Consolidated Statutes and Regulations
Consolidated Statutes
Consolidated Regulations
Annual Statutes and Regulations
Annual Statutes
Annual Regulations
Additional information
Québec Official Publisher
What’s new?
Information note
Policy of the Minister of Justice
Laws: Amendments
Laws: Provisions not in force
Laws: Provisions brought into force
Annual Statutes: PDF versions since 1996
Regulations: Amendments
Annual Regulations: PDF versions since 1996
Court Decisions
P-10, r. 12 - Regulation respecting the terms and conditions for the sale of medications
Schedule
Disposition versions
SCHEDULE III
(s. 1, 1st par., subpar. 3)
MEDICATIONS FOR HUMAN USE SOLD UNDER PHARMACEUTICAL SUPERVISION
| Substance | Specification |
| ACETAMINOPHEN | Except dosage forms for oral use in packaging units containing less than 25 dosage units of 325 mg or less and sold in single packages containing only one packaging unit |
| ACETYLSALICYLIC ACID AND ITS SALTS | Dosage forms for oral use by adults, except those in packaging units containing less than 51 dosage units of 325 mg or less and sold in single packages containing only one packaging unit |
| ALOE VERA LATEX, ITS EXTRACTS AND DERIVATIVES, EXCEPT ALLOIN | Systemic dosage forms containing 300 mg or more per dosage unit |
| ALUMINUM OXIDE | |
| AMYLOCAINE AND ITS SALTS | Dosage forms for topical use on mucous membranes, except lozenges |
| ANETHOLTRITHIONE | |
| ANTAZOLINE AND ITS SALTS | |
| ANTIPYRINE | Dosage forms for otic use |
| ATTAPULGITE, ACTIVATED | Dosage forms for systemic use recommended for treating diarrhea |
| BACITRACINS, THEIR SALTS AND DERIVATIVES | Dosage forms for topical use on the skin |
| BENZOCAINE AND ITS SALTS | Dosage forms for topical use on mucous membranes |
| BENZONATATE | |
| BENZOYL PEROXIDE | Dosage forms in concentrations of 5% or less |
| BERBERIS VULGARIS | |
| BISACODYL AND ITS SALTS | |
| BISMUTH SUBSALICYLATE | |
| BROMPHENIRAMINE AND ITS SALTS | |
| BUPIVACAINE AND ITS SALTS | Dosage forms for topical use on mucous membranes, except lozenges |
| BUTENAFINE | Dosage forms for vaginal use |
| CALCIUM POLYCARBOPHIL | |
| CAPSAICIN | Dosage forms in concentrations less than 0.075% |
| CARBINOXAMINE AND ITS SALTS | |
| CASANTHRANOL | |
| CASCARA SAGRADA, ITS EXTRACTS AND DERIVATIVES | Dosage forms containing 325 mg or more per dosage unit |
| CERAPON | |
| CETIRIZINE AND ITS SALTS | Dosage forms in concentrations of 10 mg (equivalent to 8.5 mg) or less of cetirizine base per dosage unit |
| CHARCOAL, ACTIVATED | Dosage forms for use in poisoning |
| CHLOPHEDIANOL AND ITS SALTS | |
| CHLOROPROCAINE AND ITS SALTS | Dosage forms for topical use on mucous membranes, except lozenges |
| CHLORPHENESIN | Dosage forms for topical use on the skin |
| CHLORPHENIRAMINE AND ITS SALTS | |
| CHLORZOXAZONE AND ITS SALTS | |
| CHOLINE SALICYLATE | Dosage forms for topical use |
| CIMETIDINE AND ITS SALTS | Dosage forms for oral use containing 100 mg or less per dosage unit |
| CLEMASTINE AND ITS SALTS | |
| CLOTRIMAZOLE AND ITS SALTS | Dosage forms for vaginal use |
| COAL TAR | Except shampoos or topical preparations in concentrations of 10% or less |
| DANTHRON | |
| DEHYDROCHOLIC ACID AND ITS SALTS | |
| DESOXYCHOLIC ACID AND ITS SALTS | |
| DEXBROMPHENIRAMINE AND ITS SALTS | |
| DEXCHLORPHENIRAMINE AND ITS SALTS | |
| DEXTROMETHORPHAN AND ITS SALTS | Dosage forms in packaging units containing 850 mg or less and sold in single packages containing only one packaging unit |
| DICLOFENAC DIETHYLAMINE | Dosage forms for topical use on the skin in concentrations of 1.16% or less |
| DIMETHOTHIAZINE | |
| DIPHENHYDRAMINE AND ITS SALTS | Except dosage forms for parenteral use |
| DIPHENYLPYRALINE | |
| DOCUSATE AND ITS SALTS | |
| DOXYLAMINE AND ITS SALTS | Except dosage forms sold or recommended for nausea and vomiting during pregnancy |
| DYCLONINE AND ITS SALTS | Dosage forms for topical use on mucous membranes, except lozenges |
| ELECTROLYTES | Dosage forms for colon cleansing and irrigation |
| FAMOTIDINE AND ITS SALTS | Dosage forms for oral use containing 10 mg or less per dosage unit |
| Dosage forms for oral use containing more than 10 mg and not more than 20 mg per dosage unit, in package units containing less than 51 dosage units | |
| FEXOFENADINE AND ITS SALTS | |
| FLUORIDE AND ITS SALTS | Liquid dosage forms |
| Solid dosage forms for oral use containing 1 mg or less of elemental fluoride per dosage unit | |
| FRACTAR | |
| GLYCEROARGENTINATE | |
| GLYCOL SALICYLATE | |
| GRAMICIDIN AND ITS SALTS | Dosage forms for topical use on the skin |
| HALOPROGIN | |
| HEPARIN AND ITS SALTS | Dosage forms for topical use |
| HYDROCORTISONE | Dosage forms for topical use in concentrations of 1% or less in packaging units containing 30 g or less |
| HYDROCORTISONE ACETATE | Dosage forms for topical use in concentrations of 1% or less in packaging units containing 30 g or less |
| IBUPROFEN AND ITS SALTS | Dosage forms containing 200 mg or less per dosage unit |
| IODINE, ITS SALTS AND DERIVATIVES | Dosage forms for topical use and dosage forms for oral use with recommended daily dosage between 0.16 mg and 1 mg |
| IRON, ITS SALTS AND DERIVATIVES | Dosage forms containing more than 15 mg and less than 30 mg of elemental iron per dosage unit and drops for children |
| LACTIC ACID | Dosage forms in concentrations greater than 10% |
| LACTULOSE | |
| LIDOCAINE AND ITS SALTS | Dosage forms for topical use on the skin in concentrations greater than 1% |
| LOPERAMIDE | Solid dosage forms for oral use |
| LORATADINE, ITS SALTS, DERIVATIVES AND PREPARATIONS | |
| MAGNESIUM CITRATE | Dosage forms for cathartic use |
| MAGNESIUM SALICYLATE | Except oral dosage forms also containing choline salicylate |
| MEPIVACAINE AND ITS SALTS | Dosage forms for topical use on mucous membranes, except lozenges |
| MEPYRAMINE | |
| METHOCARBAMOL | Except dosage forms for parenteral use |
| METHYL SALICYLATE | Except liquid dosage forms in concentrations greater than 30% |
| MICONAZOLE AND ITS SALTS | Dosage forms for vaginal use |
| MINERAL TAR | Except shampoos with concentrations of 5% or less |
| MINOXIDIL | Dosage forms for topical use in concentrations of 5% or less |
| NAFTIFINE AND ITS SALTS | Dosage forms for topical use on the skin |
| NAPHAZOLINE AND ITS SALTS | Dosage forms for nasal or ophthalmic use |
| NAPROXEN SODIUM | Dosage forms in packaging units containing not more than 60 dosage units of 220 mg or less and sold in single packages containing only one packaging unit |
| NARCOTINE (NOSCAPINE) AND ITS SALTS | |
| NIACINAMIDE | Dosage forms for topical use |
| NICOTINE AND ITS SALTS | Dosage forms sold as chewing gums, inhalers, lozenges or transdermal nicotine replacement patches |
| NIZATIDINE AND ITS SALTS | Dosage forms for oral use containing 75 mg or less per dosage unit |
| NOSCAPINE (NARCOTINE) AND ITS SALTS | |
| NYSTATIN, ITS SALTS AND DERIVATIVES | Dosage forms for topical use on the skin |
| ORPHENADRINE CITRATE | |
| OXETHAZAINE AND ITS SALTS | |
| OXYBUPROCAINE AND ITS SALTS | Dosage forms for topical use on mucous membranes, except lozenges |
| OXYMETAZOLINE AND ITS SALTS | Dosage forms for nasal or ophthalmic use |
| PANCREATIC ENZYMES | Except dosage forms recommended for cystic fibrosis treatment |
| PANCREATIN | |
| PHENIRAMINE AND ITS SALTS | |
| PHENYLEPHRINE AND ITS SALTS | Dosage forms for ophthalmic use in concentrations of 2.5% or less |
| PHENYLPROPANOLAMINE AND ITS SALTS | |
| PHENYLTOLOXAMINE AND ITS SALTS | |
| PINE TAR | Except shampoos in concentrations of 5% or less |
| POLYMYXINS, THEIR SALTS AND DERIVATIVES | Dosage forms for topical use on the skin |
| POVIDONE-IODINE | Dosage forms for topical use except in concentrations of 5% or less |
| PRAMOXINE AND ITS SALTS | Dosage forms for topical use on mucous membranes, except lozenges |
| PRILOCAINE AND ITS SALTS | Dosage forms for topical use on the skin |
| PROCAINE AND ITS SALTS | Dosage forms for topical use on mucous membranes, except lozenges |
| PROMETHAZINE AND ITS SALTS | Dosage forms for topical use on the skin |
| PROPARACAINE AND ITS SALTS | Dosage forms for topical use on mucous membranes, except lozenges |
| PSEUDOEPHEDRINE AND ITS SALTS | Dosage forms in packaging units containing 1,200 mg or less, sold in single packages containing only one packaging unit and containing another medicinal ingredient |
| PYRILAMINE AND ITS SALTS | |
| RANITIDINE AND ITS SALTS | Dosage forms for oral use containing 75 mg or less per dosage unit |
| Dosage forms for oral use containing more than 75 mg and not more than 150 mg per dosage unit, in package units containing less than 51 dosage units | |
| SENNA, ITS EXTRACTS AND DERIVATIVES | Dosage forms containing 8.6 mg or more of senna lycoside per dosage unit |
| SODIUM BIPHOSPHATE | Dosage forms for cathartic use |
| SODIUM CITRATE | Dosage forms use as urinary alkalizer |
| SODIUM CROMOGLICATE | Dosage forms for nasal use in concentrations of 2% or less |
| SODIUM LAURYL SULFOACETATE | Dosage forms for cathartic use |
| SODIUM PHOSPHATE | Dosage forms for cathartic use |
| SODIUM SALICYLATE | |
| SODIUM TARTRATE | Dosage forms for cathartic use |
| TETRACAINE AND ITS SALTS | Dosage forms for topical use on mucous membranes, except lozenges |
| TETRAHYDROZOLINE | Dosage forms for nasal or ophthalmic use |
| TIOCONAZOLE | Dosage forms for vaginal use |
| TRIETHANOLAMINE OLEATE | |
| TRIETHANOLAMINE SALICYLATE | Dosage forms for topical use in concentrations greater than 20% |
| TRIPELENNAMINE AND ITS SALTS | |
| TRIPROLIDINE | |
| TYROTHRICINE | |
| XYLOMETAZOLINE AND ITS SALTS | Dosage forms for nasal or ophthalmic use |
SCHEDULE III
(s. 1, 1st par., subpar. 3)
MEDICATIONS FOR HUMAN USE SOLD UNDER PHARMACEUTICAL SUPERVISION
Substance Specification
ACETAMINOPHEN Except dosage forms for oral use in packaging
units containing less than 25 dosage units of
325 mg or less and sold in single packages
containing only one packaging unit
ACETYLSALICYLIC ACID Dosage forms for oral use by adults, except
AND ITS SALTS those in packaging units containing less than
51 dosage units of 325 mg or less and sold in
single packages containing only one packaging
unit
ALOE VERA LATEX, ITS Systemic dosage forms containing 300 mg or
EXTRACTS AND DERIVATIVES, more per dosage unit
EXCEPT ALLOIN
ALUMINUM OXIDE
AMYLOCAINE AND ITS SALTS Dosage forms for topical use on mucous
membranes, except lozenges
ANETHOLTRITHIONE
ANTAZOLINE AND ITS SALTS
ANTIPYRINE Dosage forms for otic use
ATTAPULGITE, ACTIVATED Dosage forms for systemic use recommended for
treating diarrhea
BACITRACINS, THEIR SALTS Dosage forms for topical use on the skin
AND DERIVATIVES
BENZOCAINE AND ITS SALTS Dosage forms for topical use on mucous
membranes
BENZONATATE
BENZOYL PEROXIDE Dosage forms in concentrations of 5% or less
BERBERIS VULGARIS
BISACODYL AND ITS SALTS
BISMUTH SUBSALICYLATE
BROMPHENIRAMINE AND ITS SALTS
BUPIVACAINE AND ITS SALTS Dosage forms for topical use on mucous
membranes, except lozenges
BUTENAFINE Dosage forms for vaginal use
CALCIUM POLYCARBOPHIL
CAPSAICIN Dosage forms in concentrations less than 0.075%
CARBINOXAMINE AND ITS SALTS
CASANTHRANOL
CASCARA SAGRADA, ITS Dosage forms containing 325 mg or more per
EXTRACTS AND DERIVATIVES dosage unit
CERAPON
CETIRIZINE AND ITS SALTS Dosage forms in concentrations of 10 mg
(equivalent to 8.5 mg) or less of cetirizine
base per dosage unit
CHARCOAL, ACTIVATED Dosage forms for use in poisoning
CHLOPHEDIANOL AND ITS SALTS
CHLOROPROCAINE AND ITS SALTS Dosage forms for topical use on mucous
membranes, except lozenges
CHLORPHENESIN Dosage forms for topical use on the skin
CHLORPHENIRAMINE AND ITS SALTS
CHLORZOXAZONE AND ITS SALTS
CHOLINE SALICYLATE Dosage forms for topical use
CIMETIDINE AND ITS SALTS Dosage forms for oral use containing 100 mg or
less per dosage unit
CLEMASTINE AND ITS SALTS
CLOTRIMAZOLE AND ITS SALTS Dosage forms for vaginal use
COAL TAR Except shampoos or topical preparations in
concentrations of 10% or less
DANTHRON
DEHYDROCHOLIC ACID AND ITS SALTS
DESOXYCHOLIC ACID AND ITS SALTS
DEXBROMPHENIRAMINE AND ITS SALTS
DEXCHLORPHENIRAMINE AND ITS SALTS
DEXTROMETHORPHAN AND ITS SALTS Dosage forms in packaging units containing
850 mg or less and sold in single packages
containing only one packaging unit
DICLOFENAC DIETHYLAMINE Dosage forms for topical use on the skin in
concentrations of 1.16% or less
DIMETHOTHIAZINE
DIPHENHYDRAMINE AND ITS SALTS Except dosage forms for parenteral use
DIPHENYLPYRALINE
DOCUSATE AND ITS SALTS
DOXYLAMINE AND ITS SALTS Except dosage forms sold or recommended for
nausea and vomiting during pregnancy
DYCLONINE AND ITS SALTS Dosage forms for topical use on mucous
membranes, except lozenges
FAMOTIDINE AND ITS SALTS Dosage forms for oral use containing 10 mg or
less per dosage unit
Dosage forms for oral use containing more than
10 mg and not more than 20 mg per dosage unit,
in package units containing less than 51
dosage units
FEXOFENADINE AND ITS SALTS
FLUORIDE AND ITS SALTS Liquid dosage forms
Solid dosage forms for oral use containing 1 mg
or less of elemental fluoride per dosage unit
FRACTAR
GLYCEROARGENTINATE
GLYCOL SALICYLATE
GRAMICIDIN AND ITS SALTS Dosage forms for topical use on the skin
HALOPROGIN
HEPARIN AND ITS SALTS Dosage forms for topical use
HYDROCORTISONE Dosage forms for topical use in concentrations
of 1% or less in packaging units containing
30 g or less
HYDROCORTISONE ACETATE Dosage forms for topical use in concentrations
of 1% or less in packaging units containing
30 g or less
IBUPROFEN AND ITS SALTS Dosage forms containing 200 mg or less per
dosage unit
IODINE, ITS SALTS AND Dosage forms for topical use and dosage forms
DERIVATIVES for oral use with recommended daily dosage
between 0.16 mg and 1 mg
IRON, ITS SALTS AND Dosage forms containing more than 15 mg and
DERIVATIVES less than 30 mg of elemental iron per dosage
unit and drops for children
LACTIC ACID Dosage forms in concentrations greater than 10%
LACTULOSE
LIDOCAINE AND ITS SALTS Dosage forms for topical use on the skin in
concentrations greater than 1%
LOPERAMIDE Solid dosage forms for oral use
LORATADINE, ITS SALTS,
DERIVATIVES AND PREPARATIONS
MAGNESIUM CITRATE Dosage forms for cathartic use
MAGNESIUM SALICYLATE Except oral dosage forms also containing
choline salicylate
MEPIVACAINE AND ITS SALTS Dosage forms for topical use on mucous
membranes, except lozenges
MEPYRAMINE
METHOCARBAMOL Except dosage forms for parenteral use
METHYL SALICYLATE Except liquid dosage forms in concentrations
greater than 30%
MICONAZOLE AND ITS SALTS Dosage forms for vaginal use
MINERAL TAR Except shampoos with concentrations of 5% or
less
MINOXIDIL Dosage forms for topical use in concentrations
of 5% or less
NAFTIFINE AND ITS SALTS Dosage forms for topical use on the skin
NAPHAZOLINE AND ITS SALTS Dosage forms for nasal or ophthalmic use
NAPROXEN SODIUM Dosage forms in packaging units containing not
more than 60 dosage units of 220 mg or less
and sold in single packages containing
only one packaging unit
NARCOTINE (NOSCAPINE) AND
ITS SALTS
NIACINAMIDE Dosage forms for topical use
NICOTINE AND ITS SALTS Dosage forms sold as chewing gums, inhalers,
lozenges or transdermal nicotine replacement
patches
NIZATIDINE AND ITS SALTS Dosage forms for oral use containing 75 mg or
less per dosage unit
NOSCAPINE (NARCOTINE) AND
ITS SALTS
NYSTATIN, ITS SALTS AND Dosage forms for topical use on the skin
DERIVATIVES
ORPHENADRINE CITRATE
OXETHAZAINE AND ITS SALTS
OXYBUPROCAINE AND ITS SALTS Dosage forms for topical use on mucous
membranes, except lozenges
OXYMETAZOLINE AND ITS SALTS Dosage forms for nasal or ophthalmic use
PANCREATIC ENZYMES Except dosage forms recommended for cystic
fibrosis treatment
PANCREATIN
PHENIRAMINE AND ITS SALTS
PHENYLEPHRINE AND ITS SALTS Dosage forms for ophthalmic use in
concentrations of 2.5% or less
PHENYLPROPANOLAMINE AND ITS SALTS
PHENYLTOLOXAMINE AND ITS SALTS
PINE TAR Except shampoos in concentrations of 5% or less
POLYMYXINS, THEIR SALTS Dosage forms for topical use on the skin
AND DERIVATIVES
POVIDONE-IODINE Dosage forms for topical use except in
concentrations of 5% or less
PRAMOXINE AND ITS SALTS Dosage forms for topical use on mucous
membranes, except lozenges
PRILOCAINE AND ITS SALTS Dosage forms for topical use on the skin
PROCAINE AND ITS SALTS Dosage forms for topical use on mucous
membranes, except lozenges
PROMETHAZINE AND ITS SALTS Dosage forms for topical use on the skin
PROPARACAINE AND ITS SALTS Dosage forms for topical use on mucous
membranes, except lozenges
PSEUDOEPHEDRINE AND ITS SALTS Dosage forms in packaging units containing
1,200 mg or less, sold in single packages
containing only one packaging unit and
containing another medicinal ingredient
PYRILAMINE AND ITS SALTS
RANITIDINE AND ITS SALTS Dosage forms for oral use containing 75 mg or
less per dosage unit
Dosage forms for oral use containing more than
75 mg and not more than 150 mg per dosage
unit, in package units containing less than 51
dosage units
SENNA, ITS EXTRACTS AND Dosage forms containing 8.6 mg or more of senna
DERIVATIVES lycoside per dosage unit
SODIUM BIPHOSPHATE Dosage forms for cathartic use
SODIUM CITRATE Dosage forms use as urinary alkalizer
SODIUM CROMOGLICATE Dosage forms for nasal use in concentrations
of 2% or less
SODIUM LAURYL SULFOACETATE Dosage forms for cathartic use
SODIUM PHOSPHATE Dosage forms for cathartic use
SODIUM SALICYLATE
SODIUM TARTRATE Dosage forms for cathartic use
TETRACAINE AND ITS SALTS Dosage forms for topical use on mucous
membranes, except lozenges
TETRAHYDROZOLINE Dosage forms for nasal or ophthalmic use
TIOCONAZOLE Dosage forms for vaginal use
TRIETHANOLAMINE OLEATE
TRIETHANOLAMINE SALICYLATE Dosage forms for topical use in concentrations
greater than 20%
TRIPELENNAMINE AND ITS SALTS
TRIPROLIDINE
TYROTHRICINE
XYLOMETAZOLINE AND ITS SALTS Dosage forms for nasal or ophthalmic use
SCHEDULE III
(s. 1, 1st par., subpar. 3)
MEDICATIONS FOR HUMAN USE SOLD UNDER PHARMACEUTICAL SUPERVISION
Substance Specification
ACETAMINOPHEN Except dosage forms for oral use in packaging
units containing less than 25 dosage units of
325 mg or less and sold in single packages
containing only one packaging unit
ACETYLSALICYLIC ACID Dosage forms for oral use by adults, except
AND ITS SALTS those in packaging units containing less than
51 dosage units of 325 mg or less and sold in
single packages containing only one packaging
unit
ALOE VERA LATEX, ITS Systemic dosage forms containing 300 mg or
EXTRACTS AND DERIVATIVES, more per dosage unit
EXCEPT ALLOIN
ALUMINUM OXIDE
AMYLOCAINE AND ITS SALTS Dosage forms for topical use on mucous
membranes, except lozenges
ANETHOLTRITHIONE
ANTAZOLINE AND ITS SALTS
ANTIPYRINE Dosage forms for otic use
ATTAPULGITE, ACTIVATED Dosage forms for systemic use recommended for
treating diarrhea
BACITRACINS, THEIR SALTS Dosage forms for topical use on the skin
AND DERIVATIVES
BENZOCAINE AND ITS SALTS Dosage forms for topical use on mucous
membranes
BENZONATATE
BENZOYL PEROXIDE Dosage forms in concentrations of 5% or less
BERBERIS VULGARIS
BISACODYL AND ITS SALTS
BISMUTH SUBSALICYLATE
BROMPHENIRAMINE AND ITS SALTS
BUPIVACAINE AND ITS SALTS Dosage forms for topical use on mucous
membranes, except lozenges
BUTENAFINE Dosage forms for vaginal use
CALCIUM POLYCARBOPHIL
CAPSAICIN Dosage forms in concentrations less than 0.075%
CARBINOXAMINE AND ITS SALTS
CASANTHRANOL
CASCARA SAGRADA, ITS Dosage forms containing 325 mg or more per
EXTRACTS AND DERIVATIVES dosage unit
CERAPON
CETIRIZINE AND ITS SALTS Dosage forms in concentrations of 10 mg
(equivalent to 8.5 mg) or less of cetirizine
base per dosage unit
CHARCOAL, ACTIVATED Dosage forms for use in poisoning
CHLOPHEDIANOL AND ITS SALTS
CHLOROPROCAINE AND ITS SALTS Dosage forms for topical use on mucous
membranes, except lozenges
CHLORPHENESIN Dosage forms for topical use on the skin
CHLORPHENIRAMINE AND ITS SALTS
CHLORZOXAZONE AND ITS SALTS
CHOLINE SALICYLATE Dosage forms for topical use
CIMETIDINE AND ITS SALTS Dosage forms for oral use containing 100 mg or
less per dosage unit
CLEMASTINE AND ITS SALTS
CLOTRIMAZOLE AND ITS SALTS Dosage forms for vaginal use
COAL TAR Except shampoos or topical preparations in
concentrations of 10% or less
DANTHRON
DEHYDROCHOLIC ACID AND ITS SALTS
DESOXYCHOLIC ACID AND ITS SALTS
DEXBROMPHENIRAMINE AND ITS SALTS
DEXCHLORPHENIRAMINE AND ITS SALTS
DEXTROMETHORPHAN AND ITS SALTS Dosage forms in packaging units containing
850 mg or less and sold in single packages
containing only one packaging unit
DICLOFENAC DIETHYLAMINE Dosage forms for topical use on the skin in
concentrations of 1.16% or less
DIMETHOTHIAZINE
DIPHENHYDRAMINE AND ITS SALTS Except dosage forms for parenteral use
DIPHENYLPYRALINE
DOCUSATE AND ITS SALTS
DOXYLAMINE AND ITS SALTS Except dosage forms sold or recommended for
nausea and vomiting during pregnancy
DYCLONINE AND ITS SALTS Dosage forms for topical use on mucous
membranes, except lozenges
ELECTROLYTES Solution for hydration
Dosage forms for colon cleansing and irrigation
FAMOTIDINE AND ITS SALTS Dosage forms for oral use containing 10 mg or
less per dosage unit
Dosage forms for oral use containing more than
10 mg and not more than 20 mg per dosage unit,
in package units containing less than 51
dosage units
FEXOFENADINE AND ITS SALTS
FLUORIDE AND ITS SALTS Liquid dosage forms
Solid dosage forms for oral use containing 1 mg
or less of elemental fluoride per dosage unit
FRACTAR
GLYCEROARGENTINATE
GLYCOL SALICYLATE
GRAMICIDIN AND ITS SALTS Dosage forms for topical use on the skin
HALOPROGIN
HEPARIN AND ITS SALTS Dosage forms for topical use
HYDROCORTISONE Dosage forms for topical use in concentrations
of 1% or less in packaging units containing
30 g or less
HYDROCORTISONE ACETATE Dosage forms for topical use in concentrations
of 1% or less in packaging units containing
30 g or less
IBUPROFEN AND ITS SALTS Dosage forms containing 200 mg or less per
dosage unit
IODINE, ITS SALTS AND Dosage forms for topical use and dosage forms
DERIVATIVES for oral use with recommended daily dosage
between 0.16 mg and 1 mg
IRON, ITS SALTS AND Dosage forms containing more than 15 mg and
DERIVATIVES less than 30 mg of elemental iron per dosage
unit and drops for children
LACTIC ACID Dosage forms in concentrations greater than 10%
LACTULOSE
LIDOCAINE AND ITS SALTS Dosage forms for topical use on the skin in
concentrations greater than 1%
LOPERAMIDE Solid dosage forms for oral use
LORATADINE, ITS SALTS,
DERIVATIVES AND PREPARATIONS
MAGNESIUM CITRATE Dosage forms for cathartic use
MAGNESIUM SALICYLATE Except oral dosage forms also containing
choline salicylate
MEPIVACAINE AND ITS SALTS Dosage forms for topical use on mucous
membranes, except lozenges
MEPYRAMINE
METHOCARBAMOL Except dosage forms for parenteral use
METHYL SALICYLATE Except liquid dosage forms in concentrations
greater than 30%
MICONAZOLE AND ITS SALTS Dosage forms for vaginal use
MINERAL TAR Except shampoos with concentrations of 5% or
less
MINOXIDIL Dosage forms for topical use in concentrations
of 5% or less
NAFTIFINE AND ITS SALTS Dosage forms for topical use on the skin
NAPHAZOLINE AND ITS SALTS Dosage forms for nasal or ophthalmic use
NARCOTINE (NOSCAPINE) AND
ITS SALTS
NIACINAMIDE Dosage forms for topical use
NICOTINE AND ITS SALTS Dosage forms sold as chewing gums, inhalers,
lozenges or transdermal nicotine replacement
patches
NIZATIDINE AND ITS SALTS Dosage forms for oral use containing 75 mg or
less per dosage unit
NOSCAPINE (NARCOTINE) AND
ITS SALTS
NYSTATIN, ITS SALTS AND Dosage forms for topical use on the skin
DERIVATIVES
ORPHENADRINE CITRATE
OXETHAZAINE AND ITS SALTS
OXYBUPROCAINE AND ITS SALTS Dosage forms for topical use on mucous
membranes, except lozenges
OXYMETAZOLINE AND ITS SALTS Dosage forms for nasal or ophthalmic use
PANCREATIC ENZYMES Except dosage forms recommended for cystic
fibrosis treatment
PANCREATIN
PHENIRAMINE AND ITS SALTS
PHENYLEPHRINE AND ITS SALTS Dosage forms for ophthalmic use in
concentrations of 2.5% or less
PHENYLPROPANOLAMINE AND ITS SALTS
PHENYLTOLOXAMINE AND ITS SALTS
PINE TAR Except shampoos in concentrations of 5% or less
POLYMYXINS, THEIR SALTS Dosage forms for topical use on the skin
AND DERIVATIVES
POVIDONE-IODINE Dosage forms for topical use except in
concentrations of 5% or less
PRAMOXINE AND ITS SALTS Dosage forms for topical use on mucous
membranes, except lozenges
PRILOCAINE AND ITS SALTS Dosage forms for topical use on the skin
PROCAINE AND ITS SALTS Dosage forms for topical use on mucous
membranes, except lozenges
PROMETHAZINE AND ITS SALTS Dosage forms for topical use on the skin
PROPARACAINE AND ITS SALTS Dosage forms for topical use on mucous
membranes, except lozenges
PSEUDOEPHEDRINE AND ITS SALTS Dosage forms in packaging units containing
1,200 mg or less, sold in single packages
containing only one packaging unit and
containing another medicinal ingredient
PYRILAMINE AND ITS SALTS
RANITIDINE AND ITS SALTS Dosage forms for oral use containing 75 mg or
less per dosage unit
Dosage forms for oral use containing more than
75 mg and not more than 150 mg per dosage
unit, in package units containing less than 51
dosage units
SENNA, ITS EXTRACTS AND Dosage forms containing 8.6 mg or more of senna
DERIVATIVES lycoside per dosage unit
SODIUM BIPHOSPHATE Dosage forms for cathartic use
SODIUM CITRATE Dosage forms use as urinary alkalizer
SODIUM CROMOGLICATE Dosage forms for nasal use in concentrations
of 2% or less
SODIUM LAURYL SULFOACETATE Dosage forms for cathartic use
SODIUM PHOSPHATE Dosage forms for cathartic use
SODIUM SALICYLATE
SODIUM TARTRATE Dosage forms for cathartic use
TETRACAINE AND ITS SALTS Dosage forms for topical use on mucous
membranes, except lozenges
TETRAHYDROZOLINE Dosage forms for nasal or ophthalmic use
TIOCONAZOLE Dosage forms for vaginal use
TRIETHANOLAMINE OLEATE
TRIETHANOLAMINE SALICYLATE Dosage forms for topical use in concentrations
greater than 20%
TRIPELENNAMINE AND ITS SALTS
TRIPROLIDINE
TYROTHRICINE
XYLOMETAZOLINE AND ITS SALTS Dosage forms for nasal or ophthalmic use
SCHEDULE III
(s. 1, 1st par., subpar. 3)
MEDICATIONS FOR HUMAN USE SOLD UNDER PHARMACEUTICAL SUPERVISION
Substance Specification
ACETAMINOPHEN Except dosage forms for oral use in packaging
units containing less than 25 dosage units of
325 mg or less and sold in single packages
containing only one packaging unit
ACETYLSALICYLIC ACID Dosage forms for oral use by adults, except
AND ITS SALTS those in packaging units containing less than
51 dosage units of 325 mg or less and sold in
single packages containing only one packaging
unit
ALOE VERA LATEX, ITS Systemic dosage forms containing 300 mg or
EXTRACTS AND DERIVATIVES, more per dosage unit
EXCEPT ALLOIN
ALUMINUM OXIDE
AMYLOCAINE AND ITS SALTS Dosage forms for topical use on mucous
membranes, except lozenges
ANETHOLTRITHIONE
ANTAZOLINE AND ITS SALTS
ANTIPYRINE Dosage forms for otic use
ATTAPULGITE, ACTIVATED Dosage forms for systemic use recommended for
treating diarrhea
BACITRACINS, THEIR SALTS Dosage forms for topical use on the skin
AND DERIVATIVES
BENZOCAINE AND ITS SALTS Dosage forms for topical use on mucous
membranes
BENZONATATE
BENZOYL PEROXIDE Dosage forms in concentrations of 5% or less
BERBERIS VULGARIS
BISACODYL AND ITS SALTS
BISMUTH SUBSALICYLATE
BROMPHENIRAMINE AND ITS SALTS
BUPIVACAINE AND ITS SALTS Dosage forms for topical use on mucous
membranes, except lozenges
BUTENAFINE Dosage forms for vaginal use
CALCIUM POLYCARBOPHIL
CAPSAICIN Dosage forms in concentrations less than 0.075%
CARBINOXAMINE AND ITS SALTS
CASANTHRANOL
CASCARA SAGRADA, ITS Dosage forms containing 325 mg or more per
EXTRACTS AND DERIVATIVES dosage unit
CERAPON
CETIRIZINE AND ITS SALTS Dosage forms in concentrations of 10 mg
(equivalent to 8.5 mg) or less of cetirizine
base per dosage unit
CHARCOAL, ACTIVATED Dosage forms for use in poisoning
CHLOPHEDIANOL AND ITS SALTS
CHLOROPROCAINE AND ITS SALTS Dosage forms for topical use on mucous
membranes, except lozenges
CHLORPHENESIN Dosage forms for topical use on the skin
CHLORPHENIRAMINE AND ITS SALTS
CHLORZOXAZONE AND ITS SALTS
CHOLINE SALICYLATE Dosage forms for topical use
CIMETIDINE AND ITS SALTS Dosage forms for oral use containing 100 mg or
less per dosage unit
CLEMASTINE AND ITS SALTS
CLOTRIMAZOLE AND ITS SALTS Dosage forms for vaginal use
COAL TAR Except shampoos or topical preparations in
concentrations of 10% or less
DANTHRON
DEHYDROCHOLIC ACID AND ITS SALTS
DESOXYCHOLIC ACID AND ITS SALTS
DEXBROMPHENIRAMINE AND ITS SALTS
DEXCHLORPHENIRAMINE AND ITS SALTS
DEXTROMETHORPHAN AND ITS SALTS Dosage forms in packaging units containing
850 mg or less and sold in single packages
containing only one packaging unit
DIMETHOTHIAZINE
DIPHENHYDRAMINE AND ITS SALTS Except dosage forms for parenteral use
DIPHENYLPYRALINE
DOCUSATE AND ITS SALTS
DOXYLAMINE AND ITS SALTS Except dosage forms sold or recommended for
nausea and vomiting during pregnancy
DYCLONINE AND ITS SALTS Dosage forms for topical use on mucous
membranes, except lozenges
ELECTROLYTES Solution for hydration
Dosage forms for colon cleansing and irrigation
FAMOTIDINE AND ITS SALTS Dosage forms for oral use containing 10 mg or
less per dosage unit
Dosage forms for oral use containing more than
10 mg and not more than 20 mg per dosage unit,
in package units containing less than 51
dosage units
FEXOFENADINE AND ITS SALTS
FLUORIDE AND ITS SALTS Liquid dosage forms
Solid dosage forms for oral use containing 1 mg
or less of elemental fluoride per dosage unit
FRACTAR
GLYCEROARGENTINATE
GLYCOL SALICYLATE
GRAMICIDIN AND ITS SALTS Dosage forms for topical use on the skin
HALOPROGIN
HEPARIN AND ITS SALTS Dosage forms for topical use
HYDROCORTISONE Dosage forms for topical use in concentrations
of 1% or less in packaging units containing
30 g or less
HYDROCORTISONE ACETATE Dosage forms for topical use in concentrations
of 1% or less in packaging units containing
30 g or less
IBUPROFEN AND ITS SALTS Dosage forms containing 200 mg or less per
dosage unit
IODINE, ITS SALTS AND Dosage forms for topical use and dosage forms
DERIVATIVES for oral use with recommended daily dosage
between 0.16 mg and 1 mg
IRON, ITS SALTS AND Dosage forms containing more than 15 mg and
DERIVATIVES less than 30 mg of elemental iron per dosage
unit and drops for children
LACTIC ACID Dosage forms in concentrations greater than 10%
LACTULOSE
LIDOCAINE AND ITS SALTS Dosage forms for topical use on the skin in
concentrations greater than 1%
LOPERAMIDE Solid dosage forms for oral use
LORATADINE, ITS SALTS,
DERIVATIVES AND PREPARATIONS
MAGNESIUM CITRATE Dosage forms for cathartic use
MAGNESIUM SALICYLATE Except oral dosage forms also containing
choline salicylate
MEPIVACAINE AND ITS SALTS Dosage forms for topical use on mucous
membranes, except lozenges
MEPYRAMINE
METHOCARBAMOL Except dosage forms for parenteral use
METHYL SALICYLATE Except liquid dosage forms in concentrations
greater than 30%
MICONAZOLE AND ITS SALTS Dosage forms for vaginal use
MINERAL TAR Except shampoos with concentrations of 5% or
less
MINOXIDIL Dosage forms for topical use in concentrations
of 5% or less
NAFTIFINE AND ITS SALTS Dosage forms for topical use on the skin
NAPHAZOLINE AND ITS SALTS Dosage forms for nasal or ophthalmic use
NARCOTINE (NOSCAPINE) AND
ITS SALTS
NIACINAMIDE Dosage forms for topical use
NICOTINE AND ITS SALTS Dosage forms sold as chewing gums, inhalers,
lozenges or transdermal nicotine replacement
patches
NIZATIDINE AND ITS SALTS Dosage forms for oral use containing 75 mg or
less per dosage unit
NOSCAPINE (NARCOTINE) AND
ITS SALTS
NYSTATIN, ITS SALTS AND Dosage forms for topical use on the skin
DERIVATIVES
ORPHENADRINE CITRATE
OXETHAZAINE AND ITS SALTS
OXYBUPROCAINE AND ITS SALTS Dosage forms for topical use on mucous
membranes, except lozenges
OXYMETAZOLINE AND ITS SALTS Dosage forms for nasal or ophthalmic use
PANCREATIC ENZYMES Except dosage forms recommended for cystic
fibrosis treatment
PANCREATIN
PHENIRAMINE AND ITS SALTS
PHENYLEPHRINE AND ITS SALTS Dosage forms for ophthalmic use in
concentrations of 2.5% or less
PHENYLPROPANOLAMINE AND ITS SALTS
PHENYLTOLOXAMINE AND ITS SALTS
PINE TAR Except shampoos in concentrations of 5% or less
POLYMYXINS, THEIR SALTS Dosage forms for topical use on the skin
AND DERIVATIVES
POVIDONE-IODINE Dosage forms for topical use except in
concentrations of 5% or less
PRAMOXINE AND ITS SALTS Dosage forms for topical use on mucous
membranes, except lozenges
PRILOCAINE AND ITS SALTS Dosage forms for topical use on the skin
PROCAINE AND ITS SALTS Dosage forms for topical use on mucous
membranes, except lozenges
PROMETHAZINE AND ITS SALTS Dosage forms for topical use on the skin
PROPARACAINE AND ITS SALTS Dosage forms for topical use on mucous
membranes, except lozenges
PSEUDOEPHEDRINE AND ITS SALTS Dosage forms in packaging units containing
1,200 mg or less, sold in single packages
containing only one packaging unit and
containing another medicinal ingredient
PYRILAMINE AND ITS SALTS
RANITIDINE AND ITS SALTS Dosage forms for oral use containing 75 mg or
less per dosage unit
Dosage forms for oral use containing more than
75 mg and not more than 150 mg per dosage
unit, in package units containing less than 51
dosage units
SENNA, ITS EXTRACTS AND Dosage forms containing 8.6 mg or more of senna
DERIVATIVES lycoside per dosage unit
SODIUM BIPHOSPHATE Dosage forms for cathartic use
SODIUM CITRATE Dosage forms use as urinary alkalizer
SODIUM CROMOGLICATE Dosage forms for nasal use in concentrations
of 2% or less
SODIUM LAURYL SULFOACETATE Dosage forms for cathartic use
SODIUM PHOSPHATE Dosage forms for cathartic use
SODIUM SALICYLATE
SODIUM TARTRATE Dosage forms for cathartic use
TETRACAINE AND ITS SALTS Dosage forms for topical use on mucous
membranes, except lozenges
TETRAHYDROZOLINE Dosage forms for nasal or ophthalmic use
TIOCONAZOLE Dosage forms for vaginal use
TRIETHANOLAMINE OLEATE
TRIETHANOLAMINE SALICYLATE Dosage forms for topical use in concentrations
greater than 20%
TRIPELENNAMINE AND ITS SALTS
TRIPROLIDINE
TYROTHRICINE
XYLOMETAZOLINE AND ITS SALTS Dosage forms for nasal or ophthalmic use
SCHEDULE III
(s. 1, 1st par., subpar. 3)
MEDICATIONS FOR HUMAN USE SOLD UNDER PHARMACEUTICAL SUPERVISION
Substance Specification
ACETAMINOPHEN Except dosage forms for oral use in packaging
units containing less than 25 dosage units of
325 mg or less and sold in single packages
containing only one packaging unit
ACETYLSALICYLIC ACID Dosage forms for oral use by adults, except
AND ITS SALTS those in packaging units containing less than
51 dosage units of 325 mg or less and sold in
single packages containing only one packaging
unit
ALOE VERA LATEX, ITS Systemic dosage forms containing 300 mg or
EXTRACTS AND DERIVATIVES, more per dosage unit
EXCEPT ALLOIN
ALUMINUM OXIDE
AMYLOCAINE AND ITS SALTS Dosage forms for topical use on mucous
membranes, except lozenges
ANETHOLTRITHIONE
ANTAZOLINE AND ITS SALTS
ANTIPYRINE Dosage forms for otic use
ATTAPULGITE, ACTIVATED Dosage forms for systemic use recommended for
treating diarrhea
BACITRACINS, THEIR SALTS Dosage forms for topical use on the skin
AND DERIVATIVES
BENZOCAINE AND ITS SALTS Dosage forms for topical use on mucous
membranes
BENZONATATE
BENZOYL PEROXIDE Dosage forms in concentrations of 5% or less
BERBERIS VULGARIS
BISACODYL AND ITS SALTS
BISMUTH SUBSALICYLATE
BROMPHENIRAMINE AND ITS SALTS
BUPIVACAINE AND ITS SALTS Dosage forms for topical use on mucous
membranes, except lozenges
BUTENAFINE Dosage forms for vaginal use
CALCIUM POLYCARBOPHIL
CAPSAICIN Dosage forms in concentrations less than 0.075%
CARBINOXAMINE AND ITS SALTS
CASANTHRANOL
CASCARA SAGRADA, ITS Dosage forms containing 325 mg or more per
EXTRACTS AND DERIVATIVES dosage unit
CERAPON
CETIRIZINE AND ITS SALTS Dosage forms in concentrations of 10 mg
(equivalent to 8.5 mg) or less of cetirizine
base per dosage unit
CHARCOAL, ACTIVATED Dosage forms for use in poisoning
CHLOPHEDIANOL AND ITS SALTS
CHLOROPROCAINE AND ITS SALTS Dosage forms for topical use on mucous
membranes, except lozenges
CHLORPHENESIN Dosage forms for topical use on the skin
CHLORPHENIRAMINE AND ITS SALTS
CHLORZOXAZONE AND ITS SALTS
CHOLINE SALICYLATE Dosage forms for topical use
CIMETIDINE AND ITS SALTS Dosage forms for oral use containing 100 mg or
less per dosage unit
CLEMASTINE AND ITS SALTS
CLOTRIMAZOLE AND ITS SALTS Dosage forms for vaginal use
COAL TAR Except shampoos or topical preparations in
concentrations of 10% or less
DANTHRON
DEHYDROCHOLIC ACID AND ITS SALTS
DESOXYCHOLIC ACID AND ITS SALTS
DEXBROMPHENIRAMINE AND ITS SALTS
DEXCHLORPHENIRAMINE AND ITS SALTS
DEXTROMETHORPHAN AND ITS SALTS Dosage forms in packaging units containing
850 mg or less and sold in single packages
containing only one packaging unit
DIMETHOTHIAZINE
DIPHENHYDRAMINE AND ITS SALTS Except dosage forms for parenteral use
DIPHENYLPYRALINE
DOCUSATE AND ITS SALTS
DOXYLAMINE AND ITS SALTS Except dosage forms sold or recommended for
nausea and vomiting during pregnancy
DYCLONINE AND ITS SALTS Dosage forms for topical use on mucous
membranes, except lozenges
ELECTROLYTES Solution for hydration
Dosage forms for colon cleansing and irrigation
FAMOTIDINE AND ITS SALTS Dosage forms for oral use containing 10 mg or
less per dosage unit
Dosage forms for oral use containing more than
10 mg and not more than 20 mg per dosage unit,
in package units containing less than 51
dosage units
FEXOFENADINE AND ITS SALTS
FLUORIDE AND ITS SALTS Liquid dosage forms
Solid dosage forms for oral use containing 1 mg
or less of elemental fluoride per dosage unit
FRACTAR
GLYCEROARGENTINATE
GLYCOL SALICYLATE
GRAMICIDIN AND ITS SALTS Dosage forms for topical use on the skin
HALOPROGIN
HEPARIN AND ITS SALTS Dosage forms for topical use
HYDROCORTISONE Dosage forms for topical use in concentrations
of 0.5%
HYDROCORTISONE ACETATE Dosage forms for topical use in concentrations
of 0.5%
IBUPROFEN AND ITS SALTS Dosage forms containing 200 mg or less per
dosage unit
IODINE, ITS SALTS AND Dosage forms for topical use and dosage forms
DERIVATIVES for oral use with recommended daily dosage
between 0.16 mg and 1 mg
IRON, ITS SALTS AND Dosage forms containing more than 15 mg and
DERIVATIVES less than 30 mg of elemental iron per dosage
unit and drops for children
LACTIC ACID Dosage forms in concentrations greater than 10%
LACTULOSE
LIDOCAINE AND ITS SALTS Dosage forms for topical use on the skin in
concentrations greater than 1%
LOPERAMIDE Solid dosage forms for oral use
LORATADINE, ITS SALTS,
DERIVATIVES AND PREPARATIONS
MAGNESIUM CITRATE Dosage forms for cathartic use
MAGNESIUM SALICYLATE Except oral dosage forms also containing
choline salicylate
MEPIVACAINE AND ITS SALTS Dosage forms for topical use on mucous
membranes, except lozenges
MEPYRAMINE
METHOCARBAMOL Except dosage forms for parenteral use
METHYL SALICYLATE Except liquid dosage forms in concentrations
greater than 30%
MICONAZOLE AND ITS SALTS Dosage forms for vaginal use
MINERAL TAR Except shampoos with concentrations of 5% or
less
MINOXIDIL Dosage forms for topical use in concentrations
of 2% or less
NAFTIFINE AND ITS SALTS Dosage forms for topical use on the skin
NAPHAZOLINE AND ITS SALTS Dosage forms for nasal or ophthalmic use
NARCOTINE (NOSCAPINE) AND
ITS SALTS
NIACINAMIDE Dosage forms for topical use
NICOTINE AND ITS SALTS Dosage forms sold as chewing gums, inhalers,
lozenges or transdermal nicotine replacement
patches
NIZATIDINE AND ITS SALTS Dosage forms for oral use containing 75 mg or
less per dosage unit
NOSCAPINE (NARCOTINE) AND
ITS SALTS
NYSTATIN, ITS SALTS AND Dosage forms for topical use on the skin
DERIVATIVES
ORPHENADRINE CITRATE
OXETHAZAINE AND ITS SALTS
OXYBUPROCAINE AND ITS SALTS Dosage forms for topical use on mucous
membranes, except lozenges
OXYMETAZOLINE AND ITS SALTS Dosage forms for nasal or ophthalmic use
PANCREATIC ENZYMES Except dosage forms recommended for cystic
fibrosis treatment
PANCREATIN
PHENIRAMINE AND ITS SALTS
PHENYLEPHRINE AND ITS SALTS Dosage forms for ophthalmic use in
concentrations of 2.5% or less
PHENYLPROPANOLAMINE AND ITS SALTS
PHENYLTOLOXAMINE AND ITS SALTS
PINE TAR Except shampoos in concentrations of 5% or less
POLYMYXINS, THEIR SALTS Dosage forms for topical use on the skin
AND DERIVATIVES
POVIDONE-IODINE Dosage forms for topical use except in
concentrations of 5% or less
PRAMOXINE AND ITS SALTS Dosage forms for topical use on mucous
membranes, except lozenges
PRILOCAINE AND ITS SALTS Dosage forms for topical use on the skin
PROCAINE AND ITS SALTS Dosage forms for topical use on mucous
membranes, except lozenges
PROMETHAZINE AND ITS SALTS Dosage forms for topical use on the skin
PROPARACAINE AND ITS SALTS Dosage forms for topical use on mucous
membranes, except lozenges
PSEUDOEPHEDRINE AND ITS SALTS Dosage forms in packaging units containing
1,200 mg or less, sold in single packages
containing only one packaging unit and
containing another medicinal ingredient
PYRILAMINE AND ITS SALTS
RANITIDINE AND ITS SALTS Dosage forms for oral use containing 75 mg or
less per dosage unit
Dosage forms for oral use containing more than
75 mg and not more than 150 mg per dosage
unit, in package units containing less than 51
dosage units
SENNA, ITS EXTRACTS AND Dosage forms containing 8.6 mg or more of senna
DERIVATIVES lycoside per dosage unit
SODIUM BIPHOSPHATE Dosage forms for cathartic use
SODIUM CITRATE Dosage forms use as urinary alkalizer
SODIUM CROMOGLICATE Dosage forms for nasal use in concentrations
of 2% or less
SODIUM LAURYL SULFOACETATE Dosage forms for cathartic use
SODIUM PHOSPHATE Dosage forms for cathartic use
SODIUM SALICYLATE
SODIUM TARTRATE Dosage forms for cathartic use
TETRACAINE AND ITS SALTS Dosage forms for topical use on mucous
membranes, except lozenges
TETRAHYDROZOLINE Dosage forms for nasal or ophthalmic use
TIOCONAZOLE Dosage forms for vaginal use
TRIETHANOLAMINE OLEATE
TRIETHANOLAMINE SALICYLATE Dosage forms for topical use in concentrations
greater than 20%
TRIPELENNAMINE AND ITS SALTS
TRIPROLIDINE
TYROTHRICINE
XYLOMETAZOLINE AND ITS SALTS Dosage forms for nasal or ophthalmic use
SCHEDULE III
(s. 1, 1st par., subpar. 3)
MEDICATIONS FOR HUMAN USE SOLD UNDER PHARMACEUTICAL SUPERVISION
Substance Specification
ACETAMINOPHEN Except dosage forms for oral use in packaging
units containing less than 25 dosage units of
325 mg or less and sold in single packages
containing only one packaging unit
ACETYLSALICYLIC ACID Dosage forms for oral use by adults, except
AND ITS SALTS those in packaging units containing less than
51 dosage units of 325 mg or less and sold in
single packages containing only one packaging
unit
ALOE VERA LATEX, ITS Systemic dosage forms containing 300 mg or
EXTRACTS AND DERIVATIVES, more per dosage unit
EXCEPT ALLOIN
ALUMINUM OXIDE
AMYLOCAINE AND ITS SALTS Dosage forms for topical use on mucous
membranes, except lozenges
ANETHOLTRITHIONE
ANTAZOLINE AND ITS SALTS
ANTIPYRINE Dosage forms for otic use
ATTAPULGITE, ACTIVATED Dosage forms for systemic use recommended for
treating diarrhea
BACITRACINS, THEIR SALTS Dosage forms for topical use on the skin
AND DERIVATIVES
BENZOCAINE AND ITS SALTS Dosage forms for topical use on mucous
membranes
BENZONATATE
BENZOYL PEROXIDE Dosage forms in concentrations of 5% or less
BERBERIS VULGARIS
BISACODYL AND ITS SALTS
BISMUTH SUBSALICYLATE
BROMPHENIRAMINE AND ITS SALTS
BUPIVACAINE AND ITS SALTS Dosage forms for topical use on mucous
membranes, except lozenges
BUTENAFINE Dosage forms for vaginal use
CALCIUM POLYCARBOPHIL
CAPSAICIN Dosage forms in concentrations less than 0.075%
CARBINOXAMINE AND ITS SALTS
CASANTHRANOL
CASCARA SAGRADA, ITS Dosage forms containing 325 mg or more per
EXTRACTS AND DERIVATIVES dosage unit
CERAPON
CETIRIZINE AND ITS SALTS Dosage forms in concentrations of 10 mg
(equivalent to 8.5 mg) or less of cetirizine
base per dosage unit
CHARCOAL, ACTIVATED Dosage forms for use in poisoning
CHLOPHEDIANOL AND ITS SALTS
CHLOROPROCAINE AND ITS SALTS Dosage forms for topical use on mucous
membranes, except lozenges
CHLORPHENESIN Dosage forms for topical use on the skin
CHLORPHENIRAMINE AND ITS SALTS
CHLORZOXAZONE AND ITS SALTS
CHOLINE SALICYLATE Dosage forms for topical use
CIMETIDINE AND ITS SALTS Dosage forms for oral use containing 100 mg or
less per dosage unit
CLEMASTINE AND ITS SALTS
CLOTRIMAZOLE AND ITS SALTS Dosage forms for vaginal use
COAL TAR Except shampoos or topical preparations in
concentrations of 10% or less
DANTHRON
DEHYDROCHOLIC ACID AND ITS SALTS
DESOXYCHOLIC ACID AND ITS SALTS
DEXBROMPHENIRAMINE AND ITS SALTS
DEXCHLORPHENIRAMINE AND ITS SALTS
DEXTROMETHORPHAN AND ITS SALTS
DIMETHOTHIAZINE
DIPHENHYDRAMINE AND ITS SALTS Except dosage forms for parenteral use
DIPHENYLPYRALINE
DOCUSATE AND ITS SALTS
DOXYLAMINE AND ITS SALTS Except dosage forms sold or recommended for
nausea and vomiting during pregnancy
DYCLONINE AND ITS SALTS Dosage forms for topical use on mucous
membranes, except lozenges
ELECTROLYTES Solution for hydration
Dosage forms for colon cleansing and irrigation
FAMOTIDINE AND ITS SALTS Dosage forms for oral use containing 10 mg or
less per dosage unit
Dosage forms for oral use containing more than
10 mg and not more than 20 mg per dosage unit,
in package units containing less than 51
dosage units
FEXOFENADINE AND ITS SALTS
FLUORIDE AND ITS SALTS Liquid dosage forms
Solid dosage forms for oral use containing 1 mg
or less of elemental fluoride per dosage unit
FRACTAR
GLYCEROARGENTINATE
GLYCOL SALICYLATE
GRAMICIDIN AND ITS SALTS Dosage forms for topical use on the skin
HALOPROGIN
HEPARIN AND ITS SALTS Dosage forms for topical use
HYDROCORTISONE Dosage forms for topical use in concentrations
of 0.5%
HYDROCORTISONE ACETATE Dosage forms for topical use in concentrations
of 0.5%
IBUPROFEN AND ITS SALTS Dosage forms containing 200 mg or less per
dosage unit
IODINE, ITS SALTS AND Dosage forms for topical use and dosage forms
DERIVATIVES for oral use with recommended daily dosage
between 0.16 mg and 1 mg
IRON, ITS SALTS AND Dosage forms containing more than 15 mg and
DERIVATIVES less than 30 mg of elemental iron per dosage
unit and drops for children
LACTIC ACID Dosage forms in concentrations greater than 10%
LACTULOSE
LIDOCAINE AND ITS SALTS Dosage forms for topical use on the skin in
concentrations greater than 1%
LOPERAMIDE Solid dosage forms for oral use
LORATADINE, ITS SALTS,
DERIVATIVES AND PREPARATIONS
MAGNESIUM CITRATE Dosage forms for cathartic use
MAGNESIUM SALICYLATE Except oral dosage forms also containing
choline salicylate
MEPIVACAINE AND ITS SALTS Dosage forms for topical use on mucous
membranes, except lozenges
MEPYRAMINE
METHOCARBAMOL Except dosage forms for parenteral use
METHYL SALICYLATE Except liquid dosage forms in concentrations
greater than 30%
MICONAZOLE AND ITS SALTS Dosage forms for vaginal use
MINERAL TAR Except shampoos with concentrations of 5% or
less
MINOXIDIL Dosage forms for topical use in concentrations
of 2% or less
NAFTIFINE AND ITS SALTS Dosage forms for topical use on the skin
NAPHAZOLINE AND ITS SALTS Dosage forms for nasal or ophthalmic use
NARCOTINE (NOSCAPINE) AND
ITS SALTS
NIACINAMIDE Dosage forms for topical use
NICOTINE AND ITS SALTS Dosage forms sold as chewing gums, inhalers,
lozenges or transdermal nicotine replacement
patches
NIZATIDINE AND ITS SALTS Dosage forms for oral use containing 75 mg or
less per dosage unit
NOSCAPINE (NARCOTINE) AND
ITS SALTS
NYSTATIN, ITS SALTS AND Dosage forms for topical use on the skin
DERIVATIVES
ORPHENADRINE CITRATE
OXETHAZAINE AND ITS SALTS
OXYBUPROCAINE AND ITS SALTS Dosage forms for topical use on mucous
membranes, except lozenges
OXYMETAZOLINE AND ITS SALTS Dosage forms for nasal or ophthalmic use
PANCREATIC ENZYMES Except dosage forms recommended for cystic
fibrosis treatment
PANCREATIN
PHENIRAMINE AND ITS SALTS
PHENYLEPHRINE AND ITS SALTS Dosage forms for ophthalmic use in
concentrations of 2.5% or less
PHENYLPROPANOLAMINE AND ITS SALTS
PHENYLTOLOXAMINE AND ITS SALTS
PINE TAR Except shampoos in concentrations of 5% or less
POLYMYXINS, THEIR SALTS Dosage forms for topical use on the skin
AND DERIVATIVES
POVIDONE-IODINE Dosage forms for topical use except in
concentrations of 5% or less
PRAMOXINE AND ITS SALTS Dosage forms for topical use on mucous
membranes, except lozenges
PRILOCAINE AND ITS SALTS Dosage forms for topical use on the skin
PROCAINE AND ITS SALTS Dosage forms for topical use on mucous
membranes, except lozenges
PROMETHAZINE AND ITS SALTS Dosage forms for topical use on the skin
PROPARACAINE AND ITS SALTS Dosage forms for topical use on mucous
membranes, except lozenges
PSEUDOEPHEDRINE AND ITS SALTS Dosage forms in concentrations of more than
30 mg or containing more than 25 dosage units
sold in single packages containing only one
packaging unit
Dose forms for children
PYRILAMINE AND ITS SALTS
RANITIDINE AND ITS SALTS Dosage forms for oral use containing 75 mg or
less per dosage unit
Dosage forms for oral use containing more than
75 mg and not more than 150 mg per dosage
unit, in package units containing less than 51
dosage units
SENNA, ITS EXTRACTS AND Dosage forms containing 8.6 mg or more of senna
DERIVATIVES lycoside per dosage unit
SODIUM BIPHOSPHATE Dosage forms for cathartic use
SODIUM CITRATE Dosage forms use as urinary alkalizer
SODIUM CROMOGLICATE Dosage forms for nasal use in concentrations
of 2% or less
SODIUM LAURYL SULFOACETATE Dosage forms for cathartic use
SODIUM PHOSPHATE Dosage forms for cathartic use
SODIUM SALICYLATE
SODIUM TARTRATE Dosage forms for cathartic use
TETRACAINE AND ITS SALTS Dosage forms for topical use on mucous
membranes, except lozenges
TETRAHYDROZOLINE Dosage forms for nasal or ophthalmic use
TIOCONAZOLE Dosage forms for vaginal use
TRIETHANOLAMINE OLEATE
TRIETHANOLAMINE SALICYLATE Dosage forms for topical use in concentrations
greater than 20%
TRIPELENNAMINE AND ITS SALTS
TRIPROLIDINE
TYROTHRICINE
XYLOMETAZOLINE AND ITS SALTS Dosage forms for nasal or ophthalmic use
