POISONS AND THERAPEUTIC GOODS REGULATION 2008
POISONS AND THERAPEUTIC GOODS REGULATION 2008
- Made under the Poisons and Therapeutic Goods Act 1966 - As at 28 November 2023 - 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 (Repealed) PART 2 - POISONS (S1, S2, S3, S5, S6, S7) Division 1 - Packaging and labelling 7.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 1A - Preliminary 25A. Application of part 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 1A - Preliminary 68J. Application of part 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 125A. Destruction of drugs of addiction by retail pharmacists 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 - VOLUNTARY ASSISTED DYING SUBSTANCES Note Division 1 - Preliminary 128B. Definitions 128C. Application of part Division 2 - Storage 128D. Storage by authorised supplier 128E. Storage at health care establishments and residential facilities 128F. Means to unlock storage box to be kept securely Division 3 - Records Note 128G. Prescriptions to be kept 128H. Records to be kept by authorised supplier 128I. Records to be kept by administering practitioner 128J. Records to be kept by authorised disposer 128K. Records may be kept electronically Division 4 - Miscellaneous 128L. Form and use of prescription 128LA. Disposal 128LB. Mode of delivery--authorised supplier 128LC. Mode of delivery--contact person 128LD. Delivery by carrier 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 AND AUTHORITY MANAGEMENT 174A. Interpretation 174B. Objects 174C. Establishment and purpose of database 174D. Recording of information by prescribers 174E. Recording of information by pharmacists 174EA. Recording or including information on database for substances requiring authority 174EB. Secretary may include information in database 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