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Drug and Pharmacies Regulation Act
Loi sur la réglementation des médicaments et des pharmacies

ONTARIO REGULATION 297/96

GENERAL

Historical version for the period April 23, 1999 to June 3, 2008.

Last amendment: O. Reg. 180/99.

This Regulation is made in English only.

1. In this Regulation,

“Manual” means the manual published by the National Association of Pharmacy Regulatory Authorities entitled “Canada’s National Drug Scheduling System” and dated September 25, 1998, as that manual is amended from time to time. O. Reg. 180/99, s. 1.

2. (1) Schedules A and B to this Regulation are established for the purposes of Part VI of the Act. O. Reg. 180/99, s. 1.

(2) The substances included in Schedules A and B are prescribed for the purposes of Part VI of the Act. O. Reg. 180/99, s. 1.

(3) Schedule II to the Manual shall constitute Schedule C for the purposes of Part VI of the Act. O. Reg. 180/99, s. 1.

(4) The substances included in Schedule C are prescribed for the purposes of Part VI of the Act. O. Reg. 180/99, s. 1.

(5) Schedule III to the Manual shall constitute Part II of Schedule D for the purposes of Part VI of the Act. O. Reg. 180/99, s. 1.

(6) The substances included in Schedule D are prescribed for the purposes of Part VI of the Act. O. Reg. 180/99, s. 1.

(7) Schedule I to the Manual shall constituted Schedule E for the purposes of Part VI of the Act. O. Reg. 180/99, s. 1.

(8) The substances included in Schedule E are prescribed for the purposes of Part VI of the Act. O. Reg. 180/99, s. 1.

3. (1) In this section,

“advertisement” includes an announcement, directory listing or other form of communication similar to an advertisement;

“prescription services” means the compounding, dispensing or sale by retail of drugs pursuant to prescriptions and the provision of information or advice with respect to those drugs. O. Reg. 119/97, s. 1.

(2) It is a standard of accreditation of a pharmacy that the owner or operator of the pharmacy ensure that an advertisement of prescription services available in the pharmacy be in compliance with this section. O. Reg. 119/97, s. 1.

(3) The owner or operator of a pharmacy shall not, through any medium, publish, display, distribute or use, or permit, directly or indirectly, the publication, display, distribution or use through any medium of, an advertisement relating to prescription services that,

(a) is false, misleading or deceptive, whether as a result of the inclusion of information or the omission of information;

(b) is not readily comprehensible to the persons to whom it is directed;

(c) is not dignified and in good taste;

(d) contains anything that cannot be verified;

(e) contains testimonials, comparative statements or endorsements;

(f) contains a reference to a member’s area of practice or to a procedure or treatment available from a member practising in the pharmacy, unless the advertisement discloses whether or not the member has an area of expertise and, if the member does have such an area of expertise, the particular expertise;

(g) contains references to a particular brand of equipment used to assist in providing prescription services;

(h) contains information that is not relevant to the choice of a pharmacy; or

(i) contains any representations as to the safety or effectiveness or an indication for use of any specified prescription drug. O. Reg. 119/97, s. 1.

(4) An advertisement by the owner or operator of a pharmacy that includes price information relating to prescription drugs shall include the price information for at least 15 different drugs, 10 of which each belong to a different one of the following drug classifications:

1. Anti-infective agents.

2. Antineoplastic agents.

3. Autonomic agents.

4. Blood formation and coagulation drugs.

5. Cardiovascular drugs.

6. Central nervous system drugs.

7. Diagnostic agents.

8. Electrolytic, caloric and water balance drugs.

9. Cough preparations.

10. Eye, ear, nose and throat preparations.

11. Gastrointestinal drugs.

12. Gold compounds.

13. Heavy metal antagonists.

14. Hormones and substitutes.

15. Oxytocics.

16. Skin and mucous membrane preparations.

17. Spasmolytics.

18. Unclassified therapeutic agents.

19. Vitamins. O. Reg. 119/97, s. 1.

(5) If an advertisement by a member includes price information relating to prescription drugs, the advertisement shall include at a minimum the following price information with respect to each drug:

1. The dispensing fee.

2. The sum of the cost to the pharmacy plus the pharmacy’s mark-up.

3. The total cost for the prescription to the purchaser.

4. The time period during which the advertised price will be available. O. Reg. 119/97, s. 1.

(6) The price information referred to in subsection (5) shall be given for the standard reference quantity of each drug. However, if the prescription is supplied to a consumer in the package in which it was supplied to the pharmacy, the price information shall be given for the quantity contained in the package. O. Reg. 119/97, s. 1.

(7) The standard reference quantity for a drug is the reference quantity indicated in the guidelines titled “Standard Reference Quantity Guidelines”, dated January 30, 1997 and available from the College or, if it is not indicated in the College guidelines, the standard reference quantity for a drug is,

(a) for tablets or capsules, 100;

(b) for liquids, 100 millilitres; or

(c) 30 grams for solid dosage forms. O. Reg. 119/97, s. 1.

(8) An advertisement by a member that includes price information relating to prescription drugs shall include, in addition to the price information referred to in subsection (5), the following information with respect to each drug in respect of which price information is included:

1. The generic name of the drug.

2. The strength of the drug.

3. The brand name and the name of the manufacturer of the drug.

4. The dosage form of the drug.

5. The quantity of the drug for which the price information is given.

6. Any of the following services that are included in the price:

i. The establishment of patient medical profiles.

ii. Professional consultation.

iii. Health care services information.

iv. After hours emergency prescription services.

v. Delivery service. O. Reg. 119/97, s. 1.

(9) In an advertisement by a member that includes price information relating to prescription drugs, equal prominence shall be given to each drug for which price information is given and, for each of those drugs, equal prominence shall be given to all the information required under subsections (5) and (8). O. Reg. 119/97, s. 1.

4. It is a standard of accreditation for a pharmacy that the owner or operator of the pharmacy that advertises price information for a prescription drug ensure that the pharmacy does not charge any purchaser, including the Minister, more, in respect of any fee, cost or amount that is required under subsection 3 (5) to be part of the price information, than the amount set out in the advertisement. O. Reg. 119/97, s. 1.

5. Nothing in this Part prohibits the owner or operator of a pharmacy from publishing, displaying, distributing or using, or permitting, directly or indirectly, the publication, display, distribution or use of, an advertisement that relates solely to the co-payment or dispensing fee charged by the pharmacy for supplying a drug that is a listed drug product under the Ontario Drug Benefit Act to an eligible person under that Act. O. Reg. 119/97, s. 1.

SCHEDULE A

1.

Acid (calcium d-pantothenate)

2.

Acid (dexpanthenol)

3.

Alginic acid

4.

Allantoin

5.

Aloe

6.

Aloin

7.

Alum

8.

Aralia racemosa

9.

Arrowroot

10.

Attapulgite (activated)

11.

Balmony

12.

Balsam tolu

13.

Balsam mecca

14.

Benzoic acid

15.

Benzoin

16.

Benzyl alcohol

17.

Bile extract

18.

Bile salts

19.

Bisacodyl

20.

Caffeine

21.

Caffeine citrate

22.

Calcium carbonate

23.

Calcium gluconate

24.

Calcium glycerophosphate

25.

Calcium hydroxide

26.

Calcium lactate

27.

Calcium phosphate (dibasic)

28.

Calcium undecylenate

29.

Canada balsam

30.

Capsicum oleoresin

31.

Castor oil

32.

Cocoa butter

33.

Cod liver oil

34.

Copper sulfate

35.

Creosote

36.

Cynara scolymus

37.

Eucalyptol

38.

Eucalyptus

39.

Eucalyptus oil

40.

Eugenol

41.

Fennel

42.

Fir

43.

Gelatin

44.

Gentiana lutea

45.

Ginger

46.

Glycerine

47.

Guaiacol

48.

Guaifenesin

49.

Hamamelis virginiana

50.

Hemlock spruce

51.

Honey

52.

Juniper tar

53.

Lanolin

54.

Linseed

55.

Liquid paraffin (mineral oil)

56.

Magnesium sulfate (epsom salts)

57.

Motherwort common

58.

Myrrh

59.

Oats

60.

Octocrylene

61.

Oil of anise

62.

Oil of cajeput

63.

Oil of camphor

64.

Oil of cinnamon

65.

Oil of clove

66.

Oil of dill

67.

Oil of fennel

68.

Oil of fir

69.

Oil of hemlock canadian

70.

Oil of mustard expressed

71.

Oil of peppermint

72.

Oil of pine needles

73.

Oil of sassafras

74.

Oil of sweet almond

75.

Oil of thyme

76.

Oil of turpentine

77.

Olive oil

78.

Ox bile extract

79.

Pancreatin

80.

Papain

81.

Pectin

82.

Pepsin

83.

Peptone

84.

Petrolatum

85.

Petrolatum liquid

86.

Pine tar

87.

Plantago seed

88.

Poplar bud

89.

Prune

90.

Saccharine and sodium saccharine

91.

Sassafras

92.

Shark liver oil

93.

Simethicone

94.

Sodium alginate

95.

Sodium benzoate

96.

Sodium bicarbonate

97.

Sodium carbonate

98.

Sodium carboxymethyl cellulose

99.

Sodium chloride

100.

Sodium citrate

101.

Sodium dioctyl sulfosuccinate

102.

Sodium lauryl sulfate

103.

Sodium monofluorophosphate

104.

Sodium oleate

105.

Sodium phosphate dibasic

106.

Sodium tartrate

107.

Spruce gum

108.

Strawberry

109.

Sulfur

110.

Tartaric acid

111.

Thymol

112.

Turpentine

113.

White petroleum

114.

White pine

115.

Wild cherry

116.

Yeast

O. Reg. 180/99, s. 2.

SCHEDULE B
PART I

1.

2-phenylbenzimidazole-5-sulfonic acid

2.

4-methylbenzylidene camphor

3.

Acetaminophen — when sold in standard unit doses of 325mg 25 or less

4.

Acetylsalicylic acid — when sold in standard unit doses of 325 mg 51 or less

5.

Alpha-galactosidase

6.

Aluminium chlorohydrate

7.

Aluminum chloride — when in an antiperspirant preparation, not more than 5 per cent

8.

Aluminum chlorohydrate

9.

Aluminum hydroxide

10.

Aluminum hydroxide — magnesium carbonate codried gel

11.

Aluminum potassium sulfate

12.

Aluminum sesquichlorohydrate

13.

Aluminum zirconium tetrachlorohydrex glycine

14.

Aluminum zirconium trichlorohydrex glycine

15.

Ammonium bicarbonate

16.

Ammonium carbonate

17.

Ammonium chloride

18.

Ammonium hydrozide (anethole)

19.

Bacitracin and its salts and derivatives — for topical use

20.

Beef, iron and wine

21.

Benzalkonium chloride — in liquid preparations in concentrations not more than 2 per cent

22.

Benzethonium chloride — in liquid preparations in concentrations not more than 1 per cent

23.

Biguanide polyaminopropyl

24.

Bioflavanoids

25.

Biotin

26.

Bismuth subcarbonate (oxycarbonate)

27.

Bismuth subgallate

28.

Bismuth subsalicylate

29.

Boldo

30.

Buchu

31.

Butyl methoxydibenzoylmethane

32.

Carbetapentane citrate

33.

Cascara sagrada and its extracts and derivatives

34.

Cetrimide

35.

Cetylpyridinium gluconate

36.

Chamomile

37.

Charcoal (activated) — except for use in poisoning treatment

38.

Chloral hydrate — for topical use

39.

Chlorhexidine gluconate

40.

Chlorhydrol — when in an antiperspirant preparation

41.

Chlorobutanol

42.

Chloroxylenol

43.

Chlorpheniramine maleate and its salts and preparations — except for parenteral use

44.

Choline

45.

Cinnamedrine

46.

Citric acid

47.

Clove

48.

Coal tar — in concentrations of up to and including 10 per cent

49.

Cochineal

50.

Cocillana

51.

Croton oil

52.

Culver’s root

53.

Dea methoxycinnamate

54.

Dimethicone

55.

Disodium edetate

56.

Disodium lauroamphodiacetate conc.

57.

Domiphen bromide

58.

Docusate and its salts

59.

Dyclonine hydrochloride

60.

Edetic acid

61.

Essence of peppermint

62.

Frangula

63.

Glycyrrhiza glabra

64.

Glycyrrhizin

65.

Gramicidin and its salts — for topical use

66.

Hexylresorcinol

67.

Homosalate

68.

Hydrogen peroxide — not more than 3 per cent

69.

Hydroquinone — when in skin bleaching preparations, not more than 2 per cent

70.

Hydroxyquinoline

71.

Inositol

72.

Irgasan DP 300 — when in an antiperspirant preparation, not more than 0.4 per cent

73.

Iron and its salts and derivatives — in preparations containing 30 mg or less elemental iron per dosage unit or 5 ml oral liquid

74.

Juglans

75.

Ketoconazole and its salts — as a shampoo

76.

Lactic acid (CDSS) (in preparations in concentrations greater than 10 per cent — Schedule 3)

77.

Lidocaine (hydrochloride) and its salts — for topical use on the skin, including lozenge

78.

Linum usitatissimum

79.

Magaldrate

80.

Magnesium carbonate

81.

Magnesium chloride

82.

Magnesium citrate

83.

Magnesium hydroxide

84.

Magnesium oxide

85.

Magnesium trisilicate

86.

Menthol

87.

Menthyl anthranilate

88.

Merbromin (mercurochrome) solution — not more than 2 per cent

89.

Methyl salicylate

90.

Methylbenzethonium chloride — when in an antiperspirant preparation not more than 0.25 per cent

91.

Methylene blue

92.

Miconazole and its salts — for topical use

93.

Naphazoline (hydrochloride) and its salts — in oral preparations for adult use and in ophthalmic products

94.

Octyl methoxycinnamate

95.

Octyl salicylate

96.

Oil of eucalyptus

97.

Oxybenzone

98.

Oxymetazoline — in nasal preparations for adult use and in ophthalmic products, except for pediatric use

99.

Padimate O

100.

Pamabrom

101.

Pheniramine maleate and its salts

102.

Phenoxyethanol

103.

Phenyl salicylate

104.

Phenylephrine (hydrochloride) and salts and preparations for oral use, in nasal preparations for adults and in ophthalmic preparations in concentrations of 2.5 per cent or less

105.

Phenylpropanolamine bitartrate and salts

106.

Phenylpropanolamine hydrochloride and salts

107.

Phosphorus (calcium hypophosphite)

108.

Phosphorus (calcium phosphate (dibasic))

109.

Phosphorus (potassium hypophosphite)

110.

Phosphorus (sodium hypophosphite)

111.

Phytolacca decandra

112.

Polyaminopropyl biguanide

113.

Polyethylene glycol (400) — for topical administration

114.

Polyhexanide

115.

Polymyxin B (polymyxin B sulfate) and its salts and derivatives — for topical use, or in oral cavity or nasal passages

116.

Polyoxypropylene-polyoxyethylene BL copolymer

117.

Polyquaternium-1

118.

Potassium acid tartrate (cream of tartar)

119.

Potassium bicarbonate — in preparations with not more than 5 mmol/single dose

120.

Potassium chlorate — in preparations with not more than 5 mmol/single dose

121.

Potassium chloride — as a salt substitute

122.

Potassium iodide — not more than 0.01 per cent when in salt substitutes

123.

Potassium nitrate (saltpetre)

124.

Pramoxine hydrochloride

125.

Propylene glycol — topical application

126.

Pseudoephedrine and its salts and preparations

127.

Pyrilamine maleate

128.

Ranitidine and its salts — when sold in a dosage form containing not more than the equivalent of 75 mg of ranitidine

129.

Resorcinol

130.

Rhubarb root

131.

Salicylic acid and its salts — in topical preparations in concentrations up to/including 40 per cent

132.

Sanguinaria canadensis

133.

Seidlitz powders

134.

Selenium and its salts — in a preparation for internal use when sold as a nutritional supplement

135.

Selenium sulfide — when in an anti-dandruff preparation not more than 1 per cent

136.

Senecio aureus

137.

Senega

138.

Senna and its extracts and derivatives

139.

Silver acetate

140.

Silver nitrate

141.

Sodium acid pyrophosphate

142.

Sodium fluoride — when in dentifrices not more than 0.25 per cent

143.

Sodium glycerophosphate

144.

Sodium phosphate

145.

Sodium potassium tartrate (rochelle salts)

146.

Sodium salicylate

147.

Sodium sulfate

148.

Spirit of aromatic ammonia

149.

Spirit of nitrous ether

150.

Squill

151.

Stannous fluoride — when in dentifrices not more than 0.4 per cent

152.

Storax

153.

Strontium chloride — when in dentifrices not more than 10 per cent

154.

Sulisobenzone

155.

Tannic acid

156.

Taraxacum officinale weber

157.

Tea tree oil

158.

Terpin hydrate

159.

Tetrahydrozoline hydrochloride — except in nasal preparations for pediatric use

160.

Tetrapotassium pyrophosphate

161.

Tetrasodium pyrophosphate

162.

Teucrium scorodonia

163.

Titanium dioxide

164.

Titanium dioxide coated mica

165.

Triclocarban

166.

Triclosan

167.

Trolamine salicylate

168.

Undecylenic acid

169.

Urea hydrogen peroxide

170.

Viburnum opulus

171.

Xanthoxylum

172.

Xylitol

173.

Xylometazoline hydrochloride — except for nasal preparations for pediatric use

174.

Yellow dock

175.

Zinc oxide

176.

Zinc phenolsulphonate

177.

Zinc pyridinethione — when in anti-dandruff preparations, not more than 2 per cent

178.

Zinc sulphate — in preparations containing 25 mg or less of elemental zinc

179.

Zirconium hydrochloride — when in an antiperspirant preparation, not more than 5 per cent

O. Reg. 180/99, s. 2.