Updates to the Permissible Ingredients Determination for listed medicines

Therapeutic Goods (Permissible Ingredients) Determination No. 4 of 2017

27 September 2017

An updated version of the Therapeutic Goods (Permissible Ingredients) Determination was registered on the Federal Register of Legislation (FRL) in September 2017. The updated determination is titled the Therapeutic Goods (Permissible Ingredients) Determination No. 4 of 2017.

Determination No. 4 of 2017 revokes and replaces the Therapeutic Goods (Permissible Ingredients) Determination No. 3 of 2017 which commenced in July 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 287 changes have been made in the updated Determination. These changes include:

  • The addition of 6 new ingredients.
  • Changes to 276 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 5 ingredients that have been determined not to be suitable for inclusion in listed medicines.

A complete list of changes to ingredient availability in the table below.

New ingredients

  • Cis-3-Hexenyl tiglate
  • Cyclohexyl butyrate
  • Hydrogenated palm gylcerides citrate
  • Propanediol
  • Sucrose acetate palmitate stearate
  • Zinc glycinate monohydrate

Removed ingredients

  • Aloe barbadensis
  • Aloes barbados
  • Fallopia japonica
  • Matricaria recutita
  • Polygonum cuspidatum

Changed ingredients

A B C D E F G H I K L M N O P R S T U V Z

A
ACETIC ACID
ACETOMENAPHTHONE
ALARIA ESCULENTA
ALFADEX
ALOE BARBADENSIS
ALOES BARBADOS
ALSIDIUM HELMINTHOCHORTON
ANTHOXANTHUM ODORATUM
ASCOPHYLLUM NODOSUM
ASCORBIC ACID
ASCORBYL PALMITATE
AZADIRACHTA INDICA
B
BETACAROTENE
BIOTIN
BLADDERWRACK DRY
BLADDERWRACK POWDER
BORAX
BORAX PENTAHYDRATE
BORIC ACID
C
CALCIUM AMINO ACID CHELATE
CALCIUM ASCORBATE
CALCIUM ASCORBATE DIHYDRATE
CALCIUM ASPARTATE
CALCIUM ASPARTATE HYDROCHLORIDE DIHYDRATE
CALCIUM BETA-HYDROXY-BETA-METHYLBUTYRATE
CALCIUM BETA-HYDROXY-BETA-METHYLBUTYRATE MONOHYDRATE
CALCIUM CARBONATE
CALCIUM CITRATE
CALCIUM CITRATE TETRAHYDRATE
CALCIUM DIASPARTATE
CALCIUM FOLINATE
CALCIUM GLUCONATE MONOHYDRATE
CALCIUM GLYCEROPHOSPHATE
CALCIUM GLYCINATE
CALCIUM GLYCINATE DIHYDRATE
CALCIUM HYDROGEN PHOSPHATE
CALCIUM HYDROGEN PHOSPHATE DIHYDRATE
CALCIUM HYDROGEN PHOSPHATE MONOHYDRATE
CALCIUM HYDROXIDE
CALCIUM HYDROXYCITRATE
CALCIUM LACTATE
CALCIUM LACTATE GLUCONATE
CALCIUM LACTATE PENTAHYDRATE
CALCIUM LACTATE TRIHYDRATE
CALCIUM L-THREONATE
CALCIUM LYSINATE
CALCIUM METHIONINATE
CALCIUM OROTATE
CALCIUM PANTOTHENATE
CALCIUM PHOSPHATE
CALCIUM PYRUVATE
CALCIUM SODIUM LACTATE
CALCIUM SUCCINATE
CALCIUM SULFATE
CALCIUM SULFATE DIHYDRATE
CALCIUM THREONINATE
CHLORELLA VULGARIS
CHONDRUS CRISPUS
CHONDRUS DRY
CHONDRUS EXTRACT
CHROMIC CHLORIDE HEXAHYDRATE
CHROMIUM NICOTINATE
CHROMIUM PICOLINATE
CIS-3-HEXENYL TIGLATE
COD-LIVER OIL
COLECALCIFEROL
COPPER (II) ASPARTATE
COPPER (II) GLYCINATE
COPPER (II) LYSINATE
COPPER GLUCONATE
CRATEVA MAGNA
CREATINE
CREATINE MONOHYDRATE
CREATINE PHOSPHATE
CUPRIC CITRATE
CUPRIC CITRATE HEMIPENTAHYDRATE
CUPRIC OXIDE
CUPRIC SULFATE
CUPRIC SULFATE PENTAHYDRATE
CYANOCOBALAMIN
CYCLOHEXYL BUTYRATE
D
D-ALPHA-TOCOPHEROL
D-ALPHA-TOCOPHERYL ACETATE
D-ALPHA-TOCOPHERYL ACID SUCCINATE
DEXPANTHENOL
DIBASIC MAGNESIUM CITRATE TETRAHYDRATE
DIBASIC POTASSIUM PHOSPHATE
DIBASIC POTASSIUM PHOSPHATE TRIHYDRATE
DIBASIC SODIUM PHOSPHATE
DIBASIC SODIUM PHOSPHATE DIHYDRATE
DIBASIC SODIUM PHOSPHATE DODECAHYDRATE
DIBASIC SODIUM PHOSPHATE HEPTAHYDRATE
DIBASIC SODIUM PHOSPHATE MONOHYDRATE
DIPTERYX ODORATA
DL-ALPHA-TOCOPHEROL
DL-ALPHA-TOCOPHERYL ACETATE
DL-ALPHA-TOCOPHERYL ACID SUCCINATE
DOLOMITE
DRIED CALCIUM SULFATE
DRIED MAGNESIUM SULFATE
E
ECHINOPS SPINOSISSIMUS
ERGOCALCIFEROL
F
FALLOPIA JAPONICA
FENNEL BITTER SEED DRY
FENNEL OIL
FENNEL SWEET SEED DRY
FERRIC AMMONIUM CITRATE
FERRIC CHLORIDE
FERRIC CHLORIDE HEXAHYDRATE
FERRIC GLYCEROPHOSPHATE
FERRIC PYROPHOSPHATE
FERROUS FUMARATE
FERROUS GLUCONATE
FERROUS GLUCONATE DIHYDRATE
FERROUS LACTATE TRIHYDRATE
FERROUS PHOSPHATE OCTAHYDRATE
FERROUS SULFATE
FERROUS SULFATE HEPTAHYDRATE
FOENICULUM VULGARE
FOLIC ACID
FUCUS VESICULOSUS
G
GALIUM ODORATUM
GELIDIUM AMANSII
GIGARTINA MAMILLOSA
GLYCEROL
H
HALIBUT-LIVER OIL
HEAVY MAGNESIUM OXIDE
HIGH CHROMIUM YEAST
HIGH MOLYBDENUM YEAST
HIGH SELENIUM YEAST
Hydrogenated palm glycerides citrate
HYDROXOCOBALAMIN
HYDROXYAPATITE
I
INVERT SYRUP
IODINE
IRIDOPHYCUS FLACCIDUM
IRON
IRON (II) BISGLYCINE SULFATE TRIHYDRATE
IRON (II) GLYCINATE
IRON (III) GLYCINATE
IRON AMINO ACID CHELATE
IRON PHOSPHATE
K
KELP DRY
KELP POWDER
L
LAMINARIA CLOUSTONI
LAMINARIA DIGITATA
LAMINARIA JAPONICA
LEVOMEFOLATE CALCIUM
LEVOMEFOLATE GLUCOSAMINE
LIGHT MAGNESIUM OXIDE
LIGUSTICUM STRIATUM
M
MACROCYSTIS PYRIFERA
MAGNESIUM AMINO ACID CHELATE
MAGNESIUM ASCORBATE
MAGNESIUM ASCORBATE MONOHYDRATE
MAGNESIUM ASPARTATE
MAGNESIUM ASPARTATE DIHYDRATE
MAGNESIUM ASPARTATE TETRAHYDRATE
MAGNESIUM CARBONATE HYDRATE
MAGNESIUM CHLORIDE 4.5-HYDRATE
MAGNESIUM CHLORIDE HEXAHYDRATE
MAGNESIUM CITRATE
MAGNESIUM CITRATE NONAHYDRATE
MAGNESIUM CITRATE TETRADECAHYDRATE
MAGNESIUM DIGLUTAMATE
MAGNESIUM GLUCONATE
MAGNESIUM GLYCEROPHOSPHATE
MAGNESIUM GLYCINATE
MAGNESIUM HYDROXIDE
MAGNESIUM LYSINATE
MAGNESIUM METHIONINATE
MAGNESIUM OROTATE
MAGNESIUM OROTATE DIHYDRATE
MAGNESIUM OXIDE
MAGNESIUM PHOSPHATE PENTAHYDRATE
MAGNESIUM PYRUVATE
MAGNESIUM SULFATE DIHYDRATE
MAGNESIUM SULFATE HEPTAHYDRATE
MAGNESIUM SULFATE MONOHYDRATE
MAGNESIUM SULFATE TRIHYDRATE
MANGANESE (II) DIASPARTATE
MANGANESE (II) GLYCINATE
MANGANESE AMINO ACID CHELATE
MANGANESE CHLORIDE TETRAHYDRATE
MANGANESE DIASPARTATE
MANGANESE GLUCONATE
MANGANESE GLYCEROPHOSPHATE
MANGANESE OXIDE
MANGANESE SULFATE MONOHYDRATE
MANGANESE SULFATE TETRAHYDRATE
MATRICARIA RECUTITA
MIXED (HIGH-ALPHA TYPE) TOCOPHEROLS CONCENTRATE
MIXED (LOW-ALPHA TYPE) TOCOPHEROLS CONCENTRATE
MONOBASIC CALCIUM PHOSPHATE
MONOBASIC POTASSIUM PHOSPHATE
MONOBASIC SODIUM PHOSPHATE
MONOPHOSPHOTHIAMINE
MONOPHOSPHOTHIAMINE DIHYDRATE
N
NATURAL FISH OIL
NICOTINAMIDE
NICOTINAMIDE ASCORBATE
NICOTINIC ACID
O
OCTANOIC ACID
OMEGA-3 FISH OIL PHYTOSTEROL ESTERS
P
PALMARIA PALMATA
PANTHENOL
PEPPERMINT OIL TERPENES AND TERPENOIDS
PHENOL
PHYTOMENADIONE
PLECTRANTHUS BARBATUS
POLLACK-LIVER OIL
POLYGONUM CUSPIDATUM
POTASSIUM ASCORBATE
POTASSIUM ASCORBATE DIHYDRATE
POTASSIUM ASPARTATE
POTASSIUM CARBONATE
POTASSIUM CITRATE
POTASSIUM GLUCONATE
POTASSIUM GLYCEROPHOSPHATE
POTASSIUM HYDROXYCITRATE
POTASSIUM IODIDE
POTASSIUM OROTATE
POTASSIUM SULFATE
Propanediol
PYRIDOXAL 5-PHOSPHATE
PYRIDOXAL 5-PHOSPHATE MONOHYDRATE
PYRIDOXINE HYDROCHLORIDE
R
RETINOL
RETINOL ACETATE
RETINOL PALMITATE
REYNOUTRIA JAPONICA
RIBOFLAVIN
RIBOFLAVIN SODIUM PHOSPHATE
S
SARGASSUM FUSIFORME
SARGASSUM SILIQUASTRUM
SELENOCYSTEINE
SELENOMETHIONINE
SENNA OCCIDENTALIS
SHARK-LIVER OIL
SILICON DIOXIDE
SKIPJACK-LIVER OIL
SODIUM ASCORBATE
SODIUM BICARBONATE
SODIUM CARBONATE MONOHYDRATE
SODIUM CHLORIDE
SODIUM FLUORIDE
SODIUM GLYCEROPHOSPHATE
SODIUM HYDROXYCITRATE
SODIUM MONOFLUOROPHOSPHATE
SODIUM PERBORATE
SODIUM SELENATE
SODIUM SELENATE DECAHYDRATE
SODIUM SELENITE
SODIUM SELENITE PENTAHYDRATE
SORBITOL SOLUTION (70 PER CENT) (CRYSTALLISING)
SORBITOL SOLUTION (70 PER CENT) (NON-CRYSTALLISING)
SUCROSE ACETATE PALMITATE STEARATE
T
TEUCRIUM SCORODONIA
THIAMINE
THIAMINE HYDROCHLORIDE
THIAMINE NITRATE
TRAMETES VERSICOLOR
TREFRIW WELLS MINERAL WATER
TRIBASIC POTASSIUM PHOSPHATE
U
UBIDECARENONE
UBIQUINOL-10
V
VANILLIN
VEGETABLE OIL PHYTOSTEROL ESTERS
Z
ZINC AMINO ACID CHELATE
ZINC ASCORBATE
ZINC ASCORBATE MONOHYDRATE
ZINC CHLORIDE
ZINC CITRATE
ZINC CITRATE DIHYDRATE
ZINC CITRATE TRIHYDRATE
ZINC DIASPARTATE
ZINC GLUCONATE
ZINC GLYCINATE
ZINC GLYCINATE MONOHYDRATE
ZINC LYSINATE
ZINC METHIONINE SULFATE
ZINC OXIDE
ZINC SUCCINATE
ZINC SULFATE
ZINC SULFATE HEPTAHYDRATE
ZINC SULFATE HEXAHYDRATE
ZINC SULFATE MONOHYDRATE

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.