National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012)

made under sections 84AF, 84AK, 85, 85A, 88 and 101 of the

National Health Act 1953

Compilation No. 87

Compilation date:   1 January 2020

Includes amendments up to: PB 104 of 2019

Registered:    14 January 2020

This compilation is in 6 volumes

Volume 1: sections 1–26 and Schedule 1 (A–C)

Volume 2: Schedule 1 (D–K)

Volume 3: Schedule 1 (L–P)

Volume 4: Schedule 1 (Q–Z), Schedules 2 and 3

Volume 5: Schedule 4 (Part 1: A–R)

Volume 6: Schedule 4 (Part 1: S–Z, Part 3), Schedule 5 and
  Endnotes

Each volume has its own contents

About this compilation

This compilation

This is a compilation of the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012) that shows the text of the law as amended and in force on 1 January 2020 (the compilation date).

The notes at the end of this compilation (the endnotes) include information about amending laws and the amendment history of provisions of the compiled law.

Uncommenced amendments

The effect of uncommenced amendments is not shown in the text of the compiled law. Any uncommenced amendments affecting the law are accessible on the Legislation Register (www.legislation.gov.au). The details of amendments made up to, but not commenced at, the compilation date are underlined in the endnotes. For more information on any uncommenced amendments, see the series page on the Legislation Register for the compiled law.

Application, saving and transitional provisions for provisions and amendments

If the operation of a provision or amendment of the compiled law is affected by an application, saving or transitional provision that is not included in this compilation, details are included in the endnotes.

Editorial changes

For more information about any editorial changes made in this compilation, see the endnotes.

Modifications

If the compiled law is modified by another law, the compiled law operates as modified but the modification does not amend the text of the law. Accordingly, this compilation does not show the text of the compiled law as modified. For more information on any modifications, see the series page on the Legislation Register for the compiled law.

Self‑repealing provisions

If a provision of the compiled law has been repealed in accordance with a provision of the law, details are included in the endnotes.

Contents

1 Name of Instrument

4 Definitions

5 Drugs and medicinal preparations to which Part VII applies

6 Form

7 Manner of administration

8 Brand and responsible person

8A Schedule equivalent

9 Authorised prescriber

10 Prescription circumstances—Schedule 1

11 Authority required procedures

12 Authority required procedures—submission of prescription

13 Authority required procedures—authorisation

14 Streamlined authority code

15 Extended application of sections 11 to 14

16 Prescription circumstances—Schedule 2

17 Maximum quantity—Schedule 1

18 Maximum quantity conditions—Schedule 1

19 Maximum quantity—Schedule 2

20 Maximum number of repeats—Schedule 1

21 Maximum number of repeats conditions—Schedule 1

22 Maximum number of repeats—Schedule 2

23 Determined Quantity

24 Pack Quantity

25 Section 100 only supply

26 Prescriber bag only supply

Schedule 1—Ready‑prepared pharmaceutical benefits

1  Name of Instrument

 (1) This Instrument is the National Health (Listing of Pharmaceutical Benefits) Instrument 2012.

 (2) This Instrument may also be cited as PB 71 of 2012.

4  Definitions

  In this Instrument:

ABN has the same meaning as in the A New Tax System (Australian Business Number) Act 1999;

Act means the National Health Act 1953;

authorised prescriber for a pharmaceutical benefit, means a kind of person identified by a prescriber code mentioned in the column in Schedule 1 headed ‘Authorised Prescriber’ for the benefit;

CFC means chlorofluorocarbon;

CFU means colony forming unit;

circumstances code means the letter ‘C’ followed by a number;

conditions code means the letters ‘CN’ followed by a number;

electronic communication has the meaning given by subsection 5(1) of the Electronic Transactions Act 1999;

electronic prescription has the meaning given by the Regulations;

extemporaneously‑prepared pharmaceutical benefit means a pharmaceutical benefit other than a ready‑prepared pharmaceutical benefit;

General Statement for drugs for the treatment of hepatitis C means the statement set out in Part 3 of Schedule 4;

GP Management Plan means a comprehensive written plan for the treatment of a patient, prepared by a medical practitioner, that includes a description of the patient’s health care needs, management goals, actions to be taken by the patient and treatment and services the patient is likely to need;

I.M. means intramuscular;

I.U. means international unit;

I.V. means intravenous;

Medicare Benefits Schedule means the Health Insurance (General Medical Services Table) Regulations;

mmol means millimole;

palliative care patient means a patient with an active, progressive, far‑advanced disease for whom the prognosis is limited and the focus of care is the quality of life;

paper-based prescription has the meaning given by the Regulations;

PBS means Pharmaceutical Benefits Scheme;

prescriber code means any of the following codes identifying the kind of person mentioned for the code:

 (a) MP—medical practitioner;

 (b) PDP—participating dental practitioner;

 (c) AO—authorised optometrist;

 (d) MW—authorised midwife;

 (e) NP—authorised nurse practitioner;

purposes code means the letter ‘P’ followed by a number;

ready‑prepared pharmaceutical benefit means a brand of a pharmaceutical item in relation to which a determination under subsection 85(6) of the Act is in force;

Regulations means the National Health (Pharmaceutical Benefits) Regulations 1960;

residential care service has the meaning given by the Regulations;

Streamlined Authority Code means the words ‘Streamlined Authority Code’ followed by a number;

Team Care Arrangements means a document prepared by a medical practitioner, following consultation with collaborating providers, that includes a description of the treatment and service goals for the patient, the treatment and services that all collaborating providers will provide and the actions to be taken by the patient;

TGA means Therapeutic Goods Administration;

WHO means World Health Organisation.

Note: Terms used in this Instrument have the same meaning as in the Act—see section 13 of the Legislative Instruments Act 2003. These terms include:

 Chief Executive Medicare

 pharmaceutical benefit

 pharmaceutical item.

5  Drugs and medicinal preparations to which Part VII applies

 (1) For paragraph 85(2)(a) of the Act, Part VII of the Act applies to:

 (a) a drug or medicinal preparation mentioned in the column headed ‘Listed Drug’ in:

 (i) Schedule 1; or

 (ii) Part 1 of Schedule 2; and

 (b) a medicinal preparation composed of 1 or more listed drugs mentioned in subparagraph (a)(ii).

 (2) For subparagraph 85(2)(b)(i) of the Act, paragraph 85(2)(b) of the Act applies to a listed drug mentioned in subparagraph (1)(a)(ii).

 (3) For subparagraph 85(2)(b)(ii) of the Act, paragraph 85(2)(b) of the Act applies to an additive mentioned in Part 2 of Schedule 2.

Note: Part VII of the Act applies to medicinal preparations composed of 1 or more listed drugs mentioned in subsection (2) and 1 or more of the additives mentioned in subsection (3)—see paragraph 85(2)(b) of the Act.

6  Form

  For subsection 85(3) of the Act, the column headed ‘Form’ in Schedule 1 lists the form or forms for a listed drug determined for that drug.

7  Manner of administration

 (1) For subsection 85(5) of the Act, the manner of administration of a form of a listed drug mentioned in Schedule 1 is the manner of administration mentioned for that form of the drug in the column headed ‘Manner of Administration’ in Schedule 1.

 (2) For paragraph 85A(2)(c) of the Act, if a manner of administration is mentioned in Schedule 1 for a form of a listed drug, a person writing a prescription for the supply of a pharmaceutical benefit that has the listed drug in that form must, if including a manner of administration in the prescription, direct that the pharmaceutical benefit be administered in that manner.

 (3) For subsection (2), the pharmaceutical benefit is the brand of the listed drug mentioned in Schedule 1:

 (a) in the form mentioned in Schedule 1 for the listed drug; and

 (b) with the manner of administration mentioned in Schedule 1 for the form of the listed drug.

8  Brand and responsible person

 (1) A brand mentioned in the column headed ‘Brand’ in Schedule 1 for a pharmaceutical item is determined for subsection 85(6) of the Act for that pharmaceutical item.

 (2) For subsection 84AF(1) of the Act, if a code is mentioned in the column in Schedule 1 headed ‘Responsible Person’ for a brand of a pharmaceutical item, the person mentioned in subsection (3) is the responsible person for the brand of the pharmaceutical item.

 (3) For subsection (2), the person is the person mentioned in Schedule 3 for the code, with the ABN, if any, mentioned in Schedule 3 for the person.

 (4) For subsections (1) and (2), the pharmaceutical item is the listed drug mentioned in Schedule 1:

 (a) in the form mentioned in Schedule 1 for the listed drug; and

 (b) with the manner of administration mentioned in Schedule 1 for the form of the listed drug.

8A  Schedule equivalent

 (1) For subsection 85(6A) of the Act:

 (a) a brand of a pharmaceutical item with an ‘a’ located in the column headed ‘Schedule Equivalent’ in Schedule 1, is to be treated as equivalent to another brand of that pharmaceutical item that also has an ‘a’ located in the column headed ‘Schedule Equivalent’ in Schedule 1;

 (b) where paragraph (a) applies to a brand of a pharmaceutical item, a brand of the same pharmaceutical item with a ‘b’ in the column headed ‘Schedule equivalent’ in Schedule 1, is to be treated as equivalent to another brand of that pharmaceutical item that also has a ‘b’ located in the column headed ‘Schedule Equivalent’ in Schedule 1; and

 (c) where a brand of a pharmaceutical item appears in Schedule 5, that brand is to be treated as equivalent to any brand of any pharmaceutical item that is in the same schedule equivalent group as that brand in Schedule 5.

9  Authorised prescriber

 (1A) For subsection 88(1) of the Act, a medical practitioner is authorised to write a prescription for the supply of any pharmaceutical benefit.

 (1) For subsection 88(1A) of the Act, a participating dental practitioner is authorised to write a prescription for the supply of a pharmaceutical benefit if the initials PDP are mentioned for the pharmaceutical benefit in the column headed ‘Authorised Prescriber’ in Schedule 1.

 (2) For subsection 88(1C) of the Act, an authorised optometrist is authorised to write a prescription for the supply of a pharmaceutical benefit if the initials AO are mentioned for the pharmaceutical benefit in the column headed ‘Authorised Prescriber’ in Schedule 1.

 (3) For subsection 88(1D) of the Act, an authorised midwife is authorised to write a prescription for the supply of a pharmaceutical benefit if the initials MW are mentioned for the pharmaceutical benefit in the column headed ‘Authorised Prescriber’ in Schedule 1.

 (4) For subsection 88(1E) of the Act, an authorised nurse practitioner is authorised to write a prescription for the supply of a pharmaceutical benefit if the initials NP are mentioned for the pharmaceutical benefit in the column headed ‘Authorised Prescriber’ in Schedule 1.

 (5) For this section, the pharmaceutical benefit is the brand of the listed drug mentioned in Schedule 1:

 (a) in the form mentioned in Schedule 1 for the listed drug; and

 (b) with the manner of administration mentioned in Schedule 1 for the form of the listed drug.

10  Prescription circumstances—Schedule 1

 (1) This section applies to a pharmaceutical benefit if at least 1 circumstances code is mentioned in the column in Schedule 1 headed ‘Circumstances’ for the pharmaceutical benefit.

 (2) For paragraph 85(7)(a) of the Act, the pharmaceutical benefit is a relevant pharmaceutical benefit for the purposes of section 88A of the Act.

 (3) For paragraph 85(7)(b) of the Act, the circumstances in which a prescription for the supply of the pharmaceutical benefit may be written are the circumstances mentioned in Part 1 of Schedule 4 for at least 1 of the circumstances codes mentioned in Schedule 1 for the pharmaceutical benefit.

 (4) For subsection (1), the pharmaceutical benefit is the brand of the listed drug mentioned in Schedule 1:

 (a) in the form mentioned in Schedule 1 for the listed drug; and

 (b) with the manner of administration mentioned in Schedule 1 for the form of the listed drug.

11  Authority required procedures

 (1) This section applies to a pharmaceutical benefit if the circumstances mentioned in Part 1 of Schedule 4 for a circumstances code mentioned in Schedule 1 for the pharmaceutical benefit include any of the following:

 (a) Compliance with Authority Required procedures;

 (b) Compliance with Written Authority Required procedures;

 (c) Compliance with Telephone Authority Required procedures;

 (d) Compliance with Written or Telephone Authority Required procedures.

 (1A) If the circumstances mentioned in Part 1 of Schedule 4 for a circumstances code mentioned in Schedule 1 for the pharmaceutical benefit include the words ‘Compliance with Telephone Authority Required procedures’ or ‘Compliance with Written or Telephone Authority Required procedures’ treat as if the words used are ‘Compliance with Authority Required procedures’.

Note: If there is a Streamlined Authority Code section 14 continues to apply.

 (2) A prescription for the supply of the pharmaceutical benefit must be:

 (a) submitted by the authorised prescriber to the Chief Executive Medicare in accordance with section 12; and

 (b) authorised by the Chief Executive Medicare in accordance with section 13.

12  Authority required procedures—submission of prescription

 (1) A prescription is submitted in accordance with this subsection if:

 (a) the authorised prescriber submits to the Chief Executive Medicare:

 (i) the prescription itself; or

 (ii) for a medication chart prescription that is not an electronic prescription — the medication chart by which the prescription was written, or a copy of so much of that chart as would indicate that subregulation 19AA(2) of the Regulations has been complied with; or

 (b) the authorised prescriber submits details of the prescription by telephone to the Chief Executive Medicare; or

 (c) the authorised prescriber submits the prescription in accordance with the instructions in an emergency telephone message provided to the authorised prescriber by the Chief Executive Medicare; or

 (d) the authorised prescriber submits details of the prescription in accordance with subsection 12(4A) to the Chief Executive Medicare, by means of electronic communication to obtain an electronic authority.

 (2) If a circumstance mentioned in Part 1 of Schedule 4 for a circumstances code applying to the pharmaceutical benefit includes Compliance with Written Authority Required procedures, the authorised prescriber must submit a prescription for the supply of the pharmaceutical benefit to the Chief Executive Medicare in accordance with paragraph (1)(a).

 (3) If a circumstance mentioned in Part 1 of Schedule 4 for a circumstances code applying to the pharmaceutical benefit includes Compliance with Telephone Authority Required procedures, the authorised prescriber must submit a prescription for the supply of the pharmaceutical benefit to the Chief Executive Medicare in accordance with paragraph (1)(b) or (c).

 (4) If a circumstance mentioned in Part 1 of Schedule 4 for a circumstances code applying to the pharmaceutical benefit includes Compliance with Written or Telephone Authority Required procedures, the authorised prescriber must submit a prescription for the supply of the pharmaceutical benefit to the Chief Executive Medicare in accordance with paragraph (1)(a), (b) or (c).

 (4A) The prescription submitted in accordance with paragraph 12(1)(d) must be:

 (a) given to the Chief Executive Medicare in writing; and

 (b) by means of an electronic communication; and

 (c) encrypted when it is given to the Chief Executive Medicare; and

 (d) in accordance with any other requirements that would need to be met in order for the requirements to give the information in writing to be taken to have been met under the Electronic Transactions Act 1999.

 (5) For paragraph (1)(a), a prescription prepared and signed by the authorised prescriber in accordance with subsection (1) is taken to have been submitted by the authorised prescriber if it is submitted by his or her employee.

13  Authority required procedures—authorisation 

 (1) A paper-based prescription (other than a prescription submitted in accordance with paragraph 12(1)(b), (c) or (d)) may be authorised by the Chief Executive Medicare signing his or her authorisation on the prescription, and:

 (a) if the Chief Executive Medicare requires the authorised prescriber to alter the prescription — returning it to the authorised prescriber for alteration before the authorised prescriber gives it to the person in respect of whom it was prepared; or

 (b) by returning it to the authorised prescriber; or

 (c) if requested by the authorised prescriber — sending it to the person in respect of whom it was prepared.

 (1A) A medication chart prescription (other than an electronic prescription, or a prescription submitted in accordance with paragraphs 12(1)(b), (c) or (d)) may be authorised by the Chief Executive Medicare signing his or her authorisation on the medication chart prescription, or a copy of the medication chart prescription, and:

 (a) if the Chief Executive Medicare requires the authorised prescriber to alter the prescription— indicating this on the medication chart prescription or copy; and

 (b) returning the medication chart or copy to the authorised prescriber for alteration.

 (1B) An electronic prescription (other than a prescription submitted in accordance with paragraphs 12(1)(b), (c) or (d)) may be authorised by the Chief Executive Medicare writing his or her authorisation on the electronic prescription, and:

 (a) if the Chief Executive Medicare requires the authorised prescriber to alter the prescription— by returning it, including by means of an electronic communication, to the authorised prescriber for alteration; or

 (b) by returning it, including by means of electronic communication to the authorised prescriber; or

 (c) if requested by the authorised prescriber — sending it to the person in respect of whom it was prepared.

 (2) A prescription submitted in accordance with paragraph 12(1)(b) may be authorised by the Chief Executive Medicare telling the authorised prescriber by telephone, at the time the Chief Executive Medicare is given details of the prescription, that the prescription is authorised.

 (3) A prescription submitted in accordance with paragraph 12(1)(d) may be authorised by the Chief Executive Medicare sending his or her authorisation, by electronic communication, including computer automated electronic communication, to the authorised prescriber.

 (3A) If the prescription submitted is declined for authorisation, the authorised prescriber may seek review of the decision by the Chief Executive Medicare.

 (4) If the Chief Executive Medicare authorises a prescription under subsection (2) or (3):

 (a) the Chief Executive Medicare must tell the authorised prescriber the number that has been allotted to the authorised prescription: and

 (b) the authorised prescriber must:

 (i) mark that number on the prescription; and

 (ii) retain a copy of the prescription showing the number marked in accordance with subparagraph (i) for 1 year from the date the prescription was authorised.

 (5) For paragraph (4)(a), the Chief Executive Medicare must tell the authorised prescriber the number:

 (i) if the authorised prescriber is an authorised optometrist—by telephone; and

 (ii) in any other case—by telephone or by electronic communication.

 (6) A prescription submitted in accordance with paragraph 12(1)(c) is taken to have been authorised by the Chief Executive Medicare if the authorised prescriber completes the prescription in accordance with the instructions given in the emergency telephone message.

14  Streamlined authority code

 (1) This section applies to a pharmaceutical benefit if the circumstances mentioned in Schedule 4 for a circumstances code applying to the pharmaceutical benefit include a Streamlined Authority Code.

 (2) The requirements of section 12 are taken to have been complied with, and the Chief Executive Medicare is taken to have authorised the prescription of the pharmaceutical benefit under section 13, if the authorised prescriber has written the Streamlined Authority Code on the prescription.

15  Extended application of sections 11 to 14

 Sections 11 to 14 apply in relation to conditions and conditions codes as if the circumstances and circumstances codes mentioned in those sections were conditions and conditions codes.

Note: Conditions are determined in sections 18 and 21.

16  Prescription circumstances—Schedule 2

 (1) For paragraph 85(7)(a) of the Act, a pharmaceutical benefit is a relevant pharmaceutical benefit for the purposes of section 88A if:

 (a) it is:

 (i) a listed drug mentioned in Part 1 of Schedule 2; or

 (ii) an extemporaneously‑prepared pharmaceutical benefit that contains the listed drug; and

 (b) there are circumstances mentioned for the listed drug in the column headed ‘Circumstances’ in Part 1 of Schedule 2.

 (2) For paragraph 85(7)(b) of the Act, the circumstances in which a prescription for the supply of a pharmaceutical benefit mentioned in subsection (1) may be written are:

 (a) for a listed drug mentioned in subparagraph (1)(a)(i)—the circumstances mentioned in the column headed ‘Circumstances’ in Part 1 of Schedule 2 for the drug; and

 (b) for an extemporaneously‑prepared pharmaceutical benefit mentioned in subparagraph (1)(a)(ii)—the circumstances mentioned in the column headed ‘Circumstances’ in Part 1 of Schedule 2 for each listed drug contained in the pharmaceutical benefit.

Note: If an extemporaneously‑prepared pharmaceutical benefit contains more than one listed drug, a prescription for the supply of the pharmaceutical benefit may only be written if the circumstances mentioned for each of the listed drugs contained in the pharmaceutical benefit are met.

17  Maximum quantity—Schedule 1

 (1) For paragraph 85A(2)(a) of the Act, the maximum quantity or number of units of the pharmaceutical item in a pharmaceutical benefit mentioned in Schedule 1 that may, in 1 prescription for the supply of the pharmaceutical benefit, be directed by an authorised prescriber to be supplied on any 1 occasion is the quantity or number of units mentioned in the column in Schedule 1 headed ‘Maximum Quantity’ for the pharmaceutical benefit and authorised prescriber.

 (2) If at least 1 purposes code is mentioned in the column in Schedule 1 headed ‘Purposes’ for a pharmaceutical benefit, the quantity or number of units mentioned in the column headed ‘Maximum Quantity’ is the maximum for the particular purposes mentioned in Schedule 4 for each purposes code.

 (3) If no purposes code is mentioned in the column in Schedule 1 headed ‘Purposes’, the quantity or number of units mentioned in the column in Schedule 1 headed ‘Maximum Quantity’ is the maximum for all purposes, other than a purpose for which a different maximum is mentioned for the same pharmaceutical benefit.

 (4) For subsection (1) the pharmaceutical item is the listed drug mentioned in Schedule 1:

 (a) in the form mentioned in Schedule 1 for the listed drug; and

 (b) with the manner of administration mentioned in Schedule 1 for the form of the listed drug.

 (5) For this section, the pharmaceutical benefit is the brand of the listed drug mentioned in Schedule 1:

 (a) in the form mentioned in Schedule 1 for the listed drug; and

 (b) with the manner of administration mentioned in Schedule 1 for the form of the listed drug.

18  Maximum quantity conditions—Schedule 1

 (1) This section applies to a pharmaceutical benefit if a conditions code is mentioned in the column in Schedule 1 headed ‘Maximum Quantity’ for a maximum quantity or number of units for the pharmaceutical benefit.

 (2) For subsection 85A(2A) of the Act, the conditions which must be satisfied when writing a prescription for the supply of the pharmaceutical benefit to which a determination of a maximum quantity or number of units under paragraph 85A(2)(a) applies, are the conditions mentioned in Part 1 of Schedule 4 for the conditions code mentioned in Schedule 1 for the pharmaceutical benefit and the maximum quantity or number of units.

 (3) For this section, the pharmaceutical benefit is the brand of the listed drug mentioned in Schedule 1:

 (a) in the form mentioned in Schedule 1 for the listed drug; and

 (b) with the manner of administration mentioned in Schedule 1 for the form of the listed drug.

19  Maximum quantity—Schedule 2

 (1) For paragraph 85A(2)(a) of the Act, the maximum quantity or number of units of an extemporaneously‑prepared pharmaceutical benefit of a type mentioned in Part 3 of Schedule 2 that may, in 1 prescription for the supply of the pharmaceutical benefit, be directed by an authorised prescriber to be supplied on any 1 occasion is the quantity or number of units mentioned in the column headed ‘Maximum Quantity’ in Part 3 of Schedule 2 for that type of pharmaceutical benefit.

 (2) For subsection (1), the extemporaneously‑prepared pharmaceutical benefit is:

 (a) the listed drug mentioned in Part 1 of Schedule 2; or

 (b) an extemporaneously‑prepared pharmaceutical benefit that contains the listed drug.

20  Maximum number of repeats—Schedule 1

 (1) For paragraph 85A(2)(b) of the Act, the maximum number of occasions an authorised prescriber may, in 1 prescription, direct that the supply of a pharmaceutical benefit mentioned in Schedule 1 be repeated is the number in the column in Schedule 1 headed ‘Number of Repeats’ for the pharmaceutical benefit and the authorised prescriber.

 (2) If at least 1 purposes code is mentioned in the column in Schedule 1 headed ‘Purposes’ for the pharmaceutical benefit, the number of repeats mentioned in the column in Schedule 1 headed ‘Number of Repeats’ is the maximum for the particular purposes mentioned in Schedule 4 for each purposes code.

 (3) If no purposes code is mentioned in the column headed ‘Purposes’, the number of repeats mentioned in the column headed ‘Number of Repeats’ is the maximum for all purposes, other than a purpose for which a different maximum is mentioned for the same pharmaceutical benefit.

 (4) For this section, the pharmaceutical benefit is the brand of the listed drug mentioned in Schedule 1:

 (a) in the form mentioned in Schedule 1 for the listed drug; and

 (b) with the manner of administration mentioned in Schedule 1 for the form of the listed drug.

21  Maximum number of repeats conditions—Schedule 1

 (1) This section applies to a pharmaceutical benefit if a conditions code is mentioned in the column in Schedule 1 headed ‘Number of Repeats’ for the maximum number of repeats for the pharmaceutical benefit.

 (2) For subsection 85A(2A) of the Act, the conditions which must be satisfied when writing a prescription for the supply of the pharmaceutical benefit to which a determination of a maximum number of repeats under paragraph 85A(2)(b) applies, are the conditions mentioned in Part 1 of Schedule 4 for the conditions code mentioned in Schedule 1 for the pharmaceutical benefit and the maximum number of repeats.

 (3) For this section, the pharmaceutical benefit is the brand of the listed drug mentioned in Schedule 1:

 (a) in the form mentioned in Schedule 1 for the listed drug; and

 (b) with the manner of administration mentioned in Schedule 1 for the form of the listed drug.

22  Maximum number of repeats—Schedule 2

 (1) For paragraph 85A(2)(b) of the Act, the maximum number of occasions an authorised prescriber may, in 1 prescription, direct that the supply of an extemporaneously‑prepared pharmaceutical benefit of a type mentioned in Part 3 of Schedule 2 be repeated is the number in the column headed ‘Number of Repeats’ in Part 3 of Schedule 2 for that type of pharmaceutical benefit.

 (2) For this section, the extemporaneously‑prepared pharmaceutical benefit is:

 (a) the listed drug mentioned in Part 1 of Schedule 2; or

 (b) an extemporaneously‑prepared pharmaceutical benefit that contains the listed drug.

23  Determined Quantity

 (1) For subsection 84AK(3) of the Act, the quantities or numbers of units of a pharmaceutical item that are determined quantities of a listed brand of the pharmaceutical item mentioned in Schedule 1 are the quantities or numbers of units mentioned in the column in Schedule 1 headed ‘Determined Quantity’ for the listed brand of the pharmaceutical item.

 (2) For this section, the listed brand of the pharmaceutical item is the brand of the listed drug mentioned in Schedule 1:

 (a) in the form mentioned in Schedule 1 for the listed drug; and

 (b) with the manner of administration mentioned in Schedule 1 for the form of the listed drug.

 (3) For this section, the pharmaceutical item is the listed drug mentioned in Schedule 1:

 (a) in the form mentioned in Schedule 1 for the listed drug; and

 (b) with the manner of administration mentioned in Schedule 1 for the form of the listed drug.

24  Pack Quantity

 (1) For subsection 84AK(2) of the Act, the quantities or numbers of units of a pharmaceutical item that are pack quantities of a listed brand of the pharmaceutical item mentioned in Schedule 1 are the quantities or numbers of units mentioned in the column in Schedule 1 headed ‘Pack Quantity’ for the listed brand of the pharmaceutical item.

 (2) For this section, the listed brand of the pharmaceutical item is the brand of the listed drug mentioned in Schedule 1:

 (a) in the form mentioned in Schedule 1 for the listed drug; and

 (b) with the manner of administration mentioned in Schedule 1 for the form of the listed drug.

 (3) For this section, the pharmaceutical benefit is the brand of the listed drug mentioned in Schedule 1:

 (a) in the form mentioned in Schedule 1 for the listed drug; and

 (b) with the manner of administration mentioned in Schedule 1 for the form of the listed drug.

25  Section 100 only supply

 (1) For subsection 85(2A) of the Act, if the code D(100) is mentioned in the column headed ‘Section 100/Prescriber Bag only’ in Schedule 1 for a listed drug, the drug can only be supplied under special arrangements under section 100 of the Act.

 (2) For paragraph 85(8)(a) of the Act, if the code PB(100) is mentioned in the column headed ‘Section 100/Prescriber Bag only’ in Schedule 1 for a pharmaceutical benefit, the pharmaceutical benefit can only be supplied under special arrangements under section 100 of the Act.

 (3) For paragraph 85(8)(b) of the Act, if the code C(100) is mentioned in the column headed ‘Section 100/Prescriber Bag only’ in Schedule 1 for a pharmaceutical benefit, and a circumstances code is mentioned for the pharmaceutical benefit in the column headed ‘Circumstances’, the pharmaceutical benefit can be supplied in the circumstances identified in Part 1 of Schedule 4 for the circumstances code only under special arrangements under section 100 of the Act.

 (4) For this section, the pharmaceutical benefit is the brand of the listed drug mentioned in Schedule 1:

 (a) in the form mentioned in Schedule 1 for the listed drug; and

 (b) with the manner of administration mentioned in Schedule 1 for the form of the listed drug.

26  Prescriber bag only supply

 (1) For subsection 85(2AA) of the Act, if one or more of the codes D(MP), D(MW) and D(NP) are mentioned in the column headed ‘Section 100/ Prescriber Bag only’ in Schedule 1 for a listed drug other than the drug methoxyflurane, then, subject to subsection (3), the drug can only be supplied by:

 (a) where the code D(MP) is mentioned, medical practitioners under section 93 of the Act, and

 (b) where the code D(MW) is mentioned, authorised midwives under section 93AA of the Act, and

 (c) where the code D(NP) is mentioned, authorised nurse practitioners under section 93AB of the Act.

Note: A declaration in force immediately before 1 October 2012 for the purposes of subsection 85(2A) of the Act declaring that the drug methoxyflurane can only be supplied under special arrangements under section 100 of the Act, continues in force and may be dealt with on and after 1 October 2012, as if the declaration had been made for the purposes of subsection 85(2AA) of the Act and declared that methoxyflurane can only be supplied under section 93 of the Act (see Item 18 of Schedule 3 to the National Health Amendment (Pharmaceutical Benefits Scheme) Act 2012).

 (2) For subsection 85(7A) of the Act, if one or more of the codes PB(MP), PB(MW) and PB(NP) are mentioned in the column headed ‘Section 100/ Prescriber Bag only’ in Schedule 1 for a pharmaceutical benefit, then, subject to subsection (3), the pharmaceutical benefit can only be supplied by:

 (a) where the code PB(MP) is mentioned, medical practitioners under section 93 of the Act, and

 (b) where the code PB(MW) is mentioned, authorised midwives under section 93AA of the Act, and

 (c) where the code PB(NP) is mentioned, authorised nurse practitioners under section 93AB of the Act.

 (3) If :

 (a) one or more of the codes D(MP), D(MW), and D(NP) are mentioned in the column headed ‘Section 100/Prescriber Bag only’ in Schedule 1 for a listed drug; and

 (b) one or more of the codes PB(MP), PB(MW) and PB(NP) are also mentioned in the column headed ‘Section 100/Prescriber Bag only’ in Schedule 1 for a pharmaceutical benefit having the listed drug;

then:

 (c) the drug may be supplied as provided in subsection (1): and

 (d) the pharmaceutical benefit may be supplied as provided in subsection (2).

 (4) For this section, the pharmaceutical benefit is the brand of the listed drug mentioned in Schedule 1:

 (a) in the form mentioned in Schedule 1 for the listed drug; and

 (b) with the manner of administration mentioned in Schedule 1 for the form of the listed drug.

Schedule 1—Ready‑prepared pharmaceutical benefits

(sections 5 to 10, 16 to 18, 20, 21, 23 to 26)