MEDICINES AND POISONS (MEDICINES) REGULATION 2021

Queensland Consolidated Regulations

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MEDICINES AND POISONS (MEDICINES) REGULATION 2021

- Made under the Medicines and Poisons Act 2019
- As at 1 February 2024
- Reg 140 of 2021

TABLE OF PROVISIONS

CHAPTER 1 - INTRODUCTION

PART 1 - PRELIMINARY

1. Short title
2. Commencement
3. Application of regulation

PART 2 - INTERPRETATION

4. Definitions
5. References to registration under Health Practitioner Regulation National Law

PART 3 - EXEMPTIONS

6. Exemption for national blood supply arrangements—Act, s 7
6A. Exemption for S3 naloxone treatment programs—Act, s 7

PART 4 - APPROVAL OF DOCUMENTS

7. Extended practice authorities—Act, s 232
8. Departmental standards—Act, s 233

PART 5 - CATEGORIES OF MEDICINES

9. Restricted medicines
10. High-risk medicines—Act, s 40
11. Diversion-risk medicines—Act, sch 1
12. Monitored medicines—Act, sch 1

CHAPTER 2 - AUTHORISATIONS

PART 1 - APPROVED PERSONS

13. Approved persons—Act, s 54

PART 2 - PRESCRIBED CLASSES OF GENERAL APPROVALS

14. Classes of general approvals—Act, s 68
15. Acute health conditions at isolated sites
16. Emergency first aid
17. Emergency management of animals

CHAPTER 3 - STANDARD CONDITIONS FOR SUBSTANCE AUTHORITIES

PART 1 - PRELIMINARY

18. Application of chapter—Act, s 70

PART 2 - MANUFACTURING LICENCES

Division 1 - Conditions for all manufacturers

19. Application of division
20. Manufacturing must be supervised
21. Quality control
22. Open for inspection

Division 2 - Particular conditions for manufacturers of medicated feed

23. Application of division
24. Supply on prescriptions
25. Manufacturer must give and keep supply records
26. Delivery of medicated feed

PART 3 - RETAIL LICENCES

27. Selling within 25km from pharmacy
28. Selling S2 medicines in manufacturer’s pack
29. Open for inspection

PART 4 - PRESCRIBING APPROVALS FOR APPROVED OPIOIDS

30. Application of part
31. Notification when starting and stopping treatment

PART 5 - GENERAL APPROVALS

Division 1 - Acute health conditions at isolated sites

32. Appropriately qualified practitioners
33. Practitioners must be contactable

Division 2 - Emergency first aid

34. Appropriately qualified practitioners
35. Notification about events
36. Practitioners must be contactable

Division 3 - Emergency management of animals

37. Appropriately qualified veterinary surgeons
38. Veterinary surgeons must be contactable

PART 6 - ALL SUBSTANCE AUTHORITIES

39. Application of part
40. Keeping invoices
41. Availability of records for inspection
42. Notification of particular changes affecting authority
43. Stopping dealing

CHAPTER 4 - GENERAL REQUIREMENTS FOR DEALINGS

PART 1 - PRELIMINARY

44. Application of chapter—Act, s 91

PART 2 - MANUFACTURING BY COMPOUNDING

45. Application of part
46. Compounded medicine fit for use
47. Compounding for patients under departmental standard

PART 3 - BUYING BY GIVING PURCHASE ORDERS

48. Application of part
49. Definitions for part
50. When purchase order must be given
51. Nature of purchase order
52. Information for inclusion in purchase order
53. Buyer acknowledging receipt of stock of S8 medicine

PART 4 - SUPPLYING STOCK

Division 1 - Preliminary

54. Application of part
55. Definitions for part

Division 2 - Supplying in appropriate circumstances

56. Supply of S4 or S8 medicine
57. Supply of S2 or S3 medicine for authorised facility
58. Supply of S2 or S3 medicine for professional practice
59. Supply of S2 and S3 medicines to manufacturers, wholesalers or retailers
60. When supply is not otherwise permitted

Division 3 - Documentation for supply

61. Supplier to give invoice or other notice
62. Completing and keeping purchase orders

Division 4 - Delivery of supplied stock

63. Application of division
64. Secure packaging for all medicines
65. Additional requirements for packaging S8 medicines
66. Engaging carrier
67. Delivery to street address
68. Supplier to obtain receipt for stock of S8 medicines
69. Supplier to notify chief executive if no receipt provided

Division 5 - Other requirements

70. Responsibilities for employees and representatives
71. Compliance with code
72. Supplying medicine in manufacturer’s pack
73. Labels and containers must comply with Poisons Standard or approved alternatives
74. Open for inspection

PART 5 - POSSESSING STOCK FOR DELIVERY

75. Application of part
76. Storing stock within notified temperature limits
77. Stock not to be left unattended
78. Delivery to person at street address

PART 6 - PRESCRIBING MEDICINES

Division 1 - Preliminary

79. Application of part
80. Definitions for part

Division 2 - Prescribing generally

81. Reasonable necessity for therapeutic treatment

Division 3 - Prescribing for dispensing or giving treatment doses

Subdivision 1 - Written prescriptions for patients and animals

82. Application of subdivision
83. Electronic prescription
84. Sending prescription electronically
85. Generation of paper prescription using computer
86. Content of written prescription
87. Additional content of written prescription for S8 medicine
88. Signing written prescription
89. Using printed label on prescription
90. Amending written prescription

Subdivision 2 - Prescribing particular medicines for patients

91. Application of subdivision
92. Oral prescription for S4 or S8 medicine
93. Compliance with monitored medicines standard

Division 4 - Prescribing for administration by authorised persons

Subdivision 1 - Written prescriptions for patients and animals

94. Application of subdivision
95. Content of written prescription
96. Additional content of written prescription for approved opioid
97. Signing written prescription
98. Using printed label

Subdivision 2 - Oral prescriptions for patients and animals

99. Application of subdivision
100. Oral prescription

PART 7 - MAKING STANDING ORDERS

Division 1 - Preliminary

101. Meaning of clinical protocol

Division 2 - Standing orders

102. Application of division
103. Making standing order for relevant institution
104. Making other standing orders
105. Safe circumstances for making standing order
106. Content of standing order
107. Additional content of standing order under general approval
108. Standing order available for inspection

Division 3 - Clinical protocols

109. Application of division
110. Contents of clinical protocol
111. Protocol available for inspection

PART 8 - DISPENSING MEDICINES

Division 1 - Patients and animals

Subdivision 1 - Preliminary

112. Application of division

Subdivision 2 - Prescriptions

113. Dispensing on compliant written prescription
114. Dispensing on electronic prescription
115. Dispensing on digital copy of paper prescription
116. Digital copy of paper prescription for diversion-risk medicine between dispensers
117. Amending written prescription

Subdivision 3 - Medicines

118. Labelling dispensed medicine
119. Expired medicine

Subdivision 4 - Dispensing in appropriate circumstances

120. When dispensing is not otherwise permitted
121. Expired written prescription

Subdivision 5 - Records

122. Dispensing information on or with written prescription
123. Keeping fulfilled paper prescription
124. Dispensing record for dispensed medicine

Division 2 - Patients only

125. Application of division
126. Compliance with monitored medicines standard
127. Dispensing diversion-risk medicine
128. Dispensing generic medicine

PART 9 - GIVING TREATMENT DOSES OF MEDICINES

Division 1 - Preliminary

129. Application of part

Division 2 - Giving treatment doses generally

130. Reasonable necessity for therapeutic treatment
131. Giving medicine in manufacturer’s pack
132. Giving diversion-risk medicine
133. When giving treatment dose is not otherwise permitted

Division 3 - Labelling and records

134. Labelling treatment dose of medicine
135. Information on or with prescription
136. Treatment dose record

Division 4 - Expired prescriptions and medicines

137. Expired written prescription
138. Expired medicine

PART 10 - ADMINISTERING MEDICINES

139. Application of part
140. Reasonable necessity for therapeutic treatment
141. Record for administering on standing order
142. Expired written prescription

PART 11 - DISPOSING OF WASTE FROM DIVERSION-RISK MEDICINES

Division 1 - Preliminary

143. Application of part

Division 2 - S8 diversion-risk medicine waste

144. Application of division
145. Separation of waste
146. Transfer of waste for destruction
147. Destruction of waste

Division 3 - Other diversion-risk medicine waste

148. Preventing public access to waste

CHAPTER 5 - SPECIAL REQUIREMENTS FOR DEALINGS

PART 1 - PRELIMINARY

149. Application of chapter—Act, s 91

PART 2 - PHARMACISTS

Division 1 - Preliminary

150. Application of part

Division 2 - Supplying stock

151. Supply for filling another pharmacy client order
152. Records when supplying to another pharmacist

Division 3 - Selling medicines without prescriptions

Subdivision 1 - Preliminary

153. Application of division

Subdivision 2 - Labelling

154. Labelling sold medicine

Subdivision 3 - S4 medicines

155. Definition for subdivision
156. Selling S4 oral hormonal contraceptive
157. Selling S4 diversion-risk medicine
158. Selling other S4 medicines
159. Amounts when selling S4 medicine
160. Record when selling S4 medicine

Subdivision 4 - S3 medicines

161. Selling S3 medicine with instructions for use
162. Record keeping for pseudoephedrine

PART 3 - PHARMACY EMPLOYEES

163. Application of part
164. Notifying pharmacist of discrepancy
165. Selling S2 medicine in manufacturer’s pack

PART 4 - VETERINARY PROFESSIONS

Division 1 - Veterinary surgeons prescribing S4 medicines and medicated feed

166. Application of division
167. Instructions for administration to food producing animals
168. Written prescription for medicine and medicated feed
169. Sending written prescription

Division 2 - Veterinary nurses

170. Record for veterinary nurse administering on oral prescription

PART 5 - WHOLESALE REPRESENTATIVES

171. Disposal of unused starter packs

CHAPTER 6 - SUBSTANCE MANAGEMENT PLANS

172. Regulated places and responsible persons—Act, s 92
173. Matters for plan—Act, s 93
174. Review of plan—Act, s 93

CHAPTER 7 - MONITORED MEDICINES DATABASE

PART 1 - PRELIMINARY

175. Application to information from other States
176. Definitions for chapter
177. Additional purposes—Act, s 224

PART 2 - REQUIREMENT TO CHECK DATABASE

178. Relevant practitioners—Act, s 41

PART 3 - INFORMATION FOR DATABASE

179. Information recorded in database—Act, s 225
180. Information providers and relevant information—Act, s 226
181. Method for data source entities giving information—Act, s 226
182. Method for dispensers giving information—Act, s 226

PART 4 - DISCLOSURE

183. Users—Act, s 227

CHAPTER 8 - OFFENCES

PART 1 - ELECTRONIC PRESCRIPTION MANAGEMENT SYSTEMS

Division 1 - Preliminary

184. Application of part

Division 2 - Key appointments

185. Appointments for managing system

Division 3 - System managers

186. System must comply with departmental standard
187. Security measures required for system

Division 4 - System administrators

188. Giving access to the system
189. Cancelling access to the system
190. Making and keeping records of users
191. Maintaining system
192. Reporting system breaches for monitored medicines

Division 5 - Approved users

193. Protecting secure system identifiers

PART 2 - SECURE STORAGE SYSTEMS

Division 1 - Preliminary

194. Non-application of part to animal feed
195. Definitions for part

Division 2 - Medicine stores and S8 safes

Subdivision 1 - Establishing stores and S8 safes

196. Appointing establishers and managers
197. S8 safe must comply with standard
198. Storage for safety and quality of medicines
199. Preventing unauthorised access to medicines

Subdivision 2 - Managing S8 safes

200. S8 safe establisher giving access to S8 safe

Subdivision 3 - Using S8 safes and stores

201. Requirements for authorised user accessing S8 safe
202. Taking medicine from S8 safe and medicine store

Division 3 - Medicine registers

Subdivision 1 - Preliminary

203. Application of division
204. Definitions for division

Subdivision 2 - Managers keeping registers

205. Meaning of medicine register
206. Manager must make and keep register with safe or store
207. Layout of medicine register
208. Electronic register
209. Paper register
210. Replacing paper register

Subdivision 3 - Users of registers

211. Information that must be recorded in register
212. General information recorded in register
213. Specific information for particular dealings recorded in register
214. Amending register
215. Keeping secure system identifier secure
216. Making entries in paper register

Subdivision 4 - Managers reconciling registers

217. Reconciling with medicines on hand
218. Reporting lost, stolen or destroyed register

Division 4 - Carriers

219. Systems for tracking stock of medicines
220. Safe delivery of stock of S2 or S3 medicines

PART 3 - CONTAINERS

221. Restriction on used containers

PART 4 - RECORDING AND KEEPING INFORMATION

222. Writing paper documents
223. Writing electronic documents
224. Period and way of keeping records
225. Securing prescription stationery

PART 5 - REPORTING PARTICULAR MATTERS

226. Reporting lost or stolen medicine
227. Reporting failure to give written prescription
228. Reporting and preventing use of unlawful document
229. Marking non-compliant paper prescription
230. Reporting supply on false prescription or purchase order for diversion-risk medicine
231. Notification of loss or theft
232. Return of transactions for wholesale representatives
233. Giving chief executive information about particular diversion-risk medicines

PART 6 - ADVERTISING AND VENDING MACHINES

234. Unlawful advertising of medicines
235. Offence to install medicine vending machines

CHAPTER 9 - MISCELLANEOUS

PART 1 - ADMINISTRATION BY CHIEF EXECUTIVE

236. Matters to be considered before making particular extended practice authorities—Act, s 232
237. Chief executive may approve alternative ways of labelling or packaging medicines

PART 2 - FEES

Division 1 - General

238. Definitions for part and schedule 19
239. Fees payable generally

Division 2 - Exemptions

240. Manufacturing licence for S2, S3 or S4 medicines
241. Wholesale licence for S2, S3 or S4 medicines

Division 3 - Refunds

242. Rejected or withdrawn application
243. Authority granted for shorter term
244. Surrender of authority

CHAPTER 10 - REPEAL AND TRANSITIONAL PROVISIONS

PART 1 - REPEAL

245. Repeal

PART 2 - TRANSITIONAL PROVISIONS

Division 1 - Monitored medicines database

246. Prescribed day when database is fully operational—Act, s 281
247. Information transitioned to database—Act, s 225

Division 2 - Special arrangement period

248. Sending and keeping particular prescriptions during special arrangement period

Division 3 - Transitioned approvals, documents and records

249. Definitions for division
250. Certified way of packaging
251. Certified way of labelling
252. Controlled drugs registers
253. Clinical protocols
254. Orthoptist protocols
255. Practice plans
256. Chief executive’s approvals or certifications for bodies and facilities
SCHEDULE 1
SCHEDULE 2
SCHEDULE 3
SCHEDULE 4
SCHEDULE 5
SCHEDULE 6
SCHEDULE 7
SCHEDULE 8
SCHEDULE 9
SCHEDULE 10
SCHEDULE 11
SCHEDULE 12
SCHEDULE 13
SCHEDULE 14
SCHEDULE 15
SCHEDULE 16
SCHEDULE 17
SCHEDULE 18
SCHEDULE 19
SCHEDULE 20
SCHEDULE 21
SCHEDULE 22

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