POISONS AND THERAPEUTIC GOODS REGULATION 2008

New South Wales Consolidated Regulations

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POISONS AND THERAPEUTIC GOODS REGULATION 2008

- Made under the Poisons and Therapeutic Goods Act 1966
- As at 1 November 2022
- Reg 392 of 2008

TABLE OF PROVISIONS

PART 1 - PRELIMINARY

1. Name of Regulation
2. Commencement
3. Definitions
4-6. (Repealed)

PART 2 - POISONS (S1, S2, S3, S5, S6, S7)

Division 1 - Packaging and labelling

7. Packaging and labelling generally
8. Misleading labelling of substances as poisons
9. Schedule 3 substances supplied by dealers
10. Exemptions

Division 2 - Storage

11. Storage generally
12. Schedule 3 or 7 substances
13. Schedule 6 substances

Division 3 - Prescriptions

14. Unauthorised persons not to prescribe Schedule 2 or 3 substances
15. Prescription for pseudoephedrine
16. Quantity and purpose of prescriptions to be appropriate

Division 4 - Supply

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

Division 5 - Records of supply

24. Supply of certain Schedule 2 or 3 substances to be recorded

Division 6 - Miscellaneous

25. Poisons to be used or disposed of safely

PART 3 - RESTRICTED SUBSTANCES (S4)--THE ACT, S 17

Division 1 - Packaging and labelling

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

Division 2 - Storage

29. Storage generally
30. Storage of prescribed restricted substances in hospital wards
31. Responsibility for storage in hospitals
31A. Storage in managed correctional centres

Division 3 - Prescriptions

32. Prescriptions for restricted substances
33. Prescriptions may be issued only for certain purposes
34. Quantity and purpose of prescriptions to be appropriate
34A. Medication chart prescriptions
35. Form of prescription
36. Emergency prescriptions may be given by telephone or otherwise
36A. Special provisions for prescribing restricted substances--public health organisations
36B. Special provisions for prescribing restricted substances--private health facilities
37. Authority required to prescribe certain restricted substances
38. Records to be kept of certain prescriptions

Division 4 - Supply

Subdivision 1 - Supply on prescription

39. Prescriptions may be filled only if in proper form
40. Certain prescriptions not to be filled
41. Prescriptions to be endorsed
42. Prescriptions for certain substances to be kept
42A. (Repealed)

Subdivision 2 - Supply without prescription

43. Supply by certain health practitioners
44. Emergency supply by pharmacists on direction of certain health practitioners
45. Emergency supply by pharmacists otherwise than on direction of health practitioner
45A. Supply by pharmacists in accordance with determination under National Health Act 1953 of Commonwealth
46. Supply by pharmacists to health practitioners for emergency use
47. Supply by pharmacists to residential care facilities of stock for urgent use
48. Supply by pharmacists of benzylpenicillin for use in animals
48A. Supply by pharmacists of certain vaccines

Subdivision 3 - Supply in hospitals and managed correctional centres

49. Supply by pharmacists
49A. Supply by pharmacists in managed correctional centres
50. Supply in original containers

Subdivision 4 - Supply generally

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

Division 5 - Records of supply

55. Supply on prescription to be recorded
55A. Records relating to medication chart prescriptions
56. Records to be kept of certain supply of restricted substances
57. Certain supplies of restricted substances to be separately recorded

Division 6 - Administration

58. Administration by persons employed at hospitals and managed correctional centres
59. Administration of prescribed restricted substances
60. Authority required to administer certain restricted substances

Division 7 - Miscellaneous

61. Prescribed restricted substances
62. Authorised persons
63. Disclosure of other prescribed restricted substances obtained or prescribed
64. Delivery by carrier
65. Pentobarbitone sodium
66. Restricted substances to be used or disposed of safely
67. Loss or theft of prescribed restricted substances
68. Forfeiture of prescribed restricted substances

PART 3A - RESTRICTED SUBSTANCES USED FOR COSMETIC AND OTHER PURPOSES--THE ACT, PART 3, DIV 1A

Division 1 - Preliminary

68A. Definitions
68B. Application of Part

Division 2 - Administration

68C. Nurse may administer relevant substance on direction of medical practitioner or nurse practitioner
68D. Direction by medical practitioner or nurse practitioner
68E. Content of direction
68F. Records of directions

Division 3 - Miscellaneous

68G. Storage
68H. Duties of responsible providers
68I. Category 1 and category 2 requirements--the Act, s 18D(2)

PART 4 - DRUGS OF ADDICTION (S8)--THE ACT, S 24

Division 1 - Packaging and labelling

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

Division 2 - Storage

73. Storage generally
74. Responsibility for storage in hospitals
75. Storage in hospital wards
76. Storage in pharmacies
76A. Storage in managed correctional centres

Division 3 - Prescriptions

77. Unauthorised persons not to prescribe drugs of addiction
78. Prescriptions may be issued for certain purposes only
79. Quantity and purpose of prescriptions to be appropriate
80. Form of prescription
81. Emergency prescriptions may be given by telephone or otherwise
81A. Special provisions for prescribing drugs of addiction--public health organisations
82. Records of prescriptions
83. Exceptions to section 28--prescriptions generally
84. Exceptions to section 28--prescriptions for type A drugs of addiction
84A. Authority required for prescriptions for clinical trials
84B. Restriction on prescriptions for clinical trials

Division 4 - Supply

Subdivision 1 - Supply on prescription

85. Pharmacists may supply drugs of addiction on prescription
86. Certain prescriptions not to be filled
87. Prescriptions require verification
88. Prescriptions to be endorsed
89. Prescriptions and orders to be kept
90. Supply by pharmacists of type A drugs of addiction
91. Records to be kept by pharmacists of methadone or buprenorphine prescriptions
92. Supply by pharmacists of liquid methadone or buprenorphine
93. Exemptions relating to methadone or buprenorphine supply at pharmacies
94. Exceptions to section 28--supply
94AA. Authority required for supply for clinical trials
94AB. Restriction on supply for clinical trials
94A. Supply of liquid methadone or buprenorphine by pharmacists--transitional provision

Subdivision 2 - Supply without prescription

95. Supply and receipt of drugs of addiction generally
96. Emergency supply by pharmacists
97. Supply by pharmacists for emergency purposes
98. Supply of type A drugs of addiction

Subdivision 3 - Supply in hospitals and managed correctional centres

99. Supply by pharmacists
99A. Supply by pharmacists in managed correctional centres

Subdivision 4 - Manufacture, possession and supply generally

100. Unauthorised manufacture and supply of drugs of addiction prohibited
101. Possession and supply of drugs of addiction
102. Possession and manufacture of drugs of addiction by retail pharmacists
103. Possession of drugs of addiction at private health facilities and residential care facilities
104. Possession of drugs of addiction by masters of ships
105. (Repealed)
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
114. Emergency supply or supply to private health facility or residential care facility to be recorded

Subdivision 2 - Drug registers for hospital wards, residential care facilities and managed correctional centres

115. Application of Subdivision
116. Registers to be kept
117. Entries in registers

Subdivision 3 - Records generally

118. Periodical inventory of stock of drugs of addiction
119. Loss or destruction of registers
119A. Records relating to prescriptions for residents of residential care facilities

Division 6 - Administration

120. Administration by persons employed at hospitals and managed correctional centres
121. Self-administration by medical practitioners and dentists

Division 7 - Miscellaneous

122. Prescribed type A drugs of addiction
123. Prescribed type B drugs of addiction
124. Loss or theft of drugs of addiction
125. Drugs of addiction not to be destroyed
126. Destruction of unusable or unwanted drugs of addiction held by practitioners
126A. Destruction of unusable or unwanted drugs of addiction in public hospitals
127. Destruction of unusable drugs of addiction in public hospital wards
128. Destruction of unwanted drugs of addiction in private health facilities or residential care facilities
128A. Destruction of unusable or unwanted drugs of addiction in managed correctional centres

PART 4A - (Repealed)
None

PART 4B - ETORPHINE

128M. Obtaining etorphine
128N. Prescribing and supplying etorphine
128O. Regulation applies as if etorphine were drug of addiction

PART 4C - SCHEDULE 10 SUBSTANCES

128P. Schedule 10 substances

PART 5 - SUPPLY BY WHOLESALE AND BY HOLDERS OF WHOLESALER'S LICENCES AND AUTHORITIES

129. Persons authorised to possess or use substances and to be supplied by holder of wholesaler's licence or authority--the Act, ss 10 and 11
130. Restrictions on supply by wholesale
131. Records of supply by wholesale
132. Distribution of free samples
133. Storage of therapeutic substances for human use
134. Pharmacists authorised to supply by wholesale in certain circumstances

PART 6 - PREPARATION, HANDLING, SUPPLY AND LABELLING OF THERAPEUTIC GOODS

Division 1 - Preparation and handling of exposed substances

135. Application of Division
136. Preparation and handling generally
137. Personal cleanliness
138. Certain behaviour prohibited
139. Contact with hands
140. Contact with mouth
141. Bandages
142. Persons suffering from infectious diseases
143. Appliances, articles, fittings and surfaces

Division 2 - Supply of therapeutic goods

144. Premises to be free of vermin
145. Animals not permitted on premises

Division 3 - Labelling of unscheduled therapeutic substances

146. Labelling of unscheduled therapeutic substances

PART 7 - ANALYSIS AND DISPOSAL OF SEIZED GOODS

Division 1 - Analysis of seized goods

147. Samples for analysis
148. Payment for sample

Division 2 - Disposal of seized goods

149. Release of seized goods
150. Order that seized goods be forfeited
151. Order that expenses be paid
152. Storage of and interference with seized goods
153. Forfeiture of goods with consent
154. Disposal of forfeited goods

PART 8 - LICENCES AND AUTHORITIES

Division 1 - Licences to supply Schedule 2 substances

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

Division 2 - Licences to supply by wholesale poisons and restricted substances

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

Division 3 - Licences to manufacture or supply drugs of addiction

165. Applications for licences
166. Consideration of applications
167. Licences
168. Conditions of licences
169. Annual licence fees

Division 4 - Authorities

170. Authorities
171. Conditions of authorities

Division 5 - Suspension and cancellation of licences and authorities

172. Grounds for suspension or cancellation
173. Suspension or cancellation

Division 6 - Modification of applied provisions of Commonwealth therapeutic goods laws

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

PART 8A - REAL TIME PRESCRIPTION MONITORING

174A. Interpretation
174B. Objects
174C. Establishment and purpose of database
174D. Recording of information by prescribers
174E. Recording of information by pharmacists
174F. Authority to transfer information
174G. Use and disclosure of information by Secretary
174H. Use of information by certain prescribers and by pharmacists
174I. Unauthorised access to database
174J. Exemption

PART 9 - MISCELLANEOUS

175. Secretary may restrict authorisations conferred by this Regulation
175A. Exemption from storage requirements for goods requiring refrigeration
176. Records generally
177. False or misleading entries in records and registers
178. Service of notices
179. Applications for authorities under section 29
180. Quorum for Poisons Advisory Committee
181. Saving
182. Licences and authorities for substance reclassified as type A drug of addiction
183. Duty of governors of managed correctional centres--the Act, ss 17 and 24
Appendix A - Labelling of therapeutic substances
Appendix B - Special restricted substances
Appendix C - Persons authorised to possess and use substances
Appendix D - Prescribed restricted substances

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