Commonwealth Consolidated Regulations

NATIONAL HEALTH (PHARMACEUTICAL BENEFITS) REGULATIONS 2017

- made under the National Health Act 1953

TABLE OF PROVISIONS

   PART 1--PRELIMINARY

           Division 1--General

   1.      Name  
   3.      Authority  
   5.      Interpretation  

           Division 2--Application of this instrument to electronic prescriptions and electronic orders

   7.      Preparing electronic prescriptions  
   8.      Date when a prescription is written or a pharmaceutical benefit is prescribed  
   9.      Requirement to give information in writing  
   10.     Requirement to give a prescription  
   11.     Approval of kinds of electronic communications  
   12.     Approval of information technology requirements  
   12A.    Electronic medication chart system functionality requirements  

   PART 2--APPROVALS--UNDER PART VII OF THE ACT

   13.     Purpose of this Part  
   14.     Application for certain approvals to be in approved form  
   15.     Application for approval as authorised optometrist, authorised midwife or authorised nurse practitioner  
   16.     Numbering of approvals  
   17.     Certain requirements to be met after cancellation etc. of approval--approved pharmacists  

   PART 3--SAFETY--NET CONCESSION CARDS AND PHARMACEUTICAL BENEFITS ENTITLEMENT CARDS

           Division 1A--Value for safety net purposes

   17A.    Value for safety net purposes  

           Division 1--Pharmaceutical benefits prescription record forms etc.

   18.     Pharmaceutical benefits prescription record forms etc.  

           Division 2--Issue of safety net concession cards

   19.     Application for safety net concession card  
   20.     Prescribed offices  

           Division 3--Issue of pharmaceutical benefits entitlement card

   21.     Application for pharmaceutical benefits entitlement card  
   22.     Prescribed offices  

           Division 4--Additional and replacement concession cards and entitlement cards

   23.     Purpose of this Division  
   24.     Application for, and issue of, additional concession cards and entitlement cards  
   25.     Application for, and issue of, replacement concession cards and entitlement cards  
   26.     Refusal to issue additional or replacement cards by person other than the Secretary  
   27.     Refusal to issue additional or replacement cards by the Secretary  
   28.     Review of decisions  

   PART 4--SUPPLY--OF PHARMACEUTICAL BENEFITS

           Division 1--General matters relating to supply

   29.     Meaning of practitioner  
   30.     Variation of application of determination of maximum number of repeats or maximum number of quantity of units  

           Division 2--Supply by particular PBS prescribers

   31.     Meaning of practitioner  
   32.     Prescriber bag supplies--practitioners on ships  
   33.     Prescriber bag supplies--practitioners other than approved medical practitioners  
   34.     Prescriber bag supplies--supply of pharmaceutical benefits by approved pharmacists  
   35.     Prescriber bag supplies--payment for pharmaceutical benefits  
   36.     Pharmaceutical benefits obtained by approved medical practitioners for the purposes of section 93 of the Act  
   37.     Payment for pharmaceutical benefits obtained by approved medical practitioners for the purposes of section 93 of the Act  

   PART 5--PRESCRIPTIONS--AND SUPPLY

   38.     Purpose of this Part  
   39.     Writing prescriptions--general  
   40.     Writing prescriptions--prescriptions other than medication chart prescriptions  
   41.     Writing prescriptions--medication chart prescriptions  
   41A.    Writing prescriptions--additional requirements for all electronic prescriptions  
   41B.    Writing prescriptions--additional information that may be included in electronic prescriptions  
   42.     Information about status of person  
   43.     Restriction on using PBS forms  
   44.     Supply of pharmaceutical benefit on first presentation of prescription  
   45.     Supply of pharmaceutical benefit on basis of medication chart prescription  
   46.     Continued dispensing supply of pharmaceutical benefit  
   47.     Information about status of person--continued dispensing supplies and medication chart prescriptions  
   48.     Supply of pharmaceutical benefits before surrender of written prescription  
   49.     Circumstances in which quantity of repeated supply can be directed to be supplied on one occasion  
   50.     Continued dispensing supplies--repeated supply not to be supplied on one occasion  
   51.     Repeated supplies of pharmaceutical benefits  
   52.     Repeat authorisations  
   53.     Deferred supply authorisations  
   54.     Presentation of prescriptions in trading hours  
   55.     Presentation of urgent prescriptions  
   56.     Special charge for delivery  

   PART 6--OTHER--MATTERS RELATING TO PRESCRIPTIONS AND SUPPLY ETC.

   58.     Purpose of this Part  
   59.     Keeping documents--other than for continued dispensing supplies or medication chart prescriptions  
   60.     Keeping documents--continued dispensing supplies  
   61.     Keeping documents--medication chart prescriptions  
   62.     Proper stocks to be kept  
   63.     Standards of composition and purity of pharmaceutical benefits and ingredients  
   64.     Labelling of pharmaceutical benefits--full cost  
   65.     Surrender of forms  

   PART 7--PRICE--REDUCTION, PRICE DISCLOSURE AND STOCKHOLDING

           Division 1--Price reduction

   65A.    Price reductions for single brands of combination items  
   66.     Reduction day  

           Division 2--Price disclosure

              Subdivision A--Interpretation

   67.     Meaning of data collection period  
   68.     Meaning of price sampling day  
   69.     Special rules for certain listed brands  

              Subdivision B--Weighted average disclosed price

   70.     Method for determining weighted average disclosed price of listed brand of pharmaceutical item  
   71.     Step 1--net revenue for brand  
   72.     Step 2--adjusted volume for brand  
   73.     Step 3--average approved ex - manufacturer price for brand  
   73A.    Step 3A--adjusted net revenue for brand  
   74.     Step 4--disclosed price for brand  
   75.     Step 5--price percentage difference of brand  
   76.     Step 6--repeat steps for each brand of pharmaceutical item  
   77.     Step 7--total adjusted volume of brands of pharmaceutical item  
   78.     Step 8--weighted average percentage difference of brands of pharmaceutical item  
   79.     Step 9--repeat steps for each pharmaceutical item with related brands  
   80.     Step 10--weighted average percentage difference for listed brand and all related brands  
   81.     Step 11--weighted average disclosed price for listed brand of pharmaceutical item  
   82.     When weighted average disclosed price is the same as the applicable approved ex - manufacturer price  

              Subdivision C--Information that must not be taken into account

   83.     Information that must not be taken into account  
   84.     Originator brands  

              Subdivision D--Price disclosure requirements

   85.     Price disclosure requirements  

              Subdivision E--Price reduction

   85A.    Flow on price reductions for brands of combination items  

           Division 3--Stockholding requirements

   85B.    Usual demand for a brand  
   85C.    Stockholding disclosure requirements  

   PART 8--ARRANGEMENTS--FOR THE PHARMACEUTICAL BENEFITS ADVISORY COMMITTEE

           Division 1--Matters relating to the appointment of members of the Committee

   86.     Nominating bodies  
   87.     Number of nominations for appointment  
   88.     Resignation  

           Division 2--Matters relating to the procedure of the Committee

   89.     Purpose of this Division  
   90.     Presiding member  
   91.     Meetings of the Committee  
   92.     Quorum  
   93.     Voting  
   94.     Disclosure of pecuniary interests by members  
   95.     Resolutions without a formal meeting  
   96.     Reports and recommendations  

           Division 3--Matters relating to sub-committees

   97.     Remuneration for chair and members of sub - committees  

   PART 9--APPLICATION--, SAVINGS AND TRANSITIONAL PROVISIONS

   98.     Definitions  
   99.     Things done under old regulations  
   102.     Transitional provision relating to the National Health (Pharmaceutical Benefits) Amendment (Active Ingredient Prescribing) Regulations 2019  
   103.    Application provision relating to the National Health (Pharmaceutical Benefits) Amendment (2021 Measures No. 1) Regulations 2021  
   104.    Transitional provision relating to the National Health (Pharmaceutical Benefits) Amendment (2024 Measures No. 1) Regulations 2024  
   105.    Application provisions relating to the National Health (Pharmaceutical Benefits) Amendment (Medication Charts) Regulations 2024  
           SCHEDULE 1 Prescribed offices