GreatNorthCollective/greatnorth-canada-federal-laws-text huggingface dataset:
Food and Drug Regulations — C.01.015
C.01.015 (1) Subject to subsection (2), no person shall sell for human use a drug in the form of a tablet that is intended to be swallowed whole unless, when tested by the official method DO-25, Determination of the Disintegration Time of Tablets , dated July 5, 1989, (a) in the case of an uncoated tablet, the tablet disintegrates in not more than 45 minutes; (b) in the case of a plain coated tablet, the tablet disintegrates in not more than 60 minutes; and (c) in the case where the label of the drug indicates that the tablet carries an enteric coating or a coating designed to serve a purpose similar to that of an enteric coating, the tablet does not disintegrate when exposed for 60 minutes to simulated gastric fluid, but when it is subsequently exposed for a continuous period to simulated intestinal fluid, the tablet disintegrates in not more than 60 minutes. (2) Subsection (1) does not apply in respect of a drug in the form of a tablet where (a) a notice of compliance in respect of the drug in the form of a tablet has been issued under section C.08.004 or C.08.004.01; (b) [Repealed, SOR/98-423, s. 7] (c) a dissolution or disintegration test for the drug in the form of a tablet is prescribed in Division 6 of this Part; (d) the drug is labelled as complying with a standard contained in a publication referred to in Schedule B to the Act; (e) the drug has been demonstrated by an acceptable method to be available to the body; or (f) representations regarding the drug are made on its label, or in any advertisement, with respect to the site, rate or extent of release to the body of a medicinal ingredient of that drug, or the availability to the body of a medicinal ingredient of that drug. SOR/89-429, s. 2; SOR/89-455, s. 3; SOR/94-36, s. 2; SOR/98-423, s. 7; SOR/2011-88, s. 4
Food and Drug Regulations — C.01.016
C.01.016 No manufacturer shall sell a drug unless the manufacturer complies with the conditions set out in sections C.01.017 to C.01.019. SOR/95-521, s. 2; SOR/2011-31, s. 1
Food and Drug Regulations — C.01.017
C.01.017 The manufacturer shall submit to the Minister a report of all information relating to the following serious adverse drug reactions within 15 days after receiving or becoming aware of the information, whichever occurs first: (a) any serious adverse drug reaction that has occurred in Canada with respect to the drug; and (b) any serious unexpected adverse drug reaction that has occurred outside Canada with respect to the drug. SOR/95-521, s. 2; SOR/2011-31, s. 1
Food and Drug Regulations — C.01.018
C.01.018 (1) The manufacturer shall prepare an annual summary report of all information relating to adverse drug reactions and serious adverse drug reactions to the drug that it received or became aware of during the previous 12 months. (2) The annual summary report shall contain a concise, critical analysis of the adverse drug reactions and serious adverse drug reactions to the drug. (3) In preparing the annual summary report, the manufacturer shall determine, on the basis of the analysis referred to in subsection (2), whether there has been a significant change in what is known about the risks and benefits of the drug during the period covered by the report and shall include its conclusions in this regard in the summary report. (4) If, in preparing the annual summary report, the manufacturer concludes that there has been a significant change, it shall notify the Minister without delay, in writing, unless this has already been done. (5) The Minister may, for the purposes of assessing the safety and effectiveness of the drug, request in writing that the manufacturer submit to the Minister one or both of the following: (a) the annual summary reports; (b) the case reports relating to the adverse drug reactions and serious adverse drug reactions to the drug that are known to the manufacturer. (6) The Minister shall, after giving the manufacturer an opportunity to be heard, specify a period for the submission of the annual summary reports or case reports, or both, that is reasonable in the circumstances, and the manufacturer shall submit the reports within that period. SOR/2011-31, s. 1
Food and Drug Regulations — C.01.018.1
C.01.018.1 Section C.01.018 does not apply in respect of a veterinary health product. SOR/2017-76, s. 4
Food and Drug Regulations — C.01.019
C.01.019 (1) The Minister may, for the purposes of assessing the safety and effectiveness of the drug, request in writing that the manufacturer submit to the Minister an issue-related summary report. (2) The report shall contain a concise, critical analysis of the adverse drug reactions and serious adverse drug reactions to the drug, as well as case reports of all or specified adverse drug reactions and serious adverse drug reactions to the drug that are known to the manufacturer in respect of the issue that the Minister directs the manufacturer to analyze in the report. (3) The Minister shall, after giving the manufacturer an opportunity to be heard, specify a period for the submission of the report that is reasonable in the circumstances. The Minister may only specify a period that is less than 30 days if the Minister needs the information in the report to determine whether the drug poses a serious and imminent risk to human health. (4) The manufacturer shall submit the report within the specified period. SOR/2011-31, s. 1; SOR/2017-18, s. 14
Food and Drug Regulations — C.01.019.1
C.01.019.1 Section C.01.019 does not apply in respect of a veterinary health product. SOR/2017-76, s. 5
Food and Drug Regulations — C.01.020
C.01.020 (1) The manufacturer shall maintain records of the reports and case reports referred to in sections C.01.017 to C.01.019. (2) The manufacturer shall retain the records for 25 years after the day on which they were created. SOR/2011-31, s. 1
Food and Drug Regulations — C.01.020.1
C.01.020.1 (1) For the purposes of section 21.8 of the Act, hospitals are the prescribed health care institutions that shall provide information that is in their control to the Minister about a serious adverse drug reaction. (2) The following prescribed information about a serious adverse drug reaction that is in a hospital’s control shall be provided to the Minister in writing within 30 days after the day on which the serious adverse drug reaction is first documented within the hospital: (a) the name of the hospital and the contact information of a representative of that hospital; (b) the drug’s brand name, proper name or common name; (c) in the case of a drug imported under subsection C.10.001(2) or section C.10.006, the identifying code or number of the drug, if any, assigned in the country in which the drug was authorized for sale; (c.1) in the case of a drug whose sale has been authorized under subsection C.11.003(1), its identifying name, code, number or mark; (d) the drug identification number assigned for the drug, if applicable; (e) the patient’s age and sex; (f) a description of the serious adverse drug reaction; (g) the date on which the serious adverse drug reaction was first documented; (h) the date on which the patient first used the drug and, if applicable, the date on which the patient stopped using the drug; (i) the date on which the serious adverse drug reaction first occurred and, if applicable, the date on which the patient’s health was restored to its state prior to the reaction; (j) any medical condition of the patient that directly relates to the serious adverse drug reaction; (k) any concomitant therapeutic products used by the patient; and (l) the effect of the serious adverse drug reaction on the patient’s health. (3) A hospital is exempt from section 21.8 of the Act in respect of the reporting of information referred to in subsection (2) if (a) the hospital does not have in its control all of the information referred to in paragraphs (2)(b), (c), (e) and (f) in respect of the serious adverse drug reaction; or (b) the serious adverse drug reaction relates only to any of the following drugs: (i) a vaccine that was administered under a routine immunization program of a province, (ii) a drug that is authorized for sale under Division 5 of this Part, or (iii) a drug that was sold under subsection C.08.011(1). (4) In this section, hospital means a facility (a) that is licensed, approved or designated as a hospital by a province in accordance with the laws of the province to provide care or treatment to persons suffering from any form of disease or illness; or (b) that is operated by the Government of Canada and that provides health services to in-patients. SOR/2019-190, s. 2 SOR/2021-199, s. 4 SOR/2023-18, s. 1
Food and Drug Regulations — C.01.021
 4.0 g Squill and its preparations, on the basis of crude drug — 32.5 97.5 Stramonium and its preparations, on the basis of stramonium alkaloids — 0.16 0.65 Strychnine and its salts — 0.0 0.0 Tannic Acid — 150 1 000 Tetracaine, its salts and derivatives when sold or recommended for ophthalmic use 0.0 0.0 0.0 Thiocyanates 0.0 0.0 0.0 Urethane 0.0 0.0 0.0 Where drugs having similar physiological actions occur in combination, the dosage of each shall be proportionately reduced. Accurate dosagesmay be expressed in either metric units or imperial units. If the dosage is expressed in both systems, then an approximation may be used for one expression, but such approximation must precede or follow the accurate statement by which the product will be judged and must be in brackets. SOR/78-422, s. 1; SOR/80-544, s. 3; SOR/84-145, s. 1; SOR/85-715, s. 3; SOR/85-966, s. 2; SOR/88-94, s. 1; SOR/89-229, s. 2; SOR/89-548, s. 1
Food and Drug Regulations — Food and Drug Regulations
Where drugs having similar physiological actions occur in combination, the dosage of each shall be proportionately reduced.
Food and Drug Regulations — Food and Drug Regulations
Accurate dosagesmay be expressed in either metric units or imperial units. If the dosage is expressed in both systems, then an approximation may be used for one expression, but such approximation must precede or follow the accurate statement by which the product will be judged and must be in brackets.
Food and Drug Regulations — C.01.022
C.01.022 Notwithstanding paragraph C.01.021(b), the recommended single and daily dosage of a drug (a) intended to be burned and the smoke inhaled may be increased to 10 times the oral dose, and (b) intended for use as suppositories may be increased to 33 1/3 per cent in excess of the oral dose.
Food and Drug Regulations — C.01.024
C.01.024 (1) Sections C.01.021 and C.01.022 do not apply to (a) a drug sold to a drug manufacturer; or (b) a drug sold on prescription. (2) Paragraph C.01.021(c) does not apply to (a) acetaminophen; (b) acetylsalicylic acid; (c) magnesium salicylate; (d) sodium salicylate; or (e) choline salicylate. (3) Where a drug mentioned in any of paragraphs (2)(a) to (d) is recommended for children, no person shall sell the drug for human use unless both the inner and the outer labels carry a statement that it is recommended (a) that the drug be used as directed by a physician; or (b) that the maximum doses of the drug not exceed the amounts set out in the following table and that single doses not be administered more frequently than every four hours. TABLE Maximum Dose Item Column I Column II Column III Column IV Column V Column VI Column VII Age Maximum Children’s Dose (80 mg units) Acetaminophen Drops Maximum Children’s Dose (80 mg units) Maximum Children’s Dose (160 mg units) Acetaminophen Maximum Adult’s Dose (325 mg units) Maximum Single Dose (mg) Maximum Daily Dose (mg) 1 11 to under 12 years — 6 3 1.5 480 2 400 2 9 to under 11 years — 5 2.5 1.25 400 2 000 3 6 to under 9 years — 4 2 1 320 1 600 4 4 to under 6 years — 3 1.5 — 240 1 200 5 2 to under 4 years — 2 1 — 160 800 6 1 to under 2 years 1.5 or as directed by a physician — — — 120 600 7 4 months to under 1 year 1 or as directed by a physician — — — 80 400 8 0 to under 4 months 0.5 or as directed by a physician — — — 40 200 (4) Where choline salicylate is recommended for children, no person shall sell the drug for human use unless both the inner and the outer labels carry a statement that it is recommended (a) that the drug be used as directed by physician; or (b) that the maximum doses of the drug not exceed the amounts set out in the following table and that single doses not be administered more frequently than every four hours. TABLE MAXIMUM DOSE Age (Years) Adult Dosage Units (435 mg) Single Dose (mg) Maximum Daily Dose (mg) 11 to under 12 1 ½ 660 3 300 9 to under 11 1 ¼ 550 2 750 6 to under 9 1 440 2 200 4 to under 6 ¾ 330 1 650 2 to under 4 ½ 220 1 100 Under 2 As directed by physician SOR/84-145, s. 2; SOR/90-587, s. 1
Food and Drug Regulations — C.01.025
C.01.025 Both the inner and the outer labels of a drug that carry a recommended single or daily dosage or a statement of concentration in excess of the limits provided by section C.01.021 shall carry a caution that the product is to be used only on the advice of a physician.
Food and Drug Regulations — C.01.026
C.01.026 The provisions of section C.01.025 do not apply to (a) a drug sold on prescription, or (b) the inner label of a single-dose container.
Food and Drug Regulations — C.01.027
C.01.027 (1) Where a person advertises to the general public a drug for human use, the person shall not make any representation other than with respect to the brand name, proper name, common name, price and quantity of the drug if it (a) contains a drug set out in the table to section C.01.021; and (b) carries on its label (i) a statement of the recommended single or daily adult dosage that results in a single or daily adult dosage of the drug referred to in paragraph (a) in excess of the maximum dosage set out in the table to section C.01.021 for that drug, or (ii) a statement that shows a concentration of the drug referred to in paragraph (a) in excess of the maximum limit set out in the table to section C.01.021 for that drug. (2) Subsection (1) does not apply to products containing (a) acetaminophen; (b) acetylsalicylic acid; (c) choline salicylate; (d) magnesium salicylate; or (e) sodium salicylate. (3) [Repealed, SOR/94-409, s. 1] (4) Where a person advertises to the general public a drug for human use that contains acetylsalicylic acid, the person shall not make any representation with respect to its administration to or use by children or teenagers. SOR/81-358, s. 1; SOR/84-145, s. 3; SOR/85-715, s. 4(F); SOR/85-966, s. 3; SOR/93-202, s. 5; SOR/93-411, s. 1; SOR/94-409, s. 1
Food and Drug Regulations — C.01.028
C.01.028 (1) Subject to subsection (2), the inner and outer labels of a drug that contains (a) acetylsalicylic acid or any of its salts or derivatives, salicylic acid or a salt thereof, or salicylamide, where the drug is recommended for children, shall carry a cautionary statement to the effect that the drug should not be administered to a child under two years of age except on the advice of a physician; (b) boric acid or sodium borate as a medicinal ingredient shall carry a cautionary statement to the effect that the drug should not be administered to a child under three years of age; (c) hyoscine (scopolamine) or a salt thereof shall carry a cautionary statement to the effect that the drug should not be used by persons suffering from glaucoma or where it causes blurring of the vision or pressure pain within the eye; (d) phenacetin, either singly or in combination with other drugs, shall carry the following cautionary statement: “CAUTION: May be injurious if taken in large doses or for a long time. Do not exceed the recommended dose without consulting a physician.”; or (e) acetylsalicylic acid for internal use shall carry a cautionary statement to the effect that the drug should not be administered to or used by children or teenagers who have chicken pox or manifest flu symptoms before a physician or pharmacist is consulted about Reye’s syndrome, which statement shall also refer to the fact that Reye’s syndrome is a rare and serious illness. (2) Subsection (1) does not apply to a drug that is (a) intended for parenteral use only; (b) dispensed pursuant to a prescription; or (c) a prescription drug or a drug that is required to be sold under a prescription by Part G, the Benzodiazepines and Other Targeted Substances Regulations or the Narcotic Control Regulations . SOR/86-93, s. 2; SOR/88-323, s. 2(F); SOR/93-411, s. 2; SOR/2013-122, s. 7
Food and Drug Regulations — Food and Drug Regulations
“CAUTION: May be injurious if taken in large doses or for a long time. Do not exceed the recommended dose without consulting a physician.”; or
Food and Drug Regulations — C.01.029
C.01.029 (1) Subject to subsections C.01.031.2(1) and (2), the inner and outer labels of a drug (a) that contains (i) salicylic acid, a salt thereof or salicylamide, (ii) acetylsalicylic acid, or any of its salts or derivatives, (iii) acetaminophen, or (iv) more than five per cent alkyl salicylates, (a.1) that contains nicotine or any of its salts and is a vaping product as defined in section 2 of the Tobacco and Vaping Products Act but that is not referred to in paragraph 2(b) or (c) or section 3 of the Regulations Excluding Certain Vaping Products Regulated Under the Food and Drugs Act from the Application of the Tobacco and Vaping Products Act , or (b) that is in a package that contains (i) more than the equivalent of 250 mg of elemental iron, or (ii) more than the equivalent of 120 mg of fluoride ion, unless the drug is intended solely for use in dentists’ offices, shall carry a cautionary statement to the effect that the drug should be kept out of the reach of children. (2) Subject to subsections C.01.031.2(1) and (2), the inner label and outer label of a drug that is in a package shall carry a cautionary statement, to the effect that there is enough drug in the package to seriously harm a child, if the package contains (a) more than 1.5 g of salicylic acid or the equivalent quantity of any of its salts or salicylamide, (b) more than 2 g of acetylsalicylic acid or the equivalent quantity of any of its salts or derivatives, (c) more than 3.2 g of acetaminophen, (d) more than the equivalent of 250 mg of elemental iron, (e) more than the equivalent of 120 mg of fluoride ion, unless the drug is intended solely for use in dentists’ offices, or (f) in the case where the drug is a vaping product as defined in section 2 of the Tobacco and Vaping Products Act but is not referred to in paragraph 2(b) or (c) or section 3 of the Regulations Excluding Certain Vaping Products Regulated Under the Food and Drugs Act from the Application of the Tobacco and Vaping Products Act , 0.1 mg/ml or more of nicotine or the equivalent quantity of any of its salts. (3) The cautionary statements required under subsections (1) and (2) shall be preceded by a prominently displayed symbol that is octagonal in shape, conspicuous in colour and on a background of a contrasting colour. SOR/86-93, s. 2; SOR/87-484, s. 2; SOR/88-323, s. 3(F); SOR/90-587, s. 2; SOR/93-468, s. 1; SOR/2018-132, s. 1
Food and Drug Regulations — C.01.030
C.01.030 [Repealed, SOR/2003-196, s. 104]
Food and Drug Regulations — C.01.031
C.01.031 (1) Subject to section C.01.031.2, (a) no person shall sell a drug described in subsection C.01.029(1) unless (i) where the drug is recommended solely for children, it is packaged in a child resistant package, (ii) where the drug is not recommended solely for children, other than a drug referred to in subparagraph (iii), at least one of the sizes of packages available for sale is packaged in a child resistant package, and (iii) where the drug is a vaping product referred to in paragraph C.01.029(1)(a.1), it is packaged in a child resistant package; and (b) where a drug described in subsection C.01.029(1) is packaged in a package that is not a child resistant package, the outer label shall carry a statement that the drug is available in a child resistant package. (2) Subsection C.01.031.2(2) and paragraph C.01.031.2(3)(a) do not apply to a drug referred to in paragraph C.01.029(1)(a.1). SOR/86-93, s. 2; SOR/87-16, s. 1; SOR/93-468, s. 2; SOR/2018-132, s. 2
Food and Drug Regulations — C.01.031.2
C.01.031.2 (1) Sections C.01.029 to C.01.031 do not apply to a drug that is (a) a prescription drug or a drug that is required to be sold under a prescription by Part G, the Benzodiazepines and Other Targeted Substances Regulations or the Narcotic Control Regulations ; (b) intended for parenteral use only; (c) in effervescent or powder form; (d) in suppository form; (e) intended for topical use, unless it is a liquid preparation containing more than five per cent alkyl salicylates; (f) packaged in a non-reclosable package containing not more than two adult standard dosage units per package; or (g) in toothpaste form. (2) Sections C.01.029 to C.01.031 do not apply to a drug that is repackaged by a pharmacist or practitioner at the time of sale. (3) Section C.01.031 does not apply to a drug that is (a) sold only in containers that have roll-on or spray applicators or permanently installed wick applicators; (b) sold for exclusive use in animals other than household pets; or (c) intended solely for use in dentists’ offices, or packaged for hospital use only. SOR/86-93, s. 2; SOR/87-484, s. 4; SOR/88-323, s. 5(F); SOR/93-468, s. 3; SOR/2013-122, s. 8
Food and Drug Regulations — C.01.032
C.01.032 No person shall sell a corticosteroid drug for ophthalmic use unless (a) the outer label or the package insert carries, as part of the directions for use, the following statements: “Contraindications Viral diseases of the cornea and conjunctiva; Tuberculosis of the eye; Fungal diseases of the eye; Acute purulent untreated infections of the eye, which, like other diseases caused by micro-organisms, may be masked or enhanced by the presence of the steroid. Side Effects Extended ophthalmic use of corticosteroid drugs may cause increased intraocular pressure in certain individuals and in those diseases causing thinning of the cornea, perforation has been known to occur.”; and (b) the inner label carries the statements required by paragraph (a) or instructions to see the outer label or package insert for information about contraindications and side effects. SOR/2018-69, s. 18(F)
Food and Drug Regulations — Food and Drug Regulations
Viral diseases of the cornea and conjunctiva;
Food and Drug Regulations — Food and Drug Regulations
Acute purulent untreated infections of the eye, which, like other diseases caused by micro-organisms, may be masked or enhanced by the presence of the steroid.
Food and Drug Regulations — Food and Drug Regulations
Extended ophthalmic use of corticosteroid drugs may cause increased intraocular pressure in certain individuals and in those diseases causing thinning of the cornea, perforation has been known to occur.”;
Food and Drug Regulations — C.01.033
C.01.033 Section C.01.032 does not apply to a corticosteroid drug that is sold by a pharmacist under a prescription. SOR/2013-122, s. 9
Food and Drug Regulations — C.01.034
C.01.034 No person shall disseminate to a practitioner promotional literature about corticosteroid drugs for ophthalmic use unless the statements required by paragraph C.01.032(a) are included in that literature.
Food and Drug Regulations — C.01.035
C.01.035 Sections C.01.032 and C.01.034 do not apply to a drug sold solely for veterinary use.