P-10, r. 12 - Regulation respecting the terms and conditions for the sale of medications

Full text
SCHEDULE II
(s. 1, 1st par., subpar. 2)
MEDICATIONS FOR HUMAN USE SOLD UNDER PHARMACEUTICAL CONTROL
Except as otherwise provided in the Regulation, this Schedule includes, besides the medications listed below, all the drugs and substances for which notice of withdrawal from the Schedules to the Regulations concerning the sale of drugs and substances made pursuant to the Food and Drugs Act (R.S.C. 1985, c. F-27), from the list established in accordance with section 29.1 of that Act or in the Schedules to the Regulations concerning the sale of drugs and substances made pursuant to the Controlled Drugs and Substances Act (S.C. 1996, c. 19) has been given since 1 July 1998.


Substance Specification



ACETARSOL

ACETYLCYSTEINE

ACETYLSALICYLIC ACID Dosage forms recommended solely for children
AND ITS SALTS

Dosage forms for rectal use

ADIPHENE AND ITS SALTS Dosage forms for parenteral use

ADRENALINE (EPINEPHRINE)
AND ITS SALTS

ALLETHRINS

AMYLOCAINE AND ITS SALTS Dosage forms for ophthalmic or parenteral use

ANISOTROPINE AND ITS SALTS

ANTHRALIN (DITHRANOL)

ANTIHEMOPHILIC FACTOR

ANTIPYRINE Except dosage forms for otic use

APOMORPHINE AND ITS SALTS

ARGININE AND ITS SALTS

ARTEMISIA, ITS PREPARATIONS, EXTRACTS
AND COMPOUNDS

AZELAIC ACID

BACITRACINS, THEIR SALTS AND Except dosage forms for topical use on the
DERIVATIVES skin

BELLADONNA ALKALOIDS, THEIR Dosage forms for oral use
SALTS AND DERIVATIVES

BENOXINATE (OXYBUPROCAINE) Dosage forms for ophthalmic or parenteral use
HYDROCHLORIDE

BENTIROMIDE

BENZALKONIUM AND ITS SALTS Liquid dosage forms in concentrations of more
than 2%

BENZETHONIUM CHLORIDE Liquid dosage forms in concentrations of more
than 1%

BENZOCAINE AND ITS SALTS Dosage forms for ophthalmic or parenteral use

BENZYL BENZOATE

BORIC ACID AND ITS SALTS Dosage forms for systemic or ophthalmic use

BUCLIZINE

BUFEXAMAC

BUPIVACAINE AND ITS SALTS Dosage forms for ophthalmic or parenteral use

BUTACAINE Dosage forms for ophthalmic or parenteral use

CALCIUM CHLORIDE Dosage forms for parenteral use

CALCIUM DISODIUM EDETATE

CALCIUM GLUCONATE Dosage forms for parenteral use

CALCIUM POLYSTYRENE SULFONATE

CAMPHOR Dosage forms in oleaginous vehicles or
liquid forms in concentrations greater than 11%

CANTHARIDES, THEIR PREPARATIONS
AND DERIVATIVES

CAPRYLIC ACID

CAPSAICIN Dosage forms in concentration of 0.075% and
more

CHLOROPROCAINE AND ITS SALTS Dosage forms for ophthalmic or parenteral use

CHOLECYSTOKININ

CHOLINE BITARTRATE Dosage forms for parenteral use

CHROMIC CHLORIDE Dosage forms for parenteral use

CHYMOPAPAIN Dosage forms for parenteral use

CHYMOTRYPSIN Dosage forms for ophthalmic or parenteral use

CINCHOCAINE (DIBUCAINE) Dosage forms for ophthalmic or parenteral use
AND ITS SALTS

CLIDINIUM AND ITS SALTS

(N) CODEINE AND ITS SALTS Solid dosage forms containing not more than
8 mg or its equivalent of codeine phosphate per
tablet or per unit, and liquid dosage forms
containing not more than 20 mg or its
equivalent of codeine phosphate per 30 ml

A- and also containing

i. 2 additional medicinal ingredients other
than a narcotic in quantity of not less than
the regular minimum single dose for one such
ingredient or one-half of the regular minimum
single dose for each such ingredient; or

ii. 3 additional medicinal ingredients
other than a narcotic in quantity of not less
than the regular minimum single dose for one
such ingredient or one-third of the regular
minimum single dose for each such ingredient;
and

B- there is legibly and conspicuously printed
on the main panel of the label and any outer
container the full formula or true list of
all active ingredients and a caution to the
following effect:

“This preparation contains codeine and should
not be administered to children, except on
the advice of a physician or dentist.”

COLLAGENASE Dosage forms used as debriding agent

CROTAMITON

CUPRIC CHLORIDE Dosage forms for parenteral use

CYCLANDELATE

CYCLAZOCINE AND ITS SALTS

CYCLOMETHACAINE AND ITS SALTS Dosage forms for ophthalmic or parenteral use

CYCLOPENTAMINE AND ITS SALTS

CYCLOPENTOLATE AND ITS SALTS Except dosage forms for ophthalmic or
parenteral use

CYPROHEPTADINE AND ITS SALTS

DEHYDRATED ALCOHOL Dosage forms for parenteral use

DESOXYRIBONUCLEASE (PANCREATIC)

DEXTROMETHORPHAN AND ITS SALTS Dosage forms in packaging units containing
more than 850 mg

DEXTROSE Dosage forms for parenteral use or as
diagnostic or sclerosing agent

DIBUCAINE (CINCHOCAINE) Dosage forms for ophthalmic or parenteral use
AND ITS SALTS

DICYCLOMINE AND ITS SALTS

DIHYDROQUINIDINE AND ITS SALTS

DIIODOHYDROXYQUIN (IODOQUINOL) Dosage forms for topical use on the skin

DIMENHYDRINATE AND ITS SALTS

DIPERODON AND ITS SALTS Except dosage forms for topical use

DIPHENHYDRAMINE AND ITS SALTS Dosage forms for parenteral use

DITHRANOL (ANTHRALIN)

DYCLONINE Except lozenges and dosage forms for topical
use

EPHEDRINE AND ITS SALTS Dosage forms for systemic use

EPINEPHRINE (ADRENALINE)
AND ITS SALTS

ERYTHRITYL TETRANITRATE

ESDEPALLETHRIN (PIPERONYL BUTOXIDE)

ETHANOLAMINE OLEATE

ETHOHEPTAZINE

ETHYL CHLORIDE Except in trace amounts

FIBRIN

FIBRINOLYSIN

GLUCAGON

GLUTAMIC ACID AND ITS SALTS Dosage forms recommended as gastric acidifiers

GLYCOPYRROLATE AND ITS SALTS

GRAMICIDIN AND ITS SALTS Except dosage forms for topical use on the skin

HEPARIN AND ITS SALTS Except dosage forms for topical use

HEXAMINE (METHENAMINE) Except dosage forms for topical use
AND ITS SALTS

HISTAMINE AND ITS SALTS Except dosage forms for topical use

HOMATROPINE AND ITS SALTS Dosage forms for oral use containing a
maximum of 2 mg per dosage unit

HUMAN INSULIN

HYALURONIC ACID AND ITS SALTS Dosage forms in concentrations of 5% or more

HYALURONIDASE

HYDROXYEPHEDRINE AND
ITS SALTS

HYOSCINE (SCOPOLAMINE),
ITS SALTS AND DERIVATIVES

HYOSCYAMINE, ITS SALTS
AND DERIVATIVES

INOSITOL NICOTINATE

INSULIN

IODINATED CASEINE

IODINATED GYLCEROL

IODINE, ITS SALTS AND Dosage forms for oral use with recommended
DERIVATIVES daily dosage of more than 1 mg

IODOQUINOL (DIIODOHYDROXYQUIN) Dosage forms for topical use on the skin

IPECAC, ITS EXTRACTS AND
DERIVATIVES

IRON, ITS SALTS AND Dosage forms containing 30 mg or more of
DERIVATIVES elemental iron per dosage unit

ISOPROPAMIDE AND ITS SALTS

LEVARGORPHANE AND ITS SALTS

LEVONORDEFRINE

LIDOCAINE AND ITS SALTS Dosage forms for topical use on mucous
membranes

LINDANE Dosage forms for use as pediculicide or
scabicide agent

LOPERAMIDE AND ITS SALTS Liquid dosage forms for children

MAGNESIUM SULFATE Dosage forms for parenteral use

MANGANESE AND ITS SALTS Dosage forms for parenteral use

MANNITOL AND ITS SALTS

MECLIZINE AND ITS SALTS

MEPIVACAINE AND ITS SALTS Dosage forms for ophthalmic or parenteral use

METATHOHEPTAZINE AND ITS SALTS

METHANTHELINE AND ITS SALTS

METHDILAZINE AND ITS SALTS

METHENAMINE (HEXAMINE) AND Except dosage forms for topical use
ITS SALTS

METHEPTAZINE AND ITS SALTS

METHOCARBAMOL Dosage forms for parenteral use

METHYL SALICYLATE Liquid dosage forms in concentrations of more
than 30%

METHYLENE BLUE Dosage forms for parenteral use

MONOBENZONE

MONOETHANOLAMINE OLEATE

MUPIROCIN

NAPROXEN SODIUM Dosage forms in packaging units containing
more than 60 dosage units of 220 mg
or less and sold in single packages
containing only one packaging unit

NIACIN (NICOTINIC ACID) Single-ingredient dosage forms containing
50 mg or more per recommended dosage unit

NIACINAMIDE Dosage forms for systemic use containing more
than 125 mg per dosage unit

NICOTINIC ACID (NIACIN) Single-ingredient dosage forms containing
50 mg or more per recommended dosage unit

NITROGLYCERIN Immediate-release dosage forms for sublingual
use or by buccal spray

NORADRENALINE (NOREPINEPHRINE)
AND ITS SALTS

NOREPINEPHRINE (NORADRENALINE)
AND ITS SALTS

OXYBUPROCAINE (BENOXINATE) Dosage forms for ophthalmic or parenteral use
hydrochloride

OXYQUINOLINE

PANCREATIC ENZYMES Dosage forms recommended for cystic fibrosis
treatment

PANCRELIPASE

PAPAIN Dosage forms used as debriding agent

PAROXYPROPIONE

PENTAGASTRIN AND ITS SALTS

PERMETHRIN Dosage forms for topical use as pediculicide
or scabicide agent

PHENOL Dosage forms in concentrations greater than
20%

PHENOXYBENZAMINE AND ITS SALTS

PHYSOSTIGMINE SALICYLATE Dosage forms exclusively for oral or topical
use

PIPERAZINE AND ITS SALTS

PIPERONYL, ITS SALTS,
DERIVATIVES AND THEIR SALTS

PIPERONYL (ESDEPALLETHRIN)
BUTOXIDE

POLYACRYLAMIDE

POLYMYXINS, THEIR SALTS Except dosage forms for topical use on the
AND DERIVATIVES skin

POTASSIUM SALTS Except dosage forms containing 5 mmol or less
per recommended dosage unit

POVIDONE-IODINE Dosage forms for vaginal use except in
concentrations of 5% or less

PRAMOXINE AND ITS SALTS Dosage forms for ophthalmic or parenteral use

PRILOCAINE AND ITS SALTS Dosage forms for ophthalmic or parenteral use

PROCAINE AND ITS SALTS Dosage forms for ophthalmic or parenteral use

PROMETHAZINE AND ITS SALTS Dosage forms for oral use

PROPANTHELINE AND ITS SALTS

PROPARACAINE AND ITS SALTS Dosage forms for ophthalmic or parenteral use

PROPYLHEXEDRINE

PROTAMINE AND ITS SALTS

PSEUDOEPHEDRINE AND ITS SALTS Dosage forms containing no other medicinal
ingredient

Dosage forms in packaging units containing more
than 1,200 mg and containing another medicinal
ingredient

PYRANTEL AND ITS SALTS

PYRETHRINS, NATURAL AND Dosage forms for pediculicide or scabicide use
SYNTHETIC

PYRVINIUM AND ITS SALTS

QUININE AND ITS SALTS Except dosage forms recommended as analgesic
agent

RACEMETHIONINE

ROPIVACAINE AND ITS SALTS

ROSE BENGAL

RUE, ITS PREPARATIONS AND EXTRACTS

SALICYLIC ACID AND ITS SALTS Dosage forms for topical use in concentrations
greater than 40%

SCOPOLAMINE (HYOSCINE),
ITS SALTS AND DERIVATIVES

SELENIUM Dosage forms for parenteral use

SILVER NITRATE

SINCALIDE

SODIUM ACETATE Dosage forms for parenteral use

SODIUM BICARBONATE Dosage forms for parenteral use

SODIUM BIPHOSPHATE Dosage forms for parenteral use

SODIUM CHLORIDE Single-ingredient dosage forms for parenteral
use

Dosage forms for ophthalmic use in
concentrations greater than 0.9%

SODIUM CITRATE Dosage forms for parenteral use

SODIUM CROMOGLICATE Dosage forms for ophthalmic use in
concentrations of 2% or less

SODIUM IODIDE Dosage forms used as sclerosing agent

SODIUM LAURYL ETHER SULFATE Dosage forms for parasiticide use

SODIUM PHOSPHATE Dosage forms for parenteral use

SODIUM TETRADECYLSULFATE Dosage forms for use as sclerosing agent

STRAMONIUM, ITS PREPARATIONS,
EXTRACTS AND COMPOUNDS

STREPTOKINASE Dosage forms used as debriding agent

STRONTIUM AND ITS SALTS Dosage forms for parenteral use

SUTILAINS

TETRACAINE AND ITS SALTS Dosage forms for ophthalmic or parenteral use

THROMBIN

THYROGLOBULIN

THYROTROPIN

TRYPSIN

UBIQUINONE Dosage forms for oral use containing
10 mg or more

UREA Dosage forms for topical use in concentrations
greater than 25%

VITAMINS Dosage forms for parenteral use other than
those described in Schedule I

WATER FOR INJECTION Dosage forms for parenteral use

XYLOSE

(N) Medication so indicated is also subject to the terms, conditions and
modalities for sale prescribed by the Narcotic Control Regulations (C.R.C., c. 1041).
O.C. 712-98, Sch. II; O.C. 54-2001, s. 3; O.C. 698-2001, s. 2; O.C. 840-2003, s. 1; O.C. 539-2008, s. 1; I.N. 2014-01-01; O.C. 1069-2015, s. 1; O.C. 1432-2018, s. 2; O.C. 1343-2023, s. 1.
SCHEDULE II
(s. 1, 1st par., subpar. 2)
MEDICATIONS FOR HUMAN USE SOLD UNDER PHARMACEUTICAL CONTROL
Except as otherwise provided in the Regulation, this Schedule includes, besides the medications listed below, all the drugs and substances for which notice of withdrawal from the Schedules to the Regulations concerning the sale of drugs and substances made pursuant to the Food and Drugs Act (R.S.C. 1985, c. F-27), from the list established in accordance with section 29.1 of that Act or in the Schedules to the Regulations concerning the sale of drugs and substances made pursuant to the Controlled Drugs and Substances Act (S.C. 1996, c. 19) has been given since 1 July 1998.


Substance Specification



ACETARSOL

ACETYLCYSTEINE

ACETYLSALICYLIC ACID Dosage forms recommended solely for children
AND ITS SALTS

Dosage forms for rectal use

ADIPHENE AND ITS SALTS Dosage forms for parenteral use

ADRENALINE (EPINEPHRINE)
AND ITS SALTS

ALLETHRINS

AMYLOCAINE AND ITS SALTS Dosage forms for ophthalmic or parenteral use

ANISOTROPINE AND ITS SALTS

ANTHRALIN (DITHRANOL)

ANTIHEMOPHILIC FACTOR

ANTIPYRINE Except dosage forms for otic use

APOMORPHINE AND ITS SALTS

ARGININE AND ITS SALTS

ARTEMISIA, ITS PREPARATIONS, EXTRACTS
AND COMPOUNDS

AZELAIC ACID

BACITRACINS, THEIR SALTS AND Except dosage forms for topical use on the
DERIVATIVES skin

BELLADONNA ALKALOIDS, THEIR Dosage forms for oral use
SALTS AND DERIVATIVES

BENOXINATE (OXYBUPROCAINE) Dosage forms for ophthalmic or parenteral use
HYDROCHLORIDE

BENTIROMIDE

BENZALKONIUM AND ITS SALTS Liquid dosage forms in concentrations of more
than 2%

BENZETHONIUM CHLORIDE Liquid dosage forms in concentrations of more
than 1%

BENZOCAINE AND ITS SALTS Dosage forms for ophthalmic or parenteral use

BENZYL BENZOATE

BORIC ACID AND ITS SALTS Dosage forms for systemic or ophthalmic use

BUCLIZINE

BUFEXAMAC

BUPIVACAINE AND ITS SALTS Dosage forms for ophthalmic or parenteral use

BUTACAINE Dosage forms for ophthalmic or parenteral use

CALCIUM CHLORIDE Dosage forms for parenteral use

CALCIUM DISODIUM EDETATE

CALCIUM GLUCONATE Dosage forms for parenteral use

CALCIUM POLYSTYRENE SULFONATE

CAMPHOR Dosage forms in oleaginous vehicles or
liquid forms in concentrations greater than 11%

CANTHARIDES, THEIR PREPARATIONS
AND DERIVATIVES

CAPRYLIC ACID

CAPSAICIN Dosage forms in concentration of 0.075% and
more

CHLOROPROCAINE AND ITS SALTS Dosage forms for ophthalmic or parenteral use

CHOLECYSTOKININ

CHOLINE BITARTRATE Dosage forms for parenteral use

CHROMIC CHLORIDE Dosage forms for parenteral use

CHYMOPAPAIN Dosage forms for parenteral use

CHYMOTRYPSIN Dosage forms for ophthalmic or parenteral use

CINCHOCAINE (DIBUCAINE) Dosage forms for ophthalmic or parenteral use
AND ITS SALTS

CLIDINIUM AND ITS SALTS

(N) CODEINE AND ITS SALTS Solid dosage forms containing not more than
8 mg or its equivalent of codeine phosphate per
tablet or per unit, and liquid dosage forms
containing not more than 20 mg or its
equivalent of codeine phosphate per 30 ml

A- and also containing

i. 2 additional medicinal ingredients other
than a narcotic in quantity of not less than
the regular minimum single dose for one such
ingredient or one-half of the regular minimum
single dose for each such ingredient; or

ii. 3 additional medicinal ingredients
other than a narcotic in quantity of not less
than the regular minimum single dose for one
such ingredient or one-third of the regular
minimum single dose for each such ingredient;
and

B- there is legibly and conspicuously printed
on the main panel of the label and any outer
container the full formula or true list of
all active ingredients and a caution to the
following effect:

“This preparation contains codeine and should
not be administered to children, except on
the advice of a physician or dentist.”

COLLAGENASE Dosage forms used as debriding agent

CROTAMITON

CUPRIC CHLORIDE Dosage forms for parenteral use

CYCLANDELATE

CYCLAZOCINE AND ITS SALTS

CYCLOMETHACAINE AND ITS SALTS Dosage forms for ophthalmic or parenteral use

CYCLOPENTAMINE AND ITS SALTS

CYCLOPENTOLATE AND ITS SALTS Except dosage forms for ophthalmic or
parenteral use

CYPROHEPTADINE AND ITS SALTS

DEHYDRATED ALCOHOL Dosage forms for parenteral use

DESOXYRIBONUCLEASE (PANCREATIC)

DEXTROMETHORPHAN AND ITS SALTS Dosage forms in packaging units containing
more than 850 mg

DEXTROSE Dosage forms for parenteral use or as
diagnostic or sclerosing agent

DIBUCAINE (CINCHOCAINE) Dosage forms for ophthalmic or parenteral use
AND ITS SALTS

DICYCLOMINE AND ITS SALTS

DIHYDROQUINIDINE AND ITS SALTS

DIIODOHYDROXYQUIN (IODOQUINOL) Dosage forms for topical use on the skin

DIMENHYDRINATE AND ITS SALTS

DIPERODON AND ITS SALTS Except dosage forms for topical use

DIPHENHYDRAMINE AND ITS SALTS Dosage forms for parenteral use

DITHRANOL (ANTHRALIN)

DYCLONINE Except lozenges and dosage forms for topical
use

EPHEDRINE AND ITS SALTS Dosage forms for systemic use

EPINEPHRINE (ADRENALINE)
AND ITS SALTS

ERYTHRITYL TETRANITRATE

ESDEPALLETHRIN (PIPERONYL BUTOXIDE)

ETHANOLAMINE OLEATE

ETHOHEPTAZINE

ETHYL CHLORIDE Except in trace amounts

FIBRIN

FIBRINOLYSIN

GLUCAGON

GLUTAMIC ACID AND ITS SALTS Dosage forms recommended as gastric acidifiers

GLYCOPYRROLATE AND ITS SALTS

GRAMICIDIN AND ITS SALTS Except dosage forms for topical use on the skin

HEPARIN AND ITS SALTS Except dosage forms for topical use

HEXAMINE (METHENAMINE) Except dosage forms for topical use
AND ITS SALTS

HISTAMINE AND ITS SALTS Except dosage forms for topical use

HOMATROPINE AND ITS SALTS Dosage forms for oral use containing a
maximum of 2 mg per dosage unit

HUMAN INSULIN

HYALURONIC ACID AND ITS SALTS Dosage forms in concentrations of 5% or more

HYALURONIDASE

HYDROXYEPHEDRINE AND
ITS SALTS

HYOSCINE (SCOPOLAMINE),
ITS SALTS AND DERIVATIVES

HYOSCYAMINE, ITS SALTS
AND DERIVATIVES

INOSITOL NICOTINATE

INSULIN

IODINATED CASEINE

IODINATED GYLCEROL

IODINE, ITS SALTS AND Dosage forms for oral use with recommended
DERIVATIVES daily dosage of more than 1 mg

IODOQUINOL (DIIODOHYDROXYQUIN) Dosage forms for topical use on the skin

IPECAC, ITS EXTRACTS AND
DERIVATIVES

IRON, ITS SALTS AND Dosage forms containing 30 mg or more of
DERIVATIVES elemental iron per dosage unit

ISOPROPAMIDE AND ITS SALTS

LEVARGORPHANE AND ITS SALTS

LEVONORDEFRINE

LIDOCAINE AND ITS SALTS Dosage forms for topical use on mucous
membranes

LINDANE Dosage forms for use as pediculicide or
scabicide agent

LOPERAMIDE AND ITS SALTS Liquid dosage forms for children

MAGNESIUM SULFATE Dosage forms for parenteral use

MANGANESE AND ITS SALTS Dosage forms for parenteral use

MANNITOL AND ITS SALTS

MECLIZINE AND ITS SALTS

MEPIVACAINE AND ITS SALTS Dosage forms for ophthalmic or parenteral use

METATHOHEPTAZINE AND ITS SALTS

METHANTHELINE AND ITS SALTS

METHDILAZINE AND ITS SALTS

METHENAMINE (HEXAMINE) AND Except dosage forms for topical use
ITS SALTS

METHEPTAZINE AND ITS SALTS

METHOCARBAMOL Dosage forms for parenteral use

METHYL SALICYLATE Liquid dosage forms in concentrations of more
than 30%

METHYLENE BLUE Dosage forms for parenteral use

MONOBENZONE

MONOETHANOLAMINE OLEATE

MUPIROCIN

NIACIN (NICOTINIC ACID) Single-ingredient dosage forms containing
50 mg or more per recommended dosage unit

NIACINAMIDE Dosage forms for systemic use containing more
than 125 mg per dosage unit

NICOTINIC ACID (NIACIN) Single-ingredient dosage forms containing
50 mg or more per recommended dosage unit

NITROGLYCERIN Immediate-release dosage forms for sublingual
use or by buccal spray

NORADRENALINE (NOREPINEPHRINE)
AND ITS SALTS

NOREPINEPHRINE (NORADRENALINE)
AND ITS SALTS

OXYBUPROCAINE (BENOXINATE) Dosage forms for ophthalmic or parenteral use
hydrochloride

OXYQUINOLINE

PANCREATIC ENZYMES Dosage forms recommended for cystic fibrosis
treatment

PANCRELIPASE

PAPAIN Dosage forms used as debriding agent

PAROXYPROPIONE

PENTAGASTRIN AND ITS SALTS

PERMETHRIN Dosage forms for topical use as pediculicide
or scabicide agent

PHENOL Dosage forms in concentrations greater than
20%

PHENOXYBENZAMINE AND ITS SALTS

PHYSOSTIGMINE SALICYLATE Dosage forms exclusively for oral or topical
use

PIPERAZINE AND ITS SALTS

PIPERONYL, ITS SALTS,
DERIVATIVES AND THEIR SALTS

PIPERONYL (ESDEPALLETHRIN)
BUTOXIDE

POLYACRYLAMIDE

POLYMYXINS, THEIR SALTS Except dosage forms for topical use on the
AND DERIVATIVES skin

POTASSIUM SALTS Except dosage forms containing 5 mmol or less
per recommended dosage unit

POVIDONE-IODINE Dosage forms for vaginal use except in
concentrations of 5% or less

PRAMOXINE AND ITS SALTS Dosage forms for ophthalmic or parenteral use

PRILOCAINE AND ITS SALTS Dosage forms for ophthalmic or parenteral use

PROCAINE AND ITS SALTS Dosage forms for ophthalmic or parenteral use

PROMETHAZINE AND ITS SALTS Dosage forms for oral use

PROPANTHELINE AND ITS SALTS

PROPARACAINE AND ITS SALTS Dosage forms for ophthalmic or parenteral use

PROPYLHEXEDRINE

PROTAMINE AND ITS SALTS

PSEUDOEPHEDRINE AND ITS SALTS Dosage forms containing no other medicinal
ingredient

Dosage forms in packaging units containing more
than 1,200 mg and containing another medicinal
ingredient

PYRANTEL AND ITS SALTS

PYRETHRINS, NATURAL AND Dosage forms for pediculicide or scabicide use
SYNTHETIC

PYRVINIUM AND ITS SALTS

QUININE AND ITS SALTS Except dosage forms recommended as analgesic
agent

RACEMETHIONINE

ROPIVACAINE AND ITS SALTS

ROSE BENGAL

RUE, ITS PREPARATIONS AND EXTRACTS

SALICYLIC ACID AND ITS SALTS Dosage forms for topical use in concentrations
greater than 40%

SCOPOLAMINE (HYOSCINE),
ITS SALTS AND DERIVATIVES

SELENIUM Dosage forms for parenteral use

SILVER NITRATE

SINCALIDE

SODIUM ACETATE Dosage forms for parenteral use

SODIUM BICARBONATE Dosage forms for parenteral use

SODIUM BIPHOSPHATE Dosage forms for parenteral use

SODIUM CHLORIDE Single-ingredient dosage forms for parenteral
use

Dosage forms for ophthalmic use in
concentrations greater than 0.9%

SODIUM CITRATE Dosage forms for parenteral use

SODIUM CROMOGLICATE Dosage forms for ophthalmic use in
concentrations of 2% or less

SODIUM IODIDE Dosage forms used as sclerosing agent

SODIUM LAURYL ETHER SULFATE Dosage forms for parasiticide use

SODIUM PHOSPHATE Dosage forms for parenteral use

SODIUM TETRADECYLSULFATE Dosage forms for use as sclerosing agent

STRAMONIUM, ITS PREPARATIONS,
EXTRACTS AND COMPOUNDS

STREPTOKINASE Dosage forms used as debriding agent

STRONTIUM AND ITS SALTS Dosage forms for parenteral use

SUTILAINS

TETRACAINE AND ITS SALTS Dosage forms for ophthalmic or parenteral use

THROMBIN

THYROGLOBULIN

THYROTROPIN

TRYPSIN

UBIQUINONE Dosage forms for oral use containing
10 mg or more

UREA Dosage forms for topical use in concentrations
greater than 25%

VITAMINS Dosage forms for parenteral use other than
those described in Schedule I

WATER FOR INJECTION Dosage forms for parenteral use

XYLOSE

(N) Medication so indicated is also subject to the terms, conditions and
modalities for sale prescribed by the Narcotic Control Regulations (C.R.C., c. 1041).
O.C. 712-98, Sch. II; O.C. 54-2001, s. 3; O.C. 698-2001, s. 2; O.C. 840-2003, s. 1; O.C. 539-2008, s. 1; I.N. 2014-01-01; O.C. 1069-2015, s. 1; O.C. 1432-2018, s. 2.
SCHEDULE II
(s. 1, 1st par., subpar. 2)
MEDICATIONS FOR HUMAN USE SOLD UNDER PHARMACEUTICAL CONTROL
Except as otherwise provided in the Regulation, this Schedule includes, besides the medications listed below, all the drugs and substances for which notice of withdrawal from the Schedules to the Regulations concerning the sale of drugs and substances made pursuant to the Food and Drugs Act (R.S.C. 1985, c. F-27), from the list established in accordance with section 29.1 of that Act or in the Schedules to the Regulations concerning the sale of drugs and substances made pursuant to the Controlled Drugs and Substances Act (S.C. 1996, c. 19) has been given since 1 July 1998.


Substance Specification



ACETARSOL

ACETYLCYSTEINE

ACETYLSALICYLIC ACID Dosage forms recommended solely for children
AND ITS SALTS

Dosage forms for rectal use

ADIPHENE AND ITS SALTS Dosage forms for parenteral use

ADRENALINE (EPINEPHRINE)
AND ITS SALTS

ALLETHRINS

AMYLOCAINE AND ITS SALTS Dosage forms for ophthalmic or parenteral use

ANISOTROPINE AND ITS SALTS

ANTHRALIN (DITHRANOL)

ANTIHEMOPHILIC FACTOR

ANTIPYRINE Except dosage forms for otic use

APOMORPHINE AND ITS SALTS

ARGININE AND ITS SALTS

ARTEMISIA, ITS PREPARATIONS, EXTRACTS
AND COMPOUNDS

AZELAIC ACID

BACITRACINS, THEIR SALTS AND Except dosage forms for topical use on the
DERIVATIVES skin

BELLADONNA ALKALOIDS, THEIR Dosage forms for oral use
SALTS AND DERIVATIVES

BENOXINATE (OXYBUPROCAINE) Dosage forms for ophthalmic or parenteral use
HYDROCHLORIDE

BENTIROMIDE

BENZALKONIUM AND ITS SALTS Liquid dosage forms in concentrations of more
than 2%

BENZETHONIUM CHLORIDE Liquid dosage forms in concentrations of more
than 1%

BENZOCAINE AND ITS SALTS Dosage forms for ophthalmic or parenteral use

BENZYL BENZOATE

BORIC ACID AND ITS SALTS Dosage forms for systemic or ophthalmic use

BUCLIZINE

BUFEXAMAC

BUPIVACAINE AND ITS SALTS Dosage forms for ophthalmic or parenteral use

BUTACAINE Dosage forms for ophthalmic or parenteral use

CALCIUM CHLORIDE Dosage forms for parenteral use

CALCIUM DISODIUM EDETATE

CALCIUM GLUCONATE Dosage forms for parenteral use

CALCIUM POLYSTYRENE SULFONATE

CAMPHOR Dosage forms in oleaginous vehicles or
liquid forms in concentrations greater than 11%

CANTHARIDES, THEIR PREPARATIONS
AND DERIVATIVES

CAPRYLIC ACID

CAPSAICIN Dosage forms in concentration of 0.075% and
more

CHLOROPROCAINE AND ITS SALTS Dosage forms for ophthalmic or parenteral use

CHOLECYSTOKININ

CHOLINE BITARTRATE Dosage forms for parenteral use

CHROMIC CHLORIDE Dosage forms for parenteral use

CHYMOPAPAIN Dosage forms for parenteral use

CHYMOTRYPSIN Dosage forms for ophthalmic or parenteral use

CINCHOCAINE (DIBUCAINE) Dosage forms for ophthalmic or parenteral use
AND ITS SALTS

CLIDINIUM AND ITS SALTS

(N) CODEINE AND ITS SALTS Solid dosage forms containing not more than
8 mg or its equivalent of codeine phosphate per
tablet or per unit, and liquid dosage forms
containing not more than 20 mg or its
equivalent of codeine phosphate per 30 ml

A- and also containing

i. 2 additional medicinal ingredients other
than a narcotic in quantity of not less than
the regular minimum single dose for one such
ingredient or one-half of the regular minimum
single dose for each such ingredient; or

ii. 3 additional medicinal ingredients
other than a narcotic in quantity of not less
than the regular minimum single dose for one
such ingredient or one-third of the regular
minimum single dose for each such ingredient;
and

B- there is legibly and conspicuously printed
on the main panel of the label and any outer
container the full formula or true list of
all active ingredients and a caution to the
following effect:

“This preparation contains codeine and should
not be administered to children, except on
the advice of a physician or dentist.”

COLLAGENASE Dosage forms used as debriding agent

CROTAMITON

CUPRIC CHLORIDE Dosage forms for parenteral use

CYCLANDELATE

CYCLAZOCINE AND ITS SALTS

CYCLOMETHACAINE AND ITS SALTS Dosage forms for ophthalmic or parenteral use

CYCLOPENTAMINE AND ITS SALTS

CYCLOPENTOLATE AND ITS SALTS Except dosage forms for ophthalmic or
parenteral use

CYPROHEPTADINE AND ITS SALTS

DEHYDRATED ALCOHOL Dosage forms for parenteral use

DESOXYRIBONUCLEASE (PANCREATIC)

DEXTROMETHORPHAN AND ITS SALTS Dosage forms in packaging units containing
more than 850 mg

DEXTROSE Dosage forms for parenteral use or as
diagnostic or sclerosing agent

DIBUCAINE (CINCHOCAINE) Dosage forms for ophthalmic or parenteral use
AND ITS SALTS

DICYCLOMINE AND ITS SALTS

DIHYDROQUINIDINE AND ITS SALTS

DIIODOHYDROXYQUIN (IODOQUINOL) Dosage forms for topical use on the skin

DIMENHYDRINATE AND ITS SALTS

DIPERODON AND ITS SALTS Except dosage forms for topical use

DIPHENHYDRAMINE AND ITS SALTS Dosage forms for parenteral use

DITHRANOL (ANTHRALIN)

DYCLONINE Except lozenges and dosage forms for topical
use

EPHEDRINE AND ITS SALTS Dosage forms for systemic use

EPINEPHRINE (ADRENALINE)
AND ITS SALTS

ERYTHRITYL TETRANITRATE

ESDEPALLETHRIN (PIPERONYL BUTOXIDE)

ETHANOLAMINE OLEATE

ETHOHEPTAZINE

ETHYL CHLORIDE Except in trace amounts

FIBRIN

FIBRINOLYSIN

GLUCAGON

GLUTAMIC ACID AND ITS SALTS Dosage forms recommended as gastric acidifiers

GLYCOPYRROLATE AND ITS SALTS

GRAMICIDIN AND ITS SALTS Except dosage forms for topical use on the skin

HEPARIN AND ITS SALTS Except dosage forms for topical use

HEXAMINE (METHENAMINE) Except dosage forms for topical use
AND ITS SALTS

HISTAMINE AND ITS SALTS Except dosage forms for topical use

HOMATROPINE AND ITS SALTS Dosage forms for oral use containing a
maximum of 2 mg per dosage unit

HUMAN INSULIN

HYALURONIC ACID AND ITS SALTS Dosage forms in concentrations of 5% or more

HYALURONIDASE

HYDROQUINONE Dosage forms for topical use in concentrations
of 2% or more

HYDROXYEPHEDRINE AND
ITS SALTS

HYOSCINE (SCOPOLAMINE),
ITS SALTS AND DERIVATIVES

HYOSCYAMINE, ITS SALTS
AND DERIVATIVES

INOSITOL NICOTINATE

INSULIN

IODINATED CASEINE

IODINATED GYLCEROL

IODINE, ITS SALTS AND Dosage forms for oral use with recommended
DERIVATIVES daily dosage of more than 1 mg

IODOQUINOL (DIIODOHYDROXYQUIN) Dosage forms for topical use on the skin

IPECAC, ITS EXTRACTS AND
DERIVATIVES

IRON, ITS SALTS AND Dosage forms containing 30 mg or more of
DERIVATIVES elemental iron per dosage unit

ISOPROPAMIDE AND ITS SALTS

LEVARGORPHANE AND ITS SALTS

LEVONORDEFRINE

LIDOCAINE AND ITS SALTS Dosage forms for topical use on mucous
membranes

LINDANE Dosage forms for use as pediculicide or
scabicide agent

LOPERAMIDE AND ITS SALTS Liquid dosage forms for children

MAGNESIUM SULFATE Dosage forms for parenteral use

MANGANESE AND ITS SALTS Dosage forms for parenteral use

MANNITOL AND ITS SALTS

MECLIZINE AND ITS SALTS

MEPIVACAINE AND ITS SALTS Dosage forms for ophthalmic or parenteral use

METATHOHEPTAZINE AND ITS SALTS

METHANTHELINE AND ITS SALTS

METHDILAZINE AND ITS SALTS

METHENAMINE (HEXAMINE) AND Except dosage forms for topical use
ITS SALTS

METHEPTAZINE AND ITS SALTS

METHOCARBAMOL Dosage forms for parenteral use

METHYL SALICYLATE Liquid dosage forms in concentrations of more
than 30%

METHYLENE BLUE Dosage forms for parenteral use

MONOBENZONE

MONOETHANOLAMINE OLEATE

MUPIROCIN

NIACIN (NICOTINIC ACID) Single-ingredient dosage forms containing
50 mg or more per recommended dosage unit

NIACINAMIDE Dosage forms for systemic use containing more
than 125 mg per dosage unit

NICOTINIC ACID (NIACIN) Single-ingredient dosage forms containing
50 mg or more per recommended dosage unit

NITROGLYCERIN Immediate-release dosage forms for sublingual
use or by buccal spray

NORADRENALINE (NOREPINEPHRINE)
AND ITS SALTS

NOREPINEPHRINE (NORADRENALINE)
AND ITS SALTS

OXYBUPROCAINE (BENOXINATE) Dosage forms for ophthalmic or parenteral use
hydrochloride

OXYQUINOLINE

PANCREATIC ENZYMES Dosage forms recommended for cystic fibrosis
treatment

PANCRELIPASE

PAPAIN Dosage forms used as debriding agent

PAROXYPROPIONE

PENTAGASTRIN AND ITS SALTS

PERMETHRIN Dosage forms for topical use as pediculicide
or scabicide agent

PHENOL Dosage forms in concentrations greater than
20%

PHENOXYBENZAMINE AND ITS SALTS

PHYSOSTIGMINE SALICYLATE Dosage forms exclusively for oral or topical
use

PIPERAZINE AND ITS SALTS

PIPERONYL, ITS SALTS,
DERIVATIVES AND THEIR SALTS

PIPERONYL (ESDEPALLETHRIN)
BUTOXIDE

POLYACRYLAMIDE

POLYMYXINS, THEIR SALTS Except dosage forms for topical use on the
AND DERIVATIVES skin

POTASSIUM SALTS Except dosage forms containing 5 mmol or less
per recommended dosage unit

POVIDONE-IODINE Dosage forms for vaginal use except in
concentrations of 5% or less

PRAMOXINE AND ITS SALTS Dosage forms for ophthalmic or parenteral use

PRILOCAINE AND ITS SALTS Dosage forms for ophthalmic or parenteral use

PROCAINE AND ITS SALTS Dosage forms for ophthalmic or parenteral use

PROMETHAZINE AND ITS SALTS Dosage forms for oral use

PROPANTHELINE AND ITS SALTS

PROPARACAINE AND ITS SALTS Dosage forms for ophthalmic or parenteral use

PROPYLHEXEDRINE

PROTAMINE AND ITS SALTS

PSEUDOEPHEDRINE AND ITS SALTS Dosage forms containing no other medicinal
ingredient

Dosage forms in packaging units containing more
than 1,200 mg and containing another medicinal
ingredient

PYRANTEL AND ITS SALTS

PYRETHRINS, NATURAL AND Dosage forms for pediculicide or scabicide use
SYNTHETIC

PYRVINIUM AND ITS SALTS

QUININE AND ITS SALTS Except dosage forms recommended as analgesic
agent

RACEMETHIONINE

ROPIVACAINE AND ITS SALTS

ROSE BENGAL

RUE, ITS PREPARATIONS AND EXTRACTS

SALICYLIC ACID AND ITS SALTS Dosage forms for topical use in concentrations
greater than 40%

SCOPOLAMINE (HYOSCINE),
ITS SALTS AND DERIVATIVES

SELENIUM Dosage forms for parenteral use

SILVER NITRATE

SINCALIDE

SODIUM ACETATE Dosage forms for parenteral use

SODIUM BICARBONATE Dosage forms for parenteral use

SODIUM BIPHOSPHATE Dosage forms for parenteral use

SODIUM CHLORIDE Single-ingredient dosage forms for parenteral
use

Dosage forms for ophthalmic use in
concentrations greater than 0.9%

SODIUM CITRATE Dosage forms for parenteral use

SODIUM CROMOGLICATE Dosage forms for ophthalmic use in
concentrations of 2% or less

SODIUM IODIDE Dosage forms used as sclerosing agent

SODIUM LAURYL ETHER SULFATE Dosage forms for parasiticide use

SODIUM PHOSPHATE Dosage forms for parenteral use

SODIUM TETRADECYLSULFATE Dosage forms for use as sclerosing agent

STRAMONIUM, ITS PREPARATIONS,
EXTRACTS AND COMPOUNDS

STREPTOKINASE Dosage forms used as debriding agent

STRONTIUM AND ITS SALTS Dosage forms for parenteral use

SUTILAINS

TETRACAINE AND ITS SALTS Dosage forms for ophthalmic or parenteral use

THROMBIN

THYROGLOBULIN

THYROTROPIN

TRYPSIN

UBIQUINONE Dosage forms for oral use containing
10 mg or more

UREA Dosage forms for topical use in concentrations
greater than 25%

VITAMINS Dosage forms for parenteral use other than
those described in Schedule I

WATER FOR INJECTION Dosage forms for parenteral use

XYLOSE

(N) Medication so indicated is also subject to the terms, conditions and
modalities for sale prescribed by the Narcotic Control Regulations (C.R.C., c. 1041).
O.C. 712-98, Sch. II; O.C. 54-2001, s. 3; O.C. 698-2001, s. 2; O.C. 840-2003, s. 1; O.C. 539-2008, s. 1; I.N. 2014-01-01; O.C. 1069-2015, s. 1.
SCHEDULE II
(s. 1, 1st par., subpar. 2)
MEDICATIONS FOR HUMAN USE SOLD UNDER PHARMACEUTICAL CONTROL
Except as otherwise provided in the Regulation, this Schedule includes, besides the medications listed below, all the drugs and substances for which notice of withdrawal from the Schedules to the Regulations concerning the sale of drugs and substances made pursuant to the Food and Drugs Act (R.S.C. 1985, c. F-27), from the list established in accordance with section 29.1 of that Act or in the Schedules to the Regulations concerning the sale of drugs and substances made pursuant to the Controlled Drugs and Substances Act (S.C. 1996, c. 19) has been given since 1 July 1998.


Substance Specification



ACETARSOL

ACETYLCYSTEINE

ACETYLSALICYLIC ACID Dosage forms recommended solely for children
AND ITS SALTS

Dosage forms for rectal use

ADIPHENE AND ITS SALTS Dosage forms for parenteral use

ADRENALINE (EPINEPHRINE)
AND ITS SALTS

ALLETHRINS

AMYLOCAINE AND ITS SALTS Dosage forms for ophthalmic or parenteral use

ANISOTROPINE AND ITS SALTS

ANTHRALIN (DITHRANOL)

ANTIHEMOPHILIC FACTOR

ANTIPYRINE Except dosage forms for otic use

APOMORPHINE AND ITS SALTS

ARGININE AND ITS SALTS

ARTEMISIA, ITS PREPARATIONS, EXTRACTS
AND COMPOUNDS

AZELAIC ACID

BACITRACINS, THEIR SALTS AND Except dosage forms for topical use on the
DERIVATIVES skin

BELLADONNA ALKALOIDS, THEIR Dosage forms for oral use
SALTS AND DERIVATIVES

BENOXINATE (OXYBUPROCAINE) Dosage forms for ophthalmic or parenteral use
HYDROCHLORIDE

BENTIROMIDE

BENZALKONIUM AND ITS SALTS Liquid dosage forms in concentrations of more
than 2%

BENZETHONIUM CHLORIDE Liquid dosage forms in concentrations of more
than 1%

BENZOCAINE AND ITS SALTS Dosage forms for ophthalmic or parenteral use

BENZYL BENZOATE

BORIC ACID AND ITS SALTS Dosage forms for systemic or ophthalmic use

BUCLIZINE

BUFEXAMAC

BUPIVACAINE AND ITS SALTS Dosage forms for ophthalmic or parenteral use

BUTACAINE Dosage forms for ophthalmic or parenteral use

CALCIUM CHLORIDE Dosage forms for parenteral use

CALCIUM DISODIUM EDETATE

CALCIUM GLUCONATE Dosage forms for parenteral use

CALCIUM POLYSTYRENE SULFONATE

CAMPHOR Dosage forms in oleaginous vehicles or
liquid forms in concentrations greater than 11%

CANTHARIDES, THEIR PREPARATIONS
AND DERIVATIVES

CAPRYLIC ACID

CAPSAICIN Dosage forms in concentration of 0.075% and
more

CHLOROPROCAINE AND ITS SALTS Dosage forms for ophthalmic or parenteral use

CHOLECYSTOKININ

CHOLINE BITARTRATE Dosage forms for parenteral use

CHROMIC CHLORIDE Dosage forms for parenteral use

CHYMOPAPAIN Dosage forms for parenteral use

CHYMOTRYPSIN Dosage forms for ophthalmic or parenteral use

CINCHOCAINE (DIBUCAINE) Dosage forms for ophthalmic or parenteral use
AND ITS SALTS

CLIDINIUM AND ITS SALTS

(N) CODEINE AND ITS SALTS Solid dosage forms containing not more than
8 mg or its equivalent of codeine phosphate per
tablet or per unit, and liquid dosage forms
containing not more than 20 mg or its
equivalent of codeine phosphate per 30 ml

A- and also containing

i. 2 additional medicinal ingredients other
than a narcotic in quantity of not less than
the regular minimum single dose for one such
ingredient or one-half of the regular minimum
single dose for each such ingredient; or

ii. 3 additional medicinal ingredients
other than a narcotic in quantity of not less
than the regular minimum single dose for one
such ingredient or one-third of the regular
minimum single dose for each such ingredient;
and

B- there is legibly and conspicuously printed
on the main panel of the label and any outer
container the full formula or true list of
all active ingredients and a caution to the
following effect:

“This preparation contains codeine and should
not be administered to children, except on
the advice of a physician or dentist.”

COLLAGENASE Dosage forms used as debriding agent

CROTAMITON

CUPRIC CHLORIDE Dosage forms for parenteral use

CYCLANDELATE

CYCLAZOCINE AND ITS SALTS

CYCLOMETHACAINE AND ITS SALTS Dosage forms for ophthalmic or parenteral use

CYCLOPENTAMINE AND ITS SALTS

CYCLOPENTOLATE AND ITS SALTS Except dosage forms for ophthalmic or
parenteral use

CYPROHEPTADINE AND ITS SALTS

DEHYDRATED ALCOHOL Dosage forms for parenteral use

DESOXYRIBONUCLEASE (PANCREATIC)

DEXTROSE Dosage forms for parenteral use or as
diagnostic or sclerosing agent

DIBUCAINE (CINCHOCAINE) Dosage forms for ophthalmic or parenteral use
AND ITS SALTS

DICYCLOMINE AND ITS SALTS

DIHYDROQUINIDINE AND ITS SALTS

DIIODOHYDROXYQUIN (IODOQUINOL) Dosage forms for topical use on the skin

DIMENHYDRINATE AND ITS SALTS

DIPERODON AND ITS SALTS Except dosage forms for topical use

DIPHENHYDRAMINE AND ITS SALTS Dosage forms for parenteral use

DITHRANOL (ANTHRALIN)

DYCLONINE Except lozenges and dosage forms for topical
use

EPHEDRINE AND ITS SALTS Dosage forms for systemic use

EPINEPHRINE (ADRENALINE)
AND ITS SALTS

ERYTHRITYL TETRANITRATE

ESDEPALLETHRIN (PIPERONYL BUTOXIDE)

ETHANOLAMINE OLEATE

ETHOHEPTAZINE

ETHYL CHLORIDE Except in trace amounts

FIBRIN

FIBRINOLYSIN

GLUCAGON

GLUTAMIC ACID AND ITS SALTS Dosage forms recommended as gastric acidifiers

GLYCOPYRROLATE AND ITS SALTS

GRAMICIDIN AND ITS SALTS Except dosage forms for topical use on the skin

HEPARIN AND ITS SALTS Except dosage forms for topical use

HEXAMINE (METHENAMINE) Except dosage forms for topical use
AND ITS SALTS

HISTAMINE AND ITS SALTS Except dosage forms for topical use

HOMATROPINE AND ITS SALTS Dosage forms for oral use containing a
maximum of 2 mg per dosage unit

HUMAN INSULIN

HYALURONIC ACID AND ITS SALTS Dosage forms in concentrations of 5% or more

HYALURONIDASE

HYDROQUINONE Dosage forms for topical use in concentrations
of 2% or more

HYDROXYEPHEDRINE AND
ITS SALTS

HYOSCINE (SCOPOLAMINE),
ITS SALTS AND DERIVATIVES

HYOSCYAMINE, ITS SALTS
AND DERIVATIVES

INOSITOL NICOTINATE

INSULIN

IODINATED CASEINE

IODINATED GYLCEROL

IODINE, ITS SALTS AND Dosage forms for oral use with recommended
DERIVATIVES daily dosage of more than 1 mg

IODOQUINOL (DIIODOHYDROXYQUIN) Dosage forms for topical use on the skin

IPECAC, ITS EXTRACTS AND
DERIVATIVES

IRON, ITS SALTS AND Dosage forms containing 30 mg or more of
DERIVATIVES elemental iron per dosage unit

ISOPROPAMIDE AND ITS SALTS

LEVARGORPHANE AND ITS SALTS

LEVONORDEFRINE

LIDOCAINE AND ITS SALTS Dosage forms for topical use on mucous
membranes

LINDANE Dosage forms for use as pediculicide or
scabicide agent

LOPERAMIDE AND ITS SALTS Liquid dosage forms for children

MAGNESIUM SULFATE Dosage forms for parenteral use

MANGANESE AND ITS SALTS Dosage forms for parenteral use

MANNITOL AND ITS SALTS

MECLIZINE AND ITS SALTS

MEPIVACAINE AND ITS SALTS Dosage forms for ophthalmic or parenteral use

METATHOHEPTAZINE AND ITS SALTS

METHANTHELINE AND ITS SALTS

METHDILAZINE AND ITS SALTS

METHENAMINE (HEXAMINE) AND Except dosage forms for topical use
ITS SALTS

METHEPTAZINE AND ITS SALTS

METHOCARBAMOL Dosage forms for parenteral use

METHYL SALICYLATE Liquid dosage forms in concentrations of more
than 30%

METHYLENE BLUE Dosage forms for parenteral use

MONOBENZONE

MONOETHANOLAMINE OLEATE

MUPIROCIN

NIACIN (NICOTINIC ACID) Single-ingredient dosage forms containing
50 mg or more per recommended dosage unit

NIACINAMIDE Dosage forms for systemic use containing more
than 125 mg per dosage unit

NICOTINIC ACID (NIACIN) Single-ingredient dosage forms containing
50 mg or more per recommended dosage unit

NITROGLYCERIN Immediate-release dosage forms for sublingual
use or by buccal spray

NORADRENALINE (NOREPINEPHRINE)
AND ITS SALTS

NOREPINEPHRINE (NORADRENALINE)
AND ITS SALTS

OXYBUPROCAINE (BENOXINATE) Dosage forms for ophthalmic or parenteral use
hydrochloride

OXYQUINOLINE

PANCREATIC ENZYMES Dosage forms recommended for cystic fibrosis
treatment

PANCRELIPASE

PAPAIN Dosage forms used as debriding agent

PAROXYPROPIONE

PENTAGASTRIN AND ITS SALTS

PERMETHRIN Dosage forms for topical use as pediculicide
or scabicide agent

PHENOL Dosage forms in concentrations greater than
20%

PHENOXYBENZAMINE AND ITS SALTS

PHYSOSTIGMINE SALICYLATE Dosage forms exclusively for oral or topical
use

PIPERAZINE AND ITS SALTS

PIPERONYL, ITS SALTS,
DERIVATIVES AND THEIR SALTS

PIPERONYL (ESDEPALLETHRIN)
BUTOXIDE

POLYACRYLAMIDE

POLYMYXINS, THEIR SALTS Except dosage forms for topical use on the
AND DERIVATIVES skin

POTASSIUM SALTS Except dosage forms containing 5 mmol or less
per recommended dosage unit

POVIDONE-IODINE Dosage forms for vaginal use except in
concentrations of 5% or less

PRAMOXINE AND ITS SALTS Dosage forms for ophthalmic or parenteral use

PRILOCAINE AND ITS SALTS Dosage forms for ophthalmic or parenteral use

PROCAINE AND ITS SALTS Dosage forms for ophthalmic or parenteral use

PROMETHAZINE AND ITS SALTS Dosage forms for oral use

PROPANTHELINE AND ITS SALTS

PROPARACAINE AND ITS SALTS Dosage forms for ophthalmic or parenteral use

PROPYLHEXEDRINE

PROTAMINE AND ITS SALTS

PYRANTEL AND ITS SALTS

PYRETHRINS, NATURAL AND Dosage forms for pediculicide or scabicide use
SYNTHETIC

PYRVINIUM AND ITS SALTS

QUININE AND ITS SALTS Except dosage forms recommended as analgesic
agent

RACEMETHIONINE

ROPIVACAINE AND ITS SALTS

ROSE BENGAL

RUE, ITS PREPARATIONS AND EXTRACTS

SALICYLIC ACID AND ITS SALTS Dosage forms for topical use in concentrations
greater than 40%

SCOPOLAMINE (HYOSCINE),
ITS SALTS AND DERIVATIVES

SELENIUM Dosage forms for parenteral use

SILVER NITRATE

SINCALIDE

SODIUM ACETATE Dosage forms for parenteral use

SODIUM BICARBONATE Dosage forms for parenteral use

SODIUM BIPHOSPHATE Dosage forms for parenteral use

SODIUM CHLORIDE Single-ingredient dosage forms for parenteral
use

Dosage forms for ophthalmic use in
concentrations greater than 0.9%

SODIUM CITRATE Dosage forms for parenteral use

SODIUM CROMOGLICATE Dosage forms for ophthalmic use in
concentrations of 2% or less

SODIUM IODIDE Dosage forms used as sclerosing agent

SODIUM LAURYL ETHER SULFATE Dosage forms for parasiticide use

SODIUM PHOSPHATE Dosage forms for parenteral use

SODIUM TETRADECYLSULFATE Dosage forms for use as sclerosing agent

STRAMONIUM, ITS PREPARATIONS,
EXTRACTS AND COMPOUNDS

STREPTOKINASE Dosage forms used as debriding agent

STRONTIUM AND ITS SALTS Dosage forms for parenteral use

SUTILAINS

TETRACAINE AND ITS SALTS Dosage forms for ophthalmic or parenteral use

THROMBIN

THYROGLOBULIN

THYROTROPIN

TRYPSIN

UBIQUINONE Dosage forms for oral use containing
10 mg or more

UREA Dosage forms for topical use in concentrations
greater than 25%

VITAMINS Dosage forms for parenteral use other than
those described in Schedule I

WATER FOR INJECTION Dosage forms for parenteral use

XYLOSE

(N) Medication so indicated is also subject to the terms, conditions and
modalities for sale prescribed by the Narcotic Control Regulations (C.R.C., c. 1041).
O.C. 712-98, Sch. II; O.C. 54-2001, s. 3; O.C. 698-2001, s. 2; O.C. 840-2003, s. 1; O.C. 539-2008, s. 1; I.N. 2014-01-01.
SCHEDULE II
(s. 1, 1st par., subpar. 2)
MEDICATIONS FOR HUMAN USE SOLD UNDER PHARMACEUTICAL CONTROL
Except as otherwise provided in the Regulation, this Schedule includes, besides the medications listed below, all the drugs and substances for which notice of withdrawal from the Schedules to the Regulations concerning the sale of drugs and substances made pursuant to the Food and Drugs Act (R.S.C. 1985, c. F-27) or the Controlled Drugs and Substances Act (S.C. 1996, c. 19) has been given since 1 July 1998.


Substance Specification



ACETARSOL

ACETYLCYSTEINE

ACETYLSALICYLIC ACID Dosage forms recommended solely for children
AND ITS SALTS

Dosage forms for rectal use

ADIPHENE AND ITS SALTS Dosage forms for parenteral use

ADRENALINE (EPINEPHRINE)
AND ITS SALTS

ALLETHRINS

AMYLOCAINE AND ITS SALTS Dosage forms for ophthalmic or parenteral use

ANISOTROPINE AND ITS SALTS

ANTHRALIN (DITHRANOL)

ANTIHEMOPHILIC FACTOR

ANTIPYRINE Except dosage forms for otic use

APOMORPHINE AND ITS SALTS

ARGININE AND ITS SALTS

ARTEMISIA, ITS PREPARATIONS, EXTRACTS
AND COMPOUNDS

AZELAIC ACID

BACITRACINS, THEIR SALTS AND Except dosage forms for topical use on the
DERIVATIVES skin

BELLADONNA ALKALOIDS, THEIR Dosage forms for oral use
SALTS AND DERIVATIVES

BENOXINATE (OXYBUPROCAINE) Dosage forms for ophthalmic or parenteral use
HYDROCHLORIDE

BENTIROMIDE

BENZALKONIUM AND ITS SALTS Liquid dosage forms in concentrations of more
than 2%

BENZETHONIUM CHLORIDE Liquid dosage forms in concentrations of more
than 1%

BENZOCAINE AND ITS SALTS Dosage forms for ophthalmic or parenteral use

BENZYL BENZOATE

BORIC ACID AND ITS SALTS Dosage forms for systemic or ophthalmic use

BUCLIZINE

BUFEXAMAC

BUPIVACAINE AND ITS SALTS Dosage forms for ophthalmic or parenteral use

BUTACAINE Dosage forms for ophthalmic or parenteral use

CALCIUM CHLORIDE Dosage forms for parenteral use

CALCIUM DISODIUM EDETATE

CALCIUM GLUCONATE Dosage forms for parenteral use

CALCIUM POLYSTYRENE SULFONATE

CAMPHOR Dosage forms in oleaginous vehicles or
liquid forms in concentrations greater than 11%

CANTHARIDES, THEIR PREPARATIONS
AND DERIVATIVES

CAPRYLIC ACID

CAPSAICIN Dosage forms in concentration of 0.075% and
more

CHLOROPROCAINE AND ITS SALTS Dosage forms for ophthalmic or parenteral use

CHOLECYSTOKININ

CHOLINE BITARTRATE Dosage forms for parenteral use

CHROMIC CHLORIDE Dosage forms for parenteral use

CHYMOPAPAIN Dosage forms for parenteral use

CHYMOTRYPSIN Dosage forms for ophthalmic or parenteral use

CINCHOCAINE (DIBUCAINE) Dosage forms for ophthalmic or parenteral use
AND ITS SALTS

CLIDINIUM AND ITS SALTS

(N) CODEINE AND ITS SALTS Solid dosage forms containing not more than
8 mg or its equivalent of codeine phosphate per
tablet or per unit, and liquid dosage forms
containing not more than 20 mg or its
equivalent of codeine phosphate per 30 ml

A- and also containing

i. 2 additional medicinal ingredients other
than a narcotic in quantity of not less than
the regular minimum single dose for one such
ingredient or one-half of the regular minimum
single dose for each such ingredient; or

ii. 3 additional medicinal ingredients
other than a narcotic in quantity of not less
than the regular minimum single dose for one
such ingredient or one-third of the regular
minimum single dose for each such ingredient;
and

B- there is legibly and conspicuously printed
on the main panel of the label and any outer
container the full formula or true list of
all active ingredients and a caution to the
following effect:

“This preparation contains codeine and should
not be administered to children, except on
the advice of a physician or dentist.”

COLLAGENASE Dosage forms used as debriding agent

CROTAMITON

CUPRIC CHLORIDE Dosage forms for parenteral use

CYCLANDELATE

CYCLAZOCINE AND ITS SALTS

CYCLOMETHACAINE AND ITS SALTS Dosage forms for ophthalmic or parenteral use

CYCLOPENTAMINE AND ITS SALTS

CYCLOPENTOLATE AND ITS SALTS Except dosage forms for ophthalmic or
parenteral use

CYPROHEPTADINE AND ITS SALTS

DEHYDRATED ALCOHOL Dosage forms for parenteral use

DESOXYRIBONUCLEASE (PANCREATIC)

DEXTROSE Dosage forms for parenteral use or as
diagnostic or sclerosing agent

DIBUCAINE (CINCHOCAINE) Dosage forms for ophthalmic or parenteral use
AND ITS SALTS

DICYCLOMINE AND ITS SALTS

DIHYDROQUINIDINE AND ITS SALTS

DIIODOHYDROXYQUIN (IODOQUINOL) Dosage forms for topical use on the skin

DIMENHYDRINATE AND ITS SALTS

DIPERODON AND ITS SALTS Except dosage forms for topical use

DIPHENHYDRAMINE AND ITS SALTS Dosage forms for parenteral use

DITHRANOL (ANTHRALIN)

DYCLONINE Except lozenges and dosage forms for topical
use

EPHEDRINE AND ITS SALTS Dosage forms for systemic use

EPINEPHRINE (ADRENALINE)
AND ITS SALTS

ERYTHRITYL TETRANITRATE

ESDEPALLETHRIN (PIPERONYL BUTOXIDE)

ETHANOLAMINE OLEATE

ETHOHEPTAZINE

ETHYL CHLORIDE Except in trace amounts

FIBRIN

FIBRINOLYSIN

GLUCAGON

GLUTAMIC ACID AND ITS SALTS Dosage forms recommended as gastric acidifiers

GLYCOPYRROLATE AND ITS SALTS

GRAMICIDIN AND ITS SALTS Except dosage forms for topical use on the skin

HEPARIN AND ITS SALTS Except dosage forms for topical use

HEXAMINE (METHENAMINE) Except dosage forms for topical use
AND ITS SALTS

HISTAMINE AND ITS SALTS Except dosage forms for topical use

HOMATROPINE AND ITS SALTS Dosage forms for oral use containing a
maximum of 2 mg per dosage unit

HUMAN INSULIN

HYALURONIC ACID AND ITS SALTS Dosage forms in concentrations of 5% or more

HYALURONIDASE

HYDROQUINONE Dosage forms for topical use in concentrations
of 2% or more

HYDROXYEPHEDRINE AND
ITS SALTS

HYOSCINE (SCOPOLAMINE),
ITS SALTS AND DERIVATIVES

HYOSCYAMINE, ITS SALTS
AND DERIVATIVES

INOSITOL NICOTINATE

INSULIN

IODINATED CASEINE

IODINATED GYLCEROL

IODINE, ITS SALTS AND Dosage forms for oral use with recommended
DERIVATIVES daily dosage of more than 1 mg

IODOQUINOL (DIIODOHYDROXYQUIN) Dosage forms for topical use on the skin

IPECAC, ITS EXTRACTS AND
DERIVATIVES

IRON, ITS SALTS AND Dosage forms containing 30 mg or more of
DERIVATIVES elemental iron per dosage unit

ISOPROPAMIDE AND ITS SALTS

LEVARGORPHANE AND ITS SALTS

LEVONORDEFRINE

LIDOCAINE AND ITS SALTS Dosage forms for topical use on mucous
membranes

LINDANE Dosage forms for use as pediculicide or
scabicide agent

LOPERAMIDE AND ITS SALTS Liquid dosage forms for children

MAGNESIUM SULFATE Dosage forms for parenteral use

MANGANESE AND ITS SALTS Dosage forms for parenteral use

MANNITOL AND ITS SALTS

MECLIZINE AND ITS SALTS

MEPIVACAINE AND ITS SALTS Dosage forms for ophthalmic or parenteral use

METATHOHEPTAZINE AND ITS SALTS

METHANTHELINE AND ITS SALTS

METHDILAZINE AND ITS SALTS

METHENAMINE (HEXAMINE) AND Except dosage forms for topical use
ITS SALTS

METHEPTAZINE AND ITS SALTS

METHOCARBAMOL Dosage forms for parenteral use

METHYL SALICYLATE Liquid dosage forms in concentrations of more
than 30%

METHYLENE BLUE Dosage forms for parenteral use

MONOBENZONE

MONOETHANOLAMINE OLEATE

MUPIROCIN

NIACIN (NICOTINIC ACID) Single-ingredient dosage forms containing
50 mg or more per recommended dosage unit

NIACINAMIDE Dosage forms for systemic use containing more
than 125 mg per dosage unit

NICOTINIC ACID (NIACIN) Single-ingredient dosage forms containing
50 mg or more per recommended dosage unit

NITROGLYCERIN Immediate-release dosage forms for sublingual
use or by buccal spray

NORADRENALINE (NOREPINEPHRINE)
AND ITS SALTS

NOREPINEPHRINE (NORADRENALINE)
AND ITS SALTS

OXYBUPROCAINE (BENOXINATE) Dosage forms for ophthalmic or parenteral use
hydrochloride

OXYQUINOLINE

PANCREATIC ENZYMES Dosage forms recommended for cystic fibrosis
treatment

PANCRELIPASE

PAPAIN Dosage forms used as debriding agent

PAROXYPROPIONE

PENTAGASTRIN AND ITS SALTS

PERMETHRIN Dosage forms for topical use as pediculicide
or scabicide agent

PHENOL Dosage forms in concentrations greater than
20%

PHENOXYBENZAMINE AND ITS SALTS

PHYSOSTIGMINE SALICYLATE Dosage forms exclusively for oral or topical
use

PIPERAZINE AND ITS SALTS

PIPERONYL, ITS SALTS,
DERIVATIVES AND THEIR SALTS

PIPERONYL (ESDEPALLETHRIN)
BUTOXIDE

POLYACRYLAMIDE

POLYMYXINS, THEIR SALTS Except dosage forms for topical use on the
AND DERIVATIVES skin

POTASSIUM SALTS Except dosage forms containing 5 mmol or less
per recommended dosage unit

POVIDONE-IODINE Dosage forms for vaginal use except in
concentrations of 5% or less

PRAMOXINE AND ITS SALTS Dosage forms for ophthalmic or parenteral use

PRILOCAINE AND ITS SALTS Dosage forms for ophthalmic or parenteral use

PROCAINE AND ITS SALTS Dosage forms for ophthalmic or parenteral use

PROMETHAZINE AND ITS SALTS Dosage forms for oral use

PROPANTHELINE AND ITS SALTS

PROPARACAINE AND ITS SALTS Dosage forms for ophthalmic or parenteral use

PROPYLHEXEDRINE

PROTAMINE AND ITS SALTS

PYRANTEL AND ITS SALTS

PYRETHRINS, NATURAL AND Dosage forms for pediculicide or scabicide use
SYNTHETIC

PYRVINIUM AND ITS SALTS

QUININE AND ITS SALTS Except dosage forms recommended as analgesic
agent

RACEMETHIONINE

ROPIVACAINE AND ITS SALTS

ROSE BENGAL

RUE, ITS PREPARATIONS AND EXTRACTS

SALICYLIC ACID AND ITS SALTS Dosage forms for topical use in concentrations
greater than 40%

SCOPOLAMINE (HYOSCINE),
ITS SALTS AND DERIVATIVES

SELENIUM Dosage forms for parenteral use

SILVER NITRATE

SINCALIDE

SODIUM ACETATE Dosage forms for parenteral use

SODIUM BICARBONATE Dosage forms for parenteral use

SODIUM BIPHOSPHATE Dosage forms for parenteral use

SODIUM CHLORIDE Single-ingredient dosage forms for parenteral
use

Dosage forms for ophthalmic use in
concentrations greater than 0.9%

SODIUM CITRATE Dosage forms for parenteral use

SODIUM CROMOGLICATE Dosage forms for ophthalmic use in
concentrations of 2% or less

SODIUM IODIDE Dosage forms used as sclerosing agent

SODIUM LAURYL ETHER SULFATE Dosage forms for parasiticide use

SODIUM PHOSPHATE Dosage forms for parenteral use

SODIUM TETRADECYLSULFATE Dosage forms for use as sclerosing agent

STRAMONIUM, ITS PREPARATIONS,
EXTRACTS AND COMPOUNDS

STREPTOKINASE Dosage forms used as debriding agent

STRONTIUM AND ITS SALTS Dosage forms for parenteral use

SUTILAINS

TETRACAINE AND ITS SALTS Dosage forms for ophthalmic or parenteral use

THROMBIN

THYROGLOBULIN

THYROTROPIN

TRYPSIN

UBIQUINONE Dosage forms for oral use containing
10 mg or more

UREA Dosage forms for topical use in concentrations
greater than 25%

VITAMINS Dosage forms for parenteral use other than
those described in Schedule I

WATER FOR INJECTION Dosage forms for parenteral use

XYLOSE

(N) Medication so indicated is also subject to the terms, conditions and
modalities for sale prescribed by the Narcotic Control Regulations (C.R.C., c. 1041).
O.C. 712-98, Sch. II; O.C. 54-2001, s. 3; O.C. 698-2001, s. 2; O.C. 840-2003, s. 1; O.C. 539-2008, s. 1.