GreatNorthCollective/greatnorth-canada-federal-laws-text huggingface dataset:
Food and Drug Regulations — C.01.036
C.01.036 (1) No manufacturer or importer shall sell (a) a drug that contains phenacetin in combination with any salt or derivative of salicylic acid; (b) a drug for human use that contains (i) oxyphenisatin, (ii) oxyphenisatin acetate, or (iii) phenisatin; or (c) a drug for human use that contains mercury or a salt or derivative thereof, unless the drug is (i) a drug described in Schedule C or D to the Act, or (ii) one of the following drugs, namely, (A) an ophthalmic drug or other drug to be used in the area of the eye, (B) a drug for nasal administration, (C) a drug for otic administration, or (D) a drug for parenteral administration that is packaged in a multi-dose container, in which the mercury or the salt or derivative thereof is present as a preservative and the manufacturer or importer has submitted evidence to the Minister demonstrating that the only satisfactory way to maintain the sterility or stability of the drug is to use that preservative. (2) For the purpose of clause (1)(c)(ii)(A), area of the eye means the area bounded by the supraorbital and infraorbital ridges and includes the eyebrows, the skin underlying the eyebrows, the eyelids, the eyelashes, the conjunctival sac of the eye, the eyeball and the soft tissue that lies below the eye and within the infraorbital ridge. SOR/78-423, s. 2; SOR/86-93, s. 3; SOR/89-229, s. 3; SOR/2018-69, s. 27
Food and Drug Regulations — C.01.036.1
C.01.036.1 No person shall sell, or advertise for sale, nitrous oxide to the general public. SOR/78-875, s. 1
Food and Drug Regulations — C.01.037
C.01.037 (1) No person shall sell to the general public a drug that is recommended solely for children if the package in which the drug is sold contains (a) more than 1.92 g of salicylamide or salicylic acid or the equivalent quantity of a salt of salicylic acid; (b) more than 1.92 g of acetylsalicylic acid or the equivalent quantity of a salt or derivative thereof; (c) more than 3.2 g of acetaminophen in 160 mg dosage units; or (d) more than 1.92 g of acetaminophen in 80 mg dosage units. (2) Subsection (1) does not apply to a drug dispensed pursuant to a prescription. SOR/86-93, s. 4; SOR/87-484, s. 5; SOR/88-323, s. 6; SOR/90-587, s. 3
Food and Drug Regulations — C.01.038
C.01.038 A drug for human use is adulterated if it contains (a) Strychnine or any of its salts; (b) extracts or tinctures of (i) Strychnos nux vomica , (ii) Strychnos Ignatii , or (iii) a Strychnos species containing strychnine, other than those species mentioned in subparagraphs (i) and (ii); (c) Methapyrilene or any of its salts; (d) Echimidine or any of its salts; or (e) any of the following plant species or extracts or tinctures thereof: (i) Symphytum asperum , (ii) Symphytum x uplandicum , or (iii) any other plant species containing echimidine. SOR/79-512, s. 1; SOR/88-173, s. 1
Food and Drug Regulations — C.01.039
C.01.039 In vitro diagnostic products that are or contain drugs other than drugs listed in Schedule E to the Act, and drugs listed in Schedule D to the Act that are labelled for veterinary use only, are exempt from the application of this Part. SOR/97-12, s. 4
Food and Drug Regulations — C.01.040
C.01.040 No manufacturer or importer shall sell a drug for human use that contains as an ingredient (a) chloroform; or (b) arsenic or any of its salts or derivatives, other than arsenic trioxide. SOR/89-229, s. 4; SOR/2013-113, s. 1
Food and Drug Regulations — C.01.040.1
C.01.040.1 No manufacturer shall use methyl salicylate as a medicinal ingredient in a drug for internal use in humans. SOR/78-422, s. 2; SOR/78-801, s. 1; SOR/81-334, s. 2(F); SOR/89-176, s. 1; SOR/92-662, s. 1
Food and Drug Regulations — Food and Drug Regulations
C.I. (indication of the number) means the designation used to identify a colouring agent in the Colour Index published by The Society of Dyers and Colourists, as amended from time to time; ( C.I. (indication du numéro) )
Food and Drug Regulations — Food and Drug Regulations
D & C (indication of the colour and the number) means the designation used to identify, in accordance with the Code of Federal Regulations of the United States, a colouring agent that can be used in the United States in drugs and cosmetics; ( D&C (indication de la couleur et du numéro) )
Food and Drug Regulations — Food and Drug Regulations
FD & C (indication of the colour and the number) means the designation used to identify, in accordance with the Code of Federal Regulations of the United States, a colouring agent that can be used in the United States in food, drugs and cosmetics. ( FD&C (indication de la couleur et du numéro) )
Food and Drug Regulations — Food and Drug Regulations
ALIZARIN CYANINE GREEN F (D & C Green No. 5; C.I. No. 61570),
Food and Drug Regulations — Food and Drug Regulations
ALLURA RED AC (FD & C Red No. 40; C.I. No. 16035),
Food and Drug Regulations — Food and Drug Regulations
AMARANTH (Delisted FD & C Red No. 2; C.I. No. 16185),
Food and Drug Regulations — Food and Drug Regulations
ANTHOCYANIN DERIVED FROM JUICE EXPRESSED FROM FRESH EDIBLE FRUITS OR VEGETABLES,
Food and Drug Regulations — Food and Drug Regulations
BRILLIANT BLUE FCF SODIUM SALT (FD & C Blue No. 1; C.I. No. 42090),
Food and Drug Regulations — Food and Drug Regulations
BRILLIANT BLUE FCF AMMONIUM SALT (D & C Blue No. 4; C.I. No. 42090),
Food and Drug Regulations — Food and Drug Regulations
CARMOISINE (Delisted Ext. D & C Red No. 10; C.I. No. 14720),
Food and Drug Regulations — Food and Drug Regulations
EOSIN YS ACID FORM (D & C Red No. 21; C.I. No. 45380:2),
Food and Drug Regulations — Food and Drug Regulations
EOSIN YS SODIUM SALT (D & C Red No. 22; C.I. No. 45380),
Food and Drug Regulations — Food and Drug Regulations
ERYTHROSINE (FD & C Red No. 3; C.I. No. 45430),
Food and Drug Regulations — Food and Drug Regulations
FAST GREEN FCF (FD & C Green No. 3; C.I. No. 42053),
Food and Drug Regulations — Food and Drug Regulations
FLAMING RED (D & C Red No. 36; C.I. No. 12085),
Food and Drug Regulations — Food and Drug Regulations
HELINDONE PINK CN (D & C Red No. 30; C.I. No. 73360),
Food and Drug Regulations — Food and Drug Regulations
INDIGO (D & C Blue No. 6; C.I. No. 73000),
Food and Drug Regulations — Food and Drug Regulations
INDIGOTINE (FD & C Blue No. 2; C.I. No. 73015),
Food and Drug Regulations — Food and Drug Regulations
IRON OXIDES (C.I. Nos. 77489, 77491, 77492, 77499),
Food and Drug Regulations — Food and Drug Regulations
LITHOL RUBIN B SODIUM SALT (D & C Red No. 6; C.I. No. 15850),
Food and Drug Regulations — Food and Drug Regulations
LITHOL RUBIN B CALCIUM SALT (D & C Red No. 7; C.I. No. 15850:1),
Food and Drug Regulations — Food and Drug Regulations
PHLOXINE B ACID FORM (D & C Red No. 27; C.I. No. 45410:1),
Food and Drug Regulations — Food and Drug Regulations
PHLOXINE B SODIUM SALT (D & C Red No. 28; C.I. No. 45410),
Food and Drug Regulations — Food and Drug Regulations
PONCEAU SX (FD & C Red No. 4; C.I. No. 14700),
Food and Drug Regulations — Food and Drug Regulations
QUINOLINE YELLOW WS (D & C Yellow No. 10; C.I. No. 47005),
Food and Drug Regulations — Food and Drug Regulations
SUNSET YELLOW FCF (FD & C Yellow No. 6; C.I. No. 15985),
Food and Drug Regulations — Food and Drug Regulations
TARTRAZINE (FD & C Yellow No. 5; C.I. No. 19140),
Food and Drug Regulations — Food and Drug Regulations
ALIZUROL PURPLE SS (D&C Violet No. 2; C.I. No. 60725),
Food and Drug Regulations — Food and Drug Regulations
CHROMIUM HYDROXIDE GREEN (PIGMENT GREEN 18 (C.I. No. 77289)),
Food and Drug Regulations — Food and Drug Regulations
DEEP MAROON (D&C Red No. 34; C.I. No. 15880:1),
Food and Drug Regulations — Food and Drug Regulations
DIBROMOFLUORESCEIN (SOLVENT RED 72 (C.I. No. 45370:1); ORANGE No. 5 (D & C Orange No. 5)),
Food and Drug Regulations — Food and Drug Regulations
ORANGE II (D&C Orange No. 4; C.I. No. 15510),
Food and Drug Regulations — Food and Drug Regulations
PYRANINE CONCENTRATED (D&C Green No. 8; C.I. No. 59040),
Food and Drug Regulations — Food and Drug Regulations
QUINIZARIN GREEN SS (D&C Green No. 6; C.I. No. 61565),
Food and Drug Regulations — Food and Drug Regulations
TONEY RED (D&C Red No. 17; C.I. No. 26100),
Food and Drug Regulations — Food and Drug Regulations
URANINE ACID FORM (D&C Yellow No. 7; C.I. No. 45350:1),
Food and Drug Regulations — Food and Drug Regulations
URANINE SODIUM SALT (D&C Yellow No. 8; C.I. No. 45350);
Food and Drug Regulations — C.01.040.3
C.01.040.3 In deciding whether to amend the Prescription Drug List in respect of a drug, including by adding the drug to it or removing the drug from it, the Minister shall consider whether any of the following criteria apply with respect to the drug: (a) supervision by a practitioner is necessary (i) for the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state, or its symptoms, in respect of which the drug is recommended for use, or (ii) to monitor a disease, disorder or abnormal physical state, or its symptoms, in respect of which the drug is recommended for use, or to monitor the use of the drug; (b) the level of uncertainty respecting the drug, its use or its effects justifies supervision by a practitioner; or (c) use of the drug can cause harm to human or animal health or a risk to public health and the harm or the risk can be mitigated by a practitioner’s supervision. SOR/2013-122, s. 10; SOR/2017-18, s. 21(F)
Food and Drug Regulations — C.01.040.4
C.01.040.4 The Minister shall consult the general public on any proposal by the Minister to remove a drug from the Prescription Drug List. SOR/2013-122, s. 10
Food and Drug Regulations — C.01.040.5
C.01.040.5 Sections C.01.040.3 and C.01.040.4 apply, with any modifications that the circumstances require, in respect of classes of drugs. SOR/2013-122, s. 10
Food and Drug Regulations — C.01.041
C.01.041 (1) No person shall sell a prescription drug unless (a) they are entitled under the laws of a province to dispense a prescription drug and they sell it in that province under a verbal or written prescription that they received; or (b) they sell it under section C.01.043. (2) In the case of a verbal prescription, the person referred to in paragraph (1)(a) or a pharmacy technician shall create a written record of the prescription that includes the following information: (a) the date on which the prescription was received and, if applicable, the number of the prescription; (b) the name and address of the person to whom the prescription was issued; (c) the proper name, common name or brand name of the drug and its quantity; (d) the person’s name and the name of the practitioner who issued the prescription; and (e) the directions for use provided with the prescription, whether or not the practitioner authorized it to be refilled and, if refills are authorized, the number of authorized refills. (3) The person referred to in paragraph (1)(a) shall retain the written prescription referred to in subsection (1) or the record referred to in subsection (2) for at least two years after the day on which the prescription is filled. SOR/78-424, s. 2; SOR/80-543, s. 3; SOR/93-202, s. 6; SOR/93-407, s. 2; SOR/2013-122, s. 11
Food and Drug Regulations — C.01.041.1
C.01.041.1 Subject to paragraph C.01.041.3(2)(b), a pharmacist or pharmacy technician may transfer to another pharmacist or pharmacy technician a prescription for a prescription drug. SOR/78-424, s. 3; SOR/2013-122, s. 11
Food and Drug Regulations — C.01.041.2
C.01.041.2 (1) Before a pharmacist sells a drug under a prescription that was transferred under section C.01.041.1, the pharmacist or a pharmacy technician shall (a) create a written record of the name and address of the pharmacist or pharmacy technician who transferred the prescription and, if applicable, the number of authorized refills remaining and the date of the last refill; and (b) obtain a copy of the written prescription or of the written record that was created under subsection C.01.041(2), as the case may be, or, in the case of a verbal transfer, create a written record that includes the information referred to in that subsection. (2) The pharmacist shall retain the documents referred to in subsection (1) for at least two years after the day on which the prescription was filled. SOR/78-424, s. 3; SOR/2013-122, s. 11
Food and Drug Regulations — C.01.041.3
C.01.041.3 (1) A pharmacist or a pharmacy technician who transfers a prescription under section C.01.041.1 shall indicate the date of transfer on the original of the written prescription or of the written record created under subsection C.01.041(2) or in a record kept under the name of the patient in question, as the case may be. (2) When the pharmacist or pharmacy technician has transferred the prescription, (a) the pharmacist shall not make any additional sales under the prescription; and (b) the pharmacist or pharmacy technician shall not transfer the prescription to another pharmacist or pharmacy technician. SOR/78-424, s. 3; SOR/2013-122, s. 11
Food and Drug Regulations — C.01.041.4
C.01.041.4 [Repealed, SOR/2013-122, s. 11]
Food and Drug Regulations — C.01.042
C.01.042 A person referred to in paragraph C.01.041(1)(a) shall not refill a prescription for a prescription drug unless authorized by the practitioner and, in the case of such an authorization, they shall not refill a prescription more than the number of times specified by the practitioner. SOR/78-424, s. 4; SOR/2013-122, s. 11
Food and Drug Regulations — C.01.042.1
C.01.042.1 A person referred to in paragraph C.01.041(1)(a) shall indicate on the original of or on the copy of the written prescription or the written record created under subsection C.01.041(2) or in a record kept under the name of the patient in question, as the case may be, (a) the date on which the prescription was filled; (b) the date of each refill, if applicable; (c) the quantity of drug sold when the prescription was filled and, if applicable, for each refill; and (d) the name of the person who sold the drug. SOR/2013-122, s. 11
Food and Drug Regulations — C.01.043
C.01.043 (1) A person may sell a prescription drug to (a) a drug manufacturer; (b) a practitioner; (c) a wholesale druggist; (d) a pharmacist; or (e) the Government of Canada or the government of a province, for the use of a department or agency of that government, on receipt of a written order signed by the minister responsible for the department or by the person in charge of the agency, or by their duly authorized representative. (2) If a person sells a prescription drug under paragraph (1)(e), they shall retain the written order for the drug for a period of at least two years after the day on which the drug is sold. SOR/2013-122, s. 11
Food and Drug Regulations — C.01.044
C.01.044 If a person advertises a prescription drug to the general public, the person shall not make any representation other than with respect to the brand name, the proper name, the common name and the price and quantity of the drug. SOR/78-424, s. 5; SOR/93-202, s. 7; SOR/93-407, s. 3; SOR/2013-122, s. 11
Food and Drug Regulations — C.01.045
C.01.045 No person, other than one of the following, shall import a prescription drug: (a) a practitioner; (b) a drug manufacturer; (c) a wholesale druggist; (d) a pharmacist; or (e) a resident of a foreign country while a visitor in Canada. SOR/93-407, s. 4; SOR/2013-122, s. 11
Food and Drug Regulations — C.01.046
C.01.046 [Repealed, SOR/2013-122, s. 11]
Food and Drug Regulations — C.01.048
C.01.048 (1) If a practitioner or pharmacist has signed an order specifying the proper name or common name, the brand name and the quantity of a drug, other than the following, the person who receives the order may distribute or cause to be distributed the drug, in dosage form, as a sample to that practitioner or pharmacist if the drug meets the requirements of these Regulations: (a) a narcotic as defined in the Narcotic Control Regulations ; (b) a controlled drug as defined in section G.01.001; or (c) [Repealed, SOR/2020-74, s. 3] (d) a prescription drug as defined in subsection 1 (2) of the Cannabis Regulations . (1.1) A person may distribute or cause to be distributed a prescription drug as a sample under subsection (1) only to a practitioner or pharmacist who is entitled, under the laws of the province in which they are practising, to prescribe or dispense that drug, as the case may be. (2) An order referred to in subsection (1) may provide that the order be repeated at specified intervals during any period not exceeding six months. (3) Despite subsection (1), a person may distribute or cause to be distributed a drug, in dosage form, as a sample to a practitioner or pharmacist without a signed order if that drug is not a prescription drug and is part of a class of drugs that is set out in column 1 of List D, and if all of the following conditions are met: (a) the drug contains, as its only medicinal ingredients, one or more of those set out in column 2, each of which corresponds to that class, in the corresponding quantity set out in column 3, and the drug is consistent with the descriptive information set out in columns 4 to 6; (b) the expiration date of the drug falls on a day that is (i) at least 30 days after the day on which it is distributed, if the expiration date consists of a day, month and year, or (ii) in a month that follows the month in which it is distributed, if the expiration date consists only of a month and year; (c) the drug meets the requirements of these Regulations. SOR/93-202, s. 9; SOR/97-228, s. 2; SOR/2018-144, s. 366 SOR/2019-171, s. 24 SOR/2020-74, s. 3
Food and Drug Regulations — C.01.049
C.01.049 A person who, under subsection C.01.048(1), receives an order for and distributes or causes to be distributed a drug as a sample shall (a) maintain records showing (i) the name, address and description of each person to whom the drug is distributed, (ii) the brand name, quantity and form of the drug distributed, and (iii) the date upon which each such distribution was made; and (b) keep those records and all orders received for drugs in accordance with section C.01.048 for a period of not less than two years from the date upon which the distribution referred to in the records was made. SOR/93-202, s. 10 SOR/2020-74, s. 4
Food and Drug Regulations — C.01.049.1
C.01.049.1 A person may distribute or cause to be distributed a drug, in dosage form, as a sample to any consumer that is 18 years of age or older if that drug is not a prescription drug and is part of a class of drugs that is set out in column 1 of List D, and if all of the following conditions are met: (a) the drug contains, as its only medicinal ingredients, one or more of those set out in column 2, each of which corresponds to that class, in the corresponding quantity set out in column 3, and the drug is consistent with the descriptive information set out in columns 4 to 6; (b) the expiration date of the drug falls on a day that is (i) at least 30 days after the day on which it is distributed, if the expiration date consists of a day, month and year, or (ii) in a month that follows the month in which it is distributed, if the expiration date consists only of a month and year; (c) the drug meets the requirements of these Regulations. SOR/2020-74, s. 5
Food and Drug Regulations — C.01.050
C.01.050 (1) This section applies to a holder of one or more of the following therapeutic product authorizations: (a) a drug identification number that has been assigned under subsection C.01.014.2(1); and (b) a notice of compliance that has been issued under section C.08.004 or C.08.004.01. (2) The holder of a therapeutic product authorization in respect of a drug that is part of a class of drugs set out in subsection (4) shall provide the Minister with information in respect of any serious risk of injury to human health that the holder receives or becomes aware of and that is relevant to the safety of the drug, regarding (a) risks that have been communicated by any foreign regulatory authority that is set out in Part A of the List of Foreign Regulatory Authorities for the Purposes of Section C.01.050 of the Food and Drug Regulations , published by the Government of Canada on its website, as amended from time to time, or by any person who is authorized to manufacture or sell a drug within the jurisdiction of such an authority, and the manner of the communication; (b) changes that have been made to the labelling of any drug and that have been communicated to or requested by any foreign regulatory authority that is set out in Part B of the list referred to in paragraph (a); and (c) recalls, reassessments and suspensions or revocations of authorizations, including licences, in respect of any drug, that have taken place within the jurisdiction of any foreign regulatory authority that is set out in Part C of the list referred to in paragraph (a). (3) The information shall be provided to the Minister within 72 hours after the holder receives or becomes aware of it, whichever occurs first. (4) The classes of drugs are (a) prescription drugs; (b) drugs that are required to be sold under a prescription by Part G, the Benzodiazepines and Other Targeted Substances Regulations or the Narcotic Control Regulations ; and (c) drugs that are permitted to be sold without a prescription but that are to be administered only under the supervision of a practitioner. (5) Despite subsection (2), a holder of a therapeutic product authorization who provided information in accordance with (a) paragraph (2)(a) is not required to provide the same information again under that paragraph in the case where the holder receives or becomes aware of that information in respect of a foreign regulatory authority or person referred to in that paragraph; or (b) paragraph (2)(b) or (c) is not required to provide the same information again under that paragraph in the case where the holder receives or becomes aware of that information in respect of a foreign regulatory authority referred to in that paragraph. (6) In this section, foreign regulatory authority means a government agency or other entity outside Canada that has a legal right to control the manufacturing, use or sale of drugs within its jurisdiction and that may take enforcement action to ensure that drugs marketed within its jurisdiction comply with the applicable legal requirements. SOR/2018-84, s. 2 SOR/2020-262, s. 2(F)