 months from the date of first use of the relevant chart for the resident),

(i)  the name and designation of the person by whom it is issued,

(j)  the name, address and telephone number of the relevant residential care facility.

(2)  The details referred to in subclause (1A)(b) and (j) can be made out by any person.

(2A)  The details referred to in subclause (1) or (1A)(a) or (c)–(i) must be made out—

(a)  in the handwriting of the person by whom the prescription is issued, or

(b)  in such other manner as may be approved for the time being by the Director-General.

(2B)  A prescription must be signed by the person by whom it is issued (whether it complies with subclause (1) or (1A)).

(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.

(7)  In this clause—

partner of a patient includes any of the following—

(a)  the patient’s spouse,

(b)  the patient’s de facto partner,

(c)  a person with whom the patient is or was in a sexual relationship.

(8)    (Repealed)

Maximum penalty—15 penalty units.

cl 35: Am 2015 (138), Sch 1 [4] [5]; 2016 (287), Sch 1 [1] [2]; 2017 (689), cl 3 (1).

36 Emergency prescriptions may be given by telephone or otherwise

(1)  In an emergency, an authorised 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 58.

Maximum penalty—15 penalty units.

37 Authority required to prescribe certain restricted substances

(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 words that clearly indicate that the prescription has been issued under this clause.

Maximum penalty—15 penalty units.

38 Records to be kept of certain prescriptions

(1)  An authorised practitioner who prescribes a prescribed restricted substance must make a record of the following particulars—

(a)  the name, strength and quantity of the substance prescribed and the date on which it was prescribed,

(b)  if the substance is intended for the treatment of a person, the name and address of the person to be treated,

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

(d)  the maximum number of times the substance may be supplied on the prescription,

(e)  in the case of a prescription for a special restricted substance, the intervals at which the substance may be supplied on the prescription,

(f)  the directions for use, as shown on the prescription.

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

Maximum penalty—15 penalty units.

Division 4 Supply

Subdivision 1 Supply on prescription

39 Prescriptions may be filled only if in proper form

(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 a prescription that otherwise complies with clause 35(1) merely because—

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

(b)  in the case of a prescription for a special restricted substance, the prescription fails to specify the intervals at which the substance may be supplied, or

(c)  the address shown on the prescription indicates that it has been issued by a veterinary practitioner from some other State or a Territory.

(2A)  This clause does not prevent a pharmacist from supplying a substance on a medication chart prescription that otherwise complies with clause 35(1A) merely because the prescription fails to specify the maximum number of times that the substance may be supplied.

(3)  A pharmacist must not supply a restricted substance on a prescription referred to in subclause (2)(a) or (b) if it appears to the pharmacist that the substance has previously been supplied on the prescription, regardless of how many times the prescription purports to authorise the supply of the substance.

(4)  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.

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

Maximum penalty—15 penalty units.

cl 39: Am 2011 (480), Sch 1 [9]; 2015 (138), Sch 1 [6] [7].

40 Certain prescriptions not to be filled

(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 authorised practitioner by whom it was issued, or

(g)  if the prescription is dated—

(i)  in the case of a medication chart prescription—more than 4 months before the date on which the supply is requested, or

(ii)  in the case of a prescription, other than a medication chart prescription, for a prescribed restricted substance—more than 6 months before the date on which the supply is requested, or

(iii)  in any other case—more than 12 months before the date on which the supply is requested, or

(h)  in the case of a medication chart prescription—where it appears to the pharmacist that a sufficient quantity of the substance has already been supplied to the resident for the period indicated on the prescription.

(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.

cl 40: Am 2015 (138), Sch 1 [8].

41 Prescriptions to be endorsed

(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.

Maximum penalty—15 penalty units.

(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 a special restricted substance) the intervals at which the substance may be supplied are not clearly specified, or

(c)  if the prescription has reached the last occasion on which it can be supplied according to the maximum number of times specified on it.

Maximum penalty—15 penalty units.

(3)  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.

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

(5)  This clause does not apply to a medication chart prescription.

cl 41: Am 2015 (138), Sch 1 [9].

42 Prescriptions for certain substances to be kept

(1)  A pharmacist who supplies a special restricted substance on prescription must keep the prescription, whether or not the prescription authorises more than one supply of the substance.

Maximum penalty—20 penalty units.

(2)  A pharmacist must keep prescriptions for special restricted substances separate from other prescriptions (other than prescriptions for drugs of addiction).

Maximum penalty—20 penalty units.

(3)  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.

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

Subdivision 2 Supply without prescription

43 Supply by certain health practitioners

(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.

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

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

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

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

(7)  A podiatrist must not supply a restricted substance to any person otherwise than in the course of practising as a podiatrist.

Maximum penalty—15 penalty units.

cl 43: Am 2011 (480), Sch 1 [10].

44 Emergency supply by pharmacists on direction of certain health practitioners

(1)  A pharmacist may supply a person with a restricted substance (including a prescribed restricted substance) in accordance with a direction given under clause 36.

(2)  A prescription that is subsequently sent in confirmation of the direction must be dealt with in accordance with clauses 41 and 42, and details of the supply must be recorded in accordance with clause 55, in the same way as if the restricted substance had been supplied on prescription.

(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.

45 Emergency supply by pharmacists otherwise than on direction of health practitioner

(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 an authorised practitioner.

(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.

45A Supply by pharmacists in accordance with determination under National Health Act 1953 of Commonwealth

(1)  A pharmacist may supply a person with a restricted substance that is covered by the Continued Dispensing Determination under this clause if—

(a)  the supply is made in accordance with conditions that are specified in that determination, and

(b)  the supply is made in accordance with the document entitled Guidelines for the Continued Dispensing of eligible prescribed medicines by pharmacists, issued by the Pharmaceutical Society of Australia and as in force on 1 July 2012, and

(c)  the pharmacist is an approved pharmacist within the meaning of the National Health Act 1953 of the Commonwealth, and

(d)  the person is in immediate need of the substance for continuation of treatment.

(2)  In this clause, Continued Dispensing Determination means the National Health (Continued Dispensing) Determination 2012 of the Commonwealth, as in force on the commencement of the Poisons and Therapeutic Goods Amendment (Continued Dispensing) Regulation 2013.

cl 45A: Ins 2013 (551), cl 3.

46 Supply by pharmacists to health practitioners for emergency use

A pharmacist may supply an authorised practitioner with a restricted substance (including a prescribed restricted substance) for emergency use, but only on a written order signed and dated by the authorised practitioner.

47 Supply by pharmacists to residential care facilities of stock for urgent use

(1)  The responsible person for a residential care facility is authorised to have possession of a restricted substance (including a prescribed restricted substance) that is approved by the Secretary for urgent use in a residential care facility.

(2)  A retail pharmacist is authorised to supply a restricted substance (including a prescribed restricted substance) in the manufacturer’s original pack to the responsible person for a residential care facility, but only if the substance is supplied—

(a)  at the premises of, and in the course of carrying on the business of, the pharmacy, and

(b)  in accordance with a written order signed by the responsible person.

(3)  The responsible person for a residential care facility must not—

(a)  sign an order under this clause for a restricted substance unless the substance is approved by the Secretary for urgent use in that residential care facility, or

(b)  allow any restricted substance in his or her possession to be used otherwise than for administration to a resident of the residential care facility by a registered nurse in accordance with the direction of an authorised practitioner (other than a veterinary practitioner) or by an authorised practitioner (other than a veterinary practitioner).

Maximum penalty—15 penalty units.

(4)  An approval under this clause—

(a)  is to be by order in writing, and

(b)  may apply generally or may be limited to a particular residential care facility or class of residential care facilities, and

(c)  may apply generally or may be limited to a particular substance or class of substance, and

(d)  may be given unconditionally or subject to conditions.

cl 47: Am 2011 (480), Sch 1 [11]. Subst 2018 (703), Sch 1 [3].

48 Supply by pharmacists of benzylpenicillin for use in animals

(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.

48A Supply by pharmacists of certain vaccines

(1A)  This clause applies to the following vaccines—

(a)  influenza vaccine,

(b)  measles-mumps-rubella combination vaccine,

(c)  diphtheria-tetanus-pertussis combination vaccine.

(1)  A pharmacist may supply and administer a vaccine to which this clause applies at a retail pharmacy otherwise than on prescription if—

(a)  the pharmacist has completed a training course conducted by an education provider that is accredited by the Australian Pharmacy Council to provide the course, being a course that complies with any standards for the accreditation of programs to support pharmacist administration of vaccines that are published by the Australian Pharmacy Council from time to time, and

(b)  the pharmacist acts in accordance with any practice standards approved by the Secretary.

(1AA)  However, a pharmacist may not supply or administer a vaccine to which this clause applies to a person who is—

(a)  in relation to the measles-mumps-rubella combination vaccine and the diphtheria-tetanus-pertussis combination vaccine—under 16 years of age, and

(b)  in relation to an influenza vaccine—under 10 years of age.

(2)  A pharmacist who supplies a vaccine to which this clause applies to a person in accordance with this clause must record the following details—

(a)  the person’s name, address, date of birth and contact details,

(b)  the name and contact details of the person’s primary medical practitioner,

(c)  the brand, batch number and expiry date of the vaccine,

(d)  the part of the body to which the vaccine was administered,

(e)  the date on which the vaccine was administered,

(f)  the pharmacist’s name and contact details and his or her certificate of accreditation number,

(g)  the address of the pharmacy at which the vaccination was administered,

(h)  a unique reference number for the supply and administration.

Maximum penalty—15 penalty units.

cl 48A: Ins 2015 (138), Sch 1 [10]. Am 2018 (656), cl 3 (1)–(5); 2020 (79), cl 3(1) (2).

Subdivision 3 Supply in hospitals

49 Supply by pharmacists

A pharmacist employed at a hospital may supply a restricted substance—

(a)  on a prescription issued in accordance with Division 3, or

(b)  on the authorisation (whether in writing, by electronic mail, by facsimile or by any other form of electronic communication approved by the Director-General) of an authorised practitioner (other than a veterinary practitioner), where that authorisation is entered on a patient’s medication chart, or

(c)  on the requisition (whether in writing, by electronic mail, by facsimile or by any other form of electronic communication approved by the Director-General) of an authorised practitioner (other than a veterinary practitioner) or the nurse or midwife in charge of the ward in which the substance is to be used or stored.

50 Supply in original containers

(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 4 Supply generally

51 Research drugs

(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 (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.

52 Authority required to supply certain restricted substances

(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

urofollitropin (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.

53 Restricted substances may be supplied by authorised persons

A person who is not an authorised practitioner may supply a restricted substance to another person if the person by whom the substance is supplied holds an authority under Part 8 to supply the substance.

54 Quantity and purpose of supply to be appropriate

An authorised practitioner or pharmacist must not supply any restricted substance in a quantity, or for a purpose, that does not accord with the recognised therapeutic standard of what is appropriate in the circumstances.

Maximum penalty—20 penalty units or imprisonment for 6 months, or both.

Division 5 Records of supply

55 Supply on prescription to be recorded

(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 35(1) to be included in the prescription,

(b)  a unique reference number for the prescription,

(c)  the date on which the substance was supplied,

(d)  the name of the person by whom the substance was supplied.

Maximum penalty—15 penalty units.

(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.

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

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

55A Records relating to medication chart prescriptions

(1)  A pharmacist who supplies any substance to a person on a medication chart prescription must keep the prescription.

Maximum penalty—15 penalty units.

(2)  A pharmacist who supplies any substance to a person on a medication chart prescription must endorse the following particulars (in ink) on the prescription on each occasion on which the substance is dispensed—

(a)  the date on which the substance was supplied,

(b)  the address of, or number identifying, the pharmacy from which the substance was supplied,

(c)  the prescription reference number,

(d)  the quantity supplied.

Maximum penalty—15 penalty units.

(3)  The operator of a residential care facility in which medication charts are used must ensure that an employee of the facility makes a record in the medication chart of a resident of the facility of the administration of any restricted substance to the resident.

Maximum penalty—15 penalty units.

cl 55A: Ins 2015 (138), Sch 1 [11].

56 Records to be kept of certain supply of restricted substances

(1)  An authorised practitioner who supplies a restricted substance—

(a)  must record the name, strength and quantity of the substance supplied and the date on which it was supplied, and

(b)  must record—

(i)  if the supply of the restricted substance is for a patient—the name and address of the patient, or

(ii)  if the supply of the restricted substance is for an animal—the species of the animal and the name and address of the animal’s owner, or

(iii)  if the restricted substance is azithromycin and the supply is for a patient’s partner for the treatment of chlamydia—the name and email address or mobile phone number of the partner, and

(c)  must keep the record of the supply of the substance at the hospital, surgery or office of the person supplying the substance.

Maximum penalty—20 penalty units or imprisonment for 6 months, or both.

(2)  In this clause—

partner of a patient includes any of the following—

(a)  the patient’s spouse,

(b)  the patient’s de facto partner,

(c)  a person with whom the patient is or was in a sexual relationship.

(3)    (Repealed)

cl 56: Am 2016 (287), Sch 1 [3] [4]; 2017 (689), cl 3 (2).

57 Certain supplies of restricted substances to be separately recorded

(1)  A pharmacist who supplies a restricted substance as referred to in clause 45, or who supplies the restricted substance benzylpenicillin as referred to in clause 48, must record the following details of the supply in a manner approved by the 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 45, the name and address of the authorised practitioner by whom it appears to the pharmacist that the substance was last prescribed,

(f)  the date on which the substance was supplied,

(g)  the name of the person by whom the substance was supplied.

Maximum penalty—15 penalty units.

(2)  A pharmacist who supplies a restricted substance as referred to in clause 46 or clause 47 must record the following details of the supply in a manner approved by the 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 6 Administration

58 Administration by persons employed at a hospital

(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 an authorised practitioner (other than a veterinary practitioner).

(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)  An authorised practitioner 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)  An authorised practitioner 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.

59 Administration of prescribed restricted substances

(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—

(i)  a nurse practitioner in the course of practising as a nurse practitioner, or

(ii)  a midwife practitioner in the course of practising as a midwife practitioner, or

(iii)  an optometrist in the course of practising as an optometrist, or

(iv)  a podiatrist in the course of practising as a podiatrist.

Maximum penalty—20 penalty units.

(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.

cl 59: Am 2011 (480), Sch 1 [12].

60 Authority required to administer certain restricted substances

(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

urofollitropin (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 7 Miscellaneous

61 Prescribed restricted substances

(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.

62 Authorised persons

For the purposes of section 16(1)(e) of the Act, the following persons are authorised to obtain possession of prescribed restricted substances for the purposes of their profession or employment—

(a)  the director of nursing of a hospital that does not employ a chief pharmacist,

(b)  the nurse or midwife in charge of a ward in a public hospital,

(b1)  the responsible person for a residential care facility,

(b2)  a registered nurse at a residential care facility that is not a nursing home, but for the purpose only of administering doses of such substances to individual residents of the residential care facility,

(c)  a nurse or midwife who is approved for the time being by the Director-General for the purposes of this clause, or who belongs to a class of nurses or a class of midwives so approved,

(d)  any other nurse or midwife, but for the purpose only of administering doses of such substances to individual patients in a hospital,

(e)  an analyst, or a person acting under the direct personal supervision of an analyst.

cl 62: Am 2018 (703), Sch 1 [4].

63 Disclosure of other prescribed restricted substances obtained or prescribed

(1)  A person who asks an authorised practitioner (other than a veterinary practitioner)—

(a)  to supply the person with a prescribed restricted substance, or

(b)  to give the person a prescription for a prescribed restricted substance,

must disclose to the authorised practitioner the quantity of that and any other prescribed restricted substance with which the person has been supplied, or for which the person has been given prescriptions, within the last 2 months.

(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.

64 Delivery by carrier

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.

65 Pentobarbitone sodium

(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.

66 Restricted substances to be used or disposed of safely

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.

67 Loss or theft of prescribed restricted substances

(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, an authorised practitioner.

Maximum penalty—20 penalty units.

68 Forfeiture of prescribed restricted substances

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 4 Drugs of addiction (S8)

Division 1 Packaging and labelling

69 Packaging and labelling generally

(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. 80 applies, in accordance with that Order.

(2)  Despite subclause (1), an authorised 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).

(4)  Despite subclause (1), an authorised practitioner or pharmacist who supplies a drug of addiction 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 drug in accordance with that Order.

Maximum penalty—10 penalty units.

cl 69: Am 2011 (480), Sch 1 [4] [13].

70 Misleading labelling of substances as drugs of addiction

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.

71 Packages to be sealed so that broken seal is readily distinguishable

(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 an authorised practitioner in the practice of his or her profession, or

(b)  by a pharmacist on the prescription of an authorised practitioner, or

(c)  by a pharmacist employed at a hospital, on the written requisition of an authorised practitioner (other than a veterinary practitioner) 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 an authorised practitioner (other than a veterinary practitioner).

Maximum penalty—20 penalty units.

72 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

73 Storage 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 an authorised 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.

74 Responsibility for storage in hospitals

(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 director of nursing 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.

75 Storage in hospital wards

(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.

76 Storage in pharmacies

(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 coach screws 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.

(3A)  Despite subclause (1), a drug of addiction that requires refrigeration may be kept in a refrigerator rather than a safe if all of the following requirements are met—

(a)  the refrigerator must be in a room (which includes a part of a room or an enclosure) to which the public does not have access,

(b)  the refrigerator, or any cupboard or receptacle in which the refrigerator is kept, must be securely attached to a part of the premises,

(c)  the refrigerator, or the room, cupboard or receptacle in which the refrigerator is kept, must be kept securely locked when not in immediate use,

(d)  a device (including a key) that is used to securely lock anything under this subclause must—

(i)  be kept on the person of a pharmacist who is at the premises, or

(ii)  be securely locked in a safe that can be unlocked only by a pharmacist,

(e)  a code or combination that is used to securely lock anything under this subclause must not be disclosed to any person who is not a pharmacist,

(f)  the refrigerator must not be used to store any other item that is not a substance listed in Schedule 2, 3, 4 or 8 of the Poisons List or is not a therapeutic good.

(4)  This clause applies to a hospital pharmacy as well as to a retail pharmacy.

Maximum penalty—20 penalty units.

cl 76: Am 2018 (655), Sch 1 [2].

Division 3 Prescriptions

77 Unauthorised persons not to prescribe drugs of addiction

(1)  An authorised practitioner may issue a prescription for a drug of addiction.

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

Maximum penalty—20 penalty units.

78 Prescriptions may be issued for certain purposes only

(1)  A medical practitioner must not issue a prescription for a drug of addiction otherwise than for medical treatment (including in a clinical trial).

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

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

(4)  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”.

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

(6)  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.

(7)  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.

cl 78: Am 2018 (655), Sch 1 [3].

79 Quantity and purpose of prescriptions to be appropriate

An authorised 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 or imprisonment for 6 months, or both.

80 Form of prescription

(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,

(i)  if the drug of addiction is a type A drug of addiction and the person holds an authority to issue the prescription under section 29 of the Act or Part 8 of this Regulation, the reference number of the authority.

(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.

cl 80: Am 2018 (655), Sch 1 [4].

81 Emergency prescriptions may be given by telephone or otherwise

(1)  In an emergency, an authorised practitioner may direct the supply of a drug of addiction, other than an unregistered 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 120.

Maximum penalty—20 penalty units.

cl 81: Am 2018 (655), Sch 1 [5].

82 Records of prescriptions

(1)  An authorised 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.

83 Exceptions to section 28—prescriptions generally

(1)  A medical practitioner or nurse practitioner is authorised to issue a prescription for a drug of addiction, other than an unregistered 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 hospital or private health facility, 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)  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 to 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.

(3)  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.

(4)  A medical 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 prescription is issued for an in-patient in a public hospital or private health facility who was, immediately before the person’s admission to that hospital or facility, being treated with that drug of addiction, which was prescribed or supplied in accordance with the Act or this Regulation, and

(b)  the prescription is issued for the purpose of continuing the person’s treatment with that drug of addiction following the person’s admission.

(5)  A medical 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 holds an authority under Division 4 of Part 8 of this Regulation that authorises the practitioner to issue a prescription for that drug of addiction for the purposes of a clinical trial, and

(b)  the prescription is issued in accordance with the authority.

cl 83: Am 2018 (655), Sch 1 [6] [7].

84 Exceptions to section 28—prescriptions for type A drugs of addiction

(1)    (Repealed)

(2)  A medical practitioner is authorised to issue a prescription for dexamphetamine, lisdexamfetamine 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)  An authorised practitioner (other than a medical practitioner) must not issue a prescription for a type A drug of addiction.

Maximum penalty—20 penalty units.

cl 84: Am 2014 (82), Sch 1 [3] [4]; 2018 (655), Sch 1 [8] [9].

84A Authority required for prescriptions for clinical trials

A medical practitioner must not issue a prescription for a type C unregistered drug of addiction unless—

(a)  the medical practitioner holds an authority under Division 4 of Part 8 of this Regulation that authorises the practitioner to issue a prescription for that type C unregistered drug of addiction for the purposes of a clinical trial, and

(b)  the prescription is issued in accordance with the authority.

Maximum penalty—20 penalty units

cll 84A: Ins 2019 (477), Sch 1 [2].

84B Restriction on prescriptions for clinical trials

An authorised practitioner (other than a medical practitioner) must not issue a prescription for a type C unregistered drug of addiction for the purposes of a clinical trial.

Maximum penalty—20 penalty units

cll 84B: Ins 2019 (477), Sch 1 [2].

Division 4 Supply

Subdivision 1 Supply on prescription

85 Pharmacists may supply drugs of addiction on prescription

(1)  A pharmacist may supply a drug of addiction on prescription if 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—

(a)  the prescription fails to specify the maximum number of times the drug may be supplied, or

(b)  the prescription fails to specify the intervals at which the drug may be supplied.

(3)  A pharmacist must not supply a drug of addiction on a prescription referred to in subclause (2) if it appears to the pharmacist that the drug has previously been supplied on the prescription, regardless of how many times the prescription purports to authorise the supply of the drug.

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

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

Maximum penalty—20 penalty units.

86 Certain prescriptions not to be filled

(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 authorised 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.

87 Prescriptions require verification

(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.

Maximum penalty—20 penalty units.

88 Prescriptions to be endorsed

(1)  A person who supplies a drug of addiction on prescription must (on each occasion the drug is supplied) endorse the following particulars (in ink) on the prescription—

(a)  the date on which the drug was supplied,

(b)  the address of the place at which the drug was supplied,

(c)  the prescription reference number.

Maximum penalty—20 penalty units.

(2)  A person who supplies a drug of addiction 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 the intervals at which the drug 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—20 penalty units.

(3)  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.

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

89 Prescriptions and orders to be kept

(1)  A pharmacist who supplies a drug of addiction on prescription, or by order under clause 97 or 103, must keep the prescription or order, whether or not the prescription or order authorises more than one supply of the drug.

Maximum penalty—20 penalty units.

(2)  A pharmacist must keep prescriptions or orders for drugs of addiction separate from other prescriptions (other than prescriptions for special restricted substances).

Maximum penalty—20 penalty units.

(3)  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.

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

90 Supply by pharmacists of type A drugs of addiction

A pharmacist must not supply a type A drug of addiction on prescription unless—

(a)  the reference number of the authority to issue the prescription (whether given under section 29 of the Act or Part 8 of this Regulation) is shown on the prescription, or

(b)  the medical practitioner who issued the prescription was authorised to do so under clause 83(1)–(4).

Maximum penalty—20 penalty units.

cl 90: Am 2014 (82), Sch 1 [5]. Subst 2018 (655), Sch 1 [10].

91 Records to be kept by pharmacists of methadone or buprenorphine prescriptions

(1)  A pharmacist at a retail pharmacy who supplies any person with methadone in oral liquid form or buprenorphine on a prescription for the treatment of drug dependence must keep a record of the supply in accordance with this clause.

Maximum penalty—20 penalty units.

(2)  A record under this clause must contain the following particulars—

(a)  the name of the person to whom the supply was made,

(b)  the number of the prescription on which the supply was made,

(c)  the name of the person who gave the prescription,

(d)  the amount of methadone in oral liquid form or buprenorphine supplied,

(e)  the date on which the supply occurred,

(f)  if the whole or part of the methadone in oral liquid form or buprenorphine was supplied for consumption on a different day to that on which it was supplied, the day or days on which it is to be consumed and the amount to be consumed on that day or on each of those days.

(3)  Records made under this clause in relation to a particular pharmacy are to be made in writing in a book in which all such records for the pharmacy are kept.

(4)  The Director-General may from time to time approve the keeping of records under this clause in any other form.

(5)  A record made under this clause must be kept for at least 2 years from the date on which it is made.

cl 91: Am 2013 (176), Sch 1 [1].

92 Supply by pharmacists of liquid methadone or buprenorphine

(1A)  Despite clause 85, a pharmacist must not supply methadone in oral liquid form or buprenorphine on prescription for the treatment of drug dependence unless—

(a)  the methadone or buprenorphine is supplied at the premises of, and in the course of carrying on the business of, a retail pharmacy, and

(b)  the retail pharmacy is located on premises at which a pharmacist is approved to supply pharmaceutical benefits under section 90 of the National Health Act 1953 of the Commonwealth.

Maximum penalty—20 penalty units.

(1)  A pharmacist at a retail pharmacy must not, on any particular day, supply any person with methadone in oral liquid form or buprenorphine on a prescription for the treatment of drug dependence if that supply would result in more than 65 persons having been supplied with methadone in oral liquid form or buprenorphine on prescription at that pharmacy on that day.

Maximum penalty—20 penalty units.

(2)  For the purposes of subclause (1), if an amount of methadone in oral liquid form or buprenorphine is supplied for consumption on a day other than the day on which it is supplied, the supply of that amount is taken to have occurred on the day on which the amount is to be consumed.

(3)  A person is not to be counted for the purposes of subclause (1) if the person is supplied with an amount of methadone in oral liquid form or buprenorphine that is intended to last the person for at least one week and the person is supplied at that pharmacy with either of those drugs no more than once in any 7 day period.

(4)  Subclause (1) does not apply to the supply of methadone in oral liquid form or buprenorphine at a pharmacy in accordance with—

(a)  an exemption granted under clause 93, or

(b)  a licence issued under Division 3 of Part 8.

cl 92: Am 2013 (176), Sch 1 [2] [3]; 2013 No 111, Sch 3.20; 2018 (689), cl 3.

93 Exemptions relating to methadone or buprenorphine supply at pharmacies

(1)  The owner of a pharmacy may apply in writing to the Director-General for an exemption from clause 92(1A) or (1) in relation to the pharmacy.

(2)  The Director-General may require the owner of the pharmacy to furnish such information as is necessary to enable the Director-General to determine the application.

(3)  The Director-General may, by notice in writing served on the owner of the pharmacy, grant the exemption, if the Director-General is satisfied that exceptional circumstances exist that justify the granting of the exemption, or refuse to grant the exemption.

(4)  An exemption is subject to such conditions as may be specified in the notice referred to in subclause (3) and to such further conditions as the Director-General may from time to time notify in writing to the holder of the exemption.

(5)  The Director-General may from time to time vary or revoke any condition of an exemption by notice in writing served on the holder of the exemption.

(6)  An exemption remains in force until—

(a)  the expiry date (if any) specified in the exemption, or

(b)  it is surrendered or cancelled,

whichever occurs first.

(7)  The Director-General may suspend or cancel an exemption by notice in writing served on the holder of the exemption.

(8)  An exemption has no effect during any period of suspension.

(9)  For the removal of doubt, an exemption is not a licence or authority for the purposes of this Regulation.

cl 93: Am 2013 (648), cl 3 (1) (2).

94 Exceptions to section 28—supply

(1)  A medical practitioner or nurse practitioner is authorised to supply a drug of addiction, other than an unregistered 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 hospital or private health facility, and

(b)  the supply 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)  A medical practitioner or nurse practitioner is authorised to supply methadone or buprenorphine to 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)  the person is an inmate in a correctional centre (within the meaning of the Crimes (Administration of Sentences) Act 1999), and

(c)  the methadone or buprenorphine is supplied in oral dosage form for use by the person as a course of treatment while an inmate, 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 methadone or buprenorphine is supplied for the purpose of continuing the treatment that the person was receiving or was about to receive immediately before the person became an inmate.

(3)  A medical practitioner or nurse practitioner is authorised to supply a drug of addiction to 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 supply is in accordance with any conditions to which that authority is subject.

(4)  A medical practitioner is authorised to supply a drug of addiction for a person without an authority under section 29 of the Act if—

(a)  the person is an in-patient in a public hospital or private health facility who was, immediately before the person’s admission to that hospital or facility, being treated with that drug of addiction, which was prescribed or supplied in accordance with the Act or this Regulation, and

(b)  the drug of addiction is supplied for the purpose of continuing the person’s treatment with that drug of addiction following the person’s admission.

(5)  A medical practitioner is authorised to supply a drug of addiction to a person without an authority under section 29 of the Act if—

(a)  the medical practitioner holds an authority under Division 4 of Part 8 of this Regulation that authorises the practitioner to supply that drug of addiction for the purposes of a clinical trial, and

(b)  the supply of the drug of addiction is in accordance with the authority.

cl 94: Am 2018 (655), Sch 1 [11] [12].

94AA Authority required for supply for clinical trials

A medical practitioner must not supply a type C unregistered drug of addiction unless—

(a)  the medical practitioner holds an authority under Division 4 of Part 8 of this Regulation that authorises the practitioner to supply that type C unregistered drug of addiction for the purposes of a clinical trial, and

(b)  the supply of the unregistered drug is in accordance with the authority.

Maximum penalty—20 penalty units

cll 94AA: Ins 2019 (477), Sch 1 [3].

94AB Restriction on supply for clinical trials

An authorised practitioner (other than a medical practitioner) must not supply a type C unregistered drug of addiction for the purposes of a clinical trial.

Maximum penalty—20 penalty units

cll 94AB: Ins 2019 (477), Sch 1 [3].

94A Supply of liquid methadone or buprenorphine by pharmacists—transitional provision

Clause 92(1A) (as inserted by the Poisons and Therapeutic Goods Amendment (Supply by Pharmacists) Regulation 2013) does not operate to prevent a pharmacist who, before that insertion, supplied liquid methadone or buprenorphine on prescription for the treatment of drug dependence from continuing to supply methadone or buprenorphine after that insertion at the premises at which those drugs were provided by the pharmacist before that insertion.

cl 94A: Ins 2013 (176), Sch 1 [4]. Am 2013 (648), cl 3 (3).

Subdivision 2 Supply without prescription

95 Supply and receipt of drugs of addiction generally

(1)  A person who is authorised to supply drugs of addiction (whether by this Division or by an authority or licence under Part 8) may supply a drug of addiction to an authorised person, being—

(a)  any person who is authorised to have possession of such a drug of addiction, or

(b)  any other person if the other person is in possession of a certificate, signed by a person so authorised, to the effect that the other person is authorised to obtain the drug of addiction on behalf of the person so authorised.

(2)  A supplier may supply drugs of addiction under this clause on the basis of a written order signed by an authorised person or on the basis of an order received from an authorised person by telephone, electronic mail or facsimile.

(3)  A person who orders and receives a drug of addiction must notify the supplier of the receipt of the drug within 24 hours after that receipt.

(4)  The notice under subclause (3) must be in writing and must be dated and signed by an authorised person.

(5)  If a supplier, who supplies a drug of addiction on the basis of an order, does not receive written notice of the order under subclause (3) within 7 days after the drug is supplied, the supplier must report that fact to the Director-General.

(6)  A person who supplies a drug of addiction in accordance with this clause must—

(a)  keep and cancel the relevant order, and

(b)  keep the written notice under subclause (3) and (if the drug is supplied as referred to in subclause (1)(b)) the relevant certificate.

Maximum penalty—20 penalty units.

96 Emergency supply by pharmacists

(1)  A pharmacist may supply a person with a drug of addiction, other than an unregistered drug of addiction, in accordance with a direction given under clause 81.

(2)  A pharmacist who supplies a drug of addiction in accordance with this clause—

(a)  must keep and cancel the prescription that is subsequently sent in confirmation of the direction, or

(b)  if such a prescription is not received within 7 days after the drug is supplied, must report that fact to the Director-General.

Maximum penalty—20 penalty units.

cl 96: Am 2018 (655), Sch 1 [13].

97 Supply by pharmacists for emergency purposes

A pharmacist may supply an authorised practitioner with a drug of addiction, other than an unregistered drug of addiction, for emergency use, but only on a written order signed and dated by the authorised practitioner.

cl 97: Am 2018 (655), Sch 1 [14].

98 Supply of type A drugs of addiction

(1)    (Repealed)

(2)  A medical practitioner does not require an authority under section 29 of the Act to supply dexamphetamine, lisdexamfetamine or methylphenidate to a person for the purpose of testing the suitability of the person to undergo a course of medical treatment involving the use of such a substance so long as the medical practitioner holds an authority under Part 8 to supply such a substance.

(3)  A nurse practitioner, midwife practitioner, dentist or veterinary practitioner is not authorised to supply a type A drug of addiction.

(4)  This clause does not prevent a veterinary practitioner from supplying methylphenidate in solid dosage form to a person for the treatment of an animal.

cl 98: Am 2014 (82), Sch 1 [6] [7]; 2018 (655), Sch 1 [15] [16].

Subdivision 3 Supply in hospitals

99 Supply by pharmacists

(1)  A pharmacist employed at a hospital may supply a drug of addiction from the pharmacy department of the hospital—

(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 an authorised practitioner (other than a veterinary practitioner), where that authorisation is entered on a patient’s medication chart, or

(c)  on the requisition (whether in writing, by electronic mail, by facsimile or by any other form of electronic communication approved by the Director-General) of an authorised practitioner (other than a veterinary practitioner) or of the nurse or midwife in charge of the ward in which the drug is to be used or stored.

(2)  The person delivering a drug of addiction to a ward from the pharmacy department of the hospital must obtain a receipt, dated and signed, from the person to whom the drug is delivered.

Maximum penalty—20 penalty units.

Subdivision 4 Manufacture, possession and supply generally

100 Unauthorised manufacture and supply of drugs of addiction prohibited

(1)  A person must not manufacture or supply a drug of addiction unless the person is authorised to do so by this Division or by an authority or licence under Part 8.

(2)  This Division does not authorise a person to manufacture or supply drugs of addiction in contravention of any prohibition or restriction to which the person is otherwise subject.

Maximum penalty—20 penalty units.

101 Possession and supply of drugs of addiction

(1)  The following persons are authorised to have possession of, and to supply, drugs of addiction—

(a)  an authorised practitioner,

(b)  the chief pharmacist of, and any pharmacist employed in dispensing medicines at, any public hospital or other public institution,

(c)  the director of nursing of a hospital in which a pharmacist is not employed,

(d)  the nurse or midwife in charge of a ward in a public hospital,

(e)  a nurse or midwife who is approved for the time being by the Director-General for the purposes of this clause, or who belongs to a class of nurses or a class of midwives so approved,

(f)  any other nurse or midwife, but for the purpose only of administering doses of such drugs to individual patients in a hospital,

(g)  a person—

(i)  who is employed in the Ambulance Service of NSW as an ambulance officer or as an air ambulance flight nurse, and

(ii)  who is approved for the time being by the Director-General for the purposes of this clause.

(2)  The following persons are authorised to have possession of (but not to supply) drugs of addiction—

(a)  a person in charge of a laboratory used for the purpose of analysis, research or instruction, who is, or who belongs to a class of persons who are, authorised for the time being by the Director-General for the purposes of this clause,

(b)  an analyst,

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

(3)  This clause authorises a person referred to in subclause (1) or (2) to have possession of, or to supply, drugs of addiction for the purpose only of the lawful practice of the person’s profession or occupation.

(4)    (Repealed)

(5)  This clause does not authorise a nurse practitioner, midwife practitioner, dentist or veterinary practitioner to have possession of, or to supply, a type A drug of addiction (other than methylphenidate in solid dosage form, in the case of a veterinary practitioner).

cl 101: Am 2014 (82), Sch 1 [8] [9]; 2016 (409), Sch 1 [4]; 2019 (477), Sch 1 [4].

102 Possession and manufacture of drugs of addiction by retail pharmacists

(1)  A retail pharmacist is authorised—

(a)  to have possession of drugs of addiction, and

(b)  to manufacture drugs of addiction and any preparation, admixture or extract of a drug of addiction,

but only if he or she does so at the premises of, and in the course of carrying on a pharmacy business.

(2)    (Repealed)

Maximum penalty—20 penalty units.

cl 102: Am 2016 (409), Sch 1 [5].

103 Possession of drugs of addiction at private health facilities and residential care facilities

(1)  The following persons are authorised to have possession of ampoules of morphine sulphate in a quantity not exceeding 30 ampoules, each of 1 millilitre or less, at a concentration of 30 milligrams or less of morphine sulfate per millilitre—

(a)  the director of nursing of a private health facility,

(b)  the responsible person for a residential care facility,

(c)  a registered nurse at a residential care facility, but for the purpose only of administering doses of such drugs to individual residents of the residential care facility.

(2)  The director of nursing of a private health facility is authorised to have possession of no more than 5 ampoules, each of 2 millilitres or less, of pethidine hydrochloride, at a concentration of 50 milligrams or less of pethidine hydrochloride per millilitre.

(3) Order of Secretary—specified facilities The Secretary may, by order in writing, authorise the possession of a drug of addiction specified in subclause (1) or (2), in a quantity that exceeds the limit specified in subclause (1) or (2), by the following persons—

(a)  in the case of morphine sulphate—

(i)  the director of nursing of a specified private health facility, or

(ii)  the responsible person for a specified residential care facility,

(b)  in the case of pethidine hydrochloride—the director of nursing of a specified private health facility.

(4) Order of Secretary—specified classes of facilities The Secretary may, by order published in the Gazette, authorise the possession of a drug of addiction specified in subclause (1) or (2), in a quantity that exceeds the limit specified in subclause (1) or (2), by the following persons—

(a)  in the case of morphine sulphate—

(i)  the director of nursing of a specified class of private health facilities, or

(ii)  the responsible person for a specified class of residential care facilities,

(b)  in the case of pethidine hydrochloride—the director of nursing of a specified class of private health facilities.

(5)  A retail pharmacist is authorised to supply a drug of addiction to the director of nursing of a private health facility or residential care facility, or the residential care facility manager of a residential care facility, but only if the drug is supplied—

(a)  at the premises of, and in the course of carrying on the business of, the pharmacy, and

(b)  in accordance with a written order signed by the director of nursing or the residential care facility manager.

(6)  The director of nursing or the residential care facility manager must not sign an order for any quantity of a drug of addiction if the quantity of that drug that will be in the possession of the director of nursing or the residential care facility manager as a result of the order being filled will be in excess of the maximum quantity allowed by this clause.

Maximum penalty—20 penalty units.

(7)  The director of nursing of a private health facility must not allow any drug of addiction in his or her possession under subclause (1) or (2) to be used otherwise than for administration to a patient in accordance with the directions of an authorised practitioner (other than a veterinary practitioner) or by an authorised practitioner (other than a veterinary practitioner).

Maximum penalty—20 penalty units.

(8)  The responsible person for a residential care facility must not allow any drug of addiction in his or her possession under subclause (1) to be used otherwise than for administration to a resident of the facility by a registered nurse in accordance with the directions of an authorised practitioner (other than a veterinary practitioner) or by an authorised practitioner (other than a veterinary practitioner).

Maximum penalty—20 penalty units.

(9)  This clause does not limit the power of a director of nursing or a residential care facility manager to have possession of drugs of addiction, or to supply drugs of addiction to patients or residents, in accordance with the Act or this Regulation.

(10)  A person does not commit an offence under this clause in relation to any pethidine hydrochloride that was lawfully in the person’s possession before the commencement of this clause.

cl 103: Am 2011 (480), Sch 1 [14] [15]. Subst 2018 (703), Sch 1 [5].

104 Possession of drugs of addiction by masters of ships

(1)  The master of a ship is authorised to have possession of drugs of addiction that are required by law to be carried on the ship.

(2)  A pharmacist may supply drugs of addiction to the master of a ship if the pharmacist is authorised to do so by an authority under Part 8.

(3)  A person must not supply a drug of addiction to the master of a ship unless the person receives—

(a)  a written order for the drug (in duplicate) signed by the master of the ship, and

(b)  a written statement (in duplicate) signed by the master of the ship to the effect that the drug is required by law to be carried on the ship, and

(c)  a certificate, issued by the ship’s agent in New South Wales, to the effect that the signatures appearing on the order and statement are those of the master of the ship.

(4)  A person who supplies a drug of addiction in accordance with this clause—

(a)  must keep and cancel the relevant order and statement, and

(b)  must cancel the duplicate copies of the order and statement and forward them to the Director-General, together with the certificate issued by the ship’s agent, within 24 hours.

(5)    (Repealed)

Maximum penalty—20 penalty units.

cl 104: Am 2016 (409), Sch 1 [6].

105 (Repealed)

cl 105: Rep 2016 (409), Sch 1 [7].

106 Authorities to possess and administer drugs of addiction

(1)  The following persons are authorised to have possession of drugs of addiction, but only if authorised to do so by an authority under Part 8—

(a)  a person in an isolated locality,

(b)  a person in charge of a first aid post,

(c)  a person representing an organisation established for search and rescue,

(d)  any other person the Minister may from time to time approve.

(2)  A person who is so authorised to have possession of a drug of addiction is also authorised to administer the drug to another person in an emergency.

107 Mode of delivery

(1)  A person who supplies drugs of addiction must do so personally, by registered mail or by carrier.

(2)  A person who supplies a drug of addiction personally—

(a)  must deliver it to the person being supplied at the premises of the supplier or at the premises of the person being supplied, and

(b)  must obtain a receipt, dated and signed, from the person to whom it is delivered.

(3)  A person who supplies a drug of addiction by registered mail must obtain and keep written evidence of postage of the drug.

(4)  A person who supplies a drug of addiction by carrier must obtain and keep written evidence of the consignment of the drug.

(5)  A person who supplies a drug of addiction must not deliver a drug of addiction by carrier otherwise than under an arrangement under which the carrier undertakes—

(a)  to obtain a receipt, dated and signed, from the person to whom the drug is delivered, and

(b)  to deliver the receipt to the supplier.

Maximum penalty—20 penalty units.

108 Delivery by carrier

(1)  A carrier is authorised to be in possession of a package containing a drug of addiction, but for the purpose only of delivering it to the person to whom it is addressed.

(2)  A dealer (other than an authorised practitioner or pharmacist) who supplies a drug of addiction by post or by carrier must ensure that—

(a)  the drug is contained in a package that has at least one opaque covering, and

(b)  no other goods are contained in the package, and

(c)  the package contains a document—

(i)  listing the contents of the package, and

(ii)  bearing the words “SCHEDULE EIGHT—CHECK CAREFULLY” in bold face sans serif capital letters with a letter height of at least 12.5 millimetres, and

(d)  the outside of the package does not indicate that it contains a drug of addiction, and

(e)  the package is properly addressed to the person to whom the drug is being supplied.

(3)  This clause does not prevent a dealer from supplying a drug of addiction by means of a separately wrapped inner package within an outer package containing other goods so long as—

(a)  a document listing the contents of the inner package is contained in the inner package, and

(b)  the inner package is marked with the words “SCHEDULE EIGHT—CHECK CAREFULLY” in bold face sans serif capital letters with a letter height of at least 12.5 millimetres, and

(c)  the outside of the outer package does not indicate that it contains a drug of addiction, and

(d)  the outer package is properly addressed to the person to whom the drug is being supplied.

Maximum penalty—20 penalty units.

109 Quantity and purpose of supply to be appropriate

An authorised practitioner or pharmacist must not supply any 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 or imprisonment for 6 months, or both.

Division 5 Records of supply

Subdivision 1 Drug registers otherwise than for hospital wards

110 Application of Subdivision

(1)  Except as provided by subclause (2), this Subdivision applies to drugs of addiction that are kept at any place (including the pharmacy of a hospital) for the purposes of manufacture, supply, research or testing.

(2)  This Subdivision does not apply to drugs of addiction that are—

(a)  kept in a hospital ward, or

(b)  kept in a residential care facility, or

(c)  in the possession of a carrier for the purpose of those drugs of addiction being delivered to the persons to whom they are addressed.

cl 110: Subst 2018 (703), Sch 1 [6].

111 Drug registers to be kept

(1)  A person who has possession of drugs of addiction at any place must keep a separate register (a drug register) at that place.

(2)  A drug register is to be in the form of a book—

(a)  that contains consecutively numbered pages, and

(b)  that is so bound that the pages cannot be removed or replaced without trace, and

(c)  that contains provision on each page for the inclusion of the particulars required to be entered in the book.

(3)  Separate pages of the register must be used for each drug of addiction, and for each form and strength of the drug.

(4)  The Director-General may from time to time approve the keeping of a drug register in any other form.

Maximum penalty—20 penalty units.

112 Entries in drug registers

(1)  On the day on which a person manufactures, receives, supplies, administers or uses a drug of addiction at any place, the person must enter in the drug register for that place such of the following details as are relevant to the transaction—

(a)  the quantity of the drug manufactured, received, supplied, administered or used,

(b)  the name and address of the person to, from, or by, whom the drug was manufactured, received, supplied, administered or used,

(c)  in the case of a drug that has been administered to an animal or supplied for the treatment of an animal, the species of animal and the name and address of the animal’s owner,

(d)  in the case of a drug that is supplied or administered on prescription—

(i)  the prescription reference number, and

(ii)  the name of the authorised practitioner by whom the prescription was issued,

(e)  in the case of a drug that has been administered to a patient, the name of the authorised practitioner (other than a veterinary practitioner) by whom, or under whose direct personal supervision, the drug was administered,

(f)  in the case of a drug that has been administered to an animal, the name of the veterinary practitioner by whom, or under whose direct personal supervision, the drug was administered,

(g)  in the case of a drug that has been administered by a person authorised to do so by an authority under Part 8, details of the circumstances requiring administration of the drug,

(h)  in the case of a drug that has been used by a person who is in charge of a laboratory, or is an analyst, the purpose for which the drug was used,

(i)  the quantity of drugs of addiction of that kind held at that place after the transaction takes place,

(j)  any other details approved by the Director-General.

(2)  Each entry in a drug register must be dated and signed by the person by whom it is made.

(3)  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.

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

Maximum penalty—20 penalty units or imprisonment for 6 months, or both.

113 Supply on prescription to be recorded

(1)  A pharmacist who supplies a drug of addiction on prescription must record the following details in a manner approved by the Director-General—

(a)  the details required by clause 80(1) to be included in the prescription,

(b)  a unique reference number for the prescription,

(c)  the date on which the substance was supplied,

(d)  the name of the person by whom the substance was supplied.

Maximum penalty—20 penalty units.

(2)  A prescription for the supply of a drug of addiction 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.

(3)  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 the requirements of this clause.

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

114 Emergency supply or supply to private health facility or residential care facility to be recorded

A pharmacist who supplies a drug of addiction in accordance with clause 97 or 103 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—20 penalty units.

cl 114: Am 2018 (703), Sch 1 [7].

Subdivision 2 Drug registers for hospital wards and residential care facilities

pt 4, div 5, sdiv 2, hdg: Am 2018 (703), Sch 1 [8].

115 Application of Subdivision

This Subdivision applies to the following—

(a)  drugs of addiction that are kept in a hospital ward other than drugs of addiction that are kept in a pharmacy at the hospital,

(b)  drugs of addiction that are kept in a residential care facility that is a nursing home,

(c)  drugs of addiction that are kept in a residential care facility that is not a nursing home and are possessed in accordance with clause 103.

cl 115: Subst 2018 (703), Sch 1 [9].

116 Registers to be kept

(1)  The nurse or midwife in charge of a hospital ward must keep a register of drugs of addiction (a ward register) in that ward.

(2)  The responsible person for a residential care facility must keep a register of drugs of addiction (a residential care facility register) in that residential care facility.

(3)  A ward register or a residential care facility register is to be in the form of a book that—

(a)  contains consecutively numbered pages, and

(b)  is so bound that the pages cannot be removed or replaced without trace, and

(c)  contains provision on each page for the inclusion of the particulars required to be entered in the book.

(4)  Separate pages of the ward register or residential care facility register must be used for each drug of addiction and for each form and strength of the drug.

(5)  The Secretary may from time to time approve the keeping of a ward register or a residential care facility register in any other form.

Maximum penalty—20 penalty units.

cl 116: Subst 2018 (703), Sch 1 [10].

117 Entries in registers

(1)  On the day on which a person receives, supplies or administers a drug of addiction in any ward or residential care facility, the person must enter in the ward register or residential care facility register such of the following details as are relevant to the transaction—

(a)  the quantity of the drug received, supplied or administered,

(b)  the time of day when the drug was received, supplied or administered,

(c)  in the case of a drug that is supplied or administered to a patient—

(i)  the name of the patient to whom the drug was supplied or administered, and

(ii)  the name of the person by whom the supply or administration of the drug was prescribed or directed,

(d)  the quantity of drugs of addiction of that kind held in the ward or residential care facility after the transaction takes place,

(e)  any other details approved by the Director-General.

(2)  The entry must be dated and signed by the person by whom it is made and countersigned—

(a)  in the case of an entry relating to the receipt of a drug of addiction, by a person who witnessed its receipt, or

(b)  in the case of an entry relating to the supply or administration of a drug of addiction—

(i)  by the person who supervised or directed its supply or administration, or

(ii)  by a person who witnessed its supply or administration.

(3)  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.

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

Maximum penalty—20 penalty units.

cl 117: Am 2018 (703), Sch 1 [11]–[13].

Subdivision 3 Records generally

118 Periodical inventory of stock of drugs of addiction

(1)  The person responsible for maintaining a drug register at any place—

(a)  must, during the prescribed periods, make an accurate inventory of all drugs of addiction at that place, and

(b)  must endorse the relevant drug register, immediately under the last entry for each drug of addiction, with the quantity of each drug of addiction actually held and the date on which the inventory was made, and

(c)  must sign each entry.

(2)  The prescribed periods for the purposes of subclause (1)(a) are—

(a)  March and September each year, or

(b)  if the Director-General determines some other periods, either generally or in specified circumstances, the periods so determined.

(3)  A person who assumes control for a period of one month or more over any place at which drugs of addiction are held must, immediately on assuming control, make an inventory and endorse the drug register as if the inventory were an inventory made under this clause.

Maximum penalty—20 penalty units.

cll 118: Am 2018 (703), Sch 1 [14].

119 Loss or destruction of registers

Immediately after a drug register is lost or destroyed, the person responsible for keeping the register—

(a)  must give written notice to the Director-General of that fact and of the circumstances of the loss or destruction, and

(b)  must make an accurate inventory of all drugs of addiction held at the premises concerned and enter, in a new drug register, the particulars of the drugs so held.

Maximum penalty—20 penalty units.

cll 119: Am 2018 (703), Sch 1 [14].

119A Records relating to prescriptions for residents of residential care facilities

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 administration of any drug of addiction to the resident.

Maximum penalty—20 penalty units.

cl 119A: Ins 2015 (138), Sch 1 [12].

Division 6 Administration

120 Administration by persons employed at a hospital

(1)  A person employed at a hospital must not administer a drug of addiction to a patient in the hospital otherwise than on the direction of an authorised practitioner (other than a veterinary practitioner).

(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)  An authorised practitioner 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 drug of addiction is administered, the person by whom the drug was administered must report that fact to the Director-General.

(5)  An authorised practitioner who, by electronic mail or by facsimile, gives or confirms a direction for the administration of a drug of addiction to a patient must also 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 drug of addiction 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—20 penalty units.

121 Self-administration by medical practitioners and dentists

(1)  For the purposes of Division 1 of Part 2 of the Drug Misuse and Trafficking Act 1985—

(a)  a medical practitioner is authorised to self-administer a drug of addiction, but only if the medical practitioner does so for the purposes of medical treatment, and

(b)  a dentist is authorised to self-administer a drug of addiction, but only if the dentist does so for the purposes of dental treatment.

(2)  Subclause (1) does not authorise a medical practitioner or dentist to self-administer a drug of addiction for more than 7 days.

(3)  However, a medical practitioner may self-administer a drug of addiction for more than 7 days if the medical practitioner does so in accordance with an authority issued under Part 8.

(4)  This clause does not authorise a medical practitioner or dentist to self-administer an unregistered drug of addiction.

cl 121: Am 2018 (655), Sch 1 [17].

Division 7 Miscellaneous

122 Prescribed type A drugs of addiction

For the purposes of section 28 of the Act, each of the following is prescribed as a type A drug of addiction—

(a)  amphetamine,

(a1)    (Repealed)

(b)  dexamphetamine,

(b1)  lisdexamfetamine,

(c)  methylamphetamine,

(d)  methylphenidate,

(d1)    (Repealed)

(e)  phendimetrazine,

(f)  phenmetrazine,

(g)    (Repealed)

(h)  any unregistered drug of addiction that is extemporaneously compounded for a particular person for therapeutic application to that person.

cl 122: Am 2014 (82), Sch 1 [10] [11]; 2018 (655), Sch 1 [18] [19]; 2019 (477), Sch 1 [5] [6].

123 Prescribed type B drugs of addiction

For the purposes of section 28 of the Act, each of the following is prescribed as a type B drug of addiction—

(a)  a drug of addiction that is packaged and labelled in a manner that is consistent with the drug being intended for administration by injection, inhalation, spray or application to mucous membranes,

(a1)  alprazolam,

(b)  buprenorphine (other than in transdermal patches),

(c)  dextromoramide,

(d)  flunitrazepam,

(e)  hydromorphone,

(f)  methadone.

cl 123: Am 2014 (82), Sch 1 [12].

124 Loss or theft of drugs of addiction

A person who is authorised to be in possession of drugs of addiction must immediately notify the Director-General if the person loses a drug of addiction or if a drug of addiction is stolen from the person.

Maximum penalty—20 penalty units.

125 Drugs of addiction not to be destroyed

(1)  A person who is authorised to be in possession of a drug of addiction must not wilfully destroy the drug or allow the drug to be destroyed.

(2)  This clause does not apply to the destruction of a drug of addiction carried out—

(a)  by or under the direct personal supervision of a police officer or an inspector or by or under the direct personal supervision of a person authorised, whether generally or in a particular case, by an authority under Part 8 held by the person, or

(b)  by or under the direct personal supervision of a person who is in charge of a laboratory, or who is an analyst, but only if the destruction is carried out in accordance with an authority under Part 8 held by the person, or

(c)  by a person to whom the drug has been supplied by, or in accordance with the prescription of, an authorised practitioner, or

(d)  in accordance with clause 126, 127 or 128.

Maximum penalty—20 penalty units or imprisonment for 6 months, or both.

126 Destruction of unusable or unwanted drugs of addiction held by practitioners

(1)  A pharmacist who is engaged in the supply of restricted substances or drugs of addiction in a retail pharmacy and who has been notified by a relevant practitioner that a drug of addiction has become unusable or unwanted—

(a)  may (but only in the presence of the relevant practitioner) destroy the drug of addiction, either at the retail pharmacy or at the premises at which the practitioner’s practice is conducted, and

(b)  in that event, must record the fact of the destruction of the drug in the relevant practitioner’s drug register.

(2)  The entry must include the date and the name, professional registration number and signature of the pharmacist and the name and signature of the relevant practitioner.

Maximum penalty—20 penalty units.

(3)  In this clause—

relevant practitioner means a medical practitioner, a dentist or a veterinary practitioner.

126A Destruction of unusable or unwanted drugs of addiction in public hospitals

(1)  The authorised director of a public hospital may destroy any unusable or unwanted drug of addiction at the hospital but only in the presence of—

(a)  a pharmacist, or

(b)  a registered medical practitioner, or

(c)  an authorised midwife, or

(d)  an authorised nurse, or

(e)  a registered dentist.

(2)  A person who destroys a drug of addiction in accordance with this clause—

(a)  must record the fact of the destruction of the drug by an entry in the drug register maintained by the hospital, and

(b)  must ensure that the entry includes the relevant date and the name, professional registration number and signature of that person and the person who witnessed the destruction of the drug.

Maximum penalty—20 penalty units.

(3)  In this clause—

authorised director, in relation to a public hospital, means—

(a)  the director of pharmacy at that hospital, or

(b)  if no such position exists at that hospital, the person responsible for controlling drugs of addiction at that hospital, or

(c)  a pharmacist authorised in writing for the purposes of this clause by the director of pharmacy or the person responsible for controlling drugs of addiction at the hospital.

authorised midwife means a registered midwife who is in charge of a ward at a hospital or who is authorised by the director of nursing of a hospital to oversee the destruction of drugs at the hospital for the purposes of this clause.

authorised nurse means a registered nurse who is in charge of a ward at the hospital or who is authorised by the director of nursing of a hospital to oversee the destruction of drugs at the hospital for the purposes of this clause.

cl 126A: Am 2011 (480), Sch 1 [16].

127 Destruction of unusable drugs of addiction in public hospital wards

(1)  The nurse or midwife in charge of a ward in a public hospital having responsibility for a drug of addiction that becomes unusable must immediately notify the chief pharmacist of the hospital of the fact and of the circumstances under which the drug became unusable.

(2)  A pharmacist employed in a public hospital—

(a)  may (but only in the presence of a nurse or midwife) destroy the drug of addiction, and

(b)  in that event, must record the fact of the destruction of the drug in the ward register.

(3)  The entry must include the date and the name, professional registration number and signature of the pharmacist and the name and signature of the nurse or midwife who witnessed the destruction of the drug.

(4)  In the case of a public hospital for which there is no pharmacist, the functions of a chief pharmacist or pharmacist under this clause are instead the functions of—

(a)  the director of nursing of the hospital, or

(b)  the medical superintendent of the hospital,

as the chief executive officer of the hospital may determine.

Maximum penalty—20 penalty units.

128 Destruction of unwanted drugs of addiction in private health facilities or residential care facilities

(1)  A retail pharmacist who is engaged in the supply of restricted substances or drugs of addiction to any of the following—

(a)  a private health facility,

(b)  a residential care facility,

(c)  a patient in a private health facility,

(d)  a patient in a residential care facility that is a nursing home,

is, subject to subclauses (2) and (3), authorised to destroy any unwanted drug of addiction on the premises of that private health facility or residential care facility.

(2)  A retail pharmacist is only authorised to destroy an unwanted drug of addiction on the premises of a residential care facility that is not a nursing home if that drug of addiction was supplied in accordance with clause 103.

(3)  Subclause (1) applies only where the drug is destroyed in the presence of—

(a)  if the private health facility or residential care facility is the holder of a licence under Division 2 of Part 8—the person who is named on the licence as being responsible for the storage of drugs of addiction, or

(b)  in any other case—the director of nursing of the private health facility or residential care facility or the residential care facility manager.

(4)  A pharmacist who destroys a drug of addiction in accordance with this clause—

(a)  must record the fact of the destruction of the drug by an entry in the drug register maintained by the private health facility or residential care facility, and

(b)  must ensure that the entry in the drug register includes the date and the name, professional registration number and signature of the pharmacist and the name and signature of person who witnessed the destruction of the drug.

Maximum penalty—20 penalty units.

cl 128: Am 2011 (480), Sch 1 [17]. Subst 2018 (703), Sch 1 [15].

128A (Repealed)

cl 128A: Ins 2016 (409), Sch 1 [8]. Rep 2018 (655), Sch 1 [20].

Part 4A

128B–128L  (Repealed)

pt 4A (cll 128B–128L): Ins 2016 (409), Sch 1 [9]. Rep 2018 (655), Sch 1 [21].

Part 4B Etorphine

pt 4B: Ins 2016 (409), Sch 1 [9].

128M Obtaining etorphine

(1)  A person must not obtain etorphine unless the person is authorised to do so by a licence or authority under Part 8.

Maximum penalty—20 penalty units.

(2)  A reference in this clause to a licence or authority under Part 8 includes a reference to a licence or authority issued before the commencement of this Part for the purposes of clause 105 as then in force.

Parts 4C (cll 128M–128P): Ins 2016 (409), Sch 1 [9].

128N Prescribing and supplying etorphine

(1)  A person must not prescribe or supply etorphine unless it is for the treatment of an animal.

Maximum penalty—20 penalty units.

(2)  A veterinary practitioner must not prescribe or supply etorphine for the treatment of an animal unless the veterinary practitioner holds an authority under Part 8 authorising the practitioner to treat animals with the product.

Maximum penalty—20 penalty units.

(3)  A reference in this clause to an authority under Part 8 includes a reference to an authority issued before the commencement of this Part.

Parts 4C (cll 128M–128P): Ins 2016 (409), Sch 1 [9].

128O Regulation applies as if etorphine were drug of addiction

This Regulation applies to etorphine as if it were a drug of addiction.

Parts 4C (cll 128M–128P): Ins 2016 (409), Sch 1 [9].

Part 4C Schedule 10 substances

Parts 4C (cll 128M–128P): Ins 2016 (409), Sch 1 [9].

128P Schedule 10 substances

(1)  A person must not manufacture, supply or use a Schedule 10 substance unless the person is authorised to do so by an authority under Part 8.

Maximum penalty—20 penalty units or imprisonment for 6 months, or both.

(2)  In this clause—

(a)  Schedule 10 substance means a substance specified in Schedule 10 of the current Poisons Standard, and

(b)  for the purposes of determining whether a substance is so specified, the definitions, other interpretation provisions and Appendices of the current Poisons Standard apply.

Parts 4C (cll 128M–128P): Ins 2016 (409), Sch 1 [9].

Part 5 Supply by wholesale and by holders of wholesaler’s licences and authorities

129 Persons authorised to possess or use substances and to be supplied by holder of wholesaler’s licence or authority

(1)  Each person specified in Appendix C is authorised to possess and use the substances specified in relation to that person in that Appendix subject to any conditions or qualifications that may be specified.

Note—

Section 11(1) of the Act creates an offence if the holder of a wholesaler’s licence or wholesaler’s authority supplies any Schedule 1, 2, 3 or 7 substance or any restricted substance to a person other than an authorised person. An authorised person includes a person who is authorised by or under the Act to use, or have possession of, the substance concerned.

(2)  Each person who is specified in Appendix C as being authorised to possess and use a substance is, for the purposes of paragraph (d) of the definition of Supply by wholesale in section 4(1) of the Act, authorised to be supplied with wholesale quantities of the substance.

(3)  For the purposes of section 10(2)(b) of the Act, the holder of a wholesaler’s licence or wholesaler’s authority is authorised to supply a Schedule 1, 2 or 3 substance otherwise than by wholesale to any person who is specified in Appendix C as being authorised to possess and use the substance.

Note—

Section 10(1) of the Act creates an offence of supplying a substance specified in Schedule 1, 2 or 3 of the Poisons List otherwise than by wholesale except under a general supplier’s licence or a general supplier’s authority. Section 10(2) of the Act provides for exceptions to this offence.

(4)  For the purposes of section 10(4)(d) of the Act, the holder of a wholesaler’s licence or wholesaler’s authority is authorised to supply a restricted substance otherwise than by wholesale to any person who is specified in Appendix C as being authorised to possess and use the substance.

Note—

Section 10(3) of the Act creates an offence of supplying a restricted substance otherwise than by wholesale. Section 10(4) of the Act provides for exceptions to this offence.

130 Restrictions on supply by wholesale

A person must not supply by wholesale any Schedule 2, 3 or 4 substance that is for therapeutic use—

(a)  to any person in another State or a Territory, unless the person being supplied with the substance is authorised by a law of that State or Territory to obtain or supply the substance, or

(b)  to any person outside Australia, unless the person supplying the substance is authorised to do so by a law of the Commonwealth.

Maximum penalty—15 penalty units.

131 Records of supply by wholesale

(1)  A person who supplies by wholesale any regulated goods must issue an invoice to the person being supplied and must keep a copy of the invoice.

(2)  Each invoice must show—

(a)  the date of the supply, and

(b)  the name and address of the person being supplied, and

(c)  the name, strength and quantity of the substance supplied, and

(d)  the name of the supplier and the address of the premises from which the goods were supplied.

Maximum penalty—20 penalty units.

cl 131: Am 2011 (480), Sch 1 [18].

132 Distribution of free samples

Any person—

(a)  who is engaged in the manufacture, or supply by wholesale, of any poison or restricted substance for therapeutic use, or

(b)  who is acting as an agent of a person so engaged,

must not supply any such poison or restricted substance by way of distribution of free samples otherwise than in a manner approved for the time being by the Director-General.

Maximum penalty—20 penalty units.

133 Storage of therapeutic substances for human use

(1)  A person who is engaged in the supply by wholesale of therapeutic substances for human use must ensure that the recommendations and requirements of the Wholesaling Code of Practice are complied with.

Maximum penalty—20 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.

(4)  In this clause, Wholesaling Code of Practice means the Code of Practice entitled Australian Code of Good Wholesaling Practice for Therapeutic Goods for Human Use, published by the Commonwealth Government, as in force from time to time or a code of practice that replaces that Code.

134 Pharmacists authorised to supply by wholesale in certain circumstances

(1)  A pharmacist is authorised to supply a substance by wholesale to another pharmacist if—

(a)  the pharmacist is requested to do so in writing signed by the other pharmacist, and

(b)  the other pharmacist is making the request to satisfy an order of a customer, and

(c)  the pharmacist, as far as is reasonably practicable supplies to that other pharmacist only the minimum amount of the substance that is necessary to satisfy the order of that customer.

(2)  A pharmacist is authorised to supply a substance by wholesale to another pharmacist if the pharmacist has previously been supplied an amount of the substance in accordance with subclause (1) and is supplying a similar amount of the substance as a replacement for that earlier supply.

Part 6 Preparation, handling, supply and labelling of therapeutic goods

Division 1 Preparation and handling of exposed substances

135 Application of Division

This Division applies to all therapeutic goods, and all substances used in the preparation of therapeutic goods, that are unpackaged or otherwise susceptible to contamination (in this Division referred to as exposed substances).

136 Preparation and handling generally

An authorised practitioner, pharmacist or practitioner of alternative medicine must ensure that—

(a)  all exposed substances that are prepared or handled on his or her business premises are free from any contamination and from anything that is likely to render them harmful or to have an adverse effect on their efficacy, and

(b)  all persons that he or she employs in the preparation or handling of exposed substances comply with the requirements of this Division.

Maximum penalty—20 penalty units.

137 Personal cleanliness

A person who is involved in the preparation or handling of exposed substances—

(a)  must be clean and must wear clean clothing, and

(b)  must clean his or her hands (by means of soap or detergent and water or by some other suitable cleaning process) before starting work and before resuming work after using the toilet.

Maximum penalty—10 penalty units.

138 Certain behaviour prohibited

A person who is involved in the preparation or handling of exposed substances, or who is in a place that is used for preparing or handling exposed substances, must not—

(a)  urinate, defecate or spit on, or

(b)  use, smoke or chew tobacco or any other similar substance in the vicinity of, or

(c)  sit, walk, stand or lie on,

any surface used for the purpose of preparing or handling exposed substances.

Maximum penalty—10 penalty units.

139 Contact with hands

(1)  A person who is involved in the preparation or handling of exposed substances—

(a)  must not have any unnecessary human contact with any such substance, and

(b)  must not handle any such substance with his or her fingers, but must use a suitable clean implement or disposable gloves to do so, and

(c)  must not touch his or her mouth, eye, ear, nose or scalp while handling any such substance, and

(d)  must not wipe his or her hands otherwise than with a clean towel, and

(e)  must not place, so that it can come into contact with any such substance, any ticket, label or other article that is unclean or liable to contaminate any such substance or that has been in contact with the person’s mouth, and

(f)  must not place in his or her pockets any implement or gloves to be used in preparing or handling any such substance.

(2)  A person who uses disposable gloves to handle an exposed substance must dispose of the gloves as soon as practicable.

Maximum penalty—10 penalty units.

140 Contact with mouth

A person who is involved in the preparation or handling of exposed substances must not apply to his or her mouth any implement used for preparing or handling any such substance.

Maximum penalty—10 penalty units.

141 Bandages

A person who is wearing an unclean bandage or a medicated or absorbent bandage must not prepare or handle exposed substances, or use any appliance, article or fitting for preparing or handling exposed substances, unless the bandage is protected and covered with a waterproof covering.

Maximum penalty—10 penalty units.

142 Persons suffering from infectious diseases

(1)  A person who is suffering from an infectious disease, or who has any exposed cut, sore, wound or skin eruption, must not prepare or handle exposed substances, or use any appliance, article or fitting for preparing or handling exposed substances.

Maximum penalty—10 penalty units.

(2)  This clause does not apply to an activity carried out by a person if the Director-General has certified in writing that the person may carry out that activity and the person complies with any conditions contained in the certificate.

143 Appliances, articles, fittings and surfaces

(1)  A person who is involved in the preparation or handling of exposed substances must not use any appliance, article or fitting for preparing or handling any such substance unless the appliance, article or fitting—

(a)  is designed and constructed so as to be easily cleaned, and

(b)  is kept clean.

Maximum penalty—10 penalty units.

(2)  A person who is involved in the preparation or handling of exposed substances must not cause or allow any such substance to come into contact with any surface used for preparing or handling any such substance unless the surface—

(a)  is designed and constructed so as to be easily cleaned, and

(b)  is kept clean.

Maximum penalty—10 penalty units.

Division 2 Supply of therapeutic goods

144 Premises to be free of vermin

A person must not use any premises for preparing, handling or supplying therapeutic goods unless the premises are clean and free from vermin.

Maximum penalty—10 penalty units.

145 Animals not permitted on premises

(1)  A person who uses any premises for preparing, handling or supplying therapeutic goods must not cause or permit any animal to be in those premises.

Maximum penalty—10 penalty units.

(2)  This clause does not apply to the premises of a veterinary practitioner.

Division 3 Labelling of unscheduled therapeutic substances

146 Labelling of unscheduled therapeutic substances

(1)  This clause applies to all therapeutic goods that are not therapeutic devices and are not included in a Schedule of the Poisons List (in this clause referred to as unscheduled therapeutic substances).

(2)  An authorised practitioner, pharmacist or practitioner of alternative medicine must ensure that any unscheduled therapeutic substances that are supplied from his or her business premises for therapeutic use are labelled in accordance with the requirements of Appendix A.

Maximum penalty—10 penalty units.

(3)  This clause does not apply to the supply of a substance by a person referred to in subclause (2) if—

(a)  the substance is supplied, unopened, in the container in which it was received by the person, and

(b)  the container is labelled in accordance with the requirements of the Commonwealth therapeutic goods laws.

Part 7 Analysis and disposal of seized goods

Division 1 Analysis of seized goods

147 Samples for analysis

(1)  An inspector who seizes a portion or sample of regulated goods for analysis—

(a)  must immediately notify the person from whom the portion or sample was taken of the inspector’s intention to submit it for analysis, and

(b)  must divide the portion or sample into 3 parts and properly fasten and seal each part or (if that is impracticable) properly fasten and seal the whole portion or sample.

(2)  If the portion or sample is divided into 3 parts, the inspector—

(a)  must return one part to the person from whom it was taken, and

(b)  must forward another part for analysis, and

(c)  must retain the remaining part.

(3)  If the portion or sample is not divided into 3 parts, the inspector must forward the whole of it for analysis.

(4)  For the purposes of this clause, a portion or sample is properly fastened and sealed if—

(a)  it is put into a container, and

(b)  the container is marked with the name and address of the person from whom it was taken, and

(c)  the container is fastened and sealed so as to prevent the container from being opened, or the name and address being removed, without the seal’s being broken.

148 Payment for sample

Payment for a portion or sample of regulated goods that is seized for analysis is to be made by the State, at current market value—

(a)  to the person from whom those goods were taken, or

(b)  if the person was not the owner of those goods, to the owner.

Division 2 Disposal of seized goods

149 Release of seized goods

(1)  Seized goods are to be released at the end of the period of 6 months after they were seized unless, before the end of that period, a Magistrate makes an order under this Division directing them to be forfeited to the State.

(2)  This clause does not prevent seized goods from being released before the expiration of that period.

(3)  Seized goods may be released—

(a)  by or at the direction of the inspector who seized them or by or at the direction of the Director-General, and

(b)  to the owner of the goods or the person in whose possession, care, custody or control they were at the time of the seizure.

(4)  This clause does not require the release of any goods that have been damaged or destroyed in the course of analysis.

(5)  A Magistrate may, in any particular case, extend the period referred to in subclause (1).

150 Order that seized goods be forfeited

(1)  A Magistrate may order that seized goods specified in the order be forfeited to the State on the expiration of any period so specified.

(2)  Such an order does not have effect in respect of any goods that have been released under this Division.

(3)  Before a Magistrate makes an order under this clause, the Magistrate may require such notice as he or she thinks fit to be given to such persons as he or she considers appropriate.

151 Order that expenses be paid

(1)  A Magistrate may order that a person, from whom goods have been seized under section 43 of the Act and who has been convicted of an offence in connection with those goods, must pay to the Director-General such amount as the Magistrate considers appropriate to cover the reasonable costs of—

(a)  seizing the goods, and

(b)  dealing with them under this Division, and

(c)  conducting any analysis for which they have been submitted.

(2)  Before a Magistrate makes an order under this clause, the Magistrate may require such notice as he or she thinks fit to be given to such persons as he or she considers appropriate.

(3)  An order under this clause operates as an order under the Civil Procedure Act 2005, and is enforceable as such an order under the provisions of that Act.

152 Storage of and interference with seized goods

(1)  Subject to any direction of the Director-General, seized goods may be kept or stored—

(a)  at the premises at which they were seized, or

(b)  at such other place as the inspector who seized them considers appropriate.

(2)  A person must not remove, alter or interfere in any way with seized goods without the authority of an inspector or the Director-General.

Maximum penalty—20 penalty units.

153 Forfeiture of goods with consent

If the owner of seized goods or the person in whose possession, care, custody or control they were at the time of their seizure consents in writing to their forfeiture, the goods are, by virtue of that consent, forfeited to the State.

154 Disposal of forfeited goods

Any goods forfeited under this Division may be disposed of in such manner as the Director-General may direct, either generally or in any particular case or class of cases.

Part 8 Licences and authorities

Division 1 Licences to supply Schedule 2 substances

155 Applications for licences

(1)  Any person who conducts, or proposes to conduct, a retail shop may apply for a licence to supply Schedule 2 substances from the shop.

(2)  The application—

(a)  must be in the form approved by the Director-General, and

(b)  must be accompanied by an application fee of $85, and

(c)  must be lodged with the Director-General.

(3)  The Director-General may require an applicant to furnish such further information as is necessary to enable the Director-General to determine the application.

cll 155: Am 2009 (490), cl 3 (1); 2012 (450), cl 3 (1); 2014 (534), cl 3 (1); 2015 (305), cl 3 (1); 2016 (286), cl 3 (1); 2017 (265), cl 3 (1); 2018 (232), cl 3 (1); 2019 (206), cl 3 (1).

156 Consideration of applications

(1)  After considering an application under this Division, the Director-General may issue the licence for which the application is made or may refuse the application.

(2)  In particular, the Director-General may refuse an application if of the opinion that the applicant is not a fit and proper person to hold the licence for which the application is made.

(3)  A licence may not be issued or renewed unless—

(a)  in the case of premises the subject of an existing licence issued before 7 April 1989 that is in force, the Director-General is satisfied that the premises to which the application relates are at least 6.5 kilometres (measured along the shortest practicable route) from the premises of the nearest retail pharmacist, or

(b)  in any other case, the Director-General is satisfied that the premises to which the application relates are at least 20 kilometres (measured along the shortest practicable route) from the premises of the nearest retail pharmacist.

157 Licences

(1)  A licence is to be in the form for the time being approved by the Director-General.

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

(3)  A licence is not transferable.

158 Conditions of licences

(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.

159 Annual licence fees

The holder of a licence under this Division must, on or before 31 March in each year following that in which the licence was issued, pay to the Director-General an annual licence fee of $85.

cll 159: Am 2009 (490), cl 3 (1); 2012 (450), cl 3 (1); 2014 (534), cl 3 (1); 2015 (305), cl 3 (1); 2016 (286), cl 3 (1); 2017 (265), cl 3 (1); 2018 (232), cl 3 (1); 2019 (206), cl 3 (1).

Division 2 Licences to supply by wholesale poisons and restricted substances

160 Applications for licences

(1)  Any person may apply to the Director-General for a licence to supply by wholesale any poisons or restricted substances.

(2)  The application—

(a)  must be in the form approved by the Director-General, and

(b)  must be accompanied by the relevant application fee, and

(c)  must be lodged with the Director-General.

(3)  The relevant application fee is—

(a)  $76, in the case of an application by a public institution, or

(b)  $505, in any other case.

(4)  The Director-General may require an applicant to furnish such further information as is necessary to enable the Director-General to determine the application.

cll 160: Am 2009 (490), cl 3 (2); 2010 (485), cl 3 (1); 2011 (394), cl 3 (1) (2); 2012 (450), cl 3 (2); 2013 (485) cl 3 (1); 2014 (534), cl 3 (2) (3); 2015 (305), cl 3 (2) (3); 2016 (286), cl 3 (2) (3); 2017 (265), cl 3 (2) (3); 2018 (232), cl 3 (2) (3); 2019 (206), cl 3 (2) (3).

161 Consideration of applications

(1)  After considering an application under this Division, the Director-General may issue the licence for which the application is made or may refuse the application.

(2)  In particular, the Director-General may refuse an application if of the opinion that the applicant is not a fit and proper person to hold the licence for which the application is made.

(3)  A licence may not be issued unless the Director-General is satisfied that the premises to which the application relates are appropriate for the supply of the poisons or restricted substances concerned.

162 Licences

(1)  A licence is to be in a form for the time being approved by the Director-General.

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

(3)  A licence is not transferable.

163 Conditions of licences

(1)  A licence is subject to such 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.

164 Annual licence fees

The holder of a licence under this Division 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)  $76, if the holder is a public institution, or

(b)  $505, in any other case.

cll 164: Am 2009 (490), cl 3 (2); 2010 (485), cl 3 (1); 2011 (394), cl 3 (1) (2); 2012 (450), cl 3 (2); 2013 (485) cl 3 (1); 2014 (534), cl 3 (2) (3); 2015 (305), cl 3 (2) (3); 2016 (286), cl 3 (2) (3); 2017 (265), cl 3 (2) (3); 2018 (232), cl 3 (2) (3); 2019 (206), cl 3 (2) (3).

Division 3 Licences to manufacture or supply drugs of addiction

165 Applications for licences

(1)  Any person may apply to the Director-General for a licence to manufacture drugs of addiction at, or to supply drugs of addiction from, any premises.

(2)  The application—

(a)  must be in the form approved by the Director-General, and

(b)  must be accompanied by the relevant application fee, and

(c)  must be lodged with the Director-General.

(3)  The relevant application fee for a licence to manufacture drugs of addiction is—

(a)  $76, in the case of an application by a public institution, or

(b)  $673, in any other case.

(4)  The relevant application fee for a licence to supply drugs of addiction is—

(a)  $17, in the case of an application by a charitable organisation, or

(b)  $76, in the case of an application by a public institution (other than a charitable organisation), or

(c)  $338, in any other case.

(5)  The Director-General may require an applicant to furnish such further information as is necessary to enable the Director-General to determine the application.

cl 165: Am 2009 (490), cl 3 (3) (4); 2010 (485), cl 3 (2) (3); 2011 (394), cl 3 (1) (3) (4); 2012 (45), cl 3 (3) (4); 2013 (485) cl 3 (2) (3); 2014 (534), cl 3 (2) (4) (5); 2015 (305), cl 3 (2) (4)–(6); 2016 (286), cl 3 (2) (4) (5); 2017 (265), cl 3 (2) (4) (5); 2018 (232), cl 3 (2) (4)–(6); 2019 (206), cl 3 (2) (4) (5).

166 Consideration of applications

(1)  After considering an application under this Division, the Director-General may issue the licence for which the application is made or may refuse the application.

(2)  In particular, the Director-General may refuse an application if of the opinion that the applicant is not a fit and proper person to hold the licence for which the application is made.

(3)  A licence may not be issued unless the Director-General is satisfied that the premises to which the application relates are appropriate for the manufacture or supply of drugs of addiction.

(4)  The Director-General is not empowered to issue a licence under this Division for the supply, under the program known as the New South Wales Opioid Treatment Program, of methadone or buprenorphine to drug dependent persons (as defined in section 27 of the Act) unless—

(a)  the licence is a replacement licence, or

(b)  the application for the licence is made by or on behalf of an agency that—

(i)  provides drug treatment services at premises under that Program to no more than 50 drug dependent persons who are resident at the premises while they are being treated, and

(ii)  is a member of the Network of Alcohol and Other Drug Agencies Incorporated.

(5)  To avoid doubt—

(a)  subclause (4) does not affect the validity or operation of any licence to supply methadone or buprenorphine that was in force immediately before 30 June 2006, and

(b)  the Director-General may—

(i)  add conditions to, or vary or revoke the conditions of, such a licence, or

(ii)  vary the premises to which such a licence relates, on the application of the licensee.

(6)  In this clause—

replacement licence means a licence to supply methadone or buprenorphine that replaces such a licence which is in force immediately before the replacement licence is issued.

cl 166: Am 2011 (537), cl 3.

167 Licences

(1)  A licence is to be in the form for the time being approved by the Director-General.

(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.

168 Conditions of licences

(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.

169 Annual licence fees

(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)  $76, if the holder is a public institution, or

(b)  $673, 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)  $17, if the holder is a charitable organisation, or

(b)  $76, if the holder is a public institution (other than a charitable organisation), or

(c)  $338, in any other case.

cl 169: Am 2009 (490), cl 3 (3) (4); 2010 (485), cl 3 (2) (3); 2011 (394), cl 3 (1) (3) (4); 2012 (450), cl 3 (3) (4); 2013 (485) cl 3 (2) (3); 2014 (534), cl 3 (2) (4) (5); 2015 (305), cl 3 (2) (4)–(6); 2016 (286), cl 3 (2) (4) (5); 2017 (265), cl 3 (2) (4) (5); 2018 (232), cl 3 (2) (4)–(6); 2019 (206), cl 3 (2) (4) (5).

Division 4 Authorities

170 Authorities

(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)  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.

(4)  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).

(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 (4).

171 Conditions of authorities

(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 5 Suspension and cancellation of licences and authorities

172 Grounds for suspension or cancellation

(1)  The Director-General must suspend or cancel a licence or authority on the occurrence 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 holder of the licence or authority has made a representation in connection with the licence or authority (including in connection with an application for the licence or authority) that is false or misleading in a material particular,

(e)  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 a term of 5 years or more.

173 Suspension or cancellation

(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 6 Modification of applied provisions of Commonwealth therapeutic goods laws

174 Modification of applied provisions of Commonwealth therapeutic goods laws with respect to advertising

(1)  Part 2 (Advertisements) of the Therapeutic Goods Regulations 1990 of the Commonwealth is modified in its application as a law of New South Wales 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.

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

Part 9 Miscellaneous

175 Director-General may restrict authorisations conferred by this Regulation

(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)(d), 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.

Maximum penalty—20 penalty units or imprisonment for 6 months, or both.

175A Exemption from storage requirements for goods requiring refrigeration

(1)  The Secretary may grant an exemption (which may be conditional) from a requirement of this Regulation relating to the storage of goods on the grounds that compliance with the requirement is not reasonably practicable because the goods require refrigeration.

(2)  The exemption may be granted—

(a)  to a person by written instrument on the application of the person, or

(b)  for a class of goods or class of persons, by order published in the Gazette.

cl 175A: Ins 2016 (409), Sch 1 [10].

176 Records generally

(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 a period of at least 2 years, commencing on 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 or imprisonment for 6 months, or both.

177 False or misleading entries in records and registers

(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 record or 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 or imprisonment for 6 months, or both.

Note—

Section 307A of the Crimes Act 1900 creates the offence of providing false or misleading information in certain circumstances. The offence carries a maximum penalty imprisonment for 2 years, or 200 penalty units, or both.

178 Service of notices

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.

179 Applications for authorities under section 29

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.

180 Quorum for Poisons Advisory Committee

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

181 Saving

Any act, matter or thing that, on the repeal of the Poisons and Therapeutic Goods Regulation 2002, had effect under that Regulation continues to have effect under this Regulation.

182 Licences and authorities for substance reclassified as type A drug of addiction

(1)  The reclassification of a substance from a designated non-ARTG product to a type A drug of addiction by the amending regulation does not affect any licence or authority under Part 8 of this Regulation that relates to the substance and that was in force immediately before that reclassification.

(2)  Despite subclause (1), an authority referred to in that subsection that authorises the prescription or supply of a substance by a medical practitioner to treat a particular person, is taken, on the commencement of the amending regulation to be an authority of the Secretary issued under section 29 of the Act.

(3)  In this clause—

amending regulation means the Poisons and Therapeutic Goods Amendment (Cannabis and Unregistered Drugs of Addiction) Regulation 2018.

cl 182: Ins 2018 (655), Sch 1 [22].

Appendix A Labelling of therapeutic substances

(Clauses 7, 26, 69 and 146)

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.

1 General

(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 approved name, strength and quantity of the substance,

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

(d)  adequate directions for use,

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

(f)  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,

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

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

(i)  if the substance is supplied in the circumstances referred to in clause 45 or 48, the words “EMERGENCY SUPPLY”.

2 Additional 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 45 or 48 must also bear—

(a)  the unique reference number recorded under clause 57 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.

3 Warning: therapeutic substances for internal use

The label on a container of a therapeutic substance specified in Appendix F to the current Poisons Standard 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.

4 Warning: quinine

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

5 Warning: other substances

(1)  This clause applies to the following substances—

amphetamine

chlorphentermine

dexamphetamine

diethylpropion

ephedrine

lisdexamfetamine

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 B Special restricted substances

(Clause 3(1))

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 C Persons authorised to possess and use substances

(Clause 129)

Note—

Clause 129 provides that each person who is authorised by this Appendix to possess and use a substance is also authorised to be supplied with the substance, whether by wholesale or otherwise, by the holder of a wholesaler’s licence or wholesaler’s authority.

1 Medical superintendents of hospitals

The medical superintendent of a hospital is authorised to possess and, if the medical superintendent is an authorised practitioner, use any Schedule 2, 3 or 4 substance that is required for use in connection with the medical treatment of persons at the hospital.

2 (Repealed)

3 Podiatrists

A registered podiatrist is authorised to possess and use synthetic cocaine substitutes (prepared for parenteral use) if required for use in connection with the practice podiatry.

4 Dental therapists or oral health therapists

(1)  A dental therapist or oral health therapist is authorised to possess and use the following substances if required for use in connection with dental therapy or oral health therapy—

benzocaine

lignocaine

mepivacaine

prilocaine

procaine

tetracycline (in preparations for treatment of dental pulp)

triamcinolone (in preparations for treatment of dental pulp)

(2)    (Repealed)

5 Dental hygienists

(1)  A dental hygienist is authorised to possess and use the following substances if required for use in connection with his or her practice as a dental hygienist—

(a)  benzocaine,

(b)  lignocaine,

(c)  mepivacaine,

(d)  prilocaine,

(e)  procaine.

(2)    (Repealed)

6 Registered 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 possess and use vaccines if required for use in vaccinating humans.

7 Emergency medical treatment by ambulance officers

A person—

(a)  who is employed in the Ambulance Service of NSW as an ambulance officer or as an air ambulance flight nurse, and

(b)  who is approved for the time being by the Director-General for the purposes of this clause,

is authorised to possess and use any Schedule 2, 3 or 4 substance that is approved by the Director-General for use by such persons in the carrying out of emergency medical treatment.

8 Emergency medical treatment of divers

A person—

(a)  who is a dive medical technician within the NSW Police Force, and

(b)  whose duties include the carrying out (under the supervision of a medical practitioner who is qualified in underwater medicine) of emergency medical treatment on divers,

is authorised to possess and use any substance referred to in the Table to this clause if the substance is required for the emergency medical treatment of divers and the substance complies with the requirements as to form and strength set out in that Table opposite that substance.

Table

Substance	Form	Strength
adrenaline	ampoule	not more than 0.01 per cent
amoxycillin with clavulanic acid	tablet	not more than 500 milligrams (amoxycillin) and 125 milligrams (clavulanic acid)
atropine	ampoule	not more then 600 micrograms per ampoule
dexamethasone with framycetin and gramicidin	ear drops	not more than 500 micrograms (dexamethasone), 5 milligrams (framycetin) and 50 micrograms (gramicidin)
diazepam	ampoule	not more than 10 milligrams per ampoule
diclofenac	tablet	not more than 50 milligrams
frusemide	ampoule	not more than 20 milligrams per ampoule
heparin	ampoule	not more than 25,000 units per 5 millilitres
lignocaine	ampoule	not more than 1 per cent
lignocaine with chlorhexidine	ampoule	not more than 2 per cent
metronidazole	tablet	not more than 200 milligrams
naloxone	ampoule	not more than 400 micrograms per ampoule
piroxicam	gel	not more than 0.5 per cent
prochlorperazine	ampoule	not more than 12.5 milligrams per ampoule
prochlorperazine	tablet	not more than 5 milligrams
trimethoprim with sulfamethoxazole	tablet	not more than 160 milligrams (trimethoprim) and 800 milligrams (sulfamethaxozone)

9 General 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 possess and use methoxyflurane and nitrous oxide if required in connection with the carrying out of first aid.

10 Industrial first aid

A person who is in control of an industrial first aid post is authorised to possess and use any Schedule 2 substance that is required in connection with the carrying out of industrial first aid.

11 First aid in mines

A person who is trained and authorised to administer first aid at a mine (within the meaning of the Work Health and Safety (Mines) Act 2013) is authorised to possess and use methoxyflurane and nitrous oxide if required for use in connection with the carrying out of first aid at a mine.

12 Asthma 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 18(3) of this Regulation is authorised to possess and use salbutamol or terbutaline in metered aerosols if required in connection with the carrying out of first aid.

13 Anaphylaxis first aid

A person is authorised to possess and use adrenaline if—

(a)  if the person requires the adrenaline for use in connection with the carrying out of anaphylaxis first aid, and

(b)  the adrenaline is contained in single use automatic injectors that have been filled by the manufacturer and that deliver no more than 0.3 milligrams of adrenaline each, and

(c)  the person holds a current first aid certificate issued after completion of a first aid course approved by the WorkCover Authority as referred to in regulations made under the Occupational Health and Safety Act 2000, and the person has received training on the symptoms and first aid management of anaphylaxis from—

(i)  a first aid training organisation approved by the WorkCover Authority, or

(ii)  any other organisation approved by the Director-General for the purposes of clause 18(5)(b)(ii) of this Regulation.

14 Ski 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 possess and use methoxyflurane, nitrous oxide and trichloroethylene if required for use in connection with the carrying out of ski rescues.

15 Animal feedstuff production

(1)  A person who is authorised under this Regulation to obtain a Schedule 2, 3 or 4 substance is authorised to possess and use the substance if the substance is required for use in connection with the commercial production of animal feedstuff or feedstuff premixes.

(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 5 or 6 to the Poisons List applies to the substance, or

(b)  that the substance is not a poison.

16 Bee keeping

(1)  A registered beekeeper is authorised to possess and use oxytetracycline in the form of a stock medicine (within the meaning of the Stock Medicines Act 1989) if—

(a)  required by the registered beekeeper for use in the treatment or prevention of European Foulbrood disease in bees, and

(b)  the registered beekeeper holds a written authority (issued by the Secretary of the Department of Industry, Skills and Regional Development) recommending the use, by that person, of that substance for that purpose.

(2)  In this clause—

registered beekeeper means a person registered to keep bees under the Biosecurity Act 2015.

17 Persons 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 possess and use any Schedule 2, 3 or 4 substance that the holder of the licence requires for use in accordance with that licence.

18 Miscellaneous trades and industries

A person who is engaged in any of the following activities is authorised to possess and use any Schedule 2 or 3 substance that is required for use in connection with that activity—

(a)  jewellery manufacture,

(b)  electroplating,

(c)  paint manufacture,

(d)  ferrous hardening,

(e)  commercial pest control,

(f)  mining gold or other precious metals,

(g)  refining non-ferrous metals.

19 Scientifically qualified persons

A scientifically qualified person in charge of a laboratory or department, or a person acting under the direct personal supervision of such a person, is authorised to possess and use any Schedule 2, 3 or 4 substance that is required for the conduct of medical or scientific research or instruction or the conduct of quality control or analysis.

20 Masters of ships

The master of a ship is authorised to possess and use any Schedule 2, 3 or 4 substance that is required by law to be carried on the ship for use in connection with the medical treatment of persons on the ship.

Appendix D Prescribed restricted substances

(Clause 61)

Substance	Prescribed quantity
Amylobarbitone when included in Schedule 4 of the Poisons List	50.0 grams
Anabolic and androgenic steroidal agents included in Schedule 4 of the Poisons List, except when referred to elsewhere in this Appendix	5.0 grams
Androisoxazole	5.0 grams
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
Darbepoetin	0.015 grams
Dextropropoxyphene when included in Schedule 4 of the Poisons List	15.0 grams
Diazepam	2.5 grams
Diethylpropion	5.0 grams
Dihydrolone	5.0 grams
Dimethandrostanolone	5.0 grams
Dimethazine	5.0 grams
Doxapram	2.0 grams
Drostanolone	2.0 grams
Enobosarm	0.3 grams
Ephedrine	5.0 grams
Epoetins	0.01 grams or 1,000,000 International Units
Erythropoietins (except when referred to elsewhere in this Appendix)	1,000,000 International Units
Ethchlorvynol	50.0 grams
Ethinamate	50.0 grams
Ethyldienolone	5.0 grams
Ethyloestrenol	1.0 gram
Fencamfamin	1.0 gram
Fenproporex	1.0 gram
Fluoxymesterone	2.0 grams
Flurazepam	10.0 grams
Follistatin	0.1 grams
Formebolone	1.0 gram
Formyldienolone	1.0 gram
Furazabol	0.5 gram
Glutethimide	50.0 grams
Hydroxystenozol	5.0 grams
Insulin-like growth factors	0.005 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	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
Selective androgen receptor modulators	0.3 grams
Silandrone	5.0 grams
Somatropin (human growth hormone)	0.25 grams
Stanolone	10.0 grams
Stanozolol	2.0 grams
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