Amendments to the Standard for the Uniform Scheduling of Drugs and Poisons
The National Drugs and Poisons Schedule Committee directs that the amendments below be applied to the Standard for the Uniform Scheduling of Drugs and Poisons No.22 and recommends that these amendments be adopted by the States and Territories with effect from 1 September 2007 unless otherwise stated. The amendments arise from decisions made by the Committee at its February 2007 meeting and confirmed at the June 2007 meeting except where separately specified.
Principles of Scheduling
READING THE SCHEDULES – Amend section to read:
Schedule entries have been designed to be as simple as possible while retaining readability, legal integrity and as much freedom from ambiguity and contradiction as possible. As a result they are expressed in a number of ways, though this number has been kept to a minimum. It is necessary to keep this variety of expression in mind when searching or interpreting Schedule entries.
Firstly, poisons are now scheduled individually using their approved names wherever practicable although exceptions are necessary in some cases. Some of those are mentioned overleaf. Older group entries are being revised and replaced by individual entries as time permits although in some of these cases a group term has also been retained to deal with any members of the group or class that may have escaped attention but should be scheduled.
Secondly, schedule entries have been expressed in either positive or negative terms and care must be taken to distinguish between the two different forms of expression. Thus, selenium is in Schedule 6 only when one of the clauses in this schedule entry applies, while fluorides are in Schedule 6 unless one of the exempting clauses applies.
Where exceptions are included in an entry these have been emphasised by printing the word “except” in bold type.
Where the schedule entries for a poison make a specific exclusion or exemption, the requirements of this Standard do not apply to that poison within the constraints of that exclusion or exemption although controls under other legislation such as pesticide registration may apply.
Where a poison has been included in more than one Schedule the principal entry, where practicable, has been included in the most restrictive Schedule with references to the other Schedule(s) involved.
It is important to remember that a Schedule entry includes preparations containing the poison in any concentration and all salts and derivatives of the poison unless it specifically states otherwise. (See Interpretation PART 1 [paragraph 1(2)]).
It is important to note that a substance is not classed as a derivative on the basis of a single, prescriptive set of criteria. Classification of a substance as a derivative of a Scheduled poison relies on a balanced consideration of factors to decide if a substance
Part Editorial Amendments and Errata - Poisons Standard 2007 - Editorial Amendments and Errata | Zoe
has a similar nature (e.g. structurally, pharmacologically, toxicologically) to a Scheduled poison or is readily converted (either physically or chemically) to a Scheduled poison.
However, a substance is only considered a derivative of a Scheduled poison if it is not individually listed elsewhere in the Schedules, or captured by a more restrictive group or class entry. Additionally, some entries specifically exclude derivatives. Once a substance is determined to be a derivative of a Scheduled poison, the same scheduling requirements as the Scheduled poison, including limits on access, supply and availability, will apply.
Finally, when using the Standard to determine the scheduling status of a poison it may be necessary to search each relevant Schedule as well as Appendices A, B and C and the Index. In this process if the poison is not found under its “approved name” it may be shown under a group term such as:
Group Example
the parent acid of salts “oxalic acid” to find sodium oxalate
the radical of a salt “chromates” to find potassium chromate
the element “arsenic” to find arsenic trioxide
a chemical group with similar “hydrocarbons, liquid” to find kerosene
toxicological or pharmacological
activity
a pharmacological group “anabolic steroidal agents” to find
“androsterone”
Part 4 – The Schedules
Schedule 2 – New Entries
PYRETHRINS, naturally occurring, being pyrethrolone, cinerolone or jasmolone esters of chrysanthemic or pyrethric acids, for human therapeutic use in preparations containing more than 10 per cent of such substances.
Schedule 2 – Amendments
BENZYDAMINE – amend entry to read:
BENZYDAMINE in preparations for topical use, except in preparations for dermal use.
BROMPHENIRAMINE – amend entry to read:
BROMPHENIRAMINE when combined with one or more other therapeutically active substances in oral preparations when:
(a) at least one of the other therapeutically active substances is a sympathomimetic decongestant; or
(b) in a day-night pack containing brompheniramine in the bed-time dose where the day and night doses are in the same immediate container or immediate wrapper,
except in preparations for the treatment of children under 2 years of age.
CHLORPHENIRAMINE – amend entry to read:
CHLORPHENIRAMINE when combined with one or more other therapeutically active substances in oral preparations when:
(a) at least one of the other therapeutically active substances is a sympathomimetic decongestant; or
(b) in a day-night pack containing chlorpheniramine in the bed-time dose where the day and night doses are in the same immediate container or immediate wrapper,
except in preparations for the treatment of children under 2 years of age.
DEXCHLORPHENIRAMINE – amend entry to read:
DEXCHLORPHENIRAMINE when combined with one or more other therapeutically active substances in oral preparations when:
(a) at least one of the other therapeutically active substances is a sympathomimetic decongestant; or
(b) in a day-night pack containing dexchlorpheniramine in the bed-time dose where the day and night doses are in the same immediate container or immediate wrapper,
except in preparations for the treatment of children under 2 years of age.
DIPHENHYDRAMINE – amend entry to read:
DIPHENHYDRAMINE in oral preparations:
(a) in a primary pack containing ten dosage units or less, for the prevention or treatment of motion sickness; or
(b) when combined with one or more other therapeutically active substances when:
(i) at least one of the other therapeutically active substances is a sympathomimetic decongestant; or
(ii) in a day-night pack containing diphenhydramine in the bed-time dose where the day and night doses are in the same immediate container or immediate wrapper,
except in preparations for the treatment of children under 2 years of age.
DOXYLAMINE – amend entry to read:
DOXYLAMINE when combined with one or more other therapeutically active substances in oral preparations when:
(a) at least one of the other therapeutically active substances is a sympathomimetic decongestant; or
(b) in a day-night pack containing doxylamine in the bed-time dose where the day and night doses are in the same immediate container or immediate wrapper,
except in preparations for the treatment of children under 2 years of age.
(The following entry for hydrocortisone and hydrocortisone acetate was varied at the June 2007 meeting)
HYDROCORTISONE AND HYDROCORTISONE ACETATE – amend entry to read:
HYDROCORTISONE and HYDROCORTISONE ACETATE, but excluding other salts and derivatives, in preparations for human dermal use containing 0.5 per cent or less of hydrocortisone in packs containing 30 g or less of such preparations containing:
(a) no other therapeutically active substance; or
(b) an antifungal as the only other therapeutically active substance.
PHENIRAMINE – amend entry to read:
PHENIRAMINE:
(a) in eye drops; or
(b) when combined with one or more other therapeutically active substances in oral preparations when:
(i) at least one of the other therapeutically active substances is a sympathomimetic decongestant; or
(ii) in a day-night pack containing pheniramine in the bed-time dose where the day and night doses are in the same immediate container or immediate wrapper,
except in preparations for the treatment of children under 2 years of age.
PROMETHAZINE – amend entries to read:
PROMETHAZINE in oral preparations:
(a) in a primary pack containing ten dosage units or less, for the prevention or treatment of motion sickness; or
(b) when combined with one or more other therapeutically active substances when:
(i) at least one of the other therapeutically active substances is a sympathomimetic decongestant; or
(ii) in a day-night pack containing promethazine in the bed-time dose where the day and night doses are in the same immediate container or immediate wrapper,
except in preparations for the treatment of children under 2 years of age.
PYRITHIONE ZINC – amend entry to read:
PYRITHIONE ZINC for human therapeutic use, except in preparations for the treatment of the scalp containing 2 per cent or less of pyrithione zinc when compliant with the requirements of the Required Advisory Statements for Medicine Labels.
(The following entry for ranitidine was varied at the June 2007 meeting)
RANITIDINE – amend entry to read:
RANITIDINE in preparations supplied in the manufacturer’s original pack containing not more than 14 days supply except in divided preparations for oral use containing 150mg or less of ranitidine per dosage unit in the manufacturer’s original pack containing not more than 14 dosage units.
SELENIUM – amend entry to read:
SELENIUM in preparations for human therapeutic use except:
(a) for topical use containing 3.5 per cent or less of selenium sulfide;
(b) when included in Schedule 4; or
(c) for oral use with a recommended daily dose of 150 micrograms or less.
TRIMEPRAZINE – amend entry to read:
TRIMEPRAZINE when combined with one or more other therapeutically active substances in solid oral preparations when:
(a) at least one of the other therapeutically active substances is a sympathomimetic decongestant; or
(b) in a day-night pack containing trimeprazine in the bed-time dose where the day and night doses are in the same immediate container or immediate wrapper,
except in preparations for the treatment of children under 2 years of age.
TRIPROLIDINE – amend entry to read:
TRIPROLIDINE when combined with one or more other therapeutically active substances in oral preparations when:
(a) at least one of the other therapeutically active substances is a sympathomimetic decongestant; or
(b) in a day-night pack containing triprolidine in the bed-time dose where the day and night doses are in the same immediate container or immediate wrapper,
except in preparations for the treatment of children under 2 years of age.
Schedule 3 – Amendments
(The following entry for hydrocortisone and hydrocortisone acetate was varied at the June 2007 meeting)
HYDROCORTISONE AND HYDROCORTISONE ACETATE – amend entry to read:
HYDROCORTISONE and HYDROCORTISONE ACETATE, but excluding other salts and derivatives, in preparations containing 1 per cent or less of hydrocortisone:
(a) for human dermal use, in packs containing 30 g or less of such preparations; and
(i) containing no other therapeutically active substance; or
(ii) containing an antifungal but no other therapeutically active substance; or
(b) for human rectal use, when combined with a local anaesthetic but no other therapeutically active substance except unscheduled astringents:
(i) in undivided preparations, in packs of 35 grams or less; or
(ii) in packs containing 12 or less suppositories,
except when included in Schedule 2.
SELENIUM – Delete entry.
TRANEXAMIC ACID – Delete entry.
Schedule 4 – New Entries
ADRAFINIL.
EXENATIDE.
GHRH INJECTABLE PLASMID.
IVABRADINE.
MEPTAZINOL.
METHYL SALICYLATE in preparations for internal therapeutic use.
NATALIZUMAB.
SITAGLIPTIN.
SORAFENIB.
SUNITINIB.
TELBIVUDINE.
TRINITROPHENOL (excluding its derivatives) in preparations for human therapeutic use.
VARENICLINE.
Schedule 4 – Amendments
BENZYDAMINE – amend entry to read:
BENZYDAMINE except:
(a) when included in Schedule 2; or
(b) in preparations for dermal use.
(The following entry for hydrocortisone was varied at the June 2007 meeting)
HYDROCORTISONE – amend entry to read:
HYDROCORTISONE:
(a) for human use except when included in Schedule 2 or 3; or
(b) for the treatment of animals.
NICOTINE – amend entry to read:
NICOTINE in preparations for human therapeutic use except:
(a) when included in Schedule 2; or
(b) for use as an aid in withdrawal from tobacco smoking in chewing gum, lozenges, or preparations for sublingual or transdermal use.
PARACETAMOL – amend entry to read:
PARACETAMOL:
(a) when combined with aspirin, caffeine or salicylamide or any derivative of these substances except when separately specified in these Schedules;
(b) in slow release tablets or capsules containing more than 665 mg of paracetamol;
(c) in non-slow release tablets or capsules containing more than 500 mg of paracetamol; or
(d) in individually wrapped powders or sachets of granules each containing more than 1000 mg of paracetamol.
PROTIRELIN – amend entry to read:
PROTIRELIN.
(The following entry for ranitidine was varied at the June 2007 meeting)
RANITIDINE – amend entry to read:
RANITIDINE except:
(a) when included in Schedule 2; or
(b) in divided preparations for oral use containing 150mg or less of ranitidine per dosage unit when supplied in the manufacturer’s original pack containing not more than 14 dosage units.
(The following entry for selenium was varied at the June 2007 meeting)
SELENIUM – amend entry to read:
SELENIUM:
(a) for human oral use with a recommended daily dose of more than 300 micrograms; or
(b) for the treatment of animals except:
(i) when included in Schedule 6 or 7;
(ii) in solid, slow release bolus preparations each weighing 100 g or more and containing 300 mg or less of selenium per dosage unit;
(iii) in other divided preparations containing 30 micrograms or less of selenium per dosage unit;
(iv) as elemental selenium, in pellets containing 100 g/kg or less of selenium; or
(v) in feeds containing 1 g/tonne or less of selenium.
TRANEXAMIC ACID – amend entry to read:
TRANEXAMIC ACID.
(The following entry for vitamin A was varied at the June 2007 Meeting)
VITAMIN A – amend entry to read:
VITAMIN A for human therapeutic or cosmetic use except:
(a) in preparations for topical use containing 1 per cent or less of vitamin A;
(b) in preparations for internal use containing 3000 micrograms retinol equivalents or less of vitamin A per daily dose; or
(c) in preparations for parenteral nutrition replacement.
Schedule 5 – New Entry
DIMETHICODIETHYLBENZALMALONATE except when included in preparations containing 10 per cent or less of dimethicodiethylbenzalmalonate.
Schedule 5 – Amendments
BETACYFLUTHRIN – amend entry to read:
BETACYFLUTHRIN:
(a) in aqueous preparations containing 2.5 per cent or less of betacyfluthrin; or
(b) in solid preparations containing 8 per cent or less of betacyfluthrin in a plastic matrix.
METHYL SALICYLATE – amend entry to read:
METHYL SALICYLATE in preparations containing 25 per cent or less of methyl salicylate except:
(a) in preparations for therapeutic use; or
(b) in preparations containing 5 per cent or less of methyl salicylate.
PYRETHRINS – amend entry to read:
PYRETHRINS, naturally occurring, being pyrethrolone, cinerolone or jasmolone esters of chrysanthemic or pyrethric acids except:
(a) in preparations for human therapeutic use; or
(b) in preparations containing 10 per cent or less of such substances.
Schedule 6 – New Entries
† 5,6-DIHYDROXYINDOLINE.
† METHYL METHACRYLATE (excluding its derivatives) except in preparations containing 1 per cent or less of methyl methacrylate as residual monomer in a polymer.
TRINITROPHENOL (excluding its derivatives) except:
(a) in preparations for human therapeutic use; or
(b) in preparations containing 5 per cent or less of trinitrophenol.
Schedule 6 – Amendments
BIFENTHRIN – amend entry to read:
BIFENTHRIN in preparations containing 25 per cent or less of bifenthrin except in preparations containing 0.5 per cent or less of bifenthrin.
METHYL SALICYLATE – amend entry to read:
METHYL SALICYLATE except:
(a) when included in Schedule 5;
(b) in preparations for therapeutic use; or
(c) in preparations containing 5 per cent or less of methyl salicylate.
PYRITHIONE ZINC – amend entry to read:
PYRITHIONE ZINC except:
(a) when included in Schedule 2;
(b) in preparations for the treatment of the scalp containing 2 per cent or less of pyrithione zinc when compliant with the
requirements of the Required Advisory Statements for Medicine Labels; or
(c) when immobilised in solid preparations containing 0.5 per cent or less of pyrithione zinc.
Schedule 7 – New Entry
SULFENTRAZONE.
Schedule 7 – Amendment
NICOTINE – amend entry to read:
NICOTINE except:
(a) when included in Schedule 6;
(b) in preparations for human therapeutic use; or
(c) in tobacco prepared and packed for smoking.
PART 5 – appendices
Appendix C – New Entry
BASIC ORANGE 31 (2-[(4-aminophenyl)azo]-1,3-dimethyl-1H-imidazolium chloride) in preparations for skin colouration and dyeing of eyelashes or eyebrows.
5,6-DIHYDROXYINDOLINE for cosmetic use in preparations containing more than 2 per cent of 5,6-dihydroxyindoline.
Appendix E – Part 2 – New Entry
POISON STANDARD STATEMENTS
5,6-Dihydroxyindoline....................E1
Appendix E – Part 2 – Amendment
Hydroquinone – amend entry to ready:
POISON STANDARD STATEMENTS
Hydroquinone
when included in Schedule 2................A
when included in Schedule 4 or 6.............A,G2,G3,S1,E2,R2
NICOTINIC ACID for human therapeutic use in divided preparations containing 250 mg or less of nicotinic acid per dosage unit except:
(a) in preparations containing 100 mg or less of nicotinic acid per dosage unit; or
(b) nicotinamide.
Schedule 4 – Amendments
DROTECOGIN – amend entry to read:
DROTRECOGIN.
METHYLANDROSTANOLONE – amend entry to read:
# METHYLANDROSTANOLONE.
ORGANOPHOSPHORUS COMPOUNDS – amend entry to read:
ORGANOPHOSPHORUS COMPOUNDS with anticholinesterase activity for human therapeutic use except:
(a) when separately specified in these Schedules; or
(b) in preparations containing 2 per cent or less of malathion for external use.
Schedule 5 – Amendments
INDOXACARB – amend entry to read:
INDOXACARB (Includes the R and S enantiomers) in preparations containing 1 per cent or less of indoxacarb.
MALDISON – amend entry to read:
MALATHION in preparations containing 10 per cent or less of malathion except:
(a) for human therapeutic use; or
(b) in dust preparations containing 2 per cent or less of malathion.
Schedule 6 – Amendments
(The following Basic Orange 31 editorial amendment was a decision of the February 2007 meeting but was deferred for incorporation into SUSDP 22 Amendment 1 to come into effect on 1 September 2007)
BASIC ORANGE 31 – amend entry to read:
† BASIC ORANGE 31 (2-[(4-aminophenyl)azo]-1,3-dimethyl-1H-imidazolium chloride) except in hair dye preparations containing 1 per cent or less of Basic Orange 31 when the immediate container and primary pack are labelled with the following statements:
KEEP OUT OF REACH OF CHILDREN;
If in eyes wash out immediately with water; and
WARNING - This product contains ingredients which may cause skin irritation to certain individuals. A preliminary test according to the accompanying directions should be made before use. This product must not be used for dyeing eyelashes or eyebrows; to do so may be injurious to the eye.
written in letters not less than 1.5 mm in height.
MALDISON – amend entry to read:
MALATHION except:
(a) when included in Schedule 5;
(b) for human therapeutic use; or
(c) in dust preparations containing 2 per cent or less of malathion.
Appendix H – Amendment
Nicotine – Delete entry.
Part b – Effective Date 1 October 2007
Amendments to the Standard for the Uniform Scheduling of Drugs and Poisons
The National Drugs and Poisons Schedule Committee directs that the amendment below be applied to the Standard for the Uniform Scheduling of Drugs and Poisons No. 22 and recommends that these amendments be adopted by the States and Territories with effect from 1 October 2007. The following amended entry for orlistat arose from a decision made by the Committee at its February 2007 meeting, originally with an effective date of 1 September 2007. The June 2007 meeting confirmed the February 2007 decision but agreed to vary the implementation date to 1 October 2007.
Appendix H – Amendment
Orlistat – Delete entry.
Part C – Effective Date 1 January 2008
Amendments to the Standard for the Uniform Scheduling of Drugs and Poisons
The National Drugs and Poisons Schedule Committee directs that the amendments below be applied to the Standard for the Uniform Scheduling of Drugs and Poisons No.22 and recommends that these amendments be adopted by the States and Territories with effect from 1 January 2008 unless otherwise stated. The amendments arise from decisions made by the Committee at its June 2007 meeting and confirmed at the October 2007 meeting except where separately specified.
Principles of Scheduling
READING THE SCHEDULES – amend section to read:
Schedule entries have been designed to be as simple as possible while retaining readability, legal integrity and as much freedom from ambiguity and contradiction as possible. As a result they are expressed in a number of ways, though this number has been kept to a minimum. It is necessary to keep this variety of expression in mind when searching or interpreting Schedule entries.
Firstly, poisons are now scheduled individually using their approved names wherever practicable although exceptions are necessary in some cases. Some of those are mentioned overleaf. Older group entries are being revised and replaced by individual entries as time permits although in some of these cases a group term has also been retained to deal with any members of the group or class that may have escaped attention but should be scheduled.
Secondly, schedule entries have been expressed in either positive or negative terms and care must be taken to distinguish between the two different forms of expression. Thus, selenium is in Schedule 6 only when one of the clauses in this schedule entry applies, while fluorides are in Schedule 6 unless one of the exempting clauses applies.
Where exceptions are included in an entry these have been emphasised by printing the word “except” in bold type.
Where the schedule entries for a poison make a specific exclusion or exemption, the requirements of this Standard do not apply to that poison within the constraints of that exclusion or exemption although controls under other legislation such as pesticide registration may apply.
Where a schedule entry for a poison requires a specific statement to be included on a label as a condition for a product to qualify for an exemption ('reverse scheduling'), then in cases where it is impracticable for a supplier to use the exact wording of such a statement, its wording may be varied provided that the full intent and meaning of the statement is not changed.
Where a poison has been included in more than one Schedule the principal entry, where practicable, has been included in the most restrictive Schedule with references to the other Schedule(s) involved.
It is important to remember that a Schedule entry includes preparations containing the poison in any concentration and all salts and derivatives of the poison unless it specifically states otherwise. (See Interpretation PART 1 [paragraph 1(2)]).
It is important to note that a substance is not classed as a derivative on the basis of a single, prescriptive set of criteria. Classification of a substance as a derivative of a Scheduled poison relies on a balanced consideration of factors to decide if a substance has a similar nature (e.g. structurally, pharmacologically, toxicologically) to a Scheduled poison or is readily converted (either physically or chemically) to a Scheduled poison. However, a substance is only considered a derivative of a Scheduled poison if it is not individually listed elsewhere in the Schedules, or captured by a more restrictive group or class entry. Additionally, some entries specifically exclude derivatives. Once a substance is determined to be a derivative of a Scheduled poison, the same scheduling requirements as the Scheduled poison, including limits on access, supply and availability, will apply.
Finally, when using the Standard to determine the scheduling status of a poison it may be necessary to search each relevant Schedule as well as Appendices A, B and C and the Index. In this process if the poison is not found under its “approved name” it may be shown under a group term such as:
Group Example
the parent acid of salts “oxalic acid” to find sodium oxalate
the radical of a salt “chromates” to find potassium chromate
the element “arsenic” to find arsenic trioxide
a chemical group with similar “hydrocarbons, liquid” to find kerosene
toxicological or pharmacological
activity
a pharmacological group “anabolic steroidal agents” to find
“androsterone”
Part 1 – Interpretation
Paragraph 1.(3) – amend section to read:
(3) Unless the contrary intention appears where a concentration, strength or quantity is specified in a schedule or an appendix to this Standard in respect of a substance:
(a) if the substance is present as a salt, active principle or derivative (including an ester or ether), the concentration, strength or quantity is calculated as the equivalent amount of the substance that is listed in the Schedule or Appendix; and
(b) the expression “one per cent” means:
(i) in the case of a liquid preparation, 1 gram of the substance per 100 millilitres of the preparation; or
(ii) in the case of a solid, semi-solid or pressurised spray aerosol preparation, 1 gram of the substance per 100 grams of the preparation; and
(iii) any expression of greater or lesser percentages shall have a corresponding meaning; and
(c) in the case of codeine such concentration, strength or quantity is calculated as anhydrous codeine.
Part 4 – The Schedules
Schedule 2 – New Entries
PROPAMIDINE for ophthalmic use.
DIBROMOPROPAMIDINE for ophthalmic use.
Schedule 2 – Amendment
(The following entry for paracetamol was varied at the October 2007 meeting)
PARACETAMOL – amend entry to read:
PARACETAMOL for therapeutic use except:
(a) when included in Schedule 4;
(b) in individually wrapped powders or sachets of granules each containing 1000 mg or less of paracetamol as the only therapeutically active constituent (other than phenylephrine or when combined with effervescent agents) when:
(i) enclosed in a primary pack that contains not more than 12 such powders or sachets of granules;
(ii) compliant with the requirements of the Required Advisory Statements for Medicine Labels;
(iii) not labelled for the treatment of children 6 years of age or less; and
(iv) not labelled for the treatment of children under 12 years of age when combined with phenylephrine; or
(c) in tablets or capsules each containing 500 mg or less of paracetamol as the only therapeutically active constituent (other than phenylephrine or when combined with effervescent agents) when:
(i) packed in blister or strip packaging or in a container with a child-resistant closure;
(ii) in a primary pack containing not more than 25 tablets or capsules;
(iii) compliant with the requirements of the Required Advisory Statements for Medicine Labels;
(iv) not labelled for the treatment of children 6 years of age or less; and
(v) not labelled for the treatment of children under 12 years of age when combined with phenylephrine.
Schedule 3 – Amendments
(The following entry for promethazine was varied at the October 2007 meeting)
PROMETHAZINE – amend entry to read:
PROMETHAZINE in oral preparations except:
(a) when included in Schedule 2; or
(b) in preparations for the treatment of children under 2 years of age.
(The following entry for trimeprazine was varied at the October 2007 meeting)
TRIMEPRAZINE – amend entry to read:
TRIMEPRAZINE:
(a) in solid oral preparations except when included in Schedule 2; or
(b) in liquid oral preparations containing 10 mg or less of trimeprazine per 5 mL,
except in preparations for the treatment of children under 2 years of age.
Schedule 4 – New Entries
ABATACEPT.
ALISKIREN.
DARUNAVIR.
DASATINIB.
(The following entry for dibromopropamidine was varied at the October 2007 meeting)
DIBROMOPROPAMIDINE for therapeutic use except when included in Schedule 2.
FOSAPREPITANT.
GALSULFASE.
LAPATINIB.
NEPAFENAC.
NILOTINIB.
PALIPERIDONE.
PARICALCITOL.
(The following entry for propamidine was varied at the October 2007 meeting)
PROPAMIDINE for therapeutic use except when included in Schedule 2.
RANIBIZUMAB.
RIMEXOLONE.
RIMONABANT.
RUBOXISTAURIN.
# SITAXENTAN.
TRILOSTANE.
VILDAGLIPTIN.
Schedule 4 – Amendments
LANTHANUM – amend entry to read:
LANTHANUM for therapeutic use.
MERCURIC OXIDE – delete entry.
PARACETAMOL – amend entry to read:
PARACETAMOL:
(a) when combined with aspirin or salicylamide or any derivative of these substances except when separately specified in these Schedules;
(b) in tablets or capsules containing more than 665 mg of paracetamol; or
(c) in individually wrapped powders or sachets of granules each containing more than 1000 mg of paracetamol.
POTASSIUM CHLORIDE – amend entry to read:
POTASSIUM CHLORIDE in oral preparations for human therapeutic use except:
(a) when containing less than 550 mg of potassium chloride per dosage unit;
(b) in preparations for oral rehydration therapy;
(c) in preparations for oral use for bowel cleansing prior to diagnostic medical and surgical procedures; or
(d) in preparations for enteral feeding.
Schedule 5 – New Entries
CLOTHIANIDIN in preparations containing 20 per cent or less of clothianidin.
PYRASULFOTOLE.
Schedule 5 – Amendment
HYDROCARBONS, LIQUID – amend entry to read:
HYDROCARBONS, LIQUID, including kerosene, diesel (distillate), mineral turpentine, white petroleum spirit, toluene, xylene and light mineral and paraffin oils (but excluding their derivatives), except:
(a) toluene and xylene when included in Schedule 6;
(b) benzene and liquid aromatic hydrocarbons when included in Schedule 7;
(c) food grade and pharmaceutical grade white mineral oils;
(d) in solid or semi-solid preparations;
(e) in preparations containing 25 per cent or less of designated solvents;
(f) in preparations packed in pressurised spray packs;
(g) in adhesives packed in containers each containing 50 grams or less of adhesive;
(h) in writing correction fluids and thinners for writing correction fluids packed in containers having a capacity of 20 mL or less; or
(i) in other preparations when packed in containers with a capacity of 2 mL or less.
Schedule 6 – New Entry
PYRIPROLE.
Schedule 6 – Amendment
CLOTHIANIDIN – amend entry to read:
CLOTHIANIDIN except when included in Schedule 5.
PART 5 – appendices
Appendix A – New Entry
DEXTRANS, GELATIN - SUCCINYLATED & ETHERIFIED STARCHES used as plasma substitutes/ blood volume expanders.
Appendix B – Amendments
DIBROMPROPAMIDINE – delete entry.
PROPAMIDINE – delete entry.
Appendix D, Part 6 – New Entry
SITAXENTAN for human use.
Appendix K – New Entry
Paliperidone
Editorial Amendments and Errata
Schedule 2 – Amendment
HYDROCORTISONE AND HYDROCORTISONE ACETATE – amend entry to read:
HYDROCORTISONE and HYDROCORTISONE ACETATE, but excluding other salts and derivatives, in preparations for human therapeutic use containing 0.5 per cent or less of hydrocortisone:
(a) for dermal use, in packs containing 30 g or less of such preparations, containing no other therapeutically active constituent other than an antifungal substance; or
(b) for rectal use when combined with a local anaesthetic substance but no other therapeutically active constituent except unscheduled astringents:
(i) in undivided preparations in packs of 35 g or less; or
(ii) in packs containing 12 or less suppositories.
Schedule 3 – Amendment
HYDROCORTISONE AND HYDROCORTISONE ACETATE – amend entry to read:
HYDROCORTISONE and HYDROCORTISONE ACETATE, but excluding other salts and derivatives, in preparations for human therapeutic use containing 1 per cent or less of hydrocortisone:
(a) for dermal use, in packs containing 30 g or less of such preparations, containing no other therapeutically active constituent other than an antifungal substance; or
(b) for rectal use when combined with a local anaesthetic substance but no other therapeutically active constituent except unscheduled astringents:
(i) in undivided preparations, in packs of 35 g or less; or
(ii) in packs containing 12 or less suppositories,
except when included in Schedule 2.
Schedule 4 – Amendment
DIENOESTROL – amend entry to read:
DIENESTROL.
Schedule 5 – Amendment
LEVAMISOLE – amend entry to read:
LEVAMISOLE in preparations containing 15 per cent or less of levamisole for the treatment of animals except:
(a) when included in Schedule 4; or
(b) in preparations for the treatment of ornamental birds or ornamental fish, in packs containing 10 mg or less of levamisole.
Amendments to the Standard for the Uniform Scheduling of Drugs and Poisons
The National Drugs and Poisons Schedule Committee directs that the amendment below be applied to the Standard for the Uniform Scheduling of Drugs and Poisons No. 23 and recommends that these amendments be adopted by the States and Territories with effect from 1 January 2009. The following amended entry for Part 2, Paragraph 8.(2) arose from a decision made by the Committee at its June 2007 meeting.
Part 2 – Labels and Containers
Paragraph 8.(2) – amend section to read:
(2) if the poison is for a purpose or purposes other than human therapeutic use and:
(a) if the poison is in a pressurised spray aerosol preparation, as the mass of the poison per stated mass of the preparation;
(b) if the poison is a liquid in a liquid preparation, as the mass or volume of the poison per stated volume of the preparation;
(c) if the poison is a liquid in a solid or semi-solid preparation, as the mass or volume of the poison per stated mass of the preparation;
(d) if the poison is a solid or semi-solid in a liquid preparation, as the mass of the poison per stated volume of the preparation;
(e) if the poison is a solid or semi-solid in a solid or semi-solid preparation, as the mass of the poison per stated mass of the preparation;
(f) if the poison is a gas in a liquid preparation, as the mass of the poison per stated volume of the preparation;
(g) if the poison is a gas in a solid or semi-solid preparation, as the mass of the poison per stated mass of the preparation;
(h) if the poison is a gas in a gaseous preparation, as the mass of the poison per stated mass of the preparation;