Commonwealth Consolidated Regulations

NATIONAL HEALTH (PHARMACEUTICAL BENEFITS) REGULATIONS 1960

- made under the National Health Act 1953

TABLE OF PROVISIONS

   PART 1--PRELIMINARY

           Division 1.1--Interpretation

   1.      Name of Regulations [see Note 1]  
   2.      Commencement  
   3.      Repeal and saving  
   4.      Transitional  
   5.      Interpretation  

           Division 1.2--Application of Regulations to electronic prescriptions and electronic orders

   5A.     Preparing electronic prescriptions  
   5B.     Date when a prescription is written or a pharmaceutical benefit is prescribed  
   5C.     Requirement to give information in writing  
   5D.     Requirement to give a prescription  
   5E.     Approval of kinds of electronic communications  
   5F.     Approval of information technology requirements  

   PART II--APPROVALS UNDER PART VII OF THE ACT

   8.      Application for approval to be in approved form  
   8AA.    Application for approval as authorised optometrist, authorised midwife or authorised nurse practitioner  
   8A.     Numbering of approvals  
   9.      Certain requirements to be met after cancellation etc of approval  

   PART IIAAA--FORMULARIES, CO-MARKETED BRANDS AND THERAPEUTIC GROUPS

   9AAC.   Co-marketed brands  

   PART IIAA--SAFETY NET CONCESSION CARDS

   9AA.    Safety net concession card  
   9AB.    Additional concession cards  
   9AC.    Replacement concession cards  
   9AD.    Refusal to issue additional or replacement concession cards  
   9AE.    Review of decisions  
   9AF.    Prescribed offices (Act s 84DA (5))  

   PART IIA--PHARMACEUTICAL BENEFITS ENTITLEMENT CARDS

   9A.     Pharmaceutical benefits prescription record forms  
   9B.     Pharmaceutical benefits entitlement card  
   9BA.    Prescribed offices for the purposes of subsection 84E (5) of the Act  
   9C.     Additional entitlement cards  
   9D.     Replacement entitlement cards  
   9E.     Refusal to issue additional or replacement entitlement cards  
   9F.     Review of decisions  

   PART III--PHARMACEUTICAL BENEFITS

   13.     Variation of application of determination of maximum number of repeats or maximum number or quantity of units  

   PART IV--SUPPLY OF PHARMACEUTICAL BENEFITS BY MEDICAL PRACTITIONERS, AUTHORISED MIDWIVES AND AUTHORISED NURSE PRACTITIONERS

   14.     Meaning of practitioner  
   15.     Practitioners not authorised under sections 93 and 93AA of the Act  
   16.     Obtaining benefits by practitioners under sections 93 and 93AA of the Act  
   17.     Supply of pharmaceutical benefits by approved pharmacists under sections 93 and 93AA of the Act  
   18.     Payment for pharmaceutical benefits supplied under sections 93 and 93AA of the Act  
   18A.    Benefits obtained by approved medical practitioners for the purposes of section 93  

   PART V--PRESCRIPTIONS AND SUPPLY

   19.     Writing of prescriptions  
   19A.    Prescribed matters (Act s 84AA (1), (1A), (2) and (3))  
   19B.    Restriction on using PBS and NHS forms  
   20.     Recovery of cost of pharmaceutical benefits prescribed for persons not entitled or in excessive quantities  
   21.     Supply of pharmaceutical benefit on first presentation of prescription  
   22.     Supply of pharmaceutical benefits before surrender of written prescription  
   24.     Circumstances in which quantity of repeated supply can be directed to be supplied on one occasion  
   25.     Repeated supplies of pharmaceutical benefits  
   26.     Repeat authorisations  
   26A.    Deferred supply authorisations  
   27.     Presentation of prescriptions in trading hours  
   28.     Presentation of urgent prescriptions  
   30.     Special charge for delivery  
   31.     Receipt of pharmaceutical benefit  

   PART VI--MISCELLANEOUS

   32.     Retention of prescriptions etc  
   33.     Proper stocks to be kept  
   35.     Standards of composition and purity of pharmaceutical benefits and additives  
   36.     Labelling of pharmaceutical benefits -- full cost  
   37.     Surrender of forms  

   PART VIA--PRICE REDUCTIONS

           Division 1--General

   37A.    Definitions for Part VIA  
   37B.    Listed brands of pharmaceutical items, reduction days and percentages  
   37C.    Adjusted approved price to pharmacists  
   37D.    Approved ex-manufacturer price -- general  
   37DA.   Approved ex-manufacturer price -- listed brand having same drug and manner of administration as listed brand already subject to price disclosure requirements and prior disclosure cycle  

           Division 2--Weighted average disclosed price

   37DB.   Application  
   37E.    Weighted average disclosed price -- information  
   37EA.   Disclosure cycles and data collection periods for listed brands of pharmaceutical items -- general  
   37EB.   Disclosure cycles  
   37EC.   Data collection periods  
   37ED.   Listed brand having a drug and manner of administration not subject to price disclosure requirements before relevant day -- first disclosure cycle and beginning of data collection period for brand  
   37EE.   End dates for data collection periods for relevant brands covered by regulation 37ED  
   37EF.   Subsequent main disclosure cycle --subsequent data collection periods  
   37EG.   Listed brand moving from supplementary disclosure cycle A to main disclosure cycle  
   37EH.   Listed brand moving from interim supplementary disclosure cycle and supplementary disclosure cycle B to main disclosure cycle  
   37F.    Listed brand having same drug and manner of administration as listed brand already subject to price disclosure requirements -- disclosure cycle and beginning of data collection period for brand  
   37G.    Weighted average disclosed price  

           Division 3--Price disclosure requirements

   37H.    Price disclosure requirements -- content of information for reporting periods  
   37HA.   Price disclosure requirements -- prescribed person  
   37I.    Price disclosure requirements -- manner and form  
   37J.    Price disclosure requirements -- information and reporting periods  
   37JA.   Price disclosure requirements -- additional reporting periods  

           Division 4--Price reduction day

   37K.    Price reduction -- prescribed reduction day  

   PART 7--ARRANGEMENTS OF THE PHARMACEUTICAL BENEFITS ADVISORY COMMITTEE

   38.     Interpretation  
   38A.    Appointments to Committee -- nominating bodies (Act s 100B (1A))  
   38B.    Number of nominations for appointment (Act s 100B (1B))  
   39.     Chairperson  
   40.     Resignation  
   41.     Presiding member  
   42.     Meetings of the Committee  
   43.     Quorum  
   44.     Voting  
   45.     Disclosure of pecuniary interests by Chairperson and members  
   46.     Resolutions without a formal meeting  
   47.     Reports and recommendations  
   48.     Remuneration for chair and members of sub-committees  
           SCHEDULE 3 Co-marketed brands
           SCHEDULE 5 Listed brands of pharmaceutical items, reduction days and percentages
           SCHEDULE 6 Prescribed offices for subsections 84DA (5) and 84E (5) of the Act