GreatNorthCollective/greatnorth-canada-federal-laws-text huggingface dataset:
Food and Drug Regulations — C.02.009
C.02.009 (1) Each lot or batch of raw material shall be tested against the specifications for that raw material prior to its use in the fabrication of a drug. (2) No lot or batch of raw material shall be used in the fabrication of a drug unless that lot or batch of raw material complies with the specifications for that raw material. (3) Notwithstanding subsection (1), water may, prior to the completion of its tests under that subsection, be used in the fabrication of a drug. (4) If any property of a raw material is subject to change during storage of the material, including during transportation, no lot or batch of that raw material shall be used in the fabrication of a drug after the lot or batch has been stored, including during transportation, unless the raw material is retested after an appropriate interval and meets the specifications for that material. (5) Where the specifications referred to in subsections (1), (2) and (4) are not prescribed, they shall (a) be in writing; (b) be acceptable to the Minister who shall take into account the specifications contained in any publication mentioned in Schedule B to the Act; and (c) be approved by the person in charge of the quality control department. SOR/82-524, s. 3; SOR/97-12, s. 59; SOR/2018-69, s. 27 SOR/2024-238, s. 17
Food and Drug Regulations — C.02.010
C.02.010 (1) The testing referred to in section C.02.009 shall be performed on a sample taken (a) after receipt of each lot or batch of raw material on the premises of the fabricator; or (b) subject to subsection (2), before receipt of each lot or batch of raw material on the premises of the fabricator, if (i) the fabricator (A) has evidence satisfactory to the Minister to demonstrate that raw materials sold to him by the vendor of that lot or batch of raw material are consistently manufactured in accordance with and consistently comply with the specifications for those raw materials, and (B) undertakes periodic complete confirmatory testing with a frequency satisfactory to the Minister, and (ii) the raw material has not been transported or stored under conditions that may affect its compliance with the specifications for that raw material. (2) After a lot or batch of raw material is received on the premises of the fabricator, the lot or batch of raw material shall be tested for identity. SOR/82-524, s. 3; SOR/97-12, ss. 12, 60; SOR/2018-69, s. 27
Food and Drug Regulations — C.02.011
C.02.011 (1) Every fabricator, packager/labeller, distributor referred to in paragraph C.01A.003(b) and importer of a drug shall have written procedures prepared by qualified personnel in respect of the drug to ensure that the drug meets the specifications for that drug. (2) Every person required to have written procedures referred to in subsection (1) shall ensure that each lot or batch of the drug is fabricated, packaged/labelled and tested in compliance with those procedures. SOR/82-524, s. 3; SOR/97-12, s. 13
Food and Drug Regulations — C.02.012
C.02.012 (1) Every fabricator, packager/labeller, distributor referred to in section C.01A.003, importer and wholesaler of a drug shall maintain (a) a system of control that permits complete and rapid recall of any lot or batch of the drug that is on the market; and (b) a program of self-inspection. (2) Every fabricator and packager/labeller and, subject to subsections (3) and (4), every distributor referred to in paragraph C.01A.003(b) and importer of a drug shall maintain a system to ensure that any lot or batch of the drug fabricated and packaged/labelled on premises other than their own is fabricated and packaged/labelled in accordance with the requirements of this Division. (3) Subsection (2) does not apply to a distributor if the drug is fabricated, packaged/labelled and tested in Canada by a person who holds an establishment licence that authorizes those activities in respect of that drug. (4) Subsection (2) does not apply to a distributor or importer if the drug is fabricated or packaged/labelled in an MRA country at a recognized building and both of the following requirements are met: (a) the address of the building is set out in their establishment licence; and (b) they retain a copy of the batch certificate for each lot or batch of the drug that they receive. SOR/82-524, s. 3; SOR/97-12, s. 13; SOR/2000-120, s. 9; SOR/2002-368, s. 9; SOR/2013-74, s. 8 SOR/2024-136, s. 3(F)
Food and Drug Regulations — C.02.012.1
C.02.012.1 Every lot or batch of a drug shall be fabricated, packaged/labelled, tested and stored, including during transportation, in a manner that assures the quality of the drug. SOR/2024-238, s. 18
Food and Drug Regulations — C.02.013
C.02.013 (1) Every fabricator, packager/labeller, wholesaler, distributor referred to in section C.01A.003 and importer of a drug shall have on their premises in Canada a quality control department that is supervised by personnel described in section C.02.006. (2) Except in the case of a wholesaler or a distributor referred to in paragraph C.01A.003(a), the quality control department shall be a distinct organizational unit that functions and reports to management independently of any other functional unit, including the manufacturing, processing, packaging or sales unit. SOR/82-524, s. 3; SOR/89-174, s. 8(F); SOR/97-12, s. 55; SOR/2000-120, s. 10; SOR/2010-95, s. 4; SOR/2013-74, s. 9
Food and Drug Regulations — C.02.014
C.02.014 (1) Except in the case of a wholesaler or a distributor referred to in paragraph C.01A.003(a), no lot or batch of a drug shall be made available for further use in fabrication or for sale unless the person in charge of the quality control department approves the sale or the further use. (2) A drug that is returned to its fabricator, packager/labeller, wholesaler, distributor referred to in section C.01A.003 or importer shall not be made available for further use in fabrication or for further sale unless the person in charge of the quality control department approves the further sale or further use. (3) No lot or batch of a raw material or packaging/labelling material shall be used in the fabrication or packaging/labelling of a drug unless the person in charge of the quality control department approves the use. (4) No lot or batch of a drug shall be reprocessed unless the person in charge of the quality control department approves the reprocessing. SOR/82-524, s. 3; SOR/89-174, s. 8(F); SOR/97-12, ss. 14, 55; SOR/2010-95, s. 5; SOR/2013-74, s. 9
Food and Drug Regulations — C.02.015
C.02.015 (1) All fabrication, packaging/labelling, testing, storage and transportation methods and procedures that may affect the quality of a drug shall be examined and approved by the person in charge of the quality control department before their implementation. (2) The person in charge of the quality control department shall cause to be investigated any complaint or information that is received respecting the quality of a drug or its deficiencies or hazards and cause any necessary corrective action to be taken, in the case where the complaint or information relates to an activity over which the department exercises quality control. (2.1) In the case where the complaint or information that is received does not relate to an activity over which the quality control department exercises quality control, the person in charge of the department shall forward the complaint or information to the person in charge of the quality control department that exercises quality control over that activity. (3) The person in charge of the quality control department shall cause all tests or examinations required pursuant to this Division to be performed by a competent laboratory. SOR/82-524, s. 3; SOR/97-12, s. 15; SOR/2010-95, s. 6
Food and Drug Regulations — C.02.016
C.02.016 (1) Each lot or batch of packaging material shall, prior to its use in the packaging of a drug, be examined or tested against the specifications for that packaging material. (2) No lot or batch of packaging material shall be used in the packaging of a drug unless the lot or batch of packaging material complies with the specifications for that packaging material. (3) The specifications referred to in subsections (1) and (2) shall (a) be in writing; (b) be acceptable to the Minister who shall take into account the specifications contained in any publication mentioned in Schedule B to the Act; and (c) be approved by the person in charge of the quality control department. SOR/82-524, s. 3; SOR/89-174, s. 8(F); SOR/2018-69, s. 27
Food and Drug Regulations — C.02.017
C.02.017 (1) The examination or testing referred to in section C.02.016 shall be performed on a sample taken (a) after receipt of each lot or batch of packaging material on the premises of the person who packages a drug; or (b) subject to subsection (2), before receipt of each lot or batch of packaging material on the premises of the person who packages a drug, if (i) that person (A) has evidence satisfactory to the Minister to demonstrate that packaging materials sold to him by the vendor of that lot or batch of packaging material are consistently manufactured in accordance with and consistently comply with the specifications for those packaging materials, and (B) undertakes periodic complete confirmatory examination or testing with a frequency satisfactory to the Minister, (ii) the packaging material has not been transported or stored under conditions that may affect its compliance with the specifications for that packaging material. (2) After a lot or batch of packaging material is received on the premises of the person who packages a drug, (a) the lot or batch of the packaging material shall be examined or tested for identity; and (b) the labels shall be examined or tested in order to ensure that they comply with the specifications for those labels. SOR/82-524, s. 3; SOR/89-174, ss. 2(F), 8(F); SOR/97-12, s. 56(F); SOR/2018-69, s. 27
Food and Drug Regulations — C.02.018
C.02.018 (1) Each lot or batch of a drug shall, before it is made available for further use in fabrication or for sale, be tested against the specifications for that drug. (2) No lot or batch of a drug shall be made available for further use in fabrication or for sale unless it complies with the specifications for that drug. (3) The specifications referred to in subsections (1) and (2) shall (a) be in writing; (b) be approved by the person in charge of the quality control department; and (c) comply with the Act and these Regulations. SOR/82-524, s. 3; SOR/2013-74, s. 10
Food and Drug Regulations — C.02.019
; (b) the drug is (i) fabricated in Canada or in a recognized country or region, (ii) packaged/labelled in Canada or in a recognized country or region, and (iii) tested in a recognized country or region; (c) the distributor or the importer retains a copy of the batch certificate for each lot or batch of the drug that is distributed or imported, as the case may be. (6) A drug that is referred to in subsection (4.2), (4.3) or (5) and that is imported may be shipped directly to a person other than the importer if the following conditions are met: (a) before importing the drug, the importer receives a document that demonstrates that the drug complies with the specifications for that drug; (b) the importer and the distributor have measures in place to ensure that all the requirements of these Regulations in respect of the importation of the drug are met. SOR/82-524, s. 3; SOR/89-174, s. 8(F); SOR/97-12, ss. 16, 57; SOR/2000-120, s. 11; SOR/2002-368, s. 10; SOR/2013-74, s. 11; SOR/2018-69, s. 27 SOR/2020-73, s. 2 SOR/2021-45, s. 12 SOR/2024-136, s. 4 SOR/2024-238, s. 19
Food and Drug Regulations — C.02.020
C.02.020 (1) Every fabricator, packager/labeller, distributor referred to in paragraph C.01A.003(b) and importer shall maintain all of the following records on their premises in Canada for each drug that they fabricate, package/label, distribute or import: (a) except in the case of an importer of an active pharmaceutical ingredient or an active ingredient that is used in the fabrication of a drug that is of non-biological origin and that is listed in Schedule C to the Act, master production documents for the drug; (b) evidence that each lot or batch of the drug has been fabricated, packaged/labelled, tested and stored, including during transportation, in accordance with the procedures described in the master production documents; (c) evidence that the conditions under which the drug was fabricated, packaged/labelled, tested and stored, including during transportation, meet the requirements set out in this Division; (d) evidence that establishes the period during which the drug in the container in which it is sold or made available for further use in fabrication will meet the specifications for that drug; and (e) evidence that the finished product testing referred to in section C.02.018 was carried out and the results of that testing. (2) Every distributor referred to in paragraph C.01A.003(b) and importer shall make available to the Minister, on request, the results of testing performed on raw materials and packaging/labelling materials for each lot or batch of a drug that it distributes or imports. (3) Every fabricator shall maintain on their premises written specifications for all raw materials and adequate evidence of the testing of those raw materials referred to in section C.02.009 and of the test results. (4) Every person who packages a drug shall maintain on their premises written specifications for all packaging materials and adequate evidence of the examination or testing of those materials referred to in section C.02.016 and of any test results. (5) Every fabricator, packager/labeller and tester shall maintain on their premises in Canada detailed plans and specifications of each building in Canada where they fabricate, package/label or test drugs and a description of the design and construction of those buildings. (6) Every fabricator, packager/labeller and tester shall maintain on their premises in Canada personnel records in respect of each person who is employed to supervise the fabrication, packaging/labelling and testing of drugs, including the person’s title, responsibilities, qualifications, experience and training. SOR/82-524, s. 3; SOR/89-174, ss. 3(F), 8(F); SOR/97-12, ss. 17, 52, 60; SOR/2013-74, s. 11; SOR/2017-259, s. 15; SOR/2018-69, s. 27 SOR/2024-238, s. 20
Food and Drug Regulations — C.02.021
C.02.021 (1) All records and evidence of the fabrication, packaging/labelling, finished product testing referred to in section C.02.018 and storage, including storage during transportation, of a drug in dosage form that are required to be maintained under this Division shall be retained for one year after the expiration date of the drug unless the relevant establishment licence specifies some other period. (2) Subject to subsection (4), all records and evidence of the fabrication, packaging/labelling, finished product testing referred to in section C.02.018 and storage, including during transportation, of an active ingredient that are required to be maintained under this Division shall be retained in respect of each lot or batch of the active ingredient for the following period unless the relevant establishment licence specifies some other period: (a) in the case of an active ingredient that has a retest date, three years after the lot or batch has been completely distributed; or (b) in any other case, one year after the expiration date of the lot or batch. (3) Subject to subsection (4), all records and evidence of the raw material testing referred to in section C.02.009 and of the testing of packaging/labelling materials that are required to be maintained under this Division shall be retained for five years after the raw materials and packaging/labelling materials were last used in the fabrication or packaging/labelling of a drug unless the relevant establishment licence specifies some other period. (4) If a fabricator is required to maintain records and evidence in respect of the same active ingredient under subsections (2) and (3), they shall maintain them for the longest period that is applicable. SOR/82-524, s. 3; SOR/89-174, s. 8(F); SOR/92-654, s. 6; SOR/97-12, s. 18; SOR/2013-74, s. 11 SOR/2024-238, s. 21
Food and Drug Regulations — C.02.022
C.02.022 (1) Every wholesaler, distributor referred to in section C.01A.003 and importer of a drug in dosage form shall retain records of sale of each lot or batch of the drug, which enable them to recall the lot or batch from the market, for one year after the expiration date of that lot or batch unless their establishment licence specifies some other period. (2) Every distributor of an active ingredient referred to in paragraph C.01A.003(a) and every wholesaler and importer of an active ingredient shall retain records of sale of each lot or batch of the active ingredient, which enable them to recall the lot or batch from the market, for the following period unless the person holds an establishment licence that specifies some other period: (a) in the case of an active ingredient that has a retest date, three years after the lot or batch has been completely distributed; or (b) in any other case, one year after the expiration date of the lot or batch. SOR/82-524, s. 3; SOR/92-654, s. 7; SOR/97-12, s. 18; SOR/2013-74, s. 11 SOR/2024-136, s. 5(F)
Food and Drug Regulations — C.02.023
C.02.023 (1) On receipt of a complaint or any information respecting the quality of a drug or its deficiencies or hazards, every fabricator, packager/labeller, wholesaler, distributor referred to in section C.01A.003 and importer of the drug shall make a record of the complaint or information that contains the following: (a) the results of any investigation carried out under subsection C.02.015(2) and, if applicable, the corrective action taken; or (b) the name and business address of the person in charge of the quality control department to whom the complaint or information was forwarded under subsection C.02.015(2.1) and the date on which it was forwarded. (2) Records referred to in subsection (1) shall be retained for the following period unless the person holds an establishment licence that specifies some other period: (a) in the case of a drug in dosage form, one year after the expiration date of the lot or batch of the drug; and (b) in the case of an active ingredient, (i) if the active ingredient has a retest date, three years after the lot or batch has been completely distributed, or (ii) in any other case, one year after the expiration date of the lot or batch of the active ingredient. SOR/82-524, s. 3; SOR/92-654, s. 7; SOR/97-12, s. 18; SOR/2010-95, s. 7; SOR/2013-74, s. 11
Food and Drug Regulations — C.02.024
C.02.024 (1) Every fabricator, packager/labeller, distributor referred to in section C.01A.003, importer and wholesaler shall (a) maintain records of the results of the self-inspection program required by section C.02.012 and of any action taken in connection with that program; and (b) retain those records for a period of at least three years. (2) Every person who fabricates or packages/labels a drug shall (a) maintain records on the operation of the sanitation program required to be implemented under section C.02.007; and (b) retain those records for a period of at least three years. SOR/82-524, s. 3; SOR/97-12, ss. 19, 53
Food and Drug Regulations — C.02.024.1
C.02.024.1 Every distributor of an active ingredient referred to in paragraph C.01A.003(a) and every fabricator, packager/labeller, wholesaler and importer of an active ingredient shall add all of the following information to the documentation that accompanies the active ingredient, immediately after any like information that has been added by another person: (a) their establishment licence number, or if there is none, their name, address, telephone number, fax number and email address; (b) an indication whether they have fabricated, packaged/labelled, wholesaled, distributed or imported the active ingredient and the date on which that activity was carried out; (c) the expiration date; and (d) the lot number. SOR/2013-74, s. 12
Food and Drug Regulations — C.02.025
C.02.025 (1) Every distributor referred to in paragraph C.01A.003(b) and importer of a drug in dosage form shall retain in Canada a sample of each lot or batch of the packaged/labelled drug for one year after the expiration date of the drug unless their establishment licence specifies otherwise. (2) Subject to subsection (4), the fabricator of a drug in dosage form shall retain a sample of each lot or batch of raw materials used in the fabrication for two years after the materials were last used in the fabrication unless their establishment licence specifies some other period. (3) Subject to subsection (4), the fabricator of an active ingredient shall retain a sample of each lot or batch of it for the following period unless their establishment licence specifies some other period: (a) in the case of an active ingredient that has a retest date, three years after the lot or batch has been completely distributed; or (b) in any other case, one year after the expiration date of the lot or batch. (4) If a fabricator is required to maintain samples in respect of the same active ingredient under subsections (2) and (3), they shall maintain them for the longest period that is applicable. SOR/82-524, s. 3; SOR/89-174, s. 4(F); SOR/92-654, s. 8; SOR/97-12, s. 20; SOR/2013-74, s. 13 SOR/2021-46, s. 8
Food and Drug Regulations — C.02.026
C.02.026 The samples referred to in section C.02.025 shall be in an amount that is sufficient to determine whether the drug or raw material complies with the specifications for that drug or raw material. SOR/82-524, s. 3
Food and Drug Regulations — C.02.027
C.02.027 (1) Every distributor referred to in paragraph C.01A.003(b) and importer of a drug in dosage form shall establish the period during which each drug in the package in which it is sold will comply with the specifications for that drug. (2) Every fabricator and importer of an active ingredient shall establish the period during which each drug in the package in which it is sold will comply with the specifications for that drug. SOR/82-524, s. 3; SOR/97-12, s. 58; SOR/2013-74, s. 14
Food and Drug Regulations — C.02.028
C.02.028 (1) Every distributor referred to in paragraph C.01A.003(b) and importer of a drug in dosage form shall monitor, by means of a continuing program, the stability of the drug in the package in which it is sold. (2) Every fabricator and importer of an active ingredient shall monitor, by means of a continuing program, the stability of the drug in the package in which it is sold. SOR/82-524, s. 3; SOR/97-12, s. 58; SOR/2013-74, s. 14
Food and Drug Regulations — C.02.029
C.02.029 In addition to the other requirements of this Division, a drug that is intended to be sterile shall be fabricated and packaged/labelled (a) in separate and enclosed areas; (b) under the supervision of personnel trained in microbiology; and (c) by a method scientifically proven to ensure sterility. SOR/82-524, s. 3; SOR/97-12, s. 21
Food and Drug Regulations — C.02.030
C.02.030 The provisions of sections C.02.025, C.02.027 and C.02.028 do not apply to medical gases. SOR/85-754, s. 3
Food and Drug Regulations — C.03.001
C.03.001 In this Division, drug means a drug that is listed in Schedule C to the Act that is in dosage form or a drug that is an active ingredient of biological origin that can be used in the preparation of a drug listed in that Schedule; ( drogue ) licence or Canadian licence [Repealed, SOR/97-12, s. 22] manufacturer [Repealed, SOR/97-12, s. 22] master lot means a quantity of a drug from which a lot is prepared for sale by subsequent dilution or mixture; ( maître-lot ) radionuclide generator means a radioactive parent and daughter (a) contained in an ion-exchange column, or (b) dissolved in a suitable solvent in a liquid-liquid extraction system where the radioactive daughter is separated from its parent by (c) elution from the ion exchange column, or (d) a solvent extraction procedure. ( générateur de radionucléide ) SOR/97-12, s. 22; SOR/2013-74, s. 15