GreatNorthCollective/greatnorth-canada-federal-laws-text huggingface dataset:
Food and Drug Regulations — C.01.051.1
C.01.051.1 (1) A person who is ordered by the Minister under section 21.3 of the Act to recall a drug in dosage form, or an active ingredient, shall provide the Minister with the following information in the time and manner specified by the Minister: (a) the quantity of the drug that has been sold by the person at the retail level to consumers in Canada; (b) if the person has sold the drug to persons in Canada other than consumers referred to in paragraph (a), (i) the names of those persons and the quantity that has been sold to each of them, and (ii) the period during which the drug was sold to those persons; (c) the quantity of the drug that the person has exported from Canada, as well as the quantity exported by country; (d) the quantity of the drug in Canada that is in the possession or control of the person; (e) the name, title and contact information of an individual from whom the Minister may obtain additional information concerning the recall; (f) the strategy for conducting the recall; (g) any other information that the Minister has reasonable grounds to believe is necessary to mitigate the risk of injury to human health; and (h) if the person is in a position to prevent a recurrence of the situation that prompted the recall, a description of the measures that they intend to take to prevent a recurrence. (2) The person shall notify the Minister without delay of any change to the information referred to in paragraph (1)(e). (3) The person shall (a) before starting the recall, provide the Minister with a copy of any communications that the person intends to use in connection with the start of the recall; and (b) after starting the recall, provide the Minister with, on request and within the time specified by the Minister, a copy of any additional communications that the person uses, or intends to use, in connection with the recall. (4) The person shall notify the Minister in writing, within 24 hours, of the start and completion of the recall. (5) The person shall, within 30 days after completing the recall, provide the Minister with the following information in writing: (a) the results of the recall; and (b) if the person is in a position to prevent a recurrence of the situation that prompted the recall, a description of the measures that they have taken or will take to prevent a recurrence. SOR/2024-136, s. 1
Food and Drug Regulations — C.01.052
C.01.052 (1) The Minister’s power to make an order under section 21.31 of the Act in respect of a drug is subject to the following conditions: (a) the person to whom the order is made shall be the holder of one or more of the following therapeutic product authorizations in respect of the drug: (i) a drug identification number that has been assigned under subsection C.01.014.2(1), (ii) an establishment licence that has been issued under subsection C.01A.008(1), and (iii) a notice of compliance that has been issued under section C.08.004 or C.08.004.01; and (b) the Minister shall have reasonable grounds to believe that (i) in the case of a holder of a therapeutic product authorization referred to in subparagraph (a)(i) or (iii), the benefits or risks of injury to health associated with the drug are significantly different than they were when the authorization was issued, (ii) in the case of a holder of a therapeutic product authorization referred to in subparagraph (a)(ii) who is an importer, the manner in which one or more of the following activities is conducted may present a risk of injury to health associated with the drug: (A) importation , as defined in subsection C.01A.001(1), of the drug, (B) fabrication or packaging/labelling , as defined in subsection C.01A.001(1), of the drug outside Canada, or (C) testing of the drug outside Canada, and (iii) in the case of a holder of a therapeutic product authorization referred to in subparagraph (a)(ii) who is not an importer, the manner in which an activity that is authorized under the authorization is conducted may present a risk of injury to health associated with the drug. (2) The Minister shall, after examining the results of an assessment that was ordered under section 21.31 of the Act in respect of a drug, (a) provide the holder of the therapeutic product authorization with the results of the examination; and (b) ensure that a summary of the results of the examination, together with a description of any steps that the Minister has taken or may take as a consequence of the examination, is published on the Government of Canada website. SOR/2018-84, s. 3 SOR/2020-262, s. 3
Food and Drug Regulations — C.01.053
C.01.053 The Minister’s power to make an order under section 21.32 of the Act in respect of a drug is subject to the following conditions: (a) the person to whom the order is made shall be the holder of one or more of the following therapeutic product authorizations in respect of the drug: (i) a drug identification number that has been assigned under subsection C.01.014.2(1), (ii) an establishment licence that has been issued under subsection C.01A.008(1), and (iii) a notice of compliance that has been issued under section C.08.004 or C.08.004.01; (b) the Minister shall have reasonable grounds to believe that (i) in the case of a holder of a therapeutic product authorization referred to in subparagraph (a)(i) or (iii), there are significant uncertainties relating to the benefits or harms associated with the drug, (ii) in the case of a holder of a therapeutic product authorization referred to in subparagraph (a)(ii) who is an importer, the manner in which one or more of the following activities is conducted has introduced significant uncertainties relating to the benefits or harms associated with the drug: (A) importation , as defined in subsection C.01A.001(1), of the drug, (B) fabrication or packaging/labelling , as defined in subsection C.01A.001(1), of the drug outside Canada, or (C) testing of the drug outside Canada, (iii) in the case of a holder of a therapeutic product authorization referred to in subparagraph (a)(ii) who is not an importer, the manner in which an activity that is authorized under the authorization is conducted has introduced significant uncertainties relating to the benefits or harms associated with the drug, (iv) the holder of the therapeutic product authorization is unable to provide the Minister with information that is sufficient to manage those uncertainties, and (v) the applicable requirements of these Regulations, together with any terms and conditions that have been imposed on the authorization, do not allow for sufficient information to be obtained to manage those uncertainties; and (c) the Minister shall take into account the following matters: (i) whether the activities that the holder of the therapeutic product authorization will be ordered to undertake are feasible, and (ii) whether there are less burdensome ways of obtaining additional information about the drug’s effects on health or safety. SOR/2018-84, s. 3 SOR/2020-262, s. 4
Food and Drug Regulations — C.01.055 and C.01.056
C.01.055 and C.01.056 [Repealed, SOR/82-524, s. 2]
Food and Drug Regulations — C.01.061
C.01.061 (1) Where the net amount of a drug in a package is not expressed on the label in terms of number of dosage units, any 10 packages of the drug selected as provided by official method DO-31, Determination of Net Contents , dated December 7, 1988, shall contain an amount of the drug such that, when determined by that official method, the average of the net amounts of the drug in the 10 packages is not less than the net amount of the drug shown on the label. (2) Where the net amount of a drug in a package is expressed on the label in terms of the number of dosage units, any 10 packages of the drug selected as provided by official method DO-31, Determination of Net Contents , dated December 7, 1988, shall contain a number of units such that, when determined by that official method, (a) the average number of dosage units in the 10 packages is not less than the number of dosage units shown on the label; (b) no package contains less than the number of dosage units shown on the label except as provided in the table; and (c) where the drug is a controlled drug as defined in section G.01.001 or a narcotic as defined in the Narcotic Control Regulations , no package contains more than the number of dosage units shown on the label except as provided in the table to this section. TABLE Item Column I Column II Labelled Number of Dosage Units Per Package Permitted Variation from the Labelled Number 1 50 or less 0 2 More than 50, but less than 101 1 3 101 or more the greater of one unit or 0.75% of the labelled number, rounded up to the next whole number SOR/82-429, s. 4; SOR/89-455, s. 4; SOR/97-228, s. 3 SOR/2019-171, s. 24
Food and Drug Regulations — C.01.064
C.01.064 Where a drug is prepared for ophthalmic or parenteral use and contains a preservative ingredient, that ingredient (a) shall be present only in an amount necessary to obtain the intended action and that does not pose undue risk to humans or animals; and (b) shall not interfere with the therapeutic properties of the drug. SOR/90-586, s. 2
Food and Drug Regulations — C.01.065
C.01.065 No person shall sell a drug that is prepared for ophthalmic or parenteral use unless a representative sample of each lot of the drug in its immediate container (a) is tested by an acceptable method for identity, and the drug is found to be true to its proper name, or to its common name if there is no proper name; (b) is tested by an acceptable method for sterility, except (i) for living vaccines, or (ii) where the manufacturer has submitted evidence, satisfactory to the Minister to prove that processing controls ensure the sterility of the drug in its immediate container, and the drug is found to be sterile; and (c) is subjected to such further tests satisfactory to the Minister to ensure that the drug is safe to use according to directions. SOR/86-552, s. 1; SOR/90-586, s. 3; SOR/93-202, s. 12; SOR/96-399, s. 3; SOR/2018-69, s. 27
Food and Drug Regulations — C.01.066
C.01.066 No person shall sell a drug in aqueous solution that is prepared for parenteral use unless it has been prepared with non-pyrogenic water produced by distillation or reverse osmosis.
Food and Drug Regulations — C.01.067
C.01.067 (1) Subject to subsection (2), no person shall sell a drug that is prepared for parenteral use unless a representative sample of each lot of the drug in its immediate container (a) is tested by an acceptable method for the presence of pyrogens; and (b) when so tested, is found to be non-pyrogenic. (2) Subsection (1) does not apply in respect of a drug that cannot be tested for the presence of pyrogens or that is inherently pyrogenic. SOR/81-335, s. 1; SOR/96-399, s. 4
Food and Drug Regulations — C.01.068
C.01.068 Detailed records of the tests required by sections C.01.065 and C.01.067 shall be retained by the manufacturer for a period of at least one year after the expiration date on the label of the drug. SOR/85-715, s. 5; SOR/92-654, s. 3
Food and Drug Regulations — C.01.069
C.01.069 The packaging of a drug that is prepared for parenteral use shall meet the following requirements: (a) the immediate container shall be of such material and construction that (i) no deleterious substance is yielded to the drug, (ii) it is non-reactive with the drug, (iii) visual or electronic inspection of the drug is possible, (iv) protection against environmental factors that cause deterioration or contamination of the drug is provided or, where that protection cannot be provided by the immediate container, it is provided by the secondary packaging, and (v) a sufficient quantity of the drug is contained to allow withdrawal of the labelled amount of the drug; and (b) the immediate closures and any material coming into contact with the drug in its immediate container shall meet the requirements of subparagraphs (a)(i) and (ii). SOR/96-399, s. 5
Food and Drug Regulations — C.01.070
C.01.070 No person shall sell a drug that is a hypodermic tablet that does not completely dissolve in and form a clear solution with water.
Food and Drug Regulations — C.01.071
C.01.071 No person shall sell mercuric chloride tablets for household use that are packaged in lots of 200 or less, unless (a) such tablets are (i) of an irregular or angular shape, (ii) coloured blue, and (iii) packed in an immediate container that is readily distinguishable by touch; and (b) the principal display panel of both the inner and the outer labels carries in prominent type and in a colour contrasting to that of such labels (i) the design of a skull and cross-bones, and (ii) the word “Poison”. SOR/2001-181, s. 2
Food and Drug Regulations — C.01.101
C.01.101 (1) [Repealed, SOR/78-422, s. 3] (2) [Repealed, SOR/78-800, s. 1] (3) [Repealed, SOR/78-422, s. 3]
Food and Drug Regulations — C.01.121 and C.01.122
C.01.121 and C.01.122 [Repealed, SOR/80-544, s. 6]
Food and Drug Regulations — C.01.131
C.01.131 No person shall sell Aminopyrine or Dipyrone (a derivative of Aminopyrine) for oral or parenteral use, unless (a) the inner label carries the statement: “WARNING: Fatal agranulocytosis may be associated with the use of Aminopyrine and Dipyrone. It is essential that adequate blood studies be made. (See enclosed warnings and precautions)”; and (b) the outer label or the package insert carries the following statements: “WARNING: Serious and even fatal agranulocytosis is known to occur after the administration of Aminopyrine or Dipyrone. Fatal agranulocytosis has occurred after short term, intermittent and prolonged therapy with the drugs. Therefore, the use of these drugs should be as brief as possible. Bearing in mind the possibility that such reactions may occur, Aminopyrine or Dipyrone should be used only when other less potentially dangerous agents are ineffective. PRECAUTIONS: It is essential that frequent white blood cell counts and differential counts be made during treatment with these drugs. However, it is emphasized that agranulocytosis may occur suddenly without prior warning. The drug should be discontinued at the first evidence of any alteration of the blood count or sign of agranulocytosis, and the patient should be instructed to discontinue use of the drug at the first indication of sore throat or sign of other infection in the mouth or throat (pain, swelling, tenderness, ulceration).” SOR/2018-69, s. 34(F)
Food and Drug Regulations — Food and Drug Regulations
“WARNING: Fatal agranulocytosis may be associated with the use of Aminopyrine and Dipyrone. It is essential that adequate blood studies be made. (See enclosed warnings and precautions)”; and
Food and Drug Regulations — Food and Drug Regulations
“WARNING: Serious and even fatal agranulocytosis is known to occur after the administration of Aminopyrine or Dipyrone. Fatal agranulocytosis has occurred after short term, intermittent and prolonged therapy with the drugs. Therefore, the use of these drugs should be as brief as possible. Bearing in mind the possibility that such reactions may occur, Aminopyrine or Dipyrone should be used only when other less potentially dangerous agents are ineffective.
Food and Drug Regulations — Food and Drug Regulations
PRECAUTIONS: It is essential that frequent white blood cell counts and differential counts be made during treatment with these drugs. However, it is emphasized that agranulocytosis may occur suddenly without prior warning. The drug should be discontinued at the first evidence of any alteration of the blood count or sign of agranulocytosis, and the patient should be instructed to discontinue use of the drug at the first indication of sore throat or sign of other infection in the mouth or throat (pain, swelling, tenderness, ulceration).”
Food and Drug Regulations — C.01.132
C.01.132 No person shall disseminate to a practitioner promotional literature about Aminopyrine or Dipyrone unless the statements set out in section C.01.131 are included in such literature.
Food and Drug Regulations — C.01.133
C.01.133 The provisions of sections C.01.131 and C.01.132 do not apply to preparations containing Aminopyrine or Dipyrone that are (a) dispensed by a pharmacist pursuant to a prescription; or (b) sold for veterinary use only.
Food and Drug Regulations — C.01.134
C.01.134 No person shall sell coated tablets containing potassium salts, with or without thiazide diuretics, unless the inner label thereof or the package insert carries the following statement: “WARNING: A probable association exists between the use of coated tablets containing potassium salts, with or without thiazide diuretics, and the incidence of serious small bowel ulceration. Such preparations should be used only when adequate dietary supplementation is not practical, and should be discontinued if abdominal pain, distension, nausea, vomiting or gastro-intestinal bleeding occur.” SOR/2018-69, s. 34(F)
Food and Drug Regulations — Food and Drug Regulations
“WARNING: A probable association exists between the use of coated tablets containing potassium salts, with or without thiazide diuretics, and the incidence of serious small bowel ulceration. Such preparations should be used only when adequate dietary supplementation is not practical, and should be discontinued if abdominal pain, distension, nausea, vomiting or gastro-intestinal bleeding occur.”
Food and Drug Regulations — C.01.135
C.01.135 No person shall disseminate to a practitioner promotional literature about coated tablets containing potassium salts, with or without thiazide diuretics, unless the statement set out in section C.01.134 is included in such literature.
Food and Drug Regulations — C.01.136
C.01.136 The provisions of sections C.01.134 and C.01.135 do not apply to coated tablets containing potassium salts with or without thiazide diuretics that (a) are sold for veterinary use only; (b) are dispensed by a pharmacist pursuant to a prescription; or (c) contain 100 milligrams or less of elemental potassium per tablet.
Food and Drug Regulations — C.01.401
C.01.401 Except as provided in these Regulations, an antibiotic for other than parenteral use shall, in addition to meeting the requirements of section C.01.004, carry on both the inner label and outer label the potency of the drug, expressed in terms of International Units where established or, if no International Unit has been established, in terms of units, milligrams, micrograms or fractions of a gram, (a) per gram in the case of solids or viscous liquids; (b) per millilitre in the case of other liquids; and (c) per individual dosage or dispensing form in the case of antibiotic preparations put up in individual dosage or dispensing form. SOR/80-544, s. 7; SOR/92-654, s. 4
Food and Drug Regulations — C.01.410 to C.01.412
C.01.410 to C.01.412 [Repealed, SOR/80-544, s. 8]
Food and Drug Regulations — C.01.420 to C.01.422
C.01.420 to C.01.422 [Repealed, SOR/80-544, s. 8]
Food and Drug Regulations — C.01.430 to C.01.432
C.01.430 to C.01.432 [Repealed, SOR/80-544, s. 8]
Food and Drug Regulations — C.01.433
C.01.433 No person shall sell chloramphenicol and its salts and derivatives, for oral or parenteral use, unless (a) the inner label carries a warning statement to the effect that (i) bone marrow depression has been associated with the use of chloramphenicol, and (ii) the enclosed warnings and precautions should be read carefully; and (b) the outer label or the package insert carries the following: (i) a warning statement to the effect that chloramphenicol should not be used in the treatment or prophylaxis of minor infections or where it is not indicated, as in cold, influenza, or infections of the upper respiratory tract; that there are two types of bone marrow depression associated with the use of chloramphenicol; that some degree of depression of the bone marrow is commonly seen during therapy, is dose-related and is potentially reversible; that blood studies may detect early changes and; that the other type of bone marrow depression, a sudden, delayed and usually fatal bone marrow hypoplasia that may occur without warning, is very rare, and (ii) a statement of precautions to be taken to the effect that it is essential that appropriate blood studies be made during treatment with chloramphenicol and that while blood studies may detect early peripheral blood changes, such studies cannot be relied on to detect the rare and generally irreversible bone marrow depression prior to development of aplastic anemia. SOR/2018-69, s. 35(F)
Food and Drug Regulations — C.01.434
C.01.434 Section C.01.433 does not apply to chloramphenicol and its salts or derivatives that are sold by a pharmacist under a prescription. SOR/2013-122, s. 12
Food and Drug Regulations — C.01.435
C.01.435 No person shall disseminate to a practitioner promotional literature about chloramphenicol and its salts or derivatives for oral or parenteral use unless the statements set out in paragraph C.01.433(b) are included in such literature.
Food and Drug Regulations — C.01.436
C.01.436 The provisions of sections C.01.433 and C.01.435 do not apply to a drug sold solely for veterinary use.
Food and Drug Regulations — C.01.440 to C.01.442
C.01.440 to C.01.442 [Repealed, SOR/80-544, s. 8]
Food and Drug Regulations — C.01.450 to C.01.452
C.01.450 to C.01.452 [Repealed, SOR/80-544, s. 8]
Food and Drug Regulations — C.01.460 to C.01.462
C.01.460 to C.01.462 [Repealed, SOR/80-544, s. 8]
Food and Drug Regulations — C.01.470 to C.01.472
C.01.470 to C.01.472 [Repealed, SOR/80-544, s. 8]
Food and Drug Regulations — C.01.490 to C.01.497
C.01.490 to C.01.497 [Repealed, SOR/80-544, s. 8]
Food and Drug Regulations — C.01.510 to C.01.513
C.01.510 to C.01.513 [Repealed, SOR/80-544, s. 8]
Food and Drug Regulations — C.01.520 to C.01.522
C.01.520 to C.01.522 [Repealed, SOR/80-544, s. 8]
Food and Drug Regulations — C.01.530 to C.01.532
C.01.530 to C.01.532 [Repealed, SOR/80-544, s. 8]
Food and Drug Regulations — C.01.540 to C.01.542
C.01.540 to C.01.542 [Repealed, SOR/80-544, s. 8]
Food and Drug Regulations — C.01.550 to C.01.552
C.01.550 to C.01.552 [Repealed, SOR/80-544, s. 8]
Food and Drug Regulations — C.01.560 to C.01.563
C.01.560 to C.01.563 [Repealed, SOR/80-544, s. 8]
Food and Drug Regulations — C.01.570 to C.01.572
C.01.570 to C.01.572 [Repealed, SOR/80-544, s. 8]
Food and Drug Regulations — C.01.590 to C.01.592
C.01.590 to C.01.592 [Repealed, SOR/80-544, s. 8]
Food and Drug Regulations — C.01.600
C.01.600 No person shall sell for veterinary use a drug listed in the Table of Limits of Drug Dosage for Adults, other than a drug in a form not suitable for human use, unless both the inner and outer labels carry the statement “For Veterinary Use Only” or “Veterinary Use Only”. SOR/80-543, s. 5
Food and Drug Regulations — C.01.602
C.01.602 The provisions of sections C.01.401 and C.01.402 do not apply to an antibiotic in amounts less than 50 parts per million contained in an animal food.
Food and Drug Regulations — C.01.603
C.01.603 The provisions of paragraphs C.01.401 (b) and (c) and section C.01.402 do not apply to an antibiotic in amounts greater than 50 parts per million contained in an animal food.
Food and Drug Regulations — C.01.604
C.01.604 Both the inner and outer labels of a veterinary drug represented as containing a vitamin shall carry (a) a statement of the amount of each vitamin present in the drug, expressed in terms of the proper name only of the vitamin in (i) International Units per gram or per millilitre for vitamin A, provitamin A, vitamin D, and vitamin E, (ii) milligrams per gram in the case of solids or viscous liquids, or per millilitre in the case of other liquids, for thiamine, riboflavin, niacin, niacinamide, pyridoxine, d-pantothenic acid, d-panthenol, folic acid, ascorbic acid, and vitamin K, (iii) micrograms per gram in the case of solids or viscous liquids, or per millilitre in the case of other liquids, for biotin, and vitamin B 12 , (iv) Oral Units for vitamin B 12 with intrinsic factor concentrate, or (v) for vitamin products put up in individual dosage or dispensing form, the specified units per individual dosage or dispensing form; (b) except for drugs in a form not suitable for human use, the statement “For Veterinary Use Only” or “Veterinary Use Only”. SOR/80-543, s. 6