POISONS AND THERAPEUTIC GOODS REGULATION 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 (Repealed)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)

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

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
• 37 Authority required to prescribe certain restricted substances
• 38 Records to be kept of certain prescriptions

Division 4 - Supply

• 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
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
• 49 Supply by pharmacists
• 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 a hospital
• 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 4 - DRUGS OF ADDICTION (S8)

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

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
• 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

• 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
• 99 Supply by pharmacists
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

• 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 and residential care facilities
• 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 a hospital
• 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. (Repealed)

PART 4A - (Repealed)

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
• 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 9 - MISCELLANEOUS

• 175 Director-General 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
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