Queensland Consolidated Regulations

HEALTH (DRUGS AND POISONS) REGULATION 1996

TABLE OF PROVISIONS

           Contents

CHAPTER 1--INTRODUCTION

           Part 1--Preliminary

   1.      Short title

           Part 2--Interpretation

   3.      Dictionary
   4.      Meaning of manufacture
   4A.     Quality standards for dispensing certain drugs and selling certain poisons
   5.      Meaning of S2 to S9
   6.      Meaning of transaction
   7.      Application of interpretation provisions in standard to regulation
   8.      References to entering details, signing or dating entries etc.

           Part 3--Application of regulation to certain substances

   9.      Provisions not applied to morphine or opium in certain preparations
   9A.     Classification of new drugs and poisons
   9B.     Reclassifications of poisons

           Part 4--Packing and labelling

   10.     Packaging of controlled or restricted drugs or poisons
   11.     Labelling of controlled or restricted drugs or poisons—Act, s 131I
   12.     Certain containers not to be used
   13.     Camphor and naphthalene

           Part 5--Endorsements

           Division 1--Preliminary

   15.     Suitability of person to hold endorsement
   16.     Inquiries about person's criminal history

           Division 2--Applications for endorsements

   17.     Applications—form and fee
   18.     How chief executive may deal with applications
   19.     Renewal of drug licence, poison licence, treatment approval or wholesale representative licence before expiry
   20.     Renewal of drug licence, poison licence, treatment approval or wholesale representative licence after expiry

           Division 2A--Applications for operating approvals

   20A.    Purpose of division
   20B.    Who may apply for an operating approval
   20C.    Additional requirements for applications for operating approvals
   20D.    Chief executive may require further information or documents
   20E.    Deciding applications for operating approvals
   20F.    Time for deciding applications for operating approvals

           Division 3--Other provisions about endorsements

   21.     Holder of endorsement must comply with conditions
   22.     Term of drug licence, poison licence or wholesale representative licence

           Division 4--Suspension or cancellation of endorsement

   23.     Grounds for suspension or cancellation of endorsement
   24.     Procedure for suspension or cancellation of endorsement
   25.     Urgent suspension or cancellation of endorsement
   25A.    Urgent cancellation of certain approvals
   26.     Return of endorsement
   26A.    Application for amendment or repeal of decision to suspend or cancel endorsement

           Division 5--Replacement, amendment, return and surrender of endorsements

   27.     Replacement of endorsement
   28.     Amendment of endorsement on application
   29.     Amendment of endorsement without application
   30.     Minor amendment of endorsement
   31.     Date amendment of endorsement takes effect
   32.     Surrender of endorsement

           Part 6--Appeals

   33.     Decisions open to appeal
   34.     Starting an appeal
   35.     Notice of appeal to be given to chief executive
   36.     Stay of operation of decisions
   37.     Hearing procedures for appeal
   38.     Powers of court on appeal
   39.     Appeal to District Court on questions of law only

CHAPTER 2--CONTROLLED DRUGS

           Part 1--Licences

           Division 1--Preliminary

   40.     Application of pt 1
   41.     Licence to state business premises and other particulars

           Division 2--Controlled drug manufacturer licence

   42.     Restrictions on grant of controlled drug manufacturer licence
   43.     Controlled drug manufacturer licence
   44.     General conditions that apply to controlled drug manufacturer licence
   45.     Offence to manufacture controlled drugs without licence

           Division 3--Controlled drug wholesaler licence

   46.     Restrictions on grant of controlled drug wholesaler licence
   47.     Controlled drug wholesaler licence
   48.     General conditions that apply to controlled drug wholesaler licence
   49.     Offence to wholesale controlled drugs without licence

           Division 4--General

   49A.    Licensee to give invoice when selling controlled drug
   50.     Records of transactions to be kept by licensee

           Part 2--Endorsements

           Division 1--Preliminary

   51.     Endorsement needed for controlled drugs

           Division 2--Particular authorities

   52.     Anaesthetic assistants and enrolled nurses
   53.     Approved dispenser
   54.     Bases and outposts of Royal Flying Doctor Service
   55.     Carriers
   56.     Dentists
   57.     Detention centres
   58.     Doctors
   58A.    Enrolled nurses
   58B.    Hospital pharmaceutical assistants
   59.     Hospitals
   59A.    Indigenous health workers
   60.     Inspectors
   61.     Manufacturer or wholesaler of controlled drugs
   62.     Midwives
   63.     Nursing homes
   64.     Pharmacists
   64AA.   Physician's assistants
   64A.    Surgical Podiatrists
   65.     Prisons
   66.     Queensland Ambulance Service
   67.     Registered nurses
   68.     Certain registered nurses at rural hospitals
   69.     Ship's master
   70.     State analysts
   70A.    Trainees in certain occupations
   71.     Veterinary surgeons
   72.     Watch-house keepers etc.

           Division 3--General

   74.     When endorsement is not needed

           Part 3--Regulated controlled drugs

   77.     Approved drug—dronabinol (delta-9-tetrahydrocannabinol)
   78.     Specified condition drugs—amphetamine, dexamphetamine, methylamphetamine, methylphenidate, phenmetrazine

           Part 4--Prescribing and dispensing controlled drugs

           Division 1--Prescribing controlled drugs

   79.     Prescribing controlled drugs
   80.     Restrictions on making prescriptions
   81.     Oral prescription

           Division 2--Dispensing controlled drugs

   81A.    Quality standard for dispensing controlled drugs
   82.     Conditions of dispensing
   83.     Dispensing generic drugs
   84.     Dealing with paper prescriptions and certain written instructions
   84A.    Dealing with electronic prescriptions
   85.     Labelling dispensed and supplied medicines
   86.     Record of transactions involving controlled drugs to be kept by pharmacist
   87.     Entries to be made in controlled drugs record
   88.     Stock to be checked

           Part 5--Obtaining and selling controlled drugs on purchase order

   89.     Authorised persons to obtain controlled drugs on purchase order
   90.     Sale of controlled drugs to authorised persons
   91.     Delivery of controlled drugs
   92.     Sending controlled drugs by carrier etc.
   93.     Dealing with purchase orders

           Part 6--Possession and use of controlled drugs

   94.     Unlawful possession of controlled drugs
   95.     Possession by user
   96.     Issue of controlled drugs within institutions
   97.     Oral instruction must be put in writing

           Part 7--Records of controlled drugs

           Division 1--Definitions

   98.     Definitions for pt 7

           Division 2--Records at institutions with central storage point for controlled drugs

   99.     Central storer to keep main issue book for controlled drugs
   100.    Details to be recorded when controlled drugs obtained by central storer
   101.    Unit storer to keep ward drugs book for controlled drugs
   102.    Details to be recorded when controlled drugs obtained at unit
   103.    Details to be recorded when controlled drugs administered in unit
   104.    Transfer vouchers may be used for controlled drugs in certain cases
   105.    Main issue book and ward drugs book as 1 book

           Division 3--Records at institutions with only 1 storage point

   106.    Single storer to keep single storage book for controlled drugs
   107.    Details to be recorded when controlled drugs obtained
   108.    Details to be recorded when controlled drugs administered

           Division 4--Other provisions about records at institutions

   109.    Records of controlled drugs supplied to be kept
   110.    Responsibility for checking accuracy of records at institutions

           Division 5--Responsibility for keeping and checking records at places other than institutions

   111.    Records—dentists, doctors, nurse practitioners, veterinary surgeons
   112.    Records—ambulance officers, indigenous health workers and rural and isolated practice endorsed nurses
   113.    Record keeping for certain nursing practices and Queensland Ambulance Service stations
   114.    Records—other approved persons
   115.    Exemption of user from keeping records
   116.    Record to be made on day of transaction
   116A.   Discrepancy to be immediately reported to chief executive
   117.    Records not to be changed but may be corrected

           Part 8--Storage of controlled drugs

   118.    Storage of controlled drugs at institutions
   119.    Storage of controlled drugs generally

           Part 9--Treatment with and dependence on controlled drugs

   120.    Notice required if lengthy treatment with controlled drug
   121.    Controlled drugs not to be obtained unless information disclosed
   122.    Approval needed for treating drug dependent person with controlled drugs
   122A.   Approval needed to establish or operate a controlled drugs administration facility
   123.    Self-administration of controlled drugs by authorised persons prohibited

           Part 10--General

   124.    Controlled drugs for animals not to be dispensed etc. for human therapeutic use
   125.    Controlled drugs for animals not to be administered to humans
   126.    False, misleading or incomplete entries
   127.    Improper use of prescriptions for controlled drugs
   128.    False statements—controlled drugs
   129.    Production of documents about controlled drugs previously in authorised person's possession
   130.    Unsafe disposal or use of controlled drugs
   131.    Advertising controlled drugs
   131A.   Automatic machines—Act, s 106
   132.    Safe keeping of controlled drugs
   133.    Keeping records

CHAPTER 3--RESTRICTED DRUGS

           Part 1--Licences

           Division 1--Preliminary

   134.    Application of pt 1
   135.    Licence to state business premises and other particulars

           Division 2--Restricted drug manufacturer licence

   136.    Restrictions on grant of restricted drug manufacturer licences
   137.    Restricted drug manufacturer licence
   138.    General conditions that apply to restricted drug manufacturer licence
   139.    Offence to manufacture restricted drug without licence

           Division 3--Restricted drug wholesaler licence

   140.    Restrictions on grant of restricted drug wholesaler licence
   141.    Restricted drug wholesaler licence
   142.    General conditions that apply to restricted drug wholesaler licence
   143.    Offence to wholesale restricted drug without licence

           Division 4--General

   144.    Records of transactions to be kept by licensee
   145.    Persons to whom a licensee may give samples

           Part 2--Endorsements

           Division 1--Preliminary

   146.    Endorsement needed for restricted drugs

           Division 2--Wholesale representatives

   147.    Wholesale representative licence
   148.    Wholesale representative may obtain restricted drugs
   149.    Storage etc. of samples
   150.    Returns of transactions
   151.    Loss or theft of samples to be reported
   152.    Production of documents about restricted drugs previously in wholesale representative's possession
   153.    Giving samples

           Division 3--Particular endorsements

   155.    Anaesthetic assistants and enrolled nurses
   156.    Approved dispensers
   157.    Bases and outposts of Royal Flying Doctor Service
   158.    Carriers
   158A.   Dental hygienists
   158B.   Dental therapists
   159.    Dentists
   160.    Detention centres
   161.    Doctors
   162.    Enrolled nurses
   163.    Environmental health officers
   163AA.  First aid providers
   163A.   Hospital pharmaceutical assistants
   164.    Hospitals
   164A.   Indigenous health workers
   165.    Inspectors
   166.    Manufacturer or wholesaler of restricted drugs
   167.    Midwives
   168.    Mine sites etc.
   169.    Nursing homes
   170.    Optometrists
   171.    Pharmacists
   171A.   Physician's assistants
   172.    Podiatrists
   172A.   Surgical podiatrists
   173.    Prisons
   174.    Queensland Ambulance Service
   174A.   Queensland Ambulance Service—first responders
   174B.   St John Ambulance Australia—Queensland
   175.    Registered nurses
   176.    Certain registered nurses at rural hospitals
   178.    Ship's master
   179.    State analysts
   179AA.  Trainees in certain occupations
   179A.   Universities
   179B.   Veterinary nurses
   180.    Veterinary surgeons
   181.    Watch-house keepers etc.

           Division 4--General

   183.    When endorsement is not needed

           Part 3--Regulated restricted drugs

   185.    Dinoprost and dinoprostone
   186.    Acitretin, etretinate, isotretinoin and tretinoin
   186A.   Bexarotene
   186B.   Thalidomide
   187.    Clomiphene, cyclofenil, luteinising hormone and urofollitrophin
   188.    Clozapine
   188A.   Bosentan
   188B.   Teriparatide
   189.    Exemptions for some acts involving certain regulated restricted drugs

           Part 4--Prescribing and dispensing restricted drugs

           Division 1--Prescribing restricted drugs

   190.    Prescribing restricted drugs
   191.    Restrictions on making prescriptions
   192.    Oral prescription

           Division 2--Dispensing restricted drugs

   192A.   Quality standard for dispensing restricted drugs
   193.    Conditions of dispensing
   194.    Emergency sale of restricted drugs by pharmacist
   195.    Dispensing generic drugs
   196.    Interstate prescriptions
   197.    Dealing with prescriptions
   198.    Labelling dispensed medicines
   199.    Records of restricted drugs dispensed to be kept

           Part 5--Obtaining and selling restricted drugs on purchase order

   200.    Authorised persons to obtain restricted drugs on purchase order
   201.    Sale of restricted drugs to authorised persons
   202.    Delivery of restricted drugs
   203.    Dealing with purchase orders

           Part 6--Possession and use of restricted drugs

   204.    Unlawful possession of restricted drugs
   205.    Possession by user

           Part 7--Records of restricted drugs

   207.    Records of restricted drugs supplied to be kept
   208.    Records—other approved persons
   209.    Exemption of user from keeping records
   210.    Records not to be changed but may be corrected

           Part 8--Storage of restricted drugs

   211.    Storage of restricted drugs generally

           Part 9--Treatment with and dependence on restricted drugs of dependency

   212.    Restricted drugs of dependency not to be obtained unless information disclosed to dentist, doctor, nurse practitioner or surgical podiatrist
   213.    Approval needed for treating drug dependent person with restricted drugs of dependency
   213A.   Approval needed for treatment by dentist of drug dependent person with restricted drugs of dependency

           Part 10--General

   214.    Restricted drugs for animals not to be dispensed etc. for human therapeutic use
   215.    Restricted drugs for animals not to be administered to humans
   216.    False, misleading or incomplete entries
   217.    Improper use of prescriptions for restricted drugs
   218.    False statements—restricted drugs
   219.    Unsafe disposal or use of restricted drugs
   220.    Advertising of restricted drugs
   220A.   Automatic machines—Act, s 106
   221.    Safe keeping of restricted drugs
   222.    Keeping records

CHAPTER 4--POISONS

           Part 1--Licences

           Division 1--General

   223.    Application of pt 1
   224.    Licence to state business premises and other particulars

           Division 2--Poison manufacturer licence

   225.    Restrictions on grant of poison manufacturer licence
   226.    Poison manufacturer licence
   227.    Offence to manufacture S2, S3 or S7 poisons without licence

           Division 3--Poison wholesaler licence

   228.    Restrictions on grant of poison wholesaler licence
   229.    Poison wholesaler licence
   230.    Offence to wholesale poisons without licence

           Division 4--General poison licence

   231.    Restrictions on grant of general poison licence
   232.    General licence

           Division 5--Licence to sell S7 poisons for other than human therapeutic use

   233.    Restriction on grant of licence to sell S7 poisons other than for human therapeutic use
   234.    Licence to sell S7 poisons other than for human therapeutic use

           Division 6--General restrictions on sale of poisons

   235.    Wholesale and retail sales by manufacturers and wholesalers
   236.    Other restrictions on sale of poisons
   237.    Records of certain transactions by poison manufacturers and wholesalers

           Part 2--Permits for cyanide and strychnine

           Division 1--Cyanide

   238.    Obtaining, possession or use of cyanide
   238A.   Restriction on sale of cyanide
   239.    Requirements for cyanide obtained outside the State
   240.    Permit conditions

           Division 2--Strychnine

   240A.   Obtaining, possession or use of strychnine
   240B.   Restriction on sale of strychnine
   241.    Requirements for strychnine obtained outside the State
   242.    Permit conditions

           Part 3--Endorsements

           Division 1--Preliminary

   243.    Endorsement needed for S2, S3 or S7 poison

           Division 2--Particular endorsements

   245.    Approved dispensers
   246.    Outposts of Royal Flying Doctor Service
   248.    Dental hygienists
   248A.   Dental therapists
   249.    Dentists
   250.    Detention centres
   251.    Doctors
   252.    Enrolled nurses
   252A.   Hospital pharmaceutical assistants
   252B.   Indigenous health workers
   253.    Inspectors
   254.    Local governments
   255.    Midwives
   256.    Optometrists
   256A.   Particular individuals who provide child care
   256B.   Persons with certain asthma management training
   257.    Pharmacists
   258.    Pharmacy assistants
   258A.   Physician's assistants
   259.    Physiotherapists
   260.    Podiatrists
   260A.   Surgical podiatrists
   261.    Prisons
   262.    Queensland Ambulance Service
   262A.   St John Ambulance Australia—Queensland
   263.    Registered nurses
   263A.   Certain registered nurses at rural hospitals
   264A.   Ship's master
   265.    State analysts
   265AA.  Trainees in certain occupations
   265A.   Universities
   265B.   Veterinary nurses
   266.    Veterinary surgeons
   267.    Watch-house keepers etc.
   267A.   Wholesale representatives

           Division 3--General

   268.    Employees and other persons authorised
   270.    When endorsement is not needed

           Part 4--Regulated poisons

   270A.   Approval must not be granted for therapeutic use of S9 poisons
   271.    Prohibition on dispensing etc. regulated poisons
   272.    Fluoroacetic acid in baits
   273.    Prohibition on possession etc. of certain poisons

           Part 5--Dispensing or selling poisons

   273A.   Quality standard for selling S2 or S3 poisons
   274.    Dispensing or selling S2, S3 or S7 poisons
   275.    Dispensing generic poisons
   276.    Labelling dispensed medicines
   277.    Sale of S3 poisons
   278.    Restrictions on packs of organo-phosphorus compounds
   279.    Restriction on paraquat preparations

           Part 6--Storage of poisons

   284.    Storage of poisons

           Part 7--Records of sales of poisons

   285.    Record of sale of S7 poison
   285A.   Record of sale of S3 pseudoephedrine

           Part 8--General

   286.    Prohibition on dispensing or supplying poisons to child under 16
   287.    False, misleading or incorrect entries
   288.    Poisons for animals not to be dispensed etc. for human therapeutic use
   289.    Poisons for animals not to be administered to humans
   290.    Unsafe disposal of poisons
   291.    Labels and containers
   292.    Advertising of poisons
   292A.   Automatic machines—Act, s 106
   293.    Safe keeping of poisons
   294.    Embalming
   295.    Hawking of poisons
   296.    Samples of poisons
   297.    Colouring of grain baits
   298.    Vaporisers and other devices
   299.    Prohibition of sale of chalk etc. containing poison
   300.    Use of food or drink containers for poisons prohibited
   301.    Fireworks
   302.    Keeping records

CHAPTER 5--MISCELLANEOUS

           Part 1--General

   305.    Language of documents
   308.    Attempts to commit offences

           Part 1A--Optometrists Drug Authority Committee

           Division 1--Establishment and function

   308A.   Establishment
   308B.   Function

           Division 2--Membership

   308C.   Membership
   308D.   Nomination and appointment of particular members
   308E.   Term of appointment
   308F.   Chairperson
   308G.   Disqualification from membership
   308H.   Vacation of office
   308I.   When notice of resignation takes effect
   308J.   Remuneration of member

           Division 3--Drug authority committee business

   308K.   Conduct of business
   308L.   Quorum
   308M.   Conduct of meetings
   308N.   Minutes

           Part 2--Transitional provisions

           Division 1--Transitional provisions for Health (Drugs and Poisons) Amendment Regulation (No. 1) 2000

   309.    Definition for div 1
   310.    Certain authorities continue
   311.    How certain applications are to be considered

           Division 2--Transitional provision for Health (Drugs and Poisons) Amendment Regulation (No. 2) 2003

   312.    Certain persons may operate a controlled drugs administration facility without an approval

           Division 3--Transitional provision for Health (Drugs and Poisons) Amendment Regulation (No. 2) 2005

   313.    Continuation of former ocular therapeutics protocol
           APPENDIX 1 PROVISIONS NOT APPLYING TO MORPHINE OR OPIUM IN COMPOUNDED PREPARATIONS
           APPENDIX 2 APPLICATION FEES FOR LICENCES
           APPENDIX 2A DRUGS AN AMBULANCE OFFICER MAY OBTAIN, POSSESS AND ADMINISTER
           APPENDIX 2B RESTRICTED DRUGS AND POISONS FOR SURGICAL PODIATRISTS
           APPENDIX 3 WHO MUST SIGN CERTAIN PURCHASE ORDERS FOR CONTROLLED OR RESTRICTED DRUGS
           APPENDIX 4 COMPUTER-GENERATED PAPER PRESCRIPTIONS

           Part 1--Preliminary

   1.      Prescription form must be preprinted
   2.      Only prescriber may generate prescription
   4.      Requirements on generation of prescription

           Part 2--Controlled drugs

   5.      System messages
   6.      Particulars in a paper prescription that a computer may generate

           Part 3--Restricted drugs

   7.      Particulars in a paper prescription that a computer may generate
           APPENDIX 5 AREAS OF LOCAL GOVERNMENTS FORMING ISOLATED PRACTICE AREAS
           APPENDIX 6 MINIMUM REQUIREMENTS FOR CONTROLLED DRUG RECEPTACLES

           Part 1--Cabinets
           1AA. Definition for pt 1
           1AB. Certain provisions not applicable to alarm cabinets
           1. Body requirements

   2.      Door requirements
   3.      Lock requirements
   4.      Hinge requirements
   5.      Mounting requirements
   6.      Type 1 mounting
   7.      Type 2 mounting
   8.      Type 3 mounting
   9.      Type 4 mounting

           Part 2--In-floor safes

   10.     Application of part
   11.     In-floor safe

           Part 3--Above-ground safes

   12.     Certain safes taken to be a secure place
   13.     Body of safe
   14.     Safe door
   15.     Safe lock
   16.     Anchoring
           APPENDIX 7 REGULATED POISONS
           APPENDIX 8 RESTRICTED DRUGS OF DEPENDENCY
           APPENDIX 8A RURAL HOSPITALS
           APPENDIX 9 DICTIONARY
           Endnotes