Poisons Regulations 1965

Western Australia

Poisons Act 1964

Western Australia

Poisons Regulations 1965

CONTENTS

Part 1 — Preliminary

1. Citation 1

2. Interpretation 1

2AA. Prescribed office (section 64B) 5

2A. Exemptions 6

Part 2 — Licences and permits

Division 1 — General

3. Wholesaler’s licences and permits 7

5. Pharmaceutical chemist’s licence to sell poisons 8

7. Retailer’s licence to sell poisons specified in Schedule 2 to the Act 8

8. Retailer’s licence to sell poisons included in Schedule 7 to the Act 9

8A. Poisons permit (distribution of samples) 9

9. Poisons permit (industrial) 13

10. Poisons permit (educational, advisory or research) 13

10AA. Poisons permit (Health services) 13

10A. Poisons permit (departmental and hospital) 13

10B. Licence to cultivate prohibited plants 14

11. CEO may designate remote area nursing posts 14

11A. CEO may designate areas for the purposes of section 23 of the Act 14

12. Application for licence or permit (sections 24 and 25) 15

Division 2 — Needle and syringe programme

12A. Approval of needle and syringe programme 16

12B. Copy of approval to be provided 17

12C. Duties of coordinator 17

12D. Requirements relating to programme 18

12E. Direction to person 18

12F. Requirements relating to used hypodermic needles and syringes 19

Division 3 — Restrictions and obligations

15. Restriction to issue of licence or permit 20

16. Sale of poison only by licensee 20

17. Licence or permit not transferable 20

18. Licensee to display licence 21

Part 3 — Containers and labels

Division 1 — Containers

19. Adoption of SUSDP for containers and labels 22

19AA. Certain containers prohibited 22

19A. Food etc. containers to be distinguishable from poison containers 23

Division 2 — Labels

21. Labels on medicines or preparations 23

21A. Appendix K container must have appropriate label 26

24A. Carcinogenicity and teratogenicity warnings to be approved27

Division 3 — General

25. CEO may approve container or label 27

26. CEO may suspend use of container or label 27

Part 4 — Storage, disposal and loss or theft of poisons

30. Storage of substances other than those specified in regulation 56 29

31. Disposal of poisons 29

32. Notification of loss or theft of poison 29

Part 4A — Electronic prescribing systems

32A. Terms used in this Part 30

32B. Approval of electronic prescribing systems 30

32C. System administrators 32

32D. Offence provisions 32

32E. Miscellaneous rules 33

Part 5 — Sale, supply and use of poisons

Division 1 — Restrictions

33. Poison not to be sold to persons under 16 years 35

33A. Restrictions applying to veterinary preparations 35

33B. Adoption of SUSDP for certain paints 35

35. Restrictions on retail sale of substances included in Schedule 2 36

35A. Restrictions on retail sale of substances included in Schedule 3 36

35B. Storage of substances included in Schedule 3 38

35C. Advertising of substances included in Schedule 3 38

35D. Advertising of substances included in Schedule 4 39

Division 2 — Schedule 4 poisons

36. Supply of poisons included in Schedule 4 39

36AA. Provision of “approved starter packs” by registered nurses 44

36AAB. Provision of “psychiatric emergency packs” by certain registered nurses 48

36A. Storage of substances included in Schedule 4 52

36B. Record of supply or administration of substances included in Schedule 4 53

37. Conditions for prescription of a poison included in Schedule 454

38. Dispensing poisons included in Schedule 4 in emergency cases 56

38AA. Administration of poisons included in Schedule 4 in hospital 56

38C. Clomiphene and cyclofenil 57

38D. Etretinate or acitretin 57

38E. Prostaglandins 58

38F. Isotretinoin 59

38G. Thalidomide for human use 60

38H. Chloramphenicol 60

38I. Follicular stimulating hormone and luteinising hormone 61

38K. Carnidazole 61

38L. Oxolinic acid 61

38M. Clozapine 61

38N. Nitrofuran derivatives 62

38O. Bosentan for human use 62

38P. Teriparatide for human use 63

39. Veterinary use of poisons included in Schedule 4 63

39A. Stockfeed manufacturers may sell poisons included in Schedule 4 64

39BA. Use of poisons included in Schedule 4 on certificated commercial vessels 65

39BB. Use of poisons included in Schedule 4 on racing yachts 66

39B. Use of poisons included in Schedule 4 on ships and aircraft 68

39C. Use of poisons included in Schedule 4 on ships carrying livestock 69

40. Special authority to purchase poisons included in Schedule 470

40A. Delivery of a poison included in Schedule 4 on order 72

Division 3 — General

41. Revocation notice in relation to poisons included in Schedule 6 72

41A. Sale of poisons included in Schedule 7 73

41AA. Standard for intramammary antibiotic preparations 74

41AB. Camphor and naphthalene 74

41B. Record of poisons included in Schedule 3, 4 or 7 74

41C. Access to poisons included in Schedule 7 75

41D. Emergency supply of adrenaline in schools and child care centres 75

Part 6 — Drugs of addiction

Division 1 — General

42A. Interpretation 77

42. Authority for prescribed persons to procure and have poisons included in Schedule 8 77

43. Authority for pharmacists to retail, compound and dispense poisons included in Schedule 8 79

43A. Revocation notice in relation to poisons included in Schedule 8 and specified drugs 79

43B. Prescribed purposes (section 41(1)) 80

43C. Advertising of substances included in Schedule 8 80

44. Register of drugs of addiction 80

44A. Destruction of drugs of addiction and poisons included in Schedule 8 82

44B. Form of registers 84

44C. Control of access to electronic registers 85

45. Inventory of drugs of addiction 86

47. Records to be retained for 7 years and available on demand87

48. Returns from manufacturers and wholesalers 88

49A. Use of poisons included in Schedule 8 on certificated commercial vessels 88

49B. Use of poisons included in Schedule 8 on racing yachts 90

49. Use of poisons included in Schedule 8 on ships and aircraft 91

50. Used poisons included in Schedule 8 at hospitals 92

Division 2 — Supply and prescription

Subdivision 1 — Prescriptions generally

51. Prescriptions 93

Subdivision 2 — Supply and prescription to drug addicts

51A. Terms used 95

51AA. Disclosure by drug addict to medical practitioner 97

51B. Prescription and supply in accordance with this Subdivision — general provision 97

51BA. Prescribing drugs of addiction for drug addicts other than for the treatment of drug addiction97

51C. Designation of authorised prescribers and specialist prescribers 98

51CA. Appointment of medical practitioner as authorised prescriber for a drug addict 98

51CB. Appointment of co‑prescriber for a drug addict 98

51CC. Designations, authorisations and appointments — general rules 99

51D. Prescribing pharmacotherapies for the treatment of the drug addiction of a drug addict — general rules99

51DA. Prescribing pharmacotherapies for the treatment of the drug addiction of a drug addict — in a hospital101

51DB. Prescribing pharmacotherapies for the treatment of the drug addiction of a drug addict — in custody102

51DC. Prescribing pharmacotherapies for the treatment of the drug addiction of a drug addict — interim prescriptions102

51E. Dispensing drugs of addiction from a pharmacy 103

51EA. Dispensing pharmacotherapies from a pharmacy 103

Subdivision 2A — Supply and prescription of Schedule 8 poisons to persons other than drug addicts

51F. Treatment not to exceed 60 days unless authorised by CEO104

Subdivision 3 — Supply and prescription of stimulants

51FA. Terms used 106

51FB. Who may supply or prescribe a stimulant 107

51FC. Stimulant Prescribing Code 109

51FD. CEO may order treatment to be terminated or varied 110

51FE. CEO to be notified of supply or prescription 111

51FF. Current prescriber and current clinic 112

51FG. Authorisation of practitioners 113

51FH. Co‑prescribers 114

51FJ. Approval of public sector clinics 115

51FK. Change of manager 116

Subdivision 4 — Supply and prescription of other poisons

51GA. Supply of dronabinol 117

51GB. Supply of flunitrazepam 117

51H. Dentists not to prescribe or supply certain drugs of addiction119

Division 3 — Dispensing and delivery

52. Dispensing drugs of addiction 120

52A. Movement of drugs of addiction in other circumstances 127

52B. Manner of recording details 127

52C. Returns to department 127

53. Dispensing poisons included in Schedule 8 in case of emergency 128

53A. Dispensing certain poisons included in Schedule 8 129

54. Delivery of poisons included in Schedule 8 on order 130

54A. Packaging of drugs of addiction 131

55. Common carrier protected 131

Division 4 — Safe custody

56. Storing and securing drugs of addiction 132

56A. Prescribed amount of poisons included in Schedule 8 134

56B. Location of safe in premises 134

56C. Authorised persons to keep keys to safes 135

56D. Safes to be kept locked 135

56E. Pharmacist present on premises 135

56F. Keys to, and locking of, poisons cupboards and lockable drawers 136

56G. Poisons included in Schedule 8 in hospital ward 136

56H. Keys to, and locking of, cupboards in hospital wards 137

Division 5 — Restrictions on supply

57. Labelling 137

58. Improper prescribing or use of drugs of addiction 138

Part 7 — Miscellaneous provisions

59. Names of persons from whom licence or authority withdrawn to be published 139

64. Substitution of one brand of a drug for another 139

65. Form of warrant (section 55A) 140

Part 8 — Transitional provisions

Division 1 — Transitional provisions relating to the Poisons Amendment Regulations (No. 2) 2009

66. Terms used 141

67. Authorisation to prescribe drugs of addiction 141

68. Authorisation to prescribe pharmacotherapies 141

69. Prescriptions 142

70. Dispensing drugs of addiction from a pharmacy 142

Appendix A

Appendix G

Appendix H

Schedule 4 substances referred to in regulation 39(1)

Appendix J

Schedule 3 poison sales to be recorded

Appendix K

Criteria for electronic prescribing systems

Appendix L

Specified criteria for the generation of prescriptions by computer

Appendix M

Safes and additional security for storing drugs of addiction

1. Safes 165

2. Additional security requirements 166

Notes

Compilation table 167

Western Australia

Poisons Act 1964

Poisons Regulations 1965

Part 1 — Preliminary

[Heading inserted in Gazette 12 Aug 2003 p. 3664.]

[Heading deleted in Gazette 12 Aug 2003 p. 3663.]

1. Citation

These regulations may be cited as the Poisons Regulations 1965 1.

[Regulation 1 amended in Gazette 12 Oct 1984 p. 3267.]

[Heading deleted in Gazette 12 Aug 2003 p. 3663.]

2. Interpretation

(1) In these regulations unless the context requires otherwise —

animal includes bees, birds, cetaceans, crustaceans, fish, molluscs and reptiles;

approved electronic prescribing system means a system of electronic prescribing approved by the CEO under regulation 32B;

approved needle and syringe programme means a needle and syringe programme that has been approved by the CEO;

certificated commercial vessel means a fishing vessel, passenger vessel or trading ship as defined in the Western Australian Marine Act 1982 section 3(1);

child means a person under the age of 12 years;

coordinator, in relation to an approved needle and syringe programme, means the person nominated in an application referred to in regulation 12A to be the coordinator of that programme;

dermatologist means a medical practitioner who has qualifications recognised by the Medical Board as appropriate to a specialist in dermatology;

direction means regular and frequent supervision but does not necessarily imply continuous personal supervision;

director of nursing means a registered nurse appointed —

(a) to be in charge of a hospital; or

(b) to a remote area nursing post;

dispense, in relation to a medicine or a poison —

(a) means supply the medicine or poison on and in accordance with a prescription duly given by a medical practitioner, a nurse practitioner, a dentist or a veterinary surgeon; and

(b) in relation to a drug of addiction, has a meaning affected by regulation 42A;

distributor means a person who imports, sells or otherwise supplies a poison;

dosage unit means an individual dose of a poison and includes a tablet, capsule, cachet, single dose powder, or a single dose sachet of powders or granules;

experienced person means a person who for at least 5 years has been employed in the manufacture, handling or selling of poisons;

external in relation to the use of a poison, means application in the ears, eyes or nose, or to a body surface other than in the mouth, rectum, vagina, urethra or other body orifice;

gynaecologist means a medical practitioner who has qualifications recognised by the Medical Board as appropriate to a specialist in gynaecology;

immediate container includes any form of container in which a poison is directly packed, but does not include any such container intended for consumption or any immediate wrapper;

immediate wrapper means metal foil, plastic foil, waxed paper, or any other such material not intended for consumption, when used as the first wrapper for a dosage unit or dressing;

manufacture includes the processes of packing and repacking, refining manipulating and mixing any poison;

manufacturer means a person who manufactures, produces, or packs a poison;

Medical Board means the Medical Board established under section 4 of the Medical Act 1894;

obstetrician means a medical practitioner who has qualifications recognised by the Medical Board as appropriate to a specialist in obstetrics;

permit means a permit granted pursuant to the Act;

personal supervision means close and continuous control requiring the actual presence of the person exercising the supervision;

physician means a medical practitioner who has qualifications recognised by the Medical Board as appropriate to a specialist in general medicine;

poisons cupboard means a substantially made cupboard provided with an effective locking device and, except in the case of a cupboard used for the storage of a drug of addiction, having the word “Poison” conspicuously painted on the outside of the cupboard;

prescribe, in relation to a drug of addiction, has a meaning affected by regulation 42A;

psychiatrist means a medical practitioner whose name is contained in a register under section 89(1) of the Mental Health Act 1962 2;

public hospital means a public hospital as defined in section 2(1) of the Hospitals and Health Services Act 1927;

qualified person means —

(a) a medical practitioner, pharmaceutical chemist, dentist, veterinary surgeon;

(b) a person who is the holder of a degree approved by the CEO conferred by a University of the British Commonwealth;

(i) a Fellow or Associate of the Royal Australian Chemical Institute; or

(ii) a Fellow, Associate or Licentiate of the Royal Institute of Chemistry;

(d) any other person approved of by the CEO;

quarter means any one of the 3 monthly periods of any year ending on 31 March, 30 June, 30 September or 31 December;

racing yacht means a yacht participating in a race departing from this State;

registered nurse means a nurse whose name is entered in division 1 of the register referred to in section 33 of the Nurses Act 1992;

remote area nursing post means a remote area site designated as a remote area nursing post by the CEO under regulation 11;

sale includes exposing or offering for sale or having in possession for sale, whether by wholesale or retail, and also delivery with or without consideration, in any shop or store or premises appurtenant thereto by the keeper thereof or by his servant or agent; and the verb to sell has a corresponding meaning;

Schedule has the meaning given in the Act;

supply includes distribute and sell but the administration to a patient of any substance specified in any of the Schedules to the Act by a medical practitioner, nurse practitioner or dentist, or by a registered nurse when acting under the direction of a medical practitioner, or the administration of any substance specified in any of the Schedules to the Act to an animal under the direct personal supervision or under the direction of a veterinary surgeon, shall not be deemed to be supplying within the meaning of these regulations;

SUSDP has the meaning given in clause 1(1) of Appendix A to the Act;

the Act means the Poisons Act 1964.

(2) A prescription is issued electronically if it is issued under regulation 37(1A) or 51(1A).

[Regulation 2 amended in Gazette 23 Sep 1983 p. 3803; 29 Jun 1984 p. 1784; 28 Feb 1986 p. 618; 5 Dec 1986 p. 4467; 27 May 1988 p. 1769; 25 Aug 1989 p. 2842 (as amended in Gazette 6 Oct 1989 p. 3738); 8 Jun 1990 p. 2626; 23 Nov 1990 p. 5791; 12 Apr 1991 p. 1608; 7 Aug 1992 p. 3868; 25 Jun 1993 p. 3078‑9; 26 May 1994 p. 2197; 24 Jun 1994 p. 2865; 2 Sep 1994 p. 4533; 23 Dec 1994 p. 7076; 28 Apr 1995 p. 1466 and 1466‑7; 5 Sep 1995 p. 4162; 19 Sep 1995 p. 4383; 17 Jan 1996 p. 267; 19 Mar 1996 p. 1216‑17; 11 Apr 1997 p. 1829; 27 Nov 1998 p. 6343; 12 Aug 2003 p. 3658; 15 Nov 2005 p. 5603; 15 Dec 2006 p. 5630; 7 Nov 2008 p. 4805; 12 Jun 2009 p. 2109; amended by No. 9 of 2003 s. 41.]

2AA. Prescribed office (section 64B)

For the purposes of section 64B of the Act, the office of the Pharmaceutical Services, Environmental Health Branch of the department, located at Grace Vaughan House, 227 Stubbs Terrace, Shenton Park, is prescribed as the office of the department at which a copy of every standard referred to in the Act is to be kept and made available to the public for inspection.

[Regulation 2AA inserted in Gazette 19 Mar 1996 p. 1217.]

2A. Exemptions

Excluding substances included in Schedule 8 and Schedule 9 and specified drugs, the provisions of the Act do not apply to —

(a) poisons listed in Column 1 of Appendix G to the SUSDP in a product at a concentration the same or less than that specified in Column 2;

(b) poisons in a product listed in Appendix A to the SUSDP;

(c) paints, except when prepared for medicinal or cosmetic purposes, which contain substances included in Schedule 5; and

(d) paints, except when prepared for medicinal or cosmetic purposes, which contain poisons listed in the First, Second or Third Schedule of Appendix I to the SUSDP, if —

(i) the proportion of the poison is less than the proportion specified in those schedules; or

(ii) the proportion of the poison is within the limits specified in those schedules and the container is labelled in accordance with the provisions of Part 2 of the SUSDP.

[Regulation 2A inserted in Gazette 12 Nov 1993 p. 6146‑7; amended in Gazette 19 Sep 1995 p. 4383; 19 Mar 1996 p. 1217; 14 Sep 2001 p. 5073.]

[Heading deleted in Gazette 12 Aug 2003 p. 3663.]

Part 2 — Licences and permits

[Heading inserted in Gazette 12 Aug 2003 p. 3664.]

Division 1 — General

[Heading inserted in Gazette 12 Aug 2003 p. 3664.]

3. Wholesaler’s licences and permits

(1) A wholesaler’s licence authorises the licensee to procure, manufacture and supply by wholesale dealing specified poisons at or from specified premises.

(2) A wholesaler’s licence is to be in the form of Form 1 in Appendix A.

(3) A wholesaler’s licence is subject to the condition that any manufacture of a poison under the licence be carried out by —

(a) a specified qualified person or a qualified person authorised under subregulation (4); or

(b) an experienced person acting under the personal supervision of a person referred to in paragraph (a).

(4) A wholesaler’s licence is subject to the condition that any supply of a poison under the licence be carried out by —

(a) a specified qualified person or a qualified person authorised under subregulation (4); or

(b) a specified experienced person or an experienced person authorised under subregulation (4).

(5) If a person specified in a wholesaler’s licence for the purposes of subregulation (3)(a) or (4) —

(a) ceases to work for the licensee; or

(b) in the case of a qualified person specified for the purposes of subregulation (3), is unable to exercise the necessary supervision,

the CEO may in writing authorise another qualified or experienced person (as the case requires) to act in the specified person’s stead.

(6) In this regulation —

specified means specified in a wholesaler’s licence.

[Regulation 3 inserted in Gazette 14 Sep 2001 3 p. 5073‑4; amended in Gazette 15 Dec 2006 p. 5630.]

[4. Deleted in Gazette 14 Sep 2001 p. 5073.]

[Heading deleted in Gazette 12 Aug 2003 p. 3663.]

5. Pharmaceutical chemist’s licence to sell poisons

A pharmaceutical chemist shall not sell or supply any poison except at or from a pharmacy registered under the Pharmacy Act 1964, and described in the licence issued under these regulations as provided in Form 3 in Appendix A.

[Heading deleted in Gazette 12 Aug 2003 p. 3663.]

[6. Deleted in Gazette 19 Mar 1996 p. 1217.]

[Heading deleted in Gazette 12 Aug 2003 p. 3663.]

7. Retailer’s licence to sell poisons specified in Schedule 2 to the Act

This licence shall authorise the licensee to procure, and to sell by retail, poisons included in Schedule 2 at the premises described in the licence, and shall be in the Form 5 in Appendix A.

[Regulation 7 amended in Gazette 23 May 1986 p. 1716; 19 Mar 1996 p. 1217.]

[Heading deleted in Gazette 12 Aug 2003 p. 3663.]

8. Retailer’s licence to sell poisons included in Schedule 7 to the Act

This licence shall authorise the licensee to procure, and to sell by retail, poisons included in Schedule 7 to the Act at the premises described in the licence, and shall be in the Form 6 in Appendix A.

[Heading deleted in Gazette 12 Aug 2003 p. 3663.]

8A. Poisons permit (distribution of samples)

(1) This permit shall, subject to the succeeding provisions of this regulation, authorise the holder to procure from any manufacturer or wholesale supplier specified therein and to supply to certain persons, samples of poisons included in Schedule 2, 3 or 4 and the permit shall be in the Form 6B in Appendix A.

(1a) A permit under this regulation may not be issued in respect of a drug declared to be a specified drug for the purposes of the Act.

(2) A permit under this regulation may be granted only to a person who is —

(a) a representative of a person —

(i) licensed to manufacture poisons or to supply poisons by wholesale dealing; or

(ii) licensed under the provisions of the laws of any other State or Territory of the Commonwealth to manufacture poisons or to supply poisons by wholesale dealing;

(b) not less than 21 years of age; and

and the holder of a permit shall, for the purposes of these regulations, be known as a detailer.

(3) A permit under this regulation shall contain the name and address of the detailer and the name of each manufacturer or wholesale supplier whom he represents.

(4) Where a detailer ceases to represent a manufacturer or wholesale supplier named in his permit —

(a) the permit shall thereupon cease to authorise the detailer to procure samples from that manufacturer or wholesale supplier or to supply to any person samples procured at any time from that manufacturer or wholesale supplier;

(b) the detailer shall return to the manufacturer or wholesale supplier any samples that were procured from the manufacturer or wholesale supplier and that are still in the possession or control of the detailer; and

(c) within 7 days of ceasing to represent the manufacturer or wholesale supplier, the detailer shall advise the CEO in writing of the fact and deliver up therewith his permit to the CEO and the CEO shall delete from the permit the name of the manufacturer or wholesale supplier or shall cancel the permit, as the case requires.

(5) A detailer shall not supply a sample to any person who is not —

(a) a medical practitioner;

(b) a veterinary surgeon;

(d) a pharmacist.

(6) A detailer shall not procure, carry or supply a sample —

(a) in the case of an oral contraceptive, for more than 2 months use; or

(b) in any other case, for more than 7 days use,

where the use is in accordance with directions with the sample for maximum dosage, unless the person wishing to be supplied with a larger sample has first made a written request to the manufacturer or wholesale supplier represented by the detailer for the supply of the sample.

(7) Subregulation (6) does not apply to a sample of a proprietary preparation where —

(a) the sample is the smallest size manufactured for sale; and

(b) the CEO, on the recommendation of the Poisons Advisory Committee, has declared such a sample to be a sample to which subregulation (6) does not apply, notwithstanding that the sample may be used —

(i) in the case of an oral contraceptive, for more than 2 months; or

(ii) in any other case, for more than 7 days,

where the use is in accordance with directions with the sample for maximum dosage.

(8) A detailer shall not carry more than —

(a) 25 samples of any single proprietary preparation; or

(b) samples of more than 5 different proprietary preparations,

in a vehicle at any one time.

(9) Where the proper storage of a poison requires that poison be stored under special conditions or at specific temperatures, a detailer shall not store or transport that poison except in a manner which maintains those conditions or temperatures.

(10) Subject to subregulation (11), a detailer shall not cause or permit samples in his possession or control to be stored other than —

(a) on the premises of the manufacturer or wholesale supplier whom he represents; or

(b) at his address as specified in his permit.

(11) A detailer may keep samples in a vehicle while he is actually using that vehicle in the course of his business, but at no other time.

(12) Where pursuant to this regulation samples are stored at an address specified in a detailer’s permit which is not a wholesale supplier’s premises, the detailer shall cause those samples to be stored in a locked cupboard or locked refrigerator and a detailer shall not cause or permit —

(a) more than 100 samples of any single proprietary preparation; or

(b) samples of more than 5 different proprietary preparations,

to be kept at that address at any one time.

(13) A detailer shall not supply a sample unless —

(a) he has received a signed request from a person to whom he is authorised in accordance with subregulation (5) to supply the sample; and

(b) immediately upon supplying the sample, he signs and dates the request form to certify that the sample has been delivered.

(14) A detailer shall keep a record of every sample received or supplied by him and shall preserve all records so kept together with consignment notes, invoices, advice notes and request forms relating thereto, for not less than 2 years.

(15) Upon receiving a written request from the CEO a detailer shall submit all records of samples received and delivered and shall make an account of those samples to the CEO or a person authorised in accordance with section 54 of the Act.

(16) For the purposes of this regulation —

proprietary preparation means one or more forms of a poison intended for therapeutic use boxed or wrapped in a single sample package;

sample means a sample package containing a poison intended for therapeutic use included in Schedule 2, 3 or 4.

[Regulation 8A inserted in Gazette 22 Sep 1969 p. 2874‑6; amended in Gazette 29 Jun 1984 p. 1784; 12 Apr 1991 p. 1608; 16 Apr 1992 p. 1634; 7 Aug 1992 p. 3865; 25 Jun 1993 p. 3079 and 3085; 26 May 1994 p. 2201; 19 Mar 1996 p. 1218; 15 Dec 2006 p. 5630.]

[Heading deleted in Gazette 12 Aug 2003 p. 3663.]

9. Poisons permit (industrial)

This permit shall authorise the holder to purchase from a manufacturer or wholesale supplier such poisons as are specified in the permit, which shall be in the Form 7 in Appendix A.

[Regulation 9 amended in Gazette 19 Mar 1996 p. 1218.]

[Heading deleted in Gazette 12 Aug 2003 p. 3663.]

10. Poisons permit (educational, advisory or research)

This permit shall authorise the holder to purchase from a manufacturer or wholesale supplier such poisons as are specified in the permit, which shall be in the Form 8 in Appendix A.

[Regulation 10 amended in Gazette 19 Mar 1996 p. 1218.]

10AA. Poisons permit (Health services)

(1) This permit shall authorise the holder to purchase from a manufacturer or wholesale supplier such poisons as are specified in the permit, which shall be in the Form 8AA in Appendix A.

(2) The permit may not be granted to —

(a) a department or instrumentality of the State or of the Commonwealth; or

(b) a public hospital.

[Regulation 10AA inserted in Gazette 4 Apr 2006 p. 1406.]

[Heading deleted in Gazette 12 Aug 2003 p. 3663.]

10A. Poisons permit (departmental and hospital)

(1) This permit shall authorise the holder to purchase from a manufacturer or wholesale supplier such poisons as are specified in the permit which shall be in the Form 13 in Appendix A and shall not, except in the case of a permit held by a public hospital, authorise the sale of any poison obtained by the permit holder under the authority of the permit.

(2) This permit may be granted only to —

(a) a department or instrumentality of the State or of the Commonwealth; and

(b) a public hospital.

[Regulation 10A inserted in Gazette 14 Jun 1967 p. 1582; amended in Gazette 19 Mar 1996 p. 1219; 12 Aug 2003 p. 3658.]

10B. Licence to cultivate prohibited plants

A licence under section 41A of the Act shall be in the form of Form 13A in Appendix A.

[Regulation 10B inserted in Gazette 23 Aug 1996 p. 4089.]

[Heading deleted in Gazette 27 May 1988 p. 1789.]

11. CEO may designate remote area nursing posts

(1) The CEO may, in writing, designate a remote area site to be a remote area nursing post for the purposes of these regulations.

(2) The CEO may amend or withdraw a designation under subregulation (1), in writing, at any time.

[Regulation 11 inserted in Gazette 24 Jun 1994 p. 2865; amended in Gazette 15 Dec 2006 p. 5630 and 5631.]

11A. CEO may designate areas for the purposes of section 23 of the Act

(1) The CEO may, in writing, designate an area for the purposes of section 23(2)(e) of the Act.

(2) The CEO may amend or withdraw a designation under subregulation (1), in writing, at any time, subject to subregulation (4).

(3) The CEO may not designate an area under subsection (1) until after receiving —

(a) written advice with respect to the proposal to designate the area from the officer of the department who is principally responsible for providing advice on matters related to nursing; and

(b) clinical protocols for the proposed area approved in writing by —

(i) the officer referred to in paragraph (a);

(ii) the person holding or acting in the office of Executive Director, Personal Health Services in the department; and

(iii) the person holding or acting in the office known as Executive Director, Population Health, or if there is no such office at the relevant time, the office of Executive Director, Public Health and Scientific Support Services in the department.

(4) The CEO may not amend or withdraw a designation under this section until after receiving written advice with respect to the proposed action from the officer of the department who is principally responsible for providing advice on matters related to nursing.

[Regulation 11A inserted by Act No. 9 of 2003 s. 42; amended in Gazette 15 Dec 2006 p. 5630 and 5631.]

[Heading deleted in Gazette 12 Aug 2003 p. 3663.]

12. Application for licence or permit (sections 24 and 25)

(1) A person who wishes to apply for a licence under section 24 of the Act or a permit under section 25 of the Act shall lodge with the CEO an application in such form as may be approved by the CEO from time to time for that purpose.

(2) An applicant under this regulation must indicate in the application whether the application is for a period of one year or for 3 years.

(3) The appropriate fees for licences or permits, and renewals of licences or permits, are those set out in Appendix G.

(4) Where the applicant for a licence or permit applies on behalf of a corporate body or firm the application shall contain the name of a natural person who, in respect of the premises named in the application, shall be responsible for carrying out the provisions of the Act and these regulations.

(5) The CEO may only grant an application and issue a licence or permit, or renew a licence or permit, if the application under this regulation is accompanied by the appropriate fee set out in Appendix G.

[Regulation 12 inserted in Gazette 19 Mar 1996 p. 1219; amended in Gazette 15 Dec 2006 p. 5630.]

Division 2 — Needle and syringe programme

[Heading inserted in Gazette 12 Aug 2003 p. 3664.]

12A. Approval of needle and syringe programme

(1) A person may apply to the CEO for the approval of a needle and syringe programme.

(2) An application referred to in subregulation (1) shall —

(a) be in the form of Form 14 in Appendix A; and

(b) nominate a person to be the coordinator of the programme.

(3) The CEO may by notice in writing require an applicant to provide further information with respect to the application.

(4) An approval of a needle and syringe programme shall —

(a) be given by instrument in writing signed by the CEO;

(b) clearly identify the programme that is being approved by reference to the activity or activities, and the persons or class of persons engaging in the activity or activities, that constitute the programme; and

(5) The CEO is not to approve a needle and syringe programme unless the CEO is satisfied that the coordinator of the programme —

(a) has attained the age of 18 years;

(b) is a person of good character and repute and is a fit and proper person to coordinate the needle and syringe programme; and

[Regulation 12A inserted in Gazette 26 May 1994 p. 2197‑8; amended in Gazette 15 Dec 2006 p. 5630.]

12B. Copy of approval to be provided

Where the CEO approves a needle and syringe programme, the CEO is to provide a copy of the instrument of approval to the coordinator of the programme.

[Regulation 12B inserted in Gazette 26 May 1994 p. 2198; amended in Gazette 15 Dec 2006 p. 5630.]

12C. Duties of coordinator

The coordinator of an approved needle and syringe programme shall —

(a) maintain a register of all persons who participate in the conduct of the programme;

(b) ensure that persons who participate in the conduct of the programme understand the requirements of these regulations and are appropriately instructed and trained;

(d) report to the CEO any irregularities that occur in the conduct of the programme.

[Regulation 12C inserted in Gazette 26 May 1994 p. 2198; amended in Gazette 15 Dec 2006 p. 5630.]

12D. Requirements relating to programme

(1) Where the CEO approves a needle and syringe programme, the CEO may specify in the approval a requirement that the programme only be conducted —

(a) at a specified place or specified places; or

(b) between specified times.

(2) A person shall not conduct, or participate in the conduct of, an approved needle and syringe programme except at a place or between times specified in the approval.

[Regulation 12D inserted in Gazette 26 May 1994 p. 2199; amended in Gazette 15 Dec 2006 p. 5630.]

12E. Direction to person

(1) Where the CEO is of the opinion that a person is not a suitable person to participate in the conduct of an approved needle and syringe programme, the CEO may, by notice in writing served on that person, direct the person not to participate in the programme.

(2) A person shall not contravene a direction under subregulation (1).

[Regulation 12E inserted in Gazette 26 May 1994 p. 2199; amended in Gazette 15 Dec 2006 p. 5630.]

12F. Requirements relating to used hypodermic needles and syringes

(1) A person shall not, in the course of the conduct of an approved needle and syringe programme, accept any used hypodermic syringe or used hypodermic needle unless the syringe or needle has been exhausted.

(2) For the purposes of subregulation (1), a hypodermic syringe or a hypodermic needle shall be taken to have been exhausted if it contains no more than the residue of any drug.

(3) A person who, in the course of the conduct of an approved needle and syringe programme, receives any used hypodermic needle or used hypodermic syringe shall immediately place the needle and syringe in a receptacle of a type approved by the CEO and the Commissioner of Police.

[Regulation 12F inserted in Gazette 26 May 1994 p. 2199; amended in Gazette 15 Dec 2006 p. 5630.]

[Heading deleted in Gazette 12 Aug 2003 p. 3663.]

[13, 14. Deleted in Gazette 19 Mar 1996 p. 1219.]

Division 3 — Restrictions and obligations

[Heading inserted in Gazette 12 Aug 2003 p. 3664.]

15. Restriction to issue of licence or permit

A licence or permit shall not be issued to any person under the age of 21 years, unless he is a qualified person approved by the CEO.

[Regulation 15 amended in Gazette 29 Jun 1984 p. 1784; 25 Jun 1993 p. 3085; 26 May 1994 p. 2201; 15 Dec 2006 p. 5630.]

16. Sale of poison only by licensee

A sale of any poison shall not be made by any person other than the licensee or a person, not less than 15 years of age, acting on his behalf.

[Regulation 16 amended in Gazette 21 Nov 1986 p. 4270; 24 Jun 1994 p. 2865.]

17. Licence or permit not transferable

A licence or permit is not transferable from one person to another.

Provided that —

(a) a licence or permit held in the name of a person on behalf of a firm or corporate body may, on endorsement by the CEO, be transferred into the name of another person on behalf of the firm or corporate body;

(b) the holder of a licence or permit who ceases to carry on or conduct the business or practice to which the licence or permit relates shall within 14 days surrender such licence or permit to the CEO.

[Regulation 17 amended in Gazette 29 Jun 1984 p. 1784; 25 Jun 1993 p. 3085; 26 May 1994 p. 2201; 15 Dec 2006 p. 5630.]

18. Licensee to display licence

The holder of a licence shall keep such licence displayed in a conspicuous place within the premises specified in the licence.

[Heading deleted in Gazette 12 Aug 2003 p. 3663.]

Part 3 — Containers and labels

[Heading inserted in Gazette 12 Aug 2003 p. 3664.]

Division 1 — Containers

[Heading inserted in Gazette 12 Aug 2003 p. 3664.]

19. Adoption of SUSDP for containers and labels

(1) Except as provided by these regulations a person shall not store, supply or transport a poison unless the immediate container in which the poison is stored, supplied or transported complies with Part 2 of the SUSDP.

(2) Except as provided by these regulations a person shall not store, supply or transport a poison unless the container referred to in subregulation (1) bears or has securely affixed to it a label which complies with Part 2 of the SUSDP.

(2a) For the purposes of this regulation, the interpretation provisions of Part 1 of the SUSDP shall be used to interpret Part 2 of the SUSDP as adopted by this regulation.

[Regulation 19 inserted in Gazette 23 Nov 1990 p. 5791; amended in Gazette 24 Jun 1994 p. 2865; 19 Mar 1996 p. 1219.]

19AA. Certain containers prohibited

(1) An immediate container on which the name of any poison is embossed or otherwise permanently marked shall not be used except to contain that poison.

(2) A paper or plastic bag or envelope, or a cardboard box shall not be used as a container for a Schedule 2, 3, 4, 8 or 9 poison whether dispensed or not, unless the poison is also presented to the purchaser in foil or in individually sealed, measured amounts, commonly described as strip packaging, or unless the container is approved by the CEO.

(3) A paper bag shall not be used as the sole container of any poison unless it has been approved by the CEO.

[Regulation 19AA inserted in Gazette 23 Nov 1990 p. 5791; amended in Gazette 26 May 1994 p. 2201; 19 Mar 1996 p. 1219‑20; 15 Dec 2006 p. 5630.]

19A. Food etc. containers to be distinguishable from poison containers

A person shall not sell any food, drink, or condiment, or any drug or medicine for internal use, in a container —

(a) of a description which is not readily distinguishable by sight and touch from a container in which a poison intended for external use may be sold; or

(b) of a like description to that prescribed for a container in which a poison intended for external use may be sold.

[Regulation 19A inserted in Gazette 26 May 1971 p. 1773; amended in Gazette 19 Mar 1996 p. 1220.]

[Heading deleted in Gazette 12 Aug 2003 p. 3663.]

[20. Deleted in Gazette 23 Nov 1990 p. 5792.]

Division 2 — Labels

[Heading inserted in Gazette 12 Aug 2003 p. 3664.]

21. Labels on medicines or preparations

(1) Notwithstanding regulation 19, a medicine or preparation containing any poison dispensed or supplied in the course of the professional practice of —

(a) a pharmaceutical chemist, medical practitioner, nurse practitioner, registered nurse at a remote area nursing post, or dentist, for human internal use shall comply with that regulation if it is labelled in the English language with —

(i) the words “Keep out of reach of children”;

(ii) the name and strength or amount of each poison in the preparation, or the trade name and strength of the preparation (unless the trade name also uniquely identifies the strength, in which case only the trade name need be given);

(iii) the name of the patient;

(iv) a date of dispensing or supply, and a number identifying the prescription or supply which corresponds to —

(I) the entry in the Prescription Book referred to in regulation 36(3)(c), in the case of a pharmaceutical chemist; or

(II) the patient’s records, in the case of a medical practitioner, nurse practitioner, registered nurse at a remote area nursing post, or dentist;

(v) the name and address of the pharmacy, or medical or dental surgery, or area designated under section 23(2)(e) of the Act, or remote area nursing post, from which it is supplied;

(vi) the instructions given on the prescription, if dispensed by a pharmaceutical chemist, or directions for use, if supplied by a medical practitioner, nurse practitioner, registered nurse at a remote area nursing post, pharmaceutical chemist or dentist; and

(vii) the total quantity contained;

(b) a pharmaceutical chemist, medical practitioner, nurse practitioner, registered nurse at a remote area nursing post or dentist, for human external use shall comply with that regulation if it is labelled in accordance with paragraph (a), together with the words “Not to be taken”;

(c) a pharmaceutical chemist or veterinary surgeon, for use on any animal shall comply with that regulation if it is labelled in the English language with —

(i) the words “Keep out of reach of children”;

(iii) the owner’s surname and the species of animal;

(iv) instructions for the use of that medicine or preparation;

(v) a date of dispensing, and a number identifying the prescription or supply which corresponds to —

(I) the entry in the Prescription Book referred to in regulation 36(3)(c), in the case of a pharmaceutical chemist; or

(II) the patient’s records, in the case of a veterinary surgeon;

(vi) the name and address of the pharmacy, or veterinary practice, from which it is supplied;

(vii) the words “For veterinary use only” or “For animal treatment only”, together with the words “For external use only” if the medicine or preparation is not prepared for internal use; and

(viii) the total quantity contained.

(2) Subregulations (1)(a) and (b) do not apply to a medicine or preparation (containing a poison) labelled in accordance with regulation 19, if it is supplied by a medical practitioner for the purposes of therapeutic treatment of a patient over a period of not more than 3 days.

[Regulation 21 inserted in Gazette 7 Aug 1992 p. 3865‑6; amended in Gazette 24 Jun 1994 p. 2865‑6; 19 Mar 1996 p. 1220; amended by Act No. 9 of 2003 s. 43.]

21A. Appendix K container must have appropriate label

(1) A person, whether a pharmaceutical chemist or otherwise, shall not sell, supply, distribute or dispense a poison for internal human use set out in Appendix K of the SUSDP unless the container immediately containing the poison bears, or has securely affixed to it a label bearing either of the following statements —

“This medicine may cause drowsiness. If affected do not drive a motor vehicle or operate machinery. Avoid alcohol.”; or

“This medicine may cause drowsiness and may increase the effects of alcohol. If affected do not drive a motor vehicle or operate machinery.”.

(2) Subregulation (1) shall not apply to —

(a) a person licensed pursuant to section 24(1)(a) of the Act; and

(b) the supply by a medical practitioner of any poison or substance containing a poison for the purposes of therapeutic treatment to a patient while that patient is hospitalised.

(3) A statement set out in subregulation (1) shall be in letters not less than 1.5 mm in height and in a colour which provides a distinct contrast to the background colour of the container or label on which the statement appears.

(4) In this regulation —

height means the height of capital letters or lower case letters having an ascender or a descender.

[Regulation 21A inserted in Gazette 11 Jul 1986 p. 2339; amended in Gazette 19 Mar 1988 p. 838; 24 Jun 1994 p. 2866; 19 Mar 1996 p. 1220.]

[22‑24. Deleted in Gazette 23 Nov 1990 p. 5792.]

24A. Carcinogenicity and teratogenicity warnings to be approved

A person shall not include on a label a statement relating to carcinogenicity or teratogenicity in relation to any poison unless the statement in relation to the poison has been approved by the CEO.

[Regulation 24A inserted in Gazette 17 Aug 1990 p. 4081; amended in Gazette 26 May 1994 p. 2201; 19 Mar 1996 p. 1220; 15 Dec 2006 p. 5630.]

[Heading deleted in Gazette 12 Aug 2003 p. 3663.]

Division 3 — General

[Heading inserted in Gazette 12 Aug 2003 p. 3664.]

25. CEO may approve container or label

The CEO may approve, in writing, a container or label which does not comply with these regulations if, having regard to the nature of the poison and the purpose for which it is to be used, it is unlikely that the interests of safety will be adversely affected by the use of such container or label.

[Regulation 25 amended in Gazette 29 Jun 1984 p. 1784; 25 Jun 1993 p. 3085; 26 May 1994 p. 2201; 15 Dec 2006 p. 5630 and 5631.]

26. CEO may suspend use of container or label

The CEO may, in the interest of safety, suspend or prohibit the use of any form of container or label for the packing or labelling of any poison.

[Regulation 26 amended in Gazette 29 Jun 1984 p. 1784; 25 Jun 1993 p. 3085; 26 May 1994 p. 2201; 15 Dec 2006 p. 5630 and 5631.]

[27. Deleted in Gazette 23 Nov 1990 p. 5792.]

[27AA, 27A. Deleted in Gazette 24 Jun 1994 p. 2866.]

[Heading deleted in Gazette 12 Aug 2003 p. 3663.]

[28. Deleted in Gazette 23 Nov 1990 p. 5792.]

[Heading deleted in Gazette 12 Aug 2003 p. 3663.]

[29, 29A, 29B. Deleted in Gazette 28 May 1993 p. 2595.]

Part 4 — Storage, disposal and loss or theft of poisons

[Heading inserted in Gazette 12 Aug 2003 p. 3664.]

30. Storage of substances other than those specified in regulation 56

Any person having a poison, other than those specified in regulation 56, in or on any premises for the purpose of sale or use in his profession, business, trade or industry shall keep that poison in such a manner as to preclude contamination of any food, drink or condiment by the poison; and to preclude access to the poison by children.

[Regulation 30 amended in Gazette 1 Aug 1986 p. 2739; 28 May 1993 p. 2595; 19 Mar 1996 p. 1220.]

[Heading deleted in Gazette 12 Aug 2003 p. 3663.]

31. Disposal of poisons

A person shall not dispose of any poison in any place or manner likely to constitute a risk to the public.

[Heading deleted in Gazette 12 Aug 2003 p. 3663.]

32. Notification of loss or theft of poison

Every person who loses any poison or from whom any poison is stolen shall immediately notify a police officer of such loss or theft.

[Regulation 32 amended in Gazette 19 Mar 1996 p. 1220.]

[Heading deleted in Gazette 12 Aug 2003 p. 3663.]

Part 4A — Electronic prescribing systems

[Heading inserted in Gazette 7 Nov 2008 p. 4806.]

32A. Terms used in this Part

(1) In this Part and Appendix K —

access code, of an individual, means a password or other means by which the individual gains access to a system of electronic prescribing;

inappropriate use, in relation to a system of electronic prescribing, includes using the system in a way that is not in accordance with the procedures that control access to and use of the system;

system identifier, of an individual, means the code by which the identity of the individual is recorded by a system of electronic prescribing.

(2) For the purposes of this Part, an entry is made in a system of electronic prescribing if —

(a) a prescription is issued, amended or cancelled via the system; or

(b) a poison is dispensed in accordance with a prescription issued via the system; or

(i) issuing, amending or cancelling a prescription via the system; or

(ii) dispensing a poison in accordance with a prescription issued via the system.

[Regulation 32A inserted in Gazette 7 Nov 2008 p. 4806.]

32B. Approval of electronic prescribing systems

(1) The CEO may approve a system of electronic prescribing if satisfied that the system —

(a) is sufficiently secure; and

(b) is designed so that, to the extent practicable —

(i) for any particular poison — only persons authorised to prescribe that poison can use the system to prescribe the poison; and

(ii) for any particular poison — only a pharmaceutical chemist authorised to dispense the poison, or an assistant under the direct personal supervision of the pharmaceutical chemist, can use the system to dispense the poison; and

(iii) a poison dispensed in accordance with a prescription issued via the system is dispensed for the person for whom it was prescribed; and

(iv) a poison dispensed to a person in accordance with a prescription issued via the system is the poison prescribed for the person;

and

(d) complies with any other criteria the CEO thinks relevant.

(2) A reference in subregulation (1)(b) to a person authorised to prescribe or dispense a particular poison is a reference to a person authorised to do so under the Act.

(3) Before being satisfied that a system of electronic prescribing is sufficiently secure, the CEO must be satisfied that, to the extent practicable —

(a) personal information relating to prescribers, patients of prescribers and pharmaceutical chemists is protected; and

(b) access to and use of the system is controlled by appropriate procedures; and

(d) every occurrence of —

(i) a prescription being issued or amended via the system; and

(ii) a poison being dispensed in accordance with a prescription issued via the system,

is recorded by the system in a way that cannot be amended or erased.

(4) Subregulation (3) does not limit the matters that the CEO may take into account for the purposes of subregulation (1)(a).

(5) The CEO may approve a component of a system of electronic prescribing if satisfied as to the matters in subregulation (1) in relation to the component, to the extent relevant to the component.

[Regulation 32B inserted in Gazette 7 Nov 2008 p. 4806‑7.]

32C. System administrators

A system of electronic prescribing is not approved while there is no individual who is designated as the administrator of the system by the CEO.

[Regulation 32C inserted in Gazette 7 Nov 2008 p. 4808.]

32D. Offence provisions

(1) A person must not access an approved electronic prescribing system unless the person —

(a) is permitted to have access to the system according to the procedures that control access to the system; and

(b) gained access according to those procedures.

Penalty: a fine of $5 000.

(2) A person who has an access code for an approved electronic prescribing system must not —

(a) reveal the person’s access code to another person; or

(b) otherwise allow another person to have access to the system unless to do so is in accordance with the procedures that control access to the system.

Penalty: a fine of $5 000.

(3) A person must not make inappropriate use of an approved electronic prescribing system.

Penalty: a fine of $5 000.

(4) An administrator of an approved electronic prescribing system must, to the extent practicable, ensure that —

(a) a person who is permitted to have access to the system in accordance with the procedures that control access to the system is not given more than one access code; and

(b) each person who is responsible to the administrator for the operation and control of the system does not make inappropriate use of the system.

Penalty: a fine of $5 000.

[Regulation 32D inserted in Gazette 7 Nov 2008 p. 4808; amended in Gazette 28 Jul 2009 p. 2979.]

32E. Miscellaneous rules

(1) In any proceedings under this Act or the Misuse of Drugs Act 1981, if it is proved that the system identifier of a person has been recorded in the system in respect of an entry, then, in the absence of evidence to the contrary, that person is to be taken to have made the entry.

(2) Despite anything else in this Part, the administrator must, as soon as is practicable, comply with a written request by a person authorised under section 52A of the Act to make records of the system available to the person.

[Regulation 32E inserted in Gazette 7 Nov 2008 p. 4808‑9; amended in Gazette 28 Jul 2009 p. 2979.]

Part 5 — Sale, supply and use of poisons

[Heading inserted in Gazette 12 Aug 2003 p. 3664.]

Division 1 — Restrictions

[Heading inserted in Gazette 12 Aug 2003 p. 3664.]

33. Poison not to be sold to persons under 16 years

A person who sells or supplies any poison to any person who is apparently under 16 years of age commits an offence against these regulations, but this regulation does not apply to sales of pharmaceutical preparations or medicines by persons licensed to sell poisons by retail.

33A. Restrictions applying to veterinary preparations

A person shall not —

(a) administer to himself or another person; or

(b) sell or supply for human use,

a medicine or other product which contains a poison and which was prepared for use in animals.

[Regulation 33A inserted in Gazette 11 Nov 1988 p. 4444.]

33B. Adoption of SUSDP for certain paints

(1) If a paint contains a substance listed in the First, Second or Third Schedule to Appendix I of SUSDP, a person shall not manufacture, sell or use that paint except in accordance with that Appendix.

(2) For the purposes of this regulation the interpretation provisions of Part 1 of the SUSDP shall be used to interpret Appendix I of the SUSDP.

[Regulation 33B inserted in Gazette 12 Apr 1991 p. 1608; amended in Gazette 24 Jun 1994 p. 2866‑7; 16 Sep 1994 p. 4748; 19 Sep 1995 p. 4383; 14 Sep 2001 p. 5074.]

[Heading deleted in Gazette 23 May 1986 p. 1716.]

[34. Deleted in Gazette 23 May 1986 p. 1716.]

[Heading deleted in Gazette 23 May 1986 p. 1716.]

[34A-34C. Deleted in Gazette 23 May 1986 p. 1716.]

[34D. Deleted in Gazette 19 Mar 1996 p. 1220.]

[Heading deleted in Gazette 12 Aug 2003 p. 3663.]

35. Restrictions on retail sale of substances included in Schedule 2

A substance included in Schedule 2 shall not be stored for retail sale in any area or in any manner that allows physical access to that substance by any person other than —

(a) the owner of the business carried on; or

(b) a person employed,

on the premises where it is stored.

[Regulation 35 inserted in Gazette 8 Feb 1985 p. 521; amended in Gazette 19 Mar 1996 p. 1220.]

[Heading deleted in Gazette 8 Feb 1985 p. 521.]

35A. Restrictions on retail sale of substances included in Schedule 3

(1) The retail sale of a substance included in Schedule 3 shall only be by way of direct, personal sale by a pharmaceutical chemist or graduate trainee in pharmacy under the personal supervision of a pharmaceutical chemist.

(1a) Before a substance included in Schedule 3 is delivered as part of a retail sale, the pharmaceutical chemist or graduate trainee shall take all reasonable steps to ensure that there is a therapeutic need for the substance.

(1b) A pharmaceutical chemist shall not store in any part of the retail area of premises any of the substances referred to in Appendix J.

(1c) A substance referred to in Appendix J shall only be sold or supplied by direct, personal sale by a pharmaceutical chemist or by a graduate trainee in pharmacy under the personal supervision of a pharmaceutical chemist and, in the case of pseudoephedrine, before it is delivered to the purchaser, the purchaser shall give photographic evidence of his or her identity to the pharmaceutical chemist or graduate trainee, unless the purchaser’s identity is known to the pharmaceutical chemist or graduate trainee.

(2) Before a substance referred to in Appendix J is delivered to a purchaser as part of a retail sale, the pharmaceutical chemist or graduate trainee making the sale shall —

(a) record in the prescription book referred to in regulation 36(3)(c) the following details —

(i) the date of sale;

(ii) the name and address of the purchaser;

(iii) if the person for whom the substance is intended is not the purchaser, the name and address of that other person;

(iv) the name and quantity of the substance supplied;

and

(b) allocate to each sale a unique identification number or alpha‑numerical code, and record that number or code in the register; and

(i) the name and address of the pharmacy; and

(ii) the number or code allocated under paragraph (b).

(3) The prescription book referred to in this regulation shall be available for inspection upon request by an authorised officer.

(4) The seller shall retain the records required to be made under this regulation for a period of at least 2 years.

[Regulation 35A inserted in Gazette 28 Nov 1968 p. 3458; amended in Gazette 20 Sep 1985 p. 3743; 29 Aug 1990 p. 3028; 30 Nov 1990 p. 5908; 13 Dec 1991 p. 6190; 19 Mar 1996 p. 1221; 24 Jul 2007 p. 3664‑5.]

[35AA. Deleted in Gazette 11 Apr 1997 p. 1829.]

35B. Storage of substances included in Schedule 3

A substance included in Schedule 3 shall not be stored in a pharmacy in any area or in any manner that allows physical access to that substance by any person other than a person who is a member of the staff of the pharmacy.

[Regulation 35B inserted in Gazette 29 Aug 1980 p. 3028; amended in Gazette 19 Mar 1996 p. 1221.]

35C. Advertising of substances included in Schedule 3

(1) Subject to subregulations (2) and (3), a substance included in Schedule 3 shall not be advertised except in a bona fide professional or trade journal or other publication intended for circulation only within the medical, veterinary, dental or pharmaceutical professions or the wholesale and manufacturing drug trade.

(2) A substance both included in Schedule 3 and listed in Appendix H of SUSDP may be advertised by its brand name or its approved name.

(3) A substance included in Schedule 3 may be advertised if the substance is in a pregnancy testing kit.

(4) In this regulation —

approved name, in relation to a poison, means the name for the poison that is listed in the Australian Register of Therapeutic Goods, other than a brand name of the poison;

Australian Register of Therapeutic Goods means the register of that name maintained under section 17 of the Therapeutic Goods Act 1989 of the Commonwealth;

brand name, in relation to a poison, means a name given to the poison by a manufacturer of it and listed in the Australian Register of Therapeutic Goods, other than its approved name.

[Regulation 35C inserted in Gazette 23 Sep 1983 p. 3803; amended in Gazette 2 Oct 1987 p. 3776; 19 Mar 1996 p. 1221; 27 Nov 1998 p. 6343‑4.]

35D. Advertising of substances included in Schedule 4

A substance included in Schedule 4 shall not be advertised except in a publication that is normally sold or intended for sale or circulation only among —

(a) persons of the kind referred to in section 23(2) of the Act; or

(b) persons who are holders of licences granted under section 24(1)(a), (b) or (c) of the Act.

[Regulation 35D inserted in Gazette 19 Feb 1999 p. 555.]

[Heading deleted in Gazette 12 Aug 2003 p. 3663.]

Division 2 — Schedule 4 poisons

[Heading inserted in Gazette 12 Aug 2003 p. 3664; amended in Gazette 4 Jan 2005 p. 3.]

36. Supply of poisons included in Schedule 4

(1) Subject to the Act and these regulations, a person shall not sell or supply a poison included in Schedule 4 to any person unless —

(a) he or she —

(i) is satisfied that the person to whom the poison is sold or supplied is authorised under regulation 40(1) to procure the poison; and

(ii) receives from that person a written order in accordance with regulation 40(1a) or makes a record under regulation 41B;

(b) the person to whom the poison is sold or supplied is the person (or an agent of the person) in respect of whom a prescription for the poison was issued by a medical practitioner, nurse practitioner, dentist or veterinary surgeon prescribing the poison according to the requirements of these regulations;

(c) satisfied that the person to whom the poison is sold or supplied is under medical treatment with the poison and requires emergency treatment with the poison and does not sell or supply to that person more than —

(i) 3 days medication of the poison; or

(ii) where the poison is supplied in prepacked individual packs, one individual standard pack;

(d) he or she is a registered nurse working at a remote area nursing post and he or she supplies a poison, not being a psychoactive poison —

(i) in accordance with regulation 36(1)(c)(i);

(ii) for the treatment of an acute medical condition in compliance with the written standing orders of a medical practitioner which have been approved in writing by the CEO; or

(iii) for the treatment of an acute medical condition in compliance with oral instructions of a medical practitioner for that particular patient.

(1a) A person who has received a written order under subregulation (1)(a)(ii) shall keep that order for at least 2 years from the time he or she received it and produce it at any time during the 2 years from the time he or she received it when required to do so by the Executive Director.

(2) A medical practitioner, nurse practitioner, pharmaceutical chemist, or veterinary surgeon or an assistant under the direct personal supervision of a medical practitioner, nurse practitioner, pharmaceutical chemist, or veterinary surgeon shall be the only person who shall dispense a poison included in Schedule 4.

(3) The following conditions shall be observed by persons dispensing such prescriptions —

(a) the prescription shall not be dispensed more than the maximum number of times indicated by it, and on each occasion upon which it is dispensed the dispenser shall —

(i) in the case of a prescription that is not issued electronically — stamp or mark the prescription to show clearly the date upon which it is dispensed and the name and address of the pharmacy at which it is dispensed; and

(ii) in the case of a prescription that is issued electronically — indicate the date upon which it is dispensed and the name and address of the pharmacy at which it is dispensed using the means provided by the approved electronic prescribing system;

(b) the person who dispenses a prescription which does not clearly indicate the maximum number of times it is to be dispensed, or which has reached the last occasion upon which it may be dispensed according to the maximum indicated by it, shall —

(i) in the case of a prescription that is not issued electronically — write in ink, stamp or mark in legible letters across the prescription the word “cancelled”; and

(ii) in the case of a prescription that is issued electronically — cancel the prescription using the means provided by the approved electronic prescribing system;

(I) handwritten records in a bound book with sequentially numbered pages;

(II) computer records on disk or tape that can be displayed and from which printed copies of the records can be produced on demand;

(III) microfilm, microfiche, or any other photographic systems in logical sequence and retrievable form;

(IV) client record cards, which include the details set out in a prescription; or

(V) alternative recording methods which have been specifically and individually approved in writing by the CEO for the purposes of this paragraph,

are deemed to be the Prescription Book;

(ii) before the poison is handed to the purchaser the following details from the prescription shall be entered into the Prescription Book —

the name and quantity of the poison, the direction for use (if applicable), the date of issue of the prescription, the name and address of the patient, the name and address, or the name and identifying initials, of the prescriber, the date of dispensing the prescription, and the entry shall be given an identifying letter or number or combination of letter and number;

(iii) in the event of the dispensing of a repeated prescription an annotation of this fact showing the date of the repeat on the original entry in the Prescription Book shall be sufficient compliance with this regulation;

(iv) the label on the bottle or package containing the poison shall be marked with the identifying letter or number of the prescription as appearing in the Prescription Book; and

(v) the Prescription Book shall be kept at the place at which the poison included in Schedule 4 was dispensed for at least 2 years and shall be produced on demand to any person authorised in that behalf under the Act or these regulations;

(d) a prescription shall not be dispensed if it is —

(i) cancelled; or

(ii) more than 12 months old;

(e) a prescription which is illegible or defaced, or appears to have been altered or which appears to be for the purpose of enabling some unauthorised person to obtain a poison included in Schedule 4, or which does not appear to be genuine, shall not be dispensed;

(f) a pharmaceutical chemist given a prescription referred to in paragraph (e) shall forthwith inform the CEO of the relevant circumstances and the reasons for his refusal to dispense the prescription, and, in the case of a prescription that was not issued electronically, retain it.

(4) The following conditions shall be observed by persons supplying poisons included in Schedule 4 under subregulation (1)(d) —

(a) the supply shall be recorded in the client record cards of the remote area nursing post and the record cards kept for a minimum of 2 years following the last entry in those records; and

(b) the poisons shall be labelled in accordance with regulation 21(1)(a) or 21(1)(b).

[Regulation 36 amended in Gazette 19 Feb 1971 p. 518‑19; 29 Aug 1980 p. 3028; 29 Jun 1984 p. 1784; 5 Jul 1985 p. 2392; 7 Aug 1987 p. 3038; 18 Sep 1987 p. 3596; 2 Jun 1989 p. 1603; 3 Jun 1990 p. 2626; 16 Apr 1992 p. 1634; 25 Jun 1993 p. 3085; 26 May 1994 p. 2201; 24 Jun 1994 p. 2867; 19 Mar 1996 p. 1221‑2; 15 Dec 2006 p. 5630; 7 Nov 2008 p. 4809‑10; amended by Act No. 9 of 2003 s. 44.]

36AA. Provision of “approved starter packs” by registered nurses

(1) In this regulation —

approved health service means a health service (as defined in section 3(1) of the Health Services (Conciliation and Review) Act 1995, other than a health service provided by way of medical or epidemiological research) that —

(a) operates outside the metropolitan region (as defined in section 6 of the Metropolitan Region Town Planning Scheme Act 1959); and

(b) has been approved by the CEO for the purposes of this regulation;

approved name has the same meaning as in regulation 35C;

approved starter pack means a starter pack approved by the CEO for the purposes of this regulation;

brand name has the same meaning as in regulation 35C;

starter pack means a quantity of a poison included in Schedule 4, prepared by a pharmaceutical chemist and consisting of —

(a) if the poison is supplied in prepacked individual packs, one individual standard pack;

(b) if the poison is a liquid, the smallest pack of the poison available from the manufacturer; or

starter pack instruction means an instruction of the kind described in subregulation (2).

(2) A registered nurse at an approved health service may give an approved starter pack to a patient, other than an in‑patient, at the health service if orally instructed to do so by a medical practitioner, who need not be present at the health service.

(3) Before giving an approved starter pack to a patient a registered nurse must —

(a) ensure that the approved starter pack is labelled in accordance with subregulation (8); and

(b) record the details of the provision of the approved starter pack in accordance with subregulation (10).

(4) A medical practitioner must not give a starter pack instruction unless satisfied that —

(a) the patient has an acute medical condition;

(b) there is no other medical practitioner at the health service who could reasonably attend to the patient in person; and

(c) the distance from the health service to the nearest pharmacy registered under the Pharmacy Act 1964 that is open is more than 25 km.

(5) For the purposes of subregulation (4), a medical practitioner may rely on information provided by the registered nurse as to the patient’s condition, the availability of other medical practitioners and the location of the nearest open pharmacy.

(6) Within 72 hours of giving a starter pack instruction a medical practitioner must give to the registered nurse, or another registered nurse at the health service, signed, written confirmation of the instruction including —

(a) the name of the medical practitioner;

(b) the name of the registered nurse to whom the starter pack instruction was given;

(d) the date and time when the instruction was given;

(e) details of the approved starter pack;

(f) any relevant directions for use that were to be given to the patient; and

(g) any other information that the medical practitioner considers relevant.

(7) The person in charge of an approved health service must —

(a) keep all written confirmations given under subregulation (6) to registered nurses at the health service for at least 2 years; and

(b) produce them on demand to any person authorised under the Act to demand production of such records.

(8) An approved starter pack must be labelled in English with —

(a) the words “Keep out of reach of children”;

(b) the name of the patient;

(d) in relation to each poison in the approved starter pack —

(i) the approved name and strength or amount of the poison; or

(ii) if the brand name uniquely identifies the strength of the poison, that brand name;

(e) the total quantity of medication contained in the approved starter pack;

(f) the date on which the approved starter pack was given to the patient;

(g) any directions for use given by the medical practitioner;

(h) the number referred to in subregulation (10)(f) identifying the relevant entry in the health service’s Starter Pack Supply Book; and

(i) any relevant cautionary or advisory statements set out in Appendix K to the SUSDP.

(9) The person in charge of an approved health service must —

(a) maintain a Starter Pack Supply Book for the health service consisting of —

(i) handwritten records in a bound book with sequentially numbered pages; or

(ii) records kept in another manner which has been specifically and individually approved in writing by the CEO for the purposes of this paragraph;

(b) keep the Starter Pack Supply Book for at least 2 years after the last entry is made in it; and

(c) produce the Starter Pack Supply Book on demand to any person authorised under the Act to demand production of such records.

(10) Before giving an approved starter pack to a patient a registered nurse must record the following information in the health service’s Starter Pack Supply Book —

(a) the name and address of the patient;

(b) in relation to each poison in the approved starter pack —

(i) the approved name and strength or amount of the poison; or

(ii) if the brand name uniquely identifies the strength of the poison, that brand name;

(d) the name of the medical practitioner;

(e) any directions for use given by the medical practitioner;

(f) a unique number identifying the entry in the Book; and

(g) the registered nurse’s name and signature.

[Regulation 36AA inserted in Gazette 29 Jun 2001 p. 3115‑18; amended in Gazette 15 Dec 2006 p. 5630; 2 Oct 2007 p. 4965.]

36AAB. Provision of “psychiatric emergency packs” by certain registered nurses

(1) In this regulation —

approved name has the meaning given in regulation 35C;

Community Emergency Response Team means a service, provided by a public hospital, that —

(a) is provided in the metropolitan region; and

(b) responds to psychiatric emergencies in the community; and

metropolitan region has the meaning given in section 4 of the Planning and Development Act 2005;

psychiatric emergency pack means a pack, approved by the CEO for the purposes of this regulation and prepared by a pharmaceutical chemist, containing a quantity of a poison included in Schedule 4 that —

(a) if the poison is supplied in prepacked individual packs — is one individual standard pack; or

(b) if the poison is a liquid — is the smallest pack of the poison available from the manufacturer; or

Rural Community Mental Health Team means a service, provided by a public hospital, that —

(a) is provided outside the metropolitan region; and

(b) responds to psychiatric emergencies in the community; and

team medical practitioner means a medical practitioner who is a member of a Community Emergency Response Team or a Rural Community Mental Health Team;

team psychiatrist means a psychiatrist who is a member of a Community Emergency Response Team or a Rural Community Mental Health Team;

team registered nurse means a registered nurse who is a member of a Community Emergency Response Team or a Rural Community Mental Health Team.

(2) A team registered nurse may give a psychiatric emergency pack to a patient, other than an in‑patient, if instructed to do so by a team psychiatrist or a team medical practitioner, who need not be present with the nurse at the time of giving the instruction.

(3) The instruction may be given orally.

(4) The psychiatrist or medical practitioner must not give the instruction unless satisfied that the patient is in need of urgent psychiatric intervention and it is not practical for the patient to obtain the medication contained in the pack in any other way.

(5) For the purposes of subregulation (4), the psychiatrist or medical practitioner may rely on the information given by the nurse about the patient’s condition.

(6) Before giving the psychiatric emergency pack to the patient the nurse must —

(a) ensure that the pack has been labelled in accordance with subregulation (9); and

(b) record in the Emergency Pack Supply Book the information required by subregulation (11).

(7) Within 72 hours of giving the instruction the psychiatrist or medical practitioner must give the nurse, or another team member, signed, written confirmation of the instruction including —

(a) the name of the psychiatrist or medical practitioner; and

(b) the name of the nurse to whom the instruction was given; and

(d) the date and time when the instruction was given; and

(e) details of the psychiatric emergency pack; and

(f) any directions for use that were to be given to the patient; and

(g) any other information that the psychiatrist or medical practitioner considers relevant.

(8) A person in charge of a Community Emergency Response Team or a Rural Community Mental Health Team must —

(a) keep all written confirmations given under subregulation (7) for at least 2 years; and

(b) produce them on demand to any person authorised under the Act to demand production of such records.

(9) A psychiatric emergency pack must be labelled in English with —

(a) the words “keep out of reach of children”; and

(b) the name of the patient; and

(d) in relation to the poison in the psychiatric emergency pack —

(i) the approved name and strength or amount of the poison; or

(ii) if the brand name uniquely identifies the strength of the poison — that brand name;

and

(e) the total quantity of each medication contained in the psychiatric emergency pack; and

(f) the date on which the psychiatric emergency pack was given to the patient; and

(g) any directions for use given by the psychiatrist or medical practitioner; and

(h) the number referred to in subregulation (11)(f) identifying the relevant entry in the Emergency Pack Supply Book; and

(i) any relevant cautionary or advisory statements set out in Appendix K to the SUSDP.

(10) A person in charge of a Community Emergency Response Team or a Rural Community Mental Health Team must —

(a) maintain an Emergency Pack Supply Book for that Team consisting of handwritten records in a book with sequentially numbered pages; and

(b) keep the Emergency Pack Supply Book for at least 2 years after the last entry is made in it; and

(c) produce the Emergency Pack Supply Book on demand to any person authorised under the Act to demand production of such records.

(11) The information to be recorded in the Emergency Pack Supply Book is —

(a) the name and address of the patient; and

(b) in relation to the poison in the psychiatric emergency pack —

(i) the approved name and strength or amount of the poison; or

(ii) if the brand name uniquely identifies the strength of the poison — that brand name;

and

(d) the name of the psychiatrist or medical practitioner who gave the instruction; and

(e) any directions for use given by the psychiatrist or medical practitioner; and

(f) a unique number identifying the entry in the Book; and

(g) the nurse’s name and signature.

[Regulation 36AAB inserted in Gazette 2 Oct 2007 p. 4965-8.]

36A. Storage of substances included in Schedule 4

(1) A pharmaceutical chemist to whom a substance included in Schedule 4 is supplied shall not store it, or expose or offer it for sale, in any portion of a pharmacy to which persons other than members of the staff of the pharmacy have access.

(2) Subject to subregulation (3), a medical practitioner, dentist or veterinary surgeon to whom a substance included in Schedule 4 is supplied shall store it in a container, cupboard or room —

(a) at the medical practitioner’s, dentist’s or veterinary surgeon’s usual place of practice;

(b) that is kept locked; and

(c) access to which is available only to the medical practitioner, dentist or veterinary surgeon and persons under his or her personal supervision.

(3) A medical practitioner, dentist or veterinary surgeon may store substances included in Schedule 4 other than in accordance with subregulation (2) if —

(a) they are emergency supplies; and

(b) the medical practitioner, dentist or veterinary surgeon has them in his or her actual possession for the purpose of attending patients at places other than at his or her usual place of practice.

(4) In subregulation (3) —

emergency supplies means —

(a) in the case of a medical practitioner — the substances described as “Emergency Drug (Doctor’s Bag) Supplies” in the document “Schedule of Pharmaceutical Benefits”, as published from time to time by the Commonwealth Government for the purposes of Part VII of the National Health Act 1953 of the Commonwealth; or

(b) in the case of a dentist or veterinary surgeon — the substances that are ordinarily carried by dentists or veterinary surgeons who are attending patients at places other than at their usual place of practice.

[Regulation 36A inserted in Gazette 19 Feb 1999 p. 555‑6.]

36B. Record of supply or administration of substances included in Schedule 4

(1) A medical practitioner, dentist or veterinary surgeon is to record in his or her client record cards every occasion on which he or she —

(a) supplies a substance included in Schedule 4 to a person; or

(b) administers a substance included in Schedule 4 to a person or animal.

(2) A record required to be made under subregulation (1) is to include —

(a) the name, strength and quantity of the substance supplied or administered;

(b) the name and address of the person to whom the substance was supplied or administered, or of the owner of the animal to which the substance was administered; and

(3) A record required to be made under regulation (1) must be —

(a) kept for at least 2 years from the date on which the substance was supplied or administered; and

(b) made available for inspection on request by an authorised officer (other than an environmental health officer).

[Regulation 36B inserted in Gazette 19 Feb 1999 p. 556.]

[Heading deleted in Gazette 12 Aug 2003 p. 3663.]

37. Conditions for prescription of a poison included in Schedule 4

(1) A prescription for a poison included in Schedule 4 shall comply with the following conditions —

(a) it shall include —

(i) the name and address of the prescriber; and

(ii) the name and address of the patient; and

(iii) the name and quantity of the substance; and

(iv) directions for use (if necessary); and

(v) the date on which it is issued; and

(vi) the maximum number of times it may be repeated, if any, and (where applicable) the intervals at which it may be repeated;

and

(b) it shall be issued in a manner provided for in subregulation (1A) or (1B); and

[(ba) deleted]

(c) a prescription issued by a dentist shall be for dental purposes only and shall indicate that and a prescription issued by a veterinary surgeon shall be for veterinary use only and shall include the words “For veterinary use only” or “For animal treatment only”;

(d) if a prescription contains an unusual dose the prescriber shall indicate that such a dose is intended by —

(i) in the case of a prescription that is not issued electronically — underlining that part of the prescription and initialling the same in the margin; and

(ii) in the case of a prescription that is issued electronically — the means provided by the approved electronic prescribing system;

(e) a prescription shall not bear the impression of a rubber stamp or other such contrivance in lieu of the written signature of the medical practitioner, nurse practitioner, dentist or veterinary surgeon by whom it has been written; and

(f) a prescription shall not be written in cipher.

(1A) A prescription that is issued electronically shall be issued via an approved electronic prescribing system.

(1B) A prescription that is not issued electronically shall be either —

(a) written in ink in the prescriber’s own handwriting; or

(b) processed on a computer program that —

(i) complies with the criteria specified in Appendix L; or

(ii) is recommended by the Poisons Advisory Committee and approved in writing by the CEO.

The prescription shall be signed by the prescriber in his or her own handwriting.

(2) With the written approval of the CEO a medical practitioner, nurse practitioner, dentist or veterinary surgeon may issue a typewritten prescription where the CEO is satisfied that by reason of physical infirmity the prescriber is unable to write legibly in his or her own handwriting but in that case the prescriber shall sign the prescription with his or her usual signature.

[Regulation 37 inserted in Gazette 19 Feb 1971 p. 519; amended in Gazette 21 Nov 1986 p. 4269; 5 Dec 1986 p. 4467; 17 Aug 1990 p. 4081; 26 Jul 1991 p. 3854; 7 Aug 1992 p. 3869; 26 May 1994 p. 2201; 19 Mar 1996 p. 1222; 15 Dec 2006 p. 5630; 7 Nov 2008 p. 4810‑11; amended by Act No. 9 of 2003 s. 45.]

[Heading deleted in Gazette 12 Aug 2003 p. 3663.]

38. Dispensing poisons included in Schedule 4 in emergency cases

Where a medical practitioner, nurse practitioner, dentist or veterinary surgeon in a case of emergency orally or by telephone or telegram directs the dispensing of a poison included in Schedule 4, he shall forthwith write a prescription complying with the conditions prescribed in regulation 37, mark such prescription to show that it has been given as a confirmation of instructions given by him orally or by telephone or telegram, and despatch such prescription within 24 hours to the person to whom the instructions were given.

[Regulation 38 amended in Gazette 19 Mar 1996 p. 1222; amended by Act No. 9 of 2003 s. 46.]

[Heading deleted in Gazette 12 Aug 2003 p. 3663.]

[38A. Deleted in Gazette 17 Mar 1998 p. 1417.]

38AA. Administration of poisons included in Schedule 4 in hospital

(1) Subject to subregulation (2) a person, other than a medical practitioner, nurse practitioner or a dentist, shall not administer a poison included in Schedule 4 to a patient in a hospital unless the administration of the poison is authorised in writing on the medication chart of the patient by a medical practitioner, nurse practitioner or a dentist.

(2) A medical practitioner, nurse practitioner or dentist may verbally authorise the administration of a poison included in Schedule 4 and shall within 24 hours of so doing note such authorisation in writing on the medication chart of the patient.

[Regulation 38AA inserted in Gazette 28 May 1993 p. 2596; amended in Gazette 19 Mar 1996 p. 1222; amended by Act No. 9 of 2003 s. 47.]

[Heading deleted in Gazette 12 Aug 2003 p. 3663.]

[38B. Deleted in Gazette 24 Jun 1994 p. 2867.]

[Heading deleted in Gazette 12 Aug 2003 p. 3663.]

38C. Clomiphene and cyclofenil

Clomiphene or cyclofenil or a substance containing clomiphene or cyclofenil and other substances specifically prepared to stimulate ovulation shall not be prescribed except —

(a) by a gynaecologist or obstetrician;

(b) by any other medical practitioner, if authorised in writing by the CEO; or

[Regulation 38C inserted in Gazette 24 Jun 1994 p. 2868; amended in Gazette 11 Apr 1997 p. 1829; 15 Dec 2006 p. 5630.]

[Heading deleted in Gazette 12 Aug 2003 p. 3663.]

38D. Etretinate or acitretin

(1) Etretinate or acitretin or a substance containing etretinate or acitretin shall not be prescribed except by a physician or dermatologist.

(1a) Where etretinate or acitretin or a substance containing etretinate or acitretin is supplied in accordance with a prescription under subregulation (1) the supplier shall ensure that the container in which the etretinate or acitretin or the substance containing etretinate or acitretin is supplied, is labelled with a warning in the following words, or other words having the same effect —

“WARNING — CAUSES BIRTH DEFECTS”.

(2) A physician or dermatologist who prescribes etretinate or acitretin or a substance containing etretinate or acitretin shall ensure that the possibility of pregnancy has been excluded prior to the commencement of the treatment and that the patient is informed that she must not become pregnant for a period of 24 months after completion of the treatment.

[Regulation 38D inserted in Gazette 8 Feb 1985 p. 519; amended in Gazette 31 May 1985 p. 1882; 23 May 1986 p. 1716; 2 Oct 1987 p. 3776; 27 May 1988 p. 1770; 11 Nov 1988 p. 4444; 2 Jun 1989 p. 1603; 25 Jun 1993 p. 3085; 26 May 1994 p. 2201; 2 Sep 1994 p. 4533; 11 Apr 1997 p. 1829; 14 Sep 2001 p. 5074‑5; 5 Oct 2004 p. 4309.]

[Heading deleted in Gazette 12 Aug 2003 p. 3663.]

38E. Prostaglandins

Cloprostenol, dinoprost, dinoprostone, fenprostalene, fluprostenol, prostianol or a substance containing any of those prostaglandins shall not be prescribed except —

(a) by a veterinary surgeon for use in the treatment of animals; or

(b) in the case of dinoprost or dinoprostone or a substance containing dinoprost or dinoprostone —

(i) by a physician, gynaecologist or obstetrician; or

(ii) by any other medical practitioner, if authorised in writing by the CEO.

[Regulation 38E inserted in Gazette 2 Jun 1989 p. 1604; amended in Gazette 16 Apr 1992 p. 1635; 25 Jun 1993 p. 3085; 26 May 1994 p. 2201; 11 Apr 1997 p. 1830; 15 Dec 2006 p. 5630-1.]

[Heading deleted in Gazette 12 Aug 2003 p. 3663.]

38F. Isotretinoin

(1) Isotretinoin or a substance containing isotretinoin shall not be prescribed except by a physician or dermatologist.

(1a) Where isotretinoin or a substance containing isotretinoin is supplied in accordance with a prescription under subregulation (1) the supplier shall ensure that the container in which the isotretinoin or the substance containing isotretinoin is supplied, is labelled with a warning in the following words, or other words having the same effect —

“WARNING — CAUSES BIRTH DEFECTS”.

(2) A physician or dermatologist who prescribes isotretinoin or a substance containing isotretinoin shall ensure that the possibility of pregnancy has been excluded prior to the commencement of the treatment and that the patient is informed that she must not become pregnant for a period of one month after completion of the treatment.

[Regulation 38F inserted in Gazette 31 May 1985 p. 1882; amended in Gazette 23 May 1986 p. 1716; 2 Oct 1987 p. 3776; 27 May 1988 p. 1770; 2 Jun 1989 p. 1604; 25 Jun 1993 p. 3085; 26 May 1994 p. 2201; 11 Apr 1997 p. 1830; 14 Sep 2001 p. 5075; 5 Oct 2004 p. 4309.]

[Heading deleted in Gazette 12 Aug 2003 p. 3663.]

38G. Thalidomide for human use

(1) Thalidomide or a substance containing thalidomide shall not be prescribed except by a physician or dermatologist.

(2) Where thalidomide or a substance containing thalidomide is supplied in accordance with a prescription under subregulation (1) the supplier shall ensure that the container in which the thalidomide or the substance containing thalidomide is supplied, is labelled with a warning in the following words, or other words having the same effect —

“WARNING — CAUSES BIRTH DEFECTS”.

(3) A physician or dermatologist who prescribes thalidomide or a substance containing thalidomide shall ensure that the possibility of pregnancy has been excluded prior to the commencement of treatment and that the patient is informed that she must not become pregnant for a period of one month after completion of treatment.

[Regulation 38G inserted in Gazette 26 Jul 1991 p. 3854; amended in Gazette 26 May 1994 p. 2201; 19 Mar 1996 p. 1223; 11 Apr 1997 p. 1830; 14 Sep 2001 p. 5075; 5 Oct 2004 p. 4310.]

[Heading deleted in Gazette 12 Aug 2003 p. 3663.]

38H. Chloramphenicol

Chloramphenicol or substances containing chloramphenicol shall not be prescribed except —

(a) by a medical practitioner for human use; or

(b) by a veterinary surgeon for use in or on an animal not used for meat, edible offal, egg or milk production.

[Regulation 38H inserted in Gazette 2 Jun 1989 p. 1604; amended in Gazette 24 Jun 1994 p. 2868; 11 Apr 1997 p. 1830‑1.]

38I. Follicular stimulating hormone and luteinising hormone

Follicular stimulating hormone, luteinising hormone or a substance containing follicular stimulating hormone or luteinising hormone shall not be prescribed except —

(a) by a physician, gynaecologist or obstetrician;

(b) by any other medical practitioner, if authorised in writing by the CEO; or

[Regulation 38I inserted in Gazette 2 Jun 1989 p. 1604; amended in Gazette 11 Apr 1997 p. 1831; 15 Dec 2006 p. 5630‑1.]

[38J. Deleted in Gazette 19 Mar 1996 p. 1223.]

38K. Carnidazole

Carnidazole or a substance containing carnidazole shall not be prescribed except by a veterinary surgeon for use in the treatment of pigeons.

[Regulation 38K inserted in Gazette 2 Jun 1989 p. 1604; amended in Gazette 11 Apr 1997 p. 1831.]

38L. Oxolinic acid

Oxolinic acid or any substance containing oxolinic acid shall not be prescribed except by a veterinary surgeon for use in the treatment of fish.

[Regulation 38L inserted in Gazette 13 Dec 1991 p. 6191; amended in Gazette 11 Apr 1997 p. 1831.]

38M. Clozapine

Clozapine or a substance containing clozapine shall not be prescribed except —

(a) by a psychiatrist; or

(b) by any other medical practitioner authorised in writing by the CEO.

[Regulation 38M inserted in Gazette 24 Jun 1994 p. 2868; amended in Gazette 19 Mar 1996 p. 1223; 11 Apr 1997 p. 1831; 27 Nov 1998 p. 6344; 15 Dec 2006 p. 5630-1.]

38N. Nitrofuran derivatives

The nitrofuran derivatives included in Schedule 4 and listed in the Table to this regulation, or a substance containing any of those poisons, shall not be prescribed except —

(a) by a medical practitioner for human use; or

(b) by a veterinary surgeon for use in the feeding or treatment of an animal not used for meat, edible offal, egg or milk production.

Table
Nitrofuran derivatives

Furazolidone

Nifursol

Nitrofuran

Nitrofurantoin

Nitrofurazone.

[Regulation 38N inserted in Gazette 24 Jun 1994 p. 2868; amended in Gazette 19 Mar 1996 p. 1223; 11 Apr 1997 p. 1831‑2.]

38O. Bosentan for human use

(1) Bosentan or a substance containing bosentan shall not be prescribed except —

(a) by a physician; or

(b) by any other medical practitioner authorised in writing by the CEO.

(2) Where bosentan or a substance containing bosentan is supplied in accordance with a prescription under subregulation (1) the supplier shall ensure that the container in which the bosentan or the substance containing bosentan is supplied is labelled with a warning in the following words, or other words having the same effect —

“WARNING — CAUSES BIRTH DEFECTS”.

(3) A physician, or other medical practitioner, who prescribes bosentan or a substance containing bosentan shall ensure that the possibility of pregnancy has been excluded prior to the commencement of treatment and that the patient is informed that she must not become pregnant during or for a period of 3 months after completion of treatment.

[Regulation 38O inserted in Gazette 5 Oct 2004 p. 4310; amended in Gazette 15 Dec 2006 p. 5630-1.]

38P. Teriparatide for human use

Teriparatide or a substance containing teriparatide shall not be prescribed except —

(a) by a physician, a rheumatologist, an immunologist, an endocrinologist or a geriatrician; or

(b) by any other medical practitioner authorised in writing by the CEO.

[Regulation 38P inserted in Gazette 5 Oct 2004 p. 4310; amended in Gazette 15 Dec 2006 p. 5630-1.]

[Heading deleted in Gazette 12 Aug 2003 p. 3663.]

39. Veterinary use of poisons included in Schedule 4

(1) Notwithstanding the provisions of regulation 36 a pharmaceutical chemist is authorised to supply for veterinary use a poison included in Schedule 4 listed in Appendix H without a prescription where —

(a) the purchaser satisfies such pharmaceutical chemist that it is not reasonably practicable for him to obtain such a prescription;

(b) the name and address of the purchaser, date of supply, form and quantity of poison supplied, species of animal and number of animals to be treated, and a descriptive name of the disease for which the animals are to be treated, are entered in a register of poisons;

(c) the quantity of poisons supplied is not greater than is required to provide 72 hours of therapeutic treatment according to the directions for normal dosage with the poison, or in the case of a pre‑packed proprietary brand the smallest size manufactured for sale of the proprietary brand which provides 72 hours treatment; and

(d) the pharmaceutical chemist provides adequate written instructions for the use of the poison.

[(2) deleted]

[Regulation 39 inserted in Gazette 26 Aug 1977 p. 2966; amended in Gazette 2 Oct 1987 p. 3776; 19 Mar 1996 p. 1223‑4.]

39A. Stockfeed manufacturers may sell poisons included in Schedule 4

(1) Notwithstanding any other provision of these regulations a stockfeed manufacturer holding an appropriate permit under subregulation (3) may sell by retail to any person producing a written order therefor signed by a veterinary surgeon, a mixture of stockfeed with any poison included in Schedule 4 being an antibiotic or sulphonamide, in such quantity and of such composition as is specified in the order.

(2) The signed order shall be cancelled by the stockfeed manufacturer and retained by him for not less than 2 years after the sale, and upon request shall be produced for inspection to an authorised officer.

(3) A stockfeed manufacturer who wishes to sell by retail mixtures pursuant to subregulation (1) may apply to the CEO for, and at the discretion of the CEO be granted, a permit in Form 11AA in Appendix A, specifying the poisons included in Schedule 4 that may be contained in such mixtures, and any limits as to the quantity or composition of such mixtures that may be sold.

(4) The provisions of section 23 of the Act do not apply to a sale by a stockfeed manufacturer pursuant to and in accordance with this regulation or to the preparation of a mixture of stockfeed for the purposes of such sale.

[Regulation 39A inserted in Gazette 5 Oct 1979 p. 3085; amended in Gazette 29 Jun 1984 p. 1784; 25 Jun 1993 p. 3085; 26 May 1994 p. 2201; 19 Mar 1996 p. 1224; 15 Dec 2006 p. 5630-1.]

39BA. Use of poisons included in Schedule 4 on certificated commercial vessels

(1) The master of a certificated commercial vessel is authorised to procure and be in possession of any poison included in Schedule 4 that is necessary to complete the equipment of the vessel in order to comply with the requirements of the Western Australian Marine Act 1982.

(2) The holder of an appropriate licence, or any other authorised person, may supply a poison included in Schedule 4 on receipt of a written order, signed by the master of the certificated commercial vessel, certifying that the poison is necessary to complete the equipment of the vessel in order to comply with the applicable requirements of subregulation (1).

(3) The written order referred to in subregulation (2) must contain all of the following information —

(a) the date of the order;

(b) the name of the certificated commercial vessel;

(d) the name, address and signature of the master of the vessel;

(e) the quantity, form and strength of the poison ordered.

(4) The master of the certificated commercial vessel must ensure that —

(a) so far as is practicable, the poisons supplied under subregulation (2) are stored in a manner that prevents their theft, loss or unauthorised use; and

(b) a record is kept of all the poisons stored aboard the vessel.

(5) When a medical practitioner authorises the administration of one of the poisons to a person on board the certificated commercial vessel, the master of the vessel must ensure that a record is kept of all of the following information —

(a) the date on which the poison was administered;

(b) the poison being administered, the strength of the poison and the quantity that has been administered;

(d) the name and address of the medical practitioner who authorised the administration of the poison.

[Regulation 39BA inserted in Gazette 12 Jun 2009 p. 2109‑10.]

39BB. Use of poisons included in Schedule 4 on racing yachts

(1) The owner of a racing yacht is authorised to procure and be in possession of any poison included in Schedule 4 that is necessary to complete the equipment of the yacht in order to comply with the requirements of the rules known as the “Racing Rules of Sailing” made by Yachting Australia Incorporated.

(2) The holder of an appropriate licence, or any other authorised person, may supply a poison included in Schedule 4 on receipt of a written order, signed by the owner of the racing yacht, certifying that the poison is necessary to complete the equipment of the yacht in order to comply with the applicable requirements of subregulation (1).

(3) The written order referred to in subregulation (2) must contain all of the following information —

(a) the date of the order;

(b) the name of the racing yacht;

(d) the name of the yacht club organising the race;

(e) the name, address and signature of the owner of the yacht;

(f) the quantity, form and strength of the poison ordered.

(4) The owner of the racing yacht must ensure that —

(a) so far as is practicable, the poisons supplied under subregulation (2) are stored in a manner that prevents their theft, loss or unauthorised use; and

(b) a record is kept of all the poisons stored aboard the yacht.

(5) When a medical practitioner authorises the administration of one of the poisons to a person on board the racing yacht, the skipper of the yacht must ensure that a record is kept of all of the following information —

(a) the date on which the poison was administered;

(b) the poison being administered, the strength of the poison and the quantity that has been administered;

(d) the name and address of the medical practitioner who authorised the administration of the poison.

[Regulation 39BB inserted in Gazette 12 Jun 2009 p. 2110‑11.]

39B. Use of poisons included in Schedule 4 on ships and aircraft

(1) The master of a ship other than a certificated commercial vessel or a racing yacht is authorised to procure and be in possession of any poison included in Schedule 4 that is necessary to complete the equipment of the ship in order to comply with the requirements of —

(a) if the ship is registered in Australia —

(i) section 125 of the Navigation Act 1912 of the Commonwealth; or

(ii) the navigation authority of any State of Australia;

(b) if the ship is not registered in Australia —

(i) a law applying to ships in the country in which the ship is registered; or

(ii) the “International Medical Guide for Ships” (2nd. Edition), as published by the World Health Organization.

(2) The holder of an appropriate licence, or any other authorised person, may supply a poison included in Schedule 4 on receipt of a written order, signed by the master of the ship and by the manager, or a person authorised in writing by the manager, of the ship’s agents in the State, certifying that the poison is necessary to complete the equipment of the ship in order to comply with the applicable requirements of subregulation (1).

(3) The person in charge of an aircraft is authorised to be in possession of a poison included in Schedule 4, in a quantity that does not exceed the maximum permitted quantity, as specified by the Department of Transport of the Commonwealth, for the purposes of medical treatment on the aircraft.

(4) The holder of an appropriate licence, or any other authorised person, may supply a poison included in Schedule 4 on receipt of a written order, signed by the manager, or a person authorised in writing by the manager, of the airline company or firm responsible for the operation of the aircraft in the State, certifying that the poison is necessary for the purposes of medical treatment on aircraft.

[Regulation 39B inserted in Gazette 31 Dec 1993 p. 6884; amended in Gazette 19 Mar 1996 p. 1224; 12 Jun 2009 p. 2111.]

39C. Use of poisons included in Schedule 4 on ships carrying livestock

(1) The master of a ship that is to carry livestock is authorised to procure and be in possession of any poison included in Schedule 4 that is necessary for compliance —

(a) by the exporter with the Australian Livestock Export Standards — March 2001 (as amended from time to time); or

(b) by the master with order 18 of the Marine Orders Part 43: Cargo and Cargo Handling — Livestock (as amended from time to time) made under the Navigation Act 1912 of the Commonwealth.

(2) The holder of an appropriate licence or any other authorised person may supply a poison included in Schedule 4 to the master of a ship on receipt of a written order certifying that the master is authorised under subregulation (1) to procure and be in possession of the poison.

(3) The written order must be signed by the master of the ship himself or herself and by the exporter of the livestock.

(4) The master of a ship must store a poison supplied under subregulation (2) in a secure place on board the ship.

(5) In this regulation —

livestock means livestock in relation to which an exporter has given a notice of intention to export under order 6 of the Export Control (Animals) Orders as amended, made under the Export Control (Orders) Regulations 1982 in force under the Export Control Act 1982 of the Commonwealth;

exporter means a person who holds a live‑stock export licence under the Australian Meat and Live‑stock Industry Act 1997 of the Commonwealth, or a person authorised in writing by the licensee as the licensee’s agent;

master of a ship includes, except in subregulation (3), a person authorised in writing by the master as the master’s agent.

[Regulation 39C inserted in Gazette 4 Jan 2005 p. 3‑4.]

[Heading deleted in Gazette 12 Aug 2003 p. 3663.]

40. Special authority to purchase poisons included in Schedule 4

(1) Subject to subregulation (1aa), until in any particular case such authority is withdrawn —

(a) a medical practitioner;

(aa) a nurse practitioner;

(b) a pharmaceutical chemist;

(d) a veterinary surgeon;

(e) an analyst appointed under the Health Act 1911;

(f) the Director of Nursing of a hospital registered under the Hospitals and Health Services Act 1927;

(g) any other person authorised in writing by the CEO,

is authorised to procure, in accordance with subregulation (1a), a poison included in Schedule 4 to the extent that it is required for the purpose of his profession or employment, but such authority does not entitle any person to have in his possession any poison included in Schedule 4 other than in accordance with these regulations or in any quantity greater than is permitted by the CEO.

(1aa) A medical practitioner is not authorised under subregulation (1) to procure a poison included in Schedule 4 and referred to in a regulation listed in the Table, unless the medical practitioner is authorised under that regulation to prescribe the poison.

Table

regulation 38C	regulation 38G
regulation 38D	regulation 38I
regulation 38E	regulation 38M
regulation 38F	regulation 38O
	regulation 38P

(1a) A person authorised under subregulation (1) to procure a poison included in Schedule 4 shall, unless a record is made under regulation 41B in relation to the procurement of the poison, provide a written order to the person from whom he or she is attempting to procure the poison, setting out —

(a) the name, address and signature of the authorised person;

(b) the date of the order; and

(2) A person who wishes to use any poison included in Schedule 4 being an antibiotic or sulphonamide for the preparation of mixtures for sale pursuant to regulation 39A, and who holds a permit under that regulation to sell such mixtures, is authorised to procure, use and be in possession of such poison included in Schedule 4 for the preparation of such mixtures.

[Regulation 40 amended in Gazette 5 Oct 1979 p. 3085; 29 Jun 1984 p. 1784; 8 Feb 1985 p. 519; 8 Jun 1990 p. 2627; 28 May 1993 p. 2596; 25 Jun 1993 p. 3085; 26 May 1994 p. 2201; 19 Mar 1996 p. 1225; 11 Apr 1997 p. 1832; 5 Oct 2004 p. 4311; 15 Dec 2006 p. 5630-1; amended by Act No. 9 of 2003 s. 48.]

[Heading deleted in Gazette 12 Aug 2003 p. 3663.]

40A. Delivery of a poison included in Schedule 4 on order

A person who sells or supplies a poison included in Schedule 4 under regulation 36(1), other than to the holder of a prescription under regulation 36(1)(b), may deliver that poison, or cause it to be delivered only —

(a) to the person to whom he or she sold or supplied the poison; or

(b) in accordance with the written directions of a person referred to in paragraph (a).

[Regulation 40A (formerly regulation 41) inserted in Gazette 8 Jun 1990 p. 2627; amended in Gazette 19 Mar 1996 p. 1225.]

[Heading deleted in Gazette 12 Aug 2003 p. 3663.]

Division 3 — General

[Heading inserted in Gazette 12 Aug 2003 p. 3664.]

41. Revocation notice in relation to poisons included in Schedule 6

The CEO may, by notice given to a person referred to in section 23(4) of the Act, revoke the authority conferred on that person by that section in relation to poisons included in Schedule 6, and that revocation may be —

(a) total or subject to strict conditions;

(b) made in respect of all or any poisons to which the authority relates; and

[Regulation 41 inserted in Gazette 19 Mar 1996 p. 1225‑6; amended in Gazette 15 Dec 2006 p. 5630-1.]

[Heading deleted in Gazette 12 Aug 2003 p. 3663.]

41A. Sale of poisons included in Schedule 7

(1) A person who sells, by retail, any poisons included in Schedule 7 shall, in addition to any conditions and restrictions imposed by notice issued in accordance with these regulations, keep a record of sale by keeping and maintaining a register in accordance with this regulation.

(2) A person recording a sale for the purposes of subregulation (1) shall, before delivering the poison to the purchaser, record in a register kept for that purpose particulars of —

(a) the date of sale;

(b) the name and address of the purchaser;

(d) the address to which the poison is to be delivered, if that address differs from the address recorded under paragraph (b); and

(e) the place of intended use,

and obtain the signature of the purchaser to the entry in the register.

(3) The register shall be kept in one of the following forms —

(a) a book with each recording written in ink;

(b) in a form of electronic means; or

(4) A person keeping a register for the purposes of this regulation shall —

(a) keep that register for a period of at least 2 years at the licensed premises; and

(b) produce the register for inspection on demand by an authorised officer.

[Regulation 41A inserted in Gazette 19 Mar 1996 p. 1226; amended in Gazette 14 Sep 2001 p. 5076; 15 Dec 2006 p. 5630.]

41AA. Standard for intramammary antibiotic preparations