{"id":"F2017L01265","name":"National Health (Pharmaceutical Benefits Scheme‑Exempt items ‑ Section 84AH) Determination 2017","slug":"national-health-pharmaceutical-benefits-scheme-exempt-items-section-84ah-determination-2017","collection":"legislative_instrument","jurisdiction":"commonwealth","status":"in_force","isInForce":true,"actNumber":null,"makingDate":null,"administeringDepartment":null,"currentVersion":{"id":97184,"registerId":"commonwealth-F2017L01265-current","compilationNumber":null,"startDate":"2026-04-02","status":"InForce","reasons":null,"registeredAt":null},"sections":[{"sectionNumber":"1","sectionType":"section","heading":"National Health (Pharmaceutical Benefits Scheme‑Exempt items ‑ Section 84AH) Determination 2017","content":"---\nmeta-content-style-type: text/css\nmeta-content-type: application/xhtml+xml; charset=utf-8\ntitle: National Health (Pharmaceutical Benefits Scheme-Exempt items - Section 84AH) Determination 2017\n---\n\n?xml version=\"1.0\" encoding=\"utf-8\" standalone=\"no\"?>\n\n![Commonwealth Coat of Arms of Australia](image.001.png)\n\nNational Health (Pharmaceutical Benefits Scheme‑Exempt items ‑ Section 84AH) Determination 2017\n\nPB 81 of 2017\n\nmade under section 84AH of the\n\nNational Health Act 1953\n\nCompilation No. 25\n\nCompilation date: 1 December 2025\n\nIncludes amendments: F2025L01444\n\nAbout this compilation\n\nThis compilation\n\nThis is a compilation of the National Health (Pharmaceutical Benefits Scheme-Exempt items - Section 84AH) Determination 2017 that shows the text of the law as amended and in force on 1 December 2025 (the compilation date).\n\nThe notes at the end of this compilation (the endnotes) include information about amending laws and the amendment history of provisions of the compiled law.\n\nUncommenced amendments\n\nThe effect of uncommenced amendments is not shown in the text of the compiled law. The details of amendments made up to, but not commenced at, the compilation date are underlined in the endnotes. Any uncommenced amendments affecting the law are accessible on the Register (www.legislation.gov.au).\n\nApplication, saving and transitional provisions\n\nIf 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.\n\nEditorial changes\n\nFor more information about any editorial changes made in this compilation, see the endnotes.\n\nPresentational changes\n\nThe Legislation Act 2003 provides for First Parliamentary Counsel to make presentational changes to a compilation. Presentational changes are applied to give a more consistent look and feel to legislation published on the Register, and enable the user to more easily navigate those documents.\n\nModifications\n\nIf 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. Any modifications affecting the law are accessible on the Register.\n\nSelf‑repealing provisions\n\nIf a provision of the compiled law has been repealed in accordance with a provision of the law, details are included in the endnotes.\n\n \n\n \n\n \n\nContents\n\n1 Name of Instrument\n\n4 Authority\n\n5 Definitions\n\n6 Exempt items\n\nSchedule \n\nEndnotes\n\nEndnote 1—About the endnotes\n\nEndnote 2—Abbreviation key\n\nEndnote 3—Legislation history\n\nEndnote 4—Amendment history\n\n \n\n1  Name of Instrument\n\n (1) This instrument is the National Health (Pharmaceutical Benefits Scheme‑Exempt items ‑ Section 84AH) Determination 2017.\n\n (2) This instrument may also be cited as PB 81 of 2017.\n\n4  Authority\n\n  This Determination is made under section 84AH of the National Health Act 1953 (the Act).\n\n5  Definitions\n\n  In this Determination:\n\npharmaceutical item has the meaning given by section 84AB of the Act.\n\nNote: Terms used in this Determination have the same meaning as in the Act – see section 13 of the Legislation Act 2003. These terms include:\n\n • listed drug\n\n • form\n\n • manner of administration\n\n6  Exempt items\n\n  The pharmaceutical items identified in the Schedule are exempt from statutory price reductions and price disclosure requirements under Division 3A and 3B of Part VII of the Act.\n\nSchedule \n\n \n\n \n\n| Listed Drug | Form (strength, type, size, etc.) | Manner of administration |\n| --- | --- | --- |\n| Amisulpride | Oral solution 100 mg per mL, 60 mL | Oral |\n| Amoxicillin | Powder for paediatric drops 100 mg (as trihydrate) per mL, 20 mL | Oral |\n| Azithromycin | Powder for oral suspension 200 mg (as dihydrate) per 5 mL, 15mL | Oral |\n| Atenolol | Oral solution 50 mg in 10 mL, 300 mL | Oral |\n| Captopril | Oral solution 5 mg per mL,  95 mL | Oral |\n| Carbamazepine | Oral suspension 100 mg per 5 mL,  300 mL | Oral |\n| Ciclosporin | Oral liquid 100 mg per mL, 50 mL | Oral |\n| Ciclosporin | Capsule 10 mg | Oral |\n| Ciclosporin | Solution concentrate for I.V. infusion 50 mg in 1 mL | Injection |\n| Ciprofloxacin | Ear drops 3 mg (as hydrochloride) per mL, 5 mL | Application to the ear |\n| Clarithromycin | Powder for oral liquid 250 mg per 5 mL, 50 mL | Oral |\n| Clonazepam | Oral liquid 2.5 mg per mL, 10 mL | Oral |\n| Clonazepam | Injection 1 mg in 2 mL (set containing solution 1 mg in 1 mL and 1 mL diluent) | Injection |\n| Diazepam | Oral liquid 10 mg per 10 mL, 100 mL | Oral |\n| Diclofenac | Suppository containing diclofenac sodium 100 mg | Rectal |\n| Digoxin | Paediatric oral solution 50 micrograms per mL, 60 mL | Oral |\n| Escitalopram | Oral solution 20 mg (as oxalate) per mL, 15 mL | Oral |\n| Ethosuximide | Oral solution 250 mg per 5 mL, 200 mL | Oral |\n| Fluconazole | Powder for oral suspension 50 mg in 5 mL, 35 mL | Oral |\n| Furosemide | Oral solution 10 mg per mL, 30 mL | Oral |\n| Glyceryl Trinitrate | Sublingual spray (pump pack) 400 micrograms per dose, 200 doses | Sublingual |\n| Indometacin | Suppository 100 mg | Rectal |\n| Mercaptopurine | Oral suspension containing mercaptopurine monohydrate 20 mg per mL, 100 mL | Oral |\n| Methadone | Injection containing methadone hydrochloride 10 mg in 1 mL | Injection |\n| Metronidazole | Suppositories 500 mg, 10 | Rectal |\n| Metronidazole | Oral suspension containing metronidazole benzoate 320 mg per 5 mL, 100 mL | Oral |\n| Nevirapine | Oral suspension 50 mg (as hemihydrate) per 5 mL, 240 mL | Oral |\n| Oxybutynin | Transdermal patches 36 mg, 8 | Transdermal |\n| Oxycodone | Oral solution containing oxycodone hydrochloride 1 mg per mL, 1 mL | Oral |\n| Pantoprazole | Sachet containing granules 40 mg (as sodium sesquihydrate) | Oral |\n| Paracetamol | Oral liquid 240 mg per 5 mL, 200 mL | Oral |\n| Paracetamol | Suppository 500 mg | Rectal |\n| Prochlorperazine | Injection containing prochlorperazine mesilate 12.5 mg in 1 mL | Injection |\n| Salbutamol | Oral solution 2 mg (as sulfate) per 5 mL, 150 mL | Oral |\n| Salbutamol | Pressurised inhalation in breath actuated device 100 micrograms (as sulfate) per dose, 200 doses (CFC‑free formulation) | Inhalation by mouth |\n| Terbinafine | Cream containing terbinafine hydrochloride 10 mg per g, 15 g | Application |\n| Tofacitinib | Oral solution 1 mg per mL, 240 mL | Oral |\n| Tramadol | Oral drops containing tramadol hydrochloride 100 mg per mL, 10 mL | Oral |\n| Valganciclovir | Powder for oral solution 50 mg (as hydrochloride) per mL, 100 mL | Oral |\n| Valproic Acid | Tablet, crushable, containing sodium valproate 100 mg | Oral |\n| Valproic Acid | Oral liquid containing sodium valproate 200 mg per 5mL, 300 mL | Oral |\n| Valproic Acid | Oral solution containing sodium valproate 200 mg per 5mL, 300 mL | Oral |\n| Voriconazole | Powder for oral suspension 40 mg per mL, 70 mL | Oral |\n\nEndnotes\n\nEndnote 1—About the endnotes\n\nThe endnotes provide information about this compilation and the compiled law.\n\nThe following endnotes are included in every compilation:\n\nEndnote 1—About the endnotes\n\nEndnote 2—Abbreviation key\n\nEndnote 3—Legislation history\n\nEndnote 4—Amendment history\n\nAbbreviation key—Endnote 2\n\nThe abbreviation key sets out abbreviations that may be used in the endnotes.\n\nLegislation history and amendment history—Endnotes 3 and 4\n\nAmending laws are annotated in the legislation history and amendment history.\n\nThe legislation history in endnote 3 provides information about each law that has amended (or will amend) the compiled law. The information includes commencement details for amending laws and details of any application, saving or transitional provisions that are not included in this compilation.\n\nThe amendment history in endnote 4 provides information about amendments at the provision (generally section or equivalent) level. It also includes information about any provision of the compiled law that has been repealed in accordance with a provision of the law.\n\nEditorial changes\n\nThe Legislation Act 2003 authorises First Parliamentary Counsel to make editorial and presentational changes to a compiled law in preparing a compilation of the law for registration. The changes must not change the effect of the law. Editorial changes take effect from the compilation registration date.\n\nIf the compilation includes editorial changes, the endnotes include a brief outline of the changes in general terms. Full details of any changes can be obtained from the Office of Parliamentary Counsel.\n\nMisdescribed amendments\n\nA misdescribed amendment is an amendment that does not accurately describe how an amendment is to be made. If, despite the misdescription, the amendment can be given effect as intended, then the misdescribed amendment can be incorporated through an editorial change made under section 15V of the Legislation Act 2003.\n\nIf a misdescribed amendment cannot be given effect as intended, the amendment is not incorporated and “(md not incorp)” is added to the amendment history.\n\nEndnote 2—Abbreviation key\n\n \n\n| ad = added or inserted | orig = original |\n| --- | --- |\n| am = amended | p = page(s) |\n| amdt = amendment | para = paragraph(s)/subparagraph(s) |\n| C[x] = Compilation No. x | /sub‑subparagraph(s) |\n| ch = Chapter(s) | pres = present |\n| cl = clause(s) | prev = previous |\n| cont. = continued | (prev…) = previously |\n| def = definition(s) | pt = Part(s) |\n| Dict = Dictionary | r = regulation(s)/Court rule(s) |\n| disallowed = disallowed by Parliament | reloc = relocated |\n| div = Division(s) | renum = renumbered |\n| ed = editorial change | rep = repealed |\n| exp = expires/expired or ceases/ceased to have | rs = repealed and substituted |\n| effect | s = section(s)/subsection(s) |\n| gaz = gazette | /rule(s)/subrule(s)/order(s)/suborder(s) |\n| LA = Legislation Act 2003 | sch = Schedule(s) |\n| LIA = Legislative Instruments Act 2003 | SLI = Select Legislative Instrument |\n| (md) = misdescribed amendment can be given | SR = Statutory Rules |\n| effect | sub ch = Sub‑Chapter(s) |\n| (md not incorp) = misdescribed amendment | sub div = Subdivision(s) |\n| cannot be given effect | sub pt = Subpart(s) |\n| mod = modified/modification | underlining = whole or part not |\n| No. = Number(s) | commenced or to be commenced |\n| Ord = Ordinance |  |\n\n\n \n\nEndnote 3—Legislation history\n\n \n\n| Name | Registration | Commencement | Application, saving and transitional provisions |\n| --- | --- | --- | --- |\n| National Health (Pharmaceutical Benefits Scheme‑Exempt items ‑ Section 84AH) Determination 2017 (PB 81 of 2017) | 26 Sept 2017 (F2017L01265) | 26 Sept 2017 (s 2) |  |\n| National Health (Pharmaceutical Benefits Scheme‑Exempt items ‑ Section 84AH) Amendment Determination 2017 (No. 1) (PB 90 of 2017) | 30 Oct 2017 (F2017L01400) | 1 Nov 2017 (s 2) | — |\n| National Health (Pharmaceutical Benefits Scheme‑Exempt items ‑ Section 84AH) Amendment Determination 2018 (No. 1) (PB 45 of 2018) | 31 May 2018 (F2018L00694) | 1 June 2018 (s 2) | — |\n| National Health (Pharmaceutical Benefits Scheme‑Exempt items ‑ Section 84AH) Amendment Determination 2018 (No. 2) (PB 61 of 2018) | 29 June 2018 (F2018L00958) | 1 July 2018 (s 2) | — |\n| National Health (Pharmaceutical Benefits Scheme‑Exempt items ‑ Section 84AH) Amendment Determination 2018 (No. 3) (PB 72 of 2018) | 1 Aug 2018 (F2018L01074) | 1 Aug 2018 (s 2) | — |\n| National Health (Pharmaceutical Benefits Scheme‑Exempt items ‑ Section 84AH) Amendment Determination 2018 (No. 4) (PB 97 of 2018) | 26 Oct 2018 (F2018L01484) | 1 Nov 2018 (s 2) | — |\n| National Health (Pharmaceutical Benefits Scheme‑Exempt items ‑ Section 84AH) Amendment Determination 2019 (No. 1) (PB 27 of 2019) | 28 Mar 2019 (F2019L00451) | 1 Apr 2019 (s 2) | — |\n| National Health (Pharmaceutical Benefits Scheme‑Exempt items ‑ Section 84AH) Amendment Determination 2019 (No. 2) (PB 44 of 2019) | 30 May 2019 (F2019L00705) | 1 June 2019 (s 2) | — |\n| National Health (Pharmaceutical Benefits Scheme‑Exempt items ‑ Section 84AH) Amendment Determination 2020 (No. 1) (PB 51 of 2020) | 29 May 2020 (F2020L00651) | 1 June 2020 (s 2) | — |\n| National Health (Pharmaceutical Benefits Scheme‑Exempt items ‑ Section 84AH) Amendment Determination 2020 (No. 2) (PB 63 of 2020) | 30 June 2020 (F2020L00844) | 1 July 2020 (s 2) | — |\n| National Health (Pharmaceutical Benefits Scheme‑Exempt items ‑ Section 84AH) Amendment Determination 2020 (No. 3) (PB 120 of 2020) | 27 Nov 2020 (F2020L01494) | 1 Dec 2020 (s 2(1) item 1) | — |\n| National Health (Pharmaceutical Benefits Scheme‑Exempt items ‑ Section 84AH) Amendment Determination 2021 (No. 1) (PB 36 of 2021) | 31 Mar 2021 (F2021L00385) | 1 Apr 2021 (s 2(1) item 1) | — |\n| National Health (Pharmaceutical Benefits Scheme‑Exempt items ‑ Section 84AH) Amendment Determination 2021 (No. 2) (PB 68 of 2021) | 30 June 2021 (F2021L00932) | 1 July 2021 (s 2(1) item 1) | — |\n| National Health (Pharmaceutical Benefits Scheme‑Exempt items ‑ Section 84AH) Amendment Determination 2021 (No. 3) (PB 96 of 2021) | 31 Aug 2021 (F2021L01222) | 1 Sept 2021 (s 2(1) item 1) | — |\n| National Health (Pharmaceutical Benefits Scheme‑Exempt items ‑ Section 84AH) Amendment Determination 2021 (No. 4) (PB 107 of 2021) | 30 Sept 2021 (F2021L01356) | 1 Oct 2021 (s 2(1) item 1) | — |\n| National Health (Pharmaceutical Benefits Scheme‑Exempt items ‑ Section 84AH) Amendment Determination 2022 (No. 1) (PB 77 of 2022) | 29 July 2022 (F2022L01018) | 1 Aug 2022 (s 2(1) item 1) | — |\n| National Health (Pharmaceutical Benefits Scheme‑Exempt items ‑ Section 84AH) Amendment Determination 2022 (No. 2) (PB 126 of 2022) | 23 Dec 2022 (F2022L01757) | 1 Jan 2023 (s 2(1) item 1) | — |\n| National Health (Pharmaceutical Benefits Scheme‑Exempt items ‑ Section 84AH) Amendment Determination 2023 (No. 1) (PB 8 of 2023) | 31 Jan 2023 (F2023L00070) | 1 Feb 2023 (s 2(1) item 1) | — |\n| National Health (Pharmaceutical Benefits Scheme‑Exempt items ‑ Section 84AH) Amendment Determination 2023 (No. 2) (PB 77 of 2023) | 31 July 2023 (F2023L01053) | 1 Aug 2023 (s 2(1) item 1) | — |\n| National Health (Pharmaceutical Benefits Scheme‑Exempt items ‑ Section 84AH) Amendment Determination 2023 (No. 3) (PB 100 of 2023) | 29 Sept 2023 (F2023L01342) | 1 Oct 2023 (s 2(1) item 1) | — |\n| National Health (Pharmaceutical Benefits Scheme‑Exempt items ‑ Section 84AH) Amendment Determination 2023 (No. 4) (PB 122 of 2023) | 30 Nov 2023 (F2023L01583) | 1 Dec 2023 (s 2(1) item 1) | — |\n| National Health (Pharmaceutical Benefits Scheme‑Exempt items ‑ Section 84AH) Amendment Determination 2024 (No. 1) (PB 47 of 2024) | 30 Apr 2024 (F2024L00497) | 1 May 2024 (s 2(1) item 1) | — |\n| National Health (Pharmaceutical Benefits Scheme‑Exempt items ‑ Section 84AH) Amendment Determination (No. 1) 2025 (PB 80 of 2025) | 27 June 2025 (F2025L00778) | 1 July 2025 (s 2(1) item 1) | — |\n| National Health (Pharmaceutical Benefits Scheme-Exempt items - Section 84AH) Amendment Determination (No. 2) 2025 (PB 100 of 2025) | 29 Aug 2025 (F2025L01017) | 1 Sept 2025 (s 2(1) item 1) | — |\n| National Health (Pharmaceutical Benefits Scheme-Exempt items - Section 84AH) Amendment Determination (No. 3) 2025 (PB 116 of 2025) | 30 Sept 2025 (F2025L01206) | 1 Oct 2025 (s 2(1) item 1) | — |\n| National Health (Pharmaceutical Benefits Scheme-Exempt items - Section 84AH) Amendment Determination (No. 4) 2025 (PB 143 of 2025) | 27 Nov 2025 (F2025L01444) | 1 Dec 2025 (s 2(1) item 1) | — |\n\n\n \n\nEndnote 4—Amendment history\n\n \n\n| Provision affected | How affected |\n| --- | --- |\n| s 2..................... | rep LA s 48D |\n| s 3..................... | rep LA s 48C |\n| Schedule |  |\n| Schedule................. | am F2017L01400; F2018L00694; F2018L00958; F2018L01074; F2018L01484; F2019L00451; F2019L00705; F2020L00651; F2020L00844; F2020L01494; F2021L00385; F2021L00932; F2021L01222; F2021L01356; F2022L01018; F2022L01757; F2023L00070; F2023L01053; F2023L01342; F2023L01583; F2024L00497; F2025L00778; F2025L01017; F2025L01206; F2025L01444 |\n\n \n","sortOrder":0}],"analysis":{"flash_summary_failed":{"failed":true,"reason":"A positive credit balance is required for all requests, including BYOK, so fallback providers remain available. Add credits at https://vercel.com/d?to=%2F%5Bteam%5D%2F%7E%2Fai%3Fmodal%3Dtop-up to continue.","source":"analysis-cron"},"flash_summary":{"complexity_score":4,"scope_assessment":{"changed":true,"description":"Yes. The instrument’s substantive effect is defined by the Schedule (s 6). The Schedule has been amended repeatedly (see Endnote 3—listing many Amendment Determinations—and Endnote 4 noting numerous Schedule amendments), so which products are exempt has changed over time. Changes to the Schedule therefore altered the scope of exemptions without altering s 6’s mechanism."},"complexity_factors":["Direct cross‑references to other statutory definitions and regimes (relies on the Act’s definitions, see s 5 referencing s 84AB and Legislation Act terms).","Operational effect depends entirely on the Schedule: many entries with exact forms, strengths and manners of administration (precision increases compliance complexity).","Interaction with external pricing mechanisms (statutory price reductions and price disclosure under Divisions 3A and 3B) requires coordination with PBS administrative processes (see s 6).","Frequent amendments to the Schedule (multiple amendment determinations listed in Endnote 3 and amendment history in Endnote 4) increase tracking and implementation burden for suppliers and pharmacies.","Limited substantive text with high reliance on list maintenance: legal effect changes when the Schedule is updated, requiring ongoing administrative monitoring rather than one‑off interpretation."],"plain_english_summary":"This Determination names specific pharmaceutical products that are exempt from the National Health Act’s automatic statutory price reductions and from price‑disclosure reporting under Divisions 3A and 3B. It changes who must comply with pricing and reporting rules: manufacturers, importers, wholesalers, pharmacists and the PBS administrator must treat the listed forms and strengths differently from other PBS items, so businesses need to monitor the Schedule for changes (see s 6 and the Schedule)."},"kimi_summary":{"content_quality":"ok","complexity_score":2,"scope_assessment":{"changed":false,"description":"The legislation remains tightly scoped to its original purpose. It has not expanded beyond creating exemptions from price disclosure and statutory price reductions for specific pharmaceutical items. The numerous amendments have only added or removed specific medicines from the Schedule table, not altered the exemption mechanism or extended it to new categories of benefit."},"complexity_factors":["Extremely short operative provisions: only 6 sections, with sections 2 and 3 repealed, leaving just 4 substantive provisions","Single mechanism: one straightforward exemption declaration in section 6","Minimal defined terms: only one explicit definition ('pharmaceutical item'), with others incorporated by reference from the parent Act","No conditional logic: no 'if/then' structures, exceptions, or nested qualifications in the operative provisions","Simple tabular schedule: 40 rows of specific drug/form combinations with no cross-references or interpretive provisions","High amendment frequency but low structural complexity: 24 amending instruments since 2017, but all merely add/remove rows from the table without altering the legislative architecture"],"plain_english_summary":"This Determination lists specific PBS medicines—mostly paediatric liquids, injections and other specialty formulations—that are exempt from the usual price-disclosure reporting and automatic statutory price reductions. It preserves higher listed prices for manufacturers and suppliers because these forms don’t fit the standard pricing model.\n\nIt matters to pharmaceutical companies, pharmacists/hospitals, patients (possible higher co‑payments) and taxpayers (higher government spending)."}},"importantCases":[],"_links":{"self":"/api/acts/national-health-pharmaceutical-benefits-scheme-exempt-items-section-84ah-determination-2017","history":"/api/acts/national-health-pharmaceutical-benefits-scheme-exempt-items-section-84ah-determination-2017/history","analysis":"/api/acts/national-health-pharmaceutical-benefits-scheme-exempt-items-section-84ah-determination-2017/analysis","conflicts":"/api/acts/national-health-pharmaceutical-benefits-scheme-exempt-items-section-84ah-determination-2017/conflicts","importantCases":"/api/acts/national-health-pharmaceutical-benefits-scheme-exempt-items-section-84ah-determination-2017/important-cases","documents":"/api/acts/national-health-pharmaceutical-benefits-scheme-exempt-items-section-84ah-determination-2017/documents"}}