Therapeutic Goods (Serious Scarcity and Substitutable Medicine) (Cefalexin) Instrument 2023
made under section 30EK of the
Therapeutic Goods Act 1989
Compilation No. 1
Compilation date: 31 October 2023
Includes amendments up to: F2023L01407
About this compilation
This compilation
This is a compilation of the Therapeutic Goods (Serious Scarcity and Substitutable Medicine) (Cefalexin) Instrument 2023 that shows the text of the law as amended and in force on 31 October 2023 (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 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 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.
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 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If a provision of the compiled law has been repealed in accordance with a provision of the law, details are included in the endnotes.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
3 Authority
4 Definitions
5 Declaration of a serious scarcity
6 Substitution of scarce medicine by pharmacists
7 Period instrument in force
8 Repeals
Schedule 1—Scarce medicine, substitutable medicine, dose unit equivalence and specific permitted circumstances
Schedule 2—General permitted circumstances
Endnotes
Endnote 1—About the endnotes
Endnote 2—Abbreviation key
Endnote 3—Legislation history
Endnote 4—Amendment history
1 Name
This instrument is the Therapeutic Goods (Serious Scarcity and Substitutable Medicine) (Cefalexin) Instrument 2023.
3 Authority
This instrument is made under section 30EK of the Therapeutic Goods Act 1989.
4 Definitions
Note: A number of expressions used in this instrument are defined in subsection 3(1) of the Act, including the following:
(a) medicine;
(b) Register;
(c) registered goods.
In this instrument:
Act means the Therapeutic Goods Act 1989.
capsule has the same meaning as in TGO 101.
pharmacist has the same meaning as in subsection 30EK(6) of the Act.
prescriber means the person who:
(a) is authorised under a law of a State or Territory to prescribe medicine; and
(b) prescribed the scarce medicine for the patient.
registered medicine means a medicine that is included in the part of the Register for goods known as registered goods.
scarce medicine has the meaning given by section 5.
substitutable medicine has the meaning given by section 6.
TGO 101 means the Therapeutic Goods (Standard for Tablets, Capsules and Pills) (TGO 101) Order 2019.
Note: TGO 101 is a legislative instrument published on the Federal Register of Legislation at www.legislation.gov.au.
5 Declaration of a serious scarcity
For paragraph 30EK(1)(a) of the Act, a serious scarcity of the medicine specified in column 2 of each item in the table in Schedule 1 (the scarce medicine) across the whole of Australia is declared.
6 Substitution of scarce medicine by pharmacists
For paragraph 30EK(1)(b) of the Act, in relation to each item mentioned in the table in Schedule 1, each medicine specified in column 3 (the substitutable medicine) is permitted to be dispensed by a pharmacist in substitution for the scarce medicine specified in column 2, in the circumstances specified in:
(a) column 5 of that item (the specific permitted circumstances); and
(b) the table in Schedule 2 (the general permitted circumstances).
Note: Substitution is only permitted where both the specific permitted circumstances and the general permitted circumstances exist.
7 Period instrument in force
This instrument remains in force until 30 April 2024.
8 Repeals
Unless repealed earlier, this instrument is repealed at the start of 1 May 2024.
Schedule 1—Scarce medicine, substitutable medicine, dose unit equivalence and specific permitted circumstances
Note: See sections 5 and 6.
Scarce medicine, substitutable medicine, dose unit equivalence and specific permitted circumstances |
Column 1 | Column 2 | Column 3 | Column 4 | Column 5 |
Item | Scarce medicine | Substitutable medicine | Dose unit equivalence | Specific permitted circumstances |
1 | a registered medicine that: (a) contains cefalexin 125 mg/5 mL in a 100 mL oral liquid or suspension; and (b) is manufactured in the dosage form of a powder for oral liquid or suspension, as relevant | a medicine that: (a) contains cefalexin 250 mg/5 mL in a 100 mL oral liquid or suspension; and (b) is manufactured in the dosage form of a powder for oral liquid or suspension, as relevant | 250 mg of cefalexin is equivalent to 5 mL of the substitutable medicine | the pharmacist has: (a) advised the patient, or person acting on behalf of the patient, of the number of dose units in millilitres of substitutable medicine that must be taken by the patient in substitution for the prescribed dose of scarce medicine, based on the dose unit equivalence specified in column 4; and (b) ensured that the correct dose of substitutable medicine is written in millilitres on the dispensing label; and (c) if multiple bottles of substitutable medicine are dispensed—ensured that the patient’s treatment course will be completed prior to the expiry of each bottle; and (d) ensured the patient, or person acting on behalf of the patient, has access to information to support them in administering the substitutable medicine |
2 | a registered medicine that: (a) contains cefalexin 125 mg/5 mL in a 100 mL oral liquid or suspension; and (b) is manufactured in the dosage form of a powder for oral liquid or suspension, as relevant | a medicine that: (a) contains 250 mg cefalexin; and (b) is manufactured in the dosage form of a capsule | 250 mg of cefalexin is equivalent to one capsule of the substitutable medicine | the pharmacist has: (a) ensured that the patient can take the substitutable medicine in a capsule dosage form; and (b) only substituted the substitutable medicine for the scarce medicine where the prescribed dose of scarce medicine is divisible by 250 mg; and (c) advised the patient, or person acting on behalf of the patient, of the number of dose units of substitutable medicine that must be taken by the patient in substitution for the prescribed dose of scarce medicine, based on the dose unit equivalence specified in column 4; and (d) ensured that the correct number of dose units of substitutable medicine that must be taken by the patient in substitution for the prescribed dose of scarce medicine is written on the dispensing label; and (e) ensured that the patient, or person acting on behalf of the patient, has access to information to support them in administering the substitutable medicine |
3 | a registered medicine that: (a) contains cefalexin 250 mg/5 mL in a 100 mL oral liquid or suspension; and (b) is manufactured in the dosage form of a powder for oral liquid or suspension, as relevant | a medicine that: (a) contains cefalexin 125 mg/5 mL in a 100 mL oral liquid or suspension; and (b) is manufactured in the dosage form of a powder for oral liquid or suspension, as relevant | 250 mg of cefalexin is equivalent to 10 mL of the substitutable medicine | the pharmacist has: (a) advised the patient, or person acting on behalf of the patient, of the number of dose units in millilitres of substitutable medicine that must be taken by the patient in substitution for the prescribed dose of scarce medicine, based on the dose unit equivalence specified in column 4; and (b) ensured that the correct dose of substitutable medicine is written in millilitres on the dispensing label; and (c) if multiple bottles of substitutable medicine are dispensed—ensured that the patient’s treatment course will be completed prior to the expiry of each bottle; and (d) ensured the patient, or person acting on behalf of the patient, has access to information to support them in administering the substitutable medicine |
4 | a registered medicine that: (a) contains cefalexin 250 mg/5 mL in a 100 mL oral liquid or suspension; and (b) is manufactured in the dosage form of a powder for oral liquid or suspension, as relevant | a medicine that: (a) contains 250 mg cefalexin; and (b) is manufactured in the dosage form of a capsule | 250 mg of cefalexin is equivalent to one capsule of the substitutable medicine | the pharmacist has: (a) ensured that the patient can take the substitutable medicine in a capsule dosage form; and (b) only substituted the substitutable medicine for the scarce medicine where the prescribed dose of scarce medicine is divisible by 250 mg; and (c) advised the patient, or person acting on behalf of the patient, of the number of dose units of substitutable medicine that must be taken by the patient in substitution for the prescribed dose of scarce medicine, based on the dose unit equivalence specified in column 4; and (d) ensured that the correct number of dose units of substitutable medicine that must be taken by the patient in substitution for the prescribed dose of scarce medicine is written on the dispensing label; and (e) ensured that the patient, or person acting on behalf of the patient, has access to information to support them in administering the substitutable medicine |
Schedule 2—General permitted circumstances
Note: See section 6.
General permitted circumstances |
Column 1 | Column 2 |
Item | Circumstances |
1 | the patient, or person acting on behalf of the patient, has evidence of a valid prescription for the scarce medicine, unless otherwise permitted by law |
2 | the pharmacist does not have access to the scarce medicine |
3 | the prescriber has not indicated on the prescription for the scarce medicine that substitution is not permitted |
4 | the pharmacist has exercised professional judgement and determined that the patient is suitable to receive the substitutable medicine |
5 | the amount of substitutable medicine dispensed would result in the patient receiving sufficient medicine to ensure an equivalent dosage regimen and duration to that prescribed in relation to the scarce medicine |
6 | the patient, or person acting on behalf of the patient, has consented to receiving the substitutable medicine |
7 | the pharmacist makes a record of dispensing the substitutable medicine in substitution of the scarce medicine at the time of dispensing |
8 | the pharmacist has an established procedure to notify the prescriber of the substitution at the time of, or as soon as practical after, dispensing the substitutable medicine |
Endnotes
Endnote 1—About the endnotes
The endnotes provide information about this compilation and the compiled law.
The following endnotes are included in every compilation:
Endnote 1—About the endnotes
Endnote 2—Abbreviation key
Endnote 3—Legislation history
Endnote 4—Amendment history
Abbreviation key—Endnote 2
The abbreviation key 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 (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.
The 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.
Misdescribed amendments
A 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.
If a misdescribed amendment cannot be given effect as intended, the amendment is not incorporated and “(md not incorp)” is added to the amendment history.
Endnote 2—Abbreviation key
ad = added or inserted | orig = original |
am = amended | par = paragraph(s)/subparagraph(s) |
amdt = amendment | /sub‑subparagraph(s) |
c = clause(s) | pres = present |
C[x] = Compilation No. x | prev = previous |
Ch = Chapter(s) | (prev…) = previously |
def = definition(s) | Pt = Part(s) |
Dict = Dictionary | r = regulation(s)/rule(s) |
disallowed = disallowed by Parliament | reloc = relocated |
Div = Division(s) | renum = renumbered |
exp = expires/expired or ceases/ceased to have | rep = repealed |
effect | rs = repealed and substituted |
F = Federal Register of Legislation | s = section(s)/subsection(s) |
gaz = gazette | Sch = Schedule(s) |
LA = Legislation Act 2003 | Sdiv = Subdivision(s) |
LIA = Legislative Instruments Act 2003 | SLI = Select Legislative Instrument |
(md not incorp) = misdescribed amendment | SR = Statutory Rules |
cannot be given effect | Sub‑Ch = Sub‑Chapter(s) |
mod = modified/modification | SubPt = Subpart(s) |
No. = Number(s) | underlining = whole or part not |
o = order(s) | commenced or to be commenced |
Ord = Ordinance | |
Endnote 3—Legislation history
Name | Registration | Commencement | Application, saving and transitional provisions |
Therapeutic Goods (Serious Scarcity and Substitutable Medicine) (Cefalexin) Instrument 2023 | 27 Jul 2023 (F2023L01034) | 1 Aug 2023 | — |
Therapeutic Goods (Serious Scarcity and Substitutable Medicine) (Cefalexin) Amendment Instrument 2023 | 26 Oct 2023 (F2023L01407) | 31 Oct 2023 | — |
Endnote 4—Amendment history
Provision affected | How affected |
s 2……………………………… | rep LA s 48D |
s 7……………………………… | rs F2023L01407 |
s 8……………………………… | rs F2023L01407 |