O. Reg. 297/96: GENERAL"

O. Reg. 297/96: GENERAL, Drug and Pharmacies Regulation Act, R.S.O. 1990, c. H.4

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;

(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

(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.