New South Wales Consolidated Regulations

POISONS AND THERAPEUTIC GOODS REGULATION 2008

- Made under the Poisons and Therapeutic Goods Act 1966
- As at 1 July 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 (Repealed)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 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 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