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Commonwealth legislation
This Act has been repealed and is no longer in force. It is retained for historical reference.
This Determination sets the conditions for supplying and paying for pharmaceutical benefits under the National Health Act. It defines key terms, fixes how payment is calculated (different rules when a brand is named or not), requires whole-pack supply for listed items, and lists drugs and preparation types (including dangerous drugs and standard extemporaneous formulas).
It affects approved pharmacists, approved medical practitioners, prescribers and Medicare Australia: prescribing and supply choices determine how much the Commonwealth pays and what pharmacists receive, and certain written elections and notices to the CEO of Medicare Australia are required.
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Direct links to the current provisions in National Health Act 1953 - Determination under paragraph 98C(1)(b) - conditions (No. PB 79 of 2008).
Sourced from the Federal Register of Legislation (legislation.gov.au), CC BY 4.0.
Determination — Conditions (PB 79 of 2008)
as amended
made under paragraph 98C(1)(b) of the
National Health Act 1953
This compilation was prepared on 30 November 2008
taking into account amendments up to PB 111 of 2008
Prepared by the Office of Legislative Drafting and Publishing,
Attorney‑General’s Department, Canberra
Determination – conditions (PB 79 of 2008)
Commencement
Repeal
Definitions
“approved price to pharmacists” has the same meaning as in subsection 98B(3) of the Act;
“Commonwealth price” has the same meaning as in subsection 84(1) of the Act;
“extemporaneously-prepared pharmaceutical benefit” means a pharmaceutical benefit other than a ready-prepared pharmaceutical benefit;
“prescription” includes a prescription written on an authority prescription made under regulation 13 of the Regulations, a prescription required to be submitted to the Chief Executive Officer of Medicare Australia for the purposes of a determination made under subsection 85(2A) or subsection 85A(2) of the Act, a repeat authorisation, or a deferred supply authorisation;
“ready-prepared pharmaceutical benefit” means a listed brand of a pharmaceutical item;
“Regulations” means the National Health (Pharmaceutical Benefits) Regulations 1960 made under the Act;
“standard formula preparation” means an extemporaneously-prepared pharmaceutical benefit that is listed in Schedule 5 to this Determination.
Schedules
(a) pharmaceutical benefits that involve the admixture of ready-prepared ingredients are set out in Schedule 1;
(b) drugs that are used in the preparation of extemporaneously-prepared pharmaceutical benefits and that are unstable or packed sterile and unused quantities of which are unsuitable for future use are set out in Schedule 2 ;
(c) pharmaceutical benefits that are classified as dangerous drugs for the purpose of payment of a dangerous drug fee are pharmaceutical benefits that have the pharmaceutical items which have the listed drug in the form set out in Schedule 3 to this Determination;
(d) pharmaceutical benefits the complete pack of which shall be supplied regardless of any lesser quantity ordered are pharmaceutical benefits that have the pharmaceutical items which have the listed drug in the form set out in Schedule 4.
Brand identified
Brand not identified
Packs
Variation of medicinal preparation
Election – extemporaneously-prepared pharmaceutical benefits
<table cellspacing="0" cellpadding="0" style="width:453.6pt; margin-right:auto; margin-left:auto; margin-bottom:0pt; border-collapse:collapse"><thead><tr><td colspan="2" style="width:442.8pt; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; margin-bottom:3pt; text-align:center; page-break-inside:avoid"><span>SCHEDULE 1 – PHARMACEUTICAL BENEFITS THAT INVOLVE THE ADMIXTURE OF READY</span><br><span>PREPARED INGREDIENTS</span></p></td></tr><tr><td style="width:147.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:bottom"><p class="tableheader" style="margin-top:0pt; margin-bottom:0pt"><span>Listed Drug</span></p></td><td style="width:284.05pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:bottom"><p class="tableheader" style="margin-top:0pt; margin-bottom:0pt"><span>Form (strength, type, size, etc.)</span></p></td></tr></thead><tbody><tr><td style="width:147.95pt; border-top:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="tablebody"><span>Amoxycillin with Water – Purified BP</span></p></td><td style="width:284.05pt; border-top:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="tablebody" style="page-break-after:avoid"><span>Powder for paediatric oral drops 100</span><span> </span><span>mg (as trihydrate) per mL, 20</span><span> </span><span>mL</span></p></td></tr><tr><td style="width:147.95pt; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="tablebody"><span></span></p></td><td style="width:284.05pt; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="tablebody"><span>Powder for oral suspension 125</span><span> </span><span>mg (as trihydrate) per 5</span><span> </span><span>mL, 100</span><span> </span><span>mL</span></p></td></tr><tr><td style="width:147.95pt; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="tablebody"><span></span></p></td><td style="width:284.05pt; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="tablebody"><span>Powder for oral suspension 250</span><span> </span><span>mg (as trihydrate) per 5</span><span> </span><span>mL, 100</span><span> </span><span>mL</span></p></td></tr><tr><td style="width:147.95pt; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="tablebody"><span></span></p></td><td style="width:284.05pt; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="tablebody"><span>Powder for oral suspension 500</span><span> </span><span>mg (as trihydrate) per 5</span><span> </span><span>mL, 100</span><span> </span><span>mL</span></p></td></tr><tr><td style="width:147.95pt; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="tablebody"><span>Amoxycillin with Clavulanic Acid and Water</span><span> </span><span>– Purified BP</span></p></td><td style="width:284.05pt; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="tablebody" style="page-break-after:avoid"><span>Powder for oral suspension containing 125</span><span> </span><span>mg amoxycillin (as trihydrate) with 31.25</span><span> </span><span>mg clavulanic acid (as potassium clavulanate) per 5</span><span> </span><span>mL, 75</span><span> </span><span>mL</span></p><p class="tablebody" style="margin-top:3pt"><span>Powder for oral suspension containing 400</span><span> </span><span>mg amoxycillin (as trihydrate) with 57</span><span> </span><span>mg clavulanic acid (as potassium clavulanate) per 5</span><span> </span><span>mL, 60</span><span> </span><span>mL</span></p></td></tr><tr><td style="width:147.95pt; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="tablebody"><span>Azithromycin with Water</span><span> </span><span>– Purified BP</span></p></td><td style="width:284.05pt; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="tablebody"><span>Powder for oral suspension 200</span><span> </span><span>mg (as dihydrate) per 5</span><span> </span><span>mL, 15</span><span> </span><span>mL</span></p></td></tr><tr><td style="width:147.95pt; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="tablebody"><span>Cefaclor with Water</span><span> </span><span>–</span><span> </span><span>Purified BP</span></p></td><td style="width:284.05pt; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="tablebody" style="page-break-after:avoid"><span>Powder for oral suspension 125</span><span> </span><span>mg (as monohydrate) per 5</span><span> </span><span>mL, 100</span><span> </span><span>mL</span></p><p class="tablebody" style="margin-top:3pt"><span>Powder for oral suspension 250</span><span> </span><span>mg (as monohydrate) per 5</span><span> </span><span>mL, 75</span><span> </span><span>mL</span></p></td></tr><tr><td style="width:147.95pt; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="tablebody"><span>Cephalexin with Water – Purified BP</span></p></td><td style="width:284.05pt; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="tablebody" style="page-break-after:avoid"><span>Granules for oral suspension 125</span><span> </span><span>mg per 5</span><span> </span><span>mL, 100</span><span> </span><span>mL</span></p><p class="tablebody" style="margin-top:3pt"><span>Granules for oral suspension 250</span><span> </span><span>mg per 5</span><span> </span><span>mL, 100</span><span> </span><span>mL</span></p></td></tr><tr><td style="width:147.95pt; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="tablebody"><span>Clarithromycin with Water – Purified BP</span></p></td><td style="width:284.05pt; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="tablebody" style="page-break-after:avoid"><span>Powder for oral liquid 250</span><span> mg per </span><span>5 mL, 5</span><span>0 mL</span></p></td></tr><tr><td style="width:147.95pt; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="tablebody"><span>Erythromycin with Water – Purified BP</span></p></td><td style="width:284.05pt; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="tablebody" style="page-break-after:avoid"><span>Powder for oral liquid 200</span><span> </span><span>mg (as ethyl succinate) per 5</span><span> </span><span>mL, 100</span><span> </span><span>mL</span></p><p class="tablebody" style="margin-top:3pt"><span>Powder for oral liquid 400</span><span> </span><span>mg (as ethyl succinate) per 5</span><span> </span><span>mL, 100</span><span> </span><span>mL</span></p></td></tr><tr><td style="width:147.95pt; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="tablebody" style="page-break-after:avoid"><span>Flucloxacillin with Water – Purified BP</span></p></td><td style="width:284.05pt; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="tablebody" style="page-break-after:avoid"><span>Powder for oral liquid 125</span><span> </span><span>mg (as sodium) per 5</span><span> </span><span>mL, 100</span><span> </span><span>mL</span></p><p class="tablebody" style="margin-top:3pt; page-break-after:avoid"><span>Powder for oral liquid 250</span><span> </span><span>mg (as sodium) per 5</span><span> </span><span>mL, 100</span><span> </span><span>mL</span></p></td></tr><tr><td style="width:147.95pt; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="tablebody" style="page-break-after:avoid"><span>Mycophenolic Acid with Water</span><span> </span><span>– Purified BP</span></p></td><td style="width:284.05pt; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="tablebody" style="page-break-after:avoid"><span>Powder for oral suspension containing mycophenolate mofetil 1</span><span> </span><span>g per 5</span><span> </span><span>mL, 165</span><span> </span><span>mL</span></p></td></tr></tbody></table>
<table cellspacing="0" cellpadding="0" style="width:453.6pt; margin-right:auto; margin-left:auto; margin-bottom:0pt; border-collapse:collapse"><thead><tr><td colspan="2" style="width:442.8pt; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; margin-bottom:3pt; text-align:center; page-break-inside:avoid"><span>SCHEDULE 2 – DRUGS THAT ARE USED IN THE PREPARATION OF EXTEMPORANEOUSLY-PREPARED PHARMACEUTICAL BENEFITS AND THAT ARE UNSTABLE OR PACKED STERILE AND UNUSED QUANTITIES OF WHICH ARE UNSUITABLE FOR FUTURE USE</span></p></td></tr><tr><td style="width:147.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:bottom"><p class="tableheader" style="margin-top:0pt; margin-bottom:0pt"><span>Listed Drug</span></p></td><td style="width:284.05pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:bottom"><p class="tableheader" style="margin-top:0pt; margin-bottom:0pt"><span>Form (strength, type, size, etc.)</span></p></td></tr></thead><tbody><tr><td colspan="2" style="width:442.8pt; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="tablebody" style="page-break-after:avoid"><span>Water For Injections—sterilised</span><span> </span><span>BP</span></p></td></tr></tbody></table>
<table cellspacing="0" cellpadding="0" style="width:453.6pt; margin-right:auto; margin-left:auto; margin-bottom:0pt; border-collapse:collapse"><thead><tr><td colspan="2" style="width:442.8pt; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="tablebody" style="margin-top:3pt; text-align:center; page-break-after:avoid; font-size:10pt"><span>SCHEDULE 3 – PHARMACEUTICAL BENEFITS THAT ARE CLASSIFIED AS DANGEROUS DRUGS FOR THE PURPOSE OF PAYMENT OF A DANGEROUS DRUG FEE</span></p></td></tr><tr><td style="width:147.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:bottom"><p class="tableheader" style="margin-top:0pt; margin-bottom:0pt"><span>Listed Drug</span></p></td><td style="width:284.05pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:bottom"><p class="tableheader" style="margin-top:0pt; margin-bottom:0pt"><span>Form (strength, type, size, etc.)</span></p></td></tr></thead><tbody><tr><td style="width:147.95pt; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="tablebody"><span>Buprenorphine</span></p></td><td style="width:284.05pt; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="tablebody" style="page-break-after:avoid"><span>Transdermal patch 5</span><span> </span><span>mg</span></p><p class="tablebody" style="margin-top:3pt"><span>Transdermal patch 10</span><span> </span><span>mg</span></p><p class="tablebod
This is an opening excerpt, not the complete document.