Updates to the Permissible Ingredients Determination for listed medicines

Therapeutic Goods (Permissible Ingredients) Determination No. 3 of 2017

21 July 2017

An updated version of the Therapeutic Goods (Permissible Ingredients) Determination was registered on the Federal Register of Legislation (FRL) in July 2017. The updated determination is titled the Therapeutic Goods (Permissible Ingredients) Determination No. 3 of 2017.

Determination No. 3 of 2017 revokes and replaces the Therapeutic Goods (Permissible Ingredients) Determination No. 2 of 2017 which commenced in April 2017.

This update to the Determination has been undertaken under section 26BB of the Therapeutic Goods Act 1989 and its function remains the same.

A total of 67 changes have been made in the updated Determination. These changes include:

  • The addition of 4 new ingredients.
  • Changes to 55 existing ingredient entries, including:
    • making requirements for ingredients less restrictive, such as broadening the use to allow oral use when previously only for topical use;
    • making requirements for ingredients more restrictive, such as the inclusion of additional warning messages; and
    • making minor changes to make a number of entries clearer.
  • the removal of 8 ingredients that have been determined not to be suitable for inclusion in listed medicines.

A complete list of changes to ingredient availability is available below.

New ingredients

  • Active Ingredients
    • Eggshell Membrane Hydrolysate
    • Eggshell Membrane Powder
    • Guar Galactomannan
  • Excipient Ingredients
    • Tocopheryl Glucoside

Removed ingredients

  • Removal of ingredients due to safety related issues:
    • Absidia Ramosa
    • Alternaria Alternata
    • Botrytis Cinerea
    • Chaetomium Indicum
    • Claviceps Purpurea
    • Cochliobolus Heterostrophus
    • Drechslera Sorakiniana
    • Microsporum Gypseum

Changes to ingredients

A B C F G H I M N O P R S U Z

A
Ingredient name Applicable changes
Acetanisole Ingredient requirements made less restrictive
Arachis hypogaea Ingredient requirements made more restrictive
Arachis oil Ingredient requirements made more restrictive
B
Ingredient name Applicable changes
Bergamot oil Alignment with RASML
C
Ingredient name Applicable changes
Calcium Folinate Clarification of specific requirements
Camphor Correction of error
Citric acid Alignment with RASML
Citric acid dihydrate Alignment with RASML
Citric acid monohydrate Alignment with RASML
Citronellol Ingredient requirements made less restrictive
Cod-liver oil Clarification of specific requirements
Cynomorium coccineum subsp. songaricum Change of synonym name
F
Ingredient name Applicable changes
Fennel oi Ingredient requirements made more restrictive
Ferric chloride Alignment with RASML
Ferric chloride hexahydrate Alignment with RASML
Ferric glycerophosphate Alignment with RASML
Ferric pyrophosphate Alignment with RASML
Ferrous fumarate Alignment with RASML
Ferrous gluconate Alignment with RASML
Ferrous gluconate dihydrate Alignment with RASML
Ferrous lactate trihydrate Alignment with RASML
Ferrous phosphate octahydrate Alignment with RASML
Ferrous sulfate Alignment with RASML
Ferrous sulfate heptahydrate Alignment with RASML
Foeniculum vulgare Ingredient requirements made more restrictive
G
Ingredient name Applicable changes
Gamma-decalactone Ingredient requirements made less restrictive
Geraniol Ingredient requirements made less restrictive
Gymnadenia nigra Change to name and purpose
H
Ingredient name Applicable changes
Halibut-liver oil Clarification of specific requirements
I
Ingredient name Applicable changes
Ionone Ingredient requirements made less restrictive
Lime oil distilled Alignment with RASML
Linalyl acetate Ingredient requirements made less restrictive
Lippia dulcis  Change to synonym name
Lutein Clarification of specific requirements
M
Ingredient name Applicable changes
Manihot esculenta Change to synonym name and purpose
N
Ingredient name Applicable changes
Natural fish oil Clarification of specific requirements
O
Ingredient name Applicable changes
Orange oil bitter Alignment with RASML
P
Ingredient name Applicable changes
Peanut Ingredient requirements made more restrictive
Phenethyl alcohol Ingredient requirements made less restrictive
Pollack-liver oil Clarification of specific requirements
PPG-15 Stearyl ether Ingredient requirements made more restrictive
Pyrethrins Alignment with RASML
R
Ingredient name Applicable changes
Retinol Clarification of specific requirements
Retinol acetate Clarification of specific requirements
Retinol palmitate Clarification of specific requirements
Rheum rhaponticum Clarification of specific requirements
S
Ingredient name Applicable changes
Shark-liver oil Clarification of specific requirements
Skipjack-liver oil Clarification of specific requirements
Sodium Fluoride Alignment with RASML
Sodium monofluorophosphate Alignment with RASML
Strobilanthes cusia Replacement of synonym name
U
Ingredient name Applicable changes
Umbellularia californica Change to synonym name
Z
Ingredient name Applicable changes
Zinc amino acid chelate Alignment with RASML
Zinc oxide Alignment with RASML
Zinc para-phenolsulfonate Alignment with RASML

A copy of the instrument can be found on the Therapeutic goods determinations page.

More information can be found at Permissible Ingredients Determination: Frequently asked questions.