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Determination—Exempt items (PB 58 of 2007) as amended made under section 84AH of the National Health Act 1953 Compilation start date: 1 October 2014 Includes amendments up to: PB 77 of 2014 Prepared by the Office of Parliamentary Counsel, Canberra About this compilation This compilation This is a compilation of the Determination—Exempt items (PB 58 of 2007) as in force on 1 October 2014. It includes any commenced amendment affecting the legislation to that date. This compilation was prepared on 28 November 2014. The notes at the end of this compilation (the endnotes) include information about amending laws and the amendment history of each amended provision. Uncommenced amendments The effect of uncommenced amendments is not reflected in the text of the compiled law but the text of the amendments is included in the endnotes. Application, saving and transitional provisions for provisions and amendments If the operation of a provision or amendment is affected by an application, saving or transitional provision that is not included in this compilation, details are included in the endnotes. Modifications If a provision of the compiled law is affected by a modification that is in force, details are included in the endnotes. Provisions ceasing to have effect If a provision of the compiled law has expired or otherwise ceased to have effect in accordance with a provision of the law, details are included in the endnotes. Contents 1 2 Commencement .......................................................................................................... 1 Determination ............................................................................................................. 1 Schedule 1 2 Endnotes 4 Endnote 1—About the endnotes 4 Endnote 2—Abbreviation key 5 Endnote 3—Legislation history 6 Endnote 4—Amendment history Endnote 5—Uncommenced amendments [none] 8 Endnote 6—Modifications [none] 9 Endnote 7—Misdescribed amendments [none] 9 Endnote 8—Miscellaneous [none] 9 Determination—Exempt items (PB 58 of 2007) 9 i Section 1 Determination—Exempt items (PB 58 of 2007) 1 Commencement This instrument commences on 1 August 2007. 2 Determination A pharmaceutical item that has a listed drug in the form and with the manner of administration mentioned in Schedule 1 is an exempt item. Determination—Exempt items (PB 58 of 2007) 1 Schedule 1 Schedule 1 Listed Drug Form (strength, type, size, etc.) Manner of administration Amisulpride Oral solution 100 mg per mL, 60 mL Oral Amoxycillin Powder for paediatric oral drops 100 mg (as trihydrate) per mL, 20 mL Oral Artemether with Tablet (dispersible) 20 mg-120 mg Oral Azithromycin Powder for oral suspension 200 mg (as dihydrate) per 5 mL, 15mL Oral Atenolol Oral solution 50 mg in 10 mL, 300 mL Oral Baclofen Intrathecal injection 10mg in 5mL Injection Captopril Oral solution 5 mg per mL, 95 mL Oral Carbamazepine Oral suspension 100 mg per 5 mL, 300 mL Oral Ciprofloxacin Ear drops 3 mg (as hydrochloride) per mL, 5 mL Application to the ear Clarithromycin Powder for oral liquid 250 mg per 5 mL, 50 mL Oral Clonazepam Oral liquid 2.5 mg per mL, 10 mL Oral Clonazepam Injection 1 mg in 2 mL (set containing solution 1 mg in 1 mL and 1 mL Injection Lumefantrine diluent) Clozapine Oral liquid 50 mg per mL, 100 mL Oral Cefuroxime Powder for oral suspension 125 mg (as axetil) per 5 mL, 70 mL Oral Cyclosporin Oral liquid 100 mg per mL, 50 mL Oral Cyclosporin Capsule 10 mg Oral Cyclosporin Solution concentrate for I.V. infusion 50 mg in 1 mL Injection Diazepam Injection 10 mg in 2mL Injection Diazepam Oral liquid 1 mg in 1 mL, 100 mL Oral Diclofenac Suppository containing diclofenac sodium 100 mg Rectal Digoxin Paediatric oral solution 50 micrograms per mL, 60 mL Oral Efavirenz Oral solution 30 mg per mL, 180 mL Oral Erythromycin Powder for I.V. infusion 1 g (as lactobionate) Injection Escitalopram Oral solution 10 mg (as oxalate) per mL, 28 mL Oral Fluconazole Powder for oral suspension 50 mg in 5 mL, 35 mL Oral Frusemide Oral solution 10 mg per mL, 30 mL Oral Glyceryl Trinitrate Sublingual spray (pump pack) 400 micrograms per dose, 200 doses Sublingual Hydrocortisone Tablet 4 mg Oral Indomethacin Suppository 100 mg Rectal Ketoprofen Suppository 100 mg Rectal Levetiracetam Oral solution, 100 mg per mL, 300 mL Oral Levodopa with Carbidopa Tablet 200 mg-50 mg (anhydrous) (modified release) Oral Methadone Oral liquid containing methadone hydrochloride 25 mg per 5mL, 200 mL Oral Methadone Injection containing methadone hydrochloride 10 mg in 1 mL Injection Metronidazole Suppositories 500 mg, 10 Rectal Metronidazole Oral suspension containing metronidazole benzoate 320 mg per 5 mL, Oral 100 mL Mycophenolic Acid Powder for oral suspension containing mycophenolate mofetil 1 g per 5 mL, Oral 165 mL Naproxen Oral suspension 125 mg per 5mL, 474 mL Oral Nevirapine Oral suspension 50 mg (as hemihydrate) per 5 mL, 240 mL Oral Oestradiol Vaginal tablets 25 micrograms, 15 Vaginal 2 Determination—Exempt items (PB 58 of 2007) Schedule 1 Schedule 1 Listed Drug Form (strength, type, size, etc.) Manner of administration Ondansetron Syrup, 4 mg (as hydrochloride dihydrate) per 5 mL, 50mL Oral Oxycodone Oral solution containing oxycodone hydrochloride 5 mg per 5 mL, 250 mL Oral Pantoprazole Sachet containing granules 40 mg (as sodium sesquihydrate) Oral Paracetamol Oral liquid 120 mg per 5 mL, 100 mL Oral Paracetamol Oral liquid 240 mg per 5 mL, 200 mL Oral Paracetamol Tablet 665 mg (modified release) Oral Paracetamol Suppositories 500 mg, 24 Rectal Prochlorperazine Suppositories containing prochlorperazine equivalent to 25 mg Rectal prochlorperazine maleate, 5 Prochlorperazine Injection containing prochlorperazine mesylate 12.5 mg in 1 mL Injection Ranitidine Syrup 150 mg (as hydrochloride) per 10 mL, 300 mL Oral Risperidone Oral solution 1mg per mL, 100 mL Oral Roxithromycin Tablet for oral suspension 50 mg Oral Salbutamol Oral solution 2 mg (as sulfate) per 5 mL, 150 mL Oral Salbutamol Pressurised inhalation in breath actuated device 100 micrograms (as sulfate) Inhalation by mouth per dose, 200 doses (CFC-free formulation) Terbinafine Cream containing terbinafine hydrochloride 10 mg per g, 15 g Application Tramadol Oral drops containing tramadol hydrochloride 100 mg per mL, 10 mL Oral Valganciclovir Powder for oral solution 50 mg (as hydrochloride) per mL, 100 mL Oral Valproic Acid Tablet, crushable, containing sodium valproate 100 mg Oral Valproic Acid Oral liquid containing sodium valproate 200 mg per 5mL, 300 mL Oral Valproic Acid Oral solution containing sodium valproate 200 mg per 5mL, 300 mL Oral Determination—Exempt items (PB 58 of 2007) 3 Endnotes Endnote 1—About the endnotes Endnotes Endnote 1—About the endnotes The endnotes provide details of the history of this legislation and its provisions. The following endnotes are included in each compilation: Endnote 1—About the endnotes Endnote 2—Abbreviation key Endnote 3—Legislation history Endnote 4—Amendment history Endnote 5—Uncommenced amendments Endnote 6—Modifications Endnote 7—Misdescribed amendments Endnote 8—Miscellaneous If there is no information under a particular endnote, the word “none” will appear in square brackets after the endnote heading. Abbreviation key—Endnote 2 The abbreviation key in this endnote sets out abbreviations that may be used in the endnotes. Legislation history and amendment history—Endnotes 3 and 4 Amending laws are annotated in the legislation history and amendment history. The legislation history in endnote 3 provides information about each law that has amended the compiled law. The information includes commencement information for amending laws and details of application, saving or transitional provisions that are not included in this compilation. The amendment history in endnote 4 provides information about amendments at the provision level. It also includes information about any provisions that have expired or otherwise ceased to have effect in accordance with a provision of the compiled law. Uncommenced amendments—Endnote 5 The effect of uncommenced amendments is not reflected in the text of the compiled law but the text of the amendments is included in endnote 5. Modifications—Endnote 6 If the compiled law is affected by a modification that is in force, details of the modification are included in endnote 6. Misdescribed amendments—Endnote 7 An amendment is a misdescribed amendment if the effect of the amendment cannot be incorporated into the text of the compilation. Any misdescribed amendment is included in endnote 7. Miscellaneous—Endnote 8 Endnote 8 includes any additional information that may be helpful for a reader of the compilation. 4 Determination—Exempt items (PB 58 of 2007) Endnotes Endnote 2—Abbreviation key Endnote 2—Abbreviation key ad = added or inserted pres = present am = amended prev = previous c = clause(s) (prev) = previously Ch = Chapter(s) Pt = Part(s) def = definition(s) r = regulation(s)/rule(s) Dict = Dictionary Reg = Regulation/Regulations disallowed = disallowed by Parliament reloc = relocated Div = Division(s) renum = renumbered exp = expired or ceased to have effect rep = repealed hdg = heading(s) rs = repealed and substituted LI = Legislative Instrument s = section(s) LIA = Legislative Instruments Act 2003 Sch = Schedule(s) mod = modified/modification Sdiv = Subdivision(s) No = Number(s) SLI = Select Legislative Instrument o = order(s) SR = Statutory Rules Ord = Ordinance Sub-Ch = Sub-Chapter(s) orig = original SubPt = Subpart(s) par = paragraph(s)/subparagraph(s) /sub-subparagraph(s) Determination—Exempt items (PB 58 of 2007) 5 Endnotes Endnote 3—Legislation history Endnote 3—Legislation history 6 Name FRLI registration Commencement PB 58 of 2007 31 July 2007 (F2007L02404) 1 Aug 2007 PB 67 of 2007 23 Aug 2007 (F2007L02638) 1 Sept 2007 — PB 96 of 2007 16 Nov 2007 (F2007L04368) 1 Dec 2007 — PB 21 of 2008 15 Jan 2008 (F2008L00043) 1 Feb 2008 — PB 69 of 2008 10 June 2008 (F2008L02060) 1 July 2008 — PB 73 of 2008 2 July 2008 (F2008L02302) (a) — PB 84 of 2008 25 July 2008 (F2008L02623) 1 Aug 2008 — PB 112 of 2008 11 Nov 2008 (F2008L04304) (b) — PB 60 of 2009 10 July 2009 (F2009L02722) 31 July 2009 — PB 79 of 2009 17 Aug 2009 (F2009L03147) 1 Sept 2009 — PB 26 of 2010 22 Apr 2010 (F2010L01008) 1 May 2010 — PB 77 of 2010 19 July 2010 (F2010L02088) 1 Aug 2010 — PB 100 of 2010 29 Oct 2010 (F2010L02859) 1 Nov 2010 — PB 7 of 2011 19 Jan 2011 (F2011L00130) 20 Jan 2011 — PB 10 of 2011 20 Jan 2011 (F2011L00137) 21 Jan 2011 — PB 45 of 2011 23 June 2011 (F2011L01207) 1 July 2011 — PB 61 of 2011 30 Aug 2011 (F2011L01768) 1 Sept 2011 — PB 91 of 2011 30 Nov 2011 (F2011L02497) 1 Dec 2011 — PB 11 of 2012 21 Feb 2012 (F2012L00344) 1 Mar 2012 — PB 54 of 2012 30 July 2012 (F2012L01623) 1 Aug 2012 — Determination—Exempt items (PB 58 of 2007) Application, saving and transitional provisions Endnotes Endnote 3—Legislation history Name FRLI registration Commencement Application, saving and transitional provisions PB 103 of 2012 29 Nov 2012 (F2012L02285) 1 Dec 2012 — PB 65 of 2013 18 Sept 2013 (F2013L01706) 1 Oct 2013 (s 2) — PB 7 of 2014 15 Jan 2014 (F2014L00064) 1 Feb 2014 (s 2) — PB 33 of 2014 15 Apr 2014 (F2014L00412) 1 May 2014 (s 2) — PB 65 of 2014 29 Aug 2014 (F2014L01175) 1 Sept 2014 (s 2) — PB 77 of 2014 30 Sept 2014 (F2014L01305) 1 Oct 2014 (s 2) — (a) Section 1 of PB 73 of 2008 provides as follows: 1. Commencement This instrument commences immediately following the commencement of the following instruments: a) the Amendment to Special Arrangements made under subsection 100(1) of the National Health Act 1953 for the Highly Specialised Drugs Program - being amending instrument number PB 72 of 2008; b) the Amendment to the instrument that makes Determinations under sections 85, 85A and 88 of the National Health Act 1953 – being amending instrument number PB 70 of 2008. Note: Both of the amending instruments mentioned in a) and b) above are expressed to commence at 11.59pm on 31 July 2008. It is intended that this instrument commence immediately after that time and before the expiration of 31 July 2008. (b) Section 1 of PB 112 of 2008 provides as follows: 1. Commencement This instrument commences immediately following the commencement of the following instruments: a) the Amendment to the Declarations made under sections 85(2) and 85(2AA) and amendment determination under subsection 85(2A) of the National Health Act 1953 – being amending instrument number PB 108 of 2008; b) the Amendment to Determinations made under sections 85, 85A and 88 of the National Health Act 1953 – being amending instrument number PB 109 of 2008. Note: Both of the amending instruments mentioned in a) and b) above are expressed to commence at 11.59 pm on 30 November 2008. It is intended that this instrument commence immediately after that time and before the expiration of 30 November 2008. Determination—Exempt items (PB 58 of 2007) 7 Endnotes Endnote 4—Amendment history Endnote 4—Amendment history Provision affected How affected Schedule 1 Schedule 1 ..................................... am. PB 67 and 96 of 2007; PB 21, 69, 73, 84 and 112 of 2008; PB 60 and 79 of 2009; PB 26, 77 and 100 of 2010; PB 7, 10, 45, 61 and 91 of 2011; PB 11, 54 and 103 of 2012; PB 65 of 2013; PB 7, 33, 65 and 77 of 2014 8 Determination—Exempt items (PB 58 of 2007) Endnotes Endnote 5—Uncommenced amendments [none] Endnote 5—Uncommenced amendments [none] Endnote 6—Modifications [none] Endnote 7—Misdescribed amendments [none] Endnote 8—Miscellaneous [none] Determination—Exempt items (PB 58 of 2007) 9