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TGO 101 Orders/Other as amended, taking into account amendments up to Therapeutic Goods (Standard for Tablets, Capsules and Pills) Amendment Order 2020
Administered by: Health
Registered 07 Dec 2020
Start Date 28 Nov 2020

Commonwealth Coat of Arms of Australia

 

Therapeutic Goods (Standard for Tablets, Capsules and Pills) (TGO 101) Order 2019

made under section 10 of the

Therapeutic Goods Act 1989

Compilation No. 1

Compilation date:                          28 November 2020

Includes amendments up to:         F2020L01502

 


About this compilation

This compilation

This is a compilation of the Therapeutic Goods (Standard for Tablets, Capsules and Pills) (TGO 101) Order 2019 that shows the text of the law as amended and in force on 28 November 2020 (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 Legislation 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 series page on the Legislation 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 series page on the Legislation 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If a provision of the compiled law has been repealed in accordance with a provision of the law, details are included in the endnotes.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

Part 1—Preliminary                                                                                                     1

1  Name........................................................................................................................................ 1

2  Commencement........................................................................................................................ 1

3  Authority.................................................................................................................................. 1

4  Interpretation............................................................................................................................ 1

5  Standard................................................................................................................................... 4

6  Application............................................................................................................................... 4

Part 2—Tablets and capsules                                                                                       5

Division 1¾Requirements for tablets and capsules                                               5

8  General requirements................................................................................................................ 5

Division 2¾Requirements for tablets and capsules for which there is an applicable monograph       6

9  Application of Division............................................................................................................ 6

10  Tablets or capsules containing folic acid................................................................................. 6

11  Dissolution............................................................................................................................. 6

12  Uniformity relating to dosage units and weight...................................................................... 7

Division 3¾Australian specific requirements                                                        8

13  Application of Division.......................................................................................................... 8

14  Assay of each active ingredient.............................................................................................. 8

15  Tablet or capsule containing folic acid.................................................................................... 9

16  Elemental impurities and residual solvents............................................................................. 9

17  Dissolution............................................................................................................................. 9

18  Disintegration....................................................................................................................... 10

19  Fineness of dispersion.......................................................................................................... 10

20  Uniformity relating to dosage units and weight.................................................................... 10

Part 3—Pills                                                                                                                 11

21  Application of Part............................................................................................................... 11

22  General requirements............................................................................................................ 11

23  Appearance........................................................................................................................... 11

24  Water content........................................................................................................................ 11

25  Weight variation................................................................................................................... 11

26  Disintegration....................................................................................................................... 11

27  Assay of each active ingredient............................................................................................ 12

28  Elemental impurities............................................................................................................. 12

Schedule 1¾Tablets, capsules and pills: assay, disintegration and uniformity     14

Schedule 2¾Tablets and capsules: assay limits for content of active ingredient or component in a tablet or capsule                                                                                              15

Schedule 3—Pills: weight variation, disintegration and elemental impurities       16

Part 1—Weight variation: dripping pills                                                                  16

Part 2—Weight variation: sugar pills                                                                        16

Part 3—Weight variation: other pills                                                                        16

Part 4—Disintegration                                                                                                17

Part 5—Sieve pore diameter                                                                                      17

Part 6—Elemental impurities                                                                                     17

Endnotes                                                                                                                      18

Endnote 1—About the endnotes                                                                            18

Endnote 2—Abbreviation key                                                                               19

Endnote 3—Legislation history                                                                            20

Endnote 4—Amendment history                                                                           21

 

 

 


Part 1—Preliminary

1  Name

             (1)  This instrument is the Therapeutic Goods (Standard for Tablets, Capsules and Pills) (TGO 101) Order 2019.

             (2)  This instrument may also be cited as TGO 101.

2  Commencement

             (1)  Each provision of this instrument specified in column 1 of the table commences, or is taken to have commenced, in accordance with column 2 of the table. Any other statement in column 2 has effect according to its terms.

 

Commencement information

Column 1

Column 2

Column 3

Provisions

Commencement

Date/Details

1. Sections 1 to 15, and anything in this instrument not elsewhere covered by this table

31 March 2019.

31 March 2019

2. Section 16

30 June 2021.

30 June 2021

3. Sections 17 to 20

31 March 2019.

31 March 2019

4. Part 3

31 March 2021.

31 March 2021

5. Schedules 1 and 2

31 March 2019.

31 March 2019

6. Schedule 3

31 March 2021.

31 March 2021

7. Schedule 4

31 March 2019.

31 March 2019

Note:          This table relates only to the provisions of this instrument as originally made. It will not be amended to deal with any later amendments of this instrument.

             (2)  Any information in column 3 of the table is not part of this instrument. Information may be inserted in this column, or information in it may be edited, in any published version of this instrument.

3  Authority

                   This instrument is made under section 10 of the Therapeutic Goods Act 1989.

4  Interpretation

Note:          A number of expressions used in this instrument are defined in subsection 3(1) of the Act, including the following:

(a)      British Pharmacopoeia;

(b)      default standard;

(c)      European Pharmacopoeia;

(d)    export only medicine;

(e)    label;

(f)    listed goods;

(g)    medicine;

(h)    registered goods;

(i)     standard;

(j)     United States Pharmacopeia-National Formulary.

             (1)  In this instrument:

Act means the Therapeutic Goods Act 1989.

active ingredient has the same meaning as in the Regulations.

applicable monograph, in relation to therapeutic goods, means a default standard specified with reference to:

                     (a)  a formulated preparation in the British Pharmacopoeia;

                     (b)  a pharmaceutical preparation in the European Pharmacopoeia; or

                     (c)  an official product in the United States Pharmacopeia-National Formulary;

whether or not those goods are labelled as conforming to that standard, and comprises:

                     (d)  a specific monograph;

                     (e)  one or more applicable general monographs; and

                      (f)  one or more applicable general chapters;

interpreted in accordance with the General Notices section of the relevant pharmacopoeia.

Note 1:       Subsection 3(1) of the Act provides that the default standard must be interpreted in accordance with the General Notices section of the relevant pharmacopoeia.

Note 2:       Subsection 13(7) of the Act specifies how to work out whether therapeutic goods conform with a default standard at a particular time.

Australian specific requirements has the meaning given by section 8.

capsule means a solid preparation with a hard or soft shell of various shapes and capacities, containing one or more active ingredients.

chewable, in relation to a tablet, means a tablet which has been formulated to be chewed rather than swallowed whole and for which the label includes a direction to chew the tablet.

dispersible, in relation to a tablet, means an uncoated or film-coated tablet intended to be dispersed in water before administration, giving a homogeneous dispersion.

effervescent, in relation to a tablet, means an uncoated tablet generally containing acid substances and carbonates or hydrogen carbonates which react rapidly in the presence of water to release carbon dioxide, and that is intended to be dissolved or dispersed in water before administration.

enzyme means a protein that acts as a catalyst for biochemical reactions.

homoeopathic preparation has the same meaning as in the Regulations.

ICH Q3D Guideline means ICH Harmonised Guideline: Guideline for Elemental Impurities Q3D, Current Step 4 version, dated 16 December 2014.

Note:          The ICH Q3D Guideline is published by the International Council of Harmonisation at: https://www.ich.org.

mineral means an inorganic material of defined composition.

mineral compound means a salt or other compound of one or more elements that has a Recommended Dietary Intake for that element in the publication Nutrient Reference Values for Australia and New Zealand Including Recommended Dietary Intakes endorsed by the National Health and Medical Research Council on 13 July 2017.

modified-release means:

                     (a)  in relation to a tablet, a coated or uncoated tablet which contains special excipients or which is prepared by special procedures, or both, designed to modify the rate, the place or the time at which the active ingredient is, or active ingredients are, released; or

                     (b)  in relation to a capsule, a hard or soft capsule in which the contents or shell, or both, contain special excipients or are prepared by special procedures designed to modify the rate, the place or the time at which the active ingredient is, or active ingredients are, released.

pill means a solid preparation in a spherical or ovoid shape, with or without a coating, which is formed from a pliable mass that retains its shape during storage, containing one or more active ingredients, and is one of the following:

                     (a)  a honeyed pill;

                     (b)  a water-honeyed pill;

                     (c)  a watered pill;

                     (d)  a pasted pill;

                     (e)  a waxed pill;

                      (f)  a concentrated pill;

                     (g)  a dripping pill; or

                     (h)  a sugar pill.

probiotic means viable, defined micro-organisms in sufficient numbers to alter the microflora (by implantation or colonisation) in a compartment of the host.

provitamin means a chemical precursor to a vitamin.

Regulations mean the Therapeutic Goods Regulations 1990.

stated content, in relation to tablets, capsules and pills, means the quantity of the active ingredient that is stated on the label to be present in each tablet, capsule or pill.

tablet means a solid preparation containing one or more active ingredients and obtained by compressing uniform volumes of particles or by another suitable manufacturing technique, such as extrusion, moulding or freeze-drying (lyophilisation).

vitamin means a naturally occurring organic substance or a synthetic equivalent, or a salt or other compound, comprising one of the following:

                     (a)  vitamin A;

                     (b)  vitamin B1;

                     (c)  vitamin B2;

                     (d)  vitamin B3;

                     (e)  vitamin B5;

                      (f)  vitamin B6;

                     (g)  vitamin B12;

                     (h)  vitamin C;

                      (i)  vitamin D;

                      (j)  vitamin E;

                     (k)  vitamin K;

                      (l)  biotin;

                    (m)  choline; or

                     (n)  folic acid.

             (2)  Where the British Pharmacopoeia, European Pharmacopoeia or United States Pharmacopeia-National Formulary adopts a different name or number for a test or method that is referenced in this instrument, this instrument incorporates that renamed or renumbered test or method.

5  Standard

                   This instrument constitutes a standard for tablets, capsules and pills.

6  Application

             (1)  Subject to subsection (2), this instrument applies to therapeutic goods that are intended for oral administration, and manufactured in the following dosage forms:

                     (a)  tablet;

                     (b)  capsule; and

                     (c)  pill.

                    Note: Part 3 and Schedule 3 of this instrument, which sets out requirements in relation to pills, commences on 31 March 2021 in accordance with section 2.

             (2)  This instrument does not apply to therapeutic goods that are:

                     (a)  a radiopharmaceutical;

                     (b)  an export only medicine;

                     (c)  exempt under section 18 or 18A of the Act;

                     (d)  the subject of an approval or authority under section 19 of the Act; or

                     (e)  the subject of an approval under section 19A of the Act.


 

Part 2—Tablets and capsules

Division 1¾Requirements for tablets and capsules

8  General requirements

             (1)  The requirements in relation to a tablet or capsule for which there is an applicable monograph are:

                     (a)  those requirements specified in that monograph, subject to the matters specified in Division 2; or

                     (b)  those requirements specified in Division 3 (the Australian specific requirements) together with the requirements relevant to the tablet or capsule that are specified in one of the following:

                              (i)  the general monographs in the European Pharmacopoeia;

                             (ii)  the general monographs in the British Pharmacopoeia;

                            (iii)  the general chapters of the United States Pharmacopeia-National Formulary.

             (2)  The requirements in relation to a tablet or capsule for which there is no applicable monograph are:

                     (a)  the Australian specific requirements; and

                     (b)  the requirements relevant to the tablet or capsule that are specified in one of the following:

                              (i)  the general monographs in the European Pharmacopoeia;

                             (ii)  the general monographs in the British Pharmacopoeia;

                            (iii)  the general chapters of the United States Pharmacopeia-National Formulary.


 

Division 2¾Requirements for tablets and capsules for which there is an applicable monograph

9  Application of Division

                   This Division applies to tablets and capsules:

                     (a)  that are registered goods or listed goods; and

                     (b)  for which there is an applicable monograph.

10  Tablets or capsules containing folic acid

             (1)  If a tablet:

                     (a)  has a stated content of 100 micrograms or more of folic acid; and

                     (b)  is not a chewable, effervescent, dispersible or modified-release tablet;

then the following requirements are specified:

                     (c)  if folic acid is the single active ingredient¾ the dissolution requirements of the Folic Acid Tablets monograph in the United States Pharmacopeia-National Formulary; or

                     (d)  if there are multiple active ingredients¾ the dissolution requirements for folic acid in chapter <2040> Disintegration and Dissolution of Dietary Supplements of the United States Pharmacopeia-National Formulary.

             (2)  If a capsule:

                     (a)  has a stated content of 100 micrograms or more of folic acid; and

                     (b)  is not a soft capsule or a modified-release capsule;

then the following requirements are specified:

                     (c)  the dissolution requirements for folic acid in chapter <2040> Disintegration and Dissolution of Dietary Supplements of the United States Pharmacopeia-National Formulary.

11  Dissolution

                   If:

(a)    a tablet or capsule is a registered good that:

(i)  does not contain folic acid; or

(ii) is not a modified-release tablet, chewable tablet, effervescent tablet, dispersible tablet or modified-release capsule; and

(b)    the applicable monograph that is applied to the tablet or capsule does not specify a test for dissolution; and

(c)    a default standard in relation to any active ingredient contained in that tablet or capsule specifies a dissolution test for the relevant dosage form;

then the dissolution test specified for the tablet or capsule is:

(d)    the dissolution test specified in the default standard mentioned in paragraph (1)(c); or

(e)    another dissolution test that is suitable for the tablet or capsule..

Note 1:       A dissolution test is specified for tablets and capsules that are registered goods or listed goods, containing folic acid: see section 10.

Note 2:       A dissolution test will always be specified in an applicable monograph for modified-release tablets and modified-release capsules.

12  Uniformity relating to dosage units and weight

                   If:

                     (a)  the tablet or capsule is a listed good; and

                     (b)  the applicable monograph specifies a test for uniformity of dosage units;

then that test may be substituted with the test for uniformity of weight (mass) specified in Schedule 1.


 

Division 3¾Australian specific requirements

13  Application of Division

This Division applies to tablets and capsules that are registered goods or listed goods.

14  Assay of each active ingredient

             (1)  Subject to this section, the assay limits for the stated content of each active ingredient of a tablet or a capsule are specified in item 1 of the table in Schedule 1.

             (2)  If the tablet or capsule contains an active ingredient that is mentioned in an item in the table in Schedule 2, then the assay limits for that active ingredient are specified in columns 3 and 4 of that item.

             (3)  If:

                     (a)  a tablet or a capsule contains an active ingredient that is an antibiotic; and

                     (b)  a microbiological method is used in relation to the assay of that active ingredient;

then:

                     (c)  the upper fiducial limit of error of the estimated content of active ingredient in each tablet or capsule (P = 0.95) must not be less than 97.0 per cent of the stated content of active ingredient; and

                     (d)  the lower fiducial limit of error of the estimated content of active ingredient in each tablet or capsule (P = 0.95) must not be more than 115.0 per cent of the stated content of active ingredient.

             (4)  For the purposes of this section, the assay must be calculated using a pooled sample of not fewer than 20 tablets or capsules.

             (5)  If:

                     (a)  the tablet or capsule contains an active ingredient that comprises two or more components that are each quantified on the label of the medicine; and

                     (b)  the proportions of these components vary independently of each other;

then the estimated average content of each component in a pooled sample of not fewer than 20 tablets or capsules must be not less than 90.0 per cent of the stated content of each component.

             (6)  If the tablet or capsule is a homoeopathic preparation then there are no assay requirements specified in relation to that tablet or capsule.

             (7)  If:

                     (a)  the tablet or capsule contains an active ingredient that is a multi-component ingredient; and

                     (b)  no quantitative claim is made on the label of the goods for any component;

                   then there are no assay requirements specified in relation to that active ingredient.

15  Tablet or capsule containing folic acid

             (1)  If a tablet:

                     (a)  has a stated content of 100 micrograms or more of folic acid; and

                     (b)  is not a chewable, effervescent, dispersible or modified-release tablet;

then the following requirements are specified:

                     (c)  if folic acid is the single active ingredient¾ the dissolution requirements of the Folic Acid Tablets monograph of the United States Pharmacopeia-National Formulary; or

                     (d)  if there are multiple active ingredients¾ the dissolution requirements for folic acid in chapter <2040> Disintegration and Dissolution of Dietary Supplements of the United States Pharmacopeia-National Formulary.

             (2)  If a capsule:

                     (a)  has a stated content of 100 micrograms or more of folic acid; and

                     (b)  is not a soft capsule or a modified-release capsule;

then the following requirements are specified:

                     (c)  the dissolution requirements for folic acid in chapter <2040> Disintegration and Dissolution of Dietary Supplements of the United States Pharmacopeia-National Formulary.

16  Elemental impurities and residual solvents

             (1)  The requirements for elemental impurities are those specified in either one of the following:

                     (a)  chapter <2232> Elemental Contaminants in Dietary Supplements of the United States Pharmacopeia-National Formulary; or

                     (b)  the ICH Q3D Guideline.

             (2)  The limits for residual solvents are those specified in European Pharmacopoeia (5.4) for solvent impurities.

17  Dissolution

             (1)  If:

(a)    a tablet or capsule is a registered good that:

      (i)   does not contain folic acid; or

      (ii) is not a modified-release tablet, chewable tablet, effervescent tablet, dispersible tablet or modified-release capsule; and

(b)    a default standard in relation to any active ingredient contained in that tablet or capsule specifies a dissolution test for the relevant dosage form;

then the dissolution test specified for the tablet or capsule is:

(c)    the dissolution test specified in the default standard mentioned in paragraph (1)(b); or

(d)    another dissolution test that is suitable for the tablet or capsule.

             (2)  If the tablet or capsule is a modified-release tablet or capsule, then a test for dissolution that demonstrates the appropriate release of each active ingredient must be performed.

Note:          A dissolution test is specified for tablets and capsules that are registered goods or listed goods, containing folic acid: see section 15.

18  Disintegration

             (1)  Subject to subsection (2), the test for disintegration specified in item 2 of the table in Schedule 1 applies in relation to tablets or capsules that are not chewable tablets.

             (2)  If a test for dissolution of active ingredients is performed in relation to the tablet or capsule in accordance with section 15 or 17, then the tablet or capsule is not required to comply with the test for disintegration specified in item 2 of the table in Schedule 1.

19  Fineness of dispersion

                   If the tablet is a dispersible tablet, then the test for fineness of dispersion of the British Pharmacopoeia, specified in the general monograph entitled ‘Tablets’ applies in relation to that tablet.

20  Uniformity relating to dosage units and weight

                   The tests for uniformity in relation to tablets and capsules are:

                     (a)  for registered goods¾ specified in item 3 of the table in Schedule 1; and

                     (b)  for listed goods¾ specified in item 4 of the table in Schedule 1.


 

Part 3—Pills

21  Application of Part

   This Part applies to pills that are registered goods or listed goods.

22  General requirements

                   The requirements of this Part are specified in relation to pills.

23  Appearance

                   Pills must be:

                     (a)  uniform in appearance and colour; and

                     (b)  without adhesion.

24  Water content

                   The following requirements are specified in relation to water content:

                     (a)  honeyed pills and concentrated honeyed pills must not contain more than 15.0% water;

                     (b)  water-honeyed pills and concentrated water-honeyed pills must not contain more than 12.0% water; and

                     (c)  watered pills, pasted pills and concentrated watered pills must not contain more than 9.0% water.

Note:          No determination of water content is required for waxed pills.

25  Weight variation

             (1)  The weight variation in relation to a dripping pill is specified in the table in Part 1 of Schedule 3.

             (2)  The weight variation in relation to a sugar pill is specified in the table in Part 2 of Schedule 3.

             (3)  The weight variation for other pills, which are not dripping pills or sugar pills, is specified in the table in Part 3 of Schedule 3.

             (4)  The core weight variation of sugar-coated pills, which are not dripping pills or sugar pills, must be examined before coating.

Note:          Weight variation testing after coating is not required for sugar-coated pills, but must be undertaken for all other-coated pills.

26  Disintegration

             (1)  The following requirements are specified in relation to the pills mentioned in the table in Part 4 of Schedule 3 (the relevant pills):

                     (a)  a test for disintegration (the test) must be performed, subject to the remainder of this section, in accordance with the methods specified in either one of the following:

                              (i)  European Pharmacopoeia (2.9.1); or

                             (ii)  chapter <701> Disintegration of the United States Pharmacopoeia-National Formulary;

                     (b)  subject to paragraphs (c) and (d), the test must be performed using six pills, a disc, and a sieve with the relevant pore diameter specified in the table in Part 5 of Schedule 3;

                     (c)  the test may be performed, in relation to dripping pills, without a disc;

                     (d)  if, in the course of the test, one or more pills, or parts of the pills, adhere to the disc, the test must be repeated without the disc, using another six pills;

                     (e)  the entirety of the pills used in the test must pass through the sieve within the relevant time, if any, specified in the table in Part 4 of Schedule 3.

             (2)  The relevant pills are taken to comply with this section if the only residue remaining in the test comprises softened masses without a hard core.

Note:          No disintegration test is specified in relation to big-honeyed pills, pills for grinding or chewing or pills to be taken after being dispersed with hot water or yellow rice wine.

27  Assay of each active ingredient

             (1)  Subject to subsection (2), the assay limits for each active ingredient of a pill are those specified in item 1 of the table in Schedule 1.

             (2)  If:

                     (a)  a pill contains an active ingredient that is a multi-component ingredient; and

                     (b)  no quantitative claim is made on the label of the pill for any individual component;

then there are no assay requirements specified in relation to that active ingredient.

             (3)  For the purposes of this section, the assay must be calculated using a pooled sample of not fewer than 20 pills.

28  Elemental impurities

             (1)  The maximum concentration limits in relation to the following elements:

                     (a)  arsenic;

                     (b)  cadmium;

                     (c)  lead; and

                     (d)  mercury;

are specified in the table in Part 6 of Schedule 3.

             (2)  The total mass of each of the elements referred to in subsection (1) in the pill must be within the permitted daily exposure limit specified for that element in:

                     (a)  chapter <2232> Elemental Contaminants in Dietary Supplements of the United States Pharmacopeia-National Formulary; or

                     (b)  the ICH Q3D Guideline.


 

Schedule 1¾Tablets, capsules and pills: assay, disintegration and uniformity

Note:       See Part 2.

 

Column 1

Item

Column 2

Property

Column 3

Requirements

1

assay for each active ingredient

(a)    for active ingredients in registered goods¾90.0 to110.0%

(b)    for active ingredients in listed goods¾90.0 to 120.0%

2

disintegration

European Pharmacopoeia (2.9.1) or United States Pharmacopoeia-National Formulary, chapter <701>

3

uniformity of dosage units

European Pharmacopoeia (2.9.40) or United States Pharmacopoeia-National Formulary, chapter  <905>

4

uniformity of weight (mass)

European Pharmacopoeia (2.9.5) or United States Pharmacopoeia-National Formulary, chapter <711>


 

Schedule 2¾Tablets and capsules: assay limits for content of active ingredient or component in a tablet or capsule

Note:       See section 14.

 


Column 1

Item

Column 2

Active ingredient

Column 3

Not less than

(percent)

Column 4

Not more than

(percent)

1

vitamin or provitamin:

(a)    water soluble;

(b)    oil soluble;

(c)    betacarotene, panthenol, pantothenic acid or salt of pantothenic acid

 

90.0

90.0

90.0

 

150.0

165.0

175.0

2

mineral or mineral compound:

(a)    generally;

(b)    when used as a source of boron, chromium, fluorine, iodine, molybdenum or selenium

 

90.0

90.0

 

125.0

160.0

3

enzyme

90.0

200.0

4

probiotic

not less than stated content

 

 


 

Schedule 3—Pills: weight variation, disintegration and elemental impurities

Note:       See Part 3.

Part 1—Weight variation: dripping pills

Column 1

Item

Column 2

Labelled or average weight

Column 3

Variation (percent)

1

0.03 grams or less

15

2

more than 0.03 grams to 0.1 grams

12

3

more than 0.1 grams to 0.3 grams

10

4

more than 0.3 grams

7.5

Part 2Weight variation: sugar pills

Column 1

Item

Column 2

Labelled or average weight

Column 3

Variation (percent)

1

0.03grams or less

15

2

more than 0.03 grams to 0.3 grams

10

3

more than 0.3 grams

7.5

Part 3Weight variation: other pills

Column 1

Item

Column 2

Labelled or average weight

Column 3

Variation (percent)

1

0.05 grams or less

12

2

more than 0.05 grams to 0.1 grams

11

3

more than 0.1 grams  to 0.3 grams

10

4

more than 0.3 grams to 1.5 grams

9

5

more than 1.5 grams to 3 grams

8

6

more than 3 grams to 6 grams

7

7

more than 6 grams to 9 grams

6

8

more than 9 grams

5


 

Part 4Disintegration

Column 1

Item

Column 2

Pill type

Column 3

Requirement

1

small honey pills, water-honeyed pills and watered pills

the pill must completely disintegrate within 1 hour

2

concentrated pills and pasted pills

the pill must completely disintegrate within 2 hours

3

dripping pills (excluding coated dripping pills)

the pill must completely disintegrate within 30 minutes

4

coated dripping pills

the pill must completely disintegrate within 1 hour

5

waxed pills

the pill must comply with a suitable disintegration test

Part 5—Sieve pore diameter

Column 1

Item

Column 2

Pill diameter

Column 3

Sieve pore diameter

1

less than 2.5 mm

0.42 mm

2

2.5 – 3.5 mm

1.0 mm

3

more than 3.5 mm

2.0 mm

Part 6—Elemental impurities

Column 1

Item

Column 2

Element

Column 3

Requirement

1

arsenic

a maximum concentration of 2 parts per million;

2

cadmium

a maximum concentration of 1 part per million;

3

lead

a maximum concentration of 5 parts per million

4

mercury

a maximum concentration of 0.2 parts per million


 


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 the amendment to be made. If, despite the misdescription, the amendment can be given effect as intended, the amendment is incorporated into the compiled law and the abbreviation “(md)” added to the details of the amendment included in the amendment history.

If a misdescribed amendment cannot be given effect as intended, the abbreviation “(md not incorp)” is added to the details of the amendment included in the amendment history.

Endnote 2—Abbreviation key

 

ad = added or inserted

o = order(s)

am = amended

Ord = Ordinance

amdt = amendment

orig = original

c = clause(s)

par = paragraph(s)/subparagraph(s)

C[x] = Compilation No. x

    /sub‑subparagraph(s)

Ch = Chapter(s)

pres = present

def = definition(s)

prev = previous

Dict = Dictionary

(prev…) = previously

disallowed = disallowed by Parliament

Pt = Part(s)

Div = Division(s)

r = regulation(s)/rule(s)

exp = expires/expired or ceases/ceased to have

reloc = relocated

    effect

renum = renumbered

F = Federal Register of Legislation

rep = repealed

gaz = gazette

rs = repealed and substituted

LA = Legislation Act 2003

s = section(s)/subsection(s)

LIA = Legislative Instruments Act 2003

Sch = Schedule(s)

(md) = misdescribed amendment can be given

Sdiv = Subdivision(s)

    effect

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

 

    commenced or to be commenced

 

Endnote 3—Legislation history

 

Name

Registration

Commencement

Application, saving and transitional provisions

Therapeutic Goods (Standard for Tablets, Capsules and Pills) (TGO 101) Order 2019

25 Mar 2019
(F2019L00369)

s 1-15: 31 Mar 2019 (s 2(1) item 1)
s 16: 31 Mar 2021 (s 2(1) item 2)
s 17-20: 31 Mar 2019 (s 2(1) item 3)
Pt 3: 31 Mar 2021 (s 2(1) item 4)
Sch 1 and Sch 2: 31 Mar 2019 (s 2(1) item 5)
Sch 3: 31 Mar 2021 (s 2(1) item 6)
Sch 4: 31 March 2019 (s 2(1) item 7)
Remainder: 31 Mar 2019

¾

Therapeutic Goods (Standard for Tablets, Capsules and Pills) Amendment Order 2020

27 Nov 2020
(F2020L01502)

28 Nov 2020

¾

 


 

Endnote 4—Amendment history

 

Provision affected

How affected

s 2........................................

am F2020L01502

s 7........................................

rep LA s 48C

Schedule 4...........................

rep LA s 48C