Contents (2002 - 639)
Poisons and Therapeutic Goods Regulation 2002
Status information

Part 1 Preliminary

1 Name of Regulation
2 Commencement
3 Definitions
4 Authorisation of nurse practitioner under section 17A of the Act

Part 2 Poisons (S1, S2, S3, S5, S6, S7)

Division 1 Packaging and labelling

5 Packaging and labelling generally
6 Misleading labelling of substances as poisons
7 Packaging of camphor and naphthalene
8 Schedule 3 substances supplied by dealers
9 Exemptions

Division 2 Storage

10 Storage generally
11 Schedule 3 or 7 substances
12 Schedule 6 substances

Division 3 Prescriptions

13 Unauthorised persons not to prescribe Schedule 2 or 3 substances
14 Certain Schedule 3 substances
15 Quantity and purpose of prescriptions to be appropriate

Division 4 Supply

16 Schedule 2 and 3 substances may be supplied by authorised persons
17 Schedule 3 substances to be supplied personally by pharmacists
18 Prescriptions for Schedule 2 or 3 substances to be endorsed
19 Certain Schedule 7 substances to be supplied and used only under an authority
20 “Particular use” poisons may only be supplied in original containers
21 Supply of art materials, toys, furniture etc containing poisons
22 Quantity and purpose of supply to be appropriate

Division 5 Records of supply

23 Supply of certain Schedule 3 substances to be recorded

Division 6 Miscellaneous

24 Poisons to be used or disposed of safely

Part 3 Restricted substances (S4)

Division 1 Packaging and labelling

25 Packaging and labelling generally
26 Misleading labelling of substances as restricted substances
27 Exemptions

Division 2 Storage

28 Storage generally
29 Storage of prescribed restricted substances in hospital wards
30 Responsibility for storage in hospitals

Division 3 Prescriptions

31 Unauthorised persons not to prescribe restricted substances
32 Prescriptions may only be issued for certain purposes
33 Quantity and purpose of prescriptions to be appropriate
34 Form of prescription
35 Emergency prescriptions may be given by telephone or otherwise
36 Authority required to prescribe certain restricted substances
37 Records to be kept of certain prescriptions

Division 4 Supply

Subdivision 1 Supply on prescription

38 Prescriptions may be filled only if in proper form
39 Certain prescriptions not to be filled
40 Prescriptions to be endorsed
41 Prescriptions for certain substances to be kept

Subdivision 2 Supply without prescription

42 Supply by medical practitioners, nurse practitioners, dentists and veterinary surgeons
43 Emergency supply by pharmacists on direction of medical practitioners, nurse practitioners, dentists or veterinary surgeons
44 Emergency supply by pharmacists otherwise than on direction of medical practitioners, dentists or nurse practitioners
45 Supply by pharmacists to medical practitioner, dentist, veterinary surgeon or nurse practitioner for emergency use
46 Supply by pharmacists to nursing homes of stock for emergency use
47 Supply by pharmacists of benzylpenicillin for use in animals

Subdivision 3 Supply in hospitals

48 Supply by pharmacists
49 Supply in original containers: section 10

Subdivision 4 Supply generally

50 Research drugs
51 Authority required to supply certain restricted substances
52 Restricted substances may be supplied by authorised persons
53 Quantity and purpose of supply to be appropriate

Division 5 Records of supply

54 Supply on prescription to be recorded
55 Records to be kept of supply of restricted substances by medical practitioners, nurse practitioners, dentists and veterinary surgeons
56 Certain supplies of restricted substances to be separately recorded

Division 6 Administration

57 Administration by persons employed at a hospital
58 Administration of prescribed restricted substances
59 Authority required to administer certain restricted substances

Division 7 Miscellaneous

60 Prescribed restricted substances: sections 9, 10, 11, 16, 18 and 18A
61 Authorised persons: section 16 (1) (e)
62 Disclosure of other prescribed restricted substances obtained or prescribed
63 Delivery by carrier
64 Pentobarbitone sodium
65 Restricted substances to be used or disposed of safely
66 Loss or theft of prescribed restricted substances
67 Forfeiture of prescribed restricted substances

Part 4 Drugs of addiction (S8)

Division 1 Packaging and labelling

68 Packaging and labelling generally
69 Misleading labelling of substances as drugs of addiction
70 Packages to be sealed so that broken seal is readily distinguishable
71 Exemptions

Division 2 Storage

72 Storage generally
73 Responsibility for storage in hospitals
74 Storage in hospital wards
75 Storage in pharmacies

Division 3 Prescriptions

76 Unauthorised persons not to prescribe drugs of addiction
77 Form of prescription
78 Prescriptions may only be issued for certain purposes
79 Quantity and purpose of prescriptions to be appropriate
80 Emergency prescriptions may be given by telephone or otherwise
81 Records of prescriptions
82 Exceptions to section 28: prescriptions generally
83 Exceptions to section 28: prescriptions for amphetamines

Division 4 Supply

Subdivision 1 Supply on prescription

84 Pharmacists may supply drugs of addiction on prescription
85 Prescriptions may be filled only if in proper form
86 Certain prescriptions not to be filled
87 Prescriptions require verification
88 Prescriptions to be endorsed
89 Prescriptions to be kept
90 Supply by pharmacists of amphetamines
91 Records to be kept by pharmacists of methadone or buprenorphine prescriptions
92 Supply by pharmacists of methadone syrup or buprenorphine tablets
93 Exemptions relating to methadone or buprenorphine supply at pharmacies
94 Exceptions to section 28: supply

Subdivision 2 Supply without prescription

95 Supply to be on the basis of a written order
96 Emergency supply by pharmacists
97 Supply by pharmacists for emergency purposes
98 Supply of amphetamines

Subdivision 3 Supply in hospitals

99 Supply by pharmacists

Subdivision 4 Supply generally

100 Unauthorised manufacture and supply of drugs of addiction prohibited
101 Possession of drugs of addiction by medical practitioners, dentists, veterinary surgeons and hospital pharmacists
102 Possession of drugs of addiction by retail pharmacists
103 Possession of drugs of addiction by chief nurses of private hospitals
104 Possession of drugs of addiction by masters of ships
105 Possession of hallucinogens
106 Authorities to possess and administer drugs of addiction
107 Mode of delivery
108 Delivery by carrier
109 Quantity and purpose of supply to be appropriate

Division 5 Records of supply

Subdivision 1 Drug registers otherwise than for hospital wards

110 Application of Subdivision
111 Drug registers to be kept
112 Entries in drug registers
113 Supply on prescription to be recorded

Subdivision 2 Drug registers for hospital wards

114 Application of Subdivision
115 Ward registers to be kept
116 Entries in ward registers

Subdivision 3 Records generally

117 Periodical inventory of drugs of addiction stock
118 Loss or destruction of registers

Division 6 Administration

119 Administration by persons employed at a hospital
120 Self-administration by medical practitioners and dentists

Division 7 Miscellaneous

121 Prescribed drugs of addiction: section 28
122 Loss or theft of drugs of addiction
123 Drugs of addiction not to be destroyed
124 Destruction of unusable drugs of addiction in public hospital wards
125 Destruction of unwanted drugs of addiction in a private hospital, nursing home or day procedure centre

Part 5 Supply by wholesale

126 Authorised possession for supply by wholesale
127 Restrictions on supply by wholesale
128 Records of supply by wholesale
129 Distribution of free samples
130 Storage of therapeutic goods for human use

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

Division 1 Preparation and handling of exposed substances

131 Application of Division
132 Preparation and handling generally
133 Personal cleanliness
134 Spitting and smoking etc
135 Contact with hands
136 Contact with mouth
137 Bandages
138 Persons suffering from infectious diseases
139 Appliances, articles, fittings and surfaces

Division 2 Supply of therapeutic goods

140 Premises to be free of vermin
141 Animals not permitted on premises

Division 3 Labelling of unscheduled therapeutic substances

142 Labelling of unscheduled therapeutic substances

Part 7 Analysis and disposal of seized goods

Division 1 Analysis of seized goods

143 Samples for analysis
144 Payment for sample

Division 2 Disposal of seized goods

145 Release of seized goods
146 Order that seized goods be forfeited
147 Order that expenses be paid
148 Storage of and interference with seized goods
149 Forfeiture of goods with consent
150 Disposal of forfeited goods

Part 8 Licences and authorities

Division 1 Licences to supply Schedule 2 substances

151 Applications for licences
152 Consideration of applications
153 Licences
154 Conditions of licences
155 Annual licence fees

Division 2 Licences to supply by wholesale poisons and restricted substances

156 Applications for licences
157 Consideration of applications
158 Licences
159 Conditions of licences
160 Annual licence fees

Division 3 Licences to manufacture or supply drugs of addiction

161 Applications for licences
162 Consideration of applications
163 Licences
164 Conditions of licences
165 Annual licence fees

Division 4 Authorities

166 Authorities
167 Conditions of authorities

Division 5 Suspension and cancellation of licences and authorities

168 Grounds for suspension or cancellation
169 Suspension or cancellation

Division 6 Modification of applied provisions of Commonwealth therapeutic goods laws

170 Modification of applied provisions of Commonwealth therapeutic goods laws with respect to advertising: section 31 (3)

Part 9 Miscellaneous

171 Director-General may restrict authorisations conferred by this Regulation
172 Records generally
173 False or misleading entries in records and registers
174 False or misleading applications
175 Service of notices
176 Applications for authorities under section 29
177 Quorum for Poisons Advisory Committee
178 Residential centres for persons with disabilities
179 Saving

 Appendix A Labelling of therapeutic substances

 Appendix B Special restricted substances

 Appendix C Supply by wholesale

 Appendix D Prescribed restricted substances

Historical notes